USOO91681 04B2

(12) United States Patent (10) Patent No.: US 9,168,104 B2

Dein (45) Date of Patent: Oct. 27, 2015
(54) INTRA-OPERATIVE SYSTEM FOR 5,456,718 A 10/1995 Szymaitis
IDENTIFYING ANDTRACKING SURGICAL 5,463,213 A * 10/1995 Honda .......................... 235,468
SHARP OBJECTS, INSTRUMENTS, AND 5,610,811 A * 3/1997 Honda .............................. 705/2
5,629,498 A 5, 1997 Pollocket al.
SPONGES 5,637,850 A * 6/1997 Honda .......................... 235/454
5,650,596 A 7/1997 Morris et al.
(76) Inventor: John Richard Dein, Fair Oaks, CA (US) 5,678,569 A 10, 1997 Chew et al.
5,923,001 A 7/1999 Morris et al.
(*) Notice: Subject to any disclaimer, the term of this 5,931,824 A 8, 1999 Stewart et al.
patent is extended or adjusted under 35 5.996,889 A * 12/1999 Fuchs et al. ................... 235,375
U.S.C. 154(b) by 1227 days. (Continued)
(21) Appl. No.: 12/490,140 FOREIGN PATENT DOCUMENTS
WO O3073934 9, 2003
(22) Filed: Jun. 23, 2009
(65) Prior Publication Data OTHER PUBLICATIONS
US 2009/0317OO2A1 Dec. 24, 2009 Adaptive document image binarization, Sauvola et al., Elsevier, Pat
tern recognition 33, 2000, pp. 225-236.*
Related U.S. Application Data
(Continued)
(60) Provisional application No. 61/198,211, filed on Nov.
3, 2008, provisional application No. 61/132,954, filed
on Jun. 24, 2008, provisional application No. Primary Examiner — Jayesh A Patel
61/132,961, filed on Jun. 23, 2008. (74) Attorney, Agent, or Firm — Bret E. Field; Bozicevic,
Field & Francis LLP
(51) Int. Cl.
G06K 9/00 (2006.01)
A6B 9/00 (2006.01) (57) ABSTRACT
A61 B 19/08 (2006.01)
(52) U.S. Cl. Intra-operative systems for identifying Surgical sharp objects
CPC ............... A61B 19/44 (2013.01); A61 B 19/081 are provided. Aspects of the systems include an intra-opera
(2013.01); A61 B 19/5225 (2013.01); A61B tive imaging device for obtaining intra-operative Surgical
2019/442 (2013.01); A61B 2019/446 (2013.01); sharp object image data; and a Surgical sharp object auto
A61B 2019/448 (2013.01) mated shape recognition module configured to identify a
(58) Field of Classification Search Surgical sharp object from intra-operative Surgical sharp
USPC .................................. 382/103,128,321, 190 object image data. Systems of the invention may further
See application file for complete search history. include additional components, such as Surgical instrument
and/or sponge identification and tracking devices. Systems of
(56) References Cited the invention find use in a variety of methods and applica
U.S. PATENT DOCUMENTS tions, including tracking of Surgical items during a Surgical
procedure.
4490,848 A * 12/1984 Beall et al. .................... 382, 152
4,943,939 A 7, 1990 Hoover
5,374,813 A * 12/1994 Shipp ............................ 235,375 19 Claims, 22 Drawing Sheets

205

230

22
 US 9,168,104 B2
Page 2

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2005/00 15311 A1 1/2005 Frantz et al. .................... 705/26
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2005.0075564 A1* 4, 2005 Ballard ......................... 600,436
6,054,924 A 4/2000 Dames et al. 2005, 0131578 A1* 6/2005 Weaver ......................... TOO,244
6,123,185 A 9, 2000 Demarest et al. 2005, 0199645 A1* 9, 2005 Sivertsen et al. ... 221/221
6,216,029 B1 * 4/2001 Paltieli .......................... 600/427 2005/02O3470 A1* 9, 2005 Ballard ......................... 604,362
6,230,972 B1 5, 2001 Dames et al. 2005/02793.68 A1 12/2005 McCombs
6,371,379 B1 4/2002 Dames et al. 2006, O138211 A1* 6, 2006 Lubow ...... 235,375
6,644,464 B1 1 1/2003 Demarest et al. 2006/021230.6 A1* 9, 2006 Mallett et al. ..................... 705/1
6,690,964 B2 * 2/2004 Bieger et al. .................. 600,424 2006/0226957 A1* 10, 2006 Miller et al. . 340,286.07
6,777,623 B2 8, 2004 Ballard 2007/0080223 A1* 4/2007 Japuntich ...................... 235,439
6,973,202 B2 * 12/2005 Mostafavi ..................... 382,103 2007, 0083170 A1 4, 2007 Stewart et al.
6,997,305 B2 2, 2006 Demarest et al. 2007/0167801 A1* 7, 2007 Webler et al. ................. 600/459
6,998,541 B2 2/2006 Morris et al. 2007/0225550 A1* 9, 2007 Gattani et al. .. ... 600,101
7,118,029 B2 10/2006 Nycz et al. 2007,0268133 A1* 11/2007 Sanchez et al. . 340,568.1
7,164,968 B2 1/2007 Treat et al. 2007/0285249 A1* 12/2007 Blair et al. ...... 340,5723
7,180,014 B2 * 2/2007 Farber et al. ............... 177.2519 2008/0051746 A1 2/2008 Shen-Gunther ............... 604,362
7.256,696 B2 * 8/2007 Levin ......................... 340,572.1 2008/0091221 A1 4/2008 Brubaker et al.
7,307.530 B2 12/2007 Fabian et al.
7,362,228 B2 * 4/2008 Nycz et al. ................. 340,572.1 OTHER PUBLICATIONS
2. E: s: A., Radio frequency—Sponges, Rogers et al., Springer, Surgical
7,518.502 B2 * 4/2009 Austin et al. ............... 340,539.1 endoscopy, 2007, pp. 1235-1237.*
7.562,025 B2 * 7/2009 Mallett et al. ................. TO5/308 Assist—Automated system. Tracking, Rivera et al., IEEE, 978-1-
7,677.395 B2* 3/2010 Bennett et al. . 209/552 4244-1712-4, Apr. 16-17, 2008, pp. 297-302.*
7,809,184 B2 * 10/2010 Neubauer et al. 382,154 GPU based real-time—ultrasound, Novotny et al. Elsevier, 1361
8,544,751 B2 * 10/2013 Jamali et al. ... ... 235,487 8415, 2007, pp. 458-464.*
2002/0067263 A1* 6/2002 Tafoya et al. 340,572.1
2002/0116254 A1* 8, 2002 Stein et al. ...................... 70.5/11 * cited by examiner
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 US 9, 168,104 B2
1. 2
INTRA-OPERATIVE SYSTEM FOR needles and other sharp objects, Surgical sponges, and Surgi
IDENTIFYING ANDTRACKING SURGICAL cal instruments during a Surgical procedure.
SHARP OBJECTS, INSTRUMENTS, AND
SPONGES SUMMARY

CROSS-REFERENCE TO RELATED Intra-operative systems for identifying Surgical sharp

APPLICATIONS objects are provided. Aspects of the systems include an intra
operative imaging device for obtaining intra-operative Surgi
Pursuant to 35 U.S.C. S 119(e), this application claims pri cal sharp object image data; and a Surgical sharp object auto
10 mated shape recognition module configured to identify a
ority to the filing date of the U.S. Provisional Patent Appli
cation Ser. No. 61/132,961 filed Jun. 23, 2008; to the filing Surgical sharp object from intra-operative Surgical sharp
date of the U.S. Provisional Patent Application Ser. No. object image data. Systems of the invention may further
61/132,954 filed Jun. 24, 2008 and to the filing date of U.S. include additional components, such as Surgical instrument
Provisional Application Ser. No. 61/198,211 filed Nov. 3, 15
and/or sponge identification and tracking devices. Systems of
2008; the disclosures of which applications are herein incor the invention find use in a variety of methods and applica
porated by reference. tions, including tracking of Surgical items during a Surgical
procedure.
INTRODUCTION
BRIEF DESCRIPTION OF THE FIGURES
It has been estimated that in the United States alone some
25 million operations are performed annually and most FIGS. 1A and 1B provide views of a surgical sharp object
involve the use of multiple Surgical items, including needles and a handheld imager configured to recognize the Surgical
and other sharp objects, Surgical sponges, and Surgical instru sharp object via shape recognition, according to an embodi
ments. These various items can be retained unintentionally 25 ment of the invention.
within patients at the conclusion of a given operation. A FIG. 2A is a schematic of a container for identification and
retained surgical foreign body (RSFB) usually requires at disposal of a Surgical sharp object, according to an embodi
least a second Surgery for retrieval of the object, and also ment of the invention.
carries a risk for major complications including death. The FIGS. 2B and 2C are schematics of additional embodi
prevalence of retained foreign bodies is not known, though 30 ments of a container for identification and disposal of a Sur
one medical malpractice insurance company reported gical sharp object, according to embodiments of the inven
approximately 40 cases over 7 years or about 1% of all claims tion.
(Kaiser CW, Friedman S, Spurling KP. Slowick T. Kaiser H FIG. 2D is a schematic of another embodiment of a con
A. The retained surgical sponge Ann Surg 1996:224:79-84). 35
tainer for identification and disposal of a Surgical sharp
One review cited prevalence as high as "/5000 cases with an object, according to an embodiment of the invention.
associated mortality ranging from 11 to 35% (Lauwers PR, FIGS. 3A-C are schematics of various aspects of a needle
Van Hee R H. Intraperitoneal gossypibomas: The need to or other sharp object that can be identified by recognition of a
count sponges; World J Surg, 2000:24:521-527). unique identifier in one embodiment of the invention.
The Association of Perioperative Registered Nurses 40 FIGS. 4A and 4B provide a view of an embodiment of a
(AORN) recommends that counts be performed before each unique identifier recognition system that can be used to detect
procedure to establishabaseline, before closure of any cavity or recognize a unique identifier on a needle or sharp object or
Such as the stomach or a cardiac chamber, before wound its packaging.
closure begins, at end of skin closure or the end of the proce FIG. 5A provides a view of a surgical instrument with a
dure, and at the time of any permanent change in operating 45 unique identifier in the form of a 2D barcode in accordance
room personnel (Recommended practices for Sponge, sharp, with an embodiment of the invention.
and instrument counts. AORN Recommended Practices FIGS. 5B to 5E provide additional views of a surgical
Committee. Association of PeriOperative Registered Nurses. instrument with various unique identifiers in accordance with
AORNJ 1999:70: 1083-9). It is recommended that more than embodiments of the invention.
one person do the counts in a standard order, simultaneously 50 FIG. 6 provides a view of an embodiment of a unique
and audibly, and with minimal interruptions. In practice, each identifier recognition system that can be used to detect a
of the multiple counts usually takes 15-30 minutes and often unique identifier on a Surgical instrument.
slows or stops the operation. FIG.7 provides a view of another embodiment of a unique
In most cases of RSFB, manual counts indicated that all identifier recognition system that can be used to detect a
equipment was accounted for, leading to the conclusion that 55 unique identifier on a Surgical instrument.
the counts must have been incorrect (Gawande A, et al. Risk FIG. 8 provides a view of an embodiment of a unique
factors for retained instruments and sponges after Surgery identifier recognition system that can be used to detect a
New EnglJMed348:229 C235, January 2003). About 88% of unique identifier on a Surgical instrument or sharp object.
FIGS. 9A-9C are schematics of surgical sponges with
RSFB incidents occur when the count is thought to be correct. 60 unique identifiers, in accordance with embodiments of the
Furthermore, Medicare announced in October 2008 that there invention.
will be no hospital payment for RSFB. Possible causes for FIGS. 10A-10C are magnified schematic views of various
incorrect counts include staff fatigue, stress, distraction, unique identifiers that can be placed on a sponge, instrument
interruptions, time pressure, and simple human errors in or needle or other sharp item in accordance with embodi
counting and recording. 65 ments of the invention.
Therefore, there is a need for improved systems and meth FIG. 10D is a view of a detector detecting a unique iden
ods for identifying and tracking Surgical items, including tifier in accordance with an embodiment of the invention.
 US 9, 168,104 B2
3 4
FIG. 11 provides a view of an embodiment of a unique stated range includes one or both of the limits, ranges exclud
identifier recognition system that can be used to detect a ing either or both of those included limits are also included in
unique identifier on a Surgical sponge. the invention.
FIGS. 12A-Dare schematics of additional embodiments of Certain ranges are presented herein with numerical values
containers for identification and disposal of Surgical sharp being preceded by the term “about.” The term “about is used
objects and sponges, according to embodiments of the inven herein to provide literal support for the exact number that it
tion. precedes, as well as a number that is near to or approximately
FIG. 13 is a schematic of an automated detection and the number that the term precedes. In determining whether a
tracking system designed to continuously track Surgical number is near to or approximately a specifically recited
sponges, instruments and/or sharp objects according to an 10 number, the near or approximating unrecited number may be
embodiment of the invention. a number which, in the context in which it is presented,
FIG. 14 provides another view of an automated detection provides the substantial equivalent of the specifically recited
and tracking system designed to continuously track Surgical number.
sponges, instruments and/or sharp objects which also Unless defined otherwise, all technical and scientific terms
includes a container for identification and disposal of a Sur 15 used herein have the same meaning as commonly understood
gical sharp object, according to an embodiment of the inven by one of ordinary skill in the art to which this invention
tion. belongs. Although any methods and materials similar or
FIG. 15 provides another view of the automated detection equivalent to those described herein can also be used in the
and tracking system designed to continuously track Surgical practice or testing of the present invention, representative
sponges, instruments and/or sharp objects, showing integra illustrative methods and materials are now described.
tion with a processor and display unit, according to an All publications and patents cited in this specification are
embodiment of the invention. herein incorporated by reference as if each individual publi
FIG. 16 is a schematic of the large panel display of a cation or patent were specifically and individually indicated
real-time instrument count indicating the presence or absence to be incorporated by reference and are incorporated herein
of any particular instrument at any time during a Surgical 25 by reference to disclose and describe the methods and/or
procedure, according to an embodiment of the invention. materials in connection with which the publications are cited.
FIG. 17 is another schematic of a large panel display of a The citation of any publication is for its disclosure prior to the
real-time needle and sharp object count indicating the pres filing date and should not be construed as an admission that
ence or absence of the items at any time during the Surgical the present invention is not entitled to antedate Such publica
procedure, according to an embodiment of the invention. 30 tion by virtue of prior invention. Further, the dates of publi
FIG. 18 is another schematic of a large panel display of a cation provided may be different from the actual publication
real-time needle and sharp object count indicating the pres dates which may need to be independently confirmed.
ence or absence of any sponge, instrument or needlefsharp It is noted that, as used herein and in the appended claims,
object at any time during the Surgical procedure, according to the singular forms “a”, “an', and “the include plural refer
an embodiment of the invention. 35 ents unless the context clearly dictates otherwise. It is further
noted that the claims may be drafted to exclude any optional
DETAILED DESCRIPTION element. As such, this statement is intended to serve as ante
cedent basis for use of such exclusive terminology as “solely.”
Intra-operative systems for identifying Surgical sharp “only' and the like in connection with the recitation of claim
objects are provided. Aspects of the systems include an intra 40 elements, or use of a “negative' limitation.
operative imaging device for obtaining intra-operative Surgi As will be apparent to those of skill in the art upon reading
cal sharp object image data; and a Surgical sharp object auto this disclosure, each of the individual embodiments described
mated shape recognition module configured to identify a and illustrated herein has discrete components and features
Surgical sharp object from intra-operative Surgical sharp which may be readily separated from or combined with the
object image data. Systems of the invention may further 45 features of any of the other several embodiments without
include additional components, such as Surgical instrument departing from the scope or spirit of the present invention.
and/or sponge identification and tracking devices. Systems of Any recited method can be carried out in the order of events
the invention find use in a variety of methods and applica recited or in any other order which is logically possible.
tions, including tracking of Surgical items during a Surgical In further describing various aspects of the invention, the
procedure. 50 systems will be described first in greater detail, followed by a
Before the present invention is described in greater detail, review of methods and applications in which the systems find
it is to be understood that this invention is not limited to SC.
particular embodiments described, as such may, of course, Systems
vary. It is also to be understood that the terminology used As Summarized above, systems for intra-operatively iden
herein is for the purpose of describing particular embodi 55 tifying a Surgical sharp object are provided. By Surgical sharp
ments only, and is not intended to be limiting, since the scope object is meant an object that has one or more sharp features
of the present invention will be limited only by the appended and is configured to contact tissue during a Surgical proce
claims. dure. As the objects have one or more sharp features, the
Where a range of values is provided, it is understood that objects identified by systems of the invention include a thin
each intervening value, to the tenth of the module of the lower 60 cutting edge or a fine point, such that the objects are well
limit unless the context clearly dictates otherwise, between adapted for cutting or piercing tissue. Examples of Surgical
the upper and lower limit of that range and any other stated or sharp objects include, but are not limited to, needles, scalpel
intervening value in that stated range, is encompassed within blades, etc. In some instances, Surgical sharp objects are
the invention. The upper and lower limits of these smaller objects that are configured for one time use, such that they are
ranges may independently be included in the Smaller ranges 65 to be disposed of following their use in a given Surgical
and are also encompassed within the invention, Subject to any procedure, and in Some embodiment Surgical sharp objects
specifically excluded limit in the stated range. Where the are reusable.
 US 9, 168,104 B2
5 6
As indicated above, the systems are systems of intra-op to identify a Surgical sharp object from intra-operative Surgi
eratively identifying Surgical sharp objects. By intra-opera cal sharp image data obtained by the intra-operative imaging
tively identifying is meant that the systems are configured to device, e.g., as described above. The term “module” refers to
identify a Surgical sharp object during a Surgical procedure, a combination of hardware and/or software which is config
where the identification may be made in or out of the sterile ured to perform a specific given function or functions. For
field, but in certain instances the identification is made in the example, a given module may be a programmable digital
room where a given Surgical procedure is performed. By microprocessor Such as available in the form of an electronic
Surgical procedure is meant an operation, including an open controller, mainframe, server or personal computer (desktop
Surgical procedure, or a minimally-invasive Surgical proce or portable). Where the module is programmable, suitable
dure, including endoscopic procedures, such that there is at 10 programming can be communicated from a remote location
least one opening into a body where a foreign body could be to the module, or previously saved in a computer program
unintentionally left inside of a body. A Surgical procedure can product (such as a portable or fixed computer readable storage
include the actual procedure itself, as well as the period of medium, whether magnetic, optical or Solid state device
time during preparation for and after the conclusion of the based). For example, a magnetic medium or optical disk may
Surgical procedure (e.g., performing initial or final counting 15 carry the programming, and can be read by a suitable reader
and identification of a Surgical sharp object, etc.) As the communicating with a given module at its corresponding
systems are systems for identifying Surgical sharp objects, station.
they are systems that are configured to recognize or establish Surgical sharp object automated shape recognition mod
a given object as a particular Surgical sharp object, such that ules are modules that are configured to identify a Surgical
the systems provide verification of the identity of a given sharp object, Such as a needle or scalpel blade, without the
Surgical sharp object. need for an identifying label (examples of which are
Intra-Operative Imaging Device and Automated Shape Rec described in greater detail below) by a method of automated
ognition Module shape recognition, such as machine vision. Automated shape
Systems of invention include an intra-operative imaging recognition is a process by which the identification of surgical
device and an automated shape recognition module. By intra 25 sharp objects is performed using one or more of the size,
operative imaging device is meant a device that is configured shape, aspect ratio, outline, color, or other distinctive feature
to obtain intra-operative Surgical sharp object image data. In present in the image data of the Surgical sharp object. Auto
other words, the device is configured to obtain image data of mated shape recognition can be performed in two-dimensions
a Surgical sharp object in an operating room. Accordingly, this or three-dimensions. For example, a digital camera (either
imaging device of the system is located in an operating room. 30 gray-scale or color vision camera) can obtain image data of a
The intra-operative imaging device may vary depending on Surgical sharp object, which image data can then be processed
the nature of the image data that the system is configured to by the automated shape recognition module (and specifically
employ. The image data may be data for one or more still by Software and/or hardware of the module) using a machine
images, or video data. Any convenient intra-operative imag vision and image processing technique.
ing device configured to obtain Such data may be employed, 35 Any convenient machine vision and image processing
where examples of such systems include digital or analog still technique may be employed. To distinguish between specific
cameras, digital or analog video cameras, etc. Where the Surgical sharp objects such as a scalpel and a needle, the
imaging device is a camera, the camera can include one or module may use variables such as the size, shape, aspect ratio,
more lenses for optimal focus of the desired field of view onto outline, or color of the of the sharp object, certain angles or
an image sensor of the camera. The camera can be black and 40 curves, the two-dimensional projection that is unique to a
white, or color, and can be digital, or analog. The camera may given Surgical sharp object, etc. For example, the curve
be configured to obtain still or video image data. In some formed by a certain size of Surgical needle can be used to
embodiments, the camera can include a processor. In some identify the needle via automated shape recognition proto
embodiments, a camera with a processor can be used in cols.
addition to a CPU of the system, e.g., as reviewed in greater 45 The Software can take several steps to process an image.
detail below. The contain may further include one or more The image may first be manipulated to reduce noise or to
light sources, a synchronizing sensor, and input/output hard convert many shades of gray to a simple combination of black
ware or communication links with other components of a and white (binarization). Following the initial simplification,
system to report results (e.g., via a display unit, such as a the Software may count and/or identify objects in the image.
monitor). Cameras that can be used in the methods of the 50 Any Suitable software program can be used, including com
subject invention include, but are not limited to: the Cog mercially available software programs, as disclosed above,
nexTM Insight Micro Smart CameraTM with Insight-Ex are available and can be used in one embodiment of the
plorerTMVision software, SickTM Smart camera IVC-2D used invention. The methods can include use of a Software pro
with IVC StudioTM software, National InstrumentTM Smart gram to process images and detect relevant features for iden
Camera with NI Vision BuilderTM AI program, Sony XCI 55 tifying a Surgical item.
CameraTM with any suitable machine vision cameras and A given automated shape recognition module may employ
programs sold by DalsaTM, VisionxTM, MatroxTM Imaging, pre-existing Surgical sharp object data in a given automated
etc., or any other Suitable camera. shape recognition protocol, e.g., a reference with which to
The intra-operative imaging device is a device configured compare the obtained image data in order to identify a given
to obtain image data of a given Surgical sharp object, and then 60 Surgical sharp object. This pre-existing Surgical sharp object
output that obtained image data. Examples of specific types of data may be provided in the shape recognition module using
intra-operative imaging devices and systems that include the a variety of different protocols. For example, the pre-existing
same are reviewed in greater detail below. Surgical sharp object data may be introduced into the shape
In addition to the intra-operative imaging device, the sys recognition module at the time of manufacture, where the
tems include a Surgical sharp object automated shape recog 65 data may or may not be updatable depending on the nature of
nition module. This Surgical sharp object automated shape the particular module. Alternatively, prior to the beginning of
recognition module is a functional module that is configured a given Surgical procedure, the data about the specific Surgical
 US 9, 168,104 B2
7 8
sharp objects (and other items as desired) which are to be In one embodiment of the invention, the automated shape
identified using automated shape recognition (i.e., machine recognition module can contain a database of the observed
vision) are programmed into the Software. For example, in an values for the various characteristics used to identify various
aortic valve replacement procedure, the types of needles to be Surgical sharp objects, as well as other Surgical items of
used may include EthiconTM 2-0 silk SH, EthiconTMOVicryTM interest, as desired. For example, depending on slight varia
CTX-B, DeknatelTM Tevdek(R) II 3-0 AT-2, EthiconTM tions in ambient lighting and also in the Surface optical char
ProleneTM 4-0 RB-1, EthiconTM ProleneTM 6-0 BV Ethi acteristics of e.g., a Surgical needle, there might be some
bondTM ExcelTM 2-0 SH, and EthiconTM ProleneTM 7-0 BV-1 variation in the perceived size of a Surgical sharp object by the
needles. These seven different types of needles can be pro automated shape recognition module. In some embodiments,
grammed into the system prior to the start of Surgery. The 10 therefore, the system can maintain a data set, e.g., in the form
number of needles that can be programmed into a system will of a table or histogram, of the number of times a particular
vary depending on the system, but can be at least two or more, measurement of size or other characteristic (e.g., needle cur
Such as three or more, or four or more, etc. This data regarding Vature) was associated with a particular Surgical item. The
the types of needles may be introduced into the shape recog system can employ statistical techniques to determine the
nition module using any convenient protocol, where proto 15 probability that a measured size or shape can be accurately
cols of interest include both manual and automatic protocols, associated with that particular Surgical item. In some
e.g., as described in greater detail below. instances, given such a database of several characteristics,
In some embodiments, the pre-programmed information multivariate statistical analysis is performed to increase accu
can include information saved in the computer memory for a racy and reliability of the system in identifying the Surgical
particular type of Surgery (e.g., appendectomy, or knee sharp objects.
replacement) which can be recalled as needed. In some In some embodiments, if the automated shape recognition
embodiments, the pre-programmed information saved in the module is unable to make a positive identification of a needle,
computer memory can include both the type of Surgery as the automated shape recognition module can include an
well as information specific to a particular Surgeon, to reflect 'assisted identification' algorithm which can present a choice
the needle or other Surgical sharp item preferences of a spe 25 to operating room personnel, who can then positively identify
cific Surgeon. the surgical sharp object that has been discarded. For
Machine vision Software programs that can be used for example, if a needle is bent, the automated shape recognition
automated shape identification can use a number of different module can narrow the identification of the needle to two
image processing techniques for identification of an object, options, e.g. an EthiconTM 8-0 BV-1 taper point needle or an
Such as pixel counting (counts the number of light or dark 30 EthiconTM 7-0 CC tapercut needle. The choice of the two
pixels), thresholding (converts an image with gray tones to types of needles can be presented to a scrub nurse, who can
simply black and white), segmentation (used to locate and/or select the needle which corresponds to the type of needle that
count parts), pattern recognition (location of an object that was discarded.
may be rotated, partially hidden by another object, or varying It should be understood that the terms “automated shape
in size), detection of particular angle or curve, measurement 35 recognition”, “automated shape identification', and
of area or size of an object, determining the aspect ratio of the “machine vision', can all be used to indicate the automatic
object, edge detection, the outline or silhouette detection, the identification of Surgical sharp objects (such as scalpel blades
two- or three-dimensional projection of an object, template or needles) from one or more types of image data obtained for
matching, color, etc. Examples of machine vision Software the object, e.g., one or more types of image data relating to the
programs that can be used with the Subject invention include 40 size, shape, aspect ratio, outline, color, or other imageable
but are not limited to Insight-ExplorerTM Vision software, parameter of the Surgical sharp object.
IVC StudioTM software, National InstrumentTM Vision A given automated shape recognition module of a system
BuilderTM software, any suitable software programs sold by may be configured to only provide shape recognition of Sur
DalsaTM, VisionxTM, MatroxTM Imaging, etc., or any other gical sharp objects. Alternatively, the shape recognition mod
Suitable machine vision software program. Also, in some 45 ule may be configured to provide shape recognition of other
embodiments, “template matching of the outline or silhou Surgical items, such as Surgical instruments and/or sponges,
ette of a Surgical sharp object is used by a given shape recog in addition to the automated shape recognition of the Surgical
nition module to distinguish one Surgical sharp object from sharp object.
another. The location of the automated shape recognition module in
In some embodiments, the machine vision methods can use 50 the system may vary. For example, the automated shape rec
a combination of processing techniques to identify an object; ognition module may be located at a part of the system that is
for example, the detection of a particular curve and the mea distinct from the intra-operative imaging device. In yet other
Sured size may be used to identify a particular needle. As embodiments, the imaging device and automated shape rec
Such, more than one identification technique can be used in ognition module may be integrated into the same part or
order to improve the accuracy and reliability of the identifi 55 component of the system. In some embodiments the auto
cation process. For example, in Some embodiments, an mated shape recognition module can be located in a sterile
optional algorithm can be included for evaluating the remnant environment, and in other embodiments the automated shape
of suture material still attached to a needle. This can include recognition module can be located in a non-sterile environ
evaluating characteristics of the Suture, for example, if silk ment. In some embodiments, the automated shape recogni
suture is black and ProleneTM suture is blue, identifying the 60 tion module may be located in a transitional area between a
color of the attached suture can assist in the identification of sterile and non-sterile environment, e.g., as in the chute
the needle, especially in cases where a needle might be bent, embodiment disclosed below.
twisted or broken. In some embodiments, the shape recogni FIGS. 1A and 1B provide views of a surgical sharp object
tion module is configured to keep track of the accuracy rate of in the form of needle being imaged by a camera to obtain
the various techniques used, and if certain techniques are 65 image data that may be used by an automated shape recogni
more successful, those techniques could be given greater tion module of a system of the invention to identify the
weight in the recognition process. needle. FIG. 1A shows needle? suture construct 100 that
 US 9, 168,104 B2
10
includes curved needle 102 and suture 104. As shown in FIG. to obtain a sharp image. In this embodiment the device can
1B, needle imaging device 106 is a handheld camera that include dynamic shape recognition, i.e., shape recognition of
includes manual operation features 108 and sterile sleeve a Surgical item in motion as it is dropped into a container.
110, which allows the camera to operate in a surgical sterile The container may also include a display unit for display
field. The automated shape recognition module may be inte ing identifying information of the Surgical sharp object, as
grated with the camera 106 or be present in another part of the well as additional derived information, such as the current
system, as desired. counts of the number and type of items that have been placed
In another embodiment, the imaging device (and option in the container. The display of the current number and type of
ally the automated shape recognition module) may be part of items in the container can be in addition to other displays of
a Surgical sharp object disposal container. Surgical sharp 10 current counts in the operating room, e.g. as provided by a
object disposal containers can include one or more imaging system of the invention or otherwise. The display unit on the
devices, such as a camera with Suitable optics for acquiring container can be mounted permanently or it can be removably
images, a camera interface for digitizing images (known as a associated with the container in any Suitable location, such as
“frame grabber') and, where desired, an automated shape on the top or side of the container.
recognition module (which can be an embedded processor, 15 The container may be configured for Surgical sharp object
Such as a digital signal processor (DSP), for example, as disposal. Such containers may have a portion that is reusable
desired). In some embodiments, the container can further and a portion that is disposable. For example, the container
include a Surgical sharp object automated tracking module, may include a first reusable portion that includes the imaging
Such that the container is configured to automatically track device, e.g., camera. This first reusable portion can be steril
one or more Surgical sharp objects, e.g., by counting the izable (e.g., with a sterile covering), where desired. In addi
objects, etc. The container can therefore use an imaging tion to the first portion, the container may include a second
device (such as a camera) to image the Surgical sharp object to portion configured to hold the discarded Surgical sharp
obtain image data. In certain instances, the container may objects. This second portion can be separable from the first
then identify the Surgical sharp object using the image data by portion and can have a variety of different configurations,
automated shape recognition. The machine vision protocol 25 Such as a disposable plastic bag, disposable rigid receptacle,
implemented by the shape recognition module of the con etc. In some embodiments, a container may be entirely
tainer can, in Some embodiments, count only the newly added located within a sterile field (e.g., on top of a sterile back
Surgical sharp object presentina field of view, such as a sterile table), or it can be entirely located in a non-sterile field (e.g.,
back table, or in the disposal container, etc. Tracking and on the floor of the operating room). In some embodiments,
counting of only the newly added Surgical sharp object can be 30 portions of the container can be both in a sterile field and in a
performed by continuous or intermittent imaging of a group non-sterile field (e.g., a container may have a opening with a
of surgical sharp objects in a particular field of view. When a chute which is configured to be on or in the sterilefield, which
surgical sharp object is newly added to the field of view, leads to the remainder of the container which is positioned in
comparison of an image obtained prior to the addition of the a non-sterile portion of a room).
new sharp object with an image obtained after the addition of 35 In some embodiments, the container can be configured to
the new sharp object can result in discounting or subtracting receive Surgical items other than Surgical sharp objects, in
out the prior counted needle shapes and/or positions in a given addition to the Surgical sharp objects. Additional types of
image, and does not recount them. Therefore, the machine Surgical items for which the container may be configured to
vision protocol of the shape recognition module can be used receive include instruments, e.g., forceps, Scissors, etc., as
to count only the most recently discarded object. In some 40 well as textile-based items, e.g., sponges. In some embodi
embodiments, the automated shape recognition module can ments, the container can have the capability of identifying and
be used to identify and count all of the Surgical items present counting more than one category of Surgical item (e.g., both
in a field of view. For example, ifa recount is necessary, all the needles, and sponges). For containers designed for sponge
Surgical sharp objects present in a field of view can be iden disposal, the container can also have a scale which can enable
tified and counted. 45 the determination of pre-operative versus post-operative
As indicated above, Surgical sharp object disposal contain weight of the Sponges. This weight data can provide estimates
ers may include one or more Suitable light Sources, which can for operative fluid or blood loss from a patient.
be specialized light Sources Such as a light-emitting diode Containers of interest may also include Surgical sharp
(LED) illuminators, fluorescent or halogen lamps, etc. The object displayers that promote identification of the Surgical
lighting can be used to illuminate the Surgical sharp object to 50 sharp objects (as well as other Surgical items, where desired).
be imaged, and can also be used to highlight features of Displayers may take a variety of configurations. Such as a
interest and obscure or minimize the appearance of features platform, either flat or inclined, which can, in some embodi
that are not of interest (such as shadows or reflections). The ments, be back-lit, or front-lit, have direct on-axis lighting
lighting can be located in any suitable location, including on (DOAL), off-axis lighting, multi-axis lighting, etc. or can
or near the camera, or on or under a Surface or platform where 55 have one or more mirrors or other reflective surfaces for
the Surgical item to be imaged is placed, including lighting optimal identification of the Surgical sharp object or other
that is “front-lit”, “back-lit, direct on-axis lighting (DOAL). Surgical item. In some embodiments, the container can
off-axis lighting, multi-axis lighting, etc. include mechanical separators that are configured to provide
The container may include a synchronizing sensor for mechanical separation of the Surgical sharp objects and other
detecting the presence of a Surgical item to be identified, and 60 Surgical items, such as features which isolate a newly added
determining when an object is in position to be evaluated. The item from previously placed items. Separators configured for
synchronizing sensor can be any suitable sensor, such as an mechanical separation of counted from uncounted items can
optical or magnetic sensor, where the sensor can trigger include, but are not limited to: manually triggered or auto
image acquisition and processing by the imaging device of matic trap-door mechanisms; vertical or horizontal rotating
the container. For example, the synchronizing sensor triggers 65 or circulating drums, wheels, discs, or flaps; valves or flap
the camera to image the object as it passes within the viewing mechanisms; screens; magnets; compressed air driven sepa
range of the camera, and can also synchronize a lighting pulse rators; Suction separators; separation arms; use of motion
 US 9, 168,104 B2
11 12
such as shaking; etc. Power to the device may be provided The sharp object is then identified and counted, and the sys
using any convenient protocols, such as via an electrical cord, tem introduces this information into a database which con
a sterile disposable lead such as used with a Bovie cord, or can tains a record of the number and type of sharp objects counted
be provided by an internal power source, such as a battery. into the operation. After the Surgical sharp object (e.g.,
The power Source can be housed in a sterile case, covering, or 5 needle) is identified, the horizontal platform 240 opens like a
sleeve. trap door to allow the counted needle 205 to fall by gravity
FIG. 2A depicts one embodiment of a container configured into the lower chamber 235 of the container, e.g., as depicted
to identify and dispose of a Surgical sharp object. In FIG. 2A, in FIG. 2C. The physical separation of the counted item from
container 200 is configured to identify and count a Surgical the image data acquisition region of the container by the
sharp object, such as a needle 205 or other sharp object, such 10
horizontal platform 240 facilitates the detection and counting
as a scalpel blade 210. Container 200 includes imaging device of the next item. FIG. 2C depicts the open trap door through
in the form of camera 215 that is activated by the act of which the counted item drops into lower chamber 235. As
disposal of the Surgical sharp object (e.g., with a sync sensor
(not shown)) to image the Surgical sharp object (e.g., needle with the container shown in FIG. 2A, lower chamber 235 will
205 or scalpel blade 210) as it is dropped into the container 15 be separated from the remainder of the container and dis
and goes past the camera's field of view. The automated shape carded at the end of the operation.
recognition of the Surgical sharp object can be performed In FIG. 2D, an “uncounted” needle 205U and suture rem
dynamically as the sharp item slides down incline 220 by a nant 207U or other sharp object such as a scalpel 210U is
high-speed optical detection imaging device 215 (e.g., a cam dropped from the needle holder 225 through the chute 230
era capable of capturing multiple images per second). In this onto the horizontal platform 240 at the bottom of the disposal
embodiment, the high speed optical detection imaging device container. In contrast to earlier embodiments, the as-yet
is camera 215 encased in a sterile case 217 and mounted onto uncounted needle 205U falls onto the platform 240, which
a container configured to receive of and dispose of sharp can incorporate a magnet 245 or lie just above such a magnet
Surgical objects. During use, an operating room professional, 245, which limits motion of the counted items. In some
such as a scrub nurse, can release a used needle 205 with the 25 embodiments, the platform can also include a Surface that
remnant of suture 207 from the needle holder 225 or other limits movement of the counted items, e.g., a Surface covered
instrument into the container, without the need to manually with an adhesive material. The as-yet uncounted needle 205U
manipulate the used needle. The needle 205 is released and or scalpel blade 210U lies on the platform 240 among previ
allowed to drop into the chute 230 and onto an incline 220. As ously counted sharp Surgical objects (e.g. needle 205). In this
the presence of the dropped needle is sensed by a sensor (not 30 embodiment, the automated shape recognition system is con
shown), camera 215 enclosed within a sterile case 217 is figured to count only the new addition (e.g., needle 205U)
activated to capture image data, e.g., in the form of a video or present in the camera field of view. The system can be con
multiple still photos, as the sharp object slides down the figured to count only the newly discarded objects, making the
incline 220. Camera 215 may be capable of capturing image mechanical separation discussed in the embodiments of
data at many frames per second, which allows for identifica 35 FIGS. 2B and 2C unnecessary. The system is configured to
tion of the shape of the particular needle 205, and in some provide an ongoing running total of various needles 205 and
embodiments, characteristics Such as the texture, shape, or other sharp objects, such as scalpel blades 210. The auto
color of the associated suture 207. The image data obtained by mated shape recognition system may be configured to “cor
the camera is compared by the system (e.g., in computer rect for errors such as, but not limited to, needles or scalpel
memory) to data representing the items that have been regis 40 blades that overlie each other or are crossed, bent needles,
tered and counted as present at the operation. After identify needles in close proximity to other needles or sharp objects,
ing the Surgical sharp object, the system counts the discarded etc., as discussed further below.
item out of the operation (e.g., “checked out”). Components of the system can also include one or more
After dynamic automated shape recognition of the Surgical mounting devices for the imaging devices; one or more light
sharp object as it slides down the incline 220, the counted item 45 Sources; one or more containers for identification and dis
falls into the lower chamber 235 of the disposal device con posal of a Surgical sharp object; one or more display units:
taining the previously counted and discarded items. Once the devices for the input of data (e.g., a keyboard); speech recog
needle is inside the container, no further human contact with nition capability or devices; input/output hardware or com
the sharp object is possible, removing the risk of injury or munication links with other components of a system to report
illness from contact with the sharp object. Furthermore, the 50 results (e.g., a display unit, or automated speech confirmation
need for repeat counts is avoided. At the conclusion of the of a counted or identified item); one or more devices or
operation, if the counts are all correct, the lower chamber 235 features to notify operating room personnel that an item is
is simply uncoupled from the imaging unit comprising the missing or unaccounted for (e.g., an auditory or visual alarm,
camera 215 and case 217. The lower chamber 235 containing or automated speech confirmation of a counted or identified
all of the counted needles 205 and scalpel blades 210 is 55 item); one or more devices to notify operating room personnel
simply removed and incinerated in a manner similar to all of that an item has been counted or identified (e.g., a change in
the other sharp containers present in the institution. color of a photochromic dye label); a computer readable
FIGS. 2B and C show another embodiment of the device storage medium; and a CPU (Central Processing Unit) for
for identifying and disposal of a Surgical sharp object. In the integrating the components of the system.
embodiment shown in these figures, after the detection of the 60 The Subject systems can be used for automated identifica
sharp object, the object is mechanically isolated from any tion and tracking of Surgical sharp objects, instruments, and
additional added sharp objects. The container may include sponges during a Surgical procedure. The functions of the
any convenient mechanical isolation mechanism, such as a Subject Surgical item identification and tracking system can
platform which opens like a trap door. In FIG.2B, camera 215 include, but are not limited to: sensing, identifying, tracking,
within the sterile case 217 detects the needle 205 or scalpel 65 marking, managing, monitoring, controlling, checking, dat
blade 210 dropped into the chute 230 after it is released from ing, timing, billing, inventory control, medical and medicole
needle holder 225 and lands on the horizontal platform 240. gal record keeping, and comparing with protocol.
 US 9, 168,104 B2
13 14
The term “system can include the hardware means, soft includes a visible change can assist operating room personnel
ware means, and data storage means used to analyze the in verifying that an item has been counted.
information of the present invention. Systems may include a Different labels can be chosen for each individual surgical
central processing unit (CPU), input means, output means, item, such as sponges, sharp objects or instruments. For
and data storage means, etc. Any convenient computer-based example, an EMID tag may be used with a sponge and a
system may be employed in the present invention. microdot used with a hemostat. Factors that may be consid
In addition to, or in some cases alternatively, the system ered in the selection of a suitable label for each surgical item
may include a number of additional functionalities beyond can include whether or not a suitable label already exists, e.g.,
the automated shape recognition of sharp objects, e.g., as a barcode on a pre-packaged set of needles. Other factors can
described above. These additional functionalities may
10 include distance at which a label can be read, whether or not
include identification (and in Some instances tracking) of the label needs line-of-sight to be read, orientation require
Surgical items beyond Surgical sharp objects, such as instru ments, size of the label or the Surgical item, lighting require
ments for detecting or reading the label, ability to be auto
ments and Sponges. Such additional functionalities may claved, and ease of integration with the other elements of the
employ the use of unique identifiers, etc. Aspects of these 15 system, etc. In addition, each member of the operating room
additional system functionalities (which may or may not be staff can also have individual identifying labels, e.g., bar
present in a given system) are now described in greater detail. codes, that can be used to identify the personnel present in the
Unique Identifiers room for a Surgical procedure, as well as provide a method for
Additional components of the intra-operative identifica authorization (e.g., an electronic 'signature') for a instru
tion and tracking systems of the invention can include one or ment count, for example. In some embodiments, these per
more detectors configured to recognize a unique identifier Sonal identifiers can be used to assign responsibility for any
label on a Surgical item (e.g., a Surgical instrument, Surgical individually identified or tracked surgical item. For example,
sponge or even a Surgical sharp object) and a unique identifier if a surgical sharp object such as a 4-0 ProleneTM needle is
recognition module configured to identify a Surgical item by dropped into a disposal container, the system can prompt the
sensing or detecting a unique identifier present on the Surgical 25 operating room staff (e.g., Scrub nurse) who can agree or
item. As such, the system may be configured to employ disagree with the identification, and confirm with his/her
labeled Surgical items. The labeled Surgical items can include personal time stamped signature. Similarly, a dropped needle
a variety of different types of labeling, including but not can be placed in a disposal container by the circulating nurse,
limited to: optical labeling, microdots, ultrasound or acoustic who can confirm the identification of the discarded needle
labeling, microscopic labeling, DNA labeling, nanotechno 30 with his/her personal time-stamped signature. In some
logical labeling, electro magnetic identification (EMID) embodiments, the use of these personal identifiers allows the
labeling, conductive labeling, inductive labeling, magnetic or real-time assignment of responsibility for an identified or
electromagnetic labeling, magnetomechanical markers, counted Surgical item at any time during a Surgical procedure.
radiofrequency (RFID) labeling, resonant markers, capaci In some embodiments, the use of these personal identifiers
tive coupling, macroscopic or microscopic 1D or 2D bar 35 can be used for the real-time assignment of responsibility for
codes, microchips, photochromic dyes, piezochromic dye all identified or counted Surgical items during a Surgical pro
polymers, radiopaque labels, luminescent or fluorescent cedure. The identifiers can be present in any convenient loca
labels, radioactive labels, etc. tion, such as on a badge, or ID card, or bracelet, for example.
The identifier labels can be passive or active, in that they A given label can include any desired information about
can be identifiers that are read by a detector (e.g., where the 40 the items with which it is associated, including type, model,
label is a barcode and the detector is a optical barcode reader), size, composition (e.g., cotton or synthetic in the case of a
or they can be labels (i.e., identifiers) that actively transmit a Surgical sponge), manufacturer, date of manufacture, cost of
signal (e.g., where the label is a transponder and the detector the item, etc., in addition to providing unique identifying
is a receiver configured to receive a signal emitted by the information for that item. For example, if there are five hemo
transponder). The label can be added onto a Surgical item by 45 stats of similar type being used for a Surgical procedure, each
any suitable means, such as etching, laseretching, machining, hemostat can have, in addition to information indicating the
adhesive, etc., or it can be a label applied to a tag which then type of Surgical instrument, etc., unique identifying informa
can be attached to a Surgical item through adhesive or any tion such that each of the five hemostats can be individually
other suitable means. Alternatively, the label or identifier can identified and tracked. Unique identifying information can
be incorporated into the item (e.g., an EMID label woven or 50 include, but is not limited to, a unique string of numbers
otherwise incorporated into the fabric of a sponge). In some and/or letters, or a particular frequency, and can be used in
embodiments, the labels or identifiers retain their function combination with information about that particular item (e.g.,
when autoclaved or sterilized. In some embodiments, the the type or model). In some embodiments, a Surgical item can
labels or identifiers can be enclosed in a covering (e.g., a have two or more labels, and in some embodiments a Surgical
plastic covering) which allows them to retain their function 55 item can have two or more different types of labels (e.g., a
when autoclaved or sterilized. The labels can be added to a barcode and a microdot label). In some embodiments, a Sur
Surgical item at any time, e.g., during manufacturing, or in the gical item can have more than one label, e.g., a manufacturer
operating room, etc. applied label and a label applied by the hospital, or even a
Additionally, in some embodiments, the label can include label applied for a particular procedure.
an element which changes once detected. For example, the 60 It should be understood that the terms “identifier”, “label,
label may be a photochromic dye which undergoes a revers “tag” and “marker” are used interchangeably. Accordingly,
ible photochemical reaction where an absorption band in the depending on the properties of the label, the label can be used
visible part of the electromagnetic spectrum changes dramati to indicate one or more of: (a) the presence of the label (and
cally in strength or wavelength, resulting in a visible change therefore the presence of the surgical item to which the label
in color to the observer. Over time the photochromic dye can 65 is attached); (b) the identity of the label (and therefore that of
return to the original color, which allows recounting or res the Surgical item to which it is attached); and (c) the location
canning of the Surgical item. An element of a label which of the label (e.g., on the operating table or in a disposable
 US 9, 168,104 B2
15 16
sharp objects container). In some embodiments, the location Dectectors
of the label can further indicate the precise position of a label Detectors for detecting labeled Surgical items can include
with respect to predetermined co-ordinates (and hence that of but, are not limited to, detectors for reading labels, including
the surgical item to which it is attached). The label can also in conventional scanners which are adapted to sense the pres
Some embodiments provide information which can be used 5 ence of conventional integrated circuit (IC) transponders on
for a system such as an inventory or billing system. or within articles; devices that establish electromagnetic
In one embodiment, Surgical items can have a passive data fields and sense the presence of a conducting element in the
tag, such as an EMID tag, which employs Small amounts of fields. Such as dipole wire elements, microchips, microtrans
very high-permeability magnetic material, with an alternat ponders, microtransmitters or threads in the articles (which
ing magnetic field for interrogation or detection. Since the 10 may be encoded if desired); sensors for detecting electro
magnetic material can be in the form of a thin foil, wire or magnetic identification (EMID) labels; radiofrequency
film, it can be bonded directly to paper or plastic to form (RFID) label detectors; radiation detectors adapted to sense
self-supporting tags. Further details of Such labels, as well as radioactive tracers in the articles; receivers adapted to sense
the detectors that can adapted for use with the present meth signals from transmitters in the articles; sensors adapted to
ods and systems, can be found in U.S. Pat. Nos. 6,371,379, 15 sense radiopaque handles or threads in the articles; photoelec
6,230,972, and 6,054,924, the disclosures of which are herein tric or optical sensors adapted to read macroscopic or micro
incorporated by reference. In some embodiments, one or scopic 1D or 2D barcodes or other codes in or on the articles:
more of the magnetic materials on the tag is divided into optical character recognition detectors: MRI detectors which
distinct Zones such that the Zones and their relative positions sense MRI active polymers or other materials; magnetic or
can represent information or a code which is readable mag electromagnetic label detectors, magnetomechanical marker
netically by passing the tag through a magnetic field which detectors; ultrasound or acoustic readers; DNA label readers;
has a relatively small region of Zero magnetic field (a mag nanotechnological label readers; inductive label readers, con
netic null) contiguous with regions where the magnetic field ductive label readers; resonant marker detectors; capacitive
is sufficient to Saturate the magnetic material, the tag being coupling detectors and sensors; photochromic dye readers;
moved through the magnetic field and its magnetic response 25 color sensors; video cameras; transponders adapted to sense
being detected as it traverses the magnetic null. The magnets the presence of passive electronic ID radio tags; laser scan
can be a permanent magnet or an electromagnet. ners; cameras; thermal detectors; luminescence detectors;
Magnetic labeling techniques can also include magneto infrared detectors; piezoelectric detectors; fluoroscopic
striction, programmable magnetic resonance (PMR) which detectors; electronic article surveillance (EAS) system detec
employs a magnetostrictive resonator element or nonmagne 30 tors. Such as magneto-harmonic, acousto-magnetic or mag
tostrictive (insensitive to strain) magnetic material. Further netostrictive and microwave detectors, any other Suitable
details of labels or tags as well as the detectors that can be detector for detecting surgical items. In some embodiments, a
used in the present methods and systems can be found in U.S. conductive detector that can detect a Surgical item by physi
Pat. No. 5,456,718, the disclosure of which is herein incor cally touching a label directly, or by physically touching a
porated by reference. 35 surgical item with an attached label can be used to retrieve the
FIGS. 10A-10D show other embodiments of labels that can unique identifier for the Surgical item. In some embodiments,
be employed with a Surgical item, such as a sponge, instru a conductive detector can have a low power output, and can
ment or Surgical sharp object, Such as needle or scalpel. In detect the presence of a label (e.g. an electrical binary code
FIG. 10A, the information is repetitively encoded as a unique label, or integrated circuit label). In some embodiments, a
microscopic serial number assigned to that particular unique 40 circuit can beformed by the connection of electronic labels on
Surgical item, represented as a microscopic dot 1005 roughly multiple Surgical items (e.g., instruments) where each Surgi
the size of a grain of sand. Commercially available for iden cal item has an individual unique label. By physically touch
tification purposes on casino chips since the 1990s, the appli ing one instrument or label on an instrument in the circuit, the
cation of such labels 1005 to surgical items permits the iden conductive detector can simultaneously or nearly simulta
tification of each unique Surgical item, such as sponge, 45 neously detect all of the unique identifiers on all of the sur
instrument or sharp object. The application of the micro gical items in the circuit. In this embodiment, the circuit
scopic label 1005 can be performed by a spray adhesive type formed by multiple Surgical items (e.g., conductive metal
application of multiple, up to thousands, of identical labels instruments, or conductive metal added to connect instru
1005, or the multiple labels 1005 can be woven as a thread ments to complete the circuit) facilities rapid identification. In
into the fabric of the a sponge. The label1005 depicted in FIG. 50 Some embodiments, an inductive detector can be used which
10A is a number such as a unique serial number 1010 which can detect a Surgical item or multiple Surgical items by Suffi
can be read by a still camera, video camera, digital micro cient physical proximity to retrieve the unique identifier,
scope, DNA-based code reader or other software based which may or may not be connected by a conductive circuit
reader, etc., capable of reading the actual serial number or (e.g., conductive metal instruments, or conductive metal
other identifier assigned to the surgical item of interest. The 55 added to connect instruments to complete the circuit). In
detected label 1005 containing the serial number 1010 is Some embodiments, an inductive detector can also simulta
microscopic in this depiction. The reader or camera may or neously or nearly simultaneously detect all of the unique
may not be used with magnification via a microscope lens identifiers on all of the Surgical items, when the Surgical items
1015, depending on the capabilities of the detector. FIG. 10B are in sufficiently close proximity to allow inductive detec
depicts in greater detail an embodiment of a microscopic 60 tion. In some embodiments, the detector can be an imaging
label 1005 in which the identifier is 1D barcode 1020. Again, device, which can be used to obtain image data of for
the reader may or may not use magnification via lens 1015 to example, a Surgical sharp object using a process of automated
facilitate reading the unique microscope 1D barcode 1020. In shape recognition, as discussed above.
FIG. 10C, the unique identifier is a microscopic 2D barcode The detectors can be passive or active, in that a detector can
1025, identified via lens 1015. As shown in FIG. 10D, a 65 read a label (e.g., barcode, electrical binary code label, or
digital microscope 1030 can be used to digitally magnify and integrated circuit label), or a detector can actively transmit a
detect the identifiers 1005. signal to a label and check for a response (e.g., transponder).
 US 9, 168,104 B2
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The detector can also be configured to detect a label charac single detector can have more than one capability (e.g., a
teristic, such as visual characteristic. In some embodiments, single hand-held detector can be capable of reading barcodes
the detector can activate a change in a label characteristic and microdots).
(e.g., cause a change in color of a photochromic dye) on a Depending on the properties of the device, the detector can
Surgical item, which indicates that a Surgical item has been 5 perform a number of different functions, such as detecting the
counted. As indicated above, Surgical sharp object disposal presence of a label (and therefore the presence of the surgical
containers may include one or more Suitable light sources, item to which the label is attached); identifying the label (and
which can be specialized light sources such as a light-emit therefore the identity of the surgical item to which it is
ting diode (LED) illuminators, fluorescent or halogen lamps, attached); or determining the location of the label (e.g., on the
etc. The lighting can be used to illuminate the Surgical sharp 10 sterile back table or in a Surgical sharp objects disposal con
object to be imaged, and can also be used to highlight features tainer). In some embodiments, by detecting the location of the
of interest and obscure or minimize the appearance of fea
tures that are not of interest (Such as shadows or reflections). label,
respect
the precise position of the label can be determined with
to predetermined co-ordinates (and hence that of the
The lighting can be located in any Suitable location, including
on or near the camera, or on or under a surface or platform 15 surgical item to which it is attached). Detection of the label
where the Surgical item to be imaged is placed, including can also include automatic entry of the information into the
lighting that is “front-lit”, “back-lit, direct on-axis lighting system, and can include display of the information on a visual
(DOAL), off-axis lighting, multi-axis lighting, etc. display unit, e.g., an LCD or plasma monitor, of the system.
The detector for detecting the labeled surgical items can be Detection of the label can also, in some embodiments, be used
hand-held, or it can be mounted, for example, Such that it is in 20 to provide information which can be used for a system such as
a stable position relative to a table such as a sterile back table an inventory or billing system. As used herein, the terms “to
or a “mayo stand. Alternatively, the detector can be mounted sense”, “to detect”, “to scan”, “to read”, “to identify”, and “to
from a ceiling or wall fixture overhead, for example, such that register are used to indicate the process of determining the
it is in a stable position relative to an operating room table or presence of a label, the information carried by a label, the
a sterile back table. In some embodiments, the mounting 25 location of the label, the time the label is read, etc., as
apparatus or hardware for securing the detector can be adjust described above. In some embodiments, the detector can
able, such that the distance from the detector or viewing angle identify a Surgical item (e.g., forceps or Surgical needle) with
of the detector relative to the surgical items being detected can out the need for a label by using automated shape recognition,
be adjusted. In other embodiments, the mounting apparatus e.g., as discussed further above.
for securing the detector is in motion, such that the detector 30 Detection of an item can be performed when the item of
can continuously scan the items on a sterile back table or in interest is moving (such that the item is dynamically detected)
the operating field. In some embodiments, a detector can be or when the item of interest is stationary (such that the item is
capable of being hand-held or placed on a stand, for example, statically detected). For example, an item may be dynami
a detector can be held by a circulating nurse to register one or cally detected by placing the item within the range of a detec
more Surgical items, and then can be placed on a mounting 35 tor, Such as placing the item beneath a detector or moving an
apparatus on a sterile back table, so that the detector can item past a detector, or vice versa (such as where a hand-held
register items placed on the sterile back table. The detectors detector is moved past the item). For static detection, detec
can therefore be positioned to image Surgical sharp objects, tion can be performed while the item of interest is stationary,
Surgical instruments or Surgical sponges that have been e.g., on a sterile back table. In some embodiments, if the
placed onto a sterile table; e.g., a sterile back table. In some 40 detector is part of a device, such as a container for identifica
embodiments, the detector can be part of a container, Such as tion and disposal of a Surgical sharp object (such as described
a Surgical sharp objects container configured for disposal of above), the item can be scanned as it is dropped into a con
the sharps, discussed further above. tainer, e.g., a disposable sharps container. In other embodi
Factors that may be considered in the type, number, and ments, a fixed scanning device can have a slot through which
placement of detectors in the operating room can include the 45 objects may be passed through for pre-operative or post
distance at which a label can be read, whether or not the label operative Scanning. Individual objects, such as packaged
needs line-of-sight to be read, lighting requirements for Sutures or scalpel blades, or similarly, groups of objects, such
detecting or reading the label, orientation requirements, size as lap pads or sponges, can be fixed to a reusable or disposable
of labels and/or detectors, and ease of integration with the holder and Scanned for pre-operative counting. The same or a
other elements of the system. Detectors can also incorporate 50 different reusable or disposable holder for used lap pads or
or be used with a magnifying lens, and in Some embodiments, sponges can also be used for post-operative Scanning. In some
the detector can be an optical or digital microscope. embodiments, a scale can be included with a scanning device
The detector can be powered as desired, e.g., with a battery, (e.g., for Scanning sponges) for determining the weight of
with building electricity or any other suitable power source. blood or other fluid contained within the sponges and lap pads
The detector can transmit data using any convenient protocol. 55 after the Surgical procedure.
Such as via a cable connection via a wireless communication In one embodiment, such as when EMID tags are
protocol. The detector can be sterile or non-sterile, and in employed, the detectors can sense the presence of a magnetic
Some instances can change from one status to another. For tag, by passing the tag through a magnetic field which has a
example, a sterile covering may be placed over a previously relatively small region of Zero magnetic field (a magnetic
non-sterile detector, as desired. 60 null) contiguous with regions where the magnetic field is
Multiple different detectors can be used in multiple loca Sufficient to Saturate the magnetic material, the tag being
tions around the operating room. More than one detector can moved through the magnetic field and its magnetic response
be used in one location (e.g., one or more detectors can be being detected as it traverses the magnetic null. Further
mounted over the operating table), and in some embodiments, details of labels or tags as well as the detectors that can be
more than one type of detector can be used in one location 65 adapted for use with the present methods and system can be
(e.g., a barcode reader and a EMID tag reader may be found in U.S. Pat. Nos. 6,371,379, 6,230,972, and 6,054,924,
mounted on a sterile back table). In other embodiments, a the disclosures of which are herein incorporated by reference.
 US 9, 168,104 B2
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Labels and detectors, e.g., as described above, may be with a unique identifier recognition module. If the barcoding
employed in the detection and tracking of a variety of differ is absent, automated shape recognition of the blade itself can
ent Surgical items, including Surgical sharp objects (i.e., be used to detect, identify, and count the sharp object (e.g.,
sharps), instruments and Sponges. Detection and tracking of scalpel blade).
each of these types of Surgical items is now reviewed in 5 FIGS. 4A and 4B show examples of hand-held scanners
greater detail below. designed to detect the Surgical sharp objects to be counted
Sharps Detection and Tracking whether they are presented in their original packaging or have
Surgical sharp objects, such as scalpels, blades, or needles, been removed from the packaging. FIG. 4A is a schematic of
can be labeled, detected, and tracked using any of the one or a hand-held scanner 400 (or alternatively a mounted camera)
more systems and methods disclosed above. In one embodi 10 designed to detect needle and Suture packaging 410 marked
ment, the "inbound', or initial counting of a Surgical sharp with 1D barcoding 425, 2D barcoding 430, pre-printed infor
object can be performed by reading a barcode on the packag mation 415, or actual size picture 420. Also shown is scalpel
ing of a needle. The tracking of Surgical sharp objects during blade 440 marked with a 1D barcode 425 and a 2D barcode
a Surgical procedure, as well as the "outbound', or final count 450. The hand-held scanner 440 can be used to scan and
before wound closure, can be performed via a shape recog 15 identify the sharp objects and convey the information to be
nition protocol, e.g., as described above, either in conjunction processed by the system, updating the count as the items are
with or instead of a label identification protocol. As such, added to the field by the circulating staff. Alternatively, a
methods of tracking Surgical sharp objects can include imag sterile hand-held device 480 may be used by the scrub nurse
ing a Surgical sharp object to obtain image data, and then to count the needle 470 already added to the field, but not yet
identifying the Surgical sharp object using the image data by added to the count. Asterile case 460 enclosing the hand-held
automated shape recognition, as described above. In some scanner 400 maintains the sterility of the field. The informa
embodiments, imaging of the Surgical sharp object is per tion pertaining to the identification of the needle, aided by the
formed by a container configured for disposal of the Surgical additional information identifying the attached suture 475
sharp object. when desired, is transmitted, e.g., wirelessly or via sterile
In addition to Surgical sharp objects, various sizes and/or 25 cable or a cable also within the sterile case or sheath, to the
types of screws, bolts, plates and otherhardware Such as those other components of the system for data management.
used in orthopedic Surgery or neuroSurgery can be labeled, Instrument Detection and Tracking
detected and tracked using any one or more methods dis Instruments can be labeled, detected, and tracked using any
closed above, including automated shape recognition. of the one or more methods disclosed above. In one embodi
FIGS. 3A-C depict exemplary surgical sharp objects that 30 ment, the "inbound, or initial counting of a Surgical instru
include labels that can be employed for the initial count ment, tracking during a Surgical procedure, and the “out
before the operation begins. Additional items that are bound', or final count of Surgical instruments before wound
required by the Surgeon as the operation progresses can be closure can be performed by a unique identifier recognition
counted in a similar manner as needed. FIG. 3A depicts a module (e.g., by detection of a barcode, a RFID tag, or laser
pre-packaged container 310 in which the needle and suture to 35 etched tag, etc.). The methods of instrument detection can be
be added to a surgical field in a sterile manner is delivered by used with reusable or disposable instruments.
the manufacturer. The pre-packaged container 310 lists the By Surgical instruments is meant tools or implements used
name of the Suture and needle type, pre-printed information during a Surgical procedure or operation, including but not
315 such as the manufacturer (e.g., EthiconTM) and other limited to: grasperS Such as forceps, needle holders, clamps,
information of value to the hospital and staff, such as lot 40 retractors, cutting devices such as scalpels, Scissors, or tro
number. The pre-printed information can be used for cars, etc., dilators, irrigation or Suction devices, hemostats,
“inbound' counting; e.g., by a barcode reader. Pertinent to etc. In some embodiments, this can include other items that
counting the item optically is an actual size picture 320 or are used in a Surgical procedure such as Syringes, red rubber
diagram of the needle and/or a 1D barcode 325 or 2D barcode catheters, Suture holders, or any other item present in the
330 with an identifying code for that specific needle type and 45 Surgical procedure room that has the potential to be uninten
suture. FIG. 3B depicts a surgical needle 340 and suture 345 tionally retained in a patient, and is therefore is included in
after the packaging has been discarded. In some embodi operating room policy counting protocol.
ments, the exposed needle 340 and suture 345 can also be FIG. 5A depicts an example of a metal instrument used in
counted by automated shape recognition, for example, using Surgery. An instrument 500 (e.g., Scissors) can be marked by
automated shape recognition equipment, in cases where the 50 either laser etching the metal of the actual instrument or by
count was not performed already on the packaging 310 with application of a laser etched label 510 to the metal of the
an identifying picture or diagram 320, 1D barcode 325 or 2D instrument. The application of the barcode to the instrument
barcode 330, for example as shown in FIG. 3A. Some needles provides for a unique identifier assigned to the individual
340 used in Surgery are designed for repeat uses in which instrument 500. Thus, when the barcode label 510 is detected,
different lengths of suture are added to the eye of the needle. 55 the unique identification and counting of that particular
Automated shape recognition of the individual needle is par instrument 1 is accomplished. FIGS. 5B to 5E provide sche
ticularly suited to identifying these needles in cases where the matic views of various labeling possibilities for Surgical
packaging does not convey identifying information in bar instrument 500. FIG. 5B depicts a surgical instrument 500
code format. For example, the Surgical sharp object (e.g., labeled by the spray application of many multiple micro
needle) can be imaged to obtain image data, and then identi 60 scopic identifiers 520, such as commercially available
fied using automated shape recognition. FIG. 3C depicts a “microdots” with a unique identifier such as a serial number,
disposable scalpel blade 350 shown already removed from its DNA label, or 1D or 2D barcode. FIG. 5C depicts a similar
packaging (and thus removed from any associated barcode instrument 500 which has been labeled by, in this example,
information). However, in this example, the blade itself has a four small but macroscopic 2D barcodes 530 (similar to those
1D barcode 355 and/or 2D barcode 360 laser etched into the 65 described in greater detail below) at four locations on the
steel of the blade or onto a label then applied to the blade, particular instrument. FIG. 5D depicts a combination of pos
which facilitates the quick detection of the sharp object, e.g., sible labeling techniques in which the instrument 500 has
 US 9, 168,104 B2
21 22
been labeled with commercially available surgical instrument to aid the detection of the identifier. Alternatively, a parallel
tape 540 which itself has been labeled with one or more beam of appropriate light 740 (UV or otherwise) is emitted
macroscopic 2D labels 530 and/or microscopic labels 520. from another source 750 incorporated into or on the detector
FIG.5E shows yet another embodiment in which a combina 700 as the detector 700 simultaneously scans over the labels
tion of microscopic and macroscopic labels are used. In this 5 715 and/or 710 thereby activating the photochromic dye. The
embodiment, the scissors 500 have been labeled with threads photochromic dye within the polymer applied to the counted
550 incorporating microscopic labels 520 applied to the item, in this case an instrument 720, changes color once it has
instrument 500 along one axis and handle and additional been detected indicating to the operating room personnel that
microscopic labels 530 have been spray applied or wrapped the instrument has been counted. The detector 700 itself can
on the other axis of the scissors 500. Alternatively, the label 10 also indicate it has read the serial number on the instrument
may be etched, including laser etching, or applied using a label by emitting an audio beep from sound source 760 and/or
permanent direct product marking (DPM) process such as dot visual indication by illuminating a light or LED indicator 770
“peening to the particular instrument, or tag attached to the on the detector 700. In addition, the actual name of the
instrument, needle or sponge depending on the physical char counted item can be displayed if desired on the main display
acteristics of the item to be identified. In some aspects of the 15 unit to further confirm in real-time the accurate count of the
invention, more than one label as well as more than one type instrument 720.
of label as in these embodiments can be used to enhance the The use of the photochromic dye?polymer on the counted
accuracy and reliability of the methods. item can be useful in that it provides an additional indicator
A schematic view of one embodiment of the unique iden (e.g., in the form of a color change of the dye) for the oper
tifier recognition module configured to recognize an indi- 20 ating room personnel performing the count to see. Therefore,
vidual instrument is shown in FIG. 6. In FIG. 6, a handheld if the scanning personnel fail to see a Surgical item color
detection reader 600 is utilized to detect the unique identifier change of the photochromic dye, the operator of the detector
barcode label 610 applied prior to surgery to each instrument 700 immediately knows to rescan the instrument 720. There
620. The handheld reader 600 detects the label 610 and trans fore, failure of the Surgical item to be successfully scanned
mits the information via cable 630 to other parts of the sys- 25 can be determined independent of the camera/reader-based
tem, e.g., a tracking module. In order to maintain the sterility system. Conversely, time is not wasted rescanning an item
of the operative field, the detection reader 600 can be enclosed already indicated by the color change that it has been counted,
in a sterile case 640 and the connecting cable 630 can be (which can be confirmed by evaluation of the sensor system
enclosed in a sterile sleeve 645. Connecting cable 630 can display monitor) and thus the counting is expedited and the
carry information from the detection reader 600 to a central 30 entire process is more efficient.
processing unit as well as to other components of the system. Multiple different photochromic dyes are available which
In FIG. 6, the handheld detection reader 600 may be replaced may permit multiple color changes for multiple scans, if
by a reader 650 which is enclosed in a sterile case 640 to desired. The time period the photochromic dye emits the light
maintain the sterility of the operative field. The reader 650 is is also variable, which allows for much adjustment of the
analogous to reader 600, except that no connecting cable is 35 desired counting process. The photochromic dye may be
necessary because the detected information associated with applied directly to the item to be counted, can be incorporated
the unique identification of that particular instrument 620 is into or onto the labeling barcode or other identifying modality
transmitted to the central processing unit (CPU) using any or it can be applied to Surgical tape which itself is then applied
suitable method such as e.g., BLUETOOTH, WI-FI, WI to the Surgical item.
MAX or other wireless communication protocol. 40 Other protocols for marking or identifying the item as it is
Counts can be performed with the automated embodiment counted can be used as disclosed above. Examples of Such
prior to the initiation of the skin incision at the beginning of protocols include, but are not limited to, conductive detection,
the operation. In addition, counts can be performed whenever inductive detection, radiofrequency identification, piezo
desired later in the operation. The described embodiment fits chromic dye polymer changes on the counted item (touch
well with currently accepted protocols, which require the 45 initiated color change) and/or audio and/or visual signals on
agreement by two members of the operating room staff on the the detector itself. Conductive, radiofrequency, piezochromic
initial and final counts and any changes during the operation. and/or simple audio beeps or visible lights on the reader in
Recording the accuracy of the count by time-stamping the addition to the real-time appearance on the display module
performed counts automatically allows real-time accuracy are also possible modalities to indicate the Successful reading
throughout the operation. The detectors may be configured to 50 of the identifier.
read barcodes assigned to the pertinent personnel agreeing to In some embodiments, the unique identifier on a Surgical
the count. In such instances, by simply having the detector instrument is a conductive label (e.g. a label that can be
read the personnel code as instruments 620 are added to or detected through conduction, such as an electrical binary
removed from the field, the accuracy of the count and code label, or integrated circuit label) that can be detected by
counters is enhanced. 55 physically touching the label directly with an appropriate
An alternative embodiment of an instrument detector is conductive detector. In other embodiments, the unique iden
shown in FIG. 7. FIG. 7 is a schematic of a surgical instrument tifier can be detected by physically touching the Surgical
recognition detector 700 configured to detect a unique iden instrument with an attached label with a suitable conductive
tifier in the form of microscopic serial number 710 assigned to detector. In some embodiments, a conductive detector can
the unique Surgical item, Such as instrument 720. The sche- 60 have a low power output that can detect the presence of the
matic depicts one of the multiple possible methods which can label. In some embodiments, a circuit can be formed by the
be used to indicate to the operator the reading of the particular connection of electronic labels on multiple Surgical instru
serial number 710 assigned in this case to instrument 720. In ments wherein each Surgical instrument has a unique label.
this depiction, there is a photochromic dye 730 associated By physically touching one label (or instrument with attached
with, e.g., overlying or adjacent to, the serial number present 65 label) in the circuit, the conductive detector can simulta
on microscopic label 710 or adjacent to the macroscopic neously detect all of the unique identifiers on all of the sur
label. The dye is activated by light emitted by the detector 700 gical instruments in the circuit. In this embodiment, the pres
 US 9, 168,104 B2
23 24
ence of a circuit formed by multiple Surgical instruments also be obtained, which could provide an estimate of the
consisting of conductive metal in contact with the unique amount of fluid or blood loss from a patient.
identifiers facilitates the rapid identification of the surgical FIGS. 9A-C depict a woven sponge 900 or other textile
instruments in the circuit. In some embodiments, the unique based object often used in surgery. In FIG.9A, the sponge 900
identifier on a Surgical instrument is an inductive label (e.g. a is marked by weaving or otherwise incorporating one or more
label that can be detected by induction) that can be detected uniquely microscopically labeled threads 910, which could
with an appropriate inductive detector in Sufficient proximity be a unique identifier Such as microscopic or macroscopic
to detect the unique identifier. In some embodiments, an serial number or barcode, 1D barcoding, 2D barcoding, 3D
inductive detector can simultaneously detect one or more visualization based, DNA labeled, nano particle labeled,
unique identifiers on a group of one or more Surgical instru 10 radiofrequency labeling, ultrasonic, conductive, or electro
ments with an appropriate inductive detector, by bringing the magnetic labels, etc., as desired. Currently used operating
inductive detector in sufficient proximity to the group of room sponges similarly have a woven, radio-opaque, such as
instruments to detect the unique identifiers in the group of barium-based, identifier for identifying the sponge should it
instruments.
be retained in a body cavity. In some embodiments, one or
15 more labels can be used on the same sponge, including, for
FIG. 8 is a schematic view of a unique identifier recogni example, the currently used radio-opaque markers. The pur
tion module configured to recognize an individual instrument pose of the microscopically labeled thread 910 in the
800 or sharp object 810 by recognition of a unique identifier described methods is to identify the sponge 900 and prevent
(805 or 815 respectively) applied to the particular surgical the retention of the foreign body sponge 900. In this embodi
item. In this embodiment, identifier 805 is a unique micro ment, identification of the unique sponge is achieved by read
scopic serial number that has been assigned to the individual ing a microscopic label920 incorporated multiple times into
instrument 800 (depicted as scissors). The identifier 805 is the thread 910 woven one or more times into the woven
detected via magnification through lens 820 and then the sponge 900. In FIG.9B, the identical microscopic identifiers
detector 830 enclosed in a sterile case 840 reads the informa 920 are spray applied to the sponge itself, rather than incor
tion and relays it to the central processing unit via cable 850 25 porated into a single thread. The labels, whether microscopic
encased in a sterile sleeve 860. Software incorporated into the or macroscopic, single or multiple, are identical for each
central processing unit, such as optical character recognition individual counted item and label each item as unique. In FIG.
programs, identifies the item read as unique. In another 9C, a macroscopic 2D barcode label930 has been attached in
embodiment, a digital microscope/reader can digitally incor one or multiple locations on the sponge 900. The application
porate the necessary magnification to read the microscopic 30 of the macroscopic barcode label 930 to the counted item
serial number assigned to the instrument 800. If the instru provides unique identifying information assigned to the
ment needs to be removed from the field because of contami sponge 900. Thus, when the barcode label930 is detected the
nation or malfunction, a similar non-sterile reader and cable unique identifying information and counting of that particular
can be used by circulating, non-scrubbed personnel to iden sponge 900 is accomplished.
tify and count the removed instrument 800. In this manner, 35 In some embodiments, the unique identifier on a Surgical
tracking of that particular instrument is current, and the status sponge is a conductive label (e.g. a label that can be detected
of the instrument as on or off of the operative field is displayed through conduction, such as an electrical binary code label, or
in real-time for all operating room personnel to see. FIG. 8 integrated circuit label) that can be detected by physically
similarly depicts the recognition of an individual sharp object touching the label directly with an appropriate conductive
(in this case a surgical scalpel blade 810) labeled with a 40 detector. In other embodiments, the unique identifier can be
unique microscopic serial number on label 815. The detector detected by physically touching the Surgical sponge with an
830 enclosed within the sterile case 840 reads the serial num attached label with a suitable conductive detector. In some
ber of label 815 magnified by lens 820 and relays it to the embodiments, a conductive detector can have a low power
central processing unit via one of many available wireless output that can detect the presence of the label. In some
transmission systems. As described above, non-sterile similar 45 embodiments, a circuit can be formed by the connection of
detection devices are used to detect and identify and time electronic labels on multiple Surgical sponges wherein each
stamp any sponge, instrument or sharp item removed from the Surgical sponge has a unique label (e.g., with a metallic
field. All detectors in the operating room can be integrated thread, or other Suitable connection). By physically touching
into the system via wired or wireless connection to track in one label (or sponge with attached label) in the circuit, the
real-time all Surgical items such as sponges, instruments and 50 conductive detector can simultaneously detect all of the
sharp objects in use for the particular operation. unique identifiers on all of the Surgical sponges in the circuit.
Sponge Detection and Tracking In this embodiment, the presence of a circuit formed by
Textile-based items, such as sponges, gauze, towels, or lap multiple Surgical sponges connected through conduction
pads, can also be labeled, detected, and tracked using any of facilities rapid identification of all of the Surgical sponges in
the one or more methods disclosed above. In one embodi 55 the circuit. In some embodiments, the unique identifier on a
ment, the "inbound', or initial counting of a sponge or lap Surgical sponge is an inductive label (e.g. a label that can be
pad, tracking during a Surgical procedure, and the “out detected by induction) that can be detected with an appropri
bound, or final count before wound closure can be per ate inductive detector in sufficient proximity to detect the
formed by a unique identifier recognition module (e.g., by unique identifier. In some embodiments, an inductive detec
detection of a barcode attached to or embedded in a sponge; a 60 tor can simultaneously detect one or more unique identifiers
conductive or inductive tag detected by an appropriate reader, on a group of one or more Surgical sponges with an appropri
a RFID tag; or EM barcode, etc.) In some instances, textile ate inductive detector, by bringing the inductive detector in
based items are objects that are configured for one time use, Sufficient proximity to the group of sponges to detect the
such that they are to be disposed of following their use in a unique identifiers in the group of sponges.
given Surgical procedure, and in some embodiments, textile 65 FIG.11 depicts the use of a handheld detection reader 1100
based items are reusable. In some embodiments, the pre- and utilized to detect the unique microscopic identifier barcode
post-operative weight measurement of discarded sponges can label 1110 applied prior to surgery to each sponge 1125. The
 US 9, 168,104 B2
25 26
reader 1100, which can be handheld or mounted, can detect previously counted discarded sponges are not necessary,
the label 1110 incorporated into thread 1130 woven into the which eliminates recounts and re-exposure to blood contami
sponge, and transmit the information via cable 1150 to the nated items and enhances Surgical staff safety.
central processing unit. Also shown is lens 1120. In order to FIG. 12C depicts a surgical sharp object disposal unit 1225
maintain the sterility of the operative field, the detection similar to the sponge disposal unit 1200 shown in FIG. 12A
reader 1100 can be enclosed in a sterile case 1140. In FIG. 11 which similarly counts each uniquely identified needle or
the connecting cable 1150 is enclosed in a sterile sleeve 1160. sharp object as it is discarded by mechanical separation of the
FIG. 11 also shows the handheld detection reader 1170 uncounted sharp objects from the previously counted and
enclosed in a sterile case 1140 to maintain the sterility of the discarded sharp objects. As the discarded sharp objects 1235
operative field. The reader 1170 detects the unique barcode 10 (e.g., needle or scalpel blade) enters the upper portion of the
label 1110 previously applied to the surgical sponge 1125. disposal unit 1270, the camera 1240 via magnifying lens 1250
With respect to reader 1170, no connecting cable is necessary, detects the one or more sharp items with the incorporated
because the detected information associated with the unique identifier. In the lower unit 1280 the previously counted sharp
identifier 1110 of that particular sponge 1125 is transmitted to objects are collected for later disposal.
the central processing unit via any suitable wireless commu 15 FIG. 12D depicts a surgical sharp object disposal unit 1255
nication format. similar to the sponge disposal unit 28 shown in FIG. 4B. In
Disposal Containers Configures for Label Identification this embodiment, the sharp objects 1235 are detected during
Systems of the invention may include disposal containers gravity-induced “freefall” by identification of the labels asso
for a variety of Surgical items, such as sponges and sharps, ciated with the objects. Alternatively the item is detected on
where the containers are configured to detect labels applied to the inclined surface 1295 before physically sliding from the
the items. Such containers may further include automated upper disposal chamber 1270 into the lower disposal chamber
shape recognition capability, e.g., as described above. The 1280. FIG. 12D also depicts the detection of the discarded
container may have any Suitable shape, Such as cylindrical, sharp objects 1235 on the surface of the lower disposal unit
square, rectangular, etc., and as shown below. 1280, with or without backlighting of the lower disposal unit
FIGS. 12A to 12B are schematic views of various embodi 25 1280, as desired. This embodiment in FIG. 12D, like that of
ments of container devices for identifying and disposal of a the detection and counting of the discarded sponges 1210
Surgical items, such as sponges and sharps. FIG. 12A depicts shown in FIG. 12B, can be done without mechanical or physi
an embodiment of a sponge disposal unit 1200 which could be cal separation of the discarded sharp items 1235 because the
on or off the sterile field, designed to mechanically separate system is configured to identify a given sharp object as it
the uncounted discarded sponges from the previously 30 enters the disposal unit, and/or the system is configured to
counted and discarded sponges. As a discarded sponge 1210 account for the time-stamped, counted Status of the previ
with an incorporated identifier label 1220 enters the upper ously discarded sharp items present in container 1255. There
portion of the disposal unit 1230, the camera 1240 mounted fore, manual recounts of the previously counted discarded
on control arm mount 1245 detects and identifies the single sharp objects 1235 are not necessary, which improves Surgi
sponge 1210 via magnifying lens 1250 by unique identifier 35 cal staff safety.
1220. In this embodiment, mechanical separation of the In some embodiments, the disposal container can be
uncounted from counted sponges 1210 is achieved by using a entirely located within a sterile field (e.g., on top of a sterile
trap-door mechanism 1260, which separates the upper dis back table), or it can be entirely located in a non-sterile field
posal unit 1270 (which holds the uncounted sponges) from (e.g., on the floor of the operating room). In some embodi
the lower disposal unit 1280 (which holds the previously 40 ments, portions of the container can be both in a sterile field
counted Sponges). Any Suitable mechanical separation tech and in a non-sterile field (e.g., a container may have an open
niques or electrical, electromagnetic and Software or hard ing with a chute which is configured to be on or in the sterile
ware based techniques which can automate the intra-opera field, which leads to the remainder of the container which is
tive counting of Surgical sponges, instruments, and/or needles positioned in a non-sterile portion of a room). In this embodi
can be used, such as described above. After the sponge 1210 45 ment, the disposal container can have a chute, such as shown
has been uniquely identified and the information captured, in FIG. 15, on the side of the table such that the top of the
e.g., for use by another part of the system Such as Sponge chute is flush with the top of a table. In some aspects, the chute
detection module, the trap door 1260 or other mechanism can can be straight, as shown in FIG. 15, and in some embodi
facilitate movement of the sponge 1210 into the counted ments the chute can be angled. The chute can be any Suitable
group. Where desired, a power source, either electrical, bat 50 length to allow the opening of the chute to be on or in the
tery, compressed air or Suction, etc., may be employed, e.g., if sterile field, with the remainder of the container in a non
gravity alone is not sufficient to separate the items. sterile field. In some embodiments, the chute can be fixed to
FIG. 12B depicts another sponge disposal unit 1205 con a portion of the table (e.g., the ledge, or a table leg, etc.) to
figured to count each sponge 1210 as it is discarded. In this secure the chute and disposal container to the table. Any
embodiment, the camera 1240 via the magnifying lens 1250 55 portion of the disposal container and chute can be used with a
can detect one or more sponges 1210 as they slide down an sterile sheath as necessary.
incline 1215 or alternatively as the sponges 1210 simply enter In some embodiments, the disposal containers can be used
the lower disposal unit 1280 without any incline. In some with an integrated table. By integrated table is meant a table
embodiments, gravity alone can cause the Surgical item to that can be used during a Surgical procedure. Such as a sterile
“free-fall through a detection Zone or slide down an inclined 60 Surgical back table, that is configured to receive the disposal
plane with or without backlighting. The counting of the container. An integrated table can have, for example, a
sponges in this embodiment can be done without specific square-shaped box on top of the table configured to receive a
mechanical separation of counted and uncounted sponges, disposal container, or the box can be under the table, accessed
because the system is configured to identify the sponge as it through a slot in the table, or it can be located on the side of the
enters the disposal unit, and/or the system is configured to 65 table such that the top of the container is flush with the top of
account for the time-stamped, counted Status of the previ the integrated table, etc. The area of the table configured to
ously discarded sponges. Therefore, manual recounts of the receive the disposal container can be any Suitable shape Such
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27 28
that the disposal container fits inside, such as Square, rectan Surgical sharp objects by constant video monitoring of the
gular, round, etc. In some embodiments, the portion of the sterile operative field, as well as other surgical items by vari
integrated table that is on or facing the sterile field can be ous means. Items can be counted into the system and tracked
sterile, such that the disposal container itself does not have to via repeated detection events or continuous video monitoring
be sterile. In some embodiments, the integrated table can 5 and counted as off the field by disposal into device for iden
include a chute, such as shown in FIG. 15, on the side of the tifying and disposal of a Surgical sharp object or counted by a
table such that the top of the container is flush with the top of hand-held or portable device if the needle or other sharp
the integrated table, or a chute that is accessed from a slot in object falls from the sterile field. As shown, system 1400
the middle of the table. In this embodiment, the disposal includes sharps automated shape recognition disposal con
container can be positioned such that the opening to the 10 tainer 1410, which is analogous the containers described
disposal container is at the end of the chute. By integrated is above, e.g., see FIGS. 2A-2D. Container 1410 includes an
meant that the elements of the table configured to receive or imaging device 1420 for obtaining image data of an item that
accommodate the disposal container, Such as a box on top of has been placed into the container, and a processor configured
the table, a box under the table, a slot or chute in the table, etc., to identify the Surgical sharp object using the image data by
cannot be separated from the table without irreparably alter 15 automated shape recognition. Also shown are needle holder
ing the table. 1425 holding needle 1425 with attached suture 1418, prior to
System Configurations being dropped into chute 1430 of the sharps automated shape
An embodiment of a system in accordance with the inven recognition disposal container 1410, where they fall onto
tion is shown in FIG. 13. FIG. 13 depicts a schematic of an horizontal platform 1440. In FIG. 14, surgical needles 1415
automated system 1300 configured to continuously intra and other sharp objects such as scalpel blades 1417 are placed
operatively monitor the presence or absence of surgical items, on the sterile back table 1450 used by the scrub nurse to place
Such as instruments, sponges and Surgical sharp objects, dur instruments and other items such as needles 1415, sutures
ing a Surgical procedure. The Surgical sponges 1310, instru 1418 and sponges prior to their use when the Surgeon calls for
ments 1320, and sharp objects 1330 labeled with macroscopic them. As discussed above, the Subject system allows the Sur
or microscopic labels, as desired, can be placed on the sterile 25 gical personnel to place the Surgical items as used currently.
surgical back table 1350 used by the scrub nurse to place No particular placement or arrangement is needed for the
sponges, instruments or sharp objects prior to their use by the system to track the Surgical items. One or more still or video
Surgeon as the Surgeon calls for them. As depicted in FIG. 13. cameras can function as readers or scanning camera devices
one or more still or video cameras are placed relative to the (e.g., sterile camera/readers 1460 and 1470, non-sterile cam
table 1350 to function as detectors to keep the field of the table 30 era/reader 1480, or sterile camera/reader in container 1420) to
under constant Surveillance, automatically detecting and keep the table 1450 under constant surveillance, automati
recording the unique labels previously placed on the sponges cally detecting and recording the unique 1D barcodes or 2D
1310, instruments 1320, and sharp objects 1330 prior to the barcodes, or needle shape or 3D visualization of the sharp
operation. Also shown are unique identifiers 1322. items (e.g., needles, Scalpel blades). The cameras or barcode
In addition to the cameras over the sterile back table, cam 35 readers may or may not move or pan, depending on the
eras can also be placed in position to monitor the operating camera design, to constantly and continuously count the
field, as well as the “mayo stand, the special instrument tray needles and other sharp items such as Scalpel blades. The
where the scrub nurse keeps instruments that the Surgeon is embodiment shown in FIG. 14 depicts three mountings of the
immediately using. The cameras/readers may or may not devices, similar to those shown in FIG. 13. For example, one
move or pan, depending on the camera design, to constantly 40 camera 1480 is mounted on a control arm mount 1482
count and recount and record the Surgical items on the table. attached to the ceiling above or to the side of the sterile field.
In some embodiments, the “mayo stand” or sterile Surgical Another camera 1470 is mounted on a control arm mount
back table can have markers which delineate a grid on the 1472 attached to the legs of the table 1450. Similarly, another
table. Such that markers can outline areas where a particular camera/reader 1460 is placed on a movable control arm 1462,
camera/reader may scan. The camera(s) may be mounted in a 45 which has a free-standing base. The movable camera/reader
variety of ways. Three possible mountings of the cameras/ can allow the camera to be positioned as desired; e.g., over the
readers are shown in FIG. 13, though many others are pos operating table. Again, a sterile case 1422, 1464 and 1474 and
sible. For example, one camera 1360 can be mounted on a connecting sheath 1476, 1466 may be present, as desired, to
control arm mount 1362 attached to the ceiling or wall above maintain the sterility of the operative field and table 1450.
or to the side of the sterile field. Another camera 1370 can be 50 FIG. 15 depicts the overall integration of a system 1500 and
mounted on a control arm mount 1372 attached to the legs of in particular, the flow of information 1505 to and from a
the table 1350. Another of the multiple options for camera central processing unit 1510 of the system. The operating
mounting is depicted by another camera 1380 placed on a room personnel are kept informed of the pre-operative and
movable control arm 1382, which has a freestanding base, current counts of Surgical sponges 1520. Surgical instruments
which may or may not be on wheels. Any suitable system for 55 1530, and surgical needles or other sharp objects 1515 in
mounting the reader/cameras for the automation of counts of real-time via one or more display units 1550, which may be in
Surgical items can be used. However, if mounted or held close the form of LED, LCD, plasma or cathode ray monitors,
to the sterile operating field, a sterile case (1378, 1388) and among other types, as desired. The non-sterile handheld cam
sheath (1376, 1386) may be employed to maintain the sterility era or scanning devices 1560 held by the circulating nurse or
of the operative field and table 1350, as desired. If magnifi 60 the handheld Scanner 1570 with lens 1562 enclosed within a
cation is necessary, a lens (1364, 1374, 1384) can be utilized, sterile case 1572 and operated by the scrub nurse can detect
which in some embodiments can be incorporated into the case the presence or absence of a unique identifying labels 1522,
1378 or 1388. Alternatively, a digital microscope can be used multiply incorporated into thread 1524, which has been
to magnify and detect the unique labels applied or etched into woven into a sponge 1520. Also shown are identifying labels
the Surgical items. 65 1532 on instruments 1530 and surgical sharp objects 1515.
FIG. 14 is a schematic of an automated system 1400 con Needles or other sharp objects, and instruments are identified
figured to continuously monitor the presence or absence of in a similar manner. The identifying information 1505 is
 US 9, 168,104 B2
29 30
transmitted via cable or wirelessly to the central processing the bar code for the number “ten’. Similarly, five curved
unit 1510. The information 1505 is time-stamped indicating forceps may be visually identified and counted, and the bar
whether or not the sponge 1520, or sharp objects 1515 were code encoding "curved forceps” may be scanned, followed by
present at any particular time during the operation. The infor scanning of the bar code for the number “five'. In some
mation is then transmitted to a display unit 1550, such as a flat embodiments, the bar code for a particular item can have an
panel LED or plasma monitor. The information is then dis associated image, e.g., a photo of a curved forceps, next to the
played for all pertinent personnel present at the operation to bar code to help operating room personnel in location and
see. Any discrepancy in the count is then clearly indicated on identifying a particular Surgical item. In this way, the auto
the display unit 1550. mated assistance feature can increase the accuracy of tradi
Sponges 1520 dropped or discarded from the operative 10 tional counting methods.
field are scanned and identified as off the field, or “checked In all cases, the Surgical item present and counted into the
out” by the circulating nurse using a non-sterile reader 1575 operation must be accounted for at the final count or it is
or simply discarded into a sponge disposal unit 1580, which is considered a possible retained foreign surgical body (RFSB).
analogous to the sponge disposal units as described above. In cases where an item is determined to be missing, areas Such
Needles or other sharp objects dropped or discarded from the 15 as the table 1555 or the disposal units 1580 or 1590 can be
field, but not in the disposal container chamber 1590, are rescanned to verify if a Surgical item (e.g., needle) is truly
scanned off the field by the circulating nurse using a non missing. If the Surgical item is not found, an additional search
sterile camera or scanner 1560. If the sharp object is no longer of the patient (e.g., including Xray) or areas around the
needed it is simply discarded into a sharp disposal unit 1590, patient, such as in the Surgical drapes or the floor, can be made
which can be kept sterile for ease of use by the scrubbed to locate the Surgical item.
personnel or it could be non-sterile and off the field. Needles Central Processing Unit
or other sharp objects appropriately discarded into the dis The Central Processing Unit (CPU) can integrate all the
posal unit are also counted as off the field, or “checked out'. data of the automated system. The various components of the
In some embodiments, Surgical sharp objects, instruments, or system include integration of the information from any and all
sponges can be “checked out” by being placed into a chute 25 Sources, including devices for identifying and disposal of a
1556. In this embodiment, the upperportion of the chute 1556 Surgical sharp object, the one or more readers/cameras, infor
containing the opening is sterile, and is located in the sterile mation provided by one or more modules (e.g., an automated
field (e.g., the sterile back table). The lower portion of the shape recognition module; a unique identifier recognition
chute is in the non-sterile portion of the room (e.g., operating module; a Surgical instrument tracking module; a Surgical
room). The Surgical sharp objects, instruments, or sponges 30 sharp object tracking module, a Surgical sponge tracking
can then fall into disposal container 1585 from the sterile module etc.) data entered by operating room personnel
opening in chute 1556 to the portion of the container with including hand-entered or voice-entered data, and can main
non-sterile reader 1575 which is in the non-sterile portion of tain accurate counts displayed on the monitor for all essential
the room. Instruments 1530 dropped or discarded from the operating room personnel to see.
operative field are scanned and identified off the field by the 35 In certain embodiments, a system includes hardware com
circulating staff using a non-sterile reader 1560. Unless re ponents which take the form of one or more platforms, e.g., in
sterilized and returned to the field and rescanned into the field the form of servers, such that any functional elements of the
by the scrub nurse and the sterile reader 1570, the discarded system, i.e., those elements of the system that carry out spe
instrument 1530 is considered by the recording system and cific tasks (such as managing input and output of information,
central processing unit 1510 and operating room staff to be no 40 processing information, etc.) of the system may be carried out
longer on the operative field. Although not shown in FIG. 15, by the execution of Software applications on and across the
in Some embodiments a visual signal (e.g., photochromic one or more computer platforms represented of the system.
dye) can be used in addition to the counting information on The one or more platforms present in the Subject systems may
display monitor 1550 identified via optical recognition of the be any convenient type of computer platform, e.g., such as a
specific Surgical item. 45 server, main-frame computer, a work station, etc. Where more
In some embodiments, the system can be configured to than one platform is present, the platforms may be connected
recognize a non-unique identifier on a Surgical item. By non via any convenient type of connection, e.g., cabling or other
unique identifier is meant an identifier which identifies a communication system including wireless systems, either
particular type of Surgical item, e.g., a forceps, or a retractor. networked or otherwise. Where more than one platform is
In some embodiments, the "inbound' or "outbound' count of 50 present, the platforms may be co-located or they may be
a Surgical sharp object, instrument, or sponge can be per physically separated. Various operating systems may be
formed by detecting a non-unique identifier. For example, a employed on any of the computer platforms, where represen
scrub nurse can scan a non-unique identifier on ten clamps, tative operating systems include Windows, MacOS, Sun
Such that ten clamps are “checked into a Surgical procedure. Solaris, Linux, OS/400, Compaq Tru64 Unix, SGI IRIX,
In some embodiments, the "inbound' count, the “out 55 Siemens Reliant Unix, and others. The functional elements of
bound' count, or tracking of a Surgical sharp object, instru system may also be implemented in accordance with a variety
ment, or sponge can be performed using an 'automated assis of software facilitators, platforms, or other convenient
tance' feature. By automated assistance is meant that a method.
Surgical item is visually identified by operating room person The CPU can include an “assisted identification' feature,
nel, followed by selecting and then scanning an appropriate 60 which can be a separate component or part of any of the
code, such as a bar code, which corresponds to the Surgical tracking modules disclosed above, Such that data entered by
item from a menu of codes. Embodiments can also include an operating room personnel including hand-entered or Voice
option to select and then scanabarcode which corresponds to entered data in some instances can be in response to a choice
the number of items that have been visually identified and presented by the CPU; for example, ifa twisted or bent needle
counted. For example, a package often 4-0 ProleneTM needles 65 has been dropped into a disposal container and the Surgical
may be visually identified, and the bar code encoding “4-0 sharp object tracking module is able to narrow the options
ProleneTM needles' may be scanned, followed by scanning of down to four or fewer, or three or fewer options, the operating
 US 9, 168,104 B2
31 32
room personnel can then be presented with a choice e.g., three particular instrument at any time during an operation, as
options of needle types. The operating room personnel (e.g., indicated by the information processed by the central pro
a scrub nurse) can then select the type of needle that was just cessing unit. The data shown on the display screen can
discarded so that an accurate count and tracking of the needle include the name of the instrument (e.g., tissue forceps), and
is kept. In some instances, the auto-assist feature can be used the total number of similar instruments still on the operative
in instances when a tracking module is unable to definitively field, and the number of similar instruments that have been
identify a Surgical item. “checked out'. The detection of any particular instrument
In other embodiments, as in the automated assistance fea during the operation or after the operation is continuously
ture disclosed above, once a Surgical item has been identified compared to the original count and the count of instruments
or detected, the CPU can include animage of the surgical item 10 already removed from the field. Any discrepancy is noted on
for confirmation. The image can be displayed at the detector the display prominently mounted for all operating personnel
where the Surgical item is detected, or at any display unit in to see. The display screen can also note the operating room
the system. For example, if a unique identifier on a hemostat personnel present, and the identification of the personnel who
is scanned by a hand-held Scanner at a sterile back table, the Verify the Surgical item count or counts.
hand held Scanner can display a likeness of the hemostat, 15 FIG.17 shows another view of the large panel display 1700
which can be seen by the operator (e.g. scrub nurse) before the showing a needle and sharp object count indicating the pres
count of the hemostat is confirmed and added to the system. ence or absence of the sharp objects at any time during the
Inclusion of a likeness or image of the Surgical item to be operation, as indicated by the information processed by the
counted or tracked can also be used in embodiments where central processing unit. The data shown can include the num
the surgical item has an identifier that identifies the type of ber of a particular size and type of needle and Suture, or the
Surgical item (e.g., retracter) but that is not unique, or in particular other sharp object being counted. The detection of
instances in which a Surgical item is visually identified and any particular needle type or Suture type is automatically
then the appropriate bar code is scanned, as discussed above. compared to the number of similar Surgical items counted
In addition to hand-entered (e.g., using a keyboard) or originally, and the current real-time count of similar Surgical
Voice-entered data (e.g., using speech recognition software), 25 items counted by the camera mounted above the disposal
including notes on the procedure or count, etc., the CPU can chamber and/or dropped from the operative field and counted
also accept patient and staff information by Scanning badges off the field with the non-sterile handheld scanner or separate
or identification bracelets, etc. The CPU can therefore inte non-sterile detection and disposal chamber. The system thus
grate information on all personnel present in the operating automatically detects the presence or absence of the needles
room at a particular time, and can track staffing changes. 30 and other sharp objects.
In addition, the CPU can integrate the other functions of the FIG. 18 depicts an embodiment of the panel display 1800
system and/or integrated with other systems including but not showing counts of Sponges, instruments, and sharp objects
limited to inventory, billing, ordering, electronic medical which have been registered for the particular operation. The
record-keeping, and comparing with protocol. The system detection of any particular counted Surgical item, Such as a
can also be used for medicolegal records. For example, if a 35 sponge, instrument or sharp object, during the operation or
count discrepancy is found, the system can provide a record of after the operation is compared to the original count and the
the count as well as record the Surgeon’s decision (e.g., to count of the items already removed from the field. The pres
re-explore the wound, obtain an X-ray, etc.) for any future ence or absence or any of these items, or class, is kept current
medicolegal question easily retrievable. The system also pro by any number of rescans or constant still camera or video
vides a record of the counts, and a record of the operating 40 Surveillance is also possible depending on the technology
room personnel responsible for the counts. utilized. Any discrepancy is noted on the display prominently
Display mounted for all operating room personnel to see. Although
The display units of the Subject invention can be any con the display monitor embodiment shown in FIG. 18 for con
venient type of monitor operatively coupled to a CPU and can Venience displays data for three types of Surgical items (i.e.,
be of any convenient size suitable to allow visualization by 45 for “sponges”, “instruments’ and “sharps'), the display
key operating room personnel. The display unit can be free screen can display as many lines of data or entries as are
standing; e.g., can be placed on a table, or it can be mounted needed for a particular operation. For example, in some
to a stand or a wall in any convenient location. In some embodiments, there may be three types of sponges displayed,
embodiments, there can be more than one display unit that seven types of needles displayed, 10 types of instruments
displays all the current real-time tracking information. In 50 displayed, etc. Therefore, the number of Surgical item counts
addition, in Some embodiments there can be additional dis displayed and/or lines of data displayed can be four or more,
play units that can display only some of the tracking infor such as 8 or more, or 15 or more, or 20 or more, etc.
mation, Such as for example with a device for identifying and Methods
disposing of a Surgical sharp object which can have a monitor The subject methods include a method of intra-operatively
displaying the real-time count of Surgical sharp objects that 55 identifying a Surgical sharp object. Aspects of the methods
have been discarded into the container. A display unit can include obtaining a Surgical sharp object from an operative
therefore be configured to display real-time tracking infor sterile field, imaging the Surgical sharp object with an intra
mation for a Surgical item, Such that the display can include operative imaging device to obtain image data, imaging the
information on the current count, current location, etc. of any Surgical sharp object with an intra-operative imaging device
Surgical item such as a Surgical instrument, Surgical sharp 60 to obtain image data, and forwarding the image data to a
object, or Surgical sponge. A display unit can also include an Surgical sharp object automated shape recognition module
attached device for input of data, Verification of counts, elec configured to identify the Surgical sharp object from the intra
tronic signatures, etc., Such as a keyboard. A display unit can operative Surgical sharp object image data. Imaging the Sur
further have a sterile covering to allow placement of the gical sharp object can include placing the Surgical sharp
display unit on a sterile field. 65 object in the range of an intra-operative imaging device con
FIG.16 is a schematic of the large panel display 1600 of an figured to obtain image data, which can include placing the
instrument count indicating the presence or absence of any Surgical sharp object into a container configured for disposal
 US 9, 168,104 B2
33 34
of the Surgical sharp object, placing the Surgical sharp object HIPAA regulations). A comprehensive time-stamped inven
onto a sterile table. Such as an operating room table or a sterile tory of all instruments utilized for the case can therefore be
back table, or placing the Surgical sharp object within in the generated.
range of a hand-held imaging device. Tracking can include tracking of one or more Surgical
The Subject methods can further include tracking of a Sur sharp objects, Surgical instruments, or Surgical sponges.
gical sharp object. Tracking of a Surgical sharp object can Tracking of surgical items can be performed by a module (i.e.,
include placing the Surgical item within the range of a detec a combination of hardware and/or software which will per
tor, and identifying the Surgical item or items by sensing a form a tracking function) such as a Surgical instrument track
unique identifier (e.g., by reading the bar code on a package of ing module, a Surgical sponge tracking module, or a Surgical
needles). Tracking can include information on the location of 10
sharp object tracking module, etc.
the Surgical sharp object, as well as the time that an object was Once an initial count of all Surgical items to be used in the
identified by a particular sensor or detector. Tracking can Surgical procedure has been made, the count is kept accu
therefore include detecting and identifying a Surgical sharp rately during the procedure, as Sponges, instruments and
object and following the location of the Surgical sharp object
for a period of time, for example, during “check-in” or 15 sharp objects are added or removed from the field during the
“inbound' count, or for the duration of a surgical procedure, case. Each addition or removal of an item from the sterile
or for “check-out' or “outbound count, etc. Tracking of a operating field thus is counted by the detection system and is
Surgical sharp object can also include identifying a Surgical tracked and counted appropriately. The count information can
sharp object by automated shape recognition using image be displayed in a real-time manner on a display unit for all
data, as discussed above. In some embodiments, identifica operating room personnel to see. The Subject methods can
tion of the Surgical sharp object by automated shape recog also record the acceptance of responsibility for the counted
nition is performed dynamically. sponges, instruments and sharp objects both by the scrubbed
In addition to tracking of a Surgical sharp object, the meth personnel and the circulating operating room personnel.
ods can also include tracking of a Surgical item, Such as one or Finally, an electronic digital record of the count generated by
more Surgical instruments and/or one or more Surgical 25 the invention can be entered into an electronic database for the
sponges. Tracking of a Surgical item such as a Surgical instru operation and kept for future medical and medico-legal ref
ment or sponge can include placing the Surgical item within CCC.
the range of a detector, and identifying the Surgical item or The description of the present invention is provided herein
items by sensing a unique identifier (e.g., by sensing electro in certain instances with reference to a subject or patient. As
magnetic identification (EMID) label on a sponge). Tracking 30
used herein, the terms “subject' and “patient” refer to a living
can include information on the location of the Surgical item, entity such as an animal. In certain embodiments, the animals
as well as the time that an item was identified by a particular are “mammals' or “mammalian, where these terms are used
sensor or detector. Tracking can therefore include detecting broadly to describe organisms which are within the class
and identifying a Surgical item and following the location of
the Surgical item for a period of time, for example, during the 35 mammalia, including the orders carnivore (e.g., dogs and
initial registration or “check-in” or “inbound' count of a cats), rodentia (e.g., mice, guinea pigs, and rats), lagomorpha
Surgical item, during the final count or “check-out' or “out (e.g., rabbits) and primates (e.g., humans, chimpanzees, and
bound' count, or for a period of time during a Surgical pro monkeys). In certain embodiments, the Subjects, e.g.,
cedure, such as 30 minutes, or 60 minutes, or the entire patients, are humans.
duration of the procedure, etc. 40 Utility
In some embodiments, tracking of a Surgical sharp object, The methods and devices of the subject invention can be
a Surgical instrument or a sponge is accomplished via mul used with any Surgical or other invasive procedure, including
tiple detection events (e.g., the Surgical item is detected at the but not limited to procedures conducted in the operating
beginning and end of a Surgical procedure), or by continuous room, or outpatient Surgery center, or any procedure where
Video monitoring (e.g., the Surgical item is placed on a sterile 45 correct counts of Surgical items is desired. As discussed
back table, and is continuously monitored during a Surgical above, the counts of Surgical items can be continuously moni
procedure). In some embodiments, tracking of a Surgical tored, however a record of the counts at any point in time
sharp object, a Surgical instrument or a sponge can include during the procedure or operation, for example, with verify
both single detection events as well as continuous video ing electronic signatures, can be performed before Surgery
monitoring. 50 begins, after Surgery has concluded, or at any time during the
In the Subject invention, identifying and/or tracking can be procedure. Counts can also be performed before any type of
done with a detector, such as a hand-held or mounted detec hollow organ closure (e.g., closure of an intestinal loop, car
tion device. One or more detectors can be used by the oper diac chamber, peritoneum, etc.) or before wound or skin
ating room personnel to count each Surgical item at the begin closure, etc.
ning of a Surgical procedure. For example, a hand-held 55 Currently, most hospitals have policies in effect requiring
detection device enclosed in a sterile disposable case can be that Surgical personnel visually and audibly count the
used to detect a labeled item; e.g., a 1D or 2D unique barcode sponges and other textile-based objects, the Surgical instru
previously laser etched onto an instrument itself. The initial ments, and the Surgical needles and other sharp objects and
count may be performed of the actual object (e.g., Metz then hand record the results of the counts to prevent the
Scissors) or its packaging (e.g., a package containing ten 3-0 60 retention of a sponge, instrument or sharp object. Depending
needles). Once completed, the count can be electronically on the complexity and length of time of the operation, current
accepted by operating room personnel Such as the scrub nurse counting methods take two nurses approximately 15-30 min
and circulating nurse. Electronic acceptance of a count can be utes of audible manual counting per count per operation. The
an electronic record of the accepted count, or a paper record opportunities for errors in the count are numerous and obvi
of the count can be generated, or both an electronic and a 65 ous in a system designed to rely on human manual counting
paper record. The electronic or paper records can comply and pencil and paper recording methods alone. In addition,
with any legally mandated privacy laws and regulation (e.g., the needles and sharp objects have to be kept on the field for
 US 9, 168,104 B2
35 36
ongoing and final counting, even though they are not to be counting protocol requires the agreement by two members of
used again, which increases the risk of exposure to injury and the operating room staff on the initial and final counts and any
blood-borne illness. changes during the operation, similar to the methods of the
The automated nature of the current system utilizes highly Subject invention. Additionally, using the current system, no
accurate methods of detection, recordkeeping and records of 5 particular placement or arrangement of instruments on the
operating room personnel, in a time-stamped non-alterable Surgical table is needed, in contrast to methods which use
manner. Responsibility for the counts is clear, and avoids the mechanical tray counting systems or other sensing modalities
need for later reconstruction of who might or might not have dependent upon a particular spatial arrangement. The current
been present in the operating room during any particular part system permits the Surgical personnel to place the items as
of the operation. Any decisions made by the Surgeon in cases 10
desired, according to current protocol in all operating rooms.
of a count discrepancy is similarly recorded, making any The ability to place instruments, etc., in their accustomed
future medicolegal question about the reporting or non-re positions is advantageous because the arrangement of Surgi
porting of results and decisions regarding incorrect counts cal implements in most operating rooms is determined by the
easily retrievable. The accuracy and designation of responsi
bility for the counts and decisions affected by the count are all 15 personal preference of the Scrub nurse. Using the current
improved by the Subject methods and system. methods, the Scrub nurse or technician is not required to
Most importantly, the chances for errors are reduced and re-train or follow a particular protocol, which could affect the
the likelihood of incorrect counts reduced. Safety is greatly Surgeon’s call for particular items. The current methods
enhanced for the patient, who is less likely to be exposed to enhance the safety and speed of the operation as the scrub
unnecessary radiation to detect a retained foreign body. The personnel are not preoccupied with manual counting while
patient is also less likely to be subjected to an unnecessary still carrying on the physical actions of the operation, which
re-exploration of the body cavity. In addition, safety is present day counting processes require.
enhanced for all patients, because the time spent in the oper Computer Readable Storage Medium
ating room counting and recounting Surgical items is reduced, Aspects of the invention further include physical storage
thereby reducing operating time for all procedures. The cur 25 medium containing programming or instructions for carrying
rent system also decreases the likelihood of complications one or more of the tasks of a system of the invention, e.g., as
from a retained Surgical foreign body, because the incidence described above. “Computer readable storage medium' as
of retained Surgical foreign bodies is reduced. In addition, used herein refers to any storage or transmission medium that
increased accuracy of the count improves the safety of the participates in providing instructions and/or data to a com
operating room staff who will face less radiation exposure 30
puter for execution and/or processing. Examples of storage
and less exposure to blood contaminated items, especially the media include floppy disks, magnetic tape, USB, CD-ROM, a
sponges and sharp objects which are presently counted and hard disk drive, a ROM or integrated circuit, a magneto
recounted manually several times during an operation. optical disk, or a computer readable card such as a PCMCIA
Finally, the clear time-stamped unalterable nature of the
count information and the display of the information in cur 35 card and the like, whether or not such devices are internal or
rent time during the operation make the recordkeeping of the external to the computer. A file containing information may
count and the clear acceptance of responsibility automatic. be “stored on computer readable medium, where “storing
The enhanced medical record and medico-legal record of the means recording information Such that it is accessible and
Surgical items counted are a further benefit as the responsi retrievable at a later date by a computer. A file may be stored
bility of the decision makers is automated and accepted in real 40 in permanent memory.
time as the decisions are made. The overall result is a safer With respect to computer readable media, “permanent
operation for the patient and for the operating room personnel memory” refers to memory that is permanently stored on a
and less medico-legal exposure for the institution. data storage medium. Permanent memory is not erased by
The official record of the count can also be used for inven termination of the electrical Supply to a computer or proces
tory, billing, ordering, electronic medical record-keeping, or 45 sor. Computer hard-drive ROM (i.e. ROM not used as virtual
medico-legal purposes. For example, the inventory control of memory), CD-ROM, floppy disk and DVD are all examples
various sizes and/or types of instruments, etc., may be of permanent memory. Random Access Memory (RAM) is an
improved by integrating the scanned data can be transmitted example of non-permanent memory. A file in permanent
directly to the hospital inventory control system or to the memory may be editable and re-writable.
appropriate product vendor for automatic reordering. 50
To “record data, programming or other information on a
For medical record-keeping or medico-legal purposes, a computer readable medium refers to a process for storing
record of the assignment of responsibility for Surgical item information, using any convenient method. Any convenient
counts can include Verbal recorded agreement assigned by data storage structure may be chosen, based on the means
machine and accepted at the conclusion of the procedure by used to access the stored information. A variety of data pro
barcode reading or by Voice recognition of digitally recorded 55
voices of the personnel involved. Ultimately, all of the perti cessor programs and formats can be used for storage, e.g.
nent information of the count, the responsible parties per word processing text file, database format, etc.
forming the count and results of decisions based upon the A “memory” or “memory unit refers to any device which
count results are easily placed in the digital electronic medi can store information for Subsequent retrieval by a processor,
cal record produced by the central processing unit at the 60 and may include magnetic or optical devices (such as a hard
completion of the operation. Counting errors, recording disk, floppy disk, CD, or DVD), or solid state memory devices
errors, and even handwriting errors are thus eliminated pro (such as volatile or non-volatile RAM). A memory or memory
viding documentation easily retrieved for medical or medico unit may have more than one physical memory device of the
legal reasons. same or different types (for example, a memory may have
The current system also fits well with currently accepted 65 multiple memory devices such as multiple hard drives or
protocols, which leads to ease of use and acceptance of the multiple solid state memory devices or some combination of
system by operating room personnel. For example, current hard drives and solid state memory devices).
 US 9, 168,104 B2
37 38
The following examples are offered by way of illustration team consists of three operating room nurses, two Surgeons,
and not by way of limitation. and an anesthesiologist. The operating room nurses are
responsible for tracking all of the Surgical items to be used
EXPERIMENTAL during the Surgical procedure, including instruments (e.g.,
clamps, forceps, etc.), sharp objects (e.g., Scalpels, needles,
I. Current Operating Room Technique etc.), and sponges used during the Surgery or Surgical proce
A patient is prepped for an abdominal Surgical procedure dure.
and brought into the operating room. The operating room A tracking system as disclosed in FIGS. 14 and 15 is used
team consists of three operating room nurses, two Surgeons, to track the Surgical items used for the abdominal Surgical
and an anesthesiologist, who are also present in the operating 10
procedure. As the nurses prepare for the Surgery, they register
room. The operating room nurses are responsible for tracking each of the Surgical items to be used with a hand-held Scanner.
the all of the Surgical items to be used during the Surgical Specifically, a sterile hand-held scanner 1570 is used for the
procedure, including instruments (e.g., clamps, forceps, etc.),
sharp objects (e.g., Scalpels, needles, etc.), and sponges used "inbound count of all Surgical instruments, needles, scalpel
during the Surgery or Surgical procedure. Surgical instru 15 blades, sponges, pads and other Surgical items, which are
ments, needles, scalpel blades, sponges, pads and other lined up on asteriletray. The number and type of each Surgical
objects are lined up on a sterile receptacle or tray and the item is scanned into the system.
number and type of each Surgical item is counted. The total As each of the items is registered, the nurses double check
count of instruments is over 200 individual items, the total the information as it appears on the display unit 1550 of the
count of needles and sharp items is also over 200 individual tracking system, visible to all operating room personnel. For
items, and the total count of sponges is over 600 individual each of the items registered, the following information is
items to be counted. displayed: 1) the type of item (e.g., needle, clamp, sponge); 2)
An initial count of the instruments, needles and other sharp the time the item is placed into (i.e., “checked in') the track
objects, and Sponges is done by the Scrub nurse by visual and ing system; 3) the location of the item being registered; 4) the
audible counting, which is witnessed visually by the circulat 25 unique identifier assigned to each item; and 5) the total num
ing nurse. The initial count takes approximately 25 minutes. ber of each item currently registered in the tracking system.
The count data for each of the surgical items is entered by Once all of the items are registered, two operating room
pencil into a chart on a clipboard. Once all of the items have nurses verify the initial count and enter their time-stamped
been counted and recorded, the Surgery begins. electronic signatures. The Surgery then begins. The time for
Twice during the Surgery when there is a change in person 30
the initial count is 10 minutes.
nel, the count of all the Surgical implements is repeated by two As each item is used during surgery, the tracking system
of the nurses. Each additional count takes 20 minutes each.
During the operation, all instruments, unless they become tracks the current location of the item, as well as whether the
contaminated, are kept either in the operating field on the item has been removed from the tracking system, or “checked
sterile back table. Used sponges, once saturated with blood or 35 out'. For example, as one of the nurses hands a scalpel to a
other body fluids, are placed into a bucket to be manually Surgeon, the tracking system senses that the scalpel has been
separated and counted by the non-scrubbed, non-sterile or moved from the sterile back table, because the camera 1480
circulating operating room personnel. The discarded sponges over the sterile table will have the count of scalpels reduced
are then packaged for later recounts in a clear plastic shoe by one, while the sensor camera/reader 1460 over the oper
rack device. Previously used needles and sharps are kept on 40 ating table will register an increase by one of the number of
a magnetic or spongy platform, so that they are available for scalpels. The time of the transfer of location is also registered.
repeat counts as personnel change or as discrepancies in When the surgeon has finished with the scalpel, the nurse
counts arise. The recounts provide opportunity for injury to returns the scalpel to the sterile back table. The new location
staff. Before the stomach is closed, a fourth count which takes for that individual scalpel is registered, as well as time of
20 minutes is performed, and verified by two operating room 45 transfer. In another example, when a 2-0 silk needle is
personnel. returned by the Surgeonto the nurse, the used needle is placed
At the end of the Surgery, prior to wound closure, the count into the sterile sharps automated shape recognition disposal
is performed for a fifth time. During this count, there is a container 1410, on the back table. The imaging device in the
discrepancy in the number of sponges and it appears that one sharps container identifies the discarded needle as a 2-0 silk
is missing. The Surgeon is informed, and a search is begun for 50 needle, and the tracking system registers the new location and
the missing sponge. When the missing sponge cannot be time of deposition of the 2-0 silk needle into the sharps
located, the count is repeated. The final count of each of the container. The auxiliary display on the sterile sharps con
Surgical items matches the initial count and the Surgeon tainer notes the addition of the 2-0 needle to the container, and
decides to accept the final count as the accurate count. The registers the current total of 4 needles in the container. Simi
Surgery is then completed. 55 larly, a discarded sponge is dropped by the circulating nurse
In cases where the discrepancy persists after recounting, into a non-sterile sponge disposal unit 1580 on the floor. As
the surgeon must decide to whether or not to explore the the sponge passes into the container, the camera/reader scans
wound to locate the missing sponge. The Surgeon may order the sponge, and the tracking system registers the sponge as off
an X-ray examination of the patient on the operating room the field, or “checked out” by the circulating nurse.
table to rule out the presence of the radio-opaque labeled 60 For each Surgical item, each of these steps is performed.
sponge. If the patient is unstable, the Surgeon may feel it is in During the operation, the system Software continuously
the best interest of the patient to complete the operation and tracks the surgical items that have been registered with the
transfer the patient out of the operating room. tracking system. For example, if 50 clamps, 50 forceps, 70
II. Automated Correct Count scalpel blades, 70 needles, and 200 sponges have been regis
Use of Tracking System in a Surgical Procedure 65 tered, the system maintains continuous track of the location of
A patient is prepped for an abdominal Surgical procedure each item registered. At any one time, of 70 needles regis
and brought into the operating room. The operating room tered, there may be 60 needles located on the sterile back
 US 9, 168,104 B2
39 40
table, one needle in the Surgeons hand on the operating table, The prototype was able to correctly identify the type of
and 9 needles that have been placed in the sharps disposable needle approximately 99% of the time, even when the needles
container. were overlapping.
There is a change in personnel twice during the Surgery. V. Automated Shape Recognition of Surgical Sharp Objects
During each of those times, the tracking system display unit with a Disposable Sharps Container
1550 is checked to verify that all surgical items are accounted A tracking system as disclosed in FIGS. 14 and 15 which
for, and two operating room personnel Verify the current includes sterile sharps automated shape recognition disposal
count and enter their time-stamped electronic signatures. The container 1410 is used to track the surgical items used for a
time for this “count” and verification process takes two min Surgical procedure. At the start of the Surgical procedure,
utes. 10 seven different types of Surgical needles are programmed into
At the end of the Surgery, prior to wound closure, a nurse the system's automated shape recognition software program.
checks the tracking system display unit, and finds that the As the nurses prepare for the Surgery, they register each
current counts are correct, and no Surgical items are missing. package of needles to be used with the tracking system, using
The two operating room nurses responsible for the count both sterile hand-held scanner 1570. As each package of needles is
Verify the tracking system display monitor counts by entering 15 registered using the barcode on the outside of the package, the
their time-stamped electronic signatures. The operating Sur nurses double check the information as it appears on the
geons then close the wound and the Surgery is successfully display unit 1550 of the tracking system, visible to the oper
completed. ating room personnel. For each of the items registered, the
III. Automated Incorrect Count following information is displayed: 1) the type of needle; 2)
The operation initially proceeds as in Example II above, the time the package of needles is registered by the tracking
except that 60 minutes into the operation an alarm sounds. system; 3) the location of the package of needles being reg
After checking the display unit, it is determined that an item istered; 4) a unique identifier assigned to each package of
is missing. The operating room personnel check the informa needles; and 5) the total number of each individual item
tion provided on display unit 1550 for the identification of the currently registered in the sensor System (e.g., a package of
item, and it is determined that a 5-0 needle is missing. The 25 five 4-0 needles registers as a total count offive individual 4-0
display unit also shows that the particular 5-0 needle was last needles). Once all of the needles and other surgical items have
registered as being present on the operating table. The nurse been registered, two operating room personnel Verify the
locates the 5-0 needle underneath a fold in the surgical drapes. initial count and enter their time-stamped electronic signa
The needle is then placed into the sterile sharps automated tures. The Surgery then begins.
shape recognition disposal container 1410, which identifies 30 A total of three of the five 4-0 needles is used during the
the needle as a 5-0 needle. The tracking system display unit procedure. As the three used needles are placed individually
then registers the time-stamped new location of the missing into the sterile sharps automated shape recognition disposal
5-0 needle. The total needle count is determined to be correct. container 1410, equipped with imaging device 1420, the Sur
The two operating room nurses responsible for the count gical sharp object automated shape recognition module iden
both verify the tracking system display monitor counts by 35 tifies each needle correctly as a "4-0 as it is dropped into the
entering their time-stamped electronic signatures. The oper container by an operating room nurse. The tracking system
ating Surgeons then close the wound and the Surgery is suc display unit registers all three needles as being located in the
cessfully completed. disposable container, along with a time-stamp of the time the
IV. Automated Shape Recognition of Surgical Sharp Objects needles were placed into the container.
Seven types of Surgical needles were evaluated using auto 40 At the conclusion of the procedure, the tracking system
mated shape recognition. The seven needle types included an display unit indicates that two of the 4-0 needles are located
EthiconTM2 ProleneTM 65 mm TP-1 tapered needle, an Ethi on the sterile back table, as detected by the overhead mounted
conTM 7-0 ProleneTM 9 mm BV-1 tapered needle, an Ethi camera 1480. The display unit also indicates that three of the
conTM 2-0 Silk 26 mm SH tapered needle, an EthiconTM 2-0 4-0 needles are located in the sterile sharps automated shape
Temporary pacing wire 22 mm BB-1 tapered needle, a SKS-3 45 recognition disposal container 1410. Prior to suturing the
89 mm straight cutting needle, a MedtronicTM Streamline wound closed, the needle count (and remainder of the Surgical
Unipolar temporary atrial pacing lead, and a DeknatelTM 3-0 item count, e.g., instruments, other types of needles, and
17.4 mm TevdekR) polyester fiber AT-2/2 circle tapered sponges or lap pads) is determined to be correct. The two
needle. operating room nurses responsible for the count both verify
The seven needle types were programmed into the Cog 50 the tracking system display unit counts by entering their
nexTM Insight-ExplorerTM Vision machine vision software. A time-stamped electronic signatures. The operating Surgeons
CognexTM Insight Micro Smart CameraTM, vision camera was then close the wound and the Surgery is successfully com
mounted above a platform. The needles were placed one by pleted.
one onto a platform which was backlit by a battery operated Although the foregoing invention has been described in
light. The seven needles were placed sequentially on the 55 Some detail by way of illustration and example for purposes
platform. of clarity of understanding, it is readily apparent to those of
The machine vision software was able to count only the ordinary skill in the art in light of the teachings of this inven
new additions of needle, by obtaining images of the platform tion that certain changes and modifications may be made
every 80 milliseconds. When a new needle was added to the thereto without departing from the spirit or scope of the
field of view, comparison of the image obtained just prior to 60 appended claims. It is also to be understood that the termi
the addition of the new needle with the image obtained after nology used herein is for the purpose of describing particular
the addition of the new needle was made. The images were embodiments only, and is not intended to be limiting, since
then subtracted from each other. The machine vision software the scope of the present invention will be limited only by the
was able to identify only the newly added needle, as the appended claims.
previously identified needles were discounted. This method 65 Accordingly, the preceding merely illustrates the prin
worked even as the needles were dropped on top of each other, ciples of the invention. It will be appreciated that those skilled
Such that the needles were overlapping. in the art will be able to devise various arrangements which,
 US 9, 168,104 B2
41 42
although not explicitly described or shown herein, embody 12. The system according to claim 1, wherein the intra
the principles of the invention and are included within its operative imaging device is configured to obtain the surgical
spirit and scope. Furthermore, all examples and conditional sharp object image data before, during and after a surgical
language recited herein are principally intended to aid the procedure.
reader in understanding the principles of the invention and the 5 13. The system according to claim 1, wherein the intra
concepts contributed by the inventors to furthering the art, operative surgical sharp object image data comprises still
and are to be construed as being without limitation to such image or Video image data.
specifically recited examples and conditions. Moreover, all 14. The system according to claim 1, wherein identifying a
Statements herein reciting principles, aspects, and embodi Surgical sharp object from the intra-operative surgical sharp
ments of the invention as well as specific examples thereof, 10 object image data comprises a step of manipulating the intra
are intended to encompass both structural and functional operative surgical sharp object image data to reduce noise or
equivalents thereof. Additionally, it is intended that such performing binarization.
equivalents include both currently known equivalents and 15. The system according to claim 1, wherein identifying a
equivalents developed in the future, i.e., any elements devel Surgical sharp object from the intra-operative surgical sharp
oped that perform the same function, regardless of structure. 15 object image data comprises pixel counting, thresholding,
The scope of the present invention, therefore, is not intended segmentation, pattern recognition, detection of an angle or
to be limited to the exemplary embodiments shown and curve, measurement of an area or size, determination of an
described herein. Rather, the scope and spirit of present aspect ratio, edge detection, outline or silhouette detection,
invention is embodied by the appended claims. color recognition, template matching, or combinations
What is claimed is: 2O
1. A system for intra-operatively identifying a surgical thereof.
sharp object, the system comprising: 16. The system according to claim 1, wherein identifying a
an intra-operative imaging device for obtaining intra-op Surgical sharp object from the intra-operative surgical sharp
erative surgical sharp object image data comprising one object image data comprises employing pre-existing surgical
or more of a shape, size or outline of at least one surgical 25 sharp object data in an automated shape recognition protocol.
sharp object; and 17. The system according to claim 1, wherein the obtained
a Surgical sharp object automated shape recognition mod intra-operative surgical sharp object image data comprises
ule comprising a processor, a database of pre-existing the shape of the at least one surgical sharp object.
Surgical sharp object image data comprising a shape of at 18. A method of intra-operatively identifying a surgical
least one surgical sharp object, wherein the automated 30 sharp object, the method comprising:
shape recognition module is configured to identify a obtaining a surgical sharp object from an operative sterile
Surgical sharp object from the intra-operative surgical field;
sharp object image data by comparing the intra-opera imaging the surgical sharp object with an intra-operative
tive surgical sharp object image data with the pre-exist imaging device to obtain image data comprising one or
ing Surgical sharp object image data; wherein the surgi- 35 more of a shape, size or outline of at least one surgical
cal sharp object is a needle and a curve formed by a sharp object; and
certain size of the needle is used to identify the needle forwarding the image data to a surgical sharp object auto
via the automated shape recognition module. mated shape recognition module comprising a proces
2. The system according to claim 1, wherein the intra Sor, a database of pre-existing surgical sharp object
operative imaging device is part of a surgical sharp object 40 image data comprising a shape of at least one surgical
disposal container and wherein the intra-operative imaging sharp object, wherein the automated shape recognition
device is configured to obtain the intra-operative surgical module is configured to identify the surgical sharp
sharp object image data of at least one surgical sharp object object from the intra-operative surgical sharp object
within the disposal container. image data by comparing the intra-operative surgical
3. The system according to claim 2, wherein the surgical 45 sharp object image data with the pre-existing surgical
sharp object automated shape recognition module is part of sharp object image data; wherein the surgical sharp
the Surgical sharp object disposal container. object is a needle and a curve formed by a certain size of
4. The system according to claim 3, wherein the surgical the needle is used to identify the needle via the auto
sharp object automated shape recognition module is config mated shape recognition module.
ured to dynamically identify the surgical sharp object. 50 19. A Surgical sharp object disposal container comprising:
5. The system according to claim 1, wherein the surgical an intra-operative imaging device for obtaining intra-op
sharp object automated shape recognition module comprises erative surgical sharp object image data comprising one
an assisted identification algorithm. or more of a shape, size or outline of at least one surgical
6. The system according to claim 1, wherein the intra sharp object; and
operative imaging device is positioned to image surgical 55 a surgical sharp object automated shape recognition mod
sharp objects placed onto a sterile table. ule comprising a processor, a database of pre-existing
7. The system according to claim 1, wherein the intra Surgical sharp object image data comprising a shape of at
operative imaging device is a hand-held imaging device. least one surgical sharp object, wherein the automated
8. The system according to claim 1, wherein the system is shape recognition module is configured to identify a
configured to track a surgical sharp object. 60 Surgical sharp object from the intra-operative surgical
9. The system according to claim 1, wherein the system sharp object image data by comparing the intra-opera
further comprises one or more detectors. tive surgical sharp object image data with the pre-exist
10. The system according to claim 1, wherein the system is ing surgical sharp object image data; wherein the surgi
further configured to identify surgical sponge identifier cal sharp object is a needle and a curve formed by a
labels. 65 certain size of the needle is used to identify the needle
11. The system according to claim 1, wherein the system via the automated shape recognition module.
further comprises a display unit. ck ck sk sk *k