# US 10,765,563 B2 · Intra-operative system for identifying and tracking surgical sharp objects, instruments, and sponges

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- Number: US 10,765,563 B2
- Document ID: US10765563B2
- Status: Granted
- Kind: B2
- Application number: 14/861,106
- Filed: 2015-09-22
- Published: 2016-03-17
- Granted: 2020-09-08
- Earliest claimed: 2008-06-23
- Assignees: John Richard Dein
- Applicants: John Richard Dein
- Inventors: John Richard Dein
- Web page: https://patentgrep.com/patent/US10765563B2

## CPC

- A61F 13/44: with radio-opaque material or signalling means for residual material
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 50/20: Holders specially adapted for surgical or diagnostic appliances or instruments (drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02)
- A61B 50/36: for collecting or disposing of used articles
- A61B 50/362: {for sharps}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 90/94: coded with symbols, e.g. text
- A61B 90/96: using barcodes
- A61B 90/98: using electromagnetic means, e.g. transponders
- A61B 46/10: specially adapted for instruments{, e.g. microscopes}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2090/0805: {automatically, e.g. by means of magnetic, optical or photoelectric detectors}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Intra-operative systems for identifying surgical sharp objects are provided. Aspects of the systems include an intra-operative imaging device for obtaining intra-operative surgical sharp object image data; and a surgical sharp object automated shape recognition module configured to identify a surgical sharp object from intra-operative surgical sharp object image data. Systems of the invention may further include additional components, such as surgical instrument and/or sponge identification and tracking devices. Systems of the invention find use in a variety of methods and applications, including tracking of surgical items during a surgical procedure.

## Claims

### Claim 1

A method of intra-operatively identifying a used surgical sharp, the method comprising:
(a) obtaining an initial count and an initial type of surgical sharp objects, wherein the initial count of the surgical sharp objects comprises an initial count of each type of the surgical sharp objects;
(b) counting and identifying used surgical sharp objects obtained from an operative sterile field to obtain a count and an identification of the type of the used surgical sharp objects, wherein for each of the used surgical sharp objects said counting and identifying comprises:
(1) obtaining a used surgical sharp object from the operative sterile field by receiving the used surgical sharp object from a surgeon, wherein the used surgical sharp object is selected from the group consisting of a scalpel blade and a needle;
(2) imaging the used surgical sharp object with an intra-operative imaging device comprising a camera to obtain an intra-operative surgical sharp object image data of the used surgical sharp object; and
(3) forwarding the intra-operative surgical sharp object image data to a surgical sharp object automated shape recognition module comprising a processor and a database of pre-existing surgical sharp object image data, wherein the surgical sharp object automated shape recognition module counts and identifies the used surgical sharp object from the intra-operative surgical sharp object image data by comparing the intra-operative surgical sharp object image data with the pre-existing surgical sharp object image data, wherein a curvature of the imaged used surgical sharp object is used to identity the type of the used surgical sharp object via the surgical sharp object automated shape recognition module;
(c) comparing the count of each type of the used surgical sharp objects with the initial count of each type of the surgical sharp objects;
(d) outputting a result corresponding to each type of the identified and counted used surgical sharp objects; and
(e) activating a notification device to provide a notification if the count of each type of the used surgical sharp objects differs from the initial count of each type of the surgical sharp objects.

### Claim 2 (depends on 1)

The method according to claim 1, wherein imaging comprises placing the used surgical sharp object into a container configured for disposal of the used surgical sharp object.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the imaging comprises placing the used surgical sharp object onto a sterile table.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the intra-operative imaging device is a hand-held imaging device.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the method further comprises tracking a surgical sharp object.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the method further comprises tracking a surgical sponge.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the method further comprises displaying a result of said counting and comparing.

### Claim 8 (depends on 1)

The method according to claim 1, further comprising counting a number of a similar type of used surgical sharp objects, and comparing the number of the similar type of used surgical sharp objects to the initial count of the surgical sharp objects.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the intra-operative imaging device comprises the camera and a synchronizing sensor, and the imaging comprises detecting the presence of the used surgical sharp object with the synchronizing sensor and activating the camera to perform the imaging of the used surgical sharp object.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the surgical sharp objects comprise identifier labels for identifying the surgical sharp objects and performing the initial count of the surgical sharp objects.

### Claim 11 (depends on 5)

The method according to claim 5, wherein the tracking comprises continuously tracking the surgical sharp object within the operative sterile field.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the used surgical sharp object is a suture needle.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the notification device comprises an auditory alarm.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the notification device comprises a visual alarm.

### Claim 15 (depends on 1)

The method of claim 1, wherein the notification comprises a number associated with the difference between the count of used surgical sharp objects and the initial count of surgical sharp objects for each type of surgical sharp object.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the intra-operative surgical sharp object image data comprises a color of a suture attached to the needle.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the activating comprises a notification that the count of used surgical sharp objects matches the initial count of surgical sharp objects.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the curvature of the used surgical sharp object comprises an angle of a curve of the used surgical sharp object.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the curvature of the used surgical sharp object comprises a curve formed by a size of the used surgical sharp object.

### Claim 20

A method of intra-operatively identifying a used surgical sharp, the method comprising:
(a) obtaining an initial count and an initial type of surgical sharp objects, wherein the initial count of the surgical sharp objects comprises an initial count of each type of the surgical sharp objects;
(b) counting and identifying used surgical sharp objects obtained from an operative sterile field to obtain a count and an identification of the type of the used surgical sharp objects, wherein for each of the used surgical sharp objects said counting and identifying comprises:
(1) imaging a used surgical sharp object obtained from the operative sterile field with a system comprising a surgical sharp object container and an intra-operative imaging device comprising a camera to obtain an Intra-operative surgical sharp object image data of the used surgical sharp object, wherein the used surgical sharp object is one that has been received from a surgeon, the used surgical sharp object is selected from the group consisting of a scalpel blade and a needle, and the surgical sharp object container comprises a first portion comprising the intra-operative imaging device, a second portion configured to hold the used surgical sharp object, and an opening in the second portion for receiving the used surgical sharp object; and
(2) identifying the used surgical sharp object from the intra-operative surgical sharp object image data with a system comprising an automated shape recognition module comprising a processor and a database of pre-existing surgical sharp object image data, wherein the automated shape recognition module counts and identifies the used surgical sharp object from the intra-operative surgical sharp object image data by comparing the intra-operative surgical sharp object image data with the pre-existing surgical sharp object image data, wherein a curvature of the imaged used surgical sharp object is used to identify the type of the used surgical sharp object via the automated shape recognition module;
(c) comparing the count of each type of the used surgical sharp objects with the initial count of each type of the surgical sharp objects;
(d) outputting a result corresponding to each type of the identified and counted used surgical sharp objects; and
(e) activating a notification device to provide a notification if the count of each type of the used surgical sharp objects differs from the initial count of each type of the surgical sharp objects.

### Claim 21 (depends on 20)

The method according to claim 20, wherein imaging comprises placing the used surgical sharp object into a container configured for disposal of the used surgical sharp object.

### Claim 22 (depends on 20)

The method according to claim 20, wherein the imaging comprises placing the used surgical sharp object onto a sterile table.

### Claim 23 (depends on 20)

The method according to claim 20, wherein the intra-operative imaging device is a hand-held imaging device.

### Claim 24 (depends on 20)

The method according to claim 20, wherein the method further comprises tracking a surgical sharp object.

### Claim 25

A method of intra-operatively identifying a used surgical sharp, the method comprising:
(a) obtaining an initial count and an initial type of surgical sharp objects, wherein the initial count of the surgical sharp objects comprises an initial count of each type of the surgical sharp objects;
(b) counting and identifying used surgical sharp objects obtained from an operative sterile field to obtain a count and an identification of the type of the used surgical sharp objects, wherein for each of the used surgical sharp objects said counting and identifying comprises:
(1) detecting a used surgical sharp object obtained from the operative sterile field with a system comprising a surgical sharp object container and a detector to obtain data, wherein the used surgical sharp object is one that has been received from a surgeon, the used surgical sharp object is selected from the group consisting of a scalpel blade and a needle, and the surgical sharp object container comprises a first portion comprising the detector, a second portion configured to hold the used surgical sharp object, and an opening in the second portion for receiving the used surgical sharp object; and
(2) identifying the used surgical sharp object from the data with a system comprising a surgical sharp recognition module comprising a processor and a database of pre-existing surgical sharp object data, wherein the surgical shape recognition module counts and identifies the used surgical sharp object from the data by comparing the data with the pre-existing surgical sharp object data, wherein a curvature of the detected used surgical sharp object is used to identify the type of the used surgical sharp object via the surgical sharp recognition module;
(c) comparing the count of each type of the used surgical sharp objects with the initial count of each type of the surgical sharp objects;
(d) outputting a result corresponding to each type of the identified and counted used surgical sharp objects; and
(e) activating a notification device to provide a notification if the count of each type of the used surgical sharp objects differs from the initial count of each type of the surgical sharp objects.
