Apparatus and methods for monitoring objects in a surgical field

• US 8,181,860 B2
• Filed: 09/13/2007
• Issued: 05/22/2012
• Est. Priority Date: 09/13/2006
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Clearcount Medical Solutions Incorporated (Stryker Corporation)
• Inventors: Fleck, Steven, Szakelyhidi, David, Gandhi, Gautam
• Primary Examiner(s): LEE, SEUNG H
• Application Number:
  US11/901,094
• Publication Number:
  US 20080237341A1
• Time in Patent Office: 1,713 Days
• Field of Search: 235/375, 235/376, 235/383, 235/385, 235/462.01, 23547201-47203, 235/476, 235/487, 340/572.1, 340/568.1
• US Class Current: 235/380
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2050/0056 about a lateral axis in the lid plane
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2090/0805 automatically, e.g. by means of magnetic, optical or photoelectric detectors
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 50/10 Furniture specially adapted for surgical or diagnostic appliances or instruments
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/36 for collecting or disposing of used articles
• CPC Class Codes: A61B 50/37 for absorbent articles, e.g. bandages, garments, swabs or towels
• CPC Class Codes: A61B 90/08 Accessories or related features not otherwise provided for
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61F 13/36 Surgical swabs, e.g. for absorbency or packing body cavities during surgery A61F13/38 takes precedence
• CPC Class Codes: A61F 13/44 with radio-opaque material or signalling means for residual material
• CPC Class Codes: A61G 13/10 Parts, details or accessories surgical drape sheets A61B46/00
• CPC Class Codes: A61G 13/12 Rests specially adapted therefor; Arrangements of patient-supporting surfaces rests for the surgeon A61B90/60; restraining devices A61F5/37
• CPC Class Codes: A61G 2205/10 : Bar codes
• CPC Class Codes: A61G 7/0502 : Dispensers of disposable sheets
• CPC Class Codes: G06K 7/01 : Details
• CPC Class Codes: G06K 7/10316 : using at least one antenna particularly designed for interrogating the wireless record carriers antennas in general H01Q1/22
• CPC Class Codes: G06K 7/10366 : the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: G06K 7/10386 : the interrogation device being of the portable or hand-handheld type, e.g. incorporated in ubiquitous hand-held devices such as PDA or mobile phone, or in the form of a portable dedicated RFID reader
• CPC Class Codes: G06K 7/10425 : the interrogation device being arranged for interrogation of record carriers passing by the interrogation device
• CPC Class Codes: G06K 7/10475 : arrangements to facilitate interaction with further interrogation devices, e.g. such that at least two interrogation devices may function and cooperate in a network of such devices
• CPC Class Codes: G06Q 10/087 : Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G06Q 10/0875 : Itemisation or classification of parts, supplies or services, e.g. bill of materials
• CPC Class Codes: H01Q 1/2216 : used in interrogator/reader equipment

Abstract

Apparatus and methods for identifying and counting objects having identifiers entering and exiting a surgical field are provided. In one embodiment, the apparatus has an entry scanner, a hand held scanner and an exit scanner for generating a detection field and for receiving data which identifies said objects. In another embodiment, the apparatus has a plurality of lower antennas and an upper antenna for generating a detection field and for receiving data which identifies said objects. Various surgical devices with identifiers and methods for preventing electromagnetic coupling between and protecting objects and identifiers are also provided. The invention further provides apparatus and methods comprising a handheld scanner and a mat adapted to underlie a patient during a surgical procedure.

Claims

1. Scanning apparatus comprising:

a housing;

an object entry detection zone adapted to receive surgical sponges prior to introduction into a surgical site;

at least one entry scanner operatively associated with said entry detection zone and adapted to inspect said surgical sponges using RF identifiers of said surgical sponges, wherein the entry scanner is configured to detect a sponge identifier and a package identifier;

an object exit detection zone adapted to receive surgical sponges discarded after exit from said surgical site;

at least one exit scanner operatively associated with said exit detection zone and adapted to inspect said surgical sponges using the RF identifiers of said surgical sponges regardless of the orientation of said surgical sponges;

control circuitry operatively associated with said scanners and adapted to control the operation of said scanners, wherein said control circuitry is further adapted to;

store data regarding the number, identity, and package association of said surgical sponges prior to introduction into said surgical site;

perform a consistency check for each package detected using the package identifiers and determined quantities associated with the package identifiers, wherein an alert is issued when a number of sponges associated with a package identifier does not match the determined quantity associated with the package identifier;

store data regarding the number and identity of said surgical sponges after exit from said surgical site;

compare said data regarding said number and identity of surgical sponges inspected by said entry scanner with said data regarding said number and identity of surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site; and

initiate an alarm if, at the end of a surgical procedure, said comparison determines that not all surgical sponges entering the surgical site have exited the surgical site.

2. The scanning apparatus of claim 1, wherein said entry scanner has at least one entry antenna adapted to:

emit a detection field to activate the RF identifiers of said surgical sponges to facilitate counting and identifying said surgical sponges.

3. The scanning apparatus of claim 2, wherein the control circuitry is adapted to control the relative power, tuning, or phasing of signals of at least one entry antenna with respect to at least one other of said entry antennas.

4. The apparatus of claim 1, wherein the control circuitry is further adapted to store data regarding a type of said surgical sponges prior to introduction into the surgical site and the type of said surgical sponges after exit from said surgical site;

and

compare said data regarding said type of surgical sponges inspected by said entry scanner with said data regarding said type of surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site.

5. The apparatus of claim 1, wherein the control circuitry is further adapted to store data regarding the package identifier of said surgical sponges after exit from said surgical site;

and

compare said data regarding said package identifier of surgical sponges inspected by said entry scanner with said data regarding said package identifier of surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site.

6. The apparatus of claim 1, wherein said object exit detection zone comprises a bag or a bucket.

7. The apparatus of claim 1, further comprising a display, wherein the display includes the number of sponges introduced to the surgical site and the number of sponges removed from the surgical site.

8. The apparatus of claim 7, wherein the display is separate from the housing.

9. The apparatus of claim 1, wherein the alarm comprises an indicator on a display.

10. The scanning apparatus of claim 1, wherein a display is operatively associated with said control circuitry for displaying at least a part of the information stored by said control circuitry.

11. The scanning apparatus of claim 1, wherein said determined quantity associated with the package identifier is based on a quantity identifier detected from the RF identifier.

12. The scanning apparatus of claim 1, wherein said determined quantity associated with the package identifier is based on the package identifier.

13. A method comprising:

detecting surgical sponges introduced into a surgical site through an entry detection zone, at least one of said surgical sponges comprising an RF identifier adapted to store information;

said detecting including inspecting an RF identifier of at least one of said surgical sponges using at least one entry scanner operatively associated with said entry detection zone, wherein the entry scanner is configured to detect a sponge identifier and a package identifier;

receiving surgical sponges discarded through an exit detection zone;

inspecting an RF identifier of at least one of said surgical sponges using at least one exit scanner operatively associated with said exit detection zone;

controlling the operation of said scanners using control circuitry operatively associated with said scanners, wherein said controlling includes;

storing data regarding the number, identity, and package association of said surgical sponges prior to introduction into said surgical site;

performing a consistency check for each package detected using the package identifiers and determined quantities associated with the package identifiers, wherein an alert is issued when a number of sponges associated with a package identifier does not match the determined quantity associated with the package identifier;

storing data regarding the number and identity of said surgical sponges after exit from said surgical site;

comparing said data regarding said number and identity of said surgical sponges inspected by said entry scanner with said data regarding said number and identity of said surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site; and

initiating an alarm when said comparing determines that not all surgical sponges entering said surgical site have exited said surgical site.

14. The method of claim 13, wherein said controlling further includes:

storing data regarding a type of said surgical sponges prior to introduction into the surgical site and the type of said surgical sponges after exit from said surgical site; and

comparing said data regarding said type of surgical sponges inspected by said entry scanner with said data regarding said type of surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site.

15. The method of claim 13, wherein said controlling further includes:

storing data regarding the package identifier of said surgical sponges after exit from said surgical site; and

comparing said data regarding said package identifier of surgical sponges inspected by said entry scanner with said data regarding said package identifier of surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site.

16. The method of claim 13, wherein said object exit detection zone comprises a bag or a bucket.

17. The method of claim 13, further comprising displaying the number of sponges introduced to the surgical site and the number of sponges removed from the surgical site on a display.

18. The method of claim 17, wherein the display is separate from the housing.

19. The method of claim 13, wherein initiating an alarm comprises displaying an indicator on a display.

20. The method of claim 13, further comprising:

detecting a tagged sponge by the exit scanner that has not been inspected by the at least one entry scanner associated with an entry zone;

determining the package identifier corresponding to the not inspected sponge;

determining the quantity of sponges that is typically delivered in each package type associated with the not inspected package identifier;

determining how many sponges associated with the not inspected package identifier have been scanned by the exit scanner; and

displaying the expected quantity of each sponge type of the not inspected package identifier that remains undiscarded.

21. The method of claim 20, further comprising:

initiating an alarm when the expected quantity of each sponge type of the not inspected package identifier that remains undiscarded does not equal zero.

22. A computer-implemented system, comprising:

a data processor;

a computer-readable memory encoded with instructions for commanding the data processor to execute steps including;

detecting surgical sponges introduced into a surgical site through an entry detection zone, at least one of said surgical sponges comprising an RF identifier adapted to store information;

said detecting including inspecting an RF identifier of at least one of said surgical sponges using at least one entry scanner operatively associated with said entry detection zone, wherein the entry scanner is configured to detect a sponge identifier and a package identifier;

receiving surgical sponges discarded through an exit detection zone;

inspecting an RF identifier of at least one of said surgical sponges using at least one exit scanner operatively associated with said exit detection zone;

controlling the operation of said scanners using control circuitry operatively associated with said scanners, wherein said controlling includes;

storing data regarding the number, identity, and package association of said surgical sponges prior to introduction into said surgical site

performing a consistency check for each package detected using the package identifiers and determined quantities associated with the package identifiers, wherein an alert is issued when a number of sponges associated with a package identifier does not match the determined quantity associated with the package identifier;

storing data regarding the number and identity of said surgical sponges after exit from said surgical site;

comparing said data regarding said number and identity of said surgical sponges inspected by said entry scanner with said data regarding said number and identity of said surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site; and

initiating an alarm when said comparing determines that not all surgical sponges entering said surgical site have exited said surgical site.

23. A computer readable memory encoded with instructions for commanding a data processor to execute steps including:

detecting surgical sponges introduced into a surgical site through an entry detection zone, at least one of said surgical sponges comprising an RF identifier adapted to store information;

said detecting including inspecting an RF identifier of at least one of said surgical sponges using at least one entry scanner operatively associated with said entry detection zone, wherein the entry scanner is configured to detect a sponge identifier and a package identifier;

receiving surgical sponges discarded through an exit detection zone;

inspecting an RF identifier of at least one of said surgical sponges using at least one exit scanner operatively associated with said exit detection zone;

controlling the operation of said scanners using control circuitry operatively associated with said scanners, wherein said controlling includes;

storing data regarding the number, identity, and package association of said surgical sponges prior to introduction into said surgical site;

performing a consistency check for each package detected using the package identifiers and determined quantities associated with the package identifiers, wherein an alert is issued when a number of sponges associated with a package identifier does not match the determined quantity associated with the package identifier;

storing data regarding the number and identity of said surgical sponges after exit from said surgical site;

comparing said data regarding said number and identity of said surgical sponges inspected by said entry scanner with said data regarding said number and identity of said surgical sponges inspected by said exit scanner to determine if all surgical sponges entering said surgical site have been removed from said surgical site; and

initiating an alarm when said comparing determines that not all surgical sponges entering said surgical site have exited said surgical site.