Apparatus and methods for monitoring objects in a surgical field

• US 8,479,989 B2
• Filed: 08/29/2012
• Issued: 07/09/2013
• 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:
  US13/597,817
• Publication Number:
  US 20130001305A1
• Time in Patent Office: 314 Days
• Field of Search: 235/375, 235/376, 235/385, 235/439, 235/449, 235/451, 23547201-47203, 340/540
• US Class Current: 235/385
• 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. A scanning apparatus, comprising:

a scanner adapted to detect a surgical instrument identifier associated with each of a plurality of surgical instruments in a package and a package identifier;

control circuitry configured to;

perform a package status check prior to use of the surgical instruments in a surgical field based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein the package status check is configured to;

perform a consistency check for a package detected using the package identifier and a determined quantity associated with the package identifier, and

issue an alert when a number of detected surgical instrument identifiers associated with the package identifier does not match the determined quantity associated with the package identifier.

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

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

4. The apparatus of claim 1, wherein the alert can be overridden, and wherein the control circuitry is configured to track an identity of a person who overrides the alert.

5. The apparatus of claim 1, wherein a surgical instrument includes a surgical sponge, a scalpel, a needle, a medical supply, a writing instrument, a piece of apparel, a watch, a pair of glasses, dentures, a hearing aid, a surgical scrub item, a glove, and an identification card.

6. The apparatus of claim 1, wherein the control circuitry is further configured to store data regarding the number, identity, and package association of surgical instruments prior to introduction into a surgical site.

7. The apparatus of claim 6, wherein the control circuitry is further configured to store data regarding the number and identity of said surgical instruments after exit from said surgical site.

8. The apparatus of claim 7, wherein the control circuitry is further configured to compare said data regarding said number and identity of surgical instruments prior to introduction with said data regarding said number and identity of surgical instruments after exit to determine if all surgical instruments entering a surgical site have been removed from said surgical site.

9. The apparatus of claim 8, wherein the control circuitry is further configured to initiate an alert if, at the end of a surgical procedure, said comparison determines that not all surgical instruments entering the surgical site have exited the surgical site.

10. The apparatus of claim 1, wherein said surgical instruments comprise RF identifiers configured to transmit surgical instrument identifiers and package identifiers.

11. The apparatus of claim 1, further comprising:

an object entry detection zone adapted to receive surgical instruments prior to introduction into a surgical site, wherein said scanner is operatively associated with said entry detection zone.

12. The apparatus of claim 1, further comprising:

an object exit detection zone adapted to receive surgical instruments discarded after exit from said surgical site.

13. The apparatus of claim 12, further comprising:

an exit scanner operatively associated with said exit detection zone and adapted to inspect surgical instruments using RF identifiers of said surgical instruments regardless of orientations of said surgical instruments.

14. The apparatus of claim 1, further comprising:

a display, wherein the display is configured to display a number of surgical instruments introduced to a surgical site and a number of surgical instruments removed from a surgical site.

15. The apparatus of claim 1, wherein the alert comprises an indicator on a display.

16. A scanning apparatus, comprising:

a scanner adapted to detect a surgical instrument identifier and a package identifier;

control circuitry configured to;

perform a package status check based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein the package status check is configured to;

perform a re-use prevention check, wherein the re-use prevention check compares the instrument identifier or the package identifier to previously detected instrument identifiers or previously detected package identifiers to determine whether an instrument or a package has been re-scanned; and

issue an alert when the instrument or the package is determined to have been re-scanned.

17. The apparatus of claim 16, wherein the package status check prevents re-use of surgical instruments.

18. The apparatus of claim 16, wherein the package status check prevents re-use of surgical instruments in a same procedure or without sterilization.

19. A scanning apparatus, comprising:

a scanner adapted to detect a surgical instrument identifier and a package identifier;

wherein detecting the surgical instrument identifier and the package identifier is performed in an exit scanning operation, wherein the exit scanning operation identifies a surgical instrument that is being removed from a surgical site;

control circuitry configured to;

perform a package status check based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein the package status check is configured to;

determine whether the surgical instrument has been previously scanned into the surgical site based on the instrument identifier; and

issue an alert when the surgical instrument has not been previously scanned into the surgical site.

20. The apparatus of claim 19, wherein when the surgical instrument has not been previously scanned into the surgical site, the control circuitry is further configured to:

add a determined quantity associated with the package identifier to a count of surgical instruments that have been previously scanned into the surgical site or to a count of surgical instruments that have been scanned into the surgical site without being scanned into the surgical site; and

determining whether all of the determined quantity of surgical instruments have been removed from the surgical site.

21. The apparatus of claim 20, wherein the control circuitry is further configured to issue an alert when less than all of the determined quantity of surgical instruments have been removed from the surgical site.

22. A method of performing a package status check, comprising:

detecting a surgical instrument identifier associated with each of a plurality of surgical instruments in a package and a package identifier;

performing a package status check prior to use of the surgical instruments in a surgical field based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein said performing a package status check includes;

performing a consistency check for a package detected using the package identifier and a determined quantity associated with the package identifier, and

issuing an alert when a number of detected instrument identifiers associated with the package identifier does not match the determined quantity associated with the package identifier.

23. A method of performing a package status check, comprising:

detecting a surgical instrument identifier and a package identifier;

performing a package status check based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein said performing a package status check includes;

performing a re-use prevention check, wherein the re-use prevention check compares the instrument identifier or the package identifier to previously detected instrument identifiers or previously detected package identifiers to determine whether an instrument or a package has been re-scanned; and

issuing an alert when the instrument of the package is determined to have been re-scanned.

24. A method of performing a package status check, comprising:

detecting a surgical instrument identifier and a package identifier;

wherein said detecting the surgical instrument identifier and the package identifier is performed in an exit scanning operation, wherein the exit scanning operation identifies surgical instruments that are being removed from a surgical site;

performing a package status check based on the surgical instrument identifier and the package identifier, wherein the package status check is configured to issue an alert when an alert condition is detected;

wherein said performing a package status check includes;

determining whether the surgical instrument has been previously scanned into the surgical site based on the instrument identifier; and

issuing an alert when the surgical instrument has not been previously scanned into the surgical site.