Apparatus and methods for monitoring objects in a surgical field

• US 9,974,625 B2
• Filed: 04/27/2017
• Issued: 05/22/2018
• Est. Priority Date: 09/13/2006
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Combo LLC (Stryker Corporation)
• Inventors: Fleck, Steven J., Szakelyhidi, David, Gandhi, Gautam
• Primary Examiner(s): Lee, Seung
• Application Number:
  US15/498,931
• Publication Number:
  US 20170224437A1
• Time in Patent Office: 390 Days
• Field of Search: 235385
• 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 identifier 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 monitoring system for monitoring a sponge used during a surgical procedure, the sponge having an RF tag and the RF tag storing an object identifier, the monitoring system comprising:

a first scanner comprising an antenna;

a second scanner comprising an antenna, the second scanner separate from the first scanner; and

control circuitry for controlling the operation of the first scanner and the second scanner, the control circuitry operable to collect identity and location information relating to the sponge from the first scanner and the second scanner and to compile the identity and location information in a database as part of a record of the sponge, wherein the identity information includes the object identifier and the location information includes at least one of a location of the sponge immediately prior to the surgical procedure, a location of the sponge during the surgical procedure, a location of the sponge after the surgical procedure, and combinations thereof;

wherein the control circuitry establishes in the database a first flag in the record of the sponge upon an interaction between the sponge and one of the first scanner and the second scanner, and establishes in the database a second flag in the record of the sponge upon an interaction between the sponge and the other of the first scanner and the second scanner.

2. The system of claim 1, further comprising a plurality of sponges, each sponge having an RF tag, each RF tag storing an unique object identifier;

the plurality of sponges associated with a package, wherein each RF tag further stores a package identifier;

the control circuitry further configured to establish one of a first flag or a second flag for each object identifier of each of the plurality of sponges having the package identifier upon an interaction between one of the plurality sponges and one of the first scanner and the second scanner.

3. The system of claim 1, wherein the first flag comprises a first value representing an interaction between the sponge and the first scanner, and wherein the control circuitry is configured to change the first flag to a second value, different from the first value, the second value representing a second interaction between the sponge and the first scanner.

4. The system of claim 1, wherein the RF tag further stores at least one of the first flag or the second flag.

5. The system of claim 1, wherein the control circuitry is further configured to generate an alert upon an interaction between the sponge and one of the first scanner or the second scanner where the control circuitry had previously established a first or second flag representing a prior interaction between the sponge and the one of the first and second scanner.

6. The system of claim 1, further comprising a third scanner comprising an antenna, the third scanner separate from the first and second scanners;

the control circuitry operable to collect identity information relating to the sponge from the third scanner, wherein the control circuitry establishes in the database a record upon an interaction between the sponge and the third scanner.

7. The system of claim 1, wherein one of the first or the second scanner is operatively associated with a container.

8. The system of claim 6, wherein one of the first, second or the third scanner is a handheld scanner positionable within a surgical field and configured to be placed into proximity with a surgical patient.

9. A method of monitoring a sponge used during a surgical procedure, the sponge having an RF tag and the RF tag storing an object identifier, the method comprising:

receiving a data transmission including an object identifier and location information at one of a first scanner or a second scanner, wherein the location information includes at least one of a location of the sponge immediately prior to the surgical procedure, a location of the sponge during the surgical procedures, a location of the sponge after the surgical procedures, and combinations thereof;

storing the object identifier and location information in a database as part of a record of the sponge;

establishing a flag and storing the flag as part of the record of the sponge in the database; and

confirming that object identifier is new.

10. The method of claim 9, wherein the step of receiving a data transmission comprises receiving a plurality of data transmissions, each data transmission including a unique object identifier;

wherein the step of storing the received object identifier comprises storing each of the plurality of unique object identifiers as part of a plurality of records of a plurality of sponges; and

wherein the step of establishing a flag comprises establishing a plurality of flags and storing each of the plurality of flags as part of the plurality of records of each of the plurality of sponges.

11. The method of claim 10, further comprising the step of maintaining a sponge count and identification of sponges used in a surgical procedure based on the plurality of records in the database having the flag.

12. The method of claim 9, further comprising the step of removing the flag from the record of the sponge in the database.

13. The method of claim 9, wherein one of the first or the second scanner is operatively associated with a container.

14. A method of monitoring a sponge during a surgical procedure, the sponge having an RF tag and the RF tag storing an object identifier, the method comprising:

receiving a data transmission including an object identifier and location information at one of a plurality of scanners, wherein the location information includes at least one of a location of the sponge immediately prior to the surgical procedure, a location of the sponge during the surgical procedure, a location of the sponge after the surgical procedure; and

combinations thereof;

storing the object identifier and location information in a database as part of a record of the sponge;

querying the database based on the object identifier and, prior to establishing a flag, determining whether the record of the sponge includes a prior flag representing a prior interaction between the sponge and one of the plurality of scanners;

establishing a flag having a value, wherein the value identifies a use status; and

storing the flag as part of the record of the sponge in the database.

15. The method of claim 14, further comprising the step of generating an alert when the prior flag in the record of the sponge has a value equal to the flag.

16. The method of claim 15, further comprising the step of receiving an override signal at the one of the plurality of scanners to remove the alert.

17. The method claim 14, wherein the step of receiving a data transmission comprises receiving a plurality of data transmissions including a plurality of object identifiers at one of a plurality of scanners;

the step of storing the object identifiers comprising storing the plurality of object identifiers in a plurality of records of a plurality of sponges;

the step of establishing a flag comprises establishing a plurality of flags, each having a value identifying a use status; and

wherein the step of storing the flag comprises storing the plurality of flags as part of the plurality of records of the plurality of sponges, the method further comprising the step of maintaining a sponge count and identification based on the plurality of records in the database having each of the plurality of flags.

18. The method claim 14, wherein at least one of the plurality of scanners is operatively associated with a container.

19. The method of claim 14, wherein at least one of the plurality of scanners is a handheld scanner;

the method further comprising the step of positioning the handheld scanner within a surgical field in proximity with a surgical patient.