Wirelessly detectable objects for use in medical procedures and methods of making same

• US 9,717,565 B2
• Filed: 01/21/2016
• Issued: 08/01/2017
• Est. Priority Date: 01/21/2015
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Blair, William A.
• Primary Examiner(s): BLOUIN, MARK S
• Application Number:
  US15/003,515
• Publication Number:
  US 20160206399A1
• Time in Patent Office: 558 Days
• Field of Search: 3405721
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 50/37 for absorbent articles, e.g. bandages, garments, swabs or towels
• 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: G06K 7/10366 the interrogation device being adapted for miscellaneous applications

Abstract

Various embodiments of a wirelessly detectable object to be used in medical procedures are provided. One example wirelessly detectable object includes a radio frequency identification (RFID) transponder that, when interrogated, wirelessly returns a first response signal that contains identification information associated with a surgical object. The wirelessly detectable object further includes a presence transponder that, when interrogated, wirelessly returns a second response signal that does not contain identification information. The presence transponder is received and freely movable within a pouch. The presence transponder is independently movable with respect to the RFID transponder. Another example wirelessly detectable object includes at least one active antenna element and at least one passive antenna element that together operate as a directional antenna.

Claims

1. A wirelessly detectable object to use in medical procedures, comprising:

a radio frequency identification (RFID) transponder that wirelessly receives a first interrogation signal and wirelessly returns a first response signal that contains identification information associated with the wirelessly detectable object;

a presence transponder that wirelessly receives a second interrogation signal and wirelessly returns a second response signal that does not contain identification information;

a piece of absorbent material; and

a pouch comprising at least a first flexible layer that forms an interior cavity, the presence transponder received and freely movable within the interior cavity, the presence transponder independently movable with respect to the RFID transponder, the pouch physically coupled to at least a portion of the piece of absorbent material.

2. The wirelessly detectable object of claim 1 wherein the presence transponder is not directly physically attached to the RFID transponder.

3. The wirelessly detectable object of claim 1 wherein the RFID transponder is received within the interior cavity.

4. The wirelessly detectable object of claim 1 wherein the RFID transponder is received and freely movable within the interior cavity.

5. The wirelessly detectable object of claim 1 wherein the RFID transponder forms at least a portion of the first flexible layer, is embedded within the first flexible layer, or is adhered to the first flexible layer.

6. The wirelessly detectable object of claim 1 wherein the RFID transponder comprises an RFID chip and an antenna trace.

7. The wirelessly detectable object of claim 6 wherein either or both of the RFID chip and the antenna trace are embedded within the first flexible layer.

8. The wirelessly detectable object of claim 6 wherein the antenna trace of the RFID transponder comprises an active antenna element, the wirelessly detectable object further comprises a passive antenna element, and the active antenna element and the passive antenna element together form a directional antenna.

9. The wirelessly detectable object of claim 8 wherein the passive antenna element is embedded in the first flexible layer.

10. The wirelessly detectable object of claim 9 wherein the first flexible layer is physically coupled to the piece of absorbent material to form the interior cavity therebetween and at least the active antenna element of the RFID transponder is received within the interior cavity and adhered to the piece of absorbent material.

11. The wirelessly detectable object of claim 1 wherein the pouch further comprises a second flexible layer physically coupled to the first flexible layer to form the interior cavity therebetween, the second flexible layer different than the piece of absorbent material.

12. The wirelessly detectable object of claim 11 wherein the RFID transponder forms at least a portion of the second flexible layer, is embedded within the second flexible layer, or is adhered to the second flexible layer.

13. The wirelessly detectable object of claim 10, further comprising:

a passive antenna element embedded in or adhered to the first flexible layer, the passive antenna element and the RFID transponder together forming a directional antenna.

14. The wirelessly detectable object of claim 11 wherein the pouch further comprises a radio frequency (RF) weld that extends around a perimeter of the interior cavity, physically couples the first flexible layer to the second flexible layer, and seals the presence transponder within the interior cavity.

15. The wirelessly detectable object of claim 14 wherein the RF weld comprises a first RF weld and wherein the first RF weld or a second RF weld further physically couples the pouch to the piece of absorbent material.

16. The wirelessly detectable object of claim 11 wherein one or both of the first flexible layer and second flexible layer are a fabric laminate.

17. The wirelessly detectable object of claim 1 wherein the pouch further comprises a radio frequency (RF) weld that extends around a perimeter of the interior cavity, physically couples the first flexible layer to the piece of absorbent material, and seals the presence transponder within the interior cavity.

18. The wirelessly detectable object of claim 1 wherein the first flexible layer is formed of a fabric laminate.

19. The wirelessly detectable object of claim 16 wherein the fabric laminate comprises thermoplastic polyurethane and nylon fabric or polyvinyl chloride (PVC) impregnated fabric.

20. A wirelessly detectable object to use in medical procedures, comprising:

a piece of absorbent material;

a first substrate physically coupled to the piece of absorbent material;

a radio frequency identification (RFID) transponder to wirelessly receive a first interrogation signal and wirelessly return a first response signal that contains identification information associated with the wirelessly detectable object, the RFID transponder comprising an active antenna element; and

a passive antenna element;

wherein the passive antenna element and the active antenna element together operate as a directional antenna and the first substrate carries at least one of the active antenna element and the passive antenna element.

21. The wirelessly detectable object of claim 20 wherein the first substrate comprises a layer of fabric laminate.

22. The wirelessly detectable object of claim 21 wherein the fabric laminate is physically coupled to the piece of absorbent material to form an interior cavity therebetween and the wirelessly detectable object further comprises a presence transponder received and freely movable within the interior cavity, the presence transponder to wirelessly return a second response signal that does not contain identification information.

23. The wirelessly detectable object of claim 22 wherein the RFID transponder is embedded in or adhered to the layer of fabric laminate or is received within the interior cavity and adhered to the piece of absorbent material.

24. The wirelessly detectable object of claim 21 wherein the passive antenna element is located between the piece of absorbent material and the layer of fabric laminate and the active antenna element is embedded in, adhered to, or forms a portion of the layer of fabric laminate.

25. The wirelessly detectable object of claim 21 wherein the active antenna element is located between the piece of absorbent material and the layer of fabric laminate and the passive antenna element is embedded in, adhered to, or forms a portion of the layer of fabric laminate.

26. The wirelessly detectable object of claim 24 wherein the layer of fabric laminate is carried at least in part by one or more of the passive antenna element and the active antenna element.

27. The wirelessly detectable object of claim 24, further comprising:

a second layer of fabric laminate located between the passive antenna element and the piece of absorbent material.

28. The wirelessly detectable object of claim 20, further comprising:

a presence transponder physically coupled to the piece of absorbent material, the presence transponder to wirelessly return a second response signal that does not contain identification information.

29. The wirelessly detectable object of claim 20 wherein the directional antenna comprises a Yagi antenna.

30. The wirelessly detectable object of claim 20 where one or both of the active antenna element and the passive antenna element comprise conductive traces embedded within or carried on the first substrate.

31. A method to account for surgical objects used in medical procedures, the method comprising:

providing a plurality of surgical objects that have a plurality of wirelessly detectable objects respectively physically coupled thereto, each wirelessly detectable object comprising a radio frequency identification (RFID) transponder and a presence transponder;

interrogating the RFID transponder of each surgical object introduced into a surgical field;

receiving, from the interrogated RFID transponder of each surgical object introduced into the surgical field, a first response signal that contains identification information stored by such RFID transponder;

generating a first manifest of surgical objects introduced into the surgical field based at least in part on the identification information included in each first response signal;

prior to completion of a medical procedure, scanning the surgical field to interrogate any presence transponders that remain within the surgical field;

determining whether any surgical objects remain within the surgical field based at least in part on whether one or more second response signals are respectively received from one or more presence transponders responsive to the scanning, wherein the one or more second response signals do not contain identification information;

interrogating the RFID transponder of each surgical object removed from the surgical field;

receiving, from the interrogated RFID transponder of each surgical object removed from the surgical field, a third response signal that contains the identification information stored by such RFID transponder; and

generating a second manifest of surgical objects removed from the surgical field based at least in part on the identification information included in each third response signal.

32. The method of claim 31 wherein receiving a first response signal comprises receiving the first response signal that is within a first frequency range, and determining whether any surgical objects remain within the surgical field comprises determining whether any surgical objects remain within the surgical field based at least in part on whether one or more second response signals are respectively received from one or more presence transponders responsive to the scanning, the one or more second response signals within a second frequency range that provides superior transmission through bodily tissue relative to the first frequency range.

33. The method of claim 31 wherein receiving a first response signal comprises receiving the first response signal at a first physical distance from each RFID transponder, and determining whether any surgical objects remain within the surgical field comprises determining whether any surgical objects remain within the surgical field based at least in part on whether one or more second response signals are respectively received at a second physical distance from one or more presence transponders responsive to the scanning, the second physical distance greater than the first physical distance.

34. The method of claim 31, further comprising:

comparing the first manifest to the second manifest to determine whether one or more surgical objects remain within the surgical field.