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

Patent metadata

Field	Value
Publication number	US-10660726-B2
Application number	US-201615540324-A
Country	US
Kind code	B2
Filing date	Jan 21, 2016
Priority date	Jan 21, 2015
Publication date	May 26, 2020
Grant date	May 26, 2020

Abstract

Various embodiments of wirelessly detectable objects to be used in medical procedures are provided. Such may employ ionizing radiation hard wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, all of which retain structural and functional integrity when exposed to standard sterilization dosages of ionizing radiation. Additionally or alternatively, the wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, may retain structural and functional integrity when exposed to standard sterilization temperatures and/or pressures.

First claim

What is claimed is:

1. A wirelessly detectable object to use in medical procedures, comprising:
a medical procedure object for use in performing a medical procedure, wherein the medical procedure object is a sponge;
a radiation hard read only radio frequency identification (RFID) transponder that wirelessly receives a first interrogation signal and in response wirelessly returns a first response signal that provides a unique identifier, wherein the RFID transponder includes a flexible substrate, the flexible substrate forms a portion of a pouch that is attached to the sponge via at least one of a stitch, a weld or an adhesive which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes; and
an attachment structure that attaches the radiation hard read only RFID transponder to the medical procedure object.

2. The wirelessly detectable object of claim 1 wherein the attachment structure comprises at least one piece of material, the at least one piece of material attached to the sponge via at least one stitch which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher.

3. The wirelessly detectable object of claim 1 wherein the attachment structure comprises at least one piece of material, the at least one piece of material attached to the sponge via at least one weld which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher.

4. The wirelessly detectable object of claim 1 wherein the attachment structure comprises at least one piece of material, the at least one piece of material attached to the sponge via an adhesive which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

5. The wirelessly detectable object of claim 1 wherein the attachment structure comprises at least one piece of material that forms a pouch, having an interior cavity.

6. The wirelessly detectable object of claim 5 wherein the RFID transponder is received within the interior cavity of the pouch and the secured therein.

7. The wirelessly detectable object of claim 5 wherein the RFID transponder is received within the interior cavity and secured therein via one of stitches or a weld about at least a portion of a perimeter of the pouch which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

8. The wirelessly detectable object of claim 6 wherein the pouch is attached to the sponge via at least one stitch which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

9. The wirelessly detectable object of claim 6 wherein the pouch is attached to the sponge via at least one of a heat weld or a radio frequency (RF) weld which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

10. The wirelessly detectable object of claim 6 wherein the pouch is attached to the sponge via at least an adhesive which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

11. The wirelessly detectable object of claim 5 wherein the RFID transponder is received and freely movable within the interior cavity of the pouch.

12. The wirelessly detectable object of claim 5 wherein the at least one piece of material the forms the pouch comprises a fabric laminate that comprises at least one of a thermoplastic polyurethane and nylon fabric or polyvinyl chloride (PVC) impregnated fabric which retains structural and functional integrity at least at temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade at pressures of at least 1 atmosphere or higher and which retains structural and functional integrity at least at ionizing radiation dosages of between approximately 8 and 15 kGy, or between approximately 25 and 40 kGy, or between approximately 50 and 100 kGy, for from approximately 1 minute to 12 minutes.

13. A wirelessly detectable object to use in medical procedures, comprising:
a medical procedure object for use in performing a medical procedure, wherein the medical procedure object is a sponge, wherein the sponge includes a pair of outer-most fold portions and at least two inner fold portions, the inner fold portions spaced inwardly from and between the outer-most fold portions;
a first piece of radio-opaque material extending along a width of the sponge;
a second piece of radio-opaque material extending along the width of the sponge and spaced from the first radio-opaque material, wherein the first and the second pieces of radio-opaque material are carried by the inner fold portions;
a radiation hard read only radio frequency identification (RFID) transponder that wirelessly receives a first interrogation signal and in response wirelessly returns a first response signal that provides a unique identifier; and
an attachment structure that attaches the radiation hard read only RFID transponder to the medical procedure object.

14. The wirelessly detectable object of claim 1 wherein

Assignees

• Covidien Lp

Inventors

• Blair William A

Classifications

• A61F13/44

  with radio-opaque material or signalling means for residual material · CPC title

• A61B2090/0805

  automatically, e.g. by means of magnetic, optical or photoelectric detectors · CPC title

• A61B90/98 Primary

  using electromagnetic means, e.g. transponders · CPC title

• A61B2090/0813

  Accessories designed for easy sterilising, i.e. re-usable · CPC title

• A61F13/36

  Surgical swabs, e.g. for absorbency or packing body cavities during surgery (A61F13/38, A61M35/006 take precedence) · CPC title