Disposable Patch and Reusable Sensor Assembly for Use in Medical Device Localization and Mapping Systems

• US 20090318793A1
• Filed: 10/23/2008
• Published: 12/24/2009
• Est. Priority Date: 06/24/2008
• Status: Active Grant

• Current Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Original Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Inventors: Schultz, Jeffrey, Jimenez, Eduardo, Datta, Keshava, Pendekanti, Rajesh
• Granted Patent: US 9,014,778 B2
• Time in Patent Office: Days
• US Class Current: 600/391
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/063 using impedance measurements
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

An patch and sensor assembly for use in an EP mapping system has two portions: a reusable portion and a disposable portion. The reusable portion houses the biosensors used in magnetic based location and mapping systems and the electrical lead necessary to communicate between the biosensor and the mapping system. The reusable portion may also contain a portion of the electrode necessary to receive electrical signals from the body of the patient. The disposable portion of the patch and sensor assembly contains an adhesive covered flexible patch having at least a portion of the electrode used to receive electrical signals form the body of the patient and may contain the electrical lead necessary to communicate such an electrical signal to the mapping system. The disposable portion contains a receptacle adapted to receive and mechanically secure the reusable portion to the disposable portion of the assembly. Such a patch and sensor assembly is useful in hybrid magnetic and impedance based location and mapping systems such as those used in electrophysiology.

Claims

1. A patch and sensor assembly for use in a device mapping system used to map the location of a device within the body of a patient comprising a reusable portion and a disposable portion, the reusable portion comprising:

a magnetic-based biosensor for providing location information about the location of the device within the body of the patient to the device mapping system;

a housing adapted to house the biosensor having a top portion and a bottom portion; and

,

a first electrical lead for communicating an electrical signal from the biosensor to the device mapping system;

and the disposable portion comprising;

an adhesive hydrogel layer for adhering the electrode to the body of the patient;

an electrode layer disposed on the adhesive hydrogel layer;

a foam layer disposed on a portion of the electrode layer;

a second electrical lead for communicating an electrical signal from the electrode layer to the device mapping system and,

a sensor engagement element adapted to detachably receive at least a portion of the housing of the reusable portion wherein the engagement element comprises a first engagement element for engaging an indentation in the top portion of the housing of the reusable portion and a second engagement element for engaging an indentation in the proximal end of the bottom portion of said housing.

2. The patch and sensor assembly of claim 1 wherein the electrode layer comprises carbon composite coated on at least one dimension with a metallic material.

3. The patch and sensor assembly of claim 2 wherein the metallic material is silver chloride.

4. The patch and sensor assembly of claim 2 wherein the carbon composite comprises carbon fiber and polyvinyl chloride.

5. The patch and sensor assembly of claim 3 wherein the metallic material further comprises a layer of silver disposed on the silver chloride.

6. The patch and sensor assembly of claim 1 wherein the disposable portion further comprise a second foam layer disposed on the first foam layer and comprising at least one indentation adapted to receive the first electrical lead.

7. The patch and sensor assembly of claim 1 wherein the second electrical lead comprises a plurality of wires having a distal end and a proximal end and the distal ends of the plurality of wires are arrayed in a fan and positioned between the electrode layer and the foam layer.

8. The patch and sensor assembly of claim 1 wherein the foam layer is comprised of polyethylene foam with a medical grade acrylic pressure sensitive adhesive on the patient facing side.

9. The patch and sensor assembly of claim 8 wherein the foam layer has an opening for receiving a portion of the sensor engagement element.

10. The patch and sensor assembly of claim 1 wherein the reusable portion further comprises a strain relief element for reducing mechanical strain on the connection between the biosensor and the sensor cable.

11. The patch and sensor assembly of claim 1 wherein the sensor engagement element is comprised of polycarbonate.

12. The patch and sensor assembly of claim 1 wherein the disposable portion further comprises a release liner on which the hydrogel layer is disposed.

13. The patch and sensor assembly of claim 12 wherein the release liner is comprised of polyethylene terephthalate (PET) with a silicone coating on the side facing the hydrogel layer.

14. A disposable patch cable assembly for use with a reusable sensor cable assembly in a device mapping system used to map the location of a device within the body comprising:

an adhesive hydrogel layer for adhering the electrode to the body of the patient;

an electrode layer disposed on the adhesive hydrogel layer;

a foam layer disposed on a portion of the electrode layer;

an electrical lead for communicating an electrical signal from the electrode layer to the device mapping system and,

an engagement element adapted to detachably receive at least a portion of the reusable sensor cable assembly wherein the engagement element comprises a first engagement element for engaging an indentation in the top portion of the sensor cable assembly and a second engagement element for engaging an indentation in the proximal end of the sensor cable assembly.

15. The disposable patch cable assembly of claim 14 wherein the electrode layer comprises carbon composite coated on at least one dimension with a metallic material.

16. The disposable patch cable assembly of claim 15 wherein the metallic material is silver chloride.

17. The disposable patch cable assembly of claim 15 wherein the carbon composite comprises carbon fiber and polyvinyl chloride.

18. The disposable patch cable assembly of claim 16 wherein the metallic material further comprises a layer of silver disposed on the silver chloride.

19. The disposable patch cable assembly of claim 14 further comprising a second foam layer disposed on the first foam layer and comprising at least one indentation adapted to receive the first electrical lead.

20. The disposable patch cable assembly of claim 14 wherein the electrical lead comprises a plurality of wires having a distal end and a proximal end and the distal ends of the plurality of wires are arrayed in a fan and positioned between the electrode layer and the foam layer.

21. The disposable patch cable assembly of claim 14 wherein the foam layer is comprised of polyethylene foam with a medical grade acrylic pressure sensitive adhesive on the patient facing side.

22. The disposable patch cable assembly of claim 20 wherein the foam layer has an opening for receiving a portion of the sensor engagement element.

23. The disposable patch cable assembly of claim 14 further comprises a release liner on which the hydrogel layer is disposed.

24. The patch and sensor assembly of claim 23 wherein the release liner is comprised of polyethylene terephthalate (PET) with a silicone coating on the side facing the hydrogel layer.