Patch and sensor assembly for use in medical device localization and mapping systems

• US 20090318796A1
• Filed: 06/24/2008
• 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: Jimenez, Eduardo, Pendekanti, Rajesh, Datta, Keshava
• Granted Patent: US 9,737,225 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• 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 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/274 using snap or button fasteners

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;

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

, 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; and

,

an engagement element adapted to detachably receive at least a portion of the housing of the reusable portion.

2. The patch and sensor assembly of claim 1 wherein the reusable portion further comprises an electrode element capable of making electrical contact with the electrode layer of the disposable portion.

3. The patch and sensor assembly of claim 2 wherein the reusable portion further comprises a second electrical lead for communicating an electrical signal from the electrode element to the device mapping system.

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

5. The patch and sensor assembly of claim 4 wherein the metallic material is silver chloride.

6. The patch and sensor assembly of claim 4 wherein the metallic material is selected from the group consisting of:

silver chloride, gold and platinum.

7. The patch and sensor assembly of claim 1 wherein the disposable portion further comprises a second electrical lead for communicating an electrical signal to the device mapping system.

8. The patch and sensor assembly of claim 1 wherein the disposable portion further comprises and second electrical lead for communicating an electrical signal to a third electrical lead in the reusable portion wherein said third electrical lead communicates said electrical signal to the device mapping system.

9. The patch and sensor assembly of claim 1 wherein the foam layer comprises at least one indentation adapted to receive the sensor housing and sensor cable.

10. The patch and sensor assembly of claim 1 wherein the sensor housing is comprised of a polymer.

11. The patch and sensor assembly of claim 10 wherein the polymer is selected from the group consisting of polyamide, polyurethane, nylon, PEBAX and PEEK polymers and blends thereof.

12. The patch and sensor assembly of claim 1 wherein the foam layer is comprised of thermofoam.

13. 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.

14. The patch and sensor assembly of claim 1 wherein the engagement element of the disposable portion comprises one or more arcuate lips adapted to engage a ridge on the sensor housing of the reusable portion in a snap-fit manner.

15. The patch and sensor assembly of claim 1 wherein the engagement element of the disposable portion comprises one or more flexible engagement members adapted to engage one or more indentations in the sensor housing.

16. The patch and sensor assembly of claim 1 wherein the reusable portion comprises a second engagement element adapted to engage the engagement element of the disposable portion.

17. The patch and sensor assembly of claim 16 wherein the second engagement element is a mechanical snap.

18. A disposable patch assembly for use in a device mapping system used to map the location of a device within the body of a patient comprising:

an adhesive hydrogel layer for adhering the disposable patch assembly to the body of the patient;

an electrode layer disposed on the adhesive hydrogel layer;

a foam layer disposed on substantially all of the electrode layer; and

,

an engagement element adapted to detachably receive at least a portion of the housing of the reusable sensor cable assembly.

19. The disposable patch assembly of claim 18 further comprising a cable for communicating an electrical signal detected from the body of the patient to the device mapping system.

20. The disposable patch assembly of claim 19 wherein the cable terminates between the electrode layer and the foam layer.