Epicardial patch including isolated extracellular matrix with pacing electrodes

• US 8,060,219 B2
• Filed: 12/20/2004
• Issued: 11/15/2011
• Est. Priority Date: 12/20/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kim, John, Westlund, Randy, Salo, Rodney W., Heil, Ronald W. Jr., Ross, Jeffrey
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US11/017,627
• Publication Number:
  US 20060136028A1
• Time in Patent Office: 2,521 Days
• Field of Search: 607/9, 607/115, 607/116, 607/119, 607/129, 600/372, 600/373, 600/374, 600/375, 600/377, 600/391, 600/393
• US Class Current: 607/129
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

An epicardial patch includes an extracellular matrix (ECM) and a plurality of electrodes. The isolated ECM is configured for epicardial attachment over a myocardial region including an injured area to control post-injury remodeling of the myocardial region. The plurality of electrodes is configured for delivering electrical stimulation to enhance the effect of the isolated ECM in remodeling control by altering workload and stress on the myocardial region.

Claims

1. An epicardial patch to control post injury remodeling of a heart having an epicardial surface, comprising:

a biodegradable isolated extracellular matrix (ECM) sheet generally defining a shape of the epicardial patch and including an attachment surface configured to be attached to the epicardial surface of the heart; and

electrodes attached onto the attachment surface of the isolated ECM sheet,

wherein the epicardial patch is configured for the electrodes to be between the attachment surface and the epicardial surface of the heart after the attachment surface is attached to the epicardial surface of the heart; and

at least one lead having a distal end connected to the epicardial patch, one or more lead connectors, and a proximal end connected to the one or more lead connectors, the lead including one or more electrical conductors each having a distal end portion connected to at least one electrode of the electrodes and a proximal end portion connected to a connector of the one or more lead connectors.

2. The patch of claim 1, wherein the electrodes are arranged for delivering electrical energy approximately uniformly over a predetermined area.

3. The patch of claim 1, wherein the isolated ECM sheet has a center and a contour, and the electrodes comprise a plurality of peripheral electrodes distributed near the contour of the isolated ECM sheet.

4. The patch of claim 3, wherein the plurality of peripheral electrodes are approximately evenly distributed along a loop having a shape approaching the contour of the isolated ECM sheet.

5. The patch of claim 3, wherein the electrodes further comprise a center electrode at approximately the center of the isolated ECM sheet.

6. The patch of claim 5, wherein the one or more electrical conductors comprise at least a first conductor connected to the plurality of peripheral electrodes and a second conductor connected to the center electrode.

7. The patch of claim 1, wherein the isolated ECM sheet comprises a mixture of structural molecules and functional molecules present in a three-dimensional structure, which molecules are present in native ECM.

8. The patch of claim 1, wherein the isolated ECM sheet has an approximately circular shape having a diameter in a range from approximately 10 mm to approximately 150 mm.

9. The patch of claim 1, wherein the isolated ECM sheet has a thickness in a range from approximately 0.5 mm to approximately 2 mm.

10. The patch of claim 1, wherein the epicardial patch has a size modifiable using a scalpel or scissors prior to being attached onto the epicardial surface of the heart.

11. The patch of claim 1, wherein the epicardial patch comprises a thin film of silicone between each electrode of the electrodes and the attachment surface.

12. An epicardial patch for treating a heart to control post injury remodeling of the heart having an epicardial surface, comprising:

a biodegradable isolated extracellular matrix (ECM) sheet generally defining a shape of the epicardial patch and including an attachment surface and a further surface opposite to the attachment surface, the attachment surface configured to be attached to the epicardial surface of the heart;

a first conductor including a first distal end portion attached to the attachment surface;

a plurality of electrodes connected to and distributed along the first distal end portion of the first conductor;

a second conductor including a second distal end portion connected to the attachment surface; and

a center electrode connected to the second distal portion of the second conductor.

13. The epicardial patch of claim 12, wherein the first conductor comprises a plurality of branches each attached to the attachment surface of the isolated ECM sheet and connected to one electrode of the plurality of electrodes.

14. The epicardial patch of claim 12, further comprising at least one lead connector, and wherein the first conductor comprises a first proximal end connected to the at least one lead connector, and the second conductor comprises a second proximal end connected to the at least one lead connector.

15. The epicardial patch of claim 12, wherein the attachment surface has a contour and a center, the first distal end portion of the first conductor forms a loop near the contour, and the center electrode is located approximately at the center.

16. The epicardial patch of claim 15, wherein the contour of the attachment surface is approximately circular, and the first distal end portion forms an approximately circular loop having a diameter.

17. The epicardial patch of claim 15, wherein the plurality of electrodes distributed along the first distal end portion of the first conductor comprises a plurality of electrode collars approximately evenly distributed along the first distal end portion of the first conductor.

18. The epicardial patch of claim 17, wherein the plurality of electrode collars are each made of a platinum/iridium alloy and coated with iridium oxide (IROX).

19. The epicardial patch of claim 18, wherein the center electrode is made of a platinum/iridium alloy and coated with iridium oxide (IROX).

20. The epicardial patch of claim 15, wherein the center electrode comprises a fixation device.

21. The epicardial patch of claim 20, wherein the fixation device comprises a helix configured for screwing into epicardial tissue.

22. The epicardial patch of claim 15, wherein the center electrode comprises a disk electrode.

23. The epicardial patch of claim 22, wherein the disk electrode includes two or more holes allowing for suturing the disk electrode onto epicardial tissue.

24. The epicardial patch of claim 15, wherein the center electrode comprises a ring electrode.

25. The patch of claim 12, wherein the isolated ECM sheet has an approximately circular shape having a diameter in a range from approximately 10 mm to approximately 150 mm.

26. The patch of claim 12, wherein the isolated ECM sheet has a thickness in a range from approximately 0.5 mm to approximately 2 mm.

27. A cardiac rhythm management (CRM) system for controlling post injury remodeling and treating a heart having an epicardial surface, comprising:

an epicardial patch including;

a biodegradable isolated extracellular matrix (ECM) sheet generally defining a shape of the epicardial patch and including an attachment surface configured to be attached to the epicardial surface of the heart;

a plurality of electrodes attached onto the attachment surface of the isolated ECM sheet such that the plurality of electrodes is between the attachment surface and the epicardial surface of the heart after the attachment surface is attached to the epicardial surface of the heart; and

at least one lead having a distal end connected to the isolated ECM sheet and a proximal end connected to one or more lead connectors, the lead including a plurality of electrical conductors each having a first end connected to one or more electrodes of the plurality of electrodes and a second end connected to a connector of the one or more lead connectors; and

an implantable medical device including;

one or more device connectors each configured to mate one connector of the one or more lead connectors; and

a stimulation circuit coupled to the one or more device connectors and configured to deliver electrical stimulation pulses to one or more electrodes of the plurality of electrodes and to select the one or more electrodes from the plurality of electrodes such that the electrical stimulation pulses are delivered to approximately uniformly reduce loading and stress.

28. The CRM system of claim 27, wherein the attachment surface has a contour and a center, and wherein the plurality of electrodes comprises a plurality of peripheral electrodes distributed near the contour.

29. The CRM system of claim 28, wherein the plurality of electrodes further comprises a center electrode located at approximately the center.

30. The CRM system of claim 27, wherein the stimulation circuit comprises a pacing circuit to deliver pacing pulses to the one or more electrodes of the plurality of electrodes.

31. The CRM system of claim 30, wherein the implantable medical device further comprises a sensing circuit to sense one or more cardiac signals through one or more electrodes of the plurality of electrodes.

32. The CRM system of claim 31, further comprising at least one reference electrode incorporated onto the implantable medical device.

33. The CRM system of claim 32, wherein the implantable medical device further comprises a programmable electrode interface circuit providing for first electrical connections between the pacing circuit and a plurality of pacing electrodes and second electrical connections between the sensing circuit and a plurality of sensing electrodes, the plurality of pacing electrodes selected from at least the plurality of electrodes connected to the isolated ECM sheet and the at least one reference electrode, the plurality of sensing electrodes selected from at least the plurality of electrodes connected to the isolated ECM sheet and the at least one reference electrode.

34. The CRM system of claim 33, wherein the implantable medical device further comprises an electrode configuration controller, coupled to the programmable electrode interface circuit, to control the first and second electrical connections, the electrode configuration controller including an electrode selector to select the plurality of pacing electrodes from the at least the plurality of electrodes connected to the isolated ECM sheet and the at least one reference electrode and to select the plurality of sensing electrodes from the at least the plurality of electrodes connected to the isolated ECM sheet and the at least one reference electrode.

35. The CRM system of claim 34, wherein the electrode configuration controller further comprises an electrode polarity controller to designate each electrode of the selected pacing and sensing electrodes as one of a cathode and an anode.

36. The CRM system of claim 27, wherein the isolated ECM sheet comprises a mixture of structural molecules and functional molecules present in a three-dimensional structure, which molecules are present in native ECM.

37. The device of claim 27, wherein the isolated ECM sheet has an approximately circular shape having a diameter in a range from approximately 10 mm to approximately 150 mm.

38. The device of claim 27, wherein the isolated ECM sheet has a thickness in a range from approximately 0.5 mm to approximately 2 mm.