System and method for enhancing cardiac signal sensing by cardiac pacemakers through genetic treatment

• US 6,567,705 B1
• Filed: 02/28/2000
• Issued: 05/20/2003
• Est. Priority Date: 07/17/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stokes, Kenneth B., Morissette, Josée
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/514,907
• Time in Patent Office: 1,177 Days
• Field of Search: 607/119, 607/120, 607/122
• US Class Current: 607/120
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

Delivery systems for and methods of delivering ion channel protein genetic material to cardiac cells in areas adjacent to where an electrode is to be positioned in a patient'"'"'s heart to improve or correct the signal to noise ratio of cardiac signals, such as the P-wave, is described herein. More specifically, there is provided a system and method for delivering sodium ion channel proteins or nucleic acid molecules encoding sodium ion channel proteins to a site in the heart adjacent to an electrode to increase the expression of the same, thereby enhancing the cardiac signal amplitude and enabling improved sensing of cardiac signals by an implanted pacemaker.

Claims

1. A delivery system for delivering a predetermined genetic material or protein to myocardial cells of a selected location of a patient'"'"'s heart, comprising:

a sensor for locating an area of inadequate P-wave production in the heart of a patient; and

a delivery means for delivering a supply of said genetic material or protein to said selected location in said patients heart wherein said genetic material is selected from the group consisting of DNA encoding an ion channel protein, RNA encoding an ion channel protein, and an ion channel protein.

2. The delivery system of claim 1, wherein said delivery means further comprises a catheter.

3. The delivery system of claim 1, wherein said catheter is an endocardial catheter.

4. The delivery system of claim 2, wherein said delivery means comprises a hollow helical screw-in element.

5. The delivery system of claim 1, wherein said supply of genetic material is provided as a bolus to said selected location.

6. The delivery system of claim 1, wherein the delivery means forms part of the sensor.

7. The delivery system of claim 1, where the delivery means is not part of the sensor.

8. The deivery system of claim 1, wherein said selected genetic material is a recombinant nucleic acid molecule encoding the ion channel protein.

9. The delivery system of claim 8, wherein said ion channel protein is a sodium channel protein.

10. The delivery system of claim 9, wherein sodium channel protein is hH1.

11. The delivery system of claim 1, wherein said genetic material or protein increases the amplitude of the cardiac signal of said patient'"'"'s heart.

12. An implantable delivery system for delivering doses of predetermined genetic material or protein to myocardial cells in a chosen location of a patient'"'"'s heart, comprising:

a sensor for detecting cardiac signals from said chosen location;

a supply of genetic material or protein selected from group consisting of DNA encoding an ion channel protein, RNA encoding an ion channel protein, and an ion channel protein; and

an implantable delivery means for delivering said genetic material or protein to said chosen location.

13. The implantable delivery system as described in claim 12, further comprising a control means for controlling operation of said delivery means.

14. The implantable delivery system of claim 12, wherein said controlling means controls the rate of delivery of said doses.

15. The implantable delivery system of claim 12, wherein said control means comprises automatic means for automatically initiating delivery of said genetic material.

16. The delivery system of claim 12, wherein said genetic material or protein increases the amplitude of the cardiac signal of said patient'"'"'s heart.

17. The delivery system of claim 12, wherein said supply of genetic material is provided as a bolus to said selected location.

18. The delivery system of claim 12, wherein said selected general material is a recombinant nucleic acid molecule encoding the ion channel protein.

19. The delivery system of claim 18, wherein said ion channel protein is a sodium channel protein.

20. The delivery system of claim 19, wherein said sodium channel protein is hH1.

21. An implantable delivery system for delivering predetermined genetic material or protein to cardiac cells adjacent to a pacing electrode positioned in the heart of a patient, comprising:

a supply of genetic material or protein selected from the group consisting of DNA encoding an ion channel protein, RNA encoding an ion channel protein, and an ion channel protein;

a pacing electrode adapted to be positioned in the heart of a patient; and

a delivery means for delivering said genetic material or protein to said cardiac cells adjacent to said pacing electrode positioned in the heart of a patient.

22. The implantable delivery system of claim 21 wherein the pacing electrode is positioned against the inner wall of a patient'"'"'s heart.

23. The implantable delivery system of claim 21, wherein said delivery means forms part of said pacing electrode.

24. The system as described in claim 21, further comprises a control means for controlling operation of said delivery means to deliver said genetic material or protein.

25. The implantable delivery system of claim 21, further comprising a control means for controlling the rate of delivery of said doses.

26. The implantable delivery system of claim 21, wherein said control means comprises automatic means for initiating delivery of said genetic material.

27. The delivery system of claim 21, wherein said genetic material or protein increases the amplitude of the cardiac signal of said patient'"'"'s heart.

28. The delivery system of claim 21, wherein said delivery means comprises a hollow helical screw-in element.

29. The delivery system of claim 21, wherein the delivery means forms part of the sensor.

30. The delivery system of claim 21, wherein said supply of genetic material is provided as a bolus to said selected location.

31. The delivery system of claim 21, wherein said selected genetic material is a recombinant nucleic acid molecule encoding the ion channel protein.

32. The delivery system of claim 31, wherein said ion channel protein is a sodium channel protein.

33. The delivery system of claim 32, wherein said sodium channel protein is hH1.