Delivery of cardiac stimulation devices

• US 20080021532A1
• Filed: 07/21/2006
• Published: 01/24/2008
• Est. Priority Date: 07/21/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Saholt, Douglas R., Kveen, Graig L., Hastings, Roger, Gunderson, Richard C.
• Granted Patent: US 7,840,281 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Claims

1. An electrode delivery system for delivering a wireless electrode assembly into a heart chamber wall, the system comprising:

a wireless electrode assembly including a body that defines a guide wire channel extending therethrough;

a delivery catheter to direct the wireless electrode assembly through a heart chamber and toward a heart chamber wall, the delivery catheter including a distal opening through which the wireless electrode assembly is passable for delivery into the heart chamber wall; and

a guide wire instrument passable through the delivery catheter to penetrate into the heart chamber wall, the guide wire instrument having a distal tip portion that is slidable within the guide wire channel of the wireless electrode assembly when the wireless electrode assembly is advanced over the guide wire instrument into the heart chamber wall.

2. The system of claim 1, wherein the distal tip portion of the guide wire instrument is operable to define a penetration path through endocardium tissue and into myocardium tissue of the heart wall chamber, the wireless electrode assembly being slidable over the distal tip portion to implant into the myocardium tissue along the penetration path.

3. The system of claim 1, further comprising an actuation member to push the electrode assembly over the distal tip portion of the guide wire instrument and into the heart chamber wall.

4. The system of claim 2, wherein the actuation member comprises a push rod member movably adjustable within the delivery catheter.

5. The system of claim 2, wherein the actuation member and guide wire instrument are retractable from the electrode assembly when the electrode assembly is advanced into the heart chamber wall.

6. The system of claim 1, further comprising a magnetic coupling device to releasably retain the electrode assembly in a distal portion of the delivery catheter, the magnetic coupling disposed within the delivery catheter.

7. The system of claim 1, further comprising a guide sheath to direct the delivery catheter into the heart chamber, the delivery catheter being slidable within the guide sheath to navigate through one or more blood vessels and into the heart chamber.

8. The system of claim 7, wherein the delivery catheter is fully retractable from the guide sheath when the guide sheath remains disposed at least partially in the heart chamber.

9. The system of claim 1, wherein the distal tip portion of guide wire instrument includes a curved section, the wireless electrode assembly being slidable over the curved section of the distal tip portion to implant into the myocardium tissue along a penetration path that is non-perpendicular to the heart chamber wall surface.

10. The system of claim 1, wherein the distal tip portion of guide wire instrument includes a fixation device to releasably couple with heart chamber wall.

11. The system of claim 1, wherein the distal tip portion of guide wire instrument is detachable from a main body portion of the guide wire instrument so that the detachable distal tip portion is operable to remain in the heart chamber wall when the wireless electrode assembly is advanced into the heart chamber wall.

12. The system of claim 1, wherein the delivery catheter includes a fixation device to releasably engage the heart chamber wall, the fixation device being disposed proximate the distal opening of the delivery catheter.

13. The system of claim 1, wherein the wireless electrode assembly includes at least one tine extending from the body to engage heart tissue.

14. The system of claim 1, wherein the wireless electrode assembly includes an inductive coil to wirelessly receive power and includes at least one electrode surface to deliver stimulation energy to heart tissue.

15. An electrode delivery system for delivering a wireless electrode assembly into a heart chamber wall, the system comprising:

a delivery catheter to direct a wireless electrode assembly toward a heart chamber wall when the electrode assembly is disposed therein, the delivery catheter including a distal opening through which the wireless electrode assembly is passable;

an actuation member to push the electrode assembly out of the distal opening of the delivery catheter and into the heart chamber wall, the actuation member being movably adjustable within the delivery catheter; and

a guide wire instrument passable through the delivery catheter and having a distal tip portion to define a penetration path through endocardium tissue and into myocardium tissue of the heart wall chamber,

wherein when the actuation member pushes the electrode assembly out of the distal opening of the delivery catheter, the electrode assembly advances over the distal tip portion of the guide wire instrument to implant into the myocardium tissue along the penetration path.

16. The system of claim 15, further comprising a coupling device to releasably retain the electrode assembly in a distal portion of the delivery catheter when the electrode assembly is disposed in the delivery catheter.

17. The system of claim 15, further comprising a guide sheath to direct the delivery catheter into the heart chamber, the delivery catheter being slidable within the guide sheath to navigate through one or more blood vessels and into the heart chamber.

18. The system of claim 17, wherein the delivery catheter is fully retractable from the guide sheath when the guide sheath remains disposed at least partially in the heart chamber.

19. The system of claim 15, wherein the distal tip portion of guide wire instrument includes at least one sensor electrode surface to sense electrical activity in the heart chamber wall.

20. The system of claim 19, wherein the at least one sensor electrode surface is configured to delivery a test stimulation pulse to the heart chamber wall.

21. The system of claim 15, wherein the distal tip portion of guide wire instrument includes a curved section to define the penetration path through the myocardium tissue in a direction non-perpendicular to the heart chamber wall surface.

22. The system of claim 15, wherein the distal tip portion of guide wire instrument includes a fixation device to releasably couple with heart chamber wall.

23. The system of claim 15, wherein the distal tip portion of guide wire instrument is detachable from a main body portion of the guide wire instrument so that the detachable distal tip portion is operable to remain in the heart chamber wall when the wireless electrode assembly is advanced into the heart chamber wall.

24. The system of claim 15, further comprising a wireless electrode assembly for deployment from the delivery catheter and into the heart chamber wall.

25. A wireless electrode assembly for electrical stimulation of heart tissue, comprising:

a body portion at least partially containing a circuit to deliver electrical stimulation from an electrode surface;

a tissue penetration surface along the body portion to initiate penetration of the body portion into a heart chamber wall; and

a guide wire channel defined by the body portion and extending in a longitudinal direction through the body portion toward the tissue penetration surface.

26. The wireless electrode assembly of claim 25, wherein the guide wire channel is slidable over a guide wire instrument when the body portion is advanced over the guide wire instrument into the heart chamber wall.

27. The wireless electrode assembly of claim 26, wherein body portion includes a proximal surface that is magnetically attractable to a coupling device when the body portion is adjacent the coupling device.

28. The wireless electrode assembly of claim 25, wherein the body portion has a longitudinal length of about 5 mm to about 15 mm.

29. The wireless electrode assembly of claim 25, wherein the guide wire channel has a diameter of about 0.3 mm to about 0.5 mm.

30. The wireless electrode assembly of claim 25, wherein the tissue penetration surface comprises a generally conical surface.

31. The wireless electrode assembly of claim 25, further comprising at least one tine extending from the body portion to engage heart tissue.

32. The wireless electrode assembly of claim 25, further comprising a coil to wirelessly receive power from an electromagnetic field and comprising first and second electrode surfaces to delivery electrical stimulation energy to heart tissue.

33. A method for delivering a wireless electrode assembly into a heart chamber wall, the method comprising:

directing a distal portion of a delivery catheter into a heart chamber;

advancing a guide wire instrument out of the distal portion of the delivery catheter to penetrate a distal tip portion of guide wire instrument into a heart chamber wall; and

advancing a wireless electrode assembly out of the distal portion of the delivery catheter and over the distal tip portion of the guide wire instrument to implant the electrode assembly in the heart chamber wall.

34. The method of claim 33, further comprising directing a guide sheath through one or more blood vessels and into the heart chamber before directing the distal portion of the delivery catheter through the guide sheath and into a heart chamber.

35. The method of claim 34, further comprising retracting the delivery catheter from the guide sheath after the wireless electrode assembly is advanced into the heart wall chamber while the guide sheath remains disposed at least partially in the heart chamber.

36. The method of claim 33, further comprising adjusting an actuation member movably disposed in the delivery catheter to push the wireless electrode assembly over the distal tip portion of the guide wire instrument.

37. The method of claim 34, wherein the distal tip portion of the guide wire instrument defines a penetration path through endocardium tissue and into myocardium tissue of the heart wall chamber so that the wireless electrode assembly advances over the distal tip portion along the penetration path.