Delivery of cardiac stimulation devices

• US 7,840,281 B2
• Filed: 07/21/2006
• Issued: 11/23/2010
• Est. Priority Date: 07/21/2006
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US11/490,916
• Publication Number:
  US 20080021532A1
• Time in Patent Office: 1,586 Days
• Field of Search: 607/32, 607/33, 607/60, 607/61, 607/119, 607/126
• US Class Current: 607/126
• 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. A 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 into a heart chamber wall using a distal tip portion of guide wire instrument;

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 entirely within the heart chamber wall using an insertion force provided by an actuation member; and

detaching the distal tip portion of the guide wire instrument from a main body portion of the guide wire instrument at a location including mating portions along the guide wire instrument, when the actuation member is retracted toward a proximal end of the delivery catheter, after the wireless electrode assembly is implanted into the heart chamber wall.

2. The method of claim 1, comprising directing a guide sheath through one or more blood vessels and into the heart chamber via a route through the one or more blood vessels before then directing the distal portion of the delivery catheter through the guide sheath and into a heart chamber.

3. The method of claim 2, comprising retracting the delivery catheter from the guide sheath after the advancing the wireless electrode assembly out of the distal portion of the delivery catheter, the retracting performed while the guide sheath remains disposed at least partially in the heart chamber.

4. The method of claim 2, wherein the advancing the guide wire instrument out of the distal portion of the delivery catheter to penetrate into the heart chamber wall comprises using the distal tip portion of the guide wire instrument to define a penetration path through endocardium tissue and into myocardium tissue of the heart chamber wall so that the wireless electrode assembly advances over the distal tip portion of the guide wire instrument along the penetration path.

5. The method of claim 2, wherein the advancing the guide wire instrument includes penetrating into the heart chamber wall following a penetration path that is non-perpendicular to the heart chamber wall surface using a curved section of the distal tip portion of the guide wire instrument without piercing entirely through to the opposing side of the heart chamber wall.

6. The method of claim 5, comprising sliding the wireless electrode assembly along the curved section of the distal tip portion of the guide wire instrument to implant the wireless electrode assembly using the penetration path, wherein the penetration path is non-perpendicular to the heart chamber wall.

7. The method of claim 2, comprising releasably anchoring the delivery catheter to the heart chamber wall using a fixation device located near the distal opening of the delivery catheter.

8. The method of claim 7, wherein the releasably anchoring the delivery catheter to the heart chamber wall using a fixation device includes extending one or more adjustable barbs located near the distal opening of the delivery catheter into the heart chamber wall.

9. The method of claim 7, wherein the releasably anchoring the delivery catheter to the heart chamber wall using a fixation device includes screwing a distal tip portion of the delivery catheter into the heart chamber wall.

10. The method of claim 2, comprising sensing electrical activity in heart tissue using the distal tip portion of the guide wire instrument.

11. The method of claim 2, comprising electrically stimulating heart tissue using the distal tip portion of the guide wire instrument.

12. The method of claim 1, comprising adjusting the actuation member movably disposed in the delivery catheter to push the wireless electrode assembly over the distal tip portion of the guide wire instrument.

13. The method of claim 12, comprising releasably retaining the wireless electrode assembly near the distal opening of the delivery catheter.

14. The method of claim 13, wherein the releasably retaining the wireless electrode assembly includes mechanically coupling the wireless electrode assembly to a location at least partially within the delivery catheter near the distal opening of the delivery catheter using a mechanical coupling.

15. The method of claim 14, wherein the advancing the 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 includes releasing the wireless electrode assembly from the mechanical coupling using the actuation member.

16. The method of claim 14, wherein the mechanically coupling the wireless electrode assembly to the location at least partially within the delivery catheter near the distal opening of the delivery catheter includes magnetically attracting a proximal end of a body portion of the wireless electrode assembly to the location at least partially within the delivery catheter.

17. The method of claim 1, comprising anchoring the wireless electrode assembly into the heart chamber wall using a detached distal tip portion of the guide wire instrument.

18. The method of claim 17, wherein the anchoring the wireless electrode assembly into the heart chamber wall using the detached distal tip portion of the guide wire instrument includes using one or more adjustable barbs included on the detached distal tip portion of the guide wire instrument.

19. The method of claim 17, wherein the anchoring the wireless electrode assembly into the heart chamber wall using the detached distal tip portion of the guide wire instrument includes using a curved portion of the detached distal tip portion of the guide wire instrument to assist in the anchoring.