Delivery of cardiac stimulation devices

• US 9,662,487 B2
• Filed: 03/02/2016
• Issued: 05/30/2017
• Est. Priority Date: 07/21/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Kveen, Graig L., Hastings, Roger N., Gunderson, Richard C., Saholt, Douglas R.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US15/058,941
• Publication Number:
  US 20160175583A1
• Time in Patent Office: 454 Days
• 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 wireless pacing electrode delivery system, comprising:

a guide sheath including a distal end and a lumen extending to the distal end; and

an intravascularly-deliverable medical device positionable within the lumen of the guide sheath;

a fixation device attached to and extending away from the medical device, wherein the fixation device is configured to engage heart wall tissue, the fixation device configured to be advanced distal of the distal end of the guide sheath to engage the heart wall tissue;

wherein the fixation device includes four tines attached to and extending distally from a ring, the four tines having a non-deployed configuration and a deployed configuration, wherein in the non-deployed configuration the four tines point distally toward the heart wall tissue to pierce into the heart wall tissue without penetrating entirely through the heart wall, and wherein the four tines are biased to curl outwardly to the deployed configuration when unconstrained to engage the heart wall tissue.

2. The system of claim 1, wherein the four tines extend in a longitudinal orientation when constrained in the non-deployed configuration.

3. The system of claim 1, wherein the four tines contact an inner wall of the delivery system when constrained in the non-deployed configuration.

4. The system of claim 1, wherein the four tines extend distal of the distal end of the guide sheath when positioned in the deployed configuration.

5. The system of claim 1, wherein the four tines are formed of a shape memory material.

6. The system of claim 5, wherein the shape memory material is nitinol.

7. The system of claim 1, wherein the four tines extend from a distal end of the intravascularly-deliverable medical device in the deployed configuration.

8. The system of claim 1, further comprising an actuator configured to deploy the four tines from the non-deployed configuration to the deployed configuration.

9. The system of claim 8, wherein the four tines are configured to moved linearly in a longitudinal direction in response to actuation of the actuator.

10. A wireless pacing electrode delivery system, comprising:

a guide sheath including a lumen; and

an intravascularly-deliverable medical device positionable within the lumen of the guide sheath and configured to be advanced out of a distal opening of the guide sheath to engage heart wall tissue;

a fixation device attached to and extending away from the medical device, the fixation device including four tines attached to and extending distally from a ring;

wherein the four tines are constrained in a non-deployed configuration when positioned within the lumen of the guide sheath and biased toward a deployed configuration when unconstrained, wherein the four tines are curled outwardly in the deployed configuration;

wherein the four tines are configured to pierce into the heart wall tissue without penetrating entirely through the heart wall tissue to an opposite face of the heart wall tissue to engage the heart wall tissue when in the deployed configuration.

11. The system of claim 10, wherein the four tines extend in a longitudinal orientation when constrained in the non-deployed configuration.

12. The system of claim 10, wherein the four tines contact an inner wall of the delivery system when constrained in the non-deployed configuration.

13. The system of claim 10, wherein the four tines extend distal of the distal end of the guide sheath when positioned in the deployed configuration.

14. The system of claim 10, wherein the four tines are formed of a shape memory material.

15. The system of claim 14, wherein the shape memory material is nitinol.

16. The system of claim 10, wherein the four tines extend from a distal end of the intravascularly-deliverable medical device in the deployed configuration.

17. The system of claim 10, further comprising an actuator configured to deploy the four tines from the non-deployed configuration to the deployed configuration.

18. The system of claim 17, wherein the four tines are configured to moved linearly in a longitudinal direction in response to actuation of the actuator.