DELIVERY OF CARDIAC STIMULATION DEVICES

• US 20120232565A1
• Filed: 05/21/2012
• Published: 09/13/2012
• Est. Priority Date: 07/21/2006
• Status: Active Grant

• Current Assignee: Douglas R. Saholt, Graig L. Kveen, Richard C Gunderson, Roger Hastings
• Original Assignee: Douglas R. Saholt, Graig L. Kveen, Richard C Gunderson, Roger Hastings
• Inventors: HASTINGS, ROGER, GUNDERSON, RICHARD C., KVEEN, GRAIG L., SAHOLT, DOUGLAS R.
• Granted Patent: US 9,308,374 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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 system, comprising:

an intravascularly-deliverable medical device including a fixation device configured to engage heart wall tissue; and

a guide sheath defining a first lumen, the guide sheath configured to direct the intravascularly-deliverable medical device to the heart wall tissue via the first lumen;

wherein the fixation device comprises;

one or more tines having a non-deployed configuration and a deployed configuration, wherein in the deployed configuration the one or more tines extend distally from a distal end of the intravascularly-deliverable medical device to engage the heart wall tissue, wherein at least one of the one or more tines is configured to curl outwardly away from the distal end when in the deployed configuration; and

a collar coupled to the one or more tines and configured to move the one or more tines from the non-deployed configuration to the deployed configuration.

2. The system of claim 1, wherein the one or more tines are configured to have a generally longitudinal orientation when in the non-deployed configuration.

3. The system of claim 1, wherein distal movement of the collar relative to the intravascularly-deliverable medical device moves the one or more tines from the non-deployed configuration to the deployed configuration.

4. The system of claim 1, wherein the one or more tines include a shape-memory material.

5. The system of claim 1, comprising an actuator configured to actuate the collar to move the one or more tines from the non-deployed configuration to the deployed configuration.

6. The system of claim 5, wherein the actuator is coupled to the collar and configured to push or pull the collar in a longitudinal direction.

7. The system of claim 5, wherein the collar and the one or more tines are configured to move linearly in a longitudinal direction in response to a rotational actuation of the actuator.

8. The system of claim 5, wherein the actuator defines a second lumen, the second lumen sized and shaped to receive a guidewire therethrough.

9. A system, comprising:

an intravascularly-deliverable medical device including a fixation device configured to engage heart wall tissue; and

a guide sheath defining a first lumen, the guide sheath configured to direct the intravascularly-deliverable medical device to the heart wall tissue via the first lumen;

wherein the fixation device comprises;

one or more tines configured to deploy from a distal end of the intravascularly-deliverable medical device into the heart wall tissue; and

a collar coupled to the one or more tines and configured to deploy the one or more tines in response to distal movement of the collar.

10. The system of claim 9, wherein the one or more tines are user-actuatable in a longitudinal direction along a longitudinal axis of the intravascularly-deliverable medical device.

11. The system of claim 9, wherein the one or more tines are configured to curl outwardly from a distal tip region of the intravascularly-deliverable medical device when deployed from the intravascularly-deliverable medical device.

12. The system of claim 9, wherein the one or more tines include a shape-memory material.

13. The system of claim 9, wherein the collar is located circumferentially around the intravascularly-deliverable medical device.

14. The system of claim 9, comprising an actuator sized and shaped for insertion into the first lumen of the guide sheath and configured to actuate the collar;

and

wherein the one or more tines are configured to deploy from a distal end of the intravascularly-deliverable medical device into the heart wall tissue in response to user actuation of the collar via the actuator.

15. The system of claim 14, wherein the actuator is coupled to the collar and configured to push or pull the collar in a longitudinal direction.

16. The system of claim 14, wherein the collar and one or more tines are configured to move linearly in a longitudinal direction in response to a rotational actuation of the actuator.

17. A system, comprising:

a tubular member defining a lumen;

an wireless electrode assembly sized and shaped for intravascular delivery to heart wall tissue through the lumen of the tubular member, wherein the wireless electrode assembly is configured to electrically stimulate heart tissue; and

a fixation device comprising;

one or more tines configured to move from a retracted configuration to a deployed configuration to engage the heart wall tissue, wherein the one or more tines are configured to have a generally longitudinal orientation in the retracted configuration, and wherein the one or more tines are configured to curl outwardly in the deployed configuration; and

a collar coupled to the one or more tines, wherein distal movement of the collar moves the one or more tines from the retracted configuration to the deployed configuration.

18. The system of claim 17, wherein the collar is user-actuatable to move the one or more tines from the retracted configuration to the deployed configuration.

19. The system of claim 17, wherein the one or more tines include a shape-memory material.

20. The system of claim 17, comprising an actuator configured to actuate the collar;

and

wherein the one or more tines are configured to move from the retracted configuration to the deployed configuration in response to user actuation of the collar via the actuator.