Implantable medical device fixation

• US 10,835,737 B2
• Filed: 10/24/2018
• Issued: 11/17/2020
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Grubac, Vladimir, Bonner, Matthew D., Usher, Raymond W., Anderson, Thomas A., Alfoqaha, Arshad A.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US16/169,276
• Publication Number:
  US 20190054288A1
• Time in Patent Office: 755 Days
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Various fixation techniques for implantable medical device (IMDs) are described. In one example, an assembly comprises an IMD; and a set of active fixation tines attached to the IMD. The active fixation tines in the set are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from the IMD to a hooked position in which the active fixation tines bend back towards the IMD. The active fixation tines are configured to secure the IMD to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue.

Claims

1. A method of implanting an assembly in a patient, the assembly comprising:

an implantable medical device comprising;

a plurality of electrodes, and

circuitry configured to deliver cardiac pacing stimulation via the plurality of electrodes; and

a set of fixation tines attached to the implantable medical device such that the set of fixation tines extends from a distal end of the implantable medical device, wherein each fixation tine of the set of fixations tines comprises a super-elastic material, the method comprising;

holding, within a lumen of a delivery catheter, the implantable medical device and the set of fixation tines, wherein the lumen is sized to hold each fixation tine of the set of fixation tines in a spring-loaded position;

deploying each fixation tine of the set of fixation tines from the spring-loaded position to a hooked position, wherein each fixation tine of the set of fixation tines is configured to be deployed from the spring-loaded position to the hooked position by being released from the spring-loaded position and allowed to assume the hooked position;

penetrating, by a distal end of each fixation tine of the set of fixation tines and as a result of the deployment of the set of fixation tines, cardiac tissue;

generating, by each fixation tine of the set of fixation tines, a deployment force during the deployment; and

applying, by each fixation tine of the set of fixation tines, the deployment force to at least one of the cardiac tissue or the delivery catheter to pull the attached implantable medical device toward the cardiac tissue through an aperture at a distal end of the delivery catheter.

2. The method of claim 1, further comprising advancing the distal end of each fixation tine of the set of fixation tines beyond the aperture, wherein deploying each fixation tine is a result of the distal end of the fixation tine being advanced beyond the aperture.

3. The method of claim 2, wherein advancing the distal end of each fixation tine comprises advancing the implantable medical device and the set of fixation tines distally relative to the delivery catheter.

4. The method of claim 1, wherein applying the deployment force comprises applying the deployment force in a proximal direction upon the distal end of the delivery catheter.

5. The method of claim 1, wherein each fixation tine of the set of fixation tines applies a substantially outward radial force upon an inner surface of the delivery catheter when received by the delivery catheter.

6. The method of claim 1, wherein the fixation tines of the set of fixation tines are positioned substantially equidistant from each other in a circular arrangement and one of the electrodes is located at the distal end of the implantable medical device and generally centered within the circular arrangement.

7. The method of claim 6, wherein each fixation tine of the set of fixation tines is configured to apply the deployment force to the penetrated tissue in a proximal direction to distally advance the electrode toward and press the electrode onto the cardiac tissue.

8. The method of claim 6, wherein each fixation tine of the set of fixation tines comprises a generally straight segment and an arcuate segment proximal to the generally straight segment, wherein, upon deploying the set of fixation tines to the hooked position, a longitudinal position of a distal end of the generally straight segment is proximal the electrode, and a longitudinal position of at least a portion of the arcuate segment is distal the electrode.

9. The method of claim 8, wherein the distal end of each fixation tine penetrates the cardiac tissue as a result of each of the generally straight segments being configured to have a column strength sufficient to penetrate the cardiac tissue.

10. The method of claim 9, wherein the cardiac tissue comprises endocardial tissue and the column strength is insufficient to penetrate epicardial tissue.

11. The method of claim 1, further comprising applying a reloading force in a proximal direction upon a proximal portion of the implantable medical device to reload the implantable medical device into the delivery catheter lumen and return the set of fixation tines to the spring-loaded state within the delivery catheter.

12. The method of claim 11, wherein applying the reloading force further comprises:

applying a first force upon the penetrated tissue by the set of fixation tines to stretch the tissue until the tissue stiffness matches the tine straightening force; and

in response to the tissue stiffness matching the tine straightening force, applying a second force upon the penetrated tissue by the set of fixation tines to straighten each fixation tine.

13. The method of claim 11, wherein applying the reloading force comprises pulling on the implantable medical device once the set of tines have straightened sufficiently to remove the set of tines from the tissue without tearing the tissue.

14. The method of claim 1, wherein each fixation tine of the set of fixation tines defines a rectangular profile, and the distal end of each fixation tine of the set of fixation tines is rounded.

15. The method of claim 1, wherein the implantable medical device is a leadless pacemaker.

16. The method of claim 1, wherein the deployment force is generated by a relatively flattened section of each tine of the set of fixation tines configured to register the tine on an inner surface of the lumen.

17. A method of implanting an assembly in a patient, the assembly comprising:

an implantable medical device comprising;

a plurality of electrodes; and

circuitry configured to deliver cardiac pacing stimulation via the plurality of electrodes; and

a set of fixation tines attached to the implantable medical device such that the set of fixation tines extends from a distal end of the implantable medical device, wherein each fixation tine of the set of fixations tines comprises a super-elastic material and defines an oblong cross-section, wherein the set of fixation tines are positioned substantially equidistant from each other in a circular arrangement, wherein one of the electrodes is located at the distal end of the implantable medical device generally centered within the circular arrangement, wherein the set of fixation tines extend from the implantable medical device at a longitudinal position that is proximal to the electrode, the method comprising;

holding, within a lumen of a delivery catheter, the implantable medical device and the set of fixation tines, wherein the lumen is sized to hold each fixation tine of the set of fixation tines in a spring-loaded position, wherein the delivery catheter includes an aperture to the lumen that is adjacent to the distal end of the delivery catheter;

deploying each fixation tine of the set of fixation tines from the spring-loaded position to a hooked position by pushing the implantable medical device towards the distal end of the delivery catheter until the distal ends of the set of fixation tines extend out of the aperture, wherein each fixation tine of the set of fixation tines is configured to be deployed from the spring-loaded position to the hooked position by being released from the spring-loaded position and allowed to assume the hooked position;

penetrating, by a distal end of each fixation tine of the set of fixation tines and as a result of the deployment of the set of fixation tines, cardiac tissue;

generating, by each fixation tine of the set of fixation tines, a deployment force during the deployment; and

applying, by each fixation tine of the set of fixation tines, the deployment force to at least one of the cardiac tissue or the delivery catheter to pull the attached implantable medical device toward the cardiac tissue and at least partially out of the lumen through the aperture.

18. The method of claim 17, wherein deploying each fixation tine of the set of fixation tines is a result of the distal end of the fixation tine being advanced beyond the aperture.

19. The method of claim 17, wherein applying the deployment force comprises applying the deployment force in a proximal direction upon the distal end of the delivery catheter.

20. The method of claim 17, wherein each fixation tine of the set of fixation tines applies a substantially outward radial force upon an inner surface of the catheter when received by the delivery catheter.

21. The method of claim 17, wherein each fixation tine of the set of fixation tines is configured to apply the deployment force to the penetrated tissue in a proximal direction to distally advance the electrode toward and press the electrode onto the cardiac tissue.

22. The method of claim 17, further comprising applying a reloading force in a proximal direction upon a proximal portion of the implantable medical device to reload the implantable medical device into the delivery catheter lumen and return the set of fixation tines to the spring-loaded state within the delivery catheter.

23. The method of claim 22, wherein applying the reloading force further comprises:

applying a first force upon the penetrated tissue by the set of fixation tines to stretch the tissue until the tissue stiffness matches the tine straightening force; and

in response to the tissue stiffness matching the tine straightening force, applying a second force upon the penetrated tissue by the set of fixation tines to straighten each fixation tine.

24. The method of claim 22, wherein applying the reloading force comprises pulling on the implantable medical device once the set of tines have straightened sufficiently to remove the set of tines from the tissue without tearing the tissue.

25. The method of claim 17, wherein each fixation tine of the set of fixation tines comprises a generally straight segment and an arcuate segment proximal to the generally straight segment, wherein, upon deploying the set of fixation tines to the hooked position, a longitudinal position of a distal end of the generally straight segment is proximal the electrode, and a longitudinal position of at least a portion of the arcuate segment is distal the electrode.

26. The method of claim 25, wherein the distal end of each fixation tine penetrates the cardiac tissue as a result of each of the generally straight segments being configured to have a column strength sufficient to penetrate the cardiac tissue.

27. The method of claim 26, wherein the cardiac tissue comprises endocardial tissue and the column strength is insufficient to penetrate epicardial tissue.

28. The method of claim 17, wherein the deployment force is generated by a relatively flattened section of each tine of the set of fixation tines configured to register the tine on an inner surface of the lumen.