Implantable medical device fixation

• US 10,118,026 B2
• Filed: 11/10/2017
• Issued: 11/06/2018
• 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:
  US15/809,579
• Publication Number:
  US 20180064927A1
• Time in Patent Office: 361 Days
• Field of Search: 607 36, 607119, 607126, 607127, 600373, 600375
• 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. An 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 that are each deployable from a spring-loaded position to a hooked position, wherein each fixation tine of the set of fixations tines comprises a proximal end that is fixedly attached to a distal end of the implantable medical device in both the spring-loaded position and the hooked position, wherein each fixation tine of the set of fixations tines comprises a super-elastic material and is configured to have a column strength sufficient that a distal end of the tine penetrates cardiac tissue during deployment.

2. The assembly of claim 1, wherein a portion of each fixation tine adjacent the proximal end extends distally from the distal end of the implantable medical device in both the spring-loaded position and the hooked position.

3. The assembly of claim 1, 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 releasing the fixation tine from the spring-loaded position and allowing the fixation tine to assume the hooked position.

4. The assembly of claim 1, wherein the set of fixation tines is configured to generate a deployment force during deployment that pulls the attached implantable medical device toward the cardiac tissue when the distal ends penetrate the cardiac tissue.

5. The assembly of claim 1, wherein each fixation tine of the set of fixation tines is 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 and generally centered within the circular arrangement.

6. The assembly of claim 5, wherein the set of fixation tines extend from the implantable medical device at a longitudinal position that is proximal to the electrode generally centered within the circular arrangement.

7. The assembly 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, in 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.

8. The assembly of claim 1, 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.

9. The assembly of claim 8, wherein the set of fixation tines are configured to generate a deployment force during deployment that pulls the attached implantable medical device toward the cardiac tissue, wherein each of the generally straight segments is configured to apply the deployment force to the cardiac tissue during the deployment.

10. The assembly of claim 9, wherein each of the generally straight segments is configured to have the column strength sufficient to penetrate the cardiac tissue.

11. The assembly of claim 10, wherein the cardiac tissue comprises endocardial tissue, the column strength insufficient to penetrate epicardial tissue.

12. The assembly 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.

13. The assembly of claim 1, wherein the implantable medical device defines a longitudinal axis, wherein each fixation tine of the set of fixation tines includes at least a first portion that extends from the implantable medical device and a second portion that extends from the first portion, wherein in the spring-loaded position the first portion extends distally beyond the distal end of the implantable medical device and toward the longitudinal axis and the second portion extends distally from the first portion and away from the longitudinal axis, and wherein in the hooked position the first portion extends distally from the distal end of the implantable medical device the second portion bends back towards the implantable medical device.

14. The assembly of claim 13, wherein the second portion and the first portion define an arcuate shape in the spring-loaded position.

15. The assembly of claim 13, wherein the second portion is configured to bend back towards the implantable medical device such that at least some of the second portion is proximal to at least some of the first portion when the respective tine is in the hooked position.

16. The assembly of claim 1, further comprising a fixation element formed as a unitary component from a piece of the super-elastic material, the fixation element comprising a base and the set of fixation tines extending from the base.

17. The assembly of claim 1, wherein the implantable medical device is a leadless pacemaker.

18. An 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 that are each deployable from a spring-loaded position to a hooked position, wherein each fixation tine of the set of fixations tines comprises a proximal end that is fixedly attached to a distal end of the implantable medical device in both the spring-loaded position and the hooked position,

wherein each fixation tine of the set of fixation tines is 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 and is generally centered within the circular arrangement, wherein each fixation tine of the set of fixation tines extends from the implantable medical device at a longitudinal position that is proximal to the electrode, and

wherein each fixation tine of the set of fixations tines comprises a super-elastic material and defines an oblong cross-section and is configured to have a column strength sufficient that a distal end of the tine penetrates cardiac tissue during deployment.

19. The assembly of claim 18, wherein a portion of the fixation tine adjacent the proximal end extends distally from the distal end of the implantable medical device in both the spring-loaded position and the hooked position.

20. The assembly of claim 18, wherein each fixation tine of the set of fixation tines is configured to be deployable by releasing the fixation tine from the spring-loaded position and allowing the fixation tine to assume the hooked position, wherein each fixation tine of the set of fixation tines is configured to generate a deployment force during deployment that pulls the attached implantable medical device toward the cardiac tissue when the distal ends penetrate the cardiac tissue.

21. The assembly of claim 18, wherein each fixation tine of the set of fixation tines comprises a generally straight segment configured to penetrate the cardiac tissue and an arcuate segment proximal to the generally straight segment, wherein each of the generally straight segments is configured to apply a deployment force to the cardiac tissue during the deployment.

22. The assembly of claim 18, wherein the implantable medical device defines a longitudinal axis, wherein each fixation tine of the set of fixation tines includes at least a first portion that extends from the implantable medical device and a second portion that extends from the first portion, wherein in the spring-loaded position the first portion extends distally beyond the distal end of the implantable medical device and toward the longitudinal axis and the second portion extends distally from the first portion and away from the longitudinal axis, and wherein in the hooked position the first portion extends distally from the distal end of the implantable medical device and the second portion bends back towards the implantable medical device.

23. A kit comprising:

an implantable medical device comprising;

a plurality of electrodes;

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

a set of fixation tines that are each deployable from a spring-loaded position to a hooked position, wherein each fixation tine of the set of fixations tines comprises a proximal end that is fixedly attached to a distal end of the implantable medical device in both the spring-loaded position and the hooked position, wherein each fixation tine of the set of fixations tines comprises a super-elastic material and is configured to have a column strength sufficient that a distal end of the tine penetrates cardiac tissue during deployment; and

a catheter forming a lumen sized to receive the implantable medical device and hold each fixation tine of the set of fixation tines in the spring-loaded 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 releasing the fixation tine from the spring-loaded position and allowing the fixation tine to assume the hooked position, wherein the catheter includes an aperture to the lumen that is adjacent to the distal end of the catheter.

24. The kit of claim 23, wherein a portion of the fixation tine adjacent the proximal end extends distally from the distal end of the implantable medical device in both the spring-loaded position and the hooked position.

25. The kit of claim 23, wherein each fixation tine of the set of fixation tines is configured to be deployed by pushing the implantable medical device towards the distal end of the catheter until the distal end of the fixation tine extends out of the aperture.

26. The kit of claim 25, wherein each fixation tine of the set of fixation tines is configured to generate a deployment force during deployment that pulls the attached implantable medical device at least partially out of the lumen via the aperture when distal ends of the set of fixation tines penetrate the cardiac tissue.

27. The kit of claim 23, wherein:

each fixation tine of the set of fixation tines is positioned substantially equidistant from each other in a circular arrangement;

one electrode of the plurality of electrodes is located at the distal end of the implantable medical device and is generally centered within the circular arrangement;

each fixation tine of the set of fixation tines extends from the implantable medical device at a longitudinal position that is proximal to the electrode;

each fixation tine of the set of fixation tines comprises a generally straight segment and an arcuate segment proximal to the generally straight segment; and

in the hooked position, a longitudinal position of a distal end of the generally straight segment is proximal the one electrode, and a longitudinal position of at least a portion of the arcuate segment is distal the one electrode.

28. The kit of claim 23, 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;

each fixation tine of the set of fixation tines is configured to generate a deployment force during deployment that pulls the attached implantable medical device toward the cardiac tissue; and

each of the generally straight segments is configured to apply the deployment force to the cardiac tissue during the deployment.

29. The kit of claim 23, wherein the set of fixation tines are configured to generate a deployment force during deployment, wherein each tine of the set of fixation tines includes a relatively flattened section to register the tine on an inner surface of the catheter when generating the deployment force.