Implantable medical device fixation

• US 10,173,050 B2
• Filed: 11/10/2017
• Issued: 01/08/2019
• 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:
  US15/809,518
• Publication Number:
  US 20180064926A1
• Time in Patent Office: 424 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 implantable medical device comprising:

at least one housing;

a plurality of electrodes;

pacing circuitry within the at least one housing, the pacing circuitry configured to deliver cardiac pacing via the electrodes;

a power source with the at least one housing, the power source configured to power the pacing circuitry;

a fixation assembly comprising;

a fixation assembly housing fixedly connected to the at least one housing proximate a distal end of the at least one housing; and

a fixation element comprising a proximal base within the fixation assembly housing and a set of fixation tines extending distally from the proximal base and out of the fixation assembly housing, wherein each fixation tine in the set comprises a shape memory alloy material and is deployable by bending from a spring-loaded position in which a distal end of the fixation tine points away from the at least one housing to a hooked position in which the fixation tine bends back towards the at least one housing, wherein the set of fixation tines is configured to secure the implantable medical device to patient tissue when deployed while distal ends of the fixation tines are positioned adjacent to the patient tissue.

2. The implantable medical device of claim 1, wherein the distal ends of the fixation tines are proximal to the proximal base when the set of fixation tines are in the hooked position.

3. The implantable medical device of claim 1, wherein:

the set of fixation tines are in a circular arrangement about the proximal base with proximal ends of the fixation tines secured to the proximal base;

the set of fixation tines are positioned substantially equidistant from each other in the circular arrangement; and

the set of fixation tines are oriented radially outwardly relative to the circular arrangement in the hooked position.

4. The implantable medical device of claim 3, wherein the set of fixation tines and proximal base are formed as a unitary component from a piece of the shape memory alloy material.

5. The implantable medical device of claim 3, wherein:

one electrode of the plurality of electrodes is located within the circular arrangement; and

the implantable medical device is configured such that the one electrode contacts the patient tissue when the implantable medical device is secured to the patient tissue by the set of fixation tines.

6. The implantable medical device of claim 5, wherein the set of fixation tines apply a force on the patient tissue in a proximal direction to press the one electrode against the patient tissue, further comprising at least one conductor connected to the one electrode, the conductor extending from the at least one housing and through the fixation assembly housing.

7. The implantable medical device of claim 5, further comprising at least one conductor configured to couple the one electrode to the pacing circuitry,

wherein the at least one conductor extends from the at least one housing, through the fixation assembly, and to the electrode, and

wherein the fixation assembly housing electrically isolates the set of fixation tines from the at least one conductor.

8. The implantable medical device of claim 1, wherein the implantable medical device comprises a leadless pacemaker.

9. The implantable medical device of claim 1, wherein the set of fixation tines consists of four fixation tines.

10. The implantable medical device of claim 1, wherein the fixation assembly housing is configured to electrically isolate the fixation element from the at least one housing.

11. The implantable medical device of claim 1, wherein the fixation assembly housing includes a header body and a header cap configured to securely attach to each other while encompassing the proximal base of the fixation element near the distal end of the at least one housing such that the fixation element is electrically isolated from the at least one housing by the fixation assembly housing.

12. A kit comprising:

a catheter forming a lumen that includes an aperture to the lumen that is adjacent to the distal end of the catheter; and

an implantable medical device that includes;

at least one housing;

a plurality of electrodes;

pacing circuitry within the at least one housing, the pacing circuitry configured to deliver cardiac pacing via the electrodes;

a power source with the at least one housing, the power source configured to power the pacing circuitry;

a fixation assembly comprising;

a fixation assembly housing fixedly connected to the at least one housing proximate a distal end of the at least one housing; and

a fixation element comprising a proximal base within the fixation assembly housing and a set of fixation tines extending distally from the proximal base and out of the fixation assembly housing, wherein each fixation tine in the set comprises a shape memory alloy material and is deployable by bending from a spring-loaded position in which a distal end of the fixation tine points away from the at least one housing to a hooked position in which the fixation tine bends back towards the at least one housing, wherein the set of fixation tines is configured to secure the implantable medical device to patient tissue when deployed while distal ends of the fixation tines are positioned adjacent to the patient tissue,

wherein the lumen of the catheter is sized to receive the implantable medical device and hold the set of fixation tines in the spring-loaded position, and

wherein the set of fixation tines are configured to be deployed by pushing the implantable medical device towards the distal end of the catheter until the distal ends of the set of fixation tines extend out of the aperture.

13. The kit of claim 12, wherein the set of fixation tines are 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 the distal ends of the set of fixation tines penetrate the cardiac tissue.

14. The kit of claim 12, wherein the implantable medical device comprises a leadless pacemaker.

15. The kit of claim 12, wherein the set of fixation tines consists of four fixation tines.

16. The kit of claim 12, wherein the fixation assembly housing includes a header body and a header cap configured to securely attached to each other while encompassing the proximal base of the fixation element near the distal end of the at least one housing such that the fixation element is electrically isolated from the at least one housing by the fixation assembly housing.

17. The kit of claim 12, wherein the set of fixation tines and proximal base are formed as a unitary component from a piece of the shape memory alloy material.

18. The kit of claim 12, wherein:

the set of fixation tines are in a circular arrangement about the proximal base with proximal ends of the fixation tines secured to the proximal base;

the set of fixation tines are positioned substantially equidistant from each other in the circular arrangement; and

the set of fixation tines are oriented radially outwardly relative to the circular arrangement in the hooked position.

19. The kit of claim 18, wherein:

one electrode of the plurality of electrodes is located within the circular arrangement; and

the implantable medical device is configured such that the one electrode contacts the patient tissue when the implantable medical device is secured to the patient tissue by the set of fixation tines.

20. An implantable medical device comprising:

at least one housing;

a plurality of electrodes;

pacing circuitry within the at least one housing, the pacing circuitry configured to deliver cardiac pacing via the electrodes;

a power source with the at least one housing, the power source configured to power the pacing circuitry;

a fixation assembly comprising;

a fixation assembly housing fixedly connected to the at least one housing proximate a distal end of the at least one housing; and

a fixation element comprising a proximal base within the fixation assembly housing and a set of fixation tines extending distally from the proximal base and out of the fixation assembly housing,

wherein each fixation tine in the set comprises a shape memory alloy material and is deployable by bending from a spring-loaded position in which a distal end of the fixation tine points away from the at least one housing to a hooked position in which the fixation tine bends back towards the at least one housing,

wherein the set of fixation tines are in a circular arrangement about the proximal base with proximal ends of the fixation tines secured to the proximal base, the set of fixation tines are positioned substantially equidistant from each other in the circular arrangement, and the set of fixation tines are oriented radially outwardly relative to the circular arrangement in the hooked position,

wherein the set of fixation tines is configured to secure the implantable medical device to patient tissue when deployed while distal ends of the fixation tines are positioned adjacent to the patient tissue,

wherein one electrode of the plurality of electrodes is located within the circular arrangement and the implantable medical device is configured such that the one electrode contacts the patient tissue when the implantable medical device is secured to the patient tissue by the set of fixation tines,

wherein the implantable medical device further comprises at least one conductor configured to couple the one electrode to the pacing circuitry,

wherein the at least one conductor extends from the at least one housing, through the fixation assembly, and to the electrode, and

wherein the fixation assembly housing electrically isolates the set of fixation tines from the at least one conductor.