Implantable medical device fixation

• US 10,112,045 B2
• Filed: 10/28/2011
• Issued: 10/30/2018
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Anderson, Thomas A., Nippoldt, Douglas D., Swenson, III, Richard W., Grubac, Vladimir, Bonner, Matthew D., Usher, Raymond W., Alfoqaha, Arshad A.
• Primary Examiner(s): Weston, Tiffany
• Application Number:
  US13/284,761
• Publication Number:
  US 20120172690A1
• Time in Patent Office: 2,559 Days
• Field of Search: 607 4- 9, 607115, 607116, 607119, 607122, 607126, 607128
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• 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

An assembly includes an implantable medical device (IMD) including a conductive housing, and a fixation element assembly attached to the IMD. The fixation element assembly includes a set of active fixation tines and an insulator to electrically isolate the set of active fixation tines from the conductive housing of the implantable medical device. 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 implantable medical device to a hooked position in which the active fixation tines bend back towards the implantable medical device. The active fixation tines are configured to secure the implantable medical device 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 including a conductive housing; and

a fixation element assembly fixedly attached to the implantable medical device near a distal end of the conductive housing, wherein the fixation element assembly includes a set of active fixation tines and an insulator to electrically isolate the set of active fixation tines from the conductive housing of the implantable medical device,

wherein 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 implantable medical device to a hooked position in which the active fixation tines bend back towards the implantable medical device,

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

wherein the active fixation tines are in a circular arrangement about a base with proximal ends of the active fixation tines secured to the base, and

wherein the insulator includes a header body with notches to receive the active fixation tines and a header cap that combines with the header body to encompass the base such that the active fixation tines are fixedly attached to the implantable medical device at a location near the distal end of the conductive housing both when the active fixation tines are in the spring-loaded position and when the active fixation tines are in the hooked position.

2. The assembly of claim 1, wherein the header cap includes a groove configured to mate with the base.

3. The assembly of claim 1, wherein the active fixation tines are positioned substantially equidistant from each other in the circular arrangement.

4. The assembly of claim 1, wherein the active fixation tines are oriented outwardly relative to the circular arrangement.

5. The assembly of claim 1,

wherein the implantable medical device includes an electrode for at least one of sensing a physiological condition of the patient and delivering a therapy to the patient,

wherein the electrode is located within the circular arrangement, and

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

6. The assembly of claim 5, wherein the active fixation tines provide a forward pressure of the electrode on the patient tissue to assure good electrode-tissue contact.

7. The assembly of claim 5, wherein the implantable medical device comprises a leadless pacemaker.

8. The assembly of claim 1, wherein the set of active fixation tines consists of four active fixation tines.

9. The assembly of claim 1, wherein the set of active fixation tines are formed from a shape memory alloy material.

10. The assembly of claim 1, wherein the fixation element assembly and the base are a unitary component of a single material.

11. The assembly of claim 1, wherein the fixation element assembly is made of nitinol.

12. A kit for implanting an implantable medical device within a patient, the kit comprising:

the implantable medical device, wherein the implantable medical device includes a conductive housing;

a fixation element assembly fixedly attached to the implantable medical device near a distal end of the conductive housing, wherein the fixation element assembly includes a set of active fixation tines and an insulator to electrically isolate the set of active fixation tines from the conductive housing of the implantable medical device,

wherein 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 conductive housing of the implantable medical device to a hooked position in which the active fixation tines bend back towards the implantable medical device, wherein proximal ends of the active fixation tines are secured to a base, wherein the insulator encompasses the base such that the active fixation tines are fixedly attached to the implantable medical device at a location near the distal end of the conductive housing both when the active fixation tines are in the spring-loaded position and when the active fixation tines are in the hooked position,

wherein the active fixation tines are configured to secure the implantable medical device to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue;

a catheter forming a lumen configured to receive the implantable medical device and hold the active fixation tines in the spring-loaded position, wherein the lumen includes an aperture that is adjacent to a distal end of the catheter; and

a deployment element configured to initiate deployment of the active fixation tines while the implantable medical device is positioned within the lumen of the catheter,

wherein the active fixation tines are configured such that deployment of the active fixation tines from the spring-loaded position to the hooked position while the implantable medical device is positioned within the lumen of the catheter causes the active fixation tines to pull the implantable medical device out of the lumen via the aperture that is adjacent to the distal end of the catheter.

13. The kit of claim 12, further comprising a tether attached to the implantable medical device, the tether being configured to facilitate pulling the implantable medical device back into the lumen from the proximal end of the catheter after the active fixation tines pull the implantable medical device out of the lumen, wherein pulling the implantable medical device back into the lumen with the tether returns the active fixation tines to the spring-loaded position from the hooked position such that the active fixation tines can be redeployed with the deployment element.

14. The kit of claim 12, wherein, after the set of the active fixation tines is deployed to secure the implantable medical device to the patient tissue, the active fixation tines are configured to facilitate releasing the implantable medical device from the tissue without tearing the tissue by pulling the implantable medical device away from the tissue using the tether.

15. The kit of claim 12, wherein the deployment element is configured to be remotely activated by a clinician from a proximal end of the catheter.

16. The kit of claim 12, wherein the deployment element comprises means for pushing the implantable medical device towards the distal end of the catheter until the distal ends of the active fixation tines extend out of the aperture.

17. The kit of claim 12, wherein the active fixation tines are positioned substantially equidistant from each other in a circular arrangement.

18. The kit of claim 12,

wherein the active fixation tines are in a circular arrangement, and

wherein the active fixation tines are oriented outwardly relative to the circular arrangement.

19. The kit of claim 12,

wherein the active fixation tines in the set are positioned in a circular arrangement,

wherein the implantable medical device includes an electrode for at least one of sensing a physiological condition of the patient and delivering a therapy to the patient, and

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

20. The kit of claim 12, wherein the implantable medical device is a leadless pacemaker.

21. The kit of claim 12, wherein the catheter further comprises a plunger located toward a proximal end of the catheter, the plunger connected to the deployment element located toward the distal end of the catheter such that pressing on the plunger moves the deployment element distally within the lumen of the catheter to initiate deployment of the active fixation tines while the implantable medical device is positioned within the lumen of the catheter.

22. The kit of claim 21, wherein the plunger is connected to the deployment element with a wire.

23. A kit for implanting an implantable medical device within a patient, the kit comprising:

the implantable medical device, wherein the implantable medical device includes a conductive housing;

a fixation element assembly fixedly attached to the implantable medical device near a distal end of the conductive housing, wherein the fixation element assembly includes a set of active fixation tines and an insulator to electrically isolate the set of active fixation tines from the conductive housing of the implantable medical device,

wherein 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 implantable medical device to a hooked position in which the active fixation tines bend back towards the implantable medical device,

wherein the active fixation tines are configured to secure the implantable medical device to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue;

a catheter forming a lumen sized to receive the implantable medical device and hold the active fixation tines in the spring-loaded position, wherein the lumen includes an aperture that is adjacent to a distal end of the catheter; and

a deployment element configured to initiate deployment of the active fixation tines while the implantable medical device is positioned within the lumen of the catheter,

wherein the active fixation tines are configured such that deployment of the active fixation tines from the spring-loaded position to the hooked position while the implantable medical device is positioned within the lumen of the catheter causes the active fixation tines to pull the implantable medical device out of the lumen via the aperture that is adjacent to the distal end of the catheter,

wherein the active fixation tines are in a circular arrangement about a base with proximal ends of the active fixation tines secured to the base, and

wherein the insulator includes a header body with notches to receive the active fixation tines and a header cap that combines with the header body to encompass the base such that the active fixation tines are fixedly attached to the implantable medical device at a location near the distal end of the conductive housing both when the active fixation tines are in the spring-loaded position and when the active fixation tines are in the hooked position.

24. The kit of claim 23, wherein the header cap includes a groove configured to mate with the base.

25. The kit of claim 23, wherein the catheter further comprises a plunger located toward a proximal end of the catheter, the plunger connected to the deployment element located toward the distal end of the catheter such that pressing on the plunger moves the deployment element distally within the lumen of the catheter to initiate deployment of the active fixation tines while the implantable medical device is positioned within the lumen of the catheter.

26. The kit of claim 25, wherein the plunger is connected to the deployment element with a wire.