TEMPORARY LEADLESS IMPLANTABLE MEDICAL DEVICE WITH INDWELLING RETRIEVAL MECHANISM

• US 20140257324A1
• Filed: 03/07/2013
• Published: 09/11/2014
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fain, Eric S.
• Granted Patent: US 9,168,372 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A method and system are provided for removing, from an implant chamber of a heart, a leadless implantable medical device (LIMD) having a distal end and a proximal end. The distal end is configured to be actively secured to tissue in the implant chamber of the heart. The proximal end is configured to be coupled to a distal end of an indwelling retrieval mechanism (IRM). The IRM extends from the heart along a vessel, the IRM having a proximal end configured to be anchored at a temporary anchor site. The method comprises detaching the IRM from the anchor site, loading a retrieval tool over the proximal end of the IRM and along the body of the IRM. The retrieval tool has a lumen therein that receives the IRM as the retrieval tool re-enters the vessel, thereby allowing the retrieval tool to engage the LIMD.

Claims

1. A method for removing, from an implant chamber of a heart, a leadless implantable medical device (LIMD), the LIMD having a distal end and a proximal end, the distal end configured to be actively secured to tissue in the implant chamber of the heart, the proximal end configured to be coupled to a distal end of an indwelling retrieval mechanism (IRM) that extends from the heart along a vessel, the IRM having a proximal end configured to be anchored at a temporary anchor site, the method comprising:

exposing the proximal end of the IRM by detaching the IRM from the anchor site;

loading a retrieval tool over the proximal end of the IRM and along the body of the IRM, the retrieval tool having a lumen therein that receives the IRM as the retrieval tool re-enters the vessel;

causing the retrieval tool to track a path of the IRM through the vessel, into the heart and to the implant chamber until engaging the LIMD;

attaching a distal end of the retrieval tool to the proximal end of the LIMD;

manipulating the retrieval tool such that the distal end of the retrieval tool causes the LIMD to detach from cardiac tissue within the implant chamber; and

pulling at least one of the IRM and the retrieval tool to extract the LIMD from the heart.

2. The method of claim 1, further comprising sliding an introducer instrument over the proximal end of the IRM until at least a portion of the introducer instrument enters the vessel.

3. The method of claim 1, wherein the retrieval tool represents a catheter that is advanced over the IRM.

4. The method of claim 2, wherein the introducer instrument represents one of a needle or catheter.

5. The method of claim 1, further comprising forming the IRM of a flexible biocompatible and biostable material.

6. The method of claim 1, further comprising forming the IRM of a monofilament or multistrand suture thread.

7. The method of claim 1, further comprising including, on the IRM, a non-thrombogenic coating the IRM having a strength to survive a duration of a time in which the LIMD is implanted.

8. The method of claim 1, further comprising sliding a distal end of the retrieval tool over the IRM until the distal end engages the proximal end of the LIMD;

and

manipulating the retrieval tool with respect to the LIMD to securely join the distal end of the retrieval tool to the proximal end of the LIMD.

9. The method of claim 1, wherein the retrieval tool and LIMD have corresponding mating features, the method further comprising securely attaching the mating features on the retrieval tool and the LIMD to one another prior to detaching the LIMD from the cardiac tissue.

10. The method of claim 1, further comprising detaching the proximal end of the IRM from at least one of subcutaneous tissue and muscle associated with the anchor site.

11. A leadless implantable medical device (LIMD) system comprising;

a housing having a distal end and a proximal end, the distal end configured to be actively secured to tissue in an implant chamber of a heart;

at least one electrode configured to perform at least one of sensing and pacing of at least one chamber of the heart;

a processor to control sensing and pacing operations;

an indwelling retrieval mechanism (IRM) having a distal end coupled to the proximal end of the LIMD, the IRM having a body configured to extend from the heart, along a vessel and exit the vessel at an exit/re-entry point;

the IRM having a proximal end configured to be anchored at a temporary anchor site to at least one of subcutaneous tissue and muscle while the LIMD is implanted; and

the body of the IRM being formed of a flexible biocompatible and biostable material and having sufficient strength to maintain a desired level of structural integrity for a duration of time that the LIMD is implanted.

12. The LIMD system of claim 11, further comprising a retrieval tool having a body with a lumen extending therethrough and an open distal end, the distal end of the retrieval tool receiving the proximal end of IRM, the IRM sliding along the lumen of the retrieval tool as the retrieval tool is advanced to the LIMD.

13. The LIMD system of claim 11, wherein the distal end of the retrieval tool and the proximal end of the LIMD have mating features that securely attach to one another such that when rotational or longitudinal forces are applied to the retrieval tool substantially corresponding rotational and longitudinal forces are imposed onto the LIMD to manipulate the LIMD to cause the LIMD to detach from cardiac tissue within the implant chamber.

14. The LIMD system of claim 11, wherein the retrieval tool includes a threaded mating feature to engage the LIMD.

15. The LIMD system of claim 11, further comprising an introducer instrument configured to slide over the proximal end of the IRM until at least a portion of the introducer instrument enters the vessel.

16. The LIMD system of claim 11, wherein the retrieval tool represents a catheter that is advanced over the IRM.

17. The LIMD system of claim 15, wherein the introducer instrument represents one of a needle or catheter.

18. The LIMD system of claim 11, wherein the IRM is formed of a flexible biocompatible and biostable material.

19. The LIMD system of claim 11, wherein the IRM is formed of a monofilament or multistrand suture thread.

20. The LIMD system of claim 11, further comprising, on the IRM, a non-thrombogenic coating having a strength to survive a duration of a time in which the LIMD is implanted.

21. The system of claim 11, wherein the retrieval tool and LIMD have corresponding mating features configured to securely attach the retrieval tool and the LIMD to one another prior to detaching the LIMD from the cardiac tissue.

22. The system of claim 11, wherein the retrieval tool comprises:

a catheter having first and second lumen, the first lumen to receive the IRM; and

an LIMD gripper device loaded into the second lumen and advanced until projecting from an open end of the catheter, a distal end of the LIMD gripper device coupling to the proximal end of the LIMD.