Leadless cardiac pacing devices including tissue engagement verification

• US 10,080,887 B2
• Filed: 04/28/2015
• Issued: 09/25/2018
• Est. Priority Date: 04/29/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Schmidt, Brian L., Haasl, Benjamin J., Edgell, John M., Sachs, Dana
• Primary Examiner(s): ROZANSKI, MICHAEL T
• Application Number:
  US14/698,537
• Publication Number:
  US 20150306378A1
• Time in Patent Office: 1,246 Days
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable leadless cardiac pacing device including a housing having a proximal end and a distal end, an electrode positioned proximate the distal end of the housing configured to be positioned adjacent cardiac tissue, and a tissue anchoring member extending from the distal end of the housing configured to secure the housing to cardiac tissue. The device further includes a tissue engagement verification feature configured to provide feedback upon engagement of the tissue anchoring member in cardiac tissue.

Claims

1. An implantable leadless cardiac pacemaker comprising:

a housing having a proximal end and a distal end;

an electrode positioned proximate the distal end of the housing configured to be positioned adjacent cardiac tissue and stimulate the cardiac tissue;

a helical tissue anchor extending from the distal end of the housing configured to be implanted in the cardiac tissue to secure the housing to the cardiac tissue; and

a tissue engagement indicator distinct from the helical tissue anchor, the tissue engagement indicator being movable relative to the helical tissue anchor and the housing to provide feedback of a degree of engagement of the helical tissue anchor in the cardiac tissue.

2. The implantable leadless cardiac pacemaker of claim 1, wherein the tissue engagement indicator is movable from a first position relative to the housing to a second position relative to the housing.

3. The implantable leadless cardiac pacemaker of claim 2, wherein the first position is an equilibrium position, and the second position is a displaced position through application of an external force.

4. The implantable leadless cardiac pacemaker of claim 3, wherein the tissue engagement indicator moves toward the proximal end of the housing as the tissue engagement indicator moves from the first position to the second position.

5. The implantable leadless cardiac pacemaker of claim 1, wherein the tissue engagement indicator includes a radiopaque material to provide visual feedback via fluoroscopy.

6. The implantable leadless cardiac pacemaker of claim 5, wherein the radiopaque material is movable relative to the helical tissue anchor and the housing.

7. The implantable leadless cardiac pacemaker of claim 6, further comprising a radiopaque reference point which is stationary relative to the housing, wherein a distance of displacement of the radiopaque material relative to the radiopaque reference point provides visual feedback of the degree of engagement of the helical tissue anchor in the cardiac tissue.

8. The implantable leadless cardiac pacemaker of claim 1, wherein the tissue engagement indicator includes one or more tines configured to deflect upon engagement with the cardiac tissue.

9. The implantable leadless cardiac pacemaker of claim 1, wherein the tissue engagement indicator is configured to compress upon engagement with the cardiac tissue.

10. The implantable leadless cardiac pacemaker of claim 9, wherein the tissue engagement indicator comprises an open wound coil.

11. The implantable leadless cardiac pacemaker of claim 10, wherein adjacent windings of the open wound coil move closer together upon engagement of the open wound coil with the cardiac tissue.

12. The implantable leadless cardiac pacemaker of claim 9, wherein the tissue engagement indicator comprises one or more deflectable struts.

13. The implantable leadless cardiac pacemaker of claim 12, wherein the one or more deflectable struts extend between the distal end of the housing to a ring comprising a radiopaque material.

14. The implantable leadless cardiac pacemaker of claim 1, wherein the tissue engagement indicator includes a radiopaque marker configured to move along the tissue anchor upon engagement with the cardiac tissue.

15. The implantable leadless cardiac pacemaker of claim 14, wherein the radiopaque marker includes a bead slidable along the tissue anchor.

16. An implantable leadless cardiac pacemaker comprising:

a housing having a proximal end and a distal end;

an electrode positioned proximate the distal end of the housing configured to be positioned adjacent cardiac tissue and stimulate the cardiac tissue;

a helical tissue anchor extending from the distal end of the housing configured to be implanted in the cardiac tissue to secure the housing to the cardiac tissue; and

a radiopaque marker distinct from the helical tissue anchor and movable relative to the housing and the helical tissue anchor; and

a radiopaque reference point disposed on the housing and stationary relative to the housing;

wherein a distance of displacement of the radiopaque marker relative to the radiopaque reference point provides visual feedback of a degree of engagement of the helical tissue anchor in the cardiac tissue.

17. The implantable leadless cardiac pacemaker of claim 16, wherein the radiopaque marker is movable toward the proximal end of the housing as the helical tissue anchor engages the cardiac tissue.

18. The implantable leadless cardiac pacemaker of claim 17, wherein the radiopaque marker is movable from a first position relative to the housing to a second position relative to the housing;

wherein the first position is an equilibrium position, and the second position is a displaced position through application of an external force.

19. A method of implanting a leadless cardiac pacemaker having a housing, the method comprising:

advancing the leadless cardiac pacemaker into a chamber of a heart;

engaging a helical tissue anchor of the leadless cardiac pacemaker into cardiac tissue;

fluoroscopically observing a distance of displacement of a radiopaque marker of the leadless cardiac pacemaker relative to a radiopaque reference point disposed on the housing to confirm engagement of the helical tissue anchor in the cardiac tissue and verify a degree of tissue engagement of the helical tissue anchor with the cardiac tissue;

wherein the radiopaque marker is distinct from the helical tissue anchor and is moveable relative to the helical tissue anchor and the housing.

20. The method of claim 19, wherein the radiopaque marker moves toward a proximal end of the housing as the tissue anchor is engaging the cardiac tissue.