SINGLE-CHAMBER LEADLESS INTRA-CARDIAC MEDICAL DEVICE WITH DUAL-CHAMBER FUNCTIONALITY AND SHAPED STABILIZATION INTRA-CARDIAC EXTENSION

• US 20130116740A1
• Filed: 01/17/2012
• Published: 05/09/2013
• Est. Priority Date: 11/03/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bornzin, Gene A., Min, Xiaoyi, Poore, John W., Somogyi, Zoltan, Theret, Didier
• Granted Patent: US 8,700,181 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless intra-cardiac medical device (LIMD) configured to be implanted entirely within a heart of a patient includes a housing configured to be securely attached to an interior wall portion of a chamber of the heart, and a stabilizing intra-cardiac (IC) device extension connected to the housing. The stabilizing IC device extension may include a stabilizer arm, and/or an appendage arm, or an elongated body or a loop member configured to be passively secured within the heart.

Claims

1. A leadless intra-cardiac medical device configured to be implanted entirely within a heart of a patient, said device comprising:

a housing configured to be securely attached to an interior wall portion of a chamber of the heart; and

a stabilizing intra-cardiac device extension connected to the housing, wherein the extension is configured to be passively secured within the heart.

2. The device of claim 1, wherein the extension comprises a loop member.

3. The device of claim 2, wherein the loop member is configured to be passively secured within one or both of the chamber of the heart or a superior vena cava of the heart.

4. The device of claim 2, wherein the loop member comprises first and second loops connected to one another.

5. The device of claim 4, wherein each of the first and second loops comprises a perimeter that flares in a lateral direction with respect to a longitudinal axis of the loop body.

6. The device of claim 2, wherein the loop member comprises a perimeter shaped as a disc, oval, circle, tube, rectangle, or triangle.

7. The device of claim 2, wherein the loop member includes a plurality of interconnected loops.

8. The device of claim 7, wherein each of the plurality of interconnected loops are commonly aligned and oriented with respect to one another.

9. The device of claim 7, wherein the plurality of interconnected loops includes a first loop and a second loop, wherein the first loop is oriented orthogonal to the second loop.

10. The device of claim 7, wherein a first of the plurality of interconnected loops is aligned in a first orientation and a second of the plurality of interconnected loops is aligned in a second orientation, and wherein the first orientation differs from the second orientation so that the first and second of the plurality of interconnected loops are oriented out of plane with one another.

11. The device of claim 2, further comprising at least one radio marker secured to the loop member, wherein the at least one radio marker is configured to allow the device to be tracked within patient anatomy.

12. The device of claim 1, wherein the extension comprises an elongated body that includes a first curved segment that bends at an angle with respect to a longitudinal axis of the housing, wherein the first curved segment merges into a first linear region that extends laterally from the housing toward a tissue of interest, the elongated body including an electrode provided thereon at a position configured to contact the tissue of interest.

13. The device of claim 12, wherein the extension comprises a first linear region that extends laterally from the housing, along a lateral axis, until merging with a curved segment, the curved segment turning at an angle with respect to a longitudinal axis of the housing and a lateral axis of the first linear region.

14. The device of claim 12, wherein the extension comprises an elongated body that includes first and second linear regions that are joined to one another through a curved segment, the first linear region and the curved segment extending into a right atrial appendage, while the second linear region extends from the right atrial appendage toward the SVC.

15. The device of claim 12, wherein the extension comprises an elongated body that includes first and second curved segments joined to one another by a linear region, at least one of the first and second curved segments including an electrode to contact tissue of interest.

16. The device of claim 12, wherein the extension comprises an elongated body that is tubular in shape and includes a metal braid therein that resists rotational torque and longitudinal compression to facilitate delivery of rotational forces and longitudinal pressure to the housing of the LIMD.

17. The device of claim 12, further comprising an electrode located proximate a junction of a curved segment and a linear region in the extension.

18. The device of claim 12, wherein the elongated body is formed of silicon cured to a desired cross link structure such that the extension retains a predetermined preload shape.

19. The device of claim 15, wherein the extension comprises an elongated body having an electrode provided thereon, the electrode including a spring arm that is normally biased outward toward tissue of interest.

20. A method of implanting a leadless intra-cardiac medical device (LIMD) entirely within a heart of a patient, wherein the device includes a housing and a stabilizing intra-cardiac device extension connected to the housing, said method comprising:

navigating the device into the heart with an introducer assembly, the extension held in a collapsed installation shape within the introducer assembly;

positioning the introducer assembly so that the housing is proximate an implant site within the heart;

securely anchoring the housing to the implant site;

separating the introducer assembly and the device thereby allowing the extension to expand to a deployed implanted shape; and

securing the extension within a portion of the heart so that the device is entirely within the heart of the patient.

21. The method of claim 20, wherein the securing includes passively securing a loop member of the extension within a superior vena cava of the heart, and wherein the implant site is within a right atrium of the heart.

22. The method of claim 20, further comprising tracking the device within patient anatomy through a radio marker secured to the extension.

23. The method of claim 20, further comprising contacting internal tissue of the heart with at least one electrode secured to the extension.

24. The method of claim 20, wherein the loop member comprises first and second loops connected to one another.

25. The method of claim 24, wherein each of the first and second loops comprises a perimeter that flares in a lateral direction with respect to a longitudinal axis of the loop body.

26. The method of claim 20, wherein the loop member comprises a perimeter shaped as a disc, oval, circle, tube, rectangle, or triangle.

27. The method of claim 21, wherein the loop member includes a plurality of interconnected loops.

28. The method of claim 27, wherein each of the plurality of interconnected loops are commonly aligned and oriented with respect to one another.

29. The method of claim 27, wherein the plurality of interconnected loops includes a first loop and a second loop, wherein the first loop is oriented orthogonal to the second loop.

30. The method of claim 27, wherein a first of the plurality of interconnected loops is aligned in a first orientation and a second of the plurality of interconnected loops is aligned in a second orientation, and wherein the first orientation differs from the second orientation so that the first and second of the plurality of interconnected loops are oriented out of plane with one another.

31. The method of claim 20, wherein the extension comprises an elongated body, and expanding includes permitting the elongated body to expand to a pre-loaded shape in which a first curved segment bends at an angle with respect to a longitudinal axis of the housing, wherein the first curved segment merges into a first linear region that extends laterally from the housing toward a tissue of interest, the elongated body including an electrode provided thereon at a position configured to contact the tissue of interest.

32. The method of claim 20, wherein the extension comprises an elongated body, and expanding includes permitting the elongated body to expand to a pre-loaded shape such that a first linear region extends laterally from the housing, along a lateral axis, and merges with a curved segment, the curved segment turning at an angle with respect to a longitudinal axis of the housing and a lateral axis of the first linear region.

33. The method of claim 20, wherein the extension comprises an elongated body, and expanding includes permitting the elongated body to expand to a pre-loaded shape in which first and second linear regions are joined to one another through a curved segment, the method further comprising positioning the first linear region and the curved segment to extend into a right atrial appendage, and positioning the second linear region to extend from the right atrial appendage toward the SVC.

34. The method of claim 20, wherein the extension comprises an elongated body that includes first and second curved segments joined to one another by a linear region, at least one of the first and second curved segments including an electrode, the method further comprising positioning the electrode to contact tissue of interest.

35. The method of claim 20, wherein the extension comprises an elongated body that is tubular in shape and includes a metal braid, the method further comprising applying at least one of rotational and longitudinal pressure upon the extension, the braid resisting rotational torque and longitudinal compression to facilitate delivery of rotational forces and longitudinal pressure to the housing.

36. The method of claim 20, further comprising guiding the extension to engage a first region of the heart, the first region representing at least one of a superior vena cava, an inferior vena cava, a coronary sinus, and a pulmonary artery.

37. The method of claim 20, wherein the extension includes a stabilizer end-segment that is pre-formed to bend at an angle and fit against an interior of at least one of a superior vena cava, an inferior vena cava, a coronary sinus, and a pulmonary artery.

38. The method of claim 20, further comprising configuring a controller to control delivery of stimulus pulses from first and second electrodes in accordance with a DDD pacing mode to a right atrium and right ventricle, while the LIMD is entirely located in one of the right atrium and right ventricle.