Leadless pacemaker

• US 9,358,387 B2
• Filed: 03/27/2014
• Issued: 06/07/2016
• Est. Priority Date: 04/09/2013
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Suwito, Wantjinarjo, Lynch, Andrew
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Assistant Examiner(s): Abreu, Michael D
• Application Number:
  US14/227,112
• Publication Number:
  US 20140303704A1
• Time in Patent Office: 803 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• 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

Leadless pacemaker, including a hermetic housing, a pacing electrode on a distal portion of the housing, an electronics package in the housing and configured to generate/deliver pacing pulses to the electrode, and a fixation mechanism on the housing distal portion. The fixation mechanism includes at least one deformable hook-shaped thin fixation wire having an attachment portion fixedly attached at the distal portion of the housing and a free end portion which is angled or bent with respect to the attachment portion such that it extends essentially in conformity, but with a small spacing, to a neighbored surface portion of the housing such that the free end portion engages with heart tissue onto which the distal portion is pressed upon rotation of the pacemaker in the direction in which the free end portion extends from the attachment portion, and disengages upon rotation of the pacemaker in the opposite direction.

Claims

1. A leadless pacemaker, comprising:

a hermetic housing;

a pacing electrode disposed on a distal portion of the housing;

an electronics package disposed in the housing and configured to generate and deliver pacing pulses to the pacing electrode; and

a fixation mechanism, arranged on the distal portion of the housing, wherein the fixation mechanism comprises at least one deformable hook-shaped thin fixation wire having an attachment portion fixedly attached at the distal portion of the housing and a free end portion which is angled or bent with respect to the attachment portion such that it extends essentially in conformity, but with a small spacing, to a neighbored surface portion of the housing such that the free end portion engages with heart tissue onto which the distal portion of the housing is pressed upon rotation of the pacemaker in a direction in which the free end portion extends from the attachment portion, and disengages upon rotation of the pacemaker in an opposite direction,

wherein the or each fixation wire comprises a one-piece fixation wire comprising a central attachment portion and two free end portions extending from opposite ends of the central attachment portion, and

wherein the or each fixation wire lies in a single plane perpendicular to a longitudinal extent of the housing.

2. The leadless pacemaker of claim 1, wherein the fixation mechanism comprises a plurality of separate hook-shaped fixation wires, wherein the fixation wires are arranged such that the free end portions thereof essentially form segments of a closed curve comprising a circle or an ellipse, and wherein the ends of each of the wires slightly protruding from the closed curve in a distal direction.

3. The leadless pacemaker of claim 2, wherein the fixation wires are arranged such that the plane of the closed curve or virtual inner and outer closed curve is between 0.5 and 2.5 mm proximal with respect to the end face of the distal housing portion.

4. The leadless pacemaker of claim 2, wherein the fixation wires are arranged such that the plane of the closed curve or virtual inner and outer closed curve is between 1 and 2 mm proximal with respect to the end face of the distal housing portion.

5. The leadless pacemaker of claim 2, fixation wires each having one free end portion.

6. The leadless pacemaker of claim 1, wherein the attachment portion of the or each fixation wire is molded into a resin-molded distal housing portion.

7. The leadless pacemaker of claim 6, wherein the housing comprises a cylindrical or cask shaped body housing most of the electronics package, wherein the distal housing portion is conical or bell-shaped, and wherein the or each free end portion of each fixation wire extends tangentially or obliquely close to the end face of the conical or bell-shaped housing portion.

8. The leadless pacemaker of claim 1, wherein the fixation mechanism comprises a plurality of separate hook-shaped fixation wires, wherein the fixation wires are arranged such that the free end portions thereof extend obliquely from a virtual inner closed curve comprising a circle or an ellipse, accommodating the most inner points of the free end portions of all fixation wires to a virtual outer closed curve comprising a circle or an ellipse, accommodating the end tips of all fixation wires.

9. The leadless pacemaker of claim 1, wherein the or each fixation wire, when a proximal force applied in a direction along a longitudinal axis of the housing is exerted on the pacemaker in its state fixed to heart tissue, is deformable such that its two free end portions bend to adopt to the direction of the proximal force and slide out of the heart tissue without damaging it.

10. The leadless pacemaker of claim 1, wherein a projection of the or each fixation wire on a plane on which a longitudinal axis of the housing stands orthogonally is S-shaped.

11. The leadless pacemaker of claim 1, wherein the or each fixation wire is bent two-dimensionally with its attachment portion bent rearward from the or each free end portion.

12. The leadless pacemaker of claim 1, comprising 1 to 6 fixation wires each having two free end portions.

13. The leadless pacemaker of claim 1, comprising 1 or 2, fixation wires each having two free end portions.

14. The leadless pacemaker of claim 1, wherein the or each fixation wire is made from stainless steel or Nitinol.

15. The leadless pacemaker of claim 1, wherein the diameter of the or each fixation wire is between 0.1 and 0.5 mm.

16. The leadless pacemaker of claim 1, wherein the diameter of the or each fixation wire is between 0.15 and 0.38 mm.

17. Leadless pacemaker of claim 1, wherein the or at least one fixation wire forms the only or one pacing electrode.