Fixation for leadless cardiac devices

Patent metadata

Field	Value
Publication number	US-11229798-B2
Application number	US-201815915279-A
Country	US
Kind code	B2
Filing date	Mar 8, 2018
Priority date	Mar 10, 2017
Publication date	Jan 25, 2022
Grant date	Jan 25, 2022

Abstract

An implantable leadless pacing device and delivery system may comprise an implantable leadless pacing device and a catheter configured to deliver the implantable leadless packing device to a target location. The implantable device may comprise a power source, circuitry operatively coupled to the power source, a housing at least partially enclosing the circuitry, a first electrode secured relative to and offset from a longitudinal axis of the housing and exposed exterior to the housing, and a fixation mechanism secured relative to the housing. The fixation mechanism may comprise at least one tine configured to move between an elongated delivery configuration and a curved deployed configuration and radially offset from the first electrode. The catheter may comprise a distal holding section defining a cavity configured to receive the implantable leadless pacing device.

First claim

What is claimed is:

1. An implantable leadless pacing device comprising:
a power source;
circuitry operatively coupled to the power source, the circuitry configured to pace a patient's heart and/or sense electrical activity of the patient's heart;
a housing at least partially enclosing the circuitry;
a first electrode secured to and offset from a central longitudinal axis of the housing, the first electrode exposed exterior to the housing and extending distal of the housing; and
a fixation mechanism secured relative to the housing, the fixation mechanism comprising a tine configured to move between an elongated delivery configuration with a free end of the tine pointed distally and a curved deployed configuration and radially offset from the first electrode;
wherein a proximal end of the tine is affixed to the housing at a central longitudinal axis of the housing and the first electrode is diametrically spaced from the tine;
wherein when in the curved deployed configuration, the tine is configured to curve away from the first electrode with the free end of the tine located proximal of a distalmost extent of the tine.

2. The implantable leadless pacing device of claim 1 , further comprising an ultrasound marker positioned adjacent to a distal end of the tine.

3. The implantable leadless pacing device of claim 1 , wherein the tine is configured to function as an electrically active element.

4. An implantable leadless pacing device and delivery system comprising:
the implantable leadless pacing device of claim 1 ; and
a catheter configured to deliver the implantable leadless pacing device to a target location, the catheter comprising:
a distal holding section defining a cavity, the cavity configured to receive the implantable leadless pacing device.

5. The system of claim 4 , further comprising an ultrasound marker positioned adjacent to a distal end of the tine.

6. The system of claim 4 , wherein the tine is configured to be in the elongated delivery configuration when the implantable leadless pacing device is disposed within the cavity of the distal holding section.

7. The system of claim 4 , further comprising a radiopaque marker extending longitudinally along a wall of the distal holding section.

8. The system of claim 7 , wherein the tine is aligned with the radiopaque marker in the elongated delivery configuration.

9. The system of claim 4 , further comprising a retention feature disposed within a cavity of the distal holding section, the retention feature configured to bias the tine into the elongated delivery configuration.

10. The system of claim 9 , wherein the retention feature comprises a plurality of flexible fingers extending from an inner surface of the distal holding section.

11. The system of claim 9 , wherein the retention feature comprises a first end affixed to an inner wall of the distal holding section and a second free end configured to engage the tine.

12. The system of claim 4 , wherein the tine is configured to function as an electrically active element.

13. The system of claim 4 , wherein the tine comprises a conductive wire and a nitinol wire, the conductive wire and the nitinol wire positioned within an electrically insulating material.

14. The system of claim 4 , further comprising:
a protrusion extending inwardly from an inner surface of the distal holding section; and
a groove extending longitudinally in the housing of the implantable leadless pacing device;
wherein when the implantable leadless pacing device is positioned within the distal holding section, the protrusion and the groove are configured to mate such that the implantable leadless pacing device is in a predefined orientation.

15. The system of claim 4 , wherein the distal holding section comprises an inflatable atraumatic distal tip.

16. An implantable leadless pacing delivery system comprising:
an implantable leadless pacing device comprising:
a power source;
circuitry operatively coupled to the power source, the circuitry configured to pace a patient's heart and/or sense electrical activity of the patient's heart;
a housing at least partially enclosing the circuitry;
a first electrode secured to and exposed exterior to the housing;
a fixation mechanism secured relative to the housing, the fixation mechanism comprising a tine configured to move between an elongated delivery configuration and a curved deployed configuration and radially offset from the first electrode; and

a catheter configured to deliver the implantable leadless pacing device to a target location, the catheter comprising:
a distal holding section including a body and a distal tip, the body defining a cavity, the cavity configured to receive the implantable leadless pacing device,
a retention feature disposed within the cavity, the retention feature configured to bias the tine into the elongated delivery configuration,
wherein the retention feature comprises a first end affixed to an inner wall of the body at a position spaced apart proximally from the distal tip, the retention feature having a second free end configured to contact the tine.

17. The system of claim 16 , wherein when in the curved deployed configuration, the tine is configured to curve away from the first electrode.

18. The system of claim 16 , wherein the tine is configured to function as an electrically active element.

19. An implantable leadless pacing device comprising:
a power source;
circuitry operatively coupled to the power source, the circuitry configured to pace a patient's heart and/or sense electrical activity of the patient's heart;
a housing at least partially enclosing the circuitry;
a first electrode secured to and offset from a central longitudinal axis of the housing, the first electrode exposed exterior to the housing and extending distal of the housing; and
a fixation mechanism secured relative to the housing, the fixation mechanism consisting of a single tine configured to move between an elongated delivery configuration with a free end of the tine pointed distally and a curved deployed configuration and radially offset from the first electrode;
wherein a proximal end of the single tine is affixed to the housing at a central longitudinal axis of the housing and the first electrode is diametrically spaced from the single tine;
wherein when in the curved deployed configuration, the single tine is configured to curve away from the first electrode with the free end of the single tine located proximal of a distalmost extent of the single tine.

Assignees

• Cardiac Pacemakers Inc

Inventors

• Toy Peter
• Maile Keith R
• Koop Brendan Early
• Swackhamer Bryan J
• Shuros Allan Charles

Classifications

• A61N1/059

  Anchoring means · CPC title

• A61N1/3756 Primary

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/365

  controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)} · CPC title

• A61B90/39

  Markers, e.g. radio-opaque or breast lesions markers · CPC title

• A61N1/057

  Anchoring means; Means for fixing the head inside the heart · CPC title