Fixation for leadless cardiac devices

Patent metadata

Field	Value
Publication number	US-2018256902-A1
Application number	US-201815915279-A
Country	US
Kind code	A1
Filing date	Mar 8, 2018
Priority date	Mar 10, 2017
Publication date	Sep 13, 2018
Grant date	—

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 exposed exterior to 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 and a curved deployed configuration and radially offset from the first electrode; wherein when in the curved deployed configuration, the tine is configured to curve away from the first electrode.

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 . The implantable leadless pacing device of claim 1 , wherein a proximal end of the tine is affixed to the housing generally in line with a longitudinal axis of the housing and the first electrode is diametrically spaced from the tine.

5 . 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.

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

7 . The system of claim 5 , 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.

8 . The system of claim 5 , further comprising a radiopaque marker extending longitudinally along a wall of the distal holding section.

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

10 . The system of claim 5 , 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.

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

12 . The system of claim 10 , 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.

13 . The system of claim 5 , wherein the tine is configured to function as an electrically active element.

14 . The system of claim 5 , wherein the tine comprises a conductive wire and a nitinol wire, the conductive wire and the nitinol wire positioned within an electrically insulating material.

15 . The system of claim 5 , 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 device; wherein when the implantable device is positioned within the distal holding section, the protrusion and the groove are configured to mate such that the implantable device is in a predefined orientation.

16 . The system of claim 5 , wherein the distal holding section comprises an inflatable atraumatic distal tip.

17 . A method of delivering an implantable leadless pacing device to a target location within a body, the method comprising:
advancing a delivery catheter into a right atrium, the delivery catheter including at least a distal holding section defining a cavity, the cavity configured to receive an implantable leadless pacing device, wherein the implantable leadless pacing device comprises:
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 relative to and laterally offset from a longitudinal axis of the housing 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
an ultrasound marker positioned adjacent to a distal end of the at least one tine;
identifying a target location using, at least in part, the ultrasound marker; positioning the distal holding section in contact with the target location; and distally advancing the implantable leadless pacing device to secure the implantable leadless pacing device to the target tissue.

18 . The method of claim 17 , wherein the tine is configured to function as an electrically active element.

19 . The method of claim 17 , wherein the delivery catheter further comprises a protrusion extending inwardly from an inner surface of the distal holding section; and
the implantable leadless pacing device further comprises a groove extending longitudinally in the housing of the implantable device; wherein when the implantable device is positioned within the distal holding section, the protrusion and the groove are configured to mate such that the implantable device is in a predefined orientation.

20 . The method of claim 17 , wherein the distal holding section comprises at least one retention feature configured to bias the to the elongated delivery configuration, the at least one retention feature comprising a first end affixed to an inner wall of the distal holding section and a second free end configured to engage the 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

• A61B90/39

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

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title

• A61N1/365

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