Delivery devices and methods for leadless cardiac devices

Patent metadata

Field	Value
Publication number	US-10737092-B2
Application number	US-201815939745-A
Country	US
Kind code	B2
Filing date	Mar 29, 2018
Priority date	Mar 30, 2017
Publication date	Aug 11, 2020
Grant date	Aug 11, 2020

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example method for delivering the implantable leadless pacing device may include distally advancing an intermediate tubular member of a delivery system across the tricuspid valve and into the right ventricle. An outer tubular member of the delivery device may be torqued in a first direction to guide a distal holding section along the ventricular septum. The distal tip of the distal holding section may be releaseably secured to a tissue. After securing the distal tip of the distal holding section, the outer tubular member may be torqued in a second direction opposite to the first direction and the implantable leadless pacing device incrementally deployed.

First claim

What is claimed is:

1. A method of delivering an implantable leadless pacing device to a ventricular septum, the method comprising:
advancing a delivery device through the vasculature and into the right atrium, the delivery device comprising:
an outer tubular member including a lumen extending from a proximal end to a distal end thereof, the outer tubular member configured to be deflectable in a first a plane;
an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and the intermediate tubular member configured to be deflectable in a second plane different from the first plane;
an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;
a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and
a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member;

distally advancing the intermediate tubular member across the tricuspid valve and into the right ventricle;
torquing the outer tubular member in a first direction to guide the distal holding section along the ventricular septum;
releaseably securing a distal tip of the distal holding section to a tissue in the ventricular septum;
after securing the distal tip of the distal holding section, torqueing the outer tubular member in a second direction opposite to the first direction; and
incrementally deploying an implantable leadless pacing device.

2. The method of claim 1 , wherein the implantable leadless pacing device is deployed such that a longitudinal axis of the implantable leadless pacing device is at an angle of in the range of 5 to 45° to the ventricular septum.

3. The method of claim 1 , wherein releaseably securing the distal tip of the distal holding section to the tissue comprises a passive anchoring of the distal tip to the ventricular septum.

4. The method of claim 1 , wherein releaseably securing the distal tip of the distal holding section to the tissue comprises an active anchoring of an active anchoring element to the ventricular septum.

5. The method of claim 1 , further comprising unsecuring the distal tip of the distal holding section from the tissue after the implantable leadless pacing device has been at least partially deployed.

6. The method of claim 1 , wherein torquing the outer tubular member in the first direction comprises deflecting the outer tubular member in the first plane.

7. The method of claim 1 , wherein torquing the outer tubular member in the second direction opposite to the first direction orients an opening of the distal holding section towards the ventricular septum.

8. A method of delivering an implantable leadless pacing device to a ventricular septum, the method comprising:
advancing a delivery device through the vasculature and into the right atrium, the delivery device comprising:
an outer tubular member including a lumen extending from a proximal end to a distal end thereof;
an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device;
an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;
a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and
a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member;

distally advancing the intermediate tubular member across the tricuspid valve and into the right ventricle;
torquing the outer tubular member in a first direction to guide the distal holding section along the ventricular septum by rotating the first hub portion in the first direction;
releaseably securing a distal tip of the distal holding section to a tissue in the ventricular septum;
after securing the distal tip of the distal holding section, torquing the outer tubular member in a second direction opposite to the first direction by rotating the first hub portion in the second direction; and
deploying an implantable leadless pacing device from the distal holding section.

9. The method of claim 8 , wherein the implantable leadless pacing device is deployed such that a longitudinal axis of the implantable leadless pacing device is at an angle of in the range of 5 to 45° to the ventricular septum.

10. The method of claim 8 , wherein releaseably securing the distal tip of the distal holding section to the tissue comprises a passive anchoring of the distal tip to the ventricular septum.

11. The method of claim 8 , wherein releaseably securing the distal tip of the distal holding section to the tissue comprises an active anchoring of an active anchoring element to the ventricular septum.

Assignees

• Cardiac Pacemakers Inc

Inventors

• Shuros Allan Charles
• Soltis Brian

Classifications

• A61N2001/058

  Fixing tools · CPC title

• A61N2001/0578

  having means for removal or extraction · CPC title

• A61N1/057 Primary

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

• A61N1/3756

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

• A61N1/0573

  chacterised by means penetrating the heart tissue, e.g. helix needle or hook · CPC title