Delivery devices and methods for leadless cardiac devices

Patent metadata

Field	Value
Publication number	US-11389649-B2
Application number	US-201916659718-A
Country	US
Kind code	B2
Filing date	Oct 22, 2019
Priority date	Nov 20, 2015
Publication date	Jul 19, 2022
Grant date	Jul 19, 2022

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may further include a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member. A longitudinally extending groove having a proximal end and a distal end may be disposed in the intermediate hub portion. A first locking mechanism may be configured to releasably couple the intermediate hub portion and the proximal hub portion.

First claim

What is claimed is:

1. A delivery system for delivering an implantable leadless pacing device, the delivery system 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;
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 distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device; and
a handle assembly, the handle assembly comprising:
a distal hub portion affixed adjacent to the proximal end of the outer tubular member;
a proximal hub portion affixed adjacent to the proximal end of the inner tubular member,
an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member, the intermediate hub portion positioned between the distal hub portion and the proximal hub portion, the intermediate hub portion having a proximal portion configured to be slidably received within the proximal hub portion and a distal portion configured to be slidably received within the distal hub portion; and
at least one locking mechanism configured to selectively lock at least two of the distal hub portion, the proximal hub portion, or the intermediate hub portion together;

wherein the distal hub portion, the intermediate hub portion, and the proximal hub portion are individually slidable along a longitudinal axis of the handle assembly relative to each other.

2. The delivery system of claim 1 , further comprising a gripping region disposed between the proximal portion and the distal portion of the intermediate hub portion.

3. The delivery system of claim 2 , wherein the gripping region has an outer diameter greater than an outer diameter of the proximal portion and the distal portion of the intermediate hub portion.

4. The delivery system of claim 2 , wherein the gripping region includes a port in fluid communication with the lumen of the intermediate tubular member.

5. The delivery system of claim 1 , wherein the at least one locking mechanism comprises a depressible button, the depressible button configured to selectively lock the intermediate hub portion and the proximal hub portion together.

6. The delivery system of claim 5 , wherein the depressible button is biased towards a locked configuration.

7. The delivery system of claim 1 , wherein the at least one locking mechanism comprises a rotatable retaining ring, the rotatable retaining ring configured to selectively lock the intermediate hub portion and the distal hub portion together.

8. A delivery system for delivering an implantable leadless pacing device, the delivery system 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;
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 distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device; and
a handle assembly, the handle assembly comprising:
a distal hub portion affixed adjacent to the proximal end of the outer tubular member;
an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member, the intermediate hub portion having a proximal portion and a distal portion;
a proximal hub portion affixed adjacent to the proximal end of the inner tubular member, the proximal hub portion having a distal end region surrounding at least a portion of the proximal portion of the intermediate hub portion;
a first locking mechanism configured to selectively couple the intermediate hub portion to the proximal hub portion, the first locking mechanism comprising a depressible button; and
a second locking mechanism configured to selectively couple the distal hub portion to the intermediate hub portion; and

wherein the distal hub portion, the intermediate hub portion, and the proximal hub portion are individually slidable along a longitudinal axis of the handle assembly relative to each other.

9. The delivery system of claim 8 , further comprising a gripping region disposed between the proximal portion and the distal portion of the intermediate hub portion.

10. The delivery system of claim 9 , wherein the gripping region has an outer diameter greater than an outer diameter of the proximal portion and the distal portion of the intermediate hub portion.

11. The delivery system of claim 9 , wherein the gripping region includes a port in fluid communication with the lumen of the intermediate tubular member.

12. The delivery system of claim 8 , wherein the proximal portion of the intermediate hub portion includes a groove in an outer surface thereof, the groove configured to receive a mating feature disposed on an inner surface of the proximal hub portion.

13. The delivery system of claim 8 , further comprising a tether lock coupled to a proximal end of the proximal hub portion, the tether lock actuatable between a locked configuration and an unlocked configuration.

14. A delivery system for delivering an implantable leadless pacing device, the delivery system 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;
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 distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device; and
a handle assembly, the handle assembly comprising:
a distal hub portion affixed adjacent to the proximal end of the outer tubular member;
an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member;
a proximal hub portion affixed adjacent to the proximal end of the inner tubular member;
a first locking mechanism configured to selectively couple the intermediate hub portion to the proximal hub portion, the first locking mechanism comprising a depressible button movable between a locked configuration and an unlocked configuration; and
a second locking mechanism configured to selectively couple the distal hub portion to the intermediate hub portion; and

wherein the distal hub portion, the intermediate hub portion, and the proximal hub portion are individually slidable along a longitudinal axis of the handle assembly relative to each other.

15. The delivery system of claim 14 , wherein when the depressible button is in the locked configuration, the intermediate hub portion is longitudinally fixed relative to the p

Assignees

• Cardiac Pacemakers Inc

Inventors

• Soltis Brian
• Haasl Benjamin J
• Shuros Allan C
• Schmidt Brian L
• Goodman James P

Classifications

• A61N1/3756 Primary

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

• A61M25/0097

  characterised by the hub (connectors A61M39/10) · CPC title

• A61N1/059 Primary

  Anchoring means · CPC title

• A61M2025/0006

  which can be secured against axial movement, e.g. by using a locking cuff · CPC title

• A61M25/0074

  Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable · CPC title