Delivery devices and methods for leadless cardiac devices

• US 9,956,400 B2
• Filed: 10/21/2015
• Issued: 05/01/2018
• Est. Priority Date: 10/22/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haasl, Benjamin J., Schmidt, Brian L.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/919,310
• Publication Number:
  US 20160114157A1
• Time in Patent Office: 923 Days
• Field of Search: 607119
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• 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
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

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

Claims

1. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

an outer tubular member including a lumen extending from a proximal end to a distal end thereof;

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 outer tubular member;

a distal holding section extending distally of a distal end of the inner tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device;

a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member and a second hub portion affixed adjacent to the proximal end of the inner tubular member, the first hub portion including a lumen extending therein and at least a portion of the second hub portion slidably and rotatably disposed within the lumen of the first hub portion; and

a first locking mechanism having a first engaging feature on the first hub portion and a second engaging feature on the second hub portion, the first and second engaging features configured to be releasably and directly coupled together within the lumen of the first hub portion of the handle assembly;

wherein the first locking mechanism is configured to releasably couple the first hub portion and the second hub portion.

2. The delivery device of claim 1, wherein the first locking mechanism has a locked position and an unlocked position wherein the inner tubular member is held in tension in the locked position.

3. The delivery device of claim 2, wherein the outer tubular member is held in compression in the locked position.

4. The delivery device of claim 1, wherein the first hub portion and the second hub portion are individually slidable and rotatable when the first locking mechanism is in an unlocked configuration.

5. The delivery device of claim 1, wherein the first locking mechanism comprises a bayonet style locking mechanism.

6. The delivery device of claim 5, wherein the second hub portion comprises a groove positioned adjacent a distal end of the second hub portion, the groove configured to receive an inwardly extending protrusion of the first hub portion.

7. The delivery device of claim 6, wherein the groove comprises a first portion, a second portion extending generally orthogonal to the first portion, and a serif positioned at an end of the second portion.

8. The delivery device of claim 7, wherein disposing the protrusion within the serif releasably couples the outer tubular member and the inner tubular member such that longitudinal or rotational actuation of either of the outer tubular member or the inner tubular member results in corresponding actuation of both the outer tubular member and the inner tubular member.

9. The delivery device of claim 7, wherein disposing the protrusion within the serif places the inner tubular member in tension and the outer tubular member in compression.

10. The delivery device of claim 1, further comprising a push member slidably disposed within the lumen of the inner tubular member.

11. The delivery device of claim 10, further comprising a third hub portion affixed adjacent to a proximal end of the push member.

12. The delivery device of claim 11, further comprising a second locking mechanism disposed within the handle assembly.

13. The delivery device of claim 12, wherein the third hub portion is slidable and rotatable independent of either of the first hub portion or the second hub portion when the second locking mechanism is in an unlocked configuration.

14. The delivery device of claim 1, wherein the first locking mechanism is selected from the group of a snap lock, a threaded engagement, or a quick connect locking feature.

15. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

an outer tubular member including a lumen extending from a proximal end to a distal end thereof;

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 outer tubular member;

a push member having a proximal end and a distal end, the push member slidably disposed within the lumen of the inner tubular member;

a distal holding section extending distally of a distal end of the inner tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device;

a handle assembly including 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 inner tubular member, and a proximal hub portion affixed adjacent to the proximal end of the push member, a distal end portion of the intermediate hub portion slidably and rotatably disposed within a lumen of the distal hub portion and a distal end portion of the proximal hub portion slidably and rotatably disposed within a lumen of the intermediate hub portion such that the distal hub portion, the intermediate hub portion, and the proximal hub portion are arranged in a telescoping configuration such that each of the distal hub portion, intermediate hub portion, and proximal hub portion are capable of being longitudinally and rotationally actuated individually; and

a first locking mechanism positioned within the lumen of the distal hub portion and disposed between the distal hub portion and the intermediate hub portion;

wherein the first locking mechanism is configured to releasably couple the distal hub portion and the intermediate hub portion.

16. The delivery device of claim 15, wherein the first locking mechanism is user actuatable between an unlocked configuration and a locked configuration.

17. The delivery device of claim 16, wherein when in the locked configuration, the intermediate hub portion is proximally retracted to place the inner tubular member in tension and the outer tubular member in compression.

18. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

an outer tubular member including a lumen extending from a proximal end to a distal end thereof;

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 outer tubular member;

a distal holding section secured to and extending distally of a distal end of the inner tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device;

a push member having a proximal end and a distal end, the push member slidably disposed within the lumen of the inner 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 inner tubular member, and a third hub portion affixed adjacent to the proximal end of the push member, the first hub portion, the second hub portion, and the third hub portion each selectively longitudinally movable relative to each other; and

a first locking mechanism configured to releasably lock the first hub portion to the second hub portion, the first locking mechanism having a locked position and an unlocked position, wherein in the unlocked position of the first locking mechanism the first hub portion is longitudinally movable relative to the second hub portion; and

a second locking mechanism configured to releasably lock the second hub portion to the third hub portion, the second locking mechanism having a locked position and an unlocked position, wherein in the unlocked position of the second locking mechanism the second hub portion is longitudinally movable relative to the third hub portion;

wherein in the locked position of the first locking mechanism the inner tubular member is held in tension and the outer tubular member is held in compression.

19. The delivery device of claim 18, wherein the second hub portion extends proximal of the first hub portion, and the third hub portion extends proximal of the second hub portion.

20. The delivery device of claim 19, wherein a distal end portion of the second hub portion is slidably and rotatably disposed within a lumen of the first hub portion and a distal end portion of the third hub portion is slidably and rotatably disposed within a lumen of the second hub portion such that the first hub portion, the second hub portion, and the third hub portion are arranged in a telescoping configuration.