Delivery devices and methods for leadless cardiac devices

• US 10,258,802 B2
• Filed: 11/17/2016
• Issued: 04/16/2019
• Est. Priority Date: 11/20/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Soltis, Brian, Koubal, Kurt G., Haasl, Benjamin J., Kunkel, Ronald W., Schmidt, Brian L.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/354,574
• Publication Number:
  US 20170143980A1
• Time in Patent Office: 880 Days
• Field of Search: 607122, 607126
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• 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

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery system may comprise a delivery device, an implantable leadless pacing device, and a tether. The tether may be made of a material which allows for a lubricious, strong, no stretch, no memory tether. The tether may releasably secure the implantable leadless pacing device to the delivery device.

Claims

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

a delivery device, the delivery device comprising;

a tubular member including a lumen extending from a proximal end to a distal end thereof, the tubular member including a distal holding section defining a cavity therein; and

a handle assembly;

an implantable leadless pacing device configured to be disposed within the cavity of the distal holding section, the leadless pacing device comprising;

a housing having a proximal end and a distal end;

a fixation mechanism disposed adjacent the distal end; and

a tether retention feature disposed adjacent to the proximal end; and

a tether configured to releasably secure the implantable leadless pacing device to the delivery device, the tether releasably coupled to the tether retention feature of the leadless pacing device and extending to the handle assembly of the delivery device;

the tether consisting of a multifilament of ultra-high-molecular-weight polyethylene (UHMWPE) material extending from a first terminal end of the tether to a second terminal end of the tether, the UHMWPE material having a tensile strength in the range of 26.7 Newtons (N) to 89.0 N.

2. The delivery system of claim 1, wherein the UHMWPE material has a tensile strength in the range of 35.6 N to 44.5 N.

3. The delivery system of claim 1, wherein the UHMWPE material has a modulus of elasticity in the range of 96.5 gigapascals (GPa) to 131 GPa.

4. The delivery system of claim 1, wherein the UHMWPE material has a coefficient of friction of less than 0.05.

5. The delivery system of claim 1, wherein handle assembly includes a proximal hub portion, an intermediate hub portion, and a distal hub portion arranged in a telescoping arrangement such that the distal hub portion is longitudinally slidable relative to the intermediate hub portion and the proximal hub portion is longitudinally slidable relative to the intermediate hub portion;

wherein the intermediate hub portion extends distal of a distal end of the proximal hub portion and the distal hub portion extends distal of a distal end of the intermediate hub portion.

6. The delivery system of claim 5, wherein the distal end of the proximal hub portion surrounds a proximal end of the intermediate hub portion and a proximal end of the distal hub portion surrounds the distal end of the intermediate hub portion.

7. A delivery system for delivering an implantable leadless pacing device, the delivery system comprising;

a delivery device, 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 slidably disposed in the lumen of the outer tubular member, the intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member including a distal holding section positioned distal of the distal end of the outer tubular member, the distal holding section defining a cavity therein;

an inner tubular member slidably disposed in the lumen of the intermediate tubular member, the inner tubular member including a lumen extending from a proximal end to a distal end thereof; and

a handle assembly including a distal hub portion affixed to the proximal end of the outer tubular member, an intermediate hub portion affixed to the proximal end of the intermediate tubular member, and a proximal hub portion affixed to the proximal end of the inner tubular member,

wherein the intermediate hub portion extends distal of a distal end of the proximal hub portion and the distal hub portion extends distal of a distal end of the intermediate hub portion;

wherein the distal hub portion, the intermediate hub portion and the proximal hub portion are in a telescoping arrangement such that the distal hub portion is longitudinally slidable relative to the intermediate hub portion to move the intermediate tubular member relative to the outer tubular member, the proximal hub portion is longitudinally slidable relative to the intermediate hub portion to move the inner tubular member relative to the intermediate tubular member;

an implantable leadless pacing device configured to be disposed within the cavity of the distal holding section, the leadless pacing device comprising;

a housing having a proximal end and a distal end;

a fixation mechanism disposed adjacent the distal end; and

a docking member comprising a tether retention loop disposed adjacent to the proximal end; and

a tether comprising a length of material having a first end and a second end and configured to releasably secure the implantable leadless pacing device to the delivery device, the tether looped around the tether retention loop and extending through the lumen of the inner tubular member to a proximal end of the proximal hub portion of the handle assembly of the delivery device.

8. The delivery system of claim 7, wherein the tether has a tensile strength in the range of 35.6 Newtons (N) to 44.5 N.

9. The delivery system of claim 7, wherein the tether has a modulus of elasticity in the range of 96.5 gigapascals (GPa) to 131 GPa.

10. The delivery system of claim 7, wherein the tether has a coefficient of friction of less than 0.05.

11. The delivery system of claim 7, wherein the tether comprises a monofilament ultra-high-molecular-weight polyethylene (UHMWPE).

12. The delivery system of claim 7, wherein the tether comprises a multifilament UHMWPE.

13. The delivery system of claim 7, wherein the tether comprises a monofilament polyether ether ketone (PEEK).

14. The delivery system of claim 7, wherein the tether comprises a polytetrafluoroethylene (PTFE) coated nitinol wire or cable.

15. The delivery system of claim 7, wherein the tether comprises an ethylene tetrafluoroethylene (ETFE) coated nitinol wire or cable.

17. The delivery system of claim 7, wherein the first and second ends of the tether are secured to a tether cap, wherein the tether cap is removably secured to a proximal end of the proximal hub portion.

18. The delivery system of claim 17, wherein the handle assembly includes a tether lock actuatable between a locked configuration and an unlocked configuration.

19. The delivery system of claim 18, wherein the tether lock includes a port in fluid communication with the lumen of the inner tubular member.

20. The delivery system of claim 18, wherein the distal end of the proximal hub portion surrounds a proximal end of the intermediate hub portion and a proximal end of the distal hub portion surrounds the distal end of the intermediate hub portion.

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

a delivery device, the delivery device comprising;

a tubular member including a lumen extending from a proximal end to a distal end

thereof, the tubular member including a distal holding section defining a cavity therein;

a pusher member extending through the lumen of the tubular member; and

a handle assembly configured to actuate the pusher member relative to the tubular member;

an implantable leadless pacing device configured to be disposed within the cavity of the distal holding section, the leadless pacing device comprising;

a housing having a proximal end and a distal end;

a fixation mechanism disposed adjacent the distal end; and

a docking member comprising a tether retention loop disposed adjacent to the proximal end; and

a tether consisting of a length of material having a first end at a first terminal end of the tether and a second end at a second terminal end of the tether and configured to releasably secure the implantable leadless pacing device to the delivery device, the tether looped around the tether retention loop and extending to the handle assembly of the delivery device;

wherein the material forming the tether has a tensile strength in the range of 35.6 Newtons (N) to 44.5 N, a modulus of elasticity in the range of 96.5 gigapascals (GPa) to 131 GPa, and a coefficient of friction of less than 0.05.