Delivery devices and methods for leadless cardiac devices

• US 10,722,723 B2
• Filed: 08/06/2014
• Issued: 07/28/2020
• Est. Priority Date: 08/16/2013
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Schmidt, Brian L., Haasl, Benjamin J., Maile, Keith R.
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US14/452,617
• Publication Number:
  US 20150051613A1
• Time in Patent Office: 2,183 Days
• Field of Search: 606129, 606108, 607127, 607126, 607 36, 607128
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Delivery devices, systems, and methods for delivering an implantable leadless pacing device having an outer peripheral surface are disclosed. An example delivery device may include a proximal section including a distal end, and a distal holding section extending distally of a distal end of the proximal section. The distal holding section defines a cavity therein for receiving the implantable leadless pacing device, and may be configured to apply a holding force to the implantable leadless pacing device. In some cases, the distal holding section may be configured to apply a compressive force to the outer peripheral surface of the leadless pacing device when the leadless pacing device is disposed in the cavity.

Claims

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

an implantable leadless pacing device including a housing having a proximal end, a distal end, and a cylindrical outer peripheral surface having a constant outer diameter; and

a delivery device including;

a proximal section including a distal end,

a distal holding section extending distally of the distal end of the proximal section, the distal holding section includes an annular wall having an inner surface defining a cavity therein for receiving the implantable leadless pacing device, the distal holding section being configured to apply a compressive force to and conform to the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity,

wherein the inner surface presses circumferentially against the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity, and

wherein there is no gap or opening between the inner surface of the distal holding section and an entirety of the cylindrical outer peripheral surface of the housing;

wherein when the implantable leadless pacing device is fully disposed in the cavity, the distal holding section includes a distally facing opening distal of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device, the distal opening having an inner diameter that is less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device;

wherein the distal opening is configured to expand as the housing of the implantable leadless pacing device passes therethrough.

2. The delivery system of claim 1, wherein the distal holding section comprises a resilient material that applies the compressive force to the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device.

3. The delivery system of claim 1, wherein the distal holding section comprises a resilient material that elastically deforms when the implantable leadless pacing device is disposed in the cavity.

4. The delivery system of claim 1, wherein the cavity of the distal holding section comprises an inner diameter, and the inner diameter of the cavity is the same as or less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed outside of the cavity.

5. The delivery system of claim 4, wherein the inner diameter of the cavity is less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device, and the distal holding section is expandable such that the inner diameter of the cavity expands when the implantable leadless pacing device is disposed in the cavity.

6. The delivery system of claim 1, wherein the cavity of the distal holding section comprises a distal portion extending distal of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device that has an inner diameter that is less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity;

wherein the distal portion is expandable such that the inner diameter of the distal portion will expand as the implantable leadless pacing device is delivered therethrough.

7. The delivery system of claim 1, wherein the cavity of the distal holding section includes a proximal section having a first inner diameter that is the same as the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device, and a distal section that has a second inner diameter that is less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device.

8. The delivery system of claim 1, wherein the compressive force applied by the distal holding section to the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device provides circumferential frictional engagement between the distal holding section and the housing of the implantable leadless pacing device.

9. The delivery system of claim 1, wherein when the housing of the implantable leadless pacing device is disposed outside of the distal holding section, the cavity of the distal holding section includes:

a proximal portion having a first inner diameter that is less than the outer diameter of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device, and

a distal portion that has a second inner diameter at a distal end of the distal portion that is less than the first inner diameter;

wherein the proximal portion is configured to radially expand to a third inner diameter greater than the first inner diameter when the housing of the implantable leadless pacing device is disposed therein;

wherein the distal portion is configured to radially expand to the third inner diameter when the housing of the implantable leadless pacing device passes therethrough;

wherein the distal portion is configured to radially contract to a fourth inner diameter less than the third inner diameter when the implantable leadless pacing device is disposed in the proximal portion.

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

an implantable leadless pacing device including;

a housing including electrical circuitry therein, the housing having a cylindrical outer peripheral surface having a constant outer diameter; and

a fixation mechanism disposed at a distal end of the housing;

a delivery device including;

a proximal section including a distal end, and

a distal holding section extending distally of a distal end of the proximal section, the distal holding section includes an annular wall having an inner surface defining a cavity therein for receiving the implantable leadless pacing device, the distal holding section being configured to conform to the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity to provide circumferential frictional engagement with the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device,

wherein the inner surface circumferentially frictionally engages the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity while being free of any gap between the inner surface and the cylindrical outer peripheral surface of the housing.

11. The delivery system of claim 10, wherein the cavity of the distal holding section is radially expanded when the distal holding section receives the implantable leadless pacing device therein.

12. The delivery system of claim 10, wherein a distal portion of the distal holding section extending distal of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device has an inner diameter less than the outer diameter of the cylindrical outer peripheral surface of the housing when the implantable leadless pacing device is disposed in the cavity.

13. The delivery system of claim 12, wherein the distal portion is expandable such that the inner diameter of the distal portion expands as the housing of the implantable leadless pacing device passes therethrough.

14. The delivery system of claim 10, wherein the distal holding section includes a distal opening at a distal extremity thereof opening into the cavity, the distal opening having a radially collapsed diameter less than the outer diameter of the cylindrical outer peripheral surface of the housing when the implantable leadless pacing device is fully disposed in the cavity, and the distal opening having a radially expanded diameter equal to the outer diameter of the cylindrical outer peripheral surface of the housing as the housing of the implantable leadless pacing device passes through the distal opening.

15. The delivery system of claim 10, wherein the distal holding section includes a proximal portion and a distal portion located distal of the proximal portion, the proximal portion of the distal holding section circumferentially surrounding the cylindrical outer peripheral surface of the housing when the implantable leadless pacing device is fully disposed in the cavity and the distal portion of the distal holding section circumferentially surrounding the fixation mechanism when the implantable leadless pacing device is fully disposed in the cavity,

wherein the proximal portion of the distal holding section has an inner diameter equal to the outer diameter of the cylindrical outer peripheral surface of the housing when the implantable leadless pacing device is fully disposed in the cavity, and the distal portion of the distal holding section has an inner diameter less than the inner diameter of the proximal portion of the distal holding section when the implantable leadless pacing device is fully disposed in the cavity.

16. The delivery system of claim 15, wherein the distal portion of the distal holding section gradually tapers down to a smaller diameter in a distal direction from the proximal portion of the distal holding section to a distal extremity of the distal holding section.

17. The delivery system of claim 15, wherein the distal holding section includes a distal opening at a distal extremity thereof opening into the cavity, the distal opening having a radially collapsed diameter less than the inner diameter of the proximal portion of the distal holding section when the implantable leadless pacing device is fully disposed in the cavity, and the distal opening having a radially expanded diameter equal to the inner diameter of the proximal portion of the distal holding section as the implantable leadless pacing device is deployed out through the distal opening.

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

an implantable leadless pacing device including a housing having a cylindrical outer peripheral surface having a constant outer diameter; and

a delivery device including;

a proximal section including a distal end, and

a distal holding section extending distally of the distal end of the proximal section, the distal holding section includes an annular wall having an inner surface defining a cavity therein for receiving the implantable leadless pacing device, the distal holding section having an inner diameter in a relaxed state less than the outer diameter of the housing of the implantable leadless pacing device such that the distal holding section radially expands to engage an entirety of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device around an entire circumference of the housing of the implantable leadless pacing device when the implantable leadless pacing device is disposed in the cavity while being free of any gap between the inner surface and the cylindrical outer peripheral surface of the housing;

wherein a distal end of the distal holding section defines a distal opening coaxial with and opening into the cavity of the distal holding section, the distal opening having an inner diameter less than the outer diameter of the housing of the implantable leadless pacing device when the implantable leadless pacing device is fully disposed in the cavity.

19. The delivery system of claim 18, wherein a distal section of the distal holding section extending distal of the cylindrical outer peripheral surface of the housing of the implantable leadless pacing device has an inner diameter less than the outer diameter of the housing when the implantable leadless pacing device is disposed in the cavity.

20. The delivery system of claim 19, wherein the distal section is expandable such that the inner diameter of the distal section expands as the housing of the implantable leadless pacing device passes therethrough.