Leadless cardiac pacing devices

• US 10,179,236 B2
• Filed: 08/06/2014
• Issued: 01/15/2019
• 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: Haasl, Benjamin J., Sachs, Dana, Maile, Keith R.
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US14/452,680
• Publication Number:
  US 20150051616A1
• Time in Patent Office: 1,623 Days
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

Implantable leadless pacing devices and medical device systems including an implantable leadless pacing device are disclosed. An example implantable leadless pacing device may include a pacing capsule. The pacing capsule may include a housing. The housing may have a proximal region and a distal region. A first electrode may be disposed along the distal region. One or more anchoring members may be coupled to the distal region. The anchoring members may each include a region with a compound curve.

Claims

1. An implantable leadless pacing device, comprising:

a pacing capsule including a housing, the housing having a proximal region and a distal region;

a first electrode disposed along the distal region; and

a plurality of anchoring members coupled to the distal region,

wherein each of the anchoring members is capable of shifting between a first, delivery configuration when positioned within a holding region of a delivery catheter, and a second, deployed configuration when deployed therefrom, the anchoring members each including a region with a compound curve when in the deployed configuration, wherein the region with the compound curve includes a first curved section and a second curved section, wherein each anchoring member extends between a base region connected to the housing and a free end, wherein each anchoring member has first and second outer surfaces on opposite sides of the anchoring member, the first and second outer surfaces each extending between the base region and the free end, wherein the first outer surface is convex in the first curved section and concave in the second curved section, wherein the free end of each of the anchoring members includes a sharpened tip that points in a proximal direction when in the deployed configuration, and wherein each of the anchoring members includes an outermost surface proximal of the tip that is positioned radially outward of the sharpened tip in the delivery configuration.

2. The implantable leadless pacing device of claim 1, wherein the first curved section is oriented in a first direction and wherein the second curved section is oriented in a second direction different from the first direction.

3. The implantable leadless pacing device of claim 2, wherein the first direction is opposite the second direction.

4. The implantable leadless pacing device of claim 1, wherein the first curved section, the second curved section or both are capable of causing the anchoring members to move laterally away from the first electrode when the anchoring members extend within a target tissue.

5. The implantable leadless pacing device of claim 1, wherein the first curved section, the second curved section or both have a radius of curvature that varies.

6. The implantable leadless pacing device of claim 1, wherein the second outer surface is concave in the first curved section and convex in the second curved section.

7. The implantable leadless pacing device of claim 1, wherein the second curved section includes a curve extending away from the housing and up to the free end.

8. An implantable leadless pacing device system, the system comprising:

a delivery catheter having a proximal section, a distal holding section, and a lumen formed therein;

a push member slidably disposed within the lumen;

a leadless pacing device slidably received within the distal holding section, the leadless pacing device comprising;

a pacing capsule including a housing, the housing having a proximal region and a distal region,

a first electrode disposed along the distal region, and

a plurality of anchoring members coupled to the distal region, each anchoring member including first and second outer surfaces on opposite sides of the anchoring member;

wherein each of the anchoring members is capable of shifting between a first configuration when the leadless pacing device is disposed within the distal holding section and a second, deployed configuration when the leadless pacing device is advanced out from the distal holding section;

wherein the distal holding section has a longitudinal axis;

wherein each of the anchoring members is arranged substantially parallel with the longitudinal axis when the anchoring members are in the first configuration with the first outer surface contacting an inner wall surface of the distal holding section while spacing a distal sharpened tip away from the inner wall surface of the distal holding section; and

wherein each of the anchoring members includes a region with a compound curve when the anchoring members are in the deployed configuration, wherein each anchoring member has a length extending between a base region and a free end, the base region connecting the anchoring member to the housing, wherein the region with the compound curve includes a first curved section proximate the base region and a second curved section proximate the free end, wherein the first outer surface is concave in the first curved section and convex in the second curved section in the deployed configuration, wherein the second outer surface is convex in the first curved section and concave in the second curved section in the deployed configuration, and wherein the free end of each of the anchoring members includes the distal sharpened tip that points in a proximal direction when in the deployed configuration.

9. The system of claim 8, wherein the first curved section is oriented in a first direction and wherein the second curved section is oriented in a second direction different from the first direction.

10. The system of claim 9, wherein the first direction is opposite the second direction.

11. The system of claim 8, wherein a contact section of each of the anchoring members contacts an inner wall surface of the distal holding section when the anchoring members are in the first configuration.

12. The system of claim 8, wherein a contact section of each anchoring member located proximal of the free end of the anchoring member contacts the inner wall surface of the distal holding section when the anchoring members are in the first configuration.

13. The system of claim 12, wherein the contact section of each anchoring member extends between the free end of the anchoring member and a point disposed proximal of the free end.

14. The system of claim 8, wherein the first curved section, the second curved section or both of each anchoring member are capable of causing the anchoring member to move laterally away from the first electrode when the anchoring member extends within a cardiac tissue.

15. An implantable leadless pacing device system, the system comprising:

a delivery catheter having a proximal section, a distal holding section, and a lumen formed therein;

a push member slidably disposed within the lumen;

a leadless pacing device slidably received within the distal holding section, the leadless pacing device comprising;

a pacing capsule including a housing, the housing having a proximal region and a distal region,

a first electrode disposed along the distal region, and

a plurality of anchoring members coupled to the distal region;

wherein each of the anchoring members is capable of shifting between a first configuration when the leadless pacing device is disposed within the distal holding section and a second, deployed configuration when the leadless pacing device is advanced out from the distal holding section such that a free end of each of the anchoring members includes a distal tip that points in a proximal direction when in the deployed configuration;

wherein a contact section of each of the anchoring members contacts an inner wall surface of the distal holding section when the anchoring member is in the first configuration;

wherein the contact section of each of the anchoring members is positioned proximally of the distal tip of the anchoring member;

wherein the distal tip of each of the anchoring members is spaced away from the inner wall surface of the distal holding section in a radial direction when the anchoring member is in the first configuration;

wherein each of the anchoring members extends between a base region connected to the housing and the free end, wherein each anchoring member has first and second outer surfaces on opposite sides of the anchoring member, the first and second outer surfaces each extending between the base region and the free end, wherein each anchoring member includes a region with a compound curve when the anchoring members are in the deployed configuration;

wherein the region with the compound curve includes a first curved section and a second curved section located between the first curved section and the distal tip, wherein the contact section of each of the anchoring members includes a curved portion of the second curved section, wherein the first outer surface along the contact section contacts an inner surface of the distal holding section in the first configuration, wherein the first outer surface is convex through the curved portion when in the deployed configuration and in the first configuration, and wherein the second outer surface is concave through the curved portion when in the deployed configuration and in the first configuration.

16. The system of claim 15, wherein the second curved section curves away from the housing toward the distal tip of the anchoring member when in the deployed configuration.

17. The system of claim 16, wherein the distal tip is a sharpened distal tip.

18. The system of claim 15, wherein the first outer surface is concave in the first curved section and convex in the second curved section, and wherein the second outer surface is convex in the first curved section and concave in the second curved section.

19. The system of claim 15, wherein the first outer surface is convex distal of the contact section to the distal tip in the deployed configuration and in the first configuration, and the second outer surface is concave distal of the contact section to the distal tip in the deployed configuration and in the first configuration.