Delivery devices and methods for leadless cardiac devices

• US 10,265,503 B2
• Filed: 08/06/2014
• Issued: 04/23/2019
• 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: Schmidt, Brian L., Haasl, Benjamin J., Maile, Keith R., Bielefeld, Eric, Sachs, Dana, Kumar, Adwait, Gunasekara, Indaka
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US14/452,654
• Publication Number:
  US 20150051615A1
• Time in Patent Office: 1,721 Days
• Field of Search: 606129, 604528, 604529
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• 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 device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The delivery device may include more than one deflection mechanism for deflecting the proximal section at multiple deflection regions. The delivery device may include more than one tubular member that are translatable relative to one another, and the one or more tubular members may include fixed curve portions. The delivery device may include an atraumatic or bumper tip at the distal end of the holding section.

Claims

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

a proximal hub portion;

a proximal section coupled to and extending distally from the proximal hub portion, the proximal section including an outer tubular member and an inner tubular member slidably disposed in a lumen of the outer tubular member and axially translatable relative to the outer tubular member, the outer tubular member including a first deflection mechanism configured to bend at least a portion of the outer tubular member, the first deflection mechanism including a rotatable actuation member disposed at a distal end of the proximal hub portion, the rotatable actuation member being rotatable about a longitudinal axis of the proximal hub portion;

a push member slidably disposed within a lumen of the inner tubular member; and

a distal holding section extending distally of a distal end of the proximal section, the distal holding section including a proximal end fixed to a distal end of the inner tubular member and axially translatable therewith, the distal holding section having an outer surface with an outer diameter greater than an outer diameter of the inner tubular member, the distal holding section having an inner surface defining a cavity therein for receiving an implantable leadless pacing device;

wherein the distal holding section includes a body portion and a distal tip portion distal of the body portion;

wherein the body portion comprises a first polymer material that extends to an outer surface of the body portion;

wherein the distal tip portion comprises a second polymer material different from the first polymer material and having a durometer less than that of the first polymer material;

wherein the push member is configured to engage the implantable leadless pacing device and deploy the implantable leadless pacing device out of the cavity of the distal holding section;

wherein the distal holding section includes a wall extending from the outer surface to the inner surface, the wall comprising one or more conductive pathways defined in the wall that are spaced proximally from a distal end of the distal holding section;

wherein the one or more conductive pathways are formed of a conductive material.

2. The delivery device of claim 1, wherein the distal tip portion includes a wall thickness that is greater than a wall thickness of at least a portion of the body portion.

3. The delivery device of claim 1, wherein the distal tip portion includes an angled distal end surface that defines an acute angle relative to a longitudinal axis of the distal holding section.

4. The delivery device of claim 3, wherein the angled distal end surface is configured to flatten against a tissue surface of a patient when brought into contact with the tissue surface.

5. The delivery device of claim 1, wherein the distal tip portion is deformable to provide an atraumatic surface for engagement with a tissue of a patient.

6. The delivery device of claim 1, wherein the first polymer material of the body portion extends to the inner surface of the body portion.

7. The delivery device of claim 1, wherein the distal tip portion is devoid of the first polymer material.

8. The delivery device of claim 1, wherein a proximal extent of the second polymer material abuts a distal extent of the first polymer material at a junction between the body portion and the distal tip portion.

9. The delivery device of claim 1, wherein the distal holding section includes a proximal portion extending to the proximal end of the distal holding section, wherein a distal end region of the inner tubular member surrounds the proximal portion of the distal holding section.

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

a proximal hub portion;

a proximal section coupled to and extending distally from the proximal hub portion, the proximal section including an outer tubular member and an inner tubular member slidably disposed in a lumen of the outer tubular member and axially translatable relative to the outer tubular member;

a deflection mechanism configured to bend at least a portion of the outer tubular member, the deflection mechanism including a rotatable actuation member disposed at a distal end of the proximal hub portion, the rotatable actuation member being rotatable about a longitudinal axis of the proximal hub portion;

a push member slidably disposed within a lumen of the inner tubular member; and

a distal holding section extending distally of a distal end of the proximal section, the distal holding section including a proximal end fixed to a distal end of the inner tubular member and axially translatable therewith, the distal holding section having an outer surface with an outer diameter greater than an outer diameter of the inner tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device and includes including a proximal portion extending to the proximal end of the distal holding section, a distal tip portion extending to a distal end of the distal holding section, and a body portion positioned between the proximal portion and the distal tip portion,

wherein the inner tubular member extends over and surrounds the proximal portion of the distal holding section;

wherein the body portion comprises a first polymer material and the distal tip portion comprises a second polymer material different from the first polymer material;

wherein the second polymer material is softer than the first polymer material;

wherein the push member is configured to engage the implantable leadless pacing device and deploy the implantable leadless pacing device out of the cavity of the distal holding section;

wherein the distal holding section includes a wall extending from the outer surface to the inner surface, the wall comprising one or more conductive pathways defined in the wall that are spaced proximally from a distal end of the distal holding section;

wherein the one or more conductive pathways are formed of a conductive material.

11. The delivery device of claim 10, wherein the distal tip portion includes a wall thickness that is greater than a wall thickness of at least a portion of the body portion.

12. The delivery device of claim 10, wherein the distal tip portion includes an angled distal end surface that defines an acute angle relative to a longitudinal axis of the distal holding section;

wherein the angled distal end surface is configured to flatten against a tissue surface of a patient when brought into contact with the tissue surface.

13. The delivery device of claim 10, wherein the first polymer material extends from an inner surface to an outer surface of the body portion.

14. The delivery device of claim 13, wherein the distal tip portion is devoid of the first polymer material.

15. The delivery device of claim 14, wherein a proximal extent of the second polymer material abuts a distal extent of the first polymer material at a junction between the body portion and the distal tip portion.

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

a proximal section, the proximal section including an outer tubular member and an inner tubular member slidably disposed in a lumen of the outer tubular member and axially translatable relative to the outer tubular member;

a push member slidably disposed within a lumen of the inner tubular member; and

a distal holding section extending distally of a distal end of the proximal section, the distal holding section including a proximal end fixed to a distal end of the inner tubular member and axially translatable therewith, the distal holding section having an outer diameter greater than an outer diameter of the inner tubular member, the distal holding section including a wall defining the cavity for receiving the implantable leadless pacing device, wherein the wall comprises a polymeric material and one or more conductive pathways defined in the wall that are spaced proximally from a distal end of the distal holding section, wherein the one or more conductive pathways comprise a conductive material;

wherein the push member is configured to engage the implantable leadless pacing device and deploy the implantable leadless pacing device out of the cavity of the distal holding section.

17. The delivery device of claim 16, wherein the conductive material is a conductive metal.