Delivery devices and methods for leadless cardiac devices

Patent metadata

Field	Value
Publication number	US-10773089-B2
Application number	US-201815879937-A
Country	US
Kind code	B2
Filing date	Jan 25, 2018
Priority date	Jan 26, 2017
Publication date	Sep 15, 2020
Grant date	Sep 15, 2020

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may be configured to enable fluid flushing of the delivery device prior to use, to remove any air from within the device as well as providing the option of fluid flow during use of the delivery device.

First claim

What is claimed is:

1. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:
an outer tubular member including an outer tubular member lumen extending from a proximal end to a distal end thereof;
an intermediate tubular member coaxially and slidingly disposed within the outer tubular member lumen, the intermediate tubular member including an intermediate tubular member lumen extending from a proximal end to a distal end thereof;
an inner tubular member coaxially and slidingly disposed within the intermediate tubular member lumen, the inner tubular member including an inner tubular member lumen extending from a proximal end to a distal end thereof;
a distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device; and
a deployment funnel fixedly attached to the distal end of the inner tubular member, the deployment funnel moveable between an advanced position in which the deployment funnel extends distally within the distal holding section and a retracted position in which the deployment funnel is seated within a proximal portion of the distal holding section;
the deployment funnel configured to permit fluid flow from the distal end of the intermediate tubular member lumen into the distal holding section when the deployment funnel is in the retracted position.

2. The delivery device of claim 1 , wherein the deployment funnel comprises one or more apertures extending through the deployment funnel that are in fluid communication with the intermediate tubular member lumen so that fluid can flow from the distal end of the intermediate tubular member lumen and pass through the one or more apertures into the distal holding section.

3. The delivery device of claim 1 , wherein the deployment funnel comprises one or more grooves that are in fluid communication with the intermediate tubular member lumen so that fluid can flow from the distal end of the intermediate tubular member lumen and pass through the one or more grooves into the distal holding section.

4. The delivery device of claim 1 , wherein at least a portion of the deployment funnel comprises a porous material that enables fluid flow through pores thereof.

5. The delivery device of claim 1 , wherein at least a portion of the deployment funnel comprises a scaffolding material including voids that enable fluid flow therethrough.

6. The delivery device of claim 1 , wherein the deployment funnel is further configured to provide a fluid coupling between the inner tubular member lumen and the distal holding section when the deployment funnel is in the retracted position.

7. The delivery device of claim 6 , wherein the deployment funnel includes a central aperture that aligns with the inner tubular member lumen.

8. The delivery device of claim 1 , further comprising a tether removably disposed within the inner tubular member lumen and extending through the deployment funnel, the tether being configured to engage the implantable leadless pacing device.

9. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:
an outer tubular member defining an outer tubular member lumen extending from a proximal end to a distal end thereof;
an intermediate tubular member moveably disposed within the outer tubular member lumen and defining an intermediate tubular member lumen extending from a proximal end to a distal end thereof;
a distal holding section extending distally of a distal end of the intermediate tubular member and configured to accommodate an implantable leadless pacing device at least partially within the distal holding section, the intermediate tubular member moveable between a retracted position in which a proximal portion of the distal holding section seats within the outer tubular member lumen and an extended position in which the proximal portion of the distal holding section extends distally from the outer tubular member lumen;
an inner tubular member moveably disposed within the intermediate tubular member lumen and defining an inner tubular member lumen extending from a proximal end to a distal end thereof; and
a deployment funnel fixedly secured to the distal end of the inner tubular member, the inner tubular member moveable between an extended position in which the deployment funnel extends distally within the distal holding section and a retracted position in which the deployment funnel is seated within a proximal portion of the distal holding section, the deployment funnel configured to permit fluid flow from the distal end of the intermediate tubular member lumen into the distal holding section when in the retracted position.

10. The delivery device of claim 9 , wherein the deployment funnel comprises one or more apertures extending through the deployment funnel in order to permit fluid to flow past the deployment funnel in the retracted position.

11. The delivery device of claim 9 , wherein the deployment funnel comprises one or more grooves on a surface of the deployment funnel in order to permit fluid to flow past the deployment funnel in the retracted position.

12. The delivery device of claim 9 , wherein at least a portion of the deployment funnel comprises a porous material that enables fluid flow therethrough.

13. The delivery device of claim 9 , wherein the inner tubular member extends centrally through a central aperture of the deployment funnel.

14. A delivery system for delivering a leadless cardiac pacemaker (LCP), the delivery system comprising:
a deflection shaft defining a deflection shaft lumen;
an extension shaft extending through the deflection shaft lumen, the extension shaft defining an extension shaft lumen;
an LCP sleeve secured to a distal end of the extension shaft and extending distally therefrom, the LCP sleeve configured to accommodate an LCP at least partially within the LCP sleeve for delivery;
a deployment shaft extending through the extension shaft lumen, the deployment shaft defining a deployment shaft lumen; and
a deployment funnel fixedly attached to a distal end of the deployment shaft, the deployment funnel including a central aperture, the deployment funnel configured to engage the LCP for holding the LCP in place while the LCP sleeve is withdrawn proximally relative to the LCP;
the deployment funnel configured to accommodate a tether extending within the deployment shaft lumen and through the central aperture of the deployment funnel, the central aperture aligning with the deployment shaft lumen;
the deployment funnel including one or more fluid structures that enable fluid to flow from the extension shaft lumen and distally beyond the deployment funnel into the LCP sleeve.

15. The delivery system of claim 14 , wherein the deployment funnel comprises one or more grooves on a surface of the deployment funnel in order to permit fluid to flow past the deployment funnel into the LCP sleeve.

16. The delivery system of claim 15 , wherein the one or more grooves are formed on a radially outward facing surface of the deployment funnel seated against a hub portion of the LCP sleeve.

17. The delivery system of claim 15 , wherein the one or more grooves are formed on a radially inward facing surface of the deployment funnel seated against a head portion of a docking member of the LCP.

18. The delivery system of claim 15 , wherein the deployment shaft includes an aperture extending through a sidewall thereof providing a fluid pathway betwee

Assignees

• Cardiac Pacemakers Inc

Inventors

• Soltis Brian
• Haasl Benjamin J
• Goodman James P
• Hackenmueller Vincent P

Classifications

• A61M25/0082

  Catheter tip comprising a tool · CPC title

• A61N2001/058

  Fixing tools · CPC title

• A61M25/0074

  Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable · CPC title

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61N1/37512

  Pacemakers · CPC title