Implantable device delivery system

• US 10,470,906 B2
• Filed: 09/13/2016
• Issued: 11/12/2019
• Est. Priority Date: 09/15/2015
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Eller, Zeke, Robinson, Thomas Patrick, Gill, Barton, Gill, Darla, Elwood, Bryan K.
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/263,741
• Publication Number:
  US 20170071772A1
• Time in Patent Office: 1,155 Days
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Delivery systems and methods for deploying an implantable device are disclosed, which can include a delivery device having an outer tubular member and an inner assembly. The inner assembly is disposed within and is slidably movable relative to the outer tubular member. The inner assembly can include a pusher at a distal portion. The pusher abuts and restricts proximal movement, relative to the inner assembly, of a crimped implantable device within the outer tubular member. The pusher can include a slot to accommodate a suture binding mechanism of the implantable device. The delivery device can include a tip disposed at a distal end. The tip includes a tip transition zone. The inner sheath and outer tubular member can each have sections of distinct rigidity along their lengths with transition zones between the sections. A transition zone of the outer tubular member and a transition zone of the inner sheath can be longitudinally offset.

Claims

1. A delivery system for deploying a stent within a lumen of a body of a patient, the delivery system comprising:

a delivery device to position a stent at a target location within a lumen of a body of a patient, the delivery device transitionable from a delivery configuration to a deployment configuration to deploy the stent at the target location, the delivery device including an outer tubular member that, in the delivery configuration, houses the stent in a crimped state for delivery to the target location and an inner assembly that is disposed within the outer tubular member, wherein at least one of the inner assembly and the outer tubular member is slidably movable relative to the other; and

a pusher disposed at a distal portion of the inner assembly and within a distal portion of the outer tubular member and configured to engage a proximal portion of the stent in the crimped state within the outer tubular member in the delivery configuration, wherein the pusher comprises;

a push surface facing distally to abut a proximal facing surface of the stent in the crimped state and limit proximal movement of the stent relative to the pusher during deployment as the delivery device transitions from the delivery configuration to the deployed configuration; and

a slot to receive and house one or more of (i) a knot in a suture coupled to the stent or (ii) a clasp securing the ends of the suture;

wherein the inner assembly further comprises an anchor positioned distal to the push surface of the pusher, the anchor comprising a flange configured to be positioned within a proximal portion of a lumen of the stent and to engage an inner wall of the stent in the crimped state.

2. The delivery system of claim 1, wherein the slot extends radially inward from an outer surface of the pusher to form a void in the outer surface.

3. The delivery system of claim 2, wherein the outer surface of the pusher is a second surface distinct from the push surface.

4. The delivery system of claim 1, wherein the slot extends longitudinally in a proximal direction from the push surface of the pusher.

5. The delivery system of claim 4, wherein the slot extends longitudinally in a proximal direction from the push surface of the pusher along a second surface of the pusher to form a void in the push surface and the second surface of the pusher.

6. The delivery system of claim 1, further comprising a tip disposed at a distal end of the inner assembly, the tip comprising a distal section, a proximal section, and a tip transition zone,

wherein the diameter of the proximal most end of the distal section is greater than the diameter of the distal most end of the proximal section, and

wherein the tip transition zone is a chamfered step to create a smooth transition between the proximal most end of the distal section and the distal most end of the proximal section.

7. The delivery system of claim 1, wherein the inner assembly further comprises an inner sheath positioned inside of the outer tubular member and extending proximally from the pusher, and

wherein the inner sheath comprises a first inner sheath section extending distally from the proximal end to a first inner sheath transition zone and a second inner sheath section extending distally from the first inner sheath transition zone, the first inner sheath section having a first rigidity and the second inner sheath section having a second rigidity that is distinct from the first rigidity.

8. The delivery system of claim 7, wherein the outer tubular member comprises a first outer tubular member section extending distally from the proximal end to a first outer tubular member transition zone and a second outer tubular member section extending distally from the first outer tubular member transition zone, the first outer tubular member section having a third rigidity and the second outer tubular member section having a fourth rigidity that is distinct from the third rigidity.

9. The delivery system of claim 8, wherein the first inner sheath transition zone is offset along the length of the delivery system from the first outer tubular member transition zone.

17. The delivery system of claim 1, wherein the inner assembly further comprises an inner shaft member to which the pusher and anchor are secured.

18. The delivery system of claim 1, wherein the anchor comprises a proximally facing surface that is configured to abut a distal end of a row of struts forming a scaffolding structure of the stent in the crimped state, wherein the anchor abuts the distal end of the row of struts to limit distal movement of the stent relative to the anchor.

10. A delivery system for deploying an implantable device within a body of a patient, the delivery system comprising:

a delivery device comprising;

an outer tubular member configured to house and compress radially inward an implantable device;

an inner assembly disposed within the outer tubular member to engage the implantable device in a crimped state within the outer tubular member,

wherein at least one of the inner assembly and the outer tubular member is slidably movable relative to the other to deploy the implantable device; and

a pusher comprising a push surface facing distally to abut a proximal facing surface of the implantable device in the crimped state and limit proximal movement of the implantable device relative to the pusher during deployment as the delivery device transitions from a delivery configuration to a deployed configuration,

wherein the inner assembly comprises an inner sheath with a first inner sheath section extending distally from a proximal end of the delivery device to a first inner sheath transition zone and a second inner sheath section extending distally from the first inner sheath transition zone, the first inner sheath section having a first rigidity and the second inner sheath section having a second rigidity that is distinct from the first rigidity, and

wherein the inner assembly further comprises an anchor, the anchor positioned distal to the push surface of the pusher and comprising a flange configured to engage the implantable device in the crimped state and to limit distal movement of the implantable device when in the crimped state.

11. The delivery system of claim 10, wherein the outer tubular member comprises a first outer tubular member section extending distally from the proximal end to a first outer tubular member transition zone and a second outer tubular member section extending distally from the first outer tubular member transition zone, the first outer tubular member section having a third rigidity and the second outer tubular member section having a fourth rigidity that is distinct from the third rigidity.

12. The delivery system of claim 11, wherein the first inner sheath transition zone is longitudinally offset from the first outer tubular member transition zone.

14. The delivery system of claim 10, wherein the pusher further comprises a slot to receive and house one or more of (i) a knot in a suture coupled to the implantable device or (ii) a clasp securing the ends of the suture.

13. A delivery system for deploying an implantable device within a body of a patient, the delivery system comprising:

a delivery device comprising;

an outer tubular member configured to house and compress radially inward an implantable device;

an inner assembly disposed within the outer tubular member to engage the implantable device in a crimped state within the outer tubular member, wherein at least one of the inner assembly and the outer tubular member is slidably movable relative to the other to deploy the implantable device; and

a pusher comprising a push surface facing distally to abut a proximal facing surface of the implantable device in the crimped state and limit proximal movement of the implantable device relative to the pusher during deployment as the delivery device transitions from a delivery configuration to a deployed configuration,

wherein the outer tubular member comprises a first outer tubular member section extending distally from a proximal end to a first outer tubular member transition zone and a second outer tubular member section extending distally from the first outer tubular member transition zone, the first outer tubular member section having a first rigidity and the second outer tubular member section having a second rigidity that is distinct from the first rigidity, and

wherein the inner assembly comprises an anchor, the anchor positioned distal to the push surface of the pusher and comprising a flange configured to engage the implantable device in the crimped state and to limit distal movement of the implantable device when in the crimped state.

15. The delivery system of claim 13, wherein the pusher further comprises a slot to receive and house one or more of (i) a knot in a suture coupled to the implantable device or (ii) a clasp securing the ends of the suture.

16. The delivery system of claim 13 further comprising a second outer tubular member transition zone located at the distal end of the second outer tubular member section and a third outer tubular member section extending distally from the second outer tubular member transition zone.