Delivery systems and methods for sheathing and deploying an implantable device

Patent metadata

Field	Value
Publication number	US-9681969-B2
Application number	US-201213664137-A
Country	US
Kind code	B2
Filing date	Oct 30, 2012
Priority date	Oct 31, 2011
Publication date	Jun 20, 2017
Grant date	Jun 20, 2017

Abstract

Systems and methods are disclosed for delivering a stent to a lumen internal to a body of a patient and for sheathing a stent just prior to an insertion procedure. One embodiment comprises a delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration. A panchor (combination pusher and anchor) is configured to engage and limit proximal and distal movement of the implantable device. An outer sheath surrounds a distal portion of an inner member and retains the implantable device near the distal end. The outer sheath is slidably moveable relative to the inner member to deploy the implantable device. Proximal movement of a trigger results in movement of the outer sheath to deploy the implantable device. A sheathing mechanism is configured to crimp and fully sheathe the implantable device prior to a deployment procedure.

First claim

What is claimed is:

1. A delivery system for sheathing a crimpable implantable device and deploying the implantable device within a body of a patient, the delivery system comprising:
a delivery device to position and deploy the implantable device, the delivery device including a tubular member, the tubular member including an outer sheath and a pod disposed at a distal portion of the outer sheath, the pod configured to receive and house the implantable device in a crimped state for delivery to a target location within the body of the patient, the delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration; and
a sheathing mechanism that engages the tubular member of the delivery device, the sheathing mechanism including a ramped surface and a tapered member, the ramped surface to be disposed at a distal end of the outer sheath of the tubular member to collapse inwardly and compress the implantable device, the tapered member to be moved in a distal direction along the tubular member, wherein distal movement of the tapered member of the sheathing mechanism relative to the delivery device results in interaction of the tapered member and the ramped surface to crimp the implantable device and moves the outer sheath of the tubular member distally relative to a crimped portion of the implantable device to transition the delivery device from the partially sheathed configuration to the fully sheathed delivery configuration to sheathe the implantable device, wherein the distal movement of the tapered member causes distal movement of the ramped surface, and wherein the distal movement of the ramped surface is configured to pull the pod over the implantable device in the crimped state.

2. The delivery system of claim 1 , wherein the sheathing mechanism comprises:
a plurality of sheathing fingers to crimp an unsheathed portion of the implantable device, the plurality of sheathing fingers comprising the ramped surface; and
a translational member that is axially displaceable relative to the tubular member of the delivery device, the translational member comprising the tapered member disposed at a distal end of the translational member to interact with the plurality of sheathing fingers and translate axial movement of the translational member in a distal direction along the tubular member into radial force to compress and thereby crimp the unsheathed portion of the implantable device.

3. The delivery system of claim 2 , wherein the plurality of sheathing fingers are configured to engage the outer sheath of the tubular member of the delivery device and to engage the translational member as the translational member is moved distally along the tubular member of the delivery device, wherein distal movement of the translational member moves the outer sheath of the tubular member distally relative to a crimped portion of the implantable device to thereby sheathe the crimped portion of the implantable device.

4. The delivery system of claim 2 , wherein the tubular member of the delivery device comprises:
an inner member to couple to the implantable device in the partially sheathed configuration and the fully sheathed delivery configuration; and
wherein the outer sheath coaxially surrounds a distal portion of the inner member, wherein the outer sheath has a distal portion configured to enclose the implantable device in the fully sheathed delivery configuration, and wherein the outer sheath is slidably moveable relative to the inner member and proximal movement of the outer sheath relative to the inner member deploys the implantable device.

5. The delivery system of claim 4 , wherein the sheathing mechanism further comprises a tip insertion funnel to guide coupling of a tip to the inner member, wherein the tip is coupled to a distal segment of the inner member that is configured to couple to the inner member, wherein the distal segment comprises an elongate shaft, and wherein the tip insertion funnel guides the distal segment through a lumen of the implantable device to couple to the inner member of the tubular member of the delivery device.

6. The delivery system of claim 5 , wherein the tip insertion funnel comprises two halves coupled together by hinges disposed at a distal rim of the tip insertion funnel, wherein the hinges allow the tip insertion funnel to have an opened state and a closed state.

7. The delivery system of claim 4 , wherein the plurality of sheathing fingers are configured to engage the outer sheath of the tubular member of the delivery device and to engage the translational member as the translational member is moved distally along the tubular member of the delivery device, wherein distal movement of the translational member causes distal movement of the sheathing fingers, which thereby moves the outer sheath of the tubular member distally relative to the inner member and a crimped portion of the implantable device to thereby sheathe the crimped portion of the implantable device.

8. The delivery system of claim 7 , wherein the plurality of sheathing fingers are configured to engage and move the pod as the sheathing fingers are moved distally relative to the inner member.

9. The delivery system of claim 8 , wherein the delivery device further comprises a transition configured to couple the outer sheath and the pod, the transition molded to comprise a proximal end and a distal end, the proximal end having a smaller outer diameter approximately equal to a diameter of the outer sheath, the distal end having a larger outer diameter larger than the proximal end and approximately equal to a diameter of the pod.

10. The delivery system of claim 9 , wherein the pod is formed of two or more sheath layers including an outer sheath layer and one or more remaining sheath layers disposed coaxially within the outer sheath layer, and wherein the outer sheath layer of the pod is configured to be disposed over a distal portion of the transition.

11. The delivery system of claim 10 , wherein the two or more sheath layers of the pod are fused together and fused to the transition by reflowing and form a wall of the pod.

12. The delivery system of claim 9 , wherein the outer sheath is formed of two or more layers, including an outer layer and one or more remaining layers disposed coaxially within the outer layer, and wherein the outer layer of the outer sheath is configured to be disposed over a proximal portion of the transition.

13. The delivery system of claim 12 , wherein the two or more layers of the outer sheath are fused together and fused to the transition by reflowing.

14. The delivery system of claim 1 , wherein the implantable device comprises a metal scaffolding structure formed of a plurality of rows of struts oriented about a longitudinal axis to define an outer circumference of the implantable device and connected by a plurality of connectors extending longitudinally with the longitudinal axis of the implantable device.

15. The delivery system of claim 1 , wherein the implantable device is a stent comprising a valve and the partially sheathed configuration of the delivery device positions the valve in an unsheathed portion of the stent.

16. The delivery system of claim 1 , wherein the target location within the body of the patient is within a lumen.

17. A delivery system for sheathing a stent and deploying the stent within a body of a patient, the delivery system comprising:
a crimpable stent formed of a shape memory material;
a delivery device to position and deploy the stent within the body, the delivery device including a tubul

Assignees

• Merit Medical Systems Inc

Inventors

• Robinson Thomas Patrick

Classifications

• A61F2/0095

  Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02) · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2/95 Primary

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title