Systems and methods for sheathing an implantable device

• US 9,192,496 B2
• Filed: 10/30/2012
• Issued: 11/24/2015
• Est. Priority Date: 10/31/2011
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Robinson, Thomas Patrick
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/664,200
• Publication Number:
  US 20130116770A1
• Time in Patent Office: 1,120 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

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.

Claims

1. A delivery system to sheathe a stent and deploy the stent within a lumen of a body of a patient, the delivery system comprising:

a delivery device that is configured to deploy a stent within the lumen of the body of a patient, the delivery device including a tubular member that comprises an outer sheath and an inner member;

a translational member that is axially displaceable relative to the tubular member of the delivery device, the translational member comprising a tapered member disposed at a distal end of the translational member to translate axial movement of the translational member in a distal direction along the tubular member into radial force to compress and thereby crimp an unsheathed portion of the stent; and

a plurality of sheathing fingers configured to crimp and sheathe an unsheathed portion of the stent, 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 plurality of sheathing fingers, which engage the outer sheath of the tubular member to move the outer sheath distally relative to a crimped portion of the stent to thereby sheathe the crimped portion of the stent.

2. The delivery system of claim 1, wherein each of the plurality of sheathing fingers comprise a base portion and a flared portion, the base portions configured to engage and move a distal portion of the tubular member of the delivery device distally over a crimped portion of the stent to sheathe the stent as the sheathing fingers are displaced distally relative to the stent by the translational member, the flared portions configured to extend distally from the base portions, to extend distally beyond a distal end of the tubular member of the delivery device and along a length of an unsheathed portion of the stent, and to be arranged about an outer diameter of the unsheathed portion of the stent to interact with the tapered member and to receive the radial force of the tapered member to crimp the unsheathed portion of the stent upon interaction with the tapered member as the translational member is moved in the distal direction along the tubular member.

3. The delivery system of claim 1, wherein the translational member comprises:

a sheathing tube having a lumen there through with an inner diameter configured to be positioned over an outer diameter of a distal portion of the tubular member of the delivery device, wherein the sheathing tube is slidably moveable relative to the tubular member;

a sheathing funnel disposed at a distal end of the sheathing tube, the sheathing funnel comprising the tapered member, the sheathing funnel having an internal taper and ribs that interact with the plurality of sheathing fingers and the stent during sheathing to guide the stent and the plurality of sheathing fingers into the sheathing tube to crimp the stent.

4. The delivery system of claim 3, wherein the plurality of sheathing fingers are configured to engage at least one of the sheathing funnel or the sheathing tube as the sheathing tube is moved distally along the tubular member of the delivery device, wherein distal movement of the sheathing tube causes distal movement of the sheathing fingers, which thereby moves the distal portion of the tubular member distally relative to a crimped portion of the stent to thereby sheathe the crimped portion of the stent.

5. The delivery system of claim 1, wherein the stent comprises a metal scaffolding structure that does not substantially elongate when crimped and that includes a valve.

6. The delivery system of claim 1, further comprising a crimpable stent to be sheathed and deployed by the delivery system.

7. The delivery system of claim 6, wherein the crimpable stent comprises a valve configured to be disposed in an unsheathed and uncrimped portion of the stent prior to sheathing the stent into the delivery device.

8. The delivery system of claim 1, wherein the tubular member of the delivery device comprises a pod disposed at a distal end of the tubular member, the pod configured to receive and enclose the stent in a crimped state, wherein the plurality of sheathing fingers are configured to engage and move the pod as the sheathing fingers are moved distally relative to the stent.

9. The delivery system of claim 8, wherein each of the plurality of sheathing fingers comprise a base portion and a flared portion, the base portion configured to engage and move the pod as the plurality of sheathing fingers are moved distally relative to the stent, the flared portion configured to engage the translational member as the translational member is moved distally along the tubular member of the delivery device, the flared portion further configured to crimp an unsheathed portion of the stent as the flared portion is drawn into the translational member.

10. The delivery system of claim 1, further comprising:

a distal inner segment comprising an elongate shaft configured to be positioned through a lumen of the stent to couple to the inner member of the tubular member of the delivery device; and

a tip coupled to the distal inner segment and configured to be positioned at a distal end of the tubular member of the delivery device and a distal end of the stent in a crimped and fully sheathed state.

11. The delivery system of claim 10, further comprising a tip insertion funnel configured to couple to a distal end of the plurality of sheathing fingers, wherein the tip insertion funnel is configured to guide insertion of the distal inner segment through the lumen of the stent.

12. The delivery system of claim 11, 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.