Delivery systems and methods for sheathing and deploying an implantable device

• US 9,681,969 B2
• Filed: 10/30/2012
• Issued: 06/20/2017
• 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): Tyson, Melanie
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US13/664,137
• Publication Number:
  US 20130123897A1
• Time in Patent Office: 1,694 Days
• Field of Search: 623 111, 623 112, 623 115, 623 123, 606194, 606108, 606198, 606200, 29225
• 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 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 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 stent 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 configured to engage 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 stent, 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 stent and moves the outer sheath of the tubular member distally relative to a crimped portion of the stent to sheathe the stent as the delivery device transitions from the partially sheathed configuration to the fully sheathed delivery configuration, 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 stent in the crimped state.

18. The delivery system of claim 17, wherein the sheathing mechanism comprises:

a plurality of sheathing fingers each having a flared portion including the ramped surface and a base portion, the flared portions configured to extend distally from the base portion and beyond a distal end of the outer sheath and extend along a length of an unsheathed portion of the stent, such that the flared portions are arranged about an outer diameter of the unsheathed portion of the stent, wherein the flared portions are configured to crimp the unsheathed portion of the stent as they are drawn into the sheathing mechanism, the base portions configured to engage and move a portion of the tubular member of the delivery device distally over a crimped portion of the stent to sheathe the stent as the base portions are moved distally relative to the stent; 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 stent, the translational member configured to engage and move the plurality of sheathing fingers distally relative to the stent as the translational member is moved in the distal direction along the tubular member.

19. The delivery system of claim 18, wherein the translational member of the sheathing mechanism comprises:

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

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.

20. The delivery system of claim 17, wherein the stent comprises a metal scaffolding structure that does not substantially elongate when crimped and that includes a valve.

21. The delivery system of claim 20, wherein the scaffolding structure of the stent is formed of a plurality of rows of struts oriented about a longitudinal axis to define an outer circumference of the stent and connected by a plurality of connectors extending longitudinally with the longitudinal axis of the stent.

22. The delivery system of claim 17, wherein the tubular member of the delivery device comprises:

an inner member to couple to the stent in the crimped state; 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 stent 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 stent.

23. The delivery system of claim 22, wherein the tubular member of the delivery device further comprises:

a transition molded to comprise a proximal end having a smaller outer diameter approximately equal to an outer diameter of the outer sheath and a distal end having a larger outer diameter larger than the proximal end and approximately equal to an outer diameter of the pod, the pod having an outer diameter that is larger than the outer diameter of the outer sheath, the transition configured to couple the outer sheath and the pod.

24. The delivery system of claim 22, wherein the inner member of the tubular member of the delivery device further comprises:

a panchor configured to couple to a proximal portion of the stent in a partially sheathed configuration and a fully sheathed delivery configuration, wherein the panchor is a combination pusher and anchor configured to limit proximal and distal movement of the stent.

25. A method for deploying an implantable device at a target location within a body of a patient, the method comprising:

positioning a sheathing mechanism at a distal region of a tubular member of a delivery device, the sheathing mechanism comprising a plurality of sheathing fingers to engage an outer sheath of the tubular member and a translational member that is axially displaceable relative to the tubular member of the delivery device and relative to the plurality of sheathing fingers and that interacts with the plurality of sheathing fingers to translate axial movement of the translational member in a distal direction along the tubular member into radial force to compress and thereby crimp the implantable device, wherein the delivery device is in a partially sheathed configuration having an implantable device partially unsheathed and partially sheathed at a distal end of the tubular member;

grasping with a first hand the translational member of the sheathing mechanism;

grasping with a second hand the delivery device;

advancing the translational member of the sheathing mechanism in a distal direction with the first hand, and away from the second hand grasping the delivery device, while restraining distal movement of the delivery device, thereby moving the plurality of sheathing fingers of the sheathing mechanism distally relative to the implantable device and over the implantable device and causing the sheathing mechanism to translate axial distal movement along the tubular member into radial force that compresses and thereby crimps the implantable device and to move the distal region of the outer sheath of the tubular member of the delivery device over the crimped implantable device to fully sheathe the implantable device;

positioning the distal region of the tubular member of the delivery device with the crimped and sheathed implantable device within the body of the patient at a target location; and

deploying the implantable device from the delivery device at the target location.

26. The method of claim 25, further comprising:

positioning a guidewire through a lumen of the body of the patient to the target location,

wherein positioning the distal region of the tubular member of the delivery device within the body of the patient and at a target location comprises advancing the delivery, including the implantable device, over the guidewire.

27. The method of claim 25, further comprising:

removing the sheathing mechanism from the distal region of the tubular member of a delivery device after advancing the sheathing mechanism in the distal direction to fully sheathe the implantable device.

28. The method of claim 25, wherein the translational member comprises a lumen with an inner diameter configured to be positioned around an outer diameter of the distal region of the tubular member of the delivery device,

wherein positioning the sheathing mechanism includes positioning the sheathing mechanism such that the tubular member of the delivery device is positioned through the lumen of the translational member.

29. The method of claim 28, wherein the sheathing mechanism comprises:

a sheathing tube forming the lumen of the sheathing mechanism, wherein the sheathing tube is slidably moveable relative to the outer sheath of the tubular member of the delivery device; and

a sheathing funnel disposed at a distal end of the sheathing tube, the sheathing funnel having an internal taper and ribs that interact with the plurality of sheathing fingers and the implantable device during sheathing to guide the plurality of sheathing fingers into the sheathing tube and to crimp the implantable device, and

wherein positioning the sheathing mechanism further comprises;

positioning the sheathing tube and sheathing funnel over the distal region of the tubular member of the delivery device; and

arranging the plurality of sheathing fingers around and in engagement with the outer sheath at the distal region of the tubular member of the delivery device and with flared portions of the sheathing fingers disposed around the outer diameter of the unsheathed portion of the implantable device,

wherein the sheathing tube is configured to engage the sheathing fingers of the sheathing mechanism to move the outer sheath over the crimped implantable device as the sheathing tube is moved distally relative to and over the implantable device to sheath the implantable device.

30. The method of claim 25, wherein positioning the sheathing mechanism further comprises inserting a distal inner segment through a lumen of the implantable device to couple to an inner member of the delivery device, wherein a tip is coupled to the distal inner segment.

31. The method of claim 30, wherein positioning the sheathing mechanism further comprises coupling a tip insertion funnel 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 implantable device.