IMPLANTABLE DEVICE DEPLOYMENT APPARATUS

• US 20130116772A1
• Filed: 10/30/2012
• Published: 05/09/2013
• 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
• Granted Patent: US 9,456,912 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 having a tubular member 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 panchor disposed within the tubular member and configured to engage a proximal portion of the implantable device in the partially sheathed configuration and the fully sheathed delivery configuration, wherein the panchor provides a push surface and an anchor, the push surface configured to abut the implantable device and limit proximal movement of the implantable device relative to the panchor during deployment as the delivery device transitions from the fully sheathed delivery configuration to the deployed configuration and the anchor configured to engage the implantable device and limit distal movement of the implantable device relative to the panchor during sheathing as the delivery device transitions from the partially sheathed configuration to the fully sheathed delivery configuration.

2. The delivery system of claim 1, wherein the panchor comprises two or more segments rotatably coupled together to allow the panchor to be flexible.

3. The delivery system of claim 2, wherein each joint between the two or more segments of the panchor comprises a ball and socket joint, a first segment comprising a socket portion of the ball and socket joint and a second segment comprising a ball portion of the ball and socket joint.

4. The delivery system of claim 2, wherein the two or more segments include a base segment and one or more extension segments, wherein the base segment includes the push surface and the anchor, and wherein each of the one or more extension segments include an additional anchor.

5. The delivery system of claim 2, wherein each of the two or more segments include a push surface and an anchor.

6. The delivery system of claim 1, wherein the anchor of the panchor comprises a flange at a distal end of the panchor, the flange configured to be positioned within a proximal portion of a lumen of the implantable device and to engage an inner wall of the implantable device of a crimped proximal portion of the implantable device.

7. The delivery system of claim 1, wherein the anchor of the panchor comprises a plurality of protrusions about a circumference of a distal end of the panchor, the plurality of protrusions configured to be positioned within a proximal portion of a lumen of the implantable device and to engage an inner surface of the implantable device at a crimped proximal portion of the implantable device.

8. The delivery system of claim 1, wherein the anchor comprises a pentagon-shaped annular flange having five apices.

9. The delivery system of claim 8, wherein each of the five apices of the anchor is configured to be positioned between connectors of a scaffolding structure of the implantable device that interconnect annular segments in the scaffolding structure of the implantable device.

10. The delivery system of claim 1, wherein the anchor is configured to abut a distal end of a row of struts forming a scaffolding structure of the implantable device to limit distal movement of the implantable device relative to the panchor.

11. The delivery system of claim 1, wherein the push surface of the panchor is configured to abut a crimped proximal end of the implantable device when the implantable device is in a crimped or partially crimped state.

12. The delivery system of claim 1, wherein the panchor comprises a lumen defined there through to pass over a guidewire.

13. The delivery system of claim 1, wherein the panchor comprises an opening configured to receive and permanently secure a connection member of a distal inner segment of an inner member of the tubular member of the delivery device, wherein the distal inner segment comprises an elongate shaft configured to be inserted through a lumen of the implantable device and having the connection member disposed at a proximal end and a tip disposed at a distal end, and wherein the distal inner segment is inserted from a distal end of the tubular member of the delivery device into the opening of the panchor.

14. The delivery system of claim 13, wherein the opening of the panchor includes one or more deflectable tabs configured to deflect in response to contact with a tapered or ramped surface of a barb of the connection member, wherein the deflectable tabs retract to abut an orthogonal surface of the barb and thereby restrict passage of the barb back out of the opening.

15. The delivery system of claim 1, wherein the tubular member of the delivery device comprises:

an inner assembly to couple to the implantable device in the partially sheathed configuration and the fully sheathed delivery configuration, wherein the panchor is disposed at a distal end of the inner assembly; and

an outer sheath coaxially surrounding at least a distal portion of the inner assembly, including the panchor, and having a distal portion configured to enclose the panchor and the implantable device in the fully sheathed delivery configuration, wherein the outer sheath is slidably moveable relative to the inner assembly and the panchor, and wherein proximal movement of the outer sheath relative to the inner assembly deploys the implantable device.

16. A panchor deployment apparatus configured to be disposed in a tubular member of a delivery device for sheathing a crimpable implantable device and deploying the implantable device within a body of a patient, the panchor deployment apparatus comprising:

a base segment having a cylindrical shape and configured to be disposed within the tubular member of the delivery device and at least partially within a lumen of the implantable device;

a push surface disposed orthogonal to a surface of the base segment and configured to abut a proximal end of the implantable device to limit proximal movement of the implantable device relative to the panchor deployment apparatus during deployment as the delivery device transitions from the fully sheathed delivery configuration to the deployed configuration; and

an anchor configured to engage the implantable device and limit distal movement of the implantable device relative to the panchor during sheathing as the delivery device transitions from the partially sheathed configuration to the fully sheathed delivery configuration.

17. The panchor deployment apparatus of claim 16, further comprising one or more extension segments coupled to and extending distally from a distal end of the base segment, wherein the base segment includes the push surface and the anchor, and wherein each of the one or more extension segments includes an additional anchor.

18. The panchor deployment apparatus of claim 17, further comprising ball and socket joints to couple the base segment and a first extension segment and also to couple each of the one or more extension segments to each other.

19. The panchor deployment apparatus of claim 16, wherein the anchor comprises a flange at a distal end of the panchor, the flange configured to be positioned within a proximal portion of a lumen of the implantable device and to engage an inner wall of the implantable device at a crimped proximal portion of the implantable device.

20. The panchor deployment apparatus of claim 16, wherein the anchor comprises a plurality of protrusions about a circumference of a distal end of the panchor deployment apparatus, the plurality of protrusions configured to be positioned within a proximal portion of a lumen of the implantable device and to engage an inner surface of the implantable device at a crimped proximal portion of the implantable device.