Implantable device deployment apparatus

• US 9,456,912 B2
• Filed: 10/30/2012
• Issued: 10/04/2016
• 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): Shi, Katherine M
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US13/664,267
• Publication Number:
  US 20130116772A1
• Time in Patent Office: 1,435 Days
• Field of Search: 623 111- 114
• 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 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 that receives and houses 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;

a panchor disposed within the tubular member and engaging a proximal portion of the implantable device in the partially sheathed configuration and the fully sheathed configuration, wherein the panchor provides a push surface, an anchor, and an opening, the push surface facing distally to abut a proximal facing surface of 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, the anchor positioned distal to the push surface to engage the implantable device at a position distal to the proximal end of 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; and

a distal inner segment comprising an elongate shaft, a tip disposed at a distal end of the elongate shaft, and a connection member disposed at a proximal end of the elongate shaft, the distal inner segment to be inserted at a distal end of the tubular member of the delivery device to position the tip at a distal end of the tubular member with the elongate shaft extending through a lumen of the implantable device and into the opening of the panchor, the opening of the panchor to receive and secure the distal inner segment by engaging the connection member.

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 the two or more segments are each rotatably coupled at a joint disposed distal to the push surface and comprising 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 includes an additional anchor positioned distal to the anchor.

5. The delivery system of claim 2, wherein each of the two or more segments include an additional push surface and an additional 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 comprising a proximally facing surface to engage an inner surface of the implantable device at a crimped proximal portion.

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 comprises a proximally facing surface that abuts 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 disposed orthogonal to a longitudinal axis of the implantable device to abut the 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 connection member comprises a barb having an orthogonal surface oriented orthogonal to the elongate shaft, and 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 the barb of the connection member as the barb is inserted into the opening of the panchor, wherein the deflectable tabs retract to abut the orthogonal surface of the barb and thereby restrict passage of the barb back out of the opening of the panchor.

14. 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.