Delivery systems and methods of implantation for prosthetic heart valves

• US 10,639,182 B2
• Filed: 03/21/2018
• Issued: 05/05/2020
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tabor, Charles, Ryan, Timothy
• Primary Examiner(s): Rodjom, Katherine M
• Application Number:
  US15/927,841
• Publication Number:
  US 20180207013A1
• Time in Patent Office: 776 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system including an elongated body having a proximal end and a distal end, a driver mechanism positioned at the proximal end of the elongated body, an elongated threaded rod located axially distal to the driver mechanism, and a sheath including an elongated tubular portion having a hollow interior portion with a first diameter that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen.

Claims

1. A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system comprising:

a plurality of elongated stent engagement elements, wherein each stent engagement element includes a stent engagement portion for engagement with the implantable stented device;

a plurality of elongated sleeves, wherein each elongated sleeve surrounds a respective elongated stent engagement element, wherein the plurality of elongated sleeves and elongated stent engagement elements include a first position wherein each elongated sleeve surrounds a respective one of the stent engagement portions and a portion of the implantable stented device and a second position wherein each elongated sleeve is spaced proximally of the respective stent engagement portion;

an elongated sheath comprising a hollow interior portion, wherein with the elongated stent engagement elements and the elongated sleeves in the second position, the elongated sheath is configured such that advancement of the elongated sheath distally causes the stent engagement portions to move relative to a central longitudinal axis of the delivery system to disengage the stent engagement portions from the implantable stented device.

2. The delivery system of claim 1, wherein the stent engagement portion of each of the plurality of elongated stent engagement elements comprises an angled wire tip.

3. The delivery system of claim 1, wherein the stent engagement portions are configured to engage a first end of the implantable stented device.

4. The delivery system of claim 3, further comprising an elongated body including a distal tip, wherein the distal tip includes a hollow interior portion for compression and retention of a second end of the implantable stented device.

5. The delivery system of claim 4, further comprising a tip controller at a proximal end of the delivery system, wherein the tip controller is coupled to the tip to move the tip relative to the sheath for deployment of the second end of the implantable stented device.

6. The delivery system of claim 1, further comprising a stop mechanism at a proximal end of the delivery system for controlling axial movement of the sheath in a proximal direction.

7. The delivery system of claim 1, further comprising a self-expanding stented device disposed within the sheath in a delivery configuration.

8. The delivery system of claim 7, wherein the self-expanding stented device comprises a central lumen and a valve positioned within the central lumen.

9. The delivery system of claim 7, wherein the self-expanding stented device comprises a replacement prosthetic heart valve.

10. The delivery system of claim 7, wherein in the delivery configuration, a distal end of the sheath is adjacent a distal tip of the delivery system.

11. The delivery system of claim 10, wherein in the delivery configuration, the sheath retains a first end of the self-expanding stent device in a radially compressed configuration and the distal tip retains a second end of the self-expanding stent device in a radially compressed configuration.

12. The delivery system of claim 1, wherein the elongated stent engagement element comprises a wire.

13. The delivery system of claim 12, wherein the stent engagement portion of the elongated stent engagement element comprises an angle tip of the wire.

14. The delivery system of claim 1, wherein the advancement of the elongated sheath distally causes the stent engagement portions to move towards the central longitudinal axis of the delivery system to disengage the stent engagement portions from the implantable stented device.