Delivery systems and methods of implantation for prosthetic heart valves

• US 9,393,115 B2
• Filed: 01/23/2009
• Issued: 07/19/2016
• 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 R.
• Primary Examiner(s): RODJOM, KATHERINE MARIE
• Application Number:
  US12/358,789
• Publication Number:
  US 20090254165A1
• Time in Patent Office: 2,734 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/1.26
• US Class Current: 1/1
• 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:

an elongated body comprising a proximal end and a distal end comprising a tip;

a plurality of stent engagement elements, wherein each stent engagement element includes an elongated wire and an angled wire tip for engagement with the implantable stented device;

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

a driver mechanism positioned at the proximal end of the elongated body to axially translate the plurality of stent engagement elements from the first position to the second position, wherein the driver mechanism is axially translatable toward and away from the distal end of the elongated body;

an elongated threaded rod located axially distal to the driver mechanism; and

a sheath, at least a portion of which surrounds a portion of the elongated threaded rod, comprising 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, wherein with the stent engagement elements and the sleeves in the second position, the sheath is configured such that advancement of the sheath distally causes the angled wire tips to move towards a central longitudinal axis of the delivery system to disengage the angled wire tips from the implantable stented device.

2. The delivery system of claim 1, wherein the sheath further comprises a handle portion positioned axially proximal to the elongated tubular portion, wherein axial movement of the sheath is controllable with the handle portion.

3. The delivery system of claim 2, wherein the handle portion further comprises an internal threaded mechanism that is threadingly engageable with the threaded rod to provide incremental axial motion of the sheath relative to the proximal and distal ends of the elongated body.

4. The delivery system of claim 3, wherein the handle portion further comprises a control feature for releasing the inner threaded mechanism of the handle portion from its threaded engagement with the threaded rod to allow the sheath to slide axially along the elongated threaded rod.

5. The delivery system of claim 4, wherein the control feature comprises a push-button.

6. The delivery system of claim 3, wherein the handle portion further comprises a control feature for alternatively releasing the inner threaded mechanism of the handle portion from its threaded engagement with the threaded rod and engaging the threaded mechanism of the handle portion with the threaded rod.

7. The delivery system of claim 2, wherein the handle portion is rotatable about a longitudinal axis of the delivery system for axial movement of the sheath relative to the proximal and distal ends of the elongated body.

8. The delivery system of claim 7, wherein the sheath is rotatable with the handle portion.

9. The delivery system of claim 7, wherein the sheath is independently rotatable relative to the handle portion.

10. The delivery system of claim 1, wherein the tip of the distal end of the elongated body comprises a hollow interior portion for compression and retention of a distal end of a stented device.

11. The delivery system of claim 10, further comprising a tip controller at the proximal end of the elongated body for deployment of a distal end of a stented device.

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

13. The delivery system of claim 1 in combination with a self-expanding stented device.

14. The combination of claim 13, wherein the stented device comprises a central lumen and a valve positioned within the central lumen.

15. The combination of claim 13, wherein the stented device comprises a replacement prosthetic heart valve.

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

an elongated body comprising a proximal end and a distal end comprising a tip;

a driver mechanism positioned at the proximal end of the elongated body;

an elongated threaded rod located axially distal to the driver mechanism;

a sheath comprising an elongated tubular portion having a hollow interior portion that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen;

a plurality of stent engagement mechanisms, each of which is axially translatable from a distal end of the sheath by the driver mechanism and each of which includes a first portion and a second portion that extends outwardly at an angle from the first portion so that a distal end of the second portion is outwardly projecting from the first portion of its respective stent engagement mechanism, wherein the second portion of each engagement mechanism is engageable with a proximal end of a stented device; and

a plurality of sleeves surrounding the stent engagement mechanisms;

wherein movement of the driver mechanism in a proximal direction and a distal direction causes movement of the stent engagement mechanisms between a stent engagement position wherein each sleeve surrounds the second portion of a respective one of the stent engagement mechanisms and a portion of the implantable stent device and a stent deployment position wherein the second portion of each stent engagement mechanism is spaced axially distal of each respective sleeve, respectively,

wherein with the stent engagement mechanisms in the stent deployment position, movement of the sheath distally causes the stent engagement mechanisms to move toward a central axis of the elongated body such that the second portions of the stent engagement mechanisms disengage from the implantable stented device.

17. The delivery system of claim 16, wherein the second portion of each of the stent engagement mechanisms extends at an approximate 90 degree angle from the first portion of its respective stent engagement mechanism.