Delivery Systems and Methods of Implantation for Prosthetic Heart Valves

• US 20090254165A1
• Filed: 01/23/2009
• Published: 10/08/2009
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Tabor, Charles
• Granted Patent: US 9,393,115 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 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 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.

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 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.

5. The delivery system of claim 4, wherein the sheath is rotatable with the handle portion.

6. The delivery system of claim 4, wherein the sheath is independently rotatable relative to the handle portion.

7. 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

8. The delivery system of claim 7, wherein the control feature comprises a push-button.

9. 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.

10. The delivery system of claim 1, wherein the delivery system further comprises a plurality of stent engagement mechanisms that are engageable with a proximal end of a stented device, and a driver mechanism for movement of the stent engagement mechanisms between a stent engagement position and a stent deployment position.

11. The delivery system of claim 10, wherein the stent engagement mechanisms comprise a plurality of wires having distal ends that are engageable with a proximal end of a stented device.

12. The delivery system of claim 11, wherein the stent engagement mechanisms are moveable toward a central axis of the elongated body to the stent deployment position.

13. 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.

14. The delivery system of claim 13, further comprising a tip controller at the proximal end of the elongated body for deployment of a distal end of a stented device.

15. The delivery device of claim 11, further comprising a plurality of tubular sleeves, wherein each wire is at least partially positioned within one of the tubular sleeves.

16. The delivery device of claim 15, wherein the distal end of each wire is extendible beyond a distal end of its respective sleeve, and wherein each wire is axially moveable relative to its respective sleeve.

17. 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.

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

19. The combination of claim 18, wherein the stented device comprises a central lumen and a valve positioned within the central lumen.

20. The combination of claim 18, wherein the stented device comprises a replacement prosthetic heart valve.