Prosthetic valve having tapered tip when compressed for delivery

• US 8,137,398 B2
• Filed: 10/13/2008
• Issued: 03/20/2012
• Est. Priority Date: 10/13/2008
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kovalsky, Igor
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Swaminathan, Seema
• Application Number:
  US12/250,163
• Publication Number:
  US 20100094411A1
• Time in Patent Office: 1,254 Days
• Field of Search: 623/1.15, 623/1.24, 623/1.3, 623/1.31, 623/2.1, 623/2.12, 623/2.17
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis is configured to assume a compressed delivery state and an uncompressed implantation state. The prosthesis includes a support frame, which is shaped so as to define an upstream inlet having upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state. The prosthesis further includes a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

Claims

1. Assembly for delivering an aortic valve prosthesis through the vasculature of a subject, the assembly comprising:

a delivery tube; and

the valve prosthesis for attachment to a native aortic valve complex of a subject, the prosthesis configured to assume a compressed delivery state when placed partially within the delivery tube and while being passed through at least a portion of the vasculature of the subject that is remote from the aortic valve complex of the subject, and to assume an uncompressed implantation state when removed from the delivery tube, the prosthesis comprising;

a support frame, which extends partially outside of the delivery tube when the prosthesis assumes the compressed delivery state and while being passed through at least a portion of the vasculature of the subject that is remote from the aortic valve complex of the subject; and

a flexible prosthetic heart valve component, coupled to the support frame,

wherein the support frame is shaped so as to define an upstream inlet with respect to blood flow during systole, at least a portion of which extends outside of the delivery tube, and

wherein the upstream inlet comprises upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state.

2. The assembly according to claim 1, wherein the support frame has an axial length, and

wherein the portion of the upstream inlet that extends outside of the delivery tube has an axial length that is greater than 20% of an axial length of the support frame when the valve prosthesis assumes the compressed delivery state.

3. The assembly according to claim 1, wherein the upstream inlet has a greatest outer inlet diameter of at least 20 mm when the prosthesis assumes the uncompressed implantation state.

4. The assembly according to claim 1, wherein the upstream inlet has a greatest outer inlet diameter that is no greater than 6 mm when the prosthesis assumes the compressed delivery state.

5. The assembly according to claim 1,

wherein the support frame is shaped so as to define a downstream section that is configured to apply an upstream axial force to a downstream side of the native valve complex,

wherein the upstream inlet is configured to apply a downstream axial force on an upstream side of the native valve complex, and

wherein the valve prosthesis is configured such that the upstream and downstream axial forces together anchor the valve prosthesis to the native valve complex.

6. The assembly according to claim 1, wherein the entire upstream inlet extends outside of the delivery tube.

7. The assembly according to claim 1, wherein the portion of the upstream inlet has a greatest outer inlet diameter that is equal to an outer tube diameter of the delivery tube, when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube.

8. The assembly according to claim 1, wherein the portion of the upstream inlet has a greatest outer inlet diameter that is greater than an outer tube diameter of the delivery tube, when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube.

11. The assembly according to claim 1, wherein the portion of the inlet has a diameter that first increases along an upstream direction, and subsequently monotonically decreases along the upstream direction, when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube.

12. The assembly according to claim 11, wherein the upstream inlet has upstream-most elements that converge within 2 mm of a central longitudinal axis of the valve prosthesis when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube.

13. The assembly according to claim 11, wherein the prosthesis is shaped so as to define a downstream section, and a throat section between the downstream section and the portion of the inlet, and wherein a diameter of the prosthesis, when it assumes the compressed delivery state when placed partially within the delivery tube, decreases in the upstream direction from the downstream section to the throat section, and increases in the upstream direction from the throat section to the portion of the inlet.

14. The assembly according to claim 1, wherein the upstream inlet has upstream-most elements, and wherein the apparatus further comprises:

a neutral tube that is concentric with the delivery tube, wherein the valve prosthesis is partially held between the delivery tube and the neutral tube when the valve prosthesis assumes the compressed delivery state when partially placed in the delivery tube; and

a delivery tip, which is removably coupled to the neutral tube, and not coupled to the delivery tube, such that the upstream-most elements of the inlet rest against a downstream side of the delivery tip when the prosthesis assumes the collapsed delivery state.

15. The assembly according to claim 14, wherein the delivery tip has a length of less than 10 mm, and a maximum diameter of less than 4 mm.

16. The assembly according to claim 1, wherein

when the prosthesis assumes the uncompressed implantation state, the support frame is shaped so as to define two curved portions connected by an intermediary portion, shaped such that when the intermediary portion is subjected to an upstream axial force applied by the delivery tube when the prosthesis is placed partially within the delivery tube, resulting vector component forces compress the upstream inlet toward the central longitudinal axis.

9. Assembly for delivering an aortic valve prosthesis through the vasculature of a subject, the assembly comprising:

a delivery tube; and

the valve prosthesis for attachment to a native aortic valve complex of a subject, the prosthesis configured to assume a compressed delivery state when placed partially within the delivery tube and while being passed through at least a portion of the vasculature of the subject that is remote from the aortic valve complex of the subject, and to assume an uncompressed implantation state when removed from the delivery tube, the prosthesis comprising;

a support frame, which extends partially outside of the delivery tube when the prosthesis assumes the compressed delivery state and while being passed through at least a portion of the vasculature of the subject that is remote from the aortic valve complex of the subject; and

a flexible prosthetic heart valve component, coupled to the support frame,

wherein the support frame is shaped so as to define an upstream inlet with respect to blood flow during systole, at least a portion of which extends outside of the delivery tube,

wherein the upstream inlet comprises upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state, and

wherein the portion of the upstream inlet has a greatest outer inner diameter that is greater than an outer tube diameter of the delivery tube, when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube, and

further comprising an introducer sheath into which the delivery tube and valve prosthesis are placed, the introducer sheath having an inner sheath diameter less than the greatest outer inlet diameter (a) when the prosthesis assumes the compressed delivery state when placed partially within the delivery tube, and (b) before the valve prosthesis is placed into the introducer sheath.

10. The assembly according to claim 9, wherein the inner sheath diameter is no greater than 0.2 mm greater than the delivery tube outer diameter.