Prosthetic Valve for Transluminal Delivery

• US 20110213461A1
• Filed: 05/10/2011
• Published: 09/01/2011
• Est. Priority Date: 11/17/1999
• Status: Active Grant

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: BÖRTLEIN, Georg, SEGUIN, Jacques
• Granted Patent: US 8,801,779 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

Claims

1. A prosthetic device for replacing a deficient native aortic valve, the valve assembly comprising:

a collapsible and expandable annular support stent formed of a shape memory alloy and having a circular outer profile, the support stent comprising a first portion having a first expanded diameter and a second portion having a second expanded diameter, the second portion being downstream from the first portion, the second expanded diameter being substantially larger than the first expanded diameter, the support stent further comprising a central portion between the first and second portions, the central portion having a diameter sized to provide a radial gap between the support stent and the inner wall of the ascending aorta at the level of the openings of the coronary arteries; and

a collapsible and expandable valve assembly formed of biological material, the valve assembly located entirely within an interior portion of the support stent, the valve assembly having three valve leaflets and three commissural points sutured to the support stent for supporting the three valve leaflets;

wherein

the first portion of the support stent is sized for contacting the leaflets of the native aortic valve,

the second portion of the support stent is sized for contacting the inner wall of the ascending aorta at a location above the openings of the coronary arteries,

an expanded diameter of the first portion of the support stent is smaller than an expanded diameter of the second portion of the support stent, and

the support stent is formed with an open wall structure downstream of the valve assembly for allowing blood to pass through a wall of the support stent from the interior portion of the support stent to the openings of the coronary arteries.

2. The prosthetic device of claim 1, wherein the shape memory alloy is nickel titanium.

3. The prosthetic device of claim 1, wherein the support stent is formed with an expandable mesh construction.

4. The prosthetic device of claim 1, wherein the mesh construction is web-like.

5. The prosthetic device of claim 1, wherein the three valve leaflets are spaced apart from an inlet end of the support stent.

6. The prosthetic device of claim 1, wherein the support stent is collapsible to a delivery diameter sized for advancement through a femoral artery.

7. The prosthetic device of claim 1, further comprising a collapsible and expandable sheath sutured to the first portion of the support stent.

8. A prosthetic device for replacing a deficient native aortic valve, comprising:

a metallic, annular support stent having a circular outer profile and collapsible to a delivery diameter sized for advancement through a femoral artery, the support stent comprising a lower portion formed with an expandable mesh construction and having a first expanded diameter dimensioned to contact the leaflets of a native aortic valve, the support stent having an upper portion formed with an expandable mesh construction and having a second expanded diameter dimensioned to contact the inner wall of an ascending aorta in an adult human, the support stent further comprising a central portion between the lower and upper portions, the central portion being shaped to provide a radial gap between the support stent and the inner wall of the ascending aorta adjacent to the openings of the coronary arteries; and

a collapsible and expandable valve assembly located entirely within an interior portion of the support stent and formed of biological material, the valve assembly sutured to the support stent, the valve assembly having three commissural points for supporting three valve leaflets within the support stent;

wherein the three leaflets of the valve assembly are configured to open for allowing blood to flow from the left ventricle into the ascending aorta, and wherein the three leaflets of the valve assembly collapse inwardly for blocking a reverse flow of blood and wherein the support stent has an open wall structure downstream of the leaflets for allowing blood to pass through a wall of the support stent from the interior portion of the support stent to the openings of the coronary arteries, and

wherein an expanded diameter of the lower portion of the support stent is smaller than an expanded diameter of the upper portion of the support stent.

9. The prosthetic device of claim 8, wherein the metallic support stent is formed of a shape memory alloy.

10. The prosthetic device of claim 9, wherein the shape memory alloy is nickel titanium.

11. The prosthetic device of claim 8, further comprising a collapsible and expandable sheath sutured to the lower portion of the support stent.

12. The prosthetic device of claim 8, wherein the three valve leaflets are spaced apart from an inlet end of the support stent.

13. A prosthetic device for replacing a deficient native aortic valve, consisting essentially of:

a collapsible and expandable, annular support stent comprising a nickel-titanium shape memory alloy, the support stent comprising a circular outer profile, a first portion, a second portion, and a central portion extending between the first portion and the second portion, the second portion being downstream from the first portion;

a collapsible and expandable valve assembly comprising biological material and disposed within an interior of the support stent, the valve assembly comprising an inlet region, sutured to the support stent and three commissural points sutured to the support stent, the three commissural points defining three valve leaflets; and

a collapsible and expandable sheath disposed at and sutured to the first portion of the support stent;

wherein the prosthetic device has a collapsed, delivery state and an expanded, deployed state,

wherein, in the expanded, deployed state,

an expanded diameter of the first portion of the support stent is smaller than an expanded diameter of the second portion of the support stent,

the first portion of support stent is dimensioned to contact the leaflets of the native aortic valve,

the first portion of the support stent is dimensioned to not substantially deform a neighboring mitral valve,

the central portion of the support stent defines a radial gap between the support stent and an inner wall of an ascending aorta at a level of the coronary ostia,

the second portion of the support stent is dimensioned to engage the inner wall of the ascending aorta above the coronary ostia,

the support stent comprises an open-wall structure downstream of the valve assembly, thereby allowing blood to pass from the interior of the support stent to the coronary ostia, and

the three leaflets of the valve assembly have an open state that allows a forward flow of blood from the left ventricle into the ascending aorta, and a closed state that blocks a reverse flow of blood, in which the three leaflets are collapsed inwardly, and

wherein in the collapsed, delivery state, the device is dimensioned for advancement through a femoral artery.

14. The prosthetic device of claim 13, wherein the support stent comprises an expandable mesh construction.

15. The prosthetic device of claim 14, wherein the mesh construction is web-like.

16. The prosthetic device of claim 13, wherein the sheath is secured to an outside surface of the support stent.