Prosthetic heart valve

• US 10,631,978 B2
• Filed: 04/17/2014
• Issued: 04/28/2020
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Strait Access Technologies Holdings (Pty) Ltd.
• Original Assignee: Strait Access Technologies Holdings (Pty) Ltd.
• Inventors: Park, Kenneth Stuart, Appa, Harish, Visagie, Claude, Bezuidenhout, Deon, Zilla, Peter Paul
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US14/784,568
• Publication Number:
  US 20160067038A1
• Time in Patent Office: 2,203 Days
• CPC Class Codes: A61F 2/2406 without fixed axis
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents

Abstract

A prosthetic heart valve (10) which includes a stent (14) having three leaflets (12) attached thereto is provided. The stent (14) is compressible so as to be capable of being introduced into a patient'"'"'s body through a minimally invasive procedure and has a ring-like body (16) defining in its height three arch-shaped elements (18). Each element (18) includes an arc (20) and a pair of haunches (22) extending from opposite sides thereof, with three commissural posts (26) formed by the haunches (22) of adjacent elements (18). The leaflets (12) each have an attachment edge (28) and a free edge (30) with a belly (32) extending therebetween. The leaflets (12) are movable between a coapted condition, in which the free edges (30) abut and prevent fluid flow through the valve (10), and an open condition, in which fluid flow through the valve (10) is permitted. The leaflets (12) are made from a polymeric material and are moulded directly onto the stent (14) so as to provide for continuous attachment thereof.

Claims

1. A prosthetic heart valve which includes a stent having three leaflets attached thereto, the stent being compressible to a compressed condition in which it is capable of being introduced into a patient'"'"'s body through a minimally invasive procedure and further being expandable from the compressed condition to an operative condition during deployment of the valve within the patient'"'"'s body, the stent having a ring-like body with an inlet and an outlet and defining in its height three arch-shaped elements each of which has an arc and a pair of haunches extending from opposite sides thereof, with three commissural posts formed by the haunches of adjacent arch-shaped elements,

wherein primary reinforcing members are provided that span between adjacent commissural posts of the arch-shaped elements and which act to strengthen the stent so as to support the leaflets during operation of the valve, and wherein secondary reinforcing members extend between the haunches of adjacent arch-shaped elements, wherein the secondary reinforcing members are spaced apart along the length of the haunches, and additional reinforcing members provided below the arcs of the arch-shaped elements which assist in securing the stent within the valve annulus and further assist in maintaining the arch-shape of the arch-shaped elements during compression and expansion of the valve so as to ensure that the valve is able to return to its operative condition after compression thereof, and

wherein the width of the arch-shaped elements varies along their length with the arcs and peaks at the ends of the haunches being wider than the remainder of the arch-shaped elements, the variation in width ensuring that stresses in the arch-shaped elements are kept at a minimum during expansion and compression of the stent while ensuring that the stent is capable of returning to its operative condition after compression and expansion thereof,

each leaflet having an attachment edge and a free edge with a belly extending between the free edge and the attachment edge, the leaflets being movable between an open condition, in which fluid flow through the valve is permitted in a direction from the inlet to the outlet, and a coapted condition, in which the free edges abut and prevent fluid flow through the valve in an opposite direction from the outlet to the inlet, wherein the leaflets are made from a polymeric material and are attached to the stent by moulding to thereby encapsulate the arch-shaped elements so that the attachment edge of each leaflet is continuously attached along the length of an arch-shaped element, and

wherein the arch-shape is defined by a parametric curve and its mirror image along the z-axis which is wrapped about a cylinder having a diameter of the prosthetic heart valve, with the parametric curve being defined by a function A(x)=(1−

x)³P₀+3(1−

x)²xP₁+3(1−

x)x²P₂+x³P₃, with P₀ to P₃ being control points, wherein P₀ and P₃ are selected on the basis of the diameter and height of prosthetic heart valve, and wherein P₁ is selected from the range of 0≤

z≤

H and P₂ is selected from the range 0≤

x≤

π

D/6 where H is the height and D the diameter of the prosthetic heart valve.

2. A prosthetic heart valve as claimed in claim 1, wherein the shape of the free edge of the leaflets is defined by three curves defined by functions y=mx with −

c_b≤

x<

−

c_b+x_s, y=K cos(Lx)+t with −

c_b+x_s≤

x<

c_b−

x_s, and y=−

mx with c_b−

x_s≤

x≤

c_b with c_b being defined as the end points of the free edge, x_s being a function of the straight line portion of the free edge where the free edge is secured to the commissural posts, the constant m being in the range of 0.1 to 1, the constant K being in the range of −

3 to 0, the constant L being in the range of 0.05 to 1.5, and the constant t being in chosen such that the end points of the three curves meet each other.

3. A prosthetic heart valve as claimed in claim 1, wherein the belly is defined by a parametric curve in a two dimensional x-y plane, with the parametric curve being defined by a function B(x)=(1−

x)³P₀+3(1−

x)²xP₁+3(1−

x)x²P₂+x³P₃, with P₀ to P₃ being control points, wherein P₂ and P₃ remain constant, and wherein P₀ is selected from the range of 0.3D≤

P_0x≤

0.5D and 0.5H≤

P_0y≤

0.8H and P₁ is selected from the range 0.4D≤

P_1x≤

0.6D and 0.3H≤

P_1y≤

0.8H where H is the height and D the diameter of the prosthetic heart valve.

4. A prosthetic heart valve as claimed in claim 1, wherein one or more openings are provided between the haunches of adjacent arch-shaped elements.

5. A prosthetic heart valve as claimed in claim 1, wherein the stent includes biasing members capable of at least partial elastic deformation during compression of the valve and which act on adjacent haunches to bias the haunches from the compressed condition to the operative condition.

6. A prosthetic heart valve as claimed in claim 1, wherein the valve includes locating members which extend outwardly from the body of the stent to locate the valve within a natural heart valve of a patient during deployment thereof.

7. A prosthetic heart valve as claimed in claim 1, wherein the primary reinforcing members are configured to secure the stent within a valve annulus.

8. A prosthetic heart valve as claimed in claim 1, wherein the leaflets are manufactured from a polymeric material and attached to the stent by a spray moulding process comprising:

pre-moulding the leaflets to an intermediate thickness by spray coating a mould;

pre-coating the stent with the same or a similar polymeric material used for the leaflets by spray coating the stent; and

placing the pre-coated stent onto the mould and providing a final spray coat to the leaflets and the stent so as to increase the leaflet thickness to a desired final thickness and encapsulate the complementary shaped arch-shaped element of the stent to thereby ensure that the attachment edge of each leaflet is continuously attached along the length of the complementary shaped attachment surface of the stent.

9. A prosthetic heart valve as claimed in claim 8, wherein the mould is rotated during drying of the polymeric material so as to ensure that no droplets are formed.

10. A stent for a prosthetic heart valve, the stent configured to house three polymeric leaflets and being compressible to a compressed condition, in which it is capable of being introduced into a patient'"'"'s body through a minimally invasive procedure and further being expandable from the compressed condition to an operative condition during deployment of the valve within the patient'"'"'s body, the stent having a ring-like body with an inlet and an outlet and defining in its height three arch-shaped elements each of which having an arc and a pair of haunches extending from opposite sides thereof, with three commissural posts formed by the haunches of adjacent arch-shaped elements,

wherein primary reinforcing members are provided that span between adjacent commissural posts of the arch-shaped elements and which act to strengthen the stent so as to support the leaflets during operation of the valve, and wherein secondary reinforcing members extend between the haunches of adjacent arch-shaped elements, wherein the secondary reinforcing members are spaced apart along the length of the haunches, and additional reinforcing members provided below the arcs of the arch-shaped elements which assist in securing the stent within the valve annulus and further to assist in maintaining the arch-shape of the arch-shaped elements during compression and expansion of the valve so as to ensure that the valve is able to return to its operative condition after compression thereof, and

wherein the width of the arch-shaped elements varies along their length with the arcs and peaks at the ends of the haunches being wider than the remainder of the arch-shaped elements, the variation in width ensuring that stresses in the arch-shaped elements are kept at a minimum during expansion and compression of the stent while ensuring that the stent is capable of returning to its operative condition after compression and expansion thereof,

wherein each arch-shaped element provides an attachment zone along which an attachment edge of a leaflet can be continuously attached to the stent, and

wherein the arch-shape is defined by a parametric curve and its mirror image along the z-axis which is wrapped about a cylinder having a diameter of the prosthetic heart valve, with the parametric curve being defined by a function A(x)=(1−

x)³P₀+3(1−

x)²xP₁+3(1−

x)x²P₂+x³P₃, with P₀ to P₃ being control points, wherein P₀ and P₃ are selected on the basis of the diameter and height of prosthetic heart valve, and wherein P₁ is selected from the range of 0≤

z≤

H and P₂ is selected from the range 0≤

x≤

π

D/6 where H is the height and D the diameter of the prosthetic heart valve.

11. A stent as claimed in claim 10, wherein the stent includes biasing members capable of at least partial elastic deformation during compression of the stent and which act on adjacent haunches to bias the haunches from the compressed condition to the operative condition.

12. A stent as claimed in claim 10, wherein the stent includes locating members which extend outwardly from the body of the stent to locate the stent within a natural heart valve of a patient during deployment thereof.

13. A stent for a prosthetic heart valve as claimed in claim 10, wherein one or more openings are provided between the haunches of adjacent arch-shaped elements.

14. A stent as claimed in claim 10, wherein the primary reinforcing members are configured to secure the stent within a valve annulus.