WO2014165010A1

WO2014165010A1 - Tubular scaffold for fabrication of heart valves

Info

Publication number: WO2014165010A1
Application number: PCT/US2014/024125
Authority: WO
Inventors: Seyedhamed ALAVI; Arash Kheradvar
Original assignee: The Regents Of The University Of California
Priority date: 2013-03-12
Filing date: 2014-03-12
Publication date: 2014-10-09

Abstract

A tubular braided mesh scaffold for fabrication of heart valves is described. The tubular braided scaffold can be formed of a shape memory metal, such as Nitinol, and pinched or pressed to form a leaflet shape. When heat treated, the braided mesh scaffold holds and retains its valve-like shape.

Description

[0001 j TUBULAR SCAFFOLD FOR FABRICATION OF HEART

VALVES

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Application No, 1.4/094,760, filed on December 02, 2013, entitled, "Apparatus for Growing a Heart Valve in Three-Dimensions" and U.S. Provisional. Application No.

61/778,294, filed on March 12, 2013, entitled, "Tubular Braided Scaffold for Fabrication of Heart Valves "

[0004] BACKGROUND OF THE INVENTION

[0005] (1 ) Field of Invention

[0006] The present invention relates to a heart valves and, more particularly to a tubular mesh or braided scaffold for use in fabrication of heart valves.

[0007] (2) Description of Related Art

[0008] Valvular heart disease is the next cardiac epidemic. While replacement of a dysfunctional valve markedly reduces the mortality associated with it, the current options are iimited to either mechanical or bio-prosthetic heart valves. Mechanical heart, valves tend to last longer due to their stronger composition, but the lifelong need for anticoagulant medication is their major drawbacks. In contrast, bio-prosthetic heart valves, including transcatheters, do not require anticoagulant medications but they do not. last long, and are calcified rapidly due to the several production procedures such as cross-linking that, they go through.

9] Thus, a continuing need exists for a long lasting and stable heart valve that is resistant to calcification and a method for makins the same.

[00010] SUMMAR Y OF INVENTIO [0001 .1 The present invention relates to a tubular scaffold for use in fabrication of heart valves. The tubular scaffold comprises a tubular mesh material shaped into a valvular structure having at least two leaflets.

[00012] I another aspect, the mesh materia! is braided, such that the tubular mesh material is a tubular braided scaffold.

[000 3] in yet another aspect, the tubular scaffold is shaped into a tri- leaflet valvular structure.

[00014] In another aspect, the tubular scaffold is shaped into a bi-leafkt

valvular structure.

[00015] In. yet another aspect the tubular scaffold is made of polymeric

materials.

[00016] in another aspect, the tubular scaffold is made of metallic materials.

[00017] In yet another aspect, the tubular scaffold includes a leaflet portion and a tubular portion, with the leaflets formed on the leaflet portion, and wherein a shape of each leaflet corresponds to a portion of a surface of a cone which portion is defined by the intersections on the conical surface of at least two flat planes h ving peripheries on the conical surface corresponding in length respecti vel to the circumference of the base with the leaflets each having a peripheral free portion while on the other side are attached to a tubular portion.

18] In another aspect, the tubular mesh material, shaped into a valvular structure is fitted onto a frame of an artificial heart valve. Further, the scaffold is connected to a frame having a base and at least two upstanding [00019] Finally, as can be appreciated by one in the art, the present invention also compri ses a method for forming and using the invention described herein. [00020] BRIEF DESCRIPTION OF THE DRAWINGS

[0002 I] The objects, features and advantages of the present invention will be apparent from the following detailed descriptions of the various aspects of the invention in conjunction with reference to the following drawings., where:

[00022] FIG. 1 is an illustration of a tubular scaffold that has bee formed to a shape of a tri-leaflet heart valve; and

[00023] FIG . 2A is a right, side-view illustration of the tubular scaffold

according to the principles of the present invention;

[00024] FIG. 2B is a bottom-vie w illustration of the tubular scaffold according to the principles of the present in vention; [00025] FIG. 2C is a rear, side-view illustration of the tubular scaffold,

according to the principles of the present invention;

[00026] FKJ . 2 D is a top-view illustration of the tubular scaffold according to the principles of the present invention;

[00027] FIG. 3 is an illustration depicting an example of forming the tubular scaffold from a braided mesh tube;

[00028] FIG . 4 is an illustration depicting a process of forming the tubular scaffold using a scaffolding mold having a scaffolding mold first part and a scaffolding mold second pari according to the principles of the present invention; and

[00029] FIG. 5 is an illustration of a tubular scaffold according to the

principles of the present invention.

[00030] DETAILED DESCRIPTION

[00031] The present invention relates to a heart valves and, more particularly to a tubular braided scaffold for use in fabrication of heart val ves. The following description is presented to enable one of ordinary skill in the art to make and use the invention and to incorporate it in the context of particular applications. Various modifications, as well as a variety of uses in different applications will be readily apparent to those skilled in the art, and the general principles defined herei may be applied to a wide range of embodiments. Thus, the present invention is not intended to be limited to the embodiments presented, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. 00032] In the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. However, it will be apparent to one skilled in the an thai the present invention may be practiced without necessarily being limited to these specific details. In other instances, well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present invention.

[00033] The reader's attention is directed to all papers and documents which are filed concurrently with this specification and which are open to public i nspection wi th this specification, and the contents of all such papers and documents are incorporated herein by reference. All the features disclosed i this specification, (including any accompanying claims, abstract and drawings) ma be replaced by alternative features serving the same., equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is only one example of a generic series of equivalent or similar features.

[00034] Furthermore, any element in a claim that, does not explicitly state

"means for" performing a specified function, or "step for" performing a specific function, is not to be interpreted as a "means" or "step" clause as specified in 35 U.S.C. Section 1 12, Paragraph 6. In particular, the use of "step of or "act of in the claims herein is not intended to invoke the provisions of 35 U.S.C. 1 12, Paragraph 6.

[00035] Please note, if used, the labels left, right, front, back, top, bottom, forward, reverse, clockwise and counter clockwise have been used for convenience purposes only and are not intended to imply any particular fixed direction. Instead, they are used to reflect relative locations and/or directions between various portions of an object. 00036] (1) Description

[00037] The present invention relates to a scaffold for formation of heart

valves. More specifically, the present invention relates to a valvular scaffold made of a tube that has a braided (or mesh) pattern that is shaped into a ( 1 ) tri-leaflet or (2) bi-ieafiet vaivuiar structure, where the scaffold can be made from a variet materials such as but not limited to woven polymer or metallic fibers such as itinoL. The formed val ve can be late connected to a structure such as but not limited to a tri- or hi-leaflet artificial heart valve frame to become ready for implantation. The current invention, can be used as a mechanical valve. Upon proper selection of the scaffold material, it can become elastic or super elastic to provide its leaflets with enough flexibility suitable for heart valve applications. This flexibility will help the valve to improve blood flow dynamics and therefore reduce the formation of blood clots due to damaging red blood cells and finally eliminate the use of anticoagulation therapy needed for patients having mechanical heart valves.

[00038] FIG, 1 shows a tabular scaffold 100 that has been formed to a shape of a tri-leaftet bean valve. For further understanding, FlGs, 2A through 2D illustrate right, bottom, rear, and top views, respectively, of the tubular scaffold 100. As shown, the scaffold 100 is a continuous mesh without any parts sewn or attached to the valve. The whole structure has integrity so that the leaflets are not separate parts from the body of the tube.

[00039] The tubular scaffold i 00 can be formed using any suitable mechanism or technique. As a non-limiting example, a frame {such as a bioprosthetic heart valve frame) can be used as a base mold. For example and as shown in FIG. 3 a braided mesh tube 300 can he positioned (by pinching the leaflets into shape around the base mold) and heat treated to form a heart valve shape (i.e., the tubular sScaffold 1.00). if the braided mesh scaffold 100 is formed of a shape memory material, such as Nitinol, then it has memory and will hold the shape as depicted in the figures.

[00040] As another iion-limitiiig example and as shown FIG. 4, a scaffolding mold can be included that includes a scaffolding moid first part 402 and a scaffolding mold second part 404. The scaffolding mold second part 404 is formed in the shape of a desired heart valve, a non-limiting example of which includes a tri-leafiet heart valve. Alternatively, the scaffolding mold second part 404 formed to he a negative of the shape of the scaffolding mold first part 402. Thus, when a material is positioned between the sca.ffold.ing mold first, part 40.2 and the scaffolding mold second pan 404 is pressed over and onto the scaffolding mold first part 402, the material is pressed or bent into the desired heart valve shape, thereby creating a scaffold for use with the heart mold. As a non-limiting example and as shown in FIG. 4, a braided mesh rube 300 (e.g., made of Nitinol or any other mesh or braided material) can be positioned over the scaffolding moid first part 402. The scaffolding mold first 402 and second 404 parts are designed in a such a way that if you put the parts 402 and 404 together, there will be a uniform gap between their surfaces so thai there will be enoug space for the mesh 300 to be placed in between. Depe ndin g on the thickness of the mesh, the gap dimension can be adjusted.

[0004 ] Thus, the scaffolding moid second part 404 can be positioned over the metal braided mesh tube 300 such that the raetal mesh tube 300 is pressed between the scaffolding mold first^" pari 402 and scaffolding mold second part 404 (i.e., the two parts 404 and 406 are compressed together). In this aspect, upon removal from the scaffolding mold, the braided mesh tube 300 is pressed into the shape of a desired scaffold 1 0.

[00042] As noted above, the tubular scaffold 300 can be formed in any desired shape having leaflets, non-limiting examples of which include having a bi- leafiet shape and a tri -leaflet shape. In another aspect and as shown in FIG, 5, the tubular scaffold 100 includes a leaflet portion 500 and tubular portion 502, with the leaflets 504 formed on the leaflet portion 500. A shape of each leaflet 504 corresponds to a portion of a surface of a cone which portion is defined by the intersections on the conical surface of at least two flat planes having peripheries on the conical surface corresponding in length respecti vely to the circumference of the base with the leaflets 504 each having a peripheral free- portion 506 while on the other side are attached to the tubular portion 502.

[00043] In other aspect and as shown in FIG. 6, the tubular scaffold 100 can be attached fitted onto a frame 600 of an artificial heart valve. For example, a ring base 602 and two to three posts 604 would be inserted into the tubular scaffold 100 so that the scaffold 100 sits on-top and covers the valve. in this way, some part of the tube will be integrated into the frame 600 so thai the leaflets 504 are continuously connected to each other and to the base 602 and upstanding posts 604 of the frame 600. This continuous connection will, help the leaflets 504 and the valve to have more durability and prevents fatigue on the structure due to improper attachments of leaflets to the base 602 and upstanding posts 604 (as one of the reasons for failure and short term functionality of bioprosthetic heart valves is structural vulnerability and detachment of the leaflets from their base attachment).

[00044] After the tubular scaffold is formed into the desired valve shape, it can be used as is or further treated, as desired. As a non-limiting example, the tubular scaffold can be further treated by growing tissue thereon using a mold as described in U.S. Application No. 14/094,760, tiled on December 02, 2013, entitled, "Apparatus for Growing a Heart Valve in Three- Dimensions," which is incorporated by reference as though fully set forth herein.

[00045] Alternatively and/or in addition to, the formed, valve can be implanted with, or without surface modification. By using a proper coating method, the valve can become biologically active and recruit the cells inside the body to form a tissue around itself. A method of forming a biological active valve with a mesh scaffold is described in U.S. Patent Application No. 13/427,807, filed on 03/22/2012, and entitled, "Mesh Enclosed Tissue Constructs ' which is incorporated b reference as though fully set forth herein; however this is not the only method that can be used to form a hybrid biologically acti e mesh valve. The mesh pattern will help the tissue to have structural integrity from both sides of the mesh. The tissue can be even made before implantation as discussed above. By using cell culture techniques, the tissue can be grown in and around the structure in a way to enclose the mesh.

Claims

CLAIMS claimed is:

1. A tubular scaffold for fabrication of a heart valve, comprising:

a tubular nresh material shaped into a valvular structure having at least two leaflets.

2. The tubular scaffold as set forth in Claim 1, wbereiii the mesh materia! is braided, such that the tubular mesh material is a tubular braided scaffold.

3. The tubular scaffold as set forth in Claim 1 , wherein tubular scaffold is made of polymeric materials.

4. The tubular scaffold as set forth in Claim I , wherein tubular scaffold is made of metallic materials.

5. The tubular scaffold as set forth in Claim 1 , wherein the tubular

scaffold includes a leaflet portion and a tubular portion, with the leaflets formed on the leaflet portion.

6. The tubular scaffold as set forth in Claim 1 wherein a shape of each leaflet corresponds to a portion of a surface of a cone which portion is defined by the intersections on the conical surface of at least two flat planes having peripheries on the conical surface corresponding in length respecti vely to the circumference of the base wi th the leaflets each having a peripheral free portion while on the oilier side are attached to a tubular portion.

7. The tubular scaffold as set forth in Claim 1 , wherein the tubular mesh material shaped into a val vular structure is fitted onto a frame of an artificial heart valve. The tubular scaffold as set forth in Claim 1 , wherein the scaffold is connected to a frame having a base and at least two upstanding posts.

The tubular scaffold as set forth m Claim ί , wherein tubular scaffold is shaped into a fri- leaflet valvular structure.

Hie tubular scaffold as set forth in Claim I, wherein, iiibular scaffold is shaped into a bi-leafiet valvular structure.