# Patent

## Title
Heart valve annuloplasty prosthesis sewing cuffs and methods of making same

## Abstract

An annuloplasty prosthesis for a heart valve has a sewing cuff added to the conventional structure. The sewing cuff is preferably an extension of the fabric cover that is provided around the core of the prosthesis. The sewing cuff preferably extends radially outwardly from cross sections of the remainder of the prosthesis. Methods of making such a sewing cuff are also disclosed.

## Background
This application claims the benefit of U.S. provisional patent application No. 60/571,437, filed May 14, 2004, which is hereby incorporated by reference herein in its entirety.


BACKGROUND OF THE INVENTION
Annuloplasty prostheses for heart valves are well known as is shown, for example, by Alfieri et al. U.S. patent application publication US 2002/0173844 A1 and Bolling et al. U.S. patent application publication US 2003/0093148 A1. Such prostheses may be complete rings (e.g., as in the above-mentioned Alfieri et al. and Bolling et al. references), or they may be less than complete rings (e.g., as in Carpentier U.S. Pat. No. 3,656,185). The term “annuloplasty” is used herein to refer to both of these types of prostheses (i.e., both complete rings and less than completely annular structures (e.g., generally C-shaped structures)).
Typical annuloplasty prostheses include a core member surrounded by a soft fabric cover. The core member is often substantially rigid or at least semi-rigid and not penetrable by a suture needle and suture material. The fabric cover may be designed to cushion the prosthesis, and possibly also to promote tissue in-growth into the prosthesis to help integrate the prosthesis into the patient's body. It is often desired to secure the prosthesis in the patient by passing one or more suture needles and suture material through the fabric cover and adjacent tissue. Tightness and/or thinness of the fabric cover may make this difficult to do. Even if the surgeon is successful in getting proper engagement, the amount of fabric caught may be less than would be desirable for good tissue healing and over-growth.
SUMMARY OF THE INVENTION
To facilitate suturing an annuloplasty prosthesis into a patient, a sewing cuff is added to the prosthesis in accordance with the invention. Such a sewing cuff is preferably an extension of the fabric cover that is provided around the core of the prosthesis. The sewing cuff preferably extends radially outwardly from cross sections of the core and the remainder of the fabric cover. Stitching may be used to stabilize the extension. The extension may be one-piece with the fabric cover. For example, a medial portion of the cover fabric may be used to form the extension. As another example, a free edge portion of the fabric used for the cover may be used to provide the extension. The free edge portion may be folded to increase the bulk of the extension. Two free edge portions of the fabric used for the cover may be used together to form the extension. Again, folding may be used to increase the bulk of the extension.
The invention also includes various methods of making sewing cuffs such as those summarized in the preceding paragraph.
Further features of the invention, its nature and various advantages, will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a simplified cross sectional view of an illustrative embodiment of an annuloplasty prosthesis for a heart valve in accordance with the invention. FIG. 1 may be taken as shown at 1-1 in FIG. 7.
FIG. 2a is a simplified cross sectional view of an illustrative embodiment of a component that can be used in making a prosthesis like that shown in FIG. 1 in accordance with the invention.
FIG. 2b is similar to FIG. 2a, but shows a later stage in handling the component in accordance with the invention.
FIG. 2c is again similar to FIGS. 2a and 2b, but shows a still later stage in accordance with the invention.
FIG. 2d is generally similar to FIG. 1, but shows an end result from the progression of FIGS. 2a-2c in accordance with the invention.
FIGS. 3a-3c are each generally similar to FIG. 1, but show a progression in an alternative approach to making a prosthesis in accordance with the invention.
FIG. 4 is again generally similar to FIG. 1, but shows an alternative construction of a prosthesis in accordance with the invention.
FIG. 5 is once again generally similar to FIG. 1, but shows another alternative construction of a prosthesis in accordance with the invention.
FIG. 6 is again generally similar to FIG. 1, but shows still another alternative construction of a prosthesis in accordance with the invention.
FIG. 7 is a simplified plan view of an illustrative embodiment of a prosthesis in accordance with the invention.



DETAILED DESCRIPTION
The annuloplasty prosthesis 10 cross section shown in FIG. 1 includes core member 20, a layer 30 of an elastomeric material surrounding core 20, and fabric cover 40 surrounding elements 20 and 30. FIG. 1 also shows what may be described as a mini-sewing-cuff 50 extending radially outwardly from the other elements at one angular location or region around the circumference of the cross section. For completeness FIG. 7 shows a plan view of an entire illustrative annuloplasty prosthesis 10 in accordance with the invention and which can have a cross section as shown in FIG. 1 (or as in other FIGS. subsequent to FIG. 1). Although FIG. 7 shows the cross section taken at one particular location, substantially the same cross section may be found at other (or even all) locations annularly around prosthesis 10. Also, although FIG. 7 shows a prosthesis 10 that is a complete, unbroken, generally D-shaped annulus, prosthesis 10 could have other shapes, and could alternatively be only a portion of an annulus (e.g., it could be C-shaped rather than D-shaped). Still another point to be made is that although FIG. 7 shows sewing cuff 50 extending around the outside of prosthesis 10, sewing cuff 50 could alternatively be at any other location around cross sections of the prosthesis.
FIG. 7 is provided to make the point that, although most of the other FIGS. herein are of cross sections, these other FIGS. are representative cross sections of structures that extend longitudinally (e.g., out of the plane of the paper on which the cross sections are drawn).
Typical materials for the various components of prosthesis 10 will be mentioned later in this specification. For the moment it will be sufficient to point out that elastomeric layer 30 is optional and may be omitted in some embodiments of the invention. Fabric cover 40 would then be directly over core 20. The FIGS. subsequent to FIG. 1 show generalized cores 20, which can be either like core 20 in FIG. 1 or a composite of elements such as 20 and 30 in FIG. 1.
Sewing cuff 50 can be formed on prosthesis 10 in any of a number of different ways. Some examples are shown in subsequent FIGS. and described below.
In the illustrative embodiment shown in FIGS. 2a-2d, a medial (or more generally an interior) portion of fabric 40 is gradually pinched together as shown progressively in FIGS. 2a-2c until two interior creases 42a and 42b are formed and brought together (FIG. 2c). A fine suture 60 is then used to sew the two creases 42 together to create sewing cuff 50. After the sewing cuff has been sewn together, the two free ends (edges) 44a and 44b of fabric 40 are wrapped around prosthesis core 20 and stitched together as shown at 70 in FIG. 2d. Fabric 40 is pulled tightly together during stitching 70 so that it will securely and firmly wrap around prosthesis core 20.
In the alternative embodiment illustrated by FIGS. 3a-3c, fabric cover 40 is first wrapped loosely around prosthesis core 20. A portion of the fabric annulus is gradually squeezed or pinched together as shown at 41 in FIG. 3b. This eventually produces a sewing cuff. Depending on the width of the cuff required, the amount of fabric 40 squeezed or pinched together to create the cuff can vary. Suture 60 is added to hold sewing cuff 50 together as shown in FIG. 3c to complete the process.
In the further alternative embodiment shown in FIG. 4, sewing cuff 50 is created by squeezing together two otherwise free edges 46a and 46b of fabric 40 after the fabric has been wrapped around prosthesis core 20. A fine suture 60 can then be used to stitch the two single-layers fabric edges together (and around core 20) to form the sewing cuff. The width (radial outward projection) of the cuff (dimension W in FIG. 1) can be determined by adjusting the amount of excess fabric 40 used to wrap around the core. More than just the single stitch line 60 can be used to hold edges 46a and 46b together in sewing cuff 50.
In the still further alternative embodiment shown in FIG. 5, fabric 40 is loosely wrapped around prosthesis core 20 with both edges 48a and 48b free. Free edges 48 are then folded over on themselves so that each free edge becomes double-layered. The two double-layered free edges are then squeezed together, and a fine suture 60 is used to stitch the fabric together to form sewing cuff 50. A sewing cuff created in this way can be thicker (bulkier) and provide more cushioning. Free edges 48 can also be folded over multiple times to create a triple- or other multiple-layered cuff 50.
In the further illustrative embodiment shown in FIG. 6, sewing cuff 50 is first formed by folding a free edge portion of fabric 40 several times as shown at 49 to get the thickness desired. This is then stitched together with suture 60 so that the sewing cuff is stabilized and remains intact with the desired shape. The remaining free edge of fabric 40 is used to wrap around prosthesis core 20 and then stitched to the sewing cuff as shown at 70. Fabric 40 will wrap around ring core 20 securely and firmly when the process is completed.
Sewing cuff 50 may measure from about 0.25 mm to about 5.0 mm in width (see dimension W in FIG. 1 or the comparable unreferenced dimension in any of the other FIGS.). The sewing cuff may be created from a soft fabric such as polyester, PTFE, or the like, and may be the same as (or even one piece with) fabric cover 40. Sewing cuff 50 allows the surgeon to place sutures easily, and also provides substantially more fabric for tissue in-growth purposes. More sewing fabric also allows for a better cushion between the heart valve annulus and the prosthesis. As has been said, sewing cuff 50 can also be used with a prosthesis core that is first covered by a soft elastomer 30, such as silicone or the like, before it is covered by a fabric 40 with cuff 50. The sewing cuff can also be used on just prosthesis core 20 itself without any intermediate elastomer covering 30. Prosthesis core 20 can be made from any suitable material, such as stainless steel, titanium, ceramic, elgiloy, shape-memory alloy, and/or polymeric material.
It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, although the FIGS. herein show prostheses having cores 20 that are round in cross section, it will be appreciated that other core cross sectional shapes can be used instead if desired.

## Claims

1. A method of making an annuloplasty prosthesis for a heart valve comprising:
providing a piece of fabric having free edges that are substantially parallel to one another on respective opposite sides of a width of the fabric;
creasing the fabric along each of two crease lines that are each substantially parallel to the free edges and that are spaced from one another and the free edges widthwise of the fabric;
bringing the two crease lines into lengthwise contact with one another without enclosing portions of the width of the fabric that are not between the crease lines;
stitching the crease lines together along their length to produce a sewing cuff from the portion of the width of the fabric that is between the crease lines;
providing an annuloplasty prosthesis core annulus;
after the step of stitching the crease lines together, wrapping the portions of the width of the fabric that are not between the crease lines tightly around the core annulus while positioning the fabric so that the sewing cuff forms an annulus that parallels the core annulus, so that the fabric is securely and firmly wrapped around the core annulus, and so that the free edges come together lengthwise along a line that is spaced from the crease lines; and
stitching the free edges together lengthwise.

2. The method defined in claim 1, wherein the wrapping step includes positioning the fabric so that the sewing cuff extends radially outwardly from the core annulus.

3. The method defined in claim 2, wherein the wrapping step includes positioning the fabric so that the free edges come together along a line that is opposite from the sewing cuff across cross sections of the core annulus.

4. The method defined in claim 1, wherein the step of providing an annuloplasty prosthesis core annulus comprises:
providing a core member that is covered by an elastomeric material.

5. The method defined in claim 4, wherein the step of providing a core member comprises:
forming the core member from a material selected from the group consisting of stainless steel, titanium, ceramic, elgiloy, shape-memory alloy, and polymeric material.

6. The method defined in claim 4 wherein the elastomeric material comprises silicone.

7. The method defined in claim 1, wherein the step of providing a piece of fabric comprises:
selecting the fabric from the group consisting of polyester and PTFE.