# Patent

## Title
Prosthetic vascular conduit

## Abstract

A prosthetic vascular conduit for coupling to a valve having an annular portion includes a terminal collar member, radially expandable to receive the annular portion of the valve. The collar member includes a portion which is radially contractible to capture the annular portion of the valve to couple the valve to the conduit.

## Background
TECHNICAL FIELD
The present invention relates to prosthetic vascular conduits or grafts. More particularly, it relates to prosthetic vascular conduits adapted to couple with an associated valve for controlling blood flow through the conduit.
BACKGROUND
Valved conduits or grafts, which are arrangements including a prosthetic vascular conduit with an associated valve to control flow of blood through the conduit, are used for various purposes including, for example, the replacement of the aortic valve in conjunction with the ascending aorta.
The aorta is the largest blood vessel in the human body, carrying blood from the left ventricle of the heart throughout the body. The ascending aorta is the first section of the aorta, which stems from the left ventricle and extends to aortic arch. The aortic valve is located at the root of the ascending aorta and controls the blood flow by permitting blood to flow from the left ventricle into the ascending aorta while preventing or restricting blood flow in the opposite direction. The coronary arteries, which supply blood to the heart muscle itself, branch from the ascending aorta. Downstream of the aortic valve, the wall of the ascending aorta exhibits three outward protrusions approximately spaced 120 degrees apart. These protrusions are known as the Valsalva sinuses. For replacement of the aortic valve and the ascending aorta, the valve in the valved conduit is arranged at one end of the prosthetic vascular conduit with its leaflets oriented to permit blood flow from the left ventricle into the conduit, while preventing blood flow out of the conduit in the opposite direction.
Practitioners may prefer having the option of coupling the valve to the conduit just before the replacement procedure. In some cases, for example, practitioners wish to couple the valve to the conduit, possibly in the operating room, only after the specific requirements (e.g., anatomy and pathology) of the patient are known.
SUMMARY
The present invention, according to exemplary embodiments, is a prosthesis including a prosthetic vascular conduit made from a biocompatible material and having a first end and a second end, the conduit including a longitudinally flexible, tubular body portion. An expandable collar member is coupled to the first end of the vascular conduit and defines a collar diameter. The prosthesis further includes a prosthetic heart valve having an annular portion, wherein the annular portion has a diameter larger than the collar diameter, such that the annular portion is adapted to couple to the collar member.
The present invention, according to other exemplary embodiments, is a prosthetic vascular conduit for coupling to a valve having an annular portion, the conduit including a terminal collar member, radially expandable to receive the annular portion of the valve. The collar member further including a portion radially contractible to engage the annular portion of the valve to couple the valve to the conduit.
The present invention, according to other exemplary embodiments, is a method of making a prosthetic valved conduit. The method includes providing a prosthetic vascular conduit having a longitudinally flexible, tubular body portion and an expandable collar member coupled to an end of the vascular conduit, the collar member having a first unbiased diameter and a second expanded diameter; providing a prosthetic heart valve having an annular portion, wherein the annular portion has a diameter larger than the unbiased collar diameter; mounting a prosthetic vascular conduit onto a fixture; inserting a dilator member into the collar member to expand the diameter to the second expanded diameter; advancing the heart valve into the vascular conduit such that the annular portion is generally longitudinally aligned with the collar member; and removing the dilator member such that the collar member contracts and engages the annular portion.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exemplary view of a prosthetic vascular conduit as described herein shown together with a heart valve for association therewith;
FIG. 2 is an enlarged sectional view along line II-II of FIG. 1;
FIGS. 3 to 7 are exemplary of a sequence of coupling a heart valve with a prosthetic vascular conduit as described herein, wherein FIG. 7 is an enlarged view corresponding to arrow VII in FIG. 6; and
FIG. 8 is representative of the result of the coupling sequence of FIGS. 4 to 7.



DETAILED DESCRIPTION
In the following description, numerous specific details are given to provide a thorough understanding of embodiments. The embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the embodiments.
Reference throughout this specification to “one embodiment,” “an embodiment,” “exemplary embodiment,” or “various embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the use of these phrases throughout this specification is not necessarily intended to refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
In the Figures, reference 10 denotes, as a whole, a prosthetic vascular conduit intended to be coupled with a valve 12 to produce a so-called valved conduit or valve graft. Such a valved conduit may be used for replacing a native heart valve and an associated blood vessel in a patient. The aortic valve and the ascending aorta are one non-limiting example of such a valve and an associated blood vessel. The pulmonary valve and the pulmonary artery are another such example.
The valve 12 may be any type of valve adapted for replacement of a native heart valve in a patient. In various embodiments, the valve 12 is a mechanical prosthetic heart valve. In other embodiments, the valve 12 is a biological heart valve. Biological valves can be produced from animal tissues (e.g., bovine or porcine pericardium) cut, shaped and assembled (e.g., by stitching) to produce the desired valve structure. Valves for replacing a native heart valve can also be native valves derived from animals and treated to avoid degradation and adverse effects when implanted into the human body. So-called “porcine” valves obtained from native valves explanted from pigs are exemplary of this type of valves.
The valve 12 may include a rigid or semi-rigid stent or be a so-called “stentless” type. An exemplary valve suited for use in the arrangement described herein is the valve disclosed in U.S. Pat. No. 5,713,953, which is incorporated herein by reference. The valve 12 will generally include a base annular structure 14 similar to the annulus of the native valve being replaced.
In the embodiment shown, the valve 12 is associated with the conduit 10 in such a way that the valve leaflets (schematically indicated as 120) control flow of blood through the conduit by permitting blood flow into the conduit 10 (i.e., blood flow into the aorta, when the conduit 10 is used for aortic replacement) while preventing flow of blood out of the conduit in the opposite direction (i.e., back into the left ventricle of the patient when used for aortic replacement). A reverse arrangement or orientation of the valve 12 is also possible.
As shown for example in FIGS. 1 and 2, the conduit 10 includes a terminal collar member 16 for anchoring the annular portion 14 of the valve 12 to the conduit 10. The annular portion 14 of the valve 12 includes a biocompatible textile material (e.g., Dacron) and/or animal tissue (e.g., bovine or porcine pericardium) treated to be biocompatible. Anchoring the valve 12 to the conduit 10 may be achieved by stitching (i.e., suturing) performed by a practitioner by taking advantage of both the annular portion 14 of the valve 12 and the collar member 16 of the conduit 10 being adapted to be traversed by a suturing material to produce suturing stitches.
In the embodiments considered herein, the conduit 10 is comprised of a tubular textile structure. In various embodiments, the conduit 10 will have a length of from a few centimeters to 10-12 centimeters with a body portion 18 including a tubular wall of a textile material, such as Dacron, forming a corrugated (i.e., grooved) structure providing longitudinal flexibility and radial compressibility while ensuring that the conduit will not unduly radially expand under the pressure of blood flowing therethrough. According to some embodiments, the body portion 18 is made from a collagen-impregnated woven Dacron graft. These structures are conventional and well known in the area of vascular grafts.
In various embodiments used for replacing the ascending aorta, the conduit 10 also includes an intermediate portion 20 located between the body portion 18 and the collar member 16. The intermediate portion 20 may be comprised of a material adapted to permit a radial expansion of the conduit wall into the Valsalva sinuses located immediately downstream of the aortic valve. Such a radial resiliency may be due to the intermediate portion 20 being comprised of a textile material having a stitching pattern such as to bestow on the resulting fabric a certain degree of resiliency. In some embodiments, the intermediate portion 20 is pre-formed or fabricated to have a size and shape adapted to substantially mimic or replicate the shape of the native Valsalva sinus.
In various embodiments, one or both of the body portion 18 and the intermediate portion 20 of the conduit may be punctured or cut to open passages therein for connection of the coronary ostia.
In an embodiment, the collar member 16 will also similarly exhibit a certain degree of radial resiliency (i.e., expandability), possibly starting from an initial rest (i.e., unbiased or not expanded) condition where the collar member 16 has, at least marginally, a smaller diameter than the rest of the conduit 10.
The collar member 16 may be comprised of a textile material (e.g., knitted Dacron thread) connected to the intermediate portion 20 to produce a radially expandable terminal portion of the conduit 10.
In some embodiments, the collar member 16 is a separate element (e.g., formed from a separate piece of material) from the body portion 18 and/or the intermediate portion 20. Connection of the collar member 16 to the intermediate portion 20, as well as connection of the intermediate portion 20 to the body portion 18 or connection of the collar member 16 to the body portion 18 (in embodiments not including the intermediate portion 20) may be by any method or technique known in the art. In various exemplary embodiments, connection may be by one or more of knitting, stitching, or gluing.
In various embodiments, the body portion 18, the intermediate portion 20 and the collar member 16 are made from a single piece of material. For example, different sections of a same body including different knitting or stitching patterns. In various embodiments, the intermediate portion 20 can be dispensed with, whereby the collar member 16 is directly connected to the body portion 18 by any of the techniques considered.
The collar member 16 is intended to accommodate the valve 12 to permit easy, fast and reliable coupling and subsequent anchoring of the valve 12 to the conduit 10. In exemplary embodiments, the collar member 16 is intended to accommodate the annular portion 14 of the valve 12.
The collar member 16 includes a radially contractible (i.e., shrinkable) portion 160. In various embodiments, the radially contractible portion 160 is a marginal portion (i.e., an end portion of the collar member 16). In other embodiments, the radially contractible portion 160 may be an intermediate portion of the collar member 16.
Radial contraction of the portion 160 may be due to inherent contractibility and/or be achieved via a positive contracting action. Elastic contractibility is exemplary of inherent contractibility. Elastic contractibility may be achieved via an elastically contractible member such as an elastic ring of a plastics material, a metallic ring (e.g., superelastic metallic alloys such as Nitinol), or an open, radially contractible ring of a rigid or semi-rigid material such as a metal or plastics material.
Radial contraction achieved via a positive contracting action may include shape memory (e.g., of a metallic member) or loop or a slip-knot (to be actuated by the practitioner) formed of a wire-like element such as suturing wire or a thread as used for manufacturing the conduit 10. In various embodiments, as shown for example in FIG. 2, a contractible member 162 providing radial contractibility of the portion 160 of the collar 16 may be accommodated in an annular “pocket” obtained by up-turning the marginal edge of the tubular body comprising the collar 16.
Turning the marginal edge of the collar 16 inside out as schematically shown in the figures, with the terminal rim thereof fixed to the outer wall of the portion 16 (e.g., by stitching or similar means) avoids the formation of any discontinuity at the inner surface of the collar 16. Turning the marginal edge inside the collar 16 to provide such a ring-like discontinuity at the inner surface thereof may increase the action of the collar 16 in retaining the valve 12.
FIGS. 3 to 7 illustrate coupling and anchoring the valve 12 to the conduit 10 by using a fixture 100. The fixture 100 is essentially comprised of a cylindrical or tubular) body having a stable base portion 102 onto which the conduit 10 may be mounted as schematically shown in FIG. 3. As shown, the fixture has a length sufficient to extend substantially through the center of the conduit 10. In various embodiments, the collar 16 extends slightly beyond the upper end of the fixture 100 thus ensuring that the collar 16 is left free (i.e., unimpeded). As is apparent from FIGS. 3 to 7, this procedure does not require the practitioner to hold the conduit 10 and/or the valve 12.
In various embodiments, radial expansion of the collar 16 is achieved by means of a frusto-conical (e.g., funnel shaped) dilator element 104. In one embodiment, the dilator element 104 may be cylindrical instead of frusto-conical. Once the element 104 is positioned to retain the collar 16 in a radially expanded configuration (see FIG. 4), the valve 14 is advanced (i.e., lowered, in the example shown) into the element 104 until the collar 14 is in correspondence with the collar 16 with the radially contractible portion 160 capable of “embracing” the annular portion 14 of the valve 12 when the element 102 is removed (see FIG. 5). Next, the portion 160 is radially contracted (see FIG. 6), such that the portion 160 (and the collar 16) capture or embrace the annular portion 14 of the valve 12. As indicated above, radial contraction may be accomplished either by self-contractibility of the portion 160 or 162 or by a positive action exerted thereon by the practitioner.
In various embodiment, once the condition illustrated in FIG. 6 is achieved, with valve 12 coupled to the conduit 10, the valve can be further secured to the conduit 10 e.g., by means of stitches S (see FIG. 7). This action may be performed while the conduit 10 with the valve 12 received in the collar 16 is mounted on the fixture 100. In other embodiments, no stitching or suturing is performed.
This further securing of the valve 12 to the conduit 10 to produce the valved conduit as shown in FIG. 8 may also be achieved after removing from the fixture 100 the conduit 10 having the valve 12 coupled to the collar 16 (i.e., with the collar 16 securely retaining the valve 12 and preventing any accidental slippage or displacement of the valve 12 while being finally anchored to the conduit 10). Specifically, securing or anchoring (e.g., suturing) of the valve 12 to the conduit 10 may also take place together with anchoring the valve 12 to the annulus in the patient's body, so that a single stitching action achieves stitching of the valve 12 to the conduit 10 and to the annulus.
Before final anchoring, the valve 12 coupled to the collar 16 can still be rotated around the longitudinal axis X10 of the conduit 10 (see FIG. 1) to ensure the desired location of the valve leaflets and commissures therebetween with respect to parts of the intermediate portion 20 intended to protrude in the Valsalva sinuses of the patient.
Angular markers 110 (e.g., in the form of lines of contrasting color) can be provided in the wall of the conduit 10 to act as angular references in orienting the valve 12 with respect to the conduit 10. In addition or alternatively thereto, angular markers 210 can be provided in the collar member 16 to act as angular references in orienting the valve 12 with respect to the collar member 16.
Elements associated with the collar 16 to produce radial contractibility thereof (for instance wires or threads forming loops or slip-knots) can be partly or completely removed when possibly obstructive to implantation. In certain embodiments, such an element (for instance an elastic metal ring) can be left in place and used as a radiopaque marker to permit location of the valve once implanted.
Without prejudice to the underlying principles of the invention, the details and embodiments may vary, even significantly, with respect to what has been described herein, merely by way of example, without departing from the scope of the invention as defined by the annexed claims. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the above described features.

## Claims

1. A prosthesis comprising:
a prosthetic heart valve having a plurality of leaflets for controlling blood flow through the heart valve and an annular portion having a first diameter, the annular portion located at a proximal end of the prosthetic heart valve;
a prosthetic vascular conduit including a terminal collar member radially expandable to receive the prosthetic heart valve, the terminal collar member including a contractible portion radially contractible to engage the annular portion of the prosthetic heart valve such that the prosthetic heart valve is coupled to the conduit; and
a contractible member coupled to the terminal collar member at a location proximal to the annular portion and extending about a circumference of the terminal collar member;
wherein the contractible member is a suturing wire forming a loop configured to enable a practitioner to exert a positive contraction force on the terminal collar member to reduce a diameter of the contractible portion to a second diameter smaller than the first diameter of the annular portion, such that the prosthetic heart valve is captured inside the terminal collar member.

2. The conduit of claim 1, wherein the contractible portion is a distal portion of the terminal collar member.

3. The conduit of claim 1, wherein the contractible member is disposed within a pocket formed in the terminal collar member.

4. The conduit of claim 3, wherein the pocket is formed by upturning a marginal edge of the terminal collar member.

5. The conduit of claim 1, wherein the terminal collar member is formed of a material permitting suturing of the annular portion of the valve to the conduit.

6. The conduit of claim 1, wherein the terminal collar member is comprised of a textile material.

7. The conduit of claim 1, wherein the terminal collar member is formed of a separate element and is connected to an adjacent portion of the conduit by at least one of knitting, stitching, or gluing.

8. The conduit of claim 1, wherein the contractible member is removable from the terminal collar member.

9. The conduit of claim 1, wherein the terminal collar member includes a contractible member of a radiopaque material for use as a marker.

10. The conduit of claim 1, wherein the terminal collar member includes at least one angular marker for angularly referencing the valve with respect to the terminal collar member.

11. The conduit of claim 1, wherein the conduit includes a radially expandable portion adjacent the terminal collar member.