Annuloplasty Ring For Receiving A Replacement Valve

Abstract

An annuloplasty ring including elastic features that make the ring optimal for receiving a subsequent prosthetic valve via a “Valve In Ring Procedure.” The elastic features provide a squeezing force on the native valve annulus that both ensures coaptation of the native valve leaflets and also prevents paravalvular leakage around a subsequently-placed prosthetic valve.

Claims

1. A method of treating a native heart valve comprising: evaluating the state of a previously implanted annuloplasty ring at the native heart valve annulus; delivering a replacement valve to the native heart valve annulus; stretching the previously implanted annuloplasty ring to a perimeter sufficient to receive the replacement valve; aligning areas of increased stretchability of the previously implanted annuloplasty ring with commissures of the native heart valve; and, releasing the previously implanted annuloplasty ring so that the areas of increased stretchability ensure placement of a squeezing force on the replacement valve so as to prevent paravalvular leakage.

2. The method of claim 1, further comprising attaching the replacement valve to the previously implanted annuloplasty ring.

3. The method of claim 1, wherein the areas of increased stretchability of the previously implanted annuloplasty ring are disposed between a plurality of rigid members of the previously implanted annuloplasty ring.

4. The method of claim 1, wherein the areas of increased stretchability of the previously implanted annuloplasty ring are constituted by a tapered section of a core of the previously implanted annuloplasty ring.

5. The method of claim 1, wherein stretching the previously implanted annuloplasty ring includes stretching a core of the previously implanted annuloplasty ring.

6. The method of claim 5, wherein the core includes a covering.

7. The method of claim 1, wherein the native heart valve is a mitral valve.

8. The method of claim 1, wherein the native heart valve is an aortic valve.

9. The method of claim 1, wherein the previously implanted annuloplasty ring has the shape of an incomplete circle.

10. The method of claim 1, wherein the previously implanted annuloplasty ring has the shape of a complete circle.

11. A method of treating a heart valve comprising: providing an annuloplasty ring for placement at the annulus of a native heart valve; providing instructions to a user for implantation of the annuloplasty ring at the annulus; providing a replacement valve for mounting on the annuloplasty ring; providing instructions to a user for mounting the replacement valve on the annuloplasty ring; the instructions including: delivering a replacement valve to the native heart valve annulus; stretching the provided annuloplasty ring to a perimeter sufficient to receive the replacement valve; aligning areas of increased stretchability of the providing annuloplasty ring with commissures of the native heart valve; and, releasing the provided annuloplasty ring so that the areas of increased stretchability ensure placement of a squeezing force on the replacement valve so as to prevent paravalvular leakage.

12. The method of claim 11, the instructions further including attaching the replacement valve to the provided annuloplasty ring.

13. The method of claim 11, wherein the areas of increased stretchability of the provided annuloplasty ring are disposed between a plurality of rigid members of the provided annuloplasty ring.

14. The method of claim 11, wherein the areas of increased stretchability of the provided annuloplasty ring are constituted by a tapered section of a core of the provided annuloplasty ring.

15. The method of claim 11, wherein the provided annuloplasty ring includes an elastic core.

16. The method of claim 15, wherein the elastic core includes a covering.

17. A method of replacing a heart valve having an installed annuloplasty ring comprising: enlarging areas of increased stretchability of an elastic core of the installed annuloplasty ring to a size to receive a replacement valve; releasing the installed annuloplasty ring so that the installed annuloplasty ring compresses over the replacement valve; and, attaching the replacement valve to the installed annuloplasty ring.

18. The method of claim 17, wherein the elastic core of the installed annuloplasty ring includes a plurality of rigid members.

19. The method of claim 17, wherein the elastic core has a covering.

20. The method of claim 17, wherein the elastic core is a complete circle.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which

[0019] FIG. 1 is a plan view of an embodiment of a ring of the invention;

[0020] FIG. 2 is a perspective view of an embodiment of a ring of the invention having been placed at a target valve site;

[0021] FIG. 3 is a plan view of an embodiment of a ring of the invention;

[0022] FIG. 4 is a plan view of an embodiment of a ring of the invention;

[0023] FIG. 5 is a plan view of an embodiment of a ring of the invention; FIGS. 5A-5D show various examples of cross-sectional shapes of elastic features of the ring, all of which are taken along section lines A-A of FIG. 5;

[0024] FIG. 6 is a plan view of an embodiment of a ring of the invention;

[0025] FIG. 7 is a plan view of an embodiment of a ring of the invention;

[0026] FIG. 8 is a plan view of an embodiment of a ring of the invention after a VIR procedure has been performed;

[0027] FIG. 9 is a plan view of an embodiment of a ring of the invention having a cover and after a VIR procedure has been performed;

[0028] FIG. 10 is a perspective view of embodiment of a ring of the invention implanted in the annulus of a tricuspid valve;

[0029] FIG. 11 is a plan view of an embodiment of a ring of the invention after a VIR procedure has been performed; and,

[0030] FIG. 12 is a plan view of an embodiment of a ring of the invention.

DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION

[0031] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0032] Referring now to the figures, and first to FIG. 1, there is shown an embodiment 10 of an annuloplasty ring of the invention. The ring 10 generally includes an elongate core 12 that extends between a first end 14 and a second end 16. Though shown only in FIG. 8, all of the ring embodiments described herein may be covered with a material as is common in the art by, for example, a double velour fabric or other Dacron fabric. Such a fabric assists in anchoring by providing a medium for receiving sutures and also promoting in-growth of tissue. Additionally, depending on the performance of the selected core material, the need for a cover may be obviated.

[0033] The core 12 has a shape configured to establish an optimal perimeter for a human blood valve when implanted in a circulatory system. For example, the ring 10 shown in FIG. 1 has a “D” shape, and a 3 dimensional saddle shape, that corresponds to the mitral valve of the heart.

[0034] All of the various ring embodiments described herein include an elastic feature that give the ring an elastic stretchability from a resting state to a stretched state. Like a rubber band, the ring is implanted in its resting state, but is flexible and allows for normal stretching and function of the valve. When the ring is in the stretched state, a squeezing force is imparted on the object or forces, such as blood pressure, that are placing the device in the stretched state. The squeezing characteristics of the elastic ring makes the ring both stretchable and deformable, and therefore uniquely suited to receiving a prosthetic valve, such as an implanted transcatheter valve (TCV) or other prosthesis. Due to the squeezing effect of the elastic, the ring and the annular tissue to which it is fixed function as a gasket or rubber band around the prosthetic valve. The squeezing causes the ring and tissue to seal around the valve, thereby preventing paravalvular leakage and reducing the risk that the valve may move, migrate, or embolize.

[0035] More specific to the embodiment shown in FIG. 1, the ring 10 includes at least one elastic feature 20 that allows the core to be stretched from a resting state to a stretched state. In this embodiment 10, the elastic feature 20 takes the form of a tapered section having a cross-section that is smaller than a cross-section of the rest of the core 12.

[0036] By way of example, the ring 10 shown in FIG. 1 has two tapered sections 20. The number and placement of the tapered sections 20 may vary according to the intended implantation location and orientation of the ring 10. For example, FIG. 2 shows an embodiment 30 of a ring having an oblong shape to conform to the tricuspid valve. A round native valve such as the aortic valve or pulmonary valve also may be treated with a ring. The ring 30 has a core 32 that extends between ends 34 and 36 and includes a single tapered section 40 between the ends 34 and 36. The tapered section 40 is aligned with a commissure of the tricuspid valve. Ends 34 and 36 are also shown as being tapered.

[0037] One skilled in the art will understand that an annuloplasty ring is sized to accommodate a native valve but, once attached, given the elastic nature of the tissue, also imparts a force on the tissue. Thus, when it is written herein that the valve is sized and shaped to conform to a native valve, it is to be understood that the native valve annulus will, to an extent, also conform to the ring. The latter conformation is necessary to reestablish coaptation of the leaflets. Therefore, the ring is not shaped to precisely conform to a diseased valve. Rather, the ring is sized and shaped to reshape the native valve annulus to a desired configuration once implanted.

[0038] In order to impart the desired forces on the target tissue, the elongate core of the various embodiments described herein is flexible and resilient. The core may be constructed of an appropriate, biocompatible material such as silicone, medical-grade rubber, e ptfe, Goretex® or others. Alternatively, other materials may be used that are covered with a silicone layer. In some cases, additional rigidity may be desired beyond the capabilities of the selected core material. Additional rigidity may be provided by utilizing a wire core. For example, FIG. 3 shows an embodiment 50 of a ring having a core 52 that extends in a “D” shape between a first end 54 and a second end 56 and includes two tapered sections 60. An inner wire 62 extends through the core 52 to add rigidity. The inner wire 62 may be constructed of biocompatible materials including, but not limited to, Nitinol or an alloy, stainless steel, cobalt chromium, titanium, nickel or others. As seen in FIG. 3, the inner wire 62 is configured to not interfere with the elasticity provided by the tapered sections 60. The inner wire 62 is interrupted to form three sections of wire, 64, 66, and 68. The three sections 64, 66 and 68 are interrupted, or spaced apart, at the tapered sections 60.

[0039] Alternatively, if more rigidity is required at the tapered sections, an embodiment 70 of an inner wire, such as that shown in FIG. 4, may be provided. FIG. 4 shows a ring 50, such as that shown in FIG. 3, wherein the interrupted inner wire 62 has been replaced with a non-interrupted inner wire 70. The inner wire 70, however, has areas 72 of reduced diameter corresponding to the tapered sections 60. The areas 72 of reduced diameter result in the formation of three sections 74, 76, and 78 of relatively increased diameter. These sections 74, 76 and 78 are thus located in the more robust areas of the core 52 between the tapered sections 60.

[0040] The inner wire 62 may also add radiopacity to the ring. If additional radiopacity is desired, marker bands or coating may also be incorporated in the silicone or fabric.

[0041] In addition to the use or non-use of inner wires, the elastic characteristics of the tapered sections may be controlled by the use of various cross-sectional shapes at the tapered sections. For example, FIG. 5 shows the ring 50 of FIG. 3 as described above. Various cross-sectional shapes are also shown, taken along section lines A-A, which extend through the tapered section 60. FIG. 5A shows a circular cross-section; FIG. 5B shows a square cross-section; FIG. 5C shows a rectangular cross-section; and FIG. 5D shows a spiral or coil-shaped cross section. Each shape will exhibit different flexibility and stretching characteristics and the examples provided should be viewed as non-limiting.

[0042] The elastic characteristics of the ring may further be varied by employing other embodiments of the elastic features. For example, referring now to FIG. 6, there is shown an embodiment 80 of a ring of the invention. The ring 80 generally includes an elongate core 82 that extends between a first end 84 and a second end 86. The core 82 has a “D” shape that corresponds to the mitral valve of the heart but may also be shaped to conform to other valves, such as oblong valves like the tricuspid valve, or to circular valves.

[0043] The ring 80 includes at least one elastic feature 90 that allows the core to be stretched from a resting state to a stretched state. In this embodiment 80, the at least one elastic feature 90 takes on the form of an accordion section 90 in an otherwise-cylindrical core 82. The at least one accordion section 90 of FIG. 6 is shown by way of example as two spaced apart accordion sections 90, that may or may not be placed to coincide with the commissures of the target heart valve.

[0044] Alternatively, to provide different elastic characteristics, there is provided an embodiment 100, shown in FIG. 7, that generally includes an elongate core 102 that extends between a first end 104 and a second end 106. The core 102 has a “D” shape that corresponds to the mitral valve of the heart but may also be shaped to conform to other valves, such as circular valves or oblong like the tricuspid valve.

[0045] The ring 100 includes an elastic feature 110 that allows the core to be stretched from a resting state to a stretched state. In this embodiment 100, the at least one elastic feature 110 takes on the form of an accordion section 110 that extends substantially along the entire extent between the first end 104 and the second end 106. It is understood that the various features shown in the embodiments herein may be employed by other embodiments, even if all the variations are not shown in the figures. For example, the embodiments incorporating accordion-like elastic features may be used in conjunction with inner wires if increased rigidity is desired.

[0046] Further variation of performance characteristics may be provided by embodiments of the invention that comprise complete rings. Heretofore, the embodiments described have all constituted incomplete rings, including first ends and second ends with elongate cores that extend between the two ends. It should be noted that these incomplete cores may be used in conjunction with cloth covers that are either incomplete, to match the cores, or complete, thereby spanning the gap between the first end and the second end of the core with cloth. In this case, it may be desirable to suture only the areas of the ring including a core. An embodiment of this can be seen in FIG. 8 which shows an embodiment 200 of a round, incomplete ring, having an elongate core 202 extending between a first end 204 and a second end 206. The core 202 includes at least one elastic feature 210 in the form of a taper. The ring 200 also includes a cloth cover 220, shown in phantom lines to reveal the detail of the core 202. Sutures 222 are used to secure the ring 200 to the valve annulus, and a prosthetic valve V has been placed in the ring 200 via a VIR procedure. The sutures 222 extend through the cloth 220 and the core 202 but are not included in the gap 224 between the first end 204 and the second end 206.

[0047] FIG. 9 shows the embodiment 200 of FIG. 8 with the cloth cover 220 covering the core (not shown). The ring 200 has a valve V implanted therein. The sutures 222 extend around the perimeter of the ring 200 except in the gap area 224 where the core of the ring 220 is incomplete. The embodiment of FIG. 9 is round, like an aortic valve. FIG. 10 shows a similar embodiment 201, including a cloth cover 220, sutures 222 and a gap area 224. Embodiment 201 differs from 200 only in that it has an oblong shape suited for a tricuspid valve. Embodiment of 201 is shown as implanted in the annulus of a tricuspid valve. A prosthetic valve has not been implanted in the ring 201, but can be if necessary in the future.

[0048] Referring now to FIG. 11, there is shown an embodiment 120 of a ring having a complete shape that generally forms a circle to correspond to a valve such as the mitral valve. Elastic features 130 are shown as tapered sections, as described above. Because the ring 120 is complete, three tapered sections 130 are optionally provided to give uniform elastic traits. The elastic features 130 are placed in FIG. 8 in the middles of the leaflets, rather than at the commissure points, as shown in some of the aforementioned embodiments. The ring 120 optionally includes markers 126 such that the elastic features 130 of the ring 120 are easily visualized and correctly placed.

[0049] FIG. 11 is also shown as including a prosthetic valve V installed within the ring 120. It is to be understood that all of the embodiments of rings described herein are designed to provide optimal attachment platforms for prosthetic valves, even after the rings have been implanted and in use in situ for long periods of time, if necessary. Furthermore, the embodiment 120 shown in FIG. 11 is shown, by way of example, as having been sutured in place in a patient. It is thought that the complete ring of FIG. 11, may be better suited for surgical implant instead of percutaneous implant.

[0050] The embodiment 140 of FIG. 12 demonstrates a complete ring 140 in the shape of a “D”. The ring 140 has a core 142 and one or more elastic features 144 that comprise accordion sections, in this case three accordion sections, spaced apart around the circumference of the ring 140. The number of and lengths of the accordion sections may vary, as described above. The entire D ring may be a continuous accordion section.

[0051] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.