MEMORY MATERIAL VALVE

Abstract

A replacement heart valve comprising a memory shape element. The various embodiments use internal body heat to seat and retain the valve within a blood passage. The element can be provided in a variety of shapes and sizes, and is at least partially encased within an inert and pliant encasing material. The encasing material is one that is adapted to be contiguous with the structure of the valve nozzle or backflow-resistant leaf structure, and may be used in combination with existing stents or an incorporated stent, including ones having a structure similar to conventional stents.

Claims

1. a method of manufacturing, comprising: a step of providing a memory shape element, a step of encasing the memory shape element in a pliant, non-reactive, inert encasing material, and a step of forming a valve in connection with the encasing material, wherein the memory shape element comprises a memory shape material.

2. The method of claim 1, wherein the step of forming the valve comprises a procedure in which the encasing material is grasped and drawn to a desired length and then cut or otherwise attenuated to a desired size and shape.

3. The method of claim 1, wherein the step of encasing comprises a step of casting the encasing material around the memory shape element.

4. The method of claim 1, wherein the memory shape element comprises a metal ply rolled or bent or curved into a substantially circumferential ring.

5. The method of claim 1, wherein the memory shape element comprises a section helical section of a memory shape material, one selected from a list comprising a nickel-titanium wire coil and a helical nickel-titanium ribbon.

6. The method of claim 1, further comprising a step of augmenting at least one of the memory shape element and encasing material with a supplemental stent.

7. The method of claim 1, wherein the memory shape element is a stent.

8. The method of claim 1, wherein the valve is a distending nozzle.

9. The method of claim 1, wherein the valve is a three-leaf valve.

10. The method of claim 1, wherein the valve is in connection with the encasing material by being integrally formed and materially contiguous with the encasing material.

11. The method of claim 6, wherein the supplemental stent is dissimilarly shaped to the memory shape element and comprises a memory shape material.

12. The method of claim 6, wherein at least one end of the supplemental stent is a free end, and further comprising a step of appending the free end of the supplemental stent with an additional memory shape element.

13. The message of claim 12, wherein the memory shape element and the additional memory shape element abut opposite ends of the supplemental stent and do not otherwise contact one another.

14. The method of claim 6, wherein the supplemental stent is a counter-rotation helical coil.

15. The method of claim 6, wherein the supplemental stent is an expandable mesh stent.

16. The method of claim 1, wherein the memory shape element is provided and encased in the encasing material such that the element and material and valve are sized and shaped and sufficiently collapsible so as to be deliverable by a catheter to an internal organ of a mammal.

17. The method of claim 16, wherein the memory shape material and encasing material and valve are adjustable, and further comprising a step of adjusting the memory shape material and subjecting the memory shape material to conditions such that the memory shape material adopts a desired memory state, the memory state being one of a desired size and shape for any pre-existing valve in any particular mammal.

18. The method of claim 17, wherein the memory shape material and encasing material and valve are able to be retrieved and reset to a memory shape or size that is adapted to fit any of: the largest pre-existing valve in a particular mammal, the smallest valve of the same mammal, any size or shape that is between those of the largest valve and smallest valve, and any shape or size which is adapted to fit a valve which has changed in shape or size over time.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings in which like references indicate similar elements.

[0023] FIG. 1 Shows a front view of an embodiment of a valve in accordance with the present disclosure.

[0024] FIG. 2 shows a section view of an embodiment of a valve in accordance with the present disclosure.

[0025] FIG. 3(a) shows a perspective view of a ply of a memory shape material in accordance with the present disclosure.

[0026] FIG. 3(b) shows a perspective view of a ply of a memory shape material as partially rolled into a memory shape element of a valve in accordance with the present disclosure.

[0027] FIG. 3(c) shows a perspective view of a ply of a memory shape material as partially rolled into a memory shape element of a valve in accordance with the present disclosure.

[0028] FIG. 3(d) shows a perspective view of a ply of a memory shape material fully rolled into a memory shape element of a valve in accordance with the present disclosure.

[0029] FIG. 4 shows a perspective view of a helical ribbon memory shape element for a valve in accordance with the present disclosure.

[0030] FIG. 5 shows a perspective view of a helical coil memory shape element for a valve in accordance with the present disclosure.

[0031] FIG. 6 shows an elevation view of an embodiment of a valve with a helical coil memory shape element in a translucent encasement material in accordance with the present disclosure.

[0032] FIG. 7 shows a section view of an embodiment of a valve with a helical with a three-leaf construction in accordance with the present disclosure.

[0033] FIG. 8 shows a section view of an embodiment of a valve as installed in a blood-passage in accordance with the present disclosure.

[0034] FIG. 9 shows a section view of an embodiment of a valve having a counter-rotation coil in accordance with the present disclosure.

[0035] FIG. 10 shows a section view of an embodiment of a valve as installed in a blood-passage with a conventional stent in accordance with the present disclosure.

[0036] FIG. 11 shows a valve of the present invention as collapsed to fit onto a catheter.

DETAILED DESCRIPTION

[0037] The following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding. However, in certain instances, well known or conventional details are not described in order to avoid obscuring the description. References to one or an embodiment in the present disclosure are not necessarily references to the same embodiment; and, such references mean at least one.

[0038] Reference in this specification to one embodiment or an embodiment means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase in one embodiment in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments.

[0039] Referring to FIGS. 1, 2, and 6-10, each has a valve (5) comprising an inert encasing material (3), and at least one memory shape element at least partially encased within the encasing material (3).

[0040] Referring now to FIGS. 1 and 2, the encasing material (3) comprises a distending nozzle (19) and the memory shape element is a circumferential ring memory shape element (8).

[0041] Referring now to FIGS. 3a, 3b, and 3c, a memory shape material metal ply (7) is shown as flat in FIG. 3a, and as a partially rolled into a circumferential ring (8), shown partially rolled in FIGS. 3b and 3c, and fully rolled in FIG. 3c.

[0042] Referring now to FIG. 4 and FIG. 5, what are shown are alternative shape memory shape elements. FIG. 4, a ribbon of memory shape material is wrapped into a helical ribbon (13), and in FIG. 5, a wire of memory shape material is wrapped into a helical coil (11).

[0043] In FIG. 6, what is shown as an elevation view of a valve (5). Like FIG. 2, this valve (5) has an encasing material (3), a distending nozzle (19), but wherein the memory shape element is a memory shape wire wrapped into a helical coil (11). The memory shape helical coil (11) in this embodiment is visible because the encasing material (3) is translucent.

[0044] In FIG. 7, there is shown a sectioned elevation view of a valve (5) that, like FIG. 2, has a encasing material (3), a memory shape element (1), but where in the valve (5) is a three leaf valve (21) construction, rather than a nozzle (19, FIG. 2).

[0045] In FIGS. 8 and 9, there are shown sectioned elevation views of alternative valve embodiments as installed into a blood passage of a mammal, each the result of a valve-repair or valve-replacement procedure.

[0046] In FIG. 8, the valve (5) is similar to that of FIG. 2, comprising an encasing material (3), a memory shape element ring (8), and a nozzle (19). Here, though, the valve (5) is augmented with a supplemental stent (15), a similar construction to that of a conventional expandable stent, but this supplemental stent is partially encased in the encasing material (3). At a free end (23) of the supplemental stent (15) is a second memory shape element (25), also encased in encasing material (3).

[0047] In FIG. 9, a valve (5) similar to FIG. 6, instead comprising a partially encased helical coil memory shape element (9) that extends away from the nozzle (19), beyond the encasing material (3), and a counter-wound helical coil (27). The counter-wound helical coil (27) is coaxial with the partially encased helical coil (9), so that when the valve (5) is returned to the pre-set memory shape, the counter-wound helical coil (27) comes into contact with the helical coil (9) and creates friction against slippage, to ensure that the valve (5) fits securely when installed, and to its desired, pre-set shape.

[0048] In FIG. 10, the encasing material (3) of the valve (5) has a nozzle (19) and encases a helical ribbon memory shape element (13), but its valve (5) is fit-into a conventional-style stent (29), rather than the valve (5) being incorporated with a supplemental stent (FIG. 8, (15)).

[0049] FIG. 11 shows an embodiment of the present invention that is similar to FIG. 6, but is shown with a nozzle (19), coil (11), and encasing material (3), all collapsed onto a catheter (31). In this arrangement, the valve (5) may be delivered to a location in a blood passage intravenously.

[0050] In the foregoing specification, the disclosure has been described with reference to specific exemplary embodiments thereof. It will be evident that various modifications may be made thereto without departing from the broader spirit and scope as set forth in the following claims. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.