CN211156473U - Transcatheter aortic prosthetic valve and delivery system - Google Patents

Abstract

The utility model discloses a through pipe aorta artificial valve and conveying system, this artificial valve is including being latticed and radially can compress and the support that expands and install the artifical valve leaf in the support inboard, and the support has inflow end and outflow end, is provided with a plurality of fixed parts that outwards open and downwarping forms the semicircular barb at the support outflow end, fixed part one end linking bridge, the other end orientation flows the free end direction of end. The conveying system comprises a conveying pipe sheath and a containing pipe sheath, the containing pipe sheath is used for containing the bracket in the shrinkage state, and the fixing part and the adjusting part are positioned in the conveying pipe sheath. In the process of replacing the aortic valve of the heart, the fixing part is released firstly to enter the aortic sinus, then the stent is released to enter the in-situ aortic valve area, and the fixing part, the adjusting part and the unfolded stent mutually clamp the in-situ aortic valve. The utility model provides high aortic artificial valve's positioning accuracy and degree of accuracy have improved the success rate of valve replacement.

Description

Transcatheter aortic prosthetic valve and delivery system

Technical Field

The utility model relates to the technical field of artificial valves, in particular to a transcatheter aortic artificial valve and a conveying system.

Background

Aortic stenosis or insufficiency of the heart is a common cardiovascular disease in clinic and its incidence is increasing with aging population, with the incidence of aortic stenosis in people over 65 years of age reaching 2% -7%. The incidence of aortic insufficiency varies from species to species, with an incidence of about 4.9-10% and a marked increase with age. For these patients, there is a clinical need for prosthetic valve replacement to replace the diseased valve itself. Conventional cardiac Surgical Aortic Valve Replacement (SAVR) requires Surgical thoracotomy and is performed under general anesthesia and extracorporeal circulation assistance. In view of the highly invasive nature of SAVR surgery, its use is limited in elderly, complicated complications, surgical contraindications, or high risk aortic valve disorders patients. In recent years, with the development of Transcatheter Aortic Valve Replacement (TAVR), minimally invasive interventional therapy for Aortic Valve lesions has achieved good efficacy and significantly reduced surgical risks for patients. TAVR has been developed over a decade, and over 40 million patients in Europe and America have been treated by this technique.

As TAVR technology matures day by day, a variety of types and different mechanisms of transcatheter prosthetic valve systems have emerged, representative of which include the Edward Sapien series, the Meidun Corevve series, the Bordete L otus series, the ACURATE series, and the like, and the Hangzhou inspired VENUS series, and the Suzhou outstanding J-VA L VE series, among others.

Thus, there is a need for a new transcatheter aortic prosthetic valve and delivery system that addresses the foregoing problems.

SUMMERY OF THE UTILITY MODEL

The method aims to solve the problems in the existing transcatheter aortic valve replacement, namely the technical problems of accurate positioning and position adjustment of implantation of the artificial valve, prevention of valve displacement, consideration of stenosis and incomplete closure lesion and the like. The utility model discloses a first aspect provides a through pipe aorta artificial valve, including being latticedly and radially can compress and expand the support and install the inboard artifical valve leaf of support, the support has inflow end and outflow end the outflow end of support is provided with a plurality of fixed parts that outwards open and the decurrent formation semicircle form the barb, fixed part one end is connected support, other end orientation the free end direction of inflow end.

In some embodiments, a plurality of adjusting parts are further arranged at the outflow end of the stent, one end of each adjusting part is connected with the stent, and the other end of each adjusting part is outwards opened and downwards bent to form a barb shape and points to the outer side wall of the stent or outwards opened and upwards.

In some embodiments, the fixing portion and the adjusting portion are equally spaced.

In some embodiments, the number of the fixing portions and the number of the adjusting portions are equal, the fixing portions and the support form a first closed grid hole, the adjusting portions and the support form a second closed grid hole, and the second grid hole is located in the first grid hole.

In some embodiments, the adjusting part is provided with a connecting part for connecting an adjusting cable of the conveying system.

In some embodiments, the connector is a threaded hole capable of being screwed with the adjusting cable; or the connecting piece is a locking head and can be locked with the locking groove on the adjusting cable; or the connecting piece is a lock catch groove and can be locked with a lock catch head on the adjusting cable.

In some embodiments, 12 rhombic cells are transversely arranged at the outflow end, so as to form 12 vertexes, each 4 continuous vertexes form a connection area, two vertexes on the outermost side in each connection area are respectively connected with the same fixing part, and two vertexes on the innermost side in each connection area are respectively connected with the same adjusting part.

In some embodiments, the stent is laser cut or woven based on shape memory alloy and/or superelastic alloy materials.

In a second aspect of the present invention, there is also provided a delivery system for replacement of a subject's aortic heart valve, the system comprising a delivery sheath insertable into the subject's aorta, a containment sheath disposed at a distal end of the delivery sheath, and a transcatheter aortic prosthetic valve as described above;

wherein the transcatheter aortic prosthetic valve is in a compressed state, the fixation portion and adjustment portion of the transcatheter aortic prosthetic valve are disposed within a sheath distal to the delivery sheath, and a remainder of the transcatheter aortic prosthetic valve is disposed within the containment sheath.

The utility model provides a through pipe aorta artificial valve, conveying system and conveying method have following beneficial effect at least:

the outflow end of the artificial valve support is provided with a plurality of fixing parts which are outwards opened and form semi-annular barbs, so that the fixing parts are positioned in the aortic sinus, the accurate positioning and releasing of the artificial valve are realized, and the safety of transcatheter heart aortic valve replacement is improved.

Furthermore, a plurality of adjusting parts are arranged at the outflow end of the stent, the valve stent can be finely adjusted based on the adjusting parts, the positioning precision is further improved, the adjusting parts are outwards opened and downwards bent to form a barb shape after being completely released, and the tail ends point to the outer side wall of the valve stent to clamp the in-situ aortic valve, so that the artificial valve is prevented from shifting.

Drawings

Fig. 1 is a schematic perspective view of a transcatheter aortic prosthetic valve according to an embodiment of the present invention;

fig. 2 is a schematic top view of a transcatheter aortic prosthetic valve in an embodiment of the invention;

FIG. 3 is a schematic view of the main structure of a transcatheter aortic prosthetic valve adjustment cable prior to release in an embodiment of the present invention;

fig. 4 is a schematic illustration of a transcatheter aortic prosthetic valve stent in a flattened state according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of the main structure of a transcatheter aortic prosthetic valve delivery system in an embodiment of the present invention;

FIG. 6 is a schematic view of a transcatheter aortic prosthetic valve delivery system in accordance with an embodiment of the present invention in use releasing a stent retaining portion;

FIG. 7 is a schematic view of a transcatheter aortic prosthetic valve delivery system in accordance with an embodiment of the present invention in an expanded position for delivery of a valve stent;

FIG. 8 is a schematic view of an embodiment of the present invention showing a deployed state of a transcatheter aortic prosthetic valve delivery system with the adjustment cable disengaged and the prosthetic valve fully released;

fig. 9 is one of the flow diagrams of a transcatheter aortic prosthetic valve delivery method in an embodiment of the invention;

fig. 10 is a second schematic flow chart of a method of transcatheter aortic prosthetic valve delivery in accordance with an embodiment of the present invention;

fig. 11 is a third schematic flow chart of a method of transcatheter aortic prosthetic valve delivery in accordance with an embodiment of the present invention;

fig. 12 is a fourth schematic flow chart of a method of transcatheter aortic prosthetic valve delivery in an embodiment of the invention.

Detailed Description

Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only for explaining the technical principle of the present invention, and are not intended to limit the scope of the present invention.

Referring to fig. 1 to 3, fig. 1 to 3 illustrate the main structure of a transcatheter aortic prosthetic valve, and as shown, the transcatheter aortic prosthetic valve comprises a stent 1 having a lattice shape and being radially compressible and expandable, and prosthetic leaflets 2 and a skirt 3 installed inside the stent 1, and the stent 1 may be laser cut or woven based on a shape memory alloy and/or super-elastic alloy material. The artificial valve leaflet 2 is arranged at the waist position inside the bracket 1 and can be opened and closed in a one-way mode to form a blood channel for blood to enter the aorta from the left ventricle, and the number of the artificial valve leaflet 2 can be two, three or more. The material of the artificial valve leaflet 2 can be animal pericardium, such as bovine pericardium and porcine pericardium, or polymer material, such as polytetrafluoroethylene, fiber cloth or fiber membrane, and the like, or medical metal, pyrolytic carbon, and the like, and the artificial valve leaflet 2 can also be a replaceable material of other heart valves. The skirt 3 is installed inside the stent 2 to increase the sealing performance, and the material of the skirt 3 may be animal pericardium, such as bovine pericardium, porcine pericardium, or the like, or polymer material, such as polytetrafluoroethylene, fiber cloth, or fiber membrane, or the like. In some embodiments, the prosthetic valve may not include a skirt. Aforementioned artificial valve leaf 2 and 3 material of shirt and installation are prior art, no longer describe here, the utility model provides a per catheter aortic artificial valve key feature lies in:

the stent is provided with an inflow end 4 and an outflow end 5, a plurality of fixing parts 6 which are outwards opened and are downwards bent to form semi-annular barbs are arranged at the outflow end 5 of the stent 1, one end of each fixing part 6 is connected with the stent 1, and the other end of each fixing part faces to the direction of a free end of the inflow end 4. Specifically, when the fixing portion 6 is laid out flat in a two-dimensional plane, the shape of the fixing portion 6 includes, but is not limited to, a half-ring shape, a triangular shape, a rectangular shape, a half-oval shape, and an arched door shape. When the stent 1 is in a deployed three-dimensional state, the fixing part 6 is of a structure which is flared outwards and bent downwards to form a semi-annular barb (as shown in figure 3). The fixing portion 6 may have a height of 2mm to 30mm and a width of 2mm to 30mm when it is in an expanded state (or released state).

In some embodiments, a plurality of adjusting parts 7 are further provided at the outflow end 5 of the stent 1, one end of each adjusting part 7 is connected with the stent 1, and the other end is flared outwards and bent downwards to form a barb shape pointing to the outer side wall of the stent 1, or flared outwards and upwards. Specifically, when the adjusting part 7 is in a fully opened (i.e., fully released, or the adjusting cable is released) three-dimensional state, the adjusting part 7 is opened outward and bent downward in a barb shape toward the outer side wall of the stent 1 (as shown in fig. 1). When the adjusting portions 7 are not fully opened (i.e., not fully released, or the adjusting cable is not released), the adjusting portions 7 are opened outward and upward, and the plurality of adjusting portions 7 form a bell mouth shape, or a petal shape (as shown in fig. 3). The adjusting part 7 has a shape including but not limited to a triangle, a semicircular, a square, a rectangle, a semicircle, a semiellipse, and an arched door shape when the two-dimensional plane is spread out, and the height of the adjusting part may be 2mm to 30mm when the adjusting part is in an incomplete spreading state.

The fixing portions 6 and the adjusting portions 7 are provided at equal intervals, specifically, the fixing portions 6 and the adjusting portions 7 may be provided in parallel along the outflow end 5 of the stent 1 at equal intervals, for example, repeatedly arranged by the fixing portions 6, the adjusting portions 7, the fixing portions 6, the adjusting portions 7 …, etc., so as to surround the outflow end 5 of the stent 1; the fixing part 6, the adjusting part 7, the fixing part 6 …, and the like may be repeatedly arranged so as to surround the outflow end 5 of the stent 1; the adjusting part 7, the fixing part 6, the adjusting part 7, the fixing part 6, the fixing parts 6, …, etc. may be repeatedly arranged to surround the outflow end 5 of the stent 1; these surrounding modes can be adjusted by analogy according to the actual application. Of course, the fixing portion 6 may be sleeved with the adjusting portion 7, for example, one adjusting portion 7 is sleeved in one fixing portion 6, two adjusting portions 7 are sleeved in one fixing portion 6, three adjusting portions 7 are sleeved in one fixing portion 6, and the like, or one fixing portion 7 is sleeved in one adjusting portion 7, two fixing portions 6 are sleeved in one adjusting portion 7, three fixing portions 6 are sleeved in one adjusting portion 7, and the like.

Referring to fig. 4, fig. 4 exemplarily shows a flat state of the bracket after being cut open, that is, a state of cutting open and flatly laying the bracket 1 on a two-dimensional plane, as shown in fig. 4, the number of the fixing portions 6 and the adjusting portions 7 is equal, the fixing portions 6 and the bracket form a first closed grid hole, the adjusting portions 7 and the bracket form a second closed grid hole, and the second grid hole is located in the first grid hole. More specifically, the outflow end 5 is transversely provided with 12 rhombic grids so as to form 12 vertexes, each 4 continuous vertexes form a connection area, the two vertexes on the outermost side in each connection area are respectively connected with the same fixing part 6, and the two vertexes on the innermost side in each connection area are respectively connected with the same adjusting part 7. Furthermore, 3 rhombic grids are arranged in the longitudinal direction from the inflow end 4 to the outflow end 5 and are connected with each other to form the body structure of the bracket 1. In this embodiment, when the stent 1 is in the expanded state of the three-dimensional space, the vertical distance from the highest point of the adjusting portion 7 to the top point of the free end of the fixing portion 6 may be 2mm to 30 mm.

In some embodiments, a connector (not shown) is provided on the adjustment portion 7 for connecting the adjustment cable 8 of the conveying system. The delivery system is a delivery device for the prosthetic valve, and the adjustment cable 8 is a cable, in this embodiment a thin steel cable, in the delivery system that controls release and position adjustment of the prosthetic valve. More specifically, the connecting piece is a threaded hole, a thread matched with the threaded hole is arranged at the tail end of the adjusting cable 8, and the adjusting cable 8 is in threaded connection with the threaded hole; or the connecting piece is a locking head, a locking groove matched with the locking notch groove is arranged on the adjusting cable 8, and locking connection is carried out on the locking head and the locking notch groove; or the connecting piece is a lock catch groove, a lock catch head matched with the lock catch groove is arranged on the adjusting cable 8, and the adjusting cable is in lock catch connection with the lock catch head through the lock catch groove.

The embodiment of the present invention further provides a delivery system for replacing a heart aortic valve of a subject, referring to fig. 5, fig. 5 exemplarily shows the main structure of the delivery system, as shown in fig. 5, the delivery system comprises a delivery sheath 9 insertable into an aorta of the subject, a containing sheath 10 disposed at a distal end of the delivery sheath 9, and a transcatheter aortic prosthetic valve as described above; wherein, the transcatheter aortic valve prosthesis is in a compressed state, the fixing part 6 and the adjusting part 7 of the transcatheter aortic valve prosthesis are arranged in a tube sheath at the distal end of the delivery tube sheath 9, and the rest part of the transcatheter aortic valve prosthesis is arranged in the containing tube sheath 10. In addition, each adjusting part 7 is connected through different adjusting cables 8, and the other end of each adjusting cable 8 extends out of the conveying tube sheath 9, so that the operator can conveniently operate and control each part. It should be noted that the accommodating sheath 9 and the delivery sheath 10 may not be directly connected.

Referring to fig. 5 to 8, which schematically show the use flow of the conveying system, as shown in the figure, three adjusting parts 7 are connected to the bracket 1, and each adjusting part 7 is connected to one adjusting cable 8. Delivering the delivery system through a peripheral artery, preferably the femoral artery, and the containment sheath 10 down the aortic annulus into the left ventricular outflow tract; by fixedly accommodating the sheath 10, the delivery sheath 9 is withdrawn to release the fixed part 6 and the adjusting part 7; in the process of opening the fixing part 6, the fixing part 6 is accurately hooked in the three aortic sinuses 11 through the adjusting cable 8 corresponding to the fine adjustment part 7; after the position is adjusted, the conveying sheath 9 and the adjusting cable 8 are fixed, and the forward accommodating sheath 10 completely releases the valve stent into the aortic valve area; after the proper shape and position of the stent 1 of the aortic artificial valve are determined, the adjusting cable 8 on the adjusting part 7 is unfastened, so that the adjusting part 7 forms a barb shape after being completely opened and is hooked on the in-situ aortic valve 12. After the stent 1 of the artificial valve is completely expanded, the outer side wall of the stent 1, the fixing part 6 and the adjusting part 7 form a structure similar to a hairpin, and the structure clamps the in-situ aortic valve 12 together to prevent the stent 1 from falling off or shifting.

The embodiment of the present invention further provides a delivery method for replacing a heart aortic valve of a subject, the delivery method comprising:

step S1: providing a delivery system as described above;

step S2: delivering a containment sheath 10 below the aortic annulus to access the left ventricular outflow tract based on the delivery sheath 9 being threaded through the subject's peripheral artery;

step S3: the holding sheath 10 is fixed and the delivery sheath 9 is withdrawn, the fixing part 6 and the adjusting part 7 are released, so that the fixing part 6 is expanded outwards and forms a semi-annular barb to enter the aortic sinus 11;

step S4: fixing a conveying sheath 9 and an adjusting cable 8, advancing to accommodate a sheath 10 and releasing the stent 1, so that the stent 1 is unfolded and fixed in the in-situ aortic valve region;

step S5: further releasing the adjusting part 7, the adjusting part 7 is expanded to form a barb pointing to the outer side wall of the stent so as to further clamp and fix the in-situ aortic valve 12.

The conveying method provided by the invention is described below with reference to the accompanying drawings and a specific embodiment.

Referring to fig. 9 to 12, the main flow of the conveying method is exemplarily shown: after the delivery system is delivered through the peripheral artery, preferably the femoral artery, and the containment sheath 10 is delivered to the subvalvular left ventricular outflow tract; the fixing part 6 and the adjusting part 7 are released by fixing the inner core 13 of the conveying system and adjusting the cable 8, withdrawing the conveying pipe sheath 9; the fixing part 6 is opened and the position thereof is adjusted to be accurately hooked into the aortic sinus 11; after the position is adjusted, the sheath containing pipe 10 is moved forwards to release the stent 1 of the artificial valve by fixing the adjusting cable 8 and the conveying sheath pipe 9; after the shape and the position of the artificial valve are determined to be proper, the adjusting cable 8 on the adjusting part 7 is removed, so that the adjusting part 7 is unfolded and reversely hooks the in-situ aortic valve 12; after the stent 1, the fixing part 6 and the adjusting part 7 are completely opened, the outer side wall of the stent 1, the fixing part 6 and the adjusting part 7 form a structure similar to a hairpin, and the outer side wall, the fixing part 6 and the adjusting part 7 clamp the in-situ aortic valve 12 together to prevent the stent 1 from falling off or shifting. The inner core is an elongated metal tube penetrating through the center of the whole conveying system to provide support for the whole system, and other sheath tube parts and the valve stent are sleeved outside the inner core; the method comprises the following steps in sequence from inside to outside along the radial direction: the valve stent comprises an inner core, a valve stent and a sheath tube for accommodating the valve stent. The middle of the inner core metal tube can enable a longer stiffened guide wire to penetrate through, and the whole conveying system is conveyed into the heart, namely the stiffened guide wire is firstly conveyed into the heart, and then the inner core of the conveying system is sleeved with the stiffened guide wire and conveyed into the heart along the stiffened guide wire.

The utility model provides a through pipe aorta artificial valve when guaranteeing valve support accurate positioning, also provides sufficient holding power and clamping-force, prevents that valve support from shifting.

Further, the fixing part arranged at the outflow end of the stent is of a semi-annular barb structure, the fixing part is hooked at the aortic sinus part after being opened (after being released) so as to realize accurate positioning and fixing of the artificial valve, and the fixing part and the adjusting part are mutually clamped with the outer side wall of the stent after being unfolded (after being released) to form a structure similar to a hairpin, so that the fixing part and the adjusting part can jointly clamp the in-situ aortic valve so as to fix the valve stent and prevent the stent from shifting.

Further, the position of the support can be finely adjusted by the adjusting part, so that the inaccuracy of the initial release position is prevented, the heart valve replacement is failed, and the life of a subject is prevented from being influenced.

Further, the fixed part, the adjustment portion sets up the outflow end at the artificial valve support, artificial valve support and fixed part, the adjustment portion is after opening completely, the lateral wall and the fixed part of support, the adjustment portion forms similar "hairpin" structure, centre gripping normal position aortic valve jointly, prevent that the valve support from droing or shifting, compare with traditional artificial valve, utilize the mode that fixed part and adjustment portion got into the aortic sinus and centre gripping normal position aortic valve jointly, it is more simple accurate to make the release of valve support, the position is also more firm, therefore, under the state that artificial valve is opened completely, the part that the support outflow end is higher than aortic valve ring can be designed lower, prevent that the part that is higher than aortic valve ring from oppressing the coronary artery opening, arouse other complications.

It is noted that, as used herein, a "subject" is an individual including, but not limited to, an animal (e.g., a human, horse, pig, rabbit, dog, sheep, goat, non-human primate, cow, cat, guinea pig, or rodent), fish, bird, reptile, or amphibian. The term does not denote a particular age or gender. Thus, it also includes adult and newborn subjects as well as fetuses (whether male or female).

It should be noted that in the description of the present invention, various elements in the embodiments are depicted in a scale, size, deformation amount or displacement amount suitable for the description, and are not drawn in a scale of an actual element.

It should be noted that in the description of the present invention, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "front", "rear", etc. indicating the directions or positional relationships are based on the directions or positional relationships shown in the drawings, which are only for convenience of description, and do not indicate or imply that the device or element must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

Furthermore, it should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; may be a mechanical connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

The terms "comprises," "comprising," or any other similar term are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

So far, the technical solution of the present invention has been described with reference to the preferred embodiments shown in the drawings, but it is easily understood by those skilled in the art that the scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle of the present invention, a person skilled in the art can make equivalent changes or substitutions to the related technical features, and the technical solutions after these changes or substitutions will fall within the protection scope of the present invention.

Claims (9)

1. A transcatheter aortic prosthetic valve comprising a stent having a lattice shape and being radially compressible and expandable, and prosthetic valve leaflets mounted inside the stent, wherein the stent has an inflow end and an outflow end, and a plurality of anchoring portions are provided at the outflow end of the stent, the anchoring portions being outwardly flared and bent downward to form semi-annular barbs, one end of the anchoring portion being connected to the stent, and the other end thereof being directed toward a free end of the inflow end.

2. The transcatheter aortic prosthetic valve of claim 1, further comprising a plurality of adjustment members disposed at the outflow end of the stent, wherein one end of each adjustment member is connected to the stent and the other end of each adjustment member is flared outward and bent downward in a barb shape directed toward the outer sidewall of the stent or flared outward and upward.

3. The transcatheter aortic prosthetic valve of claim 2, wherein the fixation portion and the adjustment portion are equally spaced.

4. The transcatheter aortic prosthetic valve of claim 2, wherein the number of the anchoring portions and the adjustment portions are equal,

the fixing part and the support form a first closed grid hole, the adjusting part and the support form a second closed grid hole, and the second grid hole is positioned in the first grid hole.

5. The transcatheter aortic prosthetic of claim 2, wherein the adjustment portion comprises a connector configured to connect to an adjustment cable of a delivery system.

6. The transcatheter aortic prosthetic valve of claim 5, wherein the connector is a threaded hole threadably engaged with the adjustment cable; or

The connecting piece is a locking head and can be locked with the locking groove on the adjusting cable; or

The connecting piece is a lock catch groove and can be locked with a lock catch head on the adjusting cable.

7. The transcatheter aortic prosthetic valve of claim 2, wherein the outflow end has 12 diamond-shaped meshes disposed laterally, thereby forming 12 apices, each 4 consecutive apices forming a connecting region, the two apices at the outermost side of each connecting region being connected to a same one of the anchoring portions, and the two apices at the innermost side of each connecting region being connected to a same one of the adjustment portions.

8. The transcatheter aortic prosthetic valve of any one of claims 1-7, wherein the stent is laser cut or woven based on a shape memory alloy and/or superelastic alloy material.

9. A delivery system for replacement of a subject's aortic heart valve, the system comprising a delivery sheath insertable into the subject's aorta, a containment sheath disposed distal to the delivery sheath, and the transcatheter aortic prosthetic valve of any one of claims 2 to 8;

wherein the transcatheter aortic prosthetic valve is in a compressed state, the fixation portion and adjustment portion of the transcatheter aortic prosthetic valve are disposed within a sheath distal to the delivery sheath, and a remainder of the transcatheter aortic prosthetic valve is disposed within the containment sheath.

Images