CN110478085B

CN110478085B - Heart valve prosthesis and fillable structure thereof

Info

Publication number: CN110478085B
Application number: CN201910864378.9A
Authority: CN
Inventors: 吕守良; 徐磊; 施磊
Original assignee: Chengdu Serano Medical Technology Co ltd
Current assignee: Chengdu Serano Medical Technology Co ltd
Priority date: 2019-09-12
Filing date: 2019-09-12
Publication date: 2022-05-17
Anticipated expiration: 2039-09-12
Also published as: CN110478085A

Abstract

The invention provides a heart valve prosthesis and a fillable structure thereof, the heart valve prosthesis comprising: an annular cuff having an inner surface defining a blood flow path, the annular cuff having a proximal annular conduit at one end and a distal annular conduit at the other end; a valve positioned within the blood flow path and connected to the cuff, the valve being capable of allowing flow within the blood flow path in a direction that the distal annular tube points towards the proximal annular tube and preventing flow within the blood flow path in a direction that the proximal annular tube points towards the distal annular tube; an inflatable structure connected to the annular cuff having a proximal annular cavity and a distal annular cavity, the proximal annular tube surrounding the proximal annular cavity and the distal annular tube surrounding the distal annular cavity; the proximal ring cavity has a tendency to contract inwardly to reduce the circumference of the outer profile of the proximal ring cavity.

Description

Heart valve prosthesis and fillable structure thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve prosthesis and a fillable structure thereof.

Background

Aortic Stenosis (AS) is a common cardiovascular disease, and its incidence increases with age. Once AS patients have symptoms, the prognosis is very poor, and if the AS patients do not intervene in time, the median survival time of the AS patients is 2-3 years.

Surgical Aortic Valve Replacement (SAVR) is the standard treatment for severe AS patients with indications. However, patients of advanced age with complications have a very high surgical risk and slow postoperative recovery. Statistically, there are more than 1/3 patients with severe AS who are unable to perform SAVR.

Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Aortic Valve Implantation (TAVI) has the advantage of less trauma and is a new choice for the treatment of the above-mentioned patients. More and more clinical studies are also exploring the possibility of TAVR in patients with low or medium risk. Currently, the FDA in the united states has approved some products for use in patients at low or medium risk, but the suitability for use in younger patients remains to be confirmed by more clinical trials in view of the issue of durability.

Due to the valve design and the operation, various complications may occur after the valve is implanted, such as vascular complications, regurgitation, stroke, and cardiac electrical block, and the complications may include the following: (1) vascular complications, mainly related to the approach procedure, commonly used vascular complications of the transfemoral route are related to the diameter of the sheath; (2) bleeding, including complications of access puncture sites, right ventricular perforation by pacemaker leads, aortic annular rupture, aortic dissection aneurysms, left ventricular perforation by stiff guidewires, and the like; (3) cerebrovascular events such as stroke, self-expanding valve and valve overdimension are independent risk factors for thrombosis, post-balloon dilatation, valve displacement, valve-in-TAVI are independent risk factors for stroke; (4) acute kidney injury, intraoperative debris embolization of the renal artery, hypotension during rapid pacing and use of contrast agents are risk factors for acute kidney injury; (5) aortic regurgitation, which is divided into central regurgitation and paravalvular leakage, mainly paravalvular leakage, wherein the central regurgitation is related to incomplete valve deployment, and the paravalvular leakage factors include too high or too low valve position, calcification of valve placement area, and mismatch of valve size and valve ring size; (6) abnormal valve position is mostly related to poor release position, and the reasons include improper valve size, insufficient expansion, hypertrophic obstructive cardiomyopathy and the like; (7) the coronary artery is blocked by the valve leaflets of the patient, particularly calcified valve leaflets, and clinical researches show that the coronary artery is easy to block when the opening height of the coronary artery is less than 10 mm; (8) arrhythmias, including atrioventricular block and atrial fibrillation, are more prone to atrioventricular block due to the larger volume and contact area of the self-expanding valve compared to a balloon valve, and require the implantation of a permanent pacemaker for severe atrioventricular block.

US7556645B2, US8012201B2, US7435257B2, US7445630B2, US7320704B2, US7534259B2, US8377118B2 and US20090088836a1 disclose the structure of a valve prosthesis, US9603708B2, CN104602646B and CN106794064A disclose the structure of a delivery system for a valve prosthesis. The valve prosthesis is conveyed to the position of the native valve through the conveying system, and the valve prosthesis replaces the native valve to play a physiological function. The valve prosthesis is provided with a fillable structure, and a filling medium can be filled into the fillable structure or can be drawn out of the fillable structure through a conveying system; the valve prosthesis is made of flexible materials, and after the filling medium is drawn out, the valve prosthesis is in a shriveled state, so that the valve prosthesis can be conveniently conveyed. After the valve prosthesis reaches the accurate position, the filling medium is filled, so that the valve prosthesis is completely unfolded and released.

CN106794064A discloses an aortic valve implant 800, and a combined delivery system for delivering the aortic valve implant 800; the aortic valve implant 800 includes a fillable structure 813 and the combined delivery system includes a delivery catheter 900. In the aortic valve implantation through the femoral artery, in order to enable the aortic valve implant 800 to be smoothly deployed at the native valve of the heart, the aortic valve implant 800 needs to be firstly conveyed into the left ventricle of the human body, and after the aortic valve implant 800 enters the left ventricle, the filling medium is filled into the fillable structure 813, after the aortic valve implant 800 is tested to be normal in function, the filling medium in the proximal end 803 is extracted, and the proximal end 803 is in a deflated state, so that the aortic valve implant 800 can be pulled upwards to be clamped at the aortic valve annulus of the heart.

However, in surgical procedures, the difficulty of pulling the proximal end of the aortic valve implant from the left ventricle through the aortic annulus into the aorta is greater for patients with more aortic stenosis and a smaller annular opening.

Disclosure of Invention

The invention aims to provide a heart valve prosthesis and a fillable structure thereof, which are used for relieving the technical problem of the prior art that the difficulty of pulling the proximal end of the heart valve prosthesis from the left ventricle to the aorta is high when a patient with more narrow aorta and small annular opening is caused.

The above object of the present invention can be achieved by the following technical solutions:

the present invention provides a heart valve prosthesis comprising: an annular cuff having an inner surface defining a blood flow path, the annular cuff having a proximal annular tube at one end and a distal annular tube at the other end; a valve positioned within the blood flow path and connected to the cuff, the valve being configured to permit flow within the blood flow path in a direction along the distal annular duct toward the proximal annular duct and to prevent flow within the blood flow path in a direction along the proximal annular duct toward the distal annular duct; an inflatable structure connected to the annular cuff having a proximal annular cavity and a distal annular cavity, the proximal annular channel surrounding the proximal annular cavity and the distal annular channel surrounding the distal annular cavity; the proximal ring cavity has a tendency to contract inwardly to reduce the circumference of the outer profile of the proximal ring cavity.

In a preferred embodiment, the material of the proximal annular cavity is an elastic material; the circumference of the outer contour of the proximal annular channel is smaller than the circumference of the outer contour of the distal annular channel in the deflated state of the proximal annular cavity.

In a preferred embodiment, the modulus of elasticity of the material of the proximal annular cavity is smaller than the modulus of elasticity of the material of the distal annular cavity.

In a preferred embodiment, in the inflated state, the outer contour of the proximal ring cavity has a circumference L and a diameter D; in a deflated state, the circumference of the outer contour of the proximal annular cavity is L 'and the diameter is D'; the following relation is satisfied:

(D/D′)＜(L/L′)。

in a preferred embodiment, the perimeter L of the outer contour of the proximal ring cavity in the inflated state, the perimeter L' of the outer contour of the proximal ring cavity in the deflated state;

the following relation is satisfied:

150％≤(L/′)≤500％。

in a preferred embodiment, the following relationship is satisfied:

200％≤(L/L′)≤450％。

in a preferred embodiment, the following relationship is satisfied:

250％≤(L/L′)≤400％。

in a preferred embodiment, the tolerable burst pressure of the proximal ring cavity is greater than or equal to 5 atm.

In a preferred embodiment, the tolerable burst pressure of the proximal ring cavity is greater than or equal to 16 atm.

In a preferred embodiment, the material of the proximal annular cavity comprises any 1 monomer or any 2 or more mixed composite of PVC, thermoplastic elastomer, latex and silicon rubber.

In a preferred embodiment, the material of the proximal annular cavity comprises Chronoprene or Pebax.

In a preferred embodiment, the proximal annular duct is capable of preventing the outer profile of the proximal annular cavity from expanding outwards.

In a preferred embodiment, the inflatable structure comprises a strut portion disposed between the proximal annular chamber and the distal annular chamber; the proximal annular cavity and the strut part are formed separately and are fixedly connected together.

In a preferred embodiment, the heart valve prosthesis is adapted to the aortic annulus.

The invention provides a fillable structure of a heart valve prosthesis, which is applied to the heart valve prosthesis and comprises: the support column comprises a proximal annular cavity, a distal annular cavity and a support column part arranged between the proximal annular cavity and the distal annular cavity; the material of the near-end annular cavity is made of elastic material, so that the near-end annular cavity has a tendency of shrinking inwards to reduce the perimeter of the outer contour of the near-end annular cavity.

The invention has the characteristics and advantages that:

when the heart valve prosthesis provided by the invention moves from the left ventricle to the aorta, the filling medium in the proximal annular cavity can be firstly extracted, the proximal annular cavity loses the supporting effect of the filling medium, the material of the proximal annular cavity is made of an elastic material, so that the proximal annular cavity has the tendency of inward contraction, and because the proximal annular cavity is wrapped by the proximal annular pipeline, the proximal annular cavity and the proximal annular pipeline can contract inward together, the perimeter of the outer contour of the proximal annular pipeline is reduced, so that the proximal end of the heart valve prosthesis is reduced, the obstruction of the proximal end of the heart valve prosthesis when passing through the native aortic valve annulus is reduced, the proximal end of the heart valve prosthesis can smoothly move to the side of the aortic valve annulus far away from the left ventricle, and the conveying difficulty is reduced.

After the heart valve prosthesis reaches an accurate position, filling media are filled into the fillable structure, the proximal annular cavity and the distal annular cavity reach an inflated state, the proximal annular cavity applies outward expansion acting force to the proximal annular pipeline, the trend that the proximal annular pipeline contracts inwards is overcome, the annular cuff is matched with the aortic valve annulus, and the heart valve prosthesis is completely unfolded.

The heart valve prosthesis provided by the invention has better recoverable and relocatable performance, good perivalvular leakage prevention effect, easy transportation and release, accurate positioning, convenient operation, convenient adjustment to keep coaxiality with the orientation of the heart, high compressibility, capability of effectively reducing vascular complications, reducing the probability of coronary artery blockage and electrocardio conduction block, no need of using anticoagulant for the whole life, suitability for patients with aortic stenosis and more convenience for clinical operation.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic cross-sectional view of a heart and its major blood vessels;

FIG. 2 is a cross-sectional view of a heart valve prosthesis provided in accordance with the present invention positioned at the aortic annulus;

FIG. 3A is a schematic diagram of a conveyor system;

FIG. 3B is a schematic view of a heart valve prosthesis provided in accordance with the present invention attached to the delivery system of FIG. 3A;

FIG. 3C is a schematic diagram of the structure of the PFL conduit in the delivery system shown in FIG. 3A;

FIG. 3D is a cross-sectional view taken along line A-A of FIG. 3A;

FIGS. 4A-4C are schematic illustrations of steps in the partial deployment and positioning of a heart valve prosthesis;

FIGS. 5A-5E are schematic views of steps in a heart valve prosthesis deployment, testing, and repositioning process;

FIG. 6A is a schematic view of a heart valve prosthesis in a deflated state;

FIG. 6B is a top view of the heart valve prosthesis shown in FIG. 6A;

FIG. 7A is a perspective view of a heart valve prosthesis provided in accordance with the present invention in a filled state;

FIG. 7B is a top view of the heart valve prosthesis shown in FIG. 7A;

FIG. 8A is a schematic structural view of a heart valve prosthesis provided in accordance with the present invention in a filling state;

FIG. 8B is a radial cross-sectional view of the heart valve prosthesis shown in FIG. 8A;

FIG. 8C is an enlarged partial view of the upper left portion of FIG. 8B;

FIG. 9 is a schematic view of the inflatable structure of the heart valve prosthesis shown in FIG. 8A;

FIG. 10 is a schematic view of a connection port with a PFL conduit;

FIG. 11 is a schematic view of the inflatable structure of the heart valve prosthesis of the present invention shown prior to deployment in assembly with the circumferential cuff;

FIG. 12A is a schematic view of a heart valve prosthesis provided in accordance with the present invention in a deflated state;

FIG. 12B is a top view of the heart valve prosthesis shown in FIG. 12A;

FIG. 13A is a schematic view of the fabric used to form the circumferential cuff of the first embodiment of the heart valve prosthesis of the present invention;

FIG. 13B is a schematic view of the fabric used to form the cuff in a second embodiment of the heart valve prosthesis of the present invention;

FIG. 14A is a top view of a third embodiment of a heart valve prosthesis according to the present invention with the proximal annular duct attached to the elastic band;

FIG. 14B is a front view of FIG. 14A;

FIG. 14C is a top view of the attachment of the proximal annular duct to the elastic band of the fourth embodiment of the heart valve prosthesis provided in accordance with the present invention;

FIG. 14D is a front view of FIG. 14C;

FIG. 15A is a schematic view of a fifth embodiment of a heart valve prosthesis according to the present invention with the proximal annulus in a filling state;

FIG. 15B is a schematic illustration of a fifth embodiment of a heart valve prosthesis according to the present invention with the proximal annulus in a deflated state.

The reference numbers illustrate:

32. a left ventricle; 34. an aortic valve; 36. the aorta;

800. a heart valve prosthesis; 880. an axis of the annular cuff; 881. the axial direction of the annular cuff; 882. a cross-sectional direction of the annular cuff;

801. a folding part; 8011. a proximal annular conduit; 8012. a distal annular conduit;

802. an annular cuff; 8021. a weft; 8022. warp threads; 8023. a cuff waist part;

803. a proximal end of a heart valve prosthesis; 804. a distal end of a heart valve prosthesis; 805. a waist part;

812. a suture;

813. a fillable structure; 806. a pillar section; 807a, proximal ring cavity; 807b, distal ring lumen; 808. filling the channel;

809. a connection port;

810. a fill valve; 8101. a first fill valve; 8102. a second fill valve;

303. a ball; 304. a soft seal; 305. a detent ball plunger; 312. a tubular portion;

811. a one-way valve;

104. a valve; 1041. fixing the edge; 1042. a free edge;

300. snaring; 400. an elastic band;

900. a delivery catheter;

901. an outer tubular member; 902. an outer tube proximal end; 903. an outer tube distal end;

904. an inner tubular member; 905. an inner tube proximal end; 906. an inner tube distal end; 911. a marking tape;

907. a handle; 908. an external sheath handle;

912. a sheath; 913. an external sheath marker band;

914. a guidewire conduit; 915. a guidewire tube tip;

916. a PFL pipe; 917. a luer fitting; 918. a pressure reducing portion; 919. a needle; 920. PFL labeling;

921. a side port valve.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In order to make the heart valve prosthesis provided by the invention easier to understand, the heart and the way in which the heart valve prosthesis provided by the invention fits in the heart are briefly described next, as well as a delivery system, a method for its delivery and a filling medium.

Heart and heart

Fig. 1 is a schematic sectional view of a heart and its main vessels, and fig. 2 is a sectional view of a heart valve prosthesis provided in the present invention at the aortic annulus. In delivering the heart valve prosthesis, the heart valve prosthesis 800 is first delivered into the left ventricle 32, and then the heart valve prosthesis 800 is moved toward the aorta 36 with the proximal end 803 of the heart valve prosthesis crossing the aortic annulus to form the mated configuration shown in FIG. 2.

Conveying system

The delivery system is used to deliver the heart valve prosthesis 800 provided by the present invention to the aortic annulus of the heart.

The delivery system includes a delivery catheter 900. referring to fig. 3A-3D, the delivery catheter 900 may include an elongate flexible catheter body extending from a proximal end of the delivery catheter 900 to a distal end of the delivery catheter 900. In some embodiments, the catheter body has a maximum outer diameter of about 18fr (french) or less, and the outer diameter is less at the distal portion (i.e., the deployed portion) of the catheter body.

Certain features of the heart valve prosthesis 800 and the delivery catheter 900 are particularly advantageous for facilitating delivery of the heart valve prosthesis 800 within a catheter body having an outer diameter of about 18Fr or less while still maintaining a tissue valve thickness of equal to or greater than about 0.011 inches, and/or an effective orifice area of equal to or greater than about 1 square centimeter, or in another embodiment equal to or greater than about 1.3 square centimeters, or in another embodiment equal to or greater than about 1.5 square centimeters.

In one embodiment, the heart valve prosthesis 800 can be delivered through a deployment catheter having an outer diameter of 18F or less, and when fully filled, the Effective Orifice Area (Effective Orifice Area) of the heart valve prosthesis 800 is greater than or equal to 1.0 square centimeters; in another embodiment, having an effective orifice area of at least about 1.3 square centimeters; in another embodiment, has an effective orifice area of about 1.5 square centimeters. In one embodiment, the heart valve prosthesis 800 has a minimum cross-sectional flow area of at least about 1.75 square centimeters.

In some embodiments, the outer diameter of the heart valve prosthesis 800 after deployment is greater than or equal to 22 mm. In some embodiments, the catheter body and the heart valve prosthesis 800 are connected by PFL tubing 916. In one embodiment, the delivery system is compatible with a 0.035 "or 0.038" guidewire.

The delivery catheter 900 may be constructed from extruded tubing. In some embodiments, the delivery catheter 900 may incorporate braided or coiled wires and/or ribbons into the tubing to provide enhanced stiffness and rotational strength. The number of threads and/or ribbons ranges from 1 to 64. Preferably, the number of threads and/or ribbons ranges from 8 to 32. The wire has a diameter in the range of 0.0005 inch to about 0.0070 inch. If ribbons are used, the thickness is preferably less than the width, and the thickness of the ribbons can range from about 0.0005 inch to about 0.0070 inch, while the width can range from about 0.0010 inch to about 0.0100 inch. In another embodiment, using a coil as the reinforcing member, the coil may comprise between 1 and 8 number of wires or ribbons wound around the circumference of the tube and embedded in the tube. The wires may be wound loose so that they are parallel to each other and in the plane of curvature of the tube surface, or multiple wires may be wound in opposite directions in separate layers. The dimensions of the wire or ribbon used for the coil may be similar to those used for the webbing.

Referring to fig. 3A, delivery catheter 900 may include an outer tubular member 901 extending from the proximal end of delivery catheter 900 to the distal end of delivery catheter 900, and an inner tubular member 904 extending from the proximal end of delivery catheter 900 to the distal end of delivery catheter 900; the outer tubular member 901 has an outer tube proximal end 902 and an outer tube distal end 903; the inner tubular member 904 has an inner tube proximal end 905 and an inner tube distal end 906. The inner tubular member 904 may generally extend through the outer tubular member 901, such that the inner tube proximal end 905 and the inner tube distal end 906 of the inner tubular member 904 extend beyond the outer tube proximal end 902 and the outer tube distal end 903 of the outer tubular member 901, respectively.

The outer tube distal end 903 of the outer tubular member 901 may include a sheath 912 and a stem region extending proximally from the sheath 912. In some embodiments, sheath 912 is made of a polymeric material, such as KYNAR tubing. Referring to fig. 3A and 3B, a sheath 912 can receive the heart valve prosthesis 800 in a contracted state for delivery to an implantation site. In some embodiments, sheath 912 is capable of propagating at least a portion of light within the visible spectrum. This allows visualization of the orientation of the heart valve prosthesis 800 within the delivery catheter 900. In some embodiments, an outer sheath marker band 913 may be placed at the outer tube distal end 903 of the outer tubular member 901.

In some embodiments, sheath 912 may have a larger outer diameter than the trunk region of the adjacent or proximal outer tubular member 901. In these embodiments, sheath 912 and the backbone region may comprise separate tubing assemblies that are attached or otherwise coupled to one another. In other embodiments, the outer tubular member 901 can be expanded to form a larger diameter sheath 912 such that the trunk region and sheath 912 are formed from a common tubular member to facilitate reducing the diameter of the trunk region.

Referring to fig. 3A, the inner tubular proximal end 905 of the inner tubular member 904 is connected to a handle 907 to grasp and move the inner tubular member 904 relative to the outer tubular member 901. The outer tube proximal end 902 of the outer tubular member 901 can be connected to an outer sheath handle 908 to grasp and hold the outer tubular member 901 stationary relative to the inner tubular member 904. Preferably, between the outer tubular member 901 and the inner tubular member 904, a hemostatic seal 909 may be provided, and the hemostatic seal 909 may be disposed in the outer sheath handle 908. In some embodiments, the external sheath handle 908 comprises a side port valve 921, and fluid can flow into the external tubular member through the side port valve 921.

Referring to fig. 3D, the inner tubular member 904 comprises a multi-lumen hypotube. In some embodiments, the neck section 910 of the inner tubular member 904 is located at the inner tube proximal end 905. Neck section 910 can be made of stainless steel, nitinol, or another suitable material that can be used to provide additional force to move inner tubular member 904 within outer tubular member 901. In some embodiments, referring to fig. 3B, a marker band 911 is present at the inner tube distal end 906. The wall thickness of the multi-lumen hypotube ranges from 0.004 inches to 0.006 inches. Preferably, the multi-lumen hypotube has a wall thickness of about 0.0055 inches, which provides sufficient column strength and increases the bending load required to kink the hypotube. In some embodiments, referring to fig. 3D, the inner tubular member 904 includes at least four lumens, one of which may house a guidewire tubing 914 and each of the other lumens may house a placement PFL tubing 916. The guidewire channel 914 can be configured to receive a guidewire. The PFL tubing 916 can be configured to serve both as a control line for placement of the heart valve prosthesis 800 at the implantation site and as a fill tube for delivery of liquid, gas, or a filling medium to the heart valve prosthesis 800. In particular, the PFL tubing 916 may allow for angular adjustment of the heart valve prosthesis 800. That is, the valve plane of the heart valve prosthesis 800 perpendicular to its axis can be adjusted by the PFL conduit 916 to ensure the coaxiality of the heart valve prosthesis 800 and the human annulus.

Referring to fig. 3A and 3B, generally, the guidewire tube 914 may be longer than and extend through the length of the delivery catheter 900. Due to operator control, the proximal end of the guidewire tube 914 may be passed through the inner sheath handle 907; the distal end of the guidewire tube 914 can extend beyond the outer tube distal end 903 and can be coupled to a guidewire tube tip 915. The guidewire tube tip 915 can be proximal to the outer tube distal end 903 and protect the retracted heart valve prosthesis 800, for example, during advancement of the delivery catheter. The guidewire tube tip 915 can be moved away from the outer tubular member 901 by proximally retracting the outer tubular member 901 while holding the guidewire tube 914 stationary. Optionally, the guidewire tube 914 may be advanced while holding the outer tubular member 901 stationary. The guidewire tube 914 may have an inner diameter of about 0.035 inches to about 0.042 inches, thus, the catheter system is compatible with commonly used 0.035 "or 0.038" guidewires. In some embodiments, the guidewire tube 914 can have an inner diameter of about 0.014 inches to about 0.017 inches, thus, the catheter system is compatible with a 0.014 "diameter guidewire. The guidewire tube 914 may be made of a lubricious material such as polytetrafluoroethylene, polypropylene, or a polymer impregnated with polytetrafluoroethylene. The guidewire tube 914 may also be coated with a lubricious or hydrophilic coating.

The guidewire tube tip 915 may be tapered, bullet shaped, or hemispherical at the forward end. Preferably, the maximum diameter of the guidewire tube tip 915 is approximately the same as the diameter of the outer tube distal end 903. Preferably, the guidewire tube tip 915 is reduced in diameter to a diameter slightly smaller than the inside diameter of the outer sheath 912 so that the tip can engage the outer sheath 912 and provide a smooth transition. The forward end of the guide wire channel 914 is wrapped by the guide wire tube tip 915 to the forwardmost end of the guide wire tube tip 915, a guide wire may be inserted from the end of the guide wire channel 914, through the guide wire tube tip 915, in an exemplary embodiment, the guide wire tube tip 915 is connected to the guide wire channel 914, and a guide wire lumen (guide wire lumen) passes through a portion of the guide wire tube tip 915. The proximal face of the guidewire tube tip 915 also has a tapered, bullet-shaped, or hemispherical shape so that the guidewire tube tip 915 can be easily retracted across the deployed heart valve prosthesis 800 and into the deployment catheter so that, after implantation, the guidewire tube tip 915 is retracted back into the delivery catheter without becoming entangled with the heart valve prosthesis 800. The guidewire tube tip 915 can be made of a rigid polymer, such as polycarbonate, or a lower durometer material that allows flexibility, such as silicone. Alternatively, the guidewire tube tip 915 can be made from a variety of materials having different durometers. For example, the portion of the guidewire tube tip 915 that engages the outer tube distal end 903 can be made of a rigid material, while the distal and/or proximal end of the guidewire tube tip 915 can be made of a lower durometer material.

Further, the guidewire tube tip 915 is configured to be inserted directly into a blood vessel along a guidewire. In this manner, the guidewire tube tip 915 and sheath 912 can be used to directly enlarge the incoming blood vessel to accommodate an introducer catheter positioned along the delivery catheter.

Each PFL conduit 916 may extend the entire length of the delivery catheter 900. The proximal end of the PFL tubing 916 passes through the handle 907 and has a luer 917 to connect to a source of fluid, gas or filling medium. The distal end of the PFL tubing 916 extends through the hypotube lumen beyond the inner tube distal end 906 of the inner tubular member 904. Referring to fig. 3C, in some embodiments, the PFL tubing 916 includes a reduced-pressure portion 918 at the proximal end connected to the luer 917, and when manipulated by an operator, the reduced-pressure portion 918 acts to relieve tension on the PFL tubing 916. The distal end of the PFL tubing 916 includes a tip or needle 919 to connect to the heart valve prosthesis 800. In some embodiments, one end of the needle 919 has a threaded portion. In some embodiments, the distal and/or proximal end of the PFL tubing 916 may have PFL markings 920 for identification.

In some embodiments, the PFL tubing 916 is designed to accommodate easy rotation in curved anatomical structures. The PFL tubing 916 can be constructed using a polyimide braided tube, a nickel titanium alloy hypotube, or a stainless steel hypotube. Preferably, the PFL tubing 916 is made of braided polyimide, made of a polyimide inner liner braided with flat wire, encapsulated by another polyimide layer and sheathed with a polyether block polyamide and nylon outer layer; specifically, Pebax is used as the polyether block polyamide. In some embodiments, a nitinol sleeve may be added to the proximal end of the PFL tubing 916 to improve torque transmission, kink resistance, and push force. In some embodiments, a smooth silicone coating may also be used to coat the outer surface of the PFL tubing 916 and/or the inner surface of the lumen in a multi-lumen hypotube to reduce friction. In some embodiments, an inner lining material such as polytetrafluoroethylene may be used on the inner surface of the lumen in a multi-lumen hypotube to reduce friction and improve performance in bending. In addition, a non-slip coating such as silicone oil or MDX silicone or a hydrophilic coating may also be added to provide another form of friction reducing element; preferably, the silicone oil is DOW 360. This may provide precise control of the PFL conduit 916 during placement of the heart valve prosthesis 800. In some embodiments, the outside surface of the PFL pipe 916 may be jacketed and reflowed with another nylon 12 or Rilsan AESNO layer to ensure a smooth and delicate surface. In some embodiments, an anti-thrombogenic coating may also be placed on the outer surface of the PFL tubing 916 to reduce the risk of thrombus formation on the tubing.

In some embodiments, delivery catheter 900 has an outer diameter in the range of 0.030 inches to 0.200 inches and outer tubular member 901 has a wall thickness in the range of 0.005 inches to 0.060 inches. In certain embodiments, the outer diameter of outer tubular member 901 can be between about 0.215 inches and about 0.219 inches. In this embodiment, the wall thickness of outer tubular member 901 is between about 0.005 inches and about 0.030 inches. The overall length of the delivery catheter 900 ranges from about 80 centimeters to about 320 centimeters. In some embodiments, the working length of the outer tubular member 901 (from the distal end of the sheath 912 to the point where the outer tubular member 901 is connected to the outer sheath handle 908) may be about 100cm to about 120 cm. In some embodiments, the inner diameter of sheath 912 may be greater than or equal to about 0.218 inches and the outer diameter of sheath 912 is less than or equal to about 0.241 inches. In preferred embodiments, the outer diameter of sheath 912 may be less than or equal to about 0.236 inches or 18 Fr. In some embodiments, the PFL tubing 916 may have an outer diameter of less than or equal to about 0.0435 inches and a length of about 140cm to 160 cm.

Preferably, the heart valve prosthesis 800 in a contracted state fits into the sheath 912. The sheath 912 may have an outer diameter of 18Fr or less.

The retracted heart valve prosthesis 800 is generally loaded between the outer tube distal end 903 and the inner tube distal end 906. Thus, the outer tube distal end 903 may form a receptacle for the heart valve prosthesis 800. By holding the heart valve prosthesis 800 stationary while the outer tubular member 901 is collapsed, the heart valve prosthesis 800 can be exposed or pushed out of the container. Alternatively, the outer tubular member 901 may remain stationary while the inner tubular member 904 is advanced, thereby pushing the heart valve prosthesis 800 out of the container.

Conveying method

The delivery system can adopt the delivery method to deliver the heart valve prosthesis provided by the invention to the aortic valve ring of the heart.

When the medical catheter is clinically applied, the guide wire is inserted into a body, the lumen of the guide wire pipeline 914 is aligned with the guide wire and pushed into the human body, the whole delivery system enters the body along the guide wire, and the guide wire plays a guiding role. Referring to fig. 3B, a delivery catheter 900 carrying a heart valve prosthesis 800 is advanced transvascularly. In some embodiments, the delivery catheter 900 is inserted along a guidewire. In these embodiments, the guidewire tube tip 915 can be inserted directly into the vessel along the guidewire. In some embodiments, the delivery catheter 900 is advanced until the external sheath handle 908 reaches the patient. In other embodiments, the delivery catheter 900 may be advanced to a position proximate the native valve as the delivery catheter 900 is further advanced.

In other embodiments, it may be desirable to incorporate an introducer catheter that is used to establish a vascular access, with the introducer catheter being used in conjunction with the delivery catheter 900.

In some embodiments, the heart valve prosthesis 800 may be revealed or exposed by partially or fully retracting the outer tubular member 901 while holding the inner tubular member 904 stationary and allowing proper placement at or below the native valve. In some embodiments, the heart valve prosthesis may also be revealed by distally pushing the inner tubular member 904 while holding the outer tubular member 901 stationary. Once the heart valve prosthesis 800 is extracted, the heart valve prosthesis 800 can be moved proximally or distally and a fluid or filling medium can be introduced into the fillable structure 813 to provide shape and structural integrity. In some embodiments, the distal annular cavity 807b can be first filled with a first liquid and the heart valve prosthesis 800 placed at the implantation site using the connection between the heart valve prosthesis 800 and the delivery catheter 900. In some embodiments, no more than three connections are present. In some embodiments, the connector is a PFL conduit 916, which can be used to control the heart valve prosthesis 800 and fill the fillable structure 813.

Deployment of the heart valve prosthesis 800 may be controlled by a PFL conduit 916 detachably connected to the heart valve prosthesis 800. The PFL tubing 916 is attached to the heart valve prosthesis 800 such that the heart valve prosthesis 800 can be manipulated and placed after removal from the delivery catheter 900. Preferably, three PFL conduits 916 are used, the PFL conduits 916 being capable of providing precise control of the heart valve prosthesis 800 during deployment and placement. The PFL conduit 916 can be used to move the heart valve prosthesis 800 proximally and distally, or to tilt the heart valve prosthesis 800 and change its angle relative to the native anatomy to facilitate adjusting the concentricity of the heart valve prosthesis 800 with the heart.

In some embodiments, the heart valve prosthesis 800 includes multiple fill valves 810 to allow an operator to fill specific areas of the heart valve prosthesis 800 with different amounts or pressures of fluid or gas.

Referring to fig. 4A-4C, in some embodiments, the heart valve prosthesis 800 is initially partially deployed in the left ventricle 32 (fig. 4A). Partially filling the fill channel 808 allows the distal annulus 807b of the heart valve prosthesis 800 to open to nearly its full diameter while the proximal annulus 807a is in an unfilled state. The heart valve prosthesis is then pulled back to the position at or near the annulus of the aortic valve 34 (fig. 4B). In some embodiments, first, the distal annular cavity 807b is at least partially filled, and then the heart valve prosthesis 800 is proximally retracted to span the aortic valve 34. The distal annulus 807b is located on the ventricular side of the aortic annulus and positions the heart valve prosthesis 800 itself directly above the annulus of the aortic valve 34 in the aortic root. At this point, the PFL tract 916 may help separate the fused commissures by moving in the same mechanism that the cutting balloon breaks fibers or calcified lesions, enabling the PFL tract 916 to cut the tissue fused portion apart by motion. Additional fill fluid or gas may be added to completely fill the heart valve prosthesis 800 such that the heart valve prosthesis 800 extends across the native valve annulus, extending slightly to both sides (see fig. 4C). The PFL tubing 916 provides a mechanism to transfer force between the handle of the delivery catheter 900 and the heart valve prosthesis 800. The heart valve prosthesis 800 may be advanced or retracted in the proximal or distal direction by moving all of the PFL conduits 916 or the inner tubular member 904 together. By advancing only a portion of the PFL conduit 916 relative to the other PFL conduits 916, the angle and orientation of the heart valve prosthesis 800 can be adjusted relative to the native anatomy. Radiopaque markers on the heart valve prosthesis 800 or on the PFL tubing 916, or the radiopacity of the PFL tubing 916 itself, may help indicate the heart valve prosthesis 800 orientation when the operator positions and orients the heart valve prosthesis 800.

In some embodiments, the heart valve prosthesis 800 has two fill valves 810 located at each end of the fill channel 808, and a one-way valve 811 located in the fill channel 808. A one-way valve 811 is provided so that fluid or gas can flow in the direction from the proximal annular cavity 807a to the distal annular cavity 807 b. In some embodiments, the heart valve prosthesis 800 is completely filled by pressurizing a charge pump attached to the first PFL conduit 916 in communication with the first fill valve 8101 leading to the proximal annulus 807a when the charge pump attached to the second fill valve 8102 in communication with the distal annulus 807b is closed. Fluid or gas may flow through the one-way valve 811 into the distal annular cavity 807 b. The proximal annular cavity 807a is then deflated by depressurizing the charge pump attached to the second fill valve 8102. The distal ring cavity 807b will remain filled because fluid or gas cannot leak past the one-way valve 811. The heart valve prosthesis 800 is then placed across the native annulus. Once a satisfactory placement is obtained, the proximal annular cavity 807a may be filled again.

In some embodiments, the heart valve prosthesis 800 may have only one fill valve 810.

When the filling channel 808 is filled with fluid or gas, the proximal portion of the heart valve prosthesis 800 may be slightly constrained by separating the PFL conduits 916 while the distal portion is more fully expanded. Generally, the amount by which the PFL tubing 916 limits the proximal diameter of the heart valve prosthesis 800 depends on the length of the PFL tubing 916 extending beyond the outer tubular member 901, which can be adjusted by the operator. In other embodiments, a safety barrier or flow restrictor may be used to control the filling of the proximal portion of the heart valve prosthesis 800.

The heart valve prosthesis 800 may also be deflated or partially deflated for further adjustment after initial deployment. As shown in fig. 5A, the heart valve prosthesis 800 may be partially deployed and the heart valve prosthesis 800 placed against the aortic valve 34 using PFL tubing 916. The heart valve prosthesis 800 may then be fully deployed as shown in fig. 5B, and then tested as shown in fig. 4C. If the test passes, the heart valve prosthesis 800 may be deflated and moved to a more optimal position as shown in FIG. 5D. The heart valve prosthesis 800 can then be fully deployed and released from the PFL conduit 916 as shown in fig. 5E.

In some embodiments, the fluid or gas may be replaced by a filling medium that hardens to form a more permanent support structure in the body. Once the operator is satisfied with the position of the heart valve prosthesis 800, the PFL tubing 916 is then disconnected and the catheter is removed, leaving the heart valve prosthesis 800 behind (see fig. 5E), along with the hardenable filling medium. The filling medium is allowed to solidify within the fillable structure 813. Disconnection methods may include severing the attachment, rotating the screw, removing or shearing the pin, mechanically decoupling the interlocking assembly, electrically separating the fused joints, removing the constrained cylinder from the tube, crushing the engineered area, removing the collet device to reveal the mechanical joint, or other methods known in the art. In modified embodiments, the steps may be reversed or their order modified as desired.

Preferably, the guidewire exits the distal tip of the guidewire at least 5 degrees from the delivery system axial direction and at an angle between 10 degrees and 40 degrees. This allows the delivery catheter 900 to be rotated to direct the guidewire directly at the aortic valve to allow easy crossing of the valve by the guidewire. In one embodiment, the tip is shaped similarly to the shape of a tubular arterial guide catheter commonly used to traverse an aortic valve.

In another embodiment, the tip is steerable and the curvature of the tip is selectable by the operator. In one embodiment, this is accomplished by using a wire drawing.

In some embodiments, a steerable guidewire is included as an accessory.

The above methods generally describe embodiments of aortic valve replacement. However, similar or modified methods may also be used to replace the pulmonary valve or mitral or tricuspid valves. For example, the pulmonary valve may be accessed through the venous system, or through any of the femoral or jugular veins. Through the venous system described above, the mitral valve can be accessed, and then the left atrium accessed in a trans-septal manner from the right atrium. Alternatively, the mitral valve may be accessed through the arterial system as described for the aortic valve, alternatively a catheter may be used to pass through the aortic valve and then back up to the mitral valve.

Filling medium

The filling medium can be used to fill the fillable structure in the heart valve prosthesis provided by the present invention.

Any of various filling media may be used to fill the fillable structures 813 depending on the desired properties. In general, the fill medium may comprise a liquid such as water or a water-based solution such as CO₂May be introduced into the fill channel 808 at a relatively low viscosity and converted to a relatively high viscosity. The viscosity enhancement may be accomplished by polymerization by ultraviolet light or any of various known catalysts, or other chemical systems known in the art. The end point of the tack-enhancing process may be at any state of stiffness from gel to rigid structure depending on the desired properties and durability.

Useful filling media generally include those formed by mixing a plurality of components and having a curing time ranging from tens of minutes to about one hour, preferably from about twenty minutes to about one hour. These materials may be biocompatible, exhibit long-term stability (preferably at least about ten years in vivo), pose as little risk of embolism as possible, exhibit suitable mechanical properties both before and after curing, and are suitable for in vivo service of the cuff 802. For example, these materials should have a relatively low viscosity before setting or curing to facilitate the filling process of the filling channels 808. These fill media range in elastic modulus from 50psi to 400psi after cure, which balances the need for the fillable structure 813 to form an adequate seal in the body while maintaining the clinically relevant kink resistance of the cuff 802. The ideal filling medium should be radiopaque both in the short and long term, although this is not absolutely necessary.

One preferred family of hardenable filling media is two-part epoxy resins. The first part is an epoxy blend comprising a first aromatic diepoxy compound and a second aliphatic diepoxy compound. The first aromatic diepoxy compound provides good mechanical and chemical stability in an aqueous environment, but is soluble in aqueous solutions when combined with an aliphatic epoxy resin. In some embodiments, the first aromatic diepoxy compound comprises at least one N, N-diglycidylaniline group or fragment. In some embodiments, the first aromatic diepoxy compound is an optionally substituted N, N-diglycidylaniline, and the substituent may be glycidoxy or N, N-diglycidylanilino-methyl (N, N-diglycidylanilinyl-methyl). Non-limiting examples of the first aromatic diepoxy compound are N, N-diglycidylaniline, N-diglycidyl-4-glycidyloxyaniline (N, N-diglycidyl-4-glycidyloxyaniline (DGO)), and 4, 4' -methylenebis (N, N-diglycidylaniline) (MBD), and the like.

The second aliphatic diepoxy compound provides low viscosity and good solubility in aqueous solutions. In some embodiments, the second aliphatic diepoxide may be 1, 3-butadiene diepoxide, a glycidyl ether, or a C1-5 alkylene glycol glycidyl ether. Non-limiting examples of the second aliphatic diepoxy compound are 1, 3-butadiene, butanediol diglycidyl ether (BDGE), 1, 2-ethylene glycol diglycidyl ether, glycidyl ether, and the like.

In some embodiments, additional third compounds may be added to the first part of the epoxy blend to improve mechanical properties and chemical resistance. In some embodiments, the additional third compound may be an aromatic epoxy resin instead of one containing N, N-diglycidylaniline. However, as the concentration of aromatic epoxy increases, the solubility of the epoxy blend can also decrease and the viscosity can increase. Preferred third compounds may be trimethyl alkane (4-hydroxyphenyl) triglycidyl ether (THTGE), bisphenol a diglycidyl ether (BADGE), bisphenol F diglycidyl ether (BFDGE), or resorcinol diglycidyl ether (RDGE).

In some embodiments, the additional third compound may be a cycloaliphatic epoxy compound, preferably more soluble than the first aromatic diepoxy compound. It may increase mechanical properties and chemical resistance to a lesser extent than the aromatic epoxies described above, but it will not reduce solubility as much. Non-limiting examples of such cycloaliphatic epoxy resins are 1,4-cyclohexanedimethanol divinyl ether (1, 4-cyclohexanedimethanoldicyclidyl ether) and cyclohexene oxide diglycidyl ester of 1,2-cyclohexanedicarboxylate (cyclohexeneoxydididiglycidyl 1, 2-cyclohexanedicarboxide). In some embodiments, an aliphatic epoxy resin having three or more glycidyl ether groups, such as glycidyl ethers, may be added as the other third compound for the same reason. Glycidyl ethers may increase crosslinking and thus enhance mechanical properties.

Generally, as the concentration of the first aromatic diepoxide increases, the solubility of the epoxy resin blend decreases and the viscosity increases. In addition, as the concentration of the aliphatic diepoxy compound in the epoxy resin blend increases, mechanical properties and chemical resistance may be reduced. By adjusting the ratio of the first aromatic diepoxy compound and the second aliphatic diepoxy compound, one skilled in the art can control the desired properties of the epoxy blend and the quench media. In some embodiments, the addition of a third compound may allow for further tailoring of the properties of the epoxy resin.

The second part of the hardenable filling medium comprises a hardener comprising at least one alicyclic amine. Which provides a good combination of reactivity, mechanical properties and chemical resistance. Alicyclic amines may include, but are not limited to, Isophoronediamine (IPDA), 1, 3-bisaminocyclohexane (1,3-BAC), Diaminocyclohexane (DACH), N-Aminoethylpiperazine (AEP), or N-Aminoethylpiperazine (APP).

In some embodiments, an aliphatic amine may be added to the second part to increase the reaction rate, but may reduce the mechanical properties and chemical resistance. Preferred aliphatic amines have the following chemical structure:

wherein each R is independently selected from a C2-5 alkyl branch or linear chain, preferably C2 alkyl. The term "alkyl" as used herein refers to a fully saturated hydrocarbon including, but not limited to, radicals of methyl, ethyl, n-propyl, isopropyl (or i-propyl), n-butyl, isobutyl, tertiary butyl (or t-butyl), n-hexyl, and the like. For example, the term "alkyl" as used herein includes fully saturated hydrocarbons as defined by the following formula CnH2n + 2. In some embodiments, the aliphatic amines may include, but are not limited to, Tetrapentamethyleneamine (TEPA), diethylenetriamine, and triethylenetetramine. In some embodiments, the stiffening agent may further include at least one radiopaque compound, such as iodobenzoic acid.

A specific two-component medium is listed below. The medium includes:

first part-epoxy blend

(1) N, N-diglycidyl-4-glycidyloxyaniline (DGO) present in a ratio ranging from about 10 to about 70 weight percent; specifically, present in a ratio of about 50 weight percent, (2) butanediol diglycidyl ether (BDGE) is present in a ratio ranging from about 30 to 75 weight percent; specifically, in a ratio of about 50 weight percent, and optionally, (3)1,1, 4-cyclohexanedimethanol divinyl ether, in a ratio range of from about 0 to about 50 weight percent.

Second part-amine curing agent

(1) Isophorone diamine (IPDA), present in a weight percent ratio ranging from about 75 to about 100, and optionally, (2) Diethylenetriamine (DETA), present in a weight percent ratio ranging from about 0 to about 25.

Preferably, the mixed uncured filling medium has a viscosity of less than 2000 cps. In one embodiment, the epoxy-based filling medium has a viscosity of 100-200 cps. In another embodiment, the fill medium has a viscosity of less than l000 cps. In some embodiments, the epoxy-based resin mixture has an initial viscosity of less than about 50cps, or less than about 30cps after mixing. In some embodiments, the average viscosity is from about 50cps to about 60cps within the first 10 minutes after mixing the components of the two fill media. The low viscosity ensures that a filling medium, such as an 18Fr catheter, can be delivered through the filling lumen of a small diameter deployment catheter.

In some embodiments, the fill channel 808 may be connected at both ends to the PFL conduit 916. This allows the fill channel 808 to be pre-filled with a non-solidifying material such as a gas or liquid, CO if gas, is selected₂And helium are the preferred choice. Preferably, the pre-filled medium is radiopaque so as to be determinable by angiography. Contrast agents commonly used in interventional cardiology can be used to add sufficient radiopacity to most liquid pre-filled media. When it is desired to permanently leave the heart valve prosthesis 800 and exchange the pre-filled medium for a permanent filling medium, the permanent filling medium is injected into the filling channel via the first catheter connection. In some embodiments, the permanent fill medium is capable of solidifying into a semi-solid, gel, or solid state. As the permanent filling medium is introduced to the fillable structure 813, the pre-filled medium is expelled from the second catheter connection. With introduction of a permanent filling mediumVirtually all of the pre-filled media will be ejected. In one embodiment, an intermediate fill media may be used to prevent entrapment of the pre-filled media in the permanent fill media. In one embodiment, the intermediate fill medium is a gas and the pre-fill medium is a liquid. In another embodiment, the intermediate fill medium or pre-fill medium may act as a primer (primer) to assist in the permanent bonding of the fill medium to the interior surface of the fill channel. In another embodiment, the pre-fill media or the intermediate fill media acts as a mold release agent to prevent permanent fill media from sticking to the inner surfaces of the fill channel.

The permanent fill media may have a different radiopacity than the pre-filled media. Extremely radiopaque devices tend to mask other nearby features under angiography. During the pre-filling step, it may be desirable to clearly visualize the fill channel 808, and therefore, a very radiopaque fill medium may be selected. A less radiopaque filling medium may be preferred when filling the device with a permanent filling medium. The feature of less radiopacity is beneficial for visualization of normal valve function when injecting contrast agent into the ventricle or aorta.

The fill media, delivery system and method have been described above.

In a transfemoral aortic valve implantation procedure, the heart valve prosthesis 800 is deflated and folded at an oblique angle when loaded prior to loading the heart valve prosthesis 800 into the delivery catheter 900, the length of the folded heart valve prosthesis 800 is greater than the height of the expanded heart valve prosthesis 800, the cross-sectional profile of the folded heart valve prosthesis is reduced to allow loading into the sheath at the front end of the delivery catheter 900 with minimal compression volume, the cross-sectional profile of the conduit of the delivery catheter 900 is reduced to allow smooth transvascular delivery into the heart, to facilitate passage through smaller or vascularly diseased vessels, and to reduce the incidence of vascular complications.

After the heart valve prosthesis 800 is delivered into the human body through the delivery catheter 900, the heart valve prosthesis 800 cannot be smoothly unfolded at the native valve annulus of the heart due to the inclined folding, and the heart valve prosthesis 800 needs to be delivered into the left ventricle of the human body first, and after the heart valve prosthesis 800 enters the left ventricle, the filling medium is injected into the filling channel 808 of the heart valve prosthesis 800, and after the function of the heart valve prosthesis 800 is tested to be correct, the heart valve prosthesis 800 can be pulled up to the aortic valve annulus of the heart.

After testing, a vacuum is applied to the distal end of fill channel 808, and the portion above check valve 811 can be deflated, i.e., proximal annulus 807a and a portion of strut portion 806 can be deflated, while distal annulus 807b downstream of check valve 811 remains inflated. The proximal annular cavity 807a can be reduced in cross-sectional area by pulling so that the heart valve prosthesis 800 is disposed between the left ventricle and the aortic outflow tract through the native annulus, and the heart valve prosthesis 800 is fully deployed by filling the proximal annular cavity 807a of the heart valve prosthesis 800 with a filling medium, which may be followed by a release operation of the heart valve prosthesis 800.

Fig. 4A-4C show schematic views of the proximal annular cavity 807a of the heart valve prosthesis 800 in a deflated state, pulled by the PFL conduit 916. The proximal annulus 807a is thin and amorphous, and when pulled by the PFL conduit 916, the proximal annulus 807a has a cross-section that is somewhat smaller than the cross-section of the distal annulus 807b, but the proximal annulus 807a is still larger in cross-section relative to the aortic annulus and is still more obstructed from passing. There may be increased difficulty in the procedure due to over-narrowing or severe bivalvularization or calcification of the patient's aortic valve.

To alleviate the above problem, the following two ways can be adopted:

(1) in operation in vivo, 3 PFL tubes 916 connected to the heart valve prosthesis 800 are pulled back into the outer tubular member 901 of the delivery catheter 900, and the distance between the distal ends of the 3 PFL tubes 916 and the portion of the delivery catheter 800 to which the heart valve prosthesis 800 is connected is reduced, which in turn reduces the outer contour of the proximal annulus 807a of the heart valve prosthesis 800. However, because the heart valve prosthesis 800 is in vivo, the reduced extent of the proximal annular cavity 807a cannot be visually observed, which increases the difficulty of the procedure, and pulling on the delivery system increases the contact of the delivery system with the inner wall of the vessel, increasing the risk of potential vessel injury.

(2) Pulling 3 PFL tubes 916 in sequence causes different portions of the proximal annulus 807a to pass sequentially through the aortic valve, thus increasing the operating time, i.e., increasing the blood blocking time, affecting the patient's blood circulation and increasing the risk of kidney damage, although the difficulty of crossing the annulus is slightly reduced.

However, the inventors have found that the narrowing of the amorphous loose proximal ring 807a is limited by pulling alone. For patients with more aortic stenosis and small annular openings, there may be greater difficulty in pulling the proximal end 803 of the heart valve prosthesis into the aortic outflow tract.

To this endThe present inventors have developed an improvement to the heart valve prosthesis 800 to alleviate the prior art problem of difficulty in pulling the proximal end of the aortic valve prosthesis from the left ventricle 32 through the aortic annulus and into the aorta for patients with more aortic stenosis and a smaller annular opening.

The following description will be primarily in the context of replacing or repairing an abnormal or diseased aortic valve 34. However, one skilled in the art will appreciate from the disclosure herein that various features of the methods and structures disclosed herein may be applied to replace or repair a mitral valve, a pulmonary valve, and/or a tricuspid valve of a heart. In addition, one skilled in the art will also recognize that various features of the methods and structures disclosed herein may also be used in other parts of the body that contain or may benefit from the addition of valves, such as the esophagus, stomach, ureters and/or blebs, bile ducts, lymphatic system, and intestinal tract; for example, hooks are added to fit the mitral valve.

Heart valve prosthesis

The present invention provides a heart valve prosthesis, as shown in fig. 7A, 7B and 8A, the heart valve prosthesis 800 including: an cuff 802, a valve 104, and an inflatable structure 813 attached to the cuff 802; the annular cuff 802 has an inner surface defining a blood flow path, one end of the annular cuff 802 is provided with a proximal annular tube 8011, and the other end of the annular cuff 802 is provided with a distal annular tube 8012; the valve 104 is positioned in the blood flow path and connected to the cuff 802, the valve 104 being configured to allow flow in the blood flow path in a direction pointing along the distal annular tube 8012 towards the proximal annular tube 8011 and to block flow in the blood flow path in a direction pointing along the proximal annular tube 8011 towards the distal annular tube 8012; the inflatable structure 813 has a proximal annular cavity 807a and a distal annular cavity 807b, the proximal annular tube 8011 enclosing the proximal annular cavity 807a and the distal annular tube 8012 enclosing the distal annular cavity 807 b; the proximal annular conduit 8011 has a tendency to contract inwardly to reduce the circumference of the outer profile of the proximal annular conduit 8011.

When the heart valve prosthesis 800 moves from the left ventricle 32 to the aorta 36, the filling medium in the proximal annular cavity 807a can be firstly extracted, the proximal annular cavity 807a loses the supporting function of the filling medium, because the proximal annular cavity 807a is wrapped by the proximal annular pipeline 8011, the proximal annular cavity 807a and the proximal annular pipeline 8011 contract inwards together, the circumference of the outer contour of the proximal annular pipeline 8011 is reduced, so that the proximal end 803 of the heart valve prosthesis is reduced, the obstruction of the proximal end 803 of the heart valve prosthesis when passing through the native aortic annulus is reduced, the proximal end 803 of the heart valve prosthesis can move to the side of the aortic annulus far away from the left ventricle smoothly, and the conveying difficulty is reduced.

After the heart valve prosthesis 800 reaches the correct position, the filling structure 813 is filled with a filling medium, the proximal annular cavity 807a and the distal annular cavity 807b reach the filling state, the proximal annular cavity 807a exerts an outward expansion acting force on the proximal annular tube 8011, the tendency of inward contraction of the proximal annular tube 8011 is overcome, the annular cuff 802 is matched with the aortic valve 34, and the heart valve prosthesis 800 is completely unfolded.

When the proximal annular cavity 807a is filled with the filling medium, the inward contraction tendency of the proximal annular tube 8011 is overcome by the supporting force generated by the filling medium, and the proximal end 803 of the heart valve prosthesis is instantly expanded under pressure, so as to ensure that the heart valve prosthesis 800 is completely unfolded. The pressure at which the filling medium is injected into the fillable structure 813 can be adjusted and can be determined according to the requirements.

When the proximal end 803 of the heart valve prosthesis is not supported by the fillable structure 813, the cross section profile can be automatically reduced, so that the proximal end 803 of the heart valve prosthesis can conveniently enter an aortic outflow tract, the friction on an aortic valve annulus is reduced, the possibility of scraping calcified tissues is reduced, the valve can be quickly passed, the possibility of cerebrovascular stroke is reduced, and the clinical application value is very high.

Moreover, the heart valve prosthesis 800 provided by the invention has better recoverable and relocatable performance, has good perivalvular leakage prevention effect, is easy to convey and release, can be accurately positioned, is convenient to operate, is convenient to adjust to keep the coaxiality with the orientation of the heart, has high compressibility, can effectively reduce vascular complications, reduces the probability of blocking coronary arteries and causing electrocardio-conduction block, does not need to use an anticoagulant for the whole life, is more suitable for patients with aortic stenosis, and facilitates clinical operation.

Referring to fig. 2 and 8A, when the heart valve prosthesis 800 is positioned at the aortic annulus, the proximal annular tube 8011 and the proximal annular cavity 807a are located at the side of the aortic annulus near the aorta 36, and the distal annular tube 8012 and the distal annular cavity 807b are located at the side of the aortic annulus near the left ventricle 32; the end of the heart valve prosthesis 800 located in the aorta 36 serves as the proximal end 803 of the heart valve prosthesis, and the end of the heart valve prosthesis 800 located in the left ventricle 32 serves as the distal end 804 of the heart valve prosthesis. The heart valve prosthesis 800 also includes a waist 805, the waist 805 having a shape that can be considered a tubular member or hyperboloid shape, the waist 805 lines the aortic valve 34.

Referring to fig. 2, 8A and 8B, proximally, the proximal end 803 of the heart valve prosthesis forms a hoop or ring to seal blood flow to prevent it from re-entering the left ventricle 32; the distal end 804 of the heart valve prosthesis may also form a hoop or ring to seal blood from flowing forward through the outflow channel.

The valve 104 is secured to the cuff 802, the cuff 802 acting as a support in which tissue ingrowth of the valve 104 can occur in the cuff 802. In the deflated state, the cuff 802 is unable to provide support.

The direction in which the distal annular tube 8012 points towards the proximal annular tube 8011 is denoted as a first direction, and the direction in which the proximal annular tube 8011 points towards the distal annular tube 8012 is denoted as a second direction. The valve 104 is placed within the cuff 802, wherein the valve 104 is configured to allow fluid of blood to flow in a single direction. The valve 104 may be configured to move between an "open" configuration and a "closed" configuration in response to hemodynamic movement of blood pumped by the heart: in the "open" configuration, blood is flushed in a first direction toward the heart valve prosthesis 800, exiting the left ventricle 32 into the aorta 36; in the "closed" configuration, blood is prevented from flowing back through the valve 104 in the second direction. In some embodiments, the valve 104 is a tissue valve. Further, the tissue valve has a thickness equal to or greater than 0.011 inch; preferably, the tissue valve has a thickness equal to or greater than 0.018 inches. The valve 104 can have an expanded outer diameter of greater than or equal to 22mm and a tissue thickness of greater than or equal to about 0.011 inches. The compressed diameter of the heart valve prosthesis 800 may be less than or equal to about 6mm or 18 Fr.

As shown in fig. 7A-7B, the valve 104 is preferably a tissue-type heart valve that includes dimensionally stable, pre-aligned tissue leaflets. Specifically, the valve 104 can include a plurality of tissue leaflets that are templated and attached together at their tips to form a dimensionally stable and consistent assembly of coaptated tissue leaflets. In a viable single process, the individual tissue leaflets are not coupled to each other, and the individual tissue leaflets can be independently sutured to the cuff 802 with each aligned. Thus, the suture can equally withstand the load force. Each tissue leaflet includes a fixed edge 1041 secured to the cuff 802 and a free edge 1042. The free edge 1042 is open to allow blood flow in a first direction and the free edge 1042 is closed to prevent blood flow in a second direction. In some embodiments, the tissue leaflets are connected by attachment only to the cuff 802.

The connection between the valve 104 and the cuff 802 includes sewing, sleeving, bonding, interposing, welding, or interference fit. The valve 104 can be attached prior to packaging or prior to implantation in a hospital; most of the valve 104 can be suspended in a fixed solution of glutaraldehyde.

In some embodiments, the valve 104 can be constructed with flexible tissue leaflets or polymer leaflets. For example, the valve 104 may be obtained from a porcine heart valve; or constructed from other biological materials, such as bovine or equine pericardium. The biomaterial in the valve 104 generally has contours and surface features that provide laminar or non-turbulent blood flow, which can reduce the occurrence of intravascular clotting. Natural tissue valves may be obtained from animal species, typically mammals, such as humans, bovines, porcine canines, seals or kangaroos; these tissues may be obtained from heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue such as pericardial sheets, bypass grafts, blood vessels, human umbilical cord tissue, and the like. These natural tissues are typically soft tissues and typically comprise materials containing silica gel. These tissues may be living tissues, decellularized tissues or reconstituted cellular tissues. The tissue may be fixed in a cross-linked or non-cross-linked form to provide mechanical stability. Glutaraldehyde or formaldehyde are typically used for fixation, but other fixatives, such as other dialdehydes, epoxy compounds, genipin, and derivatives thereof, may also be used. Depending on the type of tissue, the application, and other factors.

The valve 104 is mounted to an annular cuff 802 and is located between a proximal end 803 of the heart valve prosthesis and a distal end 804 of the heart valve prosthesis such that, in a filling state, the heart valve prosthesis 800 deploys the aortic valve 34 or extends beyond a position in front of the aortic valve 34 and replaces the function of the aortic valve 34. The distal end 804 may be sized and shaped so that it does not interfere with the proper functioning of the mitral valve, but still properly secures the valve. For example, the distal end 804 of the heart valve prosthesis may have a notch, recess, or cut-out to prevent interference with the mitral valve. The proximal end 803 may be designed to be located in the aortic root; preferably, the proximal end 803 may be shaped in such a way that it maintains good apposition to the aortic root wall to prevent migration back into the left ventricle 32. In some embodiments, interference with coronary arteries is avoided by configuring the extended height of the heart valve prosthesis 800.

The heart valve prosthesis 800 can be stably positioned at the aortic annulus and can alleviate the need for hooks, and interference fits to the vessel wall, and can be installed without the assistance of an inflatable balloon for radial expansion, thus reducing the obstruction time of the aortic valve 34 and vessel, providing more comfort to the patient and more time for the physician to properly and accurately install the device. The heart valve prosthesis 800 may be moved or removed, and multiple moves or removals may be performed until the heart valve prosthesis 800 is permanently separated from the delivery system, allowing testing of the heart valve prosthesis 800 for proper function, sealing, and proper size prior to separation from the delivery system.

Referring to FIG. 9, the inflatable structure 813 includes a proximal annular cavity 807a, a distal annular cavity 807b, and a strut portion 806; the proximal annular cavity 807a, distal annular cavity 807b, and strut member 806 define inflation channels 808, respectively, i.e., the proximal annular cavity 807a, distal annular cavity 807b, and strut member 806 together may form one or more inflation channels 808; the fill channel 808 may be filled with air, liquid, or a fillable medium. The fill channels 808 can receive a fill medium to generally fill the fillable structures 813. In the inflated state, the proximal annular cavity 807a, the distal annular cavity 807b, and the strut portions 806 can provide structural support to the heart valve prosthesis 800 and/or help secure the heart valve prosthesis 800 within the heart. In the deflated state (i.e., the state in which there is no filling medium in the filling channel 808), the heart valve prosthesis 800 is typically a thin, flexible amorphous member that can advantageously assume a low profile form.

The cross-section of the fill channel 808 may be circular, elliptical, square, rectangular, or parabolic. The circular cross-section may vary in diameter from about 0.020 inches to about 0.100 inches, and the wall thickness may range from 0.0005 inches to about 0.010 inches. The elliptical cross-section may have an aspect ratio of 2 or 3 to 1 depending on the required cuff thickness and the required strength.

The struts 806 are between the proximal and distal annular cavities 807a, 807B, and the planes of the proximal and distal annular cavities 807a, 807B are free of struts 806, so that the struts 806 do not increase the radial thickness of the proximal annular cavity 807a and the distal annular cavity 807B when folded, as shown in fig. 8A-8B and 9, the struts 806 are deployed such that the struts 806 do not radially overlap the proximal and distal annular cavities 807a, 807B, and the struts 806 do not increase the radial thickness of the filable structure, as there is no radial overlap between the proximal and distal annular cavities 807a, 807B, such that the channel is within the radial thickness envelope defined by the proximal and distal annular cavities 807a, 807B. In another embodiment, the strut 806 may be wider in the radial direction than the proximal and distal

annular cavities

807a, 807b such that the proximal and distal

annular cavities

807a, 807b are located within the radial thickness envelope defined by the strut 806.

Further, each of the proximal and distal

annular cavities

807a, 807b may have a cross-sectional diameter of about 0.090 inches. Preferably, the proximal and distal

annular cavities

807a, 807b may have a cross-sectional diameter of about 0.060 inches.

Since the fill channels 808 are generally surrounded by the cuff 802, the attachment or encapsulation of these fill channels 808 can be in intimate contact with the cuff 802. The inflatable structure 813 can be sewn to the cuff 802 or, alternatively, wrapped into a cavity made by the cuff 802 and wandering over the cuff 802. The proximal and

distal ring cavities

807a, 807b can be secured to the cuff 802 in any of a variety of ways, for example, the proximal and

distal ring cavities

807a, 807b are encapsulated within a cavity made of cuff material and sewn to the cuff 802.

In particular, with reference to fig. 8B and 8C, at the proximal end 803 of the heart valve prosthesis, the inflatable structure 813 is provided with a fold 801 forming a proximal annular tube 8011 in which a proximal annular cavity 807a is fastened; at the distal end 804 of the heart valve prosthesis, the inflatable structure 813 is provided with a fold 801 forming a distal annular tube 8012 in which a distal annular cavity 807b is fastened. The fold 801 may be secured by a suture or suture 812. In the inflated state, the heart valve prosthesis 800 may be partially supported by the strut portions 806 surrounding the circumferential cuff 802.

The circumferential cuff 802 includes a cuff waist 8023 between folds 801 at both ends, the cuff waist 8023 and the post portion 806 in the inflatable structure 813 together forming the waist 805 of the heart valve prosthesis 800; the proximal end 803 of the heart valve prosthesis comprises a proximal annular cavity 807a and a proximal annular tube 8011; the distal end 804 of the heart valve prosthesis comprises a distal annular cavity 807b and a distal annular tube 8012. In some embodiments, as shown in fig. 9, the strut portion 806 includes a plurality of cylindrical tubes extending along the axial direction 881 of the cuff, each of the cylindrical tubes defining a respective one of the filling channels 808. Further, strut section 806 is wrapped by cuff 802; specifically, the cuff waist portion 8023 is formed by sewing a plurality of passages extending in the axial direction of the cuff 802, respectively accommodating the respective columnar tube bodies in the strut portions 806. Preferably, the cylindrical tube is parallel to the axis 880 of the cuff.

Referring to fig. 8B and 9, a portion of the strut portion 806 can extend parallel to the cross-sectional direction of the proximal annular cavity 807a and can be encapsulated within the fold 801 of the heart valve prosthesis 800. This arrangement may also help to reduce the cross-sectional profile when the heart valve prosthesis is compressed or folded.

In order to hold the heart valve prosthesis 800 in place around the valve annulus, the heart valve prosthesis 800 may have a variety of overall shapes, such as an hourglass shape. The fillable structures 813 are designed for any combination of three functions: (1) provide support for tissue displaced by the heart valve prosthesis 800; (2) provide axial and radial strength and stiffness to the heart valve prosthesis 800; (3) providing support for the valve 104.

Various shapes of the cuff 802 can be manufactured to better conform to the anatomical differences from person to person. As noted above, these shapes may include simple cylinders, hyperboloids, devices with a larger diameter in the middle and a smaller diameter at one or both ends, funnel-type configurations, or other shapes that conform to the native anatomy. The heart valve prosthesis 800 is preferably contoured in shape to engage the native anatomical features in such a way as to prevent migration of the device in the proximal and distal directions. In one embodiment, the device engagement feature is the aortic root or valve 34. In another embodiment, the device-engaging feature is a native valve annulus, a native valve, or a portion of a native valve. In certain embodiments, the feature of the heart valve prosthesis 800 engaged to prevent migration has a diameter difference between 1% and 10%; preferably, the difference in diameter of the features of the heart valve prosthesis 800 engaged to prevent migration is between 5% and 40%. In some embodiments, the diameter difference is defined by the free shape of the heart valve prosthesis 800. In another embodiment, the diameter difference prevents migration in only one direction. In another embodiment, the difference in diameter prevents migration in two directions, e.g., proximal and distal, or retrograde and forward. Similar to surgical valves, the diameter of the heart valve prosthesis 800 will range from about 14mm to about 30mm in diameter, and have a height ranging from about 10mm to about 30mm where the leaflets of the valve 104 of the heart valve prosthesis 800 are seated. The portion of the heart valve prosthesis 800 that is intended for replacement in the aortic root may have a larger diameter, preferably ranging from about 20mm to about 45 mm. In some embodiments, the heart valve prosthesis 800 may have an outer diameter greater than about 22mm when fully filled.

In one embodiment, the cuff 802 will have a diameter of between about 15mm and about 30mm, and a length of between about 6mm and about 70 mm. The thickness of the wall will have a desirable range from about 0.01mm to about 2 mm. As described above, the cuff 802 can be longitudinally supported in situ from the inflatable structure 813 to provide axial separation. The inner diameter of the cuff 802 may be of a fixed size to provide a constant size for valve 104 attachment and to provide predictable valve opening and closing functionality. Portions of the outer surface of the annular cuff 802 can optionally be compliant and allow the heart valve prosthesis 800 to achieve an interference fit with the native anatomy.

When the heart valve prosthesis 800 is inflated, the cuff 802 and the inflatable structure 813 conform to the anatomy of the patient to provide a better seal between the patient's anatomy and the heart valve prosthesis 800.

Different diameters of the heart valve prosthesis 800 may be required to replace different sizes of native valves. Different lengths of the heart valve prosthesis 800 or anchoring device will also be required for different locations in the anatomy. For example, because of the location of the ostia of the coronary arteries (left and right coronary arteries), a valve designed to replace a native aortic valve needs to have a relatively short length. Because the anatomy of the pulmonary artery allows for extra length, valves designed to replace or supplement the pulmonary valve can be of considerable length.

The annular cuff 802 may comprise a thin, flexible tubular mass to provide a compressed shape to fit inside the delivery sheath during delivery. These materials are biocompatible and may facilitate tissue growth at the commissures of the native tissue. Generally, the cuff 802 can be made from a number of different materials, such as dacron, TFE, PTFE, ePTFE, metal braid, woven material, or other commonly used medical materials, such as polyester fabric; the braid used to make the cuff 802 may be made of materials such as stainless steel, platinum, MP35N, polyester fiber, or other implantable metals or polymers. These materials may also be molded, extruded or stitched together using thermal (direct or indirect) sintering techniques, laser energy sources, ultrasonic techniques, molding or thermoforming techniques.

The cuff 802 can be manufactured by various methods. In one embodiment, the circumferential cuff 802 is made of fabric similar to those typically used in cuffs for vascular grafts or surgically implanted prosthetic heart valves. For some portions of the cuff 802, the fabric is preferably woven into a tubular shape. The fabric may also be woven into a sheet. In one embodiment, the yarns used to make the fabric are preferably plied yarns, but monofilament or braided yarns may also be used. Useful ranges for yarn diameters are from diameters approaching 0.0005 inches to diameters approaching 0.005 inches. Depending on how tight the fabric is made. Preferably, the fabric is woven with between about 50 and about 500 yarns per inch. In one embodiment, the fabric tube is woven with 200 yarns or picks per inch and a diameter of 18 mm. Each yarn was made of 20 filaments of PET material. The final thickness of this woven fabric tube was 0.005 inches for a single wall of the tube. Different weaving methods may be used depending on the desired contour of the heart valve prosthesis 800 and the desired permeability of the fabric to blood or other fluids. Any biocompatible material may be used to make the yarn, some embodiments include nylon and PET. Other materials or combinations of materials are possible including polytetrafluoroethylene, fluoropolymers, polyimides, metals including, for example, stainless steel, titanium alloys, nickel titanium alloys, or other shape memory alloys, alloys containing primarily combinations of cobalt, chromium, nickel, and molybdenum. Fibers may also be added to the yarn to increase strength or radiopacity, or to deliver drugs. The fabric tube may also be manufactured by a weaving process.

The fabric may be sewn, stitched, sealed, dissolved, bonded or bonded together to form the desired shape of the heart valve prosthesis 800. A preferred method for attaching portions of fabric together is sewing. The preferred embodiment uses a polypropylene monofilament suture material having a diameter of approximately 0.005 inches. The suture material may range in diameter from about 0.001 inches to about 0.010 inches. Larger suture materials may also be used at higher stress locations, such as at valve commissures attached to the cuff. The sewing material may be any acceptable heart valve prosthesis grade material. A biocompatible suture material such as polypropylene is preferably used. Nylon and polyethylene are also commonly used suture materials. Other materials or combinations of materials are possible including polytetrafluoroethylene, fluoropolymers, polyimide, or metals including, for example, stainless steel, titanium alloys, kevlar, nitinol, other shape memory alloys, alloys containing primarily cobalt, chromium, nickel, or molybdenum. The preferred stitching is a monofilament design. Multiple strands of braided or plied suture material may also be used. The preferred method of sewing is to use some type of lock sewing which has a design such that if the suture breaks over a portion of its length, the entire extended length of the suture will resist unraveling. And the stitching thread will still generally perform the function of holding the fabric layers together.

The thickness of the fabric of the cuff 802 can range from about 0.002 inches to 0.020 inches. The weave density can also be adjusted from a very tight weave that prevents blood from penetrating the fabric to a looser weave that allows tissue growth and completely surrounds the fabric. In certain embodiments, the fabric may have a linear mass density of about 20 denier or less.

In some embodiments, the heart valve prosthesis 800 has an expanded diameter greater than or equal to 22 millimeters, and a maximum compressed diameter less than or equal to 6 millimeters (18F).

The fill channel 808 may have three connection ports 809 to couple to the delivery catheter 900 through PFL tubing 916. In some embodiments, at least two of the connection ports 809 also serve as fill ports, and a fill medium, air, or liquid can be introduced into the fill channel 808 through the fill ports.

PFL tubing 916 can be connected to connection port 809 by a suitable connection mechanism. Referring to fig. 10, the connection between the PFL tubing 916 and the connection port 809 is a threaded connection. In some embodiments, a fill valve 810 is present in the connection port 809 and can prevent fill media from escaping the fill channel 808 after the PFL tubing is separated. In some embodiments, the distal ring cavity 807b and the proximal ring cavity 807a may be filled independently. In some embodiments, the distal annular cavity 807b can be filled from the strut portion 806 and the proximal annular cavity 807a, respectively. Separate filling may be useful during placement of the heart valve prosthesis 800 at the implantation site.

Referring to FIG. 9, the distal annular cavity 807b and the strut member 806 can be joined such that the fill channel 808 of the distal annular cavity 807b is in fluid communication with a portion of the fill channel 808 of the strut member 806. The fill channel 808 of the proximal annular cavity 807a can also be in communication with a portion of the fill channel 808 of the strut portion 806. In this manner, the proximal annular cavity 807a and a portion of the fill channel 808 of the strut member 806 can be independently filled relative to the distal annular cavity 807b and another portion of the fill channel 808 of the strut member 806.

In other embodiments, the fill channel 808 of the proximal annular cavity 807a may be in communication with the fill channel 808 of the strut member 806, while the fill channel 808 of the distal annular cavity 807b is not in communication with the fill channel of the strut member 806; the two sets of fill channels 808 can be connected to separate PFL conduits 916 to facilitate separate filling.

In other embodiments, the fill channels 808 of all of the proximal annular cavity 807a, the strut portion 806, and the distal annular cavity 807b can be in fluid communication with one another such that they can be filled from the same filling device.

In another embodiment, the inflation channels of all of the proximal annular cavity 807a, the strut member 806 and the distal annular cavity 807b may be separate and thus utilize three inflation devices.

To facilitate filling of the filling channel 808, a valve system is provided within the filling channel 808, which valve system allows one-way passage of liquid. Referring to fig. 9, two fill valves 810 may reside at the end of the fill channel 808 adjacent to the connection port 809. These fill valves 810 are used to fill and exchange fluids such as saline, contrast (developer), and fill media. The length of the fill channel 808 may vary depending on the size and geometric complexity of the heart valve prosthesis 800.

Referring to fig. 9, in an example embodiment, the fill valve 810 can be removably connected to the PFL conduit 916 to facilitate separation of the PFL conduit 916 from the heart valve prosthesis 800. Such a connection may be a screw or threaded connection, a collet system, or an interference fit for secure fastening between the fill valve 810 and the PFL tube 916. Between the ends of the fill channel 808, there may be other one-way valves 811 to allow fluid to flow in a single direction to allow for filling of each end of the fill channel 808 and exchange of fluid in a single direction. When filled with saline and contrast, the saline and contrast solution may be replaced by a curable or hardened filling medium once the heart valve prosthesis 800 is placed in the desired position. Because the filling medium can be introduced from the proximal end of the delivery catheter 900, the fluid containing saline and contrast can be pushed out the other end of the filling channel 808. Once the filling medium has completely replaced the original fluid, the PFL tubing 916 may then be disconnected from the heart valve prosthesis 800 while the heart valve prosthesis 800 remains filled and pressurized. Pressure may be maintained within the heart valve prosthesis 800 by a fill valve 810 located in the fill channel 808.

As shown in fig. 10, in an example embodiment, the fill valve 810 may have a ball 303 and a soft seal 304 to allow fluid to pass when connected and to seal when disconnected. In some cases, the heart valve prosthesis 800 has three or more connection ports 809, but only two have fill valves 810 attached. The connection port 809 without the fill valve 810 can use the same attachment means, such as a screw or threaded member, as the connection port 809 is not used for communication with the inflatable structure 813 and filling of the inflatable structure 813, so the fill valve 810 is not necessary. In other embodiments, all three connection ports 809 can have fill valves 810 to introduce fluid or fill media.

Referring to fig. 10, fill valve 810 may include tubular portion 312 with soft seal 304 and ball 303 to create sealing mechanism 313. In one embodiment, the tubular portion 312 has a length of about 0.5cm to about 2cm, an outer diameter of about 0.010 inches to about 0.090 inches, and a wall thickness of about 0.005 inches to about 0.040 inches. The material may include many polymers such as nylon, polyethylene, polyetheramide, polypropylene, or other common substances such as stainless steel, nitinol, or other metallic substances used in medical devices. The soft seal material may be incorporated as a liquid silicone rubber or other material that can be cured, thus allowing coring or punching through the seal material to form a central cavity to construct the through-hole. The soft seal 304 may be adhered to the inner diameter of the wall of the tubular portion 312 having a through hole for fluid flow. The ball 303 may move within the inner diameter of the tubular portion 312 where the ball 303 is located within the fill channel 808 under one end seal pressure and moves to other directions with the introduction of the PFL tube 916, but is not allowed to migrate too far because the retaining ball plug 305 prevents the ball 303 from moving into the fill channel 808. Since the PFL tubing 916 is screwed into the connection port 809, the ball 303 moves into an open position to allow fluid communication between the fill channel 808 and the PFL tubing 916. When separated, the ball 303 may move toward the soft seal 304 and cease fluid communication outside of any fill channel 808 to pressurize the heart valve prosthesis 800, further embodiments may utilize a spring mechanism to return the ball 303 to a sealed position, and other shaped sealing devices may be used in place of the ball 303. Duckbill seal mechanisms or flap valves may also be used to prevent fluid leakage and provide a closure system for the heart valve prosthesis 800.

Preferably, as shown in fig. 11, the inflatable structure 813 can be expanded into a tubular shape prior to assembly with the cuff 802, the inflatable structure 813 including two inflation valves 810, a first inflation valve 8101 at one end of the inflatable structure 813 near the proximal annular cavity 807a and a second inflation valve 8102 at the other end of the inflatable structure 813 near the distal annular cavity 807 b; the inflatable structure 813 also includes a one-way valve 811 located between the proximal annular cavity 807a and the distal annular cavity 807 b. In this embodiment, two fill valves 810 may serve as inlet passages for the fill medium, with the two fill valves 810 each threadably connected to the PFL conduit 916. For example, the filling medium enters the fillable structure 813 through the first filling valve 8101, follows the tubular fillable structure 813, first fills the proximal annular cavity 807a, and then, after passing through the one-way valve 811, refills the distal annular cavity 807 b. Excess fill medium may pass through second fill valve 8102 into another PFL line 916 connected to second fill valve 8102.

When implanted, the heart valve prosthesis 800 is in a compressed state and all of the filling medium in the fillable structure 813 is expelled, as in the portion above the one-way valve 811, i.e., including the proximal annulus 807a, can be aspirated through the first fill valve 8101 by a syringe vacuum connected to the luer 917 at the end of the PFL tubing 916; all of the fill medium below one-way valve 811, i.e., including distal annulus 807b, may be aspirated through second fill valve 8102 by a syringe vacuum connected to luer 917 at the end of PFL tubing 916.

As shown in fig. 4A-4C, the proximal annular cavity 807a and the distal annular cavity 807b of the heart valve prosthesis 800 in the compressed state partially overlap and cannot be expanded in situ at the annulus of the human body, after the folded heart valve prosthesis is advanced over the guide wire into the left ventricle, a filling medium, typically a saline solution containing a contrast agent, is injected into the heart valve prosthesis 800 through the PFL conduit 916 connected to the filling valve 810, the structures of the heart valve prosthesis 800 are rapidly expanded in the left ventricle 32 in sequence, after detection, the proximal annular cavity 807a is deflated through the filling valve 810, and the proximal annular cavity 807a in the deflated state is in an amorphous state 807, the cross-sectional profile thereof is reduced, and the distal annular cavity 807b is still in the inflated state due to the presence of the one-way valve 811.

The heart valve prosthesis 800 is then pulled back, i.e. towards the aorta, by the delivery catheter 900, the proximal annulus 807a passing through the aortic annulus into the aorta, while the distal annulus 807b remains in the left ventricle. At this time, the filling medium is continuously injected into the heart valve prosthesis 800 through the filling valve 810, and the proximal annular cavity 807a is in the filling state again, so that the supporting function can be exerted.

As shown in fig. 5A-5E, if the release position of the heart valve prosthesis 800 is not satisfactory, the non-curable filling medium can be withdrawn, adjusted to the desired position and then injected, and functional testing and evaluation can be performed again until the requirements are satisfied.

If the heart valve prosthesis 800 is improperly sized or if the size of the heart valve prosthesis 800 is not properly adjusted several times, the non-curable filling medium in the heart valve prosthesis 800 can be extracted, the heart valve prosthesis 800 is changed to an amorphous thin state, and a recovery operation can be performed, i.e., the heart valve prosthesis 800 is withdrawn out of the body through the catheter sheath that establishes the vascular access.

If the heart valve prosthesis 800 is sized and released in place, the non-curable filling medium may be replaced with a curable filling medium. The operation of the permutation is: the exchange of filling medium can be completed by injecting curable filling medium through the first filling valve 8101 and the curable filling medium squeezing the non-curable filling medium in the filling channel 808 out of the second filling valve 8102. The curable filling medium, after curing in the filling channel 808, may provide a more stable support for the heart valve prosthesis 800. And the pressure of the filling medium injected into the filling channel 808 can be adjusted to provide a suitable pressure, such as 5atm, 10atm, 16atm or 20atm, according to the requirement.

In one embodiment, saline and contrast are first filled into the fill channel 808 for radiopaque visualization under fluoroscopy. This may make positioning of the heart valve prosthesis 800 at the implantation site easier. Such fluid may be introduced from the proximal end of delivery catheter 900 with the aid of a filling device, such as a pressurizing pump, or other device, to pressurize the fluid in a controlled manner. This fluid can be transferred from the proximal end of the delivery catheter 900 through the PFL tubing 916, where the PFL tubing 916 connects to the heart valve prosthesis 800 through the connection port 809 at the end of each filling channel 808.

In some embodiments, portions of the annular cuff 802 may be radiopaque to assist in visualizing the position and orientation of the heart valve prosthesis 800. Markers made of platinum or tantalum or other suitable materials may be used. These markers can be used to identify critical areas of the valve that must be properly placed, for example, for an aortic valve, where the commissures of the valve 104 need to be properly placed relative to the coronary arteries.

In order to enable a larger reduction in circumference from the inflated state to the deflated state of the outer contour near the proximal end 803 of the heart valve prosthesis, the inventors have further developed a design for the heart valve prosthesis.

Example one

The material from which the proximal annular conduit 8011 is made comprises a resilient material such that the proximal annular conduit 8011 is self-constricting.

When the proximal annular cavity 807a is in the inflated state, the filling medium in the proximal annular cavity 807a exerts an outward expansion force on the proximal annular cavity 807a, and the expansion force is transmitted to the proximal annular tube 8011, so that the elastic force of the proximal annular tube 8011 itself can be overcome. The heart valve prosthesis 800 can be formed with an outer contour of the proximal annular tube 8011 that is close to and slightly larger than the outer contour of the distal annular tube 8012 as shown in fig. 7A, or can be formed with an outer contour of the proximal annular tube 8011 that is equal to the outer contour of the distal annular tube 8012 as shown in fig. 8A.

If the proximal annular tube 8011 and the proximal annular cavity 807a are both made of a flexible material with a relatively low elastic property and are not self-contracting, the outer contour of the proximal end 803 of the heart valve prosthesis 800 is reduced to a relatively small extent when the proximal annular cavity 807a is in a deflated state, as shown in fig. 6A and 6B, due to the pulling action on the proximal end of the heart valve prosthesis 800.

In the heart valve prosthesis 800 of the present embodiment, when the proximal annular cavity 807a is in the deflated state, the proximal annular tube 8011 contracts under its own elastic force, so that the outer contour of the proximal end 803 of the heart valve prosthesis is reduced to a greater extent, as shown in fig. 12A and 12B, so that the proximal end 803 of the heart valve prosthesis can more easily cross the aortic annulus under traction.

In some embodiments, the modulus of elasticity of the material of the proximal annular tube 8011 is less than the modulus of elasticity of the material of the distal annular tube 8012, such that the proximal annular tube 8011 contracts more than the distal annular tube 8012 during the transition from the inflated to the deflated state of the inflatable structure 813. In the deflated state, in which the proximal annular cavity 807a is free of filling medium, the circumference of the outer contour of the proximal annular conduit 8011 is smaller than the circumference of the outer contour of the distal annular conduit 8012, and the heart valve prosthesis 800 has a substantially tapered outer shape, facilitating passage of the proximal end 803 of the heart valve prosthesis through the aortic annulus.

When the cuff 802 is made of a fabric, the fabric includes a plurality of wefts 8021 extending around the circumferential direction of the cuff 802 and a plurality of warps 8022 extending along the axial direction 881 of the cuff. At least one of the plurality of wefts 8021 of the proximal annular tube 8011 is made of an elastic thread, so that the proximal annular tube 8011 has strong elasticity and can self-contract in a deflated state.

Specifically, the wefts for making the proximal annular duct 8011 may be all elastic threads, or only a part of the wefts may be elastic threads. Preferably, when only a portion of the weft threads 8021 are elastic threads, the elastic threads alternate with the non-elastic threads. All the wefts 8021 of the proximal annular tube 8011 are made of elastic threads, which can make the proximal annular tube 8011 have better self-contraction performance, provide larger contraction force, and can make the outline of the proximal end 803 of the heart valve prosthesis contract less. In contrast, a portion of the weft threads 8021 are elastic threads, and by designing the distribution of the elastic threads, the difficulty of producing the fabric of the cuff 802 can be reduced in the case of a proximal annular tube 8011 having a better self-contraction performance, and the difficulty of loading the fillable structure 813 and the proximal annular tube 8011 together can be reduced, so that the heart valve prosthesis 800 can be produced more easily.

In order to provide the proximal annular tube 8011 with enhanced self-shrinking properties, at least one of the warp threads 8022 of which the proximal annular tube 8011 is made is an elastic thread. The warp threads 8022 making the proximal annular duct may all be elastic threads, or only a portion may be elastic threads. The entire warp threads 8022 making up the proximal annular conduit 8011 are elastic threads that shrink the outer diameter of the proximal end 803 of the heart valve prosthesis even less. A portion of the warp threads 8022 are elastic threads to further facilitate the manufacturing operation of placing the inflatable structure 813 into the proximal annular tube 8011.

In general, the weft threads 8021 are provided around the circumferential direction of the cuff 80. As shown in fig. 13A, fig. 13A is a schematic plan view of the fabric after being unfolded along the axis 880 of the annular cuff, and the plane enclosed by the weft line 8021 is substantially perpendicular to the axis 880 of the annular cuff, i.e. the plane enclosed by the weft line 8021 is parallel to the cross section of the annular cuff 802. To improve the contractile performance of this heart valve prosthesis 800, the inventors have made adjustments to the way the fabric is placed.

In one embodiment of the present invention, as shown in fig. 13B, the angle between the plane enclosed by the weft threads 8021 and the cross-sectional direction 882 of the annular cuff is denoted as α, 15 ° ≦ α ≦ 75 °, to improve the contractibility of the proximal annular tube 8011, so that in the deflated state, the overall cross-sectional outer contour of the proximal annular tube 8011 can be reduced, and the diameter of the proximal annular tube 8011 can be reduced.

Furthermore, alpha is more than or equal to 30 degrees and less than or equal to 60 degrees. More preferably, α is 45 °, resulting in a more uniform reduction in the overall cross-sectional outer profile and tube diameter of the proximal annular tube 8011.

In general, the warp 8022 extends in a direction perpendicular to the direction in which the weft 8021 extends. As another embodiment, the fabric of the material of the proximal annular tube 8011 includes a plurality of wefts 8021 and a plurality of warps 8022, the wefts 8021 extend around the circumferential direction of the annular cuff 802, and an included angle between the extending direction of the warps 8022 and the extending direction of the wefts 8021 is smaller than 90 °; and the plane enclosed by the weft line 8021, parallel to the cross-sectional direction 882 of the cuff; the warps 8022 extend spirally along the axial direction of the annular cuff 802, at least one of the warps 8022 is an elastic weaving thread, and the elastic force of the warps 8022 has a circumferential component, so that the warps 8021 can be driven to move together, and the proximal end 803 of the heart valve prosthesis is shrunk. Preferably, a plurality of warp threads 8022, which are elastic threads, are distributed circumferentially about the axis 880 of the annular cuff.

The warp 8022 of the fabric is made of elastic weaving yarns, the weft 8021 is made of non-elastic weaving yarns, or the weft 8021 is made of elastic weaving yarns, and the warp 8022 is made of non-elastic weaving yarns, so that the production difficulty of the fabric can be reduced.

The fabric for manufacturing the annular cuff 802 is folded outwards to form the proximal annular tube 8011, and the elastic knitted thread is arranged at the corresponding position of the proximal annular tube 8011 by adjusting the position of the elastic knitted thread.

In one embodiment of the invention, the weft threads 8021 of the proximal looped conduit 8011 on the side of the annular cuff's axis 880 comprise elastic weft threads, such that the side of the proximal looped conduit 8011 adjacent the annular cuff's axis 880 is provided with elastic weft threads. The proximal annular tube 8011 is in contact with the proximal annular cavity 807a on a side thereof adjacent to the axis 880 of the cuff, which facilitates bringing the proximal annular cavity 807a to contract and reducing the outer diameter of the proximal annular tube 8011.

In another embodiment of the present invention, the wefts 8021 of the proximal annular tube 8011 on the side away from the axis of the annular cuff 802 include elastic wefts, so that the elastic weaved yarn is disposed on the side of the proximal annular tube 8011 away from the axis of the annular cuff 802, and the inner diameter of the contour of the proximal annular tube 8011 is reduced by shrinking the inner side of the proximal annular tube 8011, thereby driving the reduction of the outer diameter of the contour of the proximal annular tube 8011. The side of the proximal annular duct 8011 remote from the axis of the cuff 802 forms the outer contour of the proximal end 803 of the heart valve prosthesis, and the side contracts under the elastic action, which is beneficial to make the outer contour of the proximal end 803 of the heart valve prosthesis contract less, so as to pass through the aortic annulus.

In some embodiments, the proximal annular tube 8011, the distal annular tube 8012, and the cuff waist 8023 can be made separately, joined together by sewing, bonding, melting, or the like.

Further, the elastic threads are made of degradable materials, and after the elastic threads are implanted into a body, the elastic threads can be slowly degraded in the body, so that the pressure on the annular cuff 802 and the inflatable structure 813 is reduced, and the potential adverse effects on the human body are reduced. The elastic threads can be made of elastic fibers, and are preferably animal-derived materials with low or no immunogenicity; more preferably, the elastic threads are of a material comprising elastin.

The non-elastic threads can be made of terylene, TFE, PTFE or ePTFE.

In one embodiment of the present invention, the inflatable structure 813 is made of flexible material and has good plastic properties, the inflatable structure 813 expands or contracts slightly or not under external force, and in the inflated state, the shape and size of the proximal end 803 of the heart valve prosthesis are limited by the proximal annular cavity 807a in the inflatable structure 813. For example, nylon, polyethylene fibers, polyether acyl, or the like, which can maintain pressure, may be used as the material of the fillable structure 813.

Example two

As shown in fig. 14A and 14B, the heart valve prosthesis 800 further comprises an elastic band 400 connected to the proximal annular conduit 8011 and extending circumferentially around the annular cuff 802, such that the proximal annular conduit 8011 has a tendency to contract inwardly to reduce the circumference of the outer contour of the proximal annular conduit 8011. With the proximal annulus 807a inflated, the elastic band 400 is in an extended state, having a tendency to shorten and bring the proximal annulus 8011 together in contraction.

When the proximal annular cavity 807a is in the inflated state, the filling medium in the proximal annular cavity 807a exerts an outward expansion force on the proximal annular cavity 807a, which is transmitted to the proximal annular tube 8011, and can overcome the elastic force of the elastic band 400. The heart valve prosthesis 800 can be formed with an outer contour of the proximal annular tube 8011 that is close to and slightly larger than the outer contour of the distal annular tube 8012 as shown in fig. 7A, or the outer contour of the proximal annular tube 8011 can be equal to the outer contour of the distal annular tube 8012 as shown in fig. 8A.

In the heart valve prosthesis 800 provided in this embodiment, when the proximal annular cavity 807a is in the deflated state, the proximal annular tube 8011 is contracted by the elasticity of the elastic band 400, so that the outer contour of the proximal end 803 of the heart valve prosthesis is greatly reduced, and the circumference of the outer contour of the proximal annular tube 8011 is smaller than that of the outer contour of the distal annular tube 8012, as shown in fig. 12A and 12B, so that the proximal end 803 of the heart valve prosthesis can more easily cross the aortic annulus under the pulling action.

In an embodiment of the present invention, a plurality of snares 300 distributed along the circumference of the cuff 802 are fixedly arranged on the proximal annular tube 8011; the elastic band 400 is annular and penetrates through the ring sleeve 300, and the elastic band 400 can slide in the ring sleeve 300 in a telescopic manner, so that the elastic band 400 is conveniently connected with the proximal end annular pipeline 8011 on one hand, and the position of the elastic band 400 is more stable on the other hand. Preferably, snare 300 is a flexible snare.

Further, as shown in fig. 14A and 14B, the axis of snare 300 is perpendicular to the axis of cuff 802.

Further, a plurality of annular elastic bands 400 are disposed on the proximal annular tube 8011, and each of the elastic bands 400 is distributed along the circumferential direction of the annular cuff 802 in the axial direction, so as to apply elastic force to each position of the proximal annular tube 8011, respectively, and to urge the proximal annular tube 8011 to contract inward. Preferably, the elastic bands 400 are spaced along the axial direction of the annular cuff 802, so as to avoid interference between the elastic bands 400, so that the force applied to each position of the proximal annular tube 8011 is more uniform, and the proximal annular tube 8011 is more uniformly and stably contracted.

Further, the elastic band 400 may be disposed at any position of the proximal annular tube 8011, for example, it may be disposed on the inner wall of the proximal annular tube 8011 or the outer wall of the proximal annular tube 8011; either on the side of the proximal annular conduit 8011 remote from the distal end 804 of the heart valve prosthesis, or on the side of the proximal annular conduit 8011 proximal to the distal end 804 of the heart valve prosthesis; the proximal annular tube 8011 may be provided on the side of the proximal annular tube 8011 away from the axis of the annular cuff 802, or may be provided on the side of the proximal annular tube 8011 close to the axis 880 of the annular cuff.

Preferably, as shown in fig. 14A-14D, elastic band 400 is attached to the outer wall of proximal loop conduit 8011 by snare 300.

More preferably, as shown in fig. 14A and 14B, the elastic band 400 is located on the side of the proximal annular tube 8011 away from the axis of the annular cuff 802 such that the elastic band 400 is hooped outside the proximal annular tube 8011, facilitating inward contraction of the proximal annular tube 8011 under the action of the elastic band 400. The plane enclosed by the ring-shaped elastic band 400 is perpendicular to the axis of the cuff 802; on the proximal circular tube 8011, 2 elastic bands 400 are provided along the axis of the circular cuff 802 as shown in fig. 14B to ensure a good constricting effect.

As another more preferred embodiment, as shown in fig. 14C and 14D, 4 elastic bands 400 are provided on the proximal annular tube 8011 and respectively located at the top (the side away from the distal end 804 of the heart valve prosthesis), the bottom (the side close to the distal end 804 of the heart valve prosthesis), the outer side (the side away from the axis 880 of the annular cuff), and the inner side (the side close to the axis 880 of the annular cuff) of the proximal annular tube 8011, and the 4 elastic bands 400 cooperate to enable the proximal end 803 of the heart valve prosthesis to be contracted smaller and to enhance the reliability of contracting the proximal end 803 of the heart valve prosthesis to pass through the aortic annulus.

In another embodiment of the present invention, the elastic band 400 is in the shape of a wire, and a plurality of elastic bands 400 are provided on the proximal annular tube 8011 at intervals along the circumferential direction of the annular cuff 802. Specifically, the elastic band 400 in a linear shape extends in the circumferential direction of the cuff 802, and both ends are fixed to the outer wall of the proximal annular tube 8011, respectively, and the contraction force of the plurality of elastic bands 400 acts on the proximal annular tube 8011 at the same time, so that the proximal annular tube 8011 is urged to be contracted inward.

Further, the elastic band 400 is made of degradable material, and after being implanted in the body, the elastic band 400 can be slowly degraded in the body, so as to reduce the pressure on the cuff 802 and the inflatable structure 813 and reduce the potential adverse effect on the human body. The elastic band 400 may be made of elastic fiber, preferably animal-derived material with low or no immunogenicity; more preferably, the elastic band 400 is made of a material including elastin.

EXAMPLE III

The material of the proximal annular cavity 807a is an elastic material, so that the proximal annular cavity 807a has a tendency to contract inward to reduce the circumference of the outer contour of the proximal annular cavity 807a, and since the proximal annular tube 8011 wraps the proximal annular cavity 807a, i.e., the inner wall of the proximal annular tube 8011 contacts the proximal annular cavity 807a, the proximal annular cavity 807a contracts to bring the proximal annular tube 8011 to contract together, so that the outer contour of the proximal end 803 of the heart valve prosthesis is reduced.

When the proximal annular cavity 807a is in the inflated state, the filling medium in the proximal annular cavity 807a exerts an outward expansion force on the proximal annular cavity 807a, which can overcome the elastic force of the proximal annular cavity 807a itself. The heart valve prosthesis 800 can be formed with an outer contour of the proximal annular tube 8011 that is close to and slightly larger than the outer contour of the distal annular tube 8012 as shown in fig. 7A, or can be formed with an outer contour of the proximal annular tube 8011 that is equal to the outer contour of the distal annular tube 8012 as shown in fig. 8A.

In the heart valve prosthesis 800 provided in this embodiment, when the proximal annular cavity 807a is in the deflated state, the proximal annular cavity 807a contracts under its own elasticity, so that the outer contour of the proximal end 803 of the heart valve prosthesis is greatly reduced, as shown in fig. 12A and 12B, so that the proximal end 803 of the heart valve prosthesis can more easily pass through the aortic annulus under a pulling action.

In some embodiments, the modulus of elasticity of the material of the proximal annular cavity 807a is less than the modulus of elasticity of the material of the distal annular cavity 807 b. In the deflated state, when the proximal annular cavity 807a is empty of filling medium, the circumference of the outer contour of the proximal annular cavity 807a is smaller than the circumference of the outer contour of the distal annular cavity 807b, so that the heart valve prosthesis 800 has a substantially conical shape to facilitate passage of the proximal end 803 of the heart valve prosthesis through the aortic annulus.

The distal ring 807b will have little or no expansion and contraction under the influence of the fill medium. The proximal annular cavity 807a contracts to a greater extent from the inflated state to the deflated state. The proximal annular cavity 807a is made of an elastic material, and since the elastic material generally has a tendency to contract toward a certain shape and size, the proximal annular cavity 807a can contract into a smaller-sized annular shape in a deflated state, so that the outer contour of the proximal end 803 of the heart valve prosthesis is smaller and easier to pass through the aortic annulus.

Further, the proximal ring lumen 807a is deployed as shown in FIG. 11, keeping the proximal ring lumen 807a straight. With the proximal annular cavity 807a deployed in this manner, as shown in FIG. 15A, in the inflated state, the proximal annular cavity 807a has a circumference L and a diameter D; in the deflated state, the proximal annular cavity 807a has a circumference L and a diameter D, as shown in FIG. 15B. The following relation is satisfied:

as shown in fig. 15A and 15B, in one embodiment of the present invention, the circumference of the outer contour of the proximal ring cavity 807a in the inflated state is denoted as L, and the circumference of the outer contour of the proximal ring cavity 807a in the deflated state is denoted as L, and the following relationship is satisfied:

150％≤(L/L′)≤500％。

further, the following relation is satisfied:

200％≤(L/L′)≤450％。

further, the following relation is satisfied:

250％≤(L/L′)≤400％。

in one embodiment of the present invention, the burst pressure of the proximal annular cavity 807a is greater than or equal to 5 atm.

Further, the tolerable burst pressure of the proximal annular cavity 807a is greater than or equal to 16 atm.

In one embodiment of the present invention, the material of the proximal annular cavity 807a comprises any 1 monomer or any 2 or more mixed composite of PVC, thermoplastic elastomer, latex, silicone rubber. Preferably, in some cases, the material of the proximal annular cavity 807a comprises a thermoplastic shape, such as Chronoprene; in other cases, the material of the proximal annular cavity 807a comprises a polyether block polyamide, such as Pebax.

The material of the distal annular chamber 807b and the strut member 806 may be nylon, polyethylene fiber, or polyether acyl material capable of maintaining pressure. During manufacture, the proximal annular cavity 807a, the strut member 806 and the distal annular cavity 807b can be formed separately and secured together after formation.

In one embodiment of the present invention, the cuff 802 is made of flexible material and has good plasticity, the cuff 802 has small or no expansion under external force, the proximal annular conduit 8011 can prevent the proximal annular cavity 807a from expanding outwards in the filling state, and the shape and size of the proximal end 803 of the heart valve prosthesis are limited by the proximal annular conduit 8011, so as to avoid the filling structure 813 from being ruptured due to disorder expansion or over-local expansion. For example, the warp threads 8022 and the weft threads 8021 in the fabric for the cuff 802 are made of non-elastic threads.

The above description is only a few embodiments of the present invention, and those skilled in the art can make various changes or modifications to the embodiments of the present invention according to the disclosure of the application document without departing from the spirit and scope of the present invention.

Claims

1. A heart valve prosthesis, comprising:

an annular cuff having an inner surface defining a blood flow path, the annular cuff having a proximal annular tube at one end and a distal annular tube at the other end;

a valve positioned within the blood flow path and connected to the cuff, the valve being configured to permit flow within the blood flow path in a direction along the distal annular duct toward the proximal annular duct and to prevent flow within the blood flow path in a direction along the proximal annular duct toward the distal annular duct;

an inflatable structure connected to the annular cuff having a proximal annular cavity and a distal annular cavity, the proximal annular channel surrounding the proximal annular cavity and the distal annular channel surrounding the distal annular cavity; the proximal ring cavity has a tendency to contract inwards to reduce the circumference of the outer contour of the proximal ring cavity;

the material of the proximal annular cavity is made of elastic material; under the condition that the proximal annular cavity is in a deflated state, the perimeter of the outer contour of the proximal annular channel is smaller than the perimeter of the outer contour of the distal annular channel;

the elastic modulus of the material of the proximal annular cavity is smaller than that of the material of the distal annular cavity;

in the filling state, the perimeter of the outer contour of the proximal annular cavity is L, and the diameter of the outer contour of the proximal annular cavity is D; in a deflated state, the circumference of the outer contour of the proximal annular cavity is L 'and the diameter is D';

the following relation is satisfied:

(D/D′)＜(L/L′)；

the proximal annular channel is capable of resisting outward expansion of the outer profile of the proximal annular cavity.

2. The heart valve prosthesis of claim 1, wherein a perimeter L of an outer contour of the proximal ring cavity in the inflated state, a perimeter L' of an outer contour of the proximal ring cavity in the deflated state;

the following relation is satisfied:

150％≤(L/L′)≤500％。

3. the heart valve prosthesis of claim 2, wherein the following relationship is satisfied:

200％≤(L/L′)≤450％。

4. the heart valve prosthesis of claim 3, wherein the following relationship is satisfied:

250％≤(L/L′)≤400％。

5. the heart valve prosthesis of claim 1, wherein the tolerable burst pressure of the proximal annular cavity is greater than or equal to 5 atm.

6. The heart valve prosthesis of claim 5, wherein the tolerable burst pressure of the proximal annular cavity is greater than or equal to 16 atm.

7. The heart valve prosthesis of claim 1, wherein the material of the proximal annular cavity comprises a single body of any 1 of PVC, thermoplastic elastomer, latex, silicone rubber, or a composite of a plurality of blends of any 2 or more.

8. The heart valve prosthesis of claim 7, wherein the material of the proximal annular cavity comprises Chronoprene or Pebax.

9. The heart valve prosthesis of claim 1, wherein the fillable structure includes a strut portion disposed between the proximal annular chamber and the distal annular chamber; the proximal annular cavity and the strut part are formed separately and are fixedly connected together.

10. The heart valve prosthesis of claim 1, wherein the heart valve prosthesis is adapted to the aortic annulus.

11. A fillable structure of a heart valve prosthesis, for use in a heart valve prosthesis according to any one of claims 1-10, comprising: the support column comprises a proximal annular cavity, a distal annular cavity and a support column part arranged between the proximal annular cavity and the distal annular cavity;

the material of the near-end annular cavity is made of elastic material, so that the near-end annular cavity has a tendency of shrinking inwards to reduce the perimeter of the outer contour of the near-end annular cavity.