CN115517819A

CN115517819A - Transapical mitral valve replacement device

Info

Publication number: CN115517819A
Application number: CN202210518459.5A
Authority: CN
Inventors: 吴明明; 刘影; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-05-13
Filing date: 2022-05-13
Publication date: 2022-12-27

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve replacement device. A transapical mitral valve replacement valve device, comprising: a support mechanism which is provided with an outer frame and an inner frame connected with the outer frame; a valve leaf mechanism positioned in the inner frame; the leaflet mechanism includes: the valve leaf mechanism is connected with the inner side wall of the inner frame, and the middle part of the valve leaf mechanism can be opened and closed in a one-way mode. The valve leaflet mechanism formed by the independent artificial valve leaflets has a valve leaflet mechanism with a function similar to a one-way valve, and has a more stable and reliable structure.

Description

Transapical mitral valve replacement device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve replacement device.

Background

Valve regurgitation is a common valvular disease, such as mitral valve regurgitation, tricuspid valve regurgitation, etc. The mitral valve regurgitation is caused by incomplete valve closure, and when the left ventricle contracts, blood flow is injected into the aorta and the left atrium with lower resistance from the left ventricle, and the left atrium receives the blood returned by the left ventricle in addition to the blood returned by the pulmonary veins, so that the pressure rise of the left atrium can cause the pressure rise of the pulmonary veins and pulmonary capillaries, and then the pulmonary veins and the pulmonary capillaries expand and stagnate; simultaneously, the diastolic volume load of the left ventricle is increased, and the left ventricle is enlarged. When the acute mitral valve is not closed completely, the left atrium suddenly increases a large amount of blood backflow, which can cause the pressure in the left atrium and pulmonary veins to rise sharply, causing acute pulmonary edema.

At present, the mode of treating mitral valve regurgitation through operation mainly comprises two modes of surgical thoracotomy and medical minimally invasive operation. Open surgical chest surgery discourages a large number of patients from receiving this form of treatment due to the large surgical trauma, high risk and long-term and expensive rehabilitation after surgery. The medical minimally invasive surgery provides a novel treatment method which has smaller wound, less complication and quick postoperative rehabilitation for doctors. When medical minimally invasive surgery is performed, the mitral valve replacement device can solve the problem of mitral valve regurgitation. The existing mitral valve replacement valve device usually adopts a valve leaflet mechanism arranged in an inner frame to avoid the backflow phenomenon, the valve leaflet mechanism adopts artificial valve leaflets to realize one-way opening and closing, and when the size of the inner frame changes, the artificial valve leaflet in the inner frame also needs to change in size along with the change, and once the size is improperly adjusted, the backflow phenomenon caused by incomplete closure still exists when the artificial valve leaflet is used.

Disclosure of Invention

The invention aims to solve the technical problem that when the size of an inner frame is changed, the artificial valve leaflet still can flow backwards even if the size of the artificial valve leaflet is improperly adjusted, and aims to provide a mitral valve replacement device through the apex of the heart.

A transapical mitral valve replacement valve device, comprising:

the support mechanism is provided with an outer frame and an inner frame connected with the outer frame;

the valve leaf mechanism is positioned in the inner frame;

the leaflet mechanism includes:

the artificial valve leaflets are sequentially connected to form a valve leaflet mechanism with an outer circumference of a circular ring structure, the valve leaflet mechanism is connected with the inner side wall of the inner frame, and the middle of the valve leaflet mechanism can be opened and closed in a one-way mode.

Preferably, the mitral valve replacement device further comprises:

the film covering mechanism is coated on the bracket mechanism, and the film covering mechanism and the artificial valve leaf are mutually sewn to form a suture line track;

the prosthetic leaflet includes a leaflet body having at least one of a distal outer contour or the suture trajectory having:

a lobe base arc, the far end of which is an arc structure;

two valve leaf side arcs are respectively positioned on two sides of the valve leaf base arc, and the far end of the valve leaf side arc is also of an arc structure;

the valve leaf base arc is tangentially connected with the valve leaf side arcs on two sides to form the far end of the artificial valve leaf.

Preferably, the bottom arc of the valve leaf is a section of arc formed by a first circle center and a first radius;

the two valve leaflet side arcs are respectively a first valve leaflet side arc and a second valve leaflet side arc, the first valve leaflet side arc is a section of arc formed by a second first circle center and a second radius, and the second valve leaflet side arc is another section of arc formed by the second circle center and the second radius;

and a connecting line among the first circle center, the second circle center and the second circle center is a regular triangle.

Preferably, the side length of the regular triangle is greater than the diameter of the leaflet base arc and less than the width of the leaflet main body.

Preferably, the artificial leaflet has an axial leaflet symmetry line;

the first circle center is located on the valve leaflet symmetry line, and the second circle center are symmetrical with respect to the valve leaflet symmetry line.

Preferably, at least one of the proximal outer contour of the leaflet body or the suture trajectory has:

and the valve leaf top arc is positioned on the proximal end side of the valve leaf bottom arc, and the proximal end is of an arc structure.

Preferably, the top arc of the leaflet is a section of circular arc formed by a third circle center and a third radius, and the third circle center is located on the symmetry line of the leaflet.

Preferably, the distance from the third center of circle to the first center of circle is N times, preferably three times, the side length of the regular triangle.

Preferably, the artificial leaflet further comprises:

two ear parts respectively positioned at two sides of the proximal end of the valve leaflet main body;

the artificial valve leaflet is connected with the valve leaflet sewing hole in the inner frame through the ear parts, and the adjacent two ear parts are connected with the same valve leaflet sewing hole to cause the close contact of the proximal edges of the adjacent two artificial valve leaflets.

Preferably, the ear portion includes:

an upper ear portion located at the proximal end side;

a lower ear portion located at a distal end side of the upper ear portion;

one dodges the groove, the side is the opening, is located go up the ear with between the lower ear, through dodge the groove will go up the ear with the ear is separated down.

Preferably, the length of the avoiding groove is not greater than 2/3 of the width of the ear to prevent tear splitting of the upper and lower ears.

Preferably, the leaflet main body has a distal end edge provided with:

and the abrasion-proof edge strip is connected with the valve leaf main body in a sewing mode.

The positive progress effects of the invention are as follows: the invention adopts the mitral valve replacement valve device through the apex of the heart, and has the following advantages:

1. the valve leaflet mechanism formed by the independent artificial valve leaflets has a valve leaflet mechanism with a function similar to a one-way valve, and the structure is more stable and reliable.

2. At least one of the outer contour of the valve leaflet main body or the suture line track is defined as a determined geometric relation, and the manufactured artificial valve leaflet encloses a valve leaflet mechanism which is used in a mitral valve replacement device through the apex of the heart, so that the performance is better, and the backflow phenomenon can be well avoided.

3. When the size of the inner frame is adjusted, the inner frame is directly adjusted according to the limited geometric relationship and still has the performance consistent with that before the adjustment.

4. The design of the artificial valve leaf, especially the design of the ear part, leads the proximal edges of the adjacent artificial valve leaves to be closely contacted, and prevents the backflow caused by incomplete closure.

5. The ear of ear and lower ear carries out artificial valve leaf's fixed in the adoption, and it has realized the ear and has not been connected with tectorial membrane mechanism's mode, can effectually prevent the blood leakage that produces because of interior frame tectorial membrane valve leaf hole and cause and flow backward.

6. The design of abrasionproof strake has at first increased the anti tear ability of leaflet main part distal end, and secondly reduced the damage of the friction of leaflet main part telecentric end and tectorial membrane to artifical leaflet, improved the life of artifical leaflet, the setting of abrasionproof strake also is equivalent to the buffer layer between artifical leaflet and the tectorial membrane in addition, effectual buffering artifical leaflet is opening and shutting the in-process and is tearing the effort to the tectorial membrane, has increased this support mechanism's life.

Drawings

FIG. 1 is a schematic structural diagram of an embodiment of the present invention;

FIG. 2 (a) is a schematic view of an outer frame membrane according to the present invention;

FIG. 2 (b) is a schematic view of the connection between the outer frame cover and the outer frame according to the present invention;

FIG. 3 is an expanded view of the internal frame coating of the present invention;

FIG. 4 is a schematic structural view of a bonding film according to the present invention;

fig. 5 (a) is a schematic view showing an expanded state of the artificial leaflet of the present invention;

fig. 5 (b) is a partial connection view of the artificial leaflet of fig. 5 (a) with an inner frame covering film and an inner frame;

fig. 6 (a) is a schematic view showing another unfolding of the artificial leaflet of the present invention;

fig. 6 (b) is a partial connection diagram of the artificial leaflet of fig. 6 (a) with an inner frame covering film and an inner frame;

fig. 6 (c) is a schematic view of the connection of the artificial leaflet of fig. 6 (a) with the inner frame covering film and the inner frame;

fig. 7 is a schematic view illustrating another unfolding of the artificial leaflet of the present invention;

fig. 8 is a geometric relationship diagram of the artificial leaflet of the present invention;

FIG. 9 (a) is a perspective view of an outer frame and an inner frame according to the present invention;

FIG. 9 (b) is a front view of FIG. 9 (a);

FIG. 10 (a) is a front view of the outer frame of FIG. 9 (a);

FIG. 10 (b) is a top view of FIG. 10 (a);

FIG. 11 (a) is a front view of the inner frame of FIG. 9 (a);

FIG. 11 (b) is a schematic structural diagram of another embodiment in FIG. 11 (a);

FIG. 12 (a) is another top view of the outrigger of the present invention;

FIG. 12 (b) is a top view of the inner frame corresponding to FIG. 12 (a);

FIG. 13 (a) is another top view of the outrigger of the present invention;

FIG. 13 (b) is a partially enlarged view of FIG. 13 (a);

FIG. 14 (a) is another top view of the outrigger of the present invention;

FIG. 14 (b) is a partially enlarged view of FIG. 14 (a);

FIG. 15 is a front view of the outrigger of the present invention without barbs on the straight side of the D-shaped profile;

FIG. 16 is a view showing a positional relationship between the outer frame and the inner frame according to the present invention;

FIG. 17 is a schematic view of a mitral valve;

FIG. 18 is a schematic diagram of an application of the present invention.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

In the present invention, when describing a transcardiac mitral valve replacement device, "proximal" refers to the side of the transcardiac mitral valve replacement device that is on the side of the delivery device or in the direction of the user-manipulated end, and correspondingly, "distal" refers to the side of the transcardiac mitral valve replacement device or in the direction away from the user-manipulated end.

In the present invention, when describing a transapical mitral valve replacement device, "proximal" refers to the side of the transapical mitral valve replacement device that is closer to the apex of the heart, and correspondingly, "distal" refers to the side of the transapical mitral valve replacement device that is further from the apex of the heart.

In the present disclosure, "axial" refers to a direction between "proximal" and "distal" when describing a transapical mitral valve replacement valve device.

Referring to fig. 1 to 8, a transcardiac mitral valve replacement device includes a stent mechanism having an outer frame 100 and an inner frame 200, the outer frame 100 and the inner frame 200 being connected to each other, and a cover mechanism. The film covering mechanism is coated on the bracket mechanism.

In some embodiments, the cover mechanism includes an external scaffolding cover 300, an internal scaffolding cover 400, and a linking cover 500. The outer frame coating film 300 is coated on the outer frame 100; the inner frame coating 400 is coated on the inner frame 200; the graft membrane 500 is connected to the external and

internal scaffolding membranes

300 and 400, respectively.

The membrane covering mechanism comprises an outer frame membrane covering the outer frame, an inner frame membrane covering the inner frame and a connecting membrane, wherein the outer frame membrane covering the outer frame, the inner frame membrane covering the inner frame, and the independent outer frame membrane and the independent inner frame membrane are connected into a whole through the design of the connecting membrane, so that the stability of the transcardial mitral valve replacement valve device is greatly improved, and the phenomenon that the inner frame shakes in the outer frame is effectively prevented.

In some embodiments, referring to fig. 2 (a) and 2 (b), the outer frame coating 300 is a semi-circular structure when deployed, and the outer frame coating 300 surrounds the outside of the outer frame 100 and covers the outside surface of the outer frame 100.

In some embodiments, the distal edge of the outer frame coating 300 protrudes beyond the distal end of the outer frame 100 and is turned inward inside the outer frame 100, such that the distal edge of the outer frame coating 300 covers the distal end of the outer frame 100; the outer frame coating 300 located inside the outer frame 100 is connected to the binding coating 500.

The distal edge of the outer frame coating 300 protrudes beyond the distal tip of the outer frame 100, leaving room for attachment to the tie coating 500. Because the edge of the valve is inevitably flawed in the cutting process, in order to prevent the edge of the cover film from scratching the inner wall of the heart, when the connection cover film 500 is connected with the outer frame cover film 300, the edge of the outer frame cover film 300 inclines inwards and cannot be contacted with the inner wall of the heart, and the connection part of the outer frame cover film 300 and the connection cover film 500 is also positioned inside the outer frame cover film 300, so that the phenomenon that the edge of the cover film scratches the inner wall of the heart is avoided, preferably, the connection cover film 500 is positioned inside the outer frame cover film 300, namely, when the connection cover film 500 is viewed from the far end to the near end, the edge of the far end of the outer frame cover film 300 can be seen, but the outer edge of the connection cover film 500 cannot be seen, because the outer edge of the connection cover film 500 is shielded by the outer frame cover film 300, that is, that the connection cover film 500 is positioned inside the outer frame cover film 300, thus further ensuring that the outer edge of the connection cover film 500 cannot scratch the inner wall of the heart.

In some embodiments, referring to fig. 2 (a), the outer frame coating 300 has a plurality of outer frame coating slots 310, and the outer frame coating slots 310 correspond to the barbs 161 of the outer frame 100. Referring to fig. 2 (b), when the outer frame coating film 300 is coated on the outer frame 100, the barbs 161 of the outer frame 100 pass through the outer frame coating film slots 310.

In some embodiments, referring to fig. 2 (a), at least one arc-shaped slit is formed on the outer frame covering film 300, and the arc-shaped slit serves as a plurality of outer frame covering film slots 310.

In some embodiments, referring to fig. 3, the inner scaffolding cover 400 is in an elongated configuration when deployed, the inner scaffolding cover 400 surrounding the inside of the inner scaffolding 200 and covering the inside surface of the inner scaffolding 200. The distal end of the inner frame cover 400 has a tooth-shaped structure 410, and the tooth-shaped structure 410 is everted to the outside of the inner frame 200 and connected with the inner skirt portion 240 of the distal end of the inner frame 200. The inner frame coating film 400 with the tooth-shaped structure 410 at the distal end is more attached to the inner frame 200, which is beneficial to suture, the number of teeth in the tooth-shaped structure 410 can be determined according to the number of the inner diamond-shaped supports 241 of the inner skirt portion 240, and each tooth is positioned between two adjacent inner diamond-shaped supports 241 after being turned over.

In some embodiments, the tooth-shaped structure 410 is fixedly connected to the inner skirt portion 240 at the distal end of the inner frame 200 by sewing, but other fixing methods can be used.

In some embodiments, referring to fig. 3, a connection between the tooth structure 410 and the elongated structure forms a cuff marking line 420; the coupling coating 500 is connected to the cuff marking line 420. The connecting coating 500 is connected with the flanging marking line 420 on the inner frame coating 400, and the flanging marking line 420 is not contacted with the heart tissue, so the condition that the heart tissue is scratched cannot occur at the edge of the connecting coating 500 and the joint of the connecting part with the flanging marking line 420.

In some embodiments, referring to fig. 3, the inner frame covering film 400 is provided with leaflet holes 430, and the leaflet holes 430 are used for fixing the artificial leaflets to the inner frame 200 after passing through. When there are three artificial leaflets, as shown in fig. 3, three leaflet holes 430 are provided on the inner scaffolding cover film 400. When there are two artificial leaflets, two leaflet holes 430 are provided in the inner frame covering film 400. The number of the leaflet holes 430 is determined according to the number of the artificial leaflets.

In some embodiments, referring to fig. 4, the coupling coating 500 is a circular ring structure, the outer edge of the coupling coating 500 is connected to the outer frame coating 300, and the outer edge of the coupling coating 500 is located between the outer frame coating 300 and the outer frame 100, i.e., the outer edge of the coupling coating 500 is wrapped inside the outer frame coating 300. The inner edge of the tie coating film 500 is connected to the inner frame coating film 400 at the cuff mark line 420.

In order to prevent the edge of the connection coating film 500 from scratching the inner wall of the heart, the outer edge of the circular ring of the connection coating film 500 is positioned inside the outer frame coating film 300 when the connection coating film is connected with the outer frame coating film 300, so that the outer edge of the connection coating film 500 is covered in the outer frame coating film 300 and cannot be contacted with the inner wall of the heart, the edge of the outer frame coating film 300 inclines inwards and cannot be contacted with the inner wall of the heart, the phenomenon that the edge of the coating film scratches the inner wall of the heart cannot be caused, the inner edge of the circular ring of the connection coating film 500 is connected with the flanging marking line of the inner frame coating film 400 and cannot be contacted with the heart tissue, and the inner edge of the connection coating film 500 cannot scratch the heart tissue. Through the setting of the connection tectorial membrane 500, the original independent external frame tectorial membrane 300 and the internal frame tectorial membrane 400 are connected into a whole, the stability of the mitral valve replacement device through the apex of the heart is increased, and the phenomenon that the internal frame 200 shakes in the external frame 100 is effectively prevented.

In some embodiments, the external frame covering film 300, the internal frame covering film 400, and the tie covering film 500 are each made of a barrier PET composite film having a PET seam film.

In some embodiments, at least one layer of TPU spinning film is disposed on the side of the PET film close to the stent mechanism, that is, one layer of TPU spinning film is disposed on the side of the external frame film 300 close to the external frame 100, one layer of TPU spinning film is disposed on the side of the internal frame film 400 close to the internal frame 200, and one layer of TPU spinning film is disposed on the side of the coupling film 500 facing the gap between the external frame 100 and the internal frame 200. Because the PET material still can take place blood and permeate, so be provided with one deck TPU spinning membrane in the tectorial membrane is close to one side of gimbal mechanism, TPU spinning membrane is smooth and compact, prevents effectively that blood from permeating the tectorial membrane.

In some embodiments, a single layer of TPU spun film is provided on both sides of the PET cover film.

Both sides of the PET covering film can be provided with a layer of TPU spinning film, but the problem of preventing the PET covering film from permeating can be met only by arranging a layer of TPU spinning film on one side, so that the problem of further preventing the permeation can be solved by attaching a layer of TPU spinning film on both sides of the PET covering film. Meanwhile, the TPU spinning membrane is only arranged on one side close to the support mechanism, which is the preferred scheme, because the TPU spinning membrane is prevented from being in direct contact with the external environment, the TPU spinning membrane can adsorb impurities in the air more easily relative to the PET covering membrane, and the design effectively prevents the TPU spinning membrane from absorbing the impurities in the air.

Examples 1 to 8

Step Sa:

measuring V1 mL of tetrahydrofuran, and slowly pouring into a blue-cap bottle; then measuring V2 mL of N, N-dimethylformamide, and slowly pouring the N, N-dimethylformamide into a blue cap bottle; large magnetic stirring beads were added. And (3) placing the blue-cap bottle on a magnetic stirrer, and adjusting the rotating speed to a high speed r1 to enable the solution in the blue-cap bottle to form a vortex shape. The TPU particles were weighed and added slowly along the funnel into a blue-top bottle. Maintaining the r1 rotation speed, and continuously stirring for t1 hours, so that the TPU particles are completely dissolved. And adjusting the rotating speed of the magnetic stirrer to a low speed r2, continuously stirring for t2 hours to obtain a mixed solution of tetrahydrofuran and N, N-dimethylformamide containing a TPU solute, wherein the mixed solution has a concentration of C and can be used for electrostatic spinning, and obvious bubbles do not exist in the solution.

And Sb:

purified water was added to the ultrasonic cleaner, and a 6X 6 inch PET stitched film was placed in a 1L glass beaker, and 200. + -. 10mL of 75% ethanol aqueous solution was added; the beaker was then placed in an ultrasonic cleaning tank and ultrasonically cleaned at F1 frequency for t3 minutes. And after the ultrasonic treatment is finished, discarding the 75% ethanol aqueous solvent, injecting 500 +/-10 mL of injection water, and soaking the PET stitching film in the water for 2 minutes. After soaking, replacing 500 plus or minus 10mL of injection water, placing the mixture in an ultrasonic cleaning tank, and carrying out ultrasonic cleaning for t4 minutes at the frequency of F2. And taking out the PET sewing film, and airing to obtain the clean PET sewing film.

Step S1

And (3) naturally paving the clean PET sewing film obtained in the step Sb on dust-free release paper (such as release paper, silicone oil paper and the like), ensuring that the PET sewing film is smooth and has no wrinkles, and fixing the edges of the edges, which are 5mm, by using an adhesive tape. And flatly pasting the dust-free paper paved with the PET stitching film on a receiving plate of an electrostatic spinning machine. The size of the dust-free paper is matched with the stroke of the electrostatic spinning machine, and spinning is prevented from spraying out of a dust-free paper area.

And (4) extracting 60mL of the mixed solution of the tetrahydrofuran and the N, N-dimethylformamide containing the TPU solute obtained in the step Sa by using a syringe, fixing the mixed solution on a pushing pump, connecting the head end of the syringe with an infusion pipeline, connecting the other end of the infusion pipeline with a nozzle, and inserting a needle at the outlet of the nozzle. And starting the pushing pump to slowly push the solution in the injection syringe to the needle head, stopping pushing when liquid drops appear at the needle head, and wiping the liquid flowing out of the needle head by using dust-free cloth.

Adjusting the speeds of the X axis and the Y axis of the electrostatic spinning machine to be W1 mm/s and W2mm/s respectively, and adjusting the frequency of the pushing pump to be F3. And starting an X-axis switch, a Y-axis switch and a push pump switch of the electrostatic spinning machine to start normal movement and liquid discharge, wherein the liquid discharge speed is W3. And starting a voltage switch, adjusting the voltage and starting spinning. After the film spraying is finished, the voltage, the push pump and the electrostatic spinning machine are sequentially closed to move, the initial PET composite film is taken down together with the dust-free paper, and the initial PET composite film is placed at a specified position to be naturally dried. The composite film has clean surface and no obvious impurity.

Step S2

The inner surfaces of the two pieces of glass are wiped by dipping 75 percent of ethanol or 0.1 percent of neodell in dust-free cloth, and the glass is dried for 15 minutes. And uncovering the dust-free paper from the initial PET composite film, placing the film on the central surface of the glass, aligning the glass on the other surface, and pressing the initial PET composite film between the two surfaces of the glass smoothly and tightly without folds. The periphery of the glass is fixed by the clamp to ensure that the initial PET composite film cannot move. The oven was opened 30min in advance with the temperature set to T ℃. And placing the initial PET composite film clamped by the glass together in a constant-temperature oven at T ℃, drying for T5, and naturally airing for 30min to obtain the final anti-seepage PET composite film.

Step S3

In examples 7 to 8, the PET composite film spun with the single-sided TPU film is obtained, and then the PET composite film is reversely and naturally laid on dust-free release paper, and the steps S1 and S2 and the process parameters thereof are repeated to obtain the PET composite film with the TPU spun films spun on both sides.

TABLE 1 preparation Process parameters of the permeation-resistant PET composite films of examples 1-8

TABLE 1 preparation of barrier PET composite films for (required) examples 1-8

Effects of the embodiment

The detection requirement of the extracorporeal hydrodynamics of the artificial heart valve is tested in a Vivitro extracorporeal pulsating flow simulator according to the method 7.2.3 in YY/T1449.3-2016, and the method is used for evaluating indexes such as effective opening area, total reflux percentage and the like of the artificial heart valve through pulsating pressure and flow waveform under physiological conditions. The sealing performance of the sewing membrane is verified by combining the test data leakage amount according to observation and test of a single-layer PET membrane, a double-layer PET membrane and the PET composite membrane with one surface spun with the TPU silk membrane prepared in the example 1 corresponding to the sewed artificial heart valve under the parameter conditions of simulating 5L/min cardiac output, simulating heart rate (70 cycles per minute, 35% of systolic period) and average aortic pressure of 100 mmHg. As shown in table 2.

TABLE 2 valve hydromechanical testing

TABLE 2 (continuous) valve hydromechanical Property test

As can be seen from Table 2, the PET composite film having a total thickness of 0.21mm and a TPU spun film spun on one side, prepared in example 1, had a blood leakage amount reduced from 7.24mL to 0.63mL relative to a single PET film having a thickness of 0.2mm, and the blood permeation was greatly reduced. The PET composite film having the TPU spun film spun on one side having a total thickness of 0.21mm prepared in example 1 was reduced in blood leakage amount from 1.4mL to 0.63mL even with respect to the double PET film having a thickness of 0.4mm, indicating that the TPU spun film can greatly reduce the blood leakage amount of the seamed film.

And the TPU film has good blood compatibility and biocompatibility, and animal experiments of pigs, sheep and the like prove that the composite TPU film can enhance the adhesion, the growth and the spreading of endothelial cells on the stent and accelerate the endothelialization process. Because TPU is a high polymer material with good elasticity, the valve can be effectively attached to the native valve ring after being implanted and released, the permeability of blood is greatly reduced, and the paravalvular leakage is effectively reduced. The single-layer TPU film can achieve the effect of three layers of PET films. The PET composite film of the TPU spinning film can effectively prevent blood from permeating, and the blood permeation prevention performance is improved.

In some embodiments, referring to fig. 5 (a) -8, the transapical mitral replacement valve device further comprises a leaflet mechanism, the leaflet mechanism being located within the inner frame 200. The leaflet mechanism comprises a plurality of artificial leaflets 600, the artificial leaflets 600 are sequentially connected to form the leaflet mechanism with the outer circumference of a circular ring structure, the leaflet mechanism is connected with the inner side wall of the inner frame 200, and the middle part of the leaflet mechanism can be opened and closed in a one-way mode.

In some embodiments, the artificial leaflet 600 and the lamination mechanism are sutured to each other to form a suture track. Referring to fig. 5 (a) to 8, the artificial leaflet 600 includes a leaflet main body 610.

Since the size of the inner frame 200 may have different specifications according to actual requirements, the artificial leaflet 600 also needs to follow the change in size as the size of the inner frame 200 changes. When the film covering mechanisms are connected with each other in a sewing mode, the artificial valve leaflet 600 forms a suture line track, when the suture line track is consistent with the outer contour of the valve leaflet main body, the outer contour of the valve leaflet main body 610 and/or the suture line track have a determined geometrical relationship, and the performance of the artificial valve leaflet 600 is better. When the suture trajectory does not conform to the outer contour of the leaflet body, the suture trajectory contour needs to conform to the geometric relationship when the outer contour of the leaflet body 610 does not conform to the geometric relationship. Thus, at least one of the leaflet body 610 distal outer contour or the suture trajectory has a determined geometric relationship. The following uses as an example that the outer contour of the leaflet main body 610 has a certain geometric relationship:

referring to fig. 8, the distal outer profile of the leaflet main body 610 has a leaflet base curve 611 and two leaflet side curves. The distal end of the lobe base arc 611 is of an arc-shaped structure. The two valve leaf side arcs are respectively positioned at two sides of the valve leaf base arc 611, and the far end of the valve leaf side arc is also of an arc structure. The leaflet base arc 611 is tangentially connected with the leaflet side arcs on both sides to form the far end of the artificial leaflet 600.

In some embodiments, leaflet base curve 611 is an arc formed by a first center O1 and a first radius R1; the two leaflet side arcs are a first leaflet side arc 612a and a second leaflet side arc 612b, respectively, the first leaflet side arc 612a is a segment of arc formed by a second first center O21 and a second radius R2, and the second leaflet side arc 612b is another segment of arc formed by a second center O22 and a second radius R2; the connecting line among the first circle center O1, the second circle center O21 and the second circle center O22 is a regular triangle.

In some embodiments, the side length L of the regular triangle is greater than the diameter of the leaflet base arc 611 and less than the width D of the leaflet body. This prevents the artificial leaflet 600 from forming a narrow, long or short-humped shape that affects the performance of the leaflet and thus the performance of the artificial leaflet 600.

In some embodiments, the prosthetic leaflet has an axial leaflet symmetry line I; the first circle center O1 is located on the leaflet symmetry line I, and the second circle center O21 and the second circle center O22 are symmetrical with respect to the leaflet symmetry line I.

In some embodiments, the proximal outer profile of the leaflet main body 610 has a leaflet apex arc 613, the leaflet apex arc 613 is located on the proximal side of the leaflet base arc 611, and the proximal end of the leaflet apex arc 613 is an arc-shaped structure.

In some embodiments, the leaflet apex arc 613 is an arc formed by a third center O3 and a third radius R3, and the third center O3 is located on the leaflet symmetry line I.

In some embodiments, the distance from the third center O3 to the first center O1 is N times the side length L of the regular triangle, and preferably, the distance from the third center O3 to the first center O1 is three times the side length L of the regular triangle, i.e., the distance from the third center O3 to the first center O1 is 3L.

In some embodiments, referring to fig. 5 (a) to 8, the artificial leaflet 600 further comprises two ears 620. Two ears 620 are located on either side of the proximal end of the leaflet main body 610. The ears 620 are used to couple with the inner frame 200 to fix each artificial leaflet 600.

In some embodiments, referring to fig. 5 (b), when the artificial leaflet 600 is installed, the ears 620 are connected to the leaflet sewing hole 232 of the inner frame 200 through the leaflet holes 430 of the inner frame covering film 400 and are sutured to the leaflet main body 610 after passing through the leaflet sewing hole 232, and two adjacent ears 620 are connected to the same leaflet sewing hole 232, so that the proximal edges of two adjacent artificial leaflets 600 are in close contact, thereby preventing the backflow of blood caused by incomplete closure of the leaflet mechanism.

In some embodiments, referring to fig. 6 (a), the ears 620 include an upper ear 621, a lower ear 622, and an escape slot 623. The upper ear 621 is located on the proximal end side; the lower ear 622 is located on the distal end side of the upper ear 621; the side edges of the avoiding groove 623 are open, the avoiding groove 623 is located between the upper ear 621 and the lower ear 622, and the upper ear 621 and the lower ear 622 are separated by the avoiding groove 623. In specific implementation, an avoiding groove 623 may be formed in the original ear portion 620 from the side edge to the middle, an upper ear portion 621 may be formed on the proximal end side of the avoiding groove 623, and a lower ear portion 622 may be formed on the distal end side of the avoiding groove 623.

In some embodiments, referring to fig. 6 (b) and 6 (c), when the artificial leaflet 600 is installed, the upper ear 621 is turned over at the avoiding groove 623, the lower ear 622 sequentially passes through the leaflet hole 430 of the inner frame cover 400 and the leaflet suture hole 232 of the inner frame 200, the frame where the leaflet suture hole 232 is located is clamped into the avoiding groove 623, the inner frame cover 400 is clamped between the upper ear 621 and the lower ear 622 and is sutured together, and two adjacent ears 620 are connected with the same leaflet suture hole 232, so that the proximal edges of two adjacent artificial leaflets 600 are in close contact with each other, and the backflow of blood caused by incomplete closure of the leaflet mechanism is prevented. In this way, as compared with fig. 5 (b), it is possible to effectively prevent the backflow of blood due to the leakage of blood from the leaflet holes 430 of the inner frame cover 400.

In some embodiments, the length of the avoidance slot 623 is generally no greater than 2/3 of the width of the ear 620 to prevent tear splitting of the upper and

lower ears

621 and 622.

In some embodiments, referring to fig. 7, the distal edge of the leaflet body 610 is provided with wear strips 630, the wear strips 630 being attached to the leaflet body 610 by stitching. Adopt the mode of sewing up to combine with the leaflet main part, it is fixed firm, and abrasionproof strake 630 sets up at first has increased the tear resistance ability of leaflet main part 610 distal end, secondly has reduced the damage of the friction of leaflet main part 610 distal end and tectorial membrane to artificial leaflet, the life of artificial leaflet has been improved, and the setting of abrasionproof strake 630 also is equivalent to the buffer layer between artificial leaflet and the tectorial membrane, the effectual artifical leaflet of having cushioned is opening and shutting the effort of tearing of in-process to the tectorial membrane, the life of this anti-backflow support has been increased.

In some embodiments, referring to fig. 9 (a) to 10 (b), the outer frame 100 includes a tether end 110, an outer connecting portion 120, a supporting portion 130, and an outer skirt portion 140, which are connected in sequence from the proximal end to the distal end. When the outer frame 100 is covered with the outer frame coating 300, at least the tether end 110 is exposed to the outer frame coating 300. As shown in fig. 2 (b) and 9 (a), both the tether end 110 and the outer connecting portion 120 are exposed to the outer frame coating 300.

The tether end 110 is in a contracted form, and referring to fig. 18, the tether end 110 is connected to a tether 310. The tether 310 is pulled over the tether end 110 and secured by the apex shim 320. The invention abandons the traditional mode of connecting the tether 310 with the inner frame, but adopts the tether 310 to be connected with the outer frame 100, after the tether is stressed, the tether needs to be transmitted to the outer frame 100, then to the inner frame 200, and finally to be the valve leaflet mechanism in the inner frame 200, so the open and close influence on the valve leaflets in the valve leaflet mechanism is relatively small.

The proximal end of the outer connecting portion 120 is connected to the distal end of the tether end 110, and the outer connecting portion 120 is connected to the inner frame 200. The supporting portion 130 is a hollow column-like structure, and the inner frame 200 can be accommodated in the supporting portion 130. The distal end of the outer skirt portion 140 is in a closed configuration, and the outer skirt portion 140 has a skirt with a D-shaped profile in cross-section. The distal end of the outer frame 100 is in a furled structure, so that the inner wall of the heart can be prevented from being punctured by the tip.

In some embodiments, referring to fig. 10 (a) and 10 (b), tether end 110 has a plurality of tether link brackets 111, the plurality of tether link brackets 111 being independent of each other, each tether link bracket 111 having a tether aperture 112. Tether connecting rod support is independent each other, has at first increased the flexibility of tether end, can not produce the effort each other between each tether connecting rod support promptly, and the effectual tether end angle adaptability that has increased can have certain angular deviation, and the outrigger processing heat setting of being convenient for has secondly reduced the processing cost.

In some embodiments, the proximal and distal ends of tether link bracket 111 are each a square configuration with tether apertures 112 therein such that a square attachment frame is formed at the proximal and distal ends of tether link bracket 111, respectively.

In some embodiments, the proximal and distal ends of the square shaped connecting frame are rounded such that the square shaped connecting frame 113 forms an octagonal-like structure.

In some embodiments, referring to fig. 10 (a), when the bracket is deployed in a plane, the left and right sides of the tether link bracket 111 are planes, and the planes are parallel to each other. The left and right sides of the square connecting frame 113 are planes, and the planes are parallel to each other, which is more beneficial for the pressing and holding of the rope tying end, and further, the rope tying connecting rod bracket 111 is parallel to the left and right sides of the square connecting frame 113.

In some embodiments, referring to fig. 10 (a) and 10 (b), the outer connecting portion 120 includes a plurality of outer connecting rods 121, proximal ends of the outer connecting rods 121 are respectively connected to the distal ends of the tether ends 110, the outer connecting rods 121 are inclined outwards from the proximal ends to the distal ends, so that the plurality of outer connecting rods 121 form a hollow truncated cone-like structure, and the outer frame 100 is connected to the inner frame 200 through the outer connecting rods 121.

In some embodiments, referring to fig. 10 (a) and 10 (b), the distal end of each outer connecting rod 121 is provided with an outer suture hole 122. Referring to fig. 11 (a), the inner frame 200 is provided with inner suture holes 212, and the outer frame 100 and the inner frame 200 are sutured by suturing the outer suture holes 122 and the inner suture holes 212.

In some embodiments, the outer suture hole 122 has a larger aperture than the inner suture hole 212. So as to reduce the fitting accuracy of the inner frame 200 and the outer frame 100.

In some embodiments, referring to fig. 12 (a) and 12 (b), the outer and inner suture holes 122 and 212 are elongated kidney-shaped holes, the length direction of which is the length direction of the outer connecting rod 121, and the kidney-shaped holes are inclined outward from the proximal end to the distal end because the outer connecting rod 121 is inclined outward from the proximal end to the distal end.

The outer stitching hole and the inner stitching hole are both in long-strip waist-shaped hole design, the number of stitching circles of the stitching thread is increased, namely, compared with the stitching hole of a common round hole, stitching of a plurality of circles of stitching thread is easier to carry out, and the separation of the inner frame and the outer frame caused by the breakage of the stitching thread is prevented; and the matching precision of the inner frame and the outer frame is reduced by the elongated sewing holes, so that the processing cost is reduced, and compared with the traditional circular sewing holes, the elongated sewing holes can allow the axial displacement of the outer frame and the inner frame to a certain degree, and the inner frame and the outer frame are formed by cutting stainless steel or nickel-titanium tubes or cobalt-chromium tubes.

In some embodiments, the outer frame 100 and the inner frame 200 may be connected by riveting, bolting, or welding.

In some embodiments, a gasket is disposed between the outer frame 100 and the inner frame 200 to prevent friction between the outer frame 100 and the inner frame 200, and to buffer the outer frame 100 and the inner frame 200.

In some embodiments, referring to fig. 10 (a), support 130 comprises a plurality of X-shaped brackets 131, each X-shaped bracket 131 has two proximal connecting bars 1311 and two distal connecting bars 1312 connected to each other, a proximal end of proximal connecting bar 1311 is connected to a distal end of outer connecting portion 120, and a distal end of distal connecting bar 1312 is connected to a proximal end of outer skirt portion 140, if X-shaped brackets 131 surround support 130.

In some embodiments, the angle between the two proximal connector bars 1311 is greater than the angle between the two distal connector bars 1312.

In some embodiments, proximal connecting rod 1311 is inwardly inclined from proximal to distal, distal connecting rod 1312 is outwardly inclined from proximal to distal, and proximal connecting rod 1311 and distal connecting rod 1312 are smoothly connected, so that X-bracket 131 forms a structure in which the middle of the outer circumferential surface is inwardly recessed. To better grip the native valve leaflet and its valve annulus, it should be noted that the inner concave structure may be formed by expanding the outer skirt 140, the X-shaped stent 131 may be an inner concave structure, or the X-shaped stent 131 may be straight and concave relative to the outer skirt 140 after being smoothly transitionally connected to the outer skirt 140.

In some embodiments, referring to fig. 10 (a), the outer skirt portion 140 includes a plurality of outer diamond-shaped struts 141, each outer diamond-shaped strut 141 having a V-shaped connecting bar 1411 and an inverted V-shaped connecting bar 1412 connected to each other, a proximal end of the V-shaped connecting bar 1411 being connected to a distal end of the support portion 130, and the plurality of outer diamond-shaped struts 141 surrounding the outer skirt portion 140 having a D-shaped profile in cross section. At least the inverted V-shaped connecting rod 1412 inclines inwards from the proximal end to the distal end to form a furled structure.

Referring to fig. 17, a mitral valve 400 is generally approximately D-shaped in cross-section, having anterior 410 and posterior 420 leaflets, such that the outer skirt portion 140 also encloses a D-shaped profile in cross-section.

In some embodiments, referring to fig. 10 (a), the inward taper angle of the inverted V-shaped connecting rod 1412 is α, which ranges from 10 ° ≦ α ≦ 20 °, and the angle α is preferably 15 °. The inner endothelialization speed of the outer skirt portion 140 is affected by an excessively large furling angle, so that the inner endothelialization speed can be satisfied by an appropriate furling angle, and the inner wall of the heart is protected from being punctured by collision of the far-end of the outer skirt portion 140.

In some embodiments, the V-shaped connecting rod 1411 is inclined outward from the proximal end to the distal end to form an outwardly expanded structure, and the V-shaped connecting rod 1411 and the inverted V-shaped connecting rod 1412 are smoothly connected such that the outer skirt portion 140 forms a structure in which the middle portion of the outer circumferential surface protrudes outward.

In some embodiments, referring to FIG. 10 (a), the V-shaped connecting rod 1411 flares outwardly at an angle β in the range of 15 ≦ β ≦ 75.

In some embodiments, the angle β near the curved side of the D-shaped profile is greater than the angle β near the straight side of the D-shaped profile by no less than 25 °. That is, referring to fig. 10 (a) and 10 (b), the flared angle β of the skirt closer to the left side is smaller, and the flared angle β of the skirt closer to the right side is larger. But the difference between the maximum flare angle beta and the minimum flare angle beta is not less than 25 deg..

In some embodiments, the difference between the angle β near the curved side of the D-shaped profile and the angle β near the straight side of the D-shaped profile is 30 °, and the angle β near the straight side of the D-shaped profile is a minimum of 30 °.

The opening and closing movement ranges of the front valve leaflet 410 and the rear valve leaflet 420 are different, the structural size of the junction of the left atrium and the mitral valve annulus is different, and the outer skirt part 140 of the outer frame can be tightly attached to the inner wall of the heart by designing a gradually-changed outer expanding structure, so that the stability of the transcardial mitral valve replacement valve device after installation is improved.

In some embodiments, referring to fig. 13 (a) to 14 (b), at least one marker 150 is disposed on the outer frame 100, and preferably, two markers 150 are disposed on the outer frame 100, the two markers 150 are respectively disposed on the two outer diamond-shaped supports 141 on the straight side of the D-shaped profile, and both markers 150 are disposed on the distal ends of the two outer diamond-shaped supports 141, that is, the markers 150 are disposed on the distal end side of the inverted V-shaped connecting rod 1412. Referring to fig. 13 (b) and 14 (b), two marker pieces 150 are disposed apart from each other by a predetermined distance on one side of the outer diamond 141, that is, the marker pieces 150 are disposed on the distal end side of the inverted V-shaped connecting rod 1412. The markers are used to resolve the location of the outer frame, so that the two markers 150 do not have to be symmetrical about the symmetry line 250 perpendicular to the straight side of the D-shaped profile, and can be normally disposed on any two outer diamond-shaped holders 141 located on the side of the straight side of the D-shaped profile, thereby enabling determination of the location of the mitral valve replacement device, it is stated that disposing the two markers 150 a predetermined distance away from each other on the side of the outer diamond-shaped holders 141 can include disposing the markers 150 on the distal end of the inverted V-shaped connecting rods 1412, and when only one marker 150 is disposed, the difference with respect to the embodiment in which two markers 150 are disposed is that: only one of the two markers 150 is removed and one of the markers 150 remains.

In some embodiments, referring to fig. 13 (b), the marker 150 is a raised semicircular raised member, and the marker 150 is integrally formed with the outer diamond bracket 141.

In some embodiments, referring to fig. 14 (a) and 14 (b), marker 150 is a marker hole disposed on outer diamond stent 141, with a radiopaque marker material ("marker") mounted within the marker hole.

The marker of the present invention may be any type of protrusion or marking hole fitted with radiopaque marking material, as long as it is readily visible to the operator under the imaging device.

In some embodiments, referring to fig. 9 (a) to 10 (a) and 15, the outer frame 100 further includes a barb 160, and the barb 160 is inclined outward from the proximal end to the distal end.

The barb part is used for grabbing the native valve leaflet of mitral valve and assisting the whole sealing of valve system, reduces the valve week after the implantation and leaks. In addition, after the valve device is implanted, when the left atrium contracts, the implanted valve leaflets are washed away by blood, and the pressure of blood flow on the valve device is low. Because the existence of the apex cordis rope, the valve device is restrained in situ, but the valve device barb hooks native valve leaf, is favorable to sharing the strength of apex cordis, reduces the atress of heart muscle, reduces the damage to the heart. Secondly, the native mitral valve leaflets are prevented from moving freely in the heart, for example, if the anterior valve leaflets rotate reversely under the scouring of blood, the aorta is blocked, thereby endangering the life of the user, and the native valve leaflets are clamped between the barbs and the outer frame, so that the native valve leaflets are prevented from moving freely.

In some embodiments, the barb 160 includes a plurality of inverted V-shaped barbs 161, the proximal ends of the inverted V-shaped barbs 161 are respectively connected to the outer frame 100, the inverted V-shaped barbs 161 are inclined outward from the proximal ends to the distal ends and exposed outside the outer frame 100, and the plurality of inverted V-shaped barbs 161 surround the barb 160.

In some embodiments, the angle of outward inclination of inverted V-shaped barbs 161 is between 5 and 15.

In some embodiments, the inverted V-shaped barbs 161 on the straight side of the D-shaped profile are vertical barbs that are not inclined outward, or, referring to fig. 15, no inverted V-shaped barbs 161 are provided on the straight side of the D-shaped profile.

Because the anterior leaflet of the mitral valve is closer to the aorta, and the outward protruding barbs may affect the aorta to cause the aorta to function abnormally, the barbs close to the position of the aorta are removed, namely the barbs on the straight side of the D-shaped contour are removed, or the barb structure is retained, but the outward protruding barbs are not protruded any more, and the function of the aorta is prevented from being affected by the outward protruding barb structure by fixing the mitral valve by using the adjacent barb structure in the position.

In some embodiments, the proximal ends of the inverted V-shaped barbs 161 are integrally connected to the proximal connecting rods 1311 of two adjacent X-shaped brackets 131 respectively. The inverted-V barbs 161 are uniformly distributed on the supporting portion 130.

In some embodiments, referring to fig. 10 (a) and 10 (b), fig. 12 (a), fig. 15, the outer frame 100 includes a tether end 110, an outer connecting portion 120, a support portion 130, and an outer skirt portion 140, which are connected in sequence from the proximal end to the distal end. The tether link brackets 111 at the tether end 110 are independent of each other, the proximal end and the distal end of each tether link bracket 111 are respectively provided with a square connecting frame, and the middle of each square connecting frame is provided with a tether hole 112. The number of outer links 121 in the outer link 120 is the same as the number of tether link brackets 111, and the proximal end of each outer link 121 is connected to the distal end of a corresponding one of the tether link brackets 111. The outer end of the outer connecting rod 121 is provided with an outer sewing hole 122, and the outer sewing hole 122 may be a circular hole or a kidney-shaped hole. The number of the X-shaped brackets 131 in the support portion 130 is determined according to the outer connecting rods 121, and the two proximal connecting rods 1311 of each X-shaped bracket 131 are respectively connected with the distal ends of two adjacent outer connecting rods 121. The outer diamond supports 141 in the outer skirt part 140 are determined according to the number of the X-shaped supports 131, the proximal end part of the V-shaped connecting rod 1411 in each outer diamond support 141 is connected with one remote center connecting rod 1312 of the X-shaped support 131, and the middle parts of the adjacent outer diamond supports 141 are connected.

For example, the outer frame 100 is provided with six tether link brackets 111, and the six tether link brackets 111 are parallel to each other to enclose the tether end 110. The six tether connecting rod brackets 111 are correspondingly and independently connected with six outer connecting rods 121, and the six outer connecting rods 121 are expanded to form outer connecting parts 120. Two adjacent outer connecting rods 121 are connected with the proximal end of the same X-shaped bracket 131, so that six X-shaped brackets 131 surround the supporting part 130. Since the proximal end of each V-shaped connecting bar 1411 is connected to one distal connecting bar 1312 of the X-bracket 131, twelve outer diamond-shaped brackets 141 are required, and the twelve outer diamond-shaped brackets 141 are connected in turn to form the outer skirt 140.

In some embodiments, the external frame 100 is an external frame 100 that is integrally cut from stainless steel or nickel titanium or cobalt chromium tube. Namely, the tether end 110, the outer connecting portion 120, the supporting portion 130, the outer skirt portion 140, the marker 150 and the barb portion 160 are integrally cut from stainless steel, nickel titanium or cobalt chromium.

In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer suture holes 122 arranged side by side, the two markers 150 are convex semicircular convex members, and the barbs 160 are uniformly arranged on the supporting portions 130.

In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer suture holes 122 arranged side by side, the two markers 150 are marker holes having radiopaque marker materials mounted therein, and the barb portions 160 are uniformly arranged on the supporting portion 130.

In some embodiments, the outer sewing hole 122 of the outer connecting portion 120 of the outer frame 100 is a long-bar waist-shaped hole, the two markers 150 are convex semicircular protruding members, and the barbs 160 are uniformly arranged on the supporting portion 130.

In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer seam holes 122 arranged side by side, the two markers 150 are convex semicircular protruding members, the inverted V-shaped barbs 161 are not arranged on the straight side of the D-shaped profile, and the inverted V-shaped barbs 161 at other positions are uniformly arranged on the supporting portion 130.

In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer suture holes 122 arranged side by side, the two marker members 150 are marker holes having radiopaque marker material mounted therein, the straight side of the D-shaped profile is not provided with the inverted V-shaped barbs 161, and the inverted V-shaped barbs 161 at other positions are uniformly arranged on the supporting portion 130.

In some embodiments, referring to fig. 9 (a), 9 (b), and 11 (a), the inner frame 200 comprises, sequentially from proximal to distal, an inner attachment portion 210, a plurality of stent connection rods 220, a leaflet attachment portion 230, and an inner skirt portion 240. The inner connection portion 210 is a folded structure, and the inner connection portion 210 is connected to the outer frame 100. The plurality of support connecting rods 220 are arranged from the proximal end to the distal end in an outward inclined manner. The leaflet connecting portion 230 is connected with a leaflet mechanism. The inner skirt portion 240 and the leaflet connecting portion 230 each have a hollow column-like structure, and can accommodate the leaflet mechanism therein.

In some embodiments, the inner connection portion 210 includes a plurality of inner connection rods 211, the inner connection rods 211 have inner stitching holes 212, the inner stitching holes 212 enable the inner frame 200 to be stitched to the outer frame 100, and the plurality of inner connection rods 211 are disposed in an inclined manner from the proximal end to the distal end to the outside to form a folded structure. The inclination angle of the inner connecting rod 211 is consistent with that of the outer connecting rod 121, so that the inner connecting rod and the outer connecting rod are highly attached and connected.

Specifically, the inner suture holes 212 and the outer suture holes 122 are sutured to realize the suturing connection of the inner frame 200 and the outer frame 100. The inner suture holes 212 may be two circular suture holes as shown in fig. 11 (a) or a kidney-shaped hole as shown in fig. 12 (b).

In some embodiments, the leaflet connecting portion 230 includes a number of leaflet connecting rods 231, the leaflet connecting rods 231 having leaflet suture holes 232 through which the inner frame 200 is sutured to the leaflet mechanism, the number of leaflet connecting rods 231 enclosing the leaflet connecting portion 230.

In some embodiments, referring to fig. 11 (a), the leaflet connecting rods 231 are integer multiples of n, where n is a positive integer greater than or equal to 2, the total number of the leaflet connecting rods 231 is not greater than 24, and excessive leaflet connecting rods 231 will affect the crimping of the stent, and this embodiment is explained by taking one integer multiple of 3, i.e., 6 leaflet connecting rods 231 as an example, each leaflet connecting rod 231 is provided with one leaflet sewing hole 232, but it is stated that not every leaflet sewing hole 232 must be used for sewing the artificial leaflet, and whether to suture the artificial leaflet is determined according to the need.

In some embodiments, referring to fig. 11 (a), the present embodiment is still explained by taking an integral multiple of 3, i.e., 6 leaflet connecting rods 231 as an example, and one leaflet suture hole 232 is provided at an interval of at least one leaflet connecting rod 231.

As shown in fig. 11 (a), the leaflet connecting part 230 has six leaflet connecting rods 231, each leaflet connecting rod 231 being connected to adjacent two inner connecting rods 211 by two obliquely arranged stent connecting rods 220. When the leaflet linking rods 231 are provided with the leaflet suture holes 232, two leaflet linking rods 231 adjacent to each other are not provided with the leaflet suture holes 232. This structure is suitable for a leaflet mechanism having three leaflets. When a leaflet mechanism having two leaflets is used, two leaflet connecting rods 231 that are symmetrically disposed may be selected to have leaflet suture holes 232, and the other leaflet connecting rods 231 may not have leaflet suture holes 232, that is, when one leaflet connecting rod 231 has leaflet suture holes 232, four leaflet connecting rods 231 of two adjacent sides may not have leaflet suture holes 232.

When the number of the leaflet connecting rods 231 is changed, the arrangement mode of the leaflet suture holes 232 can also be changed according to actual requirements, which can be obtained by simple adjustment, so the description is not repeated;

in some embodiments, referring to fig. 11 (b), the width of the leaflet connecting rods 231 not provided with the leaflet suture holes 232 is 1/3-1/2 of the overall width of the leaflet connecting rods 231 provided with the leaflet suture holes 232. Such a design enhances the compressibility of the stent, and at the same time, reduces the strength difference between the leaflet connecting rods 231 provided with the leaflet suture holes 232 and the leaflet connecting rods 231 not provided with the leaflet suture holes 232, thereby promoting the mechanical balance of the stent.

In order to freely adjust the number of leaflets, for example, three leaflets can be freely used as opposed to two leaflets, and also in order to reduce the stress imbalance of the inner frame 200, as shown in fig. 11 (a), leaflet suture holes 232 are provided on the leaflet connecting rods 231.

In some embodiments, referring to fig. 11 (a), the inner skirt portion 240 includes a plurality of inner diamond-shaped struts 241, and the plurality of inner diamond-shaped struts 241 enclose a hollow quasi-cylindrical structure. One inner diamond support 241 in the inner frame 200 corresponds to two outer diamond supports 141 in the outer frame 100.

Although the skirt cross section of the outer diamond shaped support 141 in the outer frame 100 is designed with D-shaped profile, the outer diamond shaped supports 141 of the skirt are uniformly distributed and have corresponding relationship with the inner diamond shaped support 241 of the inner frame 200. The inner diamond supports 241 of one inner frame 200 correspond to the two outer diamond supports 141 of the outer frame 100.

In some embodiments, referring to fig. 16, the inner frame 200 cross-section has a line of symmetry 250 perpendicular to the straight sides of the D-shaped profile, and at least two inner suture holes 212 of the inner frame 200 and at least two inverted V-shaped barbs 161 of the outer frame 100 are located on the line of symmetry. As shown in fig. 16, the leftmost inverted V-shaped barb 161 and the rightmost inverted V-shaped barb 161 can smoothly clamp the native anterior leaflet and the native posterior leaflet, and the adjacent barb structure can assist in clamping the native leaflet and provide a foundation for the later-stage film covering.

In some embodiments, the inner frame 200 is an integrally cut inner frame 200 made of stainless steel or a nickel titanium or cobalt chromium tube. That is, the inner connecting portion 210, the stent connecting rods 220, the leaflet connecting portion 230, and the inner skirt portion 240 are integrally cut from stainless steel, nickel titanium or cobalt chromium.

In some embodiments, the inner connection part 210 of the inner frame 200 has an inner suture hole 212, the inner suture hole 212 is an elongated kidney-shaped hole, and each leaflet connecting rod 231 has a leaflet suture hole 232 thereon.

In some embodiments, the inner connection part 210 in the inner frame 200 has two circular inner suture holes 212, and each leaflet connecting rod 231 has a leaflet suture hole 232 thereon.

In some embodiments, the present transapical mitral replacement valve devices are still suitable for use in transcatheter delivery methods. Referring to fig. 18, in the application of the present invention to avoid valve regurgitation, one end of a tether 310 is connected to the tether end 110 of the outer frame 100 and the other end of the tether 310 is secured by an apex cordis pad 320, which apex cordis pad 320 may be of the prior art. In the above fixing manner, when the tether 310 is stressed, the force needs to be transmitted to the outer frame 100, then to the inner frame 200, and finally to the leaflet mechanism in the inner frame 200, so that the opening and closing of the leaflets in the leaflet mechanism is relatively less affected.

The foregoing shows and describes the general principles, principal features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A transapical mitral valve replacement valve device, comprising:

a leaflet mechanism located within the inner frame;

characterized in that the leaflet mechanism comprises:

2. The transcardiac mitral valve replacement valve device of claim 1, further comprising:

the film covering mechanism is coated on the bracket mechanism, and the film covering mechanism and the artificial valve leaflet are mutually sewn to form a suture line track;

the prosthetic leaflet includes a leaflet body having at least one of a distal outer profile or the suture trajectory having:

a lobe base arc, the far end of which is an arc structure;

two valve leaf side arcs are respectively positioned on two sides of the valve leaf base arc, and the far end of the valve leaf is also of an arc structure;

3. The mitral valve replacement device of claim 2, wherein the leaflet base arc is an arc of a circle formed by a first center and a first radius;

4. The transcardiac mitral valve replacement valve device of claim 3, wherein the side length of the regular triangle is greater than the diameter of the leaflet base arc and less than the width of the leaflet body.

5. The transcardiac mitral valve replacement valve device of claim 3, wherein the prosthetic leaflet has an axial leaflet symmetry line;

6. The transcardiac mitral valve replacement valve device of claim 5, wherein at least one of the suture trajectory or the proximal outer contour of the leaflet body has:

7. The transcardiac mitral valve replacement valve device of claim 6, wherein the leaflet apex arc is an arc of a circle having a third center of circle and a third radius, the third center of circle being located on the leaflet symmetry line.

8. The mitral valve replacement device according to claim 7, wherein the third center of the circle is N times, preferably three times, the length of the side of the regular triangle from the first center of the circle.

9. The transcardiac mitral valve replacement device of any one of claims 1-8, wherein the prosthetic leaflet further comprises:

through the ear realize artifical leaflet with leaflet sewing hole in the inner tower is connected, adjacent two the ear is connected same the leaflet sewing hole.

10. The transcardiac mitral valve replacement valve device of claim 9, wherein the ears comprise:

an upper ear portion located at the proximal end side;

a lower ear portion located at a distal end side of the upper ear portion;

11. The mitral valve replacement device of claim 10, wherein the length of the avoidance slot is no greater than 2/3 of the width of the ear.

12. The transcardiac mitral valve replacement valve device of claim 2, wherein the distal edge of the leaflet body is provided with: