CN218792635U

CN218792635U - Tectorial membrane mechanism for transcardial mitral valve replacement valve device

Info

Publication number: CN218792635U
Application number: CN202221183268.XU
Authority: CN
Inventors: 吴明明; 刘影; 冯彬; 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: 2023-04-07
Anticipated expiration: 2032-05-13

Abstract

The utility model belongs to the technical field of medical instrument, concretely relates to mitral valve replacement valve tectorial membrane mechanism for device. The utility model provides a through apex mitral valve replacement valve tectorial membrane mechanism for device, tectorial membrane mechanism cladding is on gimbal mechanism, and tectorial membrane mechanism includes: the outer frame coating is unfolded into a semicircular structure, surrounds the outer side of the outer frame of the support mechanism and is coated on the outer side surface of the outer frame; the inner frame film is unfolded into a strip-shaped structure, surrounds the inner side of the inner frame of the support mechanism and is coated on the inner side surface of the inner frame; and the connecting film is in a circular structure, the outer edge of the connecting film is connected with the outer frame film, and the inner edge of the connecting film is connected with the inner frame film. The utility model discloses a design of connection tectorial membrane becomes a whole with independent outrigger tectorial membrane and interior frame tectorial membrane connection, greatly increased through the stability of apex of the heart mitral valve replacement valve device, effectually prevented that the interior frame from rocking the emergence of phenomenon in the outrigger.

Description

Tectorial membrane mechanism for transcardial mitral valve replacement valve device

Technical Field

The utility model belongs to the technical field of medical instrument, concretely relates to mitral valve replacement valve tectorial membrane mechanism for 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, two main ways of treating mitral regurgitation through surgery include surgical thoracotomy and medical minimally invasive surgery. 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. In the conventional mitral valve replacement device, the adopted film covering method is to cover films independently, so that the inner frame and the outer frame are easy to shake, and the mitral valve replacement device is unstable.

SUMMERY OF THE UTILITY MODEL

The utility model discloses adopt independent tectorial membrane to current mitral valve replacement valve device, lead to interior frame and outrigger to rock easily, cause the unstable technical problem of device, aim at provides a through apex mitral valve replacement valve tectorial membrane mechanism for device.

A coating mechanism for a mitral valve transapical replacement valve device, the coating mechanism coated on a stent mechanism, the coating mechanism comprising:

the outer frame coating is unfolded into a semicircular structure, surrounds the outer side of the outer frame of the support mechanism and covers the outer side surface of the outer frame;

the inner frame film is unfolded into a strip-shaped structure, surrounds the inner side of the inner frame of the support mechanism and is coated on the inner side surface of the inner frame;

and the connecting coating is of a circular structure, the outer edge of the connecting coating is connected with the outer frame coating, and the inner edge of the connecting coating is connected with the inner frame coating.

Preferably, the edge of the distal end of the outer frame covering film is turned inwards and then is positioned on the inner side of the outer frame covering film;

the outer edge of the connecting coating is positioned on the inner side of the outer frame coating and is connected with the far end of the outer frame coating positioned on the inner side.

Preferably, the outer frame coating is provided with:

the outer frames are provided with film covering grooves corresponding to the barb structures on the outer frames;

when the outer frame coating film is coated on the outer frame, the barb structure on the outer frame penetrates through the outer frame coating film slot.

Preferably, at least one arc-shaped gap is formed in the outer frame covering film, and the arc-shaped gap is used as a plurality of outer frame covering film slots.

Preferably, the distal end of the inner frame covering film is provided with a tooth-shaped structure, and the tooth-shaped structure is outwards turned and then positioned on the outer side of the inner frame covering film.

Preferably, the tooth-shaped structure is fixedly connected with the inner skirt edge part of the inner frame through sewing.

As a preferred scheme, a flanging marking line is formed at the joint of the tooth-shaped structure and the long strip-shaped structure;

the inner edge of the connecting covering film is connected with the flanging marking line.

Preferably, the inner frame covering film is provided with a valve leaflet hole for the artificial valve leaflet to pass through and then to be fixed with the inner frame.

Preferably, the external frame covering film, the internal frame covering film and the connection covering film are all made of anti-permeation PET composite films, and each anti-permeation PET composite film is provided with a layer of PET sewing film.

As a preferred scheme, a TPU spinning membrane is arranged at least on one side of the anti-permeation PET composite membrane close to the support mechanism, that is, a layer of TPU spinning membrane is arranged on one side of the outer frame covering membrane close to the outer frame, a layer of TPU spinning membrane is arranged on one side of the inner frame covering membrane close to the inner frame, and a layer of TPU spinning membrane is arranged on one side of the coupling covering membrane facing a gap between the outer frame and the inner frame.

As a preferred scheme, a layer of TPU spinning membrane is arranged on each of two sides of the anti-seepage PET composite membrane so as to further improve the anti-seepage performance of blood.

The utility model discloses an actively advance the effect and lie in: the utility model discloses a membrane covering mechanism for valve device is replaced to mitral valve through the apex of the heart has following advantage:

1. the membrane covering mechanism is divided into an outer frame membrane, an inner frame membrane and a connecting membrane, the outer frame membrane covers the outer frame, the inner frame membrane covers 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 transcardiac mitral valve replacement valve device is greatly improved, and the phenomenon that the inner frame shakes in the outer frame is effectively prevented.

2. Each tectorial membrane in the tectorial membrane mechanism adopts PET to weave the material, in order to prevent it to take place blood infiltration phenomenon, adds a layer of TPU spinning membrane in the one side that is close to the supporting mechanism, and TPU spinning membrane is smooth and fine and close, prevents effectively that blood from permeating the tectorial membrane mechanism.

Drawings

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

FIG. 2 (a) is an expanded view of the outer frame film of the present invention;

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

FIG. 3 is an expanded view of the inner frame film of the present invention;

FIG. 4 is a schematic view of the structure of the coupling film according to the present invention;

fig. 5 (a) is a schematic view showing the expansion 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 another schematic view showing the expansion 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 illustrating the artificial leaflet of fig. 6 (a) being integrally connected with an inner frame covering film and an inner frame;

fig. 7 is another expanded view of the artificial leaflet of the present invention;

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

fig. 9 (a) is a perspective view of the outer frame and the inner frame of 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 of FIG. 11 (a);

fig. 12 (a) is another top view of the outer frame 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 outer frame of the present invention;

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

fig. 14 (a) is another top view of the outer frame of the present invention;

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

FIG. 15 is a front view of the outer frame of the present invention with no barbs on the straight side of the D-shaped profile;

fig. 16 is a positional relationship diagram of the outer frame and the inner frame according to the present invention;

FIG. 17 is a schematic diagram of a mitral valve configuration;

fig. 18 is a schematic view of an application of the present invention.

Detailed Description

In order to make the technical means, creation features, achievement purposes and functions of the present invention easy to understand, the present invention will be further explained with reference to the specific drawings.

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

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

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

Referring to fig. 1-8, a coating mechanism for a mitral valve transapical replacement device is applied to a mitral valve transapical replacement device as a part of the mitral valve transapical replacement device. The transcardial mitral valve replacement valve device comprises a bracket mechanism and the film covering mechanism of the utility model, wherein the bracket mechanism is provided with an outer frame 100 and an inner frame 200, and the outer frame 100 and the inner frame 200 are connected with each other. The film covering mechanism is coated on the bracket mechanism.

The coating mechanism includes an external frame coating 300, an internal frame coating 400, and a tie coating 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 coating 500 connects the outer scaffolding coating 300 and the inner scaffolding coating 400, respectively.

The utility model discloses a tectorial membrane mechanism includes the outrigger tectorial membrane, inner tower tectorial membrane and connection tectorial membrane, and the outrigger tectorial membrane covers on the outrigger, and the inner tower tectorial membrane covers on the inner tower, through the design of connection tectorial membrane, becomes a whole with independent outrigger tectorial membrane and inner tower tectorial membrane connection, greatly increased through the stability of apex of the heart mitral valve replacement valve device, effectually prevented that the inner tower from rocking the emergence of phenomenon in the outrigger.

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 over-frame coating 300 protrudes beyond the distal end of the over-frame 100 and is turned inside out of the over-frame 100 such that the distal edge of the over-frame coating 300 covers the distal end of the over-frame 100; the external frame covering film 300 located inside the external frame 100 is connected to the graft covering film 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 inner wall of the heart cannot be scratched by the edge of the cover film, preferably, the connection cover film 500 is positioned inside the outer frame cover film 300, that is, when the connection cover film 500 is viewed from the far end to the near end, the far end edge of the outer frame cover film 300 can be seen, and 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, the connection cover film 500 is positioned inside the outer frame cover film 300, so 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 external frame tectorial membrane 300 is provided with a plurality of external frame tectorial membrane slots 310, and the external frame tectorial membrane slots 310 correspond to the barbs 161 on the external frame 100. Referring to fig. 2 (b), when the outer frame coating film 300 is coated on the outer frame 100, the barbs 161 on the outer frame 100 pass through the outer frame coating groove 310.

In some embodiments, referring to fig. 2 (a), at least one arc-shaped slit is defined in the outer frame coating 300, and the arc-shaped slit serves as a plurality of outer frame coating 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 400 with the tooth-shaped structure 410 at the far end is more attached to the inner frame 200, so that the sewing is facilitated, 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 inner edge of the tie-coat film 500 is connected to the cuff mark 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 on the inner side of 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 connecting tectorial membrane 500, the original independent outer frame tectorial membrane 300 and the inner frame tectorial membrane 400 are connected into a whole, the stability of the mitral valve replacing device through the apex of the heart is increased, and the shaking phenomenon of the inner frame 200 in the outer 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 TPU spinning film is disposed on the side of the PET barrier film close to the stent structure, that is, one TPU spinning film is disposed on the side of the outer frame covering film 300 close to the outer frame 100, one TPU spinning film is disposed on the side of the inner frame covering film 400 close to the inner frame 200, and one TPU spinning film is disposed on the side of the coupling covering film 500 facing the gap between the outer frame 100 and the inner 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 disposed on both sides of the barrier PET composite film.

Both sides of the anti-seepage PET composite film can be provided with one layer of TPU spinning film, but only one single side is provided with one layer of TPU spinning film to solve the problem of preventing the anti-seepage PET composite film from permeating, so that the anti-seepage PET composite film can be prevented from permeating by attaching one layer of TPU spinning film on both sides, and the problem of permeating can be further prevented. Meanwhile, the TPU spinning membrane is only arranged on one side close to the support mechanism, so that the optimal scheme is adopted, the TPU spinning membrane is prevented from being in direct contact with the external environment, the TPU spinning membrane is relatively prevented from permeating the PET composite membrane in an impermeable mode, impurities in the air can be adsorbed easily, and the TPU spinning membrane is effectively prevented from absorbing the impurities in the air through the design.

Examples 1 to 8

Step Sa:

measuring V1 mL of tetrahydrofuran, and slowly pouring the tetrahydrofuran 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 rotating speed, and continuously stirring for t1 hour to completely dissolve TPU particles. 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 the tetrahydrofuran and the N, N-dimethylformamide containing the 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.

Step Sb:

purified water was added to the ultrasonic cleaner, and a 6X 6 inch PET slit 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. After the ultrasonic treatment is finished, 75% ethanol hydrosolvent is abandoned, 500 +/-10 mL of injection water is injected, and the PET stitching film is soaked 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 a clean PET sewing film.

Step S1

And (4) naturally and flatly 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 flat and free of wrinkles, and fixing the periphery edge of 5mm by using an adhesive tape. And then 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 tightly pressing the initial PET composite film between the two surfaces of the glass smoothly 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 (3) placing the initial PET composite film clamped by the glass together in a constant-temperature oven at the temperature of T ℃, drying for time T5, and naturally airing for 30min to obtain the final anti-permeation 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-preventing PET composite films of examples 1 to 8

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TABLE 1 (DEMAND) PREPARATION PROCESS PARAMETERS OF ANTI-PERMEATION PET COMPOSITE FILM FOR EXAMPLES 1-8

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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, exhibited a reduction in the amount of leakage of blood from 7.24mL to 0.63mL, as compared to a single-layer PET film having a thickness of 0.2mm, and the blood permeation was greatly reduced. The blood leakage amount of the PET composite film having the TPU spun film spun on one side of the total thickness of 0.21mm prepared in example 1 was reduced 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 such as 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 process of endothelialization. Because TPU is a high molecular material with good elasticity, the valve can be effectively attached to the native valve ring after being implanted and released, thereby greatly reducing the permeability of blood and effectively reducing the paravalvular leakage. 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 permeation and improve the blood permeation resistance.

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.

In some embodiments, referring to fig. 5 (a) through 8, a prosthetic leaflet 600 includes a leaflet main body 610 and two ears 620. The distal end of the leaflet main body 610 is a convex structure. 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. This configuration can effectively prevent blood from leaking out of the leaflet holes 430 of the inner graft film 400 and causing blood to flow back, as compared with fig. 5 (b).

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 the upper and

lower ears

621, 622 from tearing apart.

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 sutural mode and leaflet main part to combine, it is fixed firm, and abrasionproof strake 630 sets up at first the anti tear ability that has increased leaflet main part 610 distal end, secondly the damage to artifical leaflet of the friction of having reduced leaflet main part 610 telecentric mirror end and tectorial membrane, the life of artifical leaflet has been improved, and the setting of abrasionproof strake 630 also is equivalent to the buffer layer between artifical 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, the prosthetic leaflet 600 and the covering mechanism are sutured to one another to form a suture track.

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 main body 610 distal outer contour or the suture trajectory has a defined 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 leaflet main body 610 has a distal outer contour with a leaflet base arc 611 and two leaflet side arcs. 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 to the leaflet side arcs on both sides to form the distal 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 being located on the proximal end side of the leaflet base arc 611, the proximal end of the leaflet apex arc 613 being an arc-shaped structure.

In some embodiments, the leaflet apex arc 613 is an arc defined by a third center O3 and a third radius R3, the third center O3 being 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 the respective artificial leaflets 600.

In some embodiments, referring to fig. 9 (a) to 10 (b), the external frame 100 includes a tether end 110, an external connection portion 120, a support portion 130, and an external skirt portion 140, which are sequentially connected from a proximal end to a 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 external connection portion 120 are exposed to the external 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 utility model discloses abandoned the tradition with the mode that tether 310 and inner frame are connected, but adopt tether 310 to be connected to the outrigger 100 on, after the tether atress, need transmit earlier for outrigger 100, transmit inner frame 200 again, last be the valve leaflet mechanism in the inner frame 200, such mode is less relatively to the influence of opening and shutting of the valve leaflet in the valve leaflet mechanism.

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 mutual independence 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 secondly the outrigger processing heat setting of being convenient for has reduced the processing cost.

In some embodiments, the proximal and distal ends of tether link support 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 support 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 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 side surface and the right side surface of the square connecting frame are planes, and the planes are parallel to each other, so that the clamping of the rope tying end is more facilitated, and further, the rope tying connecting rod bracket 111 and the left side surface and the right side surface of the square connecting frame are parallel to each other.

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 sewing holes 212, and the outer frame 100 and the inner frame 200 are sewn together by sewing the outer sewing holes 122 and the inner sewing holes 212.

In some embodiments, the outer suture holes 122 have a larger pore size than the inner suture holes 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 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 having two proximal connecting bars 1311 and two distal connecting bars 1312 connected to each other, a proximal end of proximal connecting bar 1311 being connected to a distal end of outer connecting portion 120, a distal end of distal connecting bar 1312 being 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 clamp the native valve leaflet and its valve annulus, it should be noted that the recessed structure may be formed by expanding the outer skirt 140 outward, and may be the X-shaped stent 131 itself or an inwardly recessed structure, or the X-shaped stent 131 itself may be straight and, after being smoothly transitionally connected to the outer skirt 140, is recessed relative to the outer skirt 140.

In some embodiments, referring to fig. 10 (a), the outer skirt 140 comprises a plurality of outer diamond shaped struts 141, each outer diamond shaped strut 141 having interconnected V-shaped link 1411 and inverted V-shaped link 1412, the proximal end of the V-shaped link 1411 being connected to the distal end of the support 130, the plurality of outer diamond shaped struts 141 enclosing the outer skirt 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 140 also encloses a structure that is D-contoured 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 drawing angle is too large, which affects the endothelialization speed of the outer skirt portion 140, so that the proper drawing angle can satisfy the endothelialization speed, 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 range of motion of opening and shutting of preceding valve leaflet 410 and back valve leaflet 420 is different, and the structure size of the juncture of its left atrium and mitral valve annulus is different, expands the structure outward through the design gradual change, realizes making the outer skirt portion 140 of this outrigger can closely laminate the heart inner wall, has increased the stability after this installation of mitral valve replacement valve device through the apex.

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 the two markers 150 are both 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 identify the position of the outer frame, so that the two markers 150 do not have to be symmetrical about the line of symmetry 250 perpendicular to the straight sides of the D-shaped profile, but can be normally disposed on any two outer diamond-shaped holders 141 on the sides of the straight sides of the D-shaped profile, thereby enabling the position of the mitral valve replacement device to be determined, 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 portions 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 shaped 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 utility model discloses a marker can be any form's arch or install radiopaque marking material's mark hole, as long as can be convenient for operating personnel observes under image equipment can.

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 reverse under the flushing of blood, the aorta is blocked, thus endangering the life of the user, and the native valve leaflets are clamped between the barbs and the outer frame, thus preventing the native valve leaflets 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. A plurality of inverted V-shaped 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 of the tether end 110 are independent of each other, and the proximal end and the distal end of each tether link bracket 111 are respectively provided with a square connecting frame, and the middle part of the square connecting frame is provided with a tether hole 112. The number of the outer connecting rods 121 in the outer connecting portion 120 is the same as that of the tether link brackets 111, and the proximal end of each outer connecting rod 121 is connected to the distal end of a corresponding tether link bracket 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 made of stainless steel or nickel titanium tube or chromium tube cut in one piece. 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 chromium.

In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer sewing holes 122 arranged side by side, the two markers 150 are convex semicircular protruding members, and the barb portions 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 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 an elongated kidney-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 markers 150 are marker holes with 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 part 230 is connected with the 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 sewing hole 212 and the outer sewing hole 122 are sewn to realize the sewing 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), one leaflet suture hole 232 is provided spaced apart from 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 the adjacent two inner connecting rods 211 by two obliquely arranged stent connecting rods 220. When the leaflet suture hole 232 is provided in one leaflet connecting rod 231, the leaflet suture holes 232 are not provided in two leaflet connecting rods 231, one on the adjacent side thereof. This structure is suitable for a leaflet mechanism having three leaflets. When a leaflet mechanism having two leaflets is used, two symmetrically disposed leaflet connecting rods 231 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, two of which are adjacent to the leaflet connecting rod, 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 that the description is omitted;

in some embodiments, referring to fig. 11 (b), the width of the leaflet connecting rods 231 where the leaflet sewing holes 232 are not provided is 1/3-1/2 of the overall width of the leaflet connecting rods 231 where the leaflet sewing holes 232 are provided. 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 sewing holes 232 and the leaflet connecting rods 231 not provided with the leaflet sewing holes 232, and promotes 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 legs 141 in the outer frame 100 is designed with a D-shaped profile, the outer diamond shaped legs 141 of the skirt are uniformly distributed and have a corresponding relationship with the inner diamond shaped legs 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 plurality of 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 valve replacement valve devices are still suitable for transcatheter delivery methods. Referring to fig. 18, in the application of the present invention to avoid valve regurgitation, one end of the tether 310 is connected to the tether end 110 of the outer frame 100, and the other end of the tether 310 is fixed by the apex gasket 320, which may be a prior art apex gasket 320. 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 basic principles, essential 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 above embodiments, and that the foregoing embodiments and descriptions are provided only to illustrate the principles of the present invention without departing from the spirit and scope of the present invention. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. The utility model provides a membrane covering mechanism for mitral valve replacement valve device through apex of heart, membrane covering mechanism coats on stent mechanism which characterized in that, membrane covering mechanism includes:

the inner frame film is unfolded to be in a long strip-shaped structure, surrounds the inner side of the inner frame of the support mechanism and is coated on the inner side surface of the inner frame;

2. The cover mechanism for a transcardiac mitral valve replacement device of claim 1, wherein the distal edge of the outer frame cover is inverted and positioned inside the outer frame cover;

3. The cover mechanism for a mitral valve replacement device according to claim 1, wherein the outer frame cover has:

the outer frames are provided with film covering slots corresponding to the barb structures on the outer frames;

4. The cover mechanism for the mitral valve replacement device according to claim 3, wherein the outer frame cover has at least one arc-shaped slit as a plurality of outer frame cover slots.

5. The cover mechanism for a transcardiac mitral valve replacement device of claim 1, wherein the distal end of the inner frame cover has a toothed structure that is everted outside the inner frame cover.

6. The covering mechanism for the transcardiac mitral valve replacement device according to claim 5, wherein a connecting portion of the tooth-shaped structure and the elongated structure forms a flanging marking line;

7. The cover mechanism for a transcardiac mitral valve replacement device of claim 1, wherein the inner frame cover is provided with leaflet apertures.

8. The cover mechanism for a transcardiac mitral valve replacement valve device of claim 1, wherein the outer frame cover, the inner frame cover, and the coupling cover are each an impermeable PET composite film having a PET suture film.

9. The cover mechanism for the transcardiac mitral valve replacement device as set forth in claim 8, wherein at least one TPU spun film is disposed on the side of the impermeable PET composite film adjacent to the stent mechanism, i.e., one TPU spun film is disposed on the side of the outer frame cover adjacent to the outer frame, one TPU spun film is disposed on the side of the inner frame cover adjacent to the inner frame, and one TPU spun film is disposed on the side of the coupling cover facing the gap between the outer frame and the inner frame.

10. The covering mechanism for the transcardiac mitral valve replacement device according to claim 9, wherein a layer of TPU spun film is disposed on both sides of the impermeable PET composite film.