CN112137762A - Mitral regurgitation treatment device - Google Patents

Abstract

The invention provides a device for treating mitral valve regurgitation, which relates to the technical field of medical devices, and includes a stent and a basement membrane. Covered on the plane end, and the bottom membrane is arranged in a ring shape, and the through holes corresponding to the ring shape of the bottom membrane are used for blood flow; by blocking the mitral valve regurgitation position to treat mitral valve regurgitation, the operation difficulty is low, and it solves the problem of The problem of high requirements for the doctor team and equipment; and avoids the risk of sub-valvular tissue damage and outflow obstruction in the existing valve replacement and fixation process, which greatly improves the safety of the device; the device has a through hole at the bottom, which can not only It guarantees the effect of limiting prolapse and regurgitation, and completely preserves the patient's native subvalvular structure, and the through-hole design can also provide convenience for valve-in-valve technology.

Description

Mitral regurgitation treatment device

technical field

The invention relates to the technical field of medical devices, in particular to a mitral valve regurgitation treatment device.

Background technique

The heart is an important organ that provides power for human blood circulation. The heart is divided into two parts, left and right, each of which contains a ventricle and an atrium. The left ventricle and the right ventricle are blocked by the interventricular septum, and the left atrium and the right atrium are blocked by the atrial septum. The direction of blood flow between the left atrium and left ventricle is regulated by the mitral valve. A healthy mitral valve ensures that oxygen-rich blood flows from the left atrium to the left ventricle, where it is pumped to the arteries throughout the body. The direction of blood flow between the right atrium and right ventricle is regulated by the tricuspid valve. The tricuspid valve ensures that carbon dioxide-rich venous blood flows from the right atrium to the right ventricle, where it is pumped to the pulmonary artery.

Mitral regurgitation is a common valve disease in the elderly population. Mitral regurgitation (MR), also known as mitral regurgitation, is caused by rheumatic heart valve disease, mitral valve prolapse, mitral valve degeneration, mitral valve annular calcification, left ventricular increase etc.

The traditional treatment plan for mitral valve regurgitation is open thoracic valve replacement, which involves large surgical trauma and long recovery time for patients. , and some have been used in clinical practice. For valve replacement surgery, due to the complex physiological structure of the mitral valve, the diameter of the replacement artificial valve is generally large; and because of the high upward blood pressure, the artificial valve has a fixation problem, and many artificial valves have structures such as barbs, which cause great damage to the valve; Also, if the prosthetic valve enters the part of the ventricle and blocks the aortic outflow tract, the patient may be at risk of death. The solutions for mitral valve repair mainly include edge-to-edge repair and annulus angioplasty. Each of these repair methods has its own limitations. Edge-to-edge repair is a transitional product, which requires the valve leaflet to be clamped during the operation, which requires high surgical experience of the doctor, and multiple operations will cause damage to the valve. If the surgery fails, a second surgery will not be possible. Annuloplasty requires multiple rivets to fix the artificial chordae tendineae, and the rivets cause secondary damage to the mitral valve.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a mitral valve regurgitation treatment device to solve the technical problem that the treatment and repair of mitral valve regurgitation in the prior art easily causes damage to the mitral valve valve.

The mitral valve regurgitation treatment device provided by the present invention is used for interference setting in the left atrium, and includes a support and a basement membrane, the support is an annular grid structure, and one end of the support for contacting the mitral valve has a flat end arranged in a flat surface;

The bottom film is covered on the plane end, and is used for abutting on the plane of the mitral valve on the side close to the left atrium, the bottom film is arranged in an annular shape, and the through holes corresponding to the annular shape of the bottom film are used for supplying the bottom film. blood flow.

Further, the plane end is an annular plane formed by extending inwardly of the support, the bottom film includes at least two layers of films, and the annular plane penetrates between two adjacent layers of the bottom film.

Further, the support is a hollow spherical grid structure;

And/or, the plane end is a circular plane or a D-ring plane;

And/or, the bottom film is arranged in a circular ring or a D-ring.

Further, the bottom film is arranged in an annular shape, and the through holes of the bottom film are arranged concentrically with the bottom film, or the bottom film and the through holes are arranged eccentrically.

Further, the through hole is a circular hole, an oval hole or a D-shaped hole.

Further, a developing marking portion is provided on the base film or the flat end.

Further, an extension portion of the base membrane extends from one end of the stent away from the mitral valve.

Further, the extension portion is higher than the height of the left atrial appendage.

Further, one end of the bracket for contacting the mitral valve is protruded from the position of the mitral valve along the axial direction of the bracket with a protruding portion, and the bottom end of the protruding portion forms the flat end. , the bottom film is covered on the protruding part;

And/or, the basement membrane forms a bulge on the flat end facing where the mitral valve is located.

Further, the side surface of the protruding portion is inclined relative to the plane end.

Further, the end of the stent that is used for being away from the mitral valve is covered with an apical membrane.

Further, one end of the stent for contacting the mitral valve and/or the opposite end of the end is provided with a connecting joint, and the connecting joint is used for connecting with the delivery device.

Further, a limiting portion protrudes from the outer side surface of the bracket close to the plane end, and the limiting portion is used to limit the circumferential rotation of the bracket.

Further, the inner side surface of the bracket is close to the plane end, and is provided with a spreading portion spaced from the plane end, and the bottom film is sleeved between the plane end and the spreading portion.

Further, the stent has a compressed state and an expanded state, and in the expanded state, the stent is an annular grid structure;

And/or, the base membrane is fluid permeable.

Further, the material of the bracket is a memory metal alloy;

And/or, the material of the base film is PET, eTFP, or animal pericardium.

Further, the stent is provided with a covering film, the stent is entirely covered in the covering film, and the end of the covering film that is close to the mitral valve forms the base film.

The mitral valve regurgitation treatment device provided by the present invention is mainly used for the treatment of prolapsed mitral valve regurgitation, and includes a stent and a basement membrane. The plane end of the plane setting; the bottom membrane is covered on the plane end and is used to abut on the plane of the mitral valve close to the left atrium side, the bottom membrane is arranged in an annular shape, and the through holes corresponding to the annular shape of the bottom membrane are used for blood flow . In use, the device is fully released within the left atrium and fixation is achieved by the interaction forces created between it and the left atrium. The flat end of the stent is provided with a basement membrane, and the through holes of the basement membrane ensure blood flow; at the same time, the planar end cooperates with the basement membrane to press the basement membrane on the plane of the mitral valve close to the left atrium. When the valve leaflet is closed , to block the mitral valve regurgitation position, prevent the free edge of the valve leaflet from protruding into the left atrium, and avoid causing regurgitation. Compared with the prior art that requires non-interventional replacement of the valve or repairing the valve by clamping the valve leaflets, the mitral valve regurgitation treatment device of the present invention treats mitral valve regurgitation by blocking the position of the mitral valve regurgitation. The difficulty is relatively low, which effectively solves the problem of high requirements for the medical team and equipment, and has almost no damage to the valve; at the same time, the device adopts the method of spreading and fixing inside the left atrium, which avoids the destruction of the subvalve tissue during the existing valve replacement and fixation process. The risk of blocking the outflow tract greatly improves the safety of the device; further, the device has a through hole at the bottom, which can not only ensure the effect of limiting mitral valve prolapse in the treatment of regurgitation, but also completely retain the patient's native valve. The lower structure, the through hole design can also facilitate the valve-in-valve technology.

Description of drawings

In order to illustrate the specific embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the specific embodiments or the prior art. Obviously, the accompanying drawings in the following description The drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

Figure 1 is a schematic diagram of the state of mitral regurgitation in the heart;

2 is a schematic diagram of a mitral valve regurgitation treatment device provided in an embodiment of the present invention placed in the heart;

3 is a schematic diagram of a mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

Fig. 4 is the bottom view schematic diagram of Fig. 3;

5 is a schematic diagram of a position where the mitral valve regurgitation treatment device blocks mitral valve regurgitation provided by Embodiment 1 of the present invention;

6 is a schematic diagram of a stent for a mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

FIG. 7 is a schematic diagram of setting connecting joints on the stent of the mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

Fig. 8 is a schematic diagram of a further improved form of Fig. 3;

Fig. 9 is a schematic diagram of another form of further improvement of Fig. 3;

10 is a schematic diagram of a stent provided with a spreader portion of the mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

Figure 11 is a schematic diagram of Figure 10 connecting the bottom film and the top film;

FIG. 12 is a schematic diagram of setting a protruding portion of a mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

Fig. 13 is a state comparison diagram of the mitral valve regurgitation treatment device without the protruding part and the mitral valve regurgitation treatment device in the form of Fig. 12 being installed on the heart;

Fig. 14 is a schematic diagram of a further improved form of Fig. 12;

Fig. 15 is a schematic diagram of another form further improved in Fig. 12;

16 is a schematic diagram of a stent setting limit portion of a mitral valve regurgitation treatment device provided in Embodiment 1 of the present invention;

FIG. 17 is a schematic view of the state in which the mitral valve regurgitation treatment device in the form of FIG. 16 is installed in the heart;

18 is a schematic diagram of the mitral valve regurgitation treatment device provided in the first embodiment of the present invention when it is used as an auxiliary device for valve-in-valve surgery;

19 is a schematic bottom view of the mitral valve regurgitation treatment device provided in Embodiment 2 of the present invention;

Fig. 20 is a schematic diagram of setting a developing marker portion of the mitral valve regurgitation treatment device provided in the second embodiment of the present invention;

FIG. 21 is a schematic diagram of a position where the mitral valve regurgitation treatment device blocks mitral valve regurgitation provided by Embodiment 2 of the present invention;

22 is a schematic bottom view of the mitral valve regurgitation treatment device provided in Embodiment 3 of the present invention;

Fig. 23 is a schematic diagram of setting a developing marker portion of the mitral valve regurgitation treatment device provided in Embodiment 3 of the present invention;

24 is a schematic diagram of a position where the mitral valve regurgitation treatment device blocks mitral valve regurgitation provided by Embodiment 3 of the present invention;

25 is a schematic diagram of a mitral valve regurgitation treatment device provided in Embodiment 4 of the present invention;

FIG. 26 is a schematic bottom view of FIG. 25 .

Icons: 1-heart; 11-left atrium; 12-left ventricle; 13-mitral valve; 14-left atrial appendage; 15-valve middle valve; 200-stent; 201-plane end; 230-connecting joint; 240-projecting part; 300-bottom film; 301-extension part; 310-through hole; 320-developing mark part; 400-top film; - 2nd regurgitation position; P3 - 3rd regurgitation position.

Detailed ways

The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Example 1

FIG. 1 is a schematic diagram showing a mitral valve regurgitation pathology in the mitral valve 13 of the heart 1 . Usually the plane of the mitral valve 13 of the heart 1 is roughly D-shaped, and there are three main positions where regurgitation is likely to occur, which are respectively defined as the first regurgitation position P1, the second regurgitation position P2 and the third regurgitation position P3. 1 When mitral regurgitation occurs, regurgitation lesions may occur in all three regurgitation sites, or regurgitation lesions may occur in one or both of the regurgitation sites.

As shown in FIGS. 1 to 18 , the present embodiment provides a mitral valve regurgitation treatment device, which is used to be arranged in the left atrium 11 with interference, including a stent 200 and a basement membrane 300 , and the stent 200 is an annular grid structure One end (ie, the bottom end) of the stent 200 for contacting the mitral valve 13 has a plane end 201 arranged in a plane. The bottom membrane 300 is covered on the plane end 201 for abutting on the plane of the mitral valve 13 close to the left atrium 11. The bottom membrane 300 is arranged in an annular shape, and the through holes 310 corresponding to the annular shape of the bottom membrane 300 are used for blood supply. flow.

The support 200 is a ring-shaped grid structure, generally a hollow spherical grid structure that is substantially spherical. The spherical design of the device is mainly used for the fixation of the device in the left atrium 11, and the device generates a supporting force with the left atrium 11 through a certain amount of interference, thereby fixing the device. The stent 200 with the annular grid structure usually has a certain deformation adaptability, so that the device can better adapt to the structure of the left atrium 11 . And in order to facilitate the implantation of instruments through minimally invasive surgery, the stent 200 can have a compressed state and an expanded state. In the expanded state, the stent 200 is a ring-shaped grid structure; specifically, when the stent 200 is in a compressed state, the device can be placed In the corresponding conveyor, the device is delivered to the position of the left atrium 11 through the conveyor, and when the position of the left atrium 11 is reached, the device is pushed out from the conveyor, and the device returns to the deployed state at this time. The stent 200 can be a memory metal alloy, specifically a nickel-titanium alloy material. The overall design adopts a soft structure design, so that the device can better adapt to the structure of the left atrium 11 and reduce the compression on the native atrial structure and the adjacent aorta.

The flat end 201 at the bottom of the bracket 200 can play a role of supporting the bottom film 300 . The base film 300 can at least cover the regurgitation position where the lesion occurs, and the base film 300 can be fixed on the stent 200 by sewing, thermoplastic or the like. The material of the bottom film 300 can be a hard material or a soft material, specifically a polymer material, such as PET (polycondensation polymer of phthalic acid and ethylene glycol), eTFP (ethylene-tetrafluoroethylene copolymer) ; or one or more materials of animal pericardial nature. In this embodiment, the plane end 201 is a circular plane, the bottom membrane 300 is arranged in a circular shape, and the through holes 310 on the bottom membrane 300 are concentric with the bottom membrane 300 , and the diameter of the bottom membrane 300 is larger than that of the mitral valve 13 diameter to be able to cover three regurgitation locations.

In addition, the area of the central through hole 310 is usually larger than 4.0 cm ² (square centimeters) to avoid the risk of mitral valve stenosis in postoperative patients.

The mitral valve regurgitation treatment device provided in this embodiment is mainly used for the treatment of prolapsed mitral valve regurgitation. When in use, as shown in FIG. 2 , the mitral valve regurgitation treatment device is completely released in the left atrium 11 , and the fixation is achieved by the interaction force generated between the device and the left atrium 11 .

The main body support 200 of the device is a spherical grid structure, and the part where the bottom of the support 200 is in plane contact with the mitral valve 13 is a plane structure, that is, the plane end 201 is a plane structure, and the plane end 201 is provided with a base membrane 300, the base membrane There are through holes 310 on the 300, which can ensure the flow of blood. The flat end 201 at the bottom of the device is mainly combined with the bottom membrane 300 to prevent the valve leaflet from protruding into the left atrium 11 when the valve leaflet closes, thereby causing regurgitation. The treatment principle is shown in FIG. 2 .

The plane end 201 of the stent 200 of the mitral valve regurgitation treatment device in this embodiment, which is in plane contact with the mitral valve 13, corresponds to a circular plane structure, and there is a circular through hole 310 at the center of the circular plane. The through hole 310 and the plane end 201 are concentric circles. The annular base membrane 300 is equivalent to covering between the through hole 310 and the plane end 201, and the base membrane 300 between the through hole 310 and the plane end 201 can block the mitral valve regurgitation position when the mitral valve 13 is closed , as shown in Figure 5. Among them, Fig. 5 a shows the coverage schematic diagram of the first reflux position P1 and the third reflux position P3 when reflux lesions occur; Fig. 5 b shows the second reflux position P2 when reflux lesions occur. Schematic. Since the mitral valve regurgitation treatment device in this embodiment is completely symmetrical, it is not necessary to adjust the position inside the left atrium 11 when releasing, which reduces the difficulty of operation.

Compared with the prior art that requires non-invasive replacement of the valve or repairs the valve by clamping the valve leaflets, the mitral valve regurgitation treatment device of this embodiment treats mitral valve regurgitation by blocking the position of the mitral valve regurgitation, The operation difficulty is low, which effectively solves the problem of high requirements for the doctor team and equipment, and does almost no damage to the valve; at the same time, the method of spreading and fixing inside the left atrium 11 avoids the existing valve replacement and fixation process. The risk of blocking the outflow tract greatly improves the safety of the device; the device is provided with a through hole 310 at the bottom, which can not only ensure the effect of restricting prolapse and treat regurgitation, but also completely retain the patient's native subvalvular structure. , the through-hole 310 design can also facilitate the valve-in-valve technology.

In this embodiment, the mitral valve regurgitation treatment device is fixed by a spherical grid-shaped stent 200, and the device can be fixed in the left atrium 11 as a whole through a certain amount of implantation interference. The specific stent 200 can be made of nickel-titanium alloy One piece laser engraved. Further, one end of the stent 200 for contacting the mitral valve 13 or the opposite end of the end is provided with a connecting joint 230, and the connecting joint 230 is used for connecting with the delivery device.

Specifically, as shown in FIG. 7 , the upper and lower ends of the spherical grid of the stent 200 are designed with connecting joints 230 connected to the conveyor, which can realize the release mode of the instrument through the apex and the atrial septum. Specifically, when the conveyor is used, the connecting joint 230 of one of the upper end and the lower end is selected to be connected to the conveyor. When the connecting joint 230 of the upper end is selected to be connected to the conveyor, the instrument is usually delivered to the left atrium through the blood vessel. 11; when the connecting joint 230 at the lower end is selected to be connected with the delivery device, the instrument is usually delivered into the left atrium 11 through the apex of the heart.

As shown in FIG. 6 , in this embodiment, the plane end 201 is an annular plane formed by extending the bracket 200 inward. Wherein, the bottom film 300 may be one layer covering the stent 200 or two or more layers of films. Specifically, the bottom film in this embodiment is a double-layer film, and the circumferential edges of the two-layer films are sealed to form a sealed space between the two adjacent layers of films, and the annular plane passes through the two adjacent layers of the bottom film 300 . between. It is equivalent to that the adjacent bottom films 300 extend from the middle opening of the annular plane to the outer periphery, and the annular plane is wrapped between the two layers of the bottom film 300. The inner and outer membranes are sealed and connected at the circumferential edges to form a sealed space.

It can be understood that the material of the base film 300 is generally permeable to fluids, and a hollow sealing structure is formed between the multilayer films of the base film 300 for thrombus formation. Self-reinforcing can better prevent reflux. On the other hand, a smooth fluid scouring surface can be naturally formed on the plane where the bottom end of the device is in contact with blood, reducing blood retention and local turbulence.

In order to automatically increase the sealing space between the adjacent film layers of the adjacent base films 300 when the stent 200 is unfolded, as a preferred implementation manner, the inner side of the stent 200 is close to the position of the plane end 201 and is closely connected with the plane end 201 Spreading portions 220 are provided at intervals, and the bottom film 300 is sleeved between the flat end 201 and the spreading portion 220 .

Specifically, as shown in FIGS. 10 and 11 , the opening portion 220 is equivalent to the inward barb provided on the bracket 200 . Taking the bottom film 300 as an example of two layers, the bottom film 300 of the upper layer is fixed on the barb, and the bottom film 300 of the lower layer is fixed on the flat end 201 , so that when the bracket 200 is stretched, due to the gap between the barb and the flat end 201 so that when the bottom film 300 is stretched, the sealing space between the two films of the bottom film 300 increases.

It can be understood that the larger sealing space of the bottom membrane 300 is more conducive to the formation of thrombus.

Further, the end of the stent 200 of the mitral valve regurgitation treatment device of the present embodiment is used for covering the top membrane 400 at one end away from the mitral valve 13 . That is, as shown in FIG. 3 , a top film 400 is provided on the upper end of the device, and the material of the top film 400 is the same as that of the bottom film 300 , and the top film 400 also adopts a double-layer or more than two-layer film structure.

The top membrane 400 is used to limit the movement of the free end of the upper end of the stent 200 to prevent the free end from piercing the left atrium 11 , and at the same time, it can promote the endothelialization of the device at the upper end and the left atrium 11 to fix the valve.

As a further implementation of this embodiment, as shown in FIG. 3 , the base membrane 300 extends from the end of the stent 200 away from the mitral valve 13 with an extension 301 , that is, the base membrane 300 at the bottom of the device needs to have a distance from the bottom surface. A certain height can be lower than the height of the left atrial appendage 14, and the height value is 4-10 mm, so as to promote the rapid endothelialization of the instrument and the left atrium 11 and achieve effective fixation.

It should be noted that the extension portion 301 may also be higher than the height of the left atrial appendage 14 . Specifically, as shown in FIG. 8 , the extension 301 is overall higher than the left atrial appendage 14 , and the raised part is completely symmetrical; or as shown in FIG. 9 , the extension 301 corresponds to the local height of the left atrial appendage 14 . For the left atrial appendage 14, other parts are lower than the left atrial appendage 14, and the higher part is asymmetrically arranged. In another achievable manner, the bottom film 300 can also be extended upward to be integrally connected with the top film 400 , that is, the entire stent 200 is covered with a film, and the stent 200 is covered in the film. The membrane may be of a one-piece construction, and one end of the membrane close to contacting the mitral valve 13 forms the base membrane 300 , and the other end serves as the top membrane 400 .

It can be understood that, the bottom membrane 300 of the device is set high, and can completely cover the left atrial appendage 14 to achieve occlusion of the left atrium 11, which can effectively prevent the occurrence of atrial fibrillation.

Further, the bottom surface of the device can have a certain height (Fig. 15). For the bottom surface structure with a height, the part of the device protruding into the left ventricle 12 can be formed into a structure that is compatible with the restricted local native valve leaflets, thereby increasing the degree of fit. , the restricted native leaflets can be endothelialized.

Specifically, as shown in FIG. 12 , FIG. 14 and FIG. 15 , one end of the stent 200 in this embodiment for contacting the mitral valve 13 has a protrusion 240 protruding toward the position of the mitral valve 13 along the axial direction of the stent 200 . , the bottom end of the protruding part 240 forms the plane end 201 , and the bottom film 300 covers the protruding part 240 and extends upward along the bracket 200 .

It should be noted that the protruding portion 240 can also be formed by the base film 300 on the plane end 201 facing the position where the mitral valve 13 is located. The specific base film 300 can be a membrane structure with a certain thickness, a membrane structure with a certain thickness Covered on the plane end 201 , the plane end 201 protrudes to the position where the plane end 201 faces the mitral valve 13 to form a protrusion 240 .

Among them, what is shown in FIG. 13 a is the mitral valve regurgitation treatment device without the protruding part 240 , and what is shown in FIG. 13 b is the mitral valve regurgitation treatment with the protruding part 240 shown in FIG. 12 For the device, it can be seen from comparison that the mitral valve regurgitation treatment device with the protruding part 240 can make the device protrude into the left ventricle 12 to form a structure compatible with the restricted local native valve leaflets, and increase the degree of fit.

Meanwhile, it should be noted that, as shown in FIG. 14 and FIG. 15 , the height direction of the protruding portion 240 may have a certain inclination angle, that is, the side surface of the protruding portion 240 is inclined relative to the bottom end. The obliquely disposed protrusions 240 are more conducive to the part of the instrument protruding into the left ventricle 12 to form a structure compatible with the restricted local native valve leaflets.

Further, in order to avoid the rotation of the device in the left atrium 11 , a limiting portion 210 protrudes from the outer side surface of the stent 200 of the mitral valve regurgitation treatment device in this embodiment, close to the plane end 201 , and the limiting portion 210 is used for limiting. Circumferential rotation of the bracket 200 .

As shown in FIG. 16 and FIG. 17 , barbs can be provided at the bottom of the stent 200 as the limiting portion 210. Since the left atrium 11 farther away from the bottom surface is thinner, the barbs are too high or too long. Barbs will increase the risk of puncturing the atrial wall, so the barbs are located 0-4 mm from the bottom surface of the device, and the length of the barbs is about 0.5-2 mm. The limiting portion 210 in the form of barbs and the like can help the instrument to achieve fixation and reduce the risk of circumferential rotation of the instrument.

As shown in FIG. 18 , the diameter of the through hole 310 on the basement membrane 300 of the mitral valve regurgitation treatment device of the present embodiment is preferably designed to be 20-29 mm. If the patient has regurgitation again, the valve-in-valve 15 can be performed for the patient. Operation. That is, when the valve-in-valve 15 is operated, the mitral valve regurgitation treatment device of this embodiment can be used as an anchoring mechanism.

Embodiment 2

In order to increase the area of the through hole 310 to increase the effective valve area of the patient after surgical treatment and reduce the pressure difference across the valve, as shown in FIGS. 19 to 21 , the mitral valve regurgitation treatment device of this embodiment is different from the first embodiment. , the through hole 310 is arranged as an eccentric circular hole, that is, the bottom film 300 and the through hole 310 are arranged eccentrically.

The eccentric circular hole can be set on the side away from the pathological regurgitation position, and then the area of the through hole 310 can be increased to increase the effective valve orifice area and reduce the pressure difference across the valve. The reflux position P1, the second reflux position P2, the third reflux position P3) due to prolapse can be treated by rotating the release angle of the instrument during the release process, as shown in Figure 21. Show. Wherein a in Fig. 21 shows a schematic diagram of the treatment of lesions at the second reflux position P2, b in Fig. 21 shows a schematic diagram of the treatment of lesions at the third reflux position P3, and c in Fig. 21 shows the first reflux Schematic diagram of the treatment of lesions at position P1. The arrows in b in Fig. 21 and c in Fig. 24 indicate that the instrument can be rotated in this direction.

Preferably, the through hole 310 is arranged tangentially to the circular edge of the bottom film 300 to maximize the area of the through hole 310 .

Due to the form of the eccentric through hole 310, the angle of the eccentric through hole needs to be rotated around the axial direction when the instrument is implanted to ensure the treatment of regurgitation at different positions. Therefore, in order to facilitate the observation of the position and the convenience of operation, the bottom film 300 or the flat end 201 is provided with a developing device. Marking part 320 to ensure accurate release of the instrument. Specifically, as shown in FIG. 20 , the developing marking portion 320 in this embodiment may be a developing point, which is disposed on the outer edge of the base film 300 , and there are three developing points, one of which is located between the center of the base film 300 and the center of the base film 300 . On the connecting line of the tangent point and located on the side away from the tangent point, the other two developing lines are located on a straight line perpendicular to the connecting line and passing through the center of the bottom film 300 .

Other structures of the device for treating mitral valve regurgitation in this embodiment can be the same as those of the device for treating mitral valve regurgitation provided in the first embodiment, which will not be repeated here. In addition, the mitral valve regurgitation treatment device of this embodiment has the same beneficial effects as the mitral valve regurgitation treatment device provided in the first embodiment.

Embodiment 3

In order to increase the area of the through hole 310 , to increase the effective valve area of the patient after surgical treatment, and to reduce the pressure difference across the valve, as shown in FIGS. 22 to 24 , the mitral valve regurgitation treatment device in this embodiment is different from the first embodiment. As in the second embodiment, the through hole 310 is set in an oval shape.

Preferably, the through hole 310 is an ellipse that is eccentric to the base film 300 , and the short side of the ellipse of the through hole 310 is disposed tangentially to the edge of the base film 300 .

The mitral valve regurgitation treatment device in this embodiment is similar to that in the second embodiment, and can be rotated to implement regurgitation caused by prolapse at different positions, as shown in FIG. 24 . Wherein a of Fig. 24 shows a schematic diagram of the treatment when the second reflux position P2 has a lesion; b of Fig. 24 shows a schematic diagram of the treatment when a lesion occurs at the third reflux position P3; c of Fig. 24 shows the first Schematic diagram of the treatment in the event of a lesion at the reflux site P1. The arrows in Fig. 24 b and Fig. 24 c indicate that the instrument can be rotated in this direction.

As shown in FIG. 23, due to the form of the oval through hole 310, the angle needs to be rotated around the axial direction when the device is implanted to ensure the treatment of regurgitation at different positions. Therefore, in order to facilitate the observation of the position and the convenience of operation, in this implementation In an example, the bottom film 300 or the flat end 201 is also provided with a developing marking portion 320 to ensure that the instrument can be released accurately. For the specific placement position of the developing marking portion 320, reference may be made to the description of the second embodiment.

It can be understood that the eccentric elliptical through hole 310 can further increase the area of the through hole 310 compared to the second embodiment, so as to increase the effective valve area of the patient after surgical treatment and reduce the pressure difference across the valve.

Other structures of the device for treating mitral valve regurgitation in this embodiment can be the same as those of the device for treating mitral valve regurgitation provided in the first embodiment, which will not be repeated here. In addition, the mitral valve regurgitation treatment device of this embodiment has the same beneficial effects as the mitral valve regurgitation treatment device provided in the first embodiment.

Embodiment 4

As shown in FIG. 25 and FIG. 26 , the mitral valve regurgitation treatment device of this embodiment is different from Embodiment 1, Embodiment 2 and Embodiment 3. The bottom membrane 300 is set as a D-ring, and the corresponding through hole 310 is set as D type hole.

It can be understood that, the D-shaped base membrane 300 is more in line with the structural characteristics of the mitral valve 13, and the material of the base membrane 300 can be saved, but the manufacturing process is slightly complicated.

Other structures of the device for treating mitral valve regurgitation in this embodiment can be the same as those of the device for treating mitral valve regurgitation provided in the first embodiment, which will not be repeated here. In addition, the mitral valve regurgitation treatment device of this embodiment has the same beneficial effects as the mitral valve regurgitation treatment device provided in the first embodiment.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, but not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: The technical solutions described in the foregoing embodiments can still be modified, or some or all of the technical features thereof can be equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the present invention. scope.

Claims (17)

1. A mitral valve regurgitation treatment apparatus is used for being arranged in the left atrium (11) in an interference manner, and is characterized by comprising a support (200) and a base membrane (300), wherein the support (200) is of an annular grid-shaped structure, and one end of the support (200) used for contacting a mitral valve (13) is provided with a plane end (201) which is arranged in a plane manner;

basement membrane (300) cover on plane end (201) for the butt is on mitral valve (13) is close to the plane of left atrium (11) one side, basement membrane (300) are the annular setting, through-hole (310) that the annular of basement membrane (300) corresponds are used for supplying blood to flow.

2. The mitral valve regurgitation treatment apparatus according to claim 1, wherein the planar end (201) is an annular plane formed by inward extension of the stent (200), the base membrane (300) comprises at least two membranes, the circumferential edges of the two adjacent membranes are sealed to form a sealed space therebetween, and the annular plane is arranged to penetrate between the two adjacent membranes of the base membrane (300).

3. The mitral valve regurgitation treatment apparatus according to claim 1 or 2 wherein the stent (200) is a hollow spherical lattice structure;

and/or the plane end (201) is a circular plane;

and/or the bottom film (300) is arranged in a circular ring shape or a D-shaped ring shape.

4. The mitral valve regurgitation treatment apparatus according to claim 1 or 2 wherein the base membrane (300) is annular and the through holes (310) of the base membrane (300) are concentric with the base membrane (300) or the base membrane (300) is eccentric to the through holes (310).

5. The mitral valve regurgitation treatment apparatus of claim 3 wherein the through holes (310) are circular or elliptical or D-shaped holes.

6. The mitral valve regurgitation treatment apparatus according to claim 4, wherein the carrier film (300) or the planar end (201) is provided with visualizing indicia (320).

7. The mitral valve regurgitation treatment apparatus according to claim 1, wherein the carrier membrane (300) extends with an extension (301) on the stent (200) to an end remote from the mitral valve (13).

8. The mitral valve regurgitation treatment apparatus of claim 7, wherein the extension (301) is higher than the level of the left atrial appendage (14).

9. The mitral valve regurgitation treatment apparatus according to claim 1, 2, 7 or 8, wherein one end of the stent (200) for contacting the mitral valve (13) protrudes in the axial direction of the stent (200) to a position where the mitral valve (13) is located with a protrusion (240), the bottom end of the protrusion (240) forms the planar end (201), and the basement membrane (300) covers the protrusion (240);

and/or the carrier film (300) forms a bulge (240) on the planar end (201) facing the mitral valve (13) at the location of the mitral valve.

10. The mitral valve regurgitation treatment apparatus of claim 9 wherein the sides of the projections (240) are disposed obliquely to the planar end (201).

11. The mitral valve regurgitation treatment apparatus according to claim 1, 2, 7 or 8 wherein the stent (200) is adapted to be covered with a apical membrane (400) at the end distal to the mitral valve (13).

12. The mitral valve regurgitation treatment apparatus according to claim 1, 2, 7 or 8 wherein the holder (200) is provided with a connecting joint (230) at one end for contacting the mitral valve (13) and/or at an opposite end of that end, the connecting joint (230) being for connecting with a conveyor.

13. The mitral valve regurgitation treatment apparatus according to claim 1, 2, 7 or 8, wherein a position on the outer side of the stent (200) near the planar end (201) protrudes a stopper (210), and the stopper (210) is used for limiting circumferential rotation of the stent (200).

14. The mitral valve regurgitation treatment apparatus according to claim 2, wherein the inside surface of the stent (200) is adjacent to the planar end (201) and is provided with a spreading portion (220) at a distance from the planar end (201), and the base membrane (300) is sleeved between the planar end (201) and the spreading portion (220).

15. The mitral valve regurgitation treatment apparatus according to claim 1, 2, 7, 8 or 14 wherein the stent (200) has a compressed state and an expanded state, the stent (200) in the expanded state having an annular lattice-like structure;

and/or the base film (300) is fluid permeable.

16. The mitral valve regurgitation treatment apparatus of claim 15 wherein the stent (200) is made of a memory metal alloy;

and/or the presence of a gas in the gas,

the basement membrane (300) is made of PET, eTFP or animal pericardium.

17. The mitral valve regurgitation treatment apparatus of claim 1 wherein the stent (200) is provided with a covering membrane, the stent (200) is entirely covered in the covering membrane, and the covering membrane forms the base membrane (300) near one end contacting the mitral valve (13).

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