NL2032396A

NL2032396A - Medical artificial valve assembly

Info

Publication number: NL2032396A
Application number: NL2032396A
Authority: NL
Inventors: Peng Bo
Original assignee: Fuwai Yunnan Cardiovascular Hospital; Fuwai Hospital Cams & Pumc
Priority date: 2021-09-22
Filing date: 2022-07-06
Publication date: 2023-03-27
Also published as: CN113813085B; CN113813085A

Abstract

Disclosed is a medical artiﬁcial valve assembly including a stent, a valve frame and two valve cusps. The stent is of an elastic tubular structure, and can be compressed and deformed axially when subjected to a radial acting force and restore to an original shape when the radial acting force disappears. The valve frame is of an elastic annular structure, is coaXially ﬁxed into the stent and can be compressed and deformed, and a blood ﬂow channel is arranged in the valve frame. The two valve cusps are both of a hard sheet structure, are connected to the valve frame, and can rotate in the blood ﬂow channel so as to open or close the blood ﬂow channel. The present invention has structure advantages of mechanical valves and can be implanted in an intervening mode, so as to reduce trauma on patients during implanting and reduce surgical risks.

Description

MEDICAL ARTIFICIAL VALVE ASSEMBLY

TECHNICAL FIELD

[01] The present invention relates to the field of medical devices, in particular to a medical artificial valve assembly.

BACKGROUND ART

[02] Heart valves include a bicuspid valve, a tricuspid valve, an aortic valve and a pulmonary valve. Taking the bicuspid valve of the human body as an example, the bicuspid valve is a bivalve type valve and is located between a left atrium and a left ventricle, during diastole, due to blood filling, the pressure of the left atrium is increased, the bicuspid valve is opened when the atrium pressure is increased and exceeds the pressure of the left ventricle, and passive blood flow is assisted in entering the left ventricle; along with atrial systole and diastole ending, residual blood flows into the left ventricle from the left atrium; and after atrial systole is ended, the bicuspid valve is closed so as to prevent blood flow from reversing and flowing back to the left atrium from the left ventricle. The bicuspid valve includes an anterior cusp and a posterior cusp to jointly cover an opening of the bicuspid valve. The opening of the bicuspid valve is surrounded by a fiber ring named as a bicuspid valve ring. The two cusps are circumferentially attached to the bicuspid valve ring and are opened and closed like an annular hinge in the cardiac cycle process. In the bicuspid valve with a normal function, the cusps are connected to papillary muscles of the left ventricle through chordae tendineae. When the left ventricle is contracted, the bicuspid valve is forced to be closed by pressure in the ventricle, it is guaranteed that the two cusps are in coincidence through the chordae tendineae so as to prevent the two cusps from prolapsing and entering the left atrium and causing incomplete closing of the bicuspid valve, the opening and closing direction of the valve is prevented from getting wrong, and accordingly the blood is prevented from flowing back to the left atrium.

[03] Valve lesion is one of common valvular heart diseases, and pathogenesis of the valve lesion includes rheumatic, retrogressive and infectious endocarditis and the like, and artificial valve replacement is a common treatment means for curing heart valve lesion. An artificial valve can be roughly divided into a bioprosthetic valve structure and a mechanical valve structure, where bioprosthetic valves are commonly manufactured by treating heart valves of human bodies or pigs or cows (some bioprosthetic valves are synthesized through flexible artificial materials) and have the advantages that after the operation, anticoagulant drugs do not need to be taken for a long time, the possibility of complications associated anticoagulation is low, influences on daily life are weak, but structure strength is low, durability is poor, and consequently, the bioprosthetic valves are low in using safety and short in service life (commonly, 10-15 years); while mechanical valves are mainly manufactured by metal or pyrolytic carbon synthetic materials and are high in structure strength, good in durability and long in service life (for lifelong service), and using safety is high all in all although the anticoagulant drugs need to be taken.

[04] For the artificial valves of the two structures, in existing clinical practice, the mechanical valves are implanted through thoracotomy without exception, namely open sternotomy 1s carried out, the heart is arrested by using an extracorporeal circulation machine to implant the mechanical artificial valves, trauma on patients is large, and surgical risks are high; the bioprosthetic valves can be implanted in an intervening mode with low invasiveness, for example, the patent CN109009569 A discloses an artificial bicuspid valve intervening replacement device and an intervening method thereof, a support and artificial valve cusps are included, the support is made of a deformable material, the artificial valve cusps are made of a biological or non-biological flexible material, each artificial valve cusp is provided with a first end and a free end, the first ends are connected to a lower edge of the support, the free ends are opposite to the first ends, and opening configuration and closing configuration are provided between the artificial valve cusps; in the diastole period, the artificial valve cusps are configured to be open, the free ends of the artificial valve cusps are far away from one another to enter the left atrium, and accordingly, direct flowing blood is allowed to flow through an opening among the valve cusps; and in the contraction period of the left atrium, the artificial valve cusps are configured to be closed, the free ends of the artificial valve cusps move in the direction of the left atrium and are oppositely combined to close the support, and reverse blood is prevented from flowing through. [OS] As previously mentioned, if the patients place emphasis on the service life and using safety in replacement of the artificial valves, the mechanical valves are preferably considered, but thoracotomy implanting defects commonly become application obstacles of the mechanical valves; and thus, a medical artificial valve assembly is needed and has structure advantages of the mechanical valves and can be implanted in the intervening mode as well, so as to reduce trauma to the patients during implanting and reduce surgical risks.

SUMMARY

[06] For this purpose, the present invention aims at providing a medical artificial valve assembly which has structure advantages of the mechanical valves and can be implanted in an intervening mode as well, so as to reduce trauma on the patients during implanting and reduce surgical risks.

[07] To achieve the above purpose, the present invention provides the medical artificial valve assembly including a stent, a valve frame and two valve cusps.

[08] The stent is of an elastic tubular structure, and can be compressed and deformed in an axial direction when subjected to a radial acting force and restore to an original shape when the radial acting force disappears;

[09] the valve frame is of an elastic annular structure or an elastic tubular structure, is coaxially fixed into the stent and can be compressed and deformed together with the stent, and a blood flow channel is arranged in a middle of the valve frame; and

[10] the two valve cusps are both of a hard sheet structure and are detachably connected to the valve frame, and the two valve cusps can rotate in the blood flow channel after being connected to the valve frame so that the two valve cusps can open or close the blood flow channel.

[11] As a further improvement for a technical solution of the present invention, the stent includes a stent body and a membrane, the stent body is formed by weaving a shape memory alloy wire and is of a net structure, and the membrane is arranged on an outer side surface of the partial or whole stent body.

[12] As a further improvement for the technical solution of the present invention, the membrane is made of dacron.

[13] As a further improvement for the technical solution of the present invention, the stent is provided with an anchor part, and the anchor part is used for anchoring the stent in the body.

[14] As a further improvement for the technical solution of the present invention, the valve frame is spliced to the stent, and the valve cusps are made of pyrolytic carbon.

[15] As a further improvement for the technical solution of the present invention, the two valve cusps are rotationally connected to a cusp shaft and connected to the valve frame through the cusp shaft.

[16] As a further improvement for the technical solution of the present invention, two ends of the cusp shaft are each provided with an axial positioning groove, positioning rods are coaxially arranged in the positioning grooves in a sliding manner, and elastic reset pieces are arranged between inner ends of the positioning rods and bottoms of the positioning grooves; and positioning holes matched with the positioning rods and used for the positioning rods to be inserted therein are formed in the valve frame.

[17] As a further improvement for the technical solution of the present invention, the elastic reset pieces are of a compressed spring structure.

[18] As a further improvement for the technical solution of the present invention, the valve frame is connected to first developing pieces, the cusp shaft is connected to second developing pieces, and the first developing pieces and the second developing pieces are used for developing under X ray.

[19] As a further improvement for the technical solution of the present invention, the first developing pieces and the second developing pieces are of a permanent magnet structure, the first developing pieces are embedded in the positioning holes, and the second developing pieces are arranged at outer ends of the positioning rods.

[20] Compared with the prior art, the present invention has following beneficial effects: 5 21] According to the medical artificial valve assembly provided in the present invention, the structure strength of the valve cusps which serve as opening and closing parts and are of the hard sheet structure is high, so that the medical artificial valve assembly has structure advantages of mechanical valves; and meanwhile, the elastic stent and the elastic valve frame can be synchronously compressed so that the two valve cusps can be rotationally folded, accordingly, all parts can be implanted in an intervening mode, trauma on patients during implanting is effectively reduced, and surgical risks are reduced.

[22] Taking replacement of a bicuspid valve as an example, during usage, the valve frame and the stent can be connected and compressed firstly, then, a component is conveyed into a position between a left atrium and a left ventricle of a patient from apex cordis, after releasing, the stent can dilate an original bicuspid valve and is fixed to cardiac intima, then the valve cusps in a folding state are conveyed into the valve frame from the apex cordis and are connected and fixed, and thus installation of the whole artificial bicuspid valve assembly is completed.

[23] It needs to be explained that the medical artificial valve assembly can be applied to replacement operation of various heart valves including the bicuspid valve.

[24] By means of the medical artificial valve assembly provided in the present invention, the artificial valve with a mechanical valve structure can be implanted in an intervening mode, which is creative contribution of the present invention, but the existing mechanical valves are all implanted through thoracotomy; and thus, the present invention satisfies social needs and has high practicability, and further development of an angiocarpy medical technology can be better promoted.

BRIEF DESCRIPTION OF THE DRAWINGS

[25] FIG.1 is a structural schematic diagram of the present invention;

[26] FIG.2 is a schematic diagram of a connection structure of a valve frame and valve cusps of the present invention;

[27] FIG.3 is a schematic diagram of a first connection structure of the valve cusps and a cusp shaft of the present invention;

[28] FIG.4 is a schematic diagram of a second connection structure of the valve cusps and the cusp shaft of the present invention;

[29] FIG.5 is a structural schematic diagram of the valve cusps of the present invention; and

[30] FIG.6 is a structural schematic diagram of the cusp shaft of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[31] To make skill in the art better understand a technical solution of the present invention, the present invention is further described in detail in combination with drawings and specific embodiments below; and of course, the drawings are simplified schematic diagrams, and a proportion of the drawings does not limit a patented product.

[32] Embodiment

[33] As shown in FIG. 1-FIG. 6, the embodiment provides a medical artificial valve assembly including a stent 1, a valve frame 2 and two valve cusps 3. Taking application of a valve assembly into the human body bicuspid valve for replacement as an example in the embodiment, the assembly can be applied to other valves for replacement actually.

[34] The stent 1 is of an elastic tubular structure, and can be compressed and deformed in an axial direction when subjected to a radial acting force and restore to an original shape when the radial acting force disappears; preferably, the stent 1 includes a stent body 11 and a membrane 12, the stent body 11 is formed by weaving a shape memory alloy wire and is of a net structure, and the membrane 12 is arranged on an outer side surface of the partial or whole stent body 11; and the membrane 12 can be made of dacron.

[35] The stent 1 is further provided with an anchor part (not shown in drawings), and the anchor part is used for anchoring the stent 1 in the body to position the stent 1.

A shape of the anchor part is not limited here, for example, a “clamping effect” generated by utilizing atrium flanges and valve ring support in the patent

CNI104771247A “ DEVICE AND METHOD FOR TREATING MITRAL

REGURGITATION”, an anchoring element and a hook structure in the patent

CN107405194A “BICUSPID VALVE PROSTHESIS” can all achieve the purpose of the embodiment.

[36] The valve frame 2 is of an elastic annular structure (or can be of an elastic tubular structure), is coaxially fixed into the stent 1 and can be compressed and deformed together with the stent 1, a blood flow channel 2a is arranged in a middle of the valve frame 2 and used for blood flow to pass; the valve frame 2 can be made of rubber and the like; and the valve frame 2 can be connected to the stent 1 through a splicing manner. After assembly positioning, the valve frame 2 can be positioned to an original autologous bicuspid valve ring.

[37] The two valve cusps 3 are both of a hard sheet structure and are detachably connected to the valve frame 2, and the two valve cusps 2 can rotate in the blood flow channel 2a after being connected to the valve frame 2 so that the two valve cusps 3 can open or close the blood flow channel 2a. The valve cusps 3 can be in a D shape, and a principle of opening and closing the blood flow channel 2a through the valve cusps 3 is the same as an action principle of existing mechanical valves and is not repeated herein; and the valve cusps 3 are preferably made of pyrolytic carbon.

[38] According to the medical artificial valve assembly provided in the embodiment, the structure strength of the valve cusps 3 which serve as opening and closing parts and are of the hard sheet structure is high, so that the medical artificial valve assembly has structure advantages of mechanical valves; and meanwhile, the elastic stent 1 and the elastic valve frame 2 can be synchronously compressed so that the two valve cusps 3 can be rotationally folded, accordingly, all parts can be implanted in an intervening mode, trauma on patients during implanting is effectively reduced, and surgical risks are reduced.

[39] During usage, the valve frame 2 and the stent 1 can be connected and compressed firstly, then, a component is conveyed into a position between a left atrium and a left ventricle of a patient from apex cordis (in FIG. 1, a left atrium area is above the valve frame 2, and a left ventricle area is below the valve frame 2), after releasing, the stent 1 can dilate an original bicuspid valve and is fixed to cardiac intima, then the valve cusps 3 in a folding state are conveyed into the valve frame 2 from the apex cordis and are connected and fixed, and thus installation of the whole artificial bicuspid valve assembly is completed.

[40] In the embodiment, the valve cusps 3 and the valve frame 2 can be connected by adopting a following structure.

[41] The two valve cusps 3 are rotationally connected to a cusp shaft 4 and connected to the valve frame 2 through the cusp shaft 4; the cusp shaft 4 is of a round rod structure, and the two valve cusps 3 are symmetrically arranged with an axis of the cusp shaft 4 as a symmetric axis; a linear section of each D-shaped valve cusp 4 can outwards protrude to form a rotating shaft 31, rotating grooves 41 are correspondingly formed in side faces of the rotating shafts 4, the rotating shafts 31 can be clamped into the rotating grooves 41 to be rotationally connected, meanwhile, the rotating grooves 41 can serve as limiting components for the rotating shafts 31 so as to limit a rotation angle of the valve cusps 3( aperture of the valve cusps 3 in FIG. 1 and FIG. 3 is the smallest, and the blood flow channel 2a is completely closed; and aperture of the valve cusps 3 in

FIG. 2 and FIG. 4 is the largest, the two valve cusps are approximately parallel, and the blood flow channel 2a is completely opened), and accordingly the blood flow channel 2a is effectively opened and closed.

[42] Two ends (namely an upper end and a lower end in FIG. 6) of the cusp shaft 4 are each provided with an axial positioning groove 42, and the positioning grooves 42 are formed through inward concaving from an end face of the cusp shaft 4; positioning rods 5 are coaxially arranged in the corresponding positioning grooves 42 in a sliding manner, and in other words, the two positioning rods 5 correspond to the two positioning grooves 42; elastic reset pieces 6 are arranged between inner ends of the positioning rods 5 and bottoms of the positioning grooves 42 and are preferably of a compressed spring structure, two ends of the elastic reset pieces 6 are fixedly connected to the inner ends of the positioning rods 5 and the bottoms of the positioning grooves 42, the positioning rods 5 can compress the elastic reset pieces 6 when the subjected to axial acting force so as to stretch into the positioning grooves 42, and after the axial acting force disappears, the positioning rods 5 reset and stretch out of the positioning grooves 42.

[43] Positioning holes 21 matched with the positioning rods 5 and used for the positioning rods 5 to be inserted therein are formed in the valve frame 2; the two positioning holes 2 are distributed in one diameter of the valve frame 2 and can be of a through hole structure; a direction shown in FIG. 1 serves as a datum, an upper end face and a lower end face of the valve frame 2 are both of a smooth cambered surface structure, and therefore when the cusp shaft 4 enters the valve frame 2 from top to bottom or from bottom to top, the positioning rods 5 make contact with an inner wall of the valve frame 2 and are subjected to the axial acting force (for the valve frame 2, a radial acting force is applied to the valve frame 2), and accordingly, the elastic reset pieces 6 can be compressed; and when the positioning rods 5 are aligned with the positioning holes 21, the positioning rods 5 can automatically stretch into the positioning holes 21, and accordingly automatic locking is achieved.

[44] Meanwhile, the valve frame 2 is connected to first developing pieces 61, the cusp shaft 4 is connected to second developing pieces 62, the first developing pieces 61 and the second developing pieces 62 are used for developing under X ray, and therefore positions of the valve frame 2 and the cusp shaft 4 in the patient body can be known, and proceeding of interventional operation is facilitated. Preferably, the first developing pieces 61 and the second developing pieces 62 are of a permanent magnet structure, the first developing pieces 61 are embedded in the positioning holes 21, the second developing pieces 62 are arranged at outer ends of the positioning rods 5, and the positioning rods 5 can be made of permanent magnets at the time; and the first developing pieces 61 are opposite to the second developing pieces in magnetism, accordingly, the first developing pieces 61 and the second developing pieces can be mutually attracted during approaching, positioning of the cusp shaft 4 is facilitated, and meanwhile connection stability of the positioning rods 5 can be improved.

[49] It is finally explained that the text applies specific examples to elaborate the principle and the implementing manner of the present invention, the description of the above embodiment is merely used for assisting in understanding the core concept of the present invention, the present invention can be variously improved and modified without departing from the principle of the present invention, and the improvement and the modification fall within the protection scope of the present invention.

Claims

S11 - Conclusions

A medical prosthetic valve assembly comprising: a stent, a valve frame and two valve lips, the stent having an elastic tubular structure and capable of being compressed and deformed in an axial direction when subjected to a radially acting force and recovering to an original shape when the radially acting force disappears; the valve frame has an elastic annular structure or an elastic tubular structure, is coaxially fixed in the stent and can be compressed and deformed together with the stent, and a blood flow channel disposed in the center of the valve frame 1s; and the two valve cusps both have a hard plate structure and are releasably connected to the valve frame, and the two valve cusps can rotate in the blood flow channel after being connected to the valve frame such that the two valve cusps can open or close the blood flow channel.

The medical prosthetic valve assembly of claim 1, wherein the stent comprises a stent body and a membrane, the stent body is formed by weaving a shape memory alloy wire and has a net structure, and the membrane is disposed on an outer side surface of the partial or entire stent body.

The medical prosthetic valve assembly of claim 2, wherein the membrane is made of dacron.

The medical prosthetic valve assembly of claim 1, wherein the stent includes an anchor member, and the anchor member is used for anchoring the stent in the body.

The medical prosthetic valve assembly of claim 1, wherein the valve frame is spliced to the stent and the valve cusps are made of pyrolytic carbon.

The medical prosthetic valve assembly of any one of claims 1-5, wherein the two valve tabs are rotatably connected to a slip shaft and are connected to the valve frame through the slip shaft.

The medical prosthetic valve assembly of claim 6, wherein two ends of the slip shaft are each provided with an axial positioning groove, and positioning rods are slidably disposed coaxially in the corresponding positioning grooves; elastic return pieces are provided between inner ends of the positioning bars and bottoms of the positioning grooves; and locating holes corresponding to the locating rods and used for the locating rods to be inserted therein are formed in the valve frame.

The medical prosthetic valve assembly of claim 7, wherein the elastic return pieces have a compressed spring structure.

The medical prosthetic valve assembly of claim 7, wherein the valve frame is connected to first developing pieces, the slip shaft is connected to second developing pieces, and the first developing pieces and the second developing pieces are used for X-ray developing.

The medical prosthetic valve assembly of claim 7, wherein the first development pieces and the second development pieces have a permanent magnet structure, the first development pieces are embedded in the positioning holes, and the second development pieces are mounted on the ends of the positioning rods.