CN213217911U - Valve prosthesis with adjustable fixing end - Google Patents
Valve prosthesis with adjustable fixing end Download PDFInfo
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- CN213217911U CN213217911U CN202020966716.8U CN202020966716U CN213217911U CN 213217911 U CN213217911 U CN 213217911U CN 202020966716 U CN202020966716 U CN 202020966716U CN 213217911 U CN213217911 U CN 213217911U
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Abstract
The utility model relates to the field of medical equipment, in particular to a valve prosthesis with an adjustable fixed end, which comprises a bracket and a prosthetic valve, wherein the bracket comprises a bracket main body and an anchoring device, the anchoring device comprises a supporting component, an anchoring structure and a positioning piece, the joint structure is arranged at the matched joint of the supporting component and the anchoring structure, the joint structure is taken as a fulcrum, and the anchoring structure swings in a sector plane along the direction vertical to the central axis of the bracket main body; the supporting structure can swing back and forth in the direction vertical to the central axis of the bracket main body; the utility model discloses well bearing structure comprises many spinal branchs vaulting pole, and the cooperation is articulated between many spinal branchs vaulting pole for bearing structure can absorb the displacement variable of ventricle shrink phase support main part and anchoring structure end, turns into mechanical rotation with elastic deformation originally, avoids bearing structure to bear alternating stress for a long time and fatigue damage or even fracture appears.
Description
Technical Field
The utility model relates to the field of medical equipment, especially, relate to a valve prosthesis of adjustable stiff end.
Background
The heart is a slightly flattened conical sphere anteriorly and posteriorly composed of atria and ventricles. The interatrial septum and the ventricular septum separate the atrium and ventricle into left and right atria and left and right ventricles, respectively. The atria and ventricles are separated by atrioventricular valves, and the ventricles and the main and pulmonary arteries are composed of valve leaflets and valve rings. The atrioventricular valve located between the left atrium and the left ventricle is called the mitral valve, and the tricuspid valve is located between the right atrium and the right ventricle; the semilunar valve between the left ventricle and the aorta is the aortic valve, and the pulmonary valve between the right ventricle and the pulmonary artery. The main function of the heart valve is to ensure that blood flows in a single direction and the heart pumps blood rhythmically during systole or diastole, so as to promote blood circulation in vivo. The tricuspid valve is located at the orifice of the right atrioventricular, and the common onset is tricuspid valve insufficiency, namely, systolic blood flow flows back from the right ventricle to the right atrium, which causes the height of the right atrium to be enlarged, the pressure to be increased and venous blood backflow disorder. Because the right ventricle load is increased and compensated to be hypertrophic, the right heart failure and the tricuspid valve regurgitation are easily caused by pulmonary hypertension, right ventricle enlargement and tricuspid valve ring expansion, the clinical manifestations of the causes (left heart failure, pulmonary hypertension and the like) of the tricuspid valve regurgitation are common, and the right heart failure symptoms such as the tricuspid valve regurgitation, hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but when severe regurgitation occurs, surgical treatment is required, and conventional treatment means for tricuspid valve disease include medication suitable for mild to severe regurgitation and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. Many patients do not tolerate the enormous surgical risk and can only remain indefinitely at risk for death.
With the first report of aortic valve intervention replacement, many companies have done a lot of work on interventional aortic valve technology, and the technology is mature. However, the market is still blank in the field of atrioventricular valve replacement, and companies have limitations to percutaneous interventional replacement techniques for atrioventricular valves.
For example, patent CN201180020556 describes a mitral valve prosthesis from Medtronic, inc, comprising an inner support structure having a downstream portion and an upstream portion, wherein the upstream portion has a larger cross-sectional area than the downstream portion, the inner support structure being configured to be positioned at least partially on the atrial side of the native valve complex and to exert an axial force towards the left ventricle; and an outer support structure having two or more engagement arms, wherein the engagement arms are coupled to the inner support structure, wherein the prosthesis is configured to clamp a portion of a leaflet of a native valve between the inner support structure and the engagement arms upon implantation thereof. Similar to the Edwards design, the patient's native mitral valve is grasped by the upstream portion having the larger cross-sectional area against the mitral valve annulus, and by the engagement arms of the outer support structure. The whole body of the bracket still adopts a cylindrical symmetrical structure, so that a doctor still needs to select a large-sized valve to provide enough supporting force during operation, the blood supply of a left ventricular outflow tract is greatly blocked by the huge diameter of the valve, the flow rate of an aortic valve orifice is increased, the pressure is increased, and the heart failure condition is easy to occur for a long time. At the same time, the larger valve diameter fits directly across the annulus, compressing nearby tissue, including the aortic annulus.
Applicants percutaneous cardiovascular solution company discloses in the "heart valve prosthesis and method" patent document that a prosthetic heart valve (100) comprises a housing component (110) and a valve component (130). The housing assembly (110) comprises a housing body (111), the housing body (111) having a housing passage (112) extending therethrough. The housing body (111) is configured to be positioned in, or adjacent to and in communication with, a native valve orifice (16) of the heart (10), and to engage a structure of the heart (10) to secure the housing body (111) relative to the valve orifice (161). The housing assembly (111) is collapsible for delivery via the catheter (2). The valve assembly (130) includes a valve body (131), the valve body (131) having a valve passage (132) extending therethrough. The valve body (131) is configured to be secured within the housing passage (112), the valve passage (132) extending along the housing passage (112). One or more flexible valve elements (131) are secured to the valve body and extend across the valve passage (132) to prevent blood flow through the valve passage (132) in a first direction and to allow blood flow in an opposite direction. The valve assembly (130) is collapsible for delivery via the catheter (2) separately from the housing assembly (110). Also disclosed are related methods of replacing a failed or failing heart valve with a prosthetic heart valve (100); the technical defects of the scheme are as follows: the fixed connection of the shell component (110) and the intracardiac tissue is supported and connected by a plurality of rods, and the other ends of the rods are anchored in the heart of the patient by means of barbs; the heart of the human body is always in a contraction and expansion state in the operation process, the rod has no compliance, so that the rod can have structural fatigue damage and even has the risk of fracture after long-term use, on the other hand, the anchoring force of the rod in the heart through the barbs is possibly insufficient, and the valve stent has the condition of position deviation in the past for a long time, so that serious perivalvular leakage is caused.
SUMMERY OF THE UTILITY MODEL
The utility model aims at providing a possess valve prosthesis of adjustable stiff end, this valve prosthesis possesses the advantage: 1. the supporting structure consists of a plurality of supporting rods, and the plurality of supporting rods are hinged in a matched mode, so that the supporting structure can absorb displacement variables of the bracket main body and the anchoring structure end in the ventricular systole, original plastic deformation is converted into mechanical rotation, and the phenomenon that the supporting structure bears alternating stress for a long time to cause fatigue damage or even fracture is avoided; 2. the support rod is of a rigid structure, so that sufficient anchoring force can be provided for the support, the stability of the support in the intracardiac position is ensured, and the risk of perivalvular leakage caused by the inclination of the support after long-term implantation is avoided;
in order to solve the technical problem, the utility model discloses a following technical scheme can solve: the utility model provides a valve prosthesis who possesses adjustable stiff end, includes support and artificial valve, the support includes support subject and anchor, anchor connects at the supporting member of support subject near-end, cooperation including the cooperation and connects the locating piece of being connected at the anchoring structure of supporting member near-end and with the anchoring structure cooperation, anchoring structure can fix on cardiac tissue through the locating piece, supporting member and anchoring structure cooperation junction are equipped with joint structure, with joint structure is the fulcrum, the swing of sector is done along the direction of perpendicular to support subject axis to anchoring structure.
The invention can be further realized by the following technical scheme:
preferably, the support member is rigid.
Preferably, the joint structure is an articulated structure.
Preferably, the distal end of the support member is hinged to the proximal end of the stent body or the distal end of the support member is fixedly connected to the proximal end of the stent body.
Preferably, the anchoring device comprises an anchoring structure pushing system capable of pushing the anchoring structure against the patient's ventricular tissue and outputting a positioning member so that the anchoring structure is fixed on the patient's ventricular tissue.
Preferably, anchoring structure is made by many anchor rods, many anchor rod one end respectively with the bracing piece cooperation is connected, many anchor rod's the other end passes through respectively the setting element is fixed in the patient is intracardiac.
Preferably, a connecting hole is formed in each of the anchor rods, a connecting piece penetrates through the connecting hole, and the connecting pieces are connected with the positioning pieces in a matched mode.
More preferably, the connecting member is a linear structure.
Preferably, the connecting member is inserted through the connecting hole and then fixedly connected with the anchoring structure, so that the connecting strength between the positioning member and the anchoring structure can be increased.
Preferably, the setting element includes the setting element main part of being connected with the connecting piece cooperation, sets up the constant head tank on the setting element main part and the resilience barb of cooperation connection in the constant head tank.
Preferably, one end of the keeper body is provided in a tapered configuration.
More preferably, the positioner body is provided as a cylindrical structure.
More preferably, the number of the resilient barbs is 4, and the resilient barbs are uniformly arranged on the positioning member main body.
More preferably, the anchoring structure pushing system comprises a guide rail and a top core, the guide rail is arranged on the anchoring structure, the end of the guide rail is contracted, the positioning member and the top core are arranged in the guide rail, and the conical part of the positioning member penetrates through the guide rail and pricks into the intracardiac tissue of the patient by operating the top core.
More preferably, the guide rail is provided with a groove, the groove can be used for accommodating the connecting piece, the positioning piece can be smoothly inserted into intracardiac tissues, and certain interference caused by the connecting piece is avoided.
Compared with the prior art, the utility model has the advantages of:
1. the supporting member and the anchoring structure are movably connected, so that the anchoring structure can swing along with the contraction of a heart chamber in the motion process of the heart, original plastic deformation is converted into mechanical rotation, and the supporting structure is prevented from fatigue damage and even breakage caused by long-term stress bearing; 2. the support rod is of a rigid structure, so that sufficient anchoring force can be provided for the support, the stability of the support in the intracardiac position is ensured, and the risk of perivalvular leakage caused by the inclination of the support after long-term implantation is avoided;
3. the support rod is of a rigid structure and can provide enough anchoring force for the support, so that the support is not required to radially expand the valve ring of the patient, the intracardiac tissue of the patient is prevented from being pressed, the influence on the outflow channel after the support is released can be reduced, the drawing on the native valve ring is avoided, and the support rod has good clinical significance;
4. different from the mode that the anchoring needle is directly adopted as the fixing piece in the prior art, the positioning piece with the resilience barbs is adopted in the scheme, after the positioning piece is penetrated into intracardiac tissue, the resilience barbs are positioned in the positioning grooves, and when the ventricle expands, the barbs can be unfolded and firmly fixed on the cardiac tissue, so that the force required for pulling off the valve stent from the intracardiac tissue after anchoring is greatly increased, and the stability of the valve stent in the heart is ensured;
5. the positioning piece and the anchoring structure are fixedly connected by adopting a linear member, so that the connection strength of the positioning piece and the bracket is further increased, the situation that the positioning piece and the anchoring structure are pulled off after the valve prosthesis is implanted for a long time is avoided, and the practicability is very strong;
drawings
Fig. 1 is a schematic view of the overall structure of the present invention.
Fig. 2 is a schematic side view of the present invention.
Fig. 3a-3b are schematic views of the positioning member of the present invention.
Fig. 4a-4d are schematic views illustrating the delivery catheter of the present invention entering the heart to complete the anchoring process to the valve prosthesis, wherein fig. 4d is an enlarged view of a portion a in fig. 4 c.
Fig. 5 is a schematic view of the anchoring structure with the anchoring end varying with ventricular contraction during motion of the heart of the present invention.
Fig. 6a-6b are schematic structural views after the implantation of the present invention.
The names of the parts indicated by the numbers in the drawings are as follows: 1-stent, 11-stent body, 12-anchoring device, 121-support member, 122-anchoring structure, 1221-anchoring rod, 1222-attachment hole, 123-connector piece, 124-positioning piece, 1241-positioning piece body, 1242-positioning slot, 1243-resilient barb, 13-anchoring structure pushing system, 2-guide rail, 3-delivery catheter.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
The proximal end of the invention refers to the end close to the operator, and the distal end refers to the end far away from the operator.
The specific embodiment is as follows:
as shown in fig. 1, a valve prosthesis with an adjustable fixed end comprises a stent 1 and a prosthetic valve, wherein the stent 1 comprises a stent body 11 and an anchoring device 12, the anchoring device 12 comprises a supporting member 121 fittingly connected to a proximal end of the stent body 11, an anchoring structure 122 fittingly connected to a proximal end of the supporting member 121, and a positioning member 124 fittingly connected to the anchoring structure 122, the anchoring structure 122 can be fixed on cardiac tissue by the positioning member 124, a joint structure (not shown) is arranged at the fitting connection position of the supporting member 121 and the anchoring structure 122, and the joint structure (not shown) is taken as a fulcrum, and the anchoring structure 122 swings in a sector shape along a direction perpendicular to a central axis of the stent body 11; compared with the fixing device of the valve prosthesis in the existing design, the fixing device of the valve prosthesis adopts a rigid structure, and the supporting member 121 and the anchoring structure 122 are hinged in a matched manner, so that the anchoring structure 122 can swing along with the contraction of a heart chamber in the motion process of the heart, the original plastic deformation is converted into mechanical rotation, and the supporting member 121 is prevented from fatigue damage or even breakage caused by long-term stress bearing; meanwhile, the supporting member 121 and the anchoring structure 122 can still provide sufficient anchoring force for the valve prosthesis, ensure the stability of the valve prosthesis in the heart, avoid the risk of perivalvular leakage caused by the inclination of the stent 1 after long-term implantation, and also avoid the radial support of the autologous valve annulus by the stent main body 11, reduce the influence on the outflow tract after the release of the stent 1, and avoid the traction on the native valve annulus.
The components and connection modes of the components of the reversible bending valve delivery system of the present invention will be described in detail with reference to the accompanying drawings;
in this embodiment, the support member 121 is rigid; in the present application, the rigid support member 121 provides a stable anchoring force for the valve prosthesis at the endocardial position, so that the need for radially supporting the native valve annulus by providing the large-caliber support body is eliminated, and the compression of the patient's endocardial native tissue is effectively avoided.
In this embodiment, the proximal end of the support member 121 is cooperatively hinged with the distal end of the anchoring structure 122; the distal end of the supporting member 121 is hinged to the proximal end of the bracket body 11 or the distal end of the supporting member 121 is fixedly connected to the proximal end of the bracket body 11.
In some preferred embodiments, the supporting member 121 may be a rod or a plurality of rods, and when the supporting member 121 is a rod, the supporting member 121 and the anchoring structure 122 are connected in an articulated manner (in this case, the articulated structure is an articulated structure), so that the supporting member 121 and the anchoring structure 122 can limit the rotation of the bracket body 11 thereof, thereby avoiding the occurrence of paravalvular leakage; when the supporting member 121 is a plurality of rods (specifically, 2 or more than 2 rods), the supporting member 121 and the anchoring structure 122 can be connected in a hinged manner, so that the supporting member 121 can be prevented from fatigue damage or even breakage due to long-term stress bearing, and the bracket body 11 can be prevented from rotating.
As shown in fig. 4a-4d, the anchoring device 12 includes an anchoring structure pushing system 13, the anchoring structure pushing system 13 can push the anchoring structure 122 against the patient's ventricular tissue and output a positioning member 124, such that the anchoring structure 122 is fixed on the patient's ventricular tissue;
in this embodiment, the anchoring structure 122 is made of a plurality of anchoring rods 1221, one ends of the plurality of anchoring rods 1221 are respectively connected to the supporting rod 1211 in a matching manner, and the other ends of the plurality of anchoring rods 1221 are respectively fixed in the heart of the patient by the positioning members 124; the anchoring rods 1221 are provided with connecting holes 1222, a connecting member 123 is inserted into the connecting holes 1222, the connecting member 123 is connected with the positioning member 124 in a matching manner, the connecting member 123 is a linear structure, and the connecting member 123 passes through the connecting holes 1222 and then is fixedly connected with the anchoring structure 122, so that the connecting strength between the positioning member 124 and the anchoring structure 122 can be increased;
as shown in fig. 2, the positioning member 124 comprises a positioning member main body 1241 fittingly connected to the connecting member 123, a positioning groove 1242 provided on the positioning member main body 1241, and resilient barbs 1243 fittingly connected in the positioning groove 1242, one end of the positioning member main body 1241 is provided in a tapered configuration, the positioning member main body 1241 is provided in a cylindrical configuration, and the resilient barbs 1243 are provided in 4 numbers and uniformly arranged on the positioning member main body 1241; be different from the mode that directly adopts the anchoring needle as the mounting among the prior art, this application scheme adopts the setting element 124 that possesses resilience barb 1243, and after setting element 124 pierced intracardiac tissue, resilience barb 1243 was located constant head tank 1242, when waiting to the ventricular expansion, the barb can open thereupon and firmly fix on cardiac tissue, greatly increased behind the anchoring pull off required power from intracardiac tissue, guaranteed valve support 1 intracardiac firm.
In this embodiment, the anchoring structure pushing system 13 includes a guide rail and a top core, the guide rail is disposed on the anchoring structure 122, an end of the guide rail is tapered, the positioning element 124 and the top core are disposed in the guide rail, by operating the top core, a tapered portion of the positioning element 124 penetrates through the guide rail and punctures into the intracardiac tissue of the patient, a groove is disposed on the guide rail, the groove can accommodate the connecting element 123, the positioning element 124 can be smoothly inserted into the intracardiac tissue, and certain interference caused by the connecting element 123 is avoided; as shown in the figure, anchoring structure push system 13 includes guide rail and apical core (not marking), the guide rail is set up on the anchoring structure 122, guide rail tip throat, setting element 124 with apical core (not marking) is set up in the guide rail, through the operation apical core (not marking), the tapered portion of setting element 124 is followed the guide rail passes and pricks into patient's ventricle tissue on, when the ventricle expands, the barb can open thereupon and firmly fix on heart tissue, confirms the anchoring effect ideal back of anchoring needle, apical core (not marking) is withdrawn from the human body.
The working process of the utility model comprises the following steps (shown by referring to the attached drawings):
1. accessing the atrioventricular valve annulus from a minimally invasive incision in the atrial wall using a delivery catheter loaded with the heart valve prosthesis; 2. manipulating the delivery catheter to release the anchoring structure 122;
3. operating the delivery catheter to release the stent body 11;
4. manipulating the delivery catheter such that the positioning member 124 penetrates the patient's ventricular tissue;
5. withdrawing the delivery catheter from the body;
the above description is only for the preferred embodiment of the present invention, and for those skilled in the art, there are variations on the detailed description and the application scope according to the idea of the present invention, and the content of the description should not be construed as a limitation to the present invention.
Claims (9)
1. The utility model provides a valve prosthesis that possesses adjustable stiff end, includes support and artificial valve, its characterized in that: the stent comprises a stent body and an anchoring device, wherein the anchoring device comprises a supporting member which is connected to the proximal end of the stent body in a matching way, an anchoring structure which is connected to the proximal end of the supporting member in a matching way and a positioning member which is connected with the anchoring structure in a matching way, and the anchoring structure can be fixed on the heart tissue through the positioning member; the joint structure is arranged at the matched connection position of the supporting component and the anchoring structure, and the anchoring structure swings in a sector surface along the direction vertical to the central axis of the bracket main body by taking the joint structure as a fulcrum.
2. The valve prosthesis with an adjustable fixing end according to claim 1, wherein: the support member is rigid.
3. The valve prosthesis with an adjustable fixing end according to claim 1, wherein: the joint structure is a hinge structure.
4. The valve prosthesis with adjustable fixation end of claim 3, wherein: the far end of the supporting member is hinged with the near end of the bracket main body or the far end of the supporting member is fixedly connected with the near end of the bracket main body.
5. The valve prosthesis with an adjustable fixing end according to claim 1, wherein: the anchoring device further comprises an anchoring structure pushing system, wherein the anchoring structure pushing system can push the anchoring structure to abut against the intracardiac tissue of the patient and output a positioning piece, so that the anchoring structure is fixed on the intracardiac tissue of the patient.
6. The valve prosthesis with an adjustable fixing end according to claim 1, wherein: anchoring structure is formed by many anchor rods preparation, many anchor rod one end respectively with the supporting component cooperation is connected, many anchor rod's the other end passes through respectively the setting element is fixed in the patient is intracardiac.
7. The valve prosthesis with an adjustable fixation end of claim 6, wherein: the anchor rods are provided with connecting holes, connecting pieces penetrate through the connecting holes, and the connecting pieces are connected with the positioning pieces in a matched mode.
8. The valve prosthesis with an adjustable fixing end according to claim 1, wherein: the setting element includes the setting element main part of being connected with the connecting piece cooperation, sets up constant head tank and the cooperation connection resilience barb in the constant head tank in the setting element main part.
9. The valve prosthesis with an adjustable fixation end of claim 8, wherein: one end of the positioning piece main body is set to be in a conical structure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020966716.8U CN213217911U (en) | 2020-06-01 | 2020-06-01 | Valve prosthesis with adjustable fixing end |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020966716.8U CN213217911U (en) | 2020-06-01 | 2020-06-01 | Valve prosthesis with adjustable fixing end |
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| Publication Number | Publication Date |
|---|---|
| CN213217911U true CN213217911U (en) | 2021-05-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202020966716.8U Active CN213217911U (en) | 2020-06-01 | 2020-06-01 | Valve prosthesis with adjustable fixing end |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113616384A (en) * | 2021-08-23 | 2021-11-09 | 上海纽脉医疗科技股份有限公司 | Valve prosthesis with connecting part |
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2020
- 2020-06-01 CN CN202020966716.8U patent/CN213217911U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113616384A (en) * | 2021-08-23 | 2021-11-09 | 上海纽脉医疗科技股份有限公司 | Valve prosthesis with connecting part |
| CN113616384B (en) * | 2021-08-23 | 2023-11-14 | 上海纽脉医疗科技股份有限公司 | Valve prosthesis with connecting component |
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Address after: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Patentee after: Ningbo Jianshi Technology Co.,Ltd. Address before: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Patentee before: NINGBO JENSCARE BIOTECHNOLOGY Co.,Ltd. |
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| CP01 | Change in the name or title of a patent holder |