A prosthetic system with a positioning mechanism

Abstract

The present invention relates to the field of medical devices, and in particular to a prosthetic system with a positioning mechanism, comprising an artificial valve leaflet, an anchoring assembly, a guiding mechanism and a positioning mechanism; the positioning mechanism is provided with a plurality of positioning components, the artificial valve leaflet is detachably connected to the positioning component, and the guiding mechanism is connected to the anchoring assembly; at the same time, the guiding mechanism is detachably connected to the positioning component; the anchoring assembly can reach a designated position by relying on the traction between the guiding mechanism and the positioning component; the present invention detachably connects the anchoring mechanism and the positioning mechanism, and the force generated by the anchoring mechanism during the guiding needle insertion process will not act on the artificial valve leaflet, thereby avoiding wrinkling of the soft artificial valve leaflet during the needle insertion process, ensuring its anchoring effect, and having good clinical significance.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices and relates to a prosthesis system with a positioning mechanism, and in particular to a prosthesis delivery system with a positioning function for treating heart valve regurgitation. Background Art

[0002] With the aging population, the incidence of valvular heart disease has increased significantly. Mitral regurgitation (MR) is particularly prevalent, with an incidence over five times that of aortic stenosis. It is estimated that there are over 10 million patients with severe MR in my country. MR is caused by changes in the mitral valve leaflets and their structure, leading to poor anastomosis between the anterior and posterior leaflets of the mitral valve, allowing blood to flow backward from the left ventricle to the left atrium, causing symptoms. Based on its pathogenesis, MR can be divided into primary (organic) and secondary (functional), each accounting for approximately 50% of cases. Mild MR can remain asymptomatic for extended periods and have a good prognosis. Severe MR may present with symptoms such as palpitations, chest tightness, and shortness of breath. Acute, severe MR is poorly tolerated and is highly likely to die. Clinical studies have shown that drug treatment can only improve symptoms but does not prolong survival or the timing of surgery. Surgical valve repair or replacement is recognized as the standard treatment for MR and has been proven to alleviate symptoms and prolong survival. However, surgical treatment has drawbacks such as significant trauma, slow postoperative recovery, significant postoperative pain, and high risk. Furthermore, 50% of MR patients are unsuitable for surgical treatment due to high-risk factors such as impaired cardiac function, advanced age, and a history of thoracotomy, thus receiving ineffective treatment. Over the past decade, transcatheter mitral valve intervention has rapidly advanced, and the launch of the MitraClip has brought hope to many patients. Recent studies have shown that the MitraClip is more effective than drug therapy for the treatment of functional mitral regurgitation. Faced with this enormous market, major companies and investors have flocked to the field of MR treatment.

[0003] For this reason, MRI therapy is ushering in an era of interventional treatment, following traditional open-chest surgery and minimally invasive procedures. Interventional heart valve treatment offers the advantage of being less invasive than traditional treatments, offering hope to high-risk patients who are not suitable for surgery. While these interventional heart valve treatments offer numerous advantages over traditional treatments, they also face numerous technical challenges, such as difficulty in positioning. This positioning difficulty poses risks to interventional treatment. To obtain clear images, contrast agents must be administered multiple times during surgery, exposing patients to the hazards of contrast agents. Multiple, high-dose X-rays expose patients to excessive cumulative radiation exposure, exposing them to the risk of radiation damage. If positioning issues result in the implant being released in an undesirable position, dislodged, or even dislodged, the patient may face the risk of undergoing another traditional open-chest surgery, a serious life-threatening hazard. Therefore, technologies that ensure timely and accurate implant positioning are of great clinical value for interventional surgery.

[0004] Currently, the only transcatheter interventional device approved for the treatment of MR in the world is Abbott's MitraClip. Its design principle is derived from the edge-to-edge suturing technology used in surgical valve surgery. When the heart contracts, the edges of the anterior and posterior leaflets of the mitral valve cannot be aligned, resulting in a gap, causing blood flow from the left ventricle to flow back from the gap to the left atrium. The surgical edge-to-edge technology sutures the middle point of the edges of the anterior and posterior leaflets of the mitral valve, turning the mitral valve from a large hole into two small holes, thereby reducing MR. In actual operation, the control system of MitraClip is complex, the surgical route is long, and the channel is winding. The doctor needs to repeatedly fine-tune the curvature, direction, release depth, etc. of the delivery system. It takes many attempts to clamp the leaflet, so the operation time is long. It lacks the function of quickly positioning the clamping position.

[0005] Patent CN106175986A discloses a valve clipper for treating heart valve regurgitation. The first and second clipping arms can clamp objects by applying a force generated by their mutual movement and squeezing. It is clear that simply moving the clipper closer together makes it difficult to capture the leaflets, while squeezing can damage them. Similarly, the clipper lacks the ability to quickly locate and capture the leaflets, and is prone to damage.

[0006] Patent CN106606381A discloses an artificial heart valve positioning mechanism, which retracts the positioning frame after the valve is released to a certain extent, and then continues to release the valve. The problem with this design is that the positioning frame cannot be retracted after the valve is released, otherwise the positioning frame and the released valve will interfere with the subsequent release of the valve. The positioning frame cannot guarantee that it is in a positioned state throughout the entire valve release process. If the position of the valve changes after the positioning frame is retrieved, the problem of incorrect implant positioning still exists.

[0007] Therefore, technicians in this field are committed to developing a prosthetic system with a positioning mechanism. On the one hand, it can accurately position the implant throughout the entire process of releasing the implant, and at the same time, the positioning mechanism can better conform to and fit the uneven surface of the autologous valve ring to ensure complete positioning; on the other hand, it can reduce the operation time of the instrument, reduce the amount of contrast agent and radiation, and avoid collateral damage to the patient. Summary of the Invention

[0008] The present invention aims to overcome the shortcomings of the prior art by providing a prosthetic system with a positioning mechanism for patients with mitral regurgitation requiring interventional treatment. While existing valve repair systems have achieved some success in preventing regurgitation, their structures are complex and inadequately adapted to the physiology of the valve leaflets. The present invention addresses the issue of the delivery system's inability to accurately position the valve during release and implantation, while also reducing the number of instrument steps, the amount of contrast agent used, and the amount of radiation, thereby avoiding collateral damage to the patient.

[0009] In order to solve the above technical problems, the present invention is solved by the following technical solutions:

[0010] A prosthetic system with a positioning mechanism comprises an artificial valve leaflet, an anchoring assembly, a guiding mechanism and a positioning mechanism; the positioning mechanism is provided with a plurality of positioning components, the artificial valve leaflet is detachably connected to the positioning components, and the guiding mechanism is connected to the anchoring assembly; at the same time, the guiding mechanism is detachably connected to the positioning components; the anchoring assembly can reach a designated position by relying on the traction between the guiding mechanism and the positioning components.

[0011] The present invention can be further implemented by the following technical solutions:

[0012] In one embodiment, the adjacent positioning members are fixedly connected to each other or reinforcement rods are provided between the adjacent positioning members.

[0013] In a preferred embodiment, the reinforcing rod has a wavy structure.

[0014] In one embodiment, a connecting mechanism is provided on the artificial valve leaflet, and the connecting mechanism is detachably connected to the positioning member.

[0015] In one embodiment, an anchoring area is formed between adjacent connecting mechanisms, and the anchoring assembly can be pressed against the anchoring area by relying on the pulling action between the guiding mechanism and the positioning member.

[0016] In one embodiment, a positioning unit is provided at the distal end of the positioning member, and the positioning unit is detachably connected to the connecting mechanism.

[0017] In one embodiment, the positioning unit is a grid-like structure, or the positioning unit is a rod-like structure.

[0018] In one embodiment, the anchoring assembly includes an anchoring tube and a needle assembly pre-installed in the anchoring tube, the anchoring tube corresponds to one positioning unit, and the distal end portion of the anchoring tube is bendable.

[0019] In a preferred embodiment, the anchoring assembly includes three groups of anchoring tubes and three groups of needle puncture assemblies pre-installed in the anchoring tubes.

[0020] In one embodiment, the positioning member includes an extension segment, a resting segment, and a detachable connecting segment connected in sequence, an angle a is formed between the extension segment and the resting segment, and an angle b is formed between the resting segment and the detachable connecting segment; through the anatomy of the physiological structure of the human heart, it is known that angle a and angle b can adapt well to the physiological anatomy of the autologous valve ring, so that the positioning mechanism can fit the autologous valve ring more closely after release, further enhancing its positioning accuracy.

[0021] In one embodiment, the angle a is between 70° and 140°, and the angle b is between 70° and 90°.

[0022] In one embodiment, the guide mechanism includes a guide member, a control rod and a guide member; the guide member is connected to the anchor assembly, one end of the guide member passes through the guide member to form a positioning ring, and the distal end of the control rod passes through the positioning ring to form a detachable connection.

[0023] In one embodiment, a disassembly hole is provided on the positioning member, and the disassembly hole is provided corresponding to the connecting mechanism, wherein the connecting mechanism is a locking hole provided on the artificial valve leaflet or a locking ring provided on the artificial valve leaflet.

[0024] In one embodiment, the positioning mechanism further includes at least two main support members and one auxiliary support member.

[0025] In one embodiment, the positioning mechanism further includes at least two main support members and one auxiliary support member.

[0026] In one embodiment, the main support member includes a first support segment, a second support segment and a third support segment, an angle c is formed between the first support segment and the second support segment, and an angle d is formed between the second support segment and the third support segment.

[0027] In a preferred embodiment, the angle c is equal to the angle d.

[0028] In one embodiment, the first support segment and the third support segment are both provided with an adaptive bending structure; the adaptive bending structure enables the main support component to have supporting performance while better conforming to the physiological structure of the autologous valve ring and better fitting with the autologous valve ring.

[0029] In a preferred embodiment, the adaptive bending structure is a wavy rod.

[0030] In one embodiment, when the positioning mechanism is released, the third support segments on the two main support members correspond to the joint valve of the mitral valve respectively; the advantage of this design is that it can effectively improve the stability of the positioning mechanism in the autologous valve ring.

[0031] Compared with the prior art, the advantages of the present invention are:

[0032] 1. In the prior art, the artificial valve leaflets are detachably connected to the anchoring mechanism during pre-installation. The anchoring mechanism generates a force on the artificial valve leaflets during the needle-guiding process. Since the artificial valve leaflets are relatively soft, this causes the artificial valve leaflets to wrinkle in the circumferential direction, resulting in defects such as the anchoring mechanism not being able to anchor closely to the tissue and the anchoring position being deviated. The embodiments of the present invention detachably connect the anchoring mechanism to the positioning mechanism. The force generated by the anchoring mechanism during the needle-guiding process will not act on the artificial valve leaflets, thus preventing the soft artificial valve leaflets from wrinkling during the needle-guiding process, ensuring its anchoring effect, and having good clinical significance.

[0033] 2. Unlike existing technologies, one embodiment of the present invention features fixed connections between adjacent positioning units or reinforcement rods between adjacent positioning members. This design effectively prevents twisting of the positioning members and prevents adjacent positioning members from intersecting or interfering with each other when the positioning mechanism is released, ensuring the stability of each unit's anchoring.

[0034] 3. Unlike existing technologies, the present invention forms an angle a between the support segment and the abutment segment, and an angle b between the abutment segment and the detachable connection segment. This design allows the self-adhesive unit to conform to the physiological structure of the native valve annulus, ensuring a closer fit between the positioning mechanism and the native valve annulus.

[0035] 4. Unlike existing technologies, in one embodiment of the present invention, when the positioning mechanism is in the third configuration, the third support segments on the two main support members correspond to the mitral valve commissure. This design ensures the stability of the positioning mechanism during intracardiac positioning. Furthermore, both the first and third support segments are equipped with adaptive bending adjustment structures to prevent the positioning mechanism from causing pressure and damage to tissues.

[0036] 5. Different from the prior art, since the surface of the native valve annulus in the human body is a rugged and undulating surface, the positioning mechanism on the delivery system in the prior art cannot fit tightly against the surface of the native valve annulus when it is positioned against the native valve annulus, so that there is still a certain gap between the distal outlet of the fixing device and the native tissue, resulting in its anchoring needle not being able to fully penetrate the tissue for anchoring during anchoring, and the anchoring effect is general, and there is a risk of pulling off the tissue. In one embodiment of the present invention, a positioning mechanism is used to achieve positioning in the heart, saving the operation and time of the artificial prosthesis to find the anchoring position in the heart. At the same time, the positioning mechanism is divided into three parts: a supporting section, an abutting section, and a detachable connecting section. The detachable connecting section is tightly abutted against the patient's valve annulus, and the anchored area on the artificial valve leaflet is arranged corresponding to the positioning unit, so that each positioning unit and the anchored area can be ensured to fit tightly against / press the valve annulus tissue, thereby ensuring that the anchoring needle can contact and anchor with the tissue when the needle is removed. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Schematic diagram of the overall structure of the prosthesis system of the present invention.

[0038] Figures 2a to 2d Schematic diagrams of two structures of the positioning mechanism of the present invention.

[0039] Figures 3a-3b It is a schematic diagram of the structure of the artificial valve leaflet of the present invention and a schematic diagram of the relationship between the artificial valve leaflet and the connecting mechanism.

[0040] Figures 4a to 4c Schematic diagram of the structure of the positioning mechanism support member and the auxiliary support member in one embodiment of the present invention.

[0041] Figures 5a-5b Schematic diagram of the process of the prosthesis delivery system moving toward the proximal end to release the positioning mechanism in one embodiment of the present invention.

[0042] Figures 6a to 6g This is a schematic diagram of the process in which the anchoring assembly relies on the traction between the guide mechanism and the positioning member to reach the specified position and complete anchoring in one embodiment of the present invention.

[0043] Figures 7a to 7d Schematic diagram of the process of separating the guiding mechanism and the positioning component in one embodiment of the present invention.

[0044] Figures 8a to 8d Schematic diagram of the process of separating the connecting mechanism and the positioning component in one embodiment of the present invention.

[0045] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-artificial valve leaflet, 11-connecting mechanism, 111-locking hole, 112-locking ring, 12-anchoring area, 2-positioning mechanism, 21-positioning member, 211-extension section, 212-rest section, 213-detachable connecting section, 214-detachment hole, 215-connecting hole, 22-reinforcement rod, 23-positioning unit, 24-main support member, 241-first support section, 242-second support section, 243-third support section, 244-adaptive bending structure, 25-auxiliary support member, 3-guiding mechanism, 31-guide member, 32-control rod, 33-guide member, 34-positioning ring, 4-anchoring assembly, 41-anchoring tube, 42-needle assembly, 5-prosthesis delivery system, 51-control wire. DETAILED DESCRIPTION

[0046] The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

[0047] The proximal end mentioned in the present invention refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Specific embodiment one:

[0049] In the prior art, the artificial valve leaflet 1 is detachably connected to the anchoring mechanism during pre-installation. The anchoring mechanism generates a force on the artificial valve leaflet 1 during the needle-guiding process. Since the artificial valve leaflet 1 is relatively soft, the artificial valve leaflet 1 is wrinkled in the circumferential direction, resulting in the anchoring mechanism not being able to be closely anchored to the tissue and the anchoring position being deviated. When used for the treatment of mitral valve disease, such as Figure 1 As shown, a prosthesis system with a positioning mechanism, an artificial valve leaflet 1, an anchoring assembly 4, a guiding mechanism 3 and a positioning mechanism 2; a plurality of positioning members 21 are provided on the positioning mechanism 2, the artificial valve leaflet 1 is detachably connected to the positioning member 21, and the guiding mechanism 3 is connected to the anchoring assembly 4; at the same time, the guiding mechanism 3 is detachably connected to the positioning member 21; the anchoring assembly 4 can reach a specified position by relying on the traction between the guiding mechanism 3 and the positioning member 21; such a design allows the artificial valve leaflet 1 to not be affected by the traction between the guiding mechanism 3 and the positioning member 21 during the process of the guiding mechanism 3 guiding the anchoring assembly 4, thereby avoiding circumferential wrinkling of the soft artificial valve leaflet 1 and affecting the anchoring of the anchoring assembly 4.

[0050] The composition and connection method of the components of the repair system for preventing valvular regurgitation of the present invention will be described in detail below with reference to the accompanying drawings;

[0051] In this embodiment, the adjacent positioning members 21 are fixedly connected or reinforcing rods 22 are provided between the adjacent positioning members 21. Figures 2a to 2dAs shown; the advantage of this design is that it can effectively prevent the positioning member 21 from twisting. At the same time, when the positioning mechanism 2 is released, adjacent positioning members 21 will not intertwine or affect each other, thereby ensuring the stability of the anchoring needles of each unit.

[0052] In this embodiment, the reinforcing rod 22 is a wave-shaped structure. Figure 2d shown.

[0053] In this embodiment, the artificial valve leaflet 1 is provided with a connecting mechanism 11, and the connecting mechanism 11 is detachably connected to the positioning member 21. Figures 3a-3b shown.

[0054] In this embodiment, an anchoring area 12 is formed between adjacent connecting mechanisms 11, and the anchoring assembly 4 can be offset against the anchoring area 12 by relying on the traction between the guiding mechanism 3 and the positioning member 21. Figures 6d-6f shown.

[0055] In this embodiment, a positioning unit 23 is provided at the distal end of the positioning member 21 , and the positioning unit 23 is detachably connected to the connecting mechanism 11 .

[0056] In this embodiment, the positioning unit 23 is a grid structure, or the positioning unit 23 is a rod structure, such as Figures 2a to 2d shown.

[0057] In this embodiment, the anchoring assembly 4 includes an anchoring tube 41 and a needle assembly 42 pre-installed in the anchoring tube 41. The anchoring tube 41 corresponds to one of the positioning units 23. The distal end of the anchoring tube 41 can be bent. Figure 6f and 6g shown.

[0058] In this embodiment, the anchoring assembly 4 includes three groups of anchoring tubes 41 and three groups of needle puncture assemblies 42 pre-installed in the anchoring tubes 41 .

[0059] In this embodiment, the positioning member 21 includes an extension section 211, a contact section 212, and a detachable connection section 213 that are sequentially connected. Figure 4a As shown, an angle a is formed between the extension section 211 and the abutment section 212, and an angle b is formed between the abutment section 212 and the detachable connecting section 213; through the anatomy of the physiological structure of the human heart, it is known that the angle a and the angle b can adapt well to the physiological anatomy of the autologous valve ring, so that the positioning mechanism 2 can fit the autologous valve ring better after release, further enhancing its positioning accuracy.

[0060] In this embodiment, the angle a is 70° to 140°, and the angle b is 70° to 90°.

[0061] In this embodiment, the guiding mechanism 3 includes a guide member 31, a control rod 32 and a guide member 33. Figure 7a and 7b As shown; the guide member 31 is connected to the anchor assembly 4, and one end of the guide member 33 passes through the guide member 31 to form a positioning ring 34, and the distal end of the control rod 32 passes through the positioning ring 34 to form a detachable connection.

[0062] More preferably, a connecting hole 215 is provided on the positioning member 21, and one end of the guide member 33 passes through the guide member 31 and the connecting hole 215 to form a positioning ring 34 below the positioning member 21, and then the guide member 33 passes through the connecting hole 215 and the guide member 31 in turn to return to the body, and the distal end of the control rod 32 passes through the positioning ring 34 to form a detachable connection; when the control rod 32 is pulled out of the positioning ring 34, the guide mechanism 3 and the positioning member 21 are completely disassembled.

[0063] In this embodiment, the positioning member 21 is provided with a disassembly hole 214. Figures 8a to 8c As shown, the disassembly hole 214 is arranged corresponding to the connecting mechanism 11, wherein the connecting mechanism 11 is a locking hole 111 arranged on the artificial valve leaflet 1 or a locking ring 112 arranged on the artificial valve leaflet 1; it also includes a control wire 51, and when the control wire 51 passes through the disassembly hole 214 and the locking hole 111, the connection is completed. When the control wire 51 is pulled out of the disassembly hole 214 and the locking hole 111, the connecting mechanism 11 and the positioning member 21 are disassembled.

[0064] More preferably, the connecting mechanism 11 is a locking ring 112 arranged on the artificial valve leaflet 1, so that it can be detachably connected with the positioning member 21, and there can be only one puncture hole on the artificial valve leaflet 1, without any other holes, which can improve the integrity of the artificial valve leaflet 1.

[0065] In this embodiment, the positioning mechanism 2 further includes at least two main support members 24 and one auxiliary support member 25 .

[0066] In this embodiment, the main support member 24 includes a first support segment 241, a second support segment 242 and a third support segment 243. Figure 4b As shown, an angle c is formed between the first supporting segment 241 and the second supporting segment 242 , and an angle d is formed between the second supporting segment 242 and the third supporting segment 243 .

[0067] In this embodiment, the included angle c is equal to the included angle d.

[0068] In this embodiment, the first support segment 241 and the third support segment 243 are both provided with an adaptive bending structure 244; the adaptive bending structure 244 enables the main support member 24 to have supporting performance while being able to better conform to the physiological structure of the autologous valve ring and better fit the autologous valve ring.

[0069] In this embodiment, the adaptive bending structure 244 is a wavy rod.

[0070] In this embodiment, when the positioning mechanism 2 is released, the third support segments 243 on the two main support members 24 correspond to the joint valve of the mitral valve, respectively. Figure 4c As shown; the advantage of this design is that it can effectively improve the stability of the positioning mechanism 2 in the autologous valve ring.

[0071] The operating process and principle of the present invention are:

[0072] 1. The prosthesis delivery system 5 is introduced through the apical approach, passes through the patient's left ventricle and reaches the left atrium. The delivery catheter is withdrawn proximally, the positioning mechanism 2 returns to the preset shape, and the distal end of the anchoring assembly 4 is also exposed from the delivery catheter. Figure 5a and 5b As shown;

[0073] 2. Operate the guide mechanism 3 so that the distal end of the anchor assembly 4 bends and the guide member 33 is tightened. Figures 6a to 6c As shown;

[0074] 3. Move the prosthesis delivery system 5 proximally so that the positioning mechanism 2 is close to the native valve annulus. At the same time, the distal ends of the positioning members 21 conform to and closely fit the uneven surface of the native valve annulus. Figure 6d As shown;

[0075] 4. Then operate the guide mechanism 3 so that the distal end of the anchoring assembly 4 bends and abuts against the anchoring area 12, as shown in FIG. Figure 6e As shown;

[0076] 5. Operate the needle assembly 42 so that the anchoring needle penetrates the tissue and the artificial valve leaflet 1 is anchored on the native valve ring. Figure 6f As shown, the control lever 32 is operated to separate the guide mechanism 3 from the positioning member 21, as shown in FIG. Figures 7a to 7d As shown, the control wire 51 is operated again to separate the connecting mechanism 11 from the positioning member 21, as shown in FIG. Figures 8a to 8c As shown;

[0077] 6. The delivery catheter moves to the distal end, so that the positioning mechanism 2 is re-entered into the delivery catheter, and finally the prosthesis delivery system 5 is withdrawn from the body, and the artificial valve leaflet is firmly fixed in the heart. Figure 8d shown.

[0078] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there may be changes in the specific implementation methods and application scopes. The contents of this specification should not be understood as limiting the present invention.

Claims

1. A prosthesis system with a positioning mechanism, comprising: Artificial valve leaflet, anchoring assembly, guide mechanism and positioning bracket; the positioning bracket is provided with a plurality of positioning members, the artificial valve leaflet is detachably connected to the positioning member, and the guide mechanism is connected to the anchoring assembly; at the same time, the guide mechanism is detachably connected to the positioning member; the anchoring assembly can reach the specified position by relying on the traction between the guide mechanism and the positioning member; the artificial valve leaflet is provided with a connecting mechanism, the connecting mechanism is detachably connected to the positioning member, and an anchoring area is formed between adjacent connecting mechanisms, and the anchoring assembly relies on the guide mechanism to connect the positioning member. The traction between the mechanism and the positioning component can offset the anchoring area. The distal end of the positioning component is provided with a positioning unit, and the positioning unit is detachably connected to the connecting mechanism. The anchoring assembly includes an anchoring tube and a needle assembly pre-installed in the anchoring tube. The anchoring tube corresponds to one positioning unit. The distal end of the anchoring tube can be bent. The guiding mechanism includes a guide, a control rod and a guide; the guide is connected to the anchoring assembly, and one end of the guide passes through the guide to form a positioning ring, and the distal end of the control rod passes through the positioning ring to form a detachable connection.

2. A prosthesis system with a positioning mechanism according to claim 1, characterized in that: Adjacent positioning members are fixedly connected or reinforcing rods are provided between adjacent positioning members.

3. The prosthesis system with a positioning mechanism according to claim 1, characterized in that: The positioning unit is a grid-shaped structure, or the positioning unit is a rod-shaped structure.

4. The prosthesis system with a positioning mechanism according to claim 1, characterized in that: The positioning component includes an extension section, a resting section, and a detachable connecting section that are connected in sequence. An angle a is formed between the extension section and the resting section, and an angle b is formed between the resting section and the detachable connecting section.

5. The prosthesis system with a positioning mechanism according to claim 4, characterized in that: The angle a is between 70° and 140°, and the angle b is between 70° and 90°.

6. The prosthesis system with a positioning mechanism according to claim 1, characterized in that: The positioning member is provided with a disassembly hole, and the disassembly hole is arranged corresponding to the connecting mechanism, wherein the connecting mechanism is a locking hole arranged on the artificial valve leaflet or a locking ring arranged on the artificial valve leaflet.

7. The prosthesis system with a positioning mechanism according to claim 1, characterized in that: The positioning bracket also includes at least two main support members and one auxiliary support member.

8. The prosthesis system with a positioning mechanism according to claim 7, characterized in that: The main support member includes a first support segment, a second support segment and a third support segment. An angle c is formed between the first support segment and the second support segment, and an angle d is formed between the second support segment and the third support segment.

9. The prosthesis system with a positioning mechanism according to claim 8, characterized in that: The first supporting segment and the third supporting segment are both provided with an adaptive bending structure.

10. The prosthesis system with a positioning mechanism according to claim 8, characterized in that: The included angle c is equal to the included angle d.

Images