A valve prosthesis with a positioning member and its delivery system

Abstract

The present invention belongs to the field of medical devices, and particularly relates to a valve prosthesis with a positioning member, which includes a stent body and an artificial valve. A positioning member is cooperatively connected to the stent body. The positioning member includes a positioning arm and a control member. The positioning arm is fixed on the stent body. The positioning arm consists of an elastic deformation area and an elastic adaptation area. When the control member is pulled axially, the elastic adaptation area of the positioning arm moves along the height direction of the stent body, the elastic deformation area undergoes deformation, and a part of the arc length of the elastic deformation area is converted to the elastic adaptation area; when the control member is released, the elastic deformation area gradually returns to the preset shape, and a part of the arc length of the elastic adaptation area is reversely converted to the elastic deformation area, and the positioning arm gradually returns to the preset shape. The positioning arm in the present invention consists of an elastic deformation area and an elastic adaptation area. By absorbing or compensating a part of the arc length of the elastic deformation area, the elastic adaptation area can realize the conversion between the restricted state and the released state of the positioning member, and achieve the purpose of reducing its loading diameter.

Description

Technical field:

[0002] The present invention belongs to the field of medical devices, and in particular relates to a valve prosthesis with a positioning piece and a delivery system thereof. Background technology:

[0004] Aortic valve stenosis is primarily caused by sequelae of rheumatic fever, congenital aortic valve structural abnormalities, or senile aortic valve calcification. While patients are asymptomatic during the compensatory phase, those with severe aortic valve stenosis often experience fatigue, dyspnea (exertional or paroxysmal), angina, dizziness, or syncope, and may even suffer sudden death.

[0005] Aortic regurgitation means that the aortic valve opens when the ventricle contracts, and the blood in the left ventricle enters the aorta and is ejected to the whole body. It closes when the ventricle relaxes, preventing the blood in the aorta from flowing back to the left ventricle. If aortic valve insufficiency occurs, the aortic valve cannot close tightly during diastole, causing blood to flow back from the aorta into the left ventricle.

[0006] Surgical valve replacement is a traditional and effective treatment for aortic valve disease. However, patients with this condition are often elderly and have multiple organ diseases, making them physically inadequate for surgical procedures, rendering them clinically hopeless. Furthermore, the etiology of degenerative aortic valve disease remains unclear, making it difficult to treat the underlying cause or effectively curb its progression, and drug therapy is ineffective. Ideally, treatment for aortic valve disease should both improve symptoms and prolong life. Percutaneous aortic balloon valvuloplasty, previously used to treat aortic stenosis, has shown poor long-term efficacy, both in single-center data and in multicenter registries. In China, surgical valve replacement remains the primary treatment option. In recent years, researchers both domestically and internationally have conducted basic and clinical research on percutaneous aortic valve replacement, achieving several breakthroughs. This provides an effective treatment option for high-risk elderly patients with degenerative aortic valve requiring surgical valve replacement. In 2002, Cribier et al. successfully performed transcatheter aortic valve replacement (TAVR). To date, over 50,000 TAVR procedures have been performed worldwide. Studies worldwide have consistently demonstrated the safety and effectiveness of this technology for patients who are either ineligible for surgical valve replacement or who present a high risk for surgical valve replacement. Although TAVR is often performed on high-risk patients, the 30-day survival rate after surgery exceeds 90%, and hemodynamic indicators are significantly improved in patients who undergo TAVR.

[0007] However, at present, native aortic valve insufficiency is still listed as a contraindication for TAVR. The main reason is that the accurate positioning and precise release of the stent valve are the most critical technical points in TAVR surgery. There are openings of the left and right coronary arteries above the aortic valve, and the mitral valve is adjacent below the valve. If the positioning and release are inaccurate, fatal complications such as coronary artery occlusion or severe mitral regurgitation may occur. Traditional TAVR devices, whether SAPIEN or CoreValve, are mainly used for patients with severe aortic valve stenosis and are not suitable for patients with aortic valve regurgitation. In the existing technology, the device design for patients with aortic valve regurgitation

[0008] has reached a certain consensus. For example, JenaValve and Acurate abroad, and J-Valve in China all adopt a structure similar to the native leaflet positioning piece to position the three sinuses of the aortic valve, which is beneficial to the accurate positioning and implantation of the stent. However, at present, most of the above devices still use the transapical approach, which still causes relatively large trauma to patients and cannot be considered a strictly percutaneous implantation. In response to the problem of how to balance the native leaflet positioning piece and the overly large sheath, domestic scholars and engineers have made some conceptual attempts.

[0009] Patent CN2010155694.8 describes an artificial valve with a movably connected valve buckle, which includes a support frame that can be radially expanded between a compressed state and an expanded state. The support frame has an outer surface and defines a central hole around an axis along the inflow and outflow directions; a plurality of elastic leaflets connected to the support frame, which provide a one-way valve in the air when the support frame is in the expanded state; and at least one valve buckle that is axially movably connected to the support frame so that the at least one valve buckle can move along the axis between a nested position and an engaged position. In the nested position, the at least one valve buckle is located in a nested position where the support frame is in contact with or adjacent to the native valve appropriately. In the engaged position, the at least one valve buckle is offset from the support frame. The disadvantages of this design are as follows: The valve buckle is connected by being movably connected to the support frame, which may cause the valve buckle to shift in position during movement and cannot ensure that the valve buckle can reach the originally set position for connection after moving towards the support frame; secondly, there is no effective fixing structure between the valve buckle and the support frame. After the valve prosthesis is implanted, the valve buckle may have relative displacement relative to the support frame, reducing the stability of the support frame in the heart position and affecting the use of the valve.

[0010] Patent CN201620032889.6 provides a transcatheter aortic valve prosthesis device, which includes: a main stent; leaflets fixed to the inner side of the middle part of the main stent; a skirt fixed along the inner periphery of the main stent and fixed to the leaflets; wherein, the upper end of the main stent forms an upper flared structure in a three-lobe form; there are three upper circular connecting claws for loading the main stent at the upper end of the upper flared structure; the bottom end of the main stent has a lower flared structure that expands outwards to reduce paravalvular leakage; there are three lower circular connecting claws at the lower end of the lower flared structure; the aortic valve prosthesis device further includes a positioning ring located on the lower side of the main stent, and the positioning ring includes three V-shaped or U-shaped arc segments, and the ends of each of the V-shaped or U-shaped arc segments are connected to each other to form a ring, and three positioning circular connecting claws are formed on the ends; the lower circular connecting claws and the corresponding positioning circular connecting claws are respectively connected by flexible positioning wires. Although this design scheme greatly reduces the diameter of the valve prosthesis during sheath loading, the lower circular connecting claws and the corresponding positioning circular connecting claws are respectively connected by flexible positioning wires. During release and positioning, due to the upward rush of blood, there is no effective limiting / fixing structure between the positioning circular connecting claws and the lower circular connecting claws, resulting in the positioning circular connecting claws being possibly "washed away", causing it unable to be effectively and accurately positioned.

[0011] In summary, the defect of the above fixing method is that the connection position between the valve buckle and the support frame during positioning is not accurate enough and is prone to position deviation. Summary of the Invention:

[0013] The object of the present invention is to improve and remedy the defects of the prior art, and propose a valve prosthesis with a positioning member that can effectively solve the above problems. The technology of the present invention has the characteristics of accurate positioning, stable clamping, firm clamping, reducing paravalvular leakage, etc., and solves the problems that the positioning member of the prosthesis in the prior art cannot resist the blood impact force during release, the release positioning is not accurate, and it is prone to eversion during the release process.

[0014] The object of the present invention is achieved by the following technical solutions:

[0015] A valve prosthesis with a positioning member, comprising a stent body and an artificial valve cooperatively connected to the stent body. A positioning member is cooperatively connected to the stent body. The positioning member includes a positioning arm and a control member cooperatively connected to the positioning arm. The positioning arm is fixed to the stent body. The positioning arm consists of an elastic deformation zone and an elastic adaptation zone. When the control member is pulled axially, the elastic adaptation zone of the positioning arm moves along the height direction of the stent body, the elastic deformation zone deforms, and a part of the arc length of the elastic deformation zone is converted to the elastic adaptation zone. When the positioning member is in the released state, the elastic deformation zone gradually returns to a preset shape, a part of the arc length of the elastic adaptation zone is reversely converted to the elastic deformation zone, and the positioning arm gradually returns to the preset shape.

[0016] Another object of the present invention can also be further achieved by the following technical solutions:

[0017] In some embodiments, the number of the positioning members is 3. After being released, the positioning members are located at the bottom of the natural aortic sinus of the patient. The positioning members provide a certain supporting force for the stent body in the heart, while ensuring that the stent body can be safely and accurately released / implanted into the target position, preventing the stent body from being "washed away" by the blood in the heart.

[0018] In some embodiments, the positioning arm is a wire. One end of the wire is fixed to the stent body, and the other end of the wire overlaps into a "ring" in the middle region of the positioning arm and is then fixed to the stent body. The "ring" is the elastic adaptation zone. The shape of the "ring" has various forms and can be circular or oval.

[0019] In some preferred embodiments, the positioning arm is a wire. One end of the wire is fixed to the stent body, and the other end of the wire forms an inverted "U" - shaped structure or a quasi - "V" - shaped structure in the middle region of the positioning arm and is then fixed to the stent body. The inverted "U" - shaped structure or the quasi - "V" - shaped structure is the elastic adaptation zone.

[0020] In some embodiments, the elastic deformation of the elastic adaptation zone is less than the elastic deformation of the elastic deformation zone.

[0021] In some embodiments, the elastic deformation of the elastic deformation zone near the connection part with the stent body is less than the elastic deformation of the elastic deformation zone far from the connection part with the stent. The purpose of such a design is: to be more conducive to the mutual conversion of the positioning arm between the restricted state and the released state.

[0022] In some preferred embodiments, the control member and the positioning arm are detachably connected. When the positioning member is in the released state, the control member is separated from the positioning arm.

[0023] In some embodiments, when the control member is axially pulled, the elastic adaptation region and the partial stent where the artificial valve is located do not overlap with each other.

[0024] In some embodiments, the control member and the elastic adaptation region are detachably connected in cooperation; when the positioning member is in the released state, the control member and the elastic adaptation region are separated; the purpose of such a design is to greatly reduce the implant, reduce the contact and irritation to the intracardiac tissue, and be beneficial to the postoperative recovery of the patient.

[0025] In some embodiments, the positioning arm is made of a shape memory material and has a preset shape.

[0026] In some preferred embodiments, the preset shape of the positioning arm is a "W" shape, and the middle convex part of the "W" shape is the elastic adaptation region.

[0027] In some embodiments, the positioning arm is integrally structured.

[0028] In some preferred embodiments, the positioning arm is made of a shape memory alloy material.

[0029] In some embodiments, the control member is a wire or a filament, one end of the control member is detachably connected to the elastic adaptation region on the positioning arm. When the valve prosthesis is in the sheath, the positioning member is in the restricted state, and the control member pulls the positioning arm to move the elastic adaptation region along the height direction of the stent body, so that a part of the arc length of the elastic deformation region is converted to the elastic adaptation region until the axial tension of the control member and the arc length of the elastic deformation region are no longer converted by the elastic adaptation region. At this time, the elastic adaptation region on the positioning member and the partial stent where the artificial valve is located do not overlap with each other, so that the diameter of the sheath tube during valve loading can be greatly reduced.

[0030] In some embodiments, micro-spines are evenly distributed on the elastic adaptation region of the positioning arm. The micro-spines are made of a metal memory material. After the positioning arm resumes its preset shape, the micro-spines can clamp the valve leaflets, increasing the friction force with the valve leaflets, and effectively avoiding the situation that the stent body falls off in the heart.

[0031] In some preferred embodiments, micro-spines are evenly distributed on the distal part of the elastic deformation. The micro-spines are made of a metal memory material. After the positioning arm resumes its preset shape, the micro-spines can clamp the valve leaflets, increasing the friction force with the valve leaflets, and effectively avoiding the situation that the stent body falls off in the heart.

[0032] In some embodiments, the surface of the stent body is coated with a film, and the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or an animal-derived material.

[0033] The present invention can be realized through the following technical solutions:

[0034] A valve prosthesis system with a positioning member, comprising a valve prosthesis with a positioning member, a control handle, an outer sheath, and a controllable release device. The valve prosthesis with a positioning member includes a stent body, an artificial valve cooperatively connected to the stent body, and a positioning member. The stent body is cooperatively connected to the controllable release device. The positioning member includes a positioning arm and a control member. One end of the control member is detachably connected to the positioning arm, and the other end of the control member is cooperatively connected to the control handle. The positioning arm is fixed on the stent body. The positioning arm consists of an elastic deformation zone and an elastic adaptation zone. When the control handle is operated to axially pull the control member, the elastic adaptation zone of the positioning arm moves along the height direction of the stent body, the elastic deformation zone deforms, and a part of the arc length of the elastic deformation zone is converted to the elastic adaptation zone. The positioning arm is gradually retracted into the gap between the stent body and the outer sheath until the elastic adaptation zone does not overlap with the part of the stent where the artificial valve is located. At this time, the positioning arm is in a restricted state. When the control handle is operated in the reverse direction, the elastic deformation zone gradually returns to the preset shape, and a part of the arc length of the elastic adaptation zone is reversely converted to the elastic deformation zone. The positioning arm gradually extends out of the gap between the stent body and the outer sheath and returns to the preset shape. At this time, the positioning arm is in a released state.

[0035] In some embodiments, before the stent body is completely detached from the controllable release device, the positioning arm can be repeatedly switched between its restricted state and the released state.

[0036] In some embodiments, the controllable release device includes a distal release device and a proximal release device. The distal release device is located at the distal part of the valve prosthesis system. Before the distal part of the stent body is completely detached from the distal release device, the distal part of the stent body is arranged in a collapsed state within the distal release device. The proximal release device is arranged within the outer sheath and is detachably connected to the proximal end of the stent body in a cooperative manner. Before the positioning member and the distal part of the stent body are completely released, the proximal part of the stent body is restricted from being released by the proximal release device.

[0037] Compared with the prior art, the advantages of the above technical solution are as follows:

[0038] 1. The positioning member in the present invention includes a positioning arm and a control member. The positioning arm consists of an elastic deformation area and an elastic adaptation area. When the control handle is axially pulled to operate the control member, the elastic adaptation area of the positioning arm moves along the height direction of the stent body, the elastic deformation area deforms, and a part of the arc length of the elastic deformation area is transformed into the elastic adaptation area. The positioning arm is gradually retracted into the gap between the stent body and the outer sheath until the elastic adaptation area does not overlap with the part of the stent where the artificial valve is located. At this time, the positioning arm is in a restricted state, which can greatly reduce the diameter of the sheath tube during valve loading, reduce the diameter of the loading sheath tube of its delivery system, and perform a replacement operation on the patient through a vascular path, greatly reducing the trauma to the patient and being beneficial to the patient's postoperative recovery. At the same time, the elastic deformation area and the elastic adaptation area are provided on the positioning member, which can make it easier to enter the sheath and reduce the operation difficulty.

[0039] 2. The positioning arm in the present invention consists of an elastic deformation area and an elastic adaptation area. The elastic adaptation area transforms or reversely transforms a part of the arc length of the elastic deformation area, and the positioning arm gradually extends out of the gap between the stent body and the outer sheath and returns to a preset shape, or the positioning arm is gradually retracted into the gap between the stent body and the outer sheath; thus, the conversion between the release state and the restricted state of the positioning member can be achieved. At the same time, when the elastic deformation area and the elastic adaptation area transform mutually, their paths can greatly reduce the situation that the positioning member turns outward and scratches the aortic inner wall tissue during the release process.

[0040] 3. When the positioning member in the present invention is released, since a part of the arc length of the elastic adaptation area is gradually reversely transformed into the elastic deformation area, the elastic deformation area has a buffering function when contacting the patient's sinus tissue and is not easy to damage the patient's tissue, and the release process is safer and more reliable.

[0041] 4. The positioning arm in the present invention is fixedly connected to the stent body, so that the positioning arm can reach the specified position according to the preset path whether it is axially stretched, deformed or restored to the preset shape, avoiding the deviation or dislocation of the positioning member in the path during this process, improving the accuracy of the positioning member during release and positioning, and improving the success rate of the operation.

[0042] 5. In some embodiments of the present invention, the control member is set as a wire or a filament, and the control member and the positioning arm are detachably connected. When the positioning member is in the release state, the control member is separated from the positioning arm, so that the positioning arm is restored to the preset shape. The advantage of such a design is that the control member can be withdrawn from the body, greatly reducing the implant, reducing the contact and stimulation to the intracardiac tissue, and being beneficial to the patient's postoperative recovery.

[0043] 6. The positioning arm in the present invention is made of shape memory material and is an integrated structure. The advantage of such a design is that it makes the structure of the positioning arm simpler. At the same time, when the positioning part is in the released state, the positioning arm can be well restored to the preset shape, thereby improving the success rate of the positioning part release and clamping positioning.

[0044] 7. In the present invention, the elastic deformation of the elastic adaptability zone is smaller than that of the elastic deformation zone, so that the positioning arm can more easily switch between the restrained state and the released state while meeting a certain support force. The elastic adaptability zone is easier to deform than the elastic deformation zone, so that the positioning arm can adapt to the sinus width of different patients, play a buffering role during cardiac beating, and will not damage the cardiac tissue due to excessive rigidity.

[0045] 8. In the present invention, micro-thorns are evenly distributed at the distal end of the elastic adaptation zone or elastic deformation zone of the positioning arm. The purpose of this design is that after the valve prosthesis is implanted and positioned in the heart, the positioning arm can hook the patient's own valve leaflets, increase a certain anchoring force, and thus prevent the valve prosthesis from "rushing upwards". Description of the drawings:

[0047] Figure 1 Schematic diagram of the heart valve prosthesis of the present invention.

[0048] Figure 2 It is a top view of the heart valve prosthesis of the present invention.

[0049] Figures 3a - 3c This is a schematic diagram of the process of the control member pulling the positioning arm in the natural state of the heart valve prosthesis, wherein Figure 3a This is a schematic diagram of the process of the positioning part changing in the front view. Figure 3b for Figure 3a A partial enlarged view of Figure 3c Schematic diagram of the process of the positioning part changing in the side view.

[0050] Figures 4a - 4c The figure is a schematic diagram of the process of the control member pulling the positioning arm of the heart valve prosthesis in the delivery system.

[0051] Figures 5a - 5i Schematic diagram of the heart valve prosthesis release process, wherein Figure 5d yes Figure 5c Schematic diagram of the side structure, Figure 5h and Figure 5i This is a local enlarged view of the valve prosthesis after release.

[0052] Figures 6a - 6h There are two loading and releasing methods for valve prosthesis positioning parts in the prior art, wherein Figure 6c for Figure 6b A partial enlarged view of .

[0053] Figure 7 Schematic structural diagram of a heart valve prosthesis according to another embodiment.

[0054] Figures 8a - 8c Schematic process diagram of the control member pulling the positioning arm of a heart valve prosthesis in a delivery system according to another embodiment.

[0055] Figures 9a - 9d Schematic process diagram of the control member pulling the positioning arm of a heart valve prosthesis in a delivery system according to another embodiment.

[0056] Figures 10a - 10b are schematic diagrams of the release process of a heart valve prosthesis according to another embodiment. Specific implementation manner:

[0058] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the following examples are given with reference to the attached drawings to further elaborate on the present invention.

[0059] The distal end of the present invention refers to the end of the valve prosthesis away from the apex of the heart, and the proximal end refers to the end of the valve prosthesis close to the apex of the heart. Specific embodiment one:

[0061] When the heart valve prosthesis is used to treat aortic valve diseases, as Figure 1 , Figure 2 shown, it includes a stent body 1 and an artificial valve 2 connected to the stent body 1. A positioning member 3 is connected to the stent body 1. The positioning member 3 includes a positioning arm 31 and a control member 32 connected to the positioning arm 31. The positioning arm 31 is fixed on the stent body 1. The positioning arm 31 consists of an elastic deformation region 311 and an elastic adaptation region 312. When the control member 32 is pulled, the elastic adaptation region 312 of the positioning arm 31 moves along the height direction of the stent body 1, and a partial arc length of the elastic deformation region 311 is converted to the elastic adaptation region 312 (as shown in Figure 3a —3c, where the positioning member 3 in Figure 3a changes from the solid line position to the dotted line position in the direction of the arrow); when the positioning member 3 is in the released state, the elastic deformation region 311 returns, and a partial arc length of the elastic adaptation region 312 is reversely converted to the elastic deformation region 311; the positioning member 3 includes a positioning arm and a control member 32, and the positioning arm 31 consists of an elastic deformation region 311 and an elastic adaptation region 312, as shown in Figure 4aAs shown in Figure 4c, when the control handle (not shown) is operated to axially pull the control member 32, the elastic adaptation zone 312 of the positioning arm 31 moves along the height direction of the stent body 1, the elastic deformation zone 311 deforms, and a part of the arc length of the elastic deformation zone 311 is transferred to the elastic adaptation zone 312. The positioning arm 31 is gradually retracted into the gap between the stent body 1 and the outer sheath 4 until the elastic adaptation zone 312 does not overlap with the part of the stent where the artificial valve 2 is located. At this time, the positioning arm 31 is in a restricted state. At this time, the elastic adaptation zone 312 does not overlap with the part of the stent where the artificial valve 2 is located, which can greatly reduce the diameter of the sheath tube during valve loading, reduce the diameter of the loading sheath tube of its delivery system, perform a replacement operation on the patient through a vascular path, greatly reduce the trauma to the patient, and is beneficial to the patient's postoperative recovery.

[0062] In this embodiment, the number of the positioning members 3 is 3. After being released, the positioning members 3 are located at the bottom of the sinus of the patient's natural aortic sinus 8. The positioning members 3 provide a certain supporting force for the stent body 1 in the heart, while ensuring that the stent body 1 can be safely and accurately released / implanted to the target position, and preventing the stent body 1 from being "washed away" by the blood in the heart.

[0063] In this embodiment, the positioning members 3 can also clamp the patient's own valve leaflets.

[0064] In this embodiment, the positioning arm 31 is a wire. One end of the wire is fixed on the stent body 1, and the other end of the wire overlaps into a "ring" in the middle area of the positioning arm 31 and is then fixed on the stent body 1. The "ring" is the elastic adaptation zone 312. When the control member 32 pulls the elastic adaptation zone 312 of the positioning arm 31, the "ring" absorbs a part of the arc length of the elastic deformation zone 311, making the circumference of the "ring" continuously increase until the axial stretching of the control member 32 and the arc length of the elastic deformation zone 311 are no longer absorbed by the elastic adaptation zone 312. At this time, the circumference of the "ring" reaches the maximum value, and the positioning member 3 is in a restricted state.

[0065] In this embodiment, the control member 32 and the positioning arm 31 are detachably connected. When the positioning member 3 is in the released state, the control member 32 is separated from the positioning arm 31. Due to the characteristics of the material of the positioning arm 31 itself, the positioning arm 31 returns to the preset state. During this process, a part of the arc length of the elastic adaptation zone 312 is continuously compensated into the elastic deformation zone 311 until the positioning arm 31 returns to the preset state; as Figure 4aAs shown in FIG4c, when the positioning member 3 is between the inner tube and the outer sheath (i.e., in a compressed state), the arc lengths of the elastic deformation zone 311 and the elastic adaptation zone 312 can still be converted to each other by axially pulling the control member 32. At the same time, after the positioning arm 31 is released, if it needs to be readjusted, the positioning arm 31 can also be recovered by pulling the control member 32. Since the elastic deformation zone 311 and the elastic adaptation zone 312 are converted to each other, their paths can greatly reduce the situation where the positioning member 3 is everted and scraped onto the inner wall tissue of the aorta during the release process. In contrast, Figure 6a As shown in FIG6d (the arc and arrow in the figure represent the movement trajectory of the positioning member from the restricted state in the sheath to the release process), although the positioning member in the prior art can also achieve the purpose of reducing the loading tube diameter, it is very difficult to load the positioning member. The positioning member needs to be folded before loading. There is also a risk of the positioning member breaking when folding. At the same time, when the positioning member is released, the flipping process will scrape the blood vessel wall tissue, making it difficult to release and damaging the blood vessel wall tissue. In addition, the positioning member cannot be recovered after release, and the fault tolerance rate is low. Figure 6f As shown in FIG6g , the positioning piece in the prior art always overlaps with the stent during loading and releasing, resulting in a larger loading diameter and higher requirements for the access method, making it impossible to achieve true percutaneous implantation. The larger the diameter of the patient's wound, the more unfavorable it is for the patient's postoperative recovery.

[0066] In this embodiment, before the bracket body 1 is not completely separated from the controllable release device 5, the positioning arm 31 can be switched between the restricted state and the released state multiple times; Figure 3a and Figure 3b As shown in the figure (front structural diagram of valve prosthesis), when the positioning arm 31 switches between the restricted state and the released state, a "rounded corner" is generated between the elastic deformation area 311 of the positioning arm 31 and the stent body 1. Figure 3c As shown in the figure (side structural diagram of valve prosthesis), the "rounded corner" does not exist in the lateral direction; compared with the technical solution of the prior art in which the positioning member adopts a flipping technique (such as Figure 6e As shown), when the positioning member is flipped, it can be seen from the side view that the "rounded corner" exists in the lateral direction; therefore, it can be seen that the present invention provides an elastic deformation area 311 and an elastic adaptation area 312 on the positioning arm 31, so that the direction of the "rounded corner" is changed, so that when the positioning arm 31 changes between the restricted state and the released state, its path can greatly reduce the situation where the positioning member 3 is turned outward and scraped onto the inner wall tissue of the aorta during the release process.

[0067] In this embodiment, the control member 32 is detachably connected to the elastic adaptation area 312; when the positioning member 3 is in the released state, the control member 32 is separated from the elastic adaptation area 312; the purpose of this design is to greatly reduce the implant and reduce the contact and stimulation of the intracardiac tissue, which is beneficial to the postoperative recovery of the patient.

[0068] In this embodiment, the positioning arm 31 is made of a shape memory material, and the positioning arm 31 has a preset shape.

[0069] In this embodiment, the preset shape of the positioning arm 31 is a "W" shape, and the middle convex part of the "W" shape is the elastic adaptation area 312.

[0070] In this embodiment, the positioning arm 31 is integrally structured; the advantage of this design is that the structure of the positioning arm 31 is simpler, and when the positioning member 3 is in the released state, the positioning arm 31 can recover well to the preset shape, improving the success rate of the release and clamping positioning of the positioning member 3.

[0071] In this embodiment, the positioning arm 31 is made of a shape memory alloy material.

[0072] In this embodiment, the control member 32 is a wire or a filament, and one end of the control member 32 is detachably connected to the elastic adaptation area 312 on the positioning arm 31. When the control member 32 axially stretches the positioning arm 31, a part of the arc length of the elastic deformation area 311 is absorbed into the elastic adaptation area 312 until the arc length of the elastic deformation area 311 is no longer absorbed by the elastic adaptation area 312 when the control member 32 is axially stretched. At this time, the positioning member 3 is in the restricted state, and the positioning member 3 does not overlap with the stent body 1, enabling it to greatly reduce the diameter of the sheath tube during valve loading.

[0073] In this embodiment, barbs 33 are provided on the surface of the positioning arm 31 or a film 34 is coated on the surface of the positioning arm 31 (as Figure 5h and Figure 5i shown). The barbs 33 are made of a metal memory material. After the positioning arm 31 resumes the preset shape, the barbs 33 can increase the friction force on the intracardiac tissue, effectively avoiding the situation that the stent body 1 falls off in the heart; the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or an animal-derived material.

[0074] In this embodiment, the surface of the stent body 1 is coated with a film 34, and the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or an animal-derived material.

[0075] The following will gradually describe the loading and operation process of the delivery system of the valve prosthesis described in the present invention:

[0076] Step 1: Loading;

[0077] The distal end of the valve prosthesis with the positioning member 3 is cooperatively connected with the controlled release device 5. The proximal part of the stent body 1 is restricted between the inner tube 6 and the outer sheath 4, and at least part of the elastic adaptation zone is compressed within the outer sheath 4;

[0078] Step 2: Manipulate the control member 32 to place the positioning member 3 in a restricted state;

[0079] One end of the control member 32 is detachably connected to the positioning arm 31, and the other end of the control member 32 is cooperatively connected with a control handle (not shown). By operating the control handle (not shown), the control member 32 can pull and separate the positioning arm 31. By manipulating the control member 32 through the control handle (not shown), the control member 32 can pull the elastic adaptation zone 312 of the positioning arm 31 and make the elastic adaptation zone 312 move along the height direction of the stent body 1. The elastic adaptation zone 312 absorbs part of the arc length of the elastic deformation zone 311, making the circumference of the elastic adaptation zone 312 continuously increase until the axial tension of the control member 32 and the arc length of the elastic deformation zone 311 are no longer absorbed by the elastic adaptation zone 312. At this time, the circumference of the elastic adaptation zone 312 reaches the maximum value, and the positioning member 3 is in a restricted state (that is, both the stent body 1 and the positioning member 3 are compressed between the inner tube 6 and the outer sheath 4);

[0080] As Figure 5a shown in -5f, Step 3: Withdraw the outer sheath to release the positioning member 3;

[0081] By manipulating the outer sheath 4 through the control handle (not shown), the outer sheath is withdrawn to a position close to the distal end of the stent body 1. At this time, the positioning arm 31 is restricted by the control member 32, and the stent body 1 is restricted and released by the controlled release device 5. Then, by manipulating the control handle (not shown), the control member 32 is separated from the positioning arm 31. Due to the characteristics of the material of the positioning arm 31 itself, the positioning arm 31 returns to the preset state. During this process, part of the arc length of the elastic adaptation zone 312 is continuously reversely transformed into the elastic deformation zone 311. At the same time, the outer sheath 4 has not been completely withdrawn from the stent body 1. Therefore, when the positioning arm 31 starts to be released (at this time, the positioning arm 31 is most likely to turn outward), the outer sheath 4 has a force to restrict the outward turning of the positioning arm 31. Subsequently, the positioning arm 31 gradually extends from the gap between the stent body 1 and the outer sheath 4 and returns to the preset shape. At this time, the positioning arm 31 is in a released state. As Figure 5e shown, during this process, when the positioning arm 31 is released halfway, the positioning arm 31, at the same time, the stent body 1 is still restricted and released by the controlled release device 5;

[0082] As Figure 5g shown, Step 4: Completely release the stent body 1

[0083] When the positioning member 3 is in the released state, then operate the control handle (not shown) to separate the stent body 1 from the control release device 5, completing the implantation of the valve prosthesis. Specific Embodiment Two:

[0085] To better clarify the working principle of the present invention, the following will gradually describe the release process of the artificial valve 2 prosthesis of the present invention:

[0086] As Figure 7 shown, it includes a stent body 1 and an artificial valve 2 connected to the stent body 1. A positioning member 3 is connected to the stent body 1. The positioning member 3 includes a positioning arm 31 and a control member 32 connected to the positioning arm 31. The positioning arm 31 is fixed on the stent body 1. The positioning arm 31 is composed of an elastic deformation zone 311 and an elastic adaptation zone 312. When pulling the control member 32, the elastic adaptation zone 312 of the positioning arm 31 moves along the height direction of the stent body 1, and a part of the arc length of the elastic deformation zone 311 is converted to the elastic adaptation zone 312 (as Figure 8a shown in -8c); when the positioning member 3 is in the released state, the elastic deformation zone 311 returns, and a part of the arc length of the elastic adaptation zone 312 is reversely converted to the elastic deformation zone 311; the positioning member 3 includes a positioning arm 31 and a control member 32. The positioning arm 31 is composed of an elastic deformation zone 311 and an elastic adaptation zone 312. As Figure 8a shown in -8c, the control member 32 can be used to pull the positioning arm 31 to make the elastic adaptation zone 312 move along the height direction of the stent body 1, and a part of the arc length of the elastic deformation zone 311 on the positioning arm 31 is absorbed into the elastic adaptation zone 312 until the axial tension of the control member 32 and the arc length of the elastic deformation zone 311 are no longer absorbed by the elastic adaptation zone 312. At this time, the elastic adaptation zone 312 and the part of the stent where the artificial valve 2 is located do not overlap each other, which can greatly reduce the diameter of the sheath tube during valve loading, reduce the diameter of the loading sheath tube of its delivery system, perform a replacement operation on the patient through a transvascular path, greatly reduce the trauma to the patient, and be beneficial to the patient's postoperative recovery.

[0087] In this embodiment, the number of the positioning members 3 is 3. After being released, the positioning members 3 are at the bottom of the sinus of the patient's natural aortic sinus 8. The positioning members 3 provide a certain supporting force for the stent body 1 in the heart, while ensuring that the stent body 1 can be safely and accurately released / implanted into the target position, preventing the stent body 1 from being "washed away" by the blood in the heart.

[0088] In this embodiment, the positioning member 3 can also play a role in clamping the patient's own valve leaflets.

[0089] In this embodiment, the positioning arm 31 is a wire. One end of the wire is fixed on the support body 1, and the other end of the wire forms an inverted "U" - shaped structure in the middle area of the positioning arm 31 and is then fixed on the support body 1. The inverted "U" - shaped structure is the elastic adaptation area 312. When the control member 32 pulls the positioning arm 31, the elastic adaptation area 312 moves along the height direction of the support body 1. The inverted "U" - shaped structure absorbs part of the arc length of the elastic deformation area 311, causing the arc length of the inverted "U" - shaped structure to continuously increase until the axial tension of the control member 32 and the arc length of the elastic deformation area 311 are no longer absorbed by the elastic adaptation area 312. At this time, the arc length of the inverted "U" - shaped structure reaches the maximum value, and the positioning member 3 is in a restricted state.

[0090] In this embodiment, the control member 32 and the positioning arm 31 are detachably connected. When the positioning member 3 is in the release state, the control member 32 first pushes the elastic adaptation area 312 part of the positioning arm 31. Subsequently, due to the characteristics of the material of the positioning arm 31 itself, the positioning arm 31 returns to the preset state. During this process, part of the arc length of the elastic adaptation area 312 is continuously compensated into the elastic deformation area 311 until the positioning arm 31 returns to the preset state. At this time, the control member 32 and the positioning arm 31 are separated. Since the paths of the elastic deformation area 311 and the elastic adaptation area 312 can greatly reduce the situation that the positioning member 3 turns outwards and scrapes the aortic inner wall tissue during the release process.

[0091] In this embodiment, the control member 32 and the elastic adaptation area 312 are detachably connected in cooperation. When the positioning member 3 is in the release state, the control member 32 is separated from the elastic adaptation area 312. The purpose of this design is to greatly reduce the implant and reduce the contact and stimulation of the intracardiac tissue, which is beneficial to the postoperative recovery of the patient.

[0092] In this embodiment, the positioning arm 31 is made of shape - memory material and has a preset shape.

[0093] In this embodiment, the positioning arm 31 is integrally structured. The advantage of this design is that the structure of the positioning arm 31 is simpler. At the same time, when the positioning member 3 is in the release state, the positioning arm 31 can well return to the preset shape, improving the success rate of the release and clamping positioning of the positioning member 3.

[0094] In this embodiment, the positioning arm 31 is made of shape - memory alloy material.

[0095] In this embodiment, the control member 32 is a metal wire. The control member 32 has a certain rigidity, so that during the process of the positioning arm 31 starting to recover, the positioning member 32 can push the positioning arm 31 to recover to a preset shape. One end of the control member 32 is detachably connected to the elastic adaptation area 312 on the positioning arm 31. When the positioning arm 31 recovers to the preset shape, the control member 32 is separated from the positioning arm 31. The control member 32 axially stretches the positioning arm 31, so that a part of the arc length of the elastic deformation area 311 is absorbed into the elastic adaptation area 312 until the arc length of the axially stretched control member 32 and the elastic deformation area 311 is no longer absorbed by the elastic adaptation area 312. At this time, the positioning member 3 is in a restricted state, and the positioning member 3 does not overlap with the stent body 1, which can greatly reduce the diameter of the sheath during valve loading.

[0096] In this embodiment, barbs 33 are provided on the surface of the positioning arm 31 or a film 34 is covered on the surface of the positioning arm 31. The barbs 33 are made of a metal memory material. After the positioning arm 31 recovers to the preset shape, the barbs 33 can increase the friction force on the intracardiac tissue, effectively avoiding the situation that the stent body 1 falls off in the heart. The film material includes metal materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester or animal-derived materials.

[0097] In this embodiment, the surface of the stent body 1 is covered with a film 34. The film material includes metal materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester or animal-derived materials.

[0098] The loading and operation process of the delivery system of the valve prosthesis described in the present invention will be gradually described below:

[0099] Step 1: Loading;

[0100] The distal end of the valve prosthesis with the positioning member 3 is cooperatively connected with the control release device 5. The proximal part of the stent body 1 is restricted between the inner tube 6 and the outer sheath 4, and at least part of the elastic adaptation area is compressed in the outer sheath 4.

[0101] Step 2: Manipulate the control member 32 to make the positioning member 3 in a restricted state;

[0102] One end of the control member 32 is detachably connected to the positioning arm 31, and the other end of the control member 32 is cooperatively connected to a control handle (not shown). By operating the control handle (not shown), the control member 32 can pull and separate the positioning arm 31. By manipulating the control member 32 through the control handle (not shown), the control member 32 can pull the elastic adaptation zone 312 of the positioning arm 31 and make the elastic adaptation zone 312 move along the height direction of the support body 1. The elastic adaptation zone 312 absorbs a part of the arc length of the elastic deformation zone 311, making the circumference of the elastic adaptation zone 312 continuously increase until the axial tension of the control member 32 and the arc length of the elastic deformation zone 311 are no longer absorbed by the elastic adaptation zone 312. At this time, the circumference of the elastic adaptation zone 312 reaches the maximum value, and the positioning member 3 is in a restricted state (i.e., both the support body 1 and the positioning member 3 are compressed between the inner tube 6 and the outer sheath 4).

[0103] As Figure 9a shown in—9c, Step 3: Withdraw the outer sheath to release the positioning member 3;

[0104] By manipulating the outer sheath 4 through the control handle (not shown), the outer sheath is withdrawn to a position close to the distal end of the support body 1. At this time, the positioning arm 31 is restricted by the control member 32, and the support body 1 is restricted and released by the control release device 5. Subsequently, by manipulating the control handle (not shown), the control member 32 is separated from the positioning arm 31. Due to the material characteristics of the positioning arm 31 itself, the positioning arm 31 returns to the preset state. During this process, a part of the arc length of the elastic adaptation zone 312 is continuously reversely transformed into the elastic deformation zone 311. At the same time, the outer sheath 4 has not been completely withdrawn from the support body 1. Therefore, when the positioning arm 31 starts to be released (when the positioning arm 31 is most likely to turn outwards), the outer sheath 4 has a force to restrict the outward turning of the positioning arm 31. Subsequently, the positioning arm 31 continues to return until the positioning arm 31 returns to the preset state. At the same time, the support body 1 is still restricted and released by the control release device 5;

[0105] As Figure 9d shown, Step 4: Completely release the support body 1

[0106] When the positioning member 3 is in the released state, then by manipulating the control handle (not shown), the support body 1 is separated from the control release device 5, and the implantation of the valve prosthesis is completed. Specific Embodiment 3:

[0108] As Figure 10aAs shown (in the figure, the positioning arm changes from the dotted line state to the solid line state in the direction of the arrow to achieve the purpose of the positioning member releasing the clamping leaflet), when the heart valve prosthesis is used to treat bicuspid valve disease, different from the foregoing embodiment, the number of the positioning members (not shown) is two; the positioning members (not shown) include positioning arms 31 and control members (not shown) connected in cooperation with the positioning arms 31. The positioning arms 31 are fixed on the stent body 1. The positioning arms 31 are composed of an elastic deformation zone (not shown) and an elastic adaptation zone (not shown); when the positioning members (not shown) change from the restricted state to the released state, the elastic deformation zone (not shown) returns, and a partial arc length of the elastic adaptation zone (not shown) is reversely transformed into the elastic deformation zone (not shown) until the positioning arms 31 return to the preset shape, and the positioning arms 31 respectively hook the anterior leaflet and the posterior leaflet of the patient; in the prior art, as Figure 10b shown, the positioning arm 31 is released and clamps the leaflet in a folding manner. Since there is a complex physiological environment under the mitral valve annulus, with papillary muscles and many chordae tendineae, the positioning arm 31 is likely to hook the chordae tendineae or scrape the blood vessel wall of the patient during the folding process, resulting in difficulties in releasing the positioning arm 31, and at the same time, it is also easy to cause damage to the intracardiac tissue of the patient.

[0109] Finally, it should be noted that the above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A valve prosthesis with a positioning member, comprising a stent body and an artificial valve connected to the stent body, characterized in that: The bracket body is cooperatively connected with a positioning member, and the positioning member includes a positioning arm and a control member cooperatively connected with the positioning arm, and the positioning arm is fixed on the bracket body, and the positioning arm consists of an elastic deformation area and an elastic adaptation area. When the control member is pulled axially, the elastic adaptation area of the positioning arm moves along the height direction of the bracket body, the elastic deformation area is deformed, and part of the arc length of the elastic deformation area is converted to the elastic adaptation area; when the control member is released, the elastic deformation area gradually returns to the preset shape, and part of the arc length of the elastic adaptation area is reversely converted to the elastic deformation area, and the positioning arm gradually returns to the preset shape; the positioning arm is formed by winding a wire, and one end of the wire is fixed on the bracket body. On the frame, the other end of the wire is fixed to the bracket body after overlapping into a "ring" in the middle area of the positioning arm, and the "ring" is the elastic adaptation zone, or the positioning arm is wound with wire, one end of the wire is fixed to the bracket body, and the other end of the wire is fixed to the bracket body after forming an inverted "U"-shaped structure or a "V"-shaped structure in the middle area of the positioning arm, and the inverted "U"-shaped structure or the "V"-shaped structure is the elastic adaptation zone; the positioning arm is made of shape memory material, and the positioning arm has a preset shape. The elastic deformation of the elastic adaptation zone is smaller than the elastic deformation of the elastic deformation zone, and the positioning arm can be converted between the preset form and the restricted state in the outer sheath under the traction of the control member.

2. A valve prosthesis with a positioning element according to claim 1, characterized in that: The elastic deformation of the elastic deformation zone close to the connection portion with the bracket body is smaller than the elastic deformation of the elastic deformation zone away from the connection portion with the bracket body.

3. The valve prosthesis with a positioning member according to claim 1, characterized in that: The control component is detachably connected to the positioning arm.

4. The valve prosthesis with a positioning member according to claim 1, characterized in that: The control member is detachably connected to the elastic adaptation zone.

5. The valve prosthesis with a positioning member according to claim 1, characterized in that: When the control member is pulled until the positioning arm is completely deformed, the elastic adaptation area and the portion of the stent body where the artificial valve is located do not overlap with each other.

6. The valve prosthesis with a positioning member according to claim 1, characterized in that: The control member is a wire.

7. The valve prosthesis with a positioning element according to claim 1, characterized in that: The control member is a wire.

8. The valve prosthesis with a positioning element according to claim 1, characterized in that: The control member is a rod.

9. The valve prosthesis with a positioning element according to claim 1, characterized in that: Micro-thorns are evenly distributed on the elastic adaptation area.

10. The valve prosthesis with a positioning element according to claim 1, characterized in that: The elastically deformed distal end portion is evenly provided with micro-thorns.

11. A valve prosthesis system with a positioning member, characterized in that: The valve prosthesis comprises a valve prosthesis with a positioning member, a control handle, an outer sheath, and a controllable release device, wherein the valve prosthesis with a positioning member comprises a stent body, an artificial valve and a positioning member cooperatively connected to the stent body; the stent body is cooperatively connected to the controlled release device, the positioning member comprises a positioning arm and a control member, one end of the control member is detachably connected to the positioning arm, and the other end of the control member is cooperatively connected to the control handle, the positioning arm is fixed to the stent body, the positioning arm is made of shape memory material, the positioning arm has a preset shape, and the positioning arm consists of an elastic deformation area and an elastic adaptation area. When the control handle is operated to axially pull the control member, the elastic adaptation area of the positioning arm moves along the height direction of the stent body. The elastic deformation zone is deformed and part of the arc length of the elastic deformation zone is converted to the elastic adaptation zone, and the positioning arm is gradually retracted into the gap between the stent body and the outer sheath until the elastic adaptation zone and the part of the stent body where the artificial valve is located do not overlap with each other, and the positioning arm is in a restricted state at this time; when the control handle is operated in reverse, the elastic deformation zone gradually returns to the preset shape, and part of the arc length of the elastic adaptation zone is reversely converted to the elastic deformation zone, and the positioning arm gradually extends from the gap between the stent body and the outer sheath and returns to the preset shape, and the positioning arm is in a released state, and the positioning arm can be converted between the preset form and the restricted state in the outer sheath under the traction of the control member.

12. The valve prosthesis system with a positioning element according to claim 11, characterized in that: Before the bracket body is not completely separated from the controllable release device, the positioning arm can be switched between the restricted state and the released state multiple times.

13. The valve prosthesis system with a positioning element according to claim 11, characterized in that: The controllable release device includes a distal release device and a proximal release device. The distal release device is located at the distal part of the valve prosthesis system. Before the distal part of the stent body is completely separated from the distal release device, the distal part of the stent body is arranged in the distal release device in a retracted state.

14. The valve prosthesis system with a positioning element according to claim 13, characterized in that: The proximal release device is arranged in the outer sheath and is detachably connected to the proximal end of the stent body. Before the positioning piece and the distal part of the stent body are fully released, the proximal part of the stent body is restricted and released by the proximal release device.

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