Valve prosthesis delivery system

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a valve prosthesis conveying system which comprises a conveying pipeline, a valve prosthesis conveying pipeline and a valve prosthesis conveying pipeline, the conveying pipeline comprises a middle pipe and an outer pipe, a conveying passage is arranged in the outer pipe, the outer pipe and the middle pipe are each provided with a bending adjusting part, and each bending adjusting part comprises a bending adjusting section capable of adjusting the bending degree and a bending adjusting pull wire; the first bending adjusting assembly comprises a first bending adjusting handle and a first bending adjusting structure, the first bending adjusting handle is fixed to the outer pipe, the first bending adjusting structure is connected with a bending adjusting pull wire of the outer pipe, and the first bending adjusting structure drives the bending adjusting section of the outer pipe to adjust bending through the bending adjusting pull wire of the outer pipe; the second bending adjusting assembly comprises a second bending adjusting handle and a second bending adjusting structure, the second bending adjusting handle is fixed to the middle pipe, the second bending adjusting structure is connected with the bending adjusting pull wire of the middle pipe, and the second bending adjusting structure drives the bending adjusting section of the middle pipe to adjust bending through the bending adjusting pull wire of the middle pipe. Through the arrangement of the outer tube, the function of integrating the sheathing canal and the conveying tube is achieved, multi-angle bending adjustment can be achieved, and the multi-dimensional complexity degree of the mitral valve is matched.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a valve prosthesis delivery system. Background Art

[0002] The heart is divided into the left heart and the right heart by the atrioventricular septum. The left heart is divided into the left atrium and the left ventricle by the mitral valve, and the right heart is divided into the right atrium and the right ventricle by the tricuspid valve. Oxygenated blood from the pulmonary veins enters the left atrium, crosses the mitral valve into the left ventricle during heart dilation, and is transported to all parts of the body through the aorta during heart contraction. Therefore, the mitral valve bears higher pressure than the tricuspid valve in the cardiovascular system and is more prone to problems such as regurgitation. Of course, the mitral valve may also be damaged due to congenital malformations, inflammatory processes, infectious conditions, or diseases.

[0003] For many years, the definitive treatment for such damaged valves has been surgical repair or replacement of the valves during open heart surgery. However, open heart surgery is highly invasive and prone to many complications. Therefore, elderly and frail patients with defective heart valves often go untreated. Recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a much less invasive manner compared to open heart surgery. The transseptal technique for accessing the native mitral valve. The transseptal technique generally involves inserting a catheter into the right femoral vein, advancing upward along the inferior vena cava and into the right atrium, then puncturing the atrial septum and delivering the catheter into the left atrium.

[0004] There are still many problems in the interventional treatment of mitral valve diseases, especially the interventional treatment via the femoral vein. 1. The limited size of the right femoral vein, complex surgical path, etc. all limit the interventional treatment of mitral valve diseases to a certain extent. In addition, 2. During the operation of existing devices, the release of the valve prosthesis is generally judged by X-ray assistance. However, the excessive use of radiation will cause certain damage to medical staff and patients. Summary of the Invention

[0005] In view of the technical problems that the complex surgical path increases the difficulty of intervention during the implantation of the prosthesis, and if X-ray-assisted intervention is used for release, it is easy to cause damage to the operator and the patient, the present invention aims to provide a valve prosthesis delivery system.

[0006] To solve the foregoing technical problems, a first aspect of the present invention provides a valve prosthesis delivery pipeline, and the valve prosthesis delivery pipeline includes:

[0007] TIP head;

[0008] Inner tube, the inner tube is used to connect with the valve prosthesis, the distal end of the inner tube is connected and communicated with the proximal end of the TIP head, and the inner tube and the TIP head form a guide wire passage for passing a guide wire;

[0009] Middle tube, the middle tube is sleeved outside the inner tube, the distal end of the middle tube can be extended by the distal end of the inner tube, and the middle tube has an adjustable bending part;

[0010] Outer tube, the outer tube is sleeved outside the middle tube and the inner tube, the outer tube can rotate around the axis relative to the middle tube, the outer tube is located at the proximal end of the TIP head and can be hermetically connected with the TIP head, and a delivery passage for accommodating the valve prosthesis is provided inside the outer tube, and the outer tube has another adjustable bending part.

[0011] Optionally, in the valve prosthesis delivery pipeline as described above, the bending parts of the outer tube and the middle tube adopt the same structure;

[0012] The bending part includes a bending section with adjustable bending degree and a bending pull wire.

[0013] Optionally, in the valve prosthesis delivery pipeline as described above, the proximal end of the inner tube is connected with a Luer connector for connecting with an external instrument and serving as a guide wire inlet.

[0014] Optionally, in the valve prosthesis delivery pipeline as described above, the TIP head is made of silica gel material.

[0015] Optionally, in the valve prosthesis delivery pipeline as described above, the TIP head is integrally in a frustum-like structure, and the distal end of the TIP head is a tip.

[0016] Optionally, in the valve prosthesis delivery pipeline as described above, the proximal end of the TIP head has a frustum-shaped connecting part with a narrow proximal end and a wide distal end, and the TIP head is hermetically connected with the outer tube by inserting the frustum-shaped connecting part into the inside of the distal end of the outer tube.

[0017] Optionally, in the valve prosthesis delivery pipeline as described above, the valve prosthesis delivery pipeline further includes:

[0018] A clamping joint, the clamping joint is arranged inside the outer tube and can extend out of the distal end of the outer tube, the clamping joint connects the distal end of the inner tube, and a connecting interface for clamping with the valve prosthesis is arranged on the clamping joint;

[0019] An extension tube, the proximal end of the extension tube is connected with the clamping joint and communicated with the distal end of the inner tube, and the distal end of the extension tube is connected and communicated with the proximal end of the TIP head, so that the TIP head and the inner tube are connected and communicated through the extension tube.

[0020] Optionally, in the valve prosthesis delivery conduit as described above, the connection interface includes a plurality of first connection interfaces and a plurality of second connection interfaces. The plurality of first connection interfaces and the plurality of second connection interfaces are circumferentially staggered, and the axial positions of the first connection interface and the second connection interface on the snap joint are different.

[0021] Optionally, in the valve prosthesis delivery conduit as described above, the middle tube and the inner tube are combined into a single core tube, and the core tube has the bending adjustment portion. When the distal end of the core tube is connected to the snap joint, the bending adjustment portion is preset away from the snap joint by a distance.

[0022] Optionally, in the valve prosthesis delivery conduit as described above, the outer tube, the middle tube, the inner tube, and the extension tube are all composite conduits with a multi-layer structure.

[0023] Optionally, in the valve prosthesis delivery conduit as described above, the outer periphery and / or the inner side of the outer tube is coated with a biocompatible hydrophilic coating.

[0024] To solve the foregoing technical problems, a second aspect of the present invention provides a valve prosthesis delivery system, which includes:

[0025] A delivery conduit, the delivery conduit includes a middle tube and an outer tube, the outer tube is sleeved outside the middle tube, the outer tube can rotate around the axis relative to the middle tube, a delivery passage for accommodating a valve prosthesis is provided inside the outer tube, and the outer tube and the middle tube respectively have a bending adjustment portion, and the bending adjustment portion includes a bending adjustment section with an adjustable bending degree and a bending adjustment cable;

[0026] A first bending adjustment assembly, the first bending adjustment assembly includes a first bending adjustment handle and a first bending adjustment structure provided on the first bending adjustment handle. The first bending adjustment handle is fixed to the outer tube, and the outer tube is driven by the first bending adjustment handle to rotate around the axis. The first bending adjustment structure is connected to the bending adjustment cable of the outer tube, and the first bending adjustment structure drives the bending adjustment section of the outer tube to bend through the bending adjustment cable of the outer tube;

[0027] A second bending adjustment assembly, the second bending adjustment assembly includes a second bending adjustment handle and a second bending adjustment structure provided on the second bending adjustment handle. The second bending adjustment handle is fixed to the middle tube, the second bending adjustment structure is connected to the bending adjustment cable of the middle tube, and the second bending adjustment structure drives the bending adjustment section of the middle tube to bend through the bending adjustment cable of the middle tube.

[0028] Optionally, in the valve prosthesis delivery system as described above, the valve prosthesis delivery system further includes a release structure, the release structure is connected to the first bending adjustment handle, and the release structure drives the first bending adjustment handle to move axially, thereby driving the outer tube to move axially;

[0029] The release structure allows the first bending handle to rotate axially relative to the release structure, and when the first bending handle rotates axially, it drives the outer tube to rotate axially.

[0030] Optionally, in the valve prosthesis delivery system as described above, the release structure includes:

[0031] A connecting cylinder, on which a connecting threaded block is provided, and the distal end of the connecting cylinder is connected to the first bending handle and allows the first bending handle to rotate axially relative to the connecting cylinder;

[0032] A release knob, which is sleeved outside the connecting cylinder and threadedly connected to the connecting threaded block. The proximal end of the release knob is connected to the second bending handle and can rotate axially relative to the second bending handle. When the release knob rotates, it drives the connecting cylinder to move axially, and further drives the first bending handle and the outer tube to move axially;

[0033] The middle tube axially passes through the connecting cylinder and the release knob.

[0034] Optionally, in the valve prosthesis delivery system as described above, a circumferential groove is provided around the inner wall of the proximal end of the first bending handle;

[0035] The release structure further includes:

[0036] A clamping ring, which is provided at the distal end of the connecting cylinder and is clamped in the groove and can rotate axially.

[0037] Optionally, in the valve prosthesis delivery system as described above, the valve prosthesis delivery system further includes a locking structure, which is used to lock or release the clamping ring to the proximal end of the first bending handle.

[0038] Optionally, in the valve prosthesis delivery system as described above, the locking structure includes:

[0039] A locking knob, the rotation operation part of which is located outside the first bending handle, and the rod part of the locking knob is rotatably connected to the proximal end of the first bending handle and can extend radially into the inside of the first bending handle;

[0040] A plurality of locking holes are circumferentially provided on the outer circumferential surface of the clamping ring, and the end part of the rod part of the locking knob is allowed to be inserted into the locking holes.

[0041] Optionally, in the valve prosthesis delivery system as described above, a release display mark is provided on the surface of the connecting cylinder.

[0042] Optionally, in the valve prosthesis delivery system as described above, the release display mark is any one or a combination of more than one of a scale, numbers, diagrams, and written descriptions.

[0043] Optionally, in the valve prosthesis delivery system as described above, the release structure further includes:

[0044] A reinforcing cylinder, which is located in the first bending adjustment handle on the distal side of the clamping ring, the reinforcing cylinder sleeves the middle tube, and the reinforcing cylinder is used to provide support for the middle tube.

[0045] Optionally, in the valve prosthesis delivery system as described above, the valve prosthesis delivery system further includes:

[0046] A first evacuation structure, which is connected to the inside of the outer tube through a first evacuation tube;

[0047] A second evacuation structure, which is connected to the inside of the middle tube through a second evacuation tube.

[0048] Optionally, in the valve prosthesis delivery system as described above, the first bending adjustment assembly further includes:

[0049] A first clamping block, which has a clamping cut surface, the first clamping block is clamped in the first bending adjustment handle, and the proximal end of the outer tube is inserted into the first clamping block;

[0050] The first evacuation structure is inserted into the first clamping block through a first evacuation tube, and the first evacuation tube is communicated with the proximal end of the outer tube.

[0051] Optionally, in the valve prosthesis delivery system as described above, the first bending adjustment handle has an axial straight handle part and an inclined part inclinedly arranged on the axial straight handle part, so that the first bending adjustment handle forms a Y-shaped handle;

[0052] The distal end of the axial straight handle part is fixed with the proximal end of the outer tube, the proximal end of the axial straight handle part is rotatably connected with the release structure, and the middle tube passes through the axial straight handle part along the axis;

[0053] The first bending adjustment structure is arranged in the inclined part.

[0054] Optionally, in the valve prosthesis delivery system as described above, the delivery pipeline is the valve prosthesis delivery pipeline provided in the first aspect of the present invention.

[0055] Optionally, in the valve prosthesis delivery system as described above, when the delivery pipeline has a Luer connector, the Luer connector extends out of the proximal side of the second bending adjustment handle.

[0056] Optionally, in the valve prosthesis delivery system as described above, the first bending adjustment structure and the second bending adjustment structure adopt the same bending adjustment structure.

[0057] Optionally, in the valve prosthesis delivery system as described above, the bending adjustment structure includes:

[0058] A bending adjustment sleeve, wherein the proximal and distal ends of the bending adjustment sleeve are open structures, the interior of the bending adjustment sleeve is hollow, the inner wall of the bending adjustment sleeve is provided with a sleeve internal thread capable of driving a bending adjustment wire, and the outer wall of one end of the bending adjustment sleeve is provided with a bending adjustment knob;

[0059] A bending guide, the bending guide having a bending guide rod and a wire fixing ring arranged in the bending sleeve, the distal end of the bending guide rod is an open structure and is hollow inside, the wire fixing ring is sleeved outside the bending guide rod and can move axially along the bending guide rod, the wire fixing ring is provided with an external fixing ring thread, the external fixing ring thread is threadedly connected with the internal sleeve thread, and the wire fixing ring is provided with a wire fixing end;

[0060] One end of the bending adjustment wire is connected to the bending adjustment section, and the other end of the bending adjustment wire passes through the bending adjustment section, the bending adjustment guide and the bending adjustment sleeve rod in sequence and is connected to the fixed end of the wire;

[0061] When the bending adjustment knob is turned to drive the bending adjustment sleeve to rotate, the wire fixing ring moves axially along the bending adjustment guide rod, driving the bending adjustment wire on the wire fixing end to move, so as to adjust the curvature of the bending adjustment section.

[0062] The positive and progressive effects of the present invention are:

[0063] 1. The outer tube of the present invention has a delivery passage for accommodating the valve prosthesis, which can collect the valve prosthesis in the outer tube and gradually release the valve prosthesis at a suitable position. Through the setting of the outer tube, the sheath can be directly omitted when the valve prosthesis is delivered. The outer tube can play the role of the sheath and realize the integrated function of the sheath and delivery tube. This function can effectively reduce the difficulty of operating the device, make the outer diameter of the delivery system smaller, and reduce harm to the human body.

[0064] 2. The present invention can achieve multi-angle bending to match the multi-dimensional complexity of the mitral valve. The primary bending of the outer tube helps the delivery system to pass through the atrial septum after bending; the secondary bending of the middle tube facilitates the delivery of the distal end of the delivery system across the mitral valve after the delivery system enters the left atrium. Under the superposition of the outer tube and the middle tube, the effects of "multi-directional bending" and "precise bending" are achieved.

[0065] By rotating the direction of the first bending adjustment handle, the outer tube is driven to rotate to a more appropriate angle for bending, and finally the valve prosthesis is straddled and released at the optimal angle.

[0066] The present invention can omit the external locking structure, that is: after the middle tube and the outer tube are bent to a certain extent, the middle tube will squeeze the outer tube, reducing the movement range of the outer tube or even preventing it from moving, so as to achieve the self-locking function. This self-locking is mainly reflected in the bending sections of the outer tube and the inner and middle tubes. For safety reasons, a locking structure can also be provided on the first bending adjustment handle to prevent the circumferential movement of the first bending adjustment handle relative to the second bending adjustment handle.

[0067] 3. The matching design of the TIP head and the outer tube. During the delivery process of the valve prosthesis, the TIP head is hermetically connected to the outer tube, playing a role in sealing and maintaining pressure, achieving the purpose of sealed delivery, preventing excessive blood from entering the delivery system during the delivery in the blood vessel, and being able to maintain the pressure in the delivery system. While sealing the outer tube, it can also prevent blood vessel scratches. When the valve prosthesis needs to be released, the TIP head is separated from the outer tube, and the valve prosthesis can be released more quickly and conveniently.

[0068] The shape design of the TIP head, especially the tip design, is equivalent to a dilator to help the sheath tube enter the blood vessel, and can guide other thicker delivery tubes such as the outer tube to enter the blood vessel more easily.

[0069] The proximal end of the TIP head is communicated with the distal end of the inner tube, further reducing the outer diameter of the delivery system.

[0070] 4. The multiple connection interfaces of the card joint are used to be clamped with the stent connection head on the valve prosthesis. Since the axial positions of the multiple connection interfaces are different, the gradual release of the valve prosthesis can be controlled.

[0071] In a conventional delivery device, the connection joints connected to the valve prosthesis are all located at the same axial position. In this way, the proximal end of the valve prosthesis will be released simultaneously. The rapid and simultaneous release of the valve prosthesis will generate a large radial expansion force, which is likely to cause damage to the anatomical structure at the target position. In the prior art, generally, a wire is added to the valve prosthesis, and the tension of the wire is controlled through the handle end to gradually release the valve prosthesis. However, this requires designing a special wire cavity for the wire. In order to facilitate the recycling of the wire, generally at least two wire cavities need to be designed, which will inevitably increase the diameter of the delivery system.

[0072] In the present invention, by designing the connection interfaces on the clamping head to have different axial lengths to cooperate with the stent connection heads at different heights on the valve prosthesis, during the process of retracting the outer tube to release the stent or valve, the stent connection head cooperating with the distal connection interface can be released first, enabling the valve prosthesis to be initially expanded, releasing part of the radial expansion force, and then the stent connection head cooperating with the proximal connection interface is released, reducing the radial expansion force. Therefore, the damage to the tissue anatomical structure is smaller, and the diameter of the delivery system is not increased. On the contrary, due to the staggered arrangement of several connection interfaces, the diameter of the clamping head can also be reduced.

[0073] 5. In the present invention, through the design of the release structure, the connection cylinder can be driven by the rotation of the release knob to drive the outer tube to move proximally or distally through the first bending adjustment handle. When moving proximally, the valve prosthesis located inside the outer tube is gradually released. When moving distally, the proximal end of the outer tube and the TIP head are hermetically connected, facilitating the withdrawal of the delivery system from the patient's body.

[0074] The release display mark on the surface of the connection cylinder can well remind the release situation of the valve prosthesis in the body, indirectly realizing visual operation and reducing the operator's dependence on radiation.

[0075] The design of the reinforcement cylinder can be used to connect the middle tube on the one hand, and on the other hand, it can increase the support of the delivery system, prevent the middle tube from bending during transportation or limit the circumferential bending range of the middle tube, avoid circumferential bending from affecting the axial position, and improve the control accuracy of the bending position during transportation. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Referring to the accompanying drawings, the disclosure of the present invention will become more apparent. It should be understood that these drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the figures:

[0077] Figure 1 is a schematic structural diagram of the present invention;

[0078] Figure 2 is Figure 1 a partial internal perspective view of

[0079] Figure 3 is Figure 1 the front view of

[0080] Figure 4 is Figure 3 the sectional view of

[0081] Figure 5 is Figure 3 a partial internal perspective view of the proximal part of

[0082] Figure 6 is Figure 3 the sectional view of the distal part of

[0083] Figure 7 Schematic diagram of a bending process for the upward bending part of the outer tube of the present invention;

[0084] Figure 8 and Figure 9 Respectively are schematic diagrams of multi-dimensional bending of the present invention in two planes;

[0085] Figure 10 is Figure 1 Internal perspective view of the proximal segment of;

[0086] Figure 11 is Figure 10 Partial structural schematic diagram of;

[0087] Figure 12 is Figure 10 A structural schematic diagram of the bending sleeve in;

[0088] Figure 13 Another structural schematic diagram of the proximal segment of the present invention;

[0089] Figure 14 is Figure 13 Partial internal perspective view of;

[0090] Figure 15 A connection relationship diagram among the TIP head, the card connector and the inner tube of the present invention;

[0091] Figure 16 is Figure 15 Schematic diagram from another angle of;

[0092] Figure 17 A structural schematic diagram of the card connector of the present invention;

[0093] Figure 18 An unfolding schematic diagram of a valve prosthesis in the prior art;

[0094] Figures 19 to 24 An application process diagram of the present invention. Specific embodiments

[0095] The following illustrates the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through different specific embodiments. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0096] It should be noted that, without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0097] In the description of the present invention, it should be noted that the directional words, such as the terms "outside", "middle", "inside", "outside", etc., indicating directions and positional relationships are based on the directions or positional relationships shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific protection scope of the present invention.

[0098] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "several" mean two or more, unless otherwise clearly and specifically defined.

[0099] It should be noted that the "distal end", "proximal end", "distal section" and "proximal section" used in the present invention are directional terms, which are commonly used terms in the field of interventional medical devices, where "distal end" and "distal section" refer to the end or section of the valve prosthesis delivery system or delivery pipeline away from the operator during surgery, and "proximal end" and "proximal section" refer to the end or section of the valve prosthesis delivery system or delivery pipeline close to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal center and the proximal center of the valve prosthesis delivery system or delivery pipeline; "radial" refers to the direction perpendicular to the above-mentioned "axial".

[0100] Reference Figures 1 to 14 , the embodiment of the present invention provides a valve prosthesis delivery system, which is used to deliver valve prostheses, and aims to provide a small-sized valve prosthesis delivery system with at least one of the following functions: multi-dimensional bending adjustment, controllable delivery, and integrated sheath delivery. The valve prosthesis delivery system includes a delivery pipeline 100, a first bending adjustment component 200, and a second bending adjustment component 300.

[0101] The delivery pipeline 100 includes an outer tube 110 and a middle tube 120. The outer tube 110 is sleeved outside the middle tube 120. The outer tube 110 can rotate axially (circumferentially) relative to the middle tube 120. The outer tube 110 has a delivery passage 111 for accommodating the valve prosthesis. The delivery passage 111 can collect the valve prosthesis in the outer tube 110 and gradually release the valve prosthesis at a suitable position. Through the provision of the outer tube 110, when delivering the valve prosthesis, the sheath can be directly omitted. The outer tube 110 can play the role of the sheath, realizing the integrated function of the sheath and delivery tube. This function can effectively reduce the difficulty of operating the device, can make the outer diameter of the delivery system smaller, and reduce harm to the human body.

[0102] The outer tube 110 and the middle tube 120 each have a bending adjustment part, which includes a bending adjustment section with adjustable curvature and a bending adjustment cable. The design of the bending adjustment part can achieve bending at multiple angles to match the multi-dimensional complexity of the mitral valve.

[0103] Taking the outer tube 110 as an example, referring to Figure 7 , the outer tube 110 has a bending adjustment section 112 and a bending adjustment cable 113. The bending adjustment section 112 is located at the distal section of the outer tube 110, and can also be set at other positions according to the bending adjustment requirements. The distal end of the bending adjustment cable 113 is connected to the bending adjustment section 112, so as to realize the bending operation of the bending adjustment section 112 by pulling the bending adjustment cable 113 back towards the proximal end. The bending adjustment cable 113 extends along the axial direction of the outer tube 100, and the proximal end of the bending adjustment cable 113 extends out of the proximal end of the outer tube 110. The connection relationship and setting position relationship between the bending adjustment section 112 and the bending adjustment cable 113 and other designs can adopt existing technologies and will not be elaborated here.

[0104] The first bending adjustment assembly 200 includes a first bending adjustment handle 210 and a first bending adjustment structure 220 arranged on the first bending adjustment handle 210. The first bending adjustment handle 210 is fixed to the outer tube 110, and the outer tube 110 is driven by the first bending adjustment handle 210 to rotate around the axial direction. The first bending adjustment structure 220 is connected to the bending adjustment cable of the outer tube 110, and the first bending adjustment structure 220 drives the bending adjustment section of the outer tube 110 to bend through the bending adjustment cable of the outer tube 110.

[0105] The second bending adjustment assembly 300 includes a second bending adjustment handle 310 and a second bending adjustment structure 320 arranged on the second bending adjustment handle 310. The second bending adjustment handle 310 is fixed to the middle tube 120, the second bending adjustment structure 320 is connected to the bending adjustment cable of the middle tube 120, and the second bending adjustment structure 320 drives the bending adjustment section of the middle tube 120 to bend through the bending adjustment cable of the middle tube 120.

[0106] The primary bending adjustment of the outer tube 110 in the present invention helps the delivery system to bend and pass through the atrial septum after bending; the secondary bending adjustment of the middle tube 120 enables the distal end of the delivery system to be conveniently transported across the mitral valve through secondary bending after the delivery system enters the left atrium. Under the superposition effect of the outer tube 110 and the middle tube 120, the effects of "multi-directional bending" and "precision bending" are achieved.

[0107] For example, as shown in Figure 8 , the bending operation of the middle tube 120 is realized through the second bending adjustment assembly 300, so that the outer tube 110 bends in the first plane. By rotating the direction of the first bending adjustment handle 210, and then the outer tube 110 rotates. The bending operation of the outer tube 110 is realized through the first bending adjustment assembly 200, so that the outer tube 110 bends in the second plane. The superimposed state after the two bends is as shown in Figure 9 .

[0108] The present invention can omit the external locking structure, that is, after the middle tube 120 and the outer tube 110 are bent to a certain extent, the middle tube 120 will squeeze the outer tube 110, reducing the movement range of the outer tube 110 or even preventing it from moving, so as to achieve the self-locking function. This self-locking is mainly reflected in the bent sections of the outer tube 110 and the inner middle tube 120.

[0109] In some embodiments, the valve prosthesis delivery system further includes a release structure 400. The release structure 400 is connected to the first bending handle 210. The release structure 400 drives the first bending handle 210 to move axially, and then drives the outer tube 110 to move axially. When the release structure 400 drives the first bending handle 210 and the outer tube 110 to move proximally along the axis, the valve prosthesis located inside the outer tube 110 is gradually released. The release structure 400 allows the first bending handle 210 to rotate around the axis relative to the release structure 400. When the first bending handle 210 rotates around the axis, it drives the outer tube 110 to rotate around the axis, realizing the bending of the outer tube 110 in different spaces.

[0110] Due to the strong adaptability of the outer tube 110 of the present invention, it is possible to retract the catheter while maintaining the bending angle unchanged. This step can be jointly achieved by the first bending structure 220 and the release structure 400.

[0111] In some embodiments, referring to Figures 1 to 5 、 Figures 10 to 14 ,the release structure 400 includes a connection cylinder 410, a connection threaded block 420 and a release knob 430.

[0112] The connection threaded block 420 is arranged on the surface of the connection cylinder 410. The distal end of the connection cylinder 410 is connected to the first bending handle 210 and allows the first bending handle 210 to rotate around the axis relative to the connection cylinder 410. The release knob 430 is sleeved outside the connection cylinder 410 and is threadedly connected to the connection threaded block 420. The proximal end of the release knob 430 is connected to the second bending handle 310 and can rotate around the axis relative to the second bending handle 310. When the release knob 430 rotates, it drives the connection cylinder 410 to move axially, and then drives the first bending handle 210 and the outer tube 110 to move axially. The movement stroke of the connection cylinder 410 moving axially is as shown by the arrow in Figure 10 。The middle tube 120 passes through the connection cylinder 410 and the release knob 430 axially and is fixedly connected to the second bending handle 310.

[0113] A connection relationship is established between the first bending assembly 200 and the second bending assembly 300 of the present invention through the release structure 400, that is, as shown in Figure 10 ,the first bending assembly 200, the release structure 400 and the second bending assembly 300 are connected in sequence from the distal end to the proximal end. The three together form the operation part on the proximal side of the valve prosthesis delivery system.

[0114] In some embodiments, a circumferential groove is provided around the inner wall of the proximal end of the first bending handle 210.

[0115] Referring to Figure 2 , Figure 5 , Figure 10 and Figure 11 , the release structure 400 further includes a clamping ring 440. The clamping ring 440 is disposed at the distal end of the connecting tube 410. The clamping ring 440 is clamped in the groove and can rotate around the axial direction.

[0116] In some embodiments, for safety reasons, the valve prosthesis delivery system further includes a locking structure for locking or releasing the clamping ring 440 to the proximal end of the first bending handle 210 to prevent the first bending handle 210 from circumferentially moving relative to the second bending handle 310.

[0117] In some embodiments, referring to Figure 13 and Figure 14 , the locking structure includes a locking knob 510 and a plurality of locking holes 520.

[0118] The rotating operation part of the locking knob 510 is located outside the first bending handle 210. The rod part of the locking knob 510 is rotatably connected to the proximal end of the first bending handle 210 and can radially extend into the interior of the first bending handle 210. A plurality of locking holes 520 are circumferentially provided on the outer circumferential surface of the clamping ring 440. The locking holes 520 allow the end part of the rod part of the locking knob 510 to be inserted. In use, by rotating the rotating operation part of the locking knob 510, the rod part of the locking knob 510 is inserted into one of the locking holes 520 inside it, so as to lock the clamping ring 440 to the proximal end of the first bending handle 210. When it is necessary to rotate the first bending handle 210, by reversing the rotating operation part of the locking knob 510, the rod part of the locking knob 510 is separated from the locking hole 520, so as to release the clamping ring 440 from the proximal end of the first bending handle 210. At this time, the first bending handle 210 can be rotated to adjust the circumferential position of the outer tube 110.

[0119] In some embodiments, referring to Figure 10 , a release display mark 411 is provided on the surface of the connecting tube 410. The release display mark 411 can well remind the release condition of the valve prosthesis in the body, indirectly realizing visual operation and reducing the dependence of the operator on radiation.

[0120] In some embodiments, the release display mark 411 includes but is not limited to any one or a combination of multiple ones of scales, numbers, diagrams, text descriptions, etc. As Figure 10 shown, the release display mark 411 is a combination of a scale and a number.

[0121] In some embodiments, referring to Figure 2 , Figure 5, Figure 10 and Figure 11 , the release structure 400 further includes a reinforcing cylinder 450 which is located within the first bending handle 210 on the distal side of the snap ring 440. The reinforcing cylinder 450 is sleeved outside the middle tube 120 and is used to provide support for the middle tube 120. The reinforcing cylinder 450 provides additional support, avoiding the problem that the strength of a single tube is relatively low, or due to the relatively large inner diameter of the connecting cylinder 410, the movement range of thinner tubes such as the middle tube 120 will be relatively large due to the lack of circumferential constraint, ultimately resulting in a reduction in the bending position accuracy of the middle tube 120.

[0122] In some embodiments, the connecting cylinder 410, the snap ring 440 and the reinforcing cylinder 450 can be integrally formed.

[0123] In some embodiments, referring to Figures 1 to 5 , Figures 10 to 14 , the valve prosthesis delivery system further includes a first evacuation structure 610 and a second evacuation structure 620.

[0124] The first evacuation structure 610 communicates with the interior of the outer tube 110 through a first evacuation tube 611. The second evacuation structure 620 communicates with the interior of the middle tube 120 through a second evacuation tube 621. The first evacuation structure 610 and the second evacuation structure 620 are used to evacuate the air in each lumen.

[0125] In some embodiments, referring to Figure 2 , Figure 5 , Figure 10 and Figure 11 , the first bending assembly 200 further includes a first clamping block 230 which has a clamping cut surface. The first clamping block 230 is clamped within the first bending handle 210, and the proximal end of the outer tube 110 is inserted into the first clamping block 230. The design of the clamping cut surface makes the first clamping block 230 have a non-cylindrical outer circumference, which prevents the relative rotation between the first clamping block 230 and the first bending handle 210 after they are clamped.

[0126] The first evacuation structure 610 is inserted into the first clamping block 230 through the first evacuation tube 611, and the first evacuation tube 611 communicates with the proximal end of the outer tube 110.

[0127] In some embodiments, referring to Figure 10, the first bending handle 210 has an axially straight handle portion 211 and an inclined portion 212 inclinedly arranged on the axially straight handle portion 211, causing the first bending handle 210 to form a Y-shaped handle. The proximal end of the outer tube 110 is fixed to the distal end of the axially straight handle portion 211. The proximal end of the axially straight handle portion 211 is rotatably connected to a release structure 400. The middle tube 120 passes through the axially straight handle portion 211 along the axis. A first bending structure 220 is arranged inside the inclined portion 212. By arranging the first bending structure 220 inside the inclined portion 212, it not only does not affect the bending operation of the first bending structure 220 on the outer tube 110, but also well makes room for the passage of the middle tube 120.

[0128] In some embodiments, the first bending structure 220 and the second bending structure 320 adopt the same bending structure.

[0129] In some embodiments, the bending structure can adopt a bending structure in the prior art that can move the bending wire. For example, the following structure can be adopted:

[0130] Taking the first bending structure 220 as an example, refer to Figures 10 to 12 , the first bending structure 220 includes a bending sleeve 221, a bending guide and a bending knob 222. Among them, the bending guide includes a bending guide rod 223 and a wire fixing ring 224.

[0131] The proximal end and the distal end of the bending sleeve 221 are open structures. The inside of the bending sleeve 221 is hollow. The inner wall of the bending sleeve 221 is provided with an internal thread of the sleeve that can drive the bending wire. One end of the outer wall of the bending sleeve 221 is sleeved with a bending knob 222. The bending knob 222 is arranged outside the first bending handle 210 so as to rotate the bending sleeve 221 through the bending knob 222.

[0132] The bending guide rod 223 and the wire fixing ring 224 are both arranged inside the bending sleeve 221. The distal end of the bending guide rod 223 is an open structure and hollow inside. The distal end of the bending guide rod 223 extends out of the bending sleeve 221 and is fixedly connected to the first bending handle 210, so that the bending guide rod 223 is immovable relative to the bending sleeve 221 and the wire fixing ring 224. The wire fixing ring 224 is sleeved outside the bending guide rod 223 and can axially move along the bending guide rod 223. The wire fixing ring 224 is provided with an external thread of the fixing ring. The external thread of the fixing ring is threadedly connected to the internal thread of the sleeve. The wire fixing ring 224 is provided with a wire fixing end 2241, and this wire fixing end 2241 is used to fix the proximal end of the bending wire 113.

[0133] One end of the bending adjustment cable 113 is connected to the bending adjustment section 112. The other end of the bending adjustment cable 113 sequentially passes through the bending adjustment section 112, the bending adjustment guide rod 223, and the bending adjustment sleeve 221 and is then connected to the cable fixed end 2241. When the bending adjustment knob 222 is rotated to drive the bending adjustment sleeve 221 to rotate, the cable fixing ring 224 axially moves along the bending adjustment guide rod 223, driving the bending adjustment cable 113 on the cable fixed end to move, so as to adjust the bending degree of the bending adjustment section.

[0134] In some embodiments, referring to Figure 6 , Figure 15 and Figure 16 , the delivery conduit 100 includes an outer tube 110, a middle tube 120, a TIP head 130, and an inner tube 140.

[0135] The inner tube 140 is used to connect to the valve prosthesis. The distal end of the inner tube 140 is connected and communicated with the proximal end of the TIP head 130, further reducing the outer diameter of the delivery system. The inner tube 140 and the TIP head 130 form a guide wire passage for passing a guide wire. At this time, there is a passage in the second bending adjustment handle 310 that allows the inner tube 140 to pass through. The middle tube 120 is sleeved outside the inner tube 140, and the distal end of the middle tube 120 can be extended by the distal end of the inner tube 140. The outer tube 110 is sleeved outside the middle tube 120 and the inner tube 140, and the outer tube 110 is located at the proximal end of the TIP head 130 and can be hermetically connected to the TIP head 130.

[0136] With the mating design of the TIP head 130 and the outer tube 110, during the delivery of the valve prosthesis, the TIP head 130 is hermetically connected to the outer tube 110, playing a role of sealing and maintaining pressure, achieving the purpose of sealed delivery, preventing excessive blood from entering the delivery system during the delivery in the blood vessel, and being able to maintain the pressure in the delivery system. While sealing the outer tube 110, it can also prevent blood vessel scratches. When the valve prosthesis needs to be released, the TIP head 130 is separated from the outer tube 110, and the valve prosthesis can be released more quickly and conveniently.

[0137] The valve prosthesis delivery system of the present invention integrates the catheter sheath and the dilator that are separately used in conventional interventional surgeries into the same delivery system. Therefore, it brings the possibility of reducing the size of the delivery system, which can reduce the risk of damage caused by the large-size outer tube expanding the blood vessel.

[0138] The size of the catheter sheath for conventional transvenous mitral valve interventional surgery is above 29F. The present invention can reduce the diameter of the delivery system to 25F or even below.

[0139] In some embodiments, referring to Figures 1 to 5 , Figures 13 to 14, the proximal end of the inner tube 140 is connected to a Luer connector 150, which is used to connect to an external instrument to discharge the air in the inner tube. The Luer connector 150 also serves as a guide wire entry port and extends outside the proximal side of the second bending handle 310.

[0140] In some embodiments, the TIP head 130 is made of silicone material, resulting in the formation of a silicone TIP head. The silicone TIP head has a certain hardness and taper, performing the function of a dilator in a conventional catheter sheath and being preferably used to pierce the atrial septal tissue.

[0141] In some embodiments, the TIP head 130 has an overall frustum-like structure, and the distal end of the TIP head 130 is a tip 131. The shape design of the TIP head 130, especially the design of the tip 131, is equivalent to a dilator that helps the sheath enter the blood vessel and can guide other thicker delivery tubes such as the outer tube 110 to more easily enter the blood vessel.

[0142] In some embodiments, the proximal end of the TIP head 130 has a frustum-shaped connecting portion 132 with a narrow proximal end and a wide distal end. The TIP head 130 is inserted into the distal end inside the outer tube 110 through the frustum-shaped connecting portion 132 to achieve a sealed connection with the outer tube 110. The design of the frustum-shaped connecting portion 132 changes the linear connection between the TIP head 130 and the outer tube 110 to a surface connection, thus better sealing the outer tube 110.

[0143] In some embodiments, referring to Figure 6 , Figure 15 and Figure 16 , the delivery pipeline 100 further includes a card connector 160 and an extension tube 170.

[0144] The card connector 160 is disposed inside the outer tube 110 and can extend out of the distal end of the outer tube 110. The card connector 160 connects the distal end of the inner tube 140, and a connection interface for clamping with the valve prosthesis is provided on the card connector 160. The proximal end of the extension tube 170 is connected to the card connector 160 and communicates with the distal end of the inner tube 140. The distal end of the extension tube 170 is connected to and communicates with the proximal end of the TIP head 130, resulting in the connection and communication of the TIP head 130 and the inner tube 140 through the extension tube 170.

[0145] In some embodiments, referring to Figure 17 , the connection interface includes a plurality of first connection interfaces 161 and a plurality of second connection interfaces 162. The plurality of first connection interfaces 161 and the plurality of second connection interfaces 162 are arranged staggeredly in the circumferential direction, and the axial positions of the first connection interfaces 161 and the second connection interfaces 162 on the card connector 160 are different.

[0146] Conventional conveyors have connection joints with the valve prosthesis all located at the same axial position, so that the proximal end of the valve prosthesis is released simultaneously. The rapid and simultaneous release of the valve prosthesis will generate a large radial expansion force, which is likely to damage the anatomical structure at the target position. In the prior art, generally, a pull wire is added to the valve prosthesis, and the tension of the pull wire is controlled through the handle end to gradually release the valve prosthesis. However, this requires designing a special pull wire cavity for the pull wire. In order to facilitate the recovery of the pull wire, generally at least two pull wire cavities need to be designed, which will inevitably increase the diameter of the delivery system.

[0147] In the present invention, by designing the first connection interface 161 and the second connection interface 162 on the card joint 160 to have different axial lengths, to cooperate with Figure 18 the stent connection heads 810 and 820 at different heights on the valve prosthesis 800 as shown. The stent connection head 810 is clamped with the first connection interface 161, and the stent connection head 820 is clamped with the second connection interface 162. During the process of retracting the outer tube 110 to release the stent or valve, the stent connection head 810 that cooperates with the first connection interface 161 can be released first, enabling the valve prosthesis to be initially expanded and releasing part of the radial expansion force. Then, the stent connection head 820 that cooperates with the second connection interface 162 is released, and the radial expansion force is reduced. Therefore, the damage to the tissue anatomical structure is smaller, and the diameter of the delivery system will not increase. On the contrary, due to the staggered arrangement of the first connection interface 161 and the second connection interface 162, the diameter of the card joint 160 can also be reduced.

[0148] In some embodiments, the middle tube 120 and the inner tube 140 are combined into one core tube, and the core tube has a bending adjustment part. If the distal end of the core tube is connected to the card joint 160, the bending adjustment part is preset away from the joint 160 by a certain distance to prevent damage to the valve prosthesis during the secondary bending process.

[0149] In some embodiments, the outer tube 110, the middle tube 120, the inner tube 140, and the extension tube 170 are all composite conduits with a multi-layer structure.

[0150] In some embodiments, in order to reduce the resistance during the delivery process of the delivery system in the blood vessel, a biocompatible hydrophilic coating is applied to the outer periphery and / or the inner side of the outer tube 110.

[0151] In some embodiments, referring to Figures 19 to 24 , when the delivery system of the present invention is used, after the TIP head 130 of the delivery pipeline 100 enters the right ventricle upward from the femoral vein, the second bending adjustment structure 320 is first adjusted, the distal end of the middle tube 120 bends, and the TIP head 130 bends towards the atrial septum. The atrial septum 910 is punctured by using the TIP head 130. After successful puncture, the distal end of the delivery system enters the left atrium 920, as Figure 19As shown. The axis of the TIP head 130 faces the middle of the mitral valve 930. After rotating the first bending handle 210 to the appropriate position, adjust the first bending structure 220 for secondary bending, and while bending, convey the conveying system distally until the TIP head 130 reaches Figure 20 the position shown. Then adjust the release structure 400, as Figure 21 shown. Withdraw the outer tube 110 to expose the valve prosthesis 800 (which may include exposing the balloon). By the indication of the release display mark 411 released on the surface of the connecting cylinder 410, when it is judged that the valve prosthesis 800 is released to the card joint 160, as Figure 22 shown, slow down the release speed of the valve prosthesis 800, increase the release time difference between the proximal stent connectors, so that the valve prosthesis 800 is slowly and gradually released, increasing the stability and maneuverability of the release of the valve prosthesis 800. After the release is completed, as Figure 23 shown, push the outer tube 110 distally again to connect it with the TIP head 130. Then, as Figure 24 shown, withdraw the conveying system out of the body to complete the implantation of the valve prosthesis 800.

[0152] The present invention has been described in detail with reference to the embodiments in the accompanying drawings. Those of ordinary skill in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not constitute a limitation to the present invention, and the present invention will take the scope defined by the appended claims as the protection scope.

Claims

1. A valve prosthesis delivery system, characterized in that: The valve prosthesis delivery system comprises: A delivery pipeline, the delivery pipeline comprising a middle tube and an outer tube, the outer tube being sleeved outside the middle tube, the outer tube being rotatable relative to the middle tube around the axial direction, the outer tube having a delivery passage for accommodating a valve prosthesis, the outer tube and the middle tube respectively having a bending adjustment portion, the bending adjustment portion comprising a bending adjustment section with adjustable curvature and a bending adjustment pull wire; A first bending adjustment component, the first bending adjustment component comprises a first bending adjustment handle and a first bending adjustment structure arranged on the first bending adjustment handle, the first bending adjustment handle is fixed to the outer tube, the first bending adjustment handle drives the outer tube to rotate around the axial direction, the first bending adjustment structure is connected to the bending adjustment pull wire of the outer tube, and the first bending adjustment structure drives the bending adjustment section of the outer tube to bend through the bending adjustment pull wire of the outer tube; The second bending adjustment component includes a second bending adjustment handle and a second bending adjustment structure arranged on the second bending adjustment handle, the second bending adjustment handle is fixed to the middle tube, the second bending adjustment structure is connected to the bending adjustment pull wire of the middle tube, and the second bending adjustment structure drives the bending section of the middle tube to bend through the bending adjustment pull wire of the middle tube.

2. The valve prosthesis delivery system according to claim 1, characterized in that: The valve prosthesis delivery system further comprises a release structure, wherein the release structure is connected to the first bending adjustment handle, and the release structure drives the first bending adjustment handle to move axially, thereby driving the outer tube to move axially; The release structure allows the first bending adjustment handle to rotate axially relative to the release structure, and when the first bending adjustment handle rotates axially, the outer tube is driven to rotate axially; The release structure preferably comprises: A connecting tube, on which a connecting thread block is disposed, and a distal end of the connecting tube is connected to the first bending adjustment handle and allows the first bending adjustment handle to rotate axially relative to the connecting tube; A release knob, the release knob is sleeved outside the connecting tube and is threadedly connected to the connecting thread block, the proximal end of the release knob is connected to the second bending adjustment handle and can rotate axially relative to the second bending adjustment handle, and when the release knob rotates, the connecting tube is driven to move axially, thereby driving the first bending adjustment handle and the outer tube to move axially; The middle tube passes through the connecting tube and the release knob along the axial direction.

3. The valve prosthesis delivery system according to claim 2, characterized in that: A circle of grooves is arranged around the inner wall of the proximal end of the first bending adjustment handle; The release structure also includes: A clamping ring is arranged at the distal end of the connecting tube, and the clamping ring is clamped in the clamping groove and can rotate around the axial direction.

4. The valve prosthesis delivery system according to claim 3, characterized in that: The valve prosthesis delivery system further comprises a locking structure, and the locking structure is used to lock or release the clamping ring at the proximal end of the first bending adjustment handle; The locking structure preferably includes: A locking knob, wherein the rotation operation portion of the locking knob is located outside the first bending adjustment handle, and the rod portion of the locking knob is rotatably connected to the proximal end of the first bending adjustment handle and can be radially extended into the first bending adjustment handle; A plurality of locking holes are circumferentially arranged on the circumferential outer surface of the clamping ring, and the locking holes allow the rod end of the locking knob to be inserted.

5. The valve prosthesis delivery system according to claim 3, characterized in that: The surface of the connecting tube is provided with a release display mark, and the release display mark is preferably any one or more combinations of scales, numbers, icons and text descriptions; and / or, The release structure also includes: A reinforcing tube, wherein the reinforcing tube is located in the first bending adjustment handle on the distal side of the clamping ring, the reinforcing tube is sleeved on the middle tube, and the reinforcing tube is used to provide support for the middle tube.

6. The valve prosthesis delivery system according to claim 1, characterized in that: The valve prosthesis delivery system further includes: a first emptying structure, the first emptying structure is connected to the interior of the outer tube through a first emptying tube; a second emptying structure, the second emptying structure is connected to the interior of the middle tube through a second emptying tube; The first bending adjustment component preferably also includes: a first clamping block, the first clamping block having a clamping section, the first clamping block being clamped in the first bending adjustment handle, the proximal end of the outer tube being inserted in the first clamping block; the first emptying structure is inserted into the first clamping block through a first emptying pipe, and the first emptying pipe is connected to the proximal end of the outer tube.

7. The valve prosthesis delivery system according to claim 2, characterized in that: The first bending adjustment handle comprises an axial straight handle portion and an inclined portion obliquely arranged on the axial straight handle portion, so that the first bending adjustment handle forms a Y-shaped handle; The proximal end of the outer tube is fixed to the distal end of the axial straight handle, the proximal end of the axial straight handle is rotatably connected to the release structure, and the interior of the axial straight handle is axially penetrated by the middle tube; The first bending adjustment structure is disposed in the inclined portion.

8. The valve prosthesis delivery system according to claim 1, wherein: The first bending adjustment structure and the second bending adjustment structure adopt the same bending adjustment structure; The bending adjustment structure preferably includes: A bending adjustment sleeve, wherein the proximal end and the distal end of the bending adjustment sleeve are open structures, the interior of the bending adjustment sleeve is hollow, the inner wall of the bending adjustment sleeve is provided with a sleeve internal thread capable of driving a bending adjustment wire, and the outer wall of one end of the bending adjustment sleeve is provided with a bending adjustment knob; A bending guide, the bending guide having a bending guide rod and a wire fixing ring arranged in the bending sleeve, the distal end of the bending guide rod being an open structure and being hollow inside, the wire fixing ring being sleeved outside the bending guide rod and being movable axially along the bending guide rod, the wire fixing ring being provided with an external fixing ring thread, the external fixing ring thread being threadedly connected with the internal sleeve thread, and the wire fixing ring being provided with a wire fixing end; One end of the bending adjustment wire is connected to the bending adjustment section, and the other end of the bending adjustment wire passes through the bending adjustment section, the bending adjustment guide and the bending adjustment sleeve rod in sequence and then is connected to the fixed end of the wire; When the bending adjustment knob is rotated to drive the bending adjustment sleeve to rotate, the wire fixing ring moves axially along the bending adjustment guide rod, driving the bending adjustment wire on the wire fixing end to move, so as to adjust the curvature of the bending adjustment section.

9. The valve prosthesis delivery system according to any one of claims 1 to 8, characterized in that: The delivery pipeline also includes: TIP head; An inner tube, the inner tube is used to be connected to the valve prosthesis, the distal end of the inner tube is connected and communicated with the proximal end of the TIP head, and the inner tube and the TIP head form a guidewire passage for passing a guidewire; The distal end of the middle tube can be extended by the distal end of the inner tube; The outer tube is located at the proximal end of the TIP head and can be sealingly connected to the TIP head.

10. The valve prosthesis delivery system according to claim 9, characterized in that: The proximal end of the inner tube is connected to a Luer connector for connecting with an external instrument and serving as an entry port for a guide wire, and the Luer connector extends out of the proximal end side of the second bending adjustment handle.

11. The valve prosthesis delivery system according to claim 9, characterized in that: The TIP head is made of silicone; And / or, the TIP head is a truncated cone-like structure as a whole, and the distal end of the TIP head is a pointed tip; And / or, the proximal end of the TIP head has a truncated cone-shaped connecting portion which is narrow at the proximal end and wide at the distal end, and the TIP head is inserted into the distal end of the outer tube through the truncated cone-shaped connecting portion to achieve a sealed connection with the outer tube.

12. The valve prosthesis delivery system according to claim 9, wherein: The delivery pipeline also includes: A clamping joint, which is arranged in the outer tube and can extend out of the distal end of the outer tube, is connected to the distal end of the inner tube, and is provided with a connection interface for clamping with a valve prosthesis; An extension tube, the proximal end of which is connected to the card joint and communicated with the distal end of the inner tube, and the distal end of which is connected to and communicated with the proximal end of the TIP head, so that the TIP head and the inner tube are connected and communicated through the extension tube.

13. The valve prosthesis delivery system according to claim 12, wherein: The connection interface includes a plurality of first connection interfaces and a plurality of second connection interfaces, the plurality of the first connection interfaces and the plurality of the second connection interfaces are staggered along the circumferential direction, and the first connection interface and the second connection interface have different axial positions on the card connector.

14. The valve prosthesis delivery system according to claim 9, wherein: The middle tube and the inner tube are combined into a middle core tube, and the middle core tube has the bending portion. If the distal end of the middle core tube is connected to a clamping joint, the bending portion is away from the clamping joint by a preset distance.

15. The valve prosthesis delivery system according to claim 9, wherein: The outer tube, the middle tube, the inner tube and the extension tube are all composite conduits with a multi-layer structure; And / or, the outer circumference and / or inner side of the outer tube is coated with a biocompatible hydrophilic coating.

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