Anchoring part, restraining device, conveying system and conveying method

Abstract

According to the anchoring piece, the restraining device, the conveying system and the conveying method, the anchoring piece adopts an anchoring clamp clamping mode, can adapt to more pathological structures, and can effectively treat aortic valve regurgitation (or aortic valve divalvular and tetravalvular deformity accompanied by aortic valve divalvular and tetravalvular deformity) patients; the protruding anchor is arranged to hang or carry the autologous valve leaflet, valve displacement is prevented, and the perivalvular leakage risk is reduced. The restraining device is provided with a restraining part, the anchoring part is sleeved with a restraining section of the restraining part in an annular shape, a scaling section is connected with the restraining section and arranged in the releasing pipe in a penetrating mode, and the restraining force of the restraining section on the anchoring part is controlled by controlling the scaling section so as to control the releasing speed of the anchoring part. The delivery system optimizes the structure and the function of the whole system, a lumen gap can be properly widened, emptying and water passing are facilitated, the delivery system has better control force when the artificial valve is released due to introduction of the restraining device, and it is guaranteed that when the anchoring piece reaches the lesion position, the anchoring piece is slowly placed, and the aorta and the sinus floor are prevented from being damaged.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an anchor, a constraint device, a delivery system, and a delivery method. Background Art

[0002] Human heart valve diseases can lead to abnormal heart function. For example, bicuspid aortic valve malformation can cause abnormal aortic valve hemodynamics, and further induce valve stenosis or insufficiency. These diseased valves ultimately need to be replaced with artificial valves. There are currently a variety of known artificial valves and a variety of known methods for implanting these artificial valves into the human body. When replacing natural valves, the surgical implantation of artificial valves generally requires open-chest surgery, during which the heart is stopped and the patient is placed on cardiopulmonary bypass (the so-called "heart-lung machine"). In a common surgical procedure, the diseased natural valve leaflets are excised, and the artificial valve is sutured to the surrounding tissue at the annulus. Due to the trauma associated with the surgery and the subsequent duration of extracorporeal blood circulation, some patients lose their lives during the surgery or shortly thereafter. Due to the large surgical trauma and long duration required for traditional surgical procedures, many patients with natural valve lesions are unable to undergo surgery. According to some estimates, more than 50% of patients over 80 years old with valve stenosis cannot undergo valve replacement surgery.

[0003] In recent years, transcatheter aortic valve replacement (TAVR) has become a routine treatment for structural heart patients at high, medium, and low surgical risks. The emergence of TAVR technology provides a minimally invasive, fast-recovery treatment method for patients with aortic stenosis (AS) without the need for open chest and extracorporeal circulation. The main reason is that senile calcific aortic stenosis is caused by calcification of the valve itself. The artificial valve is anchored at the native leaflet and replaces the native valve to work, restoring normal blood flow at the aortic valve. However, for patients with aortic regurgitation (AR), there are fewer or no calcified sites at the aortic valve, the leaflets are relatively soft, and there is a lack of an anchoring area. Existing products for treating AS conditions are difficult to meet the needs of AR patients. Therefore, current products for the aortic regurgitation indication all include a special anchor structure. Compared with the stenosis indication, the introduction of the anchor enables the regurgitation indication device to anchor the valve under the condition of lacking a calcified anchoring area.

[0004] However, common artificial valve products that introduce an anchor structure to treat AR have certain limitations in clinical surgery, such as:

[0005] (1) The treatment effect of the valve stent is not ideal. For special pathological structures, such as an overly large aortic valve and bicuspid or quadricuspid aortic valve after lesions, existing valve stents often have problems of mismatched annulus and orifice sizes, imperfect fitting between the autologous valve leaflets and the valve stent, increasing the risks of displacement and paravalvular leakage;

[0006] (2) The interventional device damages blood vessels. An important design parameter of the artificial valve is the outer shape size of the valve in the crimped delivery state, and the anchor will increase the diameter of the artificial valve in the crimped state. When the delivery system punctures into the patient's circulatory system, the larger-diameter delivery system will also increase the difficulty of the valve passing through the vascular access, reducing the safety of device use;

[0007] (3) The surgical operation is not convenient. The introduction of the anchor makes the complexity of the valve stent and the delivery system increase. The relatively complex valve stent and system structure may cause difficulties in valve positioning and poor stability during valve release for doctors. In addition, the increase in the complexity of the delivery system also reduces the clearance between lumens, which is not conducive to drainage and water passage;

[0008] (4) There is a risk of bouncing. The common anchor structure generally uses self-expanding nitinol material, so there is a risk that the artificial valve bounces, displaces, and damages the aortic valve instantaneously during in-vivo release. Summary of the Invention

[0009] Therefore, the technical problem to be solved by the present invention is that for the artificial valve products with an anchor structure introduced in the prior art for treating AR, there are problems such as unsatisfactory treatment effect of the valve stent, damage to blood vessels by the interventional device, inconvenient surgical operation, and the risk of bouncing.

[0010] To this end, the present invention provides an anchor adapted to be connected to a stent body, and the anchor includes:

[0011] A clamping section including at least two connected anchor clips, and the two anchor clips are nested with interference to clamp the fusion ridge where two valve leaflets are connected;

[0012] A protruding anchor provided on one side of the clamping section, and the protruding anchor is a single-ring structure or a multi-ring nested structure to hang or carry the valve leaflet.

[0013] Optionally, the surface of the protruding anchor is wrapped with a polymer material.

[0014] A constraint device for constraining the above-mentioned anchor includes at least one restraint member, and the restraint member includes:

[0015] A restraint section that is annularly sleeved on the periphery of the anchor to enable the anchor to maintain a compressed state during delivery;

[0016] a scaling section connected to the binding section, the scaling section being configured to control the binding force of the binding section on the anchor to control the release speed of the anchor;

[0017] The constraint device further includes a release tube provided with a through hole, the binding section of the binding member being configured to pass through the through hole and then sleeved around the periphery of the anchor, and the scaling section being disposed inside the release tube;

[0018] or the binding section of the binding member is configured to pass through the distal end of the release tube and then sleeved around the periphery of the anchor, and the scaling section is disposed inside the release tube.

[0019] Optionally, the binding member is linear, and the linear binding member is sleeved around the periphery of the anchor in a ring shape to form the binding section, and both ends of the linear binding member form the scaling section.

[0020] Optionally, both ends of the linear binding member are arranged in parallel, and the binding member is configured to pull or deliver the scaling section to change the diameter of the binding section to control the binding force of the binding section on the anchor.

[0021] Optionally, both ends of the linear binding member are wound around each other, and the binding member is configured to pull or deliver the scaling section to change the diameter of the binding section to control the binding force of the binding section on the anchor.

[0022] Optionally, the binding member is linear, one end of the linear binding member is provided with a closed hole or a ring sleeved around the periphery of the anchor to form the binding section, and the other end of the linear binding member forms the scaling section.

[0023] Optionally:

[0024] The number of the binding members is at least two; the release tube is provided with a plurality of through holes arranged axially in alignment, the binding section of the binding member being configured to pass through the through holes and then sleeved around the periphery of the anchor, and the scaling section being disposed inside the release tube.

[0025] Optionally, a plurality of protrusions are provided on the binding section, and the protrusions are adapted to be engaged with the anchor.

[0026] Optionally, a metal wire is wound around the binding section to increase the friction between the binding section and the anchor.

[0027] Optionally, a coating and / or a polymer material are provided on the binding section to increase the friction.

[0028] A delivery system for delivering a stent body and the above-mentioned anchor, the anchor being connected to the stent body, the delivery system comprising:

[0029] A sheath tube device, which includes an inner layer tube, a middle layer tube, and an outer layer tube sleeved from the inside to the outside in sequence. A guide wire is suitable to be threaded through the inner layer tube, and a balloon is provided on the distal surface of the middle layer tube; and

[0030] The above-mentioned constraint device, in which the constraint section of the constraint piece in the constraint device is suitable to be sleeved on the periphery of the anchoring piece.

[0031] Optionally, the release tube is arranged between the middle layer tube and the outer layer tube, or the release tube is arranged outside the outer layer tube.

[0032] Optionally, the constraint device is configured to pull the constraint piece to control the bending of the sheath tube device.

[0033] Optionally, the middle layer tube is configured to press and hold the stent body proximal to the balloon. The middle layer tube rotates by operating its proximal handle during the release and positioning stage of the anchoring piece, and assists in positioning the anchoring piece during the release and positioning stage of the anchoring piece.

[0034] Optionally, the outer layer tube is configured to deliver the stent body to the position of the balloon.

[0035] A delivery method, using the above-mentioned delivery system for delivering an artificial valve. The artificial valve includes a stent body and the above-mentioned anchoring piece. The release tube in the constraint device is arranged between the middle layer tube and the outer layer tube. The delivery method includes:

[0036] Step 1: Puncture the patient's artery, place a vascular sheath in the main access, place a pigtail catheter in the auxiliary access to locate the lesion site and use it for angiography, and place the above-mentioned constraint device inside the outer layer tube;

[0037] Step 2: Use the outer layer tube to press-fit the artificial valve proximal to the balloon. Use a push sheath to send the delivery system into the vascular sheath along the guide wire. Before the anchoring piece exits the vascular sheath and opens, use the constraint device to capture the anchoring piece, or the constraint device pre-tightens the anchoring piece;

[0038] Then push the proximal end of the outer layer tube to push the artificial valve with the constraint device to the outside of the balloon, and send the delivery system into the aortic sinus;

[0039] Step 3: Gradually release the constraint device to release the anchoring piece, so that it self-expands and opens. According to the angiography and ultrasonic images, assist in observing the anatomical structure of the sinus and the positional relationship between the anchoring piece. Rotate the anchoring piece to achieve sinus alignment. Cooperate with the operation of the guide wire, push and pull the delivery system to move the artificial valve up and down, adjust the bending to achieve coaxiality, and cooperate to complete the positioning;

[0040] Step 4: Under the rapid pacing state, inflate the balloon to release the artificial valve. The clamping section of the anchoring piece clamps the fusion ridge where the two valve leaflets are connected, and the anchoring piece protrudes and anchors on the autologous valve leaflet;

[0041] Step 5: Withdraw the delivery system, confirm the immediate effect with ultrasound, close the approach, and complete the operation.

[0042] A delivery method, using the delivery system described above, is used to deliver an artificial valve, wherein the artificial valve comprises a stent body and the anchoring member described above, wherein the release tube is arranged outside the outer tube, and the delivery method comprises:

[0043] Step 1: Puncture the patient's artery, place a vascular sheath through the main approach, insert a restraint device through the auxiliary approach, and place a pigtail catheter to locate the lesion and use it for angiography;

[0044] Step 2: Use the outer tube to press fit the artificial valve onto the proximal end of the balloon, use the push sheath to push the delivery system into the vascular sheath along the guide wire, use the restraint device to capture the anchor before the anchor comes out of the vascular sheath and opens, then push the proximal end of the outer tube, push the artificial valve with the restraint device to the outside of the balloon, and deliver the delivery system into the aortic sinus;

[0045] Step 3: Gradually loosen the restraint device, release the anchor, and allow it to expand and open. Observe the relationship between the anatomic structure of the sinus and the position of the anchor with the help of angiography and ultrasound images. Rotate the anchor to align the sinus. Cooperate with the guidewire operation, push and pull the delivery system to move the artificial valve up and down, adjust the bend to achieve coaxiality, and coordinate to complete the positioning.

[0046] Step 4: Under rapid pacing, the balloon is compressed to release the artificial valve, the clamping section of the anchor clamps the fusion ridge where the two leaflets are connected, and the anchor protrudes and anchors to the native leaflet;

[0047] Step 5: Withdraw the delivery system, confirm the immediate effect with ultrasound, close the approach, and complete the operation.

[0048] Optionally, during the anchor delivery, release and retrieval stages, the anchor tension may be reduced by injecting ice water into the vascular sheath.

[0049] The anchoring member, restraining device, conveying system and conveying method provided by the present invention have the following advantages:

[0050] 1. The present invention provides an anchoring member suitable for connection with a stent body, wherein the anchoring member comprises a clamping section and a protruding anchor, wherein the clamping section comprises at least two connected anchoring clips, wherein the two anchoring clips are nested with each other in an interference fit to clamp a fusion ridge where two leaflets are connected; the protruding anchor is arranged on one side of the clamping section, and the protruding anchor is a single-ring structure or a multi-ring nested structure to mount or carry the leaflet.

[0051] The anchor of this structure adopts the clamping method of an anchor clip, which can adapt to more pathological structures and is an effective treatment option for patients with moderate to severe aortic valve regurgitation, bicuspid aortic valve, and quadricuspid aortic valve malformation. At the same time, a protruding anchor is set to carry or mount the autologous valve leaf to prevent valve displacement and effectively reduce the risk of paravalvular leakage.

[0052] 2. The present invention provides a constraint device for constraining the above-mentioned anchor. The constraint device includes at least one restraint member and a release tube. The restraint member includes a restraint section and a scaling section. The restraint section is annularly sleeved on the periphery of the anchor so that the anchor can maintain a compressed state during transportation. The scaling section is connected to the restraint section and is configured to control the binding force of the restraint section on the anchor to control the release speed of the anchor. The release tube is provided with a through hole. The restraint section of the restraint member is configured to be sleeved on the periphery of the anchor after passing through the through hole, and the scaling section is disposed inside the release tube; or the restraint section of the restraint member is configured to be sleeved on the periphery of the anchor after passing through the distal end of the release tube, and the scaling section is disposed inside the release tube.

[0053] For the constraint device of this structure, by setting the restraint section of the restraint member to be annularly sleeved on the periphery of the anchor, the scaling section is connected to the restraint section and disposed inside the release tube. By controlling the scaling section to control the binding force of the restraint section on the anchor to control the release speed of the anchor, the delivery system has better control when releasing the artificial valve (anchor and stent body), avoiding the artificial valve from bouncing due to rapid expansion at the moment of proximal release. The entire release process is more reliable, controllable, and safe. And when the anchor enters the lesion location, adjust the position of the anchor. For special anatomical structures, pull the constraint device to complete multiple bending of the delivery system sleeved inside the anchor and the stent body, and cooperate with the bending function of the system itself to ensure that the artificial valve is coaxial with the valve annulus during release. The traction of the constraint device can improve the anchoring accuracy and surgical safety.

[0054] 3. The present invention provides a constraint device, and a plurality of protrusions are provided on the restraint section, and the protrusions are adapted to be engaged with the anchor.

[0055] For the constraint device of this structure, to prevent the constraint device from slipping when restraining the anchor, a plurality of protrusions are provided on the restraint section, and the protrusions are adapted to be engaged with the anchor to increase the friction between the constraint device and the anchor and prevent the constraint device from slipping during the release process.

[0056] 4. The present invention provides a delivery system for delivering a stent body and the above-described anchoring member, the anchoring member being connected to the stent body. The delivery system includes a sheath device and a restraint device. The sheath device includes an inner layer tube, a middle layer tube, and an outer layer tube sleeved from the inside to the outside in sequence. A guide wire is adapted to be threaded through the inner layer tube, and a balloon is provided on the distal surface of the middle layer tube. The restraining section of the restraining member in the restraining device is adapted to be sleeved around the periphery of the anchoring member, and the release tube is disposed between the middle layer tube and the outer layer tube.

[0057] For the delivery system with this structure, compared with the existing sheath system, it has the functions of bending adjustment and contrast agent filling, has a relatively thick diameter, and has limited gaps between the lumens, which is not conducive to emptying and water passing. This delivery system optimizes the overall system structure and function, and the lumen gaps can be appropriately widened, which is beneficial to emptying and water passing. The introduction of the restraint device enables the delivery system to have better control force when releasing the artificial valve, ensuring that when the anchoring member reaches the lesion position, the positioning action is gentle and the myocardium is prevented from being damaged.

[0058] 5. The present invention provides a delivery method using the above-described delivery system for delivering an artificial valve. The artificial valve includes a stent body and the above-described anchoring member. The delivery method includes:

[0059] Step 1: Puncture the patient's artery, place a vascular sheath in the main access, place a pigtail catheter in the auxiliary access to locate the lesion site and use it for angiography, and place the above-described restraint device inside the outer layer tube.

[0060] Step 2: Use the outer layer tube to press-fit the artificial valve proximal to the balloon, use the push sheath to send the delivery system into the vascular sheath along the guide wire. Before the anchoring member exits the vascular sheath and expands, use the restraint device to capture the anchoring member, then push the proximal end of the outer layer tube to push the artificial valve with the restraint device to the outside of the balloon, and send the delivery system into the aortic sinus.

[0061] Step 3: Gradually release the restraint device to release the anchoring member, allowing it to self-expand and open. According to the angiography and ultrasonic images, assist in observing the anatomical structure of the sinus and the positional relationship of the anchoring member, rotate the anchoring member to achieve sinus alignment, cooperate with the operation of the guide wire, push and pull the delivery system to move the artificial valve up and down, adjust the bend to achieve coaxiality, and cooperate to complete the positioning.

[0062] Step 4: Under the condition of rapid pacing, inflate the balloon to release the artificial valve. The clamping section of the anchoring member clamps the fusion ridge where the two valve leaflets are connected, and the anchoring member protrudes and anchors on the autologous valve leaflets.

[0063] Step 5: Withdraw the delivery system, ultrasonically confirm the immediate effect, close the access, and complete the operation.

[0064] For this delivery method, since the above-described delivery system is adopted, it has all the advantages of the above-described delivery system. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0066] Figure 1 Structural schematic view of the artificial valve provided in the embodiment of the present invention;

[0067] Figure 2 Structural schematic view of the anchor provided in the embodiment of the present invention;

[0068] Figure 3 Another structural schematic view of the anchor provided in the embodiment of the present invention;

[0069] Figure 4 Structural schematic view of a single binding segment in the restraint device provided in the embodiment of the present invention;

[0070] Figure 5 Structural schematic view of two binding segments in the restraint device provided in the embodiment of the present invention;

[0071] Figure 6 Structural schematic view of three binding segments in the restraint device provided in the embodiment of the present invention;

[0072] Figure 7 Structural schematic view of the opened binding segment in the restraint device provided in the embodiment of the present invention;

[0073] Figure 8 Structural schematic view of the winding state of the scaling segment in the restraint device provided in the embodiment of the present invention;

[0074] Figure 9 Structural schematic view of the opened winding state of the scaling segment in the restraint device provided in the embodiment of the present invention;

[0075] Figure 10 Structural schematic view of the parallel state of the scaling segment in the restraint device provided in the embodiment of the present invention;

[0076] Figure 11 Structural schematic view of the opened parallel state of the scaling segment in the restraint device provided in the embodiment of the present invention;

[0077] Figure 12 Structural schematic view of the inner protrusion of the binding segment in the restraint device provided in the embodiment of the present invention;

[0078] Figure 13 For Figure 12 Schematic view of the structure when the restraint section in

[0079] Figure 14 Another schematic view of the inner protrusion of the restraint section in the restraint device provided in the embodiment of the present invention;

[0080] Figure 15 For Figure 14 Schematic view of the structure when the restraint section in

[0081] Figure 16 Another schematic view of the restraint section in the restraint device provided in the embodiment of the present invention;

[0082] Figure 17 Perspective view of the delivery system provided in the embodiment of the present invention;

[0083] Figure 18 Schematic view of the internal structure of the delivery system provided in the embodiment of the present invention;

[0084] Figure 19 Schematic diagram for positioning the auxiliary anchor of the delivery system provided in the embodiment of the present invention;

[0085] Figure 20 Schematic diagram of the delivery system for bending adjustment provided in the embodiment of the present invention (the restraint device is between the middle layer tube and the outer layer tube);

[0086] Figure 21 Schematic view of the final state of the artificial valve provided in the embodiment of the present invention;

[0087] Figure 22 Schematic diagram of the delivery system for bending adjustment provided in the embodiment of the present invention (the restraint device is outside the outer layer tube);

[0088] Explanation of reference numerals:

[0089] 1 - Anchor; 11 - Clamping section; 12 - Protruding anchor;

[0090] 2 - Bracket body;

[0091] 3 - Connection structure;

[0092] 4 - Restraint device; 41 - Restraint section; 42 - Scaling section; 43 - Protrusion; 44 - Release tube;

[0093] 5 - Tip head;

[0094] 6 - Balloon;

[0095] 7 - Inner layer tube;

[0096] 8 - Middle layer tube;

[0097] 9 - Outer tube;

[0098] 10 - Autologous valve. Detailed implementation manner

[0099] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts belong to the scope of protection of the present invention.

[0100] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0101] For the convenience of description, in this embodiment, the end close to the operator is set as the proximal end, and the end far from the operator is set as the distal end.

[0102] Embodiment 1

[0103] Clinically, for special anatomical structures, such as bicuspid deformity or AR patients, there are relatively high requirements for the valve structure and the operator. The problems brought about are unstable fixation and easy occurrence of paravalvular leakage in the short and long term. If the selected model is too large, forced clamping is likely to cause tearing and damage to the heart tissue, increasing the surgical risk. In this case, this embodiment provides an anchor 1 for adjacent sinus and leaflet clamping. In the case of selecting a smaller valve annulus, it can still be well anchored to avoid valve displacement, and the anti-reflux holes of the anchor 1 clamping adjacent valve leaflets can also effectively reduce the risk of paravalvular leakage.

[0104] As Figure 1 shown, the anchor 1 is connected to the stent body 2 through the connecting structure 3. Among them, the stent body 2 is made of cobalt-chromium alloy or other metals that can be implanted into the human body, and the connecting structure 3 is made of polymer material filaments for connecting the stent body and the anchor 1.

[0105] As Figure 2 and Figure 3As shown, in order to better anchor and avoid valve displacement and effectively reduce the risk of paravalvular leakage, this embodiment provides two anchoring members 1 with special-shaped structures. This anchoring member 1 is composed of shape memory metal to form a special-shaped closed loop, such as nickel-titanium material, and is applicable to pathological structures with a larger annulus.

[0106] In this embodiment, as Figure 2 and Figure 3 shown, the anchoring member 1 with a special-shaped structure includes a clamping section 11 and a protruding anchor 12. The clamping section 11 is composed of two connected anchor clamps. The two anchor clamps are nested with interference to achieve the clamping effect adjacent to the sinus, reducing paravalvular leakage. The above-mentioned interference nesting specifically is: in Figure 2 and Figure 3 , two anchor clamps are arranged at the lower part of the anchoring member 1, and there is partial overlap between the two anchor clamps. Therefore, when in use, the adjacent sinus is clamped through the overlapping part of the two anchor clamps to reduce paravalvular leakage. The anchor clamps preferably act on the leaflets of the left coronary sinus and the right coronary sinus of the aortic valve. Among them, the number of anchor clamps is not limited to two, and three or more can also be set, as long as there is an overlapping part to clamp the adjacent sinus.

[0107] Furthermore, as Figure 2 and Figure 3 shown, in this embodiment, the protruding anchor 12 in the anchoring member 1 with a special-shaped structure is a single annular structure arranged on one side of the clamping section 11, and its function is to mount or carry the leaflet, specifically acting on the leaflet of the non-coronary sinus on the small curvature side, or the coaptation edge of the bicuspid valve. In some embodiments, the protruding anchor 12 can also be set as multiple rings nested, and the surface of the protruding anchor 12 is wrapped with a polymer material.

[0108] The anchoring member 1 provided in this embodiment, by using the clamping method of the anchor clamps, can adapt to more pathological structures, and is an effective treatment option for patients with moderate to severe aortic valve regurgitation, aortic valve bicuspidization, and quadricuspid malformation; at the same time, the protruding anchor 12 is set to mount or carry the autologous leaflet to prevent valve displacement and effectively reduce the risk of paravalvular leakage.

[0109] Embodiment 2

[0110] This embodiment provides a constraint device 4 for constraining the anchoring member 1 in Embodiment 1. As Figures 4 to 7 shown, the constraint device 4 includes a restraint member and a release tube 44. The restraint member includes a restraint section 41 and a scaling section 42. The restraint section 41 is arranged in a ring around the circumferential side of the anchoring member 1 so that the anchoring member 1 can maintain a compressed state during delivery. The scaling section 42 is connected to the restraint section 41, and the scaling section 42 is configured to control the binding force of the restraint section 41 on the anchoring member 1 to control the release speed of the anchoring member 1.

[0111] The controllable release speed of the restraint device 4 enables the delivery system to have better control when releasing the artificial valve (anchor 1 and the stent body 2), thereby preventing the artificial valve from bouncing due to rapid expansion at the moment of release at the proximal end, making the entire release process more reliable, controllable and safe.

[0112] like Figures 4 to 6 To constrain the anchor 1 by the restraining device 4, Figure 7 The anchor 1 is in the open state. The specific structure of the restraint device 4 and the method for adjusting the restraint force of the restraint section 41 on the anchor 1 are described in detail below.

[0113] In this embodiment, if Figures 8 to 11 As shown, the binding member is linear, and the middle part of the linear binding member is arranged in a ring shape, and its function is to be conveniently arranged in the ring shape around the anchor member 1 to form a binding section 41, and accordingly, the two ends of the linear binding member constitute a zoom section 42. Among them, the above-mentioned ring-shaped arrangement of the middle part of the binding member is not limited to the middle part of the binding member, and it specifies that any part between the two ends of the binding member can be arranged in a ring shape to serve as the binding section 41.

[0114] In this embodiment, the release tube 44 is a hollow tubular structure, and its length direction is the conveying direction of the anchor 1. In this embodiment, if the number of the restraining member is one, the restraining section 41 of the restraining member can be extended from the distal end of the release tube 44 and then sleeved on the side of the anchor 1, and the zoom section 42 of the restraining member can be extended from the proximal end of the release tube 44. In some other embodiments, a through hole can also be provided on the side wall of the distal end of the release tube 44, and the restraining section 41 of the restraining member can pass through the through hole and then sleeved on the side of the anchor 1, and the zoom section 42 can be penetrated inside the release tube 44 and extended from the proximal end of the release tube 44.

[0115] In some embodiments, Figure 5 and Figure 6 As shown, when the number of restraining members is two or more, in order to ensure that the restraint device 4 does not get tangled when released, a number of through holes not less than the number of restraining members is provided on the distal side wall of the release tube 44, so that each restraining member is released by a single through hole.

[0116] In this embodiment, if Figure 8 and Figure 9 As shown, the scaling segment 42 of the linear restraint is two ends that are intertwined with each other. When the anchor 1 needs to be released, the scaling segment 42 of the restraint is delivered to the distal end. Since the restraint segment 41 is sleeved on the anchor 1, the scaling segment 42 of the restraint is blocked by the restraint segment 41 when it is delivered at the distal end, so that the distal winding part of the scaling segment 42 is separated, thereby increasing the length of the restraint segment 41 to reduce the restraining force on the anchor 1. Conversely, the scaling segment 42 of the restraint is pulled toward the proximal end to reduce the length of the restraint segment 41 and increase the restraining force on the anchor 1.

[0117] In some other embodiments, such as Figure 10 and Figure 11 shown, the scaling sections 42 of the linear restraint are two ends parallel to each other. At this time, only delivering the scaling section 42 of the restraint to the distal end or pulling the scaling section 42 of the restraint to the proximal end can achieve the control of the binding force on the anchor 1.

[0118] In some other embodiments, such as Figure 16 shown, one end of the linear restraint is sleeved on the restraint body. Specifically, a closed hole or ring can be provided at the end of the linear restraint to form a binding section 41, and the other end of the linear restraint forms the scaling section 42.

[0119] In this embodiment, to prevent the restraint device 4 from slipping when restraining the anchor 1, a plurality of protrusions 43 are provided on the binding section 41. The protrusions 43 are adapted to be engaged with the anchor 1 to increase the friction between the restraint device 4 and the anchor 1 and prevent the restraint device 4 from slipping during the release process. Of course, the friction can also be increased through surface treatment to achieve the effect of preventing the restraint device 4 from slipping during the release process.

[0120] In this embodiment, such as Figure 12 shown, the protrusion 43 is a boss provided on the binding section 41. Its position is not limited to the position in the figure and can also be set at other positions on the binding section 41 as long as it can be engaged with the anchor 1. Among them, being engaged with the anchor 1 can be understood as that the anchor 1 is provided with a groove or a clamping part adapted to the protrusion 43, etc. Figure 13 For Figure 12 the structural schematic view of the opening of the binding section 41 in

[0121] Such as Figure 14 shown, Figure 14 is another form of the protrusion 43, which is a serration provided on the inner side of the binding section 41. Its function is the same as that of the above-mentioned boss, both of which are engaged with the anchor 1 to achieve the effect of preventing the restraint device 4 from slipping during the release process. Figure 15 For Figure 14 the structural schematic view of the opening of the binding section 41 in

[0122] In some other embodiments, a metal wire can also be wound around the binding section 41 to increase the friction between the binding section 41 and the anchor 1. A coating and a polymer material can also be provided on the binding section 41 to increase the friction, or a coating or a polymer material can also be provided alone.

[0123] In this embodiment, the constraint device 4 is used to constrain the self-expanding nickel-titanium structure of the anchor 1. Compared with the existing method of using a capsule to constrain the anchor 1, its structure is simpler, which makes the entire delivery system easier to produce and quality control. In addition, compared with the capsule constraint of the prior art, the constraint device 4 can apply an adjustable radial force to the anchor 1 according to the position in the annulus and the aorta, which is more flexible and controllable, and is also easier to operate, so that the relative position of the valve frame body remains unchanged, and the entire release process is more reliable, controllable and safe.

[0124] At the same time, for the constraint device 4 in this embodiment, when the anchor 1 enters the diseased position, the position of the anchor 1 is adjusted. For special anatomical structures, by pulling the constraint device 4, multiple bending adjustments of the anchor 1 and the delivery system sleeved inside the stent body can be completed. Combining with the bending adjustment function of the system itself, it is ensured that the artificial valve is coaxial with the annulus during release. The traction of the constraint device 4 can improve the anchoring accuracy and surgical safety.

[0125] Embodiment 3

[0126] This embodiment provides a delivery system for delivering the stent body 2 and the anchor 1 in Embodiment 1. The anchor 1 is connected to the stent body 2. The delivery system includes a sheath device and the constraint device 4 in Embodiment 2. The anchor 1 and the stent body 2 are sleeved on the distal surface of the sheath device and are sent into the human body through the sheath device. The distal end of the sheath device is provided with a tip head 5-tip for easy threading.

[0127] In this embodiment, as Figure 17 and Figure 18 shown, the sheath device includes an inner layer tube 7, a middle layer tube 8, and an outer layer tube 9 sleeved in sequence from the inside to the outside. A guide wire is suitable for passing through the inner layer tube 7, and a balloon is provided on the distal surface of the middle layer tube 8. The stent body 2 and the anchor 1 are suitable for being sleeved on the periphery of the balloon.

[0128] As Figures 4 to 6 shown, the constraining section 41 of the constraining member in the constraint device 4 is suitable for being sleeved on the periphery of the anchor 1, and the release tube 44 is arranged between the middle layer tube 8 and the outer layer tube 9. In some other embodiments, the release tube 44 can also be arranged outside the outer layer tube 9, and displacement is achieved by proximal pushing and pulling. By pulling the constraint device 4, the diameter of the constraining section 41 is changed to constrain and release the anchor 1, and assist in bending adjustment of the system under special conditions.

[0129] In this embodiment, the middle layer tube 8 can press and hold the artificial valve at the proximal end of the balloon 6. During the positioning stage of the release of the anchor 1, the handle fixed to the proximal end of the middle layer tube 8 is rotated to assist in positioning the anchor 1. After positioning, the balloon 6 is pressurized by a pressure pump to expand the artificial valve. The outer layer tube 9 is an axially pushed bending adjustment lumen. After the outer layer tube 9 crosses the vascular sheath, the artificial valve can be delivered to the position of the balloon 6 by pushing its proximal end. The handle connected to the proximal end of the outer layer tube 9 controls the bending to make the system coaxial with the valve annulus.

[0130] The delivery system provided in this embodiment, compared with the existing sheath tube system, has the functions of bending adjustment and filling with contrast agent. It has a relatively thick diameter and limited space between the lumens, which is not conducive to emptying and water passing. This delivery system optimizes the overall structure and function of the system, and the space between the lumens can be appropriately widened, which is conducive to emptying and water passing. The introduction of the constraint device 4 enables the delivery system to have better control force when releasing the artificial valve, ensuring that when the anchor 1 reaches the lesion site, the anchor 1 is slowly released to prevent damage to the aorta and the bottom of the sinus.

[0131] Embodiment 4

[0132] This embodiment provides a delivery method, which uses the delivery system in Embodiment 3 to deliver an artificial valve. The artificial valve includes a stent body 2 and the anchor 1 in Embodiment 1. When the release tube in the constraint device is arranged between the middle layer tube and the outer layer tube, the delivery method includes:

[0133] Step 1: Puncture the patient's artery, place a vascular sheath in the main access, place a pigtail catheter in the auxiliary access to locate the lesion site and use it for angiography, and place the above-mentioned constraint device 4 inside the outer layer tube 9;

[0134] Step 2: Use the outer layer tube 9 to press-fit the artificial valve at the proximal end of the balloon 6, and use a push sheath to send the delivery system into the vascular sheath along the guide wire. Before the anchor 1 exits the vascular sheath and expands, use the constraint device 4 to capture the anchor 1, or the constraint device pre-tightens the anchor 1;

[0135] Then push the proximal end of the outer layer tube, and push the artificial valve tied with the constraint device 4 to the outside of the balloon 6, and send the delivery system into the aortic sinus;

[0136] Step 3: Gradually release the constraint device 4 to release the anchor 1 so that it self-expands and opens (as shown in Figure 7 and Figure 19 ). According to the angiography and ultrasound images, assist in observing the anatomical structure of the sinus and the positional relationship between the anchor 1. Rotate the anchor 1 to align the sinus, and cooperate with the operation of the guide wire. Push and pull the delivery system to move the artificial valve up and down, and adjust the bending to achieve coaxiality, and cooperate to complete the positioning (as shown in Figure 20 );

[0137] Step 4: Under the rapid pacing state, the balloon 6 is inflated to release the artificial valve (as shown inFigure 21 As shown, the clamping section 11 of the anchor 1 clamps the fusion ridge where two leaflets are connected, and the protruding anchor 12 of the anchor 1 hangs on the native leaflet.

[0138] Step Five: Withdraw the delivery system, confirm the immediate effect by ultrasound, close the access, and complete the operation.

[0139] In this embodiment, when the release tube 44 is arranged outside the outer tube 9, the delivery method is as follows:

[0140] Step One: Puncture the patient's artery, place a vascular sheath in the main access, place the restraint device 4 and a pigtail catheter in the auxiliary access to locate the lesion and use for angiography.

[0141] Step Two: Use the outer tube 9 to press-fit the artificial valve proximal to the balloon 6. Push the delivery system into the vascular sheath along the guide wire using a push sheath. Before the anchor 1 exits the vascular sheath and opens, capture the anchor 1 using the restraint device 4. Then push the proximal end of the outer tube 9 to push the artificial valve tied with the restraint device 4 to the outside of the balloon 6, and send the delivery system into the aortic sinus.

[0142] Step Three: Gradually release the restraint device 4 to release the anchor 1, allowing it to self-expand and open. Observe the anatomical structure of the sinus and the positional relationship of the anchor 1 based on angiography and ultrasound images. Rotate the anchor 1 to achieve sinus alignment. Cooperate with the operation of the guide wire, push and pull the delivery system to move the artificial valve up and down, and adjust the bend to achieve coaxiality to complete the positioning (as Figure 22 shown).

[0143] Step Four: Under rapid pacing, inflate the balloon 6 to release the artificial valve. The clamping section 11 of the anchor 1 clamps the fusion ridge where two leaflets are connected, and the protruding anchor 12 of the anchor 1 hangs on the native leaflet.

[0144] Step Five: Withdraw the delivery system, confirm the immediate effect by ultrasound, close the access, and complete the operation.

[0145] In this embodiment, during the delivery, release, and retrieval stages of the anchor 1, the tension of the anchor 1 can be reduced by injecting ice water into the vascular sheath.

[0146] The delivery method provided in this embodiment, due to using the delivery system in Embodiment 3, thus has all the advantages of the delivery system in Embodiment 3.

[0147] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation manners here. And the obvious changes or modifications derived therefrom are still within the protection scope of the present invention.

Claims

1. An anchor, adapted to be connected to a stent body (2), characterized in that, the anchor (1) includes: a clamping section (11), including at least two connected anchor clips, the two anchor clips being in interference nesting with each other to clamp the fusion ridge where two leaflets are connected;; a protruding anchor (12), provided on one side of the clamping section (11), the protruding anchor (12) being a single-ring structure or multi-ring nesting to mount or carry the leaflets.

2. The anchor according to claim 1, characterized in that, the surface of the protruding anchor (12) is wrapped with a polymer material.

3. A constraining device for constraining the anchor (1) according to claim 1 or 2, characterized in that, it includes at least one constraining member, and the constraining member includes: a constraining section (41), the constraining section (41) being annularly sleeved on the periphery of the anchor (1) so that the anchor (1) can maintain a compressed state during transportation; a scaling section (42), the scaling section (42) being connected to the constraining section (41), the scaling section (42) being configured to control the binding force of the constraining section (41) on the anchor (1) to control the release speed of the anchor (1); the constraining device (4) further includes a release tube (44) provided with through holes, and the constraining section (41) of the constraining member is configured to pass through the through holes and then be sleeved on the periphery of the anchor (1), and the scaling section (42) is disposed inside the release tube (44); or the constraining section (41) of the constraining member is configured to pass through the distal end of the release tube (44) and then be sleeved on the periphery of the anchor (1), and the scaling section (42) is disposed inside the release tube (44).

4. The constraining device according to claim 3, characterized in that, the constraining member is linear, and the linear constraining member is annularly sleeved on the periphery of the anchor (1) to form the constraining section (41), and both ends of the linear constraining member form the scaling section (42).

5. The constraining device according to claim 4, characterized in that, both ends of the linear constraining member are arranged in parallel, and the constraining member is configured to pull or deliver the scaling section (42) to change the diameter of the constraining section (41) to control the binding force of the constraining section (41) on the anchor (1).

6. The constraining device according to claim 4, characterized in that, both ends of the linear constraining member are wound around each other, and the constraining member is configured to pull or deliver the scaling section (42) to change the diameter of the constraining section (41) to control the binding force of the constraining section (41) on the anchor (1).

7. The constraining device according to claim 3, characterized in that, the constraining member is linear, one end of the linear constraining member is provided with a closed hole or a ring sleeved on the periphery of the anchor (1) to form the constraining section (41), and the other end of the linear constraining member forms the scaling section (42).

8. The constraining device according to any one of claims 3-7, characterized in that: The number of the binding members is at least two; a plurality of through holes are provided on the release tube (44) and are arranged axially aligned. The binding section (41) of the binding members is configured to pass through the through holes and then sleeved on the peripheral side of the anchoring member (1), and the scaling section (42) is arranged inside the release tube (44).

9. The restraint device according to any one of claims 3-8, characterized in that a plurality of protrusions (43) are provided on the binding section (41), and the protrusions (43) are adapted to be engaged with the anchoring member (1).

10. The restraint device according to any one of claims 3-8, characterized in that a wire is wound around the binding section (41) to increase the friction between the binding section (41) and the anchoring member (1).

11. The restraint device according to any one of claims 3-8, characterized in that a coating and / or a polymer material are provided on the binding section (41) to increase the friction.

12. A delivery system for delivering the stent body (2) and the anchoring member (1) according to claim 1 or 2, wherein the anchoring member (1) is connected to the stent body (2), characterized in that the delivery system includes: a sheath device, which includes an inner layer tube (7), a middle layer tube (8) and an outer layer tube (9) sleeved in sequence from the inside to the outside. A guide wire is adapted to be arranged inside the inner layer tube (7), and a balloon (6) is provided on the distal surface of the middle layer tube (8); and a restraint device (4) according to any one of claims 3-8, wherein the binding section (41) of the binding members in the restraint device (4) is adapted to be sleeved on the peripheral side of the anchoring member (1).

13. The delivery system according to claim 12, characterized in that the release tube (44) in the restraint device (4) is arranged between the middle layer tube (8) and the outer layer tube (9), or the release tube (44) is arranged outside the outer layer tube (9).

14. The delivery system according to claim 12 or 13, characterized in that the restraint device (4) is configured to pull the binding members to control the bending of the sheath device.

15. The delivery system according to claim 12, characterized in that the middle layer tube (8) is configured to press and hold the stent body (2) proximal to the balloon (6). The middle layer tube (8) rotates by operating its proximal handle during the release and positioning stage of the anchoring member (1), and assists in positioning the anchoring member (1) during the release and positioning stage of the anchoring member (1).

16. The delivery system according to claim 12, characterized in that the outer layer tube (9) is configured to deliver the stent body (2) to the position of the balloon (6).

17. A delivery method using the delivery system according to any one of claims 12-16 for delivering an artificial valve, the artificial valve including a stent body (2) and the anchoring member (1) according to claim 1 or 2, and the release tube (44) in the restraint device (4) is arranged between the middle layer tube (8) and the outer layer tube (9), characterized in that the delivery method includes: Step 1: Puncture the patient's artery, place a vascular sheath in the main access, place a pigtail catheter in the auxiliary access to locate the lesion site and use it for angiography, and place the restraint device described in any one of claims 3-8 inside the outer tube (9); Step 2: Use the outer tube (9) to press-fit the artificial valve onto the proximal end of the balloon (6), use the push sheath to send the delivery system into the vascular sheath along the guide wire, capture the anchor (1) with the restraint device (4) before the anchor (1) opens out of the vascular sheath, or pre-tighten the anchor (1) with the restraint device (4); Then push the proximal end of the outer tube (9) to push the artificial valve tied with the restraint device (4) to the outside of the balloon (6), and send the delivery system into the aortic sinus; Step 3: Gradually release the restraint device (4) to release the anchor (1) so that it expands and opens by itself. According to the angiography and ultrasonic images, assist in observing the sinus anatomical structure and the position of the anchor (1), rotate the anchor (1) to achieve sinus alignment, cooperate with the guide wire operation, push and pull the delivery system to move the artificial valve up and down, adjust the bend to achieve coaxiality, and cooperate to complete the positioning; Step 4: Under the rapid pacing state, inflate the balloon (6) to release the artificial valve. The clamping section (11) of the anchor (1) clamps the fusion ridge where the two valve leaflets are connected, and the protruding anchor (12) of the anchor (1) hangs on the autologous valve leaflet; Step 5: Withdraw the delivery system, confirm the immediate effect by ultrasound, close the access, and complete the operation.

18. A delivery method, using the delivery system described in any one of claims 12-16 to deliver an artificial valve. The artificial valve includes a stent body (2) and the anchor (1) described in claim 1 or 2, and a release tube (44) is arranged outside the outer tube (9), characterized in that, the delivery method includes: Step 1: Puncture the patient's artery, place a vascular sheath in the main access, place the restraint device (4) and a pigtail catheter in the auxiliary access to locate the lesion site and use it for angiography; Step 2: Use the outer tube (9) to press-fit the artificial valve onto the proximal end of the balloon (6), use the push sheath to send the delivery system into the vascular sheath along the guide wire, capture the anchor (1) with the restraint device (4) before the anchor (1) opens out of the vascular sheath, then push the proximal end of the outer tube (9) to push the artificial valve tied with the restraint device (4) to the outside of the balloon (6), and send the delivery system into the aortic sinus; Step 3: Gradually release the restraint device (4) to release the anchor (1) so that it expands and opens by itself. According to the angiography and ultrasonic images, assist in observing the sinus anatomical structure and the position of the anchor (1), rotate the anchor (1) to achieve sinus alignment, cooperate with the guide wire operation, push and pull the delivery system to move the artificial valve up and down, adjust the bend to achieve coaxiality, and cooperate to complete the positioning; Step 4: Under the rapid pacing state, inflate the balloon (6) to release the artificial valve. The clamping section (11) of the anchor (1) clamps the fusion ridge where the two valve leaflets are connected, and the protruding anchor (12) of the anchor (1) hangs on the autologous valve leaflet; Step 5: Withdraw the delivery system, confirm the immediate effect by ultrasound, close the access, and complete the operation.

19. According to the delivery method described in claim 17 or 18, characterized in that, During the transportation, release, and recovery phases of the anchor (1), the tension of the anchor (1) can be reduced by injecting ice water into the interior of the vascular sheath.

Images