A valve delivery system capable of stable release and retrieval

Abstract

The present application relates to the field of medical devices, and in particular to a valve delivery system that can be stably released and recovered, comprising: an implant device, a delivery catheter, a release device and a restraint device, wherein the restraint device can move away from and move in a restricted manner relative to the release device, and the release device is connected to the delivery catheter; when the implant device is pre-installed, the implant device and the restraint device are detachably connected, and the distal end of the implant device and the restraint device are confined in the release device; during the process of releasing the implant device, the restraint device moves away from the release device, and at the same time, during the recovery of the release device, in order to prevent the implant device from being entangled or hooked on the release device, during the process of the release device passing through the implant device, the second restraint member provides a force on the first restraint member to ensure that the first restraint member is stationary or moves slightly, so that the first restraint member and the proximal end of the release device remain in contact or proximity, and there is no space between the release device and the first restraint member for the implant device to enter.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a valve delivery system capable of stable release and recovery. Background Art

[0002] Aortic valve stenosis is mainly caused by the sequelae of rheumatic fever, congenital aortic valve structural abnormalities or senile aortic valve calcification. Patients are asymptomatic during the compensatory period, while patients with severe aortic valve stenosis often experience fatigue, dyspnea (exertional or paroxysmal), angina pectoris, dizziness or syncope, and may even die suddenly.

[0003] Aortic regurgitation means that the aortic valve opens when the ventricle contracts, and the blood in the left ventricle enters the aorta and is ejected to the whole body. It closes when the ventricle relaxes, preventing the blood in the aorta from flowing back to the left ventricle. If aortic valve insufficiency occurs, the aortic valve cannot close tightly during diastole, causing blood to flow back from the aorta into the left ventricle.

[0004] In the treatment of aortic valve disease, surgical valve replacement is a traditional and effective treatment method. However, most patients with this disease are elderly and have multiple organ diseases. Their physical conditions make it difficult for them to undergo surgery, making them hopeless patients for clinical treatment. In addition, the cause of degenerative aortic valve disease is still unclear, and it is impossible to treat the cause, nor is there an effective way to curb its development, and drug treatment is ineffective. Ideal measures for the treatment of aortic valve disease should be able to both improve the patient's symptoms and prolong their life. Percutaneous aortic balloon valvuloplasty, which was carried out in the early years, was used to treat aortic valve stenosis, but both single-center data and multi-center registration data showed that its long-term effect was poor. In China, surgical valve replacement is still a major treatment option. In recent years, some scholars at home and abroad have carried out basic and clinical research on percutaneous aortic valve replacement and have made some breakthrough progress. It provides an effective treatment method for high-risk elderly patients with aortic valve degeneration who need surgical valve replacement. In 2002, Cribier et al. successfully performed transcatheter aortic valve replacement (TAVR). To date, more than 120,000 TAVR surgeries have been completed worldwide. Studies around the world have shown that this technology is safe and effective for patients who are unable to undergo surgical valve replacement or who are at high risk of surgical valve replacement. Although most patients who undergo TAVR surgery are high-risk patients, the 30-day survival rate after surgery is higher than 90%, and the hemodynamic indicators of patients after TAVR surgery are significantly improved.

[0005] However, native aortic valve regurgitation is still listed as a contraindication for TAVR. The main reason is that the stable release of the implanted device valve and the stable recovery of the delivery system are the key technical points in TAVR surgery. There are openings for the left and right coronary arteries on the aortic valve, and the mitral valve is adjacent to the valve. If the positioning and release are unstable, fatal complications such as the implanted device flying off, coronary artery blockage, or massive mitral valve regurgitation may occur. If the delivery system is entangled or hooked with the implanted device during recovery, it will affect the state of the implanted device that has been released, or the delivery system cannot be withdrawn, directly leading to surgical failure. Traditional TAVR devices, whether SAPIEN or CoreValve, are mainly used for patients with severe aortic valve stenosis and are not suitable for patients with aortic valve regurgitation. Domestic scholars and engineers have made some conceptual attempts to solve the problems of unstable release of implanted device valves and unstable recovery of delivery systems.

[0006] Patent CN201180025091.9 provides an insertion system for inserting a self-expandable heart valve stent into a patient's body, the insertion system having a catheter system and a handle connected to a proximal section of the catheter system, the catheter system comprising: a catheter tip having a seat portion for accommodating the stent in its folded state and a stent holder for releasably fixing the stent, wherein the seat portion is composed of a first sleeve-shaped member and a second sleeve-shaped member, wherein the first and second sleeve-shaped members are movable relative to each other and relative to the stent holder; and a catheter shaft, the catheter shaft being used to connect the catheter tip to the handle, the catheter shaft comprising: A first force transmission device, the first force transmission device having a distal section connected to the first sleeve-like member and a proximal section capable of being connected to a first operating device of the handle; and a second force transmission device, the second force transmission device having a distal section connected to the second sleeve-like member and a proximal section capable of being connected to a second operating device of the handle, and a guide device having a guide tube, the guide tube having a channel extending therebetween, wherein the first force transmission device and the second force transmission device are at least partially received in the channel so as to be movable relative to the guide tube; wherein the distal end of the guide tube terminates at the proximal end of the catheter tip; and the cross-section of the guide tube is smaller than the cross-section of the catheter tip, and wherein the guide device can be releasably connected to the handle, in which embodiment, the cross-section of the second sleeve-like member is similar to that of the first sleeve-like member. The cross-sections of the components are the same, so that the sleeve-shaped component can completely enclose the stent contained in the catheter tip without a gap between the first sleeve-shaped component and the second sleeve-shaped component, thereby providing a catheter tip with a non-traumatic shape. In addition, the first and second sleeve-shaped components can move relative to each other and relative to the stent holder. The technical defects of this solution are: first, after the implant device is released, it is necessary to operate the first sleeve-shaped component to move so that it cooperates with the second sleeve-shaped component to ensure that there is no gap between the first sleeve-shaped component and the second sleeve-shaped component, which increases the operating steps of the operation and improves the difficulty of the operation; second, the implant device is adaptive, and the simple cooperation between the first sleeve-shaped structure and the second sleeve-shaped structure causes the implant device to be directly released without buffering during the release of the distal end of the implant device, causing impact on the heart, or causing the implant device that has been positioned to shift, thereby increasing the risk of the operation.

[0007] Patent CN202022259169.2 provides a delivery system for a buffered release of an implantable device, including an implantable device, an inner tube, an outer sheath, a proximal control release device and a control handle, and also includes a distal control release device, one end of the implantable device is connected to the proximal control release device, the distal control release device includes a limiting sheath, a pull head and a limiter, the limiting sheath is connected to the distal end of the inner tube, the pull head and the limiter are arranged on the inner tube, the pull head is arranged on the distal side of the limiter, when the implantable device is loaded with the delivery system, the other end of the implantable device is connected to the pull head and is restricted in the limiting sheath, and the control handle is operated to make the limiting During the process of the sheath moving toward the distal end, the pull head and the limit piece cooperate to buffer and release the other end of the implanted device, so that the other end of the implanted device gradually separates from the limiting sheath. The technical defect of this solution is that during the recovery of the delivery system, in order to pass through the aortic arch, the operator will operate the control handle to swing the delivery catheter, but this operation will cause the limiting sheath to deviate from the center line of the aortic root, and then it is easy to hit the implanted device when recovering the limiting sheath. In addition, there is a possibility that the pull head will sink completely into the limiting sheath, so that there is space at the proximal end of the limiting sheath for the implanted device to enter, which will eventually cause the implanted device to be entangled or hooked with the limiting sheath, resulting in recovery failure or displacement of the implanted device that has been positioned.

[0008] In summary, due to the unreasonable design of the pull head in the prior art, errors may easily occur in the process of releasing the distal end of the implant device or retrieving the delivery system device, resulting in the inability to normally retrieve the delivery system or the displacement of the implant device that has been positioned. Summary of the invention

[0009] This application is proposed in view of the above and other more concepts.

[0010] One of the purposes of the present application is to overcome the deficiencies of the prior art and to provide a valve delivery system that can stably release and recover the valve due to unreasonable pull head structure design, displacement of the positioned implanted device or inability to recover the delivery system normally.

[0011] According to another aspect of the present application, a valve delivery system capable of stable release and recovery is provided, comprising: an implant device, a delivery catheter, a release device and a restraint device, wherein the restraint device can move away from and move in a restricted manner relative to the release device, and the release device is connected to the delivery catheter; when the implant device is pre-installed, the implant device and the restraint device are detachably connected, and the distal end of the implant device and the restraint device are confined within the release device; in the process of releasing the distal end of the implant device, the restraint device moves away from the release device.

[0012] According to one embodiment, during the release of the implant device, the release device moves toward the distal end, the implant device expands radially and contracts axially, and the proximal end of the constraint device moves toward the proximal end as the implant device contracts axially, thereby achieving the movement of the constraint device away from the release device; during the retraction of the release device, the release device moves toward the proximal end, and when the release device passes through the implant device, the constraint device remains in contact with or adjacent to the proximal end of the release device.

[0013] According to one embodiment, the restraint device comprises at least a first restraint member, and the release device comprises a limiting portion and a receiving space. Under the action of the implant device and / or the second restraint member, the first restraint member can move within the receiving space.

[0014] According to an embodiment, the maximum outer diameter of the first restraining member is smaller than or equal to the inner diameter of the limiting portion.

[0015] According to one embodiment, the restraint device includes a first restraint member and a second restraint member, and the release device includes a limiting portion and a receiving space. Under the action of the implant device and / or the second restraint member, the first restraint member can move in the receiving space.

[0016] According to an embodiment, an inner wall of the restricting portion may be tangent to an outer wall of the first restraining member.

[0017] According to one embodiment, the implant device includes a connecting piece, and during the recovery of the release device, there is no gap or a very small gap between the first constraint member and the proximal end of the release device, the first constraint member and the release device can respectively touch and slide over the connecting piece, and the connecting piece cannot enter the accommodating space to involve or hook the release device.

[0018] According to one embodiment, the first restraining member is substantially cylindrical or spherical in shape, and is provided with a limiting structure and a groove; and during pre-installation, the distal end of the implant instrument is limited between the limiting structure and the release device.

[0019] According to one embodiment, during the pre-installation of the implant device, the connector cooperates with the limiting structure and is confined within the limiting portion. The advantage of such a design is that during the release of the distal end of the implant device, as long as the limiting structure and the limiting portion overlap in the axial direction, the connector will not detach from the limiting structure, so the distal end of the implant device will not be directly released to cause impact on the heart.

[0020] According to one embodiment, the first restraint member includes a first connecting portion, a circular portion and a second connecting portion; and the limiting structure is arranged on the circular portion and the second connecting portion, and the groove passes through the first connecting portion, the circular portion and the second connecting portion.

[0021] According to one embodiment, when the release device moves toward the proximal end until the release device is sleeved outside the first restraint, blood can pass through the groove. The advantage of such a design is that when the release device is filled with blood, the release device will not be unable to sleeve the first restraint due to excessive pressure in the accommodating space, or the first restraint will not be unable to enter the limiting portion due to excessive pressure in the accommodating space.

[0022] According to one embodiment, the delivery catheter includes an inner tube, which is connected to the release device; and the first restraint member and the second restraint member are respectively sleeved outside the inner tube, and the first restraint member can move along the inner tube.

[0023] According to one embodiment, the second restraint is movable along the inner tube.

[0024] According to one embodiment, after the distal end of the implant instrument is released, the second restraining member does not contact the first restraining member and the release device.

[0025] According to one embodiment, the second restraining member is an elastic member, one end of the elastic member is connected to or in contact with the release device, and the other end of the elastic member is connected to or in contact with the first restraining member.

[0026] According to an embodiment, the elastic member is arranged at a distal end of the first restraining member.

[0027] According to one embodiment, during the process of retrieving the release device, when the release device and the first restraint member move proximally until the first restraint member touches the implant device, the implant device provides a force in the distal direction to the first restraint member, and the elastic member provides a supporting force in the proximal direction to the first restraint member.

[0028] According to one embodiment, the elastic member is a pagoda-shaped spring, which can be compressed into a pancake or disc shape during pre-installation of the implant device.

[0029] According to one embodiment, after the implant device is released, the first constraint member is located at the proximal end of the release device. During the recovery of the release device, the first constraint member touches the implant device and remains stationary under the action of the implant device. The release device continues to move until it touches the first constraint member, and under the action of the elastic member, the proximal end of the release device maintains contact or proximity with the first constraint member. The release device and the first constraint member slide over the implant device respectively to complete the recovery.

[0030] According to one embodiment, during pre-assembly of the implant device, in the cross-sectional direction of the first restraint member, the inner tube, the first restraint member, and the release device are arranged from inside to outside.

[0031] According to one embodiment, after the distal end of the implant instrument is released, the first restraining member and the release device do not overlap at all or partially overlap in the axial direction.

[0032] According to one embodiment, during the release of the distal end of the implant instrument, the release device moves toward the distal end, and the first restraining member moves toward the proximal end relative to the release device under the action of the connecting member and the elastic member.

[0033] According to one embodiment, during the recovery of the release device, the first restraint is partially sleeved within the release device.

[0034] According to one embodiment, during the retraction of the release device, one end of the elastic member abuts against the release device, and the other end supports the first restraining member, so that the first restraining member is in contact with or adjacent to the proximal end of the release device.

[0035] According to an embodiment, when the elastic member is in a natural state, the inner wall of the limiting portion is tangent to the outer wall of the first restraining member.

[0036] According to one embodiment, the second restraint member is a flexible member / rigid member, and a control handle is further provided at the distal end of the delivery catheter. One end of the flexible member / rigid member is connected to the first restraint member, and the other end of the flexible member / rigid member is connected to the control handle.

[0037] According to one embodiment, the second restraint is disposed at a proximal end of the first restraint.

[0038] According to one embodiment, during the process of retrieving the release device, when the release device and the first restraint member move proximally until the first restraint member touches the implant device, the implant device provides a force in the distal direction to the first restraint member, and the control handle is operated so that the flexible member / rigid member provides a pulling force in the proximal direction to the first restraint member.

[0039] According to one embodiment, the restraint device further comprises a limiting rod.

[0040] According to an embodiment, the limiting rod is integrally formed with the first restraining member; or the limiting rod is permanently fixed to or detachably connected to the first restraining member.

[0041] According to one embodiment, when the first restraining member is in contact with or adjacent to the proximal end of the release device, the portion with the largest diameter of the limiting structure is sleeved in the release device.

[0042] According to one embodiment, the delivery catheter further includes an outer sheath, a bending adjustment tube, a control tube and a control device, and the control device is used to release the proximal end of the implant device.

[0043] According to one embodiment, on a cross section of the delivery catheter, the inner tube, the control tube, and the outer sheath tube are arranged from inside to outside.

[0044] According to an embodiment, the restricting tube is movable along the inner tube.

[0045] According to one embodiment, the proximal end of the implant instrument is detachably connected to the control device, the control tube can drive the control device to rotate, and then the control device drives the implant instrument to rotate, and the first restraint member can rotate relative to the inner tube.

[0046] According to one embodiment, the implant device further comprises a clamp, and the clamp can be fixed at the bottom of the aortic valve sinus.

[0047] According to one embodiment, a valve delivery system capable of stable release and retrieval includes: an implantation device, a delivery catheter, a release device and an anti-interference device; the anti-interference device can move away from the release device and move close to the release device in a restricted manner.

[0048] According to one embodiment, the delivery catheter includes an inner tube, which is connected to the release device, and the anti-interference device includes a restriction member and a support member, which are sleeved outside the inner tube and can move within the restriction device; during the process of retrieving the release device, when the support member touches the implant device, the restriction member can provide a supporting force in the proximal direction to the support member, so that the support member maintains contact or proximity with the proximal end of the release device, and there is no space in the restriction device that the implant device can enter.

[0049] According to one embodiment, the release device further comprises an anti-slip mechanism for preventing the first restraining member from escaping from the release device.

[0050] According to one embodiment, the anti-slip mechanism includes a guide rail provided on the release device and a boss provided on the first restraining member, and the boss moves along the guide rail.

[0051] Compared with the prior art, the advantages of the technical solution of the present application include at least the following:

[0052] 1. In the prior art, after the implant device is released, due to the unreasonable structural design of the pull head, when the delivery catheter passes through the aortic arch, the implant device and the restraining sheath may be entangled or hooked, making it impossible for the delivery system to be withdrawn from the heart normally, or the implant device may be displaced due to excessive force when getting rid of the implant device. The technical solution of the present application avoids the above problems. This solution adopts a valve delivery system that can be stably released and recovered. The delivery system includes a release device and a restraint device arranged on the delivery catheter. The restraint device can move away from the release device and move close to it in a restricted manner. After the implant device is released, the restraint device moves away from the release device to assist in the stable release of the distal end of the implant device. The restraint device includes a first restraint member and a second restraint member. When the release device is recovered, the release device moves toward the proximal end. In order to prevent the implanted device from being pulled or hooked on the release device, during the process of the release device passing through the implanted device, the second restraint member provides a force on the first restraint member to ensure that the first restraint member is stationary or moves slightly, so that the first restraint member and the proximal end of the release device remain in contact or proximity, and there is no space between the release device and the first restraint member that the implanted device can enter. The first restraint member and the release device can pass through the implanted device smoothly, preventing the implanted device from accidentally pulling the release device. The entire release device recovery process is simple and labor-saving, and there is no need to control the second restraint member. The operation is convenient, the recovery success rate is high, and it has good clinical significance.

[0053] 2. According to one concept of the present application, the release device includes a limiting portion and a accommodating space. When the implant device is pre-installed, the distal end of the implant device is placed in the accommodating space, and the restraint device and the implant device are detachably connected. Since the maximum outer diameter of the first restraint member is less than or equal to the inner diameter of the limiting portion, the first restraint member can move in the accommodating space, and the implant device has adaptability. When the release device is operated to move toward the distal end, the implant device expands radially and contracts axially, so that the restraint device moves toward the proximal end as the implant device contracts axially. At the same time, the second restraint member provides a proximal support force to the first restraint member to assist in releasing the distal end of the implant device, thereby achieving stable release of the implant device.

[0054] 3. According to one concept of the present application, a limiting structure is provided on the first restraint member, and the distal end of the implant device includes a connecting member. During the pre-installation of the implant device, the connecting member is restricted between the limiting structure and the limiting portion. During the release of the distal end of the implant device, since the limiting structure and the limiting portion overlap axially, the connecting member will be clamped by the limiting structure and the limiting portion inside and outside, so the distal end of the implant device will be slowly released until the connecting member is only subjected to one of the forces of the limiting structure and the limiting portion or is not subjected to any force at all, and the distal end of the implant device will be completely released. In this way, the entire release process is stable and impact-free, with a high release success rate, and will not cause the position of the implant device to shift, nor will it damage the heart tissue. The structural design is ingenious and has strong practicality.

[0055] 4. According to one concept of the present application, the first restraint member is generally spherical in shape. When the implant device touches the first restraint member, the implant device can smoothly slide over the first restraint member due to the round and smooth surface of the first restraint member, so that the implant device has a tendency to move tangent to the first restraint member and away from the release device, which can effectively prevent the implant device from entering the release device and improve the recovery success rate of the delivery system.

[0056] 5. According to one concept of the present application, the first restraint member includes a first connecting portion, a circular portion and a second connecting portion, and the groove passes through the first connecting portion, the circular portion and the second connecting portion. The purpose of such design is that during the movement of the delivery catheter, the first restraint member may be separated from the release device, but in order to ensure that the release device is not entangled by the implanted device, the first restraint member will inevitably partially enter the accommodation space of the release device. The existence of the groove is to discharge the blood in the release device to prevent the release device from being unable to install the first restraint member due to excessive pressure in the accommodation space, and the first restraint member will not be unable to enter the restriction portion due to excessive pressure.

[0057] 6. According to an idea of ​​the present application, the second restraint is an elastic member, and both ends of the elastic member are connected to the release device and the first restraint respectively. During the process of recovering the release device, when the release device and the first restraint move toward the proximal end until the first restraint touches the implant device, the implant device provides a force toward the distal direction to the first restraint. Due to its own characteristics, the elastic member automatically provides a support force toward the proximal end to the first restraint. The supporting force of the elastic member ensures that the first restraint and the proximal end of the release device are always in contact or adjacent to each other, so that there is no gap between the first restraint and the proximal end of the release device, thereby achieving the purpose that the implant device cannot involve the release device. The structural design is ingenious and does not require additional operation, which effectively improves the surgical efficiency. At the same time, the elastic member is a pagoda-shaped spring. During the pre-installation of the implant device, the pagoda-shaped spring can be compressed into a pancake shape and does not occupy space in the conveying system, thereby improving the internal space utilization of the conveying system. That is, the elastic member solves the problem of the release device being involved by the implant device without increasing the operating steps and occupying space.

[0058] 7. According to one concept of the present application, when the first restraint is in contact with or adjacent to the proximal end of the release device, the largest diameter portion of the limiting structure is sleeved within the release device. The advantage of such a design is that during the recovery of the release device, when the connector of the implanted device happens to be aligned with the limiting structure, since the largest diameter portion of the limiting structure is sleeved within the release device, the space between the limiting structure and the release device is insufficient for the connector to enter, thereby avoiding the accidental entanglement of the implanted device and the release device.

[0059] 8. According to one concept of the present application, the delivery system includes a release device and an anti-interference device arranged on the delivery catheter, and the anti-interference device includes a limiting member and a supporting member. After the implanted device is released normally, the control handle is operated to withdraw the delivery system from the body. When the release device is recovered, the release device moves toward the proximal end. In order to prevent the implanted device from pulling or hooking or interfering with the release device, when the support member contacts the implanted device, the limiting member provides a force to the support member to ensure that the support member is stationary or moves slightly, so that the support member and the proximal end of the release device remain in contact or proximity, and there is no space between the release device and the support member that the implanted device can enter. The support member and the release device can smoothly pass through the implanted device to complete the recovery of the delivery system, thereby preventing the implanted device from accidentally pulling the release device. The entire release device recovery process is simple and labor-saving, does not require manual control of the limiting member, is easy to operate, and has a high recovery success rate, which has great clinical significance.

[0060] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one, and these other technical effects may be partially described below; and they are predictable and understandable to those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0062] Figure 1a and 1b It is a schematic diagram of the overall structure of the delivery system when the implant device is pre-installed, and a schematic diagram of the state in which the restraining device and the releasing device cooperate to prevent the implant device from being hooked when the delivery system is recovered.

[0063] Figure 2a to 2d It is a schematic diagram of the position relationship and structure of the first restraining member of the present invention.

[0064] Figure 3a to 3e It is a schematic structural diagram of the elastic member of the present invention.

[0065] Figures 4a to 4h It is a schematic diagram of the operation process of releasing the implant device and retrieving the delivery system of the present invention.

[0066] Figure 5a and 5b This is another embodiment of the present invention.

[0067] The features indicated by the numbers in the accompanying drawings are as follows:

[0068] 1-implantation device, 11-connecting part, 12-clamping part, 2-delivery catheter, 21-inner tube, 22-control tube, 23-outer sheath, 24-control device, 25-bending tube, 3-releasing device, 31-limiting part, 32-accommodating space, 4-restraint device, 41-first restraining part, 411-first connecting part, 412-circular part, 413-second connecting part, 414-limiting structure, 415-groove, 42-second restraining part, 421-elastic part, 43-limiting rod, 5-control handle, 6-anti-interference device, 61-restricting part, 62-supporting part. DETAILED DESCRIPTION

[0069] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0070] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments; and may be implemented or executed in various ways. Each example is provided by way of explanation and not limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalent elements.

[0071] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0072] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0073] In the present application, the term “proximal end” or “proximal side” refers to an end or a side closer to a surgical operator, and the term “distal end” or “distal side” refers to an end or a side farther from a surgical operator.

[0074] In the present application, the term "retrieval" refers to withdrawing the release device from the heart after the implanted device is released and fixed in the heart.

[0075] In the prior art, due to the unreasonable design of the device for releasing the distal end of the implanted instrument, errors are prone to occur in the process of releasing the distal end of the implanted instrument or retrieving the delivery system device, resulting in the implanted instrument being displaced after being positioned or the delivery system being unable to be retrieved normally.

[0076] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

[0077] Embodiment 1

[0078] like Figure 1a and 1bAs shown, a valve delivery system capable of stable release and recovery according to an embodiment of the present application is illustrated, comprising: an implant device 1, a delivery catheter 2, a release device 3 and a restraint device 4, wherein the restraint device 4 can move away from and move towards the release device 3 in a restricted manner, and the release device 3 is connected to the delivery catheter 2; when the implant device 1 is pre-installed, the implant device 1 and the restraint device 4 are detachably connected, and the distal end of the implant device 1 and the restraint device 4 are confined within the release device 3; in the process of releasing the distal end of the implant device 1, the restraint device 4 moves away from the release device 3.

[0079] In the first embodiment, during the release of the implant device 1, the release device 3 moves toward the distal end, the implant device 1 expands radially and contracts axially, and the proximal end of the constraint device 4 moves toward the proximal end as the implant device 1 contracts axially, thereby achieving the movement of the constraint device 4 away from the release device 3; during the recovery of the release device 3, the release device 3 moves toward the proximal end, and when the release device 3 passes through the implant device 1, the constraint device 4 maintains contact or proximity with the proximal end of the release device 3.

[0080] In the first embodiment, the restraining device 4 includes a first restraining member 41 and a second restraining member 42, and the releasing device 3 includes a limiting portion 31 and an accommodating space 32. Under the action of the implant device 1 and / or the second restraining member 42, the first restraining member 41 can move in the accommodating space 32. Figure 2a shown.

[0081] In the first embodiment, the maximum outer diameter of the first restraining member 41 is smaller than or equal to the inner diameter of the limiting portion 31 .

[0082] In the first embodiment, the implant device 1 includes a connector 11, such as Figure 1a As shown, during the recovery of the release device 3, there is no gap or a very small gap between the first restraint 41 and the proximal end of the release device 3, the first restraint 41 and the release device 3 can respectively touch and slide over the connecting member 11, and the connecting member 11 cannot enter the accommodating space 32 to involve or hook the release device 3.

[0083] In the first embodiment, the first restraining member 41 is generally cylindrical or spherical in shape. Figure 2b~2d As shown, a limiting structure 414 and a groove 415 are provided on the first restraining member 41 ; and during pre-installation, the distal end of the implant device 1 is limited between the limiting structure 414 and the release device 3 .

[0084] In the first embodiment, during the pre-installation of the implant device 1, the connector 11 cooperates with the limiting structure 414 to be restricted within the limiting portion 31. The advantage of such a design is that during the release of the distal end of the implant device 1, as long as the limiting structure 414 and the limiting portion 31 overlap in the axial direction, the connector 11 will not detach from the limiting structure 414, so the distal end of the implant device 1 will not be directly released to cause impact on the heart.

[0085] In the first embodiment, the first restraint member 41 includes a first connection portion 411 , a circular portion 412 and a second connection portion 413 ; and the limiting structure 414 is arranged on the circular portion 412 and the second connection portion 413 , and the groove 415 passes through the first connection portion 411 , the circular portion 412 and the second connection portion 413 .

[0086] In the first embodiment, when the release device 3 moves toward the proximal end until the release device 3 is sleeved outside the first restraining member 41, blood can pass through the groove 415. Figure 2d As shown, the advantage of such a design is that when the release device 3 is filled with blood, the release device 3 will not be unable to fit the first restraining member 41 due to excessive pressure in the accommodating space 32 .

[0087] In the first embodiment, the delivery catheter 2 includes an inner tube 21 , which is connected to the release device 3 ; and the first restraint member 41 and the second restraint member 42 are respectively sleeved on the outside of the inner tube 21 , and the first restraint member 41 can move along the inner tube 21 .

[0088] In the first embodiment, the second restraining member 42 is an elastic member 421 , one end of the elastic member 421 is in contact with the release device 3 , and the other end of the elastic member 421 is in contact with the first restraining member 41 .

[0089] In the first embodiment, during the recovery of the release device 3, when the release device 3 and the first restraining member 41 move toward the proximal end until the first restraining member 41 touches the implant device 1, the implant device 1 provides a force toward the distal direction to the first restraining member 41, and the elastic member 421 provides a supporting force toward the proximal end to the first restraining member 41. Figure 4f shown.

[0090] In the first embodiment, the elastic member 421 is a pagoda-shaped spring, which can be compressed into a pancake or disc shape during the pre-installation of the implant device 1. Figure 3a to 3e shown.

[0091] In the first embodiment, after the implant device 1 is released, the first constraint member 41 is located at the proximal end of the release device 3. During the recovery of the release device 3, the first constraint member 41 touches the implant device 1 and remains stationary under the action of the implant device 1. The release device 3 continues to move until it touches the first constraint member 41. Under the action of the elastic member 421, the proximal end of the release device 3 maintains contact or proximity with the first constraint member 41. The release device 3 and the first constraint member 41 slide over the implant device 1 respectively to complete the recovery.

[0092] In the first embodiment, after the distal end of the implant device 1 is released, the first restraining member 41 and the release device 3 do not overlap at all or only overlap partially in the axial direction.

[0093] In the first embodiment, during the release of the distal end of the implant device 1 , the release device 3 moves toward the distal end, and the first restraining member 41 moves toward the proximal end relative to the release device 3 under the action of the connecting member 11 and the elastic member 421 .

[0094] In the first embodiment, during the recovery of the release device 3 , the first restraining member 41 is partially sleeved inside the release device 3 .

[0095] In the first embodiment, the restraining device 4 further includes a limiting rod 43 .

[0096] In the first embodiment, the limiting rod 43 and the first restraining member 41 are integrally formed.

[0097] In the first embodiment, the delivery catheter 2 further includes an outer sheath 23 , a bending adjustment tube 25 , a control tube 22 and a control device 24 . The control device 24 is used to release the proximal end of the implant device 1 .

[0098] In the first embodiment, the proximal end of the implant device 1 is detachably connected to the control device 24 , the control tube 22 can drive the control device 24 to rotate, and then the control device 24 drives the implant device 1 to rotate, and the first restraint member 41 can rotate relative to the inner tube 21 .

[0099] In the first embodiment, the implant device 1 further comprises a clamp 12, and the clamp 12 can be fixed at the bottom of the aortic valve sinus. Figure 4d shown.

[0100] The operation process of an exemplary release implantation device 1 and a recovery delivery system of a valve delivery system capable of stable release and recovery in the first embodiment is as follows:

[0101] 1. The delivery system enters the heart via a transvascular approach, such as Figure 4aAs shown, the outer sheath 23 is then withdrawn to release the clamp 12 on the implant device 1 and the control handle 5 is operated to position the positioning member, as shown in FIG. Figure 4b As shown;

[0102] 2. Operate the control handle 5 to move the release device 3 toward the distal end, release the distal end of the implant device 1, and the distal end of the implant device 1 is stably released under the action of the restraint device 4, as shown in FIG. Figure 4c As shown;

[0103] 3. Operate the control device 24 to release the proximal end of the implant device 1, and the implant device 1 is released. Figure 4d As shown;

[0104] 4. Operate the control handle 5 to move the release device 3 toward the proximal end, such as Figure 4e As shown, the first restraining member 41 is in contact with or adjacent to the proximal end of the release device 3, and the first restraining member 41 and the release device 3 pass smoothly through the implant device 1, and the implant device 1 will not pull the release device 3. Figure 4f and 4g As shown;

[0105] 5. The entire delivery system is removed from the heart and the implantation is complete. Figure 4h shown.

[0106] Embodiment 2

[0107] Embodiment 2 is substantially the same as embodiment 2, except that the valve delivery system of this embodiment includes an anti-interference device.

[0108] like Figure 5a As shown, a valve delivery system capable of stable release and recovery according to an embodiment of the present application is illustrated, comprising: an implant device 1, a delivery catheter 2, a release device 3 and an anti-interference device 6, wherein the anti-interference device 6 can move away from and move close to the release device 3 in a restricted manner, and the release device 3 is connected to the delivery catheter 2; when the implant device 1 is pre-installed, the implant device 1 and the restraint device 4 are detachably connected, and the distal end of the implant device 1 and the restraint device 4 are restrained in the release device 3; in the process of releasing the distal end of the implant device 1, the restraint device 4 moves away from the release device 3.

[0109] In the second embodiment, the delivery catheter 2 includes an inner tube 21, and the inner tube 21 is connected to the release device 3. The anti-interference device 6 includes a restriction member 61 and a support member 62. The restriction member 61 and the support member 62 are sleeved outside the inner tube 21, and the restriction member 61 and the support member 62 can move in the restriction device 3; during the process of retrieving the release device 3, when the support member 62 abuts against the implant device 1, the restriction member 61 can provide a supporting force in the proximal direction to the support member 62, so that the support member 62 keeps in contact or adjacent to the proximal end of the release device 3, and there is no space in the restriction device 3 that the implant device 1 can enter. Figure 5b shown.

[0110] In the second embodiment, the support member 62 is cylindrical and has a smooth surface.

[0111] In the second embodiment, the limiting member 61 is an elastic member.

[0112] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, so they will not be described again here.

[0113] The foregoing description of several embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A valve delivery system capable of stable release and recovery, comprising: An implant device, a delivery catheter, a release device and a restraint device; characterized in that: the restraint device can move away from and move close to the release device in a restricted manner relative to the release device, and the release device is connected to the delivery catheter; when the implant device is pre-installed, the implant device and the restraint device are detachably connected, and the distal end of the implant device and the restraint device are confined within the release device; in the process of releasing the distal end of the implant device, the restraint device moves away from the release device; the restraint device includes a first restraint member and a second restraint member, and the release device includes a limiting portion and a accommodating space, under the action of the second restraint member and / or the implant device, the first restraint member can move within the accommodating space, during the recovery of the release device, the release device moves toward the proximal end, and when the release device passes through the implant device, the restraint device maintains contact or proximity with the proximal end of the release device.

2. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: During the release of the implant device, the release device moves toward the distal end, the implant device expands radially and contracts axially, and the proximal end of the restraint device moves toward the proximal end as the implant device contracts axially, thereby achieving the movement of the restraint device away from the release device.

3. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The maximum outer diameter of the first restraining member is smaller than or equal to the inner diameter of the restricting portion.

4. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The implant device includes a connecting piece. During the recovery of the release device, there is no gap or a very small gap between the first restraint member and the proximal end of the release device. The first restraint member and the release device can respectively touch and slide over the connecting piece, and the connecting piece cannot enter the accommodating space to involve or hook the release device.

5. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The first restraining member is generally cylindrical or spherical in shape, and is provided with a limiting structure and a groove; and during the pre-installation of the implant device, the distal end of the implant device is limited between the limiting structure and the release device.

6. A valve delivery system capable of stable release and recovery according to claim 5, characterized in that: During the pre-installation of the implant device, the distal end of the implant device cooperates with the limiting structure and is limited within the limiting portion.

7. A valve delivery system capable of stable release and recovery according to claim 5, characterized in that: The first restraining member includes a first connecting portion, a circular portion and a second connecting portion; and the limiting structure is arranged on the circular portion and the second connecting portion, and the groove passes through the first connecting portion, the circular portion and the second connecting portion.

8. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The delivery catheter comprises an inner tube, which is connected to the release device; and the first restraining member and the second restraining member are respectively sleeved outside the inner tube, and the first restraining member can move along the inner tube.

9. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The second restraining member is an elastic member, one end of the elastic member is connected to or in contact with the release device, and the other end of the elastic member is connected to or in contact with the first restraining member.

10. A valve delivery system capable of stable release and recovery according to claim 9, characterized in that: The elastic member is a pagoda-shaped spring, which can be compressed into a pancake or disc shape during the pre-installation of the implant device.

11. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The second restraining member is a flexible member / rigid member, and a control handle is also provided at the distal end of the delivery catheter. One end of the flexible member / rigid member is connected to the first restraining member, and the other end of the flexible member / rigid member is connected to the control handle.

12. A valve delivery system capable of stable release and recovery according to claim 1, characterized in that: The restraining device further comprises a restraining rod; the restraining rod is integrally formed with the first restraining member; or the restraining rod is permanently fixed to or detachably connected to the first restraining member.

13. A valve delivery system capable of stable release and recovery according to claim 5, characterized in that: When the first restraining member keeps in contact with or close to the proximal end of the release device, the portion with the largest diameter of the limiting structure is sleeved in the release device.

14. A valve delivery system capable of stable release and recovery, comprising: An implant device, a delivery catheter, a release device and an anti-interference device; characterized in that: the anti-interference device can move away from and move close to the release device in a restricted manner, the delivery catheter includes an inner tube, the inner tube is connected to the release device, the anti-interference device includes a restriction member and a support member, the restriction member and the support member are sleeved outside the inner tube, and the restriction member and the support member can move within the restriction device; during the process of retrieving the release device, when the support member abuts against the implant device, the restriction member can provide a supporting force to the support member in the proximal direction, so that the support member remains in contact with or adjacent to the proximal end of the release device, and there is no space in the restriction device that the implant device can enter.

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