A positioning member, a valve delivery system, and a balloon-expandable interventional device

Abstract

The present invention relates to a positioning member, a valve delivery system and a balloon expansion type interventional device. The positioning member includes a fixing part and a limiting part. The fixing part is connected to the limiting part. The limiting part has a first working state and a second working state. The limiting part is tubular and includes a retaining part and a connecting part arranged alternately in the circumferential direction. In the first working state, the limiting part is folded, and the retaining part is used to position the artificial implant. The connecting part shrinks and / or folds. In the second working state, the limiting part is opened, and the connecting part is stretched and / or unfolded in the circumferential direction, so that the circumferential size of the connecting part in the second working state is greater than the size of the connecting part in the circumferential direction in the first working state. The present invention uses a foldable limiting part to limit the shape of the retracted balloon so that it will not flatten and cause scratches on human blood vessels.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a positioning component, a valve delivery system and a balloon expansion type interventional device. Background Art

[0002] Balloon dilatation medical devices are important medical devices used to treat human diseases. They are used in artificial valves, coronary stents, etc. Here, artificial valves are taken as an example. The valve is a membrane structure that can be opened and closed inside the human organ, which acts as a one-way valve, so that blood can only flow from one direction to another and cannot flow back.

[0003] Take the heart as an example. The valves inside the heart control the direction of blood flow and play a vital role in ensuring adequate blood flow through the cardiovascular system. When the native valve is damaged, it can cause serious cardiovascular damage or even death. Artificial heart valves can be used to treat heart valve diseases.

[0004] Balloon-expandable valves have good radial support and a shorter valve frame, which can effectively reduce the risks of paravalvular leakage, malignant arrhythmias, coronary sinus occlusion, etc. introduced during the treatment process. Therefore, balloon-expandable valves are widely used in replacing human valves, such as heart valves. After the artificial heart valve is implanted, the balloon needs to be deflated and withdrawn from the body. During this process, due to the poor folding memory of the balloon material, the balloon becomes flat when deflated, which can easily scratch the blood vessels in the body. Summary of the invention

[0005] Based on the above situation, in order to solve the problem of the balloon becoming flattened and scratching blood vessels when it is retracted, the main purpose of the present invention is to provide a positioning member, a valve delivery system and a balloon expansion interventional device.

[0006] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0007] A positioning member, used for positioning an artificial implant sleeved on a balloon, the positioning member comprises a fixing portion and a limiting portion, one end of the fixing portion is connected to one end of the limiting portion, and the limiting portion has a first working state and a second working state accompanying the contraction and expansion of the balloon;

[0008] The limiting portion is tubular, and comprises alternately arranged retaining portions and connecting portions in the circumferential direction, wherein the retaining portions and connecting portions are connected to form the tubular limiting portion;

[0009] In the first working state, the limiting portion is folded, the retaining portion is used to position the artificial implant; the connecting portion is contracted and / or folded;

[0010] In the second working state, the limiting part is opened, and the connecting part is stretched and / or unfolded in the circumferential direction so that the circumferential dimension of the connecting part in the second working state is greater than the circumferential dimension of the connecting part in the first working state.

[0011] Preferably, the holding part is made of a hard material, and the connecting part is made of a soft material.

[0012] Preferably, in the first working state, the connecting part is located inside the holding part, or the connecting part is located outside the holding part, or part of the connecting part is located inside the holding part and part is located outside the holding part.

[0013] Preferably, the holding part includes a first holding part and a second holding part arranged at intervals from each other. The distance between the first holding part and the axis of the positioning member is greater than the distance between the second holding part and the axis of the positioning member. The elastic deformation range of the first holding part is less than the elastic deformation range of the second holding part. Each connecting part connects an adjacent pair of the first holding part and the second holding part.

[0014] Preferably, the positioning member includes a hard elastic strip and a soft film. The hard elastic strip can be opened under force and can be reset when the force is removed. The soft film is tubular. The hard elastic strips are arranged at intervals in the circumferential direction of the soft film and are fixed to the inner surface, and / or outer surface, and / or inside the soft film.

[0015] The hard elastic strip and the soft film located inside and / or outside the hard elastic strip form the holding part, and the soft film between adjacent holding parts forms the connecting part.

[0016] Preferably, the positioning member includes a hard elastic strip and a soft film. The soft film is connected between adjacent hard elastic strips. The hard elastic strips form the holding part, and the soft film between adjacent holding parts forms the connecting part.

[0017] Preferably, the hard elastic strip is made of nitinol or hard silicone, and the soft film is made of pebax or silicone or PU or nylon or PE.

[0018] Preferably, the thickness of the hard elastic strip is 0.1 - 1 mm, and the thickness of the soft film is 0.1 - 2 mm.

[0019] Preferably, the limiting part is formed by folding a ring-shaped foldable film inward multiple times. The inner fold angles and outer fold angles formed by the folding of the foldable film form the holding part, and the foldable film between adjacent inner fold angles and outer fold angles forms the connecting part.

[0020] Preferably, in the first working state, the inner folding angle is less than 90°.

[0021] In the second working state, the inner folding angle is less than 180°.

[0022] Preferably, the number of the holding parts formed by the outer folding angle is 3 - 15.

[0023] Preferably, the thickness of the foldable film is 0.1 - 2 mm.

[0024] Preferably, the foldable film is silicone or pebax or PU or nylon or PE.

[0025] Preferably, the shape of the limiting part is frustum-shaped, straight-tube-shaped or horn-shaped.

[0026] Preferably, the radial dimension of the end of the limiting part far from the fixing part is greater than or equal to the radial dimension of the end of the limiting part close to the fixing part, and the thickness of the end of the holding part far from the fixing part is greater than or equal to the thickness of the end of the holding part close to the fixing part.

[0027] Preferably, the lengths of the holding part and the connecting part in the extending direction of the positioning member are the same, and the end faces of the holding part and the connecting part far from the fixing part are used for positioning the...

[0028] Preferably, the length of the holding part in the extending direction of the positioning member is greater than the dimension of the connecting part in the extending direction of the positioning member, and the end face of the holding part far from the fixing part is used for positioning the artificial implant.

[0029] Preferably, the free end of the holding part far from the fixing part inclines towards the direction away from the axis of the positioning member, the inner side face of the free end of the holding part is used for positioning the artificial implant, and the lengths of the holding part and the connecting part in the extending direction of the positioning member are the same, or the length of the holding part in the extending direction of the positioning member is greater than the length of the connecting part in the extending direction of the positioning member.

[0030] Preferably, the limiting part is made of a developing material and has developability, or a contrast member is arranged on the peripheral wall of the limiting part.

[0031] In order to further solve the above problems, the present invention also provides a valve delivery system, which is used to deliver an artificial implant, wherein the artificial implant is an artificial valve. The valve delivery system includes a balloon, an outer tube and an inner tube, wherein the inner tube is inserted into the outer tube, and the artificial implant is sleeved on the balloon. Distal positioning members and proximal positioning members are provided at both ends of the balloon, and at least the proximal positioning member is fixed to the outside of the balloon or the distal end of the outer tube, and the above-mentioned positioning member is used to position the artificial valve.

[0032] In order to further solve the above-mentioned problem, the present invention further provides a balloon-expandable interventional instrument, which is used to deliver an artificial implant, and the balloon-expandable interventional instrument uses the above-mentioned positioning member to position the artificial implant.

[0033] The beneficial effects of the present invention are as follows: the present invention forms a tubular limiting portion by alternately setting a holding portion and a connecting portion, in a first working state, the limiting portion is folded, and the holding portion is used to position the artificial implant; in a second working state, the limiting portion is opened, and the connecting portion is stretched and / or expanded in the circumferential direction, so that the circumferential dimension of the connecting portion in the second working state is larger than the circumferential dimension in the first working state, which can assist the balloon to be more stably expanded and avoid excessive local expansion. When the balloon is retracted, the limiting portion can be folded into a tubular shape, limiting the shape of the retracted balloon, preventing the balloon from being flattened due to poor folding memory, and preventing the blood vessels from being scratched when the balloon is withdrawn from the human body.

[0034] Other beneficial effects of the present invention will be explained in the specific implementation manner through the introduction of specific technical features and technical solutions. Through the introduction of these technical features and technical solutions, those skilled in the art should be able to understand the beneficial technical effects brought about by the technical features and technical solutions. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings.

[0036] Figure 1 A schematic structural diagram of a positioning member provided by the present invention used on an artificial implant.

[0037] Figure 2 A schematic structural diagram of an embodiment of a positioning member provided by the present invention.

[0038] Figure 3 An embodiment of a positioning member provided by the present invention is a structural schematic diagram showing an end surface of the positioning member in a first working state.

[0039] Figure 4 Another embodiment of a positioning member provided by the present invention is a structural schematic diagram showing an end surface of the positioning member in a first working state.

[0040] Figure 5 Another embodiment of the positioning member provided by the present invention is a schematic structural diagram showing the end face of the positioning member in the first working state.

[0041] Figure 6 Another embodiment of the positioning member provided by the present invention is a schematic structural diagram showing the holding part.

[0042] Figure 7 Another embodiment of the positioning member provided by the present invention is a schematic structural diagram showing another holding part.

[0043] Figure 8 Another embodiment of the positioning member provided by the present invention is a schematic structural diagram showing the foldable film.

[0044] Figure 9 A schematic structural diagram of a balloon in a contracted state of an embodiment of a valve delivery system provided by the present invention.

[0045] Figure 10 A schematic cross-sectional view of a balloon in a contracted state of an embodiment of a valve delivery system provided by the present invention.

[0046] Figure 11 A schematic structural diagram of a balloon in an expanded state of an embodiment of a valve delivery system provided by the present invention.

[0047] Figure 12 A schematic cross-sectional view of a balloon in an expanded state of an embodiment of a valve delivery system provided by the present invention.

[0048] Figure 13 A schematic structural diagram of a balloon in a contracted state of another embodiment of a valve delivery system provided by the present invention.

[0049] Figure 14 A schematic structural diagram of a balloon in an expanded state of another embodiment of a valve delivery system provided by the present invention. Detailed implementation manners

[0050] The present invention will be described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid obscuring the essence of the present invention, well-known methods, processes, procedures, and components are not described in detail.

[0051] In addition, those of ordinary skill in the art should understand that the drawings provided herein are for illustrative purposes only, and the drawings are not necessarily drawn to scale.

[0052] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

[0053] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0054] It should be noted that, in the description of the present invention, the distal end and the proximal end are relative to the operator of the delivery system. The proximal end refers to the end close to the operator, and the distal end refers to the end far away from the operator. That is, for the same component, if it is only partially extended into the patient's body, the end extending into the patient's body is the distal end, and the end located outside the body close to the operator is the proximal end.

[0055] A positioning member is used for positioning an artificial implant. The positioning member comprises a fixing part and a limiting part. One end of the fixing part is connected to one end of the limiting part. The limiting part has a first working state and a second working state accompanying the contraction and expansion of a balloon.

[0056] The limiting portion is tubular, and comprises alternately arranged retaining portions and connecting portions in the circumferential direction, wherein the retaining portions and the connecting portions are connected to form the tubular limiting portion.

[0057] In the first working state, the limiting portion is folded, the retaining portion is used to position the artificial implant; the connecting portion is contracted and / or folded toward the inside of the positioning member.

[0058] In the second working state, the limiting portion is opened, and the connecting portion is stretched and / or expanded in the circumferential direction, so that the circumferential dimension of the connecting portion in the second working state is larger than the circumferential dimension of the connecting portion in the first working state.

[0059] The present invention provides a positioning piece, which is used for positioning an artificial implant sleeved on a balloon, preventing the artificial implant from being separated from the balloon during the process of being introduced into a human body, and can also assist the balloon to perform better expansion and contraction.

[0060] Reference Figure 1 and Figure 2 The positioning member includes a fixing portion 1 and a limiting portion 2. One end of the fixing portion 1 is connected to one end of the limiting portion 2. The limiting portion 2 is used to position the artificial implant and can be folded and opened along with the contraction and expansion of the balloon, and can also assist the balloon to expand and contract better. The fixing portion 1 is used to fix the positioning member on the delivery system for delivering the artificial implant into the human body.

[0061] As an embodiment, the shape of the fixing part 1 is a circular tube. It can be understood that its shape is not limited. The fixing part 1 is tubular, and its cross-section in the radial direction can be rectangular, oval, racetrack-shaped, etc. The tubular fixing part 1 can be very conveniently fixed on the artificial implant delivery system. It can be understood that the fixing part 1 can also be a spiral ring structure, or a structure with a C-shaped cross-section in the radial direction, as long as the fixing part 1 can fix the positioning part on the artificial implant delivery system.

[0062] As an embodiment, a chamfer 11 is provided at one end of the fixing part 1 away from the artificial implant to facilitate the withdrawal of the positioning part from the body. It can be understood that the chamfer 11 can be a rounded chamfer, a right chamfer, or a combination of both. The chamfer design is applicable to any embodiment of the present invention.

[0063] The limiting part 2 has retractability. When the balloon expands, the limiting part 2 is subjected to the force from the balloon, the balloon opens, and the limiting part 2 also opens accordingly. When the balloon contracts, the limiting part 2 also contracts accordingly.

[0064] The limiting part 2 is a tubular structure, and its specific shape is not limited. It can be frustum-shaped, straight tubular, trumpet-shaped, etc. In the drawings of the present invention, the limiting part 2 is taken as an example of being frustum-shaped for schematic illustration.

[0065] As an embodiment, the radial dimension of one end of the limiting part 2 away from the fixing part 1 is larger than the radial dimension of the end close to the fixing part 1. The larger radial dimension of the limiting part 2 at the end close to the artificial implant is beneficial to the smooth opening of the limiting part 2 when the balloon expands. As another embodiment, the radial dimension of one end of the limiting part 2 away from the fixing part 1 can be equal to the radial dimension of the end close to the fixing part 1, or can be set to other dimensions, as long as the radial dimension of the end of the limiting part 2 away from the fixing part 1 is larger than the inner diameter of the artificial implant and can play a role in positioning the artificial implant.

[0066] As an embodiment, the limiting part 2 can be made of a radiopaque material and thus has radiopacity. A contrast member can also be provided on the circumferential wall of the limiting part 2 to position the artificial implant after it enters the body.

[0067] Refer to Figure 3, the limiting part 2 includes a holding part 21 and a connecting part 22. The holding part 21 and the connecting part 22 are alternately arranged in the circumferential direction of the limiting part 2. The holding part 21 and the connecting part 22 are connected to form a tubular limiting part 2. The limiting part 2 has a first working state and a second working state along with the contraction and expansion of the balloon. In the first working state, the balloon is in a contracted state, the positioning member is in a retracted state, and the holding part 21 positions the artificial implant. The holding part 21 is used to contact the artificial implant to position the artificial implant. The connecting part 22 contracts and / or folds. When the balloon expands, the positioning member switches from the first working state to the second working state. During this process, the holding part 21 moves in a direction away from the axis of the positioning member. In the second working state, the balloon expands, and the positioning member expands under force. The connecting part 22 is stretched and / or unfolded in the circumferential direction so that the circumferential dimension of the connecting part 22 in the second working state is larger than the circumferential dimension of the connecting part 22 in the first working state in the circumferential direction.

[0068] The holding part 21 may include a first holding part 211 and a second holding part 212 that are spaced apart from each other. The distance between the first holding part 211 and the axis of the positioning member is greater than the distance between the second holding part 212 and the axis of the positioning member. The elastic deformation range of the first holding part 211 is smaller than the elastic deformation range of the second holding part 212. Each connecting part 22 connects an adjacent pair of the first holding part 211 and the second holding part 212. The first holding part 211 and the second holding part 212 are arranged to improve the strength of the positioning member to position the artificial implant.

[0069] As an embodiment, in the first working state, the connecting part 22 is located between the first holding part 211 and the second holding part 212. In the second working state, the connecting part 22 is stretched and / or unfolded along the circumferential direction of the positioning member as the balloon expands.

[0070] As another embodiment, referring to Figure 4 , the holding part 21a may also only include the first holding part 211a. It can be understood that the holding part 21a can ensure that the positioning member has sufficient strength to position the artificial implant. At this time, the connecting part 22a is located inside the holding part 21a. In the first working state, the connecting part 22a contracts and / or folds inwardly towards the inside of the positioning member; in the second working state, the connecting part 22a is stretched and / or unfolded along the circumferential direction of the positioning member under force as the balloon expands.

[0071] As an embodiment, the connecting part 22a may also be partially located inside the holding part 21a and partially located outside the holding part 21a. The positional relationship between the connecting part 22a and the holding part 21a can be changed according to the specific folding direction and folding depth (the folding depth is the depth of the folds caused by the folding of the connecting part 22) of the connecting part 22a.

[0072] As another embodiment, refer to Figure 5 , the retaining portion 21b may also only include the second retaining portion 212a. It is understood that the retaining portion 21b can ensure that the positioning member has sufficient strength to position the artificial implant. At this time, the connecting portion 22b is located outside the retaining portion 21b. In the first working state, the connecting portion 22b shrinks and / or folds to the outside of the positioning member; in the second working state, the connecting portion 22b is stretched and / or unfolded along the circumferential direction of the positioning member as the balloon expands.

[0073] As an embodiment, the retaining portion 21 includes a hard material, and the connecting portion 22 is a soft material. The hard material included in the retaining portion 21 provides strength for the positioning member so as to limit the position of the artificial implant.

[0074] As a specific embodiment, the positioning member includes a hard elastic strip 23 and a soft membrane 24. The hard elastic strip 23 is made of nickel-titanium alloy or hard silicone, etc., which has a certain strength, elasticity and / or memory to provide positioning and can be restored to the first working state when the balloon is retracted. The soft membrane 24 is made of pebax (polyether block polyamide) or silicone or PU (polyurethane) or nylon or PE (polyethylene), or other film materials that can be stretched and contracted, and / or unfolded and folded.

[0075] It is understandable that the materials of the hard elastic strip 23 and the soft membrane 24 are not limited. For the hard elastic strip 23, the elastic material can be opened when subjected to force and can be reset when the force is removed, which can ensure that it can be smoothly opened with the balloon during operation, and can be restored to the shape in the first working state after the balloon is retracted. In this way, it can prevent the balloon from having poor memory and being unable to return to its original state, and ensure that the balloon and the positioning member can be smoothly withdrawn from the body. For the soft membrane 24, any material that can shrink and / or expand can be suitable for this.

[0076] As an embodiment, the thickness of the hard elastic strip 23 is 0.1-1 mm, and the thickness of the soft membrane 24 is 0.1-2 mm. As an embodiment, the thickness of the hard elastic strip 23 and the thickness of the soft membrane 24 are not necessarily within this range. It is understood that the sizes of the two can be changed according to the radial size of the artificial implant, the materials of the hard elastic strip 23 and the soft membrane 24.

[0077] The soft membrane 24 is tubular, and the rigid elastic strips 23 are arranged at intervals in the circumferential direction of the soft membrane 24. As an embodiment, the rigid elastic strips 23 are fixed inside the soft membrane 24. The rigid elastic strips 23 and the soft membrane 24 located inside and outside the rigid elastic strips 23 form the holding part 21. The holding part 21 formed by the combination of the rigid elastic strips 23 and the soft membrane 24 provides positioning with a certain strength for the artificial implant. The soft membrane 24 between adjacent holding parts 21 forms the connecting part 22. In the first working state, the connecting part 22 is folded. In the second working state, the connecting part 22 is unfolded in the circumferential direction, so that the circumferential dimension of the connecting part 22 in the second working state is larger than that in the first working state, meeting the inflation of the balloon. Specifically, referring to Figure 3 , the circumferential dimension of the connecting part 22 in the first working state is L. Among them, the circumferential dimension is the straight-line distance between the two ends of the connecting part in the circumferential direction.

[0078] As another embodiment, the rigid elastic strips 23 are fixed on the outer surface of the soft membrane 24. At this time, the rigid elastic strips 23 and the soft membrane 24 located inside the rigid elastic strips 23 form the holding part 21. The inner side surface of the rigid elastic strips 23 is completely fixed or partially fixed with the soft membrane 24. In the case of partial fixation, preferably, the two opposite side parts of the rigid elastic strips 23 in the circumferential direction are not fixed with the rigid elastic strips 23, which is beneficial for the positioning part to wrap the soft membrane 24 included in the connecting part 22 inside the rigid elastic strips 23 when being retracted, avoiding the connecting part 22 from shrinking or folding incompletely, resulting in too large an outer diameter of the positioning part and being not conducive to withdrawing from the body.

[0079] As yet another embodiment, the rigid elastic strips 23 are fixed on the inner surface of the soft membrane 24. At this time, the rigid elastic strips 23 and the soft membrane 24 located outside the rigid elastic strips 23 form the holding part 21.

[0080] As yet another embodiment, the soft membrane 24 can be arranged between adjacent rigid elastic strips 23. At this time, the rigid elastic strips 23 form the holding part 21 to provide the strength for positioning the artificial implant, and the soft membrane 24 between adjacent holding parts 21 forms the connecting part 22.

[0081] As an embodiment, the material of the connecting part 22 is stretchable. In the first working state, the connecting part 22 can contract and fold (that is, there is redundancy after contraction), and the soft membrane 24 contracts and folds itself, forming the retracted limiting part 2. In the second working state, the connecting part 22 is unfolded and stretched in the circumferential direction of the positioning part, that is, the soft membrane 24 unfolds as the balloon expands, and the soft membrane 24 gradually unfolds and is stretched as the balloon expands, forming the expanded limiting part 2.

[0082] As an embodiment, the material of the connecting portion 22 is stretchable. In the first working state, the connecting portion 22 can only contract, that is, the soft film 24 only contracts itself without folding when the balloon is not inflated (that is, there is no redundancy after contraction), forming the retracted limiting portion 2. In the second working state, the connecting portion 22 is stretched along the circumferential direction of the balloon positioning member under force, and the soft film 24 is stretched as the balloon expands, forming the expanded limiting portion 2.

[0083] As an embodiment, in the first working state, the connecting portion 22 can only fold, that is, the soft film 24 does not contract itself but only folds when the balloon is not inflated, forming the retracted limiting portion 2. In the second working state, the connecting portion 22 is unfolded along the circumferential direction of the positioning member, and the soft film 24 is unfolded as the balloon opens, forming the expanded limiting portion 2.

[0084] The forms of the connecting portion 22 in the first working state and the second working state can be changed according to the material, thickness of the soft film 24, and the length of the soft film 24 between adjacent holding portions 21.

[0085] As an embodiment, the holding portion 21 and the connecting portion 22 have the same length in the extending direction of the positioning member. The end faces of the holding portion 21 and the connecting portion 22 away from the fixing portion 1 are used to position the artificial implant. In the first working state, the ends of the holding portion 21 and the connecting portion 22 away from the fixing portion 1 are in contact with the artificial implant at the same time for positioning the artificial implant.

[0086] As an embodiment, when the holding portion 21 and the connecting portion 22 have the same length in the extending direction of the positioning member, the artificial implant can also be positioned only by the end face of the holding portion 21 away from the fixing portion 1. For example, Figure 3 The position of the dashed line c1 in the figure is the contour diagram of the artificial implant. At this time, the end face of the holding portion 21 is used for positioning, and it can play a role in positioning the artificial implant.

[0087] Referring to Figure 6 , as an embodiment, the length of the holding portion 21c in the extending direction of the positioning member is greater than the length of the connecting portion 22c in the extending direction of the positioning member. In the first working state, the end face of the holding portion 21c away from the fixing portion 1c is used to position the artificial implant, and it contacts the artificial implant to play a role in positioning the artificial implant.

[0088] Referring to Figure 7, as an embodiment, the free end of the holding portion 21d away from one end of the fixing portion 1d can be inclined in a direction away from the axis of the positioning member. When the lengths of the holding portion 21d and the connecting portion 22d in the extending direction of the positioning member are the same, with the inclination of the end of the holding portion 21d away from the fixing portion 1d, the inner side surface of the end of the holding portion 21d away from the fixing portion 1d is used to position the artificial implant. The inner side surface of the end of the holding portion 21d away from the fixing portion 1d can expand the contact surface for positioning the artificial implant, more reliably position the artificial implant, and make it not easily fall off.

[0089] Referring to Figure 6 , as an embodiment, when the length of the holding portion 21c in the extending direction of the positioning member is greater than the length of the connecting portion 22c in the extending direction of the positioning member, the free end of the holding portion 21c away from the fixing portion 1c can also be inclined in a direction away from the axis of the positioning member. At this time, the inner side surface of the free end of the holding portion 21c is used to position the artificial implant. The inclination of the free end of the holding portion 21c can increase the radial dimension of the end of the holding portion 21c and / or the connecting portion 22c away from the fixing portion 1c, expand the contact surface of the positioning member, and can more reliably position the artificial implant, making the artificial implant not easily fall off.

[0090] As an embodiment, the thickness of the end of the holding portion 21 away from the fixing portion 1 is greater than or equal to the thickness of the end of the holding portion 21 close to the fixing portion 1. The holding portion 21 with a larger thickness can provide higher strength, so that the artificial implant will not be stressed and separated from the balloon during the process of being inserted into the body. It can be understood that the thickness of the end of the holding portion 21 away from the fixing portion 1 can also be less than or equal to the thickness of the end of the holding portion 21 close to the fixing portion 1. As long as the position of the holding portion 21 away from the fixing portion 1 can contact the artificial implant, the effect of positioning the artificial implant can be achieved. It's just that when the thickness of the holding portion 21 is larger, the strength of the holding portion 21 is also higher, and the artificial implant can be positioned more stably.

[0091] As an embodiment, the holding portion 21 does not necessarily need to be composed of the rigid elastic strip 23, and the connecting portion 22 does not necessarily need to be composed of the soft film 24. For example, referring to Figure 8The limiting portion 2e is formed by folding the annular foldable film 25 inward for many times. The inner corner 251 and the outer corner 252 formed by the foldable film 25 form the retaining portion 21e. The foldable film 25 between the adjacent inner corners 251 and the outer corners 252 forms the connecting portion 22e. In the first working state, the limiting portion 2e is folded, the retaining portion 21e is located at the outer circumference of the balloon positioning member to position the artificial implant, and the foldable film 25 is folded toward the inside of the positioning member. In the second working state, the limiting portion 2e is opened, and the connecting portion 22e is unfolded in the circumferential direction, so that the circumferential dimension of the connecting portion 22e in the second working state is greater than the dimension of the connecting portion in the circumferential direction in the first working state. When the foldable film 25 is used to form the limiting portion, the foldable film 25 is folded inward for many times to form a pleated structure, which provides strength capable of positioning the artificial implant.

[0092] As an embodiment, the foldable film 25 can be made of silicone or pebax (polyether block polyamide) or PU (polyurethane) or nylon or PE (polyethylene). In the case where the limiting portion 2e is formed by the foldable film 25, there is no hard elastic strip 23 as a support, and the foldable film 25 provides positioning strength through the folds formed by folding, and the foldable film 25 itself does not shrink or stretch, so the strength and memory of the material selected for the foldable film 25 are better than the soft film 24. The foldable film 25 is preferably made of a material with memory, foldability and certain strength.

[0093] As an embodiment, the thickness of the foldable film 25 can be 0.1-2 mm. It is understood that the thickness of the foldable film 25 does not have to be within the above range, and the thickness of the foldable film 25 can satisfy that the retaining portion 21e can provide sufficient strength to the positioning member, but increasing the thickness can more stably position the artificial implant.

[0094] As an embodiment, the number of the retaining parts 21e formed by the outer folding angle 252 is 3-15. The more the number of the retaining parts 21e, the more times the foldable film 25 can be folded, and the better strength can be provided to the positioning member. However, the number of the retaining parts 21e should not be too large, as it will affect the opening and contraction of the balloon. It can be understood that the number of the retaining parts 21e is not necessarily within the above range, and the strength provided by the retaining parts 21e is sufficient to position the artificial implant and meet the requirements of the balloon opening.

[0095] As an embodiment, the angle of the inner folding angle 251 is less than 90°, so that the distance between adjacent holding parts 21e can be closer, improving the strength of the positioning member; in the second working state, the angle of the inner folding angle 251 is less than 180°. Keeping the angle of the inner folding angle 251 not too large in the second working state enables the balloon to be easily restored to the shape in the first working state when the balloon shrinks, which is used to tighten the balloon and prevent the balloon from becoming flattened due to poor memory and being difficult to withdraw from the body.

[0096] As an embodiment, in the first working state, the inner folding angle 251 does not necessarily have to be less than 90°. For example, if the foldable film 25 uses a material with relatively high strength, even if the inner folding angle 251 is greater than 90°, the holding part 21e can still provide sufficient strength to position the artificial implant. In the second working state, the inner folding angle 251 does not necessarily have to be less than 150°. For example, if a material with better memory is selected, even if the inner folding angle 251 is greater than 150°, it can still play a role in tightening the balloon when the balloon shrinks.

[0097] In a second aspect, referring to Figure 9 and Figure 10 , the present invention further provides a valve delivery system for delivering an artificial implant. The artificial implant is an artificial valve and has a proximal end a and a distal end b which are oppositely arranged, where the proximal end a is the end close to the operator. The valve delivery system includes a proximal positioning member 3, a distal positioning member 4, an inflatable balloon 5, an inner tube 6 and an outer tube 7. The inner tube 6 is disposed inside the outer tube 7 and extends out from the distal end of the outer tube 7. The balloon 5 is mounted on the inner tube 6. The proximal positioning member 3 is fixed on the inner tube 6 close to the distal end of the outer tube 7 or the proximal end of the balloon 5 or the distal end of the outer tube 7 and is located outside the balloon 5; the distal positioning member 4 is fixed at the distal end of the balloon 5 and is located inside the balloon 5. Before the balloon 5 expands, the artificial implant 8 (the label is shown in Figure 11 ) is sleeved around the balloon 5 and is limited between the proximal positioning member 3 and the distal positioning member 4, and the position is fixed and not easy to move.

[0098] As an embodiment, the proximal positioning member 3 adopts the above-mentioned positioning member. The proximal positioning member 3 is fixed on the inner tube 6 through a fixing part 1f, and the limiting part 2f faces the balloon 5.

[0099] Please refer to Figure 11 and Figure 12 , when the balloon 5 expands, the limiting part 2f of the proximal positioning member 3 is subjected to a force from the balloon 5 and opens in a direction away from the axis of the proximal positioning member 3. A part of the inner side surface of the limiting part 2 contacts the balloon 5, which is beneficial to the stable expansion of the balloon 5. When the balloon 5 shrinks, the limiting part 2f returns to the state before being stressed under the action of the elastic restoring force (such as Figure 9) During the contraction process of the balloon 5, the limiting part 2f has a clamping effect on the balloon 5. When the balloon 5 is pumped, it cannot completely return to its initial folded state and may become flat or trilobed, making it easy to scratch the blood vessel during retraction. However, in this application, the clamping effect of the limiting part 2f on the balloon 5 allows the balloon 5 to contract better, preventing the balloon 5 from being difficult to retract and effectively solving the problem of poor folding memory of the balloon 5.

[0100] Please refer to Figure 13 , as an embodiment, the distal positioning member 4a of the valve delivery system is fixed to the distal end of the balloon 5a and is located outside the balloon 5a. Both the proximal positioning member 3a and the distal positioning member 4a adopt the above-mentioned positioning members. The proximal positioning member 3a and the distal positioning member 4a are respectively fixed to the inner tube 6a and the distal end of the balloon 5a through the fixing parts 1g and 1g', and their limiting parts are respectively arranged towards the balloon 5 to position both ends of the artificial implant 8a and prevent it from moving.

[0101] Please refer to Figure 14 , when the balloon 5a expands, the proximal positioning member 3a and the distal positioning member 4a open accordingly. When the balloon 5a contracts, the proximal positioning member 3a and the distal positioning member 4a reset accordingly.

[0102] In a third aspect, the present invention also provides a balloon-expandable interventional device for delivering an artificial implant. Specifically, the artificial implant can be a valve, a coronary stent, etc. The balloon-expandable interventional device uses the above-mentioned positioning member to position the artificial implant. The positioning member can not only be used to position the balloon valve, but can be used in the balloon-expandable interventional device to position a coronary stent or a balloon, etc., and recover when the balloon is retracted to assist the balloon in retracting and avoid the balloon becoming flattened and scratching the blood vessel.

[0103] Those skilled in the art can understand that, on the premise of no conflict, the above preferred solutions can be freely combined and superimposed.

[0104] It should be understood that the above embodiments are merely exemplary and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions made by those skilled in the art to the above details will all be included within the scope of the claims of the present invention.

Claims

1. A positioning member for positioning an artificial implant sleeved on a balloon, characterized in that: The positioning member comprises a fixing portion and a limiting portion, one end of the fixing portion is connected to one end of the limiting portion, and the limiting portion has a first working state and a second working state accompanying the contraction and expansion of the balloon; The limiting portion is tubular, and comprises alternately arranged retaining portions and connecting portions in the circumferential direction, wherein the retaining portions and connecting portions are connected to form the tubular limiting portion; In the first working state, the limiting portion is retracted, and the holding portion is used to position the artificial implant; The connecting portion is folded; In the second working state, the limiting portion is opened and the connecting portion is expanded in the circumferential direction, so that the circumferential dimension of the connecting portion in the second working state is greater than the circumferential dimension of the connecting portion in the first working state.

2. The positioning member according to claim 1, wherein The retaining portion comprises a hard material, and the connecting portion comprises a soft material.

3. The positioning member according to claim 1, characterized in that, In the first working state, the connecting portion is located on the inner side of the holding portion, or the connecting portion is located on the outer side of the holding portion, or the connecting portion is partially located on the inner side of the holding portion and partially located on the outer side of the holding portion.

4. The positioning member according to claim 1, characterized in that, The retaining portion includes a first retaining portion and a second retaining portion arranged at an interval from each other, the distance between the first retaining portion and the axis center of the positioning member is greater than the distance between the second retaining portion and the axis center of the positioning member, the elastic deformation amplitude of the first retaining portion is smaller than the elastic deformation amplitude of the second retaining portion, and each connecting portion connects an adjacent pair of the first retaining portion and the second retaining portion.

5. A positioning member according to claim 1, characterized in that The positioning member comprises a hard elastic strip and a soft film, the hard elastic strip can be opened when a force is applied and can be reset when the force is removed, the soft film is tubular, the hard elastic strip is arranged at intervals in the circumferential direction of the soft film, and is fixed to the inner surface and / or outer surface of the soft film and / or inside the soft film; The hard elastic strip and the soft film located inside and / or outside the hard elastic strip form the retaining portion, and the soft film between adjacent retaining portions forms the connecting portion.

6. The positioning member according to claim 1, wherein, The positioning member includes a hard elastic strip and a soft film, the soft film is connected between adjacent hard elastic strips, the hard elastic strip forms the retaining portion, and the soft film between adjacent retaining portions forms the connecting portion.

7. A positioning member according to claim 5 or 6, characterized in that, The hard elastic strip is made of nickel-titanium alloy or hard silicone, and the soft membrane is made of pebax or silicone or PU or nylon or PE.

8. A positioning member according to claim 5 or claim 6, characterized in that, The thickness of the hard elastic strip is 0.1-1 mm, and the thickness of the soft film is 0.1-2 mm.

9. A positioning member according to claim 1, characterized in that, The limiting portion is formed by folding a ring-shaped foldable film inwardly for multiple times, the inner fold angle and the outer fold angle formed by the folding of the foldable film form the retaining portion, and the foldable film between adjacent inner fold angles and outer fold angles forms the connecting portion.

10. A positioning member according to claim 9, characterized in that, In the first working state, the inner fold angle is less than 90°; In the second working state, the inner fold angle is less than 180°.

11. A positioning member according to claim 9, wherein The number of the retaining portions formed by the outer fold angle is 3-15.

12. A positioning member according to claim 9, wherein The foldable film has a thickness of 0.1-2 mm.

13. A positioning member according to claim 9, characterized in that, The foldable film is made of silica gel, pebax, PU, nylon or PE.

14. A positioning member according to any one of claims 1-6, 9-13, characterized in that, The shape of the limiting part is frustum-shaped, straight-tube-shaped or horn-shaped.

15. A positioning member according to any one of claims 1-6, 9-13, characterized in that, The radial dimension of the end of the limiting part away from the fixing part is greater than or equal to the radial dimension of the end of the limiting part close to the fixing part; the thickness of the holding part at the end away from the fixing part is greater than or equal to the thickness of the holding part at the end close to the fixing part.

16. A positioning member according to any one of claims 1-6, 9-13, characterized in that, The holding part and the connecting part have the same length in the extending direction of the positioning member, and the end faces of the holding part and the connecting part away from the fixing part are used for positioning the artificial implant.

17. A positioning member according to any one of claims 1-6, 9-13, characterized in that, The length of the holding part in the extending direction of the positioning member is greater than the dimension of the connecting part in the extending direction of the positioning member, and the end face of the holding part away from the fixing part is used for positioning the artificial implant.

18. A positioning member according to claim 1, characterized in that, The free end of the holding part away from the fixing part inclines towards the direction away from the axis of the positioning member. The inner side surface of the free end of the holding part is used for positioning the artificial implant. The holding part and the connecting part have the same length in the extending direction of the positioning member, or the length of the holding part in the extending direction of the positioning member is greater than the length of the connecting part in the extending direction of the positioning member.

19. A positioning member according to claim 1, characterized in that, The limiting part is made of a developing material and has developability, or a contrast member is arranged on the peripheral wall of the limiting part.

20. A valve delivery system for delivering an artificial implant, where the artificial implant is an artificial valve. The valve delivery system includes a balloon, an outer tube, and an inner tube. The inner tube is disposed within the outer tube. The artificial implant is sleeved on the balloon. The two ends of the balloon are provided with a distal positioning member and a proximal positioning member, and it is characterized in that, At least the proximal positioning member is fixed outside the balloon or at the distal end of the outer tube, and the positioning member according to any one of the above claims 1-19 is used to position the artificial valve.

21. A balloon-expandable interventional device for delivering an artificial implant, characterized in that, The balloon-expandable interventional device uses the positioning member according to any one of the above claims 1-19 to position the artificial implant.

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