Heart valve stent system capable of being released step by step

Abstract

According to the step-by-step release type heart valve stent system, a multifunctional wire penetrates through a locking hole and is detachably connected with a positioning piece, when a heart valve stent is released, the positioning piece is driven through the multifunctional wire firstly, controllable folding of the positioning piece is achieved, the positioning piece can be released more accurately, and the heart valve stent can enter the valve sinus more easily; after the positioning piece is released, the multifunctional wire is disengaged from the locking hole, release of the stent body is achieved, step-by-step release of the positioning piece and the stent body is achieved, compared with direct release of the stent body, release safety is higher, it is guaranteed that flaps do not occur after the stent body is released, and after the positioning piece is released and before the stent body is released, the release safety is higher. The stent body can be recycled by withdrawing the multi-cavity tube, and the release accuracy and stability of the heart valve stent are improved.

Description

Technical Field

[0001] The invention relates to the technical field of cardiac disease interventional treatment equipment, and in particular to a step-by-step release type cardiac valve stent system. Background Art

[0002] Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive surgery for the treatment of aortic valve disease that has been widely used internationally. Through interventional catheter technology, an artificial heart valve is delivered to the position of the aortic valve, thereby completing the implantation of the artificial valve and restoring valve function. TAVR has the advantages of less trauma, faster recovery, and higher quality of life for patients after surgery, and has become the current trend in the treatment of aortic valve disease. For regurgitant aortic valve disease, current TAVR products mostly use a stent with a positioning piece. The positioning piece is inserted into the valve sinus to achieve positioning of the valve, so that the position of the valve leaflets coincides with the native leaflets of the human body, ensuring better postoperative hemodynamics of the valve. At the same time, the clamping force of the positioning piece and the valve frame on the native leaflets ensures strong support for the valve after implantation, which can be applied to regurgitant aortic valve disease.

[0003] During TAVR surgery, the main valve release method is: the delivery system delivers the valve stent to the ascending main segment, the valve stent body is compressed in the capsule cavity to be released, and the three valve positioning parts are inserted into the valve sinus by controlling the delivery system to advance and rotate, and then the valve body is released. When the patient's valve sinus is large, the positioning parts, especially the positioning parts close to the lesser bend of the blood vessel, cannot be inserted into the corresponding native valve sinus. At the same time, the simple one-way two-step release of the valve has problems such as easy valve flying and difficult recovery. Therefore, a valve replacement system that can be released in steps, has controllable positioning parts, and can be recovered at any time has practical clinical application value. Summary of the invention

[0004] Based on the above description, the present invention provides a step-by-step releasable heart valve stent system to solve the technical problems in the prior art that the positioning parts cannot be accurately positioned in the patient's body under special circumstances, resulting in easy valve flying and difficult recovery during the release process.

[0005] The technical solution of the present invention to solve the above technical problems is as follows: A step-by-step release type heart valve stent system is used for the delivery and release of a heart valve stent. The heart valve stent comprises a stent body with a hollow grid-shaped side wall, a positioning piece connected to the stent body and capable of being folded in both directions, and a support piece connected to the grid vertex at one end of the stent body. The support piece and the positioning piece are located at the same end of the stent body, and a through hole is formed on the support piece. The heart valve stent comprises an outer sheath tube, an inner sheath tube, a core rod, a capsule cavity, and a release component. The outer sheath tube is sleeved on the outer side of the inner sheath tube, the inner sheath tube is sleeved on the outer side of the core rod, and the capsule cavity is connected to the distal end of the core rod; The release assembly includes a multi-lumen tube, a locking piece and a multifunctional wire. The multi-lumen tube is sleeved between the inner sheath tube and the core rod. The multi-lumen tube is provided with a plurality of connecting holes along its length direction. The locking piece is provided in the connecting holes. A support claw that can be elastically opened is formed at the distal end of the locking piece. A locking hole is formed on the support claw. The support claw passes through the through hole and is connected to the support piece. The multifunctional wire is provided on the inner side of the inner sheath tube. The multifunctional wire passes through the locking hole and is connected to the positioning piece.

[0006] Compared with the prior art, the technical solution of this application has the following beneficial technical effects: The step-by-step releasable heart valve stent system provided in the present application adopts a multifunctional wire that passes through a locking hole and is detachably connected to a positioning piece. When the heart valve stent is released, the positioning piece is first driven by the multifunctional wire to achieve controllable folding of the positioning piece, so that the positioning piece is released more accurately and enters the valve sinus more easily. When the positioning piece is released, the multifunctional wire is disengaged from the locking hole to release the stent body, thereby achieving the step-by-step release of the positioning piece and the stent body. Compared with directly releasing the stent body, the release safety is higher, ensuring that the stent body does not fly after being released. Moreover, after the positioning piece is released and before the stent body is released, the stent body can be recovered by withdrawing the multi-lumen tube, thereby improving the accuracy and stability of the heart valve stent release.

[0007] Based on the above technical solution, the present invention can also be improved as follows.

[0008] Furthermore, the multifunctional wire is wound around the positioning member.

[0009] Furthermore, the multifunctional wire includes a proximal portion and a distal portion, the cross-sectional size of the proximal portion is larger than the cross-sectional size of the distal portion, the proximal portion is used to pass through the locking hole, and the distal portion is used to wrap around the positioning piece.

[0010] Furthermore, the multifunctional wire includes a wire material and a storage tube, and at least one end of the wire material is arranged inside the storage tube.

[0011] Furthermore, the middle portion of the wire is wound around the positioning piece, and both ends of the wire are arranged inside the storage tube.

[0012] Furthermore, the number of the communicating holes is consistent with the number of the positioning members, a multifunctional wire is arranged in each communicating hole, and all the positioning members are correspondingly equipped with a multifunctional wire.

[0013] Furthermore, an outer sheath handle is provided at the proximal end of the outer sheath tube, an inner sheath handle is provided at the proximal end of the inner sheath tube, the release assembly also includes a release handle connected to the proximal end of the multi-lumen tube, a release knob is provided at the proximal end of the release handle, the outer sheath handle is sleeved on the outside of the inner sheath tube, the inner sheath handle is movably sleeved on the outside of the multi-lumen tube, and the proximal end of the multifunctional wire penetrates into the release handle and is connected to the release knob.

[0014] Furthermore, one end of the stent body away from the positioning piece is arranged in the capsule cavity, the positioning piece is located outside the capsule cavity and folded toward the distal end, and the capsule cavity and the heart valve stent are loaded into the inner sheath tube together.

[0015] Furthermore, one end of the stent body away from the positioning member is arranged in the capsule cavity, the positioning member is located outside the capsule cavity and folded toward the proximal end, and the positioning member is installed in the inner sheath tube.

[0016] Furthermore, the cross-sectional sizes of the capsule cavity and the inner sheath tube are consistent. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A schematic diagram of the connection structure of an outer sheath tube and an outer sheath handle in a step-by-step releasable heart valve stent system provided by an embodiment of the present invention; Figure 2 A schematic structural diagram of a step-by-step releasable heart valve stent system provided by an embodiment of the present invention with the outer sheath tube and the outer sheath handle removed; Figure 3 A structural schematic diagram of a heart valve stent involved in an embodiment of the present invention is provided; Figure 4 This is a schematic diagram of a state before the heart valve stent is loaded according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the connection state between the release component and the heart valve stent in an embodiment of the present invention; Figure 6 Schematic diagram of the threading structure of the multifunctional wire in an embodiment of the present invention; Figure 7 a is a schematic diagram of the connection structure of the multifunctional wire and the positioning member, b is a schematic diagram of the multifunctional wire using a variable diameter structure, c is a schematic diagram of the state where one end of the multifunctional wire is placed in a storage tube, and d is a schematic diagram of the state where both ends of the multifunctional wire are placed in the storage tube; Figure 8 A schematic diagram of the release process of the positioning member being folded toward the distal end; Fig. 9 A schematic diagram of a loading structure in which the positioning member is folded toward the proximal end; Fig.10It is a schematic diagram of the state where the inner sheath tube and the capsule cavity have the same diameter when the positioning piece is folded toward the proximal end. DETAILED DESCRIPTION

[0018] In order to facilitate understanding of the present application, the present application will be described more fully below with reference to the relevant drawings. Embodiments of the present application are provided in the drawings. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0020] It will be appreciated that spatial relationship terms such as "under", "beneath", "below", "under", "above", "above", etc., may be used herein to describe the relationship of an element or feature shown in the figures to other elements or features. It will be appreciated that, in addition to the orientations shown in the figures, spatial relationship terms also include different orientations of the device in use and operation. For example, if the device in the accompanying drawings is flipped, an element or feature described as "under other elements" or "under it" or "under it" will be oriented as "on" the other elements or features. Thus, the exemplary terms "under" and "under" may include both upper and lower orientations. In addition, the device may also include additional orientations (e.g., rotated 90° or other orientations), and the spatial descriptors used herein are interpreted accordingly.

[0021] It should be noted that when an element is considered to be "connected" to another element, it can be directly connected to the other element, or connected to the other element through an intermediate element. The "connection" in the following embodiments should be understood as "electrical connection", "communication connection", etc. if the connected circuits, modules, units, etc. have electrical signals or data transmission between each other.

[0022] When used herein, the singular forms "a", "an", and "said / the" may also include plural forms, unless the context clearly indicates otherwise. It should also be understood that the terms "include / comprise" or "have" etc. specify the presence of stated features, wholes, steps, operations, components, parts or combinations thereof, but do not exclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts or combinations thereof.

[0023] like Figure 1-10As shown, the present application provides a step-by-step releasable heart valve stent system for the delivery and release of a heart valve stent 200 .

[0024] Among them, the heart valve stent of the present application is the main part of the stent of an artificial heart valve. The heart valve stent 20 includes a stent body 201 with a hollow grid-shaped side wall, a positioning member 202 connected to the stent body 201 and foldable in both directions, and a support member 203 connected to the grid vertex at one end of the stent body 201. The support member 203 and the positioning member 202 are located at the same end of the stent body 201, and a through hole 203a is formed on the support member 203.

[0025] Preferably, according to the currently commonly used valve stent structure, the positioning member 202 is a U-shaped structure, the middle part of the U-shape is movable and can be folded up and down, and the end of the U-shaped mechanism is connected to the stent body 201 through a connecting member 204, wherein the connecting member 204 can be a structure integrally formed with the stent body 201, or it can be an elastic structure separately connected to the stent body 201, both of which can be regarded as a part of the stent body 201.

[0026] When in use, the positioning piece 202 is inserted into the valve sinus to achieve positioning of the heart valve stent, so that the leaflets of the artificial heart valve coincide with the native leaflets of the human body, ensuring better postoperative hemodynamics of the artificial heart valve. At the same time, the clamping force of the positioning piece 202 and the heart valve stent on the native leaflets ensures strong support for the valve after implantation, thereby achieving treatment of the disease.

[0027] The step-by-step releasable heart valve stent system of the present application is used for the controllable release of the above-mentioned heart valve stent after it is delivered into the patient's body. The system includes an outer sheath tube 10, an inner sheath tube 20, a core rod 30, a capsule cavity 40 and a release component.

[0028] The outer sheath tube 10 is sleeved on the outer side of the inner sheath tube 20 , the inner sheath tube 20 is sleeved on the outer side of the core rod 30 , and the capsule cavity 40 is connected to the distal end of the core rod 30 .

[0029] The release component includes a multi-lumen tube 51, a locking piece 52 and a multifunctional wire 53. The multi-lumen tube 51 is inserted between the inner sheath tube 20 and the core rod 30. The multi-lumen tube 51 is provided with a plurality of connecting holes along its length direction. The locking piece 52 is arranged in the connecting holes. The distal end of the locking piece 52 is formed with a support claw 521 that can be elastically opened. The support claw 521 is formed with a locking hole 52a. The support claw 521 passes through the through hole 203a and is connected to the support piece 52. The multifunctional wire 53 is arranged on the inner side of the inner sheath tube 20. The multifunctional wire 53 passes through the locking hole 52a and is detachably connected to the positioning piece 202.

[0030] As a preferred embodiment, the connection between the multifunctional wire 53 and the positioning member 202 is winding, that is, the multifunctional wire 53 is wound around the positioning member 202, and the positioning member 202 can theoretically achieve up to 180° positioning adjustment under the traction of the multifunctional wire 53.

[0031] The multifunctional wire 53 includes a proximal portion 531 and a distal portion 532 . The cross-sectional size of the proximal portion 531 is larger than that of the distal portion 532 . The proximal portion 531 is used to pass through the locking hole 52 a , and the distal portion 532 is used to wrap around the positioning member 202 .

[0032] That is, the multifunctional wire 53 is a variable diameter structure, and the diameter of the proximal end 531 used to lock the support member 203 and the locking member 52 is larger than the diameter of the distal end 532 of the lifting and positioning member 202, providing a stronger locking force to ensure the positioning performance of the distal end of the stent.

[0033] The proximal portion 531 and the distal portion 532 may be integrated or independent. For example, the proximal portion 531 is a tube and the distal portion 532 is a wire. The wire may be nickel-titanium alloy wire, stainless steel wire, polymer thin tube, etc. The wire diameter is 0.05mm-0.5mm, and the head end is bent and shaped to ensure that it can be well connected to the positioning piece 202, provide a certain pulling force during the pulling process, and facilitate release.

[0034] As another preferred embodiment, the multifunctional wire 53 includes a wire material 533 and a storage tube 534 , and at least one end of the wire material 533 is disposed inside the storage tube 534 .

[0035] Storing the end of the wire 533 inside the lumen of the storage tube 534 can effectively prevent the wire head of the wire 533 from causing damage to blood vessels or tissues, and can increase the pulling stroke of the wire 533 to ensure the effectiveness of pulling the positioning member 202 off.

[0036] Optionally, one end of the wire 533 may be located outside the receiving tube 534 , and the other end may be located inside the receiving tube 534 .

[0037] Alternatively, both ends of the wire 533 may be received in the receiving tube 534 , the middle portion of the wire 533 may be wound around the positioning member 202 , and both ends of the wire 534 may be disposed in the receiving tube 534 .

[0038] As a preferred embodiment of the present application, the number of the communicating holes is consistent with the number of the positioning members 202 , a multifunctional wire 53 is arranged in each communicating hole, and all the positioning members 202 are correspondingly equipped with a multifunctional wire.

[0039] In order to enhance the operability of the system, an outer sheath handle 110 is provided at the proximal end of the outer sheath tube 10, an inner sheath handle 220 is provided at the proximal end of the inner sheath tube 20, and the release assembly also includes a release handle 54 connected to the proximal end of the multi-lumen tube 51, and a release knob 55 is provided at the proximal end of the release handle 54.

[0040] The outer sheath handle 110 is sleeved on the outside of the inner sheath tube 20 , and the inner sheath handle 220 is movably sleeved on the outside of the multi-lumen tube 51 . The proximal end of the multifunctional wire 53 penetrates into the release handle 54 and is connected to the release knob 55 .

[0041] It is understandable that it is a common technology to provide a handle at the proximal end of the sheath to extend or retract the sheath. The handle and the sheath both adopt commercially available structures. The handle is preferably a knob-controlled handle. A release knob 55 connected to the wire structure is provided at the proximal end of the release handle 54. The wire is pulled out by rotating the release knob 55 or withdrawing the release knob 55. These are common technologies in TAVR and will not be elaborated here.

[0042] However, in the present application, since the multifunctional wire 53 is passed through the locking hole 52a and connected to the positioning member 202, although the action of pulling out the multifunctional wire 53 in the present application remains unchanged, the distal end of the multifunctional wire 53 is first slightly pulled to drive the positioning member 202 to swing. After the positioning member 202 is positioned, the force is slightly increased to separate the multifunctional wire 53 from the positioning member 202 to release the positioning member, and then the multifunctional wire 53 is continued to be withdrawn to be pulled out from the locking hole 52a to release the heart valve stent. After being separated from the positioning member 202 and before being pulled out from the locking hole 52a, the user can retract the locking member 52 to recover the heart valve stent, thereby ensuring the accurate release of the heart valve stent.

[0043] Preferably, in an embodiment of the present application, the number of connecting cavities is consistent with the number of the positioning members 202, a multifunctional wire 52 is arranged in each of the connecting cavities, and all the positioning members 202 are equipped with a corresponding multifunctional wire 52. For example, there are three positioning members 202 on the stent body 201, and the multi-lumen tube 51 of the present application has three connecting cavities, and a multifunctional wire 52 is arranged in each connecting cavity, and each multifunctional wire is connected to the positioning member 202 one by one.

[0044] As an optional loading implementation scheme of the heart valve stent 200, the positioning piece 202 can be folded toward the distal end. Specifically, one end of the stent body 201 away from the positioning piece 202 is arranged in the capsule cavity 40, and the positioning piece 202 is located outside the capsule cavity 202 and folded toward the distal end. The capsule cavity 40 and the heart valve stent 200 are loaded into the inner sheath tube 20 together.

[0045] During loading, the positioning piece 202 is placed in an ice water assembly environment, facing the distal end of the stent body 201, and the proximal end of the stent body 201 is loaded into the capsule cavity 202, and then the positioning piece 202 is covered with the inner sheath tube 20; when the heart valve stent 200 is introduced into the human body, under the action of the temperature of the body fluid, the positioning piece 202 begins to fold under the traction of the connecting piece 204. As another optional loading implementation scheme of the heart valve stent 200, the positioning piece 202 can be folded toward the proximal end. Specifically, one end of the stent body 201 away from the positioning piece 202 is arranged in the capsule cavity 40, the positioning piece 202 is located outside the capsule cavity 202 and folded toward the proximal end, and the positioning piece 202 is loaded into the inner sheath tube 20.

[0046] During loading, the positioning member 202 is placed in an ice water assembly environment, facing the proximal end of the stent body 201, and then the positioning member 202 is covered with the inner sheath tube 20; when the heart valve stent 200 is introduced into the human body, the positioning member 202 begins to fold under the traction of the connecting member 204 under the action of the temperature of the body fluid. Since the valve positioning member 202 is not outside the capsule cavity 40 during assembly, the inner sheath 40 can be made to have the same diameter as the capsule cavity 20. Compared with the positioning member 202 facing the proximal end, the outer diameter of the entire sheath of the delivery system can be made smaller, which can accommodate more patients.

[0047] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A step-by-step release heart valve stent system, used for the delivery and release of a heart valve stent, the heart valve stent comprising a stent body with a hollow grid-shaped side wall, a positioning member connected to the stent body and capable of being folded in both directions, and a support member connected to the grid vertex at one end of the stent body, the support member and the positioning member are located at the same end of the stent body, and a through hole is formed on the support member; characterized in that: It includes an outer sheath tube, an inner sheath tube, a core rod, a capsule cavity and a release component; The outer sheath tube is sleeved on the outer side of the inner sheath tube, the inner sheath tube is sleeved on the outer side of the core rod, and the capsule cavity is connected to the distal end of the core rod; The release assembly includes a multi-lumen tube, a locking piece and a multifunctional wire. The multi-lumen tube is sleeved between the inner sheath tube and the core rod. The multi-lumen tube is provided with a plurality of connecting holes along its length direction. The locking piece is provided in the connecting holes. A support claw that can be elastically opened is formed at the distal end of the locking piece. A locking hole is formed on the support claw. The support claw passes through the through hole and is connected to the support piece. The multifunctional wire is provided on the inner side of the inner sheath tube. The multifunctional wire passes through the locking hole and is detachably connected to the positioning piece.

2. The step-by-step releasable heart valve stent system according to claim 1, characterized in that: The multifunctional wire is wound around the positioning member.

3. The step-by-step releasable heart valve stent system according to claim 2, characterized in that: The multifunctional wire comprises a proximal end portion and a distal end portion, the cross-sectional dimension of the proximal end portion is larger than the cross-sectional dimension of the distal end portion, the proximal end portion is used to pass through the locking hole, and the distal end portion is used to wrap around the positioning piece.

4. The step-by-step releasable heart valve stent system according to claim 2, characterized in that: The multifunctional wire comprises a wire material and a storage tube, and at least one end of the wire material is arranged inside the storage tube.

5. The step-by-step releasable heart valve stent system according to claim 4, characterized in that: The middle part of the wire is wound around the positioning piece, and both ends of the wire are arranged inside the storage tube.

6. The step-by-step releasable heart valve stent system according to claim 2, characterized in that: The number of the communicating holes is consistent with the number of the positioning members, a multifunctional thread is arranged in each communicating hole, and all the positioning members are correspondingly equipped with a multifunctional thread.

7. The step-by-step releasable heart valve stent system according to any one of claims 2 to 6, characterized in that: The proximal end of the outer sheath tube is provided with an outer sheath handle, the proximal end of the inner sheath tube is provided with an inner sheath handle, the release assembly also includes a release handle connected to the proximal end of the multi-lumen tube, the proximal end of the release handle is provided with a release knob, the outer sheath handle is sleeved on the outside of the inner sheath tube, the inner sheath handle is movably sleeved on the outside of the multi-lumen tube, and the proximal end of the multifunctional wire penetrates into the release handle and is connected to the release knob.

8. The step-by-step releasable heart valve stent system according to claim 7, characterized in that: One end of the stent body away from the positioning piece is arranged in the capsule cavity, the positioning piece is located outside the capsule cavity and folded toward the distal end, and the capsule cavity and the heart valve stent are loaded into the inner sheath tube together.

9. The step-by-step releasable heart valve stent system according to claim 7, characterized in that: One end of the support body away from the positioning piece is arranged in the capsule cavity, the positioning piece is located outside the capsule cavity and folded toward the proximal end, and the positioning piece is installed in the inner sheath tube.

10. The step-by-step releasable heart valve stent system according to claim 9, characterized in that: The capsule cavity and the inner sheath tube have the same cross-sectional size.

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