WO2023197328A1 - Endoprothèse de valvule aortique et système de transport d'endoprothèse de valvule aortique - Google Patents

Endoprothèse de valvule aortique et système de transport d'endoprothèse de valvule aortique Download PDF

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Publication number
WO2023197328A1
WO2023197328A1 PCT/CN2022/087224 CN2022087224W WO2023197328A1 WO 2023197328 A1 WO2023197328 A1 WO 2023197328A1 CN 2022087224 W CN2022087224 W CN 2022087224W WO 2023197328 A1 WO2023197328 A1 WO 2023197328A1
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WIPO (PCT)
Prior art keywords
aortic valve
stent
hook
positioning part
positioning
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Ceased
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PCT/CN2022/087224
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English (en)
Chinese (zh)
Inventor
潘湘斌
谭雄进
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Individual
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Individual
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Priority to PCT/CN2022/087224 priority Critical patent/WO2023197328A1/fr
Publication of WO2023197328A1 publication Critical patent/WO2023197328A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the present application relates to the technical field of medical devices, and specifically to an aortic valve stent and a system for delivering the aortic valve stent.
  • the aortic valve stent can be implanted into the aortic valve to treat aortic valve stenosis, insufficiency or regurgitation.
  • the blood will impact and deliver the system. Displacement occurs under the combined action of tension changes. For example, even if existing valve products are accurately positioned before release, the valve can easily slide toward the left ventricle during the release process, resulting in failed stent placement or excessive depth, leading to serious complications such as paravalvular leakage and atrioventricular block.
  • the present application is proposed to provide an aortic valve stent that overcomes the above problems or at least partially solves the above problems and a system for delivering the aortic valve stent, which system can not only percutaneously treat aortic valve stenosis, but also Aortic regurgitation can also be treated.
  • an aortic valve stent including: a stent body, the stent body has a contracted state and an expanded state, the stent body can be transported in the contracted state, and when arriving The aortic valve is then switched to an expanded state; a valve provided inside the stent body; and a first positioning portion and a second positioning portion provided outside the stent body, when the stent body is in the expanded state, The first positioning part and the second positioning part can be respectively located on both sides of the aortic valve to fix the stent body at the aortic valve.
  • a system for delivering an aortic valve stent including: the aortic valve stent as described in the first aspect of the embodiment of the present application, and a delivery device,
  • the aortic valve stent can be loaded on the delivery device when the stent body is in a contracted state.
  • the delivery device can deliver the aortic valve stent to the aortic valve and release the aortic valve stent. So as to switch the stent body to the unfolded state.
  • the aortic valve stent and the system for delivering the aortic valve stent according to the embodiments of the present application can better fix the aortic valve stent at the aortic valve and avoid the displacement of the aortic valve stent.
  • Figures 1a and 1b are schematic diagrams of an aortic valve stent according to an embodiment of the present application
  • Figure 2 is a schematic diagram of the valve of an aortic valve stent according to an embodiment of the present application
  • Figure 3 is a schematic diagram of an aortic valve stent fixed to the aortic valve according to an embodiment of the present application
  • Figures 4a and 4b are schematic diagrams of an aortic valve stent and its usage state according to another embodiment of the present application.
  • Figure 5 is a schematic diagram of the use state of an aortic valve stent according to another embodiment of the present application.
  • Figure 6 is a schematic diagram of an aortic valve stent according to yet another embodiment of the present application.
  • Figure 7 is a schematic diagram of an aortic valve stent according to yet another embodiment of the present application.
  • Figures 8a-8e illustrate the aortic valve loaded by the system for delivering the aortic valve according to an embodiment of the present application.
  • Figures 9a-9b illustrate a system for delivering an aortic valve according to an embodiment of the present application.
  • 10a and 10b are schematic diagrams of a system for delivering an aortic valve according to another embodiment of the present application.
  • an aortic valve stent 10 is provided.
  • the aortic valve stent 10 includes a stent body 11, which has a contracted state and an expanded state.
  • the stent body 11 It can be transported in a contracted state and switched to an expanded state after reaching the aortic valve; the valve 12 provided on the inside of the stent body 11; and the first positioning part 13 and the second positioning part 14 provided on the outside of the stent body 11 , when the stent body 11 is in the deployed state, the first positioning part 13 and the second positioning part 14 can be respectively located on both sides of the leaflets of the aortic valve to fix the stent body 11 at the aortic valve.
  • Figure 1a shows the structure of the stent body 11 in the expanded state
  • Figure 1b shows the structure of the stent body 11 in the contracted state
  • the stent body 11 can be a cylindrical structure composed of a grid.
  • the grid can be a rhombus shape as shown in the figure or other irregular shapes, such as a rhombus-like structure surrounded by four arc-shaped sides.
  • the advantages of the rhombus shape structure This is because the stent body 11 is easy to contract and expand.
  • the diamond-shaped grid structure of the stent body 11 can be compressed, thereby reducing the diameter of the stent body 11 so that the aortic valve stent 10 can be loaded into a delivery device.
  • the delivery device can be a conventional device commonly used in the field. Catheter delivery device. After the delivery device delivers the aortic valve stent 10 to the aortic valve, the stent body 11 can be switched to an unfolded state and thereby fixed at the aortic valve.
  • the stent body 11 can be made of nickel-titanium alloy material. Ni-titanium alloy has a certain degree of flexibility at lower temperatures. Ice water, etc. can be used to cool the stent body 11 to make it easier to compress. into a collapsed state and loaded into a conveyor. After the aortic valve stent 10 is transported to the aortic valve, the delivery device can release the aortic valve stent 10. Since the temperature in the human body is relatively high, the flexibility of the stent body 11 decreases at such a temperature, so that it can be removed more quickly. Self-expanding facilitates the fixation of the aortic valve stent 10. In some other embodiments, those skilled in the art can also use other types of memory alloys or any other suitable materials to make the stent body, which is not specifically limited.
  • the diameter of the stent body 11 can be determined according to the inner diameter of the patient's aorta, so that the top end of the stent body 11 can resist the aortic wall and work together with the first positioning portion 13 and the second positioning portion 14 to align the stent body 11 To fix.
  • FIG. 2 shows the internal structure of the aortic valve stent 10.
  • a valve 12 is provided on the inside of the stent body 11.
  • the valve 12 usually includes three leaflets.
  • the valve 12 can be used to realize the function of the aortic valve. Specifically, when the left When the ventricle contracts, the valve leaflets will rise under the impact of blood flow, and a gap will appear between the valve leaflets, allowing the blood in the left ventricle to be pumped into the aorta. When the left ventricle relaxes, the valve leaflets will descend, and the gap between the valve leaflets will They join together along the commissure to prevent blood from the aorta from flowing back into the left ventricle.
  • the valve 12 can be sewn on the stent body 11.
  • a skirt can be formed on one end of the valve 12 close to the stent body 11. The skirt can increase the contact area between the valve 12 and the stent body 11, thereby enabling better The valve 12 is fixed to the stent body 11 to prevent the valve 12 from accidentally falling off.
  • the valve 12 can be made of porcine pericardium, bovine pericardium, horse pericardium, etc. In some other embodiments, the valve 12 can also be made of other suitable bionic materials, such as the polymer material polytetrafluoroethylene. Vinyl or polyester cloth, etc. are not specifically limited.
  • a first positioning part 13 and a second positioning part 14 are provided on the outside of the stent body 11.
  • the first positioning part 13 and the second positioning part 14 can be fixed on the stent body 11 by sewing. Alternatively, they may be welded to the stent body 11 .
  • Those skilled in the art may also use other suitable methods to fix the first positioning part 13 and the second positioning part 14 to the stent body 11 , which is not specifically limited.
  • the first positioning part 13 and the second positioning part 14 will be located on both sides of the leaflets of the aortic valve respectively. Specifically, at Behind the leaflets of each aortic valve, the aortic wall will bulge outward, forming an aortic sinus between the leaflets of the aortic valve and the aortic wall, and the first positioning portion 13 will be located in the aortic sinus.
  • the main body of the first positioning portion 13 will resist the leaflets of the aortic valve, and the bottom will resist the bottom of the aortic sinus, which is beneficial to positioning during the release of the aortic valve stent 10 .
  • the second positioning part 14 will be located on the side of the leaflets of the aortic valve away from the aortic wall and resist the leaflets of the aortic valve, thereby forming a cooperation with the first positioning part 13 to secure the aortic valve stent 10 fixed.
  • the number of the first positioning parts 13 and the second positioning parts 14 is adapted to the number of leaflets of the aortic valve, that is, usually three first positioning parts 13 and three second positioning parts 14 are provided. In some embodiments, For patients with only two aortic valve leaflets, only two first positioning parts 13 and two second positioning parts 14 may be provided. In some embodiments, the number of the first positioning portion 13 and the second positioning portion 14 may also be different from the number of leaflets of the aortic valve. Such embodiments will be described in detail in the relevant sections below.
  • the aortic valve will be clamped between the first positioning part 13 and the second positioning part 14, thereby preventing the aortic valve stent 10 from being impacted by the blood in the left ventricle when the left ventricle contracts.
  • the upward displacement can also prevent the aortic valve stent 10 from being displaced downward due to the impact of blood in the aorta during left ventricular diastole, thereby obtaining a better fixation effect.
  • the first positioning part 13 and the second positioning part 14 may be arranged in an arc shape, so that the first positioning part 13 and the second positioning part 14 can have a relatively small size.
  • the large contact area achieves better fixation effect and can reduce the volume of the aortic valve stent 10 as much as possible.
  • the first positioning part 13 when the stent body 11 is in a contracted state, the first positioning part 13 may be at least partially located outside the second positioning part 14 , specifically, the end of the first positioning part 13 and the second positioning part 14
  • the ends of the positioning parts 14 will overlap to a certain extent, and the end of the first positioning part 13 is outside the end of the second positioning part 14 . Therefore, during the process of releasing the aortic valve stent 10, the first positioning part 13 can be opened before the second positioning part 14, and then the bottom of the first positioning part 13 can be positioned at the sinus bottom of the aortic valve first, and then The second positioning portion 14 is opened to complete the clamping of the aortic valve, which facilitates operation. Moreover, such overlap enables the first positioning part 13 and the second positioning part 14 to cooperate with each other when clamping the leaflets of the aortic valve, thereby achieving a better fixing effect.
  • one end of the first positioning portion 13 away from the stent body 11 is bent toward the stent body 11 to form a first hook-shaped body 131
  • the second positioning portion 14 is away from the end of the stent body 11 .
  • One end is bent away from the stent body 11 to form a second hook-shaped body 141.
  • the first hook-shaped body 131 and the second hook-shaped body 141 can cooperate with each other to clamp the leaflets of the aortic valve to the first positioning part 13 and the second positioning part 13. between positioning parts 14.
  • the bent portion of the first hook-shaped body 131 will resist the sinus floor of the aortic valve, and the end of the first hook-shaped body 131 will resist the sinus floor of the aortic valve. on the leaflets of the aortic valve.
  • the bent part of the second hook-shaped body 141 will push the leaflet ends of the aortic valve to form a certain curl and enter the position between the first hook-shaped body 131 and the second hook-shaped body 141, and the second hook-shaped body The end of 141 will be against the leaflets of the aortic valve. This creates a more stable clamping of the leaflets of the aortic valve.
  • those skilled in the art can reasonably set the angles of the bent portions of the first hook-shaped body 131 and the second hook-shaped body 141, and the first positioning portion 13 and the second positioning portion 14 on the bracket body. 11 in the open state with the bracket body 11 to obtain the desired clamping effect.
  • the angle formed between the first positioning portion 13 and the stent body 11 is 30-70 degrees when the stent body 11 is deployed.
  • the first positioning part 13 and the second positioning part 14 may be in a flat state. For example, they may be pressed by the sheath wall of the delivery system and become a flat state. At this time, the first hook-shaped body 131 and the second hook-shaped body 141 disappear due to being flattened.
  • the first positioning part 13 and the second positioning part 14 are ejected, and due to the loss of By pressing, the ends of the first positioning part 13 and the second positioning part 14 are bent to re-form the first hook-shaped body 131 and the second hook-shaped body 141 .
  • Such an embodiment can reduce the overall diameter of the aortic valve stent 10 when the stent body 11 is in the contracted state, making it easier to load and release.
  • One advantage of providing the first hook-shaped body 131 and the second hook-shaped body 141 is that the first hook-shaped body 131 and the second hook-shaped body 141 cooperate with each other to form a more stable clamping of the leaflets of the aortic valve, and further Displacement of the aortic valve stent 10 is prevented.
  • the leaflets of their aortic valves do not have calcifications and are relatively soft. It may be difficult to ensure the position of the aortic valve stent using other methods provided by related technologies. Stablize.
  • providing the first hook-shaped body 131 can also This prevents the sharper part of the first positioning part 13 from directly contacting the aortic wall, thereby avoiding damage.
  • the number of the first positioning portion 13 and the second positioning portion 14 may be adapted to the number of aortic valve leaflets. Since the clamping formed by the first hook-shaped body 131 and the second hook-shaped body 141 on the leaflets is very stable, it is difficult to adjust the clamping position of the first hook-shaped body 131 and the second hook-shaped body 141 again after the clamping is formed. In actual application, it is usually hoped that the aortic valve stent 10 can ensure good coaxiality with the aorta (the axis of the aortic valve stent 10 roughly coincides with the axis of the aortic lumen).
  • the operator may be required to release the aortic valve stent 10 during the actual release process. Before the first positioning part 13 is released or after it is released and opened, it takes a lot of time to adjust the angle and then release the second positioning part 14, so that the aortic valve stent 10 and the aorta are finally released. Good coaxiality can be ensured between them.
  • the first hook-shaped body 131 and the second hook-shaped body 141 may be provided only on part of the first positioning part 13 and the second positioning part 14, for example, only on the corresponding first positioning part.
  • 13 and a second positioning part 14 are provided with a first hook-shaped body 131 and a second hook-shaped body 141, while the other part of the first positioning part 13 and the second positioning part 14 may be arranged in an arc shape as described above. .
  • first positioning part 13 and the second positioning part 14 it is not necessary to provide the first positioning part 13 and the second positioning part 14 at each leaflet.
  • first positioning part 13 and the second positioning part 14 are only provided at one leaflet, and the first positioning part 13 and the second positioning part 14 are provided at the first positioning part.
  • the first hook-shaped body 131 and the second hook-shaped body 141 are provided on the positioning part 13 and the second positioning part 14. In such an embodiment, the first hook-shaped body 131 and the second hook-shaped body 141 pair a leaflet.
  • the coaxiality between the aortic valve stent 10 and the aorta is not good, a certain torque will be generated, so that the aortic valve stent 10 does not have the first positioning portion 13 and One side of the second positioning part 14 , or the side where only the first positioning part 13 and the second positioning part 14 are provided without the first hook-shaped body 131 and the second hook-shaped body 141 can be moved under the action of the torque.
  • a certain movement realizes automatic alignment. Therefore, the operator can quickly complete the positioning of the aortic valve stent 10 during the process of releasing the aortic valve stent 10 without spending a long time to adjust the angle.
  • FIG. 5 shows a schematic diagram of an aortic valve stent disposed at the aortic valve in the related art. It can be understood that a coronary opening is formed above the aortic sinus. The aortic valve in the related art The stent is placed on the inside of the leaflets of the aortic valve, so that the leaflets of the aortic valve will stick to the wall of the aorta under the extrusion of the aortic valve stent. If the patient's coronary artery opening is low, and/or the aortic valve has longer leaflets, which may cause the coronary opening to be blocked by the leaflets.
  • the leaflets of the aortic valve will be limited in the gap formed between the first hook-shaped body 131 and the second hook-shaped body 141 , rather than being in close contact with each other.
  • the aortic wall prevents the aortic valve leaflets from blocking the coronary opening.
  • the first positioning portion 13 can form a larger included angle with the stent body 11 when the stent body 11 is in the open state, for example, An angle of 30-70 degrees.
  • the end of the first hook-shaped body 131 is formed with a first spine-shaped body 132
  • the end of the second hook-shaped body 141 is formed with a second spine-shaped body 142.
  • the first spiny body 132 and the second spiny body 142 can at least partially penetrate into the leaflets of the aortic valve, thereby further improving the stability of the clamping.
  • barbs may be formed on the first spiny body 132 and/or the second spiny body 142 so that the first spiny body 132 and the second spiny body 142 penetrate into the aortic valve. The back of the leaf is difficult to slide out, further improving the stability of clamping.
  • the first hook-shaped body 131 and the second hook-shaped body 141 may be provided with magnetic components that attract each other, or the first thorn-shaped body 132 and the second thorn-shaped body 142 may be provided with magnetic components that attract each other. a magnetic component that enables the first hook-shaped body 131 and the second hook-shaped body 141 to move toward each other under the action of mutual attraction during the release process, making it easier to clamp the aortic valve leaflets, Moreover, after the clamping is formed, the clamping state can be maintained relatively stably.
  • the aortic valve stent 10 further includes a pulling wire 15 , the pulling wire 15 can pass through the second hook-shaped body 141 and be connected to the first hook-shaped body 131 , so that the pulling wire 15 can The first hook-shaped body 131 is pulled to move toward the second hook-shaped body 141 .
  • first hook-shaped body 131 and the second hook-shaped body 141 are arranged in cooperation with each other, during the actual release process, since the size, thickness, etc. of each patient's valve leaflets are different, The resulting clamping effect may not be stable enough, for example, not clamped tightly enough.
  • a pulling wire 15 is provided, and one end of the pulling wire 15 can pass through the second hook-shaped body 141 (the passage here means that the pulling wire 15 can pass through a certain part of the second hook-shaped body 141 and can slide relative to the second hook-shaped body 141) and the first hook-shaped body 131, so that after completing the release of the first hook-shaped body 131 and the second hook-shaped body 141, the The two ends of the pulling wire 15 (for example, operated by a conveying device) are operated to cause the first hook-shaped body 131 to move toward the second hook-shaped body 141 to achieve tighter clamping.
  • the operation of the pulling wire 15 can be stopped. Even if the force of the pulling wire 15 is lost, it will not cause Displacement occurs again between the first hook-shaped body 131 and the second hook-shaped body 141, which affects the clamping effect. Further, after the traction is completed, the traction wire 15 can be pulled out of the patient's body by operating one end of the traction wire 15 .
  • the pulling wire 15 may be configured to at least partially cut the clamped first hook-shaped body 131 and the second hook-shaped body 141 during the movement of the first hook-shaped body 131 toward the second hook-shaped body 141 .
  • the second hook-shaped body 141 is between the leaflets of the aortic valve. It can be understood that after the first hook-shaped body 131 and the second hook-shaped body 141 are released, the pulling wire 15 will be at the end of the leaflet of the aortic valve, and the pulling wire 15 can be set to have sufficient strength.
  • the pulling wire 15 can cut the leaflets of the aortic valve from the end of the leaflets of the aortic valve to further ensure that the leaflets of the aortic valve are not It will block the coronary opening.
  • a frosted layer can be provided at the position where the first positioning portion 13 and the second positioning portion 14 are in contact with the leaflets of the aortic valve.
  • the frosted layer can increase the contact between the first positioning portion 13 and the second positioning portion 14 and the leaflets of the aortic valve. The friction between the leaflets of the aortic valve further prevents the aortic valve stent 10 from being displaced.
  • Those skilled in the art can determine the position of the frosted layer according to the actual situation, and there is no limit to this.
  • the first positioning part 13 slide up and down along the aortic wall to adjust the position. Therefore, The position on the first positioning part 13 that is in contact with the aortic wall, that is, the position where the curling begins, cannot be provided with a frosted layer (even if this position may later come into contact with the leaflets of the aortic valve) to facilitate the operator's operation.
  • the stent body 11 may include a contraction section 111 and an expansion section 112 provided at both ends of the contraction section, wherein the inner diameter of the expansion section 112 gradually increases in a direction away from the contraction section 111 . That is, the stent body 11 can be an aortic valve stent with a longer body used in related technologies in this field, in which the contraction section 111 is a smaller inner diameter part in the middle of the body, and the expansion section 112 is connected to the contraction section.
  • the inner diameters above and below the section 111 gradually increase, the contraction section 111 and the expansion section 112 can be integrally formed.
  • Those skilled in the art can refer to the relevant technology in this field to specifically set the lengths of the expansion section 112 and the contraction section 111. There are no specific restrictions on the inner diameter and connection method.
  • valve 12 and the first positioning part 13 can be disposed on the contraction section 111. Therefore, referring to Figure 4b, there will be no obstruction in the section of the contraction section 111 located above the valve 12 and the first positioning part 13. Blood can flow smoothly into the coronary opening via this location.
  • the aortic valve stent 10 may further include a shrink ring 16 disposed in the middle of the stent body 11 .
  • the shrink ring 16 will shrink the middle of the stent body 11 when the stent body 11 is in an expanded state.
  • the diameter of the middle part of the stent body 11 is smaller than the diameter of both ends.
  • the shrinking ring 16 can achieve a better shrinking effect, especially for embodiments with a longer stent body 11 .
  • the shrink ring 16 can be made of flexible material to prevent the shrink ring 16 from affecting the shrinkage of the stent body 11 .
  • the shrink ring 16 can be made of multiple rigid arcs connected by flexible materials.
  • the shape of the structure can not only prevent the shrink ring 16 from affecting the shrinkage of the stent body 11, but also provide a better shrinkage effect when the stent body 11 is expanded.
  • Those skilled in the art can also use other methods to reasonably set the shrink ring 16 , there is no specific limit on this.
  • the number of shrink rings 16 is not limited to one, and multiple ones may be provided to obtain a better shrinking effect and/or to make the shape of the stent body 11 in the expanded configuration more consistent with expectations.
  • the shrink ring 16 is disposed on a side of the first positioning part 13 away from the second positioning part 14 , that is, above the connection between the first positioning part 13 and the stent body 11 , so that the shrink ring 16
  • the angle of the first positioning portion 13 can be better limited to avoid blocking the coronary opening.
  • the aortic valve stent 10 further includes a connecting ring 17 provided at one end of the stent body 11, and the connecting ring 17 is used to load the stent body 11 on the delivery device.
  • the connecting ring 17 can be disposed at the top of the stent body 11.
  • the connecting ring 17 will be the last part of the aortic valve stent 10 to leave the delivery device.
  • the connecting ring 17 can still be compressed into the delivery device, so that the placement position of the aortic valve stent 10 can be readjusted.
  • the hollow part in the middle of the connecting ring 17 can be circular, rectangular, hexagonal, etc., and the connecting ring can be welded to the stent body 11 through a short rod, or sewn to the stent body 11, and there is no specific limitation on this.
  • multiple connecting rings 17 can be provided at one end of the stent body 11 at the same intervals, for example, three are provided in a centrally symmetrical manner, so as to avoid deviation during the recycling process and lead to recycling failure.
  • a connecting ring 17 may also be provided at the bottom end of the stent body 11 , so that the lower half of the stent body 11 and the second positioning portion 14 can be retracted into the delivery device before they are completely released. .
  • both ends of the stent body 11 may expand outward to form a trumpet shape.
  • the trumpet-shaped structure formed by the expansion of the top of the stent body 11 can make the top of the stent body 11 more firmly resist the wall of the aorta, further improving the fixation effect.
  • the horn-shaped structure formed by the expansion of the bottom end of the stent body 11 can also further improve the fixing effect and avoid upward displacement of the stent body 11 .
  • a system for delivering an aortic valve stent includes an aortic valve stent as described in any of the above embodiments. 10, and the delivery device 20.
  • the aortic valve stent 10 can be loaded on the delivery device 20 when the stent body 11 is in a contracted state.
  • the delivery device 20 can deliver the aortic valve stent 10 to the aortic valve and transport the aortic valve to the aortic valve.
  • the stent 10 is released to switch the stent body 11 to the deployed state, thereby fixing the aortic valve stent 10 at the aortic valve.
  • the delivery device 20 can be a transcatheter delivery device commonly used in the art. Specifically, after the aortic valve stent 10 is loaded on the delivery device 20, the delivery device 20 can reach the aortic valve via the aorta, and then The aortic valve stent 10 is released and fixed on the aortic valve. It should be noted that the aortic valve stent 10 in FIGS. 8a to 8d and 9a to 8b is only for illustration and does not constitute a limitation on the specific structure of the aortic valve stent 10 in this application.
  • the delivery device 20 may include a loading part 21 for loading the aortic valve stent 10 and an operating part 22 for operating the movement of the loading part 21 to complete the aortic valve stent 10 device or release the aortic valve stent 10.
  • the loading part 21 and the operating part 22 can be connected through the extension part 23, which can be a flexible pipeline.
  • the extension part 23 extends in the patient's body to transport the loading part 21 to the vicinity of the aortic valve.
  • the operating portion 22 can also be used to operate to change the curvature of the flexible tube, so that the loading portion 21 can more easily reach the ascending aorta via the peripheral artery and pass through the aortic arch to the aortic valve.
  • the loading part 21 may include a first housing 211 and a second housing 212.
  • the first housing 211 and the second housing 212 can be installed in the respective locations. It moves under the operation of the operation part 22.
  • the loading part 21 includes two independently movable housings, so that the desired parts can be controlled to be released preferentially by independently operating the movement of the first housing 211 and the second housing 212 .
  • the first housing 211 can slide toward the direction of the operating portion 22 under the operation of the operating portion 22, and the second housing 212 can move away from the operating portion 22 under the operation of the operating portion 22.
  • the operation part 22 slides in the direction.
  • the operating part 22 may include a first operating part 221 for operating the first housing 211 and a second operating part 222 for operating the second housing 212.
  • the member 221 and the second operating member 222 can be a knob, a push rod, and other structures, and can be connected to the housing they operate through a transmission structure to operate the housing.
  • Those skilled in the art can refer to the description of the conveying device in the related art.
  • the operating parts and transmission structures used are used for setting, and there are no specific restrictions on this.
  • the first housing 211 and the second housing 212 can also move together under the operation of the operating part 22.
  • a knob structure can be used to simultaneously control the first housing 211 and the second housing 211.
  • the housings 212 can move towards each other to complete the loading, or move away from each other to complete the release. This will simplify the steps of the release operation, but it may need to be very precise to load the aortic valve stent 10. It is released in the desired manner.
  • the loading part 21 may also include more housings, for example, it may also include a third housing and a fourth housing (not shown in the figure). It can correspond to the positions of the first positioning part 13 and the second positioning part 14, so that the third housing and the fourth housing can be moved first to release the first positioning part 13 and the second positioning part 14 to complete positioning and fixing. Then release it in other positions.
  • the first housing 211 is formed with a first receiving cavity 213, and the second housing 212 is formed with a second receiving cavity 214.
  • the first positioning part 13 is located in the first accommodating cavity 213
  • the second positioning part 14 is located in the second accommodating cavity 214 .
  • the first housing 211 can be first operated to move in the direction of the operating part 22. Referring to FIG. 8b, the movement of the first housing 211 causes the first positioning part 13 to leave the first accommodating cavity 213. When the first positioning part 13 has completely left the first accommodation cavity 213, the first housing 211 can be stopped and positioned with the help of the released first positioning part 13. As described above, after being released, the first positioning portion 13 will form an included angle with the stent body 11, that is, the first positioning portion 13 is in an expanded state, thereby facilitating positioning.
  • the second positioning portion 14 will still be in the second receiving cavity 214 of the second housing 212. At this time, referring to Fig. 9a, the second positioning portion 14 will not move against the first housing 211.
  • the positioning part 13 generates shielding, so that the first positioning part 13 can enter the aortic sinus more smoothly and be positioned at the bottom of the sinus. Specifically, the first positioning portion 13 can be slid to the bottom of the aortic valve sinus by pushing and rotating the loading portion 21 .
  • the second housing 212 can be moved so that the second positioning part 14 is released, and then, referring to Figure 9b, the second positioning part 14 and the first positioning part 13 complete the positioning of the aortic valve. Clamping. After it is determined that the first positioning part 13 and the second positioning part 14 have been fixed in a more suitable place, the second housing 212 can continue to be moved in the direction away from the operating part 22 so that the lower half of the bracket body 11 is Complete release. Then, referring to FIG. 8d , the first housing 211 is continued to be moved so that other parts of the bracket body 11 are released.
  • the first positioning part 13 when the stent body 11 is in the contracted state, the first positioning part 13 will be located outside the second positioning part 14, that is, the first positioning part 13 and the second positioning part 14 will be There will be a certain overlapping portion.
  • the length of the second housing 212 can be correspondingly increased so that it can enter the first housing 211 and be loaded on the loading part when the aortic valve stent 10 is loaded. At 21 o'clock, it is partially located on the first positioning part 13 and the second positioning part 14 bracket.
  • the structure at the overlapping area of the first positioning part 13 and the second positioning part 14 is, from the outside to the inside, the first housing 211, the first positioning part 13, the second housing 212, the second The positioning part 14 can therefore continue to keep the second positioning part 14 from being released when the first housing 211 moves and releases the first positioning part 13 .
  • the aortic valve stent 10 may be provided with a connecting ring 17.
  • the loading part 21 may also include a connecting piece 215, which can be operated The part 22 moves under the operation to connect or disconnect with the connecting ring 17.
  • the operating part 22 may include a third operating member 223 for operating the connecting member 215.
  • the connecting member 215 may move to connect or disconnect with the connecting ring 17,
  • the connecting piece 215 can be rod-shaped and can move along the radial direction of the loading portion, so that it can move toward the center of the loading portion 21 to penetrate the connecting ring 17 for connection, or in a direction away from the center of the loading portion 21 Move to disconnect from connecting ring 17.
  • the top of the connecting member 215 can be switched into a hook form and a line form under the operation of the third operating member 223. In the hook form, it can hook the connecting ring 17 for connection, and in the line form, it can be connected with the connecting ring 17. The connecting ring 17 is disconnected.
  • the connector 215 in other suitable ways, and there is no specific limitation on this.
  • the first receiving cavity 213 of the first housing 211 can be large enough, so that the reverse movement of the first housing 211 can move the entire aortic valve stent 10 including the second positioning portion 14 All are recovered into the first accommodation cavity 213 .
  • a connecting ring can also be provided at the other end of the bracket body 11 , and similarly, a connecting piece can also be provided at the other end of the loading part 21 to connect the released second positioning part 14 and the bracket body 11 The lower part is recycled.
  • the conveying device 20 may further include a rotating part 24.
  • the rotating part 24 is provided in the extension part 23, and the operating part 22 can operate the rotating part 24 to rotate to change The orientation of the axis of the loading part 21, for example, by operating the rotating part 24 to rotate, can adjust the orientation of the axis of the loading part 21 from the direction shown in FIG. 10a to the direction shown in FIG. 10b, so that it can be more conveniently
  • the coaxiality between the aortic valve stent 10 and the aorta is adjusted.
  • the aortic valve stent 10 may include a pulling wire 15, and the pulling wire 15 may pass through the first positioning part 13 and the second positioning part 14.
  • the operating part 22 may also be It is configured to be able to operate the pulling wire 15.
  • both ends of the pulling wire 15 can be connected to the operating part 22.
  • the operating part 22 can drive the pulling wire 15 to move through the transmission structure to complete the pulling. After the pulling is completed, the pulling wire 15 can be moved. One end of the pulling wire 15 is released, and the other end of the pulling wire 15 is operated to pull the pulling wire 15 out of the patient's body.
  • the specific manner in which the operating part 22 operates the pulling wire 15 may refer to the operating manner in the loading part 21 or the connecting piece 215, or any suitable operating manner in the field, which is not limited.
  • both ends of the pulling wire 15 can pass through the operating part 22, and the operator can pull the two ends of the pulling wire directly to perform traction. After the pulling is completed, the operator can pull the side of the pulling wire 15. One end to pull the pulling wire 15 out of the patient's body.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne une endoprothèse de valvule aortique (10) et un système de transport de l'endoprothèse de valvule aortique (10). L'endoprothèse de valvule aortique (10) comprend : un corps d'endoprothèse (11), le corps d'endoprothèse (11) présentant un état contracté et un état déployé et pouvant être transporté dans l'état contracté et passé à l'état déployé après avoir été transporté jusqu'à la valvule aortique ; une valve (12) disposée sur le côté interne du corps d'endoprothèse (11) ; une première partie de positionnement (13) et une seconde partie de positionnement (14) disposées sur le côté externe du corps d'endoprothèse (11), la première partie de positionnement (13) et la seconde partie de positionnement (14) pouvant être positionnées sur les deux côtés des cuspides valvulaires de la valvule aortique respectivement lorsque le corps d'endoprothèse (11) est dans l'état déployé, de façon à fixer le corps d'endoprothèse (11) au niveau de la valvule aortique. L'endoprothèse de valvule aortique (10) et le système pour transporter l'endoprothèse de valvule aortique (10) permettent de mieux fixer l'endoprothèse de valvule aortique (10) au niveau de la valvule aortique, ce qui permet d'éviter le déplacement de l'endoprothèse de valvule aortique (10).
PCT/CN2022/087224 2022-04-15 2022-04-15 Endoprothèse de valvule aortique et système de transport d'endoprothèse de valvule aortique Ceased WO2023197328A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2022/087224 WO2023197328A1 (fr) 2022-04-15 2022-04-15 Endoprothèse de valvule aortique et système de transport d'endoprothèse de valvule aortique

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2022/087224 WO2023197328A1 (fr) 2022-04-15 2022-04-15 Endoprothèse de valvule aortique et système de transport d'endoprothèse de valvule aortique

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Citations (9)

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US20110264196A1 (en) * 2010-04-23 2011-10-27 Medtronic, Inc. Stents for Prosthetic Heart Valves
US20130144381A1 (en) * 2009-09-29 2013-06-06 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
CN103476362A (zh) * 2011-01-11 2013-12-25 汉斯·赖纳·菲古拉 用于替换心脏动脉心室瓣膜的瓣膜假体
US20150351904A1 (en) * 2014-06-06 2015-12-10 Edwards Lifesciences Corporation Prosthetic valve for replacing a mitral valve
CN105473105A (zh) * 2013-03-15 2016-04-06 心脏结构导航公司 导管引导式瓣膜置换装置和方法
CN105496608A (zh) * 2016-01-11 2016-04-20 北京迈迪顶峰医疗科技有限公司 一种经导管输送主动脉瓣瓣膜装置
CN113208776A (zh) * 2021-04-25 2021-08-06 浙江大学 人工心脏瓣膜以及输送装置
CN215458984U (zh) * 2021-04-30 2022-01-11 沛嘉医疗科技(苏州)有限公司 一种瓣膜支架和假体瓣膜组件
CN114041904A (zh) * 2021-11-24 2022-02-15 中国人民解放军海军军医大学第一附属医院 一种适用于经导管的三尖瓣膜假体

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130144381A1 (en) * 2009-09-29 2013-06-06 Cardiaq Valve Technologies, Inc. Replacement heart valves, delivery devices and methods
US20110264196A1 (en) * 2010-04-23 2011-10-27 Medtronic, Inc. Stents for Prosthetic Heart Valves
CN103476362A (zh) * 2011-01-11 2013-12-25 汉斯·赖纳·菲古拉 用于替换心脏动脉心室瓣膜的瓣膜假体
CN105473105A (zh) * 2013-03-15 2016-04-06 心脏结构导航公司 导管引导式瓣膜置换装置和方法
US20150351904A1 (en) * 2014-06-06 2015-12-10 Edwards Lifesciences Corporation Prosthetic valve for replacing a mitral valve
CN105496608A (zh) * 2016-01-11 2016-04-20 北京迈迪顶峰医疗科技有限公司 一种经导管输送主动脉瓣瓣膜装置
CN113208776A (zh) * 2021-04-25 2021-08-06 浙江大学 人工心脏瓣膜以及输送装置
CN215458984U (zh) * 2021-04-30 2022-01-11 沛嘉医疗科技(苏州)有限公司 一种瓣膜支架和假体瓣膜组件
CN114041904A (zh) * 2021-11-24 2022-02-15 中国人民解放军海军军医大学第一附属医院 一种适用于经导管的三尖瓣膜假体

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