WO2024088355A1 - 医疗装置 - Google Patents

医疗装置 Download PDF

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Publication number
WO2024088355A1
WO2024088355A1 PCT/CN2023/126911 CN2023126911W WO2024088355A1 WO 2024088355 A1 WO2024088355 A1 WO 2024088355A1 CN 2023126911 W CN2023126911 W CN 2023126911W WO 2024088355 A1 WO2024088355 A1 WO 2024088355A1
Authority
WO
WIPO (PCT)
Prior art keywords
leaflet
chamber
pad
medical device
edge portion
Prior art date
Application number
PCT/CN2023/126911
Other languages
English (en)
French (fr)
Inventor
王励
Original Assignee
合源医疗器械(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202211328166.7A external-priority patent/CN117982261A/zh
Priority claimed from CN202211327911.6A external-priority patent/CN117982260A/zh
Application filed by 合源医疗器械(上海)有限公司 filed Critical 合源医疗器械(上海)有限公司
Publication of WO2024088355A1 publication Critical patent/WO2024088355A1/zh

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Classifications

    • 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 disclosure relates to the technical field of medical devices, and in particular, to a medical device for repairing a heart valve of a patient.
  • Heart valves are valves between the atria and ventricles or between the ventricles and arteries. They play a key role in the heart's never-ending blood circulation. After blood has flowed through them, the valves close to prevent blood from flowing back.
  • the repair device has a structure similar to a clip, which improves the closure of the valve by clamping on a pair of leaflets of the valve.
  • this repair device has many disadvantages. For example, this repair device will cause the effective area of blood flow through the valve to be reduced, which may lead to another problem - stenosis. For another example, this repair device clamps a pair of leaflets together, so that the pair of leaflets cannot naturally mate and separate with the cardiac cycle. Over time, this may cause problems with the structure and function of the pair of leaflets, their related tissues, and even the structure and function of the entire valve.
  • the present disclosure provides a medical device.
  • the medical device provided by the present disclosure is used to repair a patient's heart valve.
  • the medical device includes a cushion configured to be located between a plurality of leaflets of the valve so as to enable the valve to open and close periodically by cooperating with the plurality of leaflets.
  • the medical device provided by the present disclosure can improve the closure of the valve, so that the valve can be properly closed, thereby effectively preventing or reducing the backflow of blood.
  • the medical device provided by the present disclosure has less interference with blood flow, thereby reducing the possibility of stenosis.
  • the medical device provided by the present disclosure has less influence on the movement of the leaflets, thereby less adverse effects on the structure and function of the leaflets.
  • the plurality of leaflets include a first leaflet and a second leaflet, and the pad has a first apposition surface.
  • the first apposition surface is configured to periodically apposition and separation with the first leaflet as the first leaflet or the second leaflet moves.
  • the first apposition surface is configured to be concave in a direction away from the first leaflet it faces.
  • Configuring the apposition surface to be concave in a direction away from the leaflet it faces can enable the apposition surface to better match the leaflet, thereby enabling the apposition surface to better apposition with the leaflet.
  • the valve is used to allow blood to flow from the first chamber into the second chamber and prevent blood from flowing in the opposite direction
  • the first accommodating surface is configured to gradually extend toward the first chamber and toward the side where the leaflet it faces is located.
  • a small amount of blood may still flow back from the second chamber to the first chamber.
  • the apposition surface is configured to be concave in the direction away from the leaflet it faces and gradually extend toward the first chamber to the side where the leaflet is located. This configuration can change the flow direction of blood flowing from the second chamber to the first chamber, guide the blood flow to one side, and avoid the blood flow directly facing the first chamber, thereby reducing the adverse effects of reflux on the patient's heart function.
  • the first mating surface has a first edge portion and a second edge portion located at opposite ends thereof, respectively, the first edge portion is configured to be close to the first chamber relative to the second edge portion, and the angle formed by the cross-section of the first edge portion and the cross-section of the second edge portion ranges from greater than or equal to 10 degrees to less than or equal to 45 degrees.
  • the pad further has a top surface, and the top surface is configured to face the first cavity and protrude toward the first cavity.
  • the thickness of the pad gradually increases toward the first chamber, which may cause blood to easily accumulate on the top of the pad. Configuring the top surface of the pad to bulge toward the first chamber can effectively avoid or reduce the accumulation of blood on the top of the pad.
  • the pad has a plurality of apposition surfaces including a first apposition surface.
  • the plurality of apposition surfaces are configured to face the plurality of leaflets respectively, and as the plurality of leaflets move, at least a portion of each apposition surface periodically appositions with and separates from the leaflets it faces.
  • the valve can open and close periodically through its own movement, and increase the effective closure of the leaflet through the apposition of the pad and the leaflet during the systole, thereby not only maintaining the autonomous flow of blood from the first chamber to the second chamber during the diastole, but also effectively preventing the reverse flow during the systole caused by the poor apposition of multiple leaflets.
  • the top surface is configured to gradually extend toward the second chamber from the middle thereof as it approaches the side where each leaflet is located.
  • This structure of the top surface can effectively avoid or reduce the accumulation of blood on the top of the pad.
  • this structure of the top surface can also reduce the barrier of the pad to the blood flow flowing from the first chamber to the second chamber, and better guide the blood flow from the first chamber to flow into the second chamber.
  • the angle between the cut surface in the middle of the top surface and the cut surface of the edge of the top surface close to each leaflet is in the range of greater than or equal to 10 degrees and less than or equal to 45 degrees.
  • the top surface can better guide the blood flow from the first chamber to the second chamber, thereby reducing the obstruction of blood flow from the first chamber to the second chamber.
  • the medical device further includes a support configured to be located in the first chamber and connected to the pad so as to position the pad between the plurality of leaflets.
  • the pad By means of the support disposed in the first chamber, the pad can be securely positioned between the plurality of leaflets.
  • the support member has a main body portion and a pair of connecting portions, and the pair of connecting portions are configured to extend to both sides of the pad in a width direction and be connected to the pad respectively.
  • this structure of the support member can greatly reduce the obstruction of the blood flow caused by the connection between the support member and the pad, thereby reducing the adverse effects of the medical device on the normal physiological functions of the patient.
  • the pad includes an expandable grid and a cover wrapped around the outside of the grid, wherein the cover is disposed on the top of the pad without covering any of the plurality of mating surfaces.
  • the shape and size of the pad are mainly determined by the mesh frame.
  • the mesh frame can be folded to reduce the overall size of the pad, thereby making the delivery process easier.
  • the mesh frame can be unfolded so that the pad has a suitable size and shape.
  • this structure with a mesh frame allows doctors to adaptively adjust the shape and size of the pad according to the differences in the valves of different patients, so that the pad can better match the patient's valve.
  • the cover wrapped around the outside of the mesh frame can provide a smooth surface for the pad, thereby avoiding or reducing tissue proliferation and blood adsorption on the pad on the one hand, and on the other hand, making the pad and the leaflet more closely aligned. Placing the cover only on the top of the pad but not covering the aligning surface can make the aligning surface epidermalize faster and reduce the impact on the leaflet tissue when the leaflets collide with the aligning surfaces.
  • the pad has a second mate surface, and the second mate surface is configured to mate with and separate from the second leaflet periodically as the second leaflet moves, wherein the second mate surface is configured to be concave in a direction away from the second leaflet.
  • the valve is used to allow blood to flow from the first chamber into the second chamber and prevent blood from flowing in the opposite direction, wherein the second apposition surface is configured to be oriented toward the first chamber and gradually toward the second leaflet. Extends on the side.
  • the second mating surface has a first edge portion and a second edge portion located at opposite ends thereof, respectively, the first edge portion is configured to be close to the first chamber relative to the second edge portion, and the angle formed by the cross-section of the first edge portion and the cross-section of the second edge portion ranges from greater than or equal to 10 degrees to less than or equal to 45 degrees.
  • the pad is configured to follow the movement of the second leaflet.
  • the first apposition surface is configured to periodically apposition and separation with the first leaflet as the pad follows the movement of the second leaflet.
  • the valve can open and close periodically through its own movement, and increase the effective closure of the leaflet through the apposition of the pad and the leaflet during the systole, thereby not only maintaining the autonomous flow of blood from the first chamber to the second chamber during the diastole, but also effectively preventing the reverse flow during the systole caused by the poor apposition of multiple leaflets.
  • the top surface is configured to gradually extend toward the second chamber and toward the side where the first leaflet is located.
  • This structure of the top surface can effectively avoid or reduce the accumulation of blood on the top of the pad.
  • this structure of the top surface can also reduce the barrier of the pad to the blood flow flowing from the first chamber to the second chamber, and better guide the blood flow from the first chamber to flow into the second chamber.
  • the top surface has a third edge portion and a fourth edge portion located at opposite ends thereof, respectively, the fourth edge portion is configured to be close to the second chamber relative to the third edge portion, and the angle formed by the cut surface of the third edge portion and the cut surface of the fourth edge portion ranges from greater than or equal to 10 degrees to less than or equal to 45 degrees.
  • the top surface can better guide the blood flow from the first chamber to the second chamber, thereby reducing the obstruction of blood flow from the first chamber to the second chamber.
  • the pad further has a second apposition surface, which is configured to face the second leaflet and be recessed in a direction away from the second leaflet, and to maintain apposition with the second leaflet as the pad follows the movement of the second leaflet.
  • the second apposition surface faces the second leaflet and is recessed away from the second leaflet. This structure enables the second apposition surface to better match the second leaflet and better fit the second leaflet, thereby effectively avoiding or reducing blood accumulation between the second apposition surface and the second leaflet.
  • the pad is configured to be attached to the second leaflet.
  • the pad is attached to the second leaflet so as to be able to follow the movement of the second leaflet.
  • the valve is used to allow blood to flow from a first chamber into a second chamber and prevent flow in the opposite direction
  • the medical device also includes a support member configured to be located in the first chamber and to position a pad between the first leaflet and the second leaflet, wherein the pad is connected to the support member in a manner that can follow the movement of the second leaflet.
  • the pad can be reliably positioned between the first leaflet and the second leaflet by the support member placed in the first chamber.
  • the pad is connected to the support member in a manner that it can follow the movement of the second leaflet, so that the pad follows the movement of the second leaflet, thereby causing the first apposition surface to periodically apposition and separation with the first leaflet.
  • the thickness of the pad gradually increases toward the first cavity.
  • the valve is a mitral valve, and the number of the plurality of leaflets is two; or, the valve is a three-piece valve, and the number of the plurality of leaflets is three.
  • FIG. 1 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.
  • FIG. 2 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.
  • 3A and 3B are schematic structural diagrams of a pad of the medical device in FIG. 2 .
  • FIG. 4 is a schematic diagram of the axial structure of the medical device in FIG. 2 .
  • FIG. 5 is a schematic structural diagram of a pad of a medical device according to another embodiment of the present disclosure.
  • FIG. 6 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.
  • FIG. 7 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.
  • FIG. 8A and 8B are schematic structural diagrams of a pad of the medical device in FIG. 7 .
  • FIG. 9 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.
  • FIG. 10 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.
  • the present disclosure provides a new medical device for repairing a patient's valve.
  • the present disclosure provides a medical device pad, which is configured to be located between multiple leaflets of a valve to periodically open and close the valve by cooperating with the multiple leaflets.
  • the medical device provided by the present disclosure can improve the closure of the valve, so that the valve can be properly closed, thereby effectively preventing or reducing the backflow of blood.
  • the medical device provided by the present disclosure has less interference with blood flow, thereby reducing the possibility of stenosis.
  • the medical device provided by the present disclosure has less influence on the movement of the leaflets, thereby less adverse effects on the structure and function of the leaflets.
  • the valve involved in the present disclosure may be a heart valve.
  • the valve may be a mitral valve or a tricuspid valve.
  • the multiple leaflets involved in the present disclosure may be two leaflets of the mitral valve.
  • the multiple leaflets involved in the present disclosure may be three leaflets of the tricuspid valve.
  • the medical device provided by the present disclosure is not limited to application to the mitral valve and the tricuspid valve, but may also be applied to other valves.
  • Fig. 1 is a schematic diagram of the structure of a medical device 10 according to an embodiment of the present disclosure.
  • Fig. 1 shows a state where the medical device 10 is placed at a heart valve of a patient.
  • the heart valve is located between the first chamber and the second chamber to allow blood flow from the first chamber to the second chamber and prevent reverse flow.
  • the heart valve includes a pair of leaflets FL, SL that match each other.
  • the leaflets FL and SL can naturally coapt to close the valve and separate to open the valve with the cardiac cycle, thereby allowing blood to flow from the first chamber into the second chamber and preventing the reverse flow.
  • the leaflets FL and SL cannot achieve proper coaptation, such as the amplitude of coaptation is significantly reduced, or even a gap between the two, so that blood can flow from the second chamber into the first chamber through the valve, resulting in systolic reflux.
  • the valve in FIG. 1 may be a mitral valve.
  • the first chamber is the left atrium
  • the second chamber is the left ventricle
  • one of the leaflets FL and SL is the anterior leaflet
  • the other is the posterior leaflet.
  • the medical device provided by the present disclosure is not limited to the mitral valve, but may also be applied to other heart valves.
  • the medical device 10 includes a pad 11.
  • the pad 11 When the medical device 10 is placed in the patient's heart, the pad 11 is located between the leaflet FL and the leaflet SL.
  • the pad 11 has a pair of coaptation surfaces 111, 112.
  • the pair of coaptation surfaces 111, 112 face a pair of leaflets FL, SL respectively, that is, the coaptation surface 111 faces the leaflet FL, and the coaptation surface 112 faces the leaflet SL.
  • each of the pair of coaptation surfaces 111, 112 periodically coapts and separates with the leaflet it faces.
  • the coaptation surface 111 coapts with the leaflet FL and the coaptation surface 112 coapts with the leaflet SL to prevent blood from flowing back from the second chamber to the first chamber; when the valve is opened ....
  • the valve FL and SL are separated from the coaptation surfaces 111 and 112, respectively, blood can flow from the first chamber into the second chamber.
  • the coaptation length of each coaptation surface and its corresponding leaflet can range from 6 to 12 mm.
  • the coaptation surfaces 111 and 112 can be smoothly curved surfaces to reduce resistance to blood flow.
  • the medical device can improve the closure of the valve through the pad located between a pair of leaflets, so that the pair of leaflets of the valve can be properly apposed, thereby effectively preventing or reducing the backflow of blood.
  • the medical device has less interference with the blood flow, so the possibility of stenosis can be reduced.
  • the physiological cyclic movement of each leaflet will not be disturbed or will be less disturbed. In this way, the medical device will cause fewer problems to the structure and function of the leaflets.
  • the valve can open and close periodically through its own movement, and increase the effective closure of the leaflets through the apposition of the pad and the leaflets during the systole, thereby not only maintaining the autonomous flow of blood from the first chamber to the second chamber during the diastole, but also effectively preventing the opposite flow during the systole caused by the poor apposition of the two leaflets.
  • the medical device 10 may further include a support member 12.
  • the support member 12 When the medical device 10 is placed in the patient's heart, the support member 12 is located in the first chamber and connected to the pad 11, thereby positioning the pad 11 between a pair of leaflets SL, FL.
  • the pad 11 By placing the support member 12 in the first chamber, the pad 11 can be reliably positioned between the pair of leaflets FL, SL.
  • the pad 11 can be rigidly connected to the support member 12 to always keep the pad 11 in a suitable position to prevent the position of the pad 11 from changing under the influence of blood flow or leaflets FL, SL. If the pad 11 cannot be maintained in a suitable position, it cannot be guaranteed that the pair of leaflets FL, SL can be well aligned with the pair of aligning surfaces 111, 112 every time the valve is closed.
  • the support member 12 may be ring-shaped. When the medical device 10 is installed in the patient's heart, the support member 12 may be placed at the heart's valve annulus. In some embodiments, the support member 12 may have a mesh structure. During delivery, the support member 12 may be folded to reduce its volume, making the delivery process easier; after the support member 12 is delivered to the target location, it may be unfolded again.
  • the implementation of the support member is not limited to the above, as long as the pad can be positioned between a pair of leaflets of the valve.
  • the support member may also be semi-annular or partially annular.
  • the support member may be made of a flexible material so as to deform with the contraction and relaxation of the first chamber, thereby reducing the negative impact on the physiological function of the heart.
  • Fig. 2 is a schematic diagram of the structure of a medical device 20 according to another embodiment of the present disclosure.
  • Fig. 2 shows a state where the medical device 20 is placed at a heart valve of a patient.
  • the medical device 20 includes a cushion 21 .
  • the cushion 21 may be configured to gradually increase in thickness toward the first chamber, so as to better match the shape of a pair of leaflets FL, SL and better achieve valve closure.
  • the cushion 21 When the medical device 20 is placed in the patient's heart, the cushion 21 is located between the first pair of leaflets FL, SL.
  • the cushion 21 has a pair of apposition surfaces 211, 212.
  • the pair of apposition surfaces 211, 212 respectively face the pair of leaflets FL, SL, and as the pair of leaflets FL, SL move, each of the pair of apposition surfaces 211, 212 periodically appositions and separates with the leaflet it faces.
  • the apposition surfaces 211 and 212 may both be concave surfaces.
  • the apposition surface 211 may be concave in a direction away from the leaflet (i.e., leaflet FL) it faces; and the apposition surface 212 may be concave in a direction away from the leaflet (i.e., leaflet SL) it faces.
  • the apposition surface can be made to better match the leaflet it faces, thereby making the apposition surface better with the leaflet it faces.
  • the mate surface 211 can be constructed to gradually extend toward the first chamber and toward the side where the leaflet FL it faces (i.e., the left side in FIG. 2 ); the mate surface 212 can be constructed to gradually extend toward the first chamber and toward the side where the leaflet SL it faces (i.e., the right side in FIG. 2 ).
  • a small amount of blood may still flow back from the second chamber to the first chamber.
  • the apposition surface is configured to be concave in the direction away from the leaflet it faces and gradually extend toward the first chamber to the side where the leaflet is located. This configuration can change the flow direction of blood flowing from the second chamber to the first chamber, guide the blood flow to one side, and avoid the blood flow directly facing the second chamber.
  • a chamber which can reduce the direct "impact" of reflux on the patient's atrium and pulmonary veins and reduce the impact on heart function.
  • Fig. 3A is a schematic diagram of the structure of the pad 21.
  • the thick arrows are used to schematically indicate the changing trend of the flow direction of the blood flow from the second chamber to the first chamber under the guidance of the abutment surfaces 211, 212.
  • the mating surface 211 has a first edge portion 211a and a second edge portion 211b located at opposite ends thereof.
  • first edge portion 211a is closer to the first chamber relative to the second edge portion 211b.
  • the section of the mating surface 211 tends toward the first edge portion 211a and the angle between the section at the second edge portion 211b gradually increases.
  • the value range of the angle (acute angle) ⁇ 1 formed by the section of the first edge portion 211a and the section of the second edge portion 211b can be greater than or equal to 10 degrees and less than or equal to 45 degrees.
  • the value range of ⁇ 1 can be greater than or equal to 15 degrees and less than or equal to 30 degrees.
  • the mating surface 212 has a first edge portion 212a and a second edge portion 212b located at opposite ends thereof.
  • first edge portion 212a When the medical device 20 is placed in the patient's heart, the first edge portion 212a is closer to the first chamber relative to the second edge portion 212b.
  • the section of the mating surface 212 tends toward the first edge portion 212a and the angle with the section at the second edge portion 212b gradually increases.
  • the value range of the angle (acute angle) ⁇ 2 formed by the section of the first edge portion 212a and the section of the second edge portion 212b is greater than 45 degrees and less than 90 degrees.
  • the angle ⁇ 1 and the angle ⁇ 2 may be equal or unequal, and the present disclosure does not make specific limitations on this.
  • the cushion 21 may further have a top surface 213, which may be a convex surface.
  • the top surface 213 of the cushion 21 is located at one end of the cushion close to the first chamber, and the top surface 213 faces the first chamber and convex toward the first chamber.
  • the thickness of the pad can be configured to gradually increase toward the first chamber, which may cause blood to easily accumulate on the top of the pad.
  • the pad since the pad has a convex top surface (toward the first chamber), the accumulation of blood on the top of the pad can be effectively avoided or reduced.
  • the top surface 213 of the cushion 21 may be configured to gradually extend toward the second chamber from the middle thereof as it approaches the side where each leaflet of the pair of leaflets FL, SL is located.
  • the top surface 213 gradually extends from its middle portion toward the side where the leaflet FL is located (i.e., the left side in FIG2 ) toward the second cavity (i.e., gradually extends downward in FIG2 ); and the top surface 213 gradually extends from its middle portion toward the side where the leaflet SL is located (i.e., the right side in FIG2 ) toward the second cavity (i.e., gradually extends downward in FIG2 ).
  • the top surface 213 has a structure that is high in the middle and low at both ends.
  • This structure of the top surface can effectively avoid or reduce the accumulation of blood on the top of the pad.
  • this structure of the top surface can also reduce the barrier of the pad to the blood flow flowing from the first chamber to the second chamber, and better guide the blood flow from the first chamber to flow into the second chamber.
  • Fig. 3B is a schematic diagram of the structure of the pad 21.
  • the thick arrow is used to schematically indicate the changing trend of the flow direction of the blood flow from the first chamber to the second chamber under the guidance of the top surface 213 of the pad 21.
  • the top surface 213 has edge portions 213a and 213b at both ends in the thickness direction of the pad 21.
  • the edge portion 213a is closer to the leaflet FL (or closer to the apposition surface 211) than the edge portion 213b
  • the edge portion 213b is closer to the leaflet SL (or closer to the apposition surface 212) than the edge portion 213a.
  • the angle between the cut surface at the middle portion 213c of the top surface 213 and the cut surface at the edge portion 213a is defined as ⁇ 1
  • the angle between the cut surface at the middle portion 213c and the cut surface at the edge portion 213b is defined as ⁇ 2.
  • the value range of the angle ⁇ 1 and the angle ⁇ 2 can be set to be greater than or equal to 10 degrees and less than or equal to 45 degrees.
  • the value range of ⁇ 1 is greater than or equal to 15 degrees and less than or equal to 30 degrees.
  • the top surface 213 can be a smoothly transitioned curved surface to reduce resistance to blood flow.
  • This configuration of the top surface can better guide the blood flow from the first chamber to the second chamber, thereby reducing the obstruction of the blood flow from the first chamber to the second chamber.
  • FIG. 4 is a schematic diagram of the axial structure of the medical device 20 .
  • arrow X is used to indicate the width direction of the pad
  • arrow Y is used to indicate the thickness direction of the pad
  • arrow Z is used to indicate the height direction of the pad.
  • the support member 22 includes a main body 221 and a pair of connecting parts 222.
  • the main body 221 may be annular and configured to be installed at the valve ring.
  • the main body 221 may also be semi-annular or in other shapes.
  • the pair of connecting parts 222 extend to both sides of the pad 21 in the width direction and are connected to the pad 21.
  • a pair of leaflets are located on both sides of the pad in the thickness direction, and the first chamber and the second chamber are located on both sides of the pad in the height direction.
  • the thickness direction, height direction and width direction of the pad are perpendicular to each other.
  • any one of the leaflet FL and the leaflet SL may be the "first leaflet” involved in other parts (e.g., the content of the invention part).
  • the apposition surface facing the "first leaflet” may be the "first apposition surface”; and the other of the leaflet FL and the leaflet SL may be the “second leaflet” involved in other parts (e.g., the content of the invention part).
  • the apposition surface facing the "second leaflet” may be the "second apposition surface”.
  • FIG. 5 is a schematic structural diagram of a pad 31 of a medical device according to an embodiment of the present disclosure.
  • the pad 31 includes an expandable mesh frame 31a and a cover 31b wrapped around the mesh frame 31a.
  • a pair of mating surfaces 311, 312 and a top surface 313 may be part of the outer surface of the cover 31b.
  • the cover 31b may be made of a biocompatible material and have a smooth outer surface to avoid or reduce the wear of the leaflet or discomfort caused when it cooperates with the leaflet.
  • Another implementation method may be that the cover 31b is only on the top of the pad, but does not cover the mating surface. This allows the mating surface to be epidermized faster, reducing the impact on the leaflet tissue when the leaflets collide with the mating surfaces.
  • the shape and size of the pad are mainly determined by the mesh.
  • the mesh can be folded to reduce the overall size of the pad, thereby making the delivery process easier.
  • the mesh can be unfolded so that the pad has a suitable size and shape.
  • this structure with a mesh allows doctors to adaptively adjust the shape and size of the pad according to the differences in the valves of different patients, so that the pad can better match the patient's valve.
  • the cover wrapped around the outside of the mesh can provide a smooth surface for the pad, thereby avoiding or reducing the adsorption of tissue growth and blood on the pad on the one hand, and making the pad and the leaflet more closely aligned on the other hand.
  • Fig. 6 is a schematic diagram of the structure of a medical device 40 according to an embodiment of the present disclosure.
  • Fig. 6 shows a state where the medical device 40 is placed at a heart valve of a patient.
  • the medical device 40 includes a pad 41 having a first coaptation surface 411.
  • the pad 41 When the medical device 40 is placed in the patient's heart, the pad 41 is located between the first leaflet FL and the second leaflet SL of the heart valve and moves with the second leaflet SL.
  • the first coaptation surface 411 faces the first leaflet FL and can periodically coapt and separate with the first leaflet FL as the pad 41 moves with the second leaflet SL.
  • the coaptation length between the two can range from 6 to 12 mm.
  • the medical device 40 can improve the closure of the valve, so that the first leaflet FL and the second leaflet SL can be properly apposed, thereby effectively preventing or reducing the backflow of blood.
  • the medical device 40 has less interference with the blood flow, and thus can reduce the possibility of stenosis.
  • the medical device 40 will not affect or will have less influence on the movement of the leaflets, and thus will not or will have less problems with the structure and function of the leaflets.
  • the use of the medical device 40 provided by the present disclosure does not impose any restrictions or obstacles on the spontaneous movement (closing, opening) of the valve, and at the same time, it has no association with the supporting structure of the valve, and will not produce corresponding adverse effects.
  • the physiological periodic movement of each leaflet will not be disturbed or will be less disturbed. In this way, the medical device 40 will cause fewer problems to the structure and function of the leaflets.
  • the valve can open and close periodically through its own movement, and increase the effective closure of the leaflets through the apposition of the pad 41 and the leaflets during the systole period, thereby not only maintaining the autonomous flow of blood from the first chamber to the second chamber during the diastole period, but also effectively preventing the opposite flow during the systole period caused by the poor apposition of the two leaflets.
  • the pad 41 may be attached to the second leaflet SL so as to follow the movement of the second leaflet SL.
  • the first apposition surface 411 is attached to the second leaflet SL and becomes a part thereof in a manner following the movement of the second leaflet SL, so that the first apposition surface 411 can periodically apposition and separation with the first leaflet FL accompanying the movement of the second leaflet SL.
  • the medical device 40 may further include a fixing member 42.
  • the fixing member 42 may be a pin 42.
  • the pin 42 may penetrate the second leaflet SL and attach the pad 41 to the second leaflet SL, so that the pad 41 can follow the movement of the second leaflet SL.
  • the medical device 40 may include only one nail 42 or multiple nails 42, which is not specifically limited in the present disclosure.
  • the nail 42 may be formed integrally with the pad 41, or the two may be two independent components, which is not specifically limited in the present disclosure.
  • Fig. 7 is a schematic diagram of the structure of a medical device 50 according to another embodiment of the present disclosure.
  • Fig. 7 shows a state where the medical device 50 is placed at a heart valve of a patient.
  • the medical device 50 includes a cushion 51 having a first accommodating surface 511.
  • the cushion 51 may be configured to gradually increase in thickness toward the first chamber, thereby better matching the shapes of the first leaflet FL and the second leaflet SL and better achieving valve closure.
  • the pad 51 When the medical device 50 is placed in the patient's heart, the pad 51 is located between the first leaflet FL and the second leaflet SL and can follow the movement of the second leaflet SL, and the first mate surface 511 faces the first leaflet FL and can periodically mate with and separate from the first leaflet FL as the pad 51 follows the movement of the second leaflet SL.
  • the first apposition surface 511 may be a concave surface. More specifically, when the medical device 50 is placed in the patient's heart, the first apposition surface 511 may be concave in a direction away from the first leaflet FL. In this way, the first apposition surface 511 can better match the first leaflet FL, so that the first apposition surface 511 can better apposition with the first leaflet FL.
  • the first mate surface 511 tends toward the first chamber and gradually extends toward the side where the first leaflet FL is located (ie, the left side in FIG. 7 ).
  • the first mating surface 511 is concave (in the direction away from the first leaflet FL) and tends to the first chamber and gradually extends to the side where the first leaflet FL is located.
  • This structure can increase the resistance of blood flow and reduce blood flow, and change the direction of blood flow from the second chamber to the first chamber, guide the blood flow to one side, and avoid the blood flow directly facing the first chamber and the blood vessels above, thereby reducing the impact of blood flow from the second chamber to the first chamber on the patient's heart function.
  • Fig. 8A is a schematic diagram of the structure of the pad 51. As shown in Fig. 8A, the direction indicated by the thick arrow may represent the flow direction of the blood flow from the second chamber to the first chamber under the guidance of the first mating surface 511.
  • the first mating surface 511 has a first edge portion 511a and a second edge portion 511b located at opposite ends thereof.
  • the first edge portion 511a is closer to the first chamber than the second edge portion 511b.
  • the tangent plane of the first mating surface 511 tends toward the first edge portion 511a and the angle between the tangent plane at the second edge portion 511b gradually increases.
  • the value range of the angle (acute angle) ⁇ formed by the tangent plane of the first edge portion 511a and the tangent plane of the second edge portion 511b can be greater than or equal to 10 degrees and less than or equal to 45 degrees.
  • the value range of ⁇ can be greater than or equal to 15 degrees and less than or equal to 30 degrees.
  • the cushion 51 may also have a top surface 512, which may be a convex surface.
  • the top surface 512 of the cushion 51 is located at one end of the cushion close to the first chamber, and the top surface 512 faces the first chamber and convex (towards the first chamber).
  • the thickness of the pad 51 gradually increases toward the first chamber, which may cause blood to easily accumulate on the top of the pad 51. Since the pad 51 has a convex top surface 512 (toward the first chamber), the accumulation of blood on the top of the pad 51 can be effectively avoided or reduced.
  • the top surface 512 of the pad 51 is directed toward the second chamber and gradually extends toward the side where the first leaflet FL is located (ie, the left side in FIG. 7 ).
  • This structure of the top surface 512 of the pad 51 can effectively avoid or reduce the accumulation of blood on the top of the pad 51.
  • this structure of the top surface 512 of the pad 51 can also reduce the obstruction of the pad 51 to the blood flow from the first chamber to the second chamber and the influence on the blood flow, thereby better guiding the blood flow from the first chamber to the second chamber.
  • FIG 8B is a schematic diagram of the structure of the pad 51. As shown in FIG8B, the direction indicated by the thick arrow may represent the flow direction of the blood flow from the first chamber to the second chamber under the guidance of the top surface 512 of the pad 51.
  • the top surface 512 of the pad 51 has a third edge portion 512a and a fourth edge portion 512b located at opposite ends thereof.
  • the fourth edge portion 512b is closer to the second chamber than the third edge portion 512a.
  • the angle between the tangent plane of the top surface 512 and the tangent plane at the third edge portion 512a gradually increases as it approaches the fourth edge portion 512b.
  • the value range of the angle ⁇ formed by the tangent plane of the third edge portion 512a and the tangent plane of the fourth edge portion 512b may be greater than or equal to 10 degrees and less than or equal to 45 degrees. In particular, the value range of ⁇ may be greater than or equal to 15 degrees and less than or equal to 30 degrees.
  • the top surface 512 of the pad 51 can better guide the blood flow from the first chamber to the second chamber, reducing the obstruction of the pad 51 to the blood flow from the first chamber to the second chamber.
  • the pad 51 may further have a second apposition surface 513.
  • the second apposition surface 513 may be a concave surface. More specifically, when the medical device 50 is placed in the patient's heart, the second apposition surface 513 faces the second leaflet SL and is concave in a direction away from the second leaflet SL. In addition, when the medical device 50 is placed in the patient's heart, the second apposition surface 513 remains apposition with the second leaflet SL as the pad 51 follows the movement of the second leaflet SL.
  • This structure can make the second mating surface 513 of the pad 51 better match the second leaflet SL and better fit the second leaflet SL, thereby effectively avoiding or reducing the accumulation of blood between the second mating surface 513 of the pad 51 and the second leaflet SL.
  • the medical device 50 may further include a pin 52.
  • the pin 52 may penetrate the second leaflet SL and attach the pad 51 to the second leaflet SL so that the pad 51 can follow the movement of the second leaflet SL.
  • the medical device 50 may include only one nail 52 or multiple nails 52, which is not specifically limited in the present disclosure.
  • the nail 52 may be formed integrally with the pad 51, or the two may be two independent components, which is not specifically limited in the present disclosure.
  • Fig. 9 is a schematic diagram of the structure of a medical device 60 according to another embodiment of the present disclosure.
  • Fig. 9 shows the state where the medical device 60 is placed at the heart valve of a patient.
  • the medical device 60 is substantially the same as the medical device 20, and for the purpose of brevity, the similarities are not repeated.
  • the medical device 60 includes a cushion 61 having a first apposition surface 611.
  • the cushion 61 is located between the first leaflet FL and the second leaflet SL and moves with the second leaflet SL.
  • the first apposition surface 611 periodically appositions and separates with the first leaflet FL, thereby periodically closing and opening the valve.
  • the medical device 60 further includes a clamp 62, which may be formed integrally with the pad 61.
  • the clamp 62 may also be a component independent of the pad 61.
  • the present disclosure is not limited to attaching the pad to the second leaflet SL. Positioning the pad between the first leaflet FL and the second leaflet SL and enabling the pad to follow the movement of the second leaflet SL may also be achieved by other implementations.
  • Fig. 10 is a schematic diagram of the structure of a medical device 70 according to another embodiment of the present disclosure.
  • Fig. 10 shows a state where the medical device 70 is placed at a heart valve of a patient.
  • the medical device 70 is substantially the same as the medical device 20. For the purpose of brevity, the similarities are not repeated.
  • the medical device 70 includes a cushion 71 and a support member 72.
  • the support member 72 is located in the first chamber, and the cushion 71 is connected to the support member 72 in a manner that it can follow the movement of the second leaflet SL, so that the cushion 71 is positioned between the first leaflet FL and the second leaflet SL and can follow the movement of the second leaflet SL.
  • the pad 71 can be hinged to the support member 72 so that the pad 71 can follow the movement of the second leaflet SL.
  • the medical device 70 can also include a pivot shaft 73, and the pad 71 can be hinged to the support member 72 through the pivot shaft 73.
  • the pivot shaft 73 can be fixed to the pad 71 and can be pivotally connected to the support member 72, thereby realizing the hinge connection between the pad 71 and the support member 72.
  • the pivot shaft 73 can be fixed to the support member 72 and can be pivotally connected to the pad 71, thereby realizing the hinge connection between the pad 71 and the support member 72.
  • the pad 71 may be connected to the support member via a flexible member (or portion) so that the pad 71 can move along with the second leaflet SL.
  • the pad 71 By placing the support member 72 in the first chamber, the pad 71 can be reliably positioned between the first leaflet FL and the second leaflet SL.
  • the pad 71 is connected to the support member 72 in a manner that it can follow the movement of the second leaflet SL, and it can be ensured that the pad 71 follows the movement of the second leaflet SL, so that the first apposition surface and the first leaflet FL are periodically appositioned and separated.
  • the support member 72 may be annular to reduce the impact on blood flow.
  • the support member 72 may also be semi-annular or partially annular.
  • the support member 72 may be configured to be relatively soft, or flexible, so as to adaptively deform as the first heart chamber contracts and relaxes, thereby reducing the negative impact on heart function.
  • the support member 72 can be in the shape of a foldable and unfoldable grid. During the implantation process, the support member 72 can be folded first and then unfolded in the first chamber.
  • the support member 72 can be placed at the valve annulus so that the support member 72 can be securely fixed.
  • first or second etc. may be used in the present disclosure to describe various elements (such as a first chamber and a second chamber), these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

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Abstract

一种用于修复患者的瓣膜的医疗装置(20)，瓣膜包括多个小叶。医疗装置(20)包括垫(21)，垫(21)被配置为位于瓣膜的多个小叶之间，以通过与多个小叶配合而使瓣膜周期性地打开和关闭。通过位于多个小叶之间的垫(21)，医疗装置(20)能够改善瓣膜的关闭情况，使得瓣膜能够适当地关闭，从而有效地阻止或减少血液的反流。此外，医疗装置(20)对血流的干扰较小，因此能够降低狭窄发生的可能性。此外，医疗装置(20)较少地影响小叶的运动，从而将较少地给小叶的结构和功能带来不良影响。

Description

医疗装置 技术领域
本公开涉及医疗器械技术领域，特别地，涉及一种用于修复患者的心脏瓣膜的医疗装置。
背景技术
心脏瓣膜是指心房与心室之间或心室与动脉间的瓣膜。瓣膜在心脏永不停止的血液循环活动中扮演关键角色。在血液流过后，瓣膜就会关闭，从而阻止血液反流。
若干结构性因素可能会影响心脏瓣膜的适当关闭，从而引发血液反流。以二尖瓣为例，若二尖瓣不能适当关闭，则会导致在收缩期血液从左心室通过二尖瓣流向左心房，进而损害患者的健康。相关技术提供的修复装置具有类似于夹子的结构，这种修复装置通过夹持在瓣膜的一对小叶上来改善瓣膜的关闭情况。
然而，这种修复装置存在诸多缺点。例如，这种修复装置会导致血流通过瓣膜时的有效面积减小，这可能会导致另一个问题——狭窄。又如，这种修复装置将一对小叶夹紧在一起，使得这对小叶不能随着心动周期而自然地对合和分离。随着时间的推移，这可能会给这对小叶的结构和功能，以致其相关组织，甚至整个瓣的结构和功能带来问题。
发明内容
有鉴于此，本公开提供一种医疗装置。
本公开提供的医疗装置用于修复患者的心脏瓣膜，该医疗装置包括垫，该垫被配置为位于瓣膜的多个小叶之间，以通过与多个小叶配合而使瓣膜周期性地打开和关闭。
通过位于多个小叶之间的垫，本公开提供的医疗装置能够改善瓣膜的关闭情况，使得瓣膜能够适当地关闭，从而有效地阻止或减少血液的反流。此外，本公开的提供的医疗装置对血流的干扰较小，因此能够降低狭窄发生的可能性。此外，本公开提供的医疗装置较少地影响小叶的运动，从而将较少地给小叶的结构和功能带来不良影响。
在一个可能的实现方式，多个小叶包括第一小叶和小二小叶，垫具有第一对合面。第一对合面被配置为随着第一小叶或第二小叶运动而与第一小叶周期性地对合和分离。这里，第一对合面被配置为向背离其面对的第一小叶的方向凹陷。
将对合面配置为向背离其面对的小叶的方向凹陷，能够使得该对合面更好地匹配该小叶，从而使得该对合面能够与该小叶更好地对合。
在一个可能的实现方式中，瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，第一对合面被配置为趋向第一腔室而逐渐向其面对的小叶所在侧延伸。
在某些情况下，可能仍会有较少的血液从第二腔室反流至第一腔室中。将对合面构造为向背离其面对的小叶的方向凹陷并且趋向第一腔室而逐渐向该小叶所在侧延伸，这种构造能够改变从第二腔室流向第一腔室的血液的流向，将血流引导至一侧，避免血流直面第一腔室，从而能够降低反流对患者的心脏功能的不良影响。
在一个可能的实现方式中，第一对合面具有分别位于其相对两端的第一边缘部和第二边缘部，第一边缘部被配置为相对第二边缘部靠近第一腔室，第一边缘部的切面与第二边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
第一边缘部的切面与第二边缘部的切面所成的夹角越大，对合面对从第二腔室流向第一腔室的血流的流动方向的改变越大。将二者的所呈的夹角设置在这一范围内，能够在保证小叶与对合面的良好对合的基础上，有效地将从第二腔室流向第一腔室的血流引导至一 侧。
在一个可能的实现方式中，垫还具有顶面，顶面被配置为面对第一腔室且向第一腔室的方向凸出。
为了更好地匹配多个小叶，垫的厚度趋向第一腔室而逐渐增加，这可能会导致垫的顶部容易积存血液。将垫的顶面配置为向第一腔室的方向凸出，能够有效地避免或减少血液在垫的顶部的积存。
在一个可能的实现方式中，垫具有包括第一对合面的多个对合面。多个对合面被配置为分别面对多个小叶，并且随着多个小叶移动，每个对合面的至少一部分与其面对的小叶周期性地对合和分离。
在这种实现方式，每个小叶的生理性周期运动都不会被干扰或较少地会被干扰。这样一来，医疗装置将会更少地给小叶的结构和功能带来问题。此外，瓣膜能够通过自身的运动周期性地打开和关闭，并在收缩期通过垫和小叶的对合，增加小叶有效闭合，从而不但能保持血液在舒张期从第一腔室自主流入第二腔室，并能有效阻止由于原本多个小叶对合较差而引起的在收缩期相反的流动。
在一个可能的实现方式中，顶面被配置为从其中部起，随着趋向每个小叶所在侧而逐渐向第二腔室延伸。
顶面的这种构造能够有效地避免或减少血液在垫的顶部的积存。此外，顶面的这种构造还能够降低垫对从第一腔室流向第二腔室的血流的阻挡，更好地引导血流从第一腔室流入第二腔室。
在一个可能的实现方式中，顶面的中部的切面与顶面的靠近每个小叶的边缘部分的切面所呈的夹角的取值范围为大于等于10度且小于等于45度。
以此方式，顶面能够更好地引导从第一腔室流向第二腔室的血流，从而减少对第一腔室流向第二腔室的血流阻挡。
在一个可能的实现方式中，医疗装置还包括支撑件，支撑件被配置为位于在第一腔室内并与垫连接，从而将垫定位在多个小叶之间。
通过置于第一腔室的支撑件，能够将垫可靠地定位在多个小叶之间。
在一个可能的实现方式中，支撑件具有主体部和一对连接部，一对连接部被配置为分别延伸至垫的宽度方向上的两侧并与垫连接。
当瓣膜张开时，大部分血液会沿着高度方向从垫的厚度方向上的两侧流过，最终流入第二腔室。由于大部分血液会从垫的厚度方向上的两侧流过，支撑件的这种构造能够较大程度地减小支撑件与垫连接的部分对血流的阻碍，从而减小医疗装置对患者正常生理功能的不良影响。
在一个可能的实现方式中，垫包括可延展的网架和包覆于网架外侧的罩，其中所述罩设置于所述垫的顶端而不覆盖多个对合面中的任一个。
垫的形状和尺寸主要取决于网架。在递送过程中，可以将网架折叠以减小垫的整体尺寸，从而使得递送过程更加容易。在将垫递送至目标位置后，可以将网架展开，以使得垫具有合适的尺寸和形状。此外，这种具有网架的构造使得医生能够根据不同患者的瓣膜的差异来适应性地调整垫的形状和尺寸，从而使得垫能够更好地匹配患者的瓣膜。包覆于网架外侧的罩能够为垫提供光滑的表面，从而一方面避免或减少垫上的组织赘生和血液吸附，另一方面能够使得垫与小叶的对合更加紧密。而将罩只在垫的顶端，但不覆盖在对合面上，可以使对合面较快表皮化，减少小叶同对合面相互碰合时对小叶组织的影响。
在一个可能的实现方式中，所述垫具有第二对合面，所述第二对合面被配置为随着所述第二小叶运动而与所述第二小叶周期性地对合和分离，其中所述第二对合面被配置为向背离所述第二小叶的方向凹陷。
在一个可能的实现方式中，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，其中所述第二对合面被配置为趋向所述第一腔室而逐渐向所述第二小叶所 在侧延伸。
在一个可能的实现方式中，所述第二对合面具有分别位于其相对两端的第一边缘部和第二边缘部，所述第一边缘部被配置为相对所述第二边缘部靠近所述第一腔室，所述第一边缘部的切面与所述第二边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
在一个可能的实现方式中，垫被配置为跟随第二小叶运动。这里，第一对合面被配置为伴随垫跟随第二小叶运动而与第一小叶周期性地对合和分离。
在这种实现方式，每个小叶的生理性周期运动都不会被干扰或较少地会被干扰。这样一来，医疗装置将会更少地给小叶的结构和功能带来问题。此外，瓣膜能够通过自身的运动周期性地打开和关闭，并在收缩期通过垫和小叶的对合，增加小叶有效闭合，从而不但能保持血液在舒张期从第一腔室自主流入第二腔室，并能有效阻止由于原本多个小叶对合较差而引起的在收缩期相反的流动。
在一个可能的实现方式中，顶面被配置为趋向第二腔室而逐渐向第一小叶所在侧延伸。
顶面的这种构造能够有效地避免或减少血液在垫的顶部的积存。此外，顶面的这种构造还能够降低垫对从第一腔室流向第二腔室的血流的阻挡，更好地引导血流从第一腔室流入第二腔室。
在一个可能的实现方式中，顶面具有分别位于其相对两端的第三边缘部和第四边缘部，第四边缘部被配置为相对第三边缘部靠近第二腔室，第三边缘部的切面和第四边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
以此方式，顶面能够更好地引导从第一腔室流向第二腔室的血流，从而减少对第一腔室流向第二腔室的血流阻挡。
在一个可能的实现方式中，垫还具有第二对合面，第二对合面被配置为面对第二小叶且向背离第二小叶的方向凹陷，并且伴随垫跟随第二小叶运动而与第二小叶保持对合。
第二对合面面对第二小叶且向背离第二小叶的方向凹陷，这种构造能够使得第二对合面更好地匹配第二小叶，更好地贴合第二小叶，从而能够有效地避免或减少血液在第二对合面和第二小叶之间积存。
在一个可能的实现方式中，垫被配置为附接于第二小叶。
垫附接于第二小叶，从而能够跟随第二小叶运动。
在一个可能的实现方式中，瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，医疗装置还包括支撑件，支撑件被配置为位于第一腔室内并将垫定位在第一小叶和第二小叶之间，其中垫以能够跟随第二小叶运动的方式与支撑件连接。
通过置于第一腔室的支撑件，能够将垫可靠地定位在第一小叶和第二小叶之间。垫以能够跟随第二小叶运动的方式与支撑件连接，能够保证伴随第二小叶的运动，垫跟随第二小叶运动，从而使得第一对合面与第一小叶周期性地对合和分离。
在一个可能的实现方式中，所述垫的厚度随着趋向于所述第一腔室而逐渐增加。
在一个可能的实现方式中，所述瓣膜为二尖瓣，所述多个小叶的数量为两个；或者，所述瓣膜为三件瓣，所述多个小叶的数量为三个。
附图简要说明
为了更清楚地说明本公开实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍。
应当理解，以下附图仅示出了本公开的某些实施例，而非全部。
应当理解，在附图中使用相同或相似的附图标记来表示相同或相似的元素。
应当理解，附图仅是示意性的，附图中的元素的尺寸和比例不一定精确。
图1是根据本公开一实施例的医疗装置的结构示意图。
图2是根据本公开另一实施例的医疗装置的结构示意图。
图3A和图3B是图2中的医疗装置的垫的结构示意图。
图4是图2中的医疗装置的轴侧结构示意图。
图5是根据本公开另一实施例的医疗装置的垫的结构示意图。
图6是根据本公开另一实施例的医疗装置的结构示意图。
图7是根据本公开另一实施例的医疗装置的结构示意图。
图8A和图8B是图7中的医疗装置的垫的结构示意图。
图9是根据本公开另一实施例的医疗装置的结构示意图。
图10是根据本公开另一实施例的医疗装置的结构示意图。
具体实施方式
为了使本技术领域的人员更好地理解本公开中的技术方案，下面将结合本公开实施方式中的附图，对本公开实施方式中的技术方案进行示例性地描述。显然，所描述的实施方式仅仅是本公开一部分实施方式，而非全部实施方式。
考虑到具有类似于夹子的结构的瓣膜修复装置具有前文所述的诸多缺陷，本公开提供一种新的用于修复患者的瓣膜的医疗装置。本公开提供的医疗装置垫，垫被配置为位于瓣膜的多个小叶之间，以通过与所述多个小叶配合而使所述瓣膜周期性地打开和关闭。
通过位于多个小叶之间的垫，本公开提供的医疗装置能够改善瓣膜的关闭情况，使得瓣膜能够适当地关闭，从而有效地阻止或减少血液的反流。此外，本公开的提供的医疗装置对血流的干扰较小，因此能够降低狭窄发生的可能性。此外，本公开提供的医疗装置较少地影响小叶的运动，从而将较少地给小叶的结构和功能带来不良影响。
本公开所涉及的瓣膜可以为心脏瓣膜。特别地，该瓣膜可以为二尖瓣或三尖瓣。在该瓣膜为二尖瓣的情况下，本公开中所涉及的多个小叶可以为二尖瓣的两个小叶。在该瓣膜为三尖瓣的情况下，本公开中所涉及的多个小叶可以为三尖瓣的三个小叶。应当理解，本公开提供的医疗装置并不仅限于应用在二尖瓣和三尖瓣，也可以应用在其它瓣膜上。
下面结合附图对本公开提供的医疗装置进行说明。
图1是根据本公开一实施例的医疗装置10的结构示意图。图1示出了医疗装置10被放置在患者的心脏瓣膜处的状态。
在图1(以及本公开的其它附图)中，心脏瓣膜位于第一腔室和第二腔室之间，用于允许血流从第一腔室流入第二腔室并阻止相反的流动。该心脏瓣膜包括一对相互匹配的小叶FL,SL。
正常情况下，小叶FL,SL能够随着心动周期自然地对合以关闭瓣膜和分离以打开瓣膜，从而允许血液从第一腔室流入第二腔室并阻止相反的流动。然而，对于瓣膜关闭不全的患者，当需要瓣膜关闭时，小叶FL,SL无法实现适当的对合，比如对合的幅度显著减少，甚至二者之间存在间隙，使得血流可以通过瓣膜从第二腔室流入第一腔室，导致收缩期的反流现象。
图1(以及本公开的其它附图)中的瓣膜可以为二尖瓣。对应地，第一腔室为左心房，第二腔室为左心室，小叶FL,SL中的一个为前叶，另一个为后叶。应当理解，本公开提供的医疗装置并不仅限于应用在二尖瓣，也可以应用在其它心脏瓣膜上。
参见图1，医疗装置10包括垫11。当医疗装置10被安置在患者的心脏中时，垫11位于小叶FL和小叶SL之间。垫11具有一对对合面111,112。当医疗装置10被安置在患者的心脏中时，一对对合面111,112分别面对一对小叶FL,SL，即对合面111面对小叶FL，对合面112面对小叶SL。随着心动周期的变化，一对对合面111,112中的每个对合面与其面对的小叶周期性地对合(coaptation)和分离。具体而言，当瓣膜闭合时，对合面111与小叶FL对合且对合面112与小叶SL对合，以阻止血液从第二腔室向第一腔室反流；当瓣膜张开 时，瓣膜FL,SL分别与对合面111,112分离，以允许血液从第一腔室流入第二腔室。在一个示例中，每个对合面与其对应的小叶的对合长度(coaptation length)的取值范围可以为6至12毫米。在一个示例中，对合面111,112可以为平滑过渡的曲面，以减小对血流的阻力。
在这种实现方式，通过位于一对小叶之间的垫，医疗装置能够改善瓣膜的关闭情况，使得瓣膜的一对小叶能够适当地对合，从而有效地阻止或减少血液的反流。此外，在这种实现方式，医疗装置对血流的干扰较小，因此能够降低狭窄发生的可能性。此外，在这种实现方式，每个小叶的生理性周期运动都不会被干扰或较少地会被干扰。这样一来，医疗装置将会更少地给小叶的结构和功能带来问题。此外，瓣膜能够通过自身的运动周期性地打开和关闭，并在收缩期通过垫和小叶的对合，增加小叶有效闭合，从而不但能保持血液在舒张期从第一腔室自主流入第二腔室，并能有效阻止由于原本二小叶对合较差而引起的在收缩期相反的流动。
重新参见图1，医疗装置10还可以包括支撑件12。当医疗装置10被安置在患者的心脏中时，支撑件12位于第一腔室内并与垫11连接，从而将垫11定位在一对小叶SL,FL之间。通过置于第一腔室的支撑件12，能够将垫11可靠地定位在一对小叶FL,SL之间。在一个示例中，垫11可以刚性地连接至支撑件12，以将垫11始终保持在一个合适的位置，避免垫11在血流或小叶FL,SL的影响下位置发生变化。若垫11无法被保持在一个合适的位置，则无法保证每次瓣膜闭合时一对小叶FL,SL都能与一对对合面111,112良好的对合。
支撑件的实现方式有多种，本公开对此不做具体限定。
作为一个示例，重新参见图1，支撑件12可以呈环状。当医疗装置10被安装在患者的心脏中时，支撑件12可以被安置在心脏的瓣环处。在某些实施例中，支撑件12可以具有网架构造。在递送过程中，可以先将支撑件12折叠以减少其体积，使得递送过程更加容易；在将支撑件12递送到目标位置后，可以再将其展开。
可以理解，支撑件的实现方式并不限于上述，只要能够实现将垫定位在瓣膜的一对小叶之间即可。例如，在某些实施例中，支撑件也可以呈半环状或部分环状。在某些实施例中，支撑件可以由柔性材质构成，以便跟随第一腔室的收缩和舒张而形变，进而减小对心脏生理功能的负面影响。
图2是根据本公开另一实施例的医疗装置20的结构示意图。图2示出了医疗装置20被放置在患者的心脏瓣膜处的状态。
参见图2，医疗装置20包括垫21，在某些实施例中，垫21可以被配置为趋向第一腔室而厚度逐渐增加，从而更好地匹配一对小叶FL,SL的形状，更好地实现瓣膜的关闭。
当医疗装置20被安置在患者的心脏中时，垫21位于第一对小叶FL,SL之间。垫21具有一对对合面211,212。当医疗装置20被安置在患者的心脏中时，一对对合面211,212分别面对一对小叶FL,SL，并且随着一对小叶FL，SL运动，一对对合面211,212中的每个对合面与其面对的小叶周期性地对合和分离。
对合面211,212可以均为内凹的表面。特别地，当医疗装置20被安置在患者的心脏中时，对合面211可以向背离其面对的小叶(即小叶FL)的方向凹陷；对合面212可以向背离其面对的小叶(即小叶SL)的方向凹陷。
以此方式，能够使得对合面更好地匹配其面对的小叶，从而使得对合面与其面对的小叶更好地对合。
作为一个示例，重新参见图2，当医疗装置20被安置在患者的心脏中时，对合面211可以被构造为趋向第一腔室而逐渐向其面对的小叶FL所在侧(即图2中的左侧)延伸；对合面212可以被构造为趋向第一腔室而逐渐向其面对的小叶SL所在侧(即图2中的右侧)延伸。
在某些情况下，可能仍会有较少的血液从第二腔室反流至第一腔室中。将对合面构造为向背离其面对的小叶的方向凹陷并且趋向第一腔室而逐渐向该小叶所在侧延伸，这种构造能够改变从第二腔室流向第一腔室的血液的流向，将血流引导至一侧，避免血流直面第 一腔室，从而能够降低反流对患者的心房，对肺静脉的直接“冲击”而减少对心脏功能的影响。
图3A是垫21的结构示意图。在图3A中，粗箭头用于示意性地指示从第二腔室流向第一腔室的血流在对合面211,212的引导下的流动方向的变化趋势。
参见图2和图3A，对合面211具有分别位于其相对两端的第一边缘部211a和第二边缘部211b。当医疗装置20被安置在患者的心脏中时，第一边缘部211a相对第二边缘部211b靠近第一腔室。对合面211的切面趋向第一边缘部211a而与第二边缘部211b处的切面的夹角逐渐增加。第一边缘部211a的切面与第二边缘部211b的切面所成的夹角(锐角)α1的取值范围可以为大于等于10度且小于等于45度。优选地，α1的取值范围可以为大于等于15度且小于等于30度。
对合面212具有分别位于其相对两端的第一边缘部212a和第二边缘部212b。当医疗装置20被安置在患者的心脏中时，第一边缘部212a相对第二边缘部212b靠近第一腔室。对合面212的切面趋向第一边缘部212a而与第二边缘部212b处的切面的夹角逐渐增加。第一边缘部212a的切面与第二边缘部212b的切面所成的夹角(锐角)α2的取值范围为大于45度且小于90度。夹角α1和夹角α2可以相等，也可以不相等，本公开对此不做具体限定。
第一边缘部的切面与第二边缘部的切面所成的夹角越大，对合面对从第二腔室流向第一腔室的血流的流动方向的改变越大。将二者的所呈的夹角设置在45度到90度这一范围内，能够在保证小叶与对合面的良好对合的基础上，有效地将从第二腔室流向第一腔室的血流引导至一侧。
重新参见图2，垫21还可以具有顶面213，顶面213可以为外凸的表面。特别地，当医疗装置20被安置在患者的心脏中时，垫21的顶面213位于垫的靠近第一腔室的一端，并且顶面213面对第一腔室且向第一腔室凸出。
为了更好地匹配瓣膜的一对小叶，垫的厚度可以被构造为趋向第一腔室而逐渐增加，这可能会导致垫的顶部容易积存血液。在本公开的上述实现方式中，由于垫具有(向第一腔室的方向)凸出的顶面，能够有效地避免或减少血液在垫的顶部的积存。
在一个示例中，重新参见图2，当医疗装置20被安置在患者的心脏中时，垫21的顶面213可以被构造为从其中部起，随着趋向一对小叶FL,SL中的每个小叶所在侧而逐渐向第二腔室延伸。
具体而言，如图2所示，顶面213从其中部起随着趋向小叶FL所在侧(即图2中的左侧)而逐渐向第二腔室延伸(即逐渐向图2中的下方延伸)；并且，顶面213从其中部起随着趋向小叶SL所在侧(即图2中的右侧)而逐渐向第二腔室延伸(即逐渐向图2中的下方延伸)。也就是说，顶面213具有中间高而两端低的构造。
顶面的这种构造能够有效地避免或减少血液在垫的顶部的积存。此外，顶面的这种构造还能够降低垫对从第一腔室流向第二腔室的血流的阻挡，更好地引导血流从第一腔室流入第二腔室。
图3B是垫21的结构示意图。在图3B中，粗箭头用于示意性地指示从第一腔室流向第二腔室的血流在垫21的顶面213的引导下的流动方向的变化趋势。
参见图2和图3B，顶面213在垫21的厚度方向上的两端处分别具有边缘部213a,213b。当医疗装置10被安装在患者的心脏中时，边缘部213a相对于边缘部213b更靠近小叶FL(或者说更靠近对合面211)，边缘部213b相对于边缘部213a更靠近小叶SL(或者说更靠近对合面212)。
定义顶面213的中部213c处的切面与边缘部213a处的切面的夹角为β1，定义中部213c处的切面与边缘部213b处的切面的夹角为β2。夹角β1和夹角β2的取值范围可以设置为大于等于10度且小于等于45度。优选地，α1的取值范围为大于等于15度且小于等于30度。在一个示例中，顶面213可以为平滑过渡的曲面，以减小对血流的阻力。
顶面的这种构造能够更好地引导从第一腔室流向第二腔室的血流，从而减少对第一腔室流向第二腔室的血流阻挡。
图4是医疗装置20的轴侧结构示意图。
需要说明的是，在本公开的附图中，箭头X用于指示垫的宽度方向，箭头Y用于指示垫的厚度方向，箭头Z用于指示垫的高度方向。
参见图4，支撑件22包括主体部221和一对连接部222。作为一个示例，主体部221可以呈环状，并被构造为适于安装在瓣环处。当然，在其它示例中，主体部221也可以呈半环状或其它形状。一对连接部222分别延伸至垫21的宽度方向上的两侧并与垫21连接。
一对小叶位于垫的厚度方向上的两侧，第一腔室和第二腔室位于垫的高度方向上的两侧，垫的厚度方向、高度方向和宽度方向两两垂直。当瓣膜张开时，大部分血液会从沿着高度方向从垫的厚度方向上的两侧流过，最终流入第二腔室。由于大部分血液会从垫的厚度方向上的两侧流过，支撑件的这种构造能够较大程度地减小支撑件与垫连接的部分对血液流动的阻碍，从而减小医疗装置对患者正常生理功能的影响。
需要说明的是，在本公开的上述多个实施例中，小叶FL和小叶SL中的任意一个可以为其它部分(例如，发明内容部分)所涉及的“第一小叶”。对应地，与“第一小叶”面对的对合面，可以为“第一对合面”；而小叶FL和小叶SL中的另一个可以为其它部分(例如，发明内容部分)所涉及的“第二小叶”。对应地，与“第二小叶”面对的对合面，可以为“第二对合面”。
图5是根据本公开一实施例的医疗装置的垫31的结构示意图。
参见图5，垫31包括可延展的网架31a和包覆于网架31a的罩31b。一对对合面311,312和顶面313可以为罩31b的外表面的一部分。在一个示例中，罩31b可以采用生物相容性材质并具有光滑的外表面，以避免或减少其在与小叶配合时磨损小叶或造成不适。另一实现方式可以是罩31b只在垫的顶端，但不覆盖在对合面上。这样可以使对合面较快表皮化，减少小叶同对合面相互碰合时对小叶组织的影响。
垫的形状和尺寸主要取决于网架。在递送过程中，可以将网架折叠以减小垫的整体尺寸，从而使得递送过程更加容易。在将垫递送至目标位置后，可以将网架展开，以使得垫具有合适的尺寸和形状。此外，这种具有网架的构造使得医生能够根据不同患者的瓣膜的差异来适应性地调整垫的形状和尺寸，从而使得垫能够更好地匹配患者的瓣膜。包覆于网架外侧的罩能够为垫提供光滑的表面，从而一方面避免或减少垫上的组织赘生活血液吸附，另一方面能够使得垫与小叶的对合更加紧密。
图6是根据本公开一实施例的医疗装置40的结构示意图。图6示出了医疗装置40被放置在患者的心脏瓣膜处的状态。
参见图6，医疗装置40包括垫41，垫41具有第一对合面411。当医疗装置40被安置在患者的心脏中时，垫41位于心脏瓣膜的第一小叶FL和第二小叶SL之间且跟随第二小叶SL运动，第一对合面411面对第一小叶FL且能够伴随垫41跟随第二小叶SL运动而与第一小叶FL周期性地对合(coaptation)和分离。在一个示例中，当第一对合面411与第一小叶FL对合时，二者之间的对合长度(coaptation length)的取值范围可以为6至12毫米。
通过位于一对小叶之间的垫41，医疗装置40能够改善瓣膜的关闭情况，使得第一小叶FL和第二小叶SL能够适当地对合，从而有效地阻止或减少血液的反流。此外，医疗装置40对血流的干扰较小，因此能够降低狭窄发生的可能性。此外，医疗装置40不会影响或较少地影响小叶的运动，从而不会或较少地给小叶的结构和功能带来问题。也就是说，采用本公开提供的医疗装置40，对瓣膜的自发运动(闭合，打开)没有任何限制和阻碍，同时对瓣膜的支持结构也没有关联，不会产生相应的不良的影响。也就是说，每个小叶的生理性周期运动都不会被干扰或较少地会被干扰。这样一来，医疗装置40将会更少地给小叶的结构和功能带来问题。此外，瓣膜能够通过自身的运动周期性地打开和关闭，并在收缩期通过垫41和小叶的对合，增加小叶有效闭合，从而不但能保持血液在舒张期从第一腔室自主流入第二腔室，并能有效阻止由于原本二小叶对合较差而引起的在收缩期相反的流动。
垫41可以附接于第二小叶SL以便跟随第二小叶SL运动。或者说，垫41可以以能够 跟随第二小叶SL运动的方式附接于第二小叶SL成为其一部分，从而使得第一对合面411能够伴随第二小叶SL的运动而与第一小叶FL周期性地对合和分离。
作为一种示例性的实现方式，再次参见图6，医疗装置40还可以包括固定件42。在一个示例中，固定件42可以为钉42。当医疗装置40被安置在患者的心脏中时，钉42可以穿透第二小叶SL而将垫41附接于第二小叶SL，使得垫41能够跟随第二小叶SL运动。
医疗装置40可以仅包括一个钉42，也可以包括多个钉42，对此本公开不做具体限定。钉42可以与垫41一体形成，二者也可以是两个彼此独立的构件，对此本公开实施例不做具体限定。
图7是根据本公开另一实施例的医疗装置50的结构示意图。图7示出了医疗装置50被放置在患者的心脏瓣膜处的状态。
参见图7，医疗装置50包括垫51，垫51具有第一对合面511。在某些实施例中，垫51可以被配置为趋向第一腔室而厚度逐渐增加，从而更好地匹配第一小叶FL和第二小叶SL的形状，更好地实现瓣膜的关闭。
当医疗装置50被安置在患者的心脏中时，垫51位于第一小叶FL和第二小叶SL之间且能够跟随第二小叶SL运动，第一对合面511面对第一小叶FL且能够伴随垫51跟随第二小叶SL运动而与第一小叶FL周期性地对合和分离。
第一对合面511可以为凹陷的表面。更为具体地，当医疗装置50被安置在患者的心脏中时，第一对合面511可以向背离第一小叶FL的方向凹陷。以此方式，能够使得第一对合面511更好地匹配第一小叶FL，从而使得第一对合面511能够与第一小叶FL更好地对合。
重新参见图7，在一个非限制性的示例中，当医疗装置50被安置在患者的心脏中时，第一对合面511趋向第一腔室而逐渐向第一小叶FL所在侧(即图7中的左侧)延伸。
在某些情况下，可能仍会有较少的血流从第二腔室反流至第一腔室中。第一对合面511(向背离第一小叶FL的方向)凹陷并且趋向第一腔室而逐渐向第一小叶FL所在侧延伸，这种构造能够增加血流的阻力而减少血流，并改变从第二腔室流向第一腔室的血流的流向，将血流引导至一侧，避免血流直面第一腔室以及上面的血管，从而能够降低从第二腔室流向第一腔室的血流对患者的心脏功能的影响。
图8A是垫51的结构示意图。如图8A所示，粗箭头所指的方向可以表示从第二腔室流向第一腔室的血流在第一对合面511的引导下的流动方向。
作为一种示例性的实现方式，参见图7和图8A，第一对合面511具有分别位于其相对两端的第一边缘部511a和第二边缘部511b。当医疗装置50被安置在患者的心脏中时，第一边缘部511a相对第二边缘部靠511b近第一腔室。
第一对合面511的切面趋向第一边缘部511a而与第二边缘部511b处的切面的夹角逐渐增加。第一边缘部511a的切面与第二边缘部511b的切面所成的夹角(锐角)α的取值范围可以为大于等于10度且小于等于45度。优选地，α的取值范围可以为大于等于15度且小于等于30度。
第一边缘部511a的切面与第二边缘部511b的切面所成的夹角α越大，第一对合面511对从第二腔室流向第一腔室的血流的流动方向的改变越大。将二者的所呈的夹角α设置在这一范围内，能够在保证第一小叶FL与第一对合面511的良好对合的基础上，有效地将从第二腔室流向第一腔室的血流引导至一侧。
在一个示例中，重新参见图7，垫51还可以具有顶面512，顶面512可以为外凸的表面。当医疗装置50被安置在患者的心脏中时，垫51的顶面512位于垫的靠近第一腔室的一端，并且顶面512面对第一腔室且(向第一腔室)凸出。
为了更好地匹配第一小叶FL和第二小叶SL，垫51的厚度趋向第一腔室而逐渐增加，这可能会导致垫51的顶部容易积存血液。由于垫51具有(向第一腔室的方向)凸出的顶面512，能够有效地避免或减少血液在垫51的顶部的积存。
在一个非限制性的示例中，重新参见图7，当医疗装置50被安置在患者的心脏中时， 垫51的顶面512趋向第二腔室而逐渐向第一小叶FL所在侧(即图7中的左侧)延伸。
垫51的顶面512的这种构造能够有效地避免或减少血液在垫51的顶部的积存。此外，垫51的顶面512的这种构造还能够降低垫51对从第一腔室流向第二腔室的血流的阻挡和对血流的影响，从而能够更好地引导血流从第一腔室流入第二腔室。
图8B是垫51的结构示意图。如图8B所示，粗箭头所指的方向可以表示从第一腔室流向第二腔室的血流在垫51的顶面512的引导下的流动方向。
在一个示例中，参见图7和图8B，垫51的顶面512具有分别位于其相对两端的第三边缘部512a和第四边缘部512b。当医疗装置50被安置在患者的心脏中时，第四边缘部512b相对第三边缘部512a靠近第二腔室。
顶面512的切面趋向第四边缘部512b而与第三边缘部512a处的切面的夹角逐渐增加。第三边缘部512a的切面和第四边缘部512b的切面所成的夹角β的取值范围可以为大于等于10度且小于等于45度。特别地，β的取值范围可以为大于等于15度且小于等于30度。
以此方式，垫51的顶面512能够更好地引导从第一腔室流向第二腔室的血流，减少垫51对从第一腔室流向第二腔室的血流阻挡。
在一个具体的示例中，再次参见图7，垫51还可以具有第二对合面513。第二对合面513可以为内凹的表面。更为具体地，当医疗装置50被安置在患者的心脏中时，第二对合面513面对第二小叶SL且向背离第二小叶SL的方向凹陷。此外，当医疗装置50被安置在患者的心脏中时，伴随垫51跟随第二小叶SL运动，第二对合面513与第二小叶SL保持对合。
这种构造能够使得垫51的第二对合面513更好地匹配第二小叶SL，更好地贴合第二小叶SL，从而能够有效地避免或减少血液在垫51的第二对合面513和第二小叶SL之间积存。
在一个非限制性的示例中，再次参见图7，医疗装置50还可以包括钉52。当医疗装置50被安置在患者的心脏中时，钉52可以穿透第二小叶SL而将垫51附接于第二小叶SL，使得垫51能够跟随第二小叶SL运动。
医疗装置50可以仅包括一个钉52，也可以包括多个钉52，对此本公开不做具体限定。钉52可以与垫51一体形成，二者也可以是两个彼此独立的构件，对此本公开实施例不做具体限定。
将垫附接于第二小叶SL的方式有多种，本公开对此不做具体限定。下面结合附图，示例性地给出一种可能的实现方式。
图9是根据本公开另一实施例的医疗装置60的结构示意图。图9示出了医疗装置60被放置在患者的心脏瓣膜处的状态。医疗装置60与医疗装置20大体相同，出于简洁的目的，相同之处不再赘述。
参见图9，医疗装置60包括垫61，垫61具有第一对合面611。当医疗装置60被安装在患者的心脏中时，垫61位于第一小叶FL和第二小叶SL之间且跟随第二小叶SL运动。伴随第二小叶SL运动，第一对合面611周期性地和第一小叶FL对合和分离，从而周期性地实现瓣膜的关闭和打开。
医疗装置60还包括夹持件62，夹持件62可以与垫61一体形成。当然，在其它实施例中，夹持件62也可以为一个独立于垫61的构件。当医疗装置60被安装在患者的心脏中时，夹持件62夹持第二小叶SL而将垫61附接于第二小叶SL，从而使得垫61能够跟随第二小叶SL运动。
本公开并不限于将垫附接于第二小叶SL。也可以通过其它实现方式来实现将垫定位在第一小叶FL和第二小叶SL之间并使得垫能够跟随第二小叶SL运动。
图10是根据本公开另一实施例的医疗装置70的结构示意图。图10示出了医疗装置70被放置在患者的心脏瓣膜处的状态。医疗装置70与医疗装置20的大体相同。出于简洁的目的，相同之处不再赘述。
参见图10，医疗装置70包括垫71和支撑件72。当医疗装置70被安置在患者的心脏中时，支撑件72位于第一腔室内，垫71以能够跟随第二小叶SL运动的方式与支撑件72连接，使得垫71定位在第一小叶FL和第二小叶SL之间并能够跟随第二小叶SL运动。
作为一种具体的实现方式，垫71可以与支撑件72铰接，以使垫71能够跟随第二小叶SL运动。在一个示例中，如图10所示，医疗装置70还可以包括枢转轴73，垫71可以通过枢转轴73与支撑件72铰接。例如，枢转轴73可以固定于垫71且可枢转地与支撑件72连接，从而实现垫71与支撑件72的铰接。又如，枢转轴73可以固定于支撑件72且可枢转地与垫71连接，从而实现垫71与支撑件72的铰接。
作为另一种具体的实现方式，垫71可以通过柔性的构件(或部分)与支撑件连接，以使垫71能够跟随第二小叶SL运动。
通过置于第一腔室的支撑件72，能够将垫71可靠地定位在第一小叶FL和第二小叶SL之间。垫71以能够跟随第二小叶SL运动的方式与支撑件72连接，能够保证伴随第二小叶SL的运动，垫71跟随第二小叶SL运动，从而使得第一对合面与第一小叶FL周期性地对合和分离。
在一个示例中，支撑件72可以呈环状，以减小对血流的影响。当然，在其它示例中，支撑件72也可以呈半环状或部分环状。在一个示例中，支撑件72可以被构造成较为柔软，或者说具有柔性，以随着第一心腔收缩和舒张而适应性地形变，进而减少对心脏功能的负面影响。
支撑件72的实现方式有多种，本公开对此不做具体限定。在一个非限制性的示例中，再次参见图10，支撑件72可以呈能够折叠和展开的网架状。在植入的过程中，可以先将支撑件72折叠，然后再将其在第一腔室中展开。
在某些实施例中，支撑件72可以被置于瓣环处，以使支撑件72能够被可靠地固定。
应当理解，虽然术语“第一”或“第二”等可能在本公开中用来描述各种元素(如第一腔室和第二腔室)，但这些元素不被这些术语所限定，这些术语只是用来将一个元素与另一个元素区分开。
需要说明的是，在上述具体实施方式中所描述的各个具体技术特征(元素)，在不矛盾的情况下，可以通过任何合适的方式进行组合，为了避免不必要的重复，本公开对各种可能的组合方式不再另行说明。
应当理解，在本公开实施例中，“至少一个”是指一个或者多个，“多个”是指两个或两个以上。“和/或”，描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B的情况。
应当理解，多个构件和/或部分能够由单个集成构件或部分来提供。另选地，单个集成构件或部分可以被分成分离的多个构件和/或部分。用来描述构件或部分的公开“一”或“一个”并不说为了排除其它的构件或部分。
以上所述，仅为本公开的具体实施方式，但本公开的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本公开揭露的技术范围内，可想到变化或替换，都应涵盖在本公开的保护范围之内。因此，本公开的保护范围应以权利要求的保护范围为准。

Claims (22)

  1. 一种医疗装置，用于修复患者的瓣膜，其特征在于，所述医疗装置包括垫，所述垫被配置为定位于所述瓣膜的多个小叶之间，以通过与所述多个小叶配合而使所述瓣膜周期性地打开和关闭。
  2. 根据权利要求1所述的医疗装置，其特征在于，所述多个小叶包括第一小叶和第二小叶，所述垫具有第一对合面，所述第一对合面被配置为面对所述第一小叶并随着所述第一小叶或所述第二小叶运动而与所述第一小叶周期性地对合和分离，其中所述第一对合面被配置为向背离所述第一小叶的方向凹陷。
  3. 根据权利要求2所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，其中所述第一对合面被配置为趋向所述第一腔室而逐渐向所述第一小叶所在侧延伸。
  4. 根据权利要求3所述的医疗装置，其特征在于，所述第一对合面具有分别位于其相对两端的第一边缘部和第二边缘部，所述第一边缘部被配置为相对所述第二边缘部靠近所述第一腔室，所述第一边缘部的切面与所述第二边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
  5. 根据权利要求2所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，所述垫还具有顶面，所述顶面被配置为面对所述第一腔室且向所述第一腔室的方向凸出。
  6. 根据权利要求2所述的医疗装置，其特征在于，所述垫具有包括所述第一对合面的多个对合面，所述多个对合面被配置为分别面对所述多个小叶，并且随着所述多个小叶运动，每个对合面与其面对的小叶周期性地对合和分离。
  7. 根据权利要求6所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，所述垫还具有顶面，所述顶面被配置为面对所述第一腔室且向所述第一腔室的方向凸出，其中所述顶面被配置为从其中部起，趋向每个小叶所在侧而逐渐向所述第二腔室延伸。
  8. 根据权利要求7所述的医疗装置，所述顶面的中部的切面与所述顶面的靠近每个小叶的边缘部分的切面所呈的夹角的取值范围为大于等于10度且小于等于45度。
  9. 根据权利要求6所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，所述医疗装置还包括支撑件，所述支撑件被配置为位于在所述第一腔室内并与所述垫连接，从而将所述垫定位在所述多个小叶之间。
  10. 根据权利要求9所述的医疗装置，其特征在于，所述支撑件具有主体部和一对连接部，所述一对连接部被配置为分别延伸至所述垫的宽度方向上的两侧并与所述垫连接。
  11. 根据权利要求9所述的医疗装置，其特征在于，所述垫包括可延展的网架和包覆于所述网架外侧的罩，其中所述罩设置于所述垫的顶端而不覆盖所述多个对合面中的任一个。
  12. 根据权利要求2至11中任一项所述的医疗装置，其特征在于，所述垫具有第二对合面，所述第二对合面被配置为面对所述第二小叶，随着所述第二小叶运动而与所述第二小叶周期性地对合和分离，其中所述第二对合面被配置为向背离所述第二小叶的方向凹陷。
  13. 根据权利要求12所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，其中所述第二对合面被配置为趋向所述第一腔室而逐渐向所述第二小叶所在侧延伸。
  14. 根据权利要求13所述的医疗装置，其特征在于，所述第二对合面具有分别位于其相对两端的第一边缘部和第二边缘部，所述第一边缘部被配置为相对所述第二边缘部靠近所述第一腔室，所述第一边缘部的切面与所述第二边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
  15. 根据权利要求2所述的医疗装置，其特征在于，所述垫被配置为跟随所述第二小叶 运动，所述第一对合面被配置为伴随所述垫跟随所述第二小叶运动而与所述第一小叶周期性地对合和分离。
  16. 根据权利要求15所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，所述垫还具有顶面，所述顶面被配置为面对所述第一腔室且向所述第一腔室的方向凸出，所述顶面被配置为趋向所述第二腔室而逐渐向所述第一小叶所在侧延伸。
  17. 根据权利要求16所述的医疗装置，其特征在于，所述顶面具有分别位于其相对两端的第三边缘部和第四边缘部，所述第四边缘部被配置为相对所述第三边缘部靠近所述第二腔室，所述第三边缘部的切面和所述第四边缘部的切面所成的夹角的取值范围为大于等于10度且小于等于45度。
  18. 根据权利要求15所述的医疗装置，其特征在于，所述垫还具有第二对合面，所述第二对合面被配置为面对所述第二小叶且向背离所述第二小叶的方向凹陷，并且伴随所述垫跟随所述第二小叶运动而与所述第二小叶保持对合。
  19. 根据权利要求15所述的医疗装置，其特征在于，所述垫被配置为附接于所述第二小叶。
  20. 根据权利要求15所述的医疗装置，其特征在于，所述瓣膜用于允许血液从第一腔室流入第二腔室并阻止相反方向的流动，所述医疗装置还包括支撑件，所述支撑件被配置为位于所述第一腔室内并将所述垫定位在所述第一小叶和所述第二小叶之间，其中所述垫以能够跟随所述第二小叶运动的方式与所述支撑件连接。
  21. 根据权利要求1所述的医疗装置，其特征在于，所述垫的厚度随着趋向于所述第一腔室而逐渐增加。
  22. 根据权利要求1所述的医疗装置，其特征在于，所述瓣膜为二尖瓣，所述多个小叶的数量为两个；或者，所述瓣膜为三尖瓣，所述多个小叶的数量为三个。
PCT/CN2023/126911 2022-10-27 2023-10-26 医疗装置 WO2024088355A1 (zh)

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CN111200994A (zh) * 2017-08-28 2020-05-26 爱德华兹生命科学公司 用于治疗二尖瓣反流的经导管装置
CN112773565A (zh) * 2021-02-09 2021-05-11 上海纽脉医疗科技有限公司 一种心脏瓣膜可调辅助装置及系统
CN113813084A (zh) * 2021-09-14 2021-12-21 科凯(南通)生命科学有限公司 心脏瓣膜修复器械
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CN104768500A (zh) * 2012-09-06 2015-07-08 爱德华兹生命科学公司 心脏瓣膜密封装置
US20160302917A1 (en) * 2013-06-14 2016-10-20 Hazu Gmbh Method and device for treatment of valve regurgitation
US20150230919A1 (en) * 2014-02-14 2015-08-20 Edwards Lifesciences Corporation Percutaneous leaflet augmentation
CN107106296A (zh) * 2014-11-17 2017-08-29 二尖瓣辅助治疗有限公司 用于心脏瓣膜的辅助装置
CN111200994A (zh) * 2017-08-28 2020-05-26 爱德华兹生命科学公司 用于治疗二尖瓣反流的经导管装置
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