WO2023040320A1 - Système de distribution de prothèse valvulaire, dispositif d'arrêt et élément d'arrêt s'y rapportant - Google Patents

Système de distribution de prothèse valvulaire, dispositif d'arrêt et élément d'arrêt s'y rapportant Download PDF

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Publication number
WO2023040320A1
WO2023040320A1 PCT/CN2022/093957 CN2022093957W WO2023040320A1 WO 2023040320 A1 WO2023040320 A1 WO 2023040320A1 CN 2022093957 W CN2022093957 W CN 2022093957W WO 2023040320 A1 WO2023040320 A1 WO 2023040320A1
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WO
WIPO (PCT)
Prior art keywords
stopper
artificial valve
balloon
catheter
radial
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PCT/CN2022/093957
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English (en)
Chinese (zh)
Inventor
詹航敏
虞奇峰
秦涛
Original Assignee
上海纽脉医疗科技股份有限公司
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Publication date
Priority claimed from CN202111088663.XA external-priority patent/CN114259322A/zh
Priority claimed from CN202122253299.XU external-priority patent/CN216535662U/zh
Application filed by 上海纽脉医疗科技股份有限公司 filed Critical 上海纽脉医疗科技股份有限公司
Publication of WO2023040320A1 publication Critical patent/WO2023040320A1/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 an artificial valve delivery system, in particular to a stopper for an artificial valve delivery system, an artificial valve delivery system, a stopper and an artificial valve delivery device.
  • Artificial heart valves usually refer to implantable heart valves (including aortic valve, pulmonary valve, tricuspid valve, mitral valve) that can make blood flow in one direction and have natural heart valves. Functional artificial organs.
  • transcatheter valve replacement is to introduce the artificial valve into the body through the artificial valve delivery system and place it at the position where it needs to be implanted.
  • the artificial valve delivery system generally includes a valve installation part, a connection part, and an operation part.
  • the valve installation part includes a conical head, a balloon, a catheter, etc. Adjustment button, traction device, three-way tailstock, etc., wherein the catheter runs through the entire delivery system, and the balloon is an inflatable balloon.
  • the operating part is used as a reference, and the above-mentioned components are close to the end of the operating part along the axial direction of the catheter It is called the proximal end, and the end away from the operating part is called the distal end.
  • the balloon is inflated by injecting fluid into the balloon to deploy the prosthetic valve.
  • the prosthetic valve release process needs to be combined with external equipment such as ultrasound, contrast imaging, etc. to observe the specific position of the prosthetic valve and the state of the balloon-expanded valve stent.
  • the artificial valve system usually fixes a proximal stop structure and a distal stop structure on the catheter inside the balloon, and the axial inner end of the proximal stop structure and the distal stop structure is used to accommodate the artificial valve and It is limited axially.
  • the existing one-type stop structure is composed of several independent elastic fingers.
  • the elastic fingers are generally cantilever structures and each elastic finger is independent of each other, so that each elastic finger can move and deform freely.
  • the degree is relatively large, which is prone to deformation during the delivery of the artificial valve, and the positioning accuracy of the artificial valve cannot be guaranteed, resulting in increased surgical risks.
  • Another type of stop structure is a cone, whose radial cross-sectional diameter gradually decreases in the direction away from the artificial valve.
  • the cone stop structure can reduce the degree of freedom of movement and deformation to a certain extent, but there are still the following disadvantages: 1. When the balloon is in a contracted state, the balloon is almost completely wrapped on the catheter and the stop structure. Since the circumferential edge of the cone stop structure fits well with the balloon, there is a gap between the two. The gap through which the fluid passes is small, which is not conducive to the rapid passage of fluid; 2.
  • the stop structure When the valve installation part is assembled, the stop structure needs to be inserted into the balloon in advance, and the diameter of the proximal and distal openings of the balloon is limited, so it is necessary to stop
  • the structure has a certain degree of compressibility in the radial direction, while the radial compression range of the conical structure is very limited, or even incompressible, which makes the assembly of the balloon and the stop structure more difficult.
  • the contact area between the axial inner end surface of the cone stop structure and the axial end surface of the artificial valve is relatively large, which will increase the radial friction force of the stop structure of the artificial valve at the initial stage of balloon inflation, which may lead to The artificial valve does not expand smoothly, which increases the risk of surgery.
  • the main purpose of this application is to provide a stop device for artificial valve delivery system, artificial valve delivery system, stopper and artificial valve delivery device.
  • the stopper can not only achieve uniform deformation during radial compression, but also provide a flow channel for the fluid when the balloon is deflated.
  • a stopper device for a prosthetic valve delivery system includes a balloon for setting the prosthetic valve and a catheter passing through the balloon, the fluid flows from the proximal end of the balloon into the interior of the balloon, the stop is located within the balloon and includes:
  • the first stopper includes a first tube portion and a first stopper along the axial direction of the catheter, the first tube portion is sleeved on and fixed on the catheter, and is spaced apart from the proximal end of the balloon, the first The stopper is sleeved on the catheter, the proximal end of the first stopper is affixed to the distal end of the first tube, and the distal end of the first stopper is used to limit the proximal end of the artificial valve,
  • the first stop part is an annular structure and is formed by alternately connecting several first convex parts and several first concave parts along the circumferential direction, and the inner and outer wall surfaces of the first convex part protrude outward along the radial direction of the first stop part, The inner and outer wall surfaces of the first recess are recessed inward along the radial direction of the first stopper, and the radial distance between the first protrusion and the catheter axis gradually increases from the proximal end to the dis
  • the second stopper includes a second tube part and a second stop part along the axial direction of the catheter, the second tube part is sleeved and fixed on the catheter, and is arranged near the distal end of the balloon, and the second stop part
  • the moving part is sleeved on the catheter, the distal end of the second stopper is fixedly connected to the proximal end of the second pipe part, and the proximal end of the second stopper is used to limit the distal end of the artificial valve.
  • the two stoppers are ring-shaped and formed by alternately connecting several second protrusions and second recesses along the circumferential direction. The inner and outer walls of the second protrusions protrude outward along the radial direction of the second stopper.
  • the inner and outer walls of the two recesses are recessed inward along the radial direction of the second stopper, and the radial distance between the second protrusion and the axis of the catheter gradually decreases from the proximal end to the distal end of the second stopper;
  • the axial distance between the first stopper and the second stopper matches the axial length of the artificial valve
  • fluid can pass through the plurality of first recesses and the plurality of second recesses.
  • the first stopper is a structure of constant wall thickness; the second stopper is a structure of constant wall thickness.
  • the first pipe part is connected smoothly with the first stop part; the second pipe part is connected smoothly with the second stop part.
  • the radial section of the first recess is V-shaped, several first recesses are arranged in the circumferential direction, and a first protrusion is formed between two adjacent first recesses;
  • the radial section of the second recess It is V-shaped, several second concave parts are arranged along the circumferential direction, and a second convex part is formed between two adjacent second concave parts.
  • the radial maximum distance between the first protrusion and the catheter axis is greater than half of the inner diameter of the artificial valve in a compressed state, and the first The radial minimum distance between the recess and the catheter axis is less than half of the inner diameter of the prosthetic valve in a compressed state;
  • the radial maximum distance between the second protrusion and the catheter axis is greater than half of the inner diameter of the artificial valve in a compressed state, and the second recess and the The radial minimum distance of the catheter axis is less than half of the inner diameter of the artificial valve under pressure.
  • the radial maximum distance between the first protrusion and the catheter axis is greater than half of the outer diameter of the artificial valve in a compressed state, and the first A minimum radial distance between a recess and the catheter axis is less than half the outer diameter of the prosthetic valve in a compressed state;
  • the maximum radial distance between the second protrusion and the axis of the catheter is greater than half of the outer diameter of the artificial valve in a compressed state, and the second recess and The radial minimum distance of the conduit axis is less than half the outer diameter of the prosthetic valve in a compressed state.
  • the maximum radial distance between the first protrusion and the catheter axis is 1.05-1.25 times half of the outer diameter of the artificial valve in a compressed state
  • the maximum radial distance between the second protrusion and the catheter axis is 1.05-1.25 times half of the outer diameter of the artificial valve in a compressed state.
  • the second stopper further includes a third tube portion in the axial direction, the proximal end of the third tube portion is affixed to the distal end of the second tube portion, and the distal end of the third tube portion is used for connecting with the
  • the conical head of the delivery system is fixedly connected to the distal end of the balloon, and the outer diameter of the proximal end of the third tube part is smaller than the outer diameter of the distal end of the second tube part.
  • a radially penetrating first dispensing hole is provided on the pipe wall of the first pipe part; a radially penetrating second dispensing hole is provided on the pipe wall of the second pipe part.
  • an artificial valve delivery system includes a balloon disposed at the distal end of the delivery system, a balloon connection tube for connecting the balloon, and a catheter inserted into the balloon connection tube , the proximal end of the balloon is connected and fixed with the distal end of the balloon connecting tube, the catheter passes through the distal end of the balloon connecting tube and penetrates into the balloon through the proximal end of the balloon, the balloon connecting tube
  • the tube and catheter form an annular lumen within the proximal end of the balloon through which fluid used to inflate the balloon flows into or out of the interior of the balloon;
  • the catheter is provided with the stopping device as described in the first aspect above, and the stopping device is used for axially limiting the artificial valve in the compressed state.
  • a stopper for an artificial valve delivery device the artificial valve delivery device includes a balloon for setting the artificial valve and a catheter passing through the balloon, and two stoppers are arranged at intervals on the catheter pieces,
  • the stopper includes a sleeve part and a stop part; the sleeve part is used to be sleeved and fixed on the catheter, and one end of the sleeve part is coaxially connected with the stop part; the stop part It is used to limit the artificial valve.
  • the stop part is an annular structure sleeved on the catheter and is formed by alternately connecting several convex parts and several concave parts along the circumferential direction. The inner and outer walls of the convex parts are all along the radial direction of the stop part.
  • the inner and outer wall surfaces of the concave part are recessed inward along the radial direction of the stopper part, and the radial distance between the convex part and the axis of the stopper part gradually increases in the direction away from the sleeve part, and the concave part
  • the stop part is penetrated along the axial direction of the stop part.
  • the stopper is a structure of equal wall thickness.
  • the sleeve part and the stop part are connected smoothly.
  • the radial section of the concave portion is V-shaped, and a convex portion is formed between two adjacent concave portions.
  • the highest point of the protrusion in the radial direction is arc-shaped.
  • the maximum radial distance between the convex part and the axis of the stopper is greater than half of the inner diameter of the artificial valve in a compressed state, and the distance between the concave part and the axis of the stopper The radial minimum distance is less than half of the inner diameter of the artificial valve in a compressed state.
  • the maximum radial distance between the protrusion and the axis of the stopper is greater than half of the outer diameter of the prosthetic valve in a compressed state.
  • radially penetrating glue dispensing holes are provided on the tube wall of the casing part.
  • the other end of the sleeve part is coaxially connected with an extension part
  • the extension part is in the shape of a sleeve and is sleeved and fixed on the catheter, and the outer diameter of the extension part is smaller than the outer diameter of the sleeve part.
  • an artificial valve delivery device includes a catheter, a balloon located at the distal end region of the catheter, a guide located at the distal end of the catheter, located in the balloon and arranged at intervals on the catheter. a proximal stop and a distal stop on the catheter;
  • the proximal stopper and the distal stopper are the stoppers described in the first aspect above, and the adjacent parts of the two are respective stoppers, and the proximal stopper and the The space between the distal stoppers forms a limiting space for accommodating the artificial valve in a compressed state; the proximal end of the balloon is spaced apart from the proximal stoppers.
  • the stopper device for the artificial valve delivery system of the present application firstly, through the first stopper and the second stopper on the first stopper and the second stopper, so that it is placed on the first stopper and the second stopper.
  • the artificial valve between the two stoppers is limited in the axial direction, and the structure of the first stopper and the second stopper is designed while ensuring the stopper's effect on the artificial valve.
  • the radial compressibility of the first stopper and the second stopper is improved through alternately connecting convex parts and concave parts along the circumferential direction, the compressible range is improved, and the compression deformation is more uniform and stable.
  • the first recess and the second recess can provide an optimized flow path for the fluid flowing in the balloon, especially when the balloon is in a contracted state, it can ensure that there is a gap between the first stopper, the second stopper and the balloon. There are enough gaps to serve as fluid flow channels, making the fluid flow in the balloon faster and smoother, thereby optimizing the fluid flow effect and improving the inflation and contraction effects of the balloon, helping to reduce operation time, Reduce surgical risk. Furthermore, by reasonably controlling the actual contact area between the distal end surface of the first stopper part and the proximal end surface of the artificial valve, and between the proximal end surface of the second stopper part and the distal end surface of the artificial valve, it is possible to avoid the balloon inflation during the initial stage of inflation. The excessive radial friction force on the artificial valve helps to reduce the expansion resistance of the artificial valve, making the process of artificial valve deployment smoother and reducing the risk of surgery.
  • the artificial valve delivery system of the present application adopts the above-mentioned stopping device, which can effectively limit the position of the artificial valve in the axial direction, and can improve the flow effect of the fluid in the balloon, especially when the balloon is in a contracted state.
  • the fluid provides a flow channel that improves balloon inflation and deflation, helping to improve surgical efficiency and reduce surgical risk.
  • the stopper is a circumferentially closed structure and has alternately connected convex parts and concave parts.
  • the compression performance of the stopper in the radial direction is improved, so that the stopper The radial compressibility range of the radial direction increases, and the compression deformation effect of the stopper is more reasonable, and it is more convenient to put the stopper into the balloon during the assembly process, which helps to improve the assembly efficiency;
  • the alternate The connected convex part and concave part restrain each other to a certain extent, so that the degree of freedom of deformation of the stop part can be reasonably controlled, so that the stop part is more stable and reliable in structure, and can ensure the limiting effect on the artificial valve.
  • the recess can provide an optimized flow path for the fluid in the balloon, especially when the balloon is in a contracted state, it can ensure that there is enough space between the stopper and the balloon for the fluid to pass through, making the fluid flow faster , Unobstructed, can improve the inflation and contraction effect of the balloon, help to reduce the operation time, and also reduce the operation risk.
  • the artificial valve delivery device of the present application can effectively limit the position of the artificial valve in the axial direction by using the above-mentioned stopper, and can improve the flow effect of the fluid in the balloon, especially when the balloon is in a contracted state. Providing a flow path for the fluid has a positive effect on improving balloon inflation and deflation.
  • FIG. 1 is a schematic diagram of the axial structure of the stopping device used in the artificial valve delivery system of the present application
  • FIG. 2 is a schematic diagram of the three-dimensional structure of the first stopper used in the artificial valve delivery system of the present application;
  • FIG. 3 is a schematic diagram of the three-dimensional structure of the second stopper used in the artificial valve delivery system of the present application.
  • Fig. 4 is a radial cross-sectional schematic view of the first stopper used in the artificial valve delivery system of the present application
  • Fig. 5 is a schematic structural view of the distal region of a preferred embodiment of the artificial valve delivery device of the present application.
  • proximal end and the distal end are relative to the operator of the artificial valve delivery device, the proximal end refers to the end relatively close to the operator, and the distal end refers to the end relatively far away from the operator .
  • the present application provides a stop device for an artificial valve delivery system
  • the artificial valve delivery system includes a balloon 1 for setting the artificial valve and a catheter 2 passing through the balloon
  • the catheter 2 is provided with a developing assembly 6.
  • the fluid used to inflate the balloon 1 flows into the interior of the balloon 1 from the proximal end of the balloon 1.
  • the delivery system also includes a balloon connection tube 3 for connecting the balloon 1, and the proximal end of the balloon 1 is connected to the balloon 1.
  • the distal end of the balloon connecting tube 3 is connected and fixed.
  • the catheter 2 passes through the distal end of the balloon connecting tube 3 and penetrates into the balloon 1 from the proximal end of the balloon 1.
  • the balloon connecting tube 3 and the catheter 2 are in the balloon.
  • An annular cavity 8 is formed at the proximal end of the balloon 1, and the fluid used to inflate the balloon 1 flows into or flows out of the interior of the balloon 1 through the annular cavity 8.
  • the stopping device is located inside the balloon 1 and includes a first stopper 4 and a second stopper 5 arranged on the catheter 2 .
  • the first stopper 4 includes a first tube portion 41 and a first stopper portion 42 along the axial direction of the catheter 2 .
  • the ends are arranged at intervals, the first stopper 42 is sleeved on the catheter 2, the proximal end of the first stopper 42 is affixed to the distal end of the first tube part 41, and the distal end of the first stopper 42 is used to limit the proximal end of the prosthetic valve.
  • the first stop portion 42 is an annular structure and is formed by alternately connecting several first convex portions 43 and several first concave portions 44 along the circumferential direction.
  • the inner and outer walls of the first recess 44 are recessed inward along the radial direction of the first stopper 42, and the radial distance between the first protrusion 43 and the axis of the catheter 2 starts from the proximal end of the first stopper 42. gradually increases distally.
  • the second stopper 5 includes a second tube portion 51 and a second stopper portion 52 along the axial direction of the catheter 2 , the second tube portion 51 is sleeved and fixed on the catheter 2 , and is close to the distal end, the second stopper 52 is sleeved on the catheter 2, the distal end of the second stopper 52 is affixed to the proximal end of the second tube part 51, and the proximal end of the second stopper 52 is used for limiting The distal end of the prosthetic valve.
  • the second stop portion 52 is an annular structure and is formed by alternately connecting a plurality of second convex portions 53 and a plurality of second concave portions 54 along the circumferential direction.
  • the inner and outer wall surfaces of the second recess 54 are recessed inward along the radial direction of the second stopper 52, and the radial distance between the second protrusion 53 and the axis of the catheter 2 starts from the proximal end of the second stopper 52. gradually decreases distally.
  • the "radial direction” here is not limited to the radial direction of a cylinder, a cone, etc., but is used to define that the direction is a direction perpendicular to the axial direction of the catheter.
  • “outward” and “inward” is defined with respect to the axis of the catheter as an aid to illustrate the embodiments and should not be construed as a limitation.
  • the axial distance between the first stopper 42 and the second stopper 52 matches the axial length of the artificial valve, thereby enabling the artificial valve to be placed between the first stopper and the second stopper And is limited in the axial direction.
  • the fluid can pass through several first recesses 44 and several second recesses 54, that is, when the balloon is wrapped on the circumferential outer edge of the stopper, there is a gap between the two.
  • the gaps provided by the plurality of first recesses and the plurality of second recesses, through which fluid can pass, can help improve the flow of fluid when the balloon is in a deflated state.
  • the stopper implements the axial limit of the artificial valve through the first stopper and the second stopper, and the first stopper and the second stopper are alternately provided with protrusions along the circumferential direction.
  • the compressibility and performance of the first stopper and the second stopper in the radial direction are improved, and the compression deformation effect is more Even and reasonable, it is convenient to insert the stopper into the balloon during assembly to improve assembly efficiency.
  • the radial dimensions of the first convex portion and the second convex portion gradually increase and decrease gradually from the proximal end to the distal end, so that the first stopper portion and the second stopper portion both present a three-dimensional petal-like structure as a whole,
  • the first recess and the second recess can not only provide an optimized flow path for the fluid, make the flow of the fluid in the balloon more smooth, but also increase the distance between the stopper device and the balloon when the balloon is in a contracted state.
  • the gap in the radial direction can provide a flow channel for the fluid at the initial stage of balloon inflation, facilitate the flow of fluid in the balloon, and help improve the inflation and contraction effect of the balloon.
  • the first stopper 42 is a structure of equal wall thickness, that is, the inner and outer walls of the first convex part 43 protrude radially outwards from the proximal end of the first stopper 42 to the distal end.
  • the ends are consistent, and the variation range of the inner and outer wall surfaces of the first recess 44 inwardly recessed in the radial direction is consistent from the proximal end to the distal end of the first stopper 42 .
  • the second stop portion 52 is of equal wall thickness, that is, the variation range of the radial outward protrusion of the inner and outer walls of the second convex portion 53 is consistent from the distal end to the proximal end of the second stop portion 52 , Moreover, the variation range of the inner and outer wall surfaces of the second concave portion 54 radially inwardly recessed is consistent from the distal end to the proximal end of the second stop portion 52 .
  • the structural changes of the first stopper and the second stopper are consistent in the circumferential direction and the axial direction, so that the compression range and compression performance in the radial direction are further optimized and improved, and the structure is more stable when compressed by an external force. Stable, more uniform deformation effect, easy to assemble with the balloon, and help to improve assembly efficiency.
  • the wall thickness of the first stopper 42 can gradually increase from the proximal end to the distal end of the first stopper 42, that is, the inner and outer wall surfaces of the first convex part 43 radially outward
  • the range of variation of the protrusions may be different, and the range of variation of the inner and outer walls of the first recess 44 radially inwardly recessed may also be different.
  • the wall thickness of the second stopper 52 can gradually decrease from the proximal end to the distal end of the second stopper 52, that is, the variation range of the inner and outer wall surfaces of the second protrusion 53 protruding radially outward can be different, and the change range of the inner and outer wall surfaces of the second recess 54 radially inwardly recessed may also be different.
  • the structural strength and deformation freedom of the first stopper and the second stopper can be adjusted according to actual needs, so as to meet actual use needs.
  • the materials of the first blocking member and the second blocking member are both polymer materials, such as PP.
  • the first tube part and the first stop part of the first stopper can be bonded and fixed together by means of thermal fusion, but considering that interventional medical devices such as artificial valve delivery systems should minimize the impact and damage on the inner wall of the blood vessel,
  • the first stopper is integrally formed, and similarly, the second stopper is also integrally formed to avoid the gap between the first tube part and the first stopper part, the second tube part and the first stopper part.
  • the connection between the second stoppers produces structures such as sharp points or protrusions, and the first stopper and the second stopper are more compact in structure and easy to assemble.
  • first pipe portion 41 and the first stop portion 42 there is a smooth connection between the first pipe portion 41 and the first stop portion 42, and a smooth connection between the second pipe portion 51 and the second stop portion 52.
  • the radial section of the first recess 44 is V-shaped, and the V-shape includes two sides in an angled shape.
  • first recesses 44 are arranged in the circumferential direction, and two consecutive first recesses 44 Adjacent side edges are connected to form the first protrusion 43 .
  • the radial cross-section of the second recess 54 is V-shaped, and the V-shape includes two sides that are angled.
  • Several second recesses 54 are arranged in the circumferential direction, and two consecutive second recesses 54 are adjacent to each other. The side edges of are connected to form a second convex portion 53, see FIG. 4 .
  • the highest portion of the first protrusion 43 in the radial direction is arc-shaped, and the highest portion of the second protrusion 53 in the radial direction is arc-shaped.
  • the distal end surface of the first stopper has a wave-like shape that uniformly changes in the circumferential direction
  • the proximal end surface of the second stopper also has a wave-like shape that uniformly changes in the circumferential direction, so that the first
  • the actual contact area between the distal surface of the stopper and the proximal surface of the artificial valve, and between the proximal surface of the second stopper and the distal surface of the artificial valve is reasonably controlled, which can avoid contact between the artificial valve and the first artificial valve.
  • the radial friction force between the stopper parts and between the artificial valve and the second stopper part is too large, so that the artificial valve expands more smoothly.
  • the crests of the first stopper and the second stopper in the circumferential direction are arc-shaped, which can avoid sharp structures on the circumferential wall surface of the first stopper and the second stopper, and reduce damage to the inner wall of the blood vessel. damage.
  • the radial section of the first convex portion 43 is arc-shaped, and the arc shape includes two ends.
  • first convex portions 43 are arranged along the circumferential direction. Between two consecutive first convex portions 43 Adjacent end portions are connected to form a first concave portion 44 .
  • the radial cross-section of the second protrusions 53 is arc-shaped, and the arc includes two ends.
  • second protrusions 53 are arranged along the circumferential direction, and the adjacent ends between two consecutive second protrusions 53 parts are connected to form a second concave part 54 .
  • both the distal end surface of the first stopper part and the proximal end surface of the second stopper part have a uniformly changing wave shape in the circumferential direction, and there will be no redundant sharp structures on the circumferential wall surface, which can avoid Damage to the inner wall of the blood vessel during the delivery process also helps to complete the smooth delivery process of the artificial valve.
  • the radial maximum distance between the first convex portion 43 and the axis of the catheter 2 is greater than half of the inner diameter of the artificial valve in a compressed state, and the first concave portion 44
  • the radial minimum distance from the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state; similarly, on the proximal surface of the second stopper 52, the radial maximum distance from the second protrusion 53 to the axis of the catheter 2 greater than half of the inner diameter of the artificial valve in a compressed state, and the radial minimum distance between the second recess 54 and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state.
  • the radially highest portion of the first protrusion exceeds the inner wall of the artificial valve in the compressed state, and the radially lowest portion of the first concave portion is lower than the inner wall of the artificial valve in the compressed state, so that the first stopper can be realized Axial limit when the artificial valve is in a compressed state.
  • the highest part of the second protrusion in the radial direction exceeds the inner wall of the artificial valve in the compressed state, and the lowest part of the second concave part in the radial direction is lower than the inner wall of the artificial valve in the compressed state, so that the second stopper can be realized Axial limit when the artificial valve is in a compressed state.
  • such a structure can also avoid that in some cases, if the radial minimum distance of the first recess is greater than half of the outer diameter of the artificial valve in a compressed state, it may cause the end portion of the artificial valve to enter the first stopper and In the gap between the catheters, it affects the normal release of the artificial valve.
  • the radial maximum distance between the first protrusion 43 and the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state, and the first The radial minimum distance between the concave portion 44 and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state; similarly, on the proximal surface of the second stopper 52, the diameter of the second convex portion 53 and the axis of the catheter 2 The maximum distance is greater than half of the outer diameter of the artificial valve in a compressed state, and the radial minimum distance between the second recess 54 and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state.
  • the highest portion of the first protrusion in the radial direction exceeds the outer wall of the artificial valve in the compressed state, and the lowest portion of the first concave portion in the radial direction is lower than the outer wall of the artificial valve in the compressed state, so that the first stopper can be realized Axial limit when the artificial valve is in a compressed state.
  • the highest part of the second protrusion in the radial direction exceeds the outer wall of the artificial valve in the compressed state, and the lowest part of the second concave part in the radial direction is lower than the outer wall of the artificial valve in the compressed state, so that the second stopper can be realized Axial limit when the artificial valve is in a compressed state.
  • the radially highest portions of the first convex portion and the second convex portion both exceed the outer wall of the artificial valve in the compressed state, which is equivalent to being in a structure similar to an annular groove in the compressed state of the artificial valve, so that it can be transported during delivery. It can better protect the artificial valve, reduce the contact between the artificial valve and the inner wall of the blood vessel during the movement process, and prevent other components of the delivery system from touching the outer wall of the artificial valve.
  • the radial maximum distance between the first convex portion 43 and the axis of the catheter 2 is 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state; the diameter of the second convex portion 53 and the axis of the catheter 2 The maximum distance is 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state.
  • the highest part in the radial direction of the first convex part and the second convex part is slightly higher than the outer wall of the artificial valve in the compressed state, which can realize the artificial
  • the axial limit and circumferential protection of the valve prevents the radial dimensions of the first stopper and the second stopper from being too large, avoiding unnecessary damage to the inner wall of the blood vessel, and conveniently moving the first The stopper, the second stopper and the balloon are assembled.
  • the second stopper 5 further includes a third tube part 55 in the axial direction, the proximal end of the third tube part 55 is affixed to the distal end of the second tube part 51, The distal end of the third tube part 55 is used for fixed connection with the tapered head 7 of the delivery system and the distal end of the balloon 1 , and the proximal outer diameter of the third tube part 55 is smaller than the distal outer diameter of the second tube part 51 .
  • the distal opening of the balloon 1 is wrapped on the outer side of the distal tube wall of the third tube part 55, and the proximal end of the conical head 7 and the distal end of the third tube part 55 can be fixedly connected through the end surface or fixedly connected through an insert. .
  • the second stopper provides the position-limiting function for the artificial valve, it also provides the function of fixed connection for the conical head and the distal end of the balloon, so that the structure of the artificial valve delivery system at the distal end is more compact and simple. and reduce damage to blood vessels.
  • a radially penetrating first dispensing hole 45 is provided on the pipe wall of the first pipe part 41; a radially penetrating second dispensing hole 56 is provided on the pipe wall of the second pipe part 51, by This realizes the adhesively fixed connection of the first stopper and the second stopper with the catheter.
  • the present application also provides an artificial valve delivery system, including a balloon 1 arranged at the distal end of the delivery system, a balloon connection tube 3 for connecting the balloon 1 and a balloon connection tube 3 inserted into the balloon connection tube 3.
  • a balloon connection tube 3 for connecting the balloon 1 and a balloon connection tube 3 inserted into the balloon connection tube 3.
  • Catheter 2 the proximal end of the balloon 1 is connected and fixed to the distal end of the balloon connecting tube 3, the catheter 2 passes through the distal end of the balloon connecting tube 3 and penetrates into the balloon 1 from the proximal end of the balloon 1, the balloon
  • the balloon connecting tube 3 and the catheter 2 form an annular cavity 8 at the proximal end of the balloon 1 , and the fluid used to inflate the balloon 1 flows into or out of the balloon 1 through the annular cavity 8 .
  • the catheter 2 is provided with the above-mentioned stopping device, which is used for axially limiting the artificial valve in the compressed state.
  • the artificial valve support can be effectively limited in the axial direction, and the flow of fluid in the balloon can also be optimized when the balloon is inflated and deflated.
  • the path can effectively improve the effect of fluid flow, help to improve surgical efficiency and reduce surgical risk.
  • the present application is used for the stop device of the artificial valve delivery system and the artificial valve delivery system, wherein, both the first stopper and the second stopper have a stopper with a continuous three-dimensional petal-shaped structure, which can effectively move the artificial valve in the axial direction.
  • both the first stopper and the second stopper have a stopper with a continuous three-dimensional petal-shaped structure, which can effectively move the artificial valve in the axial direction.
  • it also has good radial compressibility, and at the same time, the first concave part and the second concave part can provide an optimized flow path for the fluid, especially as a fluid channel when the balloon is in a contracted state, which helps to improve The effect of balloon expansion and contraction can improve the operation effect of the artificial valve delivery system and reduce the operation risk to a certain extent.
  • the present application provides a stopper for an artificial valve delivery device.
  • the distal region of the artificial valve delivery device includes a balloon 1 for setting the artificial valve and a catheter 2 passing through the balloon.
  • the catheter 2 is arranged at intervals Two stoppers, the two stoppers are located inside the balloon 1 .
  • An artificial valve is accommodated between the two stoppers.
  • the material of the stopper is a polymer material, such as PP, PE, K resin, PTFE, block polyether amide resin (PEBAX) and the like.
  • the stopper includes a sleeve part (such as the first pipe part 41 or the second pipe part 51) and a stopper part (such as the first stopper part 42 or the second stopper part 52), and the stopper is One-piece construction.
  • the sleeve part such as the first tube part 41 or the second tube part 51
  • the stop part such as the first stop part 42 or the second stop part The moving part 52
  • the sleeve part (such as the first tube part 41 or the second tube part 51) is used to be sleeved and fixed on the catheter 2, and one end of the sleeve part (such as the first tube part 41 or the second tube part 51) is coaxially provided with A stopper (such as the first stopper 42 or the second stopper 52).
  • the stopper (such as the first stopper 42 or the second stopper 52) is used to limit the artificial valve, and the stopper (such as the first stopper 42 or the second stopper 52) is sleeved on the catheter
  • the annular structure on 2 is formed by alternate connection of several convex portions (such as the first convex portion 43 or the second convex portion 53) and several concave portions (the first concave portion 44 or the second concave portion 54) along the circumferential direction, and the convex portion 43 (
  • the inner and outer wall surfaces of the first convex portion 43 or the second convex portion 53) protrude radially outward along the stopper portion (such as the first stopper portion 42 or the second stopper portion 52), and the concave portion 44 (or 54 ) inside and outside walls are recessed inward along the radial direction of the stopper (such as the first stopper 42 or the second stopper 52), and the convex part (such as the first convexity 43 or the second convex
  • the recess 44 (or 54) penetrates the stopper 42 (such as the first stopper 42 or the second stopper 52) along the axial direction of the stopper (such as the first stopper 42 or the second stopper 52) .
  • the fluid can pass through several recesses (the first recess 44 or the second recess 54), that is, when the balloon 1 is almost completely wrapped in the stopper (such as the first stopper 42 or the second stopper 42).
  • the circumferential outer edge of the two stoppers 52) is upward, there are still gaps provided by several recesses (first recesses 44 or second recesses 54) between the balloon 1 and the stopper, and these gaps can be used as fluid passages for supplying fluid. Fluid passes through.
  • the artificial valve can be placed between the two stoppers, and the artificial valve can be limited in the axial direction of the catheter.
  • the stopping part has convex parts and concave parts connected alternately along the circumferential direction.
  • the radial dimension of the convex part gradually increases in the direction close to the artificial valve, so that the stopping part presents a continuous three-dimensional petal-like structure, and
  • the concave part can provide a larger deformation space for the convex part in the radial direction, so that the radial compression performance of the stopper part can be improved.
  • the stop part can maintain a stable structure, and its degree of freedom of deformation can be controlled when it is subjected to external force, so that the stop part can ensure its effectiveness and stability in the process of limiting the artificial valve, and also helps to improve Limit accuracy.
  • the recess can optimize the flow path of the fluid in the balloon, especially when the balloon is in a deflated state, it can also provide a flow channel for the fluid, so as to accelerate the flow effect and improve the inflation and contraction effect of the balloon.
  • the stopper (such as the first stopper 42 or the second stopper 52) is an equal-wall thickness structure, that is, the stopper (such as the first stopper 42 or the second stopper 52) Part 52) has equal wall thickness everywhere.
  • the structural strength of the stopping part remains consistent, and this structure leaves a certain reasonable space between the inner wall surface of the stopping part and the outer tube wall of the catheter, which can further optimize and improve its compression performance, so that The deformation effect of the stopper is more reasonable when the stopper is acted by external force, and the assembly of the stopper and the balloon is more convenient.
  • the wall thickness of the stopper (such as the first stopper 42 or the second stopper 52) can gradually increase or decrease gradually in the direction close to the artificial valve, that is, the convex part (
  • the range of variation of the inner and outer walls of the first convex portion 43 or the second convex portion 53) in the above-mentioned direction can be different, the range of variation of the inner and outer walls of the concave portion 44 (the first concave portion 44 or the second concave portion 54) in the above-mentioned direction is also different. Can be different.
  • the wall thickness variation of the stopper portion can be adjusted according to actual needs to obtain corresponding structural strength and deformation freedom.
  • the stop portion (such as the first stop portion 42 or the second stop portion 52) is connected with the sleeve portion (such as the first tube portion 41 or the second tube portion 51) and the size of the end surface of the sleeve portion (such as the first tube portion 51)
  • the radial dimensions of a pipe portion 41 or the second pipe portion 51) are kept consistent, and the stopper portion (such as the first stopper portion 42 or the second stopper portion 52) gradually extends out of the convex portion in the direction away from the sleeve portion (such as the first convex portion 43 or the second convex portion 53) and the concave portion (the first concave portion 44 or the second concave portion 54). Therefore, there will be no redundant sharp structure at the junction of the cannula part and the
  • the radial section of the convex portion (such as the first convex portion 43 or the second convex portion 53) can be in the shape of a semicircle, an arc, an n-type, an inverted V shape, etc.
  • the concave portion (the first concave portion 44 or the second concave portion 54) can be in the shape of a semicircular ring, an arc, a U shape, a V shape, etc.
  • the convex portion (such as the first convex portion 43 or the second convex portion 53) and the concave portion (the first The above-mentioned shapes of the concave portion 44 or the second concave portion 54) can be freely combined.
  • the end surface of the stopper facing the artificial valve is in a wave-like shape that uniformly changes in the circumferential direction, so that the actual contact area between the stopper and the axial end surface of the artificial valve is reasonably controlled, and the artificial valve is prevented from being affected in the radial direction. If the friction force is too large, the artificial valve will unfold more smoothly.
  • the radial section of the recess (the first recess 44 or the second recess 54) is V-shaped, and several recesses (the first recess 44 or the second recess 54) are arranged circumferentially such that A convex portion (such as the first convex portion 43 or the second convex portion 53 ) is formed between two adjacent concave portions (the first concave portion 44 or the second concave portion 54 ).
  • the V shape includes two sides that are angled, and several recesses (the first recess 44 or the second recess 54) are arranged along the circumferential direction, and the two continuous recesses (the first recess 44 or the second recess 54) are connected to each other. Adjacent sides are connected to form a convex portion, so that the convex portion (such as the first convex portion 43 or the second convex portion 53 ) forms an inverted V-shaped structure.
  • the V-shaped included angle of the concave part is larger than the V-shaped included angle of the convex part, so that the accommodating space of the concave part as a fluid channel is larger, and it can also provide a larger deformation space for the convex part when it is compressed and deformed in the radial direction, which is easy to stop.
  • the moving part achieves radial compression.
  • the convex portion (such as the first convex portion 43 or the second convex portion 53) is arc-shaped at the highest point in the radial direction, that is, the convex portion (such as the first convex portion 43 or the second convex portion 53)
  • the circumferential outer edge at the V-shaped angle is a smooth transition shape, which can avoid the sharp structure of the stopper on the circumferential wall surface, so as to reduce the damage to the inner wall of the blood vessel during the delivery process, and reduce the artificial valve delivery as much as possible. risks in the process.
  • the end face of the stopper (such as the first stopper 42 or the second stopper 52) facing the artificial valve, the convex part (such as the first convex part 43 or the second convex part 53) and
  • the radial maximum distance of the axis of the catheter 2 is greater than half of the inner diameter of the artificial valve in a compressed state, and the radial minimum distance between the recess (the first recess 44 or the second recess 54) and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state.
  • the radially highest part of the convex portion exceeds the inner wall of the artificial valve in the compressed state, and the radially lowest portion of the concave portion is lower than the inner wall of the artificial valve in the compressed state, so that the stopper can be in a compressed state for the artificial valve When the axial limit.
  • the end face of the artificial valve is in contact with the end face of the stop part, so as to realize the axial limit of the artificial valve in the compressed state, and also avoid in some cases
  • the minimum radial distance of the recess is greater than half of the outer diameter of the artificial valve under compression, it may cause the end portion of the artificial valve to enter the gap between the stopper and the catheter, affecting the normal release of the artificial valve.
  • the maximum radial distance between the convex portion (such as the first convex portion 43 or the second convex portion 53 ) and the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state. Therefore, on the end surface of the stopper facing the artificial valve, the highest radial part of the protrusion is higher than the outer wall of the artificial valve in the compressed state, which is equivalent to being in a structure similar to an annular groove in the compressed state of the artificial valve. On the one hand, there is enough contact area between the stopper and the artificial valve, so as to ensure the axial limit of the artificial valve; better protection.
  • the end face of the stopper (such as the first stopper 42 or the second stopper 52) facing the artificial valve, the convex part (such as the first convex part 43 or the second convex part 53) and
  • the radial maximum distance of the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state, and the radial minimum distance between the recess (the first recess 44 or the second recess 54) and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state. half.
  • the axial limit of the artificial valve is equivalent to being in a structure similar to an annular groove when the artificial valve is in a compressed state, which can realize the protection of the artificial valve.
  • the minimum radial distance between the concave portion (the first concave portion 44 or the second concave portion 54 ) and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state.
  • the convex portion (such as the first convex portion 43 or the second convex portion 53) and the axis of the catheter 2 is greater than half of the outer diameter of the prosthetic valve in the compressed state
  • the convex portion (such as the first convex portion 43 or the second convex portion
  • the radial maximum distance between the portion 53) and the axis of the catheter 2 is preferably 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state.
  • a radially penetrating dispensing hole (the first dispensing hole 45 or the second dispensing hole 56) is set on the pipe wall of the casing part (such as the first pipe part 41 or the second pipe part 51). ), the dispensing hole (the first dispensing hole 45 or the second dispensing hole 56) at least penetrates the one-sided tube wall of the casing part (such as the first tube part 41 or the second tube part 51), thereby realizing a stop Adhesive fixation of parts and conduits.
  • the axial length of the stopper part (such as the first stopper part 42 or the second stopper part 52) is the axis of the sleeve part (such as the first tube part 41 or the second tube part 51). One-third to one-half of the length. Therefore, by reasonably controlling the axial length ratio of the sleeve part and the stopper part, the stopper can have better performance in terms of structural strength and axial positioning, and the size of the structural part can be kept within a reasonable range Inside.
  • the other end of the casing part (such as the first tube part 41 or the second tube part 51 ) is coaxially connected with an extension part (that is, the third tube part 55 in the first embodiment).
  • the extension part is sleeve-shaped, the extension part is sleeved and fixed on the catheter 2, and the outer diameter of the extension part is smaller than the outer diameter of the sleeve part (such as the first tube part 41 or the second tube part 51).
  • the extension can be used to fix the connecting guide (ie, the conical head 7 in the first embodiment), specifically, the distal end of the balloon 1 is wrapped around the extension.
  • the guide piece and the extension part can be fixedly connected through the end surface or fixedly connected by inserting.
  • the stopper provided near the distal end of the balloon can provide a position-limiting function for the artificial valve and at the same time provide an installation position for the guide and the distal end of the balloon, so that the artificial valve delivery device can be positioned at the distal end of the valve.
  • the structure is more compact and simple, and can also reduce damage to blood vessels.
  • the present application also provides an artificial valve delivery device, including an artificial valve delivery system, as shown in FIG.
  • a proximal stopper ie, the first stopper 4 in the first embodiment
  • a distal stopper ie, the second stopper 5 in the first embodiment
  • the near-end stopper and the far-end stopper are the stoppers described in the above embodiments, and the parts where the two are close to each other are respective stoppers, and the space between the proximal stopper and the far-end stopper A limited space for accommodating the artificial valve in a compressed state is formed.
  • the proximal stopper and the distal stopper can effectively limit the position of the artificial valve in the axial direction, and the recess on the stopper can also optimize the flow of fluid in the balloon when the balloon is inflated and deflated.
  • the flow path especially providing a flow channel for the fluid in the balloon deflation state, has a positive effect on improving the inflation and deflation effects of the balloon.
  • the proximal end of the balloon 1 is affixed to the catheter 2, and the proximal end of the balloon 1 is spaced apart from the proximal end stopper.
  • the tube wall of the catheter 2 is provided with several radially through openings, and the fluid used to inflate the balloon 1 flows into the interior of the balloon 1 through the openings.
  • the opening is provided between the proximal end of the balloon 1 and the proximal stop.
  • the extension part is sleeve-shaped and fixed on the catheter 2
  • the outer tube wall of the extension part is fixedly connected to the distal end of the balloon 1
  • the distal end of the extension part is fixedly connected to the guide.
  • the artificial valve delivery device is also provided with a balloon connecting tube 3, the catheter 2 passes through the balloon connecting tube 3 and enters the inside of the balloon 1, and the proximal end of the balloon 1 is affixed On the balloon connecting tube 3, the proximal end of the balloon 1 is spaced from the proximal stopper. At this time, the distance between the balloon connecting tube 3 and the proximal stopper is also set at intervals.
  • the balloon connecting tube 3 and The catheter 2 forms an annular lumen 8 at the proximal end of the balloon 1 , and the fluid used to inflate the balloon 1 flows into the interior of the balloon 1 through the annular lumen 8 through the space between the balloon connecting tube 3 and the proximal stopper.
  • the fluid flows into the interior of the balloon from the proximal end of the balloon, so that the recess on the proximal stopper can provide a fluid channel for the fluid when the balloon is in a contracted state, so as to achieve better flow effect.

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

L'invention concerne un système de distribution de prothèse valvulaire, un dispositif d'arrêt et un élément d'arrêt s'y rapportant, ainsi qu'un dispositif de distribution de prothèse valvulaire. Le dispositif d'arrêt comprend : un premier élément de blocage (4) qui comprend une première partie de tube (41) et une première partie d'arrêt (42), la première partie de tube (41) étant fixée à un cathéter (2) dans un mode de manchonnage et étant espacée de l'extrémité proximale d'un ballonnet (1), la première partie d'arrêt (42) étant montée sur le cathéter (2) et l'extrémité distale de la première partie d'arrêt (42) étant utilisée pour limiter une prothèse valvulaire ; et un second élément de blocage (5) qui comprend une seconde partie de tube (51) et une seconde partie d'arrêt (52), la seconde partie de tube (51) étant fixée au cathéter (2) dans un mode de manchonnage et étant disposée à proximité de l'extrémité distale du ballonnet (1), la seconde partie d'arrêt (52) étant montée sur le cathéter (2) et l'extrémité proximale de la seconde partie d'arrêt (52) étant utilisée pour limiter la prothèse valvulaire. La prothèse valvulaire peut être axialement limitée et l'effet d'écoulement de fluide dans le ballonnet (1) peut être optimisé, de telle sorte que l'effet de transport de la prothèse valvulaire peut être amélioré et l'efficacité d'assemblage est améliorée.
PCT/CN2022/093957 2021-09-16 2022-05-19 Système de distribution de prothèse valvulaire, dispositif d'arrêt et élément d'arrêt s'y rapportant WO2023040320A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202111088663.XA CN114259322A (zh) 2021-09-16 2021-09-16 人工瓣膜输送系统以及用于其的止动装置
CN202111088663.X 2021-09-16
CN202122253299.X 2021-09-16
CN202122253299.XU CN216535662U (zh) 2021-09-16 2021-09-16 人工瓣膜输送装置的止挡件及人工瓣膜输送装置

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WO2023040320A1 true WO2023040320A1 (fr) 2023-03-23

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CN216535662U (zh) * 2021-09-16 2022-05-17 上海纽脉医疗科技股份有限公司 人工瓣膜输送装置的止挡件及人工瓣膜输送装置
CN216535664U (zh) * 2021-09-18 2022-05-17 上海纽脉医疗科技股份有限公司 用于介入式医疗设备的挡件及介入式医疗设备

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CN103826571A (zh) * 2011-07-27 2014-05-28 爱德华兹生命科学公司 人工心脏瓣膜的传递系统
CN202859386U (zh) * 2012-09-28 2013-04-10 乐普（北京）医疗器械股份有限公司 经导管输送人工心脏瓣膜系统
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CN216535664U (zh) * 2021-09-18 2022-05-17 上海纽脉医疗科技股份有限公司 用于介入式医疗设备的挡件及介入式医疗设备

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