WO2023015601A1 - 一种治疗三尖瓣返流的修复装置 - Google Patents

一种治疗三尖瓣返流的修复装置 Download PDF

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Publication number
WO2023015601A1
WO2023015601A1 PCT/CN2021/113973 CN2021113973W WO2023015601A1 WO 2023015601 A1 WO2023015601 A1 WO 2023015601A1 CN 2021113973 W CN2021113973 W CN 2021113973W WO 2023015601 A1 WO2023015601 A1 WO 2023015601A1
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WO
WIPO (PCT)
Prior art keywords
repair device
membrane
central axis
central shaft
film
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PCT/CN2021/113973
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English (en)
French (fr)
Inventor
陈秀敏
李清
胡柏成
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上海傲流医疗科技有限公司
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Application filed by 上海傲流医疗科技有限公司 filed Critical 上海傲流医疗科技有限公司
Priority to EP21939979.7A priority Critical patent/EP4159162A4/en
Publication of WO2023015601A1 publication Critical patent/WO2023015601A1/zh

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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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • the invention relates to a repair device for treating tricuspid valve regurgitation, which belongs to the technical field of medical instruments.
  • the "upper” mentioned herein refers to the end facing the atrium; the “lower” refers to the end facing the ventricle.
  • TR Tricuspid regurgitation
  • Surgical operation is currently the most important treatment for TR, but this type of operation has the disadvantages of large trauma, many complications, and high mortality. Therefore, based on the limitations of current surgical operations, it is necessary to find a TR treatment method with less trauma, simple operation and fewer complications in this technical field.
  • the purpose of the present invention is to solve the technical problem of how to overcome the deficiencies of the prior art and provide a tricuspid valve repair device with relatively simple manufacturing process, few implants, firm fixation, and effective reduction of tricuspid valve regurgitation.
  • the technical solution adopted by the present invention is to provide a repair device for treating tricuspid valve regurgitation, which is sent to the tricuspid valve leaflet through a delivery system, including a main body stent, a flow blocking membrane and sutures;
  • the main body bracket includes a central shaft and an anchoring component for anchoring the leaflets of the tricuspid valve that is arranged radially around the central shaft; surrounding the outer wall of the central shaft, the outer periphery of the connection between the anchoring component and the central shaft is provided with a blocking flow Membrane, the blocking membrane is connected to the main frame by sutures; the outer wall of the central axis, the anchoring part and the blocking membrane form a semi-closed space around the central axis that is closed at the end near the ventricle and open at the end near the atrium; the central axis The end close to the ventricle is set as a closed end.
  • one end of the anchoring component is fixedly connected to the central shaft, and the other end of the anchoring component is radially spread apart from the central shaft; one end of the anchoring component that is fixedly connected to the central shaft is provided with a hole for passing sutures .
  • the anchoring component includes a plurality of sets of clamp arms, and the clamp arm set includes two clamp arms that can be opened and closed with each other, which are respectively set as an upper clamp arm and a lower clamp arm; the clamp arms are provided with barbs; There is a flow blocking film between the adjacent clamp arm groups and the central axis; the edge of the clamp arm is provided with a hole for threading sutures; the clamp arm is also provided with a pull wire hole for threading the control and release of the corresponding clamp arm .
  • the clip arm includes a fixed connection section that is fixedly connected to the central axis at one end close to the ventricle, and a separation section that extends from the fixed connection section to the atrium side; the fixed connection section, the separation section, and the transition between the fixed connection section and the separation section
  • the edge of the clamp arm is provided with holes for threading sutures.
  • the holes for passing sutures are set as a plurality of circular holes or slotted holes.
  • the main body bracket is set to be formed by integrally cutting and shaping a section of metal pipe, or made of memory metal after laser cutting or wire cutting and heat setting, which has a shape memory function.
  • the flow blocking membrane is made of soft hemostatic material, including animal pericardial biofilm, animal valve, PET coating, PTFE coating, PU coating or polyester fiber woven membrane.
  • the suture is made of nylon or nickel-titanium wire.
  • the flow-blocking membrane is set as a complete continuous integrally formed membrane, including a closed bottom envelope for fitting on the end of the central axis close to the ventricle, and a waist envelope wrapping the outer wall of the central axis close to the end of the ventricle and the branch choke film between adjacent clip arm groups; or a transitional choke film is also provided between the waist envelope and the branch choke film.
  • the flow blocking membrane is provided with a plurality of diaphragms, and the plurality of diaphragms are respectively sutured and connected to the main body bracket by sutures.
  • the present invention has the following beneficial effects:
  • the device of the present invention only has a flow-blocking membrane and a main body stent, and has few implants, which can reduce related side effects caused by the device; the flow-blocking part is firmly located in the center of the tricuspid valve orifice after being connected with the anchoring part, which can effectively reduce the tricuspid valve. Regurgitation in the center of the cusp; the blocking membrane can be flexibly sutured with the main frame, and the two are tightly combined to achieve a better blocking effect.
  • the device of the present invention has excellent elastic properties, and the device is convenient to shrink and recover, which simplifies the actual operation process.
  • Fig. 1 is a schematic diagram of a repair device for treating tricuspid regurgitation according to the present invention
  • Fig. 2 is a schematic diagram of the structure of the flow blocking membrane in the present invention.
  • Fig. 3 is a schematic diagram of the blocking membrane structure-suture mode in the present invention.
  • Fig. 4 is a schematic diagram of the second structure of the flow barrier film in the present invention.
  • Fig. 5 is a schematic diagram of the second suture mode of the flow blocking membrane structure in the present invention.
  • Fig. 6 is a schematic diagram of the third structure of the flow barrier film in the present invention.
  • Fig. 7 is a schematic diagram of the structure of the main body bracket with a long slot hole in the present invention.
  • Fig. 8 is a schematic diagram of the first configuration of a repair device for treating tricuspid regurgitation according to the present invention.
  • Fig. 9 is a schematic diagram of the structure of the lower clamp arm released by a repair device for treating tricuspid regurgitation according to the present invention.
  • Fig. 10 is a schematic diagram of the structure of a repair device for treating tricuspid regurgitation according to the present invention when the lower clamp arm captures and fixes the valve leaflet;
  • Fig. 11 is a schematic diagram of the repair device and valve leaflet structure after anchoring of a repair device for treating tricuspid regurgitation according to the present invention
  • Fig. 12 is an effect diagram after implantation of a repair device for treating tricuspid regurgitation according to the present invention.
  • Blocking film 21. Bottom envelope; 22. Waist film; 23. Branch blocking film; 24. Tapered blocking film; 25. Blocking film branches; 3. Sutures; 4 . Central axis; 5. Pull wire; 6. Heart; 61. Tricuspid valve leaflet; 7. Tricuspid valve repair device.
  • the present invention provides a repair device for treating tricuspid regurgitation, which is sent to the tricuspid valve leaflet 61 through a delivery system, including a main body stent 1, a flow blocking membrane 2 and a suture 3;
  • the main body stent 1 includes a central shaft 4 and an anchoring component 11 arranged radially around the central shaft 4 for anchoring the leaflets of the tricuspid valve 61; surrounding the connection between the anchoring component 11 and the central shaft 4 on the outer wall of the central shaft 4
  • the anchoring part 11 includes multiple sets of clamping arm groups, the clamping arm set includes two clamping arms that can be opened and closed with each other, which are respectively set as an upper clamping arm 112 and a lower clamping arm 111; the upper clamping arm is provided with a barb 1121; A blocking film 2 is provided between the adjacent clamp arm group and the central axis 4; the edge of the clamp arm is provided with a hole for threading the suture 3; the clamp arm is also provided with a pull wire for threading control and releasing the corresponding clamp arm 5 pull holes.
  • the clamping arm comprises a fixed connection section fixedly connected to the central axis 4 at one end near the ventricle and a separation section extending from the fixed connection section to the atrium side; Holes for threading sutures 3 are provided on the edge.
  • the holes for passing the suture 3 are set as a plurality of circular holes or slotted holes 16 .
  • the main body bracket 1 is formed by integral cutting and shaping of a section of metal tube, or is made of memory metal after laser cutting or wire cutting and heat setting, which has a shape memory function.
  • the blocking membrane 2 is made of soft hemostatic material, including animal pericardial biofilm, animal valve, PET coating, PTFE coating, PU coating, or polyester fiber woven membrane.
  • the material of the suture 3 includes nylon or nickel-titanium wire and the like.
  • the flow blocking membrane 2 is set as a complete and continuous integrally formed membrane, including a closed bottom envelope 21 for fitting on the end of the central axis 4 close to the ventricle, and a waist envelope 22 wrapping the outer wall of the central axis 4 close to the end of the ventricle and the branch choke film 23 between adjacent clip arm groups; or a transitional choke film is also provided between the waist envelope 22 and the branch choke film 23 .
  • the flow blocking membrane 2 is provided with a plurality of diaphragms, and the plurality of diaphragms are respectively sutured and connected to the main body bracket 1 by sutures 3 .
  • the present invention provides a tricuspid valve repair device 7 , which includes a main frame 1 , a flow blocking membrane 2 and a suture 3 connecting the two parts.
  • the main body stent 1 is formed by integral cutting and shaping of a section of metal tube;
  • the flow blocking membrane 2 is made of soft hemostatic material, which can be animal pericardial biofilm, animal valve, PET coating, PTFE coating, PU coating, polyester fiber or Other woven membranes.
  • the gap at the center of the main body stent 1 and the roots of the branches should be completely covered by the choke membrane 2, and after the branches of the main stent 1 are captured and fixed to the corresponding valves, the choke membrane 2 is located in the center between the leaflets to fill the valve leaflets.
  • the space between them achieves the purpose of blocking flow.
  • the flow blocking film 2 passes through the circular hole or the slotted hole ( As shown in Figure 7, the slotted hole 16) is fixed.
  • the blocking membrane 2 can completely cover the central part of the main body stent 1 and the root of the anchoring component 11, so as to repair the regurgitated valve.
  • the flow blocking membrane 2 is fixed to the main frame 1 by suturing, and the material of the suture 3 used can be nylon, braided thread or nickel-titanium wire.
  • the flow blocking membrane 2 can be formed by cutting and sewing a whole piece of membrane, or can be formed by sewing multiple pieces of membrane.
  • the flow blocking film 2 is inserted from the lower part of the main body bracket 1, and the flow blocking film 2 is connected with the reserved holes or grooves on the main body support 1 by sutures 3.
  • the main body bracket 1 part includes 2-3 anchoring parts 11 .
  • the upper and lower clamping arms of the anchoring component 11 are cut from the same metal tube.
  • the anchoring parts 11 are radially opened, and the opening angle between the anchoring parts 11 can be adjusted according to the time usage, such as 90°, 120°, 180° and so on.
  • the upper clamping arm 112 and the lower clamping arm 111 of the anchoring component 11 are heat-set to form an intersecting angle to increase the firmness of the clamped valve.
  • There are pull wire holes on the upper clamp arm 112 and the lower clamp arm 111 and the corresponding clamp arms are controlled and released by the stay wire 5 passing through the pull wire holes, and the corresponding valves are caught and fixed.
  • the present invention provides a tricuspid valve repair device with simple structure and capable of effectively reducing valve regurgitation.
  • the "upper” mentioned herein refers to the end facing the atrium after the tricuspid valve repair device is implanted in the body; the “lower” mentioned refers to the end facing the ventricle.
  • a tricuspid valve repair device 7 includes a main frame 1 , a flow blocking membrane 2 , a central shaft 4 , a suture 3 and a pull wire 5 .
  • the main body stent 1 is cut and shaped by a section of metal tube as a whole;
  • the flow blocking membrane 2 is made of soft hemostatic material, which can be animal pericardial biofilm, animal valve, PET coating, PTFE coating, PU coating, polyester fiber or other braided materials. membrane.
  • One end of the pull wire 5 is fixed on the clamp arm of the anchoring component 11, and the other end passes through the reserved hole of the central shaft 4 and is controlled by the corresponding component through the delivery system.
  • the clip arm can be controlled to capture and fix the corresponding valve through the recovery and release of the pull wire 5 .
  • the center of the main body stent 1 and the gaps at the roots of the branches should be completely covered by the blocking membrane 2, and after the branches of the main body stent 1 are captured and fixed to the corresponding valves, the blocking membrane 2 is located at the center between the valve leaflets to fill the valve.
  • the space between the leaves realizes the purpose of blocking flow.
  • the repair device includes a main body bracket 1 and a flow blocking membrane 2.
  • the main body bracket 1 includes an anchoring part 11, an upper end hole 13, a middle end hole 14, and a lower end hole 15.
  • the main body bracket 1 is composed of a nickel-titanium tube as a whole Cutting
  • the anchoring part 11 is composed of an upper clamping arm 112 and a lower clamping arm 111
  • each bracket has three anchoring parts 11, and the anchoring parts 11 are evenly distributed.
  • the central shaft 4 is located inside the main body support 1, and a hole is reserved on the shaft to allow the stay wire 5 to pass through.
  • One end of the pull wire 5 is fixed on the clip arm of the anchoring component 11 .
  • the valve leaflet is captured by pulling the upper and lower clamp arms by controlling the pull wire 5, and fixed on the valve by the natural state shaped by the upper and lower clamp arms to achieve the purpose of repair.
  • the blocking membrane 2 can be animal pericardial biofilm, animal valve, PET coating, PTFE coating, PU coating, polyester fiber or other woven membranes, and is fixed to the main body through the upper hole 13, the middle hole 14, and the lower hole 15 on bracket 1. Within the range covered by the flow blocking membrane 2 , regurgitation in the gap between the tricuspid valve leaflets 61 can be blocked.
  • the choke film 2 is composed of three parts: a bottom envelope 21 , a waist envelope 22 , and a branch choke membrane 23 .
  • the branch flow blocking films are 23 and are three pieces, and the size thereof can be determined according to the gap between the anchoring parts 11 of the main body bracket 1 .
  • the bottom envelope 21 , the waist envelope 22 and the branch blocking membrane 23 can be cut from the same material. In this way, the choke film assembly process is simple, and the overall choke performance is better.
  • the bottom coating 21 and the waist coating 22 can be made of materials with higher strength and better adhesion (such as metal braided mesh, PTFE, etc.), and the branch flow blocking film 23 can be selected to block flow.
  • Biomaterials with better performance or polymer materials such as PET; two different types of materials are assembled into the expected shape by sewing.
  • FIG. 3 it is a schematic diagram of the sewing method of the flow blocking membrane 2 and the main body bracket 1 in FIG. 2 .
  • the flow blocking film 2 is inserted from the lower end of the main body support 1 to completely cover the central part of the main body support 1 .
  • the edge of the flow blocking membrane 2 and the main body bracket 1 are sewn together by suture thread 3 .
  • the suture thread 3 passes through the upper end hole 13 on the main body bracket 1 , and the middle end hole 14 and the lower end hole 15 are sutured with the edge of the flow blocking membrane 2 .
  • the size of the flow blocking film 2 can be adjusted according to the main frame 1, so that the two can be fully fitted to achieve a better flow blocking effect.
  • the choke film branch 25 is another optional choke film structure.
  • the upper end of the choke film branch 25 is in the shape of an inverted triangle, and there is a rectangular protruding section below. In the actual assembly process, three choke film branches 25 need to be assembled together.
  • the choke membrane structure can reduce splicing between different choke membranes, and can be sewn with the main body bracket 1 . The damage and damage to the choke film are reduced, and the manufacturing process is simplified.
  • FIG. 5 it is a schematic diagram of suturing the choke film branch 25 and the main body bracket 1 in FIG. 4 .
  • the choke film branches 25 mainly cover the gaps between adjacent anchoring components 11 .
  • the edge of the flow blocking membrane 2 and the main body bracket 1 are sewn together by suture thread 3 .
  • the suture thread 3 passes through the upper end hole 13 on the main body bracket 1, and the middle end hole 14 and the lower end hole 15 are sutured to the edges on both sides of the inverted triangle of the choke membrane.
  • FIG 6 it is another optional choke film structure, which adds a section of tapered choke film 24 to the choke film structure of Figure 2, and the tapered section is anchored to the main body bracket 1.
  • the arc shape of the root of the part 11 matches, and when the flow blocking film 2 and the main body bracket 1 are sewn together, the tapered flow blocking film 24 can make the film and the support at this position more fit, and the flow blocking effect is better.
  • FIG. 7 it is a main body bracket 1 with a slotted hole 16 .
  • the long slot hole 16 for assembling with the flow blocking film 2 can reduce the restriction on the number of suture needles of the suture thread 3 during assembly.
  • a tighter sewing stitch can be used to assemble and sew the flow blocking membrane 2 and the main body bracket 1 together.
  • FIG. 8 it is the first shape structure of the tricuspid valve repair device 7 of the present invention during delivery; and the second shape structure (as shown in FIG. 1 ) in which the delivery system is released and deployed naturally.
  • the first form is a form in which the tricuspid valve repair device 7 is compressed into a strip and loaded into the delivery sheath.
  • the flexible flow blocking film 2 can be folded and recovered, and the upper clamping arm 112 and the lower clamping arm 111 are folded toward the direction of the central axis 4 to be received into the conveying system.
  • the second form is the form in which the tricuspid valve repair device 7 releases the delivery system to expand naturally.
  • the three pairs of upper and lower clamping arms are radially deployed on the outer periphery of the central axis 4, and the flow blocking membrane 2 can connect the left and right adjacent upper and lower arms.
  • the gap between the jaw sets is filled.
  • the tricuspid valve repair device 7 can be clamped and fixed step by step. Firstly, the device is sent to the expected position (right ventricle) by the delivery system, and one of the lower clamping arms 111 is first released through the driving part on the delivery system. Then, the position of the device in the heart 6 is adjusted through the control components on the delivery system, so that the target valve is placed on the lower clamping arm 111 . Release the upper clamping arm 112 to the natural state, and the barbs 1121 on the opened upper clamping arm 112 will hook the corresponding valve to prevent it from slipping from between the upper and lower clamping arms, (as shown in Figure 10 ).
  • the tricuspid valve repair device 7 can be implanted into the position of the tricuspid valve leaflet 61 through the delivery system through the thoracic or femoral artery (the delivery system is not shown), (as shown in Figure 12), and the repair device is sent into the right heart through the delivery system.
  • the location of the tricuspid valve the material and structure of the flow blocking membrane 2 can be selected to have good biocompatibility and promote endothelialization, so as to accelerate the endothelialization of postoperative valve leaflets and repair devices, and improve the safety of the device.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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)
  • Surgical Instruments (AREA)

Abstract

一种治疗三尖瓣返流的修复装置（7），属于医疗器械技术领域。包括主体支架（1）、阻流膜（2）和缝合线（3）；主体支架（1）包括中心轴（4）和设于中心轴（4）周边呈放射状张开的用于锚定三尖瓣瓣叶（61）的锚定部件（11）；锚定部件（11）与中心轴（4）连接处的外周设有阻流膜（2），阻流膜（2）通过缝合线（3）与主体支架（1）连接；中心轴外侧壁、锚定部件（11）和阻流膜（2）之间形成一环绕中心轴的靠近心室一端封闭的，靠近心房一端开口的半封闭空间；中心轴靠近心室的一端设为封闭端。所述装置仅有阻流膜（2）和主体支架（1），植入物少，可减少由器械引发的相关副作用；阻流部件通过与锚定部件（11）连接后稳固位于三尖瓣口的中央，能有效的减少三尖瓣口中央的返流；阻流膜（2）可以灵活地与主体支架（1）缝合，两者紧密结合以达到更好的阻流效果。

Description

一种治疗三尖瓣返流的修复装置 技术领域
本发明涉及一种治疗三尖瓣返流的修复装置，属于医疗器械技术领域。本文所述的“上”，是指朝向心房的一端；所述的“下”，是指朝向心室的一端。
背景技术
三尖瓣返流(TR)是常见的心脏疾病。严重的TR会导致心排量的下降以及体循环淤血，是很多心脏疾病预后不良的信号，与患者预后密切相关。外科手术是目前TR最主要的治疗手段，但此类手术具有创伤大、并发症多、死亡率高等缺陷。因此，基于目前外科手术的局限性，在本技术领域寻找一种创伤小、操作简便、并发症少的TR治疗方法十分必要。
随着生物医用材料的进步和医学影像学的发展，近10年来经导管瓣膜置换和修复治疗取得突破性进展，成为介入心脏病学的热点。目前较成熟的三尖瓣介入修复方式是采用缘对缘修复技术，以雅培公司MitraClip(PCT/USA2009/068023)和爱德华PASCAL(US2019/0321166A1)为典型的代表。然而，三尖瓣返流多来源于三个瓣叶中央的区域，缘对缘修复只能夹合瓣叶靠外周区域，效果比较有限，且经常要植入多个夹子。目前已有一些针对三尖瓣中央区域返流区的设计，但这些设计均有一些缺陷，使得未能真正应用于临床。关于二尖瓣和三尖瓣的修复器械，已经有多个专利涉及相关的内容。在以往的设计和产品中，均需要复杂的结构和零部件来实现缘对缘瓣膜修复。复杂的设计将增加器械加工制作工艺的难度，对手术操作者也提出了更高的要求，也引入了更多的风险点。所以，本技术领域亟需一种制造工艺相对简单，操作简单，安全可靠，治疗效果优异的治疗三尖瓣返流的修复装置。
发明内容
本发明的目的是为解决如何克服现有技术的不足，提供一种制造工艺相对简单，植入物少、固定牢靠、能有效减少三尖瓣返流的三尖瓣修复装置的技术问题。
为达到解决上述问题的目的，本发明所采取的技术方案是提供一种治疗三尖瓣返流的修复装置，通过输送系统送至三尖瓣叶，包括主体支架、阻流膜和缝合线；主体支架包括中心轴和设于中心轴周边呈放射状张开的用于锚定三尖瓣瓣叶的锚定部件；环绕中心轴外侧壁上锚定部件与中心轴连接处的外周设有阻流膜，阻流膜通过缝合线与主体支架连接；中心轴外侧壁、锚定部件和阻流膜之间形成一环绕中心轴的靠近心室一端封闭的，靠近心房一端开口的半封闭空间；中心轴靠近心室的一端设为封闭端。
优选地，所述锚定部件的一端与中心轴固定连接，锚定部件的另一端呈放射状张开与中心轴分离；锚定部件与中心轴固定连接的一端设有用于穿设缝合线的孔。
优选地，所述锚定部件包括多组夹臂组，夹臂组包括相互之间可开合的两个夹臂，分别设为上夹臂和下夹臂；夹臂上设有倒刺；相邻夹臂组与中心轴之间设有阻流膜；夹臂的边缘设有用于穿设缝合线的孔；夹臂上还设有用于穿设控制和释放相应夹臂的拉线的拉线孔。
优选地，所述夹臂包括靠近心室的一端与中心轴固定连接的固定连接段和固定连接段向心房一侧延伸的分离段；固定连接段、分离段以及固定连接段和分离段之间过渡的夹臂的边缘上设有用于穿设缝合线的孔。
优选地，所述用于穿设缝合线的孔设为多个圆孔或长槽孔。
优选地，所述主体支架设为由一段金属管整体切割定型而成，或由记忆金属经过激光切割或线切割后热定型制成，具有形态记忆功能。
优选地，所述阻流膜设为由软性阻血材料制造，包括动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜或聚酯纤维编织膜。
优选地，所述缝合线的材质包括尼龙或者镍钛丝。
优选地，所述阻流膜设为一完整的连续的一体成型膜，包括封闭的用于套装在中心轴靠近心室一端端部的底部包膜、包裹中心轴靠近心室一端外侧壁的腰部包膜和相邻夹臂组之间的分支阻流膜；或者腰部包膜和分支阻流膜之间还设有过渡的阻流膜。
优选地，所述阻流膜设有多个膜片，多个膜片分别通过缝合线与主体支架缝合连接。
相比现有技术，本发明具有如下有益效果：
本发明装置仅有阻流膜和主体支架，植入物少，可减少由器械引发的相关副作用；阻流部件通过与锚定部件连接后稳固位于三尖瓣口的中央，能有效的减少三尖瓣口中央的返流；阻流膜可以灵活地与主体支架缝合，两者紧密结合以达到阻流效果更好。此外，本发明装置具有优异的弹性性能，装置方便收缩和回收，简化了实际的手术操作过程。
附图说明
图1为本发明一种治疗三尖瓣返流的修复装置示意图；
图2为本发明中阻流膜结构一示意图；
图3为本发明中阻流膜结构一缝合方式示意图；
图4为本发明中阻流膜结构二示意图；
图5为本发明中阻流膜结构二缝合方式示意图；
图6为本发明中阻流膜结构三示意图；
图7为本发明中具有长槽型孔的主体支架结构示意图；
图8为本发明一种治疗三尖瓣返流的修复装置第一形态结构示意图；
图9为本发明一种治疗三尖瓣返流的修复装置释放下夹臂结构示意图；
图10为本发明一种治疗三尖瓣返流的修复装置下夹臂捕捉并固定瓣叶时的结构示意图；
图11为本发明一种治疗三尖瓣返流的修复装置锚定后的修复装置及瓣叶结构示意图；
图12为本发明一种治疗三尖瓣返流的修复装置植入后效果图。
附图标记：1.主体支架；11.锚定部件；111.下夹臂；112.上夹臂；1121.倒刺；13.上端孔；14.中端孔；15.下端孔；16.长槽孔；2.阻流膜；21.底部包膜；22.腰部包膜；23.分支阻流膜；24.锥形阻流膜；25.阻流膜分支；3.缝合线；4.中心轴；5.拉线；6.心脏；61.三尖瓣叶；7.三尖瓣修复装置。
具体实施方式
为使本发明更明显易懂，兹以优选实施例，并配合附图作详细说明如下：
如图1-12所示，本发明提供一种治疗三尖瓣返流的修复装置，通过输送系统送至三尖瓣叶61，包括主体支架1、阻流膜2和缝合线3；主体支架1包括中心轴4和设于中心轴4周边呈放射状张开的用于锚定三尖瓣61瓣叶的锚定部件11；环绕中心轴4外侧壁上锚定部件11与中心轴4连接处的外周设有阻流膜2，阻流膜2通过缝合线3与主体支架1连接；中心轴4外侧壁、锚定部件11和阻流膜2之间形成一环绕中心轴4的靠近心室一端封闭的，靠近心房一端开口的半封闭空间；中心轴4靠近心室的一端设为封闭端。锚定部件11的一端与中心轴4固定连接，锚定部件11的另一端呈放射状张开与中心轴4分离；锚定部件11与中心轴4固定连接的一端设有用于穿设缝合线的孔。锚定部件11包括多组夹臂组，夹臂组包括相互之间可开合的两个夹臂，分别设为上夹臂112和下夹臂111；上夹臂上设有倒刺1121；相邻夹臂组与中心轴4之间设有阻流膜2；夹臂的边缘设有用于穿设缝合线3的孔；夹臂上还设有用于穿设控制和释放相应夹臂的拉线5的拉线孔。夹臂包括靠近心室的一端与中心轴4固定连接的固定连接段和固定连接段向心房一侧延伸的分离段；固定连接段、分离段以及固定连接段和分离段之间过渡的夹臂的边缘上设有用于穿设缝合线3的孔。用于穿设缝合线3的孔设为多个圆孔或长槽孔16。主体支架1设为由一段金属管整体切割定型而成，或由记忆金属经过激光切割或线切割后热定型制成，具有形态记忆功能。阻流膜2设为由软性阻血材料制造，包括动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜、或聚酯纤维编织膜等。缝合线3的材质包括尼龙或者镍钛丝等。阻流膜2设为一完整的连续的一体成型膜，包括封闭的用于套装在中心轴4靠近心室一端端部的底部包膜21、包裹中心轴4靠近心室一端外侧壁的腰部包膜22和相邻夹臂组之间的分支阻流膜23；或者腰部包膜22和分支阻流膜23之间还设有过渡的阻流膜。阻流膜2设有多个膜片，多个膜片分别通过缝合线3与主体支架1缝合连接。
如图1-12所示，本发明提供一种三尖瓣修复装置7，包括主体支架1、阻流膜2以及将两部分连接的缝合线3。主体支架1由一段金属管整体切割定型而成；阻流膜2为软性阻血材料构成，可以为动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜、聚酯纤维或其他编织膜。主体支架1中心以及分支的根部的空隙应完全被阻流膜2覆盖，并在主体支架1的分支捕捉固定到相应的瓣膜 后，阻流膜2位于瓣叶之间的中心位置，填补瓣叶间的空间，实现阻流的目的。阻流膜2通过主体支架1上的锚定部件11的边缘折弯处(如图1所示中，上端孔13，下端孔15和中端孔14的位置)的圆孔或长槽孔(如图7所示中，长槽孔16)固定。阻流膜2能够将主体支架1的中心部分以及锚定部件11的根部完整覆盖，从而对返流的瓣膜进行修复。阻流膜2通过缝合的方式与主体支架1固定，所用的缝合线3的材质可以为尼龙，编织线或者镍钛丝。阻流膜2可以通过一整片膜切割缝合而成，也可以通过多片膜缝合组成。阻流膜2从主体支架1的下部套入，通过缝合线3将阻流膜2与主体支架1上预留的孔或槽通过缝合连接。实现器械阻流的目的。主体支架1部分包含2-3个锚定部件11。锚定部件11的上下夹臂由同一根金属管切割而成。锚定部件11呈放射状张开，锚定部件11之间的张开角度可以根据时间使用情况进行调整，如90°，120°，180°等。锚定部件11的上夹臂112和下夹臂111通过热定型的方式定型为相互交叉的角度，增加夹持瓣膜的牢固性。在上夹臂112和下夹臂111上有拉线孔，通过穿入拉线孔的拉线5来控制和释放对应的夹臂，捕捉和固定相应的瓣膜。
实施例
为了克服现有技术的不足，本发明提供了一种结构简单且能够有效减少瓣膜返流的三尖瓣修复装置。本文所述的“上”，是指三尖瓣修复装置植入到体内后，朝向心房的一端；所述的“下”，是指朝向心室的一端。
一种三尖瓣修复装置7，包括主体支架1、阻流膜2、中心轴4、缝合线3和拉线5组成。主体支架1由一段金属管整体切割定型；阻流膜2为软性阻血材料构成，可以为动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜、聚酯纤维或其他编织膜。拉线5一端固定于锚定部件11的夹臂上，另外一端穿过中心轴4预留的孔内并通过输送系统由对应的部件控制。可以通过拉线5的回收和释放来控制夹臂捕捉和固定对应的瓣膜。主体支架1的中心以及分支的根部的空隙应完全被阻流膜2覆盖，并在主体支架1的分支捕捉固定到相应的瓣膜后，阻流膜2位于瓣叶之间的中心位置，填补瓣叶间的空间，实现阻流的目的。
如图1所示，修复装置包括主体支架1和阻流膜2.主体支架1包括锚定部件11、上端孔13、中端孔14、下端孔15，主体支架1由一根镍钛管整体切割而成，锚定部件11是由上夹臂112和下夹臂111组合而成，每个支架分别有三个锚定 部件11，锚定部件11均匀分布。中心轴4位于主体支架1的内部，轴上预留了孔可以通过拉线5。拉线5的一端固定在锚定部件11的夹臂上。实际操作中，通过控制拉线5拉动上下夹臂来捕捉瓣叶，并由上下夹臂定型出的自然状态将其固定在瓣膜上以达到修复目的。阻流膜2可以为动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜、聚酯纤维或其他编织膜，通过上端孔13、中端孔14、下端孔15固定在主体支架1上。在阻流膜2覆盖的范围内，可以阻挡三尖瓣叶61之间间隙的返流。
如图2所示，为一种阻流膜结构，在该结构中，阻流膜2由底部包膜21，腰部包膜22，分支阻流膜23三部分组成。其中分支阻流膜为23为三片，其尺寸可以根据主体支架1的锚定部件11的间隙来确定。可选地，底部包膜21、腰部包膜22以及分支阻流膜23可以采用同种材质裁剪而成。该方式阻流膜组装工艺简单，整体阻流性能更好。在其他的实施例中，底部包膜21、腰部包膜22可以选择强度更高，贴合性能更好的材料(如金属编织网，PTFE等材料)，而分支阻流膜23可以选择阻流性能更好的生物材料或者PET等高分子材料；两种不同类别的材料通过缝合的方式组装成预期的形状。
如图3所示，为图2中的阻流膜2与主体支架1的缝合方式示意图。阻流膜2从主体支架1的下端套入，将主体支架1的中心部分完全覆盖。通过缝合线3将阻流膜2的边缘和主体支架1缝合在一起。缝合线3穿过主体支架1上的上端孔13，中端孔14和下端孔15与阻流膜2的边缘缝合。其中阻流膜2的尺寸可以根据主体支架1进行调整，使二者完全贴合来达到更好的阻流效果。
如图4所示，为另外一种可选的阻流膜结构。阻流膜分支25上端呈倒三角形，下面有矩形的伸出段。在实际组装过程中，需要三片阻流膜分支25配合组装。该阻流膜结构可以减少不同阻流膜片之间的拼接，并且能够与主体支架1缝合。减少对阻流膜的破坏和损伤，简化制作工艺。
如图5所示，为图4中的阻流膜分支25与主体支架1缝合示意图。在该设计中，主体支架1的中心部分可以通过机械结构或者其他方式封堵起来。阻流膜分支25主要覆盖在相邻的锚定部件11的间隙上。通过缝合线3将阻流膜2的边缘和主体支架1缝合在一起。具体地，缝合线3穿过主体支架1上的上端孔13，中端孔14和下端孔15与阻流膜的倒三角的两侧的边缘缝合。
如图6所示，为另外一种可选的阻流膜结构，该结构在图2的阻流膜结构中增加了一段锥形阻流膜24，该锥形段与主体支架1的锚定部件11的根部的弧形相匹配，阻流膜2和主体支架1缝合时，锥形阻流膜24可以使该位置的膜和支架更加贴合，阻流效果更好。
如图7所示，为有长槽孔16的主体支架1。与阻流膜2装配用的长槽孔16可以在组装时，减少对缝合线3的缝合针数的限制。可以采用更加紧密的缝合针脚，将阻流膜2与主体支架1组装缝合在一起。
如图8所示，为本发明三尖瓣修复装置7在输送时具有的第一形态结构；以及释放出输送系统自然展开的第二形态结构(如图1所示)。第一形态为三尖瓣修复装置7被压迫成条形装入输送鞘管的形态。柔性的阻流膜2可以折叠回收，上夹臂112、下夹臂111折向中心轴4的方向而被收入输送系统。所述的第二形态为三尖瓣修复装置7释放出输送系统自然展开的形态，此时三对上下夹臂在中心轴4的外周呈放射状展开，阻流膜2可以将左右相邻的上下夹臂组之间的空隙填满。
如图9所示，为在植入过程中，三尖瓣修复装置7可以实现分步夹持和固定。首先将装置由输送系统送入至预期位置(右心室)，通过输送系统上的驱动部件先将其中一个下夹臂111释放出来。然后通过输送系统上面的控制部件调整装置在心脏6内的位置，使目标瓣膜搭在下夹臂111上。释放上夹臂112至自然状态，张开的上夹臂112上的倒刺1121会勾住对应的瓣膜，防止其从上下夹臂之间滑脱，(如图10所示)。由于下夹臂为一体连接，且经过定型处理，自然状态的上下夹臂会夹紧对应的瓣叶，在心脏跳动时也能有效将装置锚定在三尖瓣的瓣叶中心，如图11所示。
三尖瓣修复装置7可以经胸或者经股动脉通过输送系统植入三尖瓣叶61的位置(输送系统未示出)，(如图12所示)，修复装置通过输送系统送入右心三尖瓣的位置。在该实施例中，阻流膜2可以选择生物相容性良好和促进内皮化的材质和结构，加速术后瓣叶和修复装置的内皮化，提高器械的安全性。
以上所述，仅为本发明的较佳实施例，并非对本发明任何形式上和实质上的限制，应当指出，对于本技术领域的普通技术人员，在不脱离本发明的前提下，还将可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。凡 熟悉本专业的技术人员，在不脱离本发明的精神和范围的情况下，当可利用以上所揭示的技术内容而做出的些许更动、修饰与演变的等同变化，均为本发明的等效实施例；同时，凡依据本发明的实质技术对上述实施例所作的任何等同变化的更动、修饰与演变，均仍属于本发明的技术方案的范围内。

Claims (10)

  1. 一种治疗三尖瓣返流的修复装置，通过输送系统送至三尖瓣叶，其特征在于：包括主体支架、阻流膜和缝合线；主体支架包括中心轴和设于中心轴周边呈放射状张开的用于锚定三尖瓣瓣叶的锚定部件；环绕中心轴外侧壁上锚定部件与中心轴连接处的外周设有阻流膜，阻流膜通过缝合线与主体支架连接；中心轴外侧壁、锚定部件和阻流膜之间形成一环绕中心轴的靠近心室一端封闭的，靠近心房一端开口的半封闭空间；中心轴靠近心室的一端设为封闭端。
  2. 如权利要求1所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述锚定部件的一端与中心轴固定连接，锚定部件的另一端呈放射状张开与中心轴分离；锚定部件与中心轴固定连接的一端设有用于穿设缝合线的孔。
  3. 如权利要求2所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述锚定部件包括多组夹臂组，夹臂组包括相互之间可开合的两个夹臂，分别设为上夹臂和下夹臂；夹臂上设有倒刺；相邻夹臂组与中心轴之间设有阻流膜；夹臂的边缘设有用于穿设缝合线的孔；夹臂上还设有用于穿设控制和释放相应夹臂的拉线的拉线孔。
  4. 如权利要求3所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述夹臂包括靠近心室的一端与中心轴固定连接的固定连接段和固定连接段向心房一侧延伸的分离段；固定连接段、分离段以及固定连接段和分离段之间过渡的夹臂的边缘上设有用于穿设缝合线的孔。
  5. 如权利要求4所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述用于穿设缝合线的孔设为多个圆孔或长槽孔。
  6. 如权利要求5所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述主体支架设为由一段金属管整体切割定型而成，或由记忆金属经过激光切割或线切割后热定型制成，具有形态记忆功能。
  7. 如权利要求6所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述阻流膜设为由软性阻血材料制造，包括动物心包生物膜、动物瓣膜、PET覆膜、PTFE覆膜、PU覆膜或聚酯纤维编织膜。
  8. 如权利要求7所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述缝合线的材质包括尼龙或者镍钛丝。
  9. 如权利要求8所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述阻流膜设为一完整的连续的一体成型膜，包括封闭的用于套装在中心轴靠近心室一端端部的底部包膜、包裹中心轴靠近心室一端外侧壁的腰部包膜和相邻夹臂组之间的分支阻流膜；或者腰部包膜和分支阻流膜之间还设有过渡的阻流膜。
  10. 如权利要求8所述的一种治疗三尖瓣返流的修复装置，其特征在于：所述阻流膜设有多个膜片，多个膜片分别通过缝合线与主体支架缝合连接。
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