WO2021121214A1 - 植入器械可控导引装置 - Google Patents

植入器械可控导引装置 Download PDF

Info

Publication number
WO2021121214A1
WO2021121214A1 PCT/CN2020/136450 CN2020136450W WO2021121214A1 WO 2021121214 A1 WO2021121214 A1 WO 2021121214A1 CN 2020136450 W CN2020136450 W CN 2020136450W WO 2021121214 A1 WO2021121214 A1 WO 2021121214A1
Authority
WO
WIPO (PCT)
Prior art keywords
guiding
distal end
guide
catheter
wire
Prior art date
Application number
PCT/CN2020/136450
Other languages
English (en)
French (fr)
Inventor
吕世文
陈志�
徐进
Original Assignee
宁波健世生物科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 宁波健世生物科技有限公司 filed Critical 宁波健世生物科技有限公司
Priority to EP20904036.9A priority Critical patent/EP4079260A4/en
Priority to CA3163706A priority patent/CA3163706A1/en
Priority to US17/786,311 priority patent/US20230024606A1/en
Publication of WO2021121214A1 publication Critical patent/WO2021121214A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015—Details of the distal fixation of the movable mechanical means

Definitions

  • This application relates to a medical device, and in particular to a controllable guiding device for an implanted device.
  • Minimally invasive transcatheter treatment of cardiovascular diseases has gradually become the main treatment method, such as coronary vascular stents, heart valves, occluders, large-vessel stents and other cardiovascular implanted devices.
  • the implanted devices need to be delivered to the human body through the delivery device.
  • the ideal position of the implanted device, and the implanted device needs to be fixed after reaching the target position.
  • the fixation of the heart valve prosthesis is particularly important.
  • the fixation of the aortic valve and the pulmonary valve mainly relies on the radial support force of the valve stent.
  • the valve stent is provided with clamps or protrusions, depressions and other anatomical structures.
  • the shape and characteristics are fixed; the mitral valve and tricuspid valve are fixed mainly on the basis of radial support force by adding auxiliary fixing devices, such as barbs, barbs, leaflet holders, and annulus holders And apical fixation line, fixation rod, etc.
  • auxiliary fixing devices such as barbs, barbs, leaflet holders, and annulus holders And apical fixation line, fixation rod, etc.
  • due to the complex anatomy of the mitral valve and tricuspid valve relying only on the radial support of the valve stent and other auxiliary fixation devices, on the one hand, has a relatively large impact on the native valve annulus and hinders the diastolic and contraction movement of the heart.
  • the anchor releasing device includes a delivery tube and a push rod, the anchor releasing device and the fixing unit can be Disassembling the connection, the distal portion of the anchor release device has a preset shape, so that the distal portion of the delivery tube can be bent entirely or partially, so that before the anchor is moved, the delivery The most distal end of the tube abuts against the fixing unit or against the autologous tissue.
  • the detachable connection operation between the anchor release device and the fixed unit is relatively complicated, requires high precision, and is difficult to pre-assemble. After the sheath is retracted, the detachable connection has high stress and is easy to damage the implanted device.
  • the technical problem to be solved by this application is to provide a controllable guide device for implantation equipment with simple structure, small catheter diameter, accurate positioning, and safe and reliable anchoring.
  • a controllable guiding device for an implanted device includes an implanted device, a delivery catheter and a control handle.
  • the controllable guiding device for an implanted device also includes a guide tube and a limiting wire.
  • the implanted device is provided with a shield An anchoring unit, the limiting wire is detachably connected to the implantation device, the proximal end of the limiting wire is connected to the control handle, the distal end of the guiding tube is provided with a guide, so The distal part of the guiding catheter can be bent, the proximal end of the delivery catheter and the proximal end of the guiding catheter are respectively connected to the control handle, when pre-installed, the guiding catheter and the limit The positioning wire is placed in the delivery catheter, and the limiting wire passes through the guide.
  • the implantable device controllable guiding device further includes an anchoring needle and an anchoring needle pushing member.
  • the anchoring needle and the anchoring needle pushing member are placed on the guide.
  • the anchoring needle pushing member pushes the anchoring needle to move distally, the anchoring needle can realize that the anchoring unit of the implantation device is fixed to the target tissue.
  • the distal end of the limit wire is provided with a locking hole
  • the implantation instrument is provided with a connection hole
  • the implantation instrument controllable guiding device further includes a control rod, the control rod The proximal end is connected to the control handle.
  • the distal end of the control rod is inserted into the locking hole; when the control handle is operated When the limiting wire is tightened and locked, the implantation device, the limiting wire, the control rod, and the guiding catheter form a connection, so that the relative position between them is fixed, When the control rod is operated to move axially so that the distal end of the control rod escapes from the locking hole, the disengagement of the implantation instrument and the limiting wire is realized.
  • the distal end of the control rod is provided with an anti-dropping end
  • the anti-dropping end is an inverted cone structure, a Y-shaped structure, a wave-shaped structure, or a compressible circular structure.
  • the locking hole at the distal end of the limiting wire is a compressible round hole or a U-shaped hole formed by folding back and winding multiple strands of wire.
  • the guide member is fixedly connected to the guide tube, the guide member is located at the distal end of the guide tube, and the guide member is provided with a guide hole.
  • the limit The distal end of the position wire first passes through the guide hole and then passes through the connecting hole.
  • the guide member and the guide tube are integrally formed.
  • control rod passes through a guide hole provided on the guide member.
  • the guide member is fixedly connected to the distal end of the control rod, and the guide member is provided with a guide hole.
  • the distal end of the limit wire first passes through the guide Pass through the connecting hole after the hole.
  • the guide tube passes through a guide hole provided on the guide member.
  • the anchored unit and the implantation device are an integral structure.
  • the anchored unit is a flexible piece, one end of which is connected to the implantation device.
  • the flexible member can be deformed and is made of a soft material.
  • a support skeleton is provided on the anchored unit.
  • a support skeleton is provided on the implantation device, and the anchored unit is provided on the support skeleton.
  • a limit wire can simultaneously perform multiple functions such as guiding, bending, positioning, pulling and dismounting.
  • the limit wire is used as a guide rail, which can guide and restrict the guide tube to move in a specific direction.
  • the advantages of this implementation are: on the one hand, the position of the guide tube during pre-assembly is reduced, the loading difficulty is low, and the guide tube There is a movable connection with the limit wire, there is no internal stress between the various parts during loading, and the damage to the product is small; on the other hand, if the anchoring position or anchoring effect is not ideal, the guiding catheter can be removed After the delivery catheter is taken out, the anchoring needle is reloaded, and then the anchoring operation is performed again along the limiting wire, which greatly avoids the risk of surgery.
  • the limit wire is used as a bending line to transform the distal end of the guiding catheter from an initial straight state to a fixed angle state, changing the direction of needle exit, which is conducive to achieving the expected anchoring position and simplifies the structure of the delivery device.
  • the limit wire is used as a positioning wire and is connected to a specific position on the implantation device, which can accurately locate the relative position of the needle exit of the guiding catheter and the anchored unit, and achieve precise anchoring.
  • the limit wire is used as a pulling wire.
  • the guide tube can be pulled to offset the reaction force between the anchoring needle and the anchored area, ensuring that the guide tube and the anchored area are tight before the anchoring needle is anchored. Close to, to ensure that the anchoring needle can safely and effectively fix the anchored area and the target tissue.
  • the limit wire is a detachable wire, which can be separated from the implantation device after the anchoring operation is completed.
  • Fig. 1 is a schematic structural diagram of a controllable guiding device for an implanted device in Embodiment 1 of the present application.
  • Fig. 2 is a schematic structural diagram of a controllable guiding device for an implantation device provided with an anchor needle and an anchor needle pusher in Embodiment 1 of the present application.
  • Fig. 3 is a schematic diagram of an implementation of the distal end portion of the implantable device controllable guiding device in the first embodiment of the present application.
  • 4A-4D are schematic structural diagrams of various implementations of the anchored unit in the first embodiment of the present application.
  • Figures 5 and 6 are schematic diagrams of two embodiments of the anchoring needle of the implantable device controllable guiding device of the present application.
  • Fig. 7 is a schematic diagram of an embodiment of the distal end of the anchoring needle pushing member of the implantable device controllable guiding device of the present application.
  • Fig. 8 is a schematic diagram of a connection mode of the anchor needle and the anchor needle pusher.
  • 9 to 11 are schematic diagrams of the operation of the controllable guiding device of the implanted device of the present application.
  • proximal end in this application refers to the end close to the control handle or the operator, and the distal end refers to the end far away from the control handle or the operator.
  • a controllable guiding device for an implanted device includes an implanted device 1000, a delivery catheter 1600, a control handle 1500, a guide tube 1300, and a limit wire 1200.
  • the implanted device 1000 is provided with There is an anchored unit 1102, the limit wire 1200 is detachably connected to the implant device 1000, the proximal end of the limit wire 1200 is connected to the control handle 1500, and the guide tube 1300
  • a guide 1700 is provided at the distal end, the distal end of the guiding catheter 1300 can be bent, the proximal end of the delivery catheter 1600 and the proximal end of the guiding catheter 1300 are respectively connected to the control handle 1500,
  • the guiding catheter 1300 and the limiting wire 1200 are placed in the delivery catheter 1600, and the limiting wire 1200 passes through the guide 1700.
  • the control handle 1500 When the control handle 1500 is operated, the When the guide 1700 on the guiding catheter 1300 moves distally along the limiting wire 1200, the distal portion of the guiding catheter 1300 bends and deforms, so that the distal end of the guiding catheter 1300 and The anchor unit 1102 of the implant device 1000 is abutted.
  • the distal end portion of the guiding catheter 1300 is bent and deformed, and the guiding catheter 1300 pushes the implantation during the deformation process.
  • the anchored unit 1102 of the instrument 1000 moves in a radial direction to abut against the target tissue until the limit wire 1200 is tightened, and the distal end of the guiding catheter 1300 forms a fixed angle, which is convenient for guiding the guiding catheter 1300.
  • the distal end of 2 abuts against the anchored unit 1102, so that the anchored unit 1102 fits with the target tissue.
  • the implantable device controllable guiding device further includes an anchoring needle 0100 and an anchoring needle pushing member 1800.
  • the anchoring needle 0100 and the anchoring needle pushing member 1800 are placed In the guiding catheter 1300, when the anchoring needle pusher 1800 pushes the anchoring needle 0100 to move distally, it is realized that the anchoring needle 0100 will move the anchored unit 1102 of the implantation device.
  • a plurality of circular connecting ends 1002 are also provided on the implantation device 1000, and a connecting piece 1900 and a control piece 1910 are also arranged in the delivery catheter.
  • the connecting piece 1900 is a rod-shaped structure with a ring at the distal end, and the control piece 1910 It is a hard rod or a hard wire.
  • the connecting piece 1900 first passes through the connecting end 1002, and the distal end of the control piece 1910 passes through the ring of the connecting piece 1900.
  • the distal end of the control piece 1910 and the control The sixth control of the handle 1500 is fixedly connected.
  • the implant device 1000 is provided with a support frame 1100, connecting holes 1110 and 1111.
  • the support frame 1100 is a V-shaped or diamond-shaped compressible structure with a certain strength and hardness.
  • the connecting holes 1110 and 1111 have a circular ring structure and are arranged on the support frame 1100.
  • the connecting holes 1110 and 1111 and the support frame 1100 are manufactured by laser integral cutting of nickel-iron tubes and heat treatment.
  • the space formed by the support frame 1100 is provided with an anchored unit 1102.
  • the anchored unit 1102 is a flexible piece, such as a polymer braid, and the edge (one end) of the support frame 1100 is fixed with sutures.
  • the anchored unit 1102 is made of polytetrafluoroethylene (PTFE) material and fixed on the support frame 1100 by sintering.
  • the anchored unit 1102 and the implanted device are an integral structure.
  • the anchored unit 1102 and the implantation device 1000 are an integral structure, and the support frame 1100 and the implantation device 1000 are an integral structure.
  • the anchored unit 1102 is a flexible piece, one end of which is connected to the implantation device 1000, and a support frame is provided on the anchored unit 1102, and the support frame is made of wire wound grid.
  • the anchored unit 1102 is a flexible piece, one end of which is connected to the implant device 1000, and a support skeleton is provided on the anchored unit 1102, and the support skeleton is a polymer braid.
  • the anchored unit 1102 is a rigid stent made of metal wire.
  • the anchored unit 1102 is a supporting rod. As shown in FIGS. 4A to 4D, in one embodiment, the anchored unit 1102 may be triangular, circular, isosceles trapezoid, or rectangular.
  • the implanted device is an artificial atrioventricular valve, and the valve is fixed to the ventricular wall by an anchoring needle.
  • the distal end of the limit wire 1200 is detachably connected to the support frame 1100 of the implant device 1000.
  • the limit wire 1200 is a flexible wire, made of polymer material or metal wire, and has a certain strength. And toughness, it can form a stronger connection when tightened, and the softer limit wire 1200 does not affect the position of other components when loosened.
  • the proximal end of the limit wire 1200 is connected to the first control 1510 on the control handle 1500, As shown in Figure 1 and Figure 2.
  • two limit wires are provided in the controllable guide device of the implanted instrument, and two guide members are symmetrically provided at the distal end of the guide catheter.
  • the limit wires respectively pass through the two guides, so that the distal end of the single guide tube 1300 is connected to the limit wire 1200 and the second limit wire 1201 at the same time.
  • the guide tube 1300 is The distal end can be self-positioned to the midline of the anchored unit 1102 under the action of the two guides 1700, which reduces the influence of the support frame 1100, the anchored unit 1102 and the detachable point on the exit of the guiding catheter 1300.
  • a single guide catheter 1300 can be connected to two or more limit wires at the same time, and the position of the end of the guide catheter 1300 can be automatically positioned by controlling the length of different limit wires.
  • the guide 1700 is fixedly connected to the guide catheter 1300.
  • the guide 1700 is located at the distal end of the guide catheter 1300.
  • One, two or more guide holes 1710 are provided on the guide 1700.
  • the guide 1700 has a certain strength and is made of a metal material or a high-hardness polymer material.
  • the surface of the guide 1700 is mechanically polished, and the surface is smooth and has no sharp edges to prevent damage to the tissue; in a preferred embodiment,
  • the guide 1700 and the guiding catheter 1300 are integrally formed.
  • the distal end of the guiding catheter 1300 is a bendable structure.
  • the head of the slit tube has a length of 2-10mm and no slit is provided to prevent the head of the anchor needle 0100 from getting stuck when the needle is ejected.
  • the slit tube has a certain strength and the wall thickness is more than 0.1mm;
  • the distal end of the guide tube 1300 is fixedly connected to the guide 1700 by interference fit or welding or glue connection.
  • the proximal end of the guide tube 1300 is connected to the third control 1530 on the control handle 1500.
  • the third control is used when the control handle 1500 is operated. 1530 can drive the guide tube 1300 to move in the axial direction.
  • the implantable device controllable guiding device further includes a control rod 1400, the proximal end of the control rod 1400 is connected to the second control 1520 of the control handle 1500, and the control rod 1400 is a thin rod.
  • the distal end of the control rod 1400 is provided with an anti-dropping end 1410, the anti-dropping end 1410 is an inverted cone structure, a Y-shaped structure, and a wave-shaped structure Or a compressible circular structure, etc., to prevent the distal end of the control rod 1400 from accidentally escaping from the locking hole 1110.
  • the guide 1700 is fixedly connected to the distal end of the guide tube 1300.
  • the guide 1700 is provided with two guide holes 1710.
  • the distal end of the limit wire 1200 passes through one of the guide holes 1710, and the distal end of the control rod 1400 passes through the other.
  • a guide hole 1710 which regulates the movement direction of the limit wire 1200 and the control rod 1400.
  • the guide 1700 is fixedly connected to the distal end of the control rod 1400, and two guide holes 1710 are provided on the guide 1700.
  • the distal end of the limit wire 1200 When pre-installed, the distal end of the limit wire 1200 first passes through one guide hole 1710 After passing through the connecting hole 1110, the guiding tube 1300 passes through another guiding hole, and the guiding member 1700 is movably connected to the guiding tube 1300, so that the guiding member 1700 can control the moving direction of the guiding tube 1300. As shown in Figures 1 and 2, in one embodiment, the distal end of the limit wire 1200 is provided with a locking hole 1210. When pre-installed, the locking hole 1210 first passes through the guide hole 1710 of the guide 1700.
  • the guide 1700 is movably connected to the control rod 1400, and the control rod 1400 first passes through the guide 1700 and then passes through the locking hole 1210 of the limit wire 1200.
  • the locking hole 1210 is a flexible and compressible structure, which facilitates quick and safe withdrawal from the connection hole 1110 of the implantation device 1000, and does not affect the position of the implantation device 1000; as a preferred embodiment, the limit wire 1200 It is an integral structure with the locking hole 1210.
  • the limit wire 1200 is folded in half to form a U-shaped locking hole at the end, or the limit wire 1200 is folded in half and wound around the braided head to form a locking hole; the proximal end of the limit wire 1200 and the control handle 1500
  • the first control member 1510 is connected, and when the control handle 1500 is operated, the first control member 1510 can move axially and be fixed at the stop position.
  • the anchoring needle 0100 includes at least one curved needle 0101 and a fixed end 0102 of the curved needle.
  • the distal end of the curved needle 0101 can expand in the radial direction to form a curved section 0104 when pre-installed.
  • the anchoring needle 0100 can be deformed and installed into the lumen of the guiding catheter 1300, and the anchoring needle 0100 can be restored to its preset shape when released from the guiding catheter 1300.
  • the curved needle 0101 is a nickel-titanium alloy wire that is shaped into a shape after heat treatment. Angle section 0104, the head is a sharpened sharp structure.
  • a small angle 0105 that is opposite to the direction of the angle section 0104 is provided 0.5-2mm away from the top end of the angle section 0104.
  • the setting of the angle 0105 facilitates the anchoring needle 0100 to penetrate deeper into the tissue when it is pushed out of the guiding catheter 1300;
  • the fixed end 0102 is the proximal fixing place of the curved needle 0101, which can be formed by welding or formed by the curved needle
  • the proximal end is wound into a twist formation.
  • a fixing member 0112 is provided on the outside of the fixed end 0102.
  • the fixing member 0112 is a metal annular sleeve with a length of 0.5 -3mm, the inner diameter is in close contact with the fixed end 0102; as another embodiment, as shown in Figure 6, the fixed part 0112 is a spiral fastener, and the spiral fastener is made of a metal wire that is tightly attached to the fixed end 0102 and is looped in the axial direction.
  • the anchoring needle 0100 also includes a curved needle connecting end 0103, the connecting end 0103 is the connection between the anchoring needle 0100 and the anchoring needle pusher 1800, used to control the movement of the anchoring needle 0100
  • the connecting end 0103 is a circular ring structure formed by bending the proximal end of the curved needle 0101.
  • the anchoring needle pushing member 1800 is used to push the anchoring needle 0100 out of the guiding catheter 1300, and has certain strength and toughness.
  • the distal end portion can be deformed to conform to the bending of the distal end of the guiding catheter 1300, and the anchoring needle is pushed
  • the member 1800 is a thin rod or wire structure made of metal or memory alloy material.
  • the distal end 1820 of the anchoring needle pushing member 1800 is provided with a fixing hook 1824 for It is detachably connected with the connecting end 0103 of the anchoring needle 0100 to limit the movement of the anchoring needle 0100 and increase product safety; as another embodiment, as shown in Figure 8, the anchoring needle pusher 1800 is made of stainless steel.
  • Tube production the distal part of which is provided with a cutting seam, which can conform to the bending deformation of the guiding tube 1300.
  • a puller wire 1810 is provided inside the stainless steel metal tube, and the puller wire 1810 passes through the anchoring needle 0100 After the connecting end 0103 of the stainless steel tube is folded in half and passed through the stainless steel metal tube, the proximal end extends out of the body for manual manipulation.
  • the distal end of the stainless steel metal tube is provided with a flexible section 1806, and the connecting end 0103 part of the anchor needle 0100 Located in the area defined by the flexible section 1806, it is advantageous for the anchoring needle 0100 to be recovered to the inside of the guiding catheter 1300.
  • the distal ends of the anchoring needle 0100 and the anchoring needle pushing member 1800 are respectively pre-installed inside the guiding catheter 1300, and the distal end of the anchoring needle 0100 is separated from the distal end of the guiding catheter 1300 within 0.5mm-5mm, Prevent the guide catheter 1300 from moving when retracting and retracting the sheath, causing the distal end of the anchoring needle 0100 to expose the guiding catheter 1300, which affects the needle sticking effect; as shown in Figure 2, the proximal end of the anchoring needle pusher 1800 and the control handle 1500 The fourth control 1540 is connected.
  • the distal end of the limit wire 1200 first passes through the guide hole of the guide 1700, the guide 1700 can slide along the limit wire 1200, and the guide tube 1300 is located under the implant device 1000.
  • the position staggered from the main part of the implant device 1000 on the one hand, can reduce the damage to the implant device 1000, especially the artificial valve leaflet 1105 during loading and sheathing, and on the other hand, it can greatly reduce the delivery catheter 1600
  • the diameter improves the performance of the delivery device, especially for surgical approaches, which can play a subversive role. For example, changing from the apical or atrial approach to the vascular approach can reduce the damage to the patient during puncture intervention and reduce the risk of surgery. Increase the safety of the product.
  • the guide tube 1300 is guided by the guide 1700 along the limit wire 1200 and axially farther.
  • the end of the guide tube 1300 is moved, the distal end portion of the guide catheter 1300 is bent and deformed, and together pushes the anchored unit 1102 of the implant device 1000 to move in the radial direction until the limit wire 1200 is tightened, and the distal end of the guide catheter 1300 forms The angle 1301 is fixed, and the distal end of the guide tube 1300 abuts against the anchored unit 1102 of the implantation device 1000.
  • the limiting wire 1200 functions as follows: 1.
  • the limiting wire 1200 acts as a guide rail to guide
  • the guide tube 1300 is restricted from moving in a specific direction.
  • the advantages of this implementation are: on the one hand, the position of the guide tube 1200 during pre-installation is reduced, the loading difficulty is low, and the guide tube 1300 is between the guide tube 1300 and the limit wire 1200.
  • the movable connection there is no internal stress between the various parts during loading, and the damage to the product is small; on the other hand, if the anchoring position or anchoring effect is not ideal, the guiding catheter can be withdrawn from the delivery catheter and reloaded The above-mentioned anchoring needle is then re-anchored along the limit wire 1200, which greatly avoids the risk of surgery; 2.
  • the limit wire 1200 is used as a bending line to connect the distal part of the guide catheter 1200 From the initial straight state to the fixed angle state, the needle exit direction is changed, which is beneficial to realize the expected anchoring position, and simplifies the structure of the delivery device; 3.
  • the limit wire 1200 is used as the positioning line and is connected to the implant device 1000 The specific position connection can accurately position the relative position of the needle exit of the guiding catheter 1300 and the anchored unit 1102, so as to achieve precise anchoring; 4.
  • the limit wire 1200 is used as a pulling wire to counteract the needle puncture of the guiding catheter 1300
  • the reaction force between the anchoring needle 0100 and the anchored area 1102 during operation ensures that the guiding catheter 1300 closely abuts the anchored area 1102 before the anchoring needle 0100 is anchored, ensuring that the anchoring needle safely and effectively connects the anchoring area 1102 to the anchored area 1102.
  • the target tissue is fixed; 5.
  • the limit wire 1200 is used as a detachable thread, which can be separated from the implantation device after the anchoring operation is completed.
  • the implantation device 1000 is provided with a connecting hole 1110.
  • the connecting hole 1110 may be set at the end of the implantation device 1000, or may be set at other positions of the implantation device 1000. Choose a suitable anchoring position according to the actual situation. The scope is large.
  • the implant device 1000 is first released from the delivery catheter 1600 to the initial position, and the control handle 1500 is operated to move the first control member 1510 proximally, so that the limit wire 1200 is tightened;
  • operating the control handle 1500 to move the third control 1530 causes the guide tube 1300 to move axially distally along the limit wire 1200 under the guidance of the guide 1700, and the distal part of the guide tube 1300 bends Deform, tighten and lock the limit wire 1200.
  • FIG. 10 shows that the implant device 1000 is first released from the delivery catheter 1600 to the initial position, and the control handle 1500 is operated to move the first control member 1510 proximally, so that the limit wire 1200 is tightened;
  • operating the control handle 1500 to move the third control 1530 causes the guide tube 1300 to move axially distally along the limit wire 1200 under the guidance of the guide 1700, and the distal part of the guide tube 1300 bends Deform, tighten and lock the limit wire 1200.
  • the distal end of the guiding catheter 1300 forms a fixed angle 1301, and the distal end of the guiding catheter 1300 is connected to the anchored unit of the implant device 1000 1102, the anchored unit 1102 of the implant device 1000 forms a fixed connection with the limiting wire 1200, the control rod 1400, and the guide tube 1300. At this time, the control rod 1400 and the guide tube 1300 are connected to the implant device 1000 respectively.
  • the anchored unit 1102 is close to and located at both ends of the connecting hole 1110. The distance between the end of the guide 1700 and the distal end of the locking hole 1210 is approximately equal to the length of the connecting hole 1110.
  • the anchored unit 1102 of the implant device 1000 It forms a close fit with the control rod 1400 and the guide tube 1300, the anchored unit 1102 of the implanted device 1000 has no moving space relative to the control rod 1400 and the guide tube 1300; the fourth control 1540 of the control handle 1500 is operated to make The anchoring needle pusher 1800 pushes the anchoring needle 0100 to move distally along the guiding catheter 1300, the anchoring needle 0100 is gradually released from the guiding catheter 1300 and deployed, and the tip of the anchoring needle 0100 first passes through the anchored unit 1102 , And then pierce the target tissue to realize that the anchoring needle 0100 fixes the anchored unit 1102 of the implant device 1000 to the target tissue.
  • the medical imaging equipment can be used to confirm whether the anchoring needle 0100 is anchored to the target tissue. If not, Tighten the retractor 1810 to retrieve the anchoring needle 0100 into the guiding catheter 1300, readjust the position of the implant device 1000, and then perform the anchoring operation; after the anchoring is completed, push the retractor 1810 from the anchoring needle 1800
  • the control handle 1500 is operated to move the second control 1520 in the axial direction to withdraw the distal end of the control rod 1400 from the locking hole 1210, the anchoring order of the implant device 1000
  • the connection between the element 1102 and the limit wire 1200, the control rod 1400 and the guide tube 1300 is released, and the anchored unit 1102 of the implanted device 1000 is released; finally, the sixth control 1560 of the control handle 1500 is operated to control
  • the member 1910 moves proximally until the distal end of the control member 1910 withdraws from the distal ring of the connecting member 1900, and the implant device 1000 is completely released from the delivery catheter.
  • the device of the present application is easy to disassemble, the anchored unit 1102 of the implanted device 1000 can be separated from the delivery system quickly, and the controllable guiding device will no longer affect the implanted device 1000 after separation, thereby reducing the risk of surgery.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

一种植入器械（1000）可控导引装置，包括植入器械（1000）、输送导管（1600）、控制手柄（1500）、导引导管（1300）和限位丝（1200），植入器械（1000）上设置有被锚定单元（1102），限位丝（1200）可拆卸地连接在植入器械（1000）上，限位丝（1200）的近端与控制手柄（1500）相连，导引导管（1300）的远端设置有导向件（1700），导引导管（1300）的远端部分能够弯曲，输送导管（1600）的近端和导引导管（1300）的近端被分别连接在控制手柄（1500）上，预装时，导引导管（1300）和限位丝（1200）被放置在输送导管（1600）内，限位丝（1200）穿过导向件（1700），当操作控制手柄（1500）使导引导管（1300）上的导向件（1700）沿着限位丝（1200）向远端移动时，导引导管（1300）的远端部分弯曲变形，使得导引导管（1300）的远端与植入器械（1000）的被锚定单元（1102）贴靠。

Description

植入器械可控导引装置
相关申请
本申请要求2019年12月17日申请的，申请号为201911299139.X，名称为“一种植入器械可控导引装置”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及一种医疗器械，尤其涉及一种植入器械可控导引装置。
背景技术
微创经导管治疗心血管疾病逐渐成为主要的治疗手段，如冠脉血管支架、心脏瓣膜、封堵器、大血管支架以及其他心血管植入器械需通过输送装置将植入器械输送到人体预期的理想位置，并且植入器械到达目标位置后需要固定。其中，心脏瓣膜假体的固定尤为重要，目前传统技术中，主动脉瓣膜和肺动脉瓣膜的固定主要依靠瓣膜支架径向支撑力，瓣膜支架上设置夹持件或者凸起、凹陷等利用解剖结构的形态及特征进行固定；二尖瓣瓣膜、三尖瓣瓣膜的固定主要在径向支撑力的基础上增加辅助固定的装置，如倒刺、倒钩、瓣叶夹持件、瓣环夹持装置以及心尖固定线、固定杆等。然而，因二尖瓣及三尖瓣的解剖结构较为复杂，仅仅依靠瓣膜支架的径向支撑以及其他辅助固定装置，一方面对自体瓣环的影响比较大，阻碍心脏的舒张收缩运动，不能很好的解决固定问题；另一方面，对于微创经导管的产品来说，受导管直径以及导管的性能所限，在植入器械上很难设置比较有效的、相对灵活的结构用来固定到目标解剖结构上。
专利CN201410316922.3中所述的带锚定装置的用于阻止瓣膜反流的修复系统，所述锚定件释放装置包括输送管和推杆，所述锚定件释放装置与所述固定单元可拆卸连接，所述锚定释放装置的远端部分具有预设的形状，使得所述输送管的远端部分能够整体弯曲或部分弯曲，以便于在所述锚定件被移动之前，所述输送管的最远端紧抵所述固定单元或者紧抵自体组织。该方案中锚定件释放装置与所述固定单元的可拆卸连接操作较为复杂，精度要求高，预装时难度大，并且在收鞘后，可拆卸连接处的应力大，易损伤植入器械及锚定释放装置；在锚定之前，所述输送管弯曲需依靠支撑结构来使弯角固定，否则输送管的远端很难贴靠固定单元，并且，在收鞘、放鞘的过程中因为输送管长度有变化，因此在锚定之前，输送管的远端与固定单元之间可能存在缝隙，贴靠不牢，影响锚定效果，手术风 险高；对于需要多点固定的植入器械，该方案需同时设有多个输送管，结构复杂，输送导管直径大；锚定操作结束，不能进行再次的锚定，手术风险高。
因此，本领域技术人员需要开发一种结构简单，操作有效，安全性高的植入器械输送系统和锚定装置。
发明内容
有鉴于传统技术的上述缺陷，本申请所要解决的技术问题是提供一种结构简单，导管直径小，定位准确，锚定安全可靠的植入器械可控导引装置。
本申请的目的是通过以下技术方案实现的：
一种植入器械可控导引装置，包括植入器械、输送导管和控制手柄，所述植入器械可控导引装置还包括导引导管和限位丝，所述植入器械上设置有被锚定单元，所述限位丝可拆卸地连接在所述植入器械上，所述限位丝的近端与所述控制手柄相连，所述导引导管的远端设置有导向件，所述导引导管的远端部分能够弯曲，所述输送导管的近端和所述导引导管的近端被分别连接在所述控制手柄上，预装时，所述导引导管和所述限位丝被放置在所述输送导管内，所述限位丝穿过所述导向件，当操作所述控制手柄使所述导引导管上的所述导向件沿着所述限位丝向远端移动时，所述导引导管的远端部分弯曲变形，使得所述导引导管的远端与所述植入器械的被锚定单元贴靠。
本申请的目的还可以通过以下技术方案来进一步实现：
在一个实施方式中，所述植入器械可控导引装置还包括锚定针和锚定针推送件，在预装时，所述锚定针和锚定针推送件被放置在所述导引导管内，当所述锚定针推送件推动所述锚定针向远端移动时，实现所述锚定针将所述植入器械的被锚定单元固定到目标组织上。
在一个实施方式中，所述限位丝的远端设置有锁定孔，所述植入器械上设置有连接孔，所述植入器械可控导引装置还包括控制杆，所述控制杆的近端与所述控制手柄相连，预装时，所述锁定孔穿过所述植入器械的所述连接孔后，所述控制杆的远端插入所述锁定孔；当操作所述控制手柄使得所述限位丝被拉紧并锁住时，所述植入器械、所述限位丝、所述控制杆以及所述导引导管之间形成连接，使得它们之间的相对位置固定，当操作所述控制杆轴向移动使得所述控制杆的远端脱离所述锁定孔时，实现所述植入器械与所述限位丝的解脱。
在一个实施方式中，所述控制杆的远端设有防脱端，所述防脱端为倒锥形结构、Y型结构、波浪形结构或可压缩的圆形结构等。
在一个实施方式中，所述限位丝远端的所述锁定孔为可压缩的圆孔或者多股丝线折回 绕制而成的U形孔。
在一个实施方式中，所述导向件与所述导引导管固定连接，所述导向件位于所述导引导管的远端，所述导向件上设置有导向孔，预装时，所述限位丝的远端先穿过所述导向孔后再穿过所述连接孔。
在一个实施方式中，所述导向件与所述导引导管为一体成型结构。
在一个实施方式中，所述控制杆穿过设置在所述导向件上的导向孔。
在一个实施方式中，所述导向件被固定连接在所述控制杆的远端，所述导向件上设置有导向孔，预装时，所述限位丝的远端先穿过所述导向孔后再穿过所述连接孔。
在一个实施方式中，所述导引导管穿过设置在所述导向件上的导向孔。
在一个实施方式中，所述被锚定单元与所述植入器械为一体结构。
在一个实施方式中，所述被锚定单元为柔性件，其一端与所述植入器械连接。在一个实施方式中，所述柔性件能够变形，由柔软的材料制成。
在一个实施方式中，所述被锚定单元上设置有支撑骨架。
在一个实施方式中，在所述植入器械上设置有支撑骨架，所述被锚定单元设置在所述支撑骨架上。
同传统技术相比，本申请实施例的优点在于：
1、结构简单，操作方便，一根限位丝同时起到导向、调弯、定位、牵拉、可拆卸等多种作用。
2、限位丝作为导轨，可引导并限制导引导管沿着特定方向移动，这样实施的优点是：一方面，预装时对导引导管的位置要求降低，装载难度低，并且导引导管与限位丝之间为活动连接，装载时各个零部件之间没有内应力，对产品的损伤小；另一方面，如果锚定位置或锚定效果不理想，可将所述导引导管撤出输送导管后重新装载锚定针，然后沿着所述限位丝重新进行锚定操作，极大地避免了手术风险。
3、限位丝作为调弯线，将导引导管远端从初始的直线状态转变为固定弯角状态，改变了出针方向，有利于实现预期的锚定位置，简化了输送装置的结构。
4、限位丝作为定位线，与植入器械上特定的位置连接，能精确定位导引导管的出针口与被锚定单元的相对位置，做到精准锚定。
5、限位丝作为牵拉线，在扎针操作时通过牵拉导引导管可以抵消锚定针与被锚固区域的反作用力，确保在锚定针被锚定之前导引导管与被锚固区域紧密贴靠，保证锚定针安全有效地将被锚定区域与目标组织固定。
6、限位丝作为可拆卸线，锚定操作结束后，可以与植入器械分离。
附图说明
为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。
图1是本申请实施例一中的植入器械可控导引装置的结构示意图。
图2是本申请实施例一中设置有锚定针和锚定针推送件的植入器械可控导引装置的结构示意图。
图3是本申请实施例一中的植入器械可控导引装置的远端部分的一种实施方式示意图。
图4A-4D是本申请实施例一中的被锚固单元的多种实施方式的结构示意图。
图5和图6是本申请的植入器械可控导引装置的锚定针的两种实施方式示意图。
图7是本申请的植入器械可控导引装置的锚定针推送件远端的一种实施方式示意图。
图8是锚定针和锚定针推送件的一种连接方式示意图。
图9至图11是本申请的植入器械可控导引装置的操作示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本申请所述的近端指靠近控制手柄或者操作者的一端，所述的远端指远离控制手柄或者操作者的一端。
具体实施例一：
如图1和4A所示，一种植入器械可控导引装置，包括植入器械1000、输送导管1600、控制手柄1500、导引导管1300和限位丝1200，所述植入器械1000上设置有被锚定单元1102，所述限位丝1200可拆卸地连接在所述植入器械1000上，所述限位丝1200的近端与 所述控制手柄1500相连，所述导引导管1300的远端设置有导向件1700，所述导引导管1300的远端部分能够弯曲，所述输送导管1600的近端和所述导引导管1300的近端被分别连接在所述控制手柄1500上，预装时，所述导引导管1300和所述限位丝1200被放置在所述输送导管1600内，所述限位丝1200穿过所述导向件1700，当操作所述控制手柄1500使所述导引导管1300上的所述导向件1700沿着所述限位丝1200向远端移动时，所述导引导管1300的远端部分弯曲变形，使得所述导引导管1300的远端与所述植入器械1000的被锚定单元1102贴靠。
在一个实施方式中，在所述限位丝1200和所述导向件1700的配合移动下，所述导引导管1300的远端部分弯曲变形，导引导管1300在变形过程中推动所述植入器械1000的被锚定单元1102沿径向移动向目标组织贴靠，直到所述限位丝1200被拉紧时，所述导引导管1300的远端部分形成固定弯角，便于导引导管1300的远端紧抵所述被锚定单元1102，使得被锚定单元1102与目标组织贴合。
如图2所示，所述植入器械可控导引装置还包括锚定针0100和锚定针推送件1800，在预装时，所述锚定针0100和锚定针推送件1800被放置在所述导引导管1300内，当所述锚定针推送件1800推动所述锚定针0100向远端移动时，实现所述锚定针0100将所述植入器械的被锚定单元1102固定到目标组织上。在植入器械1000上还设置有多个圆环形连接端1002，输送导管内还设置有连接件1900以及控制件1910，连接件1900为远端带有圆环的杆型结构，控制件1910为硬质杆或硬质丝，连接时，连接件1900先穿过连接端1002，控制件1910的远端再穿过连接件1900的圆环中，所述控制件的1910的远端与控制手柄1500的第六控件固定连接。
如图3和图4A所示，植入器械1000上设置有支撑骨架1100、连接孔1110和1111，支撑骨架1100为V形或菱形等可压缩的结构，有一定的强度和硬度。连接孔1110和1111为圆环形结构，被设置在支撑骨架1100上，连接孔1110和1111与支撑骨架1100由镍铁管经过激光一体切割并经热处理定型制造而成。支撑骨架1100形成的空间上设有被锚定单元1102，被锚定单元1102为柔性件，例如为高分子编织物，其边缘(一端)与支撑骨架1100用缝合线固定。在一个实施方式中，被锚定单元1102为聚四氟乙烯(PTFE)材料经烧结固定在支撑骨架1100上。在另一种实施方式中，被锚固单元1102与所述植入器械为一体结构。在另一种实施方式中，被锚定单元1102与植入器械1000为一体结构，支撑骨架1100与植入器械1000为一体结构。在一个实施方式中，所述被锚定单元1102为柔性件，其一端与植入器械1000连接，在被锚定单元1102上设置有支撑骨架，所述支撑骨架为金属丝绕制而成的网状结构。在另一个实施方式中，所述被锚定单元1102为柔性件，其一端 与植入器械1000连接，在被锚定单元1102上设置有支撑骨架，所述支撑骨架为高分子编织物。在另一个实施方式中，所述被锚定单元1102为金属丝制成的硬性支架。在另一个实施方式中，所述被锚定单元1102为支撑杆件。如图4A至4D所示，在一个实施方式中，所述被锚定单元1102可以是三角形、圆形、等腰梯形或是矩形。本实施例中，植入器械为人工房室瓣膜，所述瓣膜通过锚定针固定到心室壁上。
在预装时，限位丝1200的远端可拆卸连接在植入器械1000的支撑骨架1100上，限位丝1200为柔性线，由高分子材料或金属丝线制作而成，其具有一定的强度和韧性，拉紧时能形成强度较大的连接，松开时较柔软的限位丝1200不影响其他组件的位置，限位丝1200的近端与控制手柄1500上的第一控件1510相连，如图1和图2所示。
在一个实施方式中，如图3所示，在所述植入器械可控导引装置内设置有两根限位丝，在导引导管的远端对称地设置有两个导向件，两根限位丝分别穿过两个导向件，使得单个导引导管1300的远端同时与限位丝1200和第二限位丝1201连接，当两根限位丝拉紧时，导引导管1300的远端在两个导向件1700的作用下能自定位到被锚定单元1102的中线上，减少了支撑骨架1100、被锚定单元1102以及可拆卸点对导引导管1300出口的影响，在实施方式中，单根导引导管1300可同时连接两根或多根限位丝，通过控制不同限位丝的长度来自动定位导引导管1300端部的位置。
导向件1700与导引导管1300固定连接，导向件1700位于导引导管1300的远端，导向件1700上设置一个、两个或多个导向孔1710，预装时，限位丝1200的远端先穿过导向孔1710后再穿过连接孔1110。导向件1700具有一定的强度，由金属材料或者硬度较高的高分子材料制造，导向件1700的表面经过机械打磨，表面光滑没有锋利边缘，防止戳伤组织；在一个较佳的实施方式中，导向件1700与导引导管1300为一体成型结构，导引导管1300远端部分为可弯曲结构，由弹性较好的导管级镍钛管或者不锈钢金属管经激光雕刻去除部分材料制作而成的切缝管，切缝管的头部留有2-10mm长度不设切缝，防止锚定针0100的头部在出针时卡住，切缝管具有一定的强度，壁厚0.1mm以上；导引导管1300的远端通过过盈配合或者焊接或者胶接与导向件1700固定连接，导引导管1300的近端连接在控制手柄1500上的第三控件1530，在操作控制手柄1500时第三控件1530能带动导引导管1300沿轴向移动。
在另一个实施方式中，所述植入器械可控导引装置还包括控制杆1400，所述控制杆1400的近端与所述控制手柄1500的第二控件1520相连，控制杆1400为细杆，有一定的韧性，短距离内不易变形，由金属或记忆合金材料制造，控制杆1400的远端设置有防脱端1410，防脱端1410为倒锥形结构、Y型结构、波浪形结构或可压缩的圆形结构等，防 止控制杆1400远端从锁定孔1110中意外脱离开。导向件1700被固定连接在导引导管1300的远端，导向件1700上设置两个导向孔1710，限位丝1200的远端穿过其中一个导向孔1710，控制杆1400的远端穿过另一个导向孔1710，所述导向孔调控限位丝1200和控制杆1400的移动方向。在一个实施方式中，导向件1700被固定连接在控制杆1400的远端，导向件1700上设置有两个导向孔1710，预装时，限位丝1200的远端先穿过一个导向孔1710后再穿过连接孔1110，导引导管1300穿过另一个导向孔，导向件1700与导引导管1300活动连接，使得导向件1700能够控制导引导管1300的移动方向。如图1和图2所示，在一个实施方式中，所述限位丝1200的远端设置有锁定孔1210，预装时，所述锁定孔1210先穿过导向件1700的导向孔1710后，再穿过所述植入器械1000的所述连接孔1110，然后所述控制杆1400的远端插入所述锁定孔1210，限位丝1200与植入器械1000和控制杆1400之间形成可拆卸连接；当操作所述控制手柄1500使得所述限位丝1200被拉紧并锁住时，所述植入器械1000、所述限位丝1200、所述控制杆1400以及所述导引导管1300之间形成连接，使得它们之间的相对位置固定，当操作第二控件1520使所述控制杆1400轴向移动使得所述控制杆1400的远端1410脱离所述锁定孔1210时，实现所述植入器械1000与所述限位丝1200的解脱。控制杆1400、植入器械1000、限位丝1200以及限位件1700之间形成的可拆卸活动连接，装载时，限位丝1200的活动度较大，便于操作，降低了植入器械1000的装载难度；并且在装载到输送导管1600后植入器械1000和可控释放装置之间为活动连接，各个零部件之间有适当的活动度，减少了内应力，不易对产品造成损伤；在一个较佳实施方式中，导向件1700与控制杆1400活动连接，控制杆1400先穿过导向件1700后再穿过限位丝1200的锁定孔1210。锁定孔1210为柔性可压缩结构，有利于快速安全的从植入器械1000的连接孔1110中撤回，并且不影响植入器械1000的位置；作为一种较佳实施方式，所述限位丝1200与锁定孔1210为一体结构，限位丝1200对折在端部形成U型锁定孔，或者限位丝1200对折并缠绕编制头部形成锁定孔；限位丝1200的近端与控制手柄1500上的第一控制件1510相连接，操作控制手柄1500时，第一控制件1510能轴向移动并固定在停止位置上。
如图5所示，锚定针0100包括至少一个弯针0101和弯针固定端0102，弯针0101的远端在不受力的情况下能够沿径向展开形成弯角段0104，预装时，锚定针0100能变形安装到导引导管1300的管腔内，锚定针0100从导引导管1300中释放出来时能恢复预设的形状，弯针0101为镍钛合金丝经热处理定型成弯角段0104，头部为经打磨的尖锐状结构，作为一种实施方式，距离弯角段0104的顶端部0.5-2mm处设置有与弯角段0104的方向相反的小弯角0105，小弯角0105的设置有利于锚定针0100从导引导管1300中推出时能更 深的扎入组织；固定端0102为弯针0101的近端固定处，可通过焊接方式形成，或者由弯针的近端绕制成麻花形成，作为一种较佳实施方式，如图5所示，固定端0102的外侧设置有固定件0112，作为一种实施方式，固定件0112为金属环形套管，长度0.5-3mm，内径与固定端0102紧密接触；作为另一种实施方式，如图6所示，固定件0112为螺旋紧固件，螺旋紧固件由金属丝紧贴固定端0102沿轴向环形绕制而成；作为较佳实施方式，锚定针0100还包括弯针连接端0103，连接端0103为锚定针0100与锚定针推送件1800的连接处，用于控制锚定针0100的活动，作为一种实施方式，连接端0103为弯针0101的近端弯折形成的圆环形结构。
锚定针推送件1800用于将锚定针0100从导引导管1300中推送出去，具有一定的强度和韧性，远端部分可变形以顺应导引导管1300远端部分的弯曲，锚定针推送件1800是由金属或记忆合金材料制造的细杆或丝状结构，作为一种实施方式，如图7所示，锚定针推送件1800的远端1820端部设有固定钩1824，用于与锚定针0100的连接端0103进行可拆卸的连接，限制锚定针0100的活动，增加产品安全性；作为另一种实施方式，如图8所示，锚定针推送件1800由不锈钢金属管制作，其远端部分设有切割缝，可顺应导引导管1300的弯曲变形，作为较佳实施方式，在不锈钢金属管内部设有牵拉线1810，牵拉线1810穿过锚定针0100的连接端0103后对折穿过不锈钢金属管，近端延伸出体外，可进行人为操控，作为较佳实施方式，不锈钢金属管的远端设有柔性段1806，锚定针0100的连接端0103部分位于柔性段1806限定的区域内，有利于锚定针0100重新回收至导引导管1300内部。
锚定针0100和锚定针推送件1800的远端部分被分别预装在导引导管1300内部，锚定针0100的远端与导引导管1300的远端相距0.5mm-5mm以内的距离，防止因导引导管1300收放鞘时的移动，导致锚定针0100远端露出导引导管1300，影响扎针效果；如图2所示，锚定针推送件1800的近端与控制手柄1500的第四控件1540连接。
如图9所示，预装时，限位丝1200的远端先穿过导向件1700的导向孔，导向件1700可沿限位丝1200滑动，导引导管1300位于植入器械1000的下方，与植入器械1000的主体部分错开位置，一方面在装载及收鞘时能减少对植入器械1000，尤其是人工瓣叶1105的损伤，另一方面能极大的减小了输送导管1600的直径，提高输送装置的性能，尤其对于手术入路能起到颠覆性的作用，例如将从心尖或者心房入路改变为可从血管入路，减少穿刺介入时对患者的损伤，降低手术风险，增加了产品的安全性。
如图9、图2和图4A所示，当操作控制手柄1500移动第一控件1510和第三控件1530使导引导管1300在导向件1700的引导下沿着限位丝1200沿轴向向远端移动时，导引导 管1300的远端部分弯曲变形，并一起推动植入器械1000的被锚定单元1102沿径向移动，直到限位丝1200被拉紧时，导引导管1300远端形成固定弯角1301，并且导引导管1300的远端与植入器械1000的被锚定单元1102贴靠，在此过程中，限位丝1200的作用有：1、限位丝1200作为导轨，引导并限制导引导管1300沿着特定方向移动，这样实施的优点是：一方面，预装时对导引导管1200的位置要求降低，装载难度低，并且导引导管1300与限位丝1200之间为活动连接，装载时各个零部件之间没有内应力，对产品的损伤小；另一方面，如果锚定位置或锚定效果不理想，可将所述导引导管撤出输送导管后重新装载上所述锚定针，然后沿着所述限位丝1200重新进行锚定操作，极大的避免了手术风险；2、限位丝1200作为调弯线，将导引导管1200的远端部分从初始的直线状态转变为固定弯角状态，改变了出针方向，有利于实现预期的锚定位置,简化了输送装置的结构；3、限位丝1200作为定位线，与植入器械1000上特定的位置连接，能精确的定位导引导管1300的出针口与被锚定单元1102的相对位置，做到精准锚定；4、限位丝1200作为牵拉线，抵消导引导管1300扎针操作时锚定针0100与被锚固区1102的反作用力，确保锚定针0100在锚定之前导引导管1300与被锚固区域1102紧密贴靠，保证锚定针安全有效地将锚定区域1102与目标组织固定；5、限位丝1200作为可拆卸线，锚定操作结束后，可以与植入器械分离。
植入器械1000上设置有连接孔1110，所述连接孔1110可以设置在植入器械1000的端部，也可以设置在植入器械1000的其他位置，根据实际情况选择适合锚定的位置，适用范围大。
在手术操作中，如图9所示，植入器械1000先从输送导管1600中释放到初步位置，操作控制手柄1500使第一控制件1510往近端移动，使得限位丝1200被拉紧；如图10所示，操作控制手柄1500移动第三控件1530使导引导管1300在导向件1700的引导下沿着限位丝1200沿轴向向远端移动，导引导管1300的远端部分弯曲变形，拉紧并锁住限位丝1200，如图2所示，导引导管1300的远端部分形成固定弯角1301，并且导引导管1300的远端与植入器械1000的被锚定单元1102贴靠，植入器械1000的被锚定单元1102与限位丝1200和控制杆1400以及导引导管1300之间形成固定连接，此时控制杆1400和导引导管1300分别与植入器械1000的被锚定单元1102紧贴，并且位于连接孔1110的两端，导向件1700的端部与锁定孔1210的远端距离约等于连接孔1110的长度，植入器械1000的被锚定单元1102与控制杆1400和导引导管1300之间形成紧密配合，植入器械1000的被锚定单元1102相对于控制杆1400和导引导管1300没有活动空间；操作控制手柄1500的第四控件1540，使锚定针推送件1800推动锚定针0100沿导引导管1300向远端移动，锚定针0100逐步从导引导管1300中释放并展开，锚定针0100的针尖先穿过被锚定单元1102， 再扎到目标组织，实现锚定针0100将植入器械1000的被锚定单元1102固定到目标组织上，可以通过医学影像设备确认锚定针0100是否锚定到目标组织中，如果没有，拉紧牵拉线1810将锚定针0100回收进导引导管1300，重新调整植入器械1000的位置后再进行锚定操作；锚定结束后，将牵拉线1810从锚定针推送件1800中抽出；如图11所示，扎针完毕后，操作控制手柄1500使第二控件1520沿轴向移动使控制杆1400的远端从锁定孔1210中撤出时，植入器械1000的被锚定单元1102与限位丝1200和控制杆1400以及导引导管1300之间的连接解脱，完成植入器械1000的被锚定单元1102的释放；最后，操作控制手柄1500的第六控件1560，使得控制件1910往近端移动直到控制件1910的远端撤出连接件1900的远端圆环，植入器械1000完全与输送导管解脱。将输送导管撤出心脏，植入器械1000通过锚定针0100固定到了目标组织上。
本申请的装置拆卸简单，植入器械1000的被锚定单元1102与输送系统脱离速度快，脱离后可控导引装置不再对植入器械1000有影响，减少手术风险。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种植入器械可控导引装置，包括植入器械、输送导管和控制手柄，其特征在于，所述植入器械可控导引装置还包括导引导管和限位丝，所述植入器械上设置有被锚定单元，所述限位丝可拆卸地连接在所述植入器械上，所述限位丝的近端与所述控制手柄相连，所述导引导管的远端设置有导向件，所述导引导管的远端部分能够弯曲，所述输送导管的近端和所述导引导管的近端被分别连接在所述控制手柄上，预装时，所述导引导管和所述限位丝被放置在所述输送导管内，所述限位丝穿过所述导向件，当操作所述控制手柄使所述导引导管上的所述导向件沿着所述限位丝向远端移动时，所述导引导管的远端部分弯曲变形，使得所述导引导管的远端与所述植入器械的被锚定单元贴靠。
  2. 根据权利要求1所述的植入器械可控导引装置，其特征在于，所述植入器械可控导引装置还包括锚定针和锚定针推送件，在预装时，所述锚定针和锚定针推送件被放置在所述导引导管内，当所述锚定针推送件推动所述锚定针向远端移动时，实现所述锚定针将所述植入器械的被锚定单元固定到目标组织上。
  3. 根据权利要求1所述的植入器械可控导引装置，其特征在于，所述限位丝的远端设置有锁定孔，所述植入器械上设置有连接孔，所述植入器械可控导引装置还包括控制杆，所述控制杆的近端与所述控制手柄相连，预装时，所述锁定孔穿过所述植入器械的所述连接孔后，所述控制杆的远端插入所述锁定孔；当操作所述控制手柄使得所述限位丝被拉紧并锁住时，所述植入器械、所述限位丝、所述控制杆以及所述导引导管之间形成连接，使得它们之间的相对位置固定，当操作所述控制杆轴向移动使得所述控制杆的远端脱离所述锁定孔时，实现所述植入器械与所述限位丝的解脱。
  4. 根据权利要求3所述的植入器械可控导引装置，其特征在于，所述控制杆的远端设有防脱端，所述防脱端为倒锥形结构、Y型结构、波浪形结构或可压缩的圆形结构。
  5. 根据权利要求3所述的植入器械可控导引装置，其特征在于，所述导向件与所述导引导管固定连接，所述导向件位于所述导引导管的远端，所述导向件上设置有导向孔，预装时，所述限位丝的远端先穿过所述导向孔后再穿过所述连接孔。
  6. 根据权利要求5所述的植入器械可控导引装置，其特征在于，所述导向件与所述导引导管为一体成型结构。
  7. 根据权利要求5所述的植入器械可控导引装置，其特征在于，所述控制杆穿过设置在所述导向件上的导向孔。
  8. 根据权利要求1所述的植入器械可控导引装置，其特征在于，所述被锚定单元与 所述植入器械为一体结构。
  9. 根据权利要求1所述的植入器械可控导引装置，其特征在于，所述被锚定单元为柔性件，其一端与所述植入器械连接。
  10. 根据权利要求1所述的植入器械可控导引装置，其特征在于，所述被锚定单元上设置有支撑骨架。
PCT/CN2020/136450 2019-12-17 2020-12-15 植入器械可控导引装置 WO2021121214A1 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP20904036.9A EP4079260A4 (en) 2019-12-17 2020-12-15 CONTROLLABLE GUIDE DEVICE FOR IMPLANTABLE DEVICE
CA3163706A CA3163706A1 (en) 2019-12-17 2020-12-15 Controllable guiding device for implantable apparatus
US17/786,311 US20230024606A1 (en) 2019-12-17 2020-12-15 Controllable guiding device for implantable apparatus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201911299139.XA CN111035474B (zh) 2019-12-17 2019-12-17 一种植入器械可控导引装置
CN201911299139.X 2019-12-17

Publications (1)

Publication Number Publication Date
WO2021121214A1 true WO2021121214A1 (zh) 2021-06-24

Family

ID=70235147

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/136450 WO2021121214A1 (zh) 2019-12-17 2020-12-15 植入器械可控导引装置

Country Status (5)

Country Link
US (1) US20230024606A1 (zh)
EP (1) EP4079260A4 (zh)
CN (1) CN111035474B (zh)
CA (1) CA3163706A1 (zh)
WO (1) WO2021121214A1 (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111035474B (zh) * 2019-12-17 2024-04-26 宁波健世科技股份有限公司 一种植入器械可控导引装置
CN113599022A (zh) * 2020-10-12 2021-11-05 宁波健世科技股份有限公司 一种便于操控的瓣膜假体输送系统
CN215130899U (zh) * 2021-02-23 2021-12-14 上海臻亿医疗科技有限公司 一种植入物连接装置及植入物输送系统
CN116421321B (zh) * 2023-03-06 2024-01-09 极限人工智能有限公司 一种能够自动撤回和回位介入器械的血管介入机器人

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140107758A1 (en) * 2012-10-12 2014-04-17 St. Jude Medical, Cardiology Division, Inc. Retaining cage to permit resheathing of a tavi aortic-first transapical system
CN104055603A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种新型的带锚定装置的心脏瓣膜植入器械
CN104055602A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种植入器械释放装置
CN104055604A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的心脏瓣膜植入器械
CN104055600A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的用于阻止瓣膜反流的修复系统
CN110292464A (zh) * 2018-03-22 2019-10-01 杭州启明医疗器械股份有限公司 可调弯介入瓣膜输送系统
CN111035474A (zh) * 2019-12-17 2020-04-21 宁波健世生物科技有限公司 一种植入器械可控导引装置
CN111067666A (zh) * 2019-12-17 2020-04-28 宁波健世生物科技有限公司 经导管的瓣膜置换系统
CN211583671U (zh) * 2019-12-17 2020-09-29 宁波健世生物科技有限公司 一种植入器械可控导引装置
CN211723549U (zh) * 2019-12-17 2020-10-23 宁波健世生物科技有限公司 一种经导管瓣膜置换系统

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9522064B2 (en) * 2011-05-16 2016-12-20 Hlt, Inc. Inversion delivery device and method for a prosthesis
EP2911594B1 (en) * 2012-10-23 2018-12-05 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
CN104055601B (zh) * 2014-07-07 2016-08-24 宁波健世生物科技有限公司 一种新型的植入器械释放装置
US9750605B2 (en) * 2014-10-23 2017-09-05 Caisson Interventional, LLC Systems and methods for heart valve therapy
WO2016133950A1 (en) * 2015-02-17 2016-08-25 Medtronic Vascular Inc. Methods for anchoring a heart valve prosthesis in a transcatheter valve implantation procedure

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140107758A1 (en) * 2012-10-12 2014-04-17 St. Jude Medical, Cardiology Division, Inc. Retaining cage to permit resheathing of a tavi aortic-first transapical system
CN104055603A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种新型的带锚定装置的心脏瓣膜植入器械
CN104055602A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种植入器械释放装置
CN104055604A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的心脏瓣膜植入器械
CN104055600A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的用于阻止瓣膜反流的修复系统
CN110292464A (zh) * 2018-03-22 2019-10-01 杭州启明医疗器械股份有限公司 可调弯介入瓣膜输送系统
CN111035474A (zh) * 2019-12-17 2020-04-21 宁波健世生物科技有限公司 一种植入器械可控导引装置
CN111067666A (zh) * 2019-12-17 2020-04-28 宁波健世生物科技有限公司 经导管的瓣膜置换系统
CN211583671U (zh) * 2019-12-17 2020-09-29 宁波健世生物科技有限公司 一种植入器械可控导引装置
CN211723549U (zh) * 2019-12-17 2020-10-23 宁波健世生物科技有限公司 一种经导管瓣膜置换系统

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4079260A4

Also Published As

Publication number Publication date
US20230024606A1 (en) 2023-01-26
CA3163706A1 (en) 2021-06-24
EP4079260A4 (en) 2023-01-25
CN111035474A (zh) 2020-04-21
EP4079260A1 (en) 2022-10-26
CN111035474B (zh) 2024-04-26

Similar Documents

Publication Publication Date Title
WO2021121214A1 (zh) 植入器械可控导引装置
US11938026B2 (en) Annuloplasty implant
US10398547B2 (en) Implant with anchoring device for heart valve disease
CN111067666B (zh) 经导管的瓣膜置换系统
US8398708B2 (en) Retaining mechanisms for prosthetic valves
EP3796875B1 (en) Annuloplasty device
US20210212826A1 (en) Annuloplasty device
EP3979922B1 (en) A system and device for reshaping a heart valve annulus
CN111818877A (zh) 在部署后用于辅助置换瓣膜重新捕获和重新定位的递送系统
CN211723549U (zh) 一种经导管瓣膜置换系统
CN211583671U (zh) 一种植入器械可控导引装置
JP2022530964A (ja) 弁治療デバイス用着脱自在スライド式アクチュエータ
WO2022042477A1 (zh) 一种可多点连续定位锚定的植入器械系统
US20220218480A1 (en) Annuloplasty Implant System
RU2798940C1 (ru) Система для управляемого имплантирования искусственного атриовентрикулярного клапана
US11678987B2 (en) Coil and barb anchors for heart valve repair devices
EP3572042A1 (en) Annuloplasty device
CN114007549A (zh) 用于将物体引入解剖目标位置的医疗布置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20904036

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 3163706

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020904036

Country of ref document: EP

Effective date: 20220718