WO2021121183A1 - Système de libération réglable - Google Patents

Système de libération réglable Download PDF

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Publication number
WO2021121183A1
WO2021121183A1 PCT/CN2020/136123 CN2020136123W WO2021121183A1 WO 2021121183 A1 WO2021121183 A1 WO 2021121183A1 CN 2020136123 W CN2020136123 W CN 2020136123W WO 2021121183 A1 WO2021121183 A1 WO 2021121183A1
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WO
WIPO (PCT)
Prior art keywords
release
hole
traction
flexible section
implantation device
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PCT/CN2020/136123
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English (en)
Chinese (zh)
Inventor
董娟
李彪
胡晓明
Original Assignee
宁波迪创医疗科技有限公司
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Publication of WO2021121183A1 publication Critical patent/WO2021121183A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents

Definitions

  • This application relates to the technical field of medical devices, and in particular to a controllable release system.
  • Minimally invasive transcatheter treatment of cardiovascular diseases has gradually become the main treatment method.
  • coronary vascular stents, heart valves, occluders, large-vessel stents and other cardiovascular implant devices need to be delivered to the The ideal position expected by the human body.
  • the surgical operation process is generally to compress and deform the implanted device and load it into the delivery catheter.
  • the delivery catheter and/or the internal top tube are used to coordinate the design to realize that the position of the implanted device in the delivery catheter remains relatively unchanged.
  • the implantation device is delivered to the target location through the delivery catheter, and then the implantation device is released from the delivery catheter.
  • the position of the stent in the catheter is easy to change during the withdrawal of the delivery catheter. Because the size of the stent is much larger than that of the delivery catheter, the stent is prone to beating, which affects the positioning of the stent, and then The result of the operation is not ideal; the product cannot achieve a controlled release during the release process. Once the stent is partially or completely released from the delivery catheter, the stent cannot be recycled into the delivery catheter, so the position of the stent can no longer be carried out. Adjustment, and then the requirements of the operator are very high, and the risk of operation failure is high.
  • a retrievable rod and a proximal collection piece such as a coil
  • the retrievable rod cannot be disassembled and withdrawn, making the part of the stent connected to the delivery system It needs to be placed inside the atrium for a long time.
  • the retractable rod and the proximal collecting piece protrude from the atrial septum, not only occupying part of the atrial cavity space, but also affecting the hemodynamics in the atrium, and also causing a high risk of thrombosis.
  • the proximal end of the retrievable rod of the stent is provided with a proximal collecting piece, and the proximal collecting piece has to be placed in the center of the shunt hole, which causes the stent to be placed at the target position, which will most likely affect the shunt effect. There is also a great risk of thrombosis.
  • the proximal end of the retractable rod of the stent is provided with a proximal collecting piece, and a closed loop (coil) structure is connected to the proximal collecting piece.
  • the distal end of the grasping device adopts a hook or tab structure for inserting the implant device In the hole of the, it is connected or disassembled with the closed loop, so as to realize the deployment or withdrawal of the stent; this method has the following two problems:
  • the distal end of the release device adopts a hook.
  • This structure occupies the space in the sheath when it is received in the sheath, so the size of the sheath selected increases; in addition, it is affected by the operating space and hemodynamics.
  • the hook and the loop are not easy to connect, and it is also difficult to detach;
  • the collection device is not directly connected to the stent, but is connected through a loop connected to the distal restraint. This method is likely to cause uneven force transmission, and the device is prone to eccentric axis when the sheath is retracted. In the process of being pushed to the target position in the sheath, the thrust transmission cannot respond in time, and it may even cause the operator to continuously push the sheath handle outside the body, but the stent is not pushed out from the distal end of the sheath for a long time. .
  • the purpose of this application is to provide a controllable release system that is simple in structure, convenient to operate, safe and reliable.
  • a controllable release system includes an implantation device and a delivery system.
  • the proximal end region of the implantation device is provided with a plurality of first holes.
  • the delivery system includes a plurality of traction rods and a plurality of release wires.
  • the release wire, the plurality of traction rods, and the plurality of the first holes are in a one-to-one correspondence in number and position, and each of the traction rods is provided with a second hole and a binding member.
  • Two holes are located at the distal end of the traction rod, the binding member is located on the proximal side of the second hole, the first hole provided on the implantation instrument and all the traction rods are provided.
  • the second holes can be inserted and fitted with each other, and the release wire passes through the restraint member, the first hole or the second hole to realize the connection between the implantation device and the delivery system.
  • the binding member can restrict the movement of the release wire, and when the implantation device is released, the release wire can be displaced relative to the traction rod.
  • a flexible section is provided in the proximal region of the implantation device and/or the distal region of the traction rod, and the flexible section provided in the proximal region of the implantation device is called the first Flexible section, the first hole is provided in the proximal region of the first flexible section; the flexible section provided in the distal region of the traction rod is called the second flexible section, and the second hole is provided in The distal region of the second flexible section.
  • the first flexible section has a spring structure or a double-lumen structure, so that the distal end of the release wire is inserted into the cavity of the spring structure or the double-lumen structure.
  • the first flexible section and/or the second flexible section have a hinge structure, a necking structure, an S-wave structure or a spring structure.
  • first flexible section and/or the second flexible section are made of a material with a shape memory function, or the first flexible section and/or the second flexible section are made of an elastic material production.
  • a protrusion is provided on the first flexible section, and the protrusion is located on the distal side of the first hole to limit the two after the implantation device and the delivery system are connected. The relative position between.
  • the maximum size of the protrusion is not less than the minimum size of the second hole, and the distance between the protrusion and the first hole is 0.2mm-3mm.
  • a protrusion is provided on the second flexible section, and the protrusion is located on the proximal side of the second hole to limit the two after the implantation device and the delivery system are connected. The relative position between.
  • the maximum size of the protrusion is not less than the minimum size of the first hole, and the distance between the protrusion and the second hole is 0.2mm-3mm.
  • the traction rod has a dual-cavity or multi-cavity structure, and the release wire is placed in one cavity of the dual-cavity or multi-cavity structure.
  • the implantation device is an elastic foramen stent that can be placed at the atrial septum, and the delivery system is used to deliver and controllably release the elastic foramen stent from the outside of the body to the atrial septum.
  • the elastic pore-forming stent is a three-dimensional wavy and/or mesh structure formed by interconnecting a plurality of support rods, and the three-dimensional wavy and/or mesh structure includes the connection with the left atrial cavity.
  • the left disc attached to the atrial septal surface, the right disc attached to the atrial septal surface in the right atrial cavity, and the left disc and the right disc are arranged between the left disc and the right disc and fixedly connected to the left disc and the right disc
  • the waist part of the waist part is provided with a through hole, the through hole enables the left atrium and the right atrium to be in fluid communication, the longitudinal cross section of the elastic perforated stent is in the shape of an I-shaped, in the circumferential area of the right disc
  • a first flexible section is provided, and the first hole is located at the distal end of the first flexible section.
  • the elastic hole-making stent is formed by laser cutting and heat treatment of a shape memory alloy tube.
  • the edge of the left disc is enclosed in a circle, the diameter of the circle is in the range of 12mm-40mm, and the edge of the right disc is enclosed in a circle, and the diameter of the circle is in the range of 12mm- 40mm.
  • the diameter of the through hole is 3mm-15mm, and the axial height of the through hole is 1mm-15mm.
  • a tandem wire is provided on the edge of the left disk, the edge of the right disk, and/or the waist, and the tandem wire passes through or is wound around the support rod of the elastic orifice bracket so that the The edge of the left disk, the edge of the right disk and/or the waist form a closed circle.
  • the material of the tandem wire includes polytetrafluoroethylene (PTFE wire), polyethylene terephthalate (PET) wire, and ultra-high molecular weight polyethylene (UHMWPE) made of polymer materials.
  • the thread can also include cobalt-chromium alloy filaments, nickel-titanium alloy filaments, pure tantalum filaments, and 316L stainless steel filaments made of metal materials.
  • the wire diameter of the series line is 0.02 mm-1 mm.
  • the surface of the elastic pore-forming stent is covered with a film, and the material of the film includes a polymer film such as PET, PTFE, and silica gel.
  • the regions of the left and right disks of the elastic hole-making stent are covered with the polymer film.
  • the polymer film completely covers and wraps the inner and outer surfaces of the elastic orifice stent, so that the entire elastic orifice stent has more excellent biocompatibility.
  • the delivery system further includes a traction and collection piece, a traction handle, a release collection piece, and a release handle.
  • the distal end of the traction collection piece is fixedly connected to a plurality of the traction rods.
  • the proximal end is fixedly connected with the traction handle
  • the distal end of the release collection piece is connected with a plurality of the release wires
  • the proximal end of the release collection piece is fixedly connected with the release handle, the traction rod
  • the traction collection piece and the traction handle constitute a traction assembly
  • the release wire, the release collection piece and the release handle constitute a release assembly
  • the release assembly is located in the traction assembly, the release assembly and the traction
  • the components can move relatively.
  • the distal end of the release wire abuts against the proximal side of the implantation device, or the distal end of the release wire passes through a first The hole or the second hole provided on the traction rod extends proximally into the release collecting member.
  • the delivery system further includes a sheath assembly disposed outside the traction assembly, the sheath assembly including a sheath and a sheath handle that is sealed and fixedly connected to the proximal end of the sheath.
  • the delivery system further includes a loading sheath, the loading sheath is used to recover the connected implant device, the traction assembly, and the release assembly, and hold it in the loading sheath.
  • the loading sheath can be inserted into the loading sheath. In the sheath handle or in the sheath.
  • the restraining member is a restraining hole provided on the traction rod and passing through the traction rod.
  • the number of the restraint holes is an even number, and each of the release wires runs along the corresponding draw rod from the proximal end to the distal end in an S-shape and sequentially passes through the restraint holes, the The first hole and/or the second hole realize a detachable connection between the implantation device and the delivery system.
  • the center distance of two adjacent restraint holes is 1mm-20mm.
  • the center distance between the second hole and the adjacent restraining hole is 1 mm-20 mm.
  • the space defined by the plurality of tow bars and the second flexible section is cone-shaped, bowl-shaped or lantern-shaped.
  • the release wire is a shape memory alloy wire, and the wire diameter of the release wire is 0.05 mm-1 mm.
  • the restraint member is a restraint tube with a hollow tubular structure
  • the restraint tube is sleeved outside the traction rod
  • the inner cavity of the restraint tube can simultaneously accommodate at least one traction rod and one traction rod.
  • the release wire enables the release wire to pass through the inner cavity of the restraint tube and slide in the cavity of the restraint tube.
  • the restraint member is one or more restraint rings
  • the restraint rings are sleeved on the outer surface of the distal end region of the traction rod, and the restraint rings are fixedly connected with the release wire, so that the return The release wire is drawn, and the restraint ring and the release wire can slide along the traction rod under the action of the retraction force.
  • the first hole provided on the implantation device and the second hole provided on the traction rod in this application can be inserted and matched with each other, and the S-shaped release wire passes through the restraint, the first hole or the second hole in turn to realize the implantation device
  • the connection and assembly with the delivery system not only can be recycled in time before the implantation device and the delivery system are disassembled, the implantation device and the delivery system can be completed by pulling back the release wire after the implantation device is completely released It also makes the implantation device and the delivery system crimped and loaded into the sheath, pushed to the target position through the sheath, stretched at the target position, and connected and disassembled.
  • the series of processes are slow and continuous, which can be controlled. freed.
  • a second hole is provided on the traction rod to facilitate connection, on the other hand, it can guide the release wire during disassembly, so that the release wire can move along the traction rod to avoid knotting or entanglement of the release wire, and realize the connection between the implantation device and the delivery system. And the controllability of disassembly.
  • a binding member is provided on the traction rod.
  • the binding member can ensure the fit of each release wire to the corresponding traction rod.
  • the benefits that this brings include: a) When the implanted device and the delivery system are in an assembled connection state No matter when the implanted device is crimped, loaded in the sheath of the delivery system, and pushed to the target location, or when the implanted device is gradually released from the sheath, until it is fully stretched to the best shape, Ensure that the release wires remain independent of each other, and avoid multiple release wires that may be knotted or entangled with each other, resulting in the release wire cannot be withdrawn; b) During the operation of releasing the implanted device, when the operator pulls back the release wire When the traction rod and the binding member cooperate with each other to provide a guiding effect for the uniform transmission of the withdrawal force on the release wire, so as to ensure that the distal ends of the multiple release wires can be withdrawn from the first hole or the second hole smoothly and synchronously,
  • the application is provided with a flexible section, so that: a) It is convenient to insert and detach the connecting part at a suitable angle, so as to realize the controllable disassembly of the connecting part of the implanted device and the delivery system, and can effectively prevent the implanted device from After the delivery system is disconnected, the stab wounds to the surrounding tissues of the target location due to the distal rebound; b) After the implanted device is connected to the delivery system, due to the certain deformability, the part of the mating connection has a certain degree of flexibility.
  • Compressibility when the implanted device is loaded in the sheath, the minimum inner diameter of the sheath can be reduced, reducing the damage to the patient’s access, and also expanding the scope of application of the product; secondly, this compressibility makes the mating connection part and The size of the inner cavity of the sheath is more compact, so that no relative movement occurs between the matched parts, which helps to enhance the ease, continuity and controllability of the implantation device's push and release process.
  • the flexible section is the first flexible section, it also has the following advantages: a) When the implanted device is placed on the target and released, since the distal end of the flexible section of the implanted device is pulled and bound by the traction rod and the release wire, Make the entire release process of the implanted device slow, continuous and controllable; b) After the implanted device is completely released, the flexible section can increase the contact area and fit effect between the implanted device and the target location (such as atrial septal tissue), which is beneficial to The formation of endothelialization on the surface of the implanted device; c) Effectively avoid the local irritation reaction of the edge of the implanted device to the tissue and improve the biocompatibility.
  • the target location such as atrial septal tissue
  • the flexible section When the flexible section is the second flexible section, it also has the advantage of avoiding excessive movement of the traction rod to the distal end due to improper operation, thereby poking the target tissue, causing a local tissue reaction, or puncturing the implanted device, which affects the effectiveness of the device. advantage.
  • a protrusion is provided on the flexible section, which can limit the relative position between the implantation device and the delivery system after they are connected, so that when the implantation device and the delivery system are assembled, they are placed in the sheath and are pushed and removed. During the release process from the sheath, it is ensured that the connection and mating part does not undergo relative displacement in the axial direction, which provides sufficient guarantee for the controllable release.
  • the release wire of the present application has good resilience or bending resistance. This design enables: a) to effectively avoid the self-locking or jamming phenomenon of the connection part of the implanted device and the delivery system due to relative movement, resulting in The release wire cannot be withdrawn from the first hole and/or the second hole smoothly, and thus cannot realize the detachability of the connection and the controllable release function; b) to ensure the accurate positioning of the implanted device at the target position, and avoid the traditional technology The implanted device moves back with the withdrawal of the delivery sheath, so it can achieve a controlled release.
  • the surface of the implant device of the present application is covered with a film, which has a physical isolation effect, so that when the distal end of the release wire is located on or passes through the proximal side of the implant device, it will never touch the animal body or human tissue , To ensure that the controllable release process has sufficient safety.
  • Fig. 1 is a state where the implantation device is placed at the target position in the first embodiment, but the implantation device and the delivery system are not disassembled.
  • 2A-2D are partial schematic diagrams of the connecting part of the implanted device and the delivery system when the connection is not disassembled and released;
  • Fig. 2A, Fig. 2B, Fig. 2C and Fig. 2D respectively show the connection structure of four different embodiments.
  • Fig. 3A is a schematic diagram of a state in which the implantation device is placed at the target position but the connection with the delivery system is not disassembled when the binding member is a binding hole in the first embodiment.
  • Fig. 3B is a schematic diagram of the state after the connection between the implantation device and the delivery system in Fig. 3A is disassembled.
  • Figure 4A is a schematic diagram of the implanted device in the third embodiment placed at the target position, but the connection is not detached and released, where the distal end of the traction wire is placed at the proximal face of the implanted device, and a'and b'in the figure are implanted The state of the instrument and delivery system before disassembly.
  • 4B is a schematic diagram of the disassembly and separation of the implantation device and the delivery system in the third embodiment, and a and b in the figure are the states after the disassembly of the implantation device and the delivery system.
  • Fig. 4C is a schematic diagram of the implanted device in the third embodiment placed at the target position, but the connection is not detached and released, in which the distal end of the release wire is placed in the traction collecting piece.
  • Fig. 4D is a schematic diagram of the structure when the binding member in the third embodiment is a binding ring.
  • FIG. 5A-5H are schematic diagrams of the process in which the controlled release system in the second embodiment is placed in the sheath and gradually released, in which, FIG. 5A is the state in which the controlled release system in the second embodiment is placed in the loading sheath; FIG. 5B This is the state in which the controllable release system in the second embodiment is pushed to the distal end of the sheath through the loading sheath; Fig. 5C is the state in which the sheath is pushed to the target location of the atrial septum, but the implanted device is still placed in the sheath; Fig.
  • FIG. 5D is On the basis of Figure 5C, push the handle of the distal end of the traction collection piece to push the left disk of the implantation instrument out of the sheath;
  • Figure 5E shows the state of retracting the handle of the distal end of the sheath on the basis of Figure 5D, which will release The post-deployed left disc is placed in the left atrium area of the interatrial septum and fits the target position;
  • Figure 5F shows the state of further pushing the handle of the distal end of the traction assembly, pushing the entire implanted device and the traction rod out of the sheath;
  • Fig. 5G is based on Fig.
  • Fig. 5F further pushing the handle of the distal end of the traction collection piece, so that the right disk of the implanted device is placed on the right atrial side area of the atrial septum, and fits the target position;
  • Fig. 5H is along the arrow direction in the figure Withdraw the release handle, the implanted device and the delivery system are connected and detachable.
  • Fig. 6 is a schematic plan view showing the unfolding of the traction rod and the traction collecting piece as an integrated structure.
  • FIG. 7A and 7B are schematic diagrams of the structure of the space defined by the traction rod and the traction collecting piece at the proximal end of the traction rod, wherein FIG. 7A is a bowl shape, and FIG. 7B is a cone shape.
  • FIGS. 8A and 8B are schematic diagrams of the structure of the traction assembly and the release assembly in a natural state, respectively.
  • Fig. 9 is a schematic diagram of an elastic perforating stent provided with a series line and forming a closed coil structure.
  • Fig. 10 is a schematic diagram of an elastic hole-making stent covered with a film.
  • proximal and distal are defined herein, and the above-mentioned terms are common terms in the field of medical devices. Specifically, the “proximal end” refers to the end close to the operator during the operation, and the “distal end” refers to the end far away from the operator during the operation.
  • the controllable release system provided by the present invention includes an implantation device 1 and a delivery system 2.
  • the proximal region of the implant device 1 is provided with a plurality of first holes 1111
  • the delivery system 2 includes a plurality of traction rods 211 and a plurality of release wires 220, a plurality of release wires 220, a plurality of traction rods 211, and a plurality of first holes 1111 is one-to-one in number and position.
  • Each traction rod 211 is provided with a second hole 2111 and a binding member 210.
  • the second hole 2111 is located at the distal end of the traction rod 211, and the binding member 210 is located at the second hole 2111.
  • the first hole 1111 provided on the implantation device 1 and the second hole 2111 provided on the traction rod 211 can be inserted and fitted with each other, and the release wire 220 passes through the binding member 210, the first hole 1111 or the first hole 1111.
  • the two holes 2111 realize the connection between the implantation device 1 and the delivery system 2.
  • the binding member 210 can restrict the movement of the release wire 220.
  • the release wire 220 can be displaced relative to the traction rod 211 .
  • a binding member 210 of various embodiments can be provided on the traction rod 211 at the proximal side of the second hole 2111.
  • the binding member 210 is disposed on the traction rod 211 and penetrates the traction rod 211.
  • the restraint hole 2100 is provided with an appropriate size and shape. In some embodiments, the restraint hole 2100 may be circular, oval, rectangular, paperclip-shaped, etc., so that the release wire 220 can pass through the restraint hole smoothly. 2100.
  • the release wire 220 passes through the restraint hole 2100 on the corresponding traction rod 211 and is inserted into the first hole 1111, as shown in FIG.
  • the release wire 220 passes through the restraint hole After 2100, it can also be inserted into the second hole 2111, as shown in Figure 2A.
  • the design of the additional restraint hole 2100 ensures the fit of each release wire 220 and the corresponding traction rod 211, which brings many benefits, including: a) When the implantation device 1 and the delivery system 2 are in the assembled connection state, no matter in the implantation state While the implantation device 1 is crimped, loaded into the sheath 230 of the delivery system 2 and pushed to the target position, the implantation device 1 is gradually released from the sheath 230 until it is fully stretched to the optimal shape.
  • connection detachability and release controllability of the implantation device 1 and the delivery system 2 are realized, the overall structure is simple, the operation is convenient, and it is safe and reliable.
  • the second hole 2111 is provided on the traction rod 211 in the present invention on the one hand to facilitate connection, and on the other hand, it can guide the release wire 220 when disassembling, so that the release wire 220 can move along the traction rod 211 to avoid knotting of the release wire 220 Or winding to realize the controllability of the connection and detachment of the implantation device 1 and the delivery system 2.
  • Each traction rod 211 can be visualized with the corresponding traction rod 211's maximum fit requirement, and one or more restraint holes 2100 are provided.
  • the hole distance L1 between the 2111 and the adjacent restraint holes 2100 can be specifically set according to the requirements of the length of the traction rod 211 according to the specific application.
  • the restraints located at adjacent positions The hole spacing L2 of the holes 2100 should be preferably set to 1mm-20mm.
  • the center distance L1 of the second hole 2111 and the adjacent binding holes 2100 can also be set to 1mm-20mm.
  • the release wire 220 is passed from the proximal end to the distal end, and passes through the corresponding traction rod 211 in an S-shape. Then, the distal end of the release wire 220 passes through the first hole 1111 at the proximal end of the implantation device 1 or the second hole 2111 provided on the traction rod 211, and finally abuts against the proximal end of the implantation device 1.
  • the connection and assembly of the implantation device 1 and the delivery system 2 can be easily realized, as shown in FIG. 3A.
  • connection method is a direct connection, not an indirect connection as described in the background art. Unless the operator actively retracts the release wire 220, this assembly connection will only be disassembled. Therefore, a series of surgical operations are performed before the release wire 220 is retracted.
  • the middle connection is safe and reliable, and it also ensures the smooth operation of the entire operation, including: pulling back the traction rod 211, the implanted device 1 that has been produced and fully deployed can be crimped and loaded into the sheath of the delivery system 2 outside the body.
  • the implant device 1 can be pushed to the target position along the lumen track of the sheath 230; then the sheath 230 is withdrawn, and the implant device 1 is stretched from the distal end of the sheath 230 . It is precisely because of the high degree of safety and reliability of this assembly connection that it can be withdrawn again at any time before the connection is removed, including when the implanted device 1 has been placed at the target position and fully deployed. It enters into the sheath 230 of the delivery system 2 to realize the function of repeated recovery in time.
  • this timely and repeatable recovery allows the operator to switch to other implant equipment specifications during the operation until the selection is appropriate and the release state at the target location is the best, thus ensuring that the operation has a sufficiently high effectiveness.
  • this connection method enables the implantation device 1 and the delivery system 2 to be crimped and loaded into the sheath 230, pushed to the target position through the sheath 230, and stretched at the target position and connected and disconnected. The series of processes are slow and continuous. , Reach a controlled release.
  • the first hole 1111 provided on the implantation device 1 and the second hole 2111 provided on the traction rod 211 can be inserted and fitted with each other, after the implantation device 1 is fully deployed from the sheath 230, the operator withdraws The release wire 220 can complete the disassembly of the implantation device 1 and the delivery system 2, so that the controllable release is finally ensured.
  • the traction rod 211 has a dual-cavity or multi-cavity structure, and the release wire 220 is placed in one cavity of the dual-cavity or multi-cavity structure.
  • the conveying system 2 may further include a traction and collection piece 212, a traction handle 214, a release collection piece 221, and a release handle 224.
  • the distal end of the traction collection piece 212 is fixedly connected to a plurality of the traction rods 211, and the traction collection piece 212
  • the proximal end of the release and collection member 221 is fixedly connected to the traction handle 214, the distal end of the release collection member 221 is connected to the plurality of release wires 220, and the proximal end of the release collection member 221 is fixedly connected to the release handle 224. As shown in FIG.
  • the traction rod 211, the traction collecting member 212 and the traction handle 214 constitute the traction assembly 21; as shown in FIG. 8B, the release wire 220, the release collecting member 221 and the The release handle 224 constitutes a release assembly, the release assembly 22 is located in the traction assembly 21, and the release assembly 22 and the traction assembly 21 can move relatively.
  • the traction collection piece 212 is arranged at the proximal end of the multiple traction rods 211, and is used to gather and gather the proximal ends of all the traction rods 211. Finally, the proximal ends of all the traction rods 211 and the traction collection piece 212 are integrated and fixedly connected to ensure that all the traction rods 211 are integrated and fixed.
  • the mutual spatial positions of the traction rods 211 remain unchanged, so that when the implantation device 1 and the delivery system 2 are in the assembled connection state, no matter when the implantation device 1 is crimped or loaded in the sheath 230 of the delivery system 2, Or in the process of pushing the sheath 230 to the target position, as shown in Fig. 5, or in the process of each moment when the implantation device 1 is gradually released from the sheath 230, and even fully stretched to the best shape, such as As shown in FIG. 1, it is ensured from the beginning to the end that all the traction rods 211 and the corresponding release wires 220 are kept independent of each other.
  • the traction collecting member 212 has a hollow tubular structure, and its internal lumen can accommodate all the release wires 220 and enable all the release wires 220 to slide smoothly in the cavity.
  • the traction collecting piece 212 and the traction rod 211 can be made of cobalt-chromium alloy tube or nickel-titanium alloy tube material with shape memory function through integral cutting and heat treatment. It is not only convenient for processing and production, but also can maintain high Coaxiality.
  • the traction handle 214 provided at the proximal end of the traction collection piece 212 facilitates the operator to control the traction handle 214 to realize the controllability of the pushing process and the withdrawal process of the implantation device 1 and the delivery system 2.
  • the release and collection piece 221 is arranged at the proximal ends of the plurality of release wires 220 to gather and gather the proximal ends of all the release wires 220, and finally realize the connection between the proximal ends of all the release wires 220 and the release collection piece 221.
  • all the release wires 220 at the distal end of the release collection piece 221 can be retracted synchronously, thereby realizing the first hole 1111 of the implantation device 1 and the second hole 1111 of the delivery system 2
  • the hole 2111 is detachable, as shown in Figure 3B.
  • the release and collection member 221 is a hollow tubular structure, the inner diameter of which forms a transitional fit with the diameter of all the release wires 220 after being gathered, and the outer diameter is smaller than the inner diameter of the traction and collection member 212.
  • the proximal end of the multiple release wires 220 and the distal end of the release collecting member 221 are fixedly connected by welding, bonding or mechanical fitting.
  • the distal end of the release collecting member 221 is provided with the same number of connection holes as the release wires 220, and multiple release wires 220 pass through the corresponding connection holes 2210 to realize the connection between the release wires 220 and the release collecting member 221.
  • Nitinol wires with a certain length and good resilience. Each Nitinol wire passes through two adjacent connecting holes 2210 and extends from the connecting holes 2210. The wire forms the release wire 220.
  • This structure can also achieve the same effect and has the following advantages: a) It is beneficial to save the arrangement space of the connecting hole 2210 on the release collection piece 221, thereby reducing the outer diameter of the release collection piece 221 ; B) The multiple release wires 220 can be as close as possible to the multiple traction rods 211, shorten the length of the release wires 220, and improve the coaxiality between the release wires 220 and the traction rod 211 as much as possible; c) Avoid the traditional connection process, including welding, bonding or mechanical fitting and other connection methods to damage the material and may cause the risk of breaking and falling off.
  • the wire diameter of the release wire 220 is selected from 0.05mm-1mm, and the specific wire diameter size selected should be smaller than the minimum size of the first hole 1111 and the second hole 2111, and the number of the release wire 220 And the position corresponds to the multiple traction rods 211 one by one.
  • the release wire 220 should be inflexible. The inflexibility here is defined as good resilience or bending resistance, not flexibility. This design has the following advantages: a) Effective It is avoided that the connection part of the implantation device 1 and the delivery system 2 may move relative to each other and cause self-locking or jamming.
  • the release wire 220 cannot be withdrawn smoothly from the first hole 1111 and/or the second hole 2111, and then It is impossible to realize the detachability and controllable release function of the connection; b) to ensure the accurate positioning of the implanted device 1 at the target position, avoid the traditional technology of the implanted device 1 to have no limit in the direction along the traction rod 211, so that the implant The insertion device 1 moves back as the delivery sheath 230 is withdrawn, so that a controllable release is achieved.
  • a flexible section is provided in the proximal region of the implant device 1 and/or the distal region of the traction rod 211, and the flexible section provided in the proximal region of the implant device 1 is called the first flexible section 1110.
  • a hole 1111 is provided in the proximal region of the first flexible section 1110; the flexible section provided in the distal region of the traction rod 211 is called the second flexible section 2110, and the second hole 2111 is provided at the far end of the second flexible section 2110. ⁇ The end area.
  • the second flexible section 2110 of the distal end of the traction rod 211 can be inserted into the first hole 1111 of the proximal edge of the implant device 1 from the outside to the inside, and the release wire 220 passes through the restraint 210 and the second hole in turn. 2111, as shown in FIG. 2A, realizes the detachable connection of the implantation device 1 and the delivery system 2; in another embodiment, the first flexible section 1110 at the proximal end of the implantation device 1 can be inserted into the traction rod 211 from the outside to the inside. In the second hole 2111 at the distal end, the release wire 220 sequentially passes through the restraint 210 and the first hole 1111 to realize the controllable connection and controllable disassembly of the implantation device 1 and the delivery system 2.
  • the controllable release system is provided with a flexible section.
  • the flexible section includes a first flexible section 1110 and a second flexible section 2110.
  • the flexible section has the following advantages: a) It is convenient to fit the connection part at a suitable angle Perform interpenetrating fit and disengagement, so as to realize the controllable disassembly of the connection part of the implantation device 1 and the delivery system 2, and can effectively prevent the implantation device 1 and the delivery system 2 from being disconnected from the connection between the implantation device 1 and the delivery system 2. Tissue puncture; b) After the implantation device 1 and the delivery system 2 are matched and connected, as shown in Fig. 3A, due to the certain deformability, the matched connection part has a certain degree of compressibility.
  • the minimum inner diameter of the sheath 230 used can be reduced, which reduces the damage to the patient’s approach, and also expands the scope of application of the product; secondly, this compressibility makes it possible to fit the connecting part with the inner cavity of the sheath 230
  • the size fits of the device are more compact, so that there is no relative movement between the mating and connected components, which helps to enhance the ease, continuity and controllability of the implantation device 1’s pushing and releasing process.
  • the flexible section is the first flexible section 1110, it also has the following advantages: a) When the implanted device 1 is placed at the target position and released, the distal end of the flexible section 102 of the implanted device is received by the traction rod 211 and released.
  • the pulling and binding of the wire 220 makes the entire release process of the implantation device 1 slow, continuous and controllable; b) as shown in Figure 3B, after the implantation device 1 is completely released, the flexible section 102 can increase the implantation device 1 and The contact area and fitting effect of the target location (such as the atrial septal tissue, AS shown in Figure 3B) are conducive to the formation of endothelialization on the surface of the implanted device 1; c) effectively avoid local irritation of the tissue by the edge of the implanted device 1 Reaction to improve biocompatibility.
  • the target location such as the atrial septal tissue, AS shown in Figure 3B
  • the flexible section is the second flexible section 2111, it can also prevent the traction rod 211 from excessively moving to the distal end due to improper operation, thereby poking the target tissue, causing a local tissue response, or puncturing the implantation device 1 and affecting the implantation. Advantages of the effectiveness of device 1.
  • a protrusion 1112 is provided on the first flexible section 1110, and the protrusion 1112 is located on the distal side of the first hole 1111 to define the implantation device 1 and the The relative position between the two after the delivery system 2 is connected, or a protrusion 2112 is provided on the second flexible section 2110, and the protrusion 2112 is located at the proximal side of the second hole 2111 to limit the implantation The relative position between the device 1 and the delivery system 2 after they are connected.
  • the protrusion can ensure that the connecting part does not have relative displacement in the axial direction, which is controllable The release provides sufficient protection.
  • the outer edge of the protrusion 1112 or 2112 should be a smooth transition without affecting the sheathing, so that the implantation device 1 can be smoothly crimped and loaded into the sheath 230.
  • the first flexible section 1110 has both good resilience and certain rigidity, and the rigidity here is sufficient to make the implantation device 1 and the delivery system 2 cooperate and be loaded in the sheath 230 to push the delivery system 2
  • the implantation device 1 can also make timely mechanical response and reciprocal movement, so it is ensured that the implantation device 1 can be pushed into the target position through the sheath 230;
  • the resilience makes the implantation device 1 and the delivery system 2 connect and disassemble, the implantation device 1, especially the proximal region of the implantation device 1 near the first hole 1111, can conform to various anatomical shapes
  • the target tissue surface therefore ensures that the implantation device 1 has a wide range of applicability.
  • the first flexible section 1110 of the proximal region of the implantable device 1 may adopt a necking structure or be locally heat-treated to make it flexible, and the rod width L8 is not greater than the second flexible section 2110 corresponding to the second section.
  • the minimum part size L3 of the hole 2111 is such that the first flexible section 1110 can be inserted into the second hole 2111 from the outside to the inside, as shown in FIG. 2B. After insertion, the central axis of the first flexible section 1110 and the central axis of the second flexible section 2110 are between 1° and 80°.
  • the first hole 1111 at the distal end of the first flexible section 1110 of the implantation device is located between the multiple traction rods 211 and the implant.
  • the wire diameter of the release wire 220 is not larger than the size of the smallest part of the first hole 1111, and runs from the proximal end to the distal end along the corresponding traction rod 211, and passes through all the binding holes 2100 on the corresponding traction rod 211 in an S-shape. Then, the distal end of the release wire 220 passes through the first hole 1111 located in the space enclosed by the multiple traction rods 211 and the proximal surface of the implant device 1; finally, its distal end is placed on the proximal surface of the implant device 1.
  • the distal end of the release wire 220 passes through the first hole 1111 provided in the proximal region of the implantation device 1 and then extends proximally into the traction collecting member 212, thereby achieving the controllability of the implantation device 1 and the delivery system 2 Release the connection.
  • the stroke of retracting the release wire 220 is shortened, which is convenient for the operator to withdraw the release wire 220; when the distal end of the release wire 220 passes through
  • the first hole 1111 in the proximal region of the implantation device 1 extends proximally into the traction collection piece 212, it can be avoided that the distal end of the release wire 220 touches the target tissue during the entire process of withdrawing the release wire 220 , To ensure the safety of the release process.
  • the first flexible section 1110 of the proximal region of the implantable device 1 can also adopt a spring structure.
  • the spring structure has the following advantages: a) The spring itself is a hollow structure, and its inner cavity can be set as the first hole 1111, so in the first The distal end of the flexible section 1110 does not need to be provided with the first hole 1111; b) the distal end of the release wire 220 can be placed in the first flexible section 1110, which not only makes the multiple release wires 220 have independent channels, but also reduces the release The distal end of the wire 220 scratches the proximal surface of the implanted device 1 causing the risk of poor corrosion resistance, and at the same time, avoids the distal end of the release wire 220 from piercing the tissue at the target location (for example, the right atrial surface of the atrial septum mentioned later) and causing accidental injury; c) The longitudinal cross-sectional area of the spring structure is large, which can increase the visualization effect during the operation.
  • the first flexible section 1110 in the proximal region of the implant device 1 is an equal-diameter spring, and the distal end of the spring passes through the first flexible section at the edge of the proximal surface of the implant device 1.
  • a hole 1111 is fixedly connected to the first hole 1111, or the distal end of the spring is directly fixed to the edge of the proximal surface of the implantation device 1.
  • the inner cavity of the spring can at least accommodate the second flexible section 2110 at the distal end of the traction rod 211 and a release wire 220, so that the second flexible section 2110 can smoothly pass through the entire spring; after insertion, the distal end of the second flexible section 2110
  • the second hole 2111 is located outside the inner cavity of the distal end of the spring.
  • the first flexible section 1110 in the proximal region of the implantation device 1 is a series spring, and the series spring is composed of two equal-diameter springs with different inner diameters.
  • the spring at the distal end of the first flexible section 1110 is connected to the edge of the proximal surface of the implantation device 1, and the spring cavity at the proximal end of the first flexible section 1110 can at least accommodate the second flexible section 2110 at the distal end of the traction rod 211 and a release
  • the wire 220 allows the second flexible section 2110 and the release wire 220 to smoothly pass through the inside of the spring at the distal end of the first flexible section 1110; after insertion, the second hole 2111 at the distal end of the second flexible section 2110 is located between the two series springs Area.
  • the first flexible section 1110 has a double-cavity structure.
  • One cavity is used for fixed connection with the support rod 111 of the implantation device 1, and the other cavity is used for accommodating the distal end of the release wire 220. It can achieve the same effect as the first embodiment.
  • the first flexible section 1110 has a hinge structure and an S-wave structure. Compared with the above-mentioned embodiment, these structural designs not only have better flexibility, but also have better mechanical transmission properties. The mechanical response such as axial tension and pressure is timely, which is more helpful to control the pushing and release of the implantation device 1 in the sheath 230.
  • the first flexible section 1110 is made of a material with a shape memory function, or the first flexible section 1110 is made of a material with elasticity, which facilitates the integral manufacturing and molding of the first flexible section 1110 together with the implant device 1. , To avoid the risk of connection failure caused by the introduction of other connections between the two, of course, this is also conducive to shortening the production cycle and mass production.
  • the second flexible section 2110 in the delivery system 2 can adopt the same or similar structural design as the first flexible section 1110 on the implantation device 1.
  • the second flexible section 2110 can also be arranged to prevent the traction rod 211 from moving far away due to improper operation. Excessive movement of the tip, thereby poking the target tissue, causing a local tissue reaction, or puncturing the implant device 1, which affects the effectiveness of the device 1.
  • the space defined by the traction rod 211 and the second flexible section 2110 may be cone-shaped (as shown in FIG. 7B), bowl-shaped (as shown in FIG. 7A), or lantern-shaped (not shown), etc., to further reduce the transport system 2 Risk of piercing the target tissue distally.
  • the traction rod 211 in the delivery system 2 should be selected to have good resilience to meet the requirements of the present invention for various product access routes, especially when used for interventional surgery, the product access route is animal or human.
  • the body's own vascular system, and the vascular system usually has tortuous characteristics, which requires products, including the traction rod 211, to be designed with good shape adaptability and resilience.
  • the implanted device 1 reaches the target position such as the interatrial septum and fits the target position, at this time, the doctor observes the shape and the shunt of the implanted device 1 by means of angiography to determine the implanted device 1 Expanded form and placement position. If the effect is not satisfactory, the traction handle 214 can be retracted or the sheath 230 can be pushed forward before the mating connection is disassembled, and the fully deployed implant device 1 that has been placed at the target position can be retracted into the delivery system 2 again. In the sheath 230, the implantation device 1 is recovered and withdrawn from the body, and the specification is changed or the operation is ended as the case may be.
  • the retraction force is evenly transmitted on the release wire 220 through the interaction of the traction rod 211 and the binding member 210, so that multiple pieces are released.
  • the distal end of the wire 220 can be withdrawn from the first hole 1111 or the second hole 2111 smoothly and synchronously.
  • the first flexible section 1110 of the implantation device 1 is synchronously separated from the second hole 2111 at the distal end of the traction rod 211, or the distal end of the traction rod 211
  • the second flexible section 2110 synchronously detaches from the first hole 1111 at the distal end of the implantation device 1, thereby completing the controllable disassembly of the implantation device 1 and the delivery system 2, and finally achieving the controllable release of the implantation device 1.
  • the implantation device 1 is an elastic orifice stent 11 that can be placed at the interatrial septum, and the delivery system 2 is used to remove the elastic orifice stent 11 from Delivery outside the body and controlled release to the atrial septum.
  • the elastic foramen stent 11 is formed by connecting a plurality of support rods 111 to form a three-dimensional wave-like and/or mesh-like structure.
  • the three-dimensional wave-like and/or mesh-like structure includes a left disc that fits with the atrial septal surface in the left atrial cavity.
  • the right disc that fits the atrial septal surface in the right atrium cavity and the waist that is arranged between the left disc and the right disc and fixedly connects the left disc and the right disc.
  • a through hole is provided in the waist, and the through hole makes the left
  • the atrium and the right atrium can be in fluid communication
  • the longitudinal cross section of the elastic foraminous stent 11 is an I-shaped
  • the circumferential area of the right disc is provided with a first flexible section 1110
  • the first hole 1111 is located at the distal end of the first flexible section 1110.
  • the elastic hole-making stent 11 is formed by laser cutting and heat treatment of a shape memory alloy tube.
  • the edges of the left disk and the right disk are all enclosed in a circle, the diameter of the left disk is in the range of 12mm-40mm, and the diameter of the right disk is in the range of 12mm-40mm.
  • the diameter of the through hole is 3mm-15mm, and the axial height of the through hole is 1mm-15mm.
  • the conveying system 2 includes at least a plurality of traction rods 211 corresponding to the first hole 1111, a traction collection piece 212 fixedly connected to the proximal ends of all traction rods, a traction handle 214 fixedly connected to the proximal ends of the traction collection piece 212, and more A release wire 220 corresponding to the traction rod 211, a release collection member 221 fixedly connected to the proximal end of the release wire 220, and a release handle 224 fixedly connected to the proximal end of the release collection member 221, as shown in FIG. 1.
  • the traction rod 211, the traction collection piece 212 and the traction handle 214 constitute the traction assembly 21
  • the release wire 220, the release collection piece 221 and the release handle 224 constitute the release assembly 22, and the release assembly 22 is located in the traction assembly. 21, and the release assembly 22 and the traction assembly 21 can move relatively.
  • the multiple traction rods 211 provided in the distal region of the traction assembly 21 should be circularly rotationally symmetrical around the central axis of the traction assembly 21 and diverge distally.
  • the axis of each traction rod 211 is the same as that of the traction assembly 21.
  • the central axis is coplanar, a second flexible section 2110 is provided at the distal end area of each traction rod 211, and a second hole 2111 is provided at the distal end of the second flexible section 2110.
  • the shapes of the second hole 2111 and the first hole 1111 are paper clips with smooth edges.
  • the traction rod 211 is flat, and the number of rods is 3-20. The more the number of rods, the better the roundness, but the number of rods is not easy to be too many, otherwise the overall size of the conveying system 2 will be too large. Therefore, the number of traction rods 211 in the present invention should be set to 6-12.
  • the rod width L7 of the traction rod 211 should be set to 0.2mm-2mm, and the rod length is 5-100mm.
  • the number of binding holes 2100 varies according to the length of the traction rod 211. In some embodiments, every two adjacent binding holes
  • the hole spacing L2 of the holes 2100 is 2-20 mm.
  • the wire diameter L9 of the release wire 220 is 0.1-1 mm, and the wire diameter L9 is not greater than the minimum hole width L10 or L3 of the first hole 1111 and the second hole 2111, and the number and position are the same as those of the multiple draw rods 211.
  • the proximal ends of a plurality of release wires 220 are gathered into a bundle and placed in the release collection member 221, or the release wires 220 pass through the connection hole provided at the distal end of the release collection member 221 to realize the connection between the release wires 220 and the release collection member 221 .
  • the release wire 220 passes through all the binding holes 2100 on the corresponding traction rod 211 in an S-shape from the proximal end to the distal end, and then passes through the space defined by the multiple traction rods 211 and the right disk surface of the elastic perforated bracket 11 The first hole 1111 or the second hole 2111 of the hole, so as to realize the detachable connection and controllable release of the elastic hole-making stent 11 and the delivery system 2.
  • the first flexible section 1110 at the distal end of the right disc edge of the elastic orifice stent 11 adopts a necking structure or is locally heat-treated to make it flexible.
  • a protrusion 1112 is provided on the first flexible section 1110. As shown in FIG. 2B, the protrusion 1112 is located on the distal side of the first hole 1111. The thickness of the protrusion 1112 is not less than the hole length L3 of the second hole 2111. The distance between the protrusion 1112 and the first hole 1111 is 0.2 mm-3 mm, so as to effectively limit the relative position between the implantation device 1 and the delivery system 2 after they are connected.
  • the rod width L8 of the first flexible section 1110 is smaller than the hole width L3 of the second hole 2111, so that the first flexible section 1110 can be inserted into the second hole 2111 from the outside to the inside.
  • the central axis of the first flexible section 1110 and the central axis of the second flexible section 2110 are between 1° and 80°, and the first hole 1111 at the distal end of the first flexible section 1110 is located in the multiple traction rods 211 In the space enclosed by the right plate surface of the elastic hole-making bracket 11.
  • the wire diameter L9 of the release wire 220 is smaller than the width L10 of the first hole 1111, and runs from the proximal end to the distal end along the corresponding traction rod 211, and sequentially passes through all the restraining holes 2100 on the corresponding traction rod 211 in an S-shape.
  • the distal end of the release wire 220 passes through the first hole 1111 in the space enclosed by the multiple traction rods 211 and the right disc surface of the elastic perforating bracket 11; finally, its distal end is placed on the right disc surface of the elastic perforating bracket 11
  • One side, or the release wire 220 extends proximally into the traction collecting member 212 in the area on the right disc surface of the elastic orifice stent 11 to realize the detachable connection between the elastic orifice stent 11 and the delivery system 2.
  • the flexible section 1110 and/or 2110 has a certain deformability, so that the mating connection part has a certain degree of compressibility.
  • the inner diameter of the sheath tube 230 used can be reduced, and the damage to the patient's access path can be reduced, and the fitting connection part and the inner cavity of the sheath tube 230 can be more compactly matched. As shown in FIGS.
  • the implantation device 1 and the delivery system 2 are placed in the sheath 230 and pushed from the proximal end of the sheath 230 to the distal end of the sheath 230, and are introduced to the target location through the sheath 230 ,
  • the protrusion 1112 located on the first flexible section 1110 and on the distal side of the first hole 1111 can play a limiting role to ensure that the mating and connected components do not undergo relative displacement in the axial direction.
  • the traction handle 214 is slowly pushed, and the distal end of the implantation device 1 is slowly pushed out of the sheath 230 and gradually stretched, as shown in FIG. 5D.
  • the sheath handle 231 is slowly withdrawn to the proximal end, and the distal end of the deployed implantation device 1 is slowly placed at the target position, and is attached to the target tissue, as shown in FIG. 5E. Then, further slowly push the traction handle 231 to the distal end, so that the entire implantation device 1 and the distal end of the traction rod 211 are gradually pushed out of the sheath 230.
  • the flexible section The distal end is pulled and restrained by the traction rod 211 and the release wire 220, so that the deployment process of the proximal end of the implantation device 1 and the distal end of the traction rod 211 are slow, continuous and controllable, as shown in FIG. 5F; further slowly push the traction handle 214. Push the entire traction rod 211 out of the sheath 230, so that the implantation device 1 and the traction rod 211 are gradually and completely unfolded, and the proximal end of the implantation device 1 is placed at the target position and fits the target position, as shown in the figure Shown in 5G.
  • the doctor observes the shape and the shunt of the implanted device 1 by means of angiography to determine the deployment shape and placement position of the implanted device 1. If the effect is not satisfactory, the traction handle 214 can be retracted or the sheath 230 can be pushed forward before the mating connection is disassembled, and the fully deployed implant device 1 that has been placed at the target position can be retracted into the delivery system 2 again. In the sheath 230, the implantation device 1 can be recovered and withdrawn from the body, and the specification can be changed or the operation can be terminated as appropriate.
  • the second flexible section 2110 at the distal end of the traction rod 211 adopts a necking structure to make it flexible, and forms an angle of 1°-80° with the corresponding first flexible section 1110.
  • a protrusion 2112 is provided on the second flexible section 2110. As shown in FIG. 6, the protrusion 2112 is located on the proximal side of the second hole 2111.
  • the protrusion width L12 is not less than the hole width L10 of the first hole 1111.
  • the distance L11 between the ridge 2112 and the second hole 1111 is 0.2mm-3mm to define the relative position between the implantation device 1 and the delivery system 2 after they are connected.
  • the rod width L5 of the second flexible section 2110 is not greater than the hole width L10 corresponding to the first hole 1111, so that the second flexible section 2110 can be inserted into the first hole 1111 from the outside to the inside, as shown in FIG. 2B.
  • the central axis of the first flexible section 1110 and the central axis of the second flexible section 2110 are between 1° and 80°, and the second hole 2111 at the distal end of the second flexible section 2110 is located in the multiple traction rods 211 and the elastic hole-making stent 11 In the space enclosed by the proximal face.
  • the wire diameter of the release wire 220 is not greater than the size of the smallest part of the second hole 2111, and runs from the proximal end to the distal end along the corresponding traction rod 211, and passes through all the restraining holes 2100 on the corresponding traction rod 211 in an S-shape.
  • the distal end of the release wire 220 passes through the second hole 2111 in the space enclosed by the plurality of traction rods 211 and the right disc surface of the elastic perforated support 11; finally, its distal end is placed on the right disc surface of the elastic perforated support 11 Or the release wire 220 extends proximally into the traction collecting member 212 in the proximal region of the right disk surface of the elastic foramen stent 11, so as to realize the detachable connection between the elastic foramen stent 11 and the delivery system 2.
  • the requirements for the rod width of the first flexible section 1110 of the elastic orifice stent and the aperture size of the first hole 1111 are lower, that is, the rod width and the first flexible section 1110 of the elastic orifice stent are relatively relaxed.
  • the aperture size of the hole 1111 makes the edge design of the proximal surface of the elastic hole 1111 more rounded. This design has two advantages, including: a) reducing the elastic hole 11 to the target tissue (such as the right atrial septal tissue) Irritation, and even the risk of physical damage; b) reduce the risk of thrombus formation on the edge of the right disc of the elastic orifice stent 11.
  • the film 13 should be made of biocompatible materials.
  • the material can include PET, PTFE, silica gel and other polymer materials.
  • the arrangement of the film 13 has the following advantages: a) The surface of the film 13 is smooth.
  • the friction coefficient is low, and it is convenient to repeatedly push and recycle from the sheath 230 to the sheath 230 during the operation, which is extremely beneficial to the introduction and controllable release of the elastic stent 11 through the sheath 230; b) prevent When the support rod 111 of the elastic hole-making stent 11 is made of nickel-titanium material, the toxicity, sensitization and teratogenicity caused by the precipitation of nickel ions may ensure the biological safety of the elastic hole-making stent 11; c) promote the elastic hole-making stent The endothelialization of the left and right discs of 11 makes the left and right discs grow into one body as quickly as possible with the surface of the target tissue, ensuring the firmness of the elastic perforating stent 11 to the target tissue at the interatrial septum; d) The film 13 has a physical isolation effect, so that when the distal end of the release wire 220 is located on or passes through the proximal side of the implantation device 1, the distal
  • both the inner surface and the outer surface of the elastic orifice stent 11 are completely covered with the film 13, so that the entire elastic orifice stent 11 has more excellent biocompatibility.
  • a series line 12 is provided on the edge of the left disc, the edge of the right disc and/or the waist of the elastic orifice bracket 11, and the series line 12 will pass through or wind around the support rod 111 of the elastic orifice bracket 11 so that The edge of the left disc, the edge of the right disc and/or the waist form a closed circle.
  • a plurality of connecting holes 1112 are provided along the circumferential direction on the edge of the mesh structure of the elastic orifice stent 11, as shown in FIG. 9 and FIG. 10, the elastic orifice stent 11 is provided with through all the connecting holes.
  • the serial wire 12 of the hole 1112, the diameter of the serial wire 12 is 0.02mm-1mm, the serial wire 12 can pass through the connecting hole 1112 in the circumferential direction, and pass through the corresponding first hole 1111 on each support rod 111 Finally, a closed loop coil 12 is formed.
  • the closed loop coil 12 facilitates the adhesion of the polymer film 13 to the surface of the stent 11, and at the same time avoids multiple sheathing of the implant device 1 and the edge film 13 of the stent 11 and the elastic perforation stent. 11
  • the fit of the two has an impact, ensuring the recyclability of the implanted device 1 for many times.
  • the material of the series line 12 used can include PTFE line, PET line, UHMWPE line made of polymer materials, so that the series line 12 has good flexibility, and can also include cobalt chromium made of metal materials.
  • Alloy filaments, nickel-titanium alloy filaments, pure tantalum filaments, and 316L filaments not only make the tandem wire 12 have a certain shape memory, but also improve the roundness of the left and right disks of the elastic orifice holder 11, and also make the elastic fabric
  • the perforated stent 11 has a certain visualization effect, which is convenient for the operator to use imaging equipment to observe and control the position and shape of the elastic perforated stent 11 in time during the operation, and to detect the follow-up after the operation.
  • the film 13 completely covers and wraps the entire inner surface and outer surface of the elastic perforation bracket 11, including all the support rods 111, all the first holes 1111, the series line 12, and all the first flexible sections 1110, so that the entire The elastic hole-forming stent 11 has more excellent biocompatibility.
  • the third embodiment is different from the first embodiment in that the binding member 210 is not a binding hole 2100 provided on the traction rod 211, but a binding tube 2101 or a binding ring 2102 is provided on the traction rod 211. .
  • the restraint member 210 is a restraint tube 2101 with a hollow tubular structure, the restraint tube 2101 is sleeved outside the traction rod 211, and the restraint tube 2101 is preferably made of FEP, PTFE, PE, or POE. , PET, silicone and other polymer tubes, the inner cavity of which can accommodate at least one traction rod 211 and one release wire 220 at the same time, which not only enhances the fit between the release wire 220 and the traction rod 211, but also allows the release wire 220 to pass through smoothly.
  • the inner cavity of the restraint tube 2101 can slide in the cavity of the restraint tube 2101; at the same time, it avoids opening holes in the traction rod 211, which increases the resistance to deformation of the traction rod 211 to a certain extent, and can be used as a retraction of the release wire 220 Provide a guiding effect, thereby ensuring the effectiveness of disassembly between the connection part of the implantation device 1 and the delivery system 2.
  • the release wire 220 is located inside the traction rod 211, and its wire diameter is not larger than the hole width of the first hole 1111 and the second hole 2111.
  • the distal end of the release wire 220 extends along the corresponding traction rod 211 from the proximal end to the distal end and passes through the entire restraint tube 2101. Then, the distal end of the release wire 220 abuts against the proximal side of the implantation device 1, as shown in FIG. 4A, where a'and b'are the states before the implantation device 1 and the delivery system 2 are disassembled, as shown in FIG.
  • 4B A and b are the state after the implantation device 1 and the delivery system 2 are disassembled, or the distal end of the release wire 220 passes through the first hole 1111 provided in the proximal region of the implantation device 1 and then extends proximally to release the collection Inside the piece 212, as shown in FIG. 4C, a controllable release connection between the implantation device 1 and the delivery system 2 is realized.
  • the restraining member 210 is one or more restraining rings 2102, and the restraining rings 2102 are sleeved on the outer surface of the distal end region of the traction rod 211.
  • the restraint ring 2102 is arranged in the middle area of the traction rod 213 and is fixedly connected to the traction rod 211, and the inner cavity facilitates the smooth sliding of the release wire 220.
  • the restraint ring 2102 is located in the middle of the release wire 220 in the distal region, and the restraint ring 2102 is fixedly connected to the release wire 220.
  • the inner cavity of the restraint ring 216 can accommodate the traction rod 211, so that the release wire 220 is retracted. At this time, the restraint ring 2102 and the release wire 220 can slide along the traction rod 211 under the action of the retraction force.
  • the restraining ring 2102 preferably uses a thin-walled metal tube, of course, it is also possible to use polymer materials such as FEP, PTFE, POE, PET, and silica gel.
  • the fourth embodiment is different from the second embodiment in that the delivery system 2 further includes a sheath assembly arranged outside the traction assembly 21.
  • the sheath assembly at least includes a sheath 230 and a sheath handle 231 sealed and fixedly connected to the proximal end of the sheath 230.
  • the traction assembly 21 When the implantation device 1 is connected with the traction assembly 21 and the release assembly 22, the traction assembly 21 is pulled back, and the traction assembly 21 Both the traction rod 211 and the implantation device 1 are elastically deformed and can be retracted into the sheath 230; after the implantation device 1 is placed at the target position of the atrial septum, the release assembly 22 is pulled back, and the release wire 220 is removed from the multiple
  • the traction rod 211 and the proximal end surface of the implantation device 1 are drawn out of the first hole 1111 or the second hole 2111, so that the traction assembly 21 is separated from the implantation device 1, thereby realizing the implantation device 1 and the delivery system. 2 controlled release.
  • the delivery system 2 further includes a loading sheath 232, the outer diameter of the loading sheath 232 is not greater than the size of the inner cavity of the sheath handle 231 and the sheath 230, and is used to
  • the assembled implantation device 1, the traction assembly 21 and the release assembly 22 are pre-installed into the inner cavity of the loading sheath 232 after being crimped outside the body, and smoothly introduced into the inner cavity of the sheath 230 through the pre-installed sheath 232, During the pushing process, the friction between the distal part of the implanted instrument 1 and the sealing ring in the sheath handle 231 may be avoided, which may cause instrument damage and improper pushing.
  • the loading sheath 232 can be inserted into the sheath handle 231 or directly inserted into the proximal end of the inner cavity of the sheath 230.
  • the pre-installed sheath 232 is close to the sheath handle 231.
  • the end is detachably connected by thread fitting, snap fitting, plug fitting, etc., so that the operator can push the crimped implant device 1, together with the traction assembly 21 and the release assembly 22, through the pre-assembled sheath 232 Into the sheath 230, and further push the traction assembly 21, the implantation device 1 can be finally introduced along the inner cavity of the sheath 230 to the distal end of the sheath 230 located in the target location area.
  • the pre-assembled sheath 232 is directly connected with the sheath handle 231, which builds a channel for the pushing of the implantation device 1 and the delivery system 2, and avoids the remote part of the implantation device 1 during the pushing process. Friction with the sealing ring in the sheath handle 231 may cause damage to the instrument and poor push.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un système de libération réglable comprenant un instrument d'implantation (1) et un système de transport (2). Une pluralité de premiers trous (1111) est formée dans une région proximale de l'instrument d'implantation (1) ; le système de transport (2) comprend une pluralité de tiges de traction (211) et une pluralité de fils de libération (220) ; la pluralité de fils de libération (220), la pluralité de tiges de traction (211), et la pluralité de premiers trous (1111) sont toutes en correspondance biunivoque pour ce qui est du nombre et de la position ; chaque tige de traction (211) est pourvue d'un second trou (2111) et d'un élément de contrainte (210) ; les seconds trous (2111) sont situés aux extrémités distales des tiges de traction (211) ; les fils de libération (220) pénètrent dans les éléments de contrainte (210) et les premiers trous (1111) ou les seconds trous (2111) pour mettre en œuvre une connexion entre l'instrument d'implantation (1) et le système de transport (2). Dans un processus de transport, les éléments de contrainte (210) peuvent limiter le mouvement des fils de libération (220) ; et lorsque l'instrument d'implantation (1) est libéré, les fils de libération (220) peuvent se déplacer par rapport aux tiges de traction (211). Le système de libération réglable facilite la récupération opportune et répétée de l'instrument d'implantation (1) avant que celui-ci ne soit démonté ; dans un processus de libération, l'instrument d'implantation (1) peut être lentement étiré jusqu'à une forme optimale à partir d'un tube de gaine (230), une connexion démontable peut être mise en œuvre par le retrait des fils de libération (220) pour obtenir une fonction de libération réglable ; le système de libération réglable présente une structure globale simple, est pratique à utiliser, fiable et sécurisé.
PCT/CN2020/136123 2019-12-17 2020-12-14 Système de libération réglable WO2021121183A1 (fr)

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CN110934618A (zh) * 2019-12-17 2020-03-31 宁波迪创医疗科技有限公司 一种可控释放的系统
CN114681150A (zh) * 2020-12-31 2022-07-01 深圳市健心医疗科技有限公司 瓣膜夹合系统、输送装置及其释放组件
CN114681149A (zh) * 2020-12-31 2022-07-01 深圳市健心医疗科技有限公司 瓣膜夹合系统、输送装置及其释放组件
CN113143348A (zh) * 2021-02-18 2021-07-23 宁波迪创医疗科技有限公司 一种含有可控释放机构的支架系统
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
CN113520519A (zh) * 2021-04-30 2021-10-22 常州凯尼特医疗科技有限公司 一种可调节支架型取栓装置
CN116672137B (zh) * 2023-07-28 2023-11-07 北京华脉泰科医疗器械股份有限公司 裙边结构、分支支架组件及分支血管医疗设备

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