WO2023202318A1 - 输送系统及手柄组件 - Google Patents

输送系统及手柄组件 Download PDF

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Publication number
WO2023202318A1
WO2023202318A1 PCT/CN2023/083256 CN2023083256W WO2023202318A1 WO 2023202318 A1 WO2023202318 A1 WO 2023202318A1 CN 2023083256 W CN2023083256 W CN 2023083256W WO 2023202318 A1 WO2023202318 A1 WO 2023202318A1
Authority
WO
WIPO (PCT)
Prior art keywords
bending control
bending
control
release
housing
Prior art date
Application number
PCT/CN2023/083256
Other languages
English (en)
French (fr)
Inventor
黄青青
林兴
陈国明
Original Assignee
上海微创心通医疗科技有限公司
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 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2023202318A1 publication Critical patent/WO2023202318A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a delivery system and a handle assembly.
  • Interventional therapy is a brand-new treatment technology developed internationally in recent years. Its principle is to use modern high-tech means to perform minimally invasive treatment. Under the guidance of medical imaging equipment, special precision instruments are introduced into the human body to perform treatment on the body. Lesions are diagnosed and treated locally. This technology has the characteristics of no incision, small trauma, fast recovery, and good results, and avoids the harm caused to patients by traditional surgeries. In the past ten years, international heart valve interventional therapy has made significant progress through continuous exploration and has become the most promising branch in the field of interventional therapy.
  • the handle usually has a purely manual handle, a purely electric handle, or a manual-electric hybrid handle, all of which must ensure sufficient safety, effectiveness, and economy.
  • a purely manual handle a purely electric handle, or a manual-electric hybrid handle, all of which must ensure sufficient safety, effectiveness, and economy.
  • the functional requirements and ease of operation of the delivery system have gradually become the focus.
  • the current handles have poor performance in terms of volume, quality, reliability, bending control accuracy, and ease of operation. There are still some problems, so the structure of the handle needs to be further optimized.
  • the purpose of the present invention is to provide a conveying system and a handle assembly that can realize adaptive bending control of pipelines, thereby improving the bending control accuracy and reducing the difficulty of conveying operations.
  • the present invention provides a handle assembly for driving an implant delivery system, which includes a bending control module.
  • the bending control module includes a motion control component and a pull wire control component that can selectively contact. ;
  • the motion control component drives the wire control component to move, so that the wire control component pulls the bending control pipeline to actively bend;
  • the cable control component moves along with the bending of the bend control pipeline.
  • the handle assembly further includes a housing, and the motion control component includes a bending control driving member and a bending control moving member that are transmission connected, the bending control driving member is provided on the housing, and the bending control moving member Disposed in the housing, the cable control component includes a bending control cable fixing part and a bending control cable;
  • the bending control cable fixing member is arranged in the housing and located on one side of the bending control moving part; one end of the bending control cable is used to connect to the bending control pipeline, and the other end is connected to the bending control pipe.
  • the cable fixing part is connected; the bending control cable fixing part is used to selectively contact the bending control moving part;
  • the bending control driving part drives the bending control movable part to drive the bending control wire fixing part along the axis of the conveying system. direction movement, so that the bending control cable fixing member pulls the bending control cable to drive the bending control pipeline to actively bend;
  • the bending control cable fixing part When the bending control cable fixing part is separated from the bending control moving part, the bending control cable moves with the bending of the bending control pipeline, and drives the bending control cable fixing part along the conveyor system. A second direction of movement of the axis; said second direction being opposite to said first direction.
  • the bending control wire fixing member and the bending control wire are connected through line contact.
  • the bending control wire fixing member includes a fixing member main body and a first structural member.
  • the fixing member main body is used to selectively abut the bending control moving member.
  • the first structural member is connected to the fixed member.
  • the main body of the piece is detachably connected; the main body of the fixing piece can tighten the bending control cable, and the first structural component and the bending control cable are connected through line contact.
  • the bending-controlling wire fixing member further includes a second structural member, the fixing member body has a first hole and a second hole penetrating along its own axial direction, and the bending-controlling wire passes through the first hole in sequence. After the first hole and the second hole are inserted into the second hole, the first structural member is threadedly connected to the main body of the fixing member through the second structural member.
  • the bending control wire fixing member further includes a second structural member; the first structural member is configured There is a through hole on one side of the fixer body along the central axis; after the bending control wire is wound around the first structural member and the second structural member for at least one turn, the second structure The component is inserted into the through hole and fixedly connected with the first structural component.
  • one end of the bending control cable is connected to the bending control pipeline, and the other end is welded to the bending control cable fixing member.
  • the bending control driving member is rotatably disposed on the housing, and the motion control component further includes a bending control rotating member that is drivingly connected to the bending control driving member and the bending control moving member respectively;
  • the bending control driving member is used to drive the bending control rotating member to rotate circumferentially, so as to drive the bending control moving member to move along the first direction or the second direction.
  • the handle assembly further includes a bending control guide rod disposed in the housing, and the bending control rotating member, the bending control moving member and the bending control guide rod are sleeved and connected in sequence from outside to inside.
  • the bending control guide rod is used to guide the axial movement of the bending control moving part and/or the bending control wire fixing part.
  • the motion control component further includes a bending control indicator that is drivingly connected to the bending control rotating member, and the bending control indicator is used to identify the bending control state of the bending control pipeline; the bending control indicator The driving member is used to drive the bending control indicating member to move along the first direction or the second direction through the bending control rotating member.
  • the handle assembly further includes an inner rod locking ring.
  • the outer thread at the farthest end of the bending control guide rod is fixedly connected to the inner thread of the inner rod locking ring.
  • the inner rod locking ring The proximal end surface abuts the inner wall of the housing, and the proximal end of the bending control guide rod is connected with the housing in a concave-convex fit.
  • the handle assembly further includes a distal inner rod disposed in the housing, a part of the structure of the distal inner rod passes through the bending control guide rod, and the other part of the structure is disposed on the control bending guide rod. Bend the guide rod outside.
  • the handle assembly further includes a proximal inner rod disposed in the outer shell, the farthest end of the distal inner rod is fixedly connected to the outer shell, and the most proximal end of the distal inner rod is connected to the outer shell.
  • the farthest end of the proximal inner rod is fixedly connected, and an inner rod support ring is provided in the inner wall of the farthest end of the distal inner rod.
  • the handle assembly further includes a release module, the release module includes a transmission driving member and a release moving member, the release driving member is provided on the housing, and the release moving member The moving member is disposed in the housing; the release driving member is used to drive the release moving member to drive the conduit of the delivery system to move in the first direction or the second direction.
  • the release driving member is rotatably disposed on the housing, and the release module further includes a release rotating member that is drivingly connected to the release driving member and the release moving member respectively; the release driving member The component is used to drive the release rotating component to rotate circumferentially to drive the releasing moving component to move along the first direction or the second direction.
  • the handle assembly further includes a proximal inner rod disposed in the housing, and the release driving member, the release moving member and the proximal inner rod are sleeved and coaxially connected in sequence from outside to inside.
  • the proximal inner rod is configured to guide the axial movement of the release moving member.
  • the housing includes a catheter sheath, a bend-control limiting housing and a release limiting housing; from the distal end to the proximal end, the catheter sheath, the bend-control limiting housing, the control-control housing
  • the bending driving member, the release limiting housing and the releasing driving member are overlapped in sequence; wherein the bending control limiting housing and the release limiting housing are used to limit the bending control driving member in the axial direction movement, the release limiting housing is used to limit the movement of the release driving member in the axial direction.
  • the handle assembly further includes a housing and a release module, the release module being used to control the axial movement of the conduit of the delivery system along the axial direction of the delivery system; wherein the bending control module, the release module and The shells are connected as a whole in a bridge manner.
  • the present invention also provides a delivery system, which includes any one of the handle components and a conduit component connected to the handle component, where the conduit component includes a control-bend pipeline.
  • the handle assembly includes a bending control module
  • the bending control module includes a motion control component and a cable control component that can selectively contact; when the motion control component When in contact with the cable control component, the motion control component drives the cable control component to move, so that the cable control component pulls the bend control pipeline of the conveyor system to actively bend; when the motion control component After being separated from the cable control component, the cable control component moves along with the bending of the bend control pipeline.
  • Such a configuration can realize the active bending control of the bending pipeline in one direction and the adaptive bending of the bending pipeline, thereby effectively improving the bending control accuracy, making the conveying operation more accurate, the conveying difficulty is lower, and the conveying operation efficiency is improved. higher.
  • the cable control component includes a bending control component.
  • a cable fixing piece and a bend-controlling cable One end of the bending-controlling cable is used to connect to the bend-controlling pipeline, and the other end is connected to the bending-controlling cable fixing piece.
  • the bending control module realizes the rotation of the bending control driving part and the transmission cooperation between the bending control rotating part and the bending control moving part.
  • the rotational displacement is converted into the linear displacement of the bending control cable, which reduces the volume of the entire handle assembly.
  • the self-locking ability of the thread assembly prevents the phenomenon of retreat after active bending control in one direction, ensuring that It ensures safety and reliability, and at the same time, the thread transmission has high transmission efficiency, which further improves the bending control accuracy and efficiency.
  • Figure 1 is a partial perspective view of a delivery system according to a preferred embodiment of the present invention.
  • Figure 2 is a partial front view of the conveyor system according to the preferred embodiment of the present invention.
  • Figure 3 is a schematic diagram of the internal structure of the handle assembly according to the preferred embodiment of the present invention.
  • Figure 4 is a schematic diagram of the internal structure of the handle assembly according to the preferred embodiment of the present invention.
  • Figure 5a is an axial cross-sectional front view of the delivery system of the preferred embodiment of the present invention.
  • Figure 5b is an axial cross-sectional perspective view of the delivery system of the preferred embodiment of the present invention.
  • Figure 6 is a partial enlarged view of position a in Figure 5a;
  • Figure 7a is a schematic diagram of the bending control of the handle assembly according to the preferred embodiment of the present invention, in which the bending control wire fixing member uses bolts to fix the bending control wire;
  • Figure 7b is a transverse cross-sectional view of the main body of the fastener on the bend-control cable fastener in Figure 7a;
  • Figures 7c and 7d are structural schematic diagrams of another preferred embodiment of the present invention in which the bending control cable fastener adopts a winding method to fix the bending control cable;
  • Figure 7e shows another preferred embodiment of the present invention in which the bending control cable fastener is fixed by welding.
  • Figure 8 is a partial enlarged view of position b in Figure 5a;
  • Figure 9 is a partial enlarged view of position d in Figure 5b;
  • Figure 10 is a state diagram after the bending control indicator has moved relative to Figure 9 according to the preferred embodiment of the present invention.
  • Figure 11 is a partial enlarged view of position e in Figure 5b;
  • Figure 12 is a partial enlarged view of the bending control module according to the preferred embodiment of the present invention, in which the wire control component reaches the extreme position of active bending control;
  • Figure 13 is a partial enlarged view of the release module according to the preferred embodiment of the present invention.
  • A-catheter assembly ; 61-outer tube; 62-inner tube; 63-drainage tube; B-handle component; 10-Shell; 11-Conduit sheath; 12-Shell fixed cap; 121-Ring sleeve; 13-Bend control limit shell; 131-Transparent window; 14-Shell locking ring; 15-Release limit housing; 16-Luer connector; 20-bending control module; 21-bending control driving part; 22-bending control rotating part; 23-bending control moving part; 24-bending control wire fixing part; 241-fixing part main body; 2411-first hole; 2412- Second hole; 242, 242'-first structural member; 2421-via hole; 243, 243'-second structural member; 25-bending control cable; 26-bending control guide rod; 261-inner rod locking ring; 27-Bending control indicator piece; 271-Indicator part; 30-distal inner rod; 31-inner rod support ring; 32-fixed seat; 33
  • distal and proximal are used; “distal” is the end close to the patient; “proximal” is the end far away from the patient; “axial” refers to the direction along the The axis direction of the handle.
  • axial refers to the direction along the The axis direction of the handle.
  • transmission connection refers to the mutual abutment (including connection) between structural parts that can transmit power.
  • the transmission connection is a concave-convex fit connection, and the concave-convex fit can be a thread fit, etc.
  • on the housing may mean disposed inside the housing casing, disposed outside the housing casing, or as a part of the housing casing.
  • the core idea of the present invention is to provide a conveying system and its handle assembly.
  • the conveying system includes a connected handle assembly and a conduit assembly.
  • the conduit assembly includes a bending control pipeline
  • the handle assembly includes a bending control module
  • the bending control module includes A motion control component and a cable control component that can selectively contact; when the motion control component contacts the cable control component, the motion control component drives the cable control component to move, so that the cable control component pulls the bending control pipeline to actively bend; when After the motion control component and the cable control component are separated, the cable control component moves with the bending of the bending control pipeline, thereby realizing adaptive bending of the bending control pipeline.
  • the bend-controlled pipeline bends autonomously due to adapting to the environmental shape, thereby driving the wire control component to move.
  • the environmental shape here is mainly the blood vessel shape, and the blood vessel shape includes the spatial tubular information of the blood vessel.
  • Such a configuration can realize active bending control of the conveying system in one direction on the one hand, and adaptive bending control of the conveying system on the other hand.
  • adaptive bending control means that the bending control pipeline adjusts its own bending according to the shape of the blood vessel itself, thereby adapting to the shape of the blood vessel and bending autonomously. More specifically, when the bending is actively controlled, the bending control module of the handle assembly is used to drive the movement of the bending control pipeline to bend the bending control pipeline; when it is necessary to relax the bending control pipeline, the bending control pipeline relies on the shape of the blood vessel itself self-regulation Bend, realize adaptive bending, and make the bending control pipeline relax. At this time, the bending control pipeline adapts to the blood vessel shape to drive the movement of the cable control component; with this configuration, the bending control accuracy is higher, and it can reduce the difficulty of the delivery operation and shorten the operation. time and improve surgical efficiency.
  • the motion control component when the motion control component is in contact with the cable control component, the motion control component drives the cable control component to move along the axis of the conveyor system; when the motion control component is separated from the cable control component, the cable control component follows the control bending The pipeline bends and moves along the axis of the conveying system; thereby achieving active and adaptive bending control of the curved pipeline along the axis of the conveying system.
  • the motion control component drives the cable control component to move along the first direction of the axis of the conveying system; when the motion control component is separated from the cable control component, the cable control component follows the control
  • the elbow bends and moves along the second direction of the axis of the conveying system; the second direction is opposite to the first direction; the first direction and the second direction here are both along the axis of the conveying system, that is, the axial direction of the conveying system, That is, the first direction and the second direction are two opposite directions of a coaxial line.
  • the first direction is forward active control bending
  • the second direction is reverse adaptive bending control. At this time, one-way control bending along the axial direction of the conveying system can be achieved.
  • a preferred embodiment of the present invention provides a delivery system for delivering implants.
  • the type of the implant is not limited, for example, it can be a heart valve stent, or other implants, such as a vascular stent, an aneurysm stent, a balloon-expandable stent, a ureteral stent, a prostate stent, a peripheral stent, and a tracheobronchial stent. etc., it can also be a graft, embolization device, occlusion device, etc.
  • the delivery system as a whole includes a connected conduit assembly A and a handle assembly B; the conduit assembly
  • the connection method between A and the handle assembly B is not limited.
  • it can be a mechanical structural connection such as bonding, threading, riveting, pin connection, or an integral connection between the two.
  • the catheter assembly A and the handle Component B is connected through a mechanical structure to make the processing and assembly of the conveying system simpler and more convenient.
  • the conduit assembly A includes a bend-controlled pipeline 100 .
  • the handle assembly B includes a bending control module 20.
  • the bending control module 20 includes a motion control component and a cable control component capable of selective contact.
  • the motion control component drives the wire control component to move toward the proximal end N direction of the delivery system, so that the wire control component pulls the bend control pipeline 100 to actively bend; and when the motion control component After being separated from the cable control component, the cable control component moves toward the far end F of the conveying system as the bend-control pipeline 100 bends, thereby realizing adaptive bending of the bend-control pipeline 100 .
  • the handle assembly B further includes a housing 10, and the motion control component includes a bending control driving member 21 and a bending control moving member 23 that are transmission connected; the bending control driving member 21 is provided on the housing 10 ; In some embodiments, a portion of the housing 10 forms the bending control driving member 21 , that is, the bending control driving member 21 forms a portion of the housing 10 .
  • the bending control moving part 23 is movably disposed in the housing 10; the bending control driving part 21 drives the bending control moving part 23 to move along the axial direction of the handle assembly B.
  • the motion control component also includes a bending control rotating member 22 that is drivingly connected to the bending control driving member 21 and the bending control moving member 23 respectively; the bending control driving member 21 is used to drive the bending control rotating member 22 to rotate circumferentially to drive The bending control moving member 23 moves along the axial direction of the handle assembly B.
  • the bending control driving member 21 is a bending control sleeve, which is rotatably provided on the housing 10 . It should be noted that, as those skilled in the art can understand, in other embodiments, the bending control driving member 21 is movably provided on the housing 10 .
  • the bending control driving member 21 may be directly or indirectly connected to the bending control moving member 23 to drive the axial movement of the bending control moving member 23 .
  • the bending control driving member 21 is configured as a bending control sleeve, which has a simple structure, high control accuracy, and high transmission efficiency.
  • the cable control component includes a bending control cable fixing part 24 and a bending control cable 25.
  • One end of the bending control cable 25 is used to connect to the bending control pipeline 100, and the other end is connected to the bending control cable fixing part 24.
  • the bending control wire fixing part 24 is disposed in the housing 10 and located on one side of the bending control moving part 23 .
  • the bending control wire fixing part 24 is used to selectively contact with the bending control moving part 23 .
  • the bending control driving part 21 drives the bending control moving part 23 to drive the bending control wire fixation.
  • the member 24 moves toward the proximal end N of the conveying system, so that the bending control cable fixing member 24 pulls the bending control cable 25 to drive the bending control pipeline 100 to bend, thereby realizing active bending of the bending control pipeline 100 .
  • the bending control cable fixing part 24 is separated from the bending control movable part 23, the cable control component no longer exerts the force of the bending control movable part 23, and the bending control cable 25 moves along with the bending of the bending control pipeline 100, and drives the bending control part.
  • the wire fixing member 24 moves toward the distal end F of the conveying system, thereby realizing adaptive bending of the bend-controlled pipeline 100 and allowing the bend-controlled pipeline 100 to relax autonomously.
  • the bending control wire fixing member 24 is provided at the proximal end of the bending control moving member 23 and is used to contact the proximal end of the bending control moving member 23 .
  • the bending control rotating member 22 and the bending control moving member 23 are threadedly connected. It should also be understood that the bending control rotating member 22 can only rotate circumferentially, while the bending control moving member 23 and the bending control wire fixing member 24 can only move axially.
  • the internal threads of the bending control rotating member 22 cooperate with the external threads of the bending control moving member 23, and both sides of the bending control rotating member 22 along the axial direction are limited by the housing 10, so the bending control rotating member 22 can only Circumferential rotation.
  • the bending control driving member 21 is manually operated to rotate to drive the bending control rotating member 22 to rotate, thereby driving the bending control moving member 23 and the bending control wire fixing member 24 to move toward the proximal end N of the conveying system, and pull simultaneously
  • the bending control wire 25 moves toward the proximal end N, causing the bending control pipeline 100 to bend.
  • the bending control moving part 23 and the bending control wire fixing part 24 move to a suitable position toward the proximal end N, they stop moving to realize active bending control.
  • Those skilled in the art can set an appropriate moving distance of the bend-control wire fixation member 24 according to the instrument's approach and the degree of blood vessel curvature.
  • a limiting component can be provided in the handle assembly B, for example, with the help of the housing 10, When the bending control wire fixing part 24 moves to the extreme position, it is resisted by the housing 10, so that the bending control moving part 23 and the bending control wire fixing part 24 cannot continue to move toward the proximal end N.
  • the bending control driving member 21 is manually operated in the opposite direction to rotate to drive the bending control rotating member 22 to rotate in the opposite direction, thereby driving the bending control moving member 23 toward the far side of the conveyor system.
  • the end F moves to a certain position, so that the bending control wire fixing member 24 moves toward the distal end F.
  • the cable control part no longer exerts the force of the bending control moving part 23, and the bending control cable 25 will follow the bending of the bending control pipeline 100. And moves, and drives the bending control cable fixing member 24 to move toward the far end F of the conveying system.
  • This method realizes the adaptive bending of the bending control pipeline 100 and causes the bending control pipeline 100 to relax autonomously.
  • the conveying system of the present invention utilizes the adaptive bending control of the bending pipeline to achieve higher bending control accuracy, making the conveying operation more precise, and the conveying difficulty is lower. Operation is more efficient.
  • the handle assembly B further includes a bending control guide rod 26 disposed in the housing 10 , and the bending control moving member 23 is movably disposed on the bending control guide rod 26 to guide through the bending control guide rod 26
  • the moving direction of the bending control moving part 23 causes the bending control moving part 23 to move along the bending control guide rod 26 to improve the accuracy of motion control.
  • the bending control moving member 23 and the bending control guide rod 26 are sleeved in sequence from the outside to the inside and are arranged coaxially.
  • the bending control moving part 23 and the bending control wire fixing part 24 are both coated on the bending control guide rod 26, so that at least one of the bending control moving part 23 and the bending control cable fixing part 24 is controlled by the bending control guide rod 26.
  • Circumferential rotation is used to limit the position, so that the bending control moving part 23 and/or the bending control wire fixing part 24 can only move along the axial direction of the bending control guide rod 26 .
  • circumferential limiting structures such as bosses and/or grooves are provided on the bending control guide rod 26 to limit the circumferential rotation of the bending control moving part 23 and/or the bending control wire fixing part 24.
  • the bending control guide rod 26 is generally a hollow tube, and the inside is used to assemble a conduit of the conveying system, such as a bending control pipeline.
  • the bending control rotating member 22, the bending control moving member 23 and the bending control guide rod 26 are sleeved in sequence from the outside to the inside and arranged coaxially, that is, the bending control moving member 23 is coated on the bending control guide rod 26.
  • the bending control rotating member 22 is coated on the bending control moving member 23, the bending control guide rod 26 is connected to the housing 10, the bending control rotating member 22 has an internal thread, the bending control moving member 23 has an external thread, and the bending control moving member 23 has an external thread. Coupled with the internal thread of the bending control rotating member 22.
  • both the bending control moving member 23 and the bending control rotating member 22 adopt the structure of an annular thread sleeve, thereby realizing the centering setting of the handle assembly B and ensuring control accuracy.
  • the handle assembly B also includes an inner rod locking ring 261.
  • the outer surface of the farthest end of the bending control guide rod 26 is provided with external threads (the position indicated by the symbol S1 in Figure 5a).
  • the bending control guide rod 26 The external thread at the farthest end of the rod 26 is fixedly connected to the internal thread of the inner rod locking ring 261 , and the proximal end surface of the inner rod locking ring 261 is connected to the inner wall of the housing 10 .
  • the inner wall of the housing 10 can be snapped into the ring of the bending control guide rod 26 In the shaped gap, the limit is achieved.
  • the proximal end of the bending control guide rod 26 can be connected with the housing 10 in a concave-convex fit.
  • the advantages of providing the inner rod locking ring 261 include: on the one hand, it can lock the bending control guide rod 26 and the housing 10; on the other hand, it can also support the handle shell and enhance the strength of the handle assembly B.
  • the bending control wire fixing part 24 and the bending control wire 25 are connected through line contact.
  • Line contact means that the contact surface between the bending control wire 25 and the bending control wire fixing 24 is in the form of a line.
  • the contact line between the bending control wire 25 and the bending control wire fixing 24 can be a line formed by continuous points. It can also be a line formed by multiple spaced points; preferably, it is a line formed by multiple continuous points.
  • the benefits of connecting through wire contact include: on the one hand, it can improve the fixing force of the bending control wire 25, reduce the risk of the bending control wire 25 falling off, and improve the safety and reliability of the surgical operation; on the other hand, it can reduce the bending control module 20
  • the size reduces the volume and mass of the entire handle assembly B and improves the accuracy of conveying operation control.
  • the bending control wire fixing part 24 includes a fixing part main body 241 , and the fixing part main body 241 is used to selectively contact the bending control moving part 23 .
  • the main body 241 of the fixing member has an annular structure and is coated on the bending control guide rod 26 and arranged coaxially with the bending control guide rod 26 to further realize the centering of the handle assembly B.
  • the other end of the bending control cable 25 passes through the bending guide rod 26 and is connected to the bending control cable fixing part 24 .
  • the bending control wire fixing member 24 also includes a first structural member 242.
  • the first structural member 242 is used to detachably connect with the fixing member main body 241, and preferably the two are threadedly connected.
  • the fixing body 241 can tighten the bending control wire 25, and the first structural member 242 can be connected to the bending control wire 25 through line contact.
  • the bending control wire fixing member 24 also includes a second structural member 243 for locking the first structural member 242 and the fixing member main body 241.
  • the first structural member 242 can also be directly locked with the fixing member body 241 .
  • the first structural member 242 in the embodiment of the present invention is a screw, and preferably only the N end of the first structural member 242 is provided with threads.
  • the second structural member 243 is a nut, and the nut is used to lock the screw.
  • the fixer body 241 has a first hole 2411 and a second hole 2412 that penetrate along its own axial direction.
  • the first hole 2411 and the second hole 2412 are spaced apart in the radial direction; control One end of the bending wire 25 is fixedly connected to the bend control pipe 100. After the other end of the bending control wire 25 penetrates into the first hole 2411 and the second hole 2412 in sequence, the first structural member 242 is inserted into the second hole 2412 and connected with the main body of the fixing member.
  • the first hole 2411 may be closer to the central axis of the bending control wire fixing member 24 than the second hole 2412, or may be further away from the central axis of the bending control wire fixing member 24. It can be understood that in this manner, the bending control wire 25 and the screw are connected through line contact, so that the bending control wire 25 is tightly fixed on the bending control wire fixing member 24, which is safe, reliable and not easy to fall off. More specifically, the bending control wire 25 is inserted through the first hole 2411 (without being wound), and then bent and passed through the second hole 2412, and wound in this manner for at least one turn.
  • the bending control wire 25 may or may not wrap around the screw rod (first structural member 242 ) when penetrating into the second hole 2412 , and the head end of the screw rod is provided with threads to lock the nut (second structural member 243 ), thereby utilizing The locking of the screw rod and the nut fixes the bending control cable 25 on the fixing body 241 .
  • the advantage of setting the screw rod and nut is that the tightening degree between the screw rod and the nut can be adjusted through technological means, which increases the repeatability of the assembly of the cable control components.
  • the screw rod and nut may also be eliminated, and other mechanical fixing methods may be used to connect the bending control cable 25 and the bending control cable fixing member 24 .
  • connection between the bending control wire 25 and the bending control wire fixing part 24 can be realized in a variety of ways, for example, it can be a winding connection or a welding connection, and the corresponding connection method can be selected according to actual working conditions.
  • the bending control wire fixing component 24, in addition to the fixing component body 241, also includes a first structural component 242' and a second structural component 243'; wherein the first structural component 242'
  • the first structural member 242' is disposed on one side of the fixer body 241 along the central axis and has a through hole 2421; one end of the bending control cable 25 is connected to the bending control cable 241.
  • the pipeline 100 is connected, and the bending control wire 25 is further wound around the first structural member 242' and the second structural member 243' for at least one turn, and then the second structural member 243' is inserted into the through hole 2421 of the first structural member 242'. Lock.
  • the bending control wire 25 and the bending control wire fixing part 24 are welded and fixed. Specifically, one end of the bending control cable 25 is connected to the bending control pipeline 100 , and the other end is welded to the bending control cable fixing member 24 .
  • the bending control wire fixing part 24 can also be configured to include a fixing part main body 241, and the fixing part main body 241 is preferably made of metal material.
  • the motion control component also includes a bending control indicating member 27 that is transmission connected with the bending controlling rotating member 22.
  • the bending controlling indicating member 27 and the bending controlling rotating member 27 22 thread matching transmission connection.
  • the bending control driving member 21 is used to drive the bending control through the bending control rotating member 22
  • the indication piece 27 moves along the axial direction of the conveying system.
  • the bending control indication piece 27 and the bending control moving piece 23 move in the same direction and at the same speed, so that the operator can identify the axial direction of the bending control cable 25 according to the instructions of the bending control indication piece 27
  • the forward distance is determined to determine the current bending control degree of the bending control pipeline 100, making the bending control adjustment more precise and convenient.
  • the bending control indicator piece 27 has an annular structure and is sheathed on the bending control rotating member 22, and is threadedly connected to the bending controlling rotating member 22 and arranged coaxially, thereby further realizing the centering of the handle assembly B.
  • the bending control rotating member 22 is an annular thread sleeve and has external threads and internal threads. The external threads of the bending controlling rotating member 22 are cooperatively connected with the internal threads of the bending control indicating member 27.
  • the internal threads of the bending controlling rotating member 22 are The threads are connected with the outside of the bending control moving part 23, and the internal and external threads of the bending control rotating part 22 have the same direction and pitch, ensuring that the bending control indicator part 27, the bending control moving part 23, and the bending control wire fixing part 24 move in the same direction as The speed is consistent.
  • the operator can obtain the bending control status of the bending control pipeline 100 in real time through the transparent window 131 on the housing 10 . Furthermore, when the bend control indicator 27 moves toward the proximal end N to a certain position, it will be supported by the housing 10 to achieve an active bend control and limiting effect.
  • a protruding indicator portion 271 is provided on the outer surface of the bend control indicator 27, and the bend control pipeline 100 can be determined according to the position indicated by the indicator portion 271.
  • the current bending control degree is, that is, the bending control degree is determined according to the moving position of the bending control indicator 27 .
  • the bending control indicator 27 corresponds to the position of the transparent window 131 .
  • the housing 10 can guide the movement direction of the bend control indicator 27 and is also used to limit the extreme positions of the bend control indicator 27 when it moves toward the proximal and distal ends.
  • the distal end of the housing 10 has an inwardly curved blocking wall.
  • the limit position of the bend control indicator 27 is limited to move toward the distal end.
  • the proximal end of the housing 10 has an inwardly curved baffle wall to limit the limit position of the bend control indicator 27 to move toward the proximal end.
  • the bend control indicator 27 is only limited by the housing 10 Move back and forth between the front and rear baffles.
  • the bending control indicator 27 has an initial position corresponding to uncontrolled bending and an extreme position corresponding to active bending control. Referring to FIG. 9 , when the bend control is not implemented, the bend control indicator 27 can be in the farthest initial position. The initial position can be limited by the housing 10 so that the bend control indicator 27 cannot continue to move in the distal direction. Referring to Figure 10, when the bending is actively controlled, the bending control indicator 27 is driven to move from the initial position to the proximal direction to the intermediate position, and the operator can read the transparent window 131 corresponding to the indicator 271. to obtain the current degree of bending control. If the degree of active bending control is appropriate, the movement in the proximal direction will be stopped. Referring to FIG. 12 , if the active bending control needs to continue, the bending control indicator 27 continues to move from the intermediate position toward the proximal direction until it is resisted by the housing 10 and reaches the limit position of the active bending control.
  • a transparent window 131 is provided on the housing 10 , through which the position of the bending control indicator 27 can be directly observed.
  • the transparent window 131 is made of transparent material.
  • the transparent window 131 is provided with a scale corresponding to the bending control state.
  • the scale can be a moving distance or a directly calibrated bending gear. Each bending gear corresponds to At a predetermined degree of bend control, it is convenient for the operator to read the current scale value indicated by the indication portion 271 on the bend control indicator 27 to determine the degree of bend control of the bend control pipeline 100 .
  • the operator can clearly see the moving state of the bending control indicating member 27 through the transparent window 131, which gives the operator a clear visual prompt and can intuitively judge the bending control driving member 21. Is the direction of rotation incorrect?
  • the bending control indicator 27 is close to the scale boundary of the transparent window 131, it can also prompt the operator that it is about to be held up by the housing 10 and the rotation speed needs to be reduced to improve the safety and reliability of the operation.
  • the bending control driving member 21 is a bending control sleeve and constitutes a part of the housing 10 .
  • the bending control driving member 21 can be formed by joining two half sleeves.
  • the two half sleeves of the bending control driving member 21 can pass through Fasten the joint with screws, buckles or pins.
  • the rotational displacement of the bending control sleeve is converted into the linear displacement of the bending control wire 25, which reduces the volume of the entire handle assembly B, and the threaded assembly has a certain
  • the self-locking ability ensures that there will be no rollback after active bending control, ensuring safety and reliability.
  • the thread transmission has high transmission efficiency, which improves the bending control accuracy and efficiency.
  • the handle assembly B further includes a distal inner rod 30 and a proximal inner rod 40 disposed in the housing 10; the distal inner rod 30 and/or the proximal inner rod
  • the rods 40 are all hollow tubes, and the inside of the hollow tube is used for passing the catheter; the distal inner rod 30 and the proximal inner rod 40 are arranged along the axial direction of the handle assembly B, that is, the distal inner rod 30 is located at the distal end of the handle assembly B. , the proximal inner rod 40 is located at the proximal end of the handle assembly B.
  • a part of the structure of the distal inner rod 30 is passed through the inside of the bending control guide rod 26 and is arranged coaxially.
  • the other part of the structure is arranged on the outside of the bending control guide rod 26 and extends proximally to connect with the distal end of the proximal inner rod 40 . End fixed connection.
  • the distal inner rod 30 and the proximal inner rod 40 are coaxially arranged, and both the distal inner rod 30 and the proximal inner rod 40 remain relatively stationary with the outer shell 10 , such as the distal inner rod 30 and the outer shell 10 Fixedly connected, the distal inner rod 30 limits the axial movement and circumferential rotation of the proximal inner rod 40.
  • the distal inner rod 30 and/or the proximal inner rod 40 are preferably made of plastic material, such as ABS resin material, POM material (polyoxymethylene), PC material (polycarbonate), etc., to reduce the volume and mass of the handle assembly B , and improve the control accuracy of conveying operations.
  • plastic material such as ABS resin material, POM material (polyoxymethylene), PC material (polycarbonate), etc.
  • the farthest end of the distal inner rod 30 is threadedly connected to the housing 10, and the most proximal end of the distal inner rod 30 is fixedly connected to the farthest end of the proximal inner rod 40, such as a concave-convex fitting connection.
  • an inner rod support ring 31 is provided in the inner wall of the farthest end of the distal inner rod 30 to enhance the strength of the distal inner rod 30.
  • the material of the inner rod support ring 31 is a metal material.
  • an annular groove is provided on the inner wall of the farthest end of the distal inner rod 30 , the inner rod support ring 31 is installed in the annular groove, and the inner diameter of the inner rod support ring 31 after installation is the same as that of the distal inner rod 30 At least some of the inner walls have the same inner diameter.
  • the farthest end of the distal inner rod 30 is fixedly connected to the shell fixed cap 12 on the shell 10.
  • a ring sleeve 121 is formed inside the shell fixed cap 12. The internal thread of the ring sleeve 121 is in contact with the distal inner rod. 30 mates with external threads on the outermost surface of the distal end.
  • the inner rod support ring 31 is disposed at the position where the ring sleeve 121 is connected to the distal inner rod 30 .
  • a fixing seat 32 is provided inside the proximal end of the distal inner rod 30, and the fixing seat 32 is used to connect the catheter of the catheter assembly A.
  • the handle assembly B also includes an end cap 33, which is fixedly connected to the proximal end of the distal inner rod 30.
  • the fixing seat 32 is fixedly connected to the inside of the end cap 33, and the end cap 33 is The inner dimension is larger than the inner diameter of the distal inner rod 30 to accommodate the fixing seat 32 .
  • the end cover 33 is provided with anti-rotation and limiting measures, such as bonding, snapping and other limiting connections, to limit the axial movement and circumferential rotation of the proximal inner rod 40, so that the proximal inner rod can 40 is connected to the distal inner rod 30.
  • the end cap 33 is spliced into two parts. A part of the end cap 33 is integrally formed with the distal inner rod 30 . That is, the most proximal end of the distal inner rod 30 has a part of the end cap 33 . The other part of the structure is processed separately.
  • the two parts of the end cap 33 are tightly connected using the inner rod fixing ring 34 , for example, the internal threads of the inner rod fixing ring 34 are fixedly connected to the external threads of the end cap 33 .
  • the handle assembly B also includes a release module 50 for controlling the axial movement of the catheter in the catheter assembly A.
  • the bending control module 20, the release module 50 and the housing 10 are connected as a whole in a bridge manner. "Bridge" here It means that the bending control module 20 , the release module 50 and the shell 10 are connected as a whole in a certain manner, so that the bending control module 20 and the release module 50 are integrated on the shell 10 . It can be understood that at this time, a part of the bending control module 20 and a part of the release module 50 are used to form the shell of the housing 10.
  • a part of the shell of the housing 10 is used to form a part of the bending control module 20 and a part of the release module.
  • Mod 50 a part of the shell of the housing 10 is used to form a part of the bending control module 20 and a part of the release module.
  • the traditional handle uses a segmented design to connect the bending control and release modules in series, resulting in a large size, heavy weight and low strength of the handle assembly.
  • the bending control module and the release module are integrated into one body through a bridge connection, so that the handle assembly is smaller in size, lighter in weight, and higher in strength.
  • the release module 50 includes a release driving member 51 and a release moving member 53 that are transmission connected; the release driving member 51 is movably disposed on the housing 10 , preferably, a part of the housing 10 forms the release driving member. 51; The release moving member 53 is movably provided in the housing 10. The release driving member 51 is used to drive the release moving member 53 to drive the conduit of the delivery system to move in the axial direction.
  • the release module 50 further includes a release rotating member 52 that is drivingly connected to the release driving member 51 and the release moving member 53 respectively.
  • the release driving member 51 is used to drive the release rotating member 52 to rotate circumferentially to drive the release moving member 53 to move along the axial direction of the conveying system.
  • the release driving member 51 is a release sleeve and is rotatably disposed on the housing 10 .
  • the releasing rotating part 52 and the releasing moving part 53 are threadedly connected.
  • the release driver 51 may also be movably disposed on the housing 10 .
  • the release driving member 51 can be directly or indirectly connected to the release moving member 53 in transmission, and finally drives the release moving member 53 to move.
  • the release driving member 51 is configured as a release sleeve, which has a simple structure, high control accuracy, and high transmission efficiency.
  • the releasing rotating member 52 can only rotate circumferentially, and the releasing moving member 53 can only move axially.
  • the proximal inner rod 40 is used to guide the axial movement of the release moving member 53 and to limit the circumferential rotation of the release moving member 53 so that the release moving member 53 can only move axially forward and backward.
  • structures such as bosses or grooves can be provided on the proximal inner rod 40 to guide and limit the release moving member 53 .
  • the housing 10 is used to limit the axial movement of the release rotating member 52 so that the releasing rotating member 52 can only rotate circumferentially.
  • the release moving part 53 is sheathed on the proximal inner rod 40 to guide the axial movement of the releasing moving part 53 through the proximal inner rod 40 and to limit the circumferential rotation of the releasing moving part 53 through the proximal inner rod 40 .
  • the release moving member 53 is connected to the conduit in the conduit assembly A, which may be directly or indirectly connected to the conduit. Tube, as in this embodiment, the release moving member 53 is connected to the catheter through the Luer connector 16, thereby driving the catheter to move forward and backward along the axis of the delivery system to achieve loading and release of the implant.
  • the proximal end of the release rotating member 52 is covered with a release fixing ring 55, so that the release fixing ring 55 is used to mechanically connect the release rotating member 52, such as the release fixing ring 55 and the release rotating member 52 are threadedly connected.
  • the release fixing ring 55 and the housing 10 jointly restrict the release driving member 51 from moving in the axial direction, so that the release driving member 51 can only rotate circumferentially.
  • the release rotating part 52 , the releasing moving part 53 and the proximal inner rod 40 are sleeved in sequence and arranged coaxially, that is, the releasing rotating part 52 is coated on the releasing moving part 53 , and the releasing moving part 53 is coated on On the proximal inner rod 40 , the release rotating part 52 is threadedly connected to the releasing moving part 53 , and the releasing moving part 53 moves along the axial direction of the proximal inner rod 40 .
  • the release driving member 51 is manually operated to move (preferably rotate) to drive the release rotating member 52 to rotate, and drive the release moving member 53 and the release member 53.
  • the catheter connected to the moving member 53 retreats toward the proximal direction together.
  • the release moving member 53 will preferably be resisted by the housing 10, thereby achieving the limiting effect of retreating release; when the release distance needs to be reduced, instead
  • the release moving member 53 and the catheter connected to the release moving member 53 advance toward the distal direction.
  • the release moving member 53 is preferably resisted by the housing 10, thereby achieving Advance limit effect.
  • the release driving member 51 is preferably a release sleeve, and the release driving member 51 can also be formed by splicing two half sleeves.
  • the rotational displacement of the release sleeve is converted into the linear displacement of the conduit assembly A, which reduces the volume of the entire handle assembly B, especially when the threaded transmission connection is used, through the threaded assembly
  • the self-locking ability ensures that there will be no retraction when axially advances or retreats, ensuring safety and reliability.
  • the threaded component also has the advantage of high transmission efficiency, improving release accuracy and release efficiency.
  • the housing 10 may include a catheter sheath 11, a housing fixed cap 12, a bend control limiting housing 13, and a housing arranged in sequence from the distal end F to the proximal end N.
  • At least one of the housing fixing cap 12 and the housing locking ring 14 is preferably configured to play a fixing role, further provide support for each module, and increase the strength of the entire handle assembly B.
  • the release limit housing 15 and the release driver 51 are overlapped in sequence, which not only realizes the sealing of the mechanical components in the housing 10, but also realizes the bending control module, the release module and the shell and other pipes (such as bending control guide rods,
  • the bridge between the proximal inner rod and the distal inner rod allows the entire handle assembly B to be connected as a whole.
  • the bending control driving member 21 is disposed between the bending control limiting housing 13 and the release limiting housing 15.
  • the bending control limiting housing 13 and the releasing limiting housing 15 can prevent the bending control driving member 21 from turning.
  • the bending control limiting housing 13 is also used to prevent the bending control rotary member 22 from moving in the axial direction.
  • one housing locking ring 14 connects the bending control limit housing 13 and the bending control driving member 21, and the other housing locking ring 14 connects the bending control driving member 21 and the release limit housing 15, thereby realizing control.
  • one housing locking ring 14 is threadedly connected to the proximal end of the bending control limiting housing 13, and the other housing locking ring 14 is threadedly connected to the distal end of the release limiting housing 15.
  • the structure is simple and the assembly is easy.
  • the release limiting housing 15 can be used to limit the axial movement of the release driving member 51 .
  • the proximal end of the catheter sheath 11 is fixedly connected to the distal end of the housing fixed cap 12, and the two are coaxially arranged. They mainly serve to center the handle assembly B and are also used to align the catheter assembly A. Conduct guidance. The proximal end of the catheter sheath 11 can be engaged with the distal end of the housing fixed cap 12 .
  • the housing fixed cap 12 is also fixedly connected to the distal end of the distal inner rod 30, such as a threaded connection.
  • the shell fixed cap 12 is provided with an axially penetrating ring 121, and the outermost outer surface of the distal inner rod 30 is provided with external threads. The farthest end of the distal inner rod 30 is inserted into the ring 121 of the shell fixed cap 12 and threaded. connect.
  • the proximal end of the housing fixed cap 12 is fixedly connected to the distal end of the bending control limiting housing 13, such as the two are threadedly connected.
  • the housing fixing cap 12 can be used as a hand grip part to realize the bending control function.
  • the bending control guide rod 26 is connected to the bending control limit housing 13 and the release limit housing 15, and the bending control limit housing 13 and the release limit housing 15 prevent the bending control guide rod 26 from moving axially. and circumferential rotation. It should also be understood that the housing fixed cap 12, the distal inner rod 30, the bending control guide rod 26, the proximal inner rod 40, the shell locking ring 14 and the bending control driver 21 connect the entire handle assembly B in series.
  • the end inner rod 30 and the bending control guide rod 26 are both connected to the housing 10 to ensure that the handle assembly B as a whole does not rotate.
  • the bending control and limiting housing 13 is usually formed by two halves of the housing.
  • the bending control limiting housing 13 not only serves as a part of the housing 10, but is also used to limit the limit position of the bending control indicator 27 when it moves toward the proximal end or the distal end.
  • the bending control limit housing 13 can prevent the bending control indicator 27 from circumferential rotation, so that the bending control indicator 27 can only move forward and backward in the axial direction.
  • the bending control limit housing 13 is also used to guide the bending control. Indicates the direction of movement of member 27.
  • the Luer connector 16 can provide multiple interfaces, such as guide wire interfaces, emptying and filling interfaces, etc., and the number and functions of the interfaces can be set according to actual needs.
  • the Luer connector 16 is usually a Y-shaped structure.
  • the side interface offset with respect to the axis of the handle assembly B is generally used for emptying or filling the medium.
  • the central interface coincident with the axis of the handle assembly B is generally used for inserting the guide.
  • the catheter assembly A includes an outer tube 61 and an inner tube 62 arranged sequentially from outside to inside, that is, the inner tube 62 is arranged inside the outer tube 61 and is connected to the Luer connector 16 at its proximal end.
  • the distal end of the outer tube 61 is connected to a sheath for loading the heart valve stent; the distal end of the inner tube 62 is connected to a conical head, and the conical head and the sheath are closed to ensure the delivery system.
  • the inner tube 62 is also used to pass the guide wire, and the guide wire guides the movement of the delivery system; the outer tube 61 and the fixed seat 32 Fixed connection, the outer tube 61 and the inner tube 62 can move relative to each other; when releasing the heart valve stent, the release module controls the inner tube 62 to move forward and backward relative to the outer tube 61, exposing the heart valve stent, and the heart valve stent is separated from the sheath Post-expansion.
  • the outer tube 61 serves as the bending control pipeline 100, and a bending control cable 25 is connected to the outer tube 61.
  • the bending control module 20 controls the bending of the outer tube 61.
  • the bending control of the bending control module 20 is not limited to controlling the bending of the outer tube 61 only, and can also be used for other tubes.
  • the conduit assembly A may also include a drain pipe 63, which is fixedly connected to the fixed seat 32.
  • the drain pipe 63 functions to drain the air between the outer tube 61 and the inner tube 62.
  • the connection method between the drain pipe 63 and the fixed seat 32 is not limited, such as threaded connection or glue dispensing.
  • Bending control function When active bending control is required, first set the bending control indicator 27 on, for example, the initial position in Figure 9 Then, rotate the bending control driving member 21 counterclockwise, so that the bending control indicating member 27, the bending control moving member 23, and the bending control wire fixing member 24 all move toward the proximal end of the conveying system along the bending control guide rod 26 until the bending control is controlled.
  • the indicator part 27 pushes against the housing 10, and the bending control driving part 21 cannot continue to rotate, thereby achieving the effect of actively controlling the bending of the outer tube 61; after active bending control, if the outer tube 61 needs to be relaxed, first rotate the bending control driving part 21 clockwise, Move the bend control indicator part 27 and the bend control moving part 23 to the far end of the delivery system to reserve the movement stroke required for the bend control wire fixing part 24 for the outer tube 61 to adapt to the blood vessel shape; after that, due to the bend control wire fixation The member 24 will be pulled by the bending control cable 25 and move to a suitable position at the far end autonomously, thereby achieving the effect of adaptive bending control of the outer tube 61 and forming adaptive bending control.
  • Release function When it is necessary to retreat to release the implant, rotate the release driving member 51 counterclockwise, so that the release moving member 53 drives the inner tube 62 to move proximally synchronously through the Luer connector 16, until the release moving member 53 hits the shell 10, and the release is released.
  • the driving member 51 cannot continue to rotate to achieve the effect of retreating and releasing the implant; when the release distance needs to be reduced, the releasing driving member 51 is rotated clockwise so that the release moving member 53 drives the inner tube 62 synchronously to the distal end through the Luer connector 16 Move to the appropriate location.
  • the conveying system and its handle assembly provided by the embodiment of the present invention, active bending control and adaptive bending control are realized through the bending control module, which improves the overall bending control accuracy and reduces the difficulty of the conveying operation. Improved surgical efficiency.
  • the traditional conveyor system handle adopts a segmented design to connect the bending control and release modules as a whole, often sacrificing its weight index to ensure strength or sacrificing strength to ensure weight.
  • the present invention adopts a bridging method such as a bending control guide rod, a proximal inner rod, a distal inner rod, a shell, a threaded component and a sleeve to connect the bending control and release modules into one body, which has high mechanical strength.
  • the present invention also utilizes the cooperation between the sleeve and the threaded component to further reduce the volume and mass of the handle component, while ensuring that the handle component has sufficient strength.
  • point contact is used to connect the bending control wire, which has low fixing strength, is susceptible to interference, and has low accuracy.
  • the bending control cable and the bending control cable fixing part of the present invention are connected through line contact, which ensures the bending control strength while also reducing the size of the bending control module.
  • the bending control and release structure provided by the present invention is simple, reliable in operation, and easy to maintain.

Abstract

本发明提供一种输送系统及手柄组件，输送系统包括相连接的导管组件和手柄组件，导管组件包括控弯管路，手柄组件包括控弯模组，控弯模组包括能够选择性抵接的运动控制部件和拉线控制部件；当运动控制部件与拉线控制部件抵接时，运动控制部件驱动拉线控制部件移动，以使拉线控制部件拉动输送系统的控弯管路进行主动弯曲；当运动控制部件与拉线控制部件相分离后，拉线控制部件随控弯管路的弯曲而移动；如此配置，可以实现控弯管路的自适应弯曲，以提高控弯精度，并降低输送操作难度。

Description

输送系统及手柄组件 技术领域
本发明涉及医疗器械技术领域，特别涉及一种输送系统及手柄组件。
背景技术
经调查显示，中老年人患有冠心病、心脑血管病、心脏瓣膜病、肿瘤等疾病的几率逐年上升。这些疾病直接影响到中老年人的生活质量甚至生命安全。传统外科手术治疗仍是重病患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及身体恢复功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。
介入治疗术是国际近年来研发的一种全新的治疗技术，其原理是利用现代高科技手段进行的一种微小创伤治疗，在医学影像设备的引导下，将特制精密器械，引入人体，对体内病变进行诊断和局部治疗。这项技术具有不开刀、创伤小、恢复快、效果好等特点，避免了传统外科手术对病人造成的危害。近十年来，国际上心脏瓣膜介入治疗术经过不断的探索已经取得了明显的进步，成为介入治疗领域最具发展前景的分支。
手柄作为整个介入治疗的动力源，通常有纯手动手柄、纯电动手柄或者手动电动混合手柄，均需保证足够的安全性、有效性、经济性。随着对心脏瓣膜疾病发病机理与病变类型研究的深入，输送系统的功能需求及操作简易性要求逐步成为重点，但是目前的手柄在体积、质量、可靠性、控弯精度、操作便捷性等方面还存在一些问题，因此还需要进一步优化手柄的结构。
发明内容
本发明的目的在于提供一输送系统及手柄组件，能实现管路的自适应控弯，从而提高控弯精度，并降低输送操作难度。
为实现上述目的，本发明提供一种手柄组件，用于驱动植入物的输送系统，其包括控弯模组，所述控弯模组包括能够选择性抵接的运动控制部件和拉线控制部件；
当所述运动控制部件与所述拉线控制部件抵接时，所述运动控制部件驱动所述拉线控制部件移动，以使所述拉线控制部件拉动所述控弯管路进行主动弯曲；
当所述运动控制部件与所述拉线控制部件相分离后，所述拉线控制部件随所述控弯管路的弯曲而移动。
可选地，所述手柄组件还包括外壳，所述运动控制部件包括传动连接的控弯驱动件和控弯移动件，所述控弯驱动件设置在所述外壳上，所述控弯移动件设置于所述外壳内，所述拉线控制部件包括控弯拉线固定件和控弯拉线；
所述控弯拉线固定件设置在所述外壳内并位于所述控弯移动件的一侧；所述控弯拉线的一端用于与所述控弯管路连接，另一端与所述控弯拉线固定件连接；所述控弯拉线固定件用于与所述控弯移动件选择性抵接；
当所述控弯拉线固定件与所述控弯移动件抵接时，所述控弯驱动件驱动所述控弯移动件带动所述控弯拉线固定件沿所述输送系统的轴线的第一方向移动，以使所述控弯拉线固定件拉动所述控弯拉线带动所述控弯管路主动弯曲；
当所述控弯拉线固定件与所述控弯移动件分离后，所述控弯拉线随所述控弯管路的弯曲而移动，并驱动所述控弯拉线固定件沿所述输送系统的轴线的第二方向移动；所述第二方向与所述第一方向相反。
可选地，所述控弯拉线固定件与所述控弯拉线之间通过线接触连接。
可选地，所述控弯拉线固定件包括固定件主体和第一结构件，所述固定件主体用于与所述控弯移动件选择性抵接，所述第一结构件与所述固定件主体可拆卸连接；所述固定件主体能够张紧所述控弯拉线，且所述第一结构件与所述控弯拉线通过线接触连接。
可选地，所述控弯拉线固定件还包括第二结构件，所述固定件主体具有沿自身轴向贯通的第一孔和第二孔，所述控弯拉线依次穿过所述第一孔和所述第二孔后，所述第一结构件插入所述第二孔，并通过所述第二结构件与所述固定件主体螺纹固定连接。
可选地，所述控弯拉线固定件还包括第二结构件；所述第一结构件设置 在所述固定件主体沿中心轴线的一侧，并具有一个过孔；所述控弯拉线依次分别缠绕所述第一结构件和所述第二结构件至少一圈后，所述第二结构件插入所述过孔并与所述第一结构件固定连接。
可选地，所述控弯拉线的一端与所述控弯管路连接，另一端焊接于所述控弯拉线固定件上。
可选地，所述控弯驱动件可转动地设置于所述外壳上，所述运动控制部件还包括分别与所述控弯驱动件及所述控弯移动件传动连接的控弯转动件；
所述控弯驱动件用于驱动所述控弯转动件周向转动，以带动所述控弯移动件沿所述第一方向或所述第二方向移动。
可选地，所述手柄组件还包括设置在所述外壳内的控弯导向杆，所述控弯转动件、所述控弯移动件和所述控弯导向杆从外到内依次套接并同轴设置，所述控弯导向杆用于引导所述控弯移动件和/或所述控弯拉线固定件的轴向移动。
可选地，所述运动控制部件还包括与所述控弯转动件传动连接的控弯指示件，所述控弯指示件用于识别所述控弯管路的控弯状态；所述控弯驱动件用于通过控弯转动件驱动所述控弯指示件沿所述第一方向或所述第二方向移动。
可选地，所述手柄组件还包括内杆锁紧环，所述控弯导向杆的最远端的外螺纹与所述内杆锁紧环的内螺纹固定连接，所述内杆锁紧环的近端面抵接所述外壳的内壁，所述控弯导向杆的最近端与所述外壳凹凸配合连接。
可选地，所述手柄组件还包括设置于所述外壳内的远端内杆，所述远端内杆的一部分结构穿设于所述控弯导向杆内，另一部分结构设置于所述控弯导向杆外。
可选地，所述手柄组件还包括设置于所述外壳内的近端内杆，所述远端内杆的最远端与所述外壳固定连接，所述远端内杆的最近端与所述近端内杆的最远端固定连接，且所述远端内杆的最远端的内壁中设置有内杆支撑环。
可选地，所述手柄组件还包括释放模组，所述释放模组包括传动连接的释放驱动件和释放移动件，所述释放驱动件设置在所述外壳上，所述释放移 动件设置在所述外壳内；所述释放驱动件用于驱动所述释放移动件带动所述输送系统的导管沿所述第一方向或所述第二方向移动。
可选地，所述释放驱动件可转动地设置于所述外壳上，所述释放模组还包括分别与所述释放驱动件及所述释放移动件传动连接的释放转动件；所述释放驱动件用于驱动所述释放转动件周向转动，以带动所述释放移动件沿所述第一方向或所述第二方向移动。
可选地，所述手柄组件还包括设置于所述外壳内的近端内杆，所述释放驱动件、所述释放移动件和所述近端内杆从外到内依次套接并同轴设置，所述近端内杆用于引导所述释放移动件的轴向移动。
可选地，所述外壳包括导管护套、控弯限位壳体和释放限位壳体；从远端至近端，所述导管护套、所述控弯限位壳体、所述控弯驱动件、所述释放限位壳体和所述释放驱动件依次搭接；其中所述控弯限位壳体和所述释放限位壳体用于限制所述控弯驱动件沿轴向的移动，所述释放限位壳体用于限制所述释放驱动件沿轴向的移动。
可选地，所述手柄组件还包括外壳以及释放模组，所述释放模组用于控制输送系统的导管沿输送系统的轴向移动；其中所述控弯模组、所述释放模组和所述外壳以桥接的方式连接为一体。
为实现上述目的，本发明还提供一种输送系统，其包括任一项所述的手柄组件以及与所述手柄组件连接的导管组件，所述导管组件包括控弯管路。
在本发明提供的输送系统及其手柄组件中，所述手柄组件包括控弯模组，所述控弯模组包括能够选择性抵接的运动控制部件和拉线控制部件；当所述运动控制部件与所述拉线控制部件抵接时，所述运动控制部件驱动所述拉线控制部件移动，以使所述拉线控制部件拉动所述输送系统的控弯管路进行主动弯曲；当所述运动控制部件与所述拉线控制部件相分离后，所述拉线控制部件随所述控弯管路的弯曲而移动。如此配置，能够实现控弯管路沿一方向的主动控弯，以及控弯管路的自适应弯曲，从而有效的提高控弯精度，使输送操作更为精准，输送难度更低，输送操作效率更高。
在本发明提供的输送系统及其手柄组件中，所述拉线控制部件包括控弯 拉线固定件和控弯拉线，所述控弯拉线的一端用于与所述控弯管路连接，另一端与所述控弯拉线固定件连接，其中控弯拉线固定件与控弯拉线之间通过线接触连接，一方面提高了控弯拉线的固定力，降低了控弯拉线脱落的风险，提升了手术操作的安全性和可靠性，另一方面可以减小控弯模组的尺寸，减小整个手柄组件的体积和质量，进一步提升输送操作控制的精度。
在本发明提供的输送系统及其手柄组件中，所述控弯模组通过控弯驱动件的转动以及控弯转动件和控弯移动件之间的传动配合，实现了将控弯驱动件的旋转位移转变成控弯拉线的直线位移，减小了整个手柄组件的体积，尤其螺纹配合传动时，通过螺纹组件的自锁能力，使得一方向的主动控弯后不会产生回退现象，确保了安全性和可靠性，同时螺纹传动的传动效率高，进一步提升了控弯精度和控弯效率。
附图说明
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限定。附图中：
图1是本发明优选实施例的输送系统的局部立体示意图；
图2是本发明优选实施例的输送系统的局部主视示意图；
图3是本发明优选实施例的手柄组件的内部结构示意图；
图4是本发明优选实施例的手柄组件的内部结构示意图；
图5a是本发明优选实施例的输送系统的轴向剖面主视图；
图5b是本发明优选实施例的输送系统的轴向剖面立体图；
图6是图5a中的a位置的局部放大图；
图7a是本发明优选实施例的手柄组件的控弯原理图，其中控弯拉线固定件采用螺栓对控弯拉线进行固定；
图7b是图7a中控弯拉线固定件上的固定件主体的横向剖面图；
图7c和图7d是本发明另一优选实施例中的控弯拉线固定件采用缠绕的方式固定控弯拉线的结构原理图；
图7e是本发明另一优选实施例中的控弯拉线固定件采用焊接方式固定控 弯拉线的结构原理图；
图8是图5a中的b位置的局部放大图；
图9是图5b中的d位置的局部放大图；
图10是本发明优选实施例的控弯指示件相对于图9发生移动后的状态图；
图11是图5b中的e位置的局部放大图；
图12是本发明优选实施例的控弯模组的局部放大图，其中拉线控制部件到达主动控弯的极限位置；
图13是本发明优选实施例的释放模组的局部放大图。
[附图标记说明如下]：
A-导管组件；61-外管；62-内管；63-排空管；
B-手柄组件；
10-外壳；11-导管护套；12-外壳固定帽；121-环套；13-控弯限位壳体；
131-透明视窗；14-外壳锁紧环；15-释放限位壳体；16-鲁尔接头；
20-控弯模组；21-控弯驱动件；22-控弯转动件；23-控弯移动件；24-控弯
拉线固定件；241-固定件主体；2411-第一孔；2412-第二孔；242、242’-第一结构件；2421-过孔；243、243’-第二结构件；25-控弯拉线；26-控弯导向杆；261-内杆锁紧环；27-控弯指示件；271-指示部；
30-远端内杆；31-内杆支撑环；32-固定座；33-端盖；34-内杆固定环；40-
近端内杆；
50-释放模组；51-释放驱动件；52-释放转动件；53-释放移动件；54-释放
锁紧环；55-释放固定环；
F-远端；N-近端；100-控弯管路。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复 数对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。在本发明的描述中，除非另有说明，“多个”的含义通常是两个或两个以上。
在以下说明中，为了便于描述，使用了“远端”和“近端”；“远端”是靠近患者的一端；“近端”是远离患者的一端；“轴向”参照的是沿着手柄的轴线方向。另外，在下文的描述中，给出了大量具体的细节以便对本发明更为彻底的理解。然而，对于本领域技术人员而言显而易见的是，本发明可以无需一个或多个这些细节而得以实施。在其他的例子中，为了避免与本发明发生混淆，对于本领域公知的一些技术特征未进行描述。本文中，“正向”指的是朝输送系统的近端方向；“反向”指的是朝输送系统的远端方向。本文中，“传动连接”指的是结构件之间相互抵接(包括连接)能够传递动力，如传动连接为凹凸配合连接，凹凸配合可以是螺纹配合等。本文中，“外壳上”可以指，设置在外壳壳体的内部，设置在外壳壳体的外部，或作为外壳壳体的一部分。
本发明的核心思路在于提供一种输送系统及其手柄组件，该输送系统包括相连接的手柄组件和导管组件，导管组件包括控弯管路，手柄组件包括控弯模组，控弯模组包括能够选择性抵接的运动控制部件和拉线控制部件；当运动控制部件与拉线控制部件抵接时，运动控制部件驱动拉线控制部件移动，以使拉线控制部件拉动控弯管路进行主动弯曲；当运动控制部件与拉线控制部件相分离后，拉线控制部件随控弯管路的弯曲而移动，以此实现控弯管路的自适应弯曲。此处，所述控弯管路因适应环境形态而自主弯曲，从而带动拉线控制部件移动，这里的环境形态主要为血管形态，血管形态包括血管的空间管状信息。
如此配置，一方面可实现输送系统沿一方向的主动控弯，另一方面可实现输送系统的自适应控弯。应理解，“自适应控弯”指的是控弯管路根据血管本身的形态来调整自身的弯曲，从而适应血管形态进行自主弯曲。更具体而言，主动控弯时，利用手柄组件的控弯模组驱动控弯管路运动，使控弯管路弯曲；当需要松弛控弯管路时，控弯管路借助于血管本身形态自主调节进行 弯曲，实现自适应弯曲，使得控弯管路松弛，此时，控弯管路自适应血管形态来带动拉线控制部件运动；如此配置，控弯精度更高，并能够降低输送操作难度，缩短手术时间，提高手术效率。
在一应用场景中，当运动控制部件与拉线控制部件抵接时，运动控制部件驱动拉线控制部件沿输送系统的轴线移动；当运动控制部件与拉线控制部件相分离后，拉线控制部件随控弯管路的弯曲而沿输送系统的轴线移动；从而实现控弯管路沿输送系统轴向的主动控弯和自适应控弯。进一步地，当运动控制部件与拉线控制部件抵接时，运动控制部件驱动拉线控制部件沿输送系统的轴线的第一方向移动；当运动控制部件与拉线控制部件相分离后，拉线控制部件随控弯管的弯曲而沿输送系统的轴线的第二方向移动；第二方向与第一方向相反；这里的第一方向和第二方向均是沿输送系统的轴线方向，即输送系统的轴向，即，第一方向与第二方向为共轴线的两个相反方向。可选地，第一方向为正向的主动控弯，第二方向为反向的自适应控弯，此时，可实现沿输送系统的轴向的单向控弯。
下面结合附图和优选实施例对本发明作更进一步的详细说明。而且在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。在以下描述中，假设沿输送系统的轴向实现单向控弯，但本领域技术人员应当能够修改以下描述，在细节上作适当修改后将所述描述用于非轴向的控弯或非单向的控弯，此外，为了简明起见，在以下描述中假设第一方向为朝输送系统的近端方向，第二方向为朝输送系统的远端方向，本领域技术人员应当能够修改以下描述，在细节上作适当修改后将所述描述用于第一方向和第二方向反过来设置的情况。
请参阅图1～图4、图5a～图5b、图6、图7a～图7e，本发明优选实施例提供一种输送系统，用于递送植入物。所述植入物的种类不限定，如可以为心脏瓣膜支架，还可以是其它植入物，如血管支架、动脉瘤支架、球囊扩张支架、输尿管支架、前列腺支架、末梢支架、气管支气管支架等，还可以是移植物、栓塞装置、封堵装置等。
所述输送系统整体上包括相连接的导管组件A和手柄组件B；导管组件 A和手柄组件B之间的连接方式具体不限定，如可为粘接、螺纹旋合、铆接、销钉连接等机械结构连接，或者两者一体成型连接；本实施例中，导管组件A和手柄组件B通过机械结构连接，以使输送系统的加工和组装更加的简单和方便。其中导管组件A包括控弯管路100。
手柄组件B包括控弯模组20，控弯模组20包括能够选择性抵接的运动控制部件和拉线控制部件。当运动控制部件与拉线控制部件抵接时，运动控制部件则驱动拉线控制部件朝输送系统的近端N方向移动，以使拉线控制部件拉动控弯管路100进行主动弯曲；而当运动控制部件与拉线控制部件相分离后，拉线控制部件随控弯管路100的弯曲而朝输送系统的远端F移动，以此实现控弯管路100的自适应弯曲。
作为一实施例，所述手柄组件B还包括外壳10，所述运动控制部件包括传动连接的控弯驱动件21和控弯移动件23；所述控弯驱动件21设置在所述外壳10上；在一些实施例中，外壳10的一部分壳体形成控弯驱动件21，也即，所述控弯驱动件21构成外壳10的一部分壳体。控弯移动件23可活动地设置于外壳10内；控弯驱动件21驱动控弯移动件23沿手柄组件B的轴向移动。优选，所述运动控制部件还包括分别与控弯驱动件21及控弯移动件23传动连接的控弯转动件22；控弯驱动件21用于驱动控弯转动件22周向转动，以带动控弯移动件23沿手柄组件B的轴向移动。优选控弯驱动件21为控弯套筒，可转动地设置于外壳10上。需要说明的是，如本领域技术人员所能理解的，在其它一些实施方式中，控弯驱动件21可移动地设置在外壳10上。控弯驱动件21可以直接或间接地与控弯移动件23传动连接，以此驱动控弯移动件23的轴向移动。本实施例中，控弯驱动件21设置为控弯套筒，结构简单，控制精度高，传动效率高。
作为一实施例，所述拉线控制部件包括控弯拉线固定件24和控弯拉线25，控弯拉线25的一端用于与控弯管路100连接，另一端与控弯拉线固定件24连接。控弯拉线固定件24设置在外壳10内并位于控弯移动件23的一侧。控弯拉线固定件24用于与控弯移动件23选择性抵接。当控弯拉线固定件24与控弯移动件23抵接时，控弯驱动件21驱动控弯移动件23带动控弯拉线固定 件24朝输送系统的近端N移动，以使控弯拉线固定件24拉动控弯拉线25以带动控弯管路100弯曲，以此实现控弯管路100的主动弯曲。当控弯拉线固定件24与控弯移动件23分离后，拉线控制部件不再受控弯移动件23的作用力，控弯拉线25随同控弯管路100的弯曲而移动，并驱动控弯拉线固定件24朝输送系统的远端F移动，由此实现了控弯管路100的自适应弯曲，并使控弯管路100自主松弛。
本发明实施例中，控弯拉线固定件24设置在控弯移动件23的近端，并用于与控弯移动件23的近端抵接。
本发明实施例中，控弯转动件22与控弯移动件23螺纹配合连接。还需理解的是，控弯转动件22仅能周向转动，而控弯移动件23和控弯拉线固定件24仅能轴向移动。
在一示例中，控弯转动件22的内螺纹与控弯移动件23的外螺纹配合，且控弯转动件22沿轴向的两侧被外壳10限位，故控弯转动件22只能周向旋转。
接下去结合优选实施例，对本实施例的输送系统实现控弯管路100弯曲的操作方式作进一步的说明。
当需主动控弯时，手动操作控弯驱动件21转动来驱动控弯转动件22转动，从而带动控弯移动件23和控弯拉线固定件24朝输送系统的近端N移动，并同步拉动控弯拉线25朝近端N移动，使得控弯管路100弯曲，且当控弯移动件23和控弯拉线固定件24朝近端N移动到合适位置后，停止移动，实现主动控弯。本领域技术人员可根据器械的入路方式，结合血管弯曲程度设置合适的控弯拉线固定件24的移动距离，为了限制弯曲极限，可在手柄组件B中设置限位组件，例如借助外壳10，当控弯拉线固定件24移动到极限位置时被外壳10顶住，使控弯移动件23和控弯拉线固定件24无法继续朝近端N移动。
当控弯程度需要减弱时，则实施自主控弯，此时，反方向手动操作控弯驱动件21转动来驱动控弯转动件22反方向转动，从而带动控弯移动件23朝输送系统的远端F移动至某一位置，从而为控弯拉线固定件24朝远端F运动 腾出一定的运动空间，由于控弯拉线固定件24与控弯移动件23分离，拉线控制部件不再受控弯移动件23的作用力，控弯拉线25便随同控弯管路100的弯曲而移动，并驱动控弯拉线固定件24朝输送系统的远端F移动，该方式实现了控弯管路100的自适应弯曲，使控弯管路100自主松弛。
与现有技术中的双向控弯相比，本发明的输送系统利用控弯管路的自适应控弯，可实现更高的控弯精度，使输送操作更为精准，输送难度更低，输送操作效率更高。
作为一优选实施例，所述手柄组件B还包括设置在外壳10内的控弯导向杆26，控弯移动件23可移动地设置在控弯导向杆26上，以通过控弯导向杆26引导控弯移动件23的移动方向，使控弯移动件23沿着控弯导向杆26移动，以提升运动控制的精准性。优选，控弯移动件23和控弯导向杆26从外到内依次套接并同轴设置。进一步地，控弯移动件23和控弯拉线固定件24均外套在控弯导向杆26上，以通过控弯导向杆26对控弯移动件23和控弯拉线固定件24中的至少一个的周向转动进行限位，使控弯移动件23和/或控弯拉线固定件24只能沿控弯导向杆26的轴向移动。如控弯导向杆26上设置凸台和/或凹槽等周向限位结构来限制控弯移动件23和/或控弯拉线固定件24的周向转动。所述控弯导向杆26一般为空心管，内部用于装配输送系统的导管，导管如为控弯管路。
本发明实施例中，控弯转动件22、控弯移动件23和控弯导向杆26从外到内依次套接并同轴设置，即控弯移动件23外套在控弯导向杆26上，控弯转动件22外套在控弯移动件23上，控弯导向杆26与外壳10连接，控弯转动件22具有内螺纹，控弯移动件23具有外螺纹，控弯移动件23的外螺纹与控弯转动件22的内螺纹配合连接。如此设置，控弯移动件23和控弯转动件22均采用环形螺纹套的结构，实现手柄组件B的对中设置，确保控制精度。
参阅图5a，所述手柄组件B还包括内杆锁紧环261，控弯导向杆26的最远端的外表面设有外螺纹(如图5a的标号S1所指示的位置)，控弯导向杆26的最远端的外螺纹与内杆锁紧环261的内螺纹固定连接，内杆锁紧环261的近端面连接外壳10的内壁。可选，外壳10的内壁可卡入控弯导向杆26的环 形缺口中，实现限位。控弯导向杆26的最近端可与外壳10凹凸配合连接。这里，设置内杆锁紧环261的好处包括：一方面能够锁紧控弯导向杆26和外壳10，另一方面还能够起支撑手柄壳体作用，增强手柄组件B的强度。
作为一优选实施例，控弯拉线固定件24与控弯拉线25之间通过线接触连接。“线接触”指的是控弯拉线25与控弯拉线固定件24接触时接触面为一条线的形式，控弯拉线25与控弯拉线固定件24的接触线可以是连续点形成的线，也可以是间隔的多个点形成的线；优选多个连续点形成的线。通过线接触连接的好处包括：一方面可提高控弯拉线25的固定力，降低控弯拉线25脱落的风险，提升手术操作的安全性和可靠性，另一方面可以减小控弯模组20的尺寸，减小整个手柄组件B的体积和质量，提升输送操作控制的精度。
作为一具体实施例，参阅图7a和图7b，控弯拉线固定件24包括固定件主体241，固定件主体241用于与控弯移动件23选择性抵接。优选固定件主体241为环形结构并外套在控弯导向杆26上并与控弯导向杆26同轴设置，进一步实现手柄组件B的对中设置。此外，控弯拉线25的另一端穿过控弯导向杆26与控弯拉线固定件24连接。另外，控弯拉线固定件24还包括第一结构件242，第一结构件242用于与固定件主体241可拆卸地连接，优选两者螺纹连接。固定件主体241能够张紧控弯拉线25，且第一结构件242能够与控弯拉线25通过线接触连接。可选的，控弯拉线固定件24还包括第二结构件243，用于锁定第一结构件242和固定件主体241。当然在其他实施例中，第一结构件242也可直接与固定件主体241锁定。本发明实施例的第一结构件242为螺杆，优选仅在第一结构件242的N端设置有螺纹，第二结构件243为螺母，螺母用于锁紧螺杆。
继续参阅图7a-图7b，作为一实施例，固定件主体241具有沿自身轴向贯通的第一孔2411和第二孔2412，第一孔2411和第二孔2412在径向上间隔设置；控弯拉线25的一端与控弯管路100固定连接，控弯拉线25的另一端依次穿入第一孔2411和第二孔2412后，第一结构件242插入第二孔2412并与固定件主体241通过第二结构件243螺纹固定连接，从而利用螺杆(第二结构件243)与控弯拉线25之间的线接触来连接控弯拉线25；最后将螺母与螺 杆螺纹连接，即可固定螺杆。
其中第一孔2411相比于第二孔2412可以更靠近控弯拉线固定件24的中心轴线，也可以更远离控弯拉线固定件24的中心轴线。可以理解，在这种方式中，控弯拉线25与螺杆之间通过线接触连接，使控弯拉线25被紧紧地固定在控弯拉线固定件24上，安全可靠且不容易脱落。更具体地，控弯拉线25从第一孔2411穿入(不缠绕)，然后弯曲从第二孔2412穿出，以此方式绕设至少一圈即可。此外，控弯拉线25在穿入第二孔2412时可缠绕或不缠绕螺杆(第一结构件242)，且螺杆的头端设有螺纹以锁紧螺母(第二结构件243)，从而利用螺杆与螺母的锁定将控弯拉线25固定在固定件主体241上。设置螺杆与螺母的好处是，螺杆与螺母之间的拧紧程度可通过工艺手段调整，增加了拉线控制部件装配的可重复性。然而在其他实施例中，也可取消螺杆和螺母，而是采用其他机械固定方式，将控弯拉线25与控弯拉线固定件24连接。也即，控弯拉线25与控弯拉线固定件24之间的连接有多种实现方式，例如，可为缠绕式连接或焊接连接等形式，可根据实际工况选择对应的连接方式。
作为另一示例，如图7c和图7d所示，控弯拉线固定件24除了固定件主体241外，还包括第一结构件242’和第二结构件243’；其中第一结构件242’与固定件主体241可一体成型或分体成型固定连接；第一结构件242’设置在固定件主体241沿中心轴线的一侧，并具有一个过孔2421；控弯拉线25的一端与控弯管路100连接，且控弯拉线25进一步依次缠绕第一结构件242’和第二结构件243’至少一圈后，将第二结构件243’插入第一结构件242’的过孔2421中锁紧。
作为又一示例，如图7e所示，控弯拉线25与控弯拉线固定件24焊接固定。具体地，控弯拉线25的一端与控弯管路100连接，另一端焊接于控弯拉线固定件24上。该方式中，控弯拉线固定件24同样可配置包括固定件主体241，固定件主体241优选为金属材料。
参阅图3、图5a和图6，作为一优选实施例，所述运动控制部件还包括与控弯转动件22传动连接的控弯指示件27，优选，控弯指示件27与控弯转动件22螺纹配合传动连接。控弯驱动件21用于通过控弯转动件22驱动控弯 指示件27沿输送系统的轴向移动，控弯指示件27与控弯移动件23的移动方向和移动速度相同，使操作人员根据控弯指示件27的指示来识别控弯拉线25的轴向前进路程，从而确定控弯管路100当前的控弯程度，使控弯调节更为精确和方便。
进一步地，控弯指示件27为环形结构且外套于控弯转动件22上，并与控弯转动件22螺纹连接且同轴设置，进一步实现手柄组件B的对中设置。本发明实施例中，控弯转动件22为环形螺纹套并具有外螺纹和内螺纹，控弯转动件22的外螺纹与控弯指示件27的内螺纹配合连接，控弯转动件22的内螺纹与控弯移动件23的外配合连接，且控弯转动件22的内外螺纹旋向与螺距相同，保证控弯指示件27与控弯移动件23、控弯拉线固定件24的移动方向与速度一致。
进一步地，参阅图1和图9，操作人员可通过外壳10上的透明视窗131实时获取控弯管路100的控弯状态。进一步地，当控弯指示件27朝近端N移动到一定位置后，会被外壳10顶住，达到主动控弯限位效果。
参阅图3、图9～图10及图12，作为一示例，控弯指示件27的外表面上设置凸出的指示部271，根据该指示部271所指示的位置能够确定控弯管路100的当前控弯程度，也即，根据控弯指示件27的移动位置确定控弯程度。在优选实施例中，控弯指示件27与透明视窗131的位置对应。优选地，外壳10能够引导控弯指示件27的移动方向，并还用于限制控弯指示件27朝近端和远端移动时的极限位置，如外壳10的远端具有内弯的挡壁限定控弯指示件27朝远端移动的极限位置，外壳10的近端具有内弯的挡壁限定控弯指示件27朝近端移动的极限位置，控弯指示件27仅在外壳10所限定的前后两个挡壁之间往复移动。
在本实施例中，控弯指示件27具有对应于未控弯的初始位置和对应于主动控弯的极限位置。参阅图9，未实施控弯时，控弯指示件27可处于最远端的初始位置，该初始位置可由外壳10限定，使控弯指示件27无法继续朝远端方向移动。参阅图10，主动控弯时，控弯指示件27被驱动从初始位置向近端方向移动至中间位置，操作人员可读取指示部271所对应透明视窗131上 的刻度来获取当前控弯程度，如果主动控弯程度合适，则停止继续向近端方向的移动。参阅图12，如果主动控弯需要继续，则控弯指示件27继续由中间位置向近端方向移动直至被外壳10顶住，并达到主动控弯的极限位置。
参阅图1、图9～图10及图12，在一具体实施方式中，外壳10上设置有透明视窗131，通过透明视窗131能够直接观察控弯指示件27的位置。透明视窗131由透明材料制成，透明视窗131上设有对应于控弯状态的刻度，该刻度可以是移动距离，也可以是直接为标定好的控弯档位，每个控弯档位对应于预定的控弯程度，方便操作人员读取控弯指示件27上的指示部271所指示的当前刻度值来确定控弯管路100的控弯程度。因此，当控弯驱动件21旋转时，操作人员可以透过透明视窗131清晰地看到控弯指示件27的移动状态，给操作者明确的视觉提示，能够很直观地判断控弯驱动件21旋转方向是否有误。当控弯指示件27靠近透明视窗131的刻度边界时，还可给予操作人员提示即将被外壳10顶住，需降低旋转速度，提升手术的安全性和可靠性。
作为优选示例，控弯驱动件21为控弯套筒并构成外壳10的一部分壳体，控弯驱动件21可由两半套筒接合形成，控弯驱动件21的两半套筒之间可通过螺丝、卡扣或销钉等方式紧固接合。在此，通过控弯套筒和一系列螺纹组件的配合，将控弯套筒的旋转位移转变成控弯拉线25的直线位移，减小了整个手柄组件B的体积，而且螺纹组件具备一定的自锁能力，使得主动控弯后不会产生回退现象，确保了安全性和可靠性，同时螺纹传动的传动效率高，提升了控弯精度和控弯效率。
参阅图5a～图5b以及图9～图13，所述手柄组件B进一步还包括设置于外壳10内的远端内杆30和近端内杆40；远端内杆30和/或近端内杆40均为空心管，空心管的内部用于穿设导管；远端内杆30和近端内杆40沿手柄组件B的轴向设置，即远端内杆30位于手柄组件B的远端，近端内杆40位于手柄组件B的近端。其中远端内杆30的一部分结构穿设于控弯导向杆26的内部并同轴设置，另一部分结构设置在控弯导向杆26的外部并向近端延伸以与近端内杆40的远端固定连接。远端内杆30和近端内杆40同轴设置，远端内杆30和近端内杆40均与外壳10保持相对静止，如远端内杆30与外壳10 固定连接，远端内杆30限制近端内杆40的轴向移动和周向转动。远端内杆30和/或近端内杆40优选采用塑料材质，如采用ABS树脂材料、POM材料(聚甲醛)、PC材料(聚碳酸酯)等，以减小手柄组件B的体积和质量，并提高输送操作控制精度。
参阅图5a，作为一示例，远端内杆30的最远端与外壳10螺纹固定连接，远端内杆30的最近端与近端内杆40的最远端固定连接，如凹凸配合连接。进一步地，远端内杆30的最远端的内壁中设置有内杆支撑环31，用于增强远端内杆30的强度，内杆支撑环31的材料为金属材料。作为一示例，远端内杆30的最远端的内壁上设置环形凹槽，内杆支撑环31安装于环形凹槽内，且内杆支撑环31安装后的内径与远端内杆30的至少部分内壁的内径相同。在一实施例中，远端内杆30的最远端与外壳10上的外壳固定帽12固定连接，外壳固定帽12的内部形成有环套121，环套121的内螺纹与远端内杆30的最远端外表面上的外螺纹配合。内杆支撑环31则设置在环套121与远端内杆30相连接的位置。
参阅图5a，远端内杆30的近端内部设置有固定座32，固定座32用于连接导管组件A的导管。为了便于组装固定座32，所述手柄组件B还包括端盖33，端盖33与远端内杆30的近端固定连接，端盖33的内部固定连接有固定座32，且端盖33的内部尺寸相比于远端内杆30的内径尺寸更大以便安装固定座32。进一步地，端盖33上设置有防转和限位措施，如粘接、扣合等限位连接，以对近端内杆40的轴向移动和周向转动进行限制，使近端内杆40与远端内杆30相连。在本实施例中，端盖33由两部分结构拼接而成，端盖33的一部分结构与远端内杆30一体成型，即远端内杆30的最近端自带端盖33的一部分结构，而另一部分结构为另行加工。优选地，端盖33的两部分结构利用内杆固定环34紧固连接，如内杆固定环34的内螺纹与端盖33的外螺纹固定连接。
参阅图1～图4，图5a～图5b、图8、图11～图12及图13，所述手柄组件B还包括释放模组50，用于控制导管组件A中的导管的轴向移动。优选，控弯模组20、释放模组50和外壳10以桥接的方式连接为一体。此处的“桥接” 指的是，控弯模组20、释放模组50和外壳10以一定的方式连接为一整体，使控弯模组20和释放模组50均集成在外壳10上。可以理解，此时，控弯模组20的一部分和释放模组50的一部分用于形成外壳10的壳体，反过来，外壳10的一部分壳体用于形成一部分控弯模组20和一部分释放模组50。需知晓的是，传统手柄通过分段式设计来串接控弯与释放模组，导致手柄组件体积大、重量大，强度低。而本发明实施例通过桥接的方式将控弯模组与释放模组连接为一体，使得手柄组件的体积更小，重量更轻，强度也更高。
作为一实施例，释放模组50包括传动连接的释放驱动件51和释放移动件53；释放驱动件51可活动地设置于外壳10上，优选，所述外壳10的一部分壳体形成释放驱动件51；释放移动件53可移动地设置于外壳10内。释放驱动件51用于驱动释放移动件53带动输送系统的导管沿轴向移动。
作为一优选实施例，释放模组50还包括分别与释放驱动件51及释放移动件53传动连接的释放转动件52。释放驱动件51用于驱动释放转动件52周向转动，以带动释放移动件53沿输送系统的轴向移动。优选，释放驱动件51为释放套筒，并可转动地设置于外壳上10。优选，释放转动件52与释放移动件53螺纹配合连接。然而在其他实施例中，释放驱动件51也可以可移动地设置在外壳10上。释放驱动件51可以直接或间接地与释放移动件53传动连接，最终驱动释放移动件53移动即可。本实施例中，释放驱动件51设置为释放套筒，结构简单，控制精度高，传动效率高。
所需理解，本实施例中，释放转动件52仅可周向转动，释放移动件53仅可轴向移动。进一步地，近端内杆40用于引导释放移动件53的轴向移动，并用于对释放移动件53的周向转动进行限位，使释放移动件53仅可以在轴向前后移动。如近端内杆40上可设置凸台或凹槽等结构来引导和限位释放移动件53。进一步地，外壳10用于对释放转动件52的轴向移动进行限位，使释放转动件52仅可周向转动。
优选地，释放移动件53外套在近端内杆40上，以通过近端内杆40引导释放移动件53的轴向移动，并通过近端内杆40限制释放移动件53的周向转动。释放移动件53与导管组件A中的导管连接，可以是直接或间接地连接导 管，如本实施例中，释放移动件53通过鲁尔接头16连接导管，从而驱动导管沿输送系统的轴向前后移动，实现植入物的装载和释放。
参阅图5a和图8，作为一示例，释放转动件52的近端外套有释放固定环55，以利用释放固定环55机械连接释放转动件52，如释放固定环55与释放转动件52螺纹连接，释放固定环55与外壳10共同限制释放驱动件51沿轴向移动，使释放驱动件51仅可周向转动。
在一优选实施例中，释放转动件52、释放移动件53和近端内杆40依次套接并同轴设置，也即，释放转动件52外套于释放移动件53上，释放移动件53外套在近端内杆40上，释放转动件52与释放移动件53螺纹连接，释放移动件53沿近端内杆40的轴向移动。
实际应用时，若以朝近端N方向移动的后退来释放植入物，则手动操作释放驱动件51运动(优选转动)，以驱动释放转动件52转动，并带动释放移动件53和与释放移动件53连接的导管一起朝近端方向后退，当导管后退到一定位置后，释放移动件53优选会被外壳10顶住，从而达到后退释放的限位效果；当释放距离需要减小时，反向手动操作释放驱动件51，使释放移动件53和与释放移动件53连接的导管一起朝远端方向前进，当导管前进到一定位置后，释放移动件53优选被外壳10顶住，从而达到前进限位效果。
释放驱动件51优选为释放套筒，释放驱动件51同样可由两半套筒拼接形成。如此设置，通过释放套筒和一系列螺纹组件的配合，将释放套筒的旋转位移转变成导管组件A的直线位移，减小了整个手柄组件B的体积，尤其螺纹传动连接时，通过螺纹组件的自锁能力，使得轴向前进或后退不会产生回退现象，确保了安全性和可靠性，同时螺纹组件也具备传动效率高等优点，提升了释放精度和释放效率。
参阅图1和图2还示意了外壳10的优选结构，该外壳10可包括从远端F至近端N依次布置的导管护套11、外壳固定帽12、控弯限位壳体13、外壳锁紧环14、释放限位壳体15和鲁尔接头16。其中外壳固定帽12和外壳锁紧环14中的至少一个为优选设置，起到固定作用，能够为各个模组进一步提供支撑，增加整个手柄组件B的强度。
本发明实施例中，从远端F至近端N，导管护套11、外壳固定帽12、控弯限位壳体13、外壳锁紧环14、控弯驱动件21、外壳锁紧环14、释放限位壳体15和释放驱动件51依次搭接，不仅实现对外壳10内机械部件的密封，还实现了控弯模组、释放模组和外壳以及其他管子(如控弯导向杆、近端内杆、远端内杆)之间的桥接，使整个手柄组件B被连接为一体。也即，控弯驱动件21设置在控弯限位壳体13与释放限位壳体15之间，优选，控弯限位壳体13和释放限位壳体15能够阻止控弯驱动件21沿轴向的移动，优选控弯限位壳体13还用于阻止控弯转动件22沿轴向的移动。需理解的是，一个外壳锁紧环14连接控弯限位壳体13与控弯驱动件21，另一个外壳锁紧环14连接控弯驱动件21和释放限位壳体15，从而实现控弯限位壳体13、控弯驱动件21和释放限位壳体15之间的连接。可选地，一个外壳锁紧环14与控弯限位壳体13的近端螺纹连接，另一个外壳锁紧环14与释放限位壳体15的远端螺纹连接，结构简单，组装方便。优选，释放限位壳体15可用于限制释放驱动件51沿轴向的移动。
作为一优选实施例，导管护套11的近端与外壳固定帽12的远端固定连接，且两者同轴布置，主要起到对中手柄组件B的作用，并还用于对导管组件A进行导向。导管护套11的近端可与外壳固定帽12的远端卡合连接。
作为一优选实施例，外壳固定帽12还与远端内杆30的远端固定连接，如螺纹连接。外壳固定帽12设有轴向贯通的环套121，远端内杆30的最远端外表面设有外螺纹，远端内杆30的最远端插入外壳固定帽12的环套121并螺纹连接。
作为一优选实施例，外壳固定帽12的近端与控弯限位壳体13的远端固定连接，如两者螺纹连接。外壳固定帽12可作为实现控弯功能的手握部分。进一步地，控弯导向杆26与控弯限位壳体13及释放限位壳体15连接，由控弯限位壳体13和释放限位壳体15阻止控弯导向杆26的轴向移动和周向转动。还需理解的是，外壳固定帽12、远端内杆30、控弯导向杆26、近端内杆40、外壳锁紧环14及控弯驱动件21，将整个手柄组件B串接起来，保证了整个手柄组件B的机械强度，减小了整机的体积，也便于实际操作时的抓握。远 端内杆30和控弯导向杆26均连接外壳10，保证手柄组件B整体不发生转动。
需说明的是，控弯限位壳体13通常由两半壳体合围形成。控弯限位壳体13不仅作为外壳10的一部分，而且还用于限位控弯指示件27朝近端或远端移动时的极限位置。进一步地，控弯限位壳体13可阻止控弯指示件27的周向转动，使控弯指示件27仅可以在轴向前后移动，优选控弯限位壳体13还用于引导控弯指示件27的移动方向。还应理解的是，鲁尔接头16可提供多个接口，如导丝接口，排空和注液接口等，接口的数量和功能可以根据实际需求进行设置。所述鲁尔接头16通常为Y型结构，相对于手柄组件B的轴线偏置的旁侧接口一般用于排空或充入介质，与手柄组件B的轴线重合的中心接口一般用于插入导丝。
参阅5a，在一示范性实施例中，导管组件A包括从外到内依次设置的外管61和内管62，也即内管62设置在外管61内并近端与鲁尔接头16连接。
以输送系统输送心脏瓣膜支架为例，外管61的远端连接鞘管，用以装载心脏瓣膜支架；内管62的远端连接锥形头，锥形头与鞘管闭合来保证输送系统的密封性和穿越性能，且通过锥形头和鞘管的相对运动实现心脏瓣膜支架的释放；内管62内还用于通入导丝，导丝引导输送系统移动；外管61与固定座32固定连接，外管61和内管62可以相对运动；在实施心脏瓣膜支架释放时，释放模组控制内管62相对于外管61前后移动，将心脏瓣膜支架显露出来，心脏瓣膜支架脱离鞘管后膨胀。
在一具体实施例中，外管61作为控弯管路100，其上连接有控弯拉线25，控弯模组20对外管61进行控弯。但是需理解，控弯模组20的控弯不局限于只能对外管61控弯，也可以是其他导管。
所述导管组件A还可包括排空管63，与固定座32固定连接，排空管63的作用是排空外管61和内管62之间的空气。所述排空管63与固定座32之间的连接方式不限定，如螺纹连接或点胶粘接等。
接下去结合优选实施例对本发明提出的输送系统的操作方式做进一步的说明。
控弯功能：需要主动控弯时，首先将控弯指示件27设置在例如图9的初 始位置，然后，逆时针旋转控弯驱动件21，使控弯指示件27、控弯移动件23、控弯拉线固定件24均沿控弯导向杆26往输送系统近端移动，直至控弯指示件27顶到外壳10，控弯驱动件21无法继续旋转，达到主动控弯外管61的效果；主动控弯后，若需要松弛外管61，则首先顺时针旋转控弯驱动件21，使控弯指示件27、控弯移动件23往输送系统远端移动，以预留出为外管61自适应血管形态而控弯拉线固定件24需要的移动行程；之后，由于控弯拉线固定件24会受到控弯拉线25的拉力自主往远端移动至合适的位置，达到自适应性控弯外管61的效果，形成自适应性控弯。
释放功能：需要后退释放植入物时，逆时针旋转释放驱动件51，使释放移动件53通过鲁尔接头16带动内管62同步往近端移动，直至释放移动件53顶到外壳10，释放驱动件51无法继续旋转，达到后退释放植入物的效果；当释放距离需要减小时，则顺时针旋转释放驱动件51，使释放移动件53通过鲁尔接头16带动内管62同步往远端移动至合适的位置。
综上所述，根据本发明实施例提供的输送系统及其手柄组件，通过控弯模组实现了主动控弯以及自适应性控弯，提高了整体控弯精度，并降低了输送操作难度，提高了手术效率。此外，传统的输送系统手柄采用分段式设计将控弯与释放模块串接为一个整体，往往会牺牲其重量指标去保证强度或牺牲强度去保证重量。但是，本发明采用了控弯导向杆、近端内杆、远端内杆、外壳、螺纹组件与套筒等桥接方式，将控弯与释放模组连接为一体，具有较高的机械强度，可以较好的满足输送系统的使用需求。另外，本发明还利用套筒与螺纹组件的配合，进一步减小了手柄组件的体积和质量，同时还能够保证手柄组件具有足够的强度。再者，现有技术中，采用点接触连接控弯丝线，固定强度小，容易受干扰，精度低。而本发明的控弯拉线与控弯拉线固定件之间通过线接触连接，在保证控弯强度的同时还减小了控弯模组的尺寸。不仅于此，本发明提供的控弯和释放的结构简单，操作可靠，维护方便。
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定， 本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。

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  1. 一种手柄组件，用于驱动植入物的输送系统，其特征在于，包括控弯模组，所述控弯模组包括能够选择性抵接的运动控制部件和拉线控制部件；
    当所述运动控制部件与所述拉线控制部件抵接时，所述运动控制部件驱动所述拉线控制部件移动，以使所述拉线控制部件拉动所述输送系统的控弯管路进行主动弯曲；
    当所述运动控制部件与所述拉线控制部件相分离后，所述拉线控制部件随所述控弯管路的弯曲而移动。
  2. 根据权利要求1所述的手柄组件，其特征在于，还包括外壳，所述运动控制部件包括传动连接的控弯驱动件和控弯移动件，所述控弯驱动件设置在所述外壳上，所述控弯移动件设置于所述外壳内，所述拉线控制部件包括控弯拉线固定件和控弯拉线；
    所述控弯拉线固定件设置在所述外壳内并位于所述控弯移动件的一侧；所述控弯拉线的一端用于与所述控弯管路连接，另一端与所述控弯拉线固定件连接；所述控弯拉线固定件用于与所述控弯移动件选择性抵接；
    当所述控弯拉线固定件与所述控弯移动件抵接时，所述控弯驱动件驱动所述控弯移动件带动所述控弯拉线固定件沿所述输送系统的轴线的第一方向移动，以使所述控弯拉线固定件拉动所述控弯拉线带动所述控弯管路主动弯曲；
    当所述控弯拉线固定件与所述控弯移动件分离后，所述控弯拉线随所述控弯管路的弯曲而移动，并驱动所述控弯拉线固定件沿所述输送系统的轴线的第二方向移动；所述第二方向与所述第一方向相反。
  3. 根据权利要求2所述的手柄组件，其特征在于，所述控弯拉线固定件与所述控弯拉线之间通过线接触连接。
  4. 根据权利要求3所述的手柄组件，其特征在于，所述控弯拉线固定件包括固定件主体和第一结构件，所述固定件主体用于与所述控弯移动件选择性抵接，所述第一结构件与所述固定件主体可拆卸连接；所述固定件主体能 够张紧所述控弯拉线，且所述第一结构件与所述控弯拉线通过线接触连接。
  5. 根据权利要求4所述的手柄组件，其特征在于，所述控弯拉线固定件还包括第二结构件，所述固定件主体具有沿自身轴向贯通的第一孔和第二孔，所述控弯拉线依次穿过所述第一孔和所述第二孔后，所述第一结构件插入所述第二孔，并通过所述第二结构件与所述固定件主体螺纹固定连接。
  6. 根据权利要求4所述的手柄组件，其特征在于，所述控弯拉线固定件还包括第二结构件；所述第一结构件设置在所述固定件主体沿中心轴线的一侧，并具有一个过孔；所述控弯拉线依次分别缠绕所述第一结构件和所述第二结构件至少一圈后，所述第二结构件插入所述过孔并与所述第一结构件固定连接。
  7. 根据权利要求2所述的手柄组件，其特征在于，所述控弯拉线的一端与所述控弯管路连接，另一端焊接于所述控弯拉线固定件上。
  8. 根据权利要求2所述的手柄组件，其特征在于，所述控弯驱动件可转动地设置于所述外壳上，所述运动控制部件还包括分别与所述控弯驱动件及所述控弯移动件传动连接的控弯转动件；
    所述控弯驱动件用于驱动所述控弯转动件周向转动，以带动所述控弯移动件沿所述第一方向或所述第二方向移动。
  9. 根据权利要求8所述的手柄组件，其特征在于，还包括设置在所述外壳内的控弯导向杆，所述控弯转动件、所述控弯移动件和所述控弯导向杆从外到内依次套接并同轴设置，所述控弯导向杆用于引导所述控弯移动件和/或所述控弯拉线固定件的轴向移动。
  10. 根据权利要求8所述的手柄组件，其特征在于，所述运动控制部件还包括与所述控弯转动件传动连接的控弯指示件，所述控弯指示件用于识别所述控弯管路的控弯状态；所述控弯驱动件用于通过所述控弯转动件驱动所述控弯指示件沿所述第一方向或所述第二方向移动。
  11. 根据权利要求9所述的手柄组件，其特征在于，还包括内杆锁紧环，所述控弯导向杆的最远端的外螺纹与所述内杆锁紧环的内螺纹固定连接，所述内杆锁紧环的近端面抵接所述外壳的内壁，所述控弯导向杆的最近端与所 述外壳凹凸配合连接。
  12. 根据权利要求9所述的手柄组件，其特征在于，还包括设置于所述外壳内的远端内杆，所述远端内杆的一部分结构穿设于所述控弯导向杆内，另一部分结构设置于所述控弯导向杆外。
  13. 根据权利要求12所述的手柄组件，其特征在于，还包括设置于所述外壳内的近端内杆，所述远端内杆的最远端与所述外壳固定连接，所述远端内杆的最近端与所述近端内杆的最远端固定连接，且所述远端内杆的最远端的内壁中设置有内杆支撑环。
  14. 根据权利要求2所述的手柄组件，其特征在于，还包括释放模组，所述释放模组包括传动连接的释放驱动件和释放移动件，所述释放驱动件设置在所述外壳上，所述释放移动件设置在所述外壳内；所述释放驱动件用于驱动所述释放移动件带动所述输送系统的导管沿所述第一方向或所述第二方向移动。
  15. 根据权利要求14所述的手柄组件，其特征在于，所述释放驱动件可转动地设置于所述外壳上，所述释放模组还包括分别与所述释放驱动件及所述释放移动件传动连接的释放转动件；所述释放驱动件用于驱动所述释放转动件周向转动，以带动所述释放移动件沿所述第一方向或所述第二方向移动。
  16. 根据权利要求15所述的手柄组件，其特征在于，还包括设置于所述外壳内的近端内杆，所述释放转动件、所述释放移动件和所述近端内杆从外到内依次套接并同轴设置，所述近端内杆用于引导所述释放移动件的轴向移动。
  17. 根据权利要求14所述的手柄组件，其特征在于，所述外壳包括导管护套、控弯限位壳体和释放限位壳体；从远端至近端，所述导管护套、所述控弯限位壳体、所述控弯驱动件、所述释放限位壳体和所述释放驱动件依次搭接；其中所述控弯限位壳体和所述释放限位壳体用于限制所述控弯驱动件沿轴向的移动，所述释放限位壳体用于限制所述释放驱动件沿轴向的移动。
  18. 根据权利要求1所述的手柄组件，其特征在于，还包括外壳以及释 放模组，所述释放模组用于控制输送系统的导管沿输送系统的轴向移动；其中所述控弯模组、所述释放模组和所述外壳以桥接的方式连接为一体。
  19. 一种输送系统，其特征在于，包括如权利要求1-18任一项所述的手柄组件以及与所述手柄组件连接的导管组件，所述导管组件包括控弯管路。
PCT/CN2023/083256 2022-04-22 2023-03-23 输送系统及手柄组件 WO2023202318A1 (zh)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN112932739A (zh) * 2016-03-21 2021-06-11 爱德华兹生命科学公司 凸轮控制的多方向可操纵手柄
CN113907919A (zh) * 2021-10-12 2022-01-11 江苏臻亿医疗科技有限公司 植入物输送手柄、输送系统及其工作方法
WO2022047160A1 (en) * 2020-08-31 2022-03-03 Shifamed Holdings, Llc Access sheath for prosthetic cardiac valve delivery systems
CN115670751A (zh) * 2021-11-10 2023-02-03 科凯(南通)生命科学有限公司 三尖瓣输送器

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112932739A (zh) * 2016-03-21 2021-06-11 爱德华兹生命科学公司 凸轮控制的多方向可操纵手柄
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
WO2022047160A1 (en) * 2020-08-31 2022-03-03 Shifamed Holdings, Llc Access sheath for prosthetic cardiac valve delivery systems
CN113907919A (zh) * 2021-10-12 2022-01-11 江苏臻亿医疗科技有限公司 植入物输送手柄、输送系统及其工作方法
CN115670751A (zh) * 2021-11-10 2023-02-03 科凯(南通)生命科学有限公司 三尖瓣输送器
CN219109847U (zh) * 2021-11-10 2023-06-02 科凯(南通)生命科学有限公司 三尖瓣输送手柄

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