WO2018107940A1 - 一种导丝调节器以及输送系统控制手柄 - Google Patents

一种导丝调节器以及输送系统控制手柄 Download PDF

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Publication number
WO2018107940A1
WO2018107940A1 PCT/CN2017/111049 CN2017111049W WO2018107940A1 WO 2018107940 A1 WO2018107940 A1 WO 2018107940A1 CN 2017111049 W CN2017111049 W CN 2017111049W WO 2018107940 A1 WO2018107940 A1 WO 2018107940A1
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WIPO (PCT)
Prior art keywords
guide wire
guidewire
adjuster
outer sleeve
inner tube
Prior art date
Application number
PCT/CN2017/111049
Other languages
English (en)
French (fr)
Inventor
雷荣军
Original Assignee
杭州启明医疗器械有限公司
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 杭州启明医疗器械有限公司 filed Critical 杭州启明医疗器械有限公司
Priority to JP2019532035A priority Critical patent/JP6803095B2/ja
Priority to CA3047348A priority patent/CA3047348C/en
Priority to EP17881799.5A priority patent/EP3569157B1/en
Publication of WO2018107940A1 publication Critical patent/WO2018107940A1/zh
Priority to US16/442,032 priority patent/US11197772B2/en
Priority to US17/542,267 priority patent/US11903853B2/en

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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/013—One-way gripping collars

Definitions

  • the present invention relates to the field of medical device technology, and in particular, to a delivery system control handle and a guide wire adjuster that cooperates with the control handle.
  • Interventional surgery has less trauma to the human body and less invasiveness. It is a medical technology that has been rapidly developed and promoted in recent years. It usually requires a special delivery system to transport the medical instruments and implanted instruments to the lesion.
  • the general delivery system mainly comprises a sheath tube, a sheath core located in the sheath tube, and an operating handle.
  • the sheath core generally includes a core tube, a bracket fixing head, a mounting section and a guiding head which are sequentially connected in a direction away from the operator.
  • a thin guide wire 1 is inserted through the femoral artery or femoral vein, and the front end of the guide wire 1 enters the left ventricle 2 through the aortic valve, and the front end of the guide wire 1 is partially
  • the curl forms a support at the bottom of the left ventricle, after which the sheath-loaded sheath is fed along the guide wire 1 until reaching the aortic valve 3, and then the sheath is released to release the stent 4, which expands under the action of body temperature.
  • the tapered outer wall will slide down under the aortic valve 3, which often causes the position of the valve on the stent 4 to be low, which affects the surgical effect, and the existing solution is generally
  • the position of the stent is adjusted by pulling the sheath 5, but the special structure of the aortic arch makes the adjustment effect of the axial traction sheath 5 very limited.
  • the sheath 5 If the sheath 5 is withdrawn, the sheath 5 will tighten the inside of the abduction of the aortic arch according to the position of the dotted line in Fig. 2, and the movement is difficult to transmit to the stent;
  • the sheath 5 If the sheath 5 is pushed forward, the sheath 5 will abut the outer side of the abduction of the aortic arch according to the position of the broken line in Fig. 3, and the movement is difficult to transmit to the stent;
  • the invention provides a guide wire adjuster, which can drive the sheath to drive the support by adjusting the axial relative position of the guide wire and the sheath tube during the interventional operation, especially when the position of the support is low, lifting the support, so that the support And the valve is released and fixed at a predetermined position.
  • a guide wire adjuster comprising:
  • a guide wire receiving mechanism having a passage for wearing the guide wire
  • a guide wire driving mechanism for driving the guide wire to reciprocate along the passage.
  • the guide wire adjuster of the present invention can drive the guide wire with respect to the sheath of the delivery system, wherein the guide wire receiving mechanism is connected with the control handle of the delivery system on the one hand, and forms a channel for accommodating the guide wire on the one hand, and the shape and structure of the guide wire receiving mechanism.
  • the guide wire receiving mechanism is connected with the control handle of the delivery system on the one hand, and forms a channel for accommodating the guide wire on the one hand, and the shape and structure of the guide wire receiving mechanism.
  • the guide wire receiving mechanism comprises a housing, and the passage penetrates the housing in a straight or curved path.
  • the guide wire preferably moves in a straight line within the guide wire receiving mechanism, and a curved (e.g., curved) path may be employed locally or entirely within the range allowed by the elasticity of the guide wire.
  • the housing is provided with an adaptive structure that is fixedly coupled to the operating handle in the interventional instrument delivery system.
  • the adaptive structure is a threaded structure, a plug structure or a clamp receiving structure.
  • the control handle of the system preferably uses a fixed connection.
  • the guide wire driving mechanism is a manual, electric or pneumatic mechanism.
  • At least a portion of the guidewire drive mechanism is mounted within the guidewire receiving mechanism housing or at least a portion is external to the guidewire receiving mechanism housing.
  • the guide wire drive mechanism may be integrally disposed inside the guide wire receiving mechanism, or a part of the control member may be disposed outside the guide wire receiving mechanism to be connected by means of fitting or the like.
  • the guide wire driving mechanism has a force applying member in direct contact with the guide wire, and the force applying member moves along the channel or rotates around a space axis.
  • the spatial axis is disposed perpendicular or oppositely to the channel of the respective portion.
  • the movement of the guide wire is directly driven by the force-applying member, and the guide wire moves along its own axis, but the movement of the force-applying member can be variously selected, and is converted into the axial movement of the guide wire by a suitable method.
  • the guide wire receiving mechanism is an inner tube
  • the guide wire driving mechanism is an outer sleeve
  • the inner tube and the outer sleeve are mutually nested and axially slidably fitted with the inner tube and the outer sleeve, and the inner tube and the outer sleeve are along the inner side An axially extending guide wire passageway;
  • One end of the inner tube and the outer sleeve is provided with a connecting member, and the other end of the inner tube and the outer sleeve is provided with a guide wire locking mechanism, and the connecting member has a fixing handle with the operating handle in the interventional instrument delivery system.
  • the adaptive structure of the connection is provided.
  • the guide wire adjuster of the present invention is connected and relatively fixed by the connecting member and the operating handle in the conveying system, and the relative movement of the sheath wire (or the bracket) in the guide wire and the conveying system is realized by the relative sliding of the inner tube and the outer casing during use.
  • the guide wire When the position of the stent is low, the guide wire is pushed forward (to the lesion end), and the increase of the length of the guide wire causes the sheath to expand toward the outside of the bend at the position of the aortic arch, since the length of the intravascular sheath does not increase,
  • the distal end of the sheath (the end away from the lesion) is fixed on the operating handle, so that the proximal end of the sheath drives the bracket to move upward (toward the outer side of the bend) to correct the problem of low bracket position.
  • a conventional luer connector is commonly used at the distal end of the operating handle, and the connector has an internal thread structure that cooperates with the luer connector.
  • the connector has a plug that is mated with the operating handle.
  • One side of the corresponding operating handle has an adaptable configuration such as a socket or a jack that mates with the plug.
  • the inner tube and the outer sleeve are at least partially nested with each other.
  • one end of the inner tube is provided with a connecting member, and one end of the outer sleeve away from the connecting member is provided with a wire locking mechanism.
  • the guide wire locking mechanism comprises an axial bearing member detachably connected to the guide wire, and a driving member connected to the axial bearing member on the outer sleeve.
  • the axial bearing member protrudes from the surface of the guide wire at least in a radial direction, and the axial bearing member is driven by the driving member when the outer casing moves, and then the guide wire is driven.
  • the axial bearing member is locked to the guide wire by a screw or fixed to the guide wire by elastic clamping.
  • the driving member and the axial bearing member are relatively fixed in axial position, and the specific shapes of the driving members are not strictly limited.
  • the driving member is only a part of the outer casing, and the driving member and the axial bearing member can pass between The connecting pieces are fixed or in the form of direct plug or interference fit.
  • the guide wire locking mechanism is an abutting member embedded on the sidewall of the outer sleeve, and one end of the abutting member protrudes into the guide wire passage passage and abuts against the guide wire.
  • the abutting member may be a structure such as a threaded pin or an elastic buckle, and the guide wire is locked by radial movement.
  • the guidewire locking mechanism includes at least two resilient jaws that grip the guidewire at the end of the outer sleeve and a compression cap that is threadedly engaged with the outer sleeve to grip the respective resilient jaws.
  • the elastic jaw acts as a force applying member in direct contact with the guide wire.
  • the rotation of the pressure cap can clamp the elastic claws, and the elastic claws relatively hold the locking guide wire.
  • the structure is easy to operate and disassemble.
  • the inner wall of the pressure cap is a tapered surface for guiding the elastic claws to be relatively closed, and the axial center of the pressure cap is provided with a guide wire through hole.
  • a circumferential locking mechanism is provided between the inner tube and the outer sleeve.
  • the circumferential limiting mechanism includes a guiding groove extending in the axial direction on one of the inner tube and the outer side of the outer casing, and a limiting pin located on the other of the inner tube and the outer casing and extending into the guiding groove.
  • the circumferential limiting mechanism includes a guiding groove extending in the axial direction on the side wall of the inner tube, and a limiting pin extending on the outer casing and extending into the guiding groove.
  • the side wall of the outer casing is provided with a radial through hole, and the limiting pin is fixedly inserted in the radial through hole.
  • the outer tube of the inner tube is threaded with a drive sleeve that is rotationally coupled to the outer sleeve and axially constrained.
  • the threaded position facilitates precise adjustment of the axial position of the drive sleeve, and the drive sleeve can be used to change the position of the outer sleeve to achieve precise control of the guide wire.
  • the inner wall of the drive sleeve is provided with an annular groove
  • the outer wall of the outer sleeve is provided with a positioning member which is rotatably fitted in the annular groove
  • the annular groove can drive the axial movement of the outer sleeve by the cooperation relationship with the positioning member as the driving sleeve moves axially.
  • a drive motor is provided outside the inner tube, and a drive fit between the drive motor and the drive sleeve.
  • the driving sleeve can be rotated forward and backward by the driving motor to simplify the operation, and the operator only needs to control the switch, and does not need to rotate the driving sleeve by itself.
  • the drive motor and the drive sleeve are driven by a gear.
  • the drive sleeve is divided into axial directions.
  • the threaded section of the inner sleeve and the extension section covered on the outer sleeve, and the threaded section and the extension section are mutually inserted and fixed.
  • the annular groove is located at the abutment of the threaded section and the extended section.
  • the outer sleeve When the inner tube and the outer sleeve are relatively moved, a part of the outer sleeve may be detached from the inner tube, and sway or bend may occur. If the extension portion is coated on the outer sleeve, the overall strength may be further improved to avoid bending or even breaking.
  • the outer wall of the drive sleeve is provided with an anti-slip pattern.
  • the outer wall of the inner tube is provided with a scale marking indicating the axial position of the drive sleeve.
  • the present invention also provides a delivery system comprising an operating handle, the inside of the operating handle being provided with a guide wire extending therethrough in the axial direction, characterized in that a guide wire adjuster according to the present invention is further provided, the guide wire is adjusted
  • the connecting member in the device is fixedly connected with the distal end of the operating handle, and the guide wire passage channel communicates with the inner cavity of the operating handle.
  • the operating handle is remotely mounted with a luer connector
  • the connecting member is a nut fixed to the end of the inner tube and matched with the luer connector
  • the distal end of the operating handle is provided with a socket
  • the connecting member is a plug that first cooperates with the socket.
  • the guide wire receiving mechanism is a tubular casing
  • the guide wire driving mechanism comprises:
  • a transmission mechanism connected between the drive motor and the slider.
  • the driving motor located in the housing pulls the slider through the transmission mechanism, and then drives the guide wire to move, and the slider and the guide wire can be fixed by means of fixed clamping, tight fitting, locking and the like.
  • the transmission mechanism is a screw nut pair, and the lead screw is connected to an output shaft of the driving motor, and the nut is fixed to the slider or has an integral structure.
  • the transmission mechanism includes a gear coupled to the output shaft of the drive motor, and a rack fixed or integral with the slider, wherein the gear and the rack mesh with each other.
  • a guide groove for guiding the movement of the slider is disposed in the housing.
  • the screw nut pair or the gear and the rack meshing mechanism are all linear movements.
  • the guide groove can be used for guiding, and the guide rod or the like can also be used.
  • the guide wire receiving mechanism is a tubular housing
  • the guide wire driving mechanism comprises:
  • a transmission mechanism connected between the drive motor and the two squeeze wheels.
  • the tubular casing is more convenient to hold, for example, cylindrical, and the outer wall is provided with a non-slip texture or a convex-concave structure.
  • the transmission mechanism includes a linkage gear that is respectively fixed on the two compression wheel axles and meshes with each other, wherein one of the linkage gears is a drive gear that is directly or indirectly driven with the output shaft of the drive motor.
  • the outer peripheral surface of the two squeeze wheels is provided with anti-slip teeth or a non-slip groove for receiving the guide wire.
  • the control circuit of the motor can adopt the prior art, for example, a servo motor, and the reciprocating motion of the guide wire is realized by the forward and reverse rotation of the motor.
  • the control circuit can be in the form of software, which cooperates with the external sensing device to automatically control the movement of the guide wire in real time to further improve the degree of automation.
  • a control button for driving the motor is embedded in the housing.
  • the housing is provided with a seal at a location where the guide wire passes. It can protect the internal components of the guide wire receiving mechanism and avoid pollution.
  • the invention also provides a conveying system control handle, comprising a handle body, wherein the handle body is internally provided with a passage for guiding the guide wire, and the guide body is connected with the guide wire according to the invention
  • the handle body is connected to the guide wire receiving mechanism of the guide wire adjuster, and the passages of the handle body and the guide wire adjuster are butted against each other for wearing the guide wire.
  • the guide wire adjuster of the present invention can push the guide wire forward when the position of the support is low through the relative movement of the guide wire and the sheath (or the support) in the delivery system, and the feedback of the force drives the proximal end of the sheath to drive the support upward. Exercise to correct the problem of low bracket position.
  • FIG. 1 is a schematic view showing a position of a stent at a region of aortic valve in a prior art
  • Figure 2 is a schematic view of the back of the sheath tube of Figure 1;
  • Figure 3 is a rear view of the forward push sheath of Figure 1;
  • FIG. 4 is a schematic view showing the external structure of a guide wire adjuster according to an embodiment of the present invention.
  • FIG. 5 is a schematic structural view of a control handle of a conveying system according to an embodiment of the present invention (the guide wire regulator portion is not shown);
  • Figure 6 is an exploded view of a guide wire adjuster in accordance with an embodiment of the present invention.
  • FIG. 7 is a schematic cross-sectional structural view of a guide wire adjuster according to an embodiment of the present invention.
  • Figure 8 is an enlarged view of a portion A of Figure 7;
  • Figure 9 is a schematic view showing the position of the guide wire corrected by the delivery system of the present invention.
  • Figure 10 is a schematic view showing the internal structure of another guide wire driving mechanism
  • Figure 11 is a schematic view showing the internal structure of a third type of guide wire driving mechanism.
  • a guide wire adjuster comprises an inner tube 6 and a sleeve 7 which are nested and axially slidably fitted.
  • the inner tube 6 and the outer sleeve 7 are both hollow tubular structures, and the inner portion is axially The extended guide wire passes through the channel.
  • the inner tube 6 and the outer sleeve 7 are partially nested with each other, and the outer nesting portion is wrapped with the outer jacket 7 On the periphery of the inner tube 6.
  • One end of the inner tube 6 extends out of the outer sleeve and is provided with a connecting member 8.
  • the end of the outer sleeve 7 away from the connecting member 8 is provided with a guide wire locking mechanism 9.
  • the outer thread of the inner tube 6 is matched with the driving sleeve 10, and the driving sleeve 10 and the outer sleeve 7 are rotated. Connection and axial limit.
  • the distal end of the control handle of the delivery system is a luer connector 11, and the end of the luer connector 11 is provided with an external thread 12.
  • the connecting member 8 is a nut fixed to the end of the inner tube and matched with the luer connector 11, and the nut has an internal thread that cooperates with the external thread 12.
  • the guide wire adjuster is coupled to the luer connector 11 through the connecting member 8 .
  • the guide wire adjuster and the control handle can be fixed to each other by plugging or the like, for example, in the control handle device.
  • the wire guide and the control handle can also be fixedly connected to each other by an additional connecting member, which is at least in a detachable form for ease of operation.
  • the function of the guide wire locking mechanism 9 is to lock the positioning guide wire relative to the outer sleeve 7, including four elastic claws 9a for holding the guide wire at the end of the outer sleeve, and the number of the elastic claws 9a can also be adjusted to 3 as needed. Or other quantities.
  • the end portion of the outer sleeve is provided with an external thread
  • the guide wire locking mechanism 9 further includes a pressing cap 9b that cooperates with the external thread to tighten the elastic claws.
  • the inner wall of the pressing cap 9b guides the elastic claws to be relatively closed.
  • the tapered surface 9c, the pressing of the pressing cap 9b can tighten the elastic claws under the action of the tapered surface, and the elastic claws relatively hold the locking guide wire.
  • the axial center of the pressing cap 9b is provided with a guide wire. The lead hole 9d is worn.
  • the head of each of the elastic claws is provided with a slope matching the tapered surface 9c to facilitate the adaptive guiding of the locking guide wire.
  • the elastic jaws may be integrally formed with the outer casing, formed by cutting, or otherwise fixed to the end of the outer casing.
  • the inner tube 6 and the outer sleeve 7 are provided with each other.
  • a circumferential limiting mechanism comprising a guiding groove 6a extending in the axial direction on the side wall of the inner tube 6, and a limiting pin 7a on the outer sleeve 7 and extending into the guiding groove 6a, the outer sleeve
  • the side wall of the seventh side is provided with a radial through hole 7b, and the limit pin 7a is fixedly inserted in the radial through hole 7b.
  • the guide groove 6a may penetrate the side wall of the inner tube 6 or may be in the form of a blind groove, and the axial length of the guide groove 6a depends on the guide wire adjustment stroke.
  • the axially central portion of the inner tube 6 is provided with an external thread, where the drive sleeve 10 is threadedly fitted, and the drive sleeve is axially divided into a threaded engagement with the inner sleeve.
  • the threaded section 10a, and the extension 10b covered on the outer sleeve 7, the threaded section 10a and the extended section 10b are inserted and fixed to each other, and the outer wall of the drive sleeve 10 is provided with an anti-slip pattern.
  • extension of the extension 10b on the outer sleeve 7 further enhances the overall strength and prevents the inner tube 6 and the outer sleeve 7 from being bent or even broken.
  • the connecting portion of the threaded portion 10a and the extending portion 10b is provided with an annular groove.
  • the outer wall of the outer sleeve 7 is provided with a positioning member 7c which is rotatably fitted in the annular groove.
  • the positioning member 7c is an annular step which is embedded in the annular groove.
  • the limiting pin 7a and the radial through hole 7b are also opened at the annular step portion, and the annular step is increased in thickness compared with other portions of the outer casing 7, so as to compensate for the loss of strength at the radial through hole 7b.
  • the annular groove can drive the outer sleeve 7 to move axially through the cooperation relationship with the positioning member 7c, and then the guide wire is moved relative to the control handle.
  • a thin guide wire 1 is inserted through the femoral artery or femoral vein, and the front end of the guide wire 1 enters the left ventricle 2 through the aortic valve, and the front end of the guide wire 1 is partially
  • the curl forms a support at the bottom of the left ventricle, after which the sheath-loaded sheath is fed along the guide wire 1 until reaching the aortic valve 3, and then the sheath is released from the stent 4, which is tapered as the stent 4 is released.
  • the expanded structure, the tapered outer wall will slide down by itself under the compression of the aortic valve 3, resulting in a lower position of the valve on the stent 4.
  • the guide wire adjuster and the control handle are fixed in advance by the connecting member, and the driving sleeve is rotated, and the annular groove of the inner wall of the driving sleeve passes through the cooperation relationship with the positioning member to drive the axial movement of the outer sleeve, and the upper limit pin of the outer casing protrudes into the guiding groove. Inside, so the jacket does not rotate, only the axial slip.
  • the outer casing moves the guide wire relative to the control handle through the locking mechanism, and the operator holds the operation handle together with the position of the sheath tube, and uses the guide wire adjuster to push the guide wire forward, so that the length of the guide wire entering the blood vessel is lengthened, because the front end of the guide wire is The bottom of the left ventricle forms a support, so the elongated guide wire will drive the sheath in the direction of the arrow of Figure 9 to expand beyond the bend at the position of the aortic arch.
  • the length of the sheath entering the blood vessel does not increase, and the distal end of the sheath (the end away from the lesion) is fixed relative to the operating handle, forcing the proximal end of the sheath to move with the guide wire toward the outside of the bend, and the sheath is connected to the sheath.
  • the core also tends to pull the bracket up in the direction of Figure 9 to correct the problem of low bracket position.
  • the guidewire receiving mechanism is a tubular housing 13 having a connector 8 attached to the control handle at one end.
  • the housing 13 has a passage for threading the guide wire 1.
  • the guide wire 1 extends in a straight line in the passage.
  • One end of the guide wire 1 extends through the housing 13 from the Luer joint to the control handle, and the other end extends out of the housing 13.
  • a drive motor 14 is disposed in the casing 13, and a control button (not shown) of the drive motor 14 is embedded in the casing, and the output shaft of the drive motor 14 is connected to the lead screw 15, and the screw 15 is screw-fitted.
  • a slider 16 that is fixed to the guide wire 1.
  • the slider 16 Since the stroke of the slider 16 is limited, in order to facilitate the movement of the guide wire by a large amplitude, the slider 16 is provided with a through hole, and the aperture is slightly larger than the outer diameter of the guide wire (gap fit), and the slider 16 is provided with a penetration hole. And the locking screw 18 that abuts the guide wire 1 can release or lock the guide wire by rotating the locking screw 18.
  • the housing 13 In order to facilitate the operation of the locking screw 18, the housing 13 is provided with an opening 17, which is opened and closed by means of a flap or a sliding sleeve.
  • the locking screw 18 can be loosened, and the guide wire 1 is self-piercing in the through hole. Travel by movement.
  • the guide wire 1 is locked, the movement of the guide wire is precisely controlled by the drive mechanism, the drive motor 14 drives the lead screw 15 to rotate, and the slider 16 then pulls the guide wire 1 to reciprocate linearly.
  • a guide groove for guiding the movement of the slider 16 and restricting the flipping of the slider 16 may also be provided in the housing 13.
  • the guide wire receiving mechanism is a tubular housing 13 having a connector 8 attached to the control handle at one end.
  • the housing 13 has a passage for threading the guide wire 1.
  • the guide wire 1 extends in a straight line in the passage.
  • One end of the guide wire 1 extends through the housing 13 from the Luer joint to the control handle, and the other end extends out of the housing 13.
  • the housing 13 is internally connected with two pressing wheels 19 which cooperate with the clamping guide wire 1; the two pressing wheels 19 hold the guiding wire 1, one of which is a driving wheel, which is manually A portion of the outer edge of the drive wheel is external to the housing 13 for the user to toggle.
  • a driving motor is arranged in the casing 13, and the output shaft of the driving motor is meshed with the driving wheel through the gear transmission mechanism, and at this time, the two pressing wheels can be both in the casing, and only embedded in the casing surface. Control button with drive motor.

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Abstract

一种导丝调节器以及设有导丝调节器的输送系统控制手柄，其中导丝调节器包括：导丝承接机构（13），具有用于穿引导丝（1）的通道；导丝驱动机构（14，19），驱使导丝（1）沿通道往复运动。导丝调节器可相对于输送系统的鞘管带动导丝（1），其中导丝承接机构（13）一方面与输送系统的控制手柄连接，一方面形成容纳导丝（1）的通道，导丝承接机构（13）的形状、结构并没有严格限制，但至少可与输送系统的控制手柄连接，形成容纳导丝（1）的通道。导丝调节器可以通过导丝（1）与输送系统中鞘管(或支架（4）)的相对运动，在支架（4）位置偏低的时候，向前推送导丝（1），通过力的反馈驱使鞘管近端带动支架（4）向上运动，以纠正支架（4）位置偏低的问题。

Description

一种导丝调节器以及输送系统控制手柄 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种输送系统控制手柄以及与该控制手柄相配合的导丝调节器。
背景技术
介入手术对人体造成的创伤小，侵害性少，是近些年迅速兴起并推广的医疗技术，通常需要专门的输送系统将诊疗器械、植入器械等输送至病变部位。
一般输送系统主要包括鞘管、位于鞘管内的鞘芯以及操作手柄，沿远离操作者方向，鞘芯一般包括依次连接的芯管、支架固定头、安装段和引导头，进行瓣膜植入时，首先将覆有人造瓣膜的支架通过尾部的锁定件卡合到支架固定头上，鞘管套在鞘芯的外部，保持支架的压缩状态。
参见图1，以介入主动脉瓣膜置换手术为例，经股动脉或者股静脉穿入较细的导丝1，导丝1的前端经主动脉瓣后进入左心室2，导丝1的前端局部卷曲在左心室底部形成支撑，之后将送装载有瓣膜的鞘管沿导丝1送入，直至到达主动脉瓣3处，再后撤鞘管释放支架4，支架4在体温的作用下膨胀。
由于支架4释放时会形成锥形的扩展结构，锥形外壁在主动脉瓣3的挤压下会自行下滑，经常导致支架4上瓣膜的位置偏低，影响手术效果，现有的解决方案一般是通过牵引鞘管5来调整支架的位置，但尴尬的是主动脉弓的特殊结构使得轴向牵引鞘管5的调整效果非常有限。
参见图2，图3：
若回撤鞘管5，鞘管5会按图2中虚线位置箍紧主动脉弓的过弯处内侧，该运动难以传递到支架部位；
若前推鞘管5，鞘管5会按图3中虚线位置抵紧主动脉弓的过弯处外侧，该运动也难以传递到支架部位；
总之，通过调整鞘管很难改变支架位置，支架释放位置一旦偏低很难调整，增加了手术风险。
发明内容
本发明提供一种导丝调节器，在进行介入手术时，通过调节导丝和鞘管的轴向相对位置，可以驱使鞘管带动支架，尤其在支架位置偏低时，上提支架，使得支架和瓣膜按预定位置释放固定。
一种导丝调节器，包括：
导丝承接机构，具有用于穿引导丝的通道；
导丝驱动机构，用于驱使导丝沿通道做往复运动。
本发明导丝调节器可相对于输送系统的鞘管带动导丝，其中导丝承接机构一方面与输送系统的控制手柄连接，一方面形成容纳导丝的通道，导丝承接机构的形状、结构并没有严格限制，但至少可实现上述功能。
可选的，所述导丝承接机构包括壳体，所述通道沿直线或曲线路径贯穿壳体。
导丝在导丝承接机构内优选沿直线运动，在导丝弹性容许的范围内，也可在局部或全部采用曲线(例如弧线)路径。
可选的，所述壳体上设有与介入器械输送系统中的操作手柄固定连接的适应性结构。
所述适应性结构为螺纹结构、插接结构或卡箍容纳结构。
考虑到操作方便以及平稳的驱动导丝，使用时导丝承接机构与输送 系统的控制手柄优选采用固定连接。
可选的，所述导丝驱动机构为手动、电动或气动机构。
可选的，所述导丝驱动机构的至少一部分安装在导丝承接机构壳体内部或至少一部分处于导丝承接机构壳体外部。
为了使所述导丝调节器外观整洁，减少空间干涉，导丝驱动机构可以整体设置在导丝承接机构内部，或者一部分操控部件设置在导丝承接机构外部，以嵌装等方式连接。
可选的，所述导丝驱动机构中具有与导丝直接接触的施力件，该施力件沿所述通道运动，或绕一空间轴线旋转。
所述空间轴线与相应部分的通道垂直或相对倾斜设置。
导丝的运动，直接来自施力件的驱使，导丝沿自身轴线运动，但施力件的运动方式可选多种，通过适宜的方式转化为导丝的轴线运动。
作为优选，所述导丝承接机构为内管，所述导丝驱动机构为外套，所述内管和外套相互嵌套且沿轴向滑动配合的内管和外套，内管和外套内部为沿轴向延伸的导丝穿引通道；
所述内管和外套中，其中一者的一端设有连接件，另一者上远离连接件的一端设有导丝锁紧机构，所述连接件具有与介入器械输送系统中的操作手柄固定连接的适应性结构。
本发明导丝调节器通过所述连接件与输送系统中的操作手柄连接且相对固定，使用时通过内管和外套的相对滑动，实现导丝与输送系统中鞘管(或支架)的相对运动，在支架位置偏低的时候，向前(向病灶端)推送导丝，导丝长度的增加会使得鞘管在主动脉弓的位置朝过弯处外侧扩展，由于血管内鞘管长度并没有增加，而鞘管远端(远离病灶的一端)固定在操作手柄上，使得鞘管近端带动支架向上运动(朝过弯处外侧贴靠)，以纠正支架位置偏低的问题。
现有的操作手柄远端常见的可选用鲁尔接头，作为可选的方案，所述连接件具有与鲁尔接头相配合的内螺纹结构。
为了将连接件与操作手柄相固定，并考虑操作方便，作为可选的方案，所述连接件具有与操作手柄插接配合的插头。相应的操作手柄一侧具有与插头配合的插座或插孔等适应性构造。
内管和外套之间至少局部上是相互嵌套的，作为优选，所述内管的一端设有连接件，外套上远离连接件的一端设有导丝锁紧机构。
可选的，所述导丝锁紧机构包括可拆卸连接在导丝上的轴向承力件，以及位于外套上与轴向承力件相连的驱动件。
所述轴向承力件至少在径向上凸起于导丝表面，外套运动时通过驱动件带动轴向承力件，继而带动导丝。
作为优选，所述轴向承力件通过螺钉锁紧在导丝上，或通过弹性夹持固定在导丝上。
所述驱动件与轴向承力件保持轴向位置的相对固定即可，两者具体形状并没有严格限制，例如驱动件仅仅为外套的一部分，驱动件与轴向承力件之间可以通过连接件相固定，或采用直接插接或过盈配合等形式。
可选的，所述导丝锁紧机构为嵌装在外套侧壁上的抵紧件，该抵紧件的一端伸入导丝穿引通道与导丝抵紧。
所述抵紧件可以是螺纹销或弹性卡扣等结构，通过径向运动锁紧导丝。
作为优选，所述导丝锁紧机构包括位于外套端头的至少两个夹持导丝的弹性卡爪，以及与外套端头螺纹配合以箍紧各弹性卡爪的压帽。其中所述弹性卡爪作为与导丝直接接触的施力件。
压帽旋转可以箍紧各弹性卡爪，各弹性卡爪相对抱拢锁紧导丝，此 结构便于操作和拆装。
所述压帽的内壁为引导各弹性卡爪相对抱拢的锥面，压帽的轴心部位设有导丝穿引孔。
为了限定内管和外套的相对旋转，作为优选，所述内管和外套之间设有相互配合的周向限位机构。
所述周向限位机构包括沿轴向开设在内管和外套其中一者侧壁上的导向槽，以及位于内管和外套中另外一者上且伸入导向槽内的限位销。
作为可选的方案，所述周向限位机构包括沿轴向开设在内管侧壁上的导向槽，以及外套上且伸入导向槽内的限位销。
外套侧壁设有径向通孔，所述限位销固定插设在该径向通孔中。
为了精密调节内管和外套的相对轴向位置，作为优选，内管外部螺纹配合有驱动套，所述驱动套与外套转动连接且轴向限位。
通过螺纹便于精密调节驱动套的轴向位置，利用驱动套改变外套位置可以实现导丝的精准控制。
为了实现驱动套与外套的转动连接以及轴向限位，作为优选，所述驱动套的内壁设有环形槽，所述外套的外壁设有转动配合在环形槽内的定位件。
驱动套和外套相对转动时，随着驱动套的轴向移动，环形槽可以通过与定位件之间的配合关系，驱动外套轴向移动。
也可采用自动控制，作为优选，在内管的外部设有驱动电机，驱动电机与驱动套之间传动配合。
可以通过驱动电机带动驱动套正反旋转，以简化操作，操作者仅需控制开关即可，无需自行旋转驱动套。
可选的，所述驱动电机与驱动套之间通过齿轮传动。
为了方便加工和安装，作为进一步优选，所述驱动套沿轴向分为与 内套相连的螺纹段，以及包覆在外套上的延伸段，螺纹段与延伸段之间相互插接固定。
所述环形槽位于螺纹段与延伸段的对接处。
当内管和外套相对移动时，外套的一部分可能脱离内管，有可能发生晃动或弯曲，若有延伸段包覆在外套上，可进一步提高整体强度，避免弯曲甚至断裂。
为防止打滑，作为优选，所述驱动套的外壁带有防滑纹。
作为优选，所述内管的外壁设有指示驱动套轴向位置的刻度标识。
本发明还提供一种输送系统，包括操作手柄，操作手柄内部设有沿轴向贯通的导丝穿引其，特征在于，还设有本发明所述的导丝调节器，所述导丝调节器中的连接件与操作手柄远端固定连接，导丝穿引通道与操作手柄内腔连通。
作为优选，所述操作手柄远端安装有鲁尔接头，所述连接件为固定在内管端部且与鲁尔接头相配合的螺帽。
作为优选，所述操作手柄远端设有插座，所述连接件为与插座先配合的插头。
作为优选，所述导丝承接机构为管状的壳体，所述导丝驱动机构包括：
安装在壳体内的驱动电机；
与导丝固定在滑块；
连接在驱动电机与滑块之间的传动机构。
位于壳体内的驱动电机通过传动机构牵引滑块，继而带动导丝运动，滑块与导丝之间可采用固定夹持、紧配合穿设、锁定件等方式固定。
可选的，所述传动机构为丝杠螺母副，丝杠与驱动电机的输出轴连接，螺母与滑块相固定或为一体结构。
可选的，所述传动机构包括与驱动电机输出轴连接的齿轮，以及与滑块相固定或为一体结构的齿条，其中所述齿轮和齿条相互啮合。
所述壳体内设有引导滑块运动的导向槽。
丝杠螺母副或齿轮、齿条啮合机构，所述滑块均为直线运动，为了保持其运动的稳定性，可采用导向槽方式引导，等同的也可采用导向杆等方式。
可选的，所述导丝承接机构为管状的壳体，所述导丝驱动机构包括：
安装在壳体内的驱动电机；
转接在壳体内相互配合夹持导丝的两挤压轮；
连接在驱动电机与两挤压轮之间的传动机构。
所述管状的壳体更便于持握，例如采用圆筒状，外壁设有防滑纹理或凸凹结构。
所述传动机构包括分别固定在两挤压轮轮轴上且相互啮合的联动齿轮，其中一联动齿轮为与驱动电机输出轴直接或间接传动的主动齿轮。
两挤压轮的外周面设有与导丝相配合的防滑齿或用以容置导丝的防滑槽。
在采用电机驱动方式时，电机的控制电路可以采用现有技术，例如采用伺服电机，并通过电机的正反转实现导丝的往复运动。
控制电路可以采用软件形式，与外部感应器件相配合，对导丝的运动实时自动控制，以进一步提高自动化程度。
为了便于操作，作为优选，所述壳体上嵌装有驱动电机的控制按键。
作为优选，所述壳体在导丝穿过的位置上设有密封件。可保护导丝承接机构内部元件，避免污染。
本发明还提供一种输送系统控制手柄，包括手柄本体，该手柄本体内部设有用于穿引导丝的通道，所述手柄本体上连接有本发明所述的导丝调 节器，手柄本体与导丝调节器的导丝承接机构相连，且手柄本体与导丝调节器两者的通道相互对接用以穿引导丝。
本发明导丝调节器可以通过导丝与输送系统中鞘管(或支架)的相对运动，在支架位置偏低的时候，向前推送导丝，通过力的反馈驱使鞘管近端带动支架向上运动，以纠正支架位置偏低的问题。
附图说明
图1为现有技术中主动脉瓣处支架位置偏低的示意图；
图2为图1中回撤鞘管后示意图；
图3为图1中前推鞘管后示意图；
图4为本发明实施例中导丝调节器外部结构示意图；
图5为本发明实施例中输送系统控制手柄的结构示意图(导丝调节器部分未显示)；
图6为本发明实施例中导丝调节器的爆炸图；
图7为本发明实施例中导丝调节器剖面结构示意图；
图8为图7中A部分放大图；
图9为应用本发明输送系统调节导丝纠正支架位置后的示意图；
图10为另一种导丝驱动机构的内部结构示意图；
图11为第三种导丝驱动机构的内部结构示意图。
具体实施方式
参见图4，本实施例中一种导丝调节器，包括相互嵌套且沿轴向滑动配合的内管6和外套7，内管6和外套7均为中空管状结构，内部为沿轴向延伸的导丝穿引通道。
内管6和外套7两者的局部相互嵌套，相互嵌套的部位上，外套7包裹 在内管6外围。
内管6一端延伸出外套并设有连接件8，外套7远离连接件8的一端设有导丝锁紧机构9，内管6的外部螺纹配合有驱动套10，驱动套10与外套7转动连接且轴向限位。
参见图5，本实施例中输送系统控制手柄的远端为鲁尔接头11，鲁尔接头11末端带有外螺纹12。
结合图6至图8，连接件8为固定在内管端部且与鲁尔接头11相配合的螺帽，螺帽带有与外螺纹12相配合的内螺纹。
使用时导丝调节器通过连接件8与鲁尔接头11相配合连接，当然作为其它实施方式，导丝调节器与控制手柄之间还可以通过插接等方式相互固定，例如在控制手柄车设有插座，连接件8以插头形式与插座配合。
导丝调节器与控制手柄之间还可以通过额外的连接件相互固定连接，为便于操作，两者至少为可拆卸形式。
导丝锁紧机构9的作用是相对于外套7锁紧定位导丝，包括位于外套端头的4个夹持导丝的弹性卡爪9a，弹性卡爪9a的数量也可以根据需要调整为3个或其他数量。
外套端头部位设有外螺纹，导丝锁紧机构9还包括与该外螺纹配合以箍紧各弹性卡爪的压帽9b，压帽9b的内壁为引导各弹性卡爪相对抱拢的锥面9c，压帽9b旋转可以在锥面的作用下箍紧各弹性卡爪，各弹性卡爪相对抱拢锁紧导丝，为了穿引导丝，压帽9b的轴心部位设有导丝穿引孔9d。
各弹性卡爪的头部设有与锥面9c相配合的斜面，以便于自适应的引导抱拢锁紧导丝。弹性卡爪可以与外套为一体结构，通过切割加工而成，或通过其它方式固定在外套端部。
为了限定内管6和外套7的相对旋转，内管6和外套7之间设有相互配 合的周向限位机构，该周向限位机构包括沿轴向开设在内管6侧壁上的导向槽6a，以及位于外套7上且伸入导向槽6a内的限位销7a，外套7侧壁设有径向通孔7b，限位销7a固定插设在该径向通孔7b中。
导向槽6a可以贯穿内管6侧壁也可以采用盲槽的形式，导向槽6a轴向长度根据导丝调节行程而定。
为了精密调节内管6和外套7的相对轴向位置，内管6轴向的中部带有外螺纹，在该处螺纹配合有驱动套10，驱动套沿轴向分为与内套螺纹配合的螺纹段10a，以及包覆在外套7上的延伸段10b，螺纹段10a与延伸段10b之间相互插接固定，驱动套10的外壁带有防滑纹。
延伸段10b包覆在外套7上可以进一步提高整体强度，防止内管6和外套7相对弯曲甚至折断。
螺纹段10a与延伸段10b的衔接部位设有环形槽，外套7的外壁设有转动配合在环形槽内的定位件7c，定位件7c为环形台阶，恰嵌入环形槽内。限位销7a以及径向通孔7b也开设在环形台阶部位，环形台阶相较于外套7的其它部位厚度提高，可以弥补径向通孔7b处强度的损失，
驱动套10和外套7相对转动时，随着驱动套10的轴向移动，环形槽可以通过与定位件7c之间的配合关系，驱动外套7轴向移动，继而牵引导丝相对于控制手柄运动。
参见图9，以介入主动脉瓣膜置换手术为例，经股动脉或者股静脉穿入较细的导丝1，导丝1的前端经主动脉瓣后进入左心室2，导丝1的前端局部卷曲在左心室底部形成支撑，之后将送装载有瓣膜的鞘管沿导丝1送入，直至到达主动脉瓣3处，再后撤鞘管释放支架4，由于支架4释放时会形成锥形的扩展结构，锥形外壁在主动脉瓣3的挤压下会自行下滑，导致支架4上瓣膜的位置偏低。
利用本实施例导丝调节器解决处理过程如下：
预先已通过连接件将导丝调节器与控制手柄固定，旋转驱动套，驱动套内壁的环形槽通过与定位件之间的配合关系，驱动外套轴向移动，由于外套上限位销伸入导向槽内，因此外套并不会转动，只做轴向滑移。
外套通过锁紧机构牵引导丝相对于控制手柄运动，操作者把持操作手柄连同鞘管位置不变，利用导丝调节器前推导丝，使得进入血管的导丝长度加长，由于导丝的前端在左心室底部形成支撑，因此加长的导丝会沿图9的箭头方向带动鞘管在主动脉弓的位置朝过弯处外侧扩展。
而进入血管内的鞘管长度并没有增加，鞘管远端(远离病灶的一端)相对于操作手柄固定，迫使鞘管远端近端随导丝朝过弯处外侧运动，同时鞘管连通鞘芯也势必牵动支架沿图9中方向上提，以纠正支架位置偏低的问题。
参见图10，在另一种实施方式中，导丝承接机构为管状的壳体13，壳体一端设有与控制手柄相连接的连接件8。
壳体13内具有用于穿引导丝1的通道，导丝1在通道内沿直线延伸，导丝1一端贯穿壳体13从鲁尔接头部位进入控制手柄，另一端延伸出壳体13。
作为导丝驱动机构，壳体13内设有驱动电机14，壳体上嵌装有驱动电机14的控制按键(图中省略)，驱动电机14输出轴连接丝杠15，丝杠15上螺纹配合有与导丝1相固定的滑块16。
由于滑块16行程有限，为了便于较大幅度移动导丝，滑块16内设有穿引孔，且孔径略大于导丝外径(间隙配合)，滑块16上设有伸入穿引孔且与导丝1相抵的锁紧螺钉18，通过旋转锁紧螺钉18可使释放或锁紧导丝。为了便于操作锁紧螺钉18，壳体13上设有开口17，开口17处通过翻板或滑套等方式实现开启和封闭。
在初期安装或穿引导丝时，可旋松锁紧螺钉18，导丝1在穿引孔内自 由移动穿行。需要精确调节时锁紧导丝1，通过驱动机构精确控制导丝运动，驱动电机14带动丝杠15旋转，滑块16继而牵动导丝1直线往复运动。壳体13内还可以设置引导滑块16运动并限制的滑块16翻转的导槽。
参见图11，在另一种实施方式中，导丝承接机构为管状的壳体13，壳体一端设有与控制手柄相连接的连接件8。
壳体13内具有用于穿引导丝1的通道，导丝1在通道内沿直线延伸，导丝1一端贯穿壳体13从鲁尔接头部位进入控制手柄，另一端延伸出壳体13。
作为导丝驱动机构，壳体13内转接有相互配合夹持导丝1的两挤压轮19；两挤压轮19夹持导丝1，其中一个挤压轮为主动轮，采用手动方式时，主动轮外缘的一部分处在壳体13外部，供使用者拨动。还可以采用自动方式时，即壳体13内设有驱动电机，驱动电机输出轴通过齿轮传动机构与主动轮啮合传动，此时两挤压轮可均处在壳体内，仅在壳体表面嵌装有驱动电机的控制按键。

Claims (25)

  1. 一种导丝调节器，其特征在于，包括：
    导丝承接机构，具有用于穿引导丝的通道；
    导丝驱动机构，用于驱使导丝沿通道做往复运动。
  2. 如权利要求1所述的导丝调节器，其特征在于，所述导丝承接机构包括壳体，所述通道沿直线或曲线路径贯穿壳体。
  3. 如权利要求1所述的导丝调节器，其特征在于，所述壳体上设有与介入器械输送系统中的操作手柄固定连接的适应性结构。
  4. 如权利要求3所述的导丝调节器，其特征在于，所述适应性结构为螺纹结构、插接结构或卡箍容纳结构。
  5. 如权利要求1所述的导丝调节器，其特征在于，所述导丝驱动机构为手动、电动或气动机构。
  6. 如权利要求1所述的导丝调节器，其特征在于，所述导丝驱动机构的至少一部分安装在导丝承接机构壳体内部或至少一部分处于导丝承接机构壳体外部。
  7. 如权利要求1所述的导丝调节器，其特征在于，所述导丝驱动机构中具有与导丝直接接触的施力件，该施力件沿所述通道运动，或绕一空间轴线旋转。
  8. 如权利要求7所述的导丝调节器，其特征在于，所述空间轴线与相应部分的通道垂直或倾斜设置。
  9. 如权利要求1所述的导丝调节器，其特征在于，所述导丝承接机构为内管，所述导丝驱动机构为外套，所述内管和外套相互嵌套且沿轴向滑动配合；
    所述内管和外套中，其中一者的一端设有连接件，另一者上远离连接件的一端设有导丝锁紧机构，所述连接件具有与介入器械输送系统中 的操作手柄固定连接的适应性结构。
  10. 如权利要求9所述的导丝调节器，其特征在于，所述连接件具有与鲁尔接头相配合的内螺纹结构。
  11. 如权利要求9所述的导丝调节器，其特征在于，所述连接件具有与操作手柄插接配合的插头。
  12. 如权利要求9所述的导丝调节器，其特征在于，所述内管的一端设有连接件，外套上远离连接件的一端设有导丝锁紧机构。
  13. 如权利要求12所述的导丝调节器，其特征在于，所述导丝锁紧机构包括可拆卸连接在导丝上的轴向承力件，以及位于外套上与轴向承力件相连的驱动件。
  14. 如权利要求13所述的导丝调节器，其特征在于，所述轴向承力件通过螺钉锁紧在导丝上，或通过弹性夹持固定在导丝上。
  15. 如权利要求12所述的导丝调节器，其特征在于，所述导丝锁紧机构为嵌装在外套侧壁上的抵紧件，该抵紧件的一端伸入导丝穿引通道与导丝抵紧。
  16. 如权利要求12所述的导丝调节器，其特征在于，所述导丝锁紧机构包括位于外套端头的至少两个夹持导丝的弹性卡爪，以及与外套端头螺纹配合以箍紧各弹性卡爪的压帽。
  17. 如权利要求16所述的导丝调节器，其特征在于，所述压帽的内壁为引导各弹性卡爪相对抱拢的锥面，压帽的轴心部位设有导丝穿引孔。
  18. 如权利要求9～17任一项所述的导丝调节器，其特征在于，所述内管和外套之间设有相互配合的周向限位机构。
  19. 如权利要求18所述的导丝调节器，其特征在于，所述周向限位机构包括沿轴向开设在内管和外套其中一者侧壁上的导向槽，以及位于 内管和外套中另外一者上且伸入导向槽内的限位销。
  20. 如权利要求9～12任一项所述的导丝调节器，其特征在于，内管外部螺纹配合有驱动套，所述驱动套与外套转动连接且轴向限位。
  21. 如权利要求20所述的导丝调节器，其特征在于，所述驱动套的内壁设有环形槽，所述外套的外壁设有转动配合在环形槽内的定位件。
  22. 如权利要求21所述的导丝调节器，其特征在于，所述驱动套沿轴向分为与内套相连的螺纹段，以及包覆在外套上的延伸段，螺纹段与延伸段之间相互插接固定。
  23. 如权利要求22所述的导丝调节器，其特征在于，所述环形槽位于螺纹段与延伸段的对接处。
  24. 如权利要求20所述的导丝调节器，其特征在于，所述驱动机构还包括设置在内管外部且与驱动套之间传动配合的驱动电机。
  25. 一种输送系统控制手柄，包括手柄本体，该手柄本体内部设有用于穿引导丝的通道，其特征在于，所述手柄本体上连接有如权利要求1～23任一项所述的导丝调节器，手柄本体与导丝调节器的导丝承接机构相连，且手柄本体与导丝调节器两者的通道相互对接用以穿引导丝。
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