WO2016173495A1 - 用于输送植入体的驱动手柄及输送系统 - Google Patents

用于输送植入体的驱动手柄及输送系统 Download PDF

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Publication number
WO2016173495A1
WO2016173495A1 PCT/CN2016/080347 CN2016080347W WO2016173495A1 WO 2016173495 A1 WO2016173495 A1 WO 2016173495A1 CN 2016080347 W CN2016080347 W CN 2016080347W WO 2016173495 A1 WO2016173495 A1 WO 2016173495A1
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WO
WIPO (PCT)
Prior art keywords
implant
control unit
transmission mechanism
delivery catheter
inner tube
Prior art date
Application number
PCT/CN2016/080347
Other languages
English (en)
French (fr)
Inventor
贺志秀
刘翔
桂宝珠
李�雨
王海山
吴明明
王云蕾
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
Priority to JP2017555216A priority Critical patent/JP6564060B2/ja
Priority to EP16785926.3A priority patent/EP3290007B1/en
Priority to BR112017023224-3A priority patent/BR112017023224B1/pt
Priority to KR1020177032965A priority patent/KR102049489B1/ko
Priority to ES16785926T priority patent/ES2863224T3/es
Priority to US15/568,240 priority patent/US10813754B2/en
Publication of WO2016173495A1 publication Critical patent/WO2016173495A1/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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a driving handle and a conveying system for conveying an implant.
  • Valvular heart disease is one of the most common heart diseases in China, mainly due to valvular damage caused by rheumatic fever.
  • valve degeneration including calcification and mucus degeneration
  • metabolic disorders Damage is also increasing in our country.
  • Surgical valve replacement surgery is a highly traumatic procedure with a significant attendant risk. Patients may be temporarily disrupted by embolization and other factors associated with the extracorporeal circulation machine, and it takes several months for the patient to fully recover. And the elderly and some special people are unable to withstand the trauma caused by surgery, and require a longer recovery time or recovery.
  • Minimally invasive interventional therapy has the advantages of no need to open the chest, less trauma, and quick recovery of the patient.
  • the interventional treatment showed cases that can be treated by internal surgery, and the intervention can be treated; cases that cannot be treated by surgery can be treated by intervention.
  • the research work of valvular disease interventional therapy has been accelerated.
  • Percutaneous interventional valve implantation has progressed from experimental research to small-scale clinical parallel research. The intervention of valvular disease may break through the technical "bottleneck" and rapidly realize a wide range of clinical Application has once again become the focus of attention in the field of interventional cardiology.
  • Valve stent implantation is inseparable from the delivery catheter of the valve stent.
  • a variety of manual delivery catheters for valve stents have been developed, such as the Chinese invention patent application CN101961269A of Hangzhou Qiming Medical Devices Co., Ltd., and the Chinese invention patent application CN1961847A of Wenning. China's invention patent application CN102573703A from Medetonik, and China from Edwards Life Science Company
  • the manual delivery catheter disclosed in the patent application CN101553190A typically include an inner tube, an outer tube and a valve holder, and a push-pull traction mechanism.
  • the inner tube includes a tapered guide head and a valve stent fixation head, and the valve stent is loaded between the conical head and the valve stent fixation head of the inner tube.
  • the inner tube segment is fixed on the valve stent fixing head, the outer tube sleeve is disposed on the inner tube to surround the valve holder and can move along the outer wall of the inner tube, and the push-pull traction mechanism is connected with the guiding tube and the outer tube of the inner tube to release the valve holder .
  • Patent No. US20120239142A1 provides an electric conveyor system that can drive the advancement and retreat of the catheter by operating the electric control button on the handle to complete the loading and releasing of the valve, which is simple and labor-saving, and reduces the burden on the doctor during operation. .
  • the unknown risk of electric delivery catheters is high. Once an accident occurs, it is likely to cause a surgical failure, which may endanger the patient's life in severe cases.
  • the object of the present invention is to provide a driving handle and a conveying system for conveying an implant, and to control and drive the catheter by freely switching between manual driving and electric driving, thereby solving the existing operation and the operation of the driving handle is complicated and safe.
  • the present invention provides a driving handle for conveying an implant
  • the driving handle for conveying the implant comprises: a manual control unit, an electric control unit and a transmission mechanism; the manual control unit Connecting to the transmission mechanism to actuate the transmission mechanism to drive a delivery catheter for delivering the implant; the electric control unit is coupled to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter .
  • the transmission mechanism comprises: a motion conversion member, a main shaft and a motion transmission member, one end of the main shaft is connected to the motion conversion member, and the other end is The motion transmitting members are connected, and the motion converting member is configured to receive the manual control unit An action signal is generated to actuate the spindle, and the motion transmitting member is configured to receive an action signal output by the electric control unit to actuate the spindle.
  • the transmission mechanism further includes a defining member, a displacement member sleeved on the main shaft, and a connecting member disposed on the displacement member.
  • the defining member is for supporting and fixing the main shaft, and the main shaft is provided with an external thread that cooperates with an internal thread of the displacement member, and the connecting member is used to establish a connection between the main shaft and the conveying conduit.
  • the manual control unit comprises: a manual control member and a manual transmission shaft connected to the manual control member.
  • the electric control unit comprises: a power source, a control button and a motor, wherein the control button controls a rotation direction of the motor, and the power supply unit The control button and the motor are powered.
  • the electric control unit further includes a controller electrically connecting the control button and the motor, and the controller receives the And controlling a direction command and a speed command issued by the button, and controlling the steering and the rotation speed of the motor according to the direction command and the speed command.
  • the present invention also provides a delivery system for delivering an implant, the delivery system for delivering an implant comprising: a delivery catheter and a delivery catheter coupled to the delivery catheter as described above for delivery of the implant
  • a drive handle that drives the delivery catheter drives the delivery catheter to effect loading and release of the implant.
  • the manual control unit, the electric control unit and the transmission mechanism are all disposed in the first housing, and the proximal end of the delivery catheter Provided in the first housing.
  • the manual control unit, the electric control unit and the transmission mechanism are all disposed in the first housing, and the proximal end of the delivery catheter
  • the first housing is detachably connected to the second housing, and the opposite sides of the first housing and the second housing are respectively provided with a displacement slot.
  • Establishing the spindle and the A connecting member of the connection of the delivery catheter is detachably connected to the delivery catheter through the displacement slots on the first housing and the second housing.
  • the delivery catheter comprises an inner tube, an outer tube disposed outside a portion of the inner tube; the implant is disposed on the outer tube In the gap space between the inner tubes.
  • the conveying conduit further comprises a stabilizing tube, a stabilizing tube fixing member disposed outside a part of the outer tube, and the stabilizing tube fixing member is used for fixing The stabilizing tube.
  • the inner tube comprises a tapered guiding head and an implant fixing head
  • the implant is loaded on the tapered guiding head and the The periphery of the inner tube portion between the implant fixation heads, and one end of the implant is fixed to the implant fixation head.
  • the delivery catheter further includes an inner tube fixing member, an outer tube fixing member, the inner tube fixing member is configured to fix the inner tube, An outer tube fixture is used to secure the outer tube.
  • the driving handle for conveying the implant comprises a manual control unit, an electric control unit and a transmission mechanism, and the manual control unit and the device
  • the transmission mechanism is coupled to actuate the transmission mechanism to drive the delivery catheter;
  • the electric control unit is coupled to the transmission mechanism to actuate the electric control unit to drive the delivery catheter. Therefore, the driving handle for conveying the implant of the present invention can be freely switched between the manual driving mode and the electric driving mode to drive the delivery catheter to transport the implant, and the operation process is relatively simple, and the doctor can according to himself
  • the surgical habits complete the surgery, improve the safety factor of the device and reduce the risk of surgery.
  • Figure 1 is a front elevational view of a delivery system for delivering an implant in a first embodiment of the present invention
  • Figure 2 is a partial cross-sectional view showing a delivery system for delivering an implant in the first embodiment of the present invention
  • Figures 3a-3d are schematic illustrations of the release procedure of the implant as a valve stent, wherein Figure 3a shows the valve stent in an unreleased state, Figures 3b and 3c show the valve stent in a partially released state, Figure 3d shows Is the valve stent in a released state;
  • FIG. 4 is a top plan view of a control button of the electric control unit in the first embodiment or the second embodiment of the present invention.
  • Figure 5 is a partial cross-sectional view of a delivery system for delivering an implant in a second embodiment of the present invention.
  • a driving handle 1 for conveying an implant an inner tube 2; an inner tube fixing member 20; an inner tube emptying tube 21; an inner tube emptying tube fixing member 210; an implant fixing head 2b; an implant Loading section 2c; inner tube proximal end section 2d; tapered guiding head 2a; outer tube 3; outer tube fixing member 30; stabilizing tube 4; stabilizing tube fixing member 40; delivery catheter 5; valve holder 6; Second housing 8; snap 9; manual control unit 10; manual control member 101; manual drive shaft 102; electric control unit 11; power supply 110; power supply spring 111; power switch 112; motor 113; control button 114; The device 115; the transmission mechanism 12; the motion conversion member 120; the motion transmission member 122; the displacement member 123; the main shaft 121; the defining member 124; and the connecting member 125.
  • the delivery system for transporting an implant comprises: a delivery catheter 5 and a driving handle 1 connected to the delivery catheter for conveying the implant, wherein A drive handle 1 that delivers the implant drives the delivery catheter to effect loading and release of the implant.
  • the delivery catheter 5 comprises an inner tube 2, an outer tube 3, and a stabilizing tube 4.
  • the positional relationship between the delivery catheter 5 and the drive handle 1 for delivering the implant in the present invention is divided into two cases.
  • the delivery catheter 5 and the drive handle 1 for transporting the implant are non-detachable;
  • the second case: the delivery catheter 5 and the drive handle for transporting the implant are each From separate parts, and the two are detachably connected for use.
  • the delivery system of the present invention for delivering an implant includes the following two embodiments.
  • FIG. 1 is a front view of a delivery system for delivering an implant in the first embodiment of the present invention.
  • the delivery system for delivering an implant includes: a delivery catheter 5 and a drive handle 1 for transporting the implant connected to the proximal end of the delivery catheter 5 for transporting the implant
  • the inductive drive handle 1 drives the delivery catheter 5 to effect loading and release of the implant.
  • FIG. 2 is a partial cross-sectional view of a delivery system for delivering an implant in the first embodiment of the present invention.
  • the driving handle 1 for conveying the implant comprises: a manual control unit 10, an electric control unit 11 and a transmission mechanism 12, and the manual control unit 10 is connected with the transmission mechanism 12 to actuate the transmission
  • the mechanism 12 drives the delivery catheter 5; the electric control unit 11 is coupled to the transmission mechanism 12 to actuate the transmission mechanism 12 to drive the delivery catheter 5.
  • the manual control unit 10, the electric control unit 11 and the transmission mechanism 12 are all disposed in the first housing, and the proximal end of the delivery catheter 5 is disposed in the first housing (required It is noted that in the present application, the proximal end or the distal end is a tapered guiding head 2a opposite to the inner tube, the proximal end is one end of the tapered guiding head 2a away from the inner tube, and the distal end is a cone close to the inner tube. One end of the guide head 2a is shaped.
  • the proximal end of the delivery catheter described herein refers to one end away from the tapered guide head 2a with respect to the tapered guide head 2a of the inner tube, see Figure 1 for details.
  • the delivery catheter 5 is connected to the drive handle 1 for transporting the implant via a connector 125.
  • the manual control unit 10 actuates the transmission mechanism 12 to further drive the delivery catheter 5;
  • the electric actuation mode is selected, the electric control unit 11 actuates the transmission mechanism 12,
  • the delivery catheter 5 is further driven to deliver the implant.
  • the driving handle 1 for transporting the implant of the present invention has two modes (manual control mode and electric drive mode), and when one mode fails during the application, the other mode can be switched to replace the appearance.
  • the failure mode continues the procedure, reducing the risk of surgery when driving the delivery catheter 5 in a single mode, increasing the safety factor of the instrument.
  • the transmission mechanism 12 includes: a motion conversion member 120, a main shaft 121, a motion transmission member 122, a defining member 124, and a displacement member 123 sleeved on the main shaft 121.
  • a motion conversion member 120 One end of the main shaft 121 and the movement The conversion member 120 is connected, and the other end is connected to the motion transmission member 122.
  • the motion conversion member 120 is configured to receive an action signal output by the manual control unit 10 to actuate the spindle 121, and the motion transmission member 122 Receiving an action signal output by the electric control unit 11 to actuate the main shaft 121, the defining member 124 is for supporting and fixing the main shaft 121, and restricting the stroke of the displacement member 123, and the main shaft 121 is disposed An external thread that cooperates with an internal thread of the displacement member 123, the connector 125 is used to establish a connection of the spindle 121 to the delivery catheter 5.
  • the main shaft 121 is a screw.
  • the connection of the spindle 121 to the proximal end of the delivery catheter 5 is established by a connector 125 provided on the displacement member 123.
  • the connector 125 is coupled to the outer tube 3.
  • the preferred displacement member is a nut, although the particular choice for the displacement member includes, but is not limited to, a nut.
  • the manner in which the main shaft 121 is connected to the delivery duct 5 includes, but is not limited to, a connection by a connection member 125, as long as the displacement member 123 moves in the axial direction of the main shaft 121, and a medium is provided in the middle to enable the delivery catheter.
  • the axial relative movement between the outer tube 3 of the 5 and the inner tube 2 and the stabilization tube 4 may be performed.
  • the manual control unit 10 includes a manual control member 101 and a manual transmission shaft 102 connected to the manual control member 101.
  • the electric control unit 11 includes a power source 110, a control button 114, and a motor 113.
  • the control button 114 controls the rotation direction of the motor 113, thereby controlling the moving direction of the displacement member 123.
  • the power source 110 supplies power to the control button 114 and the motor 113.
  • the motor is a DC motor.
  • the electric control unit 11 further includes a controller 115.
  • the controller 115 receives a direction command and a speed command issued by the control button 114, and according to the The direction command and the speed command control the steering and the rotational speed of the motor 113, thereby controlling the moving direction and the moving speed of the displacement member 123.
  • the power source 110 supplies power to the controller 115 and the control button 114 via wires.
  • the motor 113 is a stepping motor.
  • the electric control unit 11 can be implemented by a built-in power source (for example, the power source 110) and a corresponding accessory (such as the power spring 111, the power switch 112), and the built-in power source can be disposed in the first housing 7.
  • the card slot (not shown) is electrically connected to the power spring 111 in the card slot, and the power switch 112 is electrically connected to the power spring 111 and the control button 114.
  • the built-in power source is a one-time power source or a charging power source.
  • the present invention has no particular requirements on the type of power source, such as a lithium battery, a zinc manganese battery, a nickel cadmium battery, and the like.
  • the electric control unit 11 can also be implemented by using an external power supply and a corresponding accessory (such as the power switch 112).
  • the power switch 112 is electrically connected to a power plug (not shown) and a control button 114.
  • the manual control unit 10, the electric control unit 11, and the transmission mechanism 12 are all disposed in the first housing 7.
  • the power spring 111, the control button 114 and the controller 115 of the electric control unit 11 are fixed on the first housing 7 by a slot fixing manner
  • the power switch 112 the manual control unit 10 and the transmission mechanism 12 Both are fixed to the first housing 7 by screws.
  • the delivery catheter 5 includes an inner tube 2 , an outer tube 3 disposed outside a portion of the inner tube 2 , and a stabilization tube 4 disposed outside a portion of the outer tube 3 .
  • the implant is loaded in a gap space between the outer tube 3 and the inner tube 2 at a distal end.
  • the inner tube 2 includes a tapered guiding head 2a and an implant fixing head 2b, and the implant is loaded between the tapered guiding head 2a and the implant fixing head 2b.
  • the periphery of the body loading section 2c is inserted, and one end of the implant is fixed to the implant fixing head 2b.
  • the "outer tube 3 disposed on the outer side of the inner tube 2" is preferably used to transport the implant, and the distal end of the outer tube 3 is preferably adjacent to the tapered guiding head 2a.
  • the main purpose of the stabilizing tube 4 is to prevent unnecessary friction between the outer tube 3 and the human tissue during the movement of the outer tube 3, which requires the stabilizing tube 4 to cover the outer tube 3 as much as possible.
  • the catheter 5 needs to pass over the position of the active arch, the bending strength of the delivery catheter 5 is required to be low, and the compliance is good; during the release of the implant, the outer tube 3 is required to move to the proximal end to Full release The implant is placed, which requires that the stabilization tube 4 does not completely cover the outer tube 3.
  • a person skilled in the art can determine the length of the outer tube 3 of the stabilizing tube 4 according to the shape of the human tissue and the type of the implant to simultaneously satisfy the above requirements.
  • the inner tube 2 is fixed to the first housing 7 by the inner tube fixing member 20, and the outer tube 3 is connected to the displacement member 123 through the outer tube fixing member 30 and the connecting member 125, and the outer tube fixing member 30 can be in the first housing 7
  • the inner tube is moved, and the stabilizing tube 4 is fixed to the first housing 7 by the stabilizing tube fixing member 40.
  • the proximal end of the inner tube 2 is fixed to the inner tube fixing member 20, and the inner tube fixing member 20 is fixed in the card slot at the proximal end of the first housing 7.
  • the proximal end of the stabilizing tube 4 is fixed to the stabilizing tube fixing member 40, and the stabilizing tube fixing member 40 is fixed in the card slot of the distal end of the first housing 7 (i.e., the end of the housing close to the tapered guiding head 2a).
  • Fig. 3a shows the valve stent 6 in an unreleased state, as is clear from Fig. 3a, in which the valve stent 6 is loaded between the conical guide head 2a and the implant fixation head 2b during delivery.
  • the outer side of the inner tube proximal end section 2d is connected to the implant fixing head 2b, and the other end is connected to the inner tube fixing member by a thread or glue or the like, on the outer periphery of the tube 2 (that is, the implant loading section 2c of the inner tube 2).
  • 20 is fixedly connected, and then the inner tube holder 20 is fixed in the card slot at the proximal end of the first housing 7, so that the inner tube 2 as a whole is fixed relative to the drive handle 1 for transporting the implant. It is in turn ensured that the valve support 6 mounted on the implant fixation head 2b remains relatively fixed to the drive handle 1 for transporting the implant.
  • the distal end of the outer tube 3 is sleeved around the periphery of the valve support 6 on the implant loading section 2c, preferably the distal end of the outer tube 3 contacts the inner tube 2
  • the proximal end face of the distal tapered guide head 2a, the proximal end of the outer tube 3 is fixed to the outer tube fixture 30.
  • one end of the main shaft 121 of the transmission mechanism 12 is connected to the motor 113 of the electric control unit 11 through the motion transmission member 122, so that when the electric drive mode is implemented, the parameters such as the direction and speed of the control button 114 are set.
  • the rotation direction and the rotation speed of the motor 113 are controlled, and then the rotation of the motor 113 is finally converted into the axial movement of the displacement member 123 through the motion transmission member 122 and the main shaft 121.
  • the outer tube 3 Since the displacement member 123 is provided with a connecting member 125 connected to the outer tube fixing member 30, the outer tube 3 is axially moved relative to the inner tube 2 and the stabilizing tube 4 by the outer tube fixing member 30;
  • the rotation of the manual control member 101 can be transmitted to the main shaft 121 through the manual transmission shaft 102 and the motion conversion member 120 on the transmission mechanism 12.
  • the main shaft 121 drives the displacement member 123 to move in the axial direction, and finally drives the outer portion.
  • the tube 3 is moved axially relative to the inner tube 2 and the stabilizing tube 4.
  • valve support 6 are the process of moving the outer tube 3 of FIG. 3a toward the proximal end of the drive handle, the valve support 6
  • the delivery catheter 5 is gradually released, and the state in which the valve support 6 is placed is in the state shown in Figs. 3b to 3d.
  • the opposite direction of the release of the valve support can be selected by the control button 114 to move the outer tube 3 and the inner tube 2 in the opposite direction to the release of the valve holder, or to release the valve
  • the manual control member 101 is manually rotated in the opposite direction of the stent to effect loading of the valve support.
  • valve stent 6 such as a heart valve stent
  • an implant such as a heart valve stent
  • the delivery device disclosed herein can be used to place other implants (e.g., vascular stents) at corresponding locations in the body in addition to the valve support.
  • the control button 114 shown in FIG. 4 includes a button in which the direction and the speed are integrated, and the direction arrow set in the first row is higher than the direction arrow in the second row.
  • the gear position is high.
  • the button pressing the arrow to the right is equivalent to the recovery of the outer tube 3 to release the implant
  • the button that is pressed to the left in the direction of the arrow is equivalent to the recovery of the outer tube 3 to achieve the installation of the implant.
  • the second embodiment differs from the first embodiment in that a second housing 8 is further included.
  • the manual control unit 10, the electric control unit 11 and the transmission mechanism 12 are all disposed on In the first housing 7, the proximal end of the delivery catheter 5 is disposed in the second housing 8, the first housing 7 is detachably connected to the second housing 8, and the first housing 7 and the opposite side of the second casing 8 are provided with displacement grooves, and the connecting member 125 passes through the displacement grooves and the conveying conduit 5 on the first casing 7 and the second casing 8 Removable connection.
  • the delivery catheter 5 includes an inner tube 2, and an outer tube 3 disposed outside a portion of the inner tube 2; the implant is loaded in a gap space between the outer tube 3 and the inner tube 2 in.
  • the delivery catheter 5 further includes an inner tube fixing member 20 and an outer tube fixing member 30.
  • the inner tube fixing member 20 is movable in the second housing 8, and the outer tube fixing member 30 is fixed to the second housing 8.
  • the connecting member 125 is detachably connected to the inner tube fixing member 20 in the form of a buckle or the like; preferably, the second housing 8 and the first housing 7 are engaged by the buckle 9.
  • the inner tube fixing member 20 is located at the proximal end of the inner tube 2 and is movable in the inner cavity of the second housing 8. More preferably, the inner tube is provided with an inner tube emptying tube 21, and the inner tube is evacuated.
  • the proximal end of the tube 21 is fixed in the proximal card slot of the second housing 8 by the inner tube evacuation tube fixing member 210; the outer tube fixing member 30 at the proximal end of the outer tube 3 is fixed to the distal end of the second housing 8 In the card slot, and the outer tube fixing member 30 is provided with an inner cavity through which the inner tube 2 can pass.
  • the inner tube holder 20 is driven to move toward the distal end of the drive handle 1 by a manual actuation mode or an electric drive mode to move the inner tube 2 in the distal direction. Since the driving handle 1 and the conveying conduit 5 can be disassembled at any time in the second embodiment, the reuse of the driving handle 1 can be realized, which saves the operation cost.
  • the manual control member 101 is rotated in the opposite direction or the upper direction parameter of the control button 114 is set to effect movement of the inner tube 2 relative to the outer tube 3 in the opposite direction.
  • the driving handle for conveying the implant comprises a manual control unit, an electric control unit and a transmission mechanism, and the manual control a unit coupled to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter; the electric control unit coupled to the transmission mechanism to actuate the electric control unit to drive the delivery catheter .
  • the driving handle for conveying the implant of the present invention can be freely switched between the manual driving mode and the electric driving mode to drive the delivery catheter to transport the implant, and the operation process is relatively simple, and the doctor can according to himself
  • the surgical habits make full use of the advantages of the two modes to complete the operation and improve the accuracy of the operation; at the same time, the existence of the two modes can improve the safety factor of the device and reduce the risk of surgery.

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Abstract

一种用于输送植入体的驱动手柄（1）及输送系统，驱动手柄（1）包括手动控制单元（10）、电动控制单元（11）及传动机构（12）。手动控制单元（10）与传动机构（12）连接，以促动传动机构（12）驱动用于输送植入体的输送导管（5）。电动控制单元（11）与传动机构（12）连接，以促动传动机构（12）驱动输送导管（5）。该驱动手柄（1）能够在手动驱控模式和电动驱控模式之间自由切换以实现驱动输送导管（5）输送植入体，操作过程较为简单。医生可根据自己的手术习惯充分利用两种模式的优点完成手术，提高手术的精准度；同时两种模式的存在可以提高器械安全系数，降低了手术风险。

Description

用于输送植入体的驱动手柄及输送系统 技术领域
本发明涉及医疗器械技术领域，特别涉及一种用于输送植入体的驱动手柄及输送系统。
背景技术
心脏瓣膜病是我国最常见的心脏病之一，其中主要为风湿热导致的瓣膜损害；近年来随着人口老龄化的发展，瓣膜退行性变(包括钙化和粘液变性等)及代谢障碍性瓣膜损害在我国也日益增多。
传统的心脏瓣膜手术是在全身麻醉下进行的心脏直视方法。穿过患者的胸骨进行切割(胸骨切开术)，并且患者的心脏被停止而血流改道通过“心肺”旁路控制机(体外循环机)。外科瓣膜置换手术是具有明显伴随风险的高创伤性手术，患者可能由于栓子和与体外循环机有关的其他因素被暂时干扰，患者完全康复需要数月的时间。并且老年人及某些特殊人群更是无法承受外科手术所带来的创伤，术后需要更长的恢复时间或者无法康复等。
微创介入治疗方法具有无需开胸，创伤小，患者恢复快等优点。近10年内介入治疗方向显示出内外科能治疗的病例，介入都能治疗；外科手术不能治疗的病例，介入也能治疗。新世纪瓣膜病介入治疗的研究工作明显加速，经皮介入瓣膜植入术，由实验研究发展到小规模临床并行的研究阶段，瓣膜病介入可能突破技术上的“瓶颈”，迅速实现广泛的临床应用，再次成为介入性心脏病学领域的关注焦点。
瓣膜支架植入术离不开瓣膜支架的输送导管，目前，已开发出多种瓣膜支架的手动输送导管，例如杭州启明医疗器械公司的中国发明专利申请CN101961269A，温宁的中国发明专利申请CN1961847A，美国麦德托尼克公司的中国发明专利申请CN102573703A，和美国爱德华兹生命科学公司的中国 发明专利申请CN101553190A中所公开的手动输送导管。这些手动输送导管通常包括内管，外管和瓣膜支架及推拉牵引机构，内管包括锥形引导头和瓣膜支架固定头，瓣膜支架装载在内管的在锥形头和瓣膜支架固定头之间的内管段上且固定于瓣膜支架固定头，外管套在内管上以包围瓣膜支架且能沿内管的外壁移动，推拉牵引机构则与内管的引导头和外管连接以释放瓣膜支架。
但是，上述手动输送导管由于是全机械式的旋转和推拉运动，操作较为繁杂费力，整个过程均需要手动操作，容易引起医生手疲劳；此外，由于是手动输送导管，其应用时对于医者的操作要求高，很容易引起误操作，进而影响操作精度或误操作，影响手术质量。
专利号为US20120239142A1的专利提供了一种电动输送器系统，可通过操作手柄上的电动控制按键，驱动导管的前进、后退，完成瓣膜的装载和释放，操作简单省力，减轻了医生操作时的负担。但是电动输送导管的未知风险较大，一旦产生意外很可能会造成手术失败，严重时可能会危及患者生命。
发明内容
本发明的目的在于提供一种用于输送植入体的驱动手柄及输送系统，通过在手动驱动和电动驱动之间自由切换的方式控制和驱动导管，解决现有的驱动手柄存在操作复杂、安全系数低的问题。
为解决上述技术问题，本发明提供一种用于输送植入体的驱动手柄，所述用于输送植入体的驱动手柄包括：手动控制单元、电动控制单元及传动机构；所述手动控制单元与所述传动机构连接，以促动所述传动机构驱动用于输送植入体的一输送导管；所述电动控制单元与所述传动机构连接，以促动所述传动机构驱动所述输送导管。
可选的，在所述用于输送植入体的驱动手柄中，所述传动机构包括：运动转换件、主轴及运动传递件，所述主轴的一端与所述运动转换件相连，另一端与所述运动传递件相连，所述运动转换件用于接收所述手动控制单元输 出的动作信号以促动所述主轴，所述运动传递件用于接收所述电动控制单元输出的动作信号以促动所述主轴。
可选的，在所述用于输送植入体的驱动手柄中，所述传动机构还包括限定件、套接于所述主轴上的位移件及设置于所述位移件上的连接件，所述限定件用于支撑和固定所述主轴，所述主轴上设置有与所述位移件的内螺纹配合的外螺纹，所述连接件用于建立所述主轴与所述输送导管的连接。
可选的，在所述用于输送植入体的驱动手柄中，所述手动控制单元包括：手动控制件及与所述手动控制件相连的手动传动轴。
可选的，在所述用于输送植入体的驱动手柄中，所述电动控制单元包括：电源、控制按键及电机，所述的控制按键控制所述电机的转动方向，所述电源给所述控制按键和所述电机供电。
可选的，在所述用于输送植入体的驱动手柄中，所述电动控制单元还包括控制器，所述控制器电连接所述控制按键和所述电机，所述控制器接收所述控制按键发出的方向指令和速度指令，并根据所述方向指令和所述速度指令控制所述电机的转向和转速。
本发明还提供一种用于输送植入体的输送系统，所述用于输送植入体的输送系统包括：输送导管及与所述输送导管连接的如上所述的用于输送植入体的驱动手柄，所述用于输送植入体的驱动手柄驱动所述输送导管以实现植入体的装载和释放。
可选的，在所述用于输送植入体的输送系统中，所述手动控制单元、所述电动控制单元及所述传动机构均设置于第一壳体中，所述输送导管的近端设置于所述第一壳体中。
可选的，在所述用于输送植入体的输送系统中，所述手动控制单元、所述电动控制单元及所述传动机构均设置于第一壳体中，所述输送导管的近端设置于第二壳体中，所述第一壳体与所述第二壳体可拆卸式连接，且所述第一壳体与所述第二壳体的相对侧均设置有位移槽，用于建立所述主轴与所述 输送导管的连接的一连接件先后通过所述第一壳体及所述第二壳体上的所述位移槽与输送导管可拆卸式连接。
可选的，在所述用于输送植入体的输送系统中，所述输送导管包括内管、设置于部分所述内管外侧的外管；所述植入体设置于所述外管与所述内管之间的间隙空间中。
可选的，在所述用于输送植入体的输送系统中，所述输送导管还包括设置于部分所述外管外侧的稳定管、稳定管固定件，所述稳定管固定件用于固定所述稳定管。
可选的，在所述用于输送植入体的输送系统中，所述内管包括锥形引导头及植入体固定头，所述植入体装载在所述锥形引导头和所述植入体固定头之间的内管部分的外围，且所述植入体一端固定于所述植入体固定头上。
可选的，在所述用于输送植入体的输送系统中，所述输送导管还包括内管固定件、外管固定件，所述内管固定件用于固定所述内管，所述外管固定件用于固定所述外管。
在本发明所提供的用于输送植入体的驱动手柄及输送系统中，所述用于输送植入体的驱动手柄包括手动控制单元、电动控制单元及传动机构，所述手动控制单元与所述传动机构连接，以促动所述传动机构驱动所述输送导管；所述电动控制单元与所述传动机构连接，以促动所述电动控制单元所述传动机构驱动所述输送导管。因此，本发明的所述用于输送植入体的驱动手柄能够在手动驱控模式和电动驱控模式之间自由切换以实现驱动输送导管输送植入体，操作过程较为简单，医生可根据自己的手术习惯完成手术，提高器械安全系数的同时还降低了手术风险。
附图说明
图1是本发明实施例一中的用于输送植入体的输送系统的主视图；
图2是本发明实施例一中的用于输送植入体的输送系统的局部剖面图；
图3a-3d是植入体为瓣膜支架的释放过程的示意图，其中，图3a显示的是瓣膜支架处于未释放状态，图3b及图3c显示的是瓣膜支架处于部分释放状态，图3d显示的是瓣膜支架处于释放状态；
图4是本发明实施例一或实施例二中电动控制单元的控制按键的俯视图；
图5是本发明实施例二中的用于输送植入体的输送系统的局部剖面图。
图中，用于输送植入体的驱动手柄1；内管2；内管固定件20；内管排空管21；内管排空管固定件210；植入体固定头2b；植入体装载段2c；内管近端段2d；锥形引导头2a；外管3；外管固定件30；稳定管4；稳定管固定件40；输送导管5；瓣膜支架6；第一壳体7；第二壳体8；卡扣9；手动控制单元10；手动控制件101；手动传动轴102；电动控制单元11；电源110；电源弹片111；电源开关112；电机113；控制按键114；控制器115；传动机构12；运动转换件120；运动传递件122；位移件123；主轴121；限定件124；连接件125。
具体实施方式
以下结合附图和具体实施例对本发明提出的用于输送植入体的驱动手柄及输送系统作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
请参考图1及图5，本发明所提供的用于输送植入体的输送系统包括：输送导管5及与所述输送导管连接的用于输送植入体的驱动手柄1，所述用于输送植入体的驱动手柄1驱动所述输送导管以实现植入体的装载和释放。在本发明的一些实施例中，所述的输送导管5，包括内管2，外管3，稳定管4。
本发明中输送导管5与用于输送植入体的驱动手柄1两者的位置关系分为两种情况。第一种情况：输送导管5与用于输送植入体的驱动手柄1为不可拆卸的整体；第二种情况：输送导管5与用于输送植入体的驱动手柄为各 自独立的部分，并且两者可拆卸式连接在一起使用。
基于输送导管5与驱动手柄1两者的位置关系，本发明的用于输送植入体的输送系统包括如下两个实施例。
实施例一
请参考图1，其为本发明实施例一中的用于输送植入体的输送系统的主视图。如图1所示，所述用于输送植入体的输送系统包括：输送导管5及与所述输送导管5近端连接的用于输送植入体的驱动手柄1，所述用于输送植入体的驱动手柄1驱动所述输送导管5以实现植入体的装载和释放。
请参考图2，其为本发明实施例一中的用于输送植入体的输送系统的局部剖面图。如图2所示的内容，可以清楚的获知用于输送植入体的驱动手柄1和输送导管5两者的相互位置关系及结构情况。其中，所述用于输送植入体的驱动手柄1包括：手动控制单元10、电动控制单元11及传动机构12，所述手动控制单元10与所述传动机构12连接，以促动所述传动机构12驱动所述输送导管5；所述电动控制单元11与所述传动机构12连接，以促动所述传动机构12驱动所述输送导管5。进一步的，所述手动控制单元10、所述电动控制单元11及所述传动机构12均设置于第一壳体中，所述输送导管5的近端设置于所述第一壳体中(需要说明的是，本申请文件中涉及近端或远端是相对内管的锥形引导头2a来说，近端为远离内管的锥形引导头2a的一端，远端为靠近内管的锥形引导头2a的一端。因此，这里所述的输送导管的近端指的是相对内管的锥形引导头2a来说远离锥形引导头2a的一端，详情请参考图1)。较佳的，所述输送导管5通过连接件125与所述用于输送植入体的驱动手柄1连接。当选择手动驱控模式时，所述手动控制单元10促动所述传动机构12，进一步驱动输送导管5；当选择电动驱控模式时，所述电动控制单元11促动所述传动机构12，进一步驱动输送导管5输送植入体。由此可见，本发明的用于输送植入体的驱动手柄1可以根据医生实际的需要选择不同的模式，操作过程较为简单，医生可根据自己的手术习惯完成手术。此外，由于 本发明的用于输送植入体的驱动手柄1存在两种模式(手动驱控模式及电动驱控模式)，在其中一个模式应用过程中出现故障时，另一种模式可以进行切换以替代出现故障的模式继续进行手术，降低使用单一模式下驱动输送导管5时的手术风险，提高了器械的安全系数。
进一步的，所述传动机构12包括：运动转换件120、主轴121、运动传递件122、限定件124及套接于所述主轴121上的位移件123，所述主轴121的一端与所述运动转换件120相连，另一端与所述运动传递件122相连，所述运动转换件120用于接收所述手动控制单元10输出的动作信号以促动所述主轴121，所述运动传递件122用于接收所述电动控制单元11输出的动作信号以促动所述主轴121，所述限定件124用于支撑和固定所述主轴121，并且限制位移件123的行程，所述主轴121上设置了与所述位移件123的内螺纹配合的外螺纹，所述连接件125用于建立所述主轴121与所述输送导管5的连接。优选的，所述主轴121为螺杆。这里，所述主轴121与所述输送导管5近端的连接是通过所述位移件123上设置的连接件125建立的。更具体而言，所述的连接件125与外管3连接。优选的位移件为螺母，当然对于位移件具体的选择包括但不局限于螺母一种。对于主轴121与所述输送导管5的连接方式包括但不局限于以通过连接件125连接一种方式建立，只要在位移件123沿主轴121的轴向移动时，中间有个媒介能使输送导管5的外管3与内管2、稳定管4之间发生轴向相对移动即可。
进一步的，所述手动控制单元10包括：手动控制件101及与所述手动控制件101相连的手动传动轴102。
进一步的，所述电动控制单元11包括：电源110、控制按键114及电机113。所述的控制按键114控制所述电机113的转动方向，进而控制位移件123的移动方向。所述的电源110给所述控制按键114和所述电机113供电。优选，所述的电机为直流电机。更优选，电动控制单元11还包括控制器115。所述控制器115接收所述控制按键114发出的方向指令和速度指令，并根据所述 方向指令和所述速度指令控制所述电机113的转向和转速，进而控制位移件123的移动方向和移动速度。所述电源110通过导线给所述控制器115和所述控制按键114供电。优选，所述的电机113为步进电机。容易理解的是，所述电动控制单元11可以用内置电源(例如电源110)以及相应配套的附件(例如电源弹片111、电源开关112)来实现，所述内置电源可设置在第一壳体7的卡槽中(图中未标出)，并与卡槽中的电源弹片111电连接，所述的电源开关112与电源弹片111、控制按键114电连接。优选，所述的内置电源为一次性电源或充电电源。本发明对电源的种类没有特别的要求，例如锂电池、锌锰电池、镍镉电池等。所述电动控制单元11也可以采用外置电源以及相应配套的附件(例如电源开关112)来实现。所述的电源开关112与电源插头(图中未标出)、控制按键114电连接。
本实施例中，所述手动控制单元10、电动控制单元11及传动机构12均设置于第一壳体7中。具体的，所述电动控制单元11的电源弹片111、控制按键114和控制器115都是通过卡槽固定方式被固定在第一壳体7上，电源开关112，手动控制单元10和传动机构12都是通过螺钉固定在第一壳体7上。
请参考图1，图2及图3a～3d，所述输送导管5包括内管2、设置于部分所述内管2外侧的外管3及设置于部分所述外管3外侧的稳定管4；所述植入体装载于所述外管3与所述内管2之间远端的间隙空间中。具体而言，所述内管2包括锥形引导头2a及植入体固定头2b，所述植入体装载在所述锥形引导头2a和所述植入体固定头2b之间的植入体装载段2c的外围，且所述植入体一端固定于所述植入体固定头2b上。所述的“设置于部分所述内管2外侧的外管3”，以输送植入体时，外管3远端端部靠近锥形引导头2a为宜。设置所述的稳定管4主要目的是在释放植入体过程中，外管3移动时，防止外管3与人体组织不必要的摩擦，这要求稳定管4尽可能的覆盖外管3。同时，在输送植入体过程中，导管5需要越过主动弓的位置，要求输送导管5的弯曲强度低，顺应性好；在释放植入体过程中，需要外管3向近端移动，以充分释 放植入体，这要求稳定管4不能完全覆盖外管3。本领域技术人员可以根据人体组织的形状和植入体的类型，确定稳定管4包覆外管3的长度，来同时满足上述要求。
进一步的，如图2所示，所述输送导管5还包括内管固定件20、外管固定件30、稳定管固定件40。所述内管固定件20位于内管2近端(即远离所述锥形引导头2a的一端)，用于固定所述内管2；所述外管固定件30位于外管3近端(即远离所述锥形引导头2a的一端)，用于固定所述外管3，且外管固定件30设有内腔，以使内管2通过；所述稳定管固定件40位于稳定管4近端(即远离所述锥形引导头2a的一端)，用于固定所述稳定管4，且稳定管固定件40设有内腔，使外管3通过。内管2通过内管固定件20固定在第一壳体7上，外管3通过外管固定件30、连接件125与位移件123连接，且外管固定件30可以在第一壳体7内移动，稳定管4通过稳定管固定件40固定在第一壳体7上。具体而言，内管2的近端固定在内管固定件20上，内管固定件20固定在第一壳体7近端的卡槽内。稳定管4的近端固定在稳定管固定件40上，稳定管固定件40固定在第一壳体7远端(即壳体靠近所述锥形引导头2a的一端)的卡槽内。
为了较好的理解在用于输送植入体的驱动手柄1的驱动下输送导管5释放植入体的过程，下面以植入体为瓣膜支架6为例，结合图3a～3d进行阐述。图3a显示的是瓣膜支架6处于未释放状态，由图3a可以清楚的获知，输送时瓣膜支架6装载在所述锥形引导头2a和所述植入体固定头2b之间的所述内管2(即为内管2的植入体装载段2c)的外围，内管近端段2d一端与所述植入体固定头2b相连，另一端通过螺纹或胶水等方法与内管固定件20固定连接，然后内管固定件20被固定在第一壳体7近端的卡槽内，使内管2整体相对用于输送植入体的驱动手柄1固定。进而确保装载于植入体固定头2b上的瓣膜支架6与用于输送植入体的驱动手柄1保持相对固定。所述外管3的远端套在植入体装载段2c上的瓣膜支架6外围，优选外管3的远端接触内管2 远端的锥形引导头2a的近端端面，外管3的近端固定于外管固定件30上。释放瓣膜支架时，无论采用手动驱控模式还是电动驱控模式，内管2、稳定管4相对驱动手柄1固定，而外管3在外管固定件30的带动下相对驱动手柄1移动。具体而言，所示传动机构12的主轴121一端通过运动传递件122与电动控制单元11的电机113相连，这样当实施电动驱控模式时，通过对控制按键114上方向、速度等参数的设定，来控制电机113的转动方向和转速，然后电机113的转动通过运动传递件122、主轴121最终转换为位移件123的轴向移动。由于所述位移件123上设置有与外管固定件30连接的连接件125，此时外管3在外管固定件30带动下相对于内管2、稳定管4进行轴向运动；当实施手动驱控模式时，手动控制件101的转动可以通过手动传动轴102、传动机构12上的运动转换件120，将运动传递给主轴121，主轴121进而驱动位移件123沿轴向移动，最终带动外管3相对于内管2、稳定管4进行轴向运动。无论是手动驱控模式还是电动驱控模式下，瓣膜支架6释放过程请参考图3a～图3d，图3b～图3d是将图3a中外管3向驱动手柄近端移动过程中，瓣膜支架6逐渐释放出输送导管5，瓣膜支架6所处的状态先后呈现图3b～图3d所示的状态。
很显然，当在体外装载瓣膜支架时，可以通过控制按键114选择与释放瓣膜支架相反的方向，使外管3与内管2之间以与释放瓣膜支架相反的方向运动，或者以与释放瓣膜支架相反的方向手动旋转手动控制件101来实现瓣膜支架的装载。
本发明实施例为以瓣膜支架6(如心脏瓣膜支架)为植入体所作的描述。本领域技术人员可以理解的是，本发明公开的输送装置除瓣膜支架外还可以用于将其它植入体(如血管支架)置入到身体的相应位置。
请参考图4，图4所示的控制按键114包括方向及速度融为一体的按键，第一排设置的方向箭头比第二排设置的方向箭头档位高，换句话说，档位高等同于速度越快，按下箭头方向朝右的按键相当于外管3回收以使植入体释 放，而按下箭头方向朝左的按键相当于外管3的恢复，以实现植入体的安装。
实施例二
请结合参考图1及图5，实施例二相比实施例一的不同在于还包括第二壳体8，所述手动控制单元10、所述电动控制单元11及所述传动机构12均设置于第一壳体7中，所述输送导管5近端设置于第二壳体8中，所述的第一壳体7与所述第二壳体8可拆卸连接，且所述第一壳体7与所述第二壳体8的相对侧均设置有位移槽，所述连接件125先后通过所述第一壳体7及所述第二壳体8上的所述位移槽与输送导管5可拆卸连接。所述的输送导管5包括内管2、设置于部分所述内管2外侧的外管3；所述植入体装载于所述外管3与所述内管2之间远端的间隙空间中。所述的输送导管5还包括内管固定件20、外管固定件30，所述内管固定件20可以在第二壳体8中移动，所述外管固定件30固定在第二壳体8的远端。优选的，连接件125通过以搭扣的形式或其他方式与内管固定件20可拆卸连接；优选的，第二壳体8与第一壳体7之间通过卡扣9卡接。
具体而言，内管固定件20位于内管2的近端，且可以在第二壳体8内腔中移动，更优选所述的内管中设有内管排空管21，内管排空管21的近端通过内管排空管固定件210固定在第二壳体8的近端卡槽中；位于外管3近端的外管固定件30固定在第二壳体8远端的卡槽中，且外管固定件30设有可以使内管2通过的内腔。当释放瓣膜支架时，通过手动驱控模式或者电动驱控模式驱使内管固定件20向驱动手柄1远端方向移动，使内管2向远端方向移动。由于实施例二中驱动手柄1与输送导管5可以随时拆卸，这样可实现驱动手柄1的重复利用，节约了手术成本。当装载瓣膜支架的时候，将手动控制件101以相反的方向旋转或者设定控制按键114上方向参数，来实现内管2以相反的方向相对于外管3移动。
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。
综上，在本发明所提供的用于输送植入体的驱动手柄及输送系统中，所述用于输送植入体的驱动手柄包括手动控制单元、电动控制单元及传动机构，所述手动控制单元与所述传动机构连接，以促动所述传动机构驱动所述输送导管；所述电动控制单元与所述传动机构连接，以促动所述电动控制单元所述传动机构驱动所述输送导管。因此，本发明的所述用于输送植入体的驱动手柄能够在手动驱控模式和电动驱控模式之间自由切换以实现驱动输送导管输送植入体，操作过程较为简单，医生可根据自己的手术习惯充分利用两种模式的优点完成手术，提高手术的精准度；同时两种模式的存在，可以提高器械安全系数，降低了手术风险。
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，均属于权利要求书的保护范围。

Claims (13)

  1. 一种用于输送植入体的驱动手柄，其特征在于，包括：手动控制单元、电动控制单元及传动机构；所述手动控制单元与所述传动机构连接，以促动所述传动机构驱动用于输送植入体的一输送导管；所述电动控制单元与所述传动机构连接，以促动所述传动机构驱动所述输送导管。
  2. 如权利要求1所述的用于输送植入体的驱动手柄，其特征在于，所述传动机构包括：运动转换件、主轴及运动传递件，所述主轴的一端与所述运动转换件相连，另一端与所述运动传递件相连，所述运动转换件用于接收所述手动控制单元输出的动作信号以促动所述主轴，所述运动传递件用于接收所述电动控制单元输出的动作信号以促动所述主轴。
  3. 如权利要求2所述的用于输送植入体的驱动手柄，其特征在于，所述传动机构还包括限定件、套接于所述主轴上的位移件及设置于所述位移件上的连接件，所述限定件用于支撑和固定所述主轴，所述主轴上设置有与所述位移件的内螺纹配合的外螺纹，所述连接件用于建立所述主轴与所述输送导管的连接。
  4. 如权利要求1所述的用于输送植入体的驱动手柄，其特征在于，所述手动控制单元包括：手动控制件及与所述手动控制件相连的手动传动轴。
  5. 如权利要求1所述的用于输送植入体的驱动手柄，其特征在于，所述电动控制单元包括：电源、控制按键及电机，所述的控制按键控制所述电机的转动方向，所述电源给所述控制按键和所述电机供电。
  6. 如权利要求5所述的用于输送植入体的驱动手柄，其特征在于，所述电动控制单元还包括控制器，所述控制器电连接所述控制按键和所述电机，所述控制器接收所述控制按键发出的方向指令和速度指令，并根据所述方向指令和所述速度指令控制所述电机的转向和转速。
  7. 一种用于输送植入体的输送系统，其特征在于，包括：输送导管及与 所述输送导管连接的如权利要求1-6中任一项所述的用于输送植入体的驱动手柄，所述用于输送植入体的驱动手柄驱动所述输送导管以实现植入体的装载和释放。
  8. 如权利要求7所述的用于输送植入体的输送系统，其特征在于，所述手动控制单元、所述电动控制单元及所述传动机构均设置于第一壳体中，所述输送导管的近端设置于所述第一壳体中。
  9. 如权利要求7所述的用于输送植入体的输送系统，其特征在于，所述手动控制单元、所述电动控制单元及所述传动机构均设置于第一壳体中，所述输送导管的近端设置于第二壳体中，所述第一壳体与所述第二壳体可拆卸式连接，且所述第一壳体与所述第二壳体的相对侧均设置有位移槽，用于建立所述主轴与所述输送导管的连接的一连接件先后通过所述第一壳体及所述第二壳体上的所述位移槽与输送导管可拆卸式连接。
  10. 如权利要求7所述的用于输送植入体的输送系统，其特征在于，所述输送导管包括内管、设置于部分所述内管外侧的外管；所述植入体设置于所述外管与所述内管之间的间隙空间中。
  11. 如权利要求10所述的用于输送植入体的输送系统，其特征在于，所述输送导管还包括设置于部分所述外管外侧的稳定管、稳定管固定件，所述稳定管固定件用于固定所述稳定管。
  12. 如权利要求10或11所述的用于输送植入体的输送系统，其特征在于，所述内管包括锥形引导头及植入体固定头，所述植入体装载在所述锥形引导头和所述植入体固定头之间的内管部分的外围，且所述植入体一端固定于所述植入体固定头上。
  13. 如权利要求10或11所述的用于输送植入体的输送系统，其特征在于，所述输送导管还包括内管固定件、外管固定件，所述内管固定件用于固定所述内管，所述外管固定件用于固定所述外管。
PCT/CN2016/080347 2015-04-29 2016-04-27 用于输送植入体的驱动手柄及输送系统 WO2016173495A1 (zh)

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