WO2020200149A1 - 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
WO2020200149A1
WO2020200149A1 PCT/CN2020/081997 CN2020081997W WO2020200149A1 WO 2020200149 A1 WO2020200149 A1 WO 2020200149A1 CN 2020081997 W CN2020081997 W CN 2020081997W WO 2020200149 A1 WO2020200149 A1 WO 2020200149A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
knob
hand
handle
drive
Prior art date
Application number
PCT/CN2020/081997
Other languages
English (en)
French (fr)
Inventor
程小明
刘世红
赵婧
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2020200149A1 publication Critical patent/WO2020200149A1/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
    • 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
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • the invention relates to the technical field of medical devices, and in particular to a drive handle and a delivery system for delivering implants.
  • Transcatheter heart valve surgery requires an interventional catheter to be delivered through the femoral artery to deliver the valve to the aortic valve area to open, thereby completing the implantation of the artificial valve and restoring the valve function.
  • the implantation of a valve is generally operated by a delivery system, and the delivery system is inseparable from the sheath that carries the valve and the handle that drives the movement of the sheath, and the handle plays a vital role in the operation.
  • the handle when loading the valve before surgery, it is generally hoped that the handle can achieve rapid withdrawal and slow advancement of the sheath to improve loading efficiency and loading success rate; and during the valve implantation process, to ensure accurate positioning .
  • the slower the valve release speed during operation the better, that is, the slower the sheath withdrawal speed, the better; and after accurate positioning, in order to avoid excessive blood pressure drop, the valve must be released quickly, that is, the sheath is required Retreat quickly.
  • the faster the valve can be retrieved the better it is for the operation, that is, the faster the sheath advances, the better.
  • different stages of the operation have different requirements for the speed of the handle.
  • the existing handle has the problem of low efficiency and accuracy in realizing the control of the valve speed and position. Therefore, it is necessary to develop a driving handle that can realize the high efficiency and high precision control of the valve speed and position.
  • the purpose of the present invention is to provide a drive handle and a delivery system for transporting implants, wherein the drive handle can control the sheath used for transporting the implants to move fast or slowly according to actual surgical requirements, so as to realize More precise positioning control and more efficient surgical operation during implant implantation process, and reduce surgical difficulty.
  • the present invention provides a driving handle for delivering implants, including a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism, and a gear switching mechanism; At least a part of the piece can be movably passed through the handheld sleeve, and the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the handheld sleeve;
  • the driving handle has a first working mode and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first working mode and the second working mode; when the When the driving handle is in the first working mode, the first driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the handheld sleeve at a first speed; When the driving handle is in the second working mode, the second driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a second speed, so The second speed is less than the first speed.
  • the driving handle further includes a gear locking mechanism provided on the handheld sleeve;
  • the gear locking mechanism When the driving handle is in the first working mode, the gear locking mechanism is configured to lock the second driving mechanism with the hand sleeve; when the driving handle is in the second In the working mode, the gear locking mechanism is also configured to lock the first driving mechanism and the hand-held sleeve.
  • the gear switching mechanism is further configured to lock the second drive mechanism with the hand-held sleeve; when the drive handle is in the In the second working mode, the gear shifting mechanism is further configured to lock the first driving mechanism and the handheld sleeve.
  • the gear switching mechanism is movably arranged on the hand-held sleeve, and the hand-held sleeve has a first position and a second position, and the gear switching mechanism can be in the first position. And the second position;
  • the gear shifting mechanism moves to the first position, the drive handle is limited to the first working mode, and the gear shifting mechanism also connects the second drive mechanism with the hand sleeve Cylinder phase lock
  • the drive handle When the gear shifting mechanism moves to the second position, the drive handle is also limited to the second working mode, and the gear shifting mechanism also connects the first drive mechanism with the handheld The sleeve is locked.
  • the gear switching mechanism includes a switch, which is movably arranged on the hand-held sleeve and located between the first drive mechanism and the second drive mechanism, and the switch is connected to the The hand-held sleeve is relatively stationary in the circumferential direction;
  • the switch When the switch is moved to the first position in the direction of the second drive mechanism, the switch is matched with the second drive mechanism, and the second drive mechanism is aligned with the hand sleeve. Lock and limit the drive handle to the first working mode;
  • the switch When the switch is moved to the second position in the direction of the first drive mechanism, the switch is matched with the first drive mechanism to align the first drive mechanism with the hand sleeve. Lock and limit the drive handle to the second working mode.
  • the first driving mechanism includes a first knob sleeved on the hand-held sleeve
  • the second driving mechanism includes a second knob sleeved on the hand-held sleeve
  • the first Both a knob and the second knob are relatively stationary in the axial direction of the handheld sleeve
  • the side of the first knob facing the second knob is provided with a first limiting portion, and the switch is provided with a third limiting portion; the first limiting portion is used to interact with the third limiting portion. Position parts cooperate to restrict the movement of the first knob in the circumferential direction of the handheld sleeve;
  • a second limit part is provided on the side of the second knob facing the first knob, and a fourth limit part is also provided on the switch, and the second limit part is used to interact with the first knob.
  • the four limit parts cooperate to limit the movement of the first knob in the circumferential direction of the handheld sleeve.
  • the first limiting portion is a first limiting slot extending axially, the first limiting slot is not connected to the inside of the first knob, and the third limiting portion is a first limiting slot.
  • Limit protrusion
  • the second limiting portion is a second limiting groove extending axially, the second limiting slot is not connected to the inside of the second knob, and the fourth limiting portion is a second limiting protrusion .
  • the switch is a sleeve structure and is movably sleeved between the first knob and the second knob, and the switch is coaxially arranged with the handheld sleeve;
  • the first knob includes a connected first cylindrical section and a third cylindrical section, the diameter of the third cylindrical section is smaller than the first cylindrical section, and the third cylindrical section is used to pass through the switch in;
  • the second knob includes a connected second cylindrical section and a fourth cylindrical section, the diameter of the fourth cylindrical section is smaller than the diameter of the second cylindrical section, and the fourth cylindrical section is used to pass through the In the switch
  • the distance that the switch moves from the second position to the first position is less than the length of the third cylindrical section, and the switch moves from the first position to the second position The distance is smaller than the length of the fourth cylindrical section.
  • a fifth limit portion is provided on the switch, and a sixth limit portion is provided on the hand sleeve; the sixth limit portion is used to cooperate with the fifth limit portion , Restricting the movement of the switch in the circumferential direction of the handheld sleeve.
  • the fifth limiting portion is a protrusion
  • the plurality of protrusions are arranged symmetrically with respect to the axis of the handheld sleeve
  • the sixth limiting portion is a hollow first limiting portion Grooves, all the protrusions are used to insert into the first limit groove, so that the switch moves along the first limit groove.
  • the driving handle further includes a first connecting piece and a second connecting piece arranged on the hand-held sleeve, the first connecting piece and the second connecting piece are at least connected to the hand-held sleeve shaft To be relatively stationary; wherein: the first connecting piece is used to restrict the movement of the first drive mechanism in the axial direction of the hand-held sleeve; the second connecting piece is used to restrict the second drive mechanism in place The movement of the handheld sleeve in the axial direction.
  • the first connecting piece includes a first connecting ring sleeved on the hand-held sleeve
  • the second connecting piece includes a second connecting ring sleeved on the hand-held sleeve;
  • the first connecting ring, the first driving mechanism, the gear shifting mechanism, the second driving mechanism and the second connecting ring are arranged in sequence and arranged coaxially with the handheld sleeve.
  • the first drive mechanism includes a first knob sleeved on the hand-held sleeve
  • the second drive mechanism includes a second knob sleeved on the hand-held sleeve
  • the first Both the knob and the second knob are axially relatively stationary with the handheld sleeve
  • the fixing member is arranged coaxially with the hand-held sleeve and has a first external thread and a second external thread that are axially spaced;
  • the first knob has a first internal thread, and the first external thread is used to communicate with the first external thread.
  • An internal thread is fitted;
  • the second knob has a second internal thread, and the second external thread is used to cooperate with the second internal thread;
  • the pitch of the first external thread is M times the pitch of the second external thread, M is an integer greater than or equal to 2.
  • the hand-held sleeve is provided with a position avoiding structure that avoids the first external thread and the second external thread, and the position avoiding structure is a hollowed second limit groove, and the first external thread Pass through the second limiting groove to fit with the first internal thread; the second external thread passes through the second limiting groove to fit with the second internal thread, and the fixing member is used It moves axially along the second limiting groove.
  • the first knob has a first groove that avoids the first external thread
  • the second knob has a second groove that avoids the second external thread
  • the driving handle also has an initial mode; when the driving handle is in the initial mode, the first external thread is accommodated in the first groove, and the second external thread is accommodated in the Second groove; and, in the initial mode, the gear switching mechanism can be driven by an external force to limit the drive handle in the first working mode or the second working mode.
  • a plurality of scale lines are axially provided on the fixing member, and the distance between any adjacent scale lines is equal to the pitch of the first external thread, and at the same time, an alignment mark is provided on the handheld sleeve, and The alignment mark is used to coincide with any one of the scale lines to limit the driving handle to the initial mode.
  • the alignment mark is an edge line of one end surface of the handheld sleeve.
  • the fixing member is a cylindrical rod, and the first external thread and the second external thread are both arranged along the circumference of the rod and occupy a part of the respective circumference.
  • first external thread and the second external thread are both multiple, and all the first external threads and all the second external threads are arranged symmetrically on their respective circumferences, and one of the first external threads is The external thread corresponds to one of the second external threads and overlaps in the axial direction.
  • the hand-held sleeve includes an axially connected hand-held section and a connecting section, the diameter of the connecting section is smaller than the diameter of the hand-held section; the first driving mechanism, the second driving mechanism, and the gear switching mechanism Are all set on the connecting section.
  • the driving handle is a manual driving handle.
  • the present invention also provides a delivery system for delivering implants, which includes the drive handle for delivering the implants, and the delivery system further includes an outer tube and an inner tube assembly;
  • the inner tube assembly is inserted in the outer tube and used to fix the implant, and is connected with the hand-held sleeve of the drive handle, and is relatively stationary with the hand-held sleeve;
  • the outer tube is connected to the fixing member of the driving handle, and the fixing member is used to drive the outer tube to move axially relative to the inner tube assembly.
  • the inner tube assembly is connected to the hand-held sleeve through the fixing member.
  • the driving handle and delivery system for delivering implants provided by the present invention have the following advantages:
  • the driving handle of the present invention includes a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism and a gear switching mechanism.
  • the working mode of the drive handle is switched to the first working mode through the gear switching mechanism.
  • the first driving mechanism can move relative to the hand-held sleeve, and the first driving mechanism is matched with the fixing part.
  • the fixed part can be driven by the first drive mechanism to move along the axis of the hand-held sleeve at the first speed.
  • the working mode of the drive handle can be switched to the second working mode through the gear switching mechanism.
  • the second drive mechanism can It is movable relative to the hand-held sleeve, and the second drive mechanism cooperates with the fixed part, so that the second drive mechanism drives the fixed part to move along the axis of the hand-held sleeve at a second speed.
  • the driving handle can control the outer tube to perform fast and slow motions, so that different surgical operation requirements can be met at different stages of the operation.
  • the gear shift mechanism is used to switch the different working modes of the drive handle, which is beneficial for the doctor to make more rapid and accurate adjustments to the drive handle according to the current surgical operation needs, thereby reducing the doctor’s operation
  • the burden in the process improves the efficiency of the operation.
  • the drive handle of the present invention is also provided with a gear locking mechanism, when the drive handle is in the first working mode, the gear locking mechanism is configured to be able to connect the second drive mechanism with The hand-held sleeve is locked; and when the drive handle is in the second working mode, the gear locking mechanism is also configured to be able to lock the first drive mechanism and the hand-held sleeve . Therefore, the interlocking of slow motion and rapid motion can be realized by the gear locking mechanism, thereby improving the accuracy of the operation of the driving handle, and at the same time, it can reduce the difficulty of operation for the doctor and further improve the efficiency of the operation.
  • the driving handle of the present invention is preferably a manual driving handle, and all the structures are arranged coaxially, which not only has high reliability, but also has a small radial size, which makes the handle small in size, light in weight, and convenient to carry and operate.
  • Figure 1a is a schematic isometric view of a conveying system in an embodiment of the present invention
  • Figure 1b is an axonometric sectional view of the conveying system in an embodiment of the present invention.
  • Figure 1c is a partial enlarged view of the delivery system in Figure 1b;
  • Figure 1d is an exploded view of the drive handle on the delivery system in Figure 1a;
  • Figure 2 is a schematic structural view of a handheld sleeve on the drive handle in an embodiment of the present invention
  • Figure 3a is an end view of a switch on the drive handle in an embodiment of the present invention.
  • Figure 3b is an axonometric sectional view of the switch on the drive handle in an embodiment of the present invention
  • Figure 4a is a front view of the first knob on the drive handle in an embodiment of the present invention.
  • Figure 4b is an end view of the first knob on the drive handle in an embodiment of the present invention.
  • Figure 5a is a front view of a second knob on the drive handle in an embodiment of the present invention.
  • Figure 5b is an end view of the second knob on the drive handle in an embodiment of the present invention.
  • Figure 6 is a schematic structural view of a fixing member on the drive handle in an embodiment of the present invention.
  • Figure 7 is a partial cross-sectional view of the delivery system in an embodiment of the present invention.
  • Fig. 8 is a schematic diagram of the valve stent loaded between the inner tube and the outer tube in an embodiment of the present invention.
  • Handheld sleeve 1 Handheld section 11; Connecting section 12; First connecting groove 121; Limiting groove-122; Proximal connecting portion 123;
  • First knob 3 first circumferential groove 31; first cylindrical section 32; first limiting groove 33; third cylindrical section 34; first groove 35; first internal thread 36; first limiting surface 37 ;
  • Switch 4 first limiting protrusion 41; second limiting protrusion 43; third limiting protrusion 42;
  • Second knob 5 second circumferential groove 51; second cylindrical section 52; second limiting groove 53; fourth cylindrical section 54; second groove 55; second internal thread 56; second limiting surface 57 ;
  • Fixing member 7 shaft 71; first external thread 72; second external thread 73;
  • Inner tube assembly 9 tapered head 91; fixed head 92; inner tube 93;
  • distal and proximal are used; “distal” is the side away from the operator of the delivery system; “proximal” is The side close to the operator of the delivery system; “Axial” refers to the direction along the axis of the handheld sleeve; “Circumferential” refers to the direction around the axis of the corresponding member.
  • a large number of specific details are given to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.
  • the core idea of the present invention is to provide a drive handle for delivering implants.
  • the drive handle is preferably a manual drive handle.
  • the manual drive handle will not occur in the electric drive handle, such as abnormal motor, transmission abnormality, etc. , So the reliability is high, and the structure is simple.
  • the drive handle provided by the present invention specifically includes a hand-held sleeve, a fixing piece, a first drive mechanism, a second drive mechanism, and a gear switching mechanism; at least a part of the fixed piece can be movably passed through the hand-held sleeve;
  • the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the handheld sleeve;
  • the driving handle has a first working mode and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first working mode and the second working mode;
  • the first driving mechanism When the driving handle is in the first working mode, the first driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a first speed
  • the second drive mechanism When the drive handle is in the second working mode, the second drive mechanism is configured to cooperate with the fixing member to drive the fixing member at a second speed along the axis of the handheld sleeve Moving, the second speed is less than the first speed.
  • the working principle of the drive handle is as follows:
  • the working mode of the drive handle needs to be switched to the first working mode (ie, fast working mode) through the gear switching mechanism.
  • the first drive mechanism can move relative to the handheld sleeve while the first drive If the mechanism cooperates with the fixing part, the fixing part can be driven by the first driving mechanism to move quickly along the axis of the hand-held sleeve;
  • the working mode of the drive handle is also switched to the second working mode (ie, slow working mode) through the gear switching mechanism.
  • the second driving mechanism can move relative to the handheld sleeve, and the first The second driving mechanism cooperates with the fixing part, so that the second driving mechanism drives the fixing part to move slowly along the axis of the handheld sleeve.
  • the gear shift mechanism is used to switch the different working modes of the drive handle, which is beneficial for the doctor to make more rapid and accurate adjustments to the drive handle according to the current surgical operation needs, thereby reducing the doctor’s operation
  • the burden in the process improves the efficiency of the operation.
  • the driving handle further includes a gear locking mechanism arranged on the handheld sleeve.
  • the gear locking mechanism When the drive handle is in the first working mode, the gear locking mechanism is configured to be able to lock the second drive mechanism with the handheld sleeve; and when the drive handle is in the In the second working mode, the gear locking mechanism is also configured to be able to lock the first driving mechanism and the hand-held sleeve. Therefore, the interlocking of slow motion and rapid motion can be realized by the gear locking mechanism, thereby improving the accuracy of the operation of the driving handle, and at the same time, it can reduce the difficulty of operation for the doctor and further improve the efficiency of the operation.
  • the second driving mechanism maintains a locked relationship with the handheld sleeve through the gear locking mechanism, so that the second driving mechanism remains stationary relative to the handheld sleeve (Neither movable nor rotatable); on the contrary, when the driving handle is in the second working mode, the first driving mechanism maintains a locked relationship with the hand-held sleeve through the gear locking mechanism, so that the second A drive mechanism remains stationary relative to the handheld sleeve. Therefore, with the help of the interlocking of slow motion and fast motion, human misoperation can be effectively avoided, thereby reducing the difficulty of the doctor's operation and improving the accuracy of the operation.
  • the gear switching mechanism is also configured to lock the second driving mechanism with the hand sleeve; when the driving handle is in all In the second working mode, the gear shifting mechanism is further configured to lock the first driving mechanism and the handheld sleeve. In this way, the locking and switching of the gear positions can be realized through a structure, which is more convenient to operate, and the structure of the driving handle is also simpler.
  • the gear shifting mechanism is movably arranged on the handheld sleeve.
  • the gear shifting mechanism has a first position and a second position; when the gear shifting mechanism moves to the first position, the drive handle is limited to the first working mode, and at the same time
  • the gear switching mechanism also locks the second drive mechanism with the hand-held sleeve; when the gear switching mechanism moves to the second position, the drive handle is limited to the second work
  • the gear shift mechanism also locks the first drive mechanism with the hand sleeve.
  • FIG. 1a is an isometric schematic view of a conveying system in an embodiment of the present invention
  • FIG. 1b is an axonometric sectional view of a conveying system in an embodiment of the present invention.
  • a delivery system for delivering an implant includes a drive handle 100 and a catheter assembly 200.
  • the catheter assembly 200 includes an outer tube 8 and an inner tube assembly 9; the inner tube assembly 9 is used to pass through the outer tube 8 and is arranged coaxially with the outer tube 8; the outer tube 8 is used to interact with the driving handle 100 Connected, so that the outer tube 8 is driven to move relative to the inner tube assembly 9 by the driving handle 100.
  • the outer tube 8 only moves axially but cannot move circumferentially, so as to ensure that the implant is released in the body positioning accuracy.
  • the driving handle 100 includes a handheld sleeve 1, a first knob 3, a switch 4, a second knob 5 and a fixing member 7.
  • the first knob 3, the switch 4 and the second knob 5 are all arranged on the hand sleeve 1, and the fixing member 7 is movably inserted in the hand sleeve 1, and is used to interact with the first knob 3 and
  • the second knob 5 is screwed together, so that the first knob 3 drives the fixing member 7 to move quickly, and the second knob 5 drives the fixing member 7 to move slowly.
  • the first knob 3 constitutes the first drive mechanism of the present invention
  • the second knob 5 constitutes the second drive mechanism of the present invention
  • the switch 4 constitutes the gear shift mechanism of the present invention.
  • the switch 4 also constitutes the gear locking mechanism of the present invention.
  • the second knob 5, the switch 4 and the first knob 3 are arranged in sequence, but in other embodiments, it can also be from the proximal end to the distal end. , Set the first knob 3, the switch 4 and the second knob 5 in sequence.
  • the preferred structure of the drive handle 100 is further described in the arrangement shown in FIG. 1a.
  • the first knob 3 and the second knob 5 can be rotatably sleeved on the hand-held sleeve 1 and preferably remain coaxial with the hand-held sleeve 1, and the two knobs are both connected to the hand-held sleeve
  • the sleeve 1 remains relatively stationary in the axial direction, that is, it can only rotate but cannot move axially.
  • the switch 4 is arranged between the first knob 3 and the second knob 5, and can be moved back and forth between the two.
  • the switch 4 is constructed as a sleeve structure and directly It is sleeved on the hand-held sleeve 1 or on two knobs, and the switch 4 can only move but cannot rotate in the circumferential direction.
  • the switch 4 and the hand-held sleeve 1 are kept coaxial.
  • the switch 4 is not limited to the sleeve form, but may also be a slider structure. The present invention does not specifically limit the structure of the switch 4.
  • the fixing member 7 can be partly inserted in the hand-held sleeve 1, or the whole can be installed in the hand-held sleeve 1. If the whole is arranged, the length of the drive handle can be reduced, which is beneficial to reduce the length of the drive handle. Volume and weight.
  • the fixing member 7 may be a circular rod, such as a screw rod, as shown in FIG. 6; or, the fixing member 7 may also be an elongated member, such as a rack, etc.;
  • the specific structure of 7 is not particularly limited, as long as it can cooperate with the above two knobs to drive the outer tube 8 to move axially. Taking FIG.
  • the fixing member 7 is configured as a circular rod, which is preferably arranged coaxially with the hand-held sleeve 1, and the shaft 71 of the rod is provided with two kinds of threads , Respectively, the first external thread 72 and the second external thread 73, the first external thread 72 and the second external thread 73 are axially spaced apart, and the pitch P1 of the first external thread 72 is greater than the pitch of the second external thread 73 P2.
  • the first knob 3 has a first inner hole, the first inner hole has a first inner thread 36, and the first inner thread 36 is used to cooperate with the first outer thread 72;
  • the second knob 5 has a second inner hole, the second inner hole has a second inner thread 56, and the second inner thread 56 is used to cooperate with the second outer thread 73.
  • the switch 4 first locks the drive handle 100 in this mode.
  • the fixing member 7 passes through the first external thread 72 and the first knob 3.
  • the first internal thread 36 is matched with each other, and as long as the first knob 3 is rotated, the fixing member 7 can be driven to move quickly along the axis of the handheld sleeve 1.
  • the drive handle 100 when the drive handle 100 needs to work in the slow working mode, the drive handle 100 is also locked in this mode through the switch 4, and the fixing member 7 is made to pass through the second external thread 73 and the second inner thread on the second knob 5.
  • the threads 56 are matched, so as long as the second knob 5 is rotated, the fixing member 7 can be driven to move slowly along the axis of the handheld sleeve 1.
  • the fixing member 7 is preferably kept relatively stationary in the circumferential direction with the hand-held sleeve 1, that is, the fixing member 7 can only move axially but cannot rotate circumferentially, so that the outer tube 8 can only be driven relative to the inner tube.
  • the component 9 moves axially.
  • the thread pitch of the first knob 3 is large, which can realize rapid movement, thereby improving the efficiency of surgery, while the thread pitch of the second knob 5 is small, which can realize slow movement, and thus can realize more precise positioning control. Make it easier for the surgeon to operate accurately and reduce the difficulty of the operation.
  • the switch 4 can not only realize the switching of working modes, but also realize the interlocking of slow motion and fast motion.
  • the switch 4 can be manually moved to the first position (the position shown in b) to limit the drive handle 100 to the fast working mode, and when the switch 4 is in the first position , It can also directly lock the second knob 5 with the handheld sleeve 1; on the contrary, if the switch 4 is manually moved to the second position (ie the position shown in a), the drive handle 100 can be switched to slow In the fast working mode, at this time, the switch 4 can also directly lock the first knob 3 with the handheld sleeve 1.
  • the switch 4 when the switch 4 moves to the first position in the direction of the second knob 5, the switch 4 can cooperate with the second knob 5 to lock the second knob 5, thereby preventing the second knob 5.
  • the switch 4 when the switch 4 moves to the second position toward the first knob 3, the switch 4 can cooperate with the first knob 3 to lock the first knob 3, thereby preventing The first knob 3 rotates; this operation is very convenient and the structure is simple.
  • a first limiting portion is provided on the side of the first knob 3 facing the second knob 5, and a third limiting portion is provided on the switch 4, when the switch 4 is located at the first limiting portion.
  • the third limiting portion cooperates with the first limiting portion to limit the rotation of the first knob 3 in the circumferential direction of the handheld sleeve 1.
  • the first limiting portion may be a first limiting groove 33 extending axially on the first knob 3, and the The three limit parts are the first limit protrusions 41 extending axially on the switch 4.
  • the first knob 3 By inserting the first limit protrusions 41 into the first limit slots 33, the first knob 3 can be easily and quickly moved. Lock with hand sleeve 1. And when the switch 4 is at the first position, the first limiting protrusion 41 also needs to be able to completely escape the first limiting groove 33 to ensure that the first knob 3 can rotate smoothly during rapid movement.
  • a second limit part is provided on the side of the second knob 5 facing the first knob 3, and a fourth limit part is also provided on the switch 4, when the switch 4 is located at the In the first position, the fourth limiting portion cooperates with the second limiting portion to limit the movement of the second knob 5 in the circumferential direction of the handheld sleeve 1.
  • the second limiting portion may optionally be a second limiting groove 53 extending axially on the second knob 5.
  • the four limit parts are the second limit protrusions 43 extending axially on the switch 4. By inserting the second limit protrusions 43 into the second limit slots 53, the second knob 5 can also be easily and quickly moved. Lock with hand sleeve 1. In the same way, when the switch 4 is in the second position, the second limit protrusion 43 also needs to be able to completely escape from the second limit groove 53, to ensure that the second knob 5 can rotate smoothly during slow motion. .
  • the switch 4 can be toggled to realize the fast working mode and the slow working mode.
  • the number of limit slots it has is not limited to one, it can also be multiple, and multiple limit slots are arranged at intervals around the axis of the handheld sleeve 1.
  • All the limit slots on the two knobs need to be aligned one by one.
  • the limit protrusions on the switch 4 can also be multiple, and the limit protrusions and the limit grooves are matched one by one to achieve a coordinated lock. tight.
  • the switch 4 is not rotatable relative to the hand-held sleeve 1, so it can limit the rotation of the corresponding knob in the first position or the second position.
  • the switch 4 is also preferably provided with a fifth limit portion, while the hand-held sleeve 1 is provided with a sixth limit portion, and the sixth limit portion is used to interact with the fifth limit portion.
  • the movement of the switch 4 in the circumferential direction of the handheld sleeve 1 is restricted.
  • the switch 4 has a third inner hole, and the third inner hole has a third limiting protrusion 42 serving as a fifth limiting portion.
  • the third limiting protrusion 42 extends along the first The three inner holes extend radially inward.
  • the hand-held sleeve 1 is provided with a radially hollowed limit groove 122.
  • the third limiting protrusion 42 is inserted into the limiting groove 122 to limit the circumferential rotation of the switch 4.
  • the width of the limiting groove 122 is greater than the width of the third limiting protrusion 42 to ensure that the switch 4 can move back and forth along the limiting groove 122.
  • the hand-held sleeve 1 is also provided with a position avoiding structure that avoids the external thread.
  • the limit groove 122 constitutes the avoidance structure, so that all the external threads on the fixing member 7 can pass through the limit groove 122 to fit with the internal threads on the knob, and the limit The groove 122 is also used to limit the fixing member 7 to only move axially along the groove.
  • the limiting groove 122 is opened from the distal end to the proximal end of the hand-held sleeve 1, but the length is less than the length of the hand-held sleeve 1, and the limiting groove 122 is hollowed in the radial direction, that is, One side of the hand-held sleeve 1 can see the opposite side through the limiting groove 122.
  • the cross section of the limiting groove 122 may be rectangular, waisted, elliptical, etc., for which the present invention is not particularly limited.
  • the present invention does not specifically limit the opening manner of the limiting groove 122, either one limiting groove 122 as shown in FIG.
  • the second external thread 73, the first external thread 42 and the switch 4 are separately provided with a limit groove 122.
  • the length of the limit groove also needs to ensure the effective stroke of the fixed part to move during fast movement and slow movement.
  • the first external thread 72 and the second external thread 73 are both provided on the shaft 71 along a part of the circumference of the circumference, that is, the first external thread 72 and the second external thread 73 are both Not a full circumference thread.
  • the second external thread 73 is not limited to be provided at the proximal end of the shaft 71, but the arrangement shown in the figure is convenient to reduce the length of the rod, thereby shortening the length of the handle.
  • a plurality of first external threads 72 can be arranged on the shaft 71, and all the first external threads 72 are distributed along the same circumferential interval.
  • the number of the first external threads 72 needs to be the same as that of the limiting groove 122.
  • N limit grooves 122 can accommodate 2N first external threads 72, where N is An integer greater than or equal to 1.
  • all the first external threads 72 are symmetrical about the axis of the shaft 71, that is, are symmetrically arranged on the shaft 71.
  • a plurality of second external threads 73 can also be arranged on the shaft 71, and all the second external threads 73 are also distributed along the same circumferential interval, and the number of the second external threads 73 needs to correspond to the limiting groove 122.
  • all the second external threads 73 are also symmetrical about the axis of the shaft 71.
  • the fixing member 71 is a rack
  • external threads can also be provided on the two opposite surfaces of the rack body. In this case, only one limiting groove 122 can be provided.
  • the transmission can be made more stable and the transmission accuracy can be higher.
  • first external thread 72 in the axial direction needs to be greater than the effective stroke of fast motion
  • second external thread 73 in the axial direction also needs to be greater than the effective stroke of slow motion.
  • first external thread 72 and the second external thread 73 may be overlapped or not (ie, circumferentially staggered), and preferably overlapped to simplify the structure and simplify the operation.
  • axially overlapping means that the orthographic projections of the first external thread 72 and the second external thread 73 in a plane along the axial direction coincide with each other in the same radial direction.
  • the overlap of orthographic projections cannot be interpreted narrowly as the same shape and size of the first external thread 72 and the second external thread 73, but should be broadly understood as the overlap of the positions of the two, for example, the center of the first external thread 72 in the circumferential direction.
  • the point coincides with the midpoint of the second external thread 73 in the circumferential direction, and this coincidence is independent of the shape and size of the thread.
  • the first knob 3 also has a first groove 35, which is arranged in the first inner hole of the first knob 3 and extends axially.
  • the first groove 35 The first internal thread 36 is divided into several parts in the circumferential direction. Therefore, when the fast motion is switched to the slow motion, if the first external thread 72 just enters the first groove 35, the mating relationship between the first external thread 72 and the first internal thread 36 can be released. Therefore, during slow motion, The first knob 3 can also just avoid the first external thread 72 on the fixing member 7.
  • the number of the first grooves 35 is consistent with the number of the first external threads 72.
  • the distribution mode of the first external thread 72 also determines the distribution mode of the first groove 35.
  • the second knob 5 also has a second groove 55, which is arranged in the second inner hole of the second knob 5 and extends axially.
  • the groove 55 divides the second internal thread 56 into several parts in the circumferential direction. Therefore, when the slow motion is switched to the fast motion, if the second external thread 73 just enters the second groove 55, the cooperation relationship between the second external thread 73 and the second internal thread 56 can be released.
  • the second knob 5 also just avoids the second external thread 73 on the fixing member 7.
  • the number of the second grooves 55 is consistent with the number of the second external threads 73.
  • first external thread 72 and the second external thread 73 may be axially coincident or not axially coincident, therefore, the first groove 35 and the second groove 55 are also the same. Therefore, when the working mode is switched, if the second external thread 73 enters the second groove 55 and the first external thread 72 also enters the first groove 35, in this case, the switch 4 can be operated.
  • the driving handle 100 further includes a first connecting piece and a second connecting piece, and both the first connecting piece and the second connecting piece are configured to be at least axially relatively stationary with the hand sleeve 1, that is, it cannot be pivoted.
  • the first connecting member is used to restrict the movement of the first knob 3 in the axial direction of the handheld sleeve 1
  • the second connecting member is used to restrict the second knob 5 in the axial direction of the handheld sleeve 1. exercise.
  • the handheld sleeve 1 itself is provided with a corresponding structure to limit the axial freedom of the two knobs. The present invention does not specifically limit this.
  • the arrangement of the first connecting piece and the second connecting piece facilitates the simplification of the structure of the handheld sleeve 1 and reduces the processing difficulty.
  • the first connecting member includes a first connecting ring 2 sleeved on the handheld sleeve 1
  • the second connecting member includes The second connecting ring 6 on the sleeve 1.
  • the first connecting ring 2, the first knob 3, the switch 4, the second knob 5, and the second connecting ring 6 are arranged in sequence, and preferably these components are all connected to the handheld
  • the sleeve 1 is arranged coaxially.
  • the second connecting ring 6, the second knob 5, the switch 4, the first knob 3 and the first connecting ring 2 are arranged in sequence.
  • the first connecting ring 2 has a first circumferential protrusion 22 (ie, a first connecting structure), and the first knob 3 has a first circumferential groove 31 (ie, a first circumferential groove 31).
  • the first circumferential protrusion 22 is inserted into the first circumferential groove 31, thereby restricting the movement of the first knob 3 in the axial direction of the handheld sleeve 1, but the first knob 3 can still be circumferentially To rotate.
  • the second connecting ring 6 has a second circumferential protrusion 61 (that is, the second connecting structure), and the second knob 5 has a second circumferential groove 51 (that is, the first Four connection structure), the second circumferential protrusion 61 is inserted into the second circumferential groove 51 to restrict the movement of the second knob 5 in the axial direction of the hand sleeve 1, but the second knob 5 can still be circumferentially Rotate.
  • the first circumferential protrusion 22 on the first connecting ring 2 can also be replaced with a circumferential groove
  • the first circumferential groove 31 on the first knob 3 can be replaced with Circumferentially convex.
  • the second circumferential protrusion 61 on the second connecting ring 6 can also be replaced with a circumferential groove
  • the second circumferential groove 51 on the second knob 5 can be replaced with a circumferential protrusion. Therefore, one of the first connection structure and the third connection structure is a circumferential protrusion, and the other is a circumferential groove; similarly, one of the second connection structure and the fourth connection structure is Circumferential convexity, the other is circumferential groove.
  • first connecting ring 2 and the second connecting ring 6 are both axially relatively stationary with the handheld sleeve 1, and the first connecting ring 2 and the second connecting ring 6 are preferably connected to the handheld sleeve. 1 Keep the circumferential direction relatively stationary, but the present invention has no particular limitation on the way of realizing circumferential fixation, which can be interference connection, keyway connection, screw connection or glue bonding.
  • the first connecting ring 2 also has a third circumferential protrusion 21, and the third circumferential protrusion 21 is inserted into the first connecting groove 121 of the hand sleeve 1.
  • the first The three circumferential protrusions 21 and the first connecting groove 121 can be fixed by interference connection, glue bonding, and the like.
  • the second connecting ring 6 also has a proximal end 62 which is sleeved on the proximal connecting portion 123 of the handheld sleeve 1 and can be glued to the proximal connecting portion 123.
  • the handheld sleeve 1 specifically includes a handheld section 11 and a connecting section 12.
  • the handheld section 11 is located at the distal end of the driving handle 100, which is convenient for the surgeon to hold the handheld section 11 Operation handle.
  • the surface of the hand-held section 11 can be made of frosted material or provided with ribs, waves, etc., to increase the friction and optimize the operation feel.
  • the connecting section 12 is located at the proximal end of the driving handle 100, and the outer diameter of the connecting section 12 is smaller than the outer diameter of the hand-held section 11.
  • the first connecting ring 2, the first knob 3, the switch 4, and the second knob 5 and the second connecting ring 6 are both arranged on the connecting section 12.
  • the limiting groove 122 extends from the handheld section 11 to the connecting section 12.
  • the first knob 3 may include a first cylindrical section 32 in the middle and a third cylindrical section 34 on both sides.
  • the outer diameter of the third cylindrical section 34 is smaller than that of the first cylindrical section.
  • the outer diameter of 32 is used for manual and rapid circumferential adjustment
  • the third cylindrical section 34 on the left is used for connecting with the first connecting ring 2
  • the third cylindrical section 34 on the right is used for setting a switch 4.
  • the third cylindrical section 34 on the left is circumferentially cut to form a first circumferential groove 31, and the third cylindrical section 34 on the right and the first cylindrical section 32 form a first limit surface 37, which can restrict switching
  • the moving distance of the switch 4, that is, when the switch 4 abuts the first limit surface 37, is limited to the second position.
  • the first limiting groove 33 is specifically opened on the first cylindrical section 32, which axially extends from the proximal end to the distal end of the first cylindrical section 32, and the first limiting groove 33 is preferably connected to the first knob 3
  • the inner hole is not connected to prevent foreign objects from entering the handle.
  • the third cylindrical section 34 on the right side preferably always cooperates with the switch 4 to prevent foreign matter from entering the handle. Therefore, the distance when the switch 4 moves from the second position to the first position should be less than the length of the third cylindrical section 34 on the right.
  • the second knob 5 may also include a second cylindrical section 52 in the middle and a fourth cylindrical section 54 on both sides.
  • the outer diameter of the fourth cylindrical section 54 is smaller than that of the second cylindrical section 52. Outer diameter.
  • the second cylindrical section 52 is used for manual slow-speed circumferential adjustment
  • the fourth cylindrical section 54 on the right is used for connecting with the second connecting ring 6
  • the fourth cylindrical section 54 on the left is used for sleeve switching Switch 4.
  • the fourth cylindrical section 54 on the right side is circumferentially cut to form a second circumferential groove 51, and the fourth cylindrical section 54 on the right and the second cylindrical section 52 form a second limit surface 57, which can restrict switching
  • the moving distance of the switch 4, that is, when the switch 4 abuts the second limit surface 57, is restricted to the first position.
  • the second limiting groove 53 is specifically opened on the second cylindrical section 52, which extends from the distal end to the proximal end of the second cylindrical section 52, and the second limiting groove 53 is preferably connected to the inside of the second knob 5 No penetration, which prevents foreign objects from entering the handle.
  • the second cylindrical section 54 preferably always cooperates with the switch 4 to prevent foreign objects from entering the handle. Therefore, the distance when the switch 4 moves from the first position to the second position is less than the length of the second cylindrical section 54.
  • M is an integer greater than or equal to 2.
  • the appropriate value of M can be selected according to the multiple difference between the fast and slow speeds of the operation, that is, the displacement produced by the first knob 3 rotating one circle is the displacement produced by the second knob 3 rotating M circles.
  • the fixing member 7, such as the shaft 71, is provided with a plurality of scale lines at an axial interval, and the distance between adjacent scale lines is equal to the pitch P1 of the first external thread 72, that is, the first knob 3 rotates
  • One circle can move the fixing member 7 by one scale, which facilitates the operator to determine the conveying stroke according to the scale line, and makes the operation more accurate and convenient.
  • an alignment mark is provided on the hand-held sleeve 1, and the alignment mark is used to coincide with any graduation line to limit the driving handle to the initial mode.
  • the switch 4 can be operated, that is, when any one of the scale lines coincides with the alignment mark on the handheld sleeve 1, it means that the drive handle is in the initial mode: two The groove on the knob just avoids the external thread on the fixing part, and the limit grooves on the two knobs are also axially aligned.
  • the alignment mark is an edge line of the distal surface of the hand-held section 11.
  • the conditions for the normal switching of the switch 4 include:
  • the first limit groove 33 on the first knob 3 is exactly the same as the second limit groove on the second knob 5.
  • the position grooves 53 are aligned, and the grooves on the two knobs avoid the external threads on the fixing member 7. At this time, it can be switched to slow motion, as long as the switch 4 is turned to the side of the first knob 3, that is, The switch 4 is separated from the second knob 5, and cooperates with the first knob 3, so that the switch 4 restricts the circumferential movement of the first knob 3.
  • the second knob 5 can be rotated, and the second knob 5 is driven and fixed.
  • Piece 7 makes slow axial movement.
  • the inner tube assembly 9 specifically includes an inner tube 93, a fixed head 92 and a tapered head 91 connected in sequence.
  • Figure 8 shows the valve stent 10 in an unreleased state. It can be clearly seen from Figure 8 that the valve stent 10 is loaded between the tapered head 91 and the fixed head 92 during delivery.
  • the outer periphery of the inner tube 93 is fixed and supported by the fixed head 92 (one end of the valve stent 10 is fixed on the fixed head 92), and the fixed head 92 is not movable (that is, all degrees of freedom are restricted), and the inner tube 93
  • the proximal end of the valve is fixedly connected to the handheld sleeve 1 by threads or glue, so that the inner tube 93 is fixed relative to the handheld sleeve 1, thereby ensuring that the valve stent 10 and the handheld sleeve 1 mounted on the fixed head 92 remain relatively fixed .
  • the distal end of the outer tube 8 is sleeved around the periphery of the valve stent 10 loaded on the inner tube 93, and the distal end of the outer tube 8 preferably contacts the proximal end surface of the tapered head 91 at the distal end of the inner tube 93.
  • the outer tube 8 can be connected to the distal end of the fixing member 7, and is preferably arranged coaxially with the fixing member 7.
  • the inner tube assembly 9 can be connected to the proximal end of the handheld sleeve 1 after passing through the outer tube 8 and the fixing member 7 in turn.
  • the proximal end of the inner tube assembly 9 can extend beyond the handheld sleeve 1 or not.
  • the outer tube 8 can be driven by the fixing member 7 to move back and forth by manual driving, so that the outer tube 8 moves back and forth relative to the inner tube assembly 9, so that the valve stent 10 can be loaded, released, and recovered.
  • the loading process of the valve stent 10 is:
  • valve stent 10 You can hold the hand piece 11 with your left hand, and turn the switch 4 to the second knob 5, and then turn the first knob 3 counterclockwise with your right hand.
  • the rotation of the first knob 3 causes the fixing member 7 to drive the outer tube 8 Withdraw quickly to the proximal end to expose the fixed head 92, and make any scale line coincide with the edge line on the hand-held section 11, and then load the valve stent 10 into the inner tube 93 at the fixed head 92 and the tapered head 91 Between the pipe sections.
  • valve stent 10 After the valve stent 10 is loaded, the valve stent 10 can be further implanted into the body through the catheter assembly 200. During the process of implanting the valve stent 10, the following operation requirements are included:
  • the driving handle 100 can be operated as follows: first, the driving handle 100 is also set in the initial mode, that is, the fixing member 7 Any scale line on the upper right coincides with the edge line on the hand-held section 11. After that, turn the switch 4 to the first knob 3, and then turn the second knob 5 counterclockwise to make the fixing member 7 drive the outer tube 8 slowly Retreat quickly; it should be known that a slow release speed is beneficial to improve the accuracy of the release position.
  • the above embodiments mainly describe the preferred structure of the driving handle when the second knob 5, the switch 4 and the first knob 3 are arranged in sequence from the proximal end to the distal end, but it should be understood that the second knob 5 and the first knob 3 The positions can also be exchanged. After the exchange, the structure and operation mode of the drive handle are basically the same as the previous embodiments. The detailed content here will not be further described. Those skilled in the art will, based on the content disclosed in this application, It should be possible to know the adjustment of the specific structure so as to modify the drive handle. It should be known that the pitch of the large thread is M times the pitch of the small thread, and the distance between any adjacent scale lines on the fixing member 7 is the pitch of the large thread.
  • the present invention does not specifically limit the structure of the first driving mechanism and the second driving mechanism, as long as the two driving mechanisms can The fast and slow movement of the fixed part can be realized.
  • the embodiment of the present invention is a description with a valve stent 10 (such as a heart valve stent) as an implant.
  • a valve stent 10 such as a heart valve stent
  • the delivery system disclosed in the present invention can be used to place other implants (such as blood vessel stents) into corresponding positions in the body in addition to the valve stent.
  • the parts in the driving handle of the present invention are all coaxially assembled, and the radial size is small, so that the handle is small in size, light in weight, and convenient to carry and operate.

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Abstract

一种用于输送植入体的驱动手柄(100)以及输送系统，可根据实际手术的需要，以不同的速度控制外管(8)运动。驱动手柄(100)具体包括手持套筒(1)、固定件(7)、第一、第二驱动机构和档位切换机构；固定件(7)可活动地穿设在手持套筒(1)内；第一、第二驱动机构和档位切换机构均设置在手持套筒(1)上；驱动手柄(100)具有第一、第二工作模式，且档位切换机构用于限定驱动手柄(100)处于第一、第二工作模式中的一个；当驱动手柄(100)处于第一工作模式时，第一驱动机构与固定件(7)相配合，以驱动固定件(7)以第一速度沿手持套筒(1)的轴线移动；当驱动手柄(100)处于第二工作模式时，第二驱动机构与固定件(7)相配合，以驱动固定件(7)以第二速度沿手持套筒(1)的轴线移动，第二速度小于第一速度。

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
随着社会经济的发展和人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明75岁以上的老年人群患瓣膜性心脏病的发病率高达13.3％。目前，采用传统外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。经导管心脏瓣膜手术具有无需开胸、创伤小、患者恢复快等优点，受到了专家学者的广泛关注。
经导管心脏瓣膜手术需要通过股动脉送入介入导管，将瓣膜输送至主动脉瓣区打开，从而完成人工瓣膜置入，恢复瓣膜功能。瓣膜的植入一般借助输送系统进行操作，而输送系统离不开装载瓣膜的鞘管以及驱动鞘管运动的手柄，且手柄在手术过程中起到了至关重要的作用。根据临床需求，在术前装载瓣膜时，一般希望手柄可以实现鞘管的快速后撤和慢速前进，以提高装载效率和装载成功率；而在瓣膜植入的过程中，为保证定位的精准，则要求操作时瓣膜释放的速度越慢越好，即鞘管后撤的速度越慢越好；进而定位准确后，为避免血压降低过多，则需要瓣膜能够快速释放，即要求鞘管能够快速后撤。而对于可回收的瓣膜来说，如果在植入过程中需要回收重新释放，则瓣膜回收的速度越快，对手术越有利，也就是说，鞘管前进的速度越快越好。总的来说，手术的不同阶段，对于手柄的快慢速操作会有不同的需求。
但是，现有的手柄在实现瓣膜速度和位置的控制上存在效率和精度低的问题，因此，有必要开发一种驱动手柄，能够实现瓣膜速度和位置的高效率和高精度的控制。
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，其中的驱动手柄根据实际手术的需要，可以控制用于输送植入体的鞘管做快速或慢速运动，实现植入体植入过程中的更精准的定位控制和更高效率的手术操作，并降低手术难度。
为实现上述目的或其他相关目的，本发明提供一种用于输送植入体的驱动手柄，包括手持套筒、固定件、第一驱动机构、第二驱动机构和档位切换机构；所述固定件的至少一部分可活动地穿设在所述手持套筒内，所述第一驱动机构、第二驱动机构和档位切换机构均设置在所述手持套筒上；
所述驱动手柄具有第一工作模式和第二工作模式，且所述档位切换机构用于限定所述驱动手柄处于所述第一工作模式与所述第二工作模式中的一个；当所述驱动手柄处于所述第一工作模式时，所述第一驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第一速度沿所述手持套筒的轴线移动；当所述驱动手柄处于所述第二工作模式时，所述第二驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第二速度沿所述手持套筒的轴线移动，所述第二速度小于所述第一速度。
可选的，所述驱动手柄还包括设置于所述手持套筒上的档位锁紧机构；
当所述驱动手柄处于所述第一工作模式时，所述档位锁紧机构被配置为将所述第二驱动机构与所述手持套筒相锁定；当所述驱动手柄处于所述第二工作模式时，所述档位锁紧机构还被配置为将所述第一驱动机构与所述手持套筒相锁定。
可选的，当所述驱动手柄处于所述第一工作模式时，所述档位切换机构还被配置为将所述第二驱动机构与所述手持套筒相锁定；当所述驱动手柄处于所述第二工作模式时，所述档位切换机构还被配置为将所述第一驱动机构与所述手持套筒相锁定。
可选的，所述档位切换机构可移动地设置在所述手持套筒上，所述手持套筒上具有第一位置和第二位置，所述档位切换机构能够在所述第一位置和所述第二位置之间移动；
当所述档位切换机构运动至所述第一位置时，所述驱动手柄被限定至所述第一工作模式，且所述档位切换机构还将所述第二驱动机构与所述手持套筒相锁定；
当所述档位切换机构运动至所述第二位置时，所述驱动手柄还被限定至所述第二工作模式，且所述档位切换机构还将所述第一驱动机构与所述手持套筒相锁定。
可选的，所述档位切换机构包括包括一切换开关，可移动地设置于所述手持套筒上并位于所述第一驱动机构和第二驱动机构之间，且所述切换开关与所述手持套筒周向相对静止；
当所述切换开关朝所述第二驱动机构方向移动至所述第一位置时，所述切换开关与所述第二驱动机构相配合，将所述第二驱动机构与所述手持套筒相锁定，并将驱动手柄限定在第一工作模式；
当所述切换开关朝所述第一驱动机构方向移动至所述第二位置时，所述切换开关与所述第一驱动机构相配合，将所述第一驱动机构与所述手持套筒相锁定，并将驱动手柄限定在第二工作模式。
可选的，所述第一驱动机构包括套设在所述手持套筒上的第一旋钮，所述第二驱动机构包括套设在所述手持套筒上的第二旋钮，且所述第一旋钮和所述第二旋钮均与所述手持套筒轴向相对静止；其中：
所述第一旋钮朝向所述第二旋钮的一侧设置有第一限定部，且所述切换开关上设置有第三限位部；所述第一限位部用于与所述第三限位部相配合，以限制所述第一旋钮在所述手持套筒周向上的运动；
所述第二旋钮朝向所述第一旋钮的一侧设置有第二限位部，且所述切换开关上还设置有第四限位部，所述第二限位部用于与所述第四限位部相配合，以限制所述第一旋钮在所述手持套筒周向上的运动。
可选的，所述第一限位部为轴向延伸的第一限位槽，所述第一限位槽与所述第一旋钮的内部不连通，所述第三限位部为第一限位凸起；
所述第二限位部为轴向延伸的第二限位槽，所述第二限位槽与所述第二旋钮的内部不连通，所述第四限位部为第二限位凸起。
可选的，所述切换开关为一套筒结构且可移动地套设在所述第一旋钮和所述第二旋钮之间，且所述切换开关与所述手持套筒同轴设置；
所述第一旋钮包括相连的第一圆柱段和第三圆柱段，所述第三圆柱段的直径小于所述第一圆柱段，且所述第三圆柱段用于穿设在所述切换开关中；
所述第二旋钮包括相连的第二圆柱段和第四圆柱段，所述第四圆柱段的直径小于所述第二圆柱段的直径，且所述第四圆柱段用于穿设在所述切换开关中；
其中：所述切换开关自所述第二位置移动至所述第一位置的距离小于所述第三圆柱段的长度，且所述切换开关自所述第一位置移动至所述第二位置的距离小于所述第四圆柱段的长度。
可选的，所述切换开关上设置有第五限位部，所述手持套筒上设置有第六限位部；所述第六限位部用于与所述第五限位部相配合，限制所述切换开关在所述手持套筒周向上的运动。
可选的，所述第五限位部为一凸起，所述凸起为多个且关于所述手持套筒的轴线对称设置，所述第六限位部为一镂空的第一限位沟槽，所有所述凸起用于插入所述第一限位沟槽，使所述切换开关沿着所述第一限位沟槽移动。
可选的，所述驱动手柄还包括设置在所述手持套筒上的第一连接件和第二连接件，所述第一连接件和所述第二连接件至少与所述手持套筒轴向相对静止；其中：所述第一连接件用于限制所述第一驱动机构在所述手持套筒轴向上的运动；所述第二连接件用于限制所述第二驱动机构在所述手持套筒轴向上的运动。
可选的，所述第一连接件包括套设在所述手持套筒上的第一连接环，所述第二连接件包括套设在所述手持套筒上的第二连接环；所述第一连接环、第一驱动机构、档位切换机构、第二驱动机构和第二连接环依次设置并与所述手持套筒同轴设置。
可选的，所述第一驱动机构包括套设在所述手持套筒上的第一旋钮，所述第二驱动机构包括套设在所述手持套筒上的第二旋钮，所述第一旋钮和所 述第二旋钮均与所述手持套筒轴向相对静止；
所述固定件与所述手持套筒同轴设置并具有轴向间隔的第一外螺纹和第二外螺纹；所述第一旋钮具有第一内螺纹，所述第一外螺纹用于与第一内螺纹配合；所述第二旋钮具有第二内螺纹，所述第二外螺纹用于与第二内螺纹配合；所述第一外螺纹的螺距为第二外螺纹的螺距的M倍，M为大于或等于2的整数。
可选的，所述手持套筒上设置有避让所述第一外螺纹和第二外螺纹的避位结构，所述避位结构为镂空的第二限位沟槽，所述第一外螺纹穿过所述第二限位沟槽与所述第一内螺纹配合；所述第二外螺纹穿过所述第二限位沟槽与所述第二内螺纹配合，且所述固定件用于沿着所述第二限位沟槽做轴向运动。
可选的，所述第一旋钮具有避让所述第一外螺纹的第一凹槽，所述第二旋钮具有避让所述第二外螺纹的第二凹槽；
所述驱动手柄还具有一初始模式；当所述驱动手柄位于所述初始模式时，所述第一外螺纹容置于所述第一凹槽，且所述第二外螺纹容置于所述第二凹槽；并且，在所述初始模式下，所述档位切换机构能够被外力驱动而将所述驱动手柄限定在所述第一工作模式或第二工作模式。
可选的，所述固定件上轴向设置有多条刻度线，且任意相邻刻度线的距离等于第一外螺纹的螺距，同时，所述手持套筒上设置有对准标志，所述对准标志用于与任意一条刻度线相重合，以将所述驱动手柄限定在所述初始模式。
可选的，所述对准标志为所述手持套筒一端面的边缘线。
可选的，所述固定件为一圆柱形的杆件，所述第一外螺纹和所述第二外螺纹均沿所述杆件的周向设置且占据各自圆周的一部分。
可选的，所述第一外螺纹和第二外螺纹均为多个，所有所述第一外螺纹和所有所述第二外螺纹分别在各自的圆周上对称设置，且一个所述第一外螺纹和一个所述第二外螺纹对应并在轴向上重合。
可选的，所述手持套筒包括轴向连接的手持段和连接段，所述连接段的 直径小于所述手持段的直径；所述第一驱动机构、第二驱动机构和档位切换机构均设置在所述连接段上。
可选的，所述驱动手柄为手动驱动手柄。
为实现上述目的，本发明还提供一种用于输送植入体的输送系统，包括所述的用于输送植入体的驱动手柄，且所述输送系统还包括外管和内管组件；
所述内管组件穿设在所述外管中，并用于固定所述植入体，且与所述驱动手柄的所述手持套筒连接，并与所述手持套筒相对静止；
所述外管与所述驱动手柄的所述固定件连接，所述固定件用于驱动所述外管相对于所述内管组件做轴向运动。
可选的，所述内管组件穿过所述固定件与所述手持套筒连接。
综上所述，本发明提供的用于输送植入体的驱动手柄及输送系统具有如下优点：
第一、本发明的驱动手柄包括手持套筒、固定件、第一驱动机构、第二驱动机构和档位切换机构。实际使用时，通过档位切换机构将驱动手柄的工作模式切换至第一工作模式，该模式下，第一驱动机构能够相对于手持套筒活动，同时第一驱动机构与固定件相配合，便可由第一驱动机构驱动固定件沿手持套筒的轴线以第一速度运动，反之，亦通过档位切换机构将驱动手柄的工作模式切换至第二工作模式，该模式下，第二驱动机构能够相对于手持套筒活动，且第二驱动机构与固定件相配合，从而由第二驱动机构驱动固定件沿手持套筒的轴线以第二速度运动。进而实际操作时，只要将固定件与输送系统的外管相连接，便可由该驱动手柄控制外管做快速和慢速运动，这样在手术的不同阶段，均可满足不同的手术操作要求。并且，在手术过程中，借助于档位切换机构来实现驱动手柄之不同工作模式的切换，有利于医生根据当前的手术操作需要对驱动手柄做出更快速和准确的调整，从而减轻医生在手术过程中的负担，提高手术效率。
第二、本发明的驱动手柄还设置有档位锁紧机构，当所述驱动手柄处于所述第一工作模式时，所述档位锁紧机构被配置为能够将所述第二驱动机构与所述手持套筒相锁定；而当所述驱动手柄处于所述第二工作模式时，所述 档位锁紧机构还被配置为能够将所述第一驱动机构与所述手持套筒相锁定。因此，可通过档位锁紧机构实现慢速运动和快速运动的互锁，从而提高驱动手柄操作的准确性，同时也可以降低医生的操作难度，进一步提高手术效率。
第三、本发明的驱动手柄优选为手动驱动手柄，且所有结构均同轴布置，这样不仅可靠性高，而且径向尺寸较小，使得手柄体积小，重量轻，方便携带与操作。
附图说明
图1a是本发明一实施例中的输送系统的等轴示意图；
图1b是本发明一实施例中的输送系统的轴测剖面图；
图1c是图1b中输送系统的局部放大图；
图1d是图1a中输送系统上驱动手柄的分解图；
图2是本发明一实施例中驱动手柄上手持套筒的结构示意图；
图3a是本发明一实施例中驱动手柄上切换开关的端面图；
图3b是本发明一实施例中驱动手柄上切换开关的轴测剖面图
图4a是本发明一实施例中驱动手柄上第一旋钮的主视图；
图4b是本发明一实施例中驱动手柄上第一旋钮的端面图；
图5a是本发明一实施例中驱动手柄上第二旋钮的主视图；
图5b是本发明一实施例中驱动手柄上第二旋钮的端面图；
图6是本发明一实施例中驱动手柄上固定件的结构示意图；
图7是本发明一实施例中输送系统的局部剖视图；
图8是本发明一实施例中的瓣膜支架装载于内管与外管之间的示意图。
图中：
驱动手柄100；
手持套筒1；手持段11；连接段12；第一连接槽121；限位沟槽-122；近端连接部123；
第一连接环2；第三周向凸起21；第一周向凸起22；
第一旋钮3；第一周向沟槽31；第一圆柱段32；第一限位槽33；第三圆 柱段34；第一凹槽35；第一内螺纹36；第一限位面37；
切换开关4；第一限位凸起41；第二限位凸起43；第三限位凸起42；
第二旋钮5；第二周向沟槽51；第二圆柱段52；第二限位槽53；第四圆柱段54；第二凹槽55；第二内螺纹56；第二限位面57；
第二连接环6；第二周向凸起61；近端部62；
固定件7；杆身71；第一外螺纹72；第二外螺纹73；
导管组件200；
外管8；
内管组件9；锥形头91；固定头92；内管93；
瓣膜支架10。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，除非另有说明，“多个”的含义是两个或两个以上。
在以下说明中，为了便于描述，使用了“远端”和“近端”、“轴向”以及“周向”；“远端”是远离输送系统操作者的一侧；“近端”是接近输送系统操作者的一侧；“轴向”参照的是沿着手持套筒的轴线方向；“周向”参照的是围绕对应构件的轴线方向。另外，在下文的描述中，给出了大量具体的细节以便提供对本发明更为彻底的理解。然而，对于本领域技术人员而言显而易见的是，本发明可以无需一个或多个这些细节而得以实施。在其他的例子 中，为了避免与本发明发生混淆，对于本领域公知的一些技术特征未进行描述。
本发明的核心思想在于提供一种用于输送植入体的驱动手柄，该驱动手柄优选为手动驱动手柄，手动驱动手柄不会发生在电动驱动手柄中容易出现的诸如电机异常、传动异常等故障，因此可靠性高，而且结构也简单。
本发明提供的驱动手柄具体包括手持套筒、固定件、第一驱动机构、第二驱动机构和档位切换机构；所述固定件的至少一部分可活动地穿设在所述手持套筒内；所述第一驱动机构、第二驱动机构和档位切换机构均设置在所述手持套筒上；
其中：所述驱动手柄具有第一工作模式和第二工作模式，且所述档位切换机构用于限定所述驱动手柄处于所述第一工作模式与所述第二工作模式中的一个；
当所述驱动手柄处于所述第一工作模式时，所述第一驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第一速度沿所述手持套筒的轴线移动；当所述驱动手柄处于所述第二工作模式时，所述第二驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第二速度沿所述手持套筒的轴线移动，所述第二速度小于所述第一速度。
所述驱动手柄的工作原理如下：
a)快速运动：需要通过档位切换机构将驱动手柄的工作模式切换至第一工作模式(即快速工作模式)，该模式下，第一驱动机构能够相对于手持套筒活动，同时第一驱动机构与固定件相配合，便可由第一驱动机构驱动固定件沿手持套筒的轴线做快速运动；
b)慢速运动：亦通过档位切换机构将驱动手柄的工作模式切换至第二工作模式(即慢速工作模式)，该模式下，第二驱动机构能够相对于手持套筒活动，且第二驱动机构与固定件相配合，从而由第二驱动机构驱动固定件沿手持套筒的轴线做慢速运动。
显然，在手术过程中，借助于档位切换机构来实现驱动手柄之不同工作模式的切换，有利于医生根据当前的手术操作需要对驱动手柄做出更快速和 准确的调整，从而减轻医生在手术过程中的负担，提高手术效率。
进一步的，所述驱动手柄还包括设置在手持套筒上的档位锁紧机构。当所述驱动手柄处于所述第一工作模式时，所述档位锁紧机构被配置为能够将所述第二驱动机构与所述手持套筒相锁定；而当所述驱动手柄处于所述第二工作模式时，所述档位锁紧机构还被配置为能够将所述第一驱动机构与所述手持套筒相锁定。因此，可通过档位锁紧机构实现慢速运动和快速运动的互锁，从而提高驱动手柄操作的准确性，同时也可以降低医生的操作难度，进一步提高手术效率。具体来说，当所述驱动手柄处于第一工作模式时，所述第二驱动机构通过档位锁紧机构与手持套筒保持锁紧关系，从而使第二驱动机构相对于手持套筒保持静止(既不可移动，也不可转动)；相反的，当所述驱动手柄处于第二工作模式时，所述第一驱动机构则通过档位锁紧机构与手持套筒保持锁紧关系，从而使第一驱动机构相对于手持套筒保持静止。因此，借助于慢速运动和快速运动的互锁，可有效避免人为误操作，从而降低医生的操作难度，提高手术操作的准确性。
进一步的，当所述驱动手柄处于所述第一工作模式时，所述档位切换机构还被配置为将所述第二驱动机构与所述手持套筒相锁定；当所述驱动手柄处于所述第二工作模式时，所述档位切换机构还被配置为将所述第一驱动机构与所述手持套筒相锁定。这样可通过一个结构实现档位的锁紧和切换，操作起来更为方便，而且驱动手柄的结构也更简单。
进一步的，所述档位切换机构可移动地设置在所述手持套筒上。具体的，所述档位切换机构具有第一位置和第二位置；当所述档位切换机构运动至所述第一位置时，所述驱动手柄被限定至所述第一工作模式，同时所述档位切换机构还将所述第二驱动机构与所述手持套筒相锁定；当所述档位切换机构运动至所述第二位置时，所述驱动手柄被限定至所述第二工作模式，同时所述档位切换机构还将所述第一驱动机构与所述手持套筒相锁定。实际使用时，只要手动驱动档位切换机构移动至上述位置，便可方便、快速地切换至对应的工作模式，而且当档位切换机构移动至这些位置时，通过自身的结构便可将对应的驱动机构与手持套筒相锁紧，这样结构更为简单，操作更为方便。
以下参考附图，对所述驱动手柄以及包含该驱动手柄的输送系统的优选结构以及工作方式作进一步说明。
首先请参考图1a和图1b，图1a是本发明一实施例中的输送系统的等轴示意图，图1b是本发明一实施例中的输送系统的轴测剖面图。如图1a和图1b所示，一种用于输送植入体的输送系统，包括驱动手柄100和导管组件200。所述导管组件200包括外管8和内管组件9；所述内管组件9用于穿设在外管8中并与外管8同轴布置；所述外管8则用于与驱动手柄100连接，从而由驱动手柄100驱动外管8相对于内管组件9运动，优选的，所述外管8仅做轴向运动而不能做周向运动，这样可确保植入体在体内释放时的定位精度。
所述驱动手柄100包括手持套筒1、第一旋钮3、切换开关4、第二旋钮5和固定件7。所述第一旋钮3、切换开关4和第二旋钮5均设置在手持套筒1上，而所述固定件7可活动地穿设在手持套筒1中，并用于与第一旋钮3和第二旋钮5通过螺纹配合，从而由第一旋钮3驱动固定件7做快速运动，并由第二旋钮5驱动固定件7做慢速运动。应理解：所述第一旋钮3即构成本发明的第一驱动机构；所述第二旋钮5即构成本发明的第二驱动机构；而所述切换开关4构成本发明的档位切换机构，并优选所述切换开关4还构成本发明的档位锁紧机构。
在本发明实施例中，从驱动手柄的近端到远端，所述第二旋钮5、切换开关4和第一旋钮3依次设置，但在其他实施例中，也可从近端到远端，依次设置第一旋钮3、切换开关4和第二旋钮5。以下描述中，为便于叙述，以图1a所示的布置方式对驱动手柄100的优选结构作进一步的说明。
如图1a和图1b所示，所述第一旋钮3和第二旋钮5均可转动地套在手持套筒1上并优选与手持套筒1保持同轴，而且该两个旋钮均与手持套筒1保持轴向相对静止，也即，只能转动而不能轴向移动。另外，所述切换开关4设置在第一旋钮3和第二旋钮5之间，并可在两者之间来回移动，本发明实施例中，所述切换开关4被构造成套筒结构而直接套在手持套筒1或套在两个旋钮上，且该切换开关4只能移动而不能周向转动，优选切换开关4与手持套筒1保持同轴。当然，所述切换开关4不限于套筒形式，也可以是滑块 结构，本发明对切换开关4的结构不作具体限制。
所述固定件7既可以是一部分穿设在手持套筒1中，也可以是整个都设置在手持套筒1中，若整个设置则可以减小驱动手柄的长度，有利于减小驱动手柄的体积和重量。所述固定件7可为圆形的杆件，如丝杆等，如图6所示；或者，所述固定件7也可为长条形的构件，如齿条等；本发明对固定件7的具体结构不作特别的限制，只要其能够与上述两旋钮相配合，驱动外管8做轴向移动即可。以图6所示为例，所述固定件7被构造成圆形的杆件，该杆件优选与手持套筒1同轴设置，且所述杆件的杆身71上设置有两种螺纹，分别是第一外螺纹72和第二外螺纹73，所述第一外螺纹72和第二外螺纹73轴向间隔分布，且第一外螺纹72的螺距P1大于第二外螺纹73的螺距P2。同时如图4b所示，所述第一旋钮3具有第一内孔，所述第一内孔具有第一内螺纹36，所述第一内螺纹36用于与第一外螺纹72相配合；如图5b所示，所述第二旋钮5具有第二内孔，所述第二内孔具有第二内螺纹56，所述第二内螺纹56用于与第二外螺纹73相配合。
具体使用时，当驱动手柄100需要工作在快速工作模式时，首先由切换开关4将驱动手柄100锁定在该模式，此时，所述固定件7通过第一外螺纹72与第一旋钮3上的第一内螺纹36相配合，进而只要旋转第一旋钮3，便可驱动固定件7沿手持套筒1的轴线做快速运动。
反之，当驱动手柄100需要工作在慢速工作模式时，亦通过切换开关4将驱动手柄100锁定在该模式，并使固定件7通过第二外螺纹73与第二旋钮5上的第二内螺纹56相配合，故而只要旋转第二旋钮5，便可驱动固定件7沿手持套筒1的轴线做慢速运动。
本发明实施例中，所述固定件7优选与手持套筒1保持周向相对静止，即固定件7只能轴向移动而不能周向转动，从而驱动外管8也只能相对于内管组件9做轴向运动。显然，所述第一旋钮3的螺纹螺距较大，可实现快速运动，从而提高手术效率，而第二旋钮5的螺纹螺距较小，可实现慢速运动，从而能实现更精准的定位控制，使术者更容易精准操作，降低手术难度。
此外，所述切换开关4除了可以实现工作模式的切换外，还可以实现慢 速运动和快速运动的互锁。如图1a所示，可手动将切换开关4拨动至第一位置(即b所示位置)，即可将驱动手柄100限定在快速工作模式，而且当切换开关4位于所述第一位置时，其还能够直接将第二旋钮5与手持套筒1相锁紧；反之，若手动将切换开关4拨动至第二位置(即a所示位置)，即可将驱动手柄100切换至慢速工作模式，此时，切换开关4还能够直接将第一旋钮3与手持套筒1相锁紧。例如，所述切换开关4朝第二旋钮5方向移动至所述第一位置时，所述切换开关4能够与第二旋钮5相配合而将第二旋钮5锁紧，从而防止第二旋钮5转动；而当所述切换开关4朝第一旋钮3方向移动至所述第二位置时，所述切换开关4又能够与第一旋钮3相配合而将第一旋钮3锁紧，以此防止第一旋钮3转动；这样的操作非常方便，而且结构也简单。
可选的，所述第一旋钮3朝向第二旋钮5的一侧设置有第一限定部，同时所述切换开关4上设置有第三限位部，当所述切换开关4位于所述第二位置时，所述第三限位部与所述第一限位部相配合，限定第一旋钮3在手持套筒1周向上的转动。如图3a～图3b所示，并结合图1c～图1d及图4，所述第一限位部可选为第一旋钮3上轴向延伸的第一限位槽33，而所述第三限位部为切换开关4上轴向延伸的第一限位凸起41，通过将第一限位凸起41插入第一限位槽33中，便可方便、快速地将第一旋钮3与手持套筒1锁定。并且当所述切换开关4位于所述第一位置时，所述第一限位凸起41还需要能够完全脱离第一限位槽33，确保快速运动时第一旋钮3能够顺利转动。
可选的，所述第二旋钮5朝向第一旋钮3的一侧设置有第二限位部，同时所述切换开关4上还设置有第四限位部，当所述切换开关4位于所述第一位置时，所述第四限位部与所述第二限位部相配合，限定第二旋钮5在手持套筒1周向上的运动。如图3a～图3b，以及图5所示，并结合图1c和图1d，所述第二限位部可选为第二旋钮5上轴向延伸的第二限位槽53，所述第四限位部为切换开关4上轴向延伸的第二限位凸起43，通过将第二限位凸起43插入第二限位槽53中，也可方便、快速地将第二旋钮5与手持套筒1锁定。同理，当所述切换开关4位于所述第二位置时，所述第二限位凸起43也需要能够完全脱离第二限位槽53，确保慢速运动时第二旋钮5能够顺利转动。
还应知晓的是，实际使用时，当所述第一限位槽33和第二限位槽53在轴向上对齐时，方可拨动切换开关4，实现快速工作模式和慢速工作模式的切换。而且针对任意一个旋钮来说，其所具有的限位槽的数量也不限于一个，还可以是多个，多个限位槽围绕手持套筒1的轴线间隔设置，当然，在切换工作模式时，两个旋钮上的所有限位槽需要一一对齐。相对应的，当每个旋钮上的限位槽为多个时，所述切换开关4上的限位凸起亦可以为多个，限位凸起和限位槽一一配合，实现配合锁紧。
如前所述，切换开关4相对于手持套筒1不可转动，故而其能够在上述第一位置或第二位置时均能限制对应旋钮的转动。为此，所述切换开关4上还优选设置有第五限位部，同时所述手持套筒1上设置有第六限位部，所述第六限位部用于与第五限位部相配合，限制切换开关4在手持套筒1周向上的运动。如图3a所示，所述切换开关4具有第三内孔，所述第三内孔具有充当第五限位部的第三限位凸起42，所述第三限位凸起42沿第三内孔的径向向内延伸。同时如图2所示，所述手持套筒1上设置有径向镂空的限位沟槽122。所述第三限位凸起42插入所述限位沟槽122中，以此限定切换开关4的周向转动。优选的，所述第三限位凸起42为多个并优选对称分布，更优选的，所述第三限位凸起42为两个，防转动效果好，结构也简单。当然，所述限位沟槽122的宽度大于第三限位凸起42的宽度，确保切换开关4能够沿着限位沟槽122来回移动。
进一步的，为了确保固定件7上的外螺纹能够与旋钮上的内螺纹相配合，所述手持套筒1上还设置有避让外螺纹的避位结构。优选的，所述限位沟槽122即构成所述避位结构，使固定件7上的所有外螺纹能够穿过该限位沟槽122与旋钮上的内螺纹相配合，而且所述限位沟槽122还用于限制固定件7仅沿着该沟槽做轴向移动。如图2所示，所述限位沟槽122自手持套筒1的远端向近端开设，但长度小于手持套筒1的长度，而且限位沟槽122在径向上形成镂空，即在手持套筒1的一侧透过限位沟槽122可看见相对的另一侧。所述限位沟槽122的横截面可以是矩形、腰形、椭圆形等形状，对此，本发明没有特别的限制。而且本发明对限位沟槽122的开设方式也不作具体的限 定，既可以一次性开设一条如图2所示的限位沟槽122，也可以轴向分段地开设多条限位沟槽122，如为第二外螺纹73、第一外螺纹42和切换开关4均单独设置一条限位沟槽122。总之，只要确保固定件7上的外螺纹能够穿过对应的限位沟槽与旋钮配合即可，同时也需要确保切换开关4能够在对应的限位沟槽中移动并正常切换即可，另外，限位沟槽的长度也需要确保固定件在快速运动和慢速运动时所要移动的有效行程。
如图6所示，所述第一外螺纹72和所述第二外螺纹73均在所述杆身71上沿圆周的一部分周长设置，即第一外螺纹72和第二外螺纹73均不是全周长螺纹。其中第二外螺纹73不限制设置在杆身71的近端，只不过图示设置便于缩小杆件的长度，进而缩短手柄的长度。
本发明实施例中，在杆身71上可布置多个第一外螺纹72，且所有第一外螺纹72沿同一圆周间隔分布，当然第一外螺纹72的数量需与限位沟槽122相对应，如一个径向镂空的限位沟槽122可同时容置两个对称的第一外螺纹72，那么，N个限位沟槽122即可容置2N个第一外螺纹72，N为大于或等于1的整数。优选的，所有第一外螺纹72关于杆身71的轴线对称，即对称设置在杆身71上。同理，在杆身71也可布置多个第二外螺纹73，所有第二外螺纹73亦沿同一圆周间隔分布，且第二外螺纹73的数量需与限位沟槽122相对应。优选的，所有第二外螺纹73也关于杆身71的轴线对称。然而，所述固定件71若为齿条，也可在齿条本体的两个相对面上均设置外螺纹，此时可仅设置一个限位沟槽122。本发明通过设置多个第一外螺纹72或多个第二外螺纹72可使传动更平稳，传动精度更高。另外，每个第一外螺纹72在轴向上的总螺距需要大于快速运动的有效行程，同时每个第二外螺纹73在轴向上的总螺距也需要大于慢速运动的有效行程。此外，从轴向上看，第一外螺纹72和第二外螺纹73可以是重合，也可以不重合(即周向错开)，优选两者重合，以简化结构，简化操作。这里，“轴向重合”指的是第一外螺纹72和第二外螺纹73沿着轴向，在同一径向上的平面内的正投影相重合。正投影相重合并不能狭义地理解为第一外螺纹72和第二外螺纹73的形状和大小相同，而是应该广义理解为两者的位置重叠，例如第一外螺纹72在周向上的中点与 第二外螺纹73在周向上的中点重合，此重合无关螺纹的形状和大小。
实际使用时，若要确保切换开关4能够正常切换，优选满足以下条件：
a)快速运动向慢速运动转换：第一旋钮3上的第一限位槽33和第二旋钮5上的第二限位槽53相对齐，确保第二限位凸起43脱离第二限位槽53后，第一限位凸起41能够顺利插入第一限位槽33，同时使第一旋钮3和第二旋钮5与固定件7解除螺纹配合；
b)慢速运动向快速运动转换：第一旋钮3上的第一限位槽33和第二旋钮5上的第二限位槽53相对齐，确保第一限位凸起41脱离第一限位槽33后，第二限位凸起43能够顺利插入第二限位槽53，同时使第一旋钮3和第二旋钮5与固定件7解除螺纹配合。
如图4b所示，所述第一旋钮3还具有第一凹槽35，所述第一凹槽35设置在第一旋钮3的第一内孔中并轴向延伸，显然第一凹槽35将第一内螺纹36在周向上分割成若干部分。于是，在快速运动向慢速运动切换时，若第一外螺纹72正好进入第一凹槽35，便可解除第一外螺纹72和第一内螺纹36的配合关系，因此慢速运动时，第一旋钮3也可正好避让开固定件7上的第一外螺纹72。优选的，所述第一凹槽35的数量与第一外螺纹72的数量相一致。当然，第一外螺纹72的分布方式也决定了第一凹槽35的分布方式。
同理如图5b所示，所述第二旋钮5还具有第二凹槽55，所述第二凹槽55设置在第二旋钮5的第二内孔中并轴向延伸，显然第二凹槽55将第二内螺纹56在周向上分割成若干部分。于是，在慢速运动向快速运动切换时，若第二外螺纹73正好进入第二凹槽55，便可解除第二外螺纹73和第二内螺纹56的配合关系，因此快速运动时，第二旋钮5也正好避让开固定件7上的第二外螺纹73。而且，所述第二凹槽55的数量与第二外螺纹73的数量相一致。应了解，基于第一外螺纹72和第二外螺纹73既可轴向重合，也可轴向不重合，因此，所述第一凹槽35和第二凹槽55也是如此。因此，在切换工作模式时，若第二外螺纹73进入第二凹槽55，同时第一外螺纹72也进入第一凹槽35，在此情况下，方可操作切换开关4。
进一步的，所述驱动手柄100还包括第一连接件和第二连接件，所述第 一连接件和第二连接件均被配置为至少与手持套筒1保持轴向相对静止，即不可轴向移动。其中，所述第一连接件用于限制第一旋钮3在手持套筒1之轴向上的运动，同时所述第二连接件用于限制第二旋钮5在手持套筒1之轴向上的运动。然而，在其他实施例中，也可以是手持套筒1自身设置有相应的结构来限制两个旋钮的轴向自由度。本发明对此不作具体限定。这里，第一连接件和第二连接件的设置，便于简化手持套筒1的结构，降低加工难度。
更进一步的，如图1a～图1b，及图1d所示，所述第一连接件包括套设在手持套筒1上的第一连接环2，所述第二连接件包括套设在手持套筒1上的第二连接环6。在一个实施例中，从远端到近端，所述第一连接环2、第一旋钮3、切换开关4、第二旋钮5和第二连接环6依次设置，并优选这些构件均与手持套筒1同轴布置，在其他实施例中，从远端到近端，第二连接环6、第二旋钮5、切换开关4、第一旋钮3和第一连接环2依次设置。
如图1c及图4a所示，所述第一连接环2具有第一周向凸起22(即第一连接结构)，同时所述第一旋钮3具有第一周向沟槽31(即第三连接结构)，所述第一周向凸起22插入第一周向沟槽31中，从而限制第一旋钮3在手持套筒1之轴向上的运动，但第一旋钮3仍可周向转动。
如图1c及图5a所示，所述第二连接环6具有第二周向凸起61(即第二连接结构)，同时所述第二旋钮5具有第二周向沟槽51(即第四连接结构)，所述第二周向凸起61插入第二周向沟槽51中，限制第二旋钮5在手持套筒1之轴向上的运动，但第二旋钮5仍可周向转动。当然，在其他实施例中，所述第一连接环2上的第一周向凸起22也可替换为周向沟槽，而第一旋钮3上的第一周向沟槽31可替换为周向凸起。同样的，所述第二连接环6上的第二周向凸起61也可替换为周向沟槽，同时第二旋钮5上的第二周向沟槽51可替换为周向凸起。因此，所述第一连接结构和第三连接结构中的一个为周向凸起，另一个为周向沟槽；同样的，所述第二连接结构和所述第四连接结构中的一个为周向凸起，另一个为周向沟槽。
本发明实施例中，所述第一连接环2和第二连接环6均与手持套筒1保持轴向相对静止，所述第一连接环2和第二连接环6还优选与手持套筒1保 持周向相对静止，但对于实现周向固定的方式，本发明没有特别的限制，可以是过盈连接、键槽连接、螺钉连接或胶水粘接等。
继续参阅图1c和图2，所述第一连接环2还具有第三周向凸起21，所述第三周向凸起21插入手持套筒1的第一连接槽121中，这里，第三周向凸起21与第一连接槽121可过盈连接、胶水粘接等实现固定。所述第二连接环6还具有一近端部62，所述近端部62套设在手持套筒1的近端连接部123上并可与近端连接部123胶水粘接。
进一步的，如图1b和图2所示，所述手持套筒1具体包括手持段11和连接段12，所述手持段11位于驱动手柄100的远端，便于术者握持手持段11来操作手柄。为了便于操作，所述手持段11的表面可以采用磨砂材料或者设置棱条、波浪等，以增加摩擦力，优化操作手感，对此，本发明没有特别的限制。所述连接段12位于驱动手柄100的近端，且连接段12的外径小于手持段11的外径，其中，所述第一连接环2、第一旋钮3、切换开关4、第二旋钮5和第二连接环6均设置在连接段12上。所述限位沟槽122自手持段11延伸至连接段12。
进一步的，如图4a所示，所述第一旋钮3可包括中间的第一圆柱段32和位于两侧的第三圆柱段34，所述第三圆柱段34的外径小于第一圆柱段32的外径。其中，所述第一圆柱段32用于手动快速周向调节，而左侧的第三圆柱段34用于与第一连接环2连接，右侧的第三圆柱段34用于套设切换开关4。因此，左侧的第三圆柱段34上环切形成有第一周向沟槽31，而右侧的第三圆柱段34与第一圆柱段32形成有第一限位面37，可限制切换开关4的移动距离，即当切换开关4与第一限位面37抵靠时，即限制在第二位置。所述第一限位槽33具体开设在第一圆柱段32上，其自第一圆柱段32的近端向远端轴向延伸，且所述第一限位槽33优选与第一旋钮3的内孔不连通，这样可防止异物进入手柄。另外，右侧的第三圆柱段34优选与切换开关4始终配合，以此防止异物进入手柄内部。因此，当切换开关4自第二位置移动至第一位置的距离应小于右侧的第三圆柱段34的长度。
如图5a所示，所述第二旋钮5也可包括中间的第二圆柱段52和位于两 侧的第四圆柱段54，所述第四圆柱段54的外径小于第二圆柱段52的外径。其中，所述第二圆柱段52用于手动慢速周向调节，而右侧的第四圆柱段54用于与第二连接环6连接，左侧的第四圆柱段54用于套设切换开关4。因此，右侧的第四圆柱段54上环切形成有第二周向沟槽51，而右侧的第四圆柱段54与第二圆柱段52形成有第二限位面57，可限制切换开关4的移动距离，即当切换开关4与第二限位面57抵靠时，即限制在第一位置。所述第二限位槽53具体开设在第二圆柱段52上，其自第二圆柱段52的远端面向近端延伸，且所述第二限位槽53优选与第二旋钮5的内部不贯通，这样可防止异物进入手柄。另外，所述第二圆柱段54优选与切换开关4始终配合，以此防止异物进入手柄内部。因此，当切换开关4自第一位置移动至第二位置的距离小于第二圆柱段54的长度。
进一步的，所述第一外螺纹72的螺距P1和第二外螺纹73的螺距P2优选存在如下关系：P1＝M*P2，M为大于或等于2的整数。其中，可根据手术对快速和慢速的倍数差距需要来选择合适的M值，即第一旋钮3旋转一圈所产生的位移，为第二旋钮3旋转M圈所产生的位移。
更进一步的，所述固定件7，如所述杆身71上轴向间隔设置有多条刻度线，且相邻刻度线的距离等于第一外螺纹72的螺距P1，即第一旋钮3旋转一圈可使固定件7移动一个刻度，这样便于术者根据刻度线确定输送行程，使得操作更为准确和方便。更优选的，所述手持套筒1上设置有对准标志，该对准标志用于与任意一条刻度线相重合，以将驱动手柄限定在初始模式。所述驱动手柄位于所述初始模式时，方可操作切换开关4，即当任意一条刻度线与所述手持套筒1上的对准标志相重合时，即表明驱动手柄处于初始模式：两个旋钮上的凹槽正好避让开固定件上的外螺纹，同时两个旋钮上的限位槽也轴向对齐。
可选的，所述对准标志为手持段11之远端面的边缘线。
因此，本发明实施例中，所述切换开关4能够正常切换的条件包括：
第一、P1＝M*P2；
第二、任意相邻刻度线之间的距离为P1；
第三、确保任意一条刻度线能够与对准标志相重合。
更详细地说，当固定件7上任一条刻度线刚好与手持段11上的边缘线重合时，所述第一旋钮3上的第一限位槽33正好与第二旋钮5上的第二限位槽53对齐，且两个旋钮上的凹槽各自避让开固定件7上的外螺纹，此时，可以转换到慢速运动，只要将切换开关4向第一旋钮3侧拨动，即使得切换开关4与第二旋钮5相分离，而与第一旋钮3相配合，使切换开关4限制住第一旋钮3的周向运动，此时可以旋转第二旋钮5，第二旋钮5驱动固定件7作慢速轴向移动。进而当固定件7上的任一条刻度线刚好与手持段11上的边缘线重合时，可确保第二旋钮5上的第二限位槽53正好与第一旋钮3上的第二限位槽33对齐，同时两个旋钮上的凹槽也各自避让开固定件7上的外螺纹，此时，可以转换到快速运动，只要将切换开关4向第二旋钮5侧拨动，即使得切换开关4与第一旋钮3相分离，而与第二旋钮5相配合。同理，转换到快速运动后，当固定件7上的任一条刻度线刚好与手持段11上的边缘线重合时，又可转换到慢速运动。
进一步，如图8所示，由近端到远端，所述内管组件9具体包括顺序连接的内管93、固定头92和锥形头91。以植入体为瓣膜支架10为例，图8显示的是瓣膜支架10处于未释放状态，由图8可以清楚的获知，输送时瓣膜支架10装载在锥形头91和固定头92之间的内管93的外围，并通过固定头92对其进行固定支撑(瓣膜支架10的一端固定于固定头92上)，而固定头92不可活动(即所有自由度均被限制)，而内管93的近端通过螺纹或胶水等方式与手持套筒1固定连接，使内管93整体相对于手持套筒1固定，进而确保装载于固定头92上的瓣膜支架10与手持套筒1保持相对固定。外管8的远端套在装载于内管93上的瓣膜支架10的外围，优选外管8的远端接触内管93远端的锥形头91的近端端面。
实际使用时，如图1b所示，所述外管8可与固定件7的远端连接，并优选与固定件7同轴布置。另外，所述内管组件9依次穿过外管8和固定件7后可与手持套筒1的近端连接，其中，内管组件9的近端可伸出手持套筒1，也可不伸出手持套筒1。那么，可通过手动驱动的方式由固定件7带动外管8 前后移动，使外管8相对于内管组件9前后移动，便可实现对瓣膜支架10的装载、释放和回收等操作。
更具体而言，瓣膜支架10的装载过程为：
首先，将驱动手柄100设置在初始模式：即固定件7上任一刻度线刚好与手持套筒1上的边缘线重合，优选的，令锥形头91和外管8的远端部接触。
之后装载瓣膜支架10：可左手握住手持段11，并将切换开关4拨动至第二旋钮5，进而右手逆时针旋转第一旋钮3，第一旋钮3的转动使固定件7带动外管8向近端快速后撤，以暴露出固定头92，并使任一条刻度线与手持段11上的边缘线重合，进而将瓣膜支架10装载到内管93位于固定头92和锥形头91之间的管段上。
然后，将切换开关4拨动至第一旋钮3，再顺时针旋转第二旋钮5，第二旋钮5的转动使固定件7带动外管8向远端慢速前进，从而使外管8的远端套设在装载于内管93上的瓣膜支架10的外围。
瓣膜支架10装载完毕后，可进一步通过导管组件200将瓣膜支架10植入体内，在植入瓣膜支架10的过程中，包括如下的操作要求：
首先，定位之前，为了缓慢释放支架，需要外管8以较慢的速度后撤，此时，可对驱动手柄100做这样的操作：首先将驱动手柄100也设置在初始模式，即固定件7上的任一刻度线刚好与手持段11上的边缘线重合，之后，将切换开关4拨动至第一旋钮3，随后，逆时针旋转第二旋钮5，使固定件7带动外管8慢速后撤；应知晓，缓慢的释放速度有利于提高释放位置的精准度。
其次，定位之后，为提高释放的效率，节省手术时间，需要这样操作：将驱动手柄100设置在初始模式，然后，将切换开关4拨动至第二旋钮5，接着逆时针旋转第一旋钮3，使固定件7带动外管8快速后撤；但是在瓣膜支架释放的最后阶段，为了检查瓣膜支架的位置，也为了避免释放速度过快造成瞬间冲击影响，需要再次慢速释放瓣膜支架。
那么在瓣膜支架10回收的过程中，可将切换开关4拨动至第二旋钮5，进而再顺时针旋转第一旋钮3，使固定件7带动外管8向远端快速前进，即可 实现瓣膜支架10的快速回收。
因此，在手术的不同阶段，根据操作要求，通过调节驱动手柄100的行进速度，方便满足不同的手术操作要求，从而提高手术效率，降低手术难度，提高瓣膜支架的定位精度，达到较好的治疗效果。
上述实施例主要说明了从近端到远端，依次布置第二旋钮5、切换开关4和第一旋钮3时驱动手柄的优选结构，但应知晓的是，第二旋钮5和第一旋钮3的位置也可互换，互换之后，驱动手柄的结构与操作方式也与前述实施例基本相同，这里详细的内容不再进一步叙述，本领域技术人员在本申请文件公开的内容的基础上，应当能够知晓具体结构的调整，从而加以修饰得到该驱动手柄。应知晓的是，大螺纹的螺距为小螺纹的螺距的M倍，且固定件7上任意相邻的刻度线之间的距离为大螺纹的螺距，同时当驱动手柄处于初始模式时，还需要满足：任意一条刻度线与手持套筒上远端的边缘线重合时，切换开关能够顺利与对应的旋钮配合，且两个旋钮均与固定件解除螺纹配合关系，在满足这些条件下，可以保证切换开关4能够在慢速运动和快速运动之间切换。
最后，本发明较佳实施例如上所述，但不限于上述实施例所公开的范围，例如本发明对于第一驱动机构和第二驱动机构的结构不作特别的限定，只要通过两个驱动机构能够实现固定件的快速与慢速移动便可。另外，本发明实施例为以瓣膜支架10(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，本发明公开的输送系统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。并且本发明驱动手柄中的零件均同轴装配，径向尺寸较小，使得手柄体积小，重量轻，方便携带与操作。
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (22)

  1. 一种用于输送植入体的驱动手柄，其特征在于，包括手持套筒、固定件、第一驱动机构、第二驱动机构和档位切换机构；所述固定件的至少一部分可活动地穿设在所述手持套筒内，所述第一驱动机构、所述第二驱动机构和所述档位切换机构均设置在所述手持套筒上；
    所述驱动手柄具有第一工作模式和第二工作模式，且所述档位切换机构用于限定所述驱动手柄处于所述第一工作模式与所述第二工作模式中的一个；当所述驱动手柄处于所述第一工作模式时，所述第一驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第一速度沿所述手持套筒的轴线移动；当所述驱动手柄处于所述第二工作模式时，所述第二驱动机构被配置为与所述固定件相配合，以驱动所述固定件以第二速度沿所述手持套筒的轴线移动，所述第二速度小于所述第一速度。
  2. 根据权利要求1所述的用于输送植入体的驱动手柄，其特征在于，还包括设置于所述手持套筒上的档位锁紧机构；
    当所述驱动手柄处于所述第一工作模式时，所述档位锁紧机构被配置为将所述第二驱动机构与所述手持套筒相锁定；当所述驱动手柄处于所述第二工作模式时，所述档位锁紧机构被配置为将所述第一驱动机构与所述手持套筒相锁定。
  3. 根据权利要求1所述的用于输送植入体的驱动手柄，其特征在于，当所述驱动手柄处于所述第一工作模式时，所述档位切换机构还被配置为将所述第二驱动机构与所述手持套筒相锁定；当所述驱动手柄处于所述第二工作模式时，所述档位切换机构还被配置为将所述第一驱动机构与所述手持套筒相锁定。
  4. 根据权利要求3所述的用于输送植入体的驱动手柄，其特征在于，所述档位切换机构可移动地设置在所述手持套筒上，所述手持套筒上具有第一位置和第二位置，所述档位切换机构能够在所述第一位置和所述第二位置之间移动；
    当所述档位切换机构运动至所述第一位置时，所述驱动手柄被限定至所述第一工作模式，且所述档位切换机构还将所述第二驱动机构与所述手持套筒相锁定；
    当所述档位切换机构运动至所述第二位置时，所述驱动手柄还被限定至所述第二工作模式，且所述档位切换机构还将所述第一驱动机构与所述手持套筒相锁定。
  5. 根据权利要求4所述的用于输送植入体的驱动手柄，其特征在于，所述档位切换机构包括一切换开关，可移动地设置于所述手持套筒上并位于所述第一驱动机构和所述第二驱动机构之间，且所述切换开关与所述手持套筒周向相对静止；
    当所述切换开关朝所述第二驱动机构方向移动至所述第一位置时，所述切换开关与所述第二驱动机构相配合，将所述第二驱动机构与所述手持套筒相锁定，并将所述驱动手柄限定在第一工作模式；
    当所述切换开关朝所述第一驱动机构方向移动至所述第二位置时，所述切换开关与所述第一驱动机构相配合，将所述第一驱动机构与所述手持套筒相锁定，并将所述驱动手柄限定在第二工作模式。
  6. 根据权利要求5所述的用于输送植入体的驱动手柄，其特征在于，所述第一驱动机构包括套设在所述手持套筒上的第一旋钮，所述第二驱动机构包括套设在所述手持套筒上的第二旋钮，且所述第一旋钮和所述第二旋钮均与所述手持套筒轴向相对静止；其中：
    所述第一旋钮朝向所述第二旋钮的一侧设置有第一限定部，且所述切换开关上设置有第三限位部，所述第一限位部用于与所述第三限位部相配合，以限制所述第一旋钮在所述手持套筒周向上的运动；
    所述第二旋钮朝向所述第一旋钮的一侧设置有第二限位部，且所述切换开关上还设置有第四限位部，所述第二限位部用于与所述第四限位部相配合，以限制所述第一旋钮在所述手持套筒周向上的运动。
  7. 根据权利要求6所述的用于输送植入体的驱动手柄，其特征在于，所述第一限位部为轴向延伸的第一限位槽，所述第一限位槽与所述第一旋钮的内部不连通，所述第三限位部为第一限位凸起；
    所述第二限位部为轴向延伸的第二限位槽，所述第二限位槽与所述第二旋钮的内部不连通，所述第四限位部为第二限位凸起。
  8. 根据权利要求6所述的用于输送植入体的驱动手柄，其特征在于，所述切换开关为一套筒结构且可移动地套设在所述第一旋钮和所述第二旋钮之间，且所述切换开关与所述手持套筒同轴设置；
    所述第一旋钮包括相连的第一圆柱段和第三圆柱段，所述第三圆柱段的直径小于所述第一圆柱段，且所述第三圆柱段用于穿设在所述切换开关中；
    所述第二旋钮包括相连的第二圆柱段和第四圆柱段，所述第四圆柱段的直径小于所述第二圆柱段的直径，且所述第四圆柱段用于穿设在所述切换开关中；
    其中：所述切换开关自所述第二位置移动至所述第一位置的距离小于所述第三圆柱段的长度，且所述切换开关自所述第一位置移动至所述第二位置的距离小于所述第四圆柱段的长度。
  9. 根据权利要求5-8中任一项所述的用于输送植入体的驱动手柄，其特征在于，所述切换开关上设置有第五限位部，所述手持套筒上设置有第六限 位部；所述第六限位部用于与所述第五限位部相配合，限制所述切换开关在所述手持套筒周向上的运动。
  10. 根据权利要求9所述的用于输送植入体的驱动手柄，其特征在于，所述第五限位部为一凸起，所述凸起为多个且关于所述手持套筒的轴线对称设置，所述第六限位部为一镂空的第一限位沟槽，所有所述凸起用于插入所述第一限位沟槽，使所述切换开关沿着所述第一限位沟槽移动。
  11. 根据权利要求1-8中任一项所述的用于输送植入体的驱动手柄，其特征在于，还包括设置在所述手持套筒上的第一连接件和第二连接件，所述第一连接件和所述第二连接件至少与所述手持套筒轴向相对静止；其中：
    所述第一连接件用于限制所述第一驱动机构在所述手持套筒轴向上的运动；所述第二连接件用于限制所述第二驱动机构在所述手持套筒轴向上的运动。
  12. 根据权利要求11所述的用于输送植入体的驱动手柄，其特征在于，所述第一连接件包括套设在所述手持套筒上的第一连接环，所述第二连接件包括套设在所述手持套筒上的第二连接环；所述第一连接环、所述第一驱动机构、所述档位切换机构、所述第二驱动机构和所述第二连接环依次设置并与所述手持套筒同轴设置。
  13. 根据权利要求1所述的用于输送植入体的驱动手柄，其特征在于，所述第一驱动机构包括套设在所述手持套筒上的第一旋钮，所述第二驱动机构包括套设在所述手持套筒上的第二旋钮，所述第一旋钮和所述第二旋钮均与所述手持套筒轴向相对静止；
    所述固定件与所述手持套筒同轴设置并具有轴向间隔的第一外螺纹和第二外螺纹；所述第一旋钮具有第一内螺纹，所述第一外螺纹用于与第一内螺纹配合；所述第二旋钮具有第二内螺纹，所述第二外螺纹用于与第二内螺纹 配合；所述第一外螺纹的螺距为所述第二外螺纹的螺距的M倍，M为大于或等于2的整数。
  14. 根据权利要求13所述的用于输送植入体的驱动手柄，其特征在于，所述手持套筒上设置有避让所述第一外螺纹和第二外螺纹的避位结构，所述避位结构为镂空的第二限位沟槽，所述第一外螺纹穿过所述第二限位沟槽与所述第一内螺纹配合；所述第二外螺纹穿过所述第二限位沟槽与所述第二内螺纹配合，且所述固定件用于沿着所述第二限位沟槽做轴向运动。
  15. 根据权利要求13所述的用于输送植入体的驱动手柄，其特征在于，所述第一旋钮具有避让所述第一外螺纹的第一凹槽，所述第二旋钮具有避让所述第二外螺纹的第二凹槽；
    所述驱动手柄还具有一初始模式；当所述驱动手柄位于所述初始模式时，所述第一外螺纹容置于所述第一凹槽，且所述第二外螺纹容置于所述第二凹槽；并且，在所述初始模式下，所述档位切换机构能够被外力驱动而将所述驱动手柄限定在所述第一工作模式或第二工作模式。
  16. 根据权利要求15所述的用于输送植入体的驱动手柄，其特征在于，所述固定件上轴向设置有多条刻度线，且任意相邻刻度线的距离等于第一外螺纹的螺距，所述手持套筒上设置有对准标志，所述对准标志用于与任意一条刻度线相重合，以将所述驱动手柄限定在所述初始模式。
  17. 根据权利要求13-16中任一项所述的用于输送植入体的驱动手柄，其特征在于，所述固定件为一圆柱形的杆件，所述第一外螺纹和所述第二外螺纹均沿所述杆件的周向设置且占据各自圆周的一部分。
  18. 根据权利要求17所述的用于输送植入体的驱动手柄，其特征在于，所述第一外螺纹和第二外螺纹均为多个，所有所述第一外螺纹和所有所述第二外螺纹分别在各自的圆周上对称设置，且一个所述第一外螺纹和一个所述 第二外螺纹对应并在轴向上重合。
  19. 根据权利要求1-8中任一项所述的用于输送植入体的驱动手柄，其特征在于，所述手持套筒包括轴向连接的手持段和连接段，所述连接段的直径小于所述手持段的直径；所述第一驱动机构、所述第二驱动机构和所述档位切换机构均设置在所述连接段上。
  20. 根据权利要求1-8中任一项所述的用于输送植入体的驱动手柄，其特征在于，所述驱动手柄为手动驱动手柄。
  21. 一种用于输送植入体的输送系统，其特征在于，包括根据权利要求1-20中任一项所述的用于输送植入体的驱动手柄，且所述输送系统还包括外管和内管组件；
    所述内管组件穿设在所述外管中，并用于固定所述植入体，且与所述驱动手柄的所述手持套筒连接，并与所述手持套筒相对静止；
    所述外管与所述驱动手柄的所述固定件连接，所述固定件用于驱动所述外管相对于所述内管组件做轴向运动。
  22. 根据权利要求21所述的用于输送植入体的输送系统，其特征在于，所述内管组件穿过所述固定件与所述手持套筒连接。
PCT/CN2020/081997 2019-04-04 2020-03-30 用于输送植入体的驱动手柄及输送系统 WO2020200149A1 (zh)

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