WO2023016213A1 - 一种手柄、输送器及医用装置 - Google Patents

一种手柄、输送器及医用装置 Download PDF

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Publication number
WO2023016213A1
WO2023016213A1 PCT/CN2022/106787 CN2022106787W WO2023016213A1 WO 2023016213 A1 WO2023016213 A1 WO 2023016213A1 CN 2022106787 W CN2022106787 W CN 2022106787W WO 2023016213 A1 WO2023016213 A1 WO 2023016213A1
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WO
WIPO (PCT)
Prior art keywords
limiting
tube
positioning seat
handle
release
Prior art date
Application number
PCT/CN2022/106787
Other languages
English (en)
French (fr)
Inventor
刘世红
林兴
冀丽军
陈国明
Original Assignee
上海微创心通医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Priority to EP22855196.6A priority Critical patent/EP4368122A1/en
Publication of WO2023016213A1 publication Critical patent/WO2023016213A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, in particular to a handle, a conveyor and a medical device.
  • the heart valve is the gate of the heart's blood circulation. Once narrowed or insufficient, the heart will suffer from insufficient power or failure, and symptoms such as chest tightness, asthma, general edema, weakness, and chest pain will endanger the life and quality of life of the elderly.
  • VHD valvular heart disease
  • traditional surgery is still the first choice for the treatment of such diseases.
  • traditional surgery has high risk and high mortality. Not even a chance of surgery.
  • Interventional surgery is a brand-new treatment technology developed in recent years, and it is a minimally invasive surgical treatment.
  • Interventional therapy is to introduce special medical devices into the human body through a conveyor under the guidance of medical imaging equipment to diagnose and locally treat lesions in the body. Interventional treatment does not require surgery, and compared with traditional surgery, it has the advantages of less trauma, faster recovery, and better results.
  • Interventional therapy can be used to treat heart valve diseases, and can also be used to treat other diseases.
  • the medical devices are also different.
  • the medical device is an artificial valve
  • vascular diseases the medical device It can be a medical stent or the like.
  • the feeder typically includes a handle for loading the medical device and including an inner tube and an outer tube, and a handle for connecting to the catheter assembly and controlling the inner tube and/or outer tube to enable the medical device to be introduced human body.
  • the handle needs to ensure sufficient safety, effectiveness and economy.
  • the purpose of the present invention is to provide a handle, a conveyor and a medical device.
  • the movement of the release tube can be suspended when the release tube moves to a predetermined position to meet the use requirements.
  • the present invention provides a handle for controlling a catheter assembly
  • the catheter assembly includes an outer tube and an inner tube partially penetrated in the outer tube, the outer tube and the inner tube One is the release tube;
  • the handle includes:
  • a first driving part for driving the release tube to move in a predetermined direction
  • the limiting assembly includes a first limiting mechanism and a second limiting mechanism, the first limiting mechanism is partially disposed in the housing and connected to the housing, and is configured to be able to surround the release the axis of the tube rotates; the second limiting mechanism is disposed in the housing and configured to move with the movement of the release tube;
  • the handle is configured such that when the first driving part drives the release tube to move in a predetermined direction and makes the release tube reach a predetermined position, the first limit mechanism cooperates with the second limit mechanism , so as to prevent the release tube from continuing to move along the predetermined direction; when the first limit mechanism rotates around the axial direction of the release tube, the first limit mechanism is disengaged from the second limit mechanism When , the first driving part is allowed to drive the release tube to continue to move along the predetermined direction.
  • the handle further includes a first connecting component, which is arranged in the housing, is in transmission connection with the first driving part, and is also used for connecting with the proximal end of the release tube. Connection; the second limiting mechanism is connected to the first connection component.
  • the first limiting mechanism includes a first positioning seat and a first limiting part;
  • the first positioning seat is connected to the housing and is configured to be able to rotate around the axis of the release tube
  • the first limiting part is connected to the first positioning seat, and at least partially protrudes from the predetermined end surface of the first positioning seat;
  • the second limiting mechanism includes a second limiting part;
  • the handle is configured such that the first limiting portion and the second limiting portion at least partially overlap in the circumferential direction, and when the first limiting portion and the second limiting portion abut against each other, the second limiting portion A limiting mechanism cooperates with the second limiting mechanism, when the first positioning seat rotates around the axis of the release tube and makes the first limiting part align with the second limiting part in the circumferential direction When staggered, the second limiting mechanism is disengaged from the first limiting mechanism.
  • the first limiting part is movably connected to the first positioning seat, and is configured to be able to move along the axial direction of the release tube to change the protrusion of the first limiting part.
  • the first positioning seat is provided with a screw hole extending through the axial direction of the release tube, the first limiting part is a screw, and the screw is passed through the screw hole.
  • the housing is provided with a first chute extending in the circumferential direction; the first limit mechanism further includes a first lever, and one end of the first lever is connected to the first position The other end passes through the first sliding slot and protrudes outside the housing.
  • the first limiting mechanism further includes a first elastic sleeve, the first elastic sleeve is sleeved on the first driving lever, and the outer wall of the first elastic sleeve is in contact with the first slide groove. The groove wall contacts and deforms the first elastic sleeve.
  • the first positioning seat has a ring structure and has an inner hole, and the proximal end of the first connecting component passes through the inner hole and is connected with the first driving part.
  • the number of the first limiting parts is multiple, the plurality of the first limiting parts are arranged in sequence along the circumference of the first positioning seat, and each of the first limiting parts protrudes The length of the part of the predetermined end surface of the first positioning seat decreases sequentially along the first direction, so that the axial distance from each of the first limiting parts to the second limiting part is along the first direction. one direction increases sequentially;
  • the handle is configured such that when the first positioning seat is rotated around the axis of the release tube in the second direction and one of the first limiting parts is staggered from the second limiting part in the circumferential direction, the other One of the first limiting portions can at least partially overlap the second limiting portion in the circumferential direction; the second direction is opposite to the first direction.
  • the first driving part is rotatably connected to the proximal end of the housing;
  • the first connecting assembly includes a screw rod, the distal end of the screw rod is connected to the proximal end of the release tube, and the distal end of the screw rod is
  • the second limit mechanism is connected on the surface, and the outer surface of the proximal end of the screw rod is provided with an external thread, which cooperates with the internal thread on the first driving part to perform screw transmission; or,
  • the first connection assembly includes a threaded sleeve and a screw rod, the threaded sleeve is connected to the inner wall of the first driving part and is configured to be able to rotate synchronously with the first driving part, and the inner wall of the threaded sleeve is An internal thread is provided; the distal end of the screw rod is connected to the proximal end of the release tube, and the outer surface of the distal end of the screw rod is connected with the second limit mechanism, and the proximal end of the screw rod An external thread is provided on the outer surface, and cooperates with the internal thread on the threaded sleeve for screw transmission.
  • an observation window is provided on the housing for observing the movement of the screw rod.
  • the release tube is the outer tube, and the predetermined direction is a direction from the distal end to the proximal end; or,
  • the release tube is the inner tube, and the predetermined direction is a proximal-to-distal direction.
  • the present invention also provides a delivery device, comprising a catheter assembly and the handle as described in any one of the preceding, the catheter assembly includes an outer tube and an inner tube partially passing through the outer tube ;
  • the handle is connected to the proximal end of the catheter assembly and is used to control the catheter assembly so that axial relative movement occurs between the inner tube and the outer tube.
  • the present invention also provides a medical device, comprising a medical implant and the aforementioned conveyor, the medical implant is loaded on the distal end of the catheter assembly and compressed on the In the space between the outer tube and the inner tube.
  • the present invention also provides a delivery device, comprising a catheter assembly and the above-mentioned handle, the catheter assembly includes an outer tube and an inner tube partially passing through the outer tube, the outer tube One of the tube and the inner tube is a release tube; the handle is connected to the proximal end of the catheter assembly and is used to control the movement of the release tube in a predetermined direction so that the inner tube and the outer tube Axial relative movement occurs between them; the second limiting mechanism is connected to the release tube.
  • the present invention also provides a medical device, comprising a medical implant and the aforementioned conveyor, the medical implant is loaded on the distal end of the catheter assembly and compressed on the In the space between the outer tube mechanism and the inner tube mechanism.
  • the handle, conveyor and medical device of the present invention have the following advantages:
  • the aforementioned conveyor includes a catheter assembly and a handle;
  • the catheter assembly includes an outer tube and an inner tube partially penetrated in the outer tube, and axial relative movement can be generated between the outer tube and the inner tube,
  • One of the outer tube and the inner tube is a release tube;
  • the handle includes a housing, a first driving part and a limit assembly; wherein the first driving part is used to drive the release tube along a predetermined Direction movement;
  • the limiting assembly includes a first limiting mechanism and a second limiting mechanism, the first limiting mechanism is partially disposed in the housing and connected to the housing, and is configured to be able to rotate around the axis of the release tube;
  • the second limit mechanism is arranged in the housing and configured to move simultaneously with the release tube;
  • the handle is configured to drive the When the release tube moves along a predetermined direction and reaches a predetermined position, the first limit mechanism cooperates with the second limit mechanism to prevent the release tube from continuing to move along the predetermined direction.
  • the release tube When the position mechanism rotates around the axis of the release tube and disengages the first limit mechanism from the second limit mechanism, the release tube is allowed to continue to move along the predetermined direction; the conveyor can release When the tube moves to the predetermined position, the stopper assembly is used to temporarily stop the release tube from moving in the predetermined direction, so as to facilitate the operator to perform other operations and meet the use requirements; afterward, it can be released by rotating the first stopper mechanism.
  • the cooperation between the first limiting mechanism and the second limiting mechanism allows the first driving part to continue to drive the release tube to move in a predetermined direction, which is simple and convenient to use.
  • the aforementioned conveyor includes a catheter assembly, a housing, a first driving part, and a limit assembly;
  • the catheter assembly includes an outer tube mechanism and an inner tube mechanism, and the inner tube mechanism is partially passed through the outer tube mechanism,
  • One of the outer tube mechanism and the inner tube mechanism is a release tube mechanism;
  • the housing is connected to the proximal end of the catheter assembly, the first driving part is connected to the release tube mechanism, and is used to Driving the release tube mechanism to move in a predetermined direction;
  • the limit assembly includes a first limit mechanism and a second limit mechanism, the first limit mechanism is partially arranged in the housing and connected to the on the housing, and is configured to be able to rotate around the axis of the housing;
  • the second limit mechanism is arranged in the housing and connected to the release tube mechanism;
  • the conveyor is configured to When the release tube mechanism moves to a predetermined position along a predetermined direction, the second limit mechanism cooperates with the first limit mechanism and prevents the release tube mechanism from continuing to move along the predetermined direction.
  • the release tube mechanism When the first limit mechanism rotates around the axis of the release tube mechanism and disengages the second limit mechanism from the first limit mechanism, the release tube mechanism is allowed to continue moving along the predetermined direction;
  • the conveyor can temporarily prevent the release tube mechanism from continuing along the predetermined direction by using the limiting component, so as to facilitate the operator to perform other operations and meet the use requirements;
  • a limiting mechanism releases the cooperation between the first limiting mechanism and the second limiting mechanism, and allows the first driving part to continue driving the release tube mechanism to retreat along a predetermined direction, which is simple and convenient to use.
  • Fig. 1 is a schematic structural view of a conveyor provided by the present invention according to an embodiment
  • Fig. 2 is a partial structural schematic diagram of a conveyor provided by the present invention according to an embodiment
  • Fig. 3 is a partial structural schematic diagram of a conveyor provided according to an embodiment of the present invention, in which part of the housing is omitted and the internal structure of the housing is shown;
  • Fig. 4 is a partially enlarged schematic view of the conveyor provided according to an embodiment of the present invention, in which the outer tube is in a state before it moves from the distal end to the proximal end;
  • Fig. 5 is a partially enlarged schematic view of the conveyor provided according to an embodiment of the present invention, in which the outer tube moves from the distal end to the proximal end to a predetermined position and the first limiting mechanism and the second limiting mechanism cooperate with each other;
  • Fig. 6 is a partially enlarged schematic view of the conveyor provided according to an embodiment of the present invention, in which the first limiting mechanism and the second limiting mechanism are disengaged;
  • Fig. 7 is a partially enlarged schematic view of the conveyor shown in Fig. 3;
  • Fig. 8 is a schematic structural view of the second connecting component of the conveyor provided according to an embodiment of the present invention.
  • Fig. 9 is a schematic structural view of a third connecting component of the conveyor provided according to an embodiment of the present invention.
  • Fig. 10 is a schematic structural view of the anti-rotation member of the conveyor provided according to an embodiment of the present invention.
  • each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense of including “and/or”, unless the content clearly indicates otherwise, and the terms “installation”, “connection” and “connection” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • proximal refers to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of the operator using the medical device, although “proximal”, “ Distal end” is not limiting, but “proximal end” generally refers to the end of the medical device that is close to the operator during normal operation, and “distal end” generally refers to the end that first enters the patient's body, that is, “proximal end”.
  • the “end” is the end away from the patient, and the “distal end” is the end close to the patient.
  • axial refers to a direction coincident with or parallel to the central axis of the medical device; “radial” refers to a direction perpendicular to the central axis of the medical device.
  • the present embodiment provides a delivery device for delivering and releasing a medical implant to a target location in a patient.
  • the medical implants include but not limited to medical stents, valve prostheses, embolic coils and the like.
  • FIG. 1 shows a schematic diagram of the overall structure of the conveyor
  • FIG. 2 shows a schematic structural appearance of a handle 1000 of the conveyor
  • FIG. 3 shows a schematic structural diagram of the handle 1000 omitting part of the housing.
  • the delivery device includes a handle 1000 and a catheter assembly, wherein the catheter assembly may include an outer tube 2100 and an inner tube 2200 partially pierced inside the outer tube 2100 , and the Axial relative movement can be generated between the outer tube 2100 and the inner tube 2200 .
  • One of the outer tube 2100 and the inner tube 2200 is a release tube, that is, when the medical implant is crimped between the outer tube 2100 and the inner tube 2200, by manipulating the release tube The tube moves along the axial direction of the handle 1000 to realize the release of the medical implant.
  • the outer tube 2100 when the outer tube 2100 is the release tube, the operator releases the medical implant by retracting the outer tube 2100 (that is, the outer tube 2100 moves in the direction from the distal end to the proximal end).
  • the inner tube 2200 is the release tube, the operator releases the medical implant by pushing the inner tube 2200 (that is, the inner tube 2200 moves in the direction from the proximal end to the distal end).
  • the operator can also recover the medical implant by manipulating the release tube along the axis of the handle 1000.
  • the outer tube 2100 is used as the release tube as an example for description, but this should not limit the example of the present invention.
  • the catheter assembly is used to load the medical implant and deliver the medical implant into a patient.
  • the handle 1000 is connected to the proximal end of the catheter assembly, and is used to control the catheter assembly, so that the outer tube 2100 and the inner tube 2200 can move axially relative to each other, so that the medical implant The drug is released at the target location in the patient's body.
  • the handle 1000 includes a housing 1110 , a first driving part 1120 and a limiting assembly.
  • the first driving part 1120 is preferably connected to the housing 1110 and used to drive the outer tube 2100 to move axially relative to the inner tube 2200 to complete the release of the medical implant.
  • the limit assembly includes a first limit mechanism 1310 and a second limit mechanism 1320 .
  • the first limiting mechanism 1310 is partially disposed in the housing 1110 and can be connected to the inner wall of the housing 1110, and is configured to be able to rotate around the axis of the outer tube 2100. It should be noted that , the axis of the housing 1110 may coincide with the axis of the outer tube 2100 .
  • the second limiting mechanism 1320 is disposed in the housing and configured to move simultaneously with the outer tube 2100 .
  • the handle further includes the first connection assembly, the first connection assembly is arranged in the housing 1110, and is in transmission connection with the first driving part 1120, and is also used for It is connected with the proximal end of the outer tube 2100. In this way, the first connection assembly is used to move under the drive of the first driving part 1120 and drive the outer tube 2100 to move axially relative to the inner tube 2200 .
  • the handle 1000 is configured such that when the first driving part 1120 drives the outer tube 2100 to move in a predetermined direction and makes the outer tube 2100 reach a predetermined position, the first limiting mechanism 1310 and the second The limiting mechanism 1320 cooperates with each other and prevents the first driving part 1120 from driving the outer tube 2100 to continue to move along the predetermined direction.
  • the first limiting mechanism 1310 rotates around the axis of the outer tube 2100 and makes
  • the first driving part 1120 is allowed to drive the outer tube 2100 to continue moving along the predetermined direction.
  • the predetermined direction is a direction from the distal end to the proximal end.
  • the first limiting mechanism 1310 and the second limiting mechanism 1320 are in a non-cooperating state, at this time the The first driving part 1120 can drive the outer tube 2100 to move from the distal end to the proximal end, and start to release the medical implant.
  • the movement of the outer tube 2100 in the direction from the distal end to the proximal end is referred to as withdrawing.
  • withdrawing the movement of the outer tube 2100 in the direction from the distal end to the proximal end.
  • the operator can execute Other operations, such as adjusting the posture of the medical implant, etc.
  • the cooperation between the first limiting mechanism 1310 and the second limiting mechanism 1320 can be released by rotating the first limiting mechanism 1310, so that the first driving part 1120 can drive the outer tube 2100 to continue to retreat.
  • the operator can pause and withdraw the outer tube 2100 at the predetermined position during operation, and the operation Accurate is conducive to successfully completing the release of the medical implant.
  • the first driving unit 1120 may be a manual driving mechanism or an electric driving mechanism, which is not limited in this embodiment of the present invention.
  • the first limiting mechanism 1310 includes a first positioning seat 1311 and a first limiting portion 1312 .
  • the first positioning seat 1311 is connected to the inner wall of the casing 1110 and configured to be able to rotate around the axis of the outer tube 2100 .
  • the first limiting portion 1312 is connected to the first positioning seat 1311, and at least partially protrudes from the distal end surface of the first positioning seat 1311, and the first limiting portion 1312 follows the The first positioning seat 1311 moves synchronously.
  • the second limiting mechanism 1320 includes a second limiting portion 1321 .
  • the handle 1000 is configured such that before starting to release the medical implant, the second limiting part 1321 is located at the distal side of the first limiting part 1312 and is circumferentially aligned with the first limiting part 1312.
  • the bit portion 1312 at least partially overlaps, and is spaced from the first limiting portion 1312 by a predetermined distance in the axial direction (as shown in FIG. 4 ); when starting to release the medical implant, the first driving portion 1120 first Drive the outer tube 2100 to retract a predetermined distance and make the outer tube 2100 reach the predetermined position, and make the second limiting portion 1321 abut against the first limiting portion 1312 (as shown in FIG.
  • the second limiting mechanism 1320 cooperates with the first limiting mechanism 1310, when the first positioning seat 1311 rotates around the axis of the outer tube 2100 and makes the first limiting part
  • the second limiting mechanism 1320 is disengaged from the first limiting mechanism 1310 .
  • the predetermined direction is the direction from the proximal end to the distal end, and the first limiting portion at least partially protrudes from the first positioning seat
  • the proximal end face of the first limiting part, and the second limiting part is located on the proximal side of the first limiting part (not shown in the figure).
  • the first positioning seat 1311 may be a circular structure with an inner hole.
  • the first connecting component can pass through the inner hole and be connected with the first driving part 1120 .
  • the first positioning seat 1311 may include two semicircular positioning blocks joined together.
  • the number of the first limiting parts 1312 is multiple, and the plurality of the first limiting parts 1312 are arranged sequentially along the circumferential direction of the first positioning seat 1311, and the plurality of the first limiting parts
  • the length of the portion of the portion 1312 protruding from the distal end surface of the first positioning seat 1311 decreases successively along the first direction, so that along the first direction, each first limiting portion 1312 reaches the second limiting portion.
  • the axial distance of the portion 1321 increases sequentially.
  • the handle 1000 is configured such that the first positioning seat 1311 rotates around the axis of the outer tube 2100 along the second direction and makes one of the first stoppers 1312 circumferentially aligned with the first positioning portion 1312 .
  • the two limiting portions 1321 are staggered, the other first limiting portion 1312 can at least partially overlap the second limiting portion 1321 in the circumferential direction.
  • the second direction is opposite to the first direction, for example, the first direction is clockwise, and the second direction is correspondingly counterclockwise.
  • the first positioning seat 1311 is determined according to the number of the first limiting parts 1312 and the distance between two adjacent first limiting parts 1312 in the circumferential direction of the first positioning seat 1311 The angle of each rotation.
  • the number of the first limiting parts is two (not shown in the figure), which are respectively the first sub-limiting part and the second sub-limiting part.
  • the first direction is arranged at intervals on the first positioning seat, and the angle between the two sub-limiting seats is ⁇ .
  • the first driving part drives the outer tube back
  • the second limiting part first abuts against the first sub-limiting part
  • the operator can make the first positioning seat along the The second direction rotates around the axis of the outer tube, and the rotation angle of the first positioning seat is ⁇ , so that the first sub-limiting part is staggered from the second limiting part in the circumferential direction, and the The second sub-limiting portion at least partially overlaps with the second limiting portion in the circumferential direction.
  • the first driving part can drive the outer tube to continue to retreat until the second limiting part abuts against the second sub-limiting part.
  • the operator can rotate the first positioning seat along the second direction again, so that the second sub-limiting part is staggered from the second limiting part in the circumferential direction.
  • the number of the first limiting parts may also be more than three.
  • the first limiting mechanism 1310 includes only one first limiting part 1312 as an example for description in the following, but those skilled in the art can modify the following description to make it suitable for the described
  • the first limiting mechanism 1310 includes more than two first limiting parts 1312 .
  • the first limiting portion 1312 is movably connected to the first positioning seat 1311 and is configured to move along the axial direction of the outer tube 2100 and change the position of the first limiting portion.
  • the length of the portion 1312 protruding from the distal end surface of the first positioning seat 1311 is used to change the predetermined distance between the first limiting portion and the second limiting portion.
  • the advantage of such setting is that the predetermined distance can be adjusted according to the specific type and size of the medical implant when assembling the conveyor, so as to enhance the universal applicability of the conveyor.
  • the first positioning seat 1311 is provided with a screw hole extending through the axial direction thereof, and the first limiting portion 1312 may be formed by a screw, and the screw is passed through the screw hole.
  • the first limiting part 1312 is formed by using a screw because the adjustment of the screw is simple and convenient, and the adjustment range is wide. Even if the processing error is large, it can be compensated by rotating the screw to ensure effective limiting.
  • the first limiting portion 1312 can be fixed with fastening screws to further improve reliability.
  • the housing 1110 is further provided with a first sliding slot 1111 extending along its circumference.
  • the first limiting mechanism 1310 also includes a first driving rod 1313, one end of the first driving rod 1313 is connected to the first positioning seat 1311, and the other end passes through the first sliding slot 1111 and protrudes out.
  • the exterior of the housing 1110 The first driving rod 1313 can be used to receive the external force provided by the operator and drive the first positioning seat 1311 to rotate around the axis of the outer tube 2100 , which is convenient for operation.
  • the first limit mechanism 1310 also includes a first elastic sleeve 1314, the first elastic sleeve 1314 is sleeved on the first dial 1313, and is preferably detachably sleeved on the first dial on the rod 1313 , and the outer wall of the first elastic sleeve 1314 is in contact with the groove wall of the first slide groove 1111 to make the first elastic sleeve 1314 deform.
  • the specific position of the first sliding groove 1111 and its length in the circumferential direction of the housing 1110 can be determined according to the first limiting portion 1312.
  • the dimensions of the first limiting portion 1312 and the second limiting portion 1321 in the circumferential direction of the housing 1110 are determined.
  • the first shifting rod 1313 when the first shifting rod 1313 is located at one end of the first chute 1111 , the first limiting portion 1312 at least partially overlaps the second limiting portion 1321 in the circumferential direction, and when When the first driving rod 1313 is located at the other end of the first chute 1111, the first limiting portion 1312 is offset from the second limiting portion 1321 in the circumferential direction, which is convenient for judging the position of the first positioning seat. Whether the 1311 rotates in place, it is easy to use.
  • the first driving part 1120 is, for example, a manual driving mechanism, and it is rotatably connected to the proximal end of the housing 1110.
  • the first driving part 1120 rotates under the action of an external force
  • the first connecting component moves accordingly and drives the outer tube 2100 to move axially.
  • the first connection assembly includes a threaded sleeve 1210 and a screw rod 1220 .
  • the outer wall of the threaded sleeve 1210 is connected to the inner wall of the first driving part 1120 (that is, the threaded sleeve 1210 is located on the proximal side of the first positioning seat 1311 ), and can be synchronized with the first driving part 1120 Rotate, the inner wall of the threaded sleeve 1210 is also provided with internal threads.
  • the distal end of the screw rod 1220 is connected to the outer tube 2100, and the second limit mechanism 1320 is connected to the outer surface of the distal end of the screw rod 1220, and the outer surface of the proximal end of the screw rod 1220 is An external thread is provided and cooperates with the internal thread of the threaded sleeve 1210 for screw transmission.
  • the inner wall of the first driving part has an internal thread
  • the first connection assembly only includes a screw
  • the external thread on the proximal end of the screw is compatible with the first
  • the internal thread of the driving part cooperates to perform screw transmission (not shown in the figure).
  • the screw rod 1220 can be integrally formed with the second limiting mechanism 1320 , or can be formed separately and then connected together.
  • the casing 1110 is also provided with an observation window 1113 extending along its axial direction, through which the operator can observe the movement of the screw rod 1220, and then know the movement of the outer tube 2100, and judge The moving direction and distance of the outer tube.
  • the screw rod 1220 may also be provided with a scale line, which is visible to the outside through the observation window 1113 , so that the operator can grasp the moving distance of the outer tube 2100 in real time.
  • the handle 1000 preferably further includes a second driving part 1130 , and the second driving part 1130 is arranged on the The proximal side of the first driving part 1120 is described above.
  • the proximal end of the inner tube 2200 protrudes from the proximal end of the outer tube 2100, and extends to the second driving part 1130, and is directly or indirectly connected with the second driving part 1130, so that the second driving part 1130
  • the second driving part 1130 can drive the inner tube 2200 to move axially under the action of external force.
  • the handle 1000 further includes a second connection component and a third connection component, and the second connection component is disposed in the housing 1110 and connected to the inner wall of the housing 1110, the third connecting component is partially disposed in the second driving part 1130 and connected to the second driving part 1130, and the third connecting component is It is configured to be able to rotate around the axis of the second driving part 1130 , and the third connecting component is used for selectively connecting with the second connecting component.
  • the handle 1000 is configured such that when the third connecting component is connected to the second connecting component, the second driving part 1130 remains axially relatively stationary with the housing 1110 and the first driving part 1120 , and prevent the second driving part 1130 from driving the inner tube 2200 to move axially, when the third connecting assembly rotates around the axis of the second driving part 1130 and makes the third connecting assembly and the
  • the second driving part 1130 is allowed to move in a direction away from the housing 1110 and the first driving part 1120 under the action of an external force and drive the inner tube 2200 in the distal direction.
  • the proximal direction moves (ie, drives the inner tube 2200 back).
  • the operator can release the connection between the third connection component and the second connection component, and then make the second driving part 1130 away from the casing 1110
  • the inner tube 2200 is quickly withdrawn to the inside of the outer tube 2100 to reduce adverse effects on the patient.
  • the second driving part 1130 can be manually driven by the operator, or driven by an electric device to move.
  • the second connecting assembly includes a second positioning seat 1410 , a connecting tube 1420 and a third limiting portion 1430 .
  • the second positioning seat 1410 is connected to the inner wall of the housing 1110 .
  • the coupling tube 1420 is connected to the second positioning seat 1410 and a proximal end of the coupling tube 1420 extends toward the second driving part 1130 .
  • the third limiting portion 1430 is connected to the junction tube 1420 , preferably connected to the proximal end of the junction tube 1420 , and extends outward along the radial direction of the junction tube 1420 .
  • the third limiting portion 1430 extends outward along the radial direction of the joint tube 1420 , including the situation that the third limiting portion 1430 extends strictly radially, and also includes extending substantially radially. In other cases, as long as the third limiting portion 1430 protrudes from the outer peripheral surface of the connecting tube 1420 .
  • the third connection assembly includes a third positioning seat 1510 , the third positioning seat 1510 is movably connected to the inner wall of the second driving part 1130 , and is configured to be able to surround the inner wall of the second driving part 1130 . Axis rotation.
  • the third positioning seat 1510 is provided with a first central through hole 1511 and a relief groove 1512, the first central through hole 1511 is used for passing through the proximal end of the connecting tube 1420, the relief groove 1512 is connected with the The first central through hole 1511 communicates and is used for passing through the third limiting portion 1430 .
  • the third limiting portion 1430 When the third limiting portion 1430 is located on the proximal side of the third positioning seat 1510 and is circumferentially staggered with the relief groove 1512 , and the third limiting portion 1430 presses against the third positioning seat 1510 When the seat 1510 is on, the third connection component is connected with the second connection component. At this time, the third limiting part 1430 and the third positioning seat 1510 limit each other to prevent the second driving part 1130 from moving axially under the action of an external force, which also prevents the second driving part from moving in the axial direction. 1130 drives the inner tube 2200 to move axially.
  • the third positioning seat 1510 rotates around the axis of the second driving part 1130 under the action of an external force, until the relief groove 1512 at least partially overlaps with the third limiting part 1430 in the circumferential direction and allows the When the third limiting portion 1430 passes through, the third connecting component is disconnected from the second connecting component. At this time, the third limiting part 1430 and the third positioning seat 1510 are released from mutual limiting, and no longer hinder the movement of the second driving part 1130 from the distal end to the proximal end.
  • the operator can pull back the second driving part 1130, and drive the inner tube 2200 to retract, and at the same time, the third positioning seat 1510 moves along the direction from the distal end to the proximal end, and the engagement The tube 1420 and the third limiting portion 1430 pass through the third positioning seat 1510 and move to the distal side of the third positioning seat 1510 at the same time.
  • the proximal end of the inner tube 2200 passes through the first positioning seat 1311 and the connecting tube 1420 and is directly or indirectly connected to the second driving part 1130 .
  • the shape and size of the relief groove 1512 match the shape and size of the third limiting portion 1430 .
  • the shapes of the third limiting portion 1430 and the relief groove 1512 are fan-shaped, and the size of the relief groove 1512 is slightly larger than that of the third limiting portion 1430 The size is such that the third limiting portion 1430 can pass through the relief groove 1512 .
  • the shapes of the third limiting portion 1430 and the relief groove 1512 may also be square, special-shaped, and the like.
  • a guide surface (not shown in the figure) is formed on the distal end of the third limiting portion 1430, and the distance from the guide surface to the axis of the joint tube 1420 is along the direction from the distal end to the proximal end. gradually increase so that the third limiting portion 1430 can pass through the relief groove 1512 smoothly.
  • the number of the third limiting portion 1430 is preferably multiple, and a plurality of the third limiting portions 1430 are evenly arranged along the circumference of the joint pipe 1420 to improve the connection between the third connection assembly and the second connection.
  • the number of the relief grooves 1512 may be equal to the number of the third limiting portions 1430 , and the two are arranged correspondingly.
  • the number and arrangement of the third limiting portion 1430 determine that the third connecting component and the second connecting component switch from a connected state to a non-connected state (that is, the two are disconnected). , the rotation angle of the third positioning seat 1510 .
  • the third positioning seat 1510 can be A predetermined direction (clockwise or counterclockwise) is rotated by 90°, so that the third connection component and the second connection component are switched from a connected state to a non-connected state.
  • the second driving part 1130 is provided with a second sliding slot 1131 extending along the circumferential direction of the second driving part 1130 at a position corresponding to the third positioning seat 1510 .
  • the third connection assembly further includes a second driving rod 1520, one end of the second driving rod 1520 is connected to the third positioning seat 1510, and the other end passes through the second sliding slot 1131 and extends out of the The outside of the second driving part 1130 is used to receive the external force applied by the operator and drive the third positioning seat 1510 to rotate.
  • the position and length of the second chute 1131 (that is, the size of the second chute 1131 in the circumferential direction of the second driving part 1130 ) is determined according to the number and arrangement of the third limiting parts 1430 , but usually when the third connecting component is connected with the second connecting component, the second shift lever 1520 is located at one end of the second sliding slot 1131, and when the third connecting component is connected with the second When the connection assembly is disconnected, the second shift lever 1520 is located at the other end of the second sliding slot, so as to judge whether the third positioning seat 1510 is rotated in place.
  • the third connection assembly further includes a second elastic sleeve 1530
  • the second elastic sleeve 1530 is preferably detachably set on the second lever 1520, and the outer wall of the second elastic sleeve 1530 is in contact with the The groove wall of the second sliding groove 1131 contacts and deforms the second elastic sleeve 1530 .
  • there is a mutual pressing force between the second elastic sleeve 1530 and the groove wall of the second sliding groove 1131 when the operator applies an external force to make the second driving rod 1520 move along the second sliding groove 1131
  • a resistance is generated between the second elastic sleeve 1530 and the groove wall of the second chute 1131.
  • the resistance can enhance the operator's feel, and on the other hand, the operator needs to provide
  • the second shift lever 1520 can only be moved with a relatively large force, so as to avoid misoperation.
  • the resistance when the second lever 1520 moves can be adjusted, and the second elastic sleeve 1530 can be directly replaced after wear, which is convenient for maintenance.
  • the second positioning seat 1410 since the second positioning seat 1410 is connected to the housing 1110, the proximal end of the joint tube 1420 needs to extend to the second driving part 1130, that is to say, the second connecting assembly spans The first driving part 1120 . In order to prevent the second connection component from interfering with the connection between the first connection component and the first driving part 1120 , the structure of the second connection component needs to be reasonably designed.
  • the second positioning seat 1410 includes a first sub-positioning seat 1411 , a connecting arm 1412 and a second sub-positioning seat 1413 .
  • the first sub-positioning seat 1411 is connected to the inner wall of the housing 1110 .
  • the two ends of the connecting arm 1412 are respectively connected with the first sub-positioning seat 1411 and the second sub-positioning seat 1413, and the number of the connecting arms 1412 is at least two, preferably two, and the two The connecting arms 1412 are arranged at intervals along the circumference of the first sub-positioning seat 1411 .
  • the connecting tube 1420 is connected to the proximal end surface of the second sub-positioning seat 1413 . It can be understood that, both the first sub-positioning seat 1411 and the second sub-positioning seat 1413 are provided with a channel communicating with the inner cavity of the junction tube 1420 for the screw rod 1220 and the inner cavity.
  • the tube 2200 runs through (specifically, the proximal end of the screw rod 1220 passes through the passage on the first sub-positioning seat 1411, and the proximal end of the inner tube 2200 passes through the passage on the second sub-positioning seat 1413)
  • the external thread on the screw rod 1220 passes through the gap between the two connecting arms 1412 and connects with the threaded sleeve 1210 (or with the inner wall of the first driving part 1120 ). Compatible with the internal thread.
  • the handle 1000 further includes an auxiliary assembly plate 1610 , the shape of the auxiliary assembly plate 1610 is preferably circular, and a circular second sliding slot is provided on the distal end surface thereof.
  • the auxiliary assembly plate 1610 is used to fit on the joint tube 1420 , and the distal end of the auxiliary assembly plate 1610 is pressed against the proximal end surface of the second sub-positioning seat 1413 .
  • the proximal end of the first driving part 1120 is inserted into the second sliding groove, and can rotate along the second sliding groove under the action of external force.
  • the third connecting component is connected with the second connecting component, the distal end of the second driving part 1130 presses against the proximal end surface of the auxiliary assembly plate 1610 .
  • an annular groove matching the distal end of the second driving part 1130 may be provided on the proximal end surface of the auxiliary assembly plate 1610 .
  • the handle 1000 also includes a fourth connection assembly, the fourth connection assembly is connected to the inner wall of the second driving part 1130 and is also used to connect with the inner tube 2200
  • the proximal end connection that is, the inner tube 2200 is indirectly connected to the second driving part 1130 through the fourth connection assembly.
  • the fourth connection assembly includes an anti-rotation member 1710, and the anti-rotation member 1710 has a second central through hole 1711 through which the inner tube 2200 passes.
  • the anti-rotation part 1710 includes a first anti-rotation part 1712 and a second anti-rotation part 1713.
  • the first anti-rotation part 1712 is connected to the inner wall of the second driving part 1130 and is configured to be connected to the second anti-rotation part 1713.
  • the two driving parts 1130 keep relatively stationary in the circumferential direction
  • the second anti-rotation part 1713 is at least partially inserted into the lumen of the coupling tube 1420 and is configured to keep relatively stationary in the circumferential direction with the coupling tube 1420 .
  • both the first anti-rotation portion 1712 and the second anti-rotation portion 1713 have a non-rotating shape, for example, the cross-sections of the first anti-rotation portion 1712 and the second anti-rotation portion 1713 are both rectangle.
  • the shape of the cross-section of at least a part of the inner cavity of the junction tube 1420 matches the shape of the second anti-rotation part 1713 , that is, the cross-section of at least a part of the inner cavity of the junction tube 1420 is also rectangle.
  • the proximal end of the inner tube 2200 passes through the second driving part 1130 and is connected with a luer connector for connecting with a syringe or other external devices.
  • the housing 1110 is preferably an assembled structure, including a first sub-housing and a second sub-housing, the first driving part 1120 and the third sub-housing.
  • the driving part 1130 is also an assembled structure, the first driving part 1120 includes a third sub-housing and a fourth sub-housing, and the second driving part 1130 includes a fifth sub-housing and a sixth sub-housing.
  • the handle 1000 also includes a first fastening ring 1101 and a second fastening ring 1102 (marked in FIG. 1 ).
  • the first fastening ring 1101 is arranged between the housing 1110 and the first driving part 1120 to make the two firmly connected, and the second fastening ring 1102 is arranged on the second driving part 1130 the proximal end, so that the fifth sub-housing and the sixth sub-housing are firmly connected.
  • the conveyor provided in the embodiment of the present invention is provided with an emptying pipe, and the setting method of the emptying pipe refers to the prior art.
  • this embodiment also provides a handle, which is the handle 1000 as mentioned above.
  • this embodiment also provides a medical device, including a medical implant and the aforementioned delivery device, the medical implant is loaded on the distal end of the catheter assembly and compressed on the inner tube 2200 and the space between the outer tube 2100.
  • This embodiment provides a conveyor.
  • the difference between this embodiment and Embodiment 1 is that the second limiting mechanism is connected to the release tube.
  • this embodiment also provides a medical device, including a medical implant and the transporter, the medical implant is loaded on the distal end of the catheter assembly, and compressed between the outer tube mechanism and the delivery device. the space between the inner tube bodies.

Abstract

本发明提供了一种手柄、输送器及医用装置，输送器包括手柄，手柄包括壳体、第一驱动部及限位组件，第一驱动部用于驱使释放管沿预定方向移动；限位组件包括第一限位机构和第二限位机构，第一限位机构设于壳体内并能绕释放管的轴线旋转；第二限位机构被配置为与释放管同时移动；当释放管沿预定方向移动至预定位置时，第一限位机构与第二限位机构配合并阻止释放管继续沿预定方向移动，当第一限位机构旋转并使第一限位机构与第二限位机构解除配合时，允许释放管继续沿预定方向继续移动。该输送器可在释放管移动至预定位置时，利用所述限位组件来暂时阻止释放管沿预定方向继续移动，以方便施术者执行其他操作，满足使用需求。

Description

一种手柄、输送器及医用装置 技术领域
本发明涉及医疗器械技术领域，具体涉及一种手柄、输送器及医用装置。
背景技术
心脏瓣膜是心脏血液循环的大门，一旦出现狭窄或关闭不全，心脏就会出现动力不足或衰竭，出现胸闷、气喘、全身浮肿、无力、胸痛等症状，是危害老年人生命和生存质量的隐患。随着人口老龄化和医疗技术的发展，心脏瓣膜病(valvular heart disease，VHD)已成为第三大心血管疾病，严重危害着人类健康。目前，传统外科手术仍是这类疾病的首选治疗方案，但是对于高龄、合并多器官疾病、有开胸史以及身体恢复功能较差的患者来说传统外科手术风险大、死亡率高，部分患者甚至没有手术的机会。
介入治疗手术是近年来研发的一种全新的治疗技术，是一种微创伤手术治疗法。介入治疗是在医学影像设备的引导下通过输送器将特制的医疗器械引入人体，对体内病变进行诊断和局部治疗。介入治疗无需开刀，相较于传统外科手术，其具有创伤小、恢复快、效果好等优势。介入治疗手术可用于治疗心脏瓣膜病，也可以用于治疗其他疾病，根据具体疾病的不同，所述医疗器械也有所不同，例如针对心脏瓣膜病，医疗器械是人工瓣膜，针对血管疾病，医疗器械可以是医用支架等。
输送器通常包括手柄和导管组件，导管组件用于装载医疗器械并包括内管和外管，手柄用于与导管组件连接并对内管和/或外管进行控制，以使医疗器械能够被引入人体。手柄作为整个介入手术过程中动力源，其需要保证足够的安全性、有效性和经济性。在介入手术的不同阶段对手柄的操作有不同的需求，例如在控制外管回撤以释放医用植入物的过程中，当外管回撤至预定位置时，施术者可能需要暂停回撤并执行其他操作例如调整医用植入物的位姿等，因此需要进一步优化手柄的结构，以满足不同的使用需求。
发明内容
本发明的目的在于提供一种手柄、输送器及医用装置，利用该输送器输送并释放医用植入物时，可在释放管移动至预定位置时，可暂停释放管移动，满足使用需求。
为实现上述目的，本发明提供了一种手柄，用于控制导管组件，所述导管组件包括外 管和部分地穿设在所述外管内的内管，所述外管和所述内管中的一个为释放管；所述手柄包括：
壳体；
第一驱动部，用于驱使所述释放管沿预定方向移动；以及，
限位组件，包括第一限位机构和第二限位机构，所述第一限位机构部分地设置在所述壳体内并连接于所述壳体上，且被配置为能够绕所述释放管的轴线旋转；所述第二限位机构设置在所述壳体内，并被配置用于随所述释放管的移动而移动；
所述手柄被配置为当所述第一驱动部驱使所述释放管沿预定方向移动并使所述释放管抵达预定位置时，所述第一限位机构与所述第二限位机构相互配合，以阻止所述释放管继续沿所述预定方向移动；当所述第一限位机构绕所述释放管的轴向旋转使所述第一限位机构与所述第二限位机构解除配合时，允许所述第一驱动部驱使所述释放管继续沿所述预定方向移动。
可选地，所述手柄还包括第一连接组件，所述第一连接组件设置于所述壳体内，并与所述第一驱动部传动连接，且还用于与所述释放管的近端连接；所述第二限位机构连接于所述第一连接组件上。
可选地，所述第一限位机构包括第一定位座和第一限位部；所述第一定位座连接于所述壳体上，并被配置为能够绕所述释放管的轴线旋转；所述第一限位部连接于所述第一定位座上，并至少部分地凸出于所述第一定位座的预定端面；所述第二限位机构包括第二限位部；
所述手柄被配置为所述第一限位部与所述第二限位部在周向上至少部分重合，且第一限位部与所述第二限位部相互抵接时，所述第一限位机构与所述第二限位机构相互配合，当所述第一定位座绕所述释放管的轴线旋转并使所述第一限位部在周向上与所述第二限位部错开时，所述第二限位机构与所述第一限位机构解除配合。
可选地，所述第一限位部可活动地连接于所述第一定位座上，并被配置为能够沿所述释放管的轴向移动，以改变所述第一限位部凸出于所述第一定位座之预定端面的部分的长度。
可选地，所述第一定位座上设有沿所述释放管的轴向贯通地延伸的螺孔，所述第一限位部为螺杆，所述螺杆穿设在所述螺孔中。
可选地，所述壳体上设有沿周向延伸的第一滑槽；所述第一限位机构还包括第一拨杆，所述第一拨杆的一端连接在所述第一定位座上，另一端穿过所述第一滑槽并伸出所述壳体的外部。
可选地，所述第一限位机构还包括第一弹性套，所述第一弹性套套装在所述第一拨杆上，且所述第一弹性套的外壁与所述第一滑槽的槽壁接触并使所述第一弹性套产生形变。
可选地，所述第一定位座为环形结构并具有内孔，所述第一连接组件的近端穿过所述内孔并与所述第一驱动部连接。
可选地，所述第一限位部的数量为多个，多个所述第一限位部沿所述第一定位座的周向依次布置，且每个所述第一限位部凸出于所述第一定位座之预定端面的部分的长度沿第一方向依次减小，以使每个所述第一限位部到所述第二限位部的轴向距离沿所述第一方向依次增大；
所述手柄被配置为当所述第一定位座沿第二方向绕所述释放管的轴线旋转并使一个所述第一限位部在周向与所述第二限位部错开时，另一个所述第一限位部能够在周向上与所述第二限位部至少部分重叠；所述第二方向与所述第一方向相反。
可选地，所述第一驱动部可转动地连接于所述壳体的近端端部；
所述第一驱动部的内壁上设有内螺纹，所述第一连接组件包括丝杆，所述丝杆的远端与所述释放管的近端连接，且所述丝杆的远端外表面上连接有所述第二限位机构，所述丝杆的近端外表面上设有外螺纹，并与所述第一驱动部上的内螺纹相配合以进行螺旋传动；或者，
所述第一连接组件包括螺纹套和丝杆，所述螺纹套连接于所述第一驱动部的内壁上并被配置为能够随所述第一驱动部同步旋转，所述螺纹套的内壁上设有内螺纹；所述丝杆的远端与所述释放管的近端连接，且所述丝杆的远端外表面上连接有所述第二限位机构，所述丝杆的近端外表面上设有外螺纹，并与所述螺纹套上的内螺纹相配合以进行螺旋传动。
可选地，所述壳体上设有观察窗，用于观察所述丝杆的运动。
可选地，所述释放管为所述外管，所述预定方向为远端到近端的方向；或者，
所述释放管为所述内管，所述预定方向为近端到远端的方向。
为实现上述目的，本发明还提供了一种输送器，包括导管组件和如前中任一项所述的手柄，所述导管组件包括外管和部分地穿设在所述外管内的内管；所述手柄连接于所述导 管组件的近端，并用于控制所述导管组件，以使所述内管和所述外管之间产生轴向相对运动。
为实现上述目的，本发明还提供了一种医用装置，包括医用植入物和如前所述的输送器，所述医用植入物装载于所述导管组件的远端，并压缩于所述外管与所述内管之间的空间内。
为实现上述目的，本发明还提供了一种输送器，包括导管组件和如前所述的手柄，所述导管组件包括外管和部分地穿设在所述外管内的内管，所述外管和所述内管中的一者为释放管；所述手柄连接于所述导管组件的近端，并用于控制所述释放管沿预定方向移动，以使所述内管和所述外管之间产生轴向相对移动；所述第二限位机构连接于所述释放管上。
为实现上述目的，本发明还提供了一种医用装置，包括医用植入物和如前所述的输送器，所述医用植入物装载于所述导管组件的远端，并压缩于所述外管机构与所述内管机构之间的空间内。
与现有技术相比，本发明的手柄、输送器及医用装置具有如下优点：
前述的输送器包括导管组件和手柄；所述导管组件包括外管和部分地穿设在所述外管内的内管，且所述外管和所述内管之间能够产生轴向相对运动，所述外管和所述内管中的一者为释放管；所述手柄包括壳体、第一驱动部和限位组件；其中，所述第一驱动部用于驱使所述释放管沿预定方向移动；所述限位组件包括第一限位机构和第二限位机构，所述第一限位机构部分地设置在所述壳体内并连接于所述壳体上，且被配置为能够绕所述释放管的轴线旋转；所述第二限位机构设置在所述壳体内并被配置为与所述释放管同时移动；所述手柄被配置为当所述第一驱动部驱使所述释放管沿预定方向移动并抵达预定位置时，所述第一限位机构与所述第二限位机构相互配合，并阻止所述释放管继续沿所述预定方向移动，当所述第一限位机构绕所述释放管的轴线旋转并使所述第一限位机构与所述第二限位机构解除配合时，允许所述释放管继续沿所述预定方向移动；该输送器可在释放管移动至预定位置时，利用所述限位组件来暂时阻止释放管沿预定方向继续移动，以方便施术者执行其他操作，满足使用需求；之后可通过旋转所述第一限位机构来解除第一限位机构和所述第二限位机构的配合，并允许所述第一驱动部继续驱使所述释放管沿预定方向移动，使用简单方便。
前述的输送器包括导管组件、壳体、第一驱动部和限位组件；所述导管组件包括外管 机构和内管机构，所述内管机构部分地穿设在所述外管机构内，所述外管机构和所述内管机构中的一者为释放管机构；所述壳体连接于所述导管组件的近端，所述第一驱动部与所述释放管机构连接，并用于驱使所述释放管机构沿预定方向移动；所述限位组件包括第一限位机构和第二限位机构，所述第一限位机构部分地设置在所述壳体内，并连接于所述壳体上，且被配置为能够绕所述壳体的轴线旋转；所述第二限位机构设置在所述壳体内，并连接于所述释放管机构上；所述输送器被配置为当所述释放管机构沿预定方向移动至预定位置时，所述第二限位机构与所述第一限位机构相互配合，并阻止所述释放管机构继续沿所述预定方向移动，当所述第一限位机构绕所述释放管机构的轴线旋转并使所述第二限位机构与所述第一限位机构解除配合时，允许所述释放管机构继续沿所述预定方向移动；该输送器可在释放管机构移动至预定位置时，利用所述限位组件来暂时阻止释放管机构继续沿预定方向，以方便施术者执行其他操作，满足使用需求；之后可通过旋转所述第一限位机构来解除第一限位机构和所述第二限位机构的配合，并允许所述第一驱动部继续驱使所述释放管机构沿预定方向回撤，使用简单方便。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1是本发明根据一实施例所提供的输送器的结构示意图；
图2是本发明根据一实施例所提供的输送器的局部结构示意图；
图3是本发明根据一实施例所提供的输送器的局部结构示意图，图中略去了部分壳体并示出壳体内部的结构；
图4是本发明根据一实施例所提供的输送器的局部放大示意图，图中外管处于尚未沿远端向近端移动前的状态；
图5是本发明根据一实施例所提供的输送器的局部放大示意图，图中外管沿远端向近端移动至预定位置且第一限位机构和第二限位机构相互配合；
图6是本发明根据一实施例所提供的输送器的局部放大示意图，图中第一限位机构与第二限位机构解除配合；
图7是图3所示的输送器的局部放大示意图；
图8是本发明根据一实施例所提供的输送器之第二连接组件的结构示意图；
图9是本发明根据一实施例所提供的输送器之第三连接组件的结构示意图；
图10是本发明根据一实施例所提供的输送器之防转动件的结构示意图。
[附图标记说明如下]：
1000-手柄，1101-第一紧固环，1102-第二紧固环，1110-壳体，1111-第一滑槽，1113-观察窗，1120-第一驱动部，1130-第二驱动部，1131-第二滑槽，1210-螺纹套，1220-丝杆，1310-第一限位机构，1311-第一定位座，1312-第一限位部，1320-第二限位机构，1321-第二限位部，1313-第一拨杆，1314-第一弹性套，1410-第二定位座，1411-第一子定位座，1412-连接臂，1413-第二子定位座，1420-接合管，1430-第三限位部，1510-第三定位座，1511-第一中心通孔，1512-退让槽，1520-第二拨杆，1530-第二弹性套，1610-辅助装配板，1710-防转动件，1711-第二中心通孔，1712-第一防转部，1713-第二防转部；
2100-外管，2200-内管。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的型态、数量及比例可为一种随意的改变，且其组件布局型态也可能更为复杂。
另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的， 术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
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。附图中相同或相似的附图标记代表相同或相似的部件。
在本文中，术语“近端”、“远端”是从使用该医疗器械的施术者角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近施术者的一端，而“远端”通常是指首先进入患者体内的一端，也即“近端”是远离患者的一端，“远端”是靠近患者的一端。术语“轴向”是指与该医疗器械的中心轴重合或平行的方向；“径向”是指与该医疗器械的中心轴垂直的方向。
<实施例一>
本实施例提供了一种输送器，所述输送器用于将医用植入物输送并释放至患者体内的目标位置处。所述医用植入物包括但不限于医用支架、瓣膜假体、栓塞弹簧圈等。
图1示出了所述输送器的整体结构示意图，图2示出了所述输送器的手柄1000的结构外观示意图，图3示出了所述手柄1000略去部分壳体后的结构示意图。
请参考图1至图3，所述输送器包括手柄1000和导管组件，其中，所述导管组件可包括外管2100和部分地穿设在所述外管2100内部的内管2200，且所述外管2100和所述内管2200之间能够产生轴向相对移动。所述外管2100和所述内管2200中的一者为释放管，即当所述医用植入物压握于所述外管2100与所述内管2200之间时，通过操纵所述释放管沿所述手柄1000的轴向移动，可以实现所述医用植入物的释放。具体地，当所述外管2100为所述释放管时，操作者通过回撤所述外管2100(即所述外管2100沿远端向近端的方向移动)来释放所述医用植入物，当所述内管2200为所述释放管时，操作者通过推送所述内管2200(即所述内管2200沿近端向远端的方向移动)来释放所述医用植入物。本领域技术人员可以理解，施术者也可以通过操纵所述释放管沿所述手柄1000的轴向来 回收医用植入。以下，以所述外管2100为所述释放管为例进行说明，但其不应当对本发明实例构成限制。
所述导管组件用于装载所述医用植入物，并将所述医用植入物输送至患者体内。所述手柄1000连接于所述导管组件的近端，并用于控制所述导管组件，以使所述外管2100与所述内管2200之间产生轴向相对移动，以将所述医用植入物释放在患者体内的目标位置处。具体来说，所述手柄1000包括壳体1110、第一驱动部1120和限位组件。所述第一驱动部1120优选连接于所述壳体1110上并用于驱使外管2100相对于所述内管2200做轴向移动，以完成所述医用植入物的释放。所述限位组件包括第一限位机构1310和第二限位机构1320。所述第一限位机构1310部分地设置在所述壳体1110内并可连接于所述壳体1110的内壁上，且被配置为能够绕所述外管2100的轴线旋转，需要说明的是，所述壳体1110的轴线可以与所述外管2100的轴线相重合。所述第二限位机构1320设置在所述壳体内并被配置为与所述外管2100同时移动。在一个优选的实施例中，所述手柄还包括所述第一连接组件，所述第一连接组件设置于所述壳体1110内，并与所述第一驱动部1120传动连接，且还用于与所述外管2100的近端连接。这样一来，所述第一连接组件用于在所述第一驱动部1120的驱使下运动，并带动所述外管2100相对于所述内管2200轴向移动。
所述手柄1000被配置为当所述第一驱动部1120驱使所述外管2100沿预定方向移动并使所述外管2100抵达预定位置时，所述第一限位机构1310与所述第二限位机构1320相互配合，并阻止所述第一驱动部1120驱使所述外管2100继续沿所述预定方向移动，当所述第一限位机构1310绕所述外管2100的轴线旋转并使所述第一限位机构1310与所述第二限位机构1320解除配合时，允许所述第一驱动部1120驱使所述外管2100继续沿所述预定方向移动。所述预定方向为沿远端向近端的方向。
也就是说，在所述输送器将所述医用装置输送至体内并尚未开始释放前，所述第一限位机构1310和所述第二限位机构1320处于非配合的状态，此时所述第一驱动部1120可驱使所述外管2100沿远端向近端的方向移动，并开始释放所述医用植入物。后文中为简化描述，将所述外管2100沿远端向近端的方向的移动称之为回撤。当所述外管2100移动至预定位置时，所述第一限位机构1310和所述第二限位机构1320相互配合，以使得所述外管2100暂停回撤，此时施术者可执行其他操作，例如调整所述医用植入物的姿态等。待施术者完成相关操作后，可通过旋转所述第一限位机构1310来解除所述第一限位机构1310 与所述第二限位机构1320的配合，从而使得所述第一驱动部1120可驱使所述外管2100继续回撤。本实施例中，通过设置所述限位组件，并在组装时根据实际需要设定所述预定位置，使得施术者在操作时可在所述预定位置暂停回撤所述外管2100，操作准确，有利于顺利地完成所述医用植入物的释放。
需要说明的是，所述第一驱动部1120可以是手动驱动机构，也可以是电动驱动机构，本发明实施例对此不作限定。
请重点参考图3至图6，在一个示范性的实施例中，所述第一限位机构1310包括第一定位座1311和第一限位部1312。所述第一定位座1311连接于所述壳体1110的内壁上，并被配置为能够绕所述外管2100的轴线旋转。所述第一限位部1312连接于所述第一定位座1311上，并至少部分地凸出于所述第一定位座1311的远端端面，且所述第一限位部1312随所述第一定位座1311同步运动。所述第二限位机构1320包括第二限位部1321。所述手柄1000被配置为在开始释放所述医用植入物之前，所述第二限位部1321位于所述第一限位部1312的远端侧，并在周向上与所述第一限位部1312至少部分重叠，且在轴向上与所述第一限位部1312间隔预定距离(如图4所示)；开始释放所述医用植入物时，所述第一驱动部1120首先驱使所述外管2100回撤预定距离并使所述外管2100抵达所述预定位置，并使所述第二限位部1321与所述第一限位部1312抵接(如图5所示)，以使得所述第二限位机构1320与所述第一限位机构1310相互配合，当所述第一定位座1311绕所述外管2100的轴线旋转并使得所述第一限位部1312在周向上与所述第二限位部1321错开时(如图6所示)，所述第二限位机构1320与所述第一限位机构1310解除配合。可以理解的是，若所述释放管是所述内管时，所述预定方向为由近端到远端的方向，所述第一限位部至少部分地凸出于所述第一定位座的近端端面，且所述第二限位部位于所述第一限位部的近端侧(图中未示出)。
本实施例中，所述第一定位座1311可以是圆环形结构，并具有一内孔。所述第一连接组件可穿过所述内孔并与所述第一驱动部1120连接。为便于装配，所述第一定位座1311可包括相互拼接的两个半圆形定位块。进一步地，所述第一限位部1312的数量为多个，多个所述第一限位部1312沿所述第一定位座1311的周向依次布置，且多个所述第一限位部1312凸出于所述第一定位座1311之远端端面的部分的长度沿第一方向依次减小，如此沿所述第一方向，各个第一限位部1312到所述第二限位部1321的轴向距离依次增大。此 种情形下，所述手柄1000被配置为所述第一定位座1311沿第二方向绕所述外管2100的轴线旋转并使一个所述第一限位部1312在周向上与所述第二限位部1321错开时，另一个所述第一限位部1312能够在周向上与所述第二限位部1321至少部分重叠。所述第二方向与所述第一方向相反，所述第一方向例如为顺时针方向，所述第二方向则相应为逆时针方向。
实际工作中，根据所述第一限位部1312的数量以及相邻两个所述第一限位部1312在所述第一定位座1311的周向上的距离来确定所述第一定位座1311每次旋转的角度。在一实施例中，所述第一限位部的数量为两个(图中未示出)，分别为第一子限位部和第二子限位部，这两个子限位部沿所述第一方向间隔地布置在所述第一定位座上，且两个所述子限位座之间的夹角为Φ。当所述第一驱动部驱使所述外管回撤时，所述第二限位部首先与所述第一子限位部抵接，此时施术者可使所述第一定位座沿第二方向绕所述外管的轴线旋转，且所述第一定位座的旋转角度为Φ，以使所述第一子限位部在周向上与所述第二限位部错开，并使所述第二子限位部在周向上与所述第二限位部至少部分重叠。此后，所述第一驱动部可驱使所述外管继续回撤直至所述第二限位部与所述第二子限位部抵接。接着施术者可再次沿所述第二方向旋转所述第一定位座，以使所述第二子限位部在周向上与所述第二限位部错开。可理解，所述第一限位部的数量还可以是三个以上。为方便描述，后文中一律以所述第一限位机构1310仅包括一个所述第一限位部1312为例进行说明，但本领域技术人员可以对以下描述进行修改以使其适应于所述第一限位机构1310包括两个以上的所述第一限位部1312的情形。
较佳地，所述第一限位部1312可活动地连接于所述第一定位座1311上，并被配置为能够沿所述外管2100的轴向移动，并改变所述第一限位部1312凸出于所述第一定位座1311之远端端面的部分的长度，以改变所述第一限位部与所述第二限位部之间的所述预定距离。这样设置的好处在于，可在装配所述输送器时，根据所述医用植入物的具体类型、尺寸等调整所述预定距离，增强所述输送器的普遍适用性。可选地，所述第一定位座1311上设有沿其轴向贯通地延伸的螺孔，所述第一限位部1312可由一螺杆构成，所述螺杆穿设在所述螺孔中。利用螺杆来形成所述第一限位部1312，是因为螺杆调节简单、方便，调节幅宽大，即使加工误差较大，也可以通过旋转螺杆来补偿，确保限位有效。可用紧盯螺钉固定所述第一限位部1312，进一步提高可靠性。
进一步地，所述壳体1110上还设有沿其周向延伸的第一滑槽1111。所述第一限位机 构1310还包括第一拨杆1313，所述第一拨杆1313的一端连接于所述第一定位座1311上，另一端穿过所述第一滑槽1111并伸出所述壳体1110的外部。所述第一拨杆1313可用于接受施术者所提供的外力并驱使所述第一定位座1311绕所述外管2100的轴线旋转，方便操作。
更进一步地，所述第一限位机构1310还包括第一弹性套1314，所述第一弹性套1314套装在所述第一拨杆1313上，并优选可拆卸地套装在所述第一拨杆1313上，且所述第一弹性套1314的外壁与所述第一滑槽1111的槽壁接触并使得所述第一弹性套1314产生变形。也就是说，所述第一弹性套1314与所述第一滑槽1111的槽壁之间具有挤压力，以使得所述第一拨杆1313在外力的作用下移动以驱使所述第一定位座1311旋转时，所述第一弹性套1314与所述第一滑槽1111的槽壁之间产生阻力。这样设置的优点是一方面可增强施术者的手感，另一方面还使得施术者需要提供具有一定大小的外力才能够使第一拨杆1313运动，避免误操作。通过调整所述第一弹性套1314的尺寸可调节所述第一拨杆1313移动时的阻力，并且所述第一弹性套1314在磨损后可直接更换，维护方便。
当所述第一限位机构1310仅包括一个所述第一限位部1312时，所述第一滑槽1111的具体位置及其在所述壳体1110的周向上的长度可根据所述第一限位部1312和所述第二限位部1321在所述壳体1110的周向上的尺寸来确定。较佳地，当所述第一拨杆1313位于所述第一滑槽1111的一端时，所述第一限位部1312在周向上与所述第二限位部1321至少部分重叠，而当所述第一拨杆1313位于所述第一滑槽1111的另一端时，所述第一限位部1312在周向上与所述第二限位部1321错开，方便判断所述第一定位座1311是否旋转到位，使用简单。
本实施例中，所述第一驱动部1120例如是手动驱动机构，且其可转动地连接于所述壳体1110的近端端部，当所述第一驱动部1120在外力的作用下旋转时，所述第一连接组件随之运动并驱使所述外管2100沿轴向移动。为实现该目的，请返回参考图3，所述第一连接组件包括螺纹套1210和丝杆1220。所述螺纹套1210的外壁与所述第一驱动部1120的内壁连接(即所述螺纹套1210位于所述第一定位座1311的近端侧)，并能够随所述第一驱动部1120同步旋转，所述螺纹套1210的内壁上还设有内螺纹。所述丝杆1220的远端与所述外管2100连接，且所述丝杆1220的远端外表面上连接有所述第二限位机构1320，所述丝杆1220的近端外表面上设有外螺纹，并与所述螺纹套1210的内螺纹相配合以进行螺 旋传动。或者，在替代性的实施例中，所述第一驱动部的内壁上具有内螺纹，所述第一连接组件只包括丝杆，所述丝杆的近端上的外螺纹与所述第一驱动部的内螺纹相配合以进行螺旋传动(图中未示出)。可理解的是，所述丝杆1220可与所述第二限位机构1320一体成型，也可分别成型后再连接于一体。
所述壳体1110上还设有沿其轴向延伸的观察窗1113，施术者可通过所述观察窗1113观察所述丝杆1220的移动，进而获知所述外管2100的移动情况，判断外管移动方向和距离。不仅于此，所述丝杆1220上还可以设置刻度线，所述刻度线透过所述观察窗1113对外部可见，以便于施术者实时掌握所述外管2100的移动距离。
进一步地，请返回参考图1至图3，在所述外管2100作为所述释放管的情况下，所述手柄1000还优选包括第二驱动部1130，所述第二驱动部1130布置在所述第一驱动部1120的近端侧。所述内管2200的近端从所述外管2100的近端伸出，并延伸至所述第二驱动部1130，且与所述第二驱动部1130直接或间接地连接，从而所述第二驱动部1130能够在外力的作用下驱使所述内管2200做轴向运动。
请重点参考图3并结合图9，在一个非限制性的实施例中，所述手柄1000还包括第二连接组件和第三连接组件，所述第二连接组件设置在所述壳体1110内并连接于所述壳体1110的内壁上，所述第三连接组件部分地设置在所述第二驱动部1130内并连接于所述第二驱动部1130上，且所述第三连接组件被配置为能够绕所述第二驱动部1130的轴线旋转，所述第三连接组件用于与所述第二连接组件选择性地连接。所述手柄1000被配置为当所述第三连接组件与所述第二连接组件连接时，所述第二驱动部1130与所述壳体1110及所述第一驱动部1120保持轴向相对静止，并阻止所述第二驱动部1130驱使所述内管2200做轴向移动，当所述第三连接组件绕所述第二驱动部1130的轴线旋转并使所述第三连接组件与所述第二连接组件解除连接时，允许所述第二驱动部1130在外力的作用下沿远离所述壳体1110及所述第一驱动部1120的方向移动并驱使所述内管2200沿远端向近端的方向移动(也即驱使所述内管2200回撤)。如此，施术者可在所述医用植入物释放完成后，解除所述第三连接组件与所述第二连接组件的连接，然后使所述第二驱动部1130沿远离所述壳体1110的方向移动，进而驱使所述内管2200快速地回撤至回到所述外管2100的内部，降低对患者的不良影响。所述第二驱动部1130可由施术者手动驱动，或由电动装置驱动移动。
请重点参考图7至图9，所述第二连接组件包括第二定位座1410、接合管1420和第 三限位部1430。所述第二定位座1410连接于所述壳体1110的内壁上。所述接合管1420连接于所述第二定位座1410上且所述接合管1420的近端朝向所述第二驱动部1130延伸。所述第三限位部1430连接于所述接合管1420上，并优选连接于所述接合管1420的近端端部，并沿所述接合管1420的径向向外延伸。此处，所述第三限位部1430沿所述接合管1420的径向向外延伸，包括所述第三限位部1430严格地沿径向延伸的情形，也包括大致地沿径向延伸的情形，只要所述第三限位部1430凸出于所述接合管1420的外周面即可。所述第三连接组件包括第三定位座1510，所述第三定位座1510可活动地连接于所述第二驱动部1130的内壁上，并被配置为能够绕所述第二驱动部1130的轴线旋转。所述第三定位座1510上设有第一中心通孔1511和退让槽1512，所述第一中心通孔1511用于供所述接合管1420的近端贯穿，所述退让槽1512与所述第一中心通孔1511连通并用于供所述第三限位部1430贯穿。
当所述第三限位部1430位于所述第三定位座1510的近端侧并在周向上与所述退让槽1512错开，且所述第三限位部1430压抵在所述第三定位座1510上时，所述第三连接组件与所述第二连接组件连接。此时所述第三限位部1430与所述第三定位座1510彼此限位以阻止所述第二驱动部1130在外力的作用下沿轴向移动，也就阻止了所述第二驱动部1130驱使所述内管2200做轴向移动。当所述第三定位座1510在外力的作用下绕所述第二驱动部1130的轴线旋转，直至所述退让槽1512在周向上与所述第三限位部1430至少部分重叠，并允许所述第三限位部1430穿过时，所述第三连接组件与所述第二连接组件解除连接。此时所述第三限位部1430与所述第三定位座1510解除相互限位，并不再对所述第二驱动部1130沿远端向近端的移动造成阻碍。于是，施术者可回拉所述第二驱动部1130，并驱使所述内管2200回撤，同时所述第三定位座1510随之沿远端向近端的方向移动，且所述接合管1420和所述第三限位部1430同时穿过所述第三定位座1510并移动至所述第三定位座1510的远端侧。
可理解的是，在组装所述输送器时，所述内管2200的近端穿过所述第一定位座1311、所述接合管1420后与所述第二驱动部1130直接或间接的连接。
本实施例中优选所述退让槽1512的形状、尺寸与所述第三限位部1430的形状、尺寸相匹配。以图8及图9所示为例，所述第三限位部1430和所述退让槽1512的形状均为扇形，且所述退让槽1512的尺寸略大于所述第三限位部1430的尺寸，以使所述第三限位部 1430能够穿过所述退让槽1512。在其他实施例中，所述第三限位部1430和所述退让槽1512的形状还可以是方形、异形等。进一步地，所述第三限位部1430的远端上还形成有导向面(图中未示出)，所述导向面到所述接合管1420的轴线的距离沿远端到近端的方向逐渐增大，以使所述第三限位部1430能够顺滑地穿过所述退让槽1512。
所述第三限位部1430的数量优选为多个，多个所述第三限位部1430沿所述接合管1420的周向均匀布置，改善所述第三连接组件和所述第二连接组件连接时所述第三定位座1510的受力均衡性，提高使用寿命。所述退让槽1512的数量可与所述第三限位部1430的数量相等，且两者对应布置。本领域技术人员可理解，所述第三限位部1430的数量及布置方式决定了所述第三连接组件和所述第二连接组件从连接状态切换至非连接状态(即两者解除连接)时，所述第三定位座1510的旋转角度。例如，当所述第三限位部1430的数量为两个，且两个所述第三限位部1430沿所述接合管1420的周向均匀布置时，所述第三定位座1510可沿预定方向(顺时针方向或逆时针方向)旋转90°，以使得所述第三连接组件和所述第二连接组件从连接状态切换至非连接状态。
为方便操作，所述第二驱动部1130对应于所述第三定位座1510的位置处设有沿所述第二驱动部1130的周向延伸的第二滑槽1131。所述第三连接组件还包括第二拨杆1520，所述第二拨杆1520的一端连接于所述第三定位座1510上，另一端穿过所述第二滑槽1131并伸出所述第二驱动部1130的外部，以便于接受施术者所施加的外力，并驱使所述第三定位座1510旋转。所述第二滑槽1131的位置及长度(即所述第二滑槽1131在所述第二驱动部1130的周向上的尺寸)根据所述第三限位部1430的数量和布置方式来确定，但通常当所述第三连接组件与所述第二连接组件连接时，所述第二拨杆1520位于所述第二滑槽1131的一端，当所述第三连接组件与所述第二连接组件解除连接时，所述第二拨杆1520位于所述第二滑槽的另一端，便于判断所述第三定位座1510是否旋转到位。
进一步地，所述第三连接组件还包括第二弹性套1530，所述第二弹性套1530优选可拆卸地套装在所述第二拨杆1520上，且所述第二弹性套1530的外壁与所述第二滑槽1131的槽壁接触，并使所述第二弹性套1530发生形变。换句话说，所述第二弹性套1530与所述第二滑槽1131的槽壁之间存在相互挤压力，当施术者施加外力以使所述第二拨杆1520沿所述第二滑槽1131移动时，所述第二弹性套1530与所述第二滑槽1131的槽壁之间产生阻力，该阻力一方面可增强施术者的手感，另一方面使得施术者需要提供较大的力才能使 所述第二拨杆1520移动，避免误操作。通过调整所述第二弹性套1530的尺寸可调节所述第二拨杆1520移动时的阻力，并且所述第二弹性套1530在磨损后可直接更换，维护方便。
此外，由于所述第二定位座1410连接于所述壳体1110上，所述接合管1420的近端需延伸至所述第二驱动部1130处，也就是说所述第二连接组件横跨所述第一驱动部1120。为避免所述第二连接组件对所述第一连接组件与所述第一驱动部1120的连接造成干涉，需要对所述第二连接组件的结构进行合理设计。请重点参考图8，所述第二定位座1410包括第一子定位座1411、连接臂1412和第二子定位座1413。所述第一子定位座1411连接于所述壳体1110的内壁上。所述连接臂1412的两端分别与所述第一子定位座1411和所述第二子定位座1413连接，所述连接臂1412的数量至少为两个，优选为两个，两个所述连接臂1412沿所述第一子定位座1411的周向间隔布置。所述接合管1420连接于所述第二子定位座1413的近端端面上。可理解的是，所述第一子定位座1411和所述第二子定位座1413上均设有与所述接合管1420的内腔连通的通道，以供所述丝杆1220及所述内管2200贯穿(具体是所述丝杆1220的近端穿过所述第一子定位座1411上的通道，所述内管2200的近端穿过所述第二子定位座1413上的通道)组装所述输送器时，所述丝杆1220上的外螺纹透过两个所述连接臂1412之间的间隙与所述螺纹套1210上(或与所述第一驱动部1120的内壁上)的内螺纹相配合。
较佳地，所述接合管1420的远端端面的面积小于所述第二子定位座1413的近端端面的面积。请参考图7，所述手柄1000还包括辅助装配板1610，所述辅助装配板1610的形状优选为圆形，且其远端端面上设有圆形的第二滑槽。所述辅助装配板1610用于套装在所述接合管1420上，且所述辅助装配板1610的远端压抵在所述第二子定位座1413的近端端面上。与此同时，所述第一驱动部1120的近端端部插入所述第二滑槽内，并能够在外力的作用下沿所述第二滑槽旋转。当所述第三连接组件与所述第二连接组件连接时，所述第二驱动部1130的远端端部压抵在所述辅助装配板1610的近端端面上。当然，所述辅助装配板1610的近端端面上可设置与所述第二驱动部1130的远端端部相匹配的环形凹槽。
请继续参考图7并结合图10，所述手柄1000还包括第四连接组件，所述第四连接组件连接于所述第二驱动部1130的内壁上，并还用于与所述内管2200的近端连接(即所述内管2200通过所述第四连接组件与所述第二驱动部1130间接地连接)。可选地，所述第四连接组件包括防转动件1710，所述防转动件1710具有供所述内管2200贯穿的第二中心通 孔1711。所述防转动件1710包括第一防转部1712和第二防转部1713，所述第一防转部1712连接于所述第二驱动部1130的内壁上，并被配置为与所述第二驱动部1130保持周向相对静止，所述第二防转部1713至少部分插入所述接合管1420的内腔并被配置为与所述接合管1420保持周向相对静止。具体地，所述第一防转部1712和所述第二防转部1713均具有非回转的外形，例如所述第一防转部1712和所述第二防转部1713的横截面均为矩形。所述接合管1420的内腔的至少部分区域的横截面的形状与所述第二防转部1713的外形相匹配，也即所述接合管1420的内腔的至少部分区域的横截面也为矩形。通过设置所述防转动件1710，使得施术者在拉动所述第二驱动部1130以驱使所述内管2200沿远端向近端的方向移动时避免所述内管2200转动。
此外，所述内管2200的近端端部穿过所述第二驱动部1130，并连接有鲁尔接头，以用于与注射器或其他外接设备连接。
还需要说明的是，为了方便组装所述输送器，所述壳体1110优选为拼装式结构，包括第一子壳体和第二子壳体，所述第一驱动部1120和所述第三驱动部1130也为拼装式结构，所述第一驱动部1120包括第三子壳体和第四子壳体，所述第二驱动部1130包括第五子壳体和第六子壳体。此外所述手柄1000还包括第一紧固环1101和第二紧固环1102(如图1所标注)。所述第一紧固环1101设于所述壳体1110与所述第一驱动部1120之间，以使两者连接牢固，所述第二紧固环1102设置于所述第二驱动部1130的近端，以使所述第五子壳体和所述第六子壳体连接牢固。
还需要说明的是，本发明实施例所提供的输送器上设置有排空管，所述排空管的设置方式参考现有技术。
进一步地，本实施例还提供了一种手柄，所述手柄是如前所述的手柄1000。
更进一步地，本实施例还提供了一种医用装置，包括医用植入物和前述的输送器，所述医用植入物装载于所述导管组件的远端，并压缩于所述内管2200与所述外管2100之间的空间内。
<实施例二>
本实施例提供了一种输送器，本实施例与实施例一的区别之处在于，所述第二限位机构连接于所述释放管上。
进一步地，本实施例还提供了一种医用装置，包括医用植入物和所述输送器，所述医 用植入物装载于所述导管组件的远端，并压缩于所述外管机构和所述内管机构之间的空间内。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (16)

  1. 一种手柄，用于控制导管组件，所述导管组件包括外管和部分地穿设在所述外管内的内管，所述外管和所述内管中的一个为释放管；其特征在于，所述手柄包括：
    壳体；
    第一驱动部，用于驱使所述释放管沿预定方向移动；以及，
    限位组件，包括第一限位机构和第二限位机构，所述第一限位机构部分地设置在所述壳体内并连接于所述壳体上，且被配置为能够绕所述释放管的轴线旋转；所述第二限位机构设置在所述壳体内，并被配置用于随所述释放管的移动而移动；
    所述手柄被配置为当所述第一驱动部驱使所述释放管沿预定方向移动并使所述释放管抵达预定位置时，所述第一限位机构与所述第二限位机构相互配合，以阻止所述释放管继续沿所述预定方向移动；当所述第一限位机构绕所述释放管的轴向旋转使所述第一限位机构与所述第二限位机构解除配合时，允许所述第一驱动部驱使所述释放管继续沿所述预定方向移动。
  2. 根据权利要求1所述的手柄，其特征在于，所述手柄还包括第一连接组件，所述第一连接组件设置于所述壳体内，并与所述第一驱动部传动连接，且还用于与所述释放管的近端连接；所述第二限位机构连接于所述第一连接组件上。
  3. 根据权利要求2所述的手柄，其特征在于，所述第一限位机构包括第一定位座和第一限位部；所述第一定位座连接于所述壳体上，并被配置为能够绕所述释放管的轴线旋转；所述第一限位部连接于所述第一定位座上，并至少部分地凸出于所述第一定位座的预定端面；所述第二限位机构包括第二限位部；
    所述手柄被配置为所述第一限位部与所述第二限位部在周向上至少部分重合，且所述第一限位部与所述第二限位部相互抵接时，所述第一限位机构与所述第二限位机构相互配合，当所述第一定位座绕所述释放管的轴线旋转并使所述第一限位部在周向上与所述第二限位部错开时，所述第二限位机构与所述第一限位机构解除配合。
  4. 根据权利要求3所述的手柄，其特征在于，所述第一限位部可活动地连接于所述第一定位座上，并被配置为能够沿所述释放管的轴向移动，以改变所述第一限位部凸出于所述第一定位座之预定端面的部分的长度。
  5. 根据权利要求4所述的手柄，其特征在于，所述第一定位座上设有沿所述释放管的轴向贯通地延伸的螺孔，所述第一限位部为螺杆，所述螺杆穿设在所述螺孔中。
  6. 根据权利要求3所述的手柄，其特征在于，所述壳体上设有沿周向延伸的第一滑槽；所述第一限位机构还包括第一拨杆，所述第一拨杆的一端连接在所述第一定位座上，另一端穿过所述第一滑槽并伸出所述壳体的外部。
  7. 根据权利要求6所述的手柄，其特征在于，所述第一限位机构还包括第一弹性套，所述第一弹性套套装在所述第一拨杆上，且所述第一弹性套的外壁与所述第一滑槽的槽壁接触并使所述第一弹性套产生形变。
  8. 根据权利要求3-7中任一项所述的手柄，其特征在于，所述第一定位座为环形结构并具有内孔，所述第一连接组件的近端穿过所述内孔并与所述第一驱动部连接。
  9. 根据权利要求8中所述的手柄，其特征在于，所述第一限位部的数量为多个，多个所述第一限位部沿所述第一定位座的周向依次布置，且每个所述第一限位部凸出于所述第一定位座之预定端面的部分的长度沿第一方向依次减小，以使每个所述第一限位部到所述第二限位部的轴向距离沿所述第一方向依次增大；
    所述手柄被配置为当所述第一定位座沿第二方向绕所述释放管的轴线旋转并使一个所述第一限位部在周向与所述第二限位部错开时，另一个所述第一限位部能够在周向上与所述第二限位部至少部分重叠；所述第二方向与所述第一方向相反。
  10. 根据权利要求2-7中任一项所述的手柄，其特征在于，所述第一驱动部可转动地连接于所述壳体的近端端部；
    所述第一驱动部的内壁上设有内螺纹，所述第一连接组件包括丝杆，所述丝杆的远端与所述释放管的近端连接，且所述丝杆的远端外表面上连接有所述第二限位机构，所述丝杆的近端外表面上设有外螺纹，并与所述第一驱动部上的内螺纹相配合以进行螺旋传动；或者，
    所述第一连接组件包括螺纹套和丝杆，所述螺纹套连接于所述第一驱动部的内壁上并被配置为能够随所述第一驱动部同步旋转，所述螺纹套的内壁上设有内螺纹；所述丝杆的远端与所述释放管的近端连接，且所述丝杆的远端外表面上连接有所述第二限位机构，所述丝杆的近端外表面上设有外螺纹，并与所述螺纹套上的内螺纹相配合以进行螺旋传动。
  11. 根据权利要求10所述的手柄，其特征在于，所述壳体上设有观察窗，用于观察 所述丝杆的运动。
  12. 根据权利要求1-7中任一项所述的手柄，其特征在于，所述释放管为所述外管，所述预定方向为远端到近端的方向；或者，
    所述释放管为所述内管，所述预定方向为近端到远端的方向。
  13. 一种输送器，其特征在于，包括导管组件和如权利要求1-12中任一项所述的手柄，所述导管组件包括外管和部分地穿设在所述外管内的内管；所述手柄连接于所述导管组件的近端，并用于控制所述导管组件，以使所述内管和所述外管之间产生轴向相对运动。
  14. 一种医用装置，其特征在于，包括医用植入物和如权利要求13所述的输送器，所述医用植入物装载于所述导管组件的远端，并压缩于所述外管与所述内管之间的空间内。
  15. 一种输送器，其特征在于，包括导管组件和如权利要求1所述的手柄，所述导管组件包括外管和部分地穿设在所述外管内的内管，所述外管和所述内管中的一者为释放管；所述手柄连接于所述导管组件的近端，并用于控制所述释放管沿预定方向移动，以使所述内管和所述外管之间产生轴向相对移动；所述第二限位机构连接于所述释放管上。
  16. 一种医用装置，其特征在于，包括医用植入物和如权利要求15所述的输送器，所述医用植入物装载于所述导管组件的远端，并压缩于所述外管机构与所述内管机构之间的空间内。
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