WO2020103760A1 - Poignée d'entraînement et système de distribution utilisé pour la pose d'un implant - Google Patents

Poignée d'entraînement et système de distribution utilisé pour la pose d'un implant

Info

Publication number
WO2020103760A1
WO2020103760A1 PCT/CN2019/118486 CN2019118486W WO2020103760A1 WO 2020103760 A1 WO2020103760 A1 WO 2020103760A1 CN 2019118486 W CN2019118486 W CN 2019118486W WO 2020103760 A1 WO2020103760 A1 WO 2020103760A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
control knob
transmission mechanism
delivering
drive
Prior art date
Application number
PCT/CN2019/118486
Other languages
English (en)
Chinese (zh)
Inventor
刘祥
刘世红
程小明
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 WO2020103760A1 publication Critical patent/WO2020103760A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents

Definitions

  • the present invention relates to the technical field of medical devices, and in particular, to a driving handle and a delivery system for delivering implants.
  • Transcatheter heart valve surgery has the advantages of no need for thoracotomy, less trauma, and faster recovery of patients, and has received extensive attention from experts and scholars.
  • This operation requires delivery of an interventional catheter 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 valve function.
  • the implantation of the valve is generally performed by means of a delivery system, and the delivery system is inseparable from the sheath carrying the valve and the handle that drives the movement of the sheath, and the handle plays a vital role in the surgical procedure.
  • the objective of the present invention is to provide a driving handle and a delivery system for delivering an implant, wherein the driving handle can control the sheath used to deliver the implant to be fast or slow according to the needs of actual surgery Exercise to achieve more precise positioning control and more efficient surgical operation during the implantation process, and reduce the difficulty of surgery.
  • the present invention provides a drive handle for delivering an implant, which includes a hand-held sleeve, a fixed sleeve, a first drive mechanism, a second drive mechanism, and a transmission mechanism;
  • At least a portion of the fixed sleeve is movably inserted in the handheld sleeve; the first drive mechanism, the second drive mechanism, and the transmission mechanism are all movably disposed in the On the handheld sleeve;
  • the first drive mechanism is connected to the fixed sleeve, and is configured to directly drive the fixed sleeve to move along the axis of the drive handle at a first speed when subjected to an external force;
  • the second driving mechanism is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism further drives the first driving mechanism and the fixed sleeve to synchronously move along the driving handle at a second speed , The second speed is not equal to the first speed.
  • the fixed sleeve is configured to remain relatively stationary circumferentially with the handheld sleeve.
  • the second driving mechanism, the transmission mechanism and the first driving mechanism are arranged in order from the proximal end to the distal end of the driving handle. Or, from the proximal end to the distal end of the driving handle, the first driving mechanism, the transmission mechanism, and the second driving mechanism are sequentially arranged.
  • the first speed is greater than the second speed, or the first speed is less than the second speed.
  • the first drive mechanism includes a first control knob
  • the second drive mechanism includes a second control knob
  • the first control knob and the second control knob can be movably nested in On the handheld sleeve;
  • the first control knob and the fixed sleeve are connected by a thread
  • the second control knob and the transmission mechanism or the handheld sleeve are connected by a thread
  • the thread pitch on the second control knob The pitch of the thread on the first control knob is not equal
  • the first control knob is configured to rotate counterclockwise
  • the fixed sleeve is driven to move at the first speed in the first direction
  • the first control knob rotates clockwise
  • the second control knob when the second control knob is configured to rotate clockwise, pushing the transmission mechanism to drive the first control knob and the fixed sleeve to move in the second direction at the second speed simultaneously,
  • the transmission mechanism is driven to drive the first control knob and the fixed sleeve to move at the second speed in the first direction simultaneously.
  • the first direction is toward the proximal end of the drive handle, and the second direction is toward the distal end of the drive handle.
  • the inner surface of the second control knob and the outer surface of the hand-held sleeve are respectively provided with mutually matching internal threads And an external thread, and the second control knob is configured to be at least relatively axially stationary with the transmission mechanism.
  • the transmission mechanism is provided with one of a convex portion and a concave portion
  • the second control knob is provided with a convex portion and a concave portion In the other one, the convex portion and the concave portion cooperate.
  • the inner surface of the second control knob and the outer surface of the transmission mechanism are provided with mutually matching internal threads and external
  • the second control knob is rotatably provided on the handheld sleeve.
  • the handheld sleeve is provided with one of a convex portion and a concave portion
  • the second control knob is provided with a convex portion and a concave portion In the other one, the convex portion and the concave portion cooperate.
  • a first limiting portion is provided on the transmission mechanism
  • a second limiting portion is provided on the handheld sleeve
  • the first limiting portion is used to communicate with the second limiting portion Cooperate to limit the circumferential movement of the transmission mechanism.
  • the first limiting portion is a protrusion
  • the second limiting portion is a guide groove extending and hollowed in the axial direction of the handheld sleeve.
  • the number and position of the protrusions match the guide groove.
  • the transmission mechanism includes a ring sleeve, which is movably sleeved on the handheld sleeve, and respectively The first control knob and the second control knob are connected.
  • the handheld sleeve is provided with an axially extending and hollow guide groove, and the outer surface of the fixed sleeve is provided with an external thread provided along a part of the circumference, and the fixed sleeve The external thread on the barrel extends through the guide groove.
  • the hand-held sleeve cooperates with the internal thread on the internal surface of the first control knob; The external threads on the barrel match.
  • the external threads on the fixed sleeve are two and are arranged symmetrically.
  • the hand-held sleeve includes an axially provided hand-held portion and a connecting portion, the diameter of the connecting portion is smaller than the diameter of the hand-held portion; and the first control knob, the second control knob And the transmission mechanism are both provided on the connecting portion.
  • the present invention also provides a delivery system for delivering an implant, which includes the drive handle for delivering the implant according to any one of the foregoing, and the delivery system further Including outer tube and inner tube components;
  • the inner tube assembly is penetrated in the outer tube and used to fix the implant, and is connected to the hand-held sleeve of the driving handle, and is kept relatively still with the hand-held sleeve ;
  • the outer tube is connected to the fixed sleeve of the drive handle, and the fixed sleeve is used to drive the outer tube to perform axial movement relative to the inner tube assembly.
  • the inner tube assembly includes a sequentially connected inner tube, a fixed head and a tapered head; the proximal end of the inner tube is connected to the handheld sleeve, the inner tube is at the fixed head The section between the conical head is used to load the implant.
  • the driving handle of the present invention includes a hand-held sleeve, a fixed sleeve, a first drive mechanism, a second drive mechanism and a transmission mechanism, at least a part of the fixed sleeve is movably penetrated in the hand-held sleeve,
  • the first drive mechanism, the second drive mechanism, and the transmission mechanism are all movably disposed on the hand-held sleeve, and the first drive mechanism is connected to the fixed sleeve and is configured
  • the second driving mechanism is configured to push the transmission mechanism when the external force is applied, and the transmission mechanism further drives the The first drive mechanism and the fixed The sleeve moves synchronously along the axis
  • the fixed sleeve is connected to the outer tube of the delivery system to control the outer
  • the fast retreat and slow advance of the tube can also control the fast advance and slow retreat of the outer tube, so that different surgical operation requirements can be met at different stages of the operation.
  • the first speed is greater than the second speed as an illustration.
  • the first drive mechanism can achieve rapid outer tube Withdrawing to facilitate the rapid loading of the heart valve and improve the loading efficiency; after the heart valve is loaded, the second drive mechanism can be used to achieve the slow advance of the outer tube to ensure the success rate of loading; and then in the process of heart valve implantation, The second driving mechanism is used to control the withdrawal of the outer tube at a slower speed, so as to control the release rate of the heart valve, realize the accurate positioning of the heart valve, ensure the success rate of the operation, and reduce the difficulty of the operation; For the valve, if it needs to be recovered and re-released during the implantation process, the first drive mechanism can be used to control the outer tube to advance at a faster speed to realize the rapid recovery of the heart valve, improve the recovery efficiency, and shorten the operation time.
  • the first drive mechanism includes a first control knob
  • the second drive mechanism includes a second control knob
  • the first control knob and the fixed sleeve are connected by a thread
  • the second control knob is connected with the transmission mechanism or the hand-held sleeve through a thread, so that when the first control knob is rotated in one direction, the fixed sleeve can be driven to drive the outer tube to quickly advance, and the first control knob is directed to the other When rotating in the direction, the fixed sleeve can be driven to drive the outer tube to quickly retreat.
  • the transmission mechanism can be driven to drive the first control knob, the fixed sleeve and the outer tube to slowly retreat, and
  • the transmission mechanism is driven to drive the first control knob, the fixed sleeve, and the outer tube to advance slowly.
  • the thread with a small pitch converts the angular displacement of the circumferential rotation into the linear displacement of the fixed sleeve with higher precision, enabling more precise positioning control.
  • FIG. 1 is a schematic diagram of a delivery system in an embodiment of the invention.
  • FIG. 2 is a partial schematic view of a delivery system in which an inner tube assembly is omitted in an embodiment of the present invention
  • FIG. 3 is a partial enlarged view of the delivery system shown in FIG. 2 in the area A;
  • FIG. 4 is an exploded view of a driving handle for delivering an implant in an embodiment of the present invention.
  • FIG. 5 is an assembly diagram of a driving handle for delivering an implant in an embodiment of the present invention.
  • FIG. 6 is a perspective view of a handheld sleeve in an embodiment of the present invention.
  • FIG. 7 is a perspective view of a fixing sleeve in an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of a valve stent loaded between an inner tube and an outer tube in an embodiment of the present invention.
  • drive handle 10 hand-held sleeve 1; hand-held portion 11; connecting portion 12; second external thread 13; guide groove 14; fixed sleeve 2; cylindrical body 21; first external thread 22; first drive Mechanism 3; first control knob 31; transmission mechanism 4; ring sleeve 41; circumferential groove 42; second drive mechanism 5; second control knob 51; catheter assembly 20; outer tube 6; inner tube assembly 7; tapered Head 71; fixed head 72; inner tube 73; valve holder 8
  • distal and proximal are used; “distal” is the side away from the operator of the delivery system; “near “End” is the side close to the operator of the conveyor system; “Axial” refers to the direction of the axis along the drive handle; “Circumferential” refers to the direction of the axis around the corresponding mechanical component.
  • a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention may One or more of these details are required to be implemented. 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 driving handle for delivering an implant, the driving handle including a hand-held sleeve, a fixing sleeve, a first driving mechanism, a second driving mechanism, and a transmission mechanism; the fixing At least a part of the sleeve is movably penetrated in the handheld sleeve; the first driving mechanism, the second driving mechanism and the transmission mechanism are all movably arranged on the handheld sleeve; wherein :
  • the first drive mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the drive handle at a first speed when subjected to an external force;
  • the second driving mechanism is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism further drives the driving handle at a second speed in synchronization with the first driving mechanism and the fixed sleeve The axis moves, and the second speed is not equal to the first speed.
  • the first speed is greater than the second speed
  • the first drive mechanism can quickly drive the fixed sleeve movement
  • the second drive mechanism can be driven by a transmission mechanism
  • the first driving mechanism and the fixed sleeve simultaneously perform slow motion.
  • the fixing sleeve Before loading, the fixing sleeve can be driven by the first driving mechanism to drive the outer tube to quickly withdraw (ie, the first direction), so as to quickly load the valve stent on the delivery system On the inner tube, improve the loading efficiency;
  • the valve stent is released: During the implantation process, the second driving mechanism drives the fixed sleeve to drive the outer tube to slowly withdraw (ie, the first direction) to achieve the slow release of the valve stent, thereby accurately positioning The implantation position of the valve stent to ensure the accuracy of the positioning position;
  • the recovery of the valve stent After implantation, if it is found that the positioning is not correct and the valve stent needs to be released again, the valve stent can be recovered again. At this time, the fixed sleeve can be driven by the first driving mechanism to quickly advance (ie The second direction), to quickly recover the valve stent into the outer tube, thereby improving the recovery efficiency and shortening the operation time. [0056] Obviously, through the above operation, the drive handle can control the movement of the outer tube at different speeds according to the needs of the operation, so that the doctor can better control the loading speed of the valve stent, the implantation speed and the implantation position, thereby reducing Positioning error improves surgical efficiency.
  • the first speed may also be less than the second speed, in this case, the first driving mechanism is used to slowly drive the fixed sleeve movement, and The second driving mechanism is used to quickly drive the fixed sleeve to move, but the specific operation method is the same as the foregoing embodiment.
  • FIG. 1 is a schematic diagram of a delivery system in an embodiment of the present invention
  • FIG. 2 is a partial schematic diagram of a delivery system in which an inner tube assembly is omitted in an embodiment of the present invention
  • FIG. 3 is 2 is a partially enlarged view of the delivery system shown in FIG. 2 in the area A
  • FIG. 4 is an exploded view of a driving handle for delivering an implant in an embodiment of the present invention
  • FIG. 5 is an embodiment of the present invention is used for
  • Fig. 6 is a perspective view of a hand-held sleeve in an embodiment of the invention
  • Fig. 7 is a perspective view of a fixed sleeve in an embodiment of the invention
  • Fig. 8 is an implementation of the invention
  • the valve stent is loaded between the inner tube and the outer tube.
  • an embodiment of the present invention provides a delivery system for delivering an implant, which includes a driving handle 10 and a catheter assembly 20.
  • the catheter assembly 20 includes an outer tube 6 and an inner tube assembly 7; the outer tube 6 is disposed outside the inner tube assembly 7 and is coaxially arranged with the inner tube assembly 7, and the outer tube 6 can be axially moved relative to the inner tube assembly 7, here
  • the outer tube 6 is preferably not allowed to move in the circumferential direction.
  • the outer tube 6 is connected to the movable component on the driving handle 10, so that the movable component drives the outer tube 6 to move axially relative to the inner tube assembly 7 to realize the outer tube 6 Advance and retreat.
  • “advance” refers to the direction of movement toward the distal end of the drive handle 10; “backward” refers to the direction opposite to “advance”, that is, toward the proximal end of the drive handle 10.
  • the implant is used to fix the inner tube assembly 7, and the inner tube assembly 7 needs to be connected to the stationary component on the drive handle 10 to ensure that the inner tube assembly 7 is always fixed during operation.
  • the driving handle 10 of this embodiment specifically includes a handheld sleeve 1, The fixed sleeve 2, the first drive mechanism 3, the transmission mechanism 4 and the second drive mechanism 5; at least a portion of the fixed sleeve 2 can be movably penetrated in the handheld sleeve 1 (preferably the entire fixed sleeve 2 is provided in the handheld Inside sleeve 1), and preferably fixed sleeve 2 It is relatively stationary in the circumferential direction with the handheld sleeve 1, and the fixed sleeve 2 is connected to the outer tube 6 to drive the outer tube 6 to move in the axial direction of the drive handle 10 through the fixed sleeve 2.
  • the transmission mechanism 4 and the first driving mechanism 3 are sequentially movably arranged on the hand-held sleeve 1, and the transmission The mechanism 4 is connected to the first drive mechanism 3 and the second drive mechanism 5, respectively.
  • the first drive mechanism 3 is connected to the fixed sleeve 2 and is configured to directly drive the fixed sleeve 2 to move along the axis of the drive handle 10 at a first speed when subjected to an external force
  • the second drive mechanism 5 is configured to receive
  • the transmission mechanism 4 is pushed, and then the transmission mechanism 4 drives the first driving mechanism 3 and the fixed sleeve 2 to move along the axis of the driving handle 10 at the second speed V2 simultaneously.
  • the first speed VI and the second speed V2 are not equal.
  • the first speed VI is greater than the second speed V2 as an example, and the structure and operation mode of the driving handle 10 will be further described.
  • the first drive mechanism 3 directly drives the fixed sleeve 2 to make rapid movement along the axial direction of the drive handle 10, and the second drive mechanism 5 drives the first through the transmission mechanism 4
  • the driving mechanism 3 and the fixed sleeve 2 move slowly along the axial direction of the drive handle 10, so that the speed at which the fixed sleeve 2 advances and retreats is not the same, that is, the moving speed of the outer tube 6 connected to the fixed sleeve 2 It can be adjusted according to the needs of actual surgery.
  • the first drive mechanism 3 includes a first control knob 31 having an internal thread
  • the second drive mechanism 5 includes a second control knob 51 having an internal thread.
  • Both the first control knob 31 and the second control knob 51 can be movably sleeved on the handheld sleeve 1, and the internal thread pitch on the first control knob 31 is greater than the internal thread pitch on the second control knob 51, so that the first The first speed VI is greater than the second speed V2, so as to ensure that the first control knob 31 has a large displacement and speed for one rotation, and realizes a fast movement, while the second control knob 51 has a small displacement and speed for one rotation, which can be achieved Slow motion, so configured, the structure of the driving handle is simple, the cost is low, and the operation is also convenient. Moreover, the rotation of the screw thread of the control knob is converted into a linear displacement of the fixed sleeve 2 with high precision, which can achieve more accurate positioning control of the implant.
  • the fixed sleeve 2 is preferably connected to the first control knob 31 by threads.
  • a first external thread 22 is provided on the outer surface of the fixed sleeve 2, and the first external thread 22 It is only provided along a part of the circumference of the fixed sleeve 2, so that the first external thread 22 and the internal thread on the first control knob 31 cooperate to realize the connection between the fixed sleeve 2 and the first control knob 31.
  • the second control knob 51 preferably passes through the transmission mechanism 4 Threaded connection, or threaded connection with the handheld sleeve 1.
  • the driving handle 10 can be operated in the following manner, as shown in FIGS. 1 to 7:
  • the fixed sleeve 2 specifically includes a hollow cylindrical body 21, the outer surface of the cylindrical body 21 is provided with a first external thread 22, and the first external thread 22 only It is arranged along a part of the circumference of the cylindrical body 21 and is used to cooperate with the internal thread (not marked) on the first control knob 31.
  • the number of the first external threads 22 may be one, two, or more than two. Here, two are preferably arranged symmetrically to ensure the stability of the motion transmission.
  • the number of threads of the first external thread 22 is not specifically limited, and can be selectively set according to the actual travel required to move, and the first external thread 22 is preferably provided at the proximal end of the cylindrical body 21, which can shorten the fixing sleeve 2 length.
  • the first external thread 22 is provided on the proximal end surface of the cylindrical body 21, but broadly understood as provided on the outer surface of the cylindrical body 21 located at the proximal end.
  • the second control knob 51 and the hand-held sleeve 1 are connected by a thread, and at least axially relatively stationary with the transmission mechanism 4 (that is, the transmission mechanism 4 is driven to move axially), and the second control The thread pitch on the knob 51 is smaller than the thread pitch on the first control knob 31 to ensure that the first speed VI is greater than the second speed V2.
  • a second external thread 13 is provided on the outer surface of the handheld sleeve 1, the second external thread 13 is provided along the entire circumference of the handheld sleeve 1, and is used to communicate with the second The internal threads (not shown) on the inner surface of the knob 51 are matched.
  • the second control knob 51 rotates on the hand-held sleeve 1
  • the threads of the two are relatively displaced, so that the second control knob 51 is only held along
  • the axial movement of the sleeve 1 drives the transmission mechanism 4 to move only in the axial direction.
  • the second external thread 13 is disposed at the proximal end of the handheld sleeve 1, which can effectively reduce the length of the handheld sleeve 1.
  • the second external thread 13 is provided on the proximal end surface of the handheld sleeve 1, but broadly understood as provided on the outer surface of the proximal end of the handheld sleeve 1.
  • the hand-held sleeve 1 includes an axial hand-held portion 11 and a connection portion 12, and the first control knob 31, the second control knob 51 and the transmission mechanism 4 are all provided on the connection portion 12, preferably, connected
  • the outer diameter of the portion 12 is smaller than the outer diameter of the hand-held portion 11, thereby forming a T-shaped hand-held sleeve 1. Therefore, in actual operation, the doctor can hold the hand-held portion 11 with one hand to ensure that the hand-held sleeve 1 is fixed, and the other hand can turn the first control knob 31 or the second control knob 51 to adjust, so The operation is more comfortable and convenient.
  • the connecting portion 12 is also provided with a hollow guide groove 14 in the axial direction, so that the fixed sleeve 2 only moves axially along the guide groove 14 to prevent the circumferential movement of the fixed sleeve 2 from affecting Positioning effect, and the first external thread 22 on the fixed sleeve 2 further extends through the guide groove 14 and the handheld sleeve 1 cooperates with the internal thread on the first control knob 31.
  • the number and position of the guide grooves 14 are matched with the first external threads 22.
  • the number of the guide grooves 14 is two and is symmetrically arranged.
  • the length of the guide groove 14 is not limited to that disclosed in FIG. 6, one end starts from the proximal end surface of the hand-held portion 11, and the other end ends at the distal end of the second external thread 13.
  • the shape of the guide groove 14 may be a rectangle, a waist, an ellipse, etc., which is not specifically limited.
  • the transmission mechanism 4 and the second control knob 51 preferably remain relatively stationary (including axial and circumferential directions), so that the second control knob 51 is pushed
  • the transmission mechanism 4 moves synchronously in the axial direction.
  • the transmission mechanism 4 and the second control knob 51 are connected in a snap-fit manner.
  • the transmission mechanism 4 is provided with one of a convex portion and a concave portion
  • the second control knob 51 is provided with a convex portion and a concave portion
  • the convex part and the concave part cooperate, so that the connection between the two can be realized simply and conveniently Pick up.
  • the transmission mechanism 4 of this embodiment preferably includes a ring sleeve 41, which is movably sleeved on the connection portion 12 of the hand-held sleeve 1, and respectively
  • the first control knob 31 and the second control knob 51 are connected.
  • the ring sleeve 41 is engaged with the first control knob 31, for example, the side of the ring sleeve 41 facing the first control knob 31 is provided with a circumferential groove 42 (recess), and at the same time, the first control knob 31 is provided There is a hook (convex part), and the connection between the two can be achieved simply by the cooperation of the hook and the circumferential groove 42.
  • the first control knob 31 when the first control knob 31 is turned on the hand-held sleeve 1, the first control knob 31 is screwed with the fixed sleeve 2, so that the first control knob 31 makes a rotational movement relative to the ring sleeve 41 (the ring sleeve 41 does not Move), and drive the fixed sleeve 2 to move only in the axial direction (because the fixed sleeve 2 has a limit in the direction of rotation).
  • the ring sleeve 41 is provided with a first limit portion, and the hand sleeve 1 is provided with a second limit portion.
  • the first limit portion cooperates with the second limit portion to limit the ring sleeve 41 Circumferential movement.
  • the first limiting portion is preferably a protrusion (not shown) provided on the inside of the ring sleeve 41 for cooperating with the guide groove 14 on the handheld sleeve 1 to limit the circumferential movement of the ring sleeve 41, that is, the ring
  • the sleeve 41 can only move axially along the guide groove 14.
  • the guide groove 14 can not only provide a linear stroke track for the fixed sleeve 2, so that the fixed sleeve 2 makes an axial movement along the guide groove 14, but also can provide a linear stroke track for the ring sleeve 41, so that the ring sleeve 41 It also moves axially along the guide groove 14. Furthermore, the number and position of the protrusions on the ring sleeve 41 and the number and position of the guide grooves 14 match. Therefore, the number of the protrusions is preferably plural and symmetrically arranged.
  • the inner surface of the second control knob 51 is provided with an internal thread (not shown), and is connected with the handheld sleeve
  • the second external thread 13 on the outer surface cooperates.
  • the second control knob 51 is snap-fitted with the ring sleeve 41, and the structure is relatively simple.
  • the side of the ring sleeve 41 facing the second control knob 51 is provided with a circumferential groove 42 (concave portion), and the second control knob 51 is provided with a hook (convex portion), Through the cooperation of the hook and the circumferential groove 42, the connection between the two can also be achieved conveniently and quickly.
  • the second control knob 51 and the ring sleeve 41 are connected by a thread, at this time, the second control knob 51 is rotatably provided on the hand-held sleeve 1, and the second control knob 51
  • the thread pitch is smaller than the thread pitch on the first control knob 31 to ensure that the first speed VI is greater than the second speed V2.
  • the handheld sleeve 1 and the second control knob 51 are connected in a snap-fit manner.
  • the handheld sleeve 1 is provided with a circumferential groove (recess) having the same structure as the ring sleeve 41, so that the second control knob 51 It also cooperates with the circumferential groove on the hand-held sleeve 1 through the snap hook. Therefore, when the second control knob 51 is turned, the driving ring sleeve 41 is connected through the thread It only moves in the axial direction and drives the first control knob 31 and the fixed sleeve 2 to make an axial movement.
  • the ring sleeve 41 since the ring sleeve 41 has a limit in the rotation direction, it can only move in the axial direction.
  • the proximal end of the outer tube 6 is specifically connected to the cylindrical body 21 on the fixed sleeve 2, but may be connected to any end of the cylindrical body 21.
  • the inner tube assembly 7 needs to be connected to the hand-held sleeve 1 and remains stationary relative to the hand-held sleeve 1.
  • the inner tube 73 on the inner tube assembly 7 passes through the fixed sleeve 2 and is connected to the hand-held sleeve 1
  • the connection section 12 is detachably connected.
  • the inner tube assembly 7 specifically includes an inner tube 73, a fixed head 72, and a tapered head 71 that are connected in sequence.
  • FIG. 8 shows that the valve support 8 is in an unreleased state. It can be clearly seen from FIG.
  • the periphery of the inner tube 73 is fixedly supported by the fixing head 72 (the end of the valve holder 8 is fixed to the fixing head 72), and the fixing head 72 is not movable (that is, all degrees of freedom are restricted), and the inner tube 73
  • the proximal end of the valve is fixedly connected to the connecting section 12 on the handheld sleeve 1 by means of threads or glue, etc., so that the entire inner tube 73 is fixed relative to the driving handle 10, thereby ensuring the valve holder 8 and the driving handle loaded on the fixing head 72 10 Keep it relatively fixed.
  • the distal end of the outer tube 6 is sheathed on the periphery of the valve holder 8 loaded on the inner tube 73.
  • the distal end of the outer tube 6 contacts the proximal end surface of the tapered head 71 at the distal end of the inner tube 73. Then, the outer tube 6 can be driven to move forward and backward by manual driving, so that the outer tube 6 moves forward and backward relative to the inner tube assembly 7, and operations such as loading, releasing and recycling of the valve stent 8 can be realized.
  • the loading of the valve holder 8 the hand portion 11 can be held with the left hand, and the first control knob 31 can be rotated counterclockwise with the right hand. In order to expose the portion of the inner tube 73 between the fixed head 72 and the tapered head 71 to load the valve support 8 onto the inner tube 73;
  • the compression of the valve holder 8 After loading the valve holder 8, the second control knob 51 is rotated clockwise. The rotation of the second control knob 51 causes the ring sleeve 41, the first control knob 31, and the fixed sleeve 2 and the outer tube 6 move forward simultaneously and slowly, the valve holder 8 can be pressed and held in the outer tube 6;
  • valve holder 8 Furthermore, the release of the valve holder 8: During the implantation process, the second control knob 51 is rotated counterclockwise, and the rotation of the second control knob 51 causes the ring sleeve 41, the first control knob 31, the fixing sleeve 2 and the outer The tube 6 slowly retreats synchronously to achieve the slow withdrawal of the outer tube 6 to slowly release the valve support 8; [0089] Further recovery of the valve stent 8: If the valve stent 8 is found to be inaccurately positioned during implantation, the valve stent 8 can be re-entered into the outer tube 6, so the first control knob 31 can be rotated clockwise again, the first The rotation of the control knob 31 only causes the fixed sleeve 2 and the outer tube 6 to advance synchronously and rapidly, and realizes the rapid advancement of the outer tube 6 to quickly recover the valve holder 8.
  • the above embodiment mainly illustrates the structure and operation mode of the driving handle when the first speed VI is greater than the second speed V2, but when the first speed VI is less than the second speed V2, the structure and operating mode of the driving handle are also
  • the foregoing embodiments are basically the same, except that the thread pitch on the first control knob 31 is smaller than the thread pitch on the second control knob 51, which also changes the corresponding operation mode, namely:
  • the first driving mechanism 3, the transmission mechanism 4 and the second driving mechanism 5 may also be sequentially arranged, while The first drive mechanism 3 is also connected to the fixed sleeve 2.
  • the structure and principle of the driving handle are basically the same as those described in the previous embodiment, and the same technical effect as the previous embodiment can be achieved, but the position of some structural features will be adjusted, such as the second external thread 13 moves toward the distal end of the hand-held sleeve 1, which can be specifically positioned near the proximal end surface of the hand-held portion 11, and the guide groove 14 starts at the proximal end of the second external thread 13, etc.
  • the first driving mechanism connected to the fixing sleeve 2 is disposed at the proximal end of the driving handle 10, and relatively speaking, the length of the fixing sleeve 2 is increased.
  • the preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments.
  • the present invention does not particularly limit the structure of the first driving mechanism and the second driving mechanism, as long as the two The driving mechanism can realize fast and slow movement of the fixed sleeve 2.
  • the embodiments of the present invention are described using the valve stent 8 (such as a heart valve stent) as an implant.
  • the delivery system disclosed in the present invention can be used to place other implants (such as vascular stents) into corresponding positions of the body in addition to the valve stent.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne une poignée d'entraînement (10) et un système de pose utilisé pour la pose d'un implant, qui peuvent entraîner un tube externe (6) utilisé pour poser l'implant afin d'effectuer un mouvement à vitesse variable, c'est-à-dire que la poignée (10) commande le tube externe (6) à se déplacer à différentes vitesses selon les besoins chirurgicaux réels, améliorant ainsi l'efficacité de la chirurgie et réduisant la difficulté de la chirurgie. La poignée d'entraînement (10) comprend spécifiquement un manchon tenu à la main (1), un manchon fixe (2), un premier et un second mécanisme d'entraînement (3, 5) et un mécanisme de transmission (4); au moins une partie du manchon fixe (2) pénètre de manière mobile dans le manchon tenu à la main (1); le premier et le second mécanisme d'entraînement (3, 5) et le mécanisme de transmission (4) peuvent tous être disposés de manière mobile sur le manchon tenu à la main (1); le premier mécanisme d'entraînement (3) est relié au manchon fixe (2), et est conçu pour entraîner directement le manchon fixe (2) à se déplacer le long d'un axe de la poignée d'entraînement (10) à une première vitesse (V1) lors de la réception d'une force externe; le second mécanisme d'entraînement (5) étant conçu pour pousser le mécanisme de transmission (4) lors de la réception d'une force externe, le mécanisme de transmission (4) entraînant le premier mécanisme d'entraînement (3) et le manchon fixe (2) à se déplacer de manière synchrone à une seconde vitesse (V2) le long de l'axe de la poignée d'entraînement (10), la seconde vitesse (V2) n'étant pas égale à la première vitesse (V1).
PCT/CN2019/118486 2018-11-23 2019-11-14 Poignée d'entraînement et système de distribution utilisé pour la pose d'un implant WO2020103760A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201811408443.9A CN111214310A (zh) 2018-11-23 2018-11-23 用于输送植入体的驱动手柄及输送系统
CN201811408443.9 2018-11-23

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Publication number Priority date Publication date Assignee Title
CN115702808A (zh) * 2021-08-09 2023-02-17 上海微创心通医疗科技有限公司 一种手柄、输送器及医用装置

Citations (6)

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US20100211115A1 (en) * 2008-12-24 2010-08-19 Jeff Tyber Compression screw assembly, an orthopedic fixation system including a compression screw assembly and method of use
CN102348418A (zh) * 2009-03-16 2012-02-08 C·R·巴德公司 具有旋转切割装置的活检装置
CN103961194A (zh) * 2014-05-21 2014-08-06 苏州英络医疗器械有限公司 一种高回缩性血管支架输送系统
CN203935216U (zh) * 2014-06-27 2014-11-12 瑞奇外科器械(中国)有限公司 外科手术器械的弯转装置及外科手术器械
CN105050549A (zh) * 2012-08-10 2015-11-11 阿尔图拉医疗公司 支架输送系统以及相关方法
CN105455864A (zh) * 2014-09-05 2016-04-06 瑞奇外科器械(中国)有限公司 外科手术器械的驱动装置及外科手术器械

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100211115A1 (en) * 2008-12-24 2010-08-19 Jeff Tyber Compression screw assembly, an orthopedic fixation system including a compression screw assembly and method of use
CN102348418A (zh) * 2009-03-16 2012-02-08 C·R·巴德公司 具有旋转切割装置的活检装置
CN105050549A (zh) * 2012-08-10 2015-11-11 阿尔图拉医疗公司 支架输送系统以及相关方法
CN103961194A (zh) * 2014-05-21 2014-08-06 苏州英络医疗器械有限公司 一种高回缩性血管支架输送系统
CN203935216U (zh) * 2014-06-27 2014-11-12 瑞奇外科器械(中国)有限公司 外科手术器械的弯转装置及外科手术器械
CN105455864A (zh) * 2014-09-05 2016-04-06 瑞奇外科器械(中国)有限公司 外科手术器械的驱动装置及外科手术器械

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