CN116942373B - Synchronous control handle device and use method thereof - Google Patents
Synchronous control handle device and use method thereof Download PDFInfo
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- CN116942373B CN116942373B CN202311195629.1A CN202311195629A CN116942373B CN 116942373 B CN116942373 B CN 116942373B CN 202311195629 A CN202311195629 A CN 202311195629A CN 116942373 B CN116942373 B CN 116942373B
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- 230000001360 synchronised effect Effects 0.000 title claims abstract description 42
- 238000000034 method Methods 0.000 title claims description 14
- 230000008878 coupling Effects 0.000 claims abstract description 18
- 238000010168 coupling process Methods 0.000 claims abstract description 18
- 238000005859 coupling reaction Methods 0.000 claims abstract description 18
- 238000007789 sealing Methods 0.000 claims description 27
- 238000002513 implantation Methods 0.000 claims description 20
- 230000002093 peripheral effect Effects 0.000 claims description 9
- 239000007788 liquid Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 230000008602 contraction Effects 0.000 claims description 3
- 230000009471 action Effects 0.000 claims description 2
- 238000010494 dissociation reaction Methods 0.000 description 16
- 230000005593 dissociations Effects 0.000 description 16
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 210000004115 mitral valve Anatomy 0.000 description 6
- 239000007943 implant Substances 0.000 description 5
- 208000005907 mitral valve insufficiency Diseases 0.000 description 5
- 206010067171 Regurgitation Diseases 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000013152 interventional procedure Methods 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 230000008439 repair process Effects 0.000 description 3
- 206010027727 Mitral valve incompetence Diseases 0.000 description 2
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000013016 damping Methods 0.000 description 2
- 210000003709 heart valve Anatomy 0.000 description 2
- 230000003068 static effect Effects 0.000 description 2
- 239000012815 thermoplastic material Substances 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- MWCLLHOVUTZFKS-UHFFFAOYSA-N Methyl cyanoacrylate Chemical compound COC(=O)C(=C)C#N MWCLLHOVUTZFKS-UHFFFAOYSA-N 0.000 description 1
- 208000012287 Prolapse Diseases 0.000 description 1
- 208000025747 Rheumatic disease Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 238000010009 beating Methods 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 208000016569 congenital mitral valve insufficiency Diseases 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000007654 ischemic lesion Effects 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 230000000552 rheumatic effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000001631 vena cava inferior Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application provides a synchronous control handle device which comprises a handle shell, push-pull rods, linkage shifting sheets and a synchronous piece, wherein the push-pull rods are arranged on two sides of an axis of an adjusting handle, the synchronous piece is fixedly connected with one of the push-pull rods, so that the push-pull rods and the synchronous piece are axially fixed and slide together in an axial direction, the synchronous piece is selectively coupled with the other push-pull rod under the control of the linkage shifting sheets, the other push-pull rod and the synchronous piece are axially fixed and slide together in an axial direction in a coupling state, the other push-pull rod can slide relative to the synchronous piece in an axial direction in a non-coupling state, and the synchronous piece is rotationally switched relative to the axis of the adjusting handle in a coupling state and a non-coupling state.
Description
Technical Field
The present application relates generally to a handle device and associated methods and associated systems for controlling synchronized control of interventional procedures that facilitate sealing of a native heart valve and preventing or reducing regurgitation therein.
Background
Mitral/tricuspid insufficiency is one of the most common valve pathologies at present, mainly due to mitral/tricuspid annuloplasty, chordae tendineae insufficiency, mitral/tricuspid mucous degeneration, valve leaflet prolapse, rheumatic heart valve disease, ischemic lesions, etc. Mitral/tricuspid valve direct vision annuloplasty and prosthetic valve replacement are the most effective methods for treating mitral/tricuspid valve insufficiency, but because the surgery requires technical support of extracorporeal circulation, the trauma to the human body is relatively large, and the complications and mortality rate are relatively high for elderly patients and patients with more complications.
In the prior art, for treating mitral valve/tricuspid valve regurgitation, the curative effect of mitral valve/tricuspid valve clamping operation is most reliable, the mitral valve clamping device sends an implantable clip to the vicinity of the mitral valve through interatrial puncture, and the free edges of the front and rear valve leaflets are clamped and fixed, so that the valve leaflets are well combined at the end systole, and the regurgitation is reduced. For example, chinese patent application CN116035766a discloses a valve repair device that uses a valve clip to make the leaflets well coapt at the end of systole and reduce regurgitation, however, the valve clip uses a spring hose and a release wire to drive a threaded locking rod to rotate, since the intervention treatment usually uses the inferior vena cava to enter or enter from the jugular vein, far from the heart, when torque is transmitted at a long distance, the spring hose and the release wire can generate insufficient torque transmission, especially when the clamp arm needs larger torque at the final stage of clamping the valve, however, the structure cannot transmit large torque, and can generate insufficient clamp arm clamping force, and the risk of falling off the clamp arm; in addition, after the valve is clamped, the release wire is required to be pulled, and the hook ring at the front end of the release wire is deformed by utilizing the pulling force and separated from the limiting pin, so that the valve needs larger pulling force when the release wire is separated, and secondary damage is easily caused to the valve which is clamped; international patent WO2022188845A1 discloses a valve clamp, this valve clamp includes the slide bar, set up the thread bush at the slide bar front end, the slide bar passes through the external screw thread connection of thread bush and actuating lever, after holding the valve, utilize the unblock piece to lock the actuating lever, thereby screw out the thread bush of slide bar from the external screw thread of actuating lever, this unblock piece structure is complicated, and when the slide bar is screwed out from the external screw thread of actuating lever, slide bar reaction force is in the actuating lever, because actuating lever and valve clamp are locked by the unblock piece, reaction force can drive the valve clamp and rotate, cause the potential damage of pulling to the valve that has already held.
For a control handle device, chinese patent CN115281894a discloses a control handle of a valve clip, the control handle has a control lever for controlling a pull wire, the control lever drives the pull wire to move, a limit protrusion is arranged on the control lever, the limit protrusion cooperates with two limit grooves to realize limit and lock the control lever, however, in the prior art, when the upper clamping piece is released, the control lever needs to be pushed from a distal end to loosen the pull wire, then the upper clamping piece is utilized to capture a valve, since the valve is continuously opened and closed in the process of beating with the heart, the window opportunity of releasing the pull wire is shorter, the two control levers are contacted and limited from the limit grooves in the shorter window opportunity, then the control lever is pushed, the operation steps are two steps, the shorter window opportunity is complicated, a higher operation level is required, in the process of pushing the control lever, the different pushing forces of the two control levers of an operator easily cause asynchronous release of the upper clamping piece, the upper asynchronous release of the upper clamping piece affects the capturing state of the valve, the capturing state of the valve may occur, the capturing state of one side is not to the valve, the capturing device is not captured or the capturing state of the valve is not required, and the capturing effect is not required to be repeated, but the capturing effect is long, and the capturing effect is not required to capture the valve is repeatedly required, and the valve has a small part is repeatedly long.
It is therefore an aim of embodiments of the present application to provide a handle device, method and system for simultaneous control of interventional procedures for control and ease of operation, reducing risk of valve clip device detachment, preventing potential damage to the valve by the valve clip device, and enabling rapid valve capture.
Disclosure of Invention
In view of the shortcomings of valve repair devices of the prior art, the present application provides a synchronous control handle device, method and system for interventional procedures, which are applicable to the treatment of mitral/tricuspid valve regurgitation in the heart.
The embodiment of the application provides a handle device for synchronously controlling an interventional operation, which comprises a control handle and a valve clamping piece device, wherein the control handle comprises a guide handle, a conveying handle and an adjusting handle, the guide handle and the conveying handle are conventional handles used for controlling the entry and the guide of a sheath in the interventional operation treatment, and the adjusting handle is used for controlling the contraction and the expansion of the valve clamping piece device so as to realize the clamping and fixing of the valve clamping piece device to a valve.
The valve clamping piece device comprises a conveying base, an implantation base and a lower clamping base from top to bottom in sequence, wherein the implantation base is hinged with clamping arms, the two clamping arms are rotatably connected with the implantation base through a first hinge shaft, an upper clamping piece is arranged above the clamping arms, a protruding thorn is arranged on one side, close to the clamping arms, of the upper clamping piece, and clamping fixation of a valve is realized through cooperation of the clamping arms, the protruding thorns and the upper clamping piece; the upper clamping piece is an elastic piece, and is usually made of thermoplastic materials, the upper clamping piece can be kept at two sides close to the implantation base through the upper clamping pull wire, when the pulling force of the upper clamping pull wire is released, the upper clamping piece is unfolded to a certain angle under the action of the self elastic force of the upper clamping piece, namely the upper clamping piece rotates around the direction away from the implantation base, and the valve is captured.
The upper clamping piece is connected to the lower end of the implantation base, the clamping arm is hinged to the lower end of the implantation base through a first hinge shaft, one end of the rotating arm is hinged to the lower clamping base through a third hinge shaft, the other end of the rotating arm is hinged to the middle of the clamping arm through a second hinge shaft, one end of the rotating rod is rotatably connected with the lower clamping base, the rotating rod is provided with external threads and is connected with the internal threads of the implantation base, the rotating rod is rotatably connected with the lower clamping base through limiting protrusions and the like, and therefore the rotating rod is guaranteed to rotate relative to the lower clamping base without axial relative movement.
The conveying base is in limit connection with the implantation base, for example, limit connection of the conveying base and the implantation base is realized through an S-shaped hasp and a boss groove lap joint mode, the conveying base is provided with a middle channel, a rotating rod handle is arranged in the middle channel in a penetrating mode, one end of the rotating rod handle is connected with the rotating rod in a rotation preventing mode, the other end of the rotating rod handle is connected with an adjusting handle, the rotating rod handle is provided with an inner channel, a dissociation rod is arranged in the inner channel of the rotating rod handle in a penetrating mode, one end of the dissociation rod is connected with the rotating rod through a first thread, the other end of the dissociation rod is connected with the adjusting handle, one end of the rotating rod handle is provided with a limit ring protruding inwards in a radial direction, one end of the dissociation rod is connected with a boss, and the boss of the dissociation rod acts on the limit ring and applies force to the rotating rod through the first thread connection of the dissociation rod and the rotating rod; through above-mentioned setting, through the joint rotation of dissociation pole and dwang handle side, drive the dwang rotatory, because the dwang with implant base screw-thread fit for the dwang rotates simultaneously, reciprocates and drives down the clamp base and reciprocate, down clamp the base when moving down, thereby realize the shrink and the expansion of centre gripping arm, the joint rotation of dissociation pole and dwang handle side can realize big torsion long distance torsion and carry, produces under the circumstances of great torsion to the dwang, can realize centre gripping arm and last clamping piece cooperation, fixed to the better centre gripping of valve, prevents that the centre gripping arm from inefficacy during the long-time work of heart.
The adjusting handle comprises a handle shell, push-pull rods arranged on two sides of the axis of the adjusting handle, a linkage pulling piece and a synchronizing piece, wherein the push-pull rods on two sides are symmetrically arranged about the axis of the adjusting handle, the push-pull rods axially slide on the handle shell, the push-pull rods are fixedly connected with pull wires, and the pull wires can be fixed with the push-pull rods in a threaded compression, clamping and other modes; the stay wire is connected with the upper clamping piece in a double-stranded wire mode, and the stay wire can be pulled out after the valve is clamped in the connecting mode; the synchronous piece is fixedly connected with one of the push-pull rods in a joint way, so that the push-pull rod and the synchronous piece are axially fixed and slide together in the axial direction, the synchronous piece is selectively coupled with the other push-pull rod under the control of the linkage pulling piece, the other push-pull rod and the synchronous piece are axially fixed and slide together in the axial direction in the coupled state, the other push-pull rod can slide relative to the synchronous piece in the axial direction in the uncoupled state, and the synchronous piece is rotationally switched relative to the axis of the adjusting handle in the coupled state and the uncoupled state. The handle device with synchronous control is arranged, the control synchronizing piece is in a coupling state, when the asymmetric pushing force pushes the push-pull rod to release the upper clamping piece during operation, the situation of unsynchronized release of the upper clamping piece caused by the asymmetric pushing force is avoided, the synchronous release of the upper clamping piece can be realized, the probability of capturing a valve or a valve leaflet by the upper clamping piece is improved, the device unlocking is not required, the synchronous release can be realized only through pushing and pulling, and the operation steps are simplified.
In a preferred embodiment, at least one protrusion is arranged on the surface of the synchronizing piece, the linkage pulling piece is penetrated through with a clamping groove corresponding to the protrusion along the axial direction, the linkage pulling piece is sleeved between the synchronizing piece and the handle shell and rotates along the axis of the adjusting handle to drive the synchronizing piece to rotate around the axis, and the protrusion of the synchronizing piece slides in the clamping groove in the sliding process of the push-pull rod; in other preferred modes, a clamping groove can be formed in the outer surface of the synchronous piece, and the linkage shifting piece is provided with an inward protrusion.
In a preferred embodiment, the push-pull rod is provided with a first push-pull rod and a second push-pull rod, the push-pull rods each comprise an extension part which is arranged radially towards the inside of the handle shell, a first opening is transversely formed in the outer peripheral surface of the synchronizing piece, the first opening is a circumferentially closed opening, the extension part of the first push-pull rod or the second push-pull rod stretches into the first opening to form the joint fixation of the first push-pull rod or the second push-pull rod and the synchronizing piece, and the first opening is preferably provided with a width matched with the extension part, so that the first push-pull rod and the synchronizing piece do not slide on the handle shell in a relative axial movement.
In a preferred embodiment, an open slot is formed in the peripheral surface of the synchronizing member along the axial direction, and the extension part of the second push-pull rod slides in the open slot, and the position is the uncoupled state of the synchronizing member; the outer peripheral surface of the synchronizing piece is transversely provided with a second opening along the first opening, the second opening is adjacent to the opening groove, so that the second opening is a non-closed opening, and when the extending part of the second push-pull rod slides to a certain position in the opening groove, the extending part of the second push-pull rod can be clamped in the second opening by rotating the synchronizing piece, and the position is the coupling state of the synchronizing piece. Preferably, the second opening has a width adapted to the extension such that the second push-pull rod and the synchronizing member do not slide on the handle housing in a coupled state with a relative axial movement.
Preferably, a sliding block is arranged between the extension part and the push-pull rod, a sliding groove is arranged at the corresponding position of the handle shell, when the push-pull rod slides along the axial direction, the sliding block slides in the sliding groove, so that the resistance of the push-pull rod during sliding is reduced, and the time for releasing the upper clamping piece to capture is shortened.
Preferably, a sealing cavity is arranged in the handle shell, sealing liquid is filled in the sealing cavity, the sealing liquid is usually physiological saline, the sealing cavity is provided with two connecting holes, the push-pull rod is inserted into the connecting holes and connected with the sealing cavity, at least one sealing ring is arranged in the connecting holes, the push-pull rod and the sealing cavity are sealed, meanwhile, friction force is generated on the push-pull rod, the friction force is large enough, the push-pull rod keeps static when the elastic force of the upper clamping piece is pulled by a pull wire, the damping limit of the push-pull rod is realized by the arrangement of the sealing ring, the push-pull rod can be kept at a specific position, when the upper clamping piece is released, only the push-pull rod is required to be operated to descend, the release of the upper clamping piece is realized, the push-pull rod is not required to be rotated to unlock firstly, the operation steps are simplified, and the capturing possibility of the upper clamping piece to a valve is improved.
Preferably, the linkage plectrum sets up to two to use the axis to set up as central symmetry, the arch of synchronizing piece sets up to two, two protruding and the cooperation of different linkage plectrum be provided with toggle switch on the linkage plectrum, the handle shell is provided with the operation window, toggle switch sets up in the operation window, stirs through operating personnel, thereby realizes that toggle switch winds the rotation of axis and drives the rotation of synchronizing piece. By the arrangement, the torque of the rotation of the synchronous piece is increased, and the synchronous piece is rapidly switched between a non-coupling state and a coupling state.
When the capturing time of an object is determined, the linkage pulling piece is operated in advance to rotate, so that the synchronous piece is in a coupling state, and the push-pull rod can be pushed by asymmetric pushing force in a limited window time, so that the synchronous release of the upper clamping piece is realized; when the capturing areas of the two upper clamping pieces are different or one of the upper clamping pieces does not effectively capture or captures little, the synchronous piece is in a non-coupling state by controlling the linkage shifting piece, then the push-pull rod with relatively less capturing is pulled, so that the corresponding upper clamping piece is in a contracted state, then the push-pull rod is pushed, the upper clamping piece is controlled to be released again, the corresponding object is captured again, and the operation is repeated until the object is captured successfully by the upper clamping piece.
According to the technical scheme, the synchronous control handle device for preventing mitral valve/tricuspid valve regurgitation and the related method are characterized in that the synchronous piece is controlled to enable the upper clamping piece to synchronously release by controlling the synchronous piece, so that the valve capturing effect is improved; when the valve is not successfully captured, the synchronous piece is in a non-coupling state by rotating the linkage pulling piece, the corresponding push-pull rod is pulled to reset to release and capture the corresponding upper clamping piece again, and the rapid switching of the coupling to the non-coupling state can be realized through the operation.
Drawings
FIG. 1 is a schematic view of a handle device of the present application operating a valve clip device;
FIG. 2 is a schematic view of the valve clip apparatus of the present application as a whole;
FIG. 3 is a cross-sectional view of the valve clip apparatus of the present application in a contracted state;
FIG. 4 is an enlarged schematic view of portion B of FIG. 3 in accordance with the present application;
FIG. 5 is a partial cross-sectional view of the adjustment handle of portion A of FIG. 1 in accordance with the present application;
FIG. 6 is a schematic view of the internal structure of the adjusting handle according to the present application;
FIG. 7 is a schematic illustration of the uncoupled state of the present application with one side of the linkage tab removed;
FIG. 8 is a schematic view of the coupled state of the present application with one side of the linkage tab removed;
fig. 9 is a schematic structural view of a synchronizing member in the present application.
Reference numerals illustrate:
the valve clip assembly comprises a valve clip assembly, an 11-adjusting handle, a 12-delivery handle, a 13-guiding handle, a 2-handle housing, a 21-disconnecting lever, a 21-boss, a 22-rotating lever handle, a 221-limit ring, a 23-delivery base, a 231-pull wire channel, a 24-pull wire, a 25-upper clip, a 26-first hinge shaft, a 27-implant base, a 28-clamping arm, a 29-second hinge shaft, a 3-sealing cavity, a 30-rotating lever, a 31-rotating arm, a 32-third hinge shaft, a 33-lower clamping base, a 34-first push-pull lever, a 35-second push-pull lever, a 36-linked toggle, 361-toggle switch, a 37-synchronizing member, 371-open slot, 372-first opening, 373-second opening, 374-boss, 38-extension, 39-slider, and 40-slide slot.
Detailed Description
The present application will be further described in detail below with reference to specific embodiments and with reference to the accompanying drawings, in order to make the objects, technical solutions and advantages of the present application more apparent.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The terms "comprises," "comprising," and/or the like, as used herein, specify the presence of stated features, steps, operations, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, or components.
All terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art unless otherwise defined. It should be noted that the terms used herein should be construed to have meanings consistent with the context of the present specification and should not be construed in an idealized or overly formal manner.
Certain embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments are shown. Indeed, various embodiments of the disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.
In view of the shortcomings of the valve repair devices of the prior art, the present application provides a valve clip device 1 and a method of using the valve clip device 1, which can be applied to the treatment of mitral/tricuspid regurgitation in the heart.
The embodiment of the application provides a control handle for interventional operation, and fig. 1 is a schematic diagram of a valve clamping piece device operated by the control handle, and the valve clamping piece device comprises the control handle and a valve clamping piece device 1, wherein the control handle comprises an adjusting handle 11, a conveying handle 12 and a guiding handle 13, the guiding handle 13 and the conveying handle 12 are conventional handles used for controlling the entry and the guiding of a sheath tube in interventional operation treatment, and the adjusting handle 11 is used for controlling the contraction and the expansion of the valve clamping piece device so as to realize the clamping and fixing of the valve clamping piece device to a valve.
The valve clamping piece device comprises a conveying base 23, an implantation base 27 and a lower clamping base 33 from top to bottom in sequence, as shown in fig. 2, a clamping arm 28 is hinged on the implantation base 27, the two clamping arms 28 are rotatably connected with the implantation base 27 through a first hinge shaft 26, an upper clamping piece 25 is arranged above the clamping arm 28, a thorn is arranged on one side, adjacent to the clamping arm 28, of the upper clamping piece 25, and clamping fixation of a valve is realized through cooperation of the clamping arm 28, the thorn and the upper clamping piece 25; the upper clip 25 is a resilient sheet, typically a thermoplastic material, and is held adjacent to the implant base 27 by an upper clip cord, such that when the tension of the upper clip cord is released, the upper clip 25 expands to an angle, typically 150-210 °, under its own elastic force, i.e., the upper clip 25 rotates in a direction away from the implant base 27.
The upper clamping piece 25 is connected to the lower end of the implantation base 27, the clamping arm 28 is hinged to the lower end of the implantation base 27 through the first hinge shaft 26, one end of the rotating arm 31 is hinged to the lower clamping base 33 through the third hinge shaft 32, the other end of the rotating arm 31 is hinged to the middle position of the clamping arm 28 through the second hinge shaft 29, one end of the rotating rod 30 is rotatably connected with the lower clamping base 33, the rotating rod 30 is provided with external threads and is connected with the internal threads of the implantation base 27, the rotating rod 30 and the lower clamping base 33 can be rotatably connected in a limiting protrusion mode and the like, and therefore the rotating rod 30 is guaranteed to rotate relative to the lower clamping base 33 without axial relative movement.
The conveying base 23 is in limit connection with the implantation base 27, for example, limit connection between the conveying base 23 and the implantation base 27 is realized by an S-shaped hasp and boss groove lap connection mode, the conveying base 23 is provided with a middle channel, a rotating rod handle 22 is penetrated in the middle channel, one end of the rotating rod handle 22 is connected with the rotating rod 30 in a rotation preventing mode, the other end of the rotating rod handle is connected with the adjusting handle 11, the rotating rod handle 22 is provided with an internal channel, a dissociation rod 21 is penetrated in the internal channel of the rotating rod handle 22, one end of the dissociation rod 21 is connected with the rotating rod 30 through a first thread, the other end of the dissociation rod 21 is connected with the adjusting handle 11, one end of the rotating rod handle 22 connected with the rotating rod 30 is provided with a limit ring 221 protruding inwards in a radial direction, one end of the dissociation rod 21 connected with the rotating rod 30 is provided with a boss 211, and the boss 211 of the dissociation rod 21 acts on the limit ring 221 and applies force to the rotating rod 30 through a first thread connection of the dissociation rod 21 and the rotating rod 30, and the specific reference is made to fig. 4; through the above arrangement, through the common rotation of the dissociation pole 21 and the rotation pole handle 22 side, drive the rotation pole to rotate, because the rotation pole with implant base screw thread cooperation for the rotation pole reciprocates and drives down clamp base and reciprocate, down clamp base when reciprocating, thereby realize the shrink and the expansion of centre gripping arm 28, the common rotation of dissociation pole 21 and rotation pole handle 22 side can realize big torsion long distance torsion and carry, under the circumstances of producing great torsion to the rotation pole, can realize centre gripping arm 28 and last clamping piece 25 cooperation, to the better centre gripping of valve fixed, prevent that centre gripping arm 28 from losing efficacy when heart long-time work, figure 3 is the section view that valve clamping piece device is in the shrink state.
In a preferred embodiment, the external thread of the rotating rod 30 is opposite to the first thread, so that when the detaching rod 21 is detached from the rotating rod 30, the detaching rod 21 is independently rotated in the same direction, so that the lower clamping base 33 has a tendency to move upwards, the clamping force of the clamping arm 28 and the upper clamping piece 25 on the valve is further increased, and the clamping and fixing effect on the heart valve is improved.
The adjusting handle 11 comprises a handle shell 2, two push-pull rods arranged on two sides of the axis of the adjusting handle 11, a linkage pulling piece 36 and a synchronizing piece 37, the push-pull rods on the two sides are symmetrically arranged about the axis of the adjusting handle 11, the push-pull rods slide on the handle shell 2 along the axial direction, the push-pull rods are fixedly connected with a pull wire 24, and the pull wire 24 can be fixed with the push-pull rods in a threaded compression, clamping and other modes; the stay wire 24 is connected with the upper clamping piece in a double-stranded wire mode, and the stay wire 24 can be pulled out after the valve is clamped; the synchronizing member 37 is fixedly engaged with one of the two push-pull rods, so that the push-pull rod is axially fixed with the synchronizing member 37 and slides together in the axial direction, the synchronizing member 37 is selectively coupled with the other push-pull rod under the control of the linkage pulling piece 36, the other push-pull rod is axially fixed with the synchronizing member 37 and slides together in the axial direction in the coupled state, the other push-pull rod can slide relative to the synchronizing member 37 in the axial direction in the uncoupled state, and the synchronizing member 37 is rotationally switched relative to the axis of the adjusting handle 11 in the coupled state and the uncoupled state. The handle device with synchronous control is arranged, the control synchronizing piece 37 is in a coupling state, when the asymmetric pushing force pushes the push-pull rod to release the upper clamping piece during operation, the situation of unsynchronized release of the upper clamping piece caused by the asymmetric pushing force is avoided, the synchronous release of the upper clamping piece can be realized, the probability of capturing a valve or a valve leaflet by the upper clamping piece is improved, the unlocking of the device is not needed, the synchronous release can be realized only through pushing and pulling, and the operation steps are simplified.
In a preferred embodiment, at least one protrusion 374 is disposed on the surface of the synchronizing member 37, the linkage pulling piece 36 is axially penetrating through a clamping groove corresponding to the protrusion 374, the linkage pulling piece 36 is sleeved between the synchronizing member 37 and the handle housing 2, and rotates along the axis of the adjusting handle to drive the synchronizing member 37 to rotate around the axis, and during the sliding process of the push-pull rod, the protrusion 374 of the synchronizing member 37 slides in the clamping groove; in other preferred embodiments, a slot may be provided on the outer surface of the synchronizing member 37, and the linkage tab 36 may be provided with an inward protrusion.
In a preferred embodiment, the push-pull rod has a first push-pull rod 34 and a second push-pull rod 35, each push-pull rod comprises an extension part which is arranged radially towards the inside of the handle shell 2, a first opening 372 is transversely formed on the outer peripheral surface of the synchronizing piece 37, the first opening 372 is a circumferentially closed opening, the extension part of the first push-pull rod 34 or the second push-pull rod 35 stretches into the first opening 372 to form the joint fixation of the first push-pull rod 34 or the second push-pull rod 35 and the synchronizing piece 37, and the first opening 372 preferably has a width matched with the extension part, so that the first push-pull rod 34 and the synchronizing piece 37 do not slide on the handle shell 2 in a relative axial movement.
In a preferred embodiment, an open groove 371 is axially formed on the outer peripheral surface of the synchronizing member 37, and the extension portion of the second push-pull rod 35 slides in the open groove 371, that is, the uncoupled state of the synchronizing member 37; a second opening 373 is provided on the outer peripheral surface of the synchronizing member 37 along the transverse direction of the first opening 372, the second opening 373 is adjacent to the opening slot 371, so that the second opening 373 is a non-closed opening, and when the extending portion of the second push-pull rod 35 slides in the opening slot 371 to a certain position, the extending portion of the second push-pull rod 35 can be clamped in the second opening 373 by rotating the synchronizing member 37, and the position is the coupling state of the synchronizing member 37. Preferably, the second opening 373 has a width adapted to the extension such that no relative axial movement of the second push-pull rod 35 and the synchronizing member 37 slides on the handle housing 2 in the coupled state.
Preferably, a sliding block is arranged between the extension part and the push-pull rod, a sliding groove is arranged at the corresponding position of the handle shell 2, when the push-pull rod slides along the axial direction, the sliding block slides in the sliding groove, so that the resistance of the push-pull rod during sliding is reduced, and the time for releasing the upper clamping piece to capture is shortened.
Preferably, a sealing cavity is arranged in the handle shell 2, sealing liquid is filled in the sealing cavity, the sealing liquid is usually normal saline, the sealing cavity is provided with two connecting holes, the push-pull rod is inserted into the connecting holes and connected with the sealing cavity, at least one sealing ring is arranged in the connecting holes, the push-pull rod and the sealing cavity are sealed, meanwhile, friction force is generated on the push-pull rod, the friction force is large enough to enable the push-pull rod to keep static when the elastic force of the upper clamping piece is pulled by the pull wire 24, the setting of the sealing ring enables damping limit of the push-pull rod to be achieved, the push-pull rod can be kept at a specific position, when the upper clamping piece is released, only the push-pull rod is required to be operated to descend, release of the upper clamping piece is achieved, the push-pull rod is not required to be rotated to unlock firstly, operation steps are simplified, and the capturing possibility of the upper clamping piece to a valve is improved.
Preferably, the number of the linkage shifting sheets 36 is two, the linkage shifting sheets are symmetrically arranged by taking the axis as the center, the number of the protrusions 374 of the synchronizing piece 37 is two, the two protrusions 374 are matched with different linkage shifting sheets 36, a toggle switch 361 is arranged on the linkage shifting sheets 36, the handle shell 2 is provided with an operation window, the toggle switch 361 is arranged in the operation window, and the rotation of the toggle switch 361 around the axis is realized by toggling of an operator, so that the rotation of the synchronizing piece 37 is driven. By increasing the torque of the rotation of the synchronizing member 37 by the above arrangement, the rapid switching of the synchronizing member 37 in the uncoupled state and the coupled state is achieved.
When the capturing time of the object is determined, the linkage pulling piece 36 is operated in advance to rotate, so that the synchronizing piece 37 is in a coupling state, and the push-pull rod can be pushed by asymmetric pushing force in a limited window time, so that the synchronous release of the upper clamping piece is realized; when the capturing areas of the two upper clamping pieces are different or one of the upper clamping pieces does not effectively capture or captures little, the synchronous piece 37 is in a non-coupling state by controlling the linkage pulling piece 36, then the push-pull rod with relatively less capturing is pulled, so that the corresponding upper clamping piece is in a reset state, then the push-pull rod is pushed, the upper clamping piece is controlled to be released again, the corresponding object is captured again, and the operation is repeated until the object is captured successfully by the upper clamping piece.
Claims (9)
1. The synchronous control handle device comprises a control handle and a valve clamping piece device, wherein the control handle comprises a conveying handle and an adjusting handle, the conveying handle is used for controlling the entering of a sheath tube, and the adjusting handle is used for controlling the contraction and the expansion of the valve clamping piece device so as to realize the clamping and fixing of the valve clamping piece device to a valve; the valve clamping piece device is characterized by comprising two clamping arms and an implantation base, wherein the two clamping arms are rotationally connected with the implantation base through a first hinge shaft, an upper clamping piece is arranged above the clamping arms, and the clamping and fixing of a valve are realized through the matching of the clamping arms and the upper clamping piece; the upper clamping piece is connected with the stay wire, the upper clamping piece can be kept in a contracted state through the stay wire, and when the tension of the upper clamping and stay wire is released, the upper clamping piece is unfolded to an unfolded state under the action of the self elastic force;
the adjusting handle comprises a handle shell, push-pull rods, linkage pulling sheets and a synchronizing piece, wherein the push-pull rods are arranged on two sides of the axis of the adjusting handle, the push-pull rods slide on the handle shell along the axial direction, the push-pull rods are fixedly connected with pull wires, the synchronizing piece is fixedly connected with one of the push-pull rods in a joint mode, so that the push-pull rods and the synchronizing piece are axially fixed and slide along the axial direction together, the synchronizing piece is selectively coupled with the other push-pull rod under the control of the linkage pulling sheets, the other push-pull rod and the synchronizing piece are axially fixed and slide along the axial direction together in a coupled state, and when the other push-pull rod is in an uncoupled state, the other push-pull rod can slide along the axial direction relative to the synchronizing piece, and the synchronizing piece is rotationally switched relative to the axis of the adjusting handle in a coupled state and an uncoupled state;
the surface of the synchronizing piece is provided with at least one bulge, the linkage plectrum axially penetrates through the clamping groove corresponding to the bulge, and in the sliding process of the push-pull rod, the bulge of the synchronizing piece slides in the clamping groove.
2. The handle assembly of claim 1 wherein said linkage paddle is disposed between said synchronizing member and said handle housing and rotates along an axis of the adjustment handle to rotate said synchronizing member about said axis.
3. The handle device according to claim 1, wherein the push-pull rod comprises a first push-pull rod and a second push-pull rod, the push-pull rods each comprise an extension part which is arranged radially towards the inside of the handle shell, a first opening is transversely formed in the outer peripheral surface of the synchronous piece, the first opening is a circumferentially closed opening, and the extension part of the first push-pull rod or the second push-pull rod extends into the first opening to form the joint fixation of the first push-pull rod or the second push-pull rod and the synchronous piece.
4. A handle device according to claim 3, wherein an open groove is provided in the outer peripheral surface of the synchronizing member in the axial direction, and the extension portion of the second push-pull rod slides in the open groove.
5. The handle device according to claim 4, wherein a second opening is provided on an outer peripheral surface of the synchronizing member in a lateral direction of the first opening, the second opening being adjacent to the open groove such that the second opening is a non-closed opening, and the extending portion of the second push-pull rod is engaged with the second opening by rotating the synchronizing member when the extending portion of the second push-pull rod slides to a certain position in the open groove.
6. A handle arrangement according to claim 3, wherein a slide is provided between the extension and the push-pull rod, and a slide groove is provided in the handle housing in a corresponding position, the slide sliding in the slide groove when the push-pull rod slides in the axial direction.
7. The handle device according to claim 1, wherein a sealing cavity is arranged in the handle housing, sealing liquid is filled in the sealing cavity, two connecting holes are arranged in the sealing cavity, the push-pull rod is inserted into the connecting holes and connected with the sealing cavity, at least one sealing ring is arranged in the connecting holes, and friction force is generated on the push-pull rod when the push-pull rod is sealed with the connecting holes of the sealing cavity, and the friction force enables the push-pull rod to remain stationary when the elastic force of the upper clamping piece is pulled by a stay wire.
8. The handle device according to claim 1, wherein the number of the linkage paddles is two, the linkage paddles are symmetrically arranged with respect to the axis as a center, the number of the protrusions of the synchronizing member is two, and the two protrusions are matched with different linkage paddles.
9. A method of operating the synchronous control handle device according to any one of claims 1 to 8, when the capturing timing of the subject is determined, operating the linkage pulling piece in advance to rotate, causing the synchronizing piece to be in a coupled state, pushing the push-pull rod, and achieving synchronous release of the upper clip piece; when one of the upper clamping pieces is determined to not capture an effective object, the synchronous piece is in a non-coupling state through controlling the linkage shifting piece, the corresponding push-pull rod is pulled, the corresponding upper clamping piece is in a contracted state, then the push-pull rod is pushed, the upper clamping piece is controlled to be released again, the corresponding object is captured again, and the operation is repeated until the object is captured successfully by the upper clamping piece.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311195629.1A CN116942373B (en) | 2023-09-18 | 2023-09-18 | Synchronous control handle device and use method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311195629.1A CN116942373B (en) | 2023-09-18 | 2023-09-18 | Synchronous control handle device and use method thereof |
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| CN116942373B true CN116942373B (en) | 2023-12-12 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110536659A (en) * | 2017-04-26 | 2019-12-03 | 爱德华兹生命科学公司 | Delivery device for prosthetic heart valve |
| CN113599022A (en) * | 2020-10-12 | 2021-11-05 | 宁波健世科技股份有限公司 | Valve prosthesis conveying system convenient to control |
| CN115281894A (en) * | 2022-07-22 | 2022-11-04 | 北京领健医疗科技有限公司 | Valve presss from both sides control handle, conveyor and valve repair system |
| WO2023125162A1 (en) * | 2021-12-28 | 2023-07-06 | 瀚芯医疗科技(深圳)有限公司 | Valve clip and valve clip system |
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2023
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110536659A (en) * | 2017-04-26 | 2019-12-03 | 爱德华兹生命科学公司 | Delivery device for prosthetic heart valve |
| CN113599022A (en) * | 2020-10-12 | 2021-11-05 | 宁波健世科技股份有限公司 | Valve prosthesis conveying system convenient to control |
| WO2023125162A1 (en) * | 2021-12-28 | 2023-07-06 | 瀚芯医疗科技(深圳)有限公司 | Valve clip and valve clip system |
| CN115281894A (en) * | 2022-07-22 | 2022-11-04 | 北京领健医疗科技有限公司 | Valve presss from both sides control handle, conveyor and valve repair system |
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| CN116942373A (en) | 2023-10-27 |
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