WO2022078147A1 - Système de distribution permettant l'amortissement de la libération d'un dispositif d'implant - Google Patents

Système de distribution permettant l'amortissement de la libération d'un dispositif d'implant Download PDF

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Publication number
WO2022078147A1
WO2022078147A1 PCT/CN2021/118539 CN2021118539W WO2022078147A1 WO 2022078147 A1 WO2022078147 A1 WO 2022078147A1 CN 2021118539 W CN2021118539 W CN 2021118539W WO 2022078147 A1 WO2022078147 A1 WO 2022078147A1
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WIPO (PCT)
Prior art keywords
delivery system
limiting member
sheath
slider
inner tube
Prior art date
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PCT/CN2021/118539
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English (en)
Chinese (zh)
Inventor
郑玲和
李毅斌
范维云
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宁波健世生物科技有限公司
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Publication of WO2022078147A1 publication Critical patent/WO2022078147A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath

Definitions

  • the invention belongs to the field of medical devices, and in particular relates to a delivery system capable of buffering and releasing implanted devices.
  • Aortic valve stenosis is mainly caused by the sequelae of rheumatic fever, congenital aortic valve structural abnormalities or senile aortic valve calcification. Patients are asymptomatic during the compensation period, and most patients with severe aortic valve stenosis have symptoms of fatigue, dyspnea (exertional or paroxysmal), angina pectoris, dizziness or syncope, and even sudden death.
  • Aortic valve regurgitation means that the aortic valve opens when the ventricle contracts, and the blood flow in the left ventricle enters the aorta and is ejected to the whole body. In valve insufficiency, the aortic valve cannot close tightly during diastole, causing blood to flow backward from the aorta into the left ventricle.
  • aortic valve disease In the treatment of aortic valve disease, surgical valve replacement is a traditional and effective treatment. However, most of the patients with this type of disease are elderly and have multiple organ diseases at the same time, making it difficult for them to accept surgical operations, thus becoming patients with no hope of clinical treatment. In addition, the etiology of degenerative aortic valve disease is still not very clear, and there is no effective treatment for the cause, and there is no effective method to curb its development, and the drug treatment effect is not good. The ideal treatment for aortic valve disease should both improve the patient's symptoms and prolong their lifespan.
  • Percutaneous balloon aortic valvuloplasty performed in the early years, was used to treat aortic stenosis, but both single-center data and multicenter registries found poor long-term outcomes.
  • surgical valve replacement is still a major treatment option.
  • some scholars at home and abroad have carried out basic and clinical research on percutaneous aortic valve replacement, and achieved some breakthroughs.
  • Cribier et al. successfully performed transcatheter aortic valve replacement (TAVR). So far, more than 50,000 TAVR surgeries have been completed worldwide. or patients at high risk for surgical valve replacement, this technique is safe and effective.
  • TAVR transcatheter aortic valve replacement
  • TAVR native aortic regurgitation
  • the main reason is that the accurate positioning and precise release of the implanted device valve are the most critical technical points in TAVR surgery. There are left and right coronary openings on the aortic valve, and the mitral valve is adjacent to the valve. If the positioning and release are not accurate, there may be fatal complications such as coronary occlusion or massive mitral regurgitation.
  • Traditional TAVR devices either SAPIEN or CoreValve, are mainly used in patients with severe aortic stenosis and are not suitable for patients with aortic regurgitation. In the prior art, a certain consensus has been achieved in the design of devices for patients with aortic valve regurgitation.
  • J-Valve and Acurate in foreign countries and J-Valve in China all use structures similar to native valve leaflet locators to locate the aorta.
  • the three sinuses of the flap which facilitates the accurate positioning of the implanted instrument for implantation.
  • the above devices are still mostly from the transapical approach, and the trauma to the patient is still relatively large, so they cannot be regarded as percutaneous implantation in the strict sense.
  • domestic researchers and engineers have made some conceptual attempts to deal with the problem of how to take into account the problem of the autologous leaflet positioning member and the sheath tube being too large.
  • Patent CN201180023133.5 discloses a delivery system (30) for percutaneously deploying a stented prosthetic heart valve (160), the delivery system (30) comprising: an inner shaft assembly (34), the inner shaft The assembly includes an intermediate portion providing a coupling structure (120) configured to selectively mate with a prosthetic heart valve (160); a delivery sheath assembly slidably disposed on the On the inner shaft assembly (34), the delivery sheath assembly includes a tubular bladder and a delivery shaft, wherein the bladder extends from the distal end of the delivery shaft and is configured to compressively contain a prosthetic heart valve (160) cooperating with the coupling structure (120); and a handle (38) coupled to the inner shaft assembly (34) and the delivery sheath assembly, the The handle includes a housing having proximal and distal ends, the handle (38) holding a first actuator (142a, 144) and a second actuator (142b, 150), the An actuator (142a, 144) selectively applies force to the delivery sheath assembly and the second actuator
  • the disadvantage of this technical solution is that the release of the stent is a process of "the length of the stent is shortened and gradually expanded in the circumferential direction”. "Retraction force”, if the distal end of the delivery system is not provided with a restriction structure for stent release, it is likely to cause the stent to be released in advance, resulting in uncontrollable stent release, which greatly increases the risk of surgery.
  • the purpose of the present invention is to overcome the deficiencies of the prior art, and to provide a valve delivery system that can limit the premature release of stents for patients with aortic stenosis who need interventional treatment.
  • the invention solves the problem of early release of the implanted device during the process of restoring the preset shape.
  • a delivery system that can buffer and release an implanted device, comprising an implanted device, an inner tube, an outer sheath, a proximal control release device and a control handle
  • the valve delivery system also includes A distal controlled release device, one end of the implantation device is connected to the proximal controlled release device, the distal controlled release device includes a restraining sheath, a pull head and a limiting member, and the restraining sheath is far away from the inner tube end connection
  • the slider and the stopper are arranged on the inner tube, the slider is arranged on the distal side of the stopper, when the implantation device is loaded with the delivery system
  • the other end of the implantation device is connected with the slider and is restricted in the restriction sheath.
  • the slider is connected to the restriction sheath.
  • the cooperating of the limiting piece can buffer release the other end of the implantation
  • the slider is axially movable along the inner tube.
  • the stopper can prevent the slider from moving further proximally axially.
  • the stopper is fixedly connected to the proximal controlled release device or the stopper can be pivoted along the inner tube between the proximal controlled release device and the slider to move.
  • the slider is fixedly connected to the limiting member or the slider is separated from the limiting member.
  • the slider is separated from the limiting member. Steps are arranged between the limiting members.
  • the limiting member is a sleeve member.
  • the limiting member when at least one end of the limiting member is fixedly connected with the proximal control release device or the slider, the limiting member is a piece.
  • the limiting member when the limiting member is a sleeve member, the limiting member can protect the implantation device, because the implantation device is prone to friction with the inner tube when it rotates, thereby preventing the implantation.
  • the implanted device will cause certain damage, and the smooth surface limiter isolates the inner tube from the implanted device and plays an effective protective role.
  • the stopper is evenly provided with a number of incisions.
  • the advantage of this design is that the stopper can also adapt to a certain degree of curvature, which makes it easier for the delivery system to enter the meandering blood vessel. Adjust and adapt.
  • the stopper is a tubular member.
  • the other end of the implantation device is always restricted by the slider within the confinement sheath.
  • the other end of the implant device is provided with a limiting hole, and the limiting hole is detachably connected with the slider.
  • a limiting protrusion is provided on the slider.
  • the diameter of the limiting hole is larger than the diameter of the limiting protrusion.
  • the proximal controlled release device includes a connector and a control wire.
  • the connecting member includes a base fixedly connected to the other end of the transmission member, a plurality of connecting claws uniformly arranged on the base, and a hole-like structure is provided on the connecting claw.
  • control wire is made of Nitinol wire with a diameter of 0.2mm-0.5mm.
  • the limiting member is fixed on the connecting member.
  • the slider moves toward the proximal end with the axial contraction of the implantation device, and the slider stops moving toward the proximal end after touching the limiting member.
  • the limiting member is fixedly connected with the slider.
  • the slider drives the limiting members to move toward the proximal end together with the axial contraction of the implantation device, and the limiting member does not move toward the proximal end after touching the connecting member.
  • the limiting member can move axially independently.
  • the slider moves toward the proximal end along with the axial contraction of the implantation device. After the slider touches the limiter, the slider drives the limiter toward the proximal end together. The end moves until the limiting piece touches the connecting piece, and the slider and the connecting piece no longer move toward the proximal end.
  • the valve delivery system further includes an adjustment mechanism, one end of the adjustment mechanism is connected to the control handle, and the other end of the adjustment mechanism is connected to the proximal control release device, when the implantation
  • the control handle is operated so that the adjustment mechanism drives the proximal control release device to rotate, and the proximal control release device drives the implantation device to rotate.
  • the distally controlled release device rotates with the implantation device and remains relatively stationary with the implantation device.
  • the adjustment mechanism is a transmission rod, one end of the transmission rod is connected with the control handle, and the other end of the transmission rod is connected with the proximal control release device.
  • a rotation structure is provided between the inner tube and the distal control release device, and the control handle is operated so that the adjustment mechanism drives the implantation device to rotate and further drives the distal control When the release device is rotated, both the inner tube and the outer sheath remain stationary.
  • the rotating structure includes a boss provided on the inner tube and a groove provided in the control release, the boss being provided in the groove.
  • the rotating structure may be a bearing
  • the end of the distal end of the inner tube is sleeved in the bearing
  • the outer ring of the bearing is fixed with the distal control release device to operate the control handle
  • the present invention is provided with a remote control release device, the implanted device is connected to the limit protrusion on the slider through the limit hole, and the slider can move axially on the inner tube, Not only can it be adapted to implant devices with different axial lengths, but at the same time, due to the limiting effect of the limiter on the slider, the implant device will move to the distal end of the limiting sheath until it is separated from the implant device.
  • the slider can move axially with the implantation device until it reaches the limiter, and the limiter reaches the proximal control release device, so that the slider cooperates with the limiter and the proximal control release device for implantation
  • An axial force on the distal end of the device offsets the axial contraction force of the implanted device, which can gradually release the contraction force of the implanted device, making the release of the implanted device more controllable; in contrast to the prior art, There is no component at the distal end of the conveyor to give the implanted device an axial force, which limits the radial expansion and axial contraction of the implanted device during the movement of the sheath to the distal end.
  • the implanted device cannot be controlled by the axial force, the The axial contraction of the implanted device is uncontrollable, which can easily cause the implanted device to suddenly pop out of the control release device, making the position of the implanted device uncontrollable;
  • the limiting member of the present invention can be a sleeve member, and the advantage of such a design is that the limiting member is arranged between the inner tube and the implanted device to prevent the inner tube and the implanted device from occurring when the implanted device rotates. Friction, which in turn causes damage to the implanted device, and the limiter protects the implanted device;
  • a rotating mechanism is provided between the inner tube and the limiting sheath of the present invention, so that relative rotation is always maintained between the inner tube and the limiting sheath.
  • the adjusting mechanism drives the implanted device to rotate, the There is friction between the implanted devices, so that the implanted device drives the rotation of the limiting sheath; at the same time, the inner tube remains stationary relative to the implanted device, so that the resistance encountered by the implanted device during the rotation adjustment process is smaller, which is convenient for adjustment;
  • the fixed connection of the sheath is limited, and the implanted device will encounter greater resistance when it is rotated and adjusted.
  • the implanted device will encounter greater resistance when rotating and Pushing the limiting sheath enables the distal end of the implanted device to be released and at the same time rotates with the implanted device, resulting in a complicated structure design of the control handle of the delivery system, which is not conducive to the operation of medical personnel;
  • the solution of adjusting/rotating the implanted device by directly rotating the control handle in the prior art due to the friction between the outer sheath and the blood vessel wall and the long and meandering distance of the blood vessels in the human body, the control handle and the distal implanted device are caused. It is always difficult to achieve precise transmission through the external adjustment.
  • the implanted device needs a specific circumferential position, precise adjustment cannot be achieved.
  • the present invention is provided with an adjustment mechanism.
  • the adjustment mechanism is used to adjust the circumferential position of the implanted device to achieve precise control, which can effectively avoid the right non-junction (the position of the conduction bundle) and prevent patients from conduction block and stroke during the operation. Align the sparser side of the grid with the coronary ostium to avoid coronary blockage; or place the implanted instrument with positioning pieces into the sinus precisely.
  • FIG. 1a to 1f are schematic diagrams of the process of the present invention for restricting the sheath to move the implantation device distally, wherein FIG. 1c is a partial enlarged view of FIG. 1b, FIG. 1e is a partial enlarged view of FIG. 1d, and FIG. f is another embodiment.
  • FIG. 2a-2c are schematic structural diagrams of the present invention when the limiting sheath moves to the limiting hole of the implanted device, wherein FIG. 2b is a partial enlarged view of FIG. 1a, and FIG. 2c is a force analysis diagram of the slider at this time.
  • 3a-3c are schematic layout views of various embodiments of the slider, the limiting member and the connecting member of the present invention.
  • 4a-4d are schematic diagrams of the process of completely releasing the distal end and the proximal end of the implantation device of the present invention.
  • 5a-5c are schematic diagrams of various embodiments of the rotating structure of the present invention.
  • 6a-6e are schematic views of various implementation structures of the slider and the limiting member of the present invention.
  • FIG. 8 is a schematic structural diagram of another embodiment of the present invention.
  • proximal end in the present invention refers to the end close to the operator, and the distal end refers to the end away from the operator.
  • the limiting sheath 41 is connected to the distal end of the inner tube 5
  • the slider 42 and the limiting member 43 are sleeved on the inner tube 5
  • the slider 42 is arranged on the limiting member 43
  • the other end of the implantation device 1 is connected to the puller 42 and is restricted in the restriction sheath 41.
  • the slider 42 When operating the control handle 2. During the process of moving the restricting sheath 41 to the distal end, the slider 42 cooperates with the limiting member 43 to restrict the other end of the implantation device 1 from disengaging from the restricting sheath 41 in advance;
  • the positioning member 43 is fixedly connected with the connecting member (as shown in Figs. 1c and 3a), the restricting sheath 41 moves to the distal end, the implantation device 1 expands radially and contracts axially, and the slider 42 moves with the With the axial contraction of the implant device 1, the inner tube 5 moves axially toward the proximal end, as shown in Figures 1d and 1e (the arrow in Figure 1e is the moving direction of the slider 42).
  • the implant device 1 moves to touch the limiting member 43 , the proximal end of the slider 42 is supported by the limiting member 43 , and the limiting protrusion 421 on the slider 42 passes through the limiting hole 11
  • the axial force of the implant device 1 is balanced, as shown in FIGS. 2 a to 2 c ; when the proximal end of the limiting sheath 41 moves to the position close to the limiting hole 11 , the implant device 1 faces radially. and axial expansion, the limiting hole 11 gradually moves away from the limiting protrusion 421 to realize the release of the distal end of the implant device 1, as shown in Figs. 4a and 4b.
  • the slider 42 can move axially on the outer surface of the limiting member 43, as shown in FIG. 1f (the arrow in the figure is the moving direction of the slider 42).
  • the limiting member 43 is provided with a force-bearing boss 431
  • the slider moves to the force-bearing boss 431 with the axial contraction of the implant device 1, and the force-bearing boss 431 is provided to the slider 42 shaft
  • the slider 42 and the implant device 1 are balanced by force and no longer move axially.
  • the control handle 2 is provided with a rotating member 21, a spinning knob 22, a locking knob 23 and a remote control release button 24.
  • the rotating member 21 can control the adjustment mechanism 6.
  • Rotation (the connection method of controlling the rotation can be the connection method of the knob and the screw)
  • the wire drawing knob 22 can operate the control wire 32 to realize the separation of the connector 31 and the proximal end of the implantation device 1, and the
  • the remote control release button 24 can operate the remote control release device 4, and the locking knob 23 can control the inner tube 5 and the adjustment mechanism 6 to achieve relative rotation or synchronous rotation, as shown in Figure 1c .
  • one end of the implantation device 1 is controlled and released by the proximal controlled release device 3 , and the proximal controlled release device 3 includes the connecting piece 31 and the control wire 32 .
  • the proximal end of the instrument 1 is restricted on the connecting piece 31 by the control wire 32, and the connecting piece 31 is connected with the adjustment mechanism 6, and the control handle 2 is operated to rotate the adjustment mechanism 6, and the adjustment mechanism 6
  • the connecting piece 31 is driven to rotate, and the connecting piece 31 drives the implantation device 1 to rotate.
  • the adjustment mechanism 6 is a limiting member, and the adjustment mechanism 6 is made of medical grade stainless steel.
  • a rotating structure 7 is provided between the inner tube 5 and the restraining sheath 41 , so that between the inner tube 5 and the distal control release device 4
  • the rotating structure 7 includes a boss 71 provided on the inner tube 5 and a groove 72 set in the restraining sheath 41, and the boss 71 is set in the groove 72
  • the rotating structure 7 is a bearing 73
  • the distal end of the inner tube 5 is sleeved in the bearing 73
  • the outer ring of the bearing 73 is connected to the bearing 73 .
  • the limiting sheath 41 is fixed so that the inner tube 5 and the distal control release device 4 are always kept in relative rotation.
  • the working principle of the present invention is:
  • the valve delivery system has a control handle 2, and the control handle 2 is provided with a rotating member 21, a wire drawing knob 22 and a distal control release button 24, which respectively control the adjustment mechanism 6, the control wire 32 and the distal end
  • the control release device 4 the control handle 2 is also provided with a locking knob 23, which can control the inner tube 5 and the adjustment mechanism 6 to achieve relative rotation or synchronous rotation
  • the inner tube 5 and the restriction sheath 41 are connected to the inner tube 5, and the slider 42, the adjustment mechanism 6 and the proximal control release device 3 are also connected between the inner tube 5 and the restriction sheath 41.
  • the end control release device 3 includes a connecting piece 31 and a control wire 32, the proximal end of the implantation device 1 is detachably connected with the connecting piece 31 through the control wire 32, and the distal end and the distal end of the implantation device 1 are controlled to release
  • the device 4 is matched and connected, and the limiting protrusion 421 on the slider 42 passes through the limiting hole 11 of the implantation device 1; the valve delivery system is operated and adjusted so that the positioning member 12 on the implantation device 1 is released to the target position, Operate the locking knob 23 so that the inner tube 5 and the adjustment mechanism 6 are in a state of relative rotation, operate the distal control release button 24, and more specifically, operate the limiting sheath 41 toward the distal end of the axial direction Moving, the implanted device 1 limited by the limiting sheath 41 gradually returns to the preset shape, the implanted device 1 expands radially and contracts axially, the implanted device 1 drives the slider 42 toward the proximal axial direction After the slider
  • the slider 42 restricts the axial release of the implanted device 1.
  • the implanted device 1 Because the axial support will not occur in advance, the pull head 42 is stressed as shown in FIG. 2c , the proximal end of the pull head 42 receives the support force F1 of the limiting member 31, and the distal end of the pull head 42 obtains the limit protrusion 421.
  • the axial force F2 of the implanted device 1, the operation limiting sheath 41 continues to move to the distal end until the limiting hole 11, the limiting hole 11 of the implanting device 1 is gradually separated from the limiting protrusion 421 on the slider 42, and the operating limiting sheath is 41 leaves the limiting hole 11, and the distal end of the implantation device 1 is completely released, as shown in Figures 4a and 4b;
  • the proximal end of the implantation device 1 is no longer restricted to the connector 31, and the implantation device 1 is completely released in the heart, as shown in Figures 4c and 4d.
  • the limiting member 43 is separated from the connecting member 31 (as shown in FIGS. 7 a and 7 b ), and the layout relationship between the slider 42 , the limiting member 43 and the connecting member 31
  • the restraining sheath 41 moves to the distal end
  • the implantation device 1 expands radially and contracts axially
  • the puller 42 shrinks the inner tube with the axial contraction of the implantation device 1 . 5.
  • the slider 42 is fixedly connected with the limiting member 43 (as shown in FIG.
  • the slider 42 and the limiting member 43 move axially together, and the The limiting member 43 moves to touch the connecting member 31 , the proximal end of the limiting member 43 is supported by the connecting member 31 , and the limiting protrusion 421 on the slider 42 passes through the limiting hole 11 .
  • the axial force of the implant device 1 is balanced, as shown in Figures 7c and 7d (in the force analysis of Figure 7d, the slider 42 and the shown limiter 43 are regarded as a whole); when the limiter sheath 41 When the proximal end moves close to the limiting hole 11 , the implant device 1 expands radially and axially, and the limiting hole 11 gradually leaves the limiting protrusion 421 to realize the implantation device 1's distal release.
  • both the slider and the limiter can move axially on the inner tube 5 independently (as shown in FIG. 8 ), the slider 42 and the limiter
  • the layout relationship between 43 and the connecting piece 31 is shown in Figure 3c, the restricting sheath 41 moves to the distal end, the implantation device 1 expands radially and contracts axially, and the slider 42 follows the implantation.
  • the axial contraction of the insertion instrument 1 moves axially toward the proximal end on the inner tube 5, the slider 42 moves to touch the limiter 43, and the slider 42 pushes the limiter 43 to move axially.
  • the limiting member 43 moves to touch the connecting member 31 , the proximal end of the limiting member 43 is supported by the connecting member 31 , the slider 42 is supported by the limiting member 43 , and the slider
  • the limiting protrusions 421 on the 42 pass through the limiting holes 11 to balance the axial force of the implant device 1 .
  • the working principle of the present invention is:
  • the valve delivery system has a control handle 2, and the control handle 2 is provided with a rotating member 21, a wire drawing knob 22 and a distal control release button 24, which respectively control the adjustment mechanism 6, the control wire 32 and the distal end
  • the control release device 4 the control handle 2 is also provided with a locking knob 23, which can control the inner tube 5 and the adjustment mechanism 6 to achieve relative rotation or synchronous rotation
  • the inner tube 5 and the restriction sheath 41 are connected to the inner tube 5, and the slider 42, the adjustment mechanism 6 and the proximal control release device 3 are also connected between the inner tube 5 and the restriction sheath 41.
  • the end control release device 3 includes a connecting piece 31 and a control wire 32, the proximal end of the implantation device 1 is detachably connected with the connecting piece 31 through the control wire 32, and the distal end and the distal end of the implantation device 1 are controlled to release
  • the device 4 is matched and connected, and the limiting protrusion 421 on the slider 42 passes through the limiting hole 11 of the implantation device 1; the valve delivery system is operated and adjusted so that the positioning member 12 on the implantation device 1 is released to the target position, Operate the locking knob 23 so that the inner tube 5 and the adjustment mechanism 6 are in a state of relative rotation, operate the distal control release button 24, and more specifically, operate the limiting sheath 41 toward the distal end of the axial direction Moving, the implanted device 1 limited by the limiting sheath 41 gradually returns to the preset shape, the implanted device 1 expands radially and contracts axially, the implanted device 1 drives the slider 42 toward the proximal axial direction moving, the
  • the slider 42 restricts the axial release of the implanted device 1, and the implanted device 1 is axially released.
  • the support will not be released in advance.
  • the slider 42 and the limiter 43 are subjected to force as shown in Figure 7d (the slider 42 and the limiter 43 are regarded as a whole in the figure), and the proximal end of the limiter 43 is obtained.
  • the supporting force F1 of the connector 31, the distal end of the slider 42 obtains the axial force F2 of the implantation device 1 at the limiting protrusion 421, and the operation limiting sheath 41 continues to move to the distal end until the limiting hole 11, and the implantation device 1.
  • the limiting hole 11 is gradually separated from the limiting protrusion 421 on the slider 42, the limiting sheath 41 is operated to leave the limiting hole 11, and the distal end of the implanted device 1 is completely released; 32 is separated from the implantation device 1 and the connecting piece 31, the proximal end of the implantation device 1 is no longer restricted on the connecting piece 31, and the implantation device 1 is completely released in the heart.

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  • 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

L'invention concerne un système de distribution permettant l'amortissement de la libération d'un dispositif d'implant (1). Le système de distribution comprend le dispositif d'implant (1), un tube interne, une gaine externe, un appareil de commande de libération proximale (3), une poignée de commande (2), et un appareil de commande de libération distale (4). Une extrémité du dispositif d'implant (1) est reliée à l'appareil de commande de libération proximale (3). L'appareil de commande de libération distale (4) comprend une gaine de limitation (41), une tête de traction (42) et un élément de limitation de position (43). La gaine de limitation (41) est reliée à une extrémité distale du tube interne. La tête de traction (42) et l'élément de limitation de position (43) sont disposés sur le tube interne. La tête de traction (42) est disposée au niveau d'un côté distal de l'élément de limitation de position (43). Lorsque le dispositif d'implant (1) est chargé sur le système de distribution, l'autre extrémité du dispositif d'implant (1) est reliée à la tête de traction (42) et limitée à l'intérieur de la gaine de limitation (41). Pendant le processus d'opération de la poignée de commande (2) pour amener la gaine de limitation (41) à se déplacer vers une extrémité distale, la tête de traction (42) et l'élément de limitation de position (43) coopèrent pour amortir la libération de l'autre extrémité du dispositif d'implant (1), de manière à obtenir une libération progressive de l'autre extrémité du dispositif d'implant (1) depuis la gaine de limitation (41). L'invention résout le problème selon lequel le dispositif d'implant (1) se désaligne, sort de sa place, ou autre en raison d'une libération prématurée ou soudaine de la limitation pendant un processus de libération à l'intérieur d'un corps.
PCT/CN2021/118539 2020-10-12 2021-09-15 Système de distribution permettant l'amortissement de la libération d'un dispositif d'implant WO2022078147A1 (fr)

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CN202011087177.1 2020-10-12

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Publication number Priority date Publication date Assignee Title
WO2023208232A1 (fr) * 2022-04-29 2023-11-02 武汉唯柯医疗科技有限公司 Système d'administration pour endoprothèse de type valvule cardiaque interventionnelle

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2832322A1 (fr) * 2013-07-30 2015-02-04 Nvt Ag Système de déploiement d'une prothèse de valvule cardiaque
CN109953843A (zh) * 2017-12-26 2019-07-02 杭州唯强医疗科技有限公司 主动脉支架的输送释放装置
WO2020030073A1 (fr) * 2018-08-09 2020-02-13 杭州唯强医疗科技有限公司 Dispositif de transport et système de transport pour commander la libération pas à pas d'endoprothèse
CN111053634A (zh) * 2018-10-16 2020-04-24 先健科技(深圳)有限公司 植入器械的释放组件、植入器械输送器及输送系统
CN212996893U (zh) * 2020-10-12 2021-04-20 宁波健世生物科技有限公司 一种可缓冲释放植入器械的输送系统

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2832322A1 (fr) * 2013-07-30 2015-02-04 Nvt Ag Système de déploiement d'une prothèse de valvule cardiaque
CN109953843A (zh) * 2017-12-26 2019-07-02 杭州唯强医疗科技有限公司 主动脉支架的输送释放装置
WO2020030073A1 (fr) * 2018-08-09 2020-02-13 杭州唯强医疗科技有限公司 Dispositif de transport et système de transport pour commander la libération pas à pas d'endoprothèse
CN111053634A (zh) * 2018-10-16 2020-04-24 先健科技(深圳)有限公司 植入器械的释放组件、植入器械输送器及输送系统
CN212996893U (zh) * 2020-10-12 2021-04-20 宁波健世生物科技有限公司 一种可缓冲释放植入器械的输送系统

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