WO2022078147A1

WO2022078147A1 - Delivery system enabling release cushioning of implant device

Info

Publication number: WO2022078147A1
Application number: PCT/CN2021/118539
Authority: WO
Inventors: 郑玲和; 李毅斌; 范维云
Original assignee: 宁波健世生物科技有限公司
Priority date: 2020-10-12
Filing date: 2021-09-15
Publication date: 2022-04-21
Also published as: CN113796987A

Abstract

A delivery system enabling release cushioning of an implant device (1). The delivery system comprises the implant device (1), an inner tube, an outer sheath, a proximal release control apparatus (3), a control handle (2), and a distal release control apparatus (4). One end of the implant device (1) is connected to the proximal release control apparatus (3). The distal release control apparatus (4) comprises a limiting sheath (41), a pulling head (42), and a position-limiting member (43). The limiting sheath (41) is connected to a distal end of the inner tube. The pulling head (42) and the position-limiting member (43) are disposed on the inner tube. The pulling head (42) is disposed at a distal side of the position-limiting member (43). When the implant device (1) is loaded on the delivery system, the other end of the implant device (1) is connected to the pulling head (42) and limited within the limiting sheath (41). During the process of operating the control handle (2) to cause the limiting sheath (41) to move toward a distal end, the pulling head (42) and the position-limiting member (43) cooperate to cushion the release of the other end of the implant device (1), so as to achieve a gradual release of the other end of the implant device (1) from the limiting sheath (41). The invention solves the problem in which the implant device (1) becomes misaligned, moves out of place, and the like due to a premature or sudden release from limitation during a release process inside a body.

Description

A delivery system for cushioning and releasing implantable devices

This application claims the priority of the Chinese Patent Application for Invention No. 202011087177.1 filed in China on October 13, 2020, "A Delivery System for Buffered Release Implantable Devices", the entire contents of which are incorporated by reference in in this application.

technical field

The invention belongs to the field of medical devices, and in particular relates to a delivery system capable of buffering and releasing implanted devices.

Background technique

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.

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. In China, surgical valve replacement is still a major treatment option. In recent years, some scholars at home and abroad have carried out basic and clinical research on percutaneous aortic valve replacement, and achieved some breakthroughs. Provides an effective treatment for high-risk elderly patients with aortic valve degeneration requiring surgical valve replacement. In 2002, 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. Although most of the high-risk patients underwent TAVR, the postoperative 30-day survival rate was higher than 90%, and the hemodynamic parameters of patients after TAVR were significantly improved.

However, native aortic regurgitation is still listed as a contraindication for TAVR. 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. For example, JenaValve 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. However, 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 scholars 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 (142b, 150) selectively applies force to the inner shaft assembly (34) , to retract the prosthetic heart valve (160), the first actuating member and the second actuating member simultaneously operate relative to the handle to provide the delivery sheath assembly and the An inner shaft assembly applies a force to induce recapture of the prosthetic heart valve (160) into the bladder, the first actuator positioned at the proximal end and the distal end and including a user interface slidably retained by the housing, the user interface extending at least partially to the outside of the housing in a slotted opening and in a longitudinal direction relative to the housing within the opening is slidable, wherein the first actuating member is operative toward the distal end to apply a distal force to the bladder, the second actuating member is positioned at the proximal end, wherein the second actuator is operative to apply a proximal force to the prosthetic heart valve away from the proximal end in spaced relation to the distal end. 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.

Therefore, how to limit the early release of the stent, make the stent release process controllable, reduce the uncertain factors in the operation, and improve the success rate of the operation has become an urgent problem for medical personnel at present.

SUMMARY OF THE INVENTION

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.

The object of the present invention is achieved through the following solutions: 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, and 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. During the operation of the control handle to move the restriction sheath to the distal end, the slider is connected to the restriction sheath. The cooperating of the limiting piece can buffer release the other end of the implantation device and gradually disengage the limiting sheath.

The object of the present invention can also be further realized through the following technical solutions:

In one embodiment, the slider is axially movable along the inner tube.

In one embodiment, the stopper can prevent the slider from moving further proximally axially.

In one embodiment, 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.

In one embodiment, the slider is fixedly connected to the limiting member or the slider is separated from the limiting member. When the slider is separated from the limiting member, the slider is separated from the limiting member. Steps are arranged between the limiting members.

In one embodiment, the limiting member is a sleeve member.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, the stopper is a tubular member.

In one embodiment, when the control handle is operated so that the restraining sheath moves distally and is not completely separated from the other end of the implantation device, the other end of the implantation device is always restricted by the slider within the confinement sheath.

In one embodiment, the other end of the implant device is provided with a limiting hole, and the limiting hole is detachably connected with the slider.

In one embodiment, a limiting protrusion is provided on the slider.

In one embodiment, the diameter of the limiting hole is larger than the diameter of the limiting protrusion.

In one embodiment, the proximal controlled release device includes a connector and a control wire.

In a preferred embodiment, 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.

In a preferred embodiment, the control wire is made of Nitinol wire with a diameter of 0.2mm-0.5mm.

In one embodiment, the limiting member is fixed on the connecting member.

In one embodiment, 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.

In one embodiment, the limiting member is fixedly connected with the slider.

In one embodiment, 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.

In one embodiment, the limiting member can move axially independently.

In one embodiment, 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.

In one embodiment, 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 When the device needs a specific circumferential position, 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.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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.

In a preferred embodiment, the rotating structure may be a bearing, the end of the distal end of the inner tube is sleeved in the bearing, and the outer ring of the bearing is fixed with the distal control release device to operate the control handle When the adjustment mechanism drives the implantation device to rotate and further drives the distal control release device to rotate, both the inner tube and the outer sheath remain stationary.

Compared with the prior art, the advantages of the present invention are:

1. Different from other delivery systems, 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. Axial contraction, 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. Since 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;

2. 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;

3. 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. When 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. On the one hand, 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;

4. 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. When the implanted device needs a specific circumferential position, precise adjustment cannot be achieved. However, 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.

Description of drawings

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.

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.

7a-7d are schematic structural diagrams of another embodiment of the present invention.

FIG. 8 is a schematic structural diagram of another embodiment of the present invention.

The names of the parts referred to by the numbers in the drawings are as follows: 1- Implantation device, 11- Limit hole, 12- Positioning piece, 2- Control handle, 21- Rotating piece, 22- Spinning knob, 23- Locking Knob, 24-distal control release button, 3-proximal control release device, 31-connector, 32-control wire, 4-distal control release device, 41-restriction sheath, 42-pull head, 43-limit Parts, 421-limiting protrusion, 431-stressed boss, 5-inner tube, 6-adjustment mechanism, 7-rotation structure, 71-boss, 72-groove, 73-bearing.

Detailed ways

The present invention will be described in further detail below with reference to the accompanying drawings and embodiments.

The 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.

Specific embodiment one

In one embodiment, as shown in Figures 1a and 1b, a valve delivery system that can limit the premature release of a stent includes an implantation device 1, a delivery catheter, a proximal controlled release device 3, and a control handle 2, the valve delivering The system further includes a distal controlled release device 4, one end of the implant device 1 is connected to the proximal controlled release device 3, and the distal controlled release device 4 includes a limiting sheath 41, a pull head 42 and a limiting member 43, 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 , and the slider 42 is arranged on the limiting member 43 On the distal side of the implantation device 1, when the implantation device is loaded with the delivery system, the other end of the implantation device 1 is connected to the puller 42 and is restricted in the restriction sheath 41. 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). 42 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.

In one embodiment, 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). As shown in 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 To support the force, the slider 42 and the implant device 1 are balanced by force and no longer move axially.

In one embodiment, 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. As shown in 1b, 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 .

In one embodiment, 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.

In one embodiment, the adjustment mechanism 6 is a limiting member, and the adjustment mechanism 6 is made of medical grade stainless steel.

In one embodiment, as shown in FIGS. 5 a and 5 b , 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 To implement the relative rotation, 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, When the adjustment mechanism 6 drives the implanted device 1 to rotate, due to the friction between the implanted device 1 and the limiting sheath 41, the implanted device 1 drives the limiting sheath 41 to rotate; The inner tube 5 remains stationary, so that the implant device 1 encounters less resistance during the rotational adjustment process, which facilitates adjustment.

In another embodiment, as shown in FIG. 5c , the rotating structure 7 is a bearing 73 , the distal end of the inner tube 5 is sleeved in the bearing 73 , and 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:

As shown in Figure 1b, 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 42 touches the stopper 43, the slider 42 no longer moves toward the proximal end. As shown in FIG. 2b, 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.

Specific embodiment two

Different from the above-mentioned embodiment, 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 As shown in FIG. 3b , the restraining sheath 41 moves to the distal end, the implantation device 1 expands radially and contracts axially, and the puller 42 shrinks the inner tube with the axial contraction of the implantation device 1 . 5. Move axially toward the proximal end, the slider 42 is fixedly connected with the limiting member 43 (as shown in FIG. 6c ), 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.

In another embodiment, 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:

As shown in Figure 7a, 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 limiting member 43 moves together due to being fixed with the slider 42. As shown in FIG. 7b, 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.

The above contents are only preferred embodiments of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific embodiments and application scope. limits.

Claims

A delivery system capable of buffering and releasing an implantation device, comprising an implantation device, an inner tube, an outer sheath, a proximal controlled release device and a control handle, wherein the valve delivery system further comprises a distal controlled release device, the implantation device One end of the insertion instrument is connected to the proximal controlled release device, the distal controlled release device includes a restricting sheath, a pulling head and a limiting member, the restricting sheath is connected to the distal end of the inner tube, and the pulling head and the The stopper is arranged on the inner tube, the slider is arranged on the distal side of the stopper, and when the implantation device and the delivery system are loaded, the other end of the implantation device is connected to the end of the stopper. The pull head is connected and limited in the restraint sheath, and in the process of operating the control handle to make the restraint sheath move to the distal end, the pull head cooperates with the limiter to buffer and release the restraint sheath. The other end of the implantation device is implanted, and the other end of the implantation device is gradually separated from the restraining sheath.
The delivery system of claim 1, wherein the slider is axially movable along the inner tube.
The delivery system of claim 1, wherein the limiting member can prevent the slider from further axially moving toward the proximal end.
A delivery system for buffering and releasing implantable instruments according to claim 1, wherein the limiting member is fixedly connected with the proximal control release device or the limiting member can be positioned along the inner tube in a fixed manner. There is axial movement between the proximal control release and the slider.
The delivery system for cushioning and releasing implantable devices according to claim 1, wherein the pulling head is fixedly connected with the limiting member or the pulling head is separated from the limiting member, when the pulling head is fixedly connected with the limiting member When the head is separated from the limiting member, a step is provided between the slider and the limiting member.
The delivery system of claim 1, wherein the limiting member is a sleeve member.
A delivery system capable of buffering and releasing implantable devices according to claim 1, wherein 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 pieces.
A delivery system capable of buffering and releasing implantable instruments according to claim 1, wherein a plurality of cut lines are provided on the limiting member.
The delivery system for buffering and releasing implantable instruments according to claim 1, wherein the valve delivery system further comprises 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 control handle. Connected to the proximal control release device, when the implant device needs a specific circumferential position, the control handle is operated so that the adjustment mechanism drives the proximal control release device to rotate, and the proximal control release The device drives the implantation device to rotate, and during the process, the distal controlled release device rotates along with the implantation device and remains relatively stationary with the implantation device.
A delivery system capable of buffering and releasing implantable instruments according to claim 1, wherein a rotating structure is provided between the inner tube and the distal control release device, and operating the control handle makes the adjustment mechanism When the implantation device is driven to rotate and the distal control release device is further driven to rotate, both the inner tube and the outer sheath remain stationary.