A delivery system capable of buffering the release of an implantable device

Abstract

The present invention relates to the field of medical devices, and in particular to a delivery system capable of buffering the release of an implantable device, comprising an implantable device, an inner tube, an outer sheath, a proximal control release device, a control handle and a distal control release device, wherein one end of the implantable device is connected to the proximal control release device, and the distal control release device comprises a limiting sheath, a pulling head and a limiting member, wherein the limiting sheath is connected to the distal end of the inner tube, the pulling head and the limiting member are arranged on the inner tube, and the pulling head is arranged on the distal side of the limiting member. When the implantable device is loaded with a delivery system, the other end of the implantable device is connected to the pulling head and is limited in the limiting sheath. In the process of operating the control handle to move the limiting sheath toward the distal end, the pulling head cooperates with the limiting member to buffer the release of the other end of the implantable device, so that the other end of the implantable device gradually detaches from the limiting sheath. The present invention solves the problems of premature and instantaneous detachment of the implantable device from the restriction during the release process in the body, resulting in deviation or flight in the body.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to a delivery system capable of buffering and releasing an implantable device. Background Art

[0002] 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 compensatory period, while patients with severe aortic valve stenosis often experience fatigue, dyspnea (exertional or paroxysmal), angina pectoris, dizziness or syncope, and may even die suddenly.

[0003] Aortic regurgitation means that the aortic valve opens when the ventricle contracts, and the blood in the left ventricle enters the aorta and is ejected to the whole body. It closes when the ventricle relaxes, preventing the blood in the aorta from flowing back to the left ventricle. If aortic valve insufficiency occurs, the aortic valve cannot close tightly during diastole, causing blood to flow back from the aorta into the left ventricle.

[0004] In the treatment of aortic valve disease, surgical valve replacement is a traditional and effective treatment method. However, most patients with this disease are elderly and have multiple organ diseases. Their physical conditions make it difficult for them to undergo surgery, making them hopeless patients for clinical treatment. In addition, the cause of degenerative aortic valve disease is still unclear, and it is impossible to treat the cause, nor is there an effective way to curb its development, and drug treatment is ineffective. Ideal measures for the treatment of aortic valve disease should be able to both improve the patient's symptoms and prolong their life. Percutaneous aortic balloon valvuloplasty, which was carried out in the early years, was used to treat aortic valve stenosis, but both single-center data and multi-center registration data showed that its long-term effect was poor. 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 have made some breakthrough progress. It provides an effective treatment method for high-risk elderly patients with aortic valve degeneration who need surgical valve replacement. In 2002, Cribier et al. successfully performed transcatheter aortic valve replacement (TAVR). To date, more than 50,000 TAVR surgeries have been completed worldwide. Studies around the world have shown that this technology is safe and effective for patients who are unable to undergo surgical valve replacement or who are at high risk of surgical valve replacement. Although most patients who undergo TAVR surgery are high-risk patients, the 30-day survival rate after surgery is higher than 90%, and the hemodynamic indicators of patients after TAVR surgery are significantly improved.

[0005] However, at present, native aortic valve 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 openings for the left and right coronary arteries on the aortic valve, and the mitral valve is adjacent to the valve. If the positioning and release are not accurate, fatal complications such as coronary artery blockage or massive mitral valve regurgitation may occur. Traditional TAVR devices, whether SAPIEN or CoreValve, are mainly used for patients with severe aortic valve stenosis and are not suitable for patients with aortic valve regurgitation. In the prior art, a certain consensus has been reached on the design of devices for patients with aortic valve regurgitation. For example, JenaValve and Acurate from abroad and J-Valve from China all use structures similar to autologous leaflet positioning parts to locate the three sinuses of the aortic valve, which is conducive to the accurate positioning and implantation of implanted devices. However, the above devices are still mostly introduced through the transapical approach, which is still relatively traumatic to patients and cannot be regarded as percutaneous implantation in the strict sense. Domestic scholars and engineers have made some conceptual attempts to balance the issues of autologous valve leaflet positioning and the oversized sheath.

[0006] Patent CN201180023133.5 discloses a delivery system (30) for percutaneously deploying a prosthetic heart valve (160) with a stent, the delivery system (30) comprising: an inner shaft assembly (34), the inner shaft assembly comprising a middle portion providing a coupling structure (120), the coupling structure (120) being configured to selectively cooperate with the prosthetic heart valve (160); a delivery sheath assembly, the delivery sheath assembly being slidably disposed on the inner shaft assembly (34), the delivery sheath assembly comprising a tubular capsule and a delivery shaft, wherein the capsule extends from a distal end of the delivery shaft and is configured to compressively contain a prosthetic heart valve (160) that cooperates with the coupling structure (120); and a handle (38) coupled to the inner shaft assembly (34) and the delivery sheath assembly, the handle including a housing having a proximal end and a distal end, the handle (38) retaining a first actuator (142a, 144) and a second actuator (142b, 150), The first 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 actuator and the second actuator simultaneously operate relative to the handle to apply force to the delivery sheath assembly and the inner shaft assembly to cause the prosthetic heart valve (160) to be recaptured into the capsule, and the first actuator is positioned at the proximal end The invention relates to a device for delivering a prosthetic heart valve, wherein the first actuator is operated toward the distal end to apply a distal force to the capsule-like member, and the second actuator is positioned at the proximal end, wherein the second actuator is operated away from the proximal end in a spaced relationship with the distal end to apply a proximal force to the prosthetic heart valve. The defect of this technical solution is that since the release of the stent is a process of "shortening the length of the stent and gradually expanding circumferentially", and in this process, since the stent itself is restoring the preset shape, there will be a large "retraction force". If a limiting structure for the release of the stent is not set at the distal end of the delivery system, it is very likely that the stent will be released prematurely, resulting in uncontrollable release of the stent, which greatly increases the risk of surgery.

[0007] Therefore, how to limit the premature release of the stent, make the stent release process controllable, reduce the uncertainty factors in the operation, and improve the success rate of the operation has become an urgent problem that medical personnel need to solve. Summary of the invention

[0008] The purpose of the present invention is to overcome the shortcomings of the prior art and provide a valve delivery system that can limit the premature release of the stent for patients with aortic stenosis who need interventional treatment. The present invention solves the problem of premature release of the implanted device during the process of restoring the preset shape.

[0009] The objective of the present invention is achieved through the following scheme: a delivery system that can buffer the release of an implantable device, comprising an implantable device, an inner tube, an outer sheath, a proximal control release device and a control handle, the valve delivery system also comprising a distal control release device, one end of the implantable device is connected to the proximal control release device, the distal control release device comprises a limiting sheath, a pull head and a limit member, the limiting sheath is connected to the distal end of the inner tube, the pull head and the limit member are arranged on the inner tube, the pull head is arranged on the distal side of the limit member, when the implantable device is loaded with the delivery system, the other end of the implantable device is connected to the pull head and is restricted in the limiting sheath, in the process of operating the control handle to move the limiting sheath toward the distal end, the pull head and the limit member cooperate to buffer the release of the other end of the implantable device and gradually detach from the limiting sheath.

[0010] The purpose of the present invention can be further achieved by the following technical solutions:

[0011] In one embodiment, the pulling head is axially movable along the inner tube.

[0012] In one embodiment, the stopper can prevent the slider from further axially moving toward the proximal end.

[0013] In one embodiment, the stopper is fixedly connected to the proximal end control release device or the stopper can move axially along the inner tube between the proximal end control release device and the pull head.

[0014] In one embodiment, the pull head is fixedly connected to the limiting member or the pull head is separated from the limiting member. When the pull head is separated from the limiting member, a step is provided between the pull head and the limiting member.

[0015] In one embodiment, the limiting member is a sleeve member.

[0016] In one embodiment, when at least one end of the limiting member is fixedly connected to the proximal control release device or the pull head, the limiting member is a sheet member.

[0017] In one embodiment, when the limiting member is a sleeve member, the limiting member can protect the implantable device. Since the implantable device is easily rubbed against the inner tube when rotating, thereby causing certain damage to the implantable device, the limiting member with a smooth surface isolates the inner tube from the implantable device, thereby playing an effective protective role.

[0018] In one embodiment, a plurality of cut lines are evenly distributed on the limiter. The advantage of such a design is that the limiter can also adapt to a certain degree of curvature, so that the delivery system is easier to adjust and adapt when entering a winding blood vessel.

[0019] In one embodiment, the limiting member is a tubular member.

[0020] In one embodiment, when the control handle is operated to cause the limiting sheath to move distally and not completely detach from the other end of the implant instrument, the other end of the implant instrument is always limited within the limiting sheath by the pulling head.

[0021] In one embodiment, a limiting hole is provided at the other end of the implantation device, and the limiting hole is detachably connected to the pull head.

[0022] In one embodiment, a limiting protrusion is provided on the slider.

[0023] In one embodiment, the diameter of the limiting hole is larger than the diameter of the limiting protrusion.

[0024] In one embodiment, the proximal controlled release device includes a connector and a control wire.

[0025] In a preferred embodiment, the connecting member includes a base fixedly connected to the other end of the transmission member, and a plurality of connecting claws evenly arranged on the base, and the connecting claws are provided with a hole structure.

[0026] In a preferred embodiment, the control wire is made of nickel-titanium alloy wire with a diameter of 0.2 mm-0.5 mm.

[0027] In one embodiment, the limiting member is fixed on the connecting member.

[0028] In one embodiment, the pull head moves toward the proximal end as the implant device contracts axially, and the pull head stops moving toward the proximal end after contacting the limiting member.

[0029] In one embodiment, the limiting member is fixedly connected to the slider.

[0030] In one embodiment, the pull head drives the limiting member to move toward the proximal end together with the axial contraction of the implant device, and the limiting member stops moving toward the proximal end after touching the connecting member.

[0031] In one embodiment, the stopper is independently axially movable.

[0032] In one embodiment, the pull head moves toward the proximal end as the implant device contracts axially. After the pull head touches the limit member, the pull head drives the limit member to move toward the proximal end until the limit member touches the connector, and the pull head and the connector no longer move toward the proximal end.

[0033] In one embodiment, the valve delivery system also includes an adjustment mechanism, one end of which is connected to the control handle, and the other end of which is connected to the proximal control release device. When the implant device requires a specific circumferential position, the control handle is operated to cause the adjustment mechanism to drive the proximal control release device to rotate, and the proximal control release device drives the implant device to rotate. During this process, the distal control release device rotates with the implant device and remains relatively stationary with the implant device.

[0034] In one embodiment, the adjustment mechanism is a transmission rod, one end of which is connected to the control handle, and the other end of which is connected to the proximal control release device.

[0035] In one embodiment, a rotating structure is provided between the inner tube and the distal control release device, and when the control handle is operated so that the adjustment mechanism drives the implant device to rotate and further drives the distal control release device to rotate, the inner tube and the outer sheath remain stationary.

[0036] In one embodiment, the rotating structure includes a boss disposed on the inner tube and a groove disposed in the control release device, and the boss is disposed in the groove.

[0037] In a preferred embodiment, the rotating structure can be a bearing, and the distal end of the inner tube is sleeved in the bearing. The outer ring of the bearing is fixed to the distal control release device, so that when the control handle is operated so that the adjustment mechanism drives the implant device to rotate and further drives the distal control release device to rotate, the inner tube and the outer sheath remain stationary.

[0038] Compared with the prior art, the advantages of the present invention are:

[0039] 1. Different from other conveying systems, the present invention is provided with a distal control release device. The implant device is connected to the limiting protrusion on the pull head through the limiting hole, and the pull head can move axially on the inner tube. It can not only adapt to implant devices with different axial lengths, but also, due to the limiting effect of the limiting member on the pull head, the limiting sheath moves to the distal end until it is separated from the implant device. The implant device will shrink axially, and the pull head can cooperate with the implant device to move axially until it hits the limiting member. The limiting member hits the proximal control release device, so that the pull head cooperates with the limiting member and the proximal control release device to give an axial force to the distal end of the implant device, which offsets the axial contraction force of the implant device, and can gradually release the contraction force of the implant device, making the release of the implant device more controllable. In contrast, in the prior art, there is no component at the distal end of the conveyor to give the implant device an axial force. When the limiting sheath moves to the distal end, the implant device expands radially and shrinks axially. Since the implant device cannot be controlled by the axial force, the axial contraction of the implant device is uncontrollable, which easily causes the implant device to suddenly pop out of the control release device, making the position of the implant device uncontrollable.

[0040] 2. The limiting member of the present invention may be a sleeve member. The advantage of such a design is that the limiting member is arranged between the inner tube and the implant device, so as to prevent the inner tube from rubbing against the inside of the implant device when the implant device rotates, thereby preventing damage to the implant device. The limiting member protects the implant device.

[0041] 3. A rotating mechanism is provided between the inner tube and the limiting sheath of the present invention, so that the inner tube and the limiting sheath always maintain relative rotation. When the adjustment mechanism drives the implant device to rotate, the friction between the implant device and the inner wall of the limiting sheath causes the implant device to drive the limiting sheath to rotate. At the same time, the inner tube remains stationary relative to the implant device, so that the resistance encountered by the implant device during the rotation adjustment process is smaller, which is convenient for adjustment. If the inner tube is fixedly connected to the limiting sheath, the implant device will encounter greater resistance during the rotation adjustment. On the one hand, the inner tube must rotate together, resulting in greater resistance during the rotation adjustment of the implant device. On the other hand, the inner tube must push the limiting sheath so that the distal end of the implant device can be released and rotate with the implant device, resulting in a rather complicated structure design of the control handle of the delivery system, which is not conducive to the operation of medical personnel.

[0042] 4. In the prior art, the implant device is adjusted / rotated by directly rotating the control handle. However, due to the friction between the outer sheath and the blood vessel wall and the long and winding distance of the blood vessels in the human body, it is always difficult to achieve precise transmission between the control handle and the distal implant device. When the implant device requires a specific circumferential position, precise regulation cannot be achieved. The present invention is provided with an adjustment mechanism. By operating the control handle while keeping the outer sheath stationary, the adjustment mechanism is used to adjust the circumferential position of the implant device to achieve precise regulation, which can effectively avoid the right non-intersection (conduction bundle position) to prevent the patient from having conduction block, stroke, etc. during the operation; at the same time, the sparser side of the grid can be aligned with the coronary artery ostium to avoid coronary artery blockage; or the implant device with a positioning piece can be accurately inserted into the sinus. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figures 1a to 1f This is a schematic diagram of the process of the limiting sheath moving toward the distal end of the implantation device of the present invention, wherein Figure 1c for Figure 1b A partial enlarged view of Figure 1e for Figure 1d A partial enlarged view of FIG. 4 , FIG. f is another embodiment.

[0044] Figure 2a to 2c This is a schematic diagram of the structure of the limiting sheath of the present invention when it moves to the limiting hole of the implantation device, wherein Figure 2b for Figure 1a A partial enlarged view of Figure 2c This is the force analysis diagram of the pull head at this time.

[0045] Figure 3a to 3c It is a schematic diagram of the layout of various embodiments of the slider, the limiter and the connector of the present invention.

[0046] Figures 4a to 4d This is a schematic diagram of the process of complete release of the distal and proximal ends of the implantable device of the present invention.

[0047] Figure 5a to 5c Schematic diagrams of various embodiments of the rotating structure of the present invention.

[0048] Figure 6a~6e Schematic diagrams of various implementation structures of the slider and the limiter of the present invention.

[0049] Figures 7a to 7d It is a schematic structural diagram of another embodiment of the present invention.

[0050] Figure 8 It is a structural schematic diagram of another embodiment of the present invention.

[0051] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-implant instrument, 11-limiting hole, 12-positioning member, 2-control handle, 21-rotating member, 22-wire drawing knob, 23-locking knob, 24-distal control release button, 3-proximal control release device, 31-connecting member, 32-control wire, 4-distal control release device, 41-limiting sheath, 42-pulling head, 43-limiting member, 421-limiting protrusion, 431-force boss, 5-inner tube, 6-adjustment mechanism, 7-rotating structure, 71-boss, 72-groove, 73-bearing. DETAILED DESCRIPTION

[0052] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0053] The proximal end mentioned in the present invention refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Specific embodiment one:

[0055] In one embodiment, if Figure 1a and 1b As shown, a valve delivery system capable of limiting the early release of a stent comprises an implantation device 1, a delivery catheter, a proximal control release device 3 and a control handle 2, wherein the valve delivery system further comprises a distal control release device 4, wherein one end of the implantation device 1 is connected to the proximal control release device 3, wherein the distal control release device 4 comprises a limiting sheath 41, a pull head 42 and a limiting member 43, wherein the limiting sheath 41 is connected to the distal end of the inner tube 5, wherein the pull head 42 and the limiting member 43 are sleeved on the inner tube 5, wherein the pull head 42 is arranged on the distal side of the limiting member 43, and when the implantation device is loaded with the delivery system, the other end of the implantation device 1 is connected to the pull head 42 and is limited in the limiting sheath 41, and in the process of operating the control handle 2 to make the limiting sheath 41 move toward the distal end, the pull head 42 cooperates with the limiting member 43 to limit the other end of the implantation device 1 from being separated from the limiting sheath 41 in advance; and the limiting member 43 is fixedly connected to the connecting member (such as Figure 1c and 3a As shown in FIG. 1 ), the limiting sheath 41 moves distally, the implant device 1 expands radially and contracts axially, and the pull head 42 moves axially toward the proximal end on the inner tube 5 as the implant device 1 contracts axially, as shown in FIG. Figure 1d and 1e As shown ( Figure 1e The middle arrow indicates the moving direction of the pull head 42). When the pull head 42 moves to touch the limiting member 43, the proximal end of the pull head 42 is supported by the limiting member 43, and the limiting protrusion 421 on the pull head 42 passes through the limiting hole 11 to balance the axial force of the implant device 1. Figure 2a to 2cAs shown; when the proximal end of the limiting sheath 41 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, thereby releasing the distal end of the implant device 1, as shown Figure 4a and 4b shown.

[0056] In one embodiment, the pull head 42 can move axially on the outer surface of the stopper 43. Figure 1f As shown (the arrow in the figure indicates the moving direction of the pull head 42), a force boss 431 is provided on the limit member 43. The pull head moves to the force boss 431 as the implant device 1 contracts axially. The force boss 431 provides axial support force to the pull head 42. The pull head 42 and the implant device 1 are in force balance and no longer move axially.

[0057] In one embodiment, the control handle 2 has a rotating member 21, a wire drawing knob 22, a locking knob 23 and a distal control release button 24, as shown in 1b, the rotating member 21 can control the rotation of the adjustment mechanism 6 (the connection method for controlling the rotation can adopt a connection method of a knob and a screw), the wire drawing knob 22 can operate the control wire 32 to achieve the separation of the connecting member 31 and the proximal end of the implant device 1, the distal control release button 24 can control the distal 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 1b. Figure 1c shown.

[0058] In one embodiment, one end of the implant instrument 1 is controlled and released by the proximal control release device 3, and the proximal control release device 3 includes the connecting member 31 and the control wire 32. The proximal end of the implant instrument 1 is restricted on the connecting member 31 by the control wire 32, and the connecting member 31 is connected to the adjustment mechanism 6. The control handle 2 is operated to rotate the adjustment mechanism 6, and the adjustment mechanism 6 drives the connecting member 31 to rotate, and the connecting member 31 drives the implant instrument 1 to rotate.

[0059] In one embodiment, the adjustment mechanism 6 is a limiter, and the adjustment mechanism 6 is made of medical-grade stainless steel.

[0060] In one embodiment, if Figure 5a and 5bAs shown, a rotating structure 7 is arranged between the inner tube 5 and the limiting sheath 41, so that the inner tube 5 and the distal control release device 4 can maintain relative rotation. The rotating structure 7 includes a boss 71 arranged on the inner tube 5 and a groove 72 arranged in the limiting sheath 41. The boss 71 is arranged in the groove 72. When the adjustment mechanism 6 drives the implant device 1 to rotate, due to the friction between the implant device 1 and the limiting sheath 41, the implant device 1 drives the limiting sheath 41 to rotate; at the same time, the inner tube 5 remains stationary, so that the resistance encountered by the implant device 1 during the rotation adjustment process is smaller, which is convenient for adjustment.

[0061] In another embodiment, Figure 5c As shown, 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 fixed to the limiting sheath 41, so that the inner tube 5 and the distal control release device 4 always maintain relative rotation.

[0062] The working principle of the present invention is:

[0063] like Figure 1b As shown, the valve delivery system has a control handle 2, on which a rotating member 21, a wire drawing knob 22 and a distal control release button 24 are provided, which respectively control the adjustment mechanism 6, the control wire 32 and the distal control release device 4; the control handle 2 is also provided with a locking knob 23, and the locking knob 23 can control the inner tube 5 and the adjustment mechanism 6 to achieve relative rotation or synchronous rotation; the distal end of the control handle 2 is cooperatively connected with the inner tube 5 and the limiting sheath 41 connected with the inner tube 5, and the inner tube 5 and the limiting sheath 41 are also cooperatively connected with a pull head 42, the adjustment mechanism 6 and the proximal control release device 3, and the proximal control release device 3 includes a connecting member 31 and a control wire 32, and the proximal end of the implant device 1 forms a movable Disassembly connection, the distal end of the implant device 1 is connected with the distal control release device 4, and the limiting protrusion 421 on the pull head 42 passes through the limiting hole 11 of the implant device 1; operate the adjustment valve delivery system so that the positioning member 12 on the implant 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, more specifically, operate the limiting sheath 41 to move axially toward the distal end, and the implant device 1 restricted by the limiting sheath 41 gradually restores the preset shape, the implant device 1 radially expands and axially contracts, and the implant device 1 drives the pull head 42 to move axially toward the proximal end. After the pull head 42 touches the limit member 43, the pull head 42 no longer moves toward the proximal end. Figure 2bAs shown, at this time, the pull head 42 limits the axial release of the implant device 1, and the implant device 1 will not be released prematurely due to the axial support. The pull head 42 is subjected to the force as shown in FIG. Figure 2c As shown in the figure, the proximal end of the pull head 42 obtains the support force F1 of the limit member 31, and the distal end of the pull head 42 obtains the axial force F2 of the implant device 1 at the limit protrusion 421, and the operating limit sheath 41 continues to move distally until the limit hole 11, and the limit hole 11 of the implant device 1 gradually separates from the limit protrusion 421 on the pull head 42, and the operating limit sheath 41 leaves the limit hole 11, and the distal end of the implant device 1 is completely released, as shown in Figures 4a and 4b; the wire drawing knob 22 is operated to make the control wire 32 separate from the implant device 1 and the connecting member 31, and the proximal end of the implant device 1 is no longer restricted on the connecting member 31, and the implant device 1 is completely released in the heart, as shown in Figures 4a and 4b. Figure 4c and 4d shown. Specific embodiment 2:

[0065] Different from the above-mentioned embodiment, the limiting member 43 is separated from the connecting member 31 (such as Figure 7a and 7b As shown in FIG. 1 ), the layout relationship between the pull head 42, the stopper 43 and the connecting member 31 is as follows: Figure 3b As shown, the limiting sheath 41 moves toward the distal end, the implant device 1 expands radially and contracts axially, and the pull head 42 moves axially toward the proximal end on the inner tube 5 as the implant device 1 contracts axially. The pull head 42 is fixedly connected to the stopper 43 (as shown in FIG. Figure 6c As shown in FIG. 1 ), the pull head 42 and the limiter 43 move axially together, the limiter 43 moves to touch the connecting member 31, the proximal end of the limiter 43 is supported by the connecting member 31, and the limiter protrusion 421 on the pull head 42 passes through the limiter hole 11 to balance the axial force of the implant device 1, as shown in FIG. Figure 7c and 7d As shown ( Figure 7d In the force analysis, the pull head 42 and the limiting member 43 are regarded as a whole); when the proximal end of the limiting sheath 41 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, thereby realizing the release of the distal end of the implant device 1.

[0066] In another embodiment, the pull head and the stopper can be independently axially movable on the inner tube 5 (eg Figure 8 As shown in FIG. 1 ), the layout relationship between the pull head 42, the stopper 43 and the connecting member 31 is as follows: Figure 3cAs shown, the limiting sheath 41 moves toward the distal end, the implant device 1 expands radially and contracts axially, and the pull head 42 moves axially toward the proximal end on the inner tube 5 as the implant device 1 contracts axially. The pull head 42 moves until it touches the limiting member 43, and the pull head 42 pushes the limiting member 43 to move axially. The limiting member 43 moves until it touches the connecting member 31. The proximal end of the limiting member 43 is supported by the connecting member 31, and the pull head 42 is supported by the limiting member 43. The limiting protrusion 421 on the pull head 42 balances the axial force of the implant device 1 through the limiting hole 11.

[0067] The working principle of the present invention is:

[0068] like Figure 7a As shown, the valve delivery system has a control handle 2, on which a rotating member 21, a wire drawing knob 22 and a distal control release button 24 are provided, which respectively control the adjustment mechanism 6, the control wire 32 and the distal control release device 4; the control handle 2 is also provided with a locking knob 23, and the locking knob 23 can control the inner tube 5 and the adjustment mechanism 6 to achieve relative rotation or synchronous rotation; the distal end of the control handle 2 is cooperatively connected with the inner tube 5 and the limiting sheath 41 connected with the inner tube 5, and the inner tube 5 and the limiting sheath 41 are also cooperatively connected with a pull head 42, the adjustment mechanism 6 and the proximal control release device 3, and the proximal control release device 3 includes a connecting member 31 and a control wire 32, and the proximal end of the implant device 1 is connected to the connecting member 31 through the control wire 32. The implant device 1 is detachably connected, the distal end of the implant device 1 is cooperatively connected with the distal control release device 4, and the limiting protrusion 421 on the pull head 42 passes through the limiting hole 11 of the implant device 1; the valve delivery system is operated to adjust the valve delivery system so that the positioning member 12 on the implant device 1 is released to the target position, the locking knob 23 is operated to make the inner tube 5 and the adjustment mechanism 6 in a state of relative rotation, and the distal control release button 24 is operated. More specifically, the limiting sheath 41 is operated to move axially toward the distal end, and the implant device 1 restricted by the limiting sheath 41 gradually restores the preset shape, the implant device 1 radially expands and axially contracts, and the implant device 1 drives the pull head 42 to move axially toward the proximal end, and the limiting member 43 moves together with the pull head 42 because it is fixed, such as Figure 7b As shown, at this time, the pull head 42 limits the axial release of the implant device 1, and the implant device 1 will not be released prematurely due to the axial support. The pull head 42 and the limiter 43 are subjected to the force as shown in FIG. Figure 7dAs shown (in the figure, the pull head 42 and the limit member 43 are regarded as a whole), the proximal end of the limit member 43 obtains the support force F1 of the connecting member 31, and the distal end of the pull head 42 obtains the axial force F2 of the implant device 1 at the limit protrusion 421, and the operating limit sheath 41 continues to move toward the distal end until the limit hole 11, and the limit hole 11 of the implant device 1 gradually separates from the limit protrusion 421 on the pull head 42, and the operating limit sheath 41 leaves the limit hole 11, and the distal end of the implant device 1 is completely released; the wire drawing knob 22 is operated to make the control wire 32 separate from the implant device 1 and the connecting member 31, and the proximal end of the implant device 1 is no longer restricted on the connecting member 31, and the implant device 1 is completely released in the heart.

[0069] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there will be changes in the specific implementation methods and application scopes. The content of this specification should not be understood as limiting the present invention.

Claims

1. A delivery system capable of buffering and releasing an implantable device, comprising an implantable device, an inner tube, an outer sheath, a proximal controlled release device and a control handle, characterized in that: The delivery system also includes a distal control release device, one end of the implant instrument is connected to the proximal control release device, the distal control release device includes a limiting sheath, a pull head and a limit piece, the limiting sheath is connected to the distal end of the inner tube, the pull head and the limit piece are arranged on the inner tube, and the pull head is arranged on the distal side of the limit piece. When the implant instrument is loaded with the delivery system, the other end of the implant instrument is connected to the pull head and is restricted in the limiting sheath. In the process of operating the control handle to move the limiting sheath toward the distal end, the pull head and the limit piece cooperate to buffer and release the other end of the implant instrument, so that the other end of the implant instrument gradually detaches from the limiting sheath; the delivery system also includes an adjustment mechanism, a rotating structure is arranged between the inner tube and the distal control release device, and when the control handle is operated to make the adjustment mechanism drive the implant instrument to rotate and further drive the distal control release device to rotate, the inner tube and the outer sheath both remain stationary; the pull head can move along the axial direction of the inner tube.

2. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: The limiting member can prevent the slider from further axially moving toward the proximal end.

3. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: The limiting member is fixedly connected to the proximal end control release device or the limiting member can move axially along the inner tube between the proximal end control release device and the pulling head.

4. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: The pull head is fixedly connected to the limiting member or the pull head is separated from the limiting member. When the pull head is separated from the limiting member, a step is arranged between the pull head and the limiting member.

5. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: The limiting member is a sleeve member.

6. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: When at least one end of the limiting member is fixedly connected to the proximal control release device or the pull head, the limiting member is a sheet member.

7. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: The limiting member is provided with a plurality of cut lines.

8. A delivery system for a buffer-release implantable device according to claim 1, characterized in that: 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 circumferential position of the implant device needs to be adjusted, the control handle is operated to cause the adjustment mechanism to drive the proximal control release device to rotate, and the proximal control release device drives the implant device to rotate. During this process, the distal control release device rotates with the implant device and remains relatively still with the implant device.

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