A transcatheter heart valve delivery apparatus

Abstract

The present application relates to the technical field of medical devices, in particular to a transcatheter heart valve delivery device, comprising a rear catheter, a front catheter and a pull rope, a plurality of hook rope assemblies are installed on the front catheter in a circumferential array, the plurality of hook rope assemblies adjust different sliding strokes through gas, and then the rear catheter and the front catheter slide relative to each other to expand the balloon, at the same time, the hook rope assemblies at different positions hook the pull rope to pull the inner wall of the balloon, so as to realize adaptive adjustment of the edge shape of the balloon; through the sliding cooperation of the front catheter and the rear catheter, the umbrella-shaped stent inside the balloon is expanded and contracted, thereby assisting the balloon to expand quickly to position the valve implantation site, the hook rope assemblies pull the pull rope to adjust the expansion outer diameter of the balloon, so that the balloon obtains an expansion positioning shape more suitable for the implantation site, and the accuracy and close fit of the heart valve implantation release position are ensured.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a transcatheter heart valve delivery device. BACKGROUND

[0002] The heart is a very important organ of the human body, and the heart valve will open and close accordingly with the contraction and diastole of the heart, so the valve of the heart must be able to withstand the extrusion of blood and the surrounding annulus and the scouring of blood for a long time. If the valve cannot be completely closed or opened insufficiently due to disease or other reasons, it will cause blood reflux and insufficient blood supply. For example, stenosis of the valve will cause poor blood circulation or insufficiency, which will greatly increase the burden of the heart and cause heart failure. For such heart valve diseases, the traditional treatment method is to open the chest, stop the heart, open the heart under low temperature body circulation support, and perform surgical repair or replacement of the artificial valve. After the operation is completed, the heart is restarted and subsequent operations are completed. Surgical valve replacement surgery has large trauma, and the recovery time of the patient is long, so it is often contraindicated for elderly patients due to old age, poor physical condition, severe disease or other diseases.

[0003] The minimally invasive surgical technique is continuously developing, among which the artificial heart valve can be introduced into the patient's body by catheter, that is, the heart valve is placed by minimally invasive interventional surgery, so the surgery does not need to open the chest, and thus the trauma is small and the postoperative recovery is fast. It provides a new solution for those heart valve stenosis patients who cannot prolong their life or relieve their pain by current conventional treatment methods.

[0004] At present, the process of implanting an interventional artificial heart valve into the body usually relies on a certain delivery device to deliver the interventional artificial heart valve to the predetermined site for release. However, the existing delivery device cannot well meet the application requirements, especially the connection mechanism between the delivery device and the artificial heart valve usually has the following disadvantages: single function, low stability of connection with the valve and accuracy of release, complex connection and release operation, etc. Moreover, the release process is single, and it is difficult to adjust if the position is found to be inaccurate after the stent is expanded. In addition, it is difficult to ensure that the artificial heart valve can closely fit the implantation site when the heart valve is expanded by the inflation of the balloon, and the shape of the balloon is unstable, thereby causing poor fit and easy falling off of the artificial heart valve implantation.

[0005] In view of the above situation, in order to overcome the above technical problems, the present application designs a transcatheter heart valve delivery device, which solves the above technical problems. SUMMARY

[0006] The technical purposes to be achieved by the present application are as follows: through the sliding cooperation of the front catheter and the rear catheter, the umbrella-shaped stent inside the balloon is expanded in turn, thereby assisting the balloon to expand and position the valve implantation position quickly, and through the gas injection adjustment of the plurality of gas injection cylinders, the hook rope assembly pulls the rope to adjust the expansion outer diameter of the balloon when the umbrella-shaped stent is expanded inside the balloon, so that the balloon obtains an expansion and positioning shape more suitable for the implantation position, and the problems of unstable shape change of the balloon, and poor fitting and easy falling of the artificial heart valve implantation are solved.

[0007] In order to achieve the above technical purposes, the present application provides the following technical scheme.

[0008] The present application provides a transcatheter heart valve delivery device, which comprises:

[0009] a balloon for loading a crimped heart valve in a contracted state and expanding the heart valve in an expanded state;

[0010] a delivery tube for delivering the balloon loaded with the heart valve to an implantation position of the heart of a patient;

[0011] an operation handle connected to a proximal end of the delivery tube;

[0012] a delivery head for pre-alignment and puncture into an aortic valve orifice after the balloon passes through an aortic arch, the delivery head being connected to a distal end of the balloon;

[0013] The present application further comprises a rear catheter, a front catheter and a rope, the rear catheter passes through the delivery tube and reaches the implantation position of the heart, the proximal end of the balloon is connected to the rear catheter, the front catheter is coaxially and slidingly installed inside the rear catheter, and the distal end of the balloon is connected to the front catheter.

[0014] The delivery head is connected to the distal end of the balloon, pre-alignment and puncture into the aortic valve orifice after the balloon passes through the aortic arch, and ensures accurate implantation of the valve. The rear catheter reaches the implantation position of the heart through the delivery tube and is connected to the proximal end of the balloon. The front catheter is coaxially and slidingly installed inside the rear catheter, and the distal end of the balloon is connected to the front catheter. The sliding cooperation of the rear catheter and the front catheter enables the balloon to move and expand smoothly. The rope is connected to the inner wall of the balloon, the tension of the rope is adjusted to control the shape and expansion outer diameter of the balloon, and the balloon is adapted to the shape of the heart valve during implantation to achieve close fitting.

[0015] The rear catheter is hingedly connected with a sliding rocker, a pull rope is threaded through the sliding rocker, one end of the pull rope is connected to the inner wall of the maximum outer diameter of the balloon, and the other end of the pull rope is connected to the rear catheter; the front catheter is hingedly connected with one end of a support rod through a hinged seat ring on the front catheter, the other end of the support rod is hingedly connected to the middle part of the sliding rocker, and a plurality of hook rope assemblies are circumferentially arranged on the front catheter; the hook rope assemblies are adjusted by gas to have different sliding strokes, and when the rear catheter and the front catheter slide to support the balloon, the hook rope assemblies at different positions hook the pull rope to pull the inner wall of the balloon, so that the edge shape of the balloon is adaptively adjusted.

[0016] The hinged structure of the annular hinged structure and the sliding rocker enables the pull rope to accurately control the shape of the balloon; the hinged connection of the front catheter and the support rod and the pneumatic adjustment of the hook rope assembly make the fine adjustment of the balloon shape more flexible; and the mutual sliding support between the rear catheter and the front catheter enables the balloon to better fit the opening of the implantation site, thereby enhancing the adaptability and stability of the balloon in different implantation scenarios and ensuring accurate implantation and close fitting of the heart valve.

[0017] The rear catheter comprises sliding rockers, guide wheels and guide rings, the bottom ends of the sliding rockers are hingedly connected in a circumferential array on the rear catheter, guide rope grooves are formed in the sliding rockers for threading the pull rope, the lower end sidewalls of the sliding rockers are provided with the guide wheels, a set of guide rings is correspondingly arranged on the upper end of the rear catheter, each set of guide rings comprises two guide rings, one guide ring is used for threading the pull rope, and the other guide ring is used for fixing the lower end of the pull rope, and the upper end of the pull rope is connected to the inner wall of the balloon.

[0018] The guide rope grooves and the guide wheels accurately control the path of the pull rope, ensure that the pull rope is smoothly and controllably pulled inside the balloon, the universal guide wheels allow the pull rope to move freely at different angles, avoid the pull rope from being stuck or damaged due to friction, and the two guide rings ensure that the hook rope section formed by the pull rope is straight and stable, thereby providing a reliable traction path for the hook rope assembly; through the above structure, the hook rope assembly can flexibly adjust the shape of the balloon, so that the balloon can better adapt to the implantation site.

[0019] The front catheter comprises a hinged seat ring, a support rod, a pressure valve and a hook rope assembly, the hinged seat ring is arranged on the upper end of the front catheter, one end of the support rod is hingedly connected with the hinged seat ring, the other end of the support rod is hingedly connected with the middle part of the sliding rocker, the pressure valve is arranged on the front catheter, when the front catheter and the rear catheter slide to retract the sliding rocker and the support rod, the hinged connection between the support rod and the sliding rocker presses down the pressure valve, and the hook rope assembly is arranged on the front catheter and aligned with the pull rope between the two guide rings.

[0020] The pressing valve controls the folding range of the support rod and the sliding rocker through the limiting height, ensures the smoothness when it is unfolded, and helps to quickly unfold, improves the accuracy and efficiency of operation, reduces operation errors, improves the safety and success rate of operation.

[0021] The pressing valve comprises a valve shell, a valve cap and a valve core, the bottom of the valve shell is mounted on the front conduit, the bottom end of the inside of the valve shell is mounted with the valve core, the upper end of the valve core is slidably mounted with the valve cap, the inside of the valve core is provided with an air inlet channel, the bottom end of the air inlet channel is connected with an external air source, air guide grooves are arranged on the top end of the valve core, a communication cavity is arranged at the bottom end of the valve cap, a valve closing cavity is arranged above the communication cavity and is slidably matched with the top of the valve core, the top end of the air inlet channel is communicated with the communication cavity through the air guide grooves, and then is communicated with the air inlet channel arranged at the top of the valve cap, and the valve core and the valve cap are slidably reset by a spring.

[0022] The cooperation of the pressing valve with the folding state of the support rod and the sliding rocker ensures that the gas circuit is closed when the device is not unfolded, preventing accidental gas leakage; when the support rod and the sliding rocker are unfolded, the pressing valve is automatically opened, ensuring that the balloon inside is inflated synchronously, the stability and control of the gas filling process are ensured through the spring mechanism and the air guide channel, which helps the balloon to expand smoothly, reduces the damage to the transplantation site, and improves the safety and success rate of the operation.

[0023] A plurality of air injection barrels are circumferentially arranged in the front conduit, one end of each air injection barrel is connected with an air injection pipe, the air injection pipe is connected with an external air injection source, and a hook rope assembly is slidably mounted in each air injection barrel.

[0024] The independent control of the plurality of air injection barrels ensures the accurate control of different parts of the inner wall of the balloon, the position of each hook rope assembly is adjusted independently through the plurality of air injection barrels, the shape of the balloon is accurately adjusted, the specific inflation method can be needle cylinder injection or electric control inflation of a micro air pump, and then the accuracy of gas injection is ensured, a one-way valve and a corresponding air path design are arranged in the inflation pipeline to prevent gas leakage, the stability and safety of the system are ensured, and the balloon can better adapt to complex transplantation environment, ensure the close fitting and accurate positioning of the heart valve,

[0025] The hook rope assembly comprises a piston head, a connecting rod and a hook rope head, the piston head is slidably mounted in the air injection barrel, the bottom end of the piston head is connected with the connecting rod, and the bottom end of the connecting rod is connected with the hook rope head, a sliding groove is arranged on the front conduit and the rear conduit for the hook rope head to slide through, and the hook rope head slides along the sliding groove and hooks the pull rope.

[0026] The piston head forms a cylinder model in the gas injection cylinder, injects a controllable amount of gas, makes the piston head slide a certain stroke, thereby driving the hook rope head at the front end of the connecting rod to change position; when the front guide pipe and the rear guide pipe slide close to each other, the hook rope head slides in the sliding groove, after adjustment in conformity with the size of the implantation site, the hook rope heads at different positions hook the pull rope to pull the balloon to shape, so that the balloon is more fitted to the shape of the implantation site, the expansion outer diameter of the balloon is adjusted to ensure accurate implantation and close fitting of the heart valve, and the success rate of the operation and the postoperative recovery effect of the patient are improved.

[0027] The beneficial effects of the present application are as follows:

[0028] 1. The present application is assisted by the sliding cooperation of the front guide pipe and the rear guide pipe, so that the umbrella-shaped support inside the balloon expands and contracts, thereby assisting the balloon to quickly expand and position the valve implantation site, and the expansion outer diameter of the balloon is adjusted by the gas injection of the plurality of gas injection cylinders, so that the hook rope assembly pulls the pull rope to adjust the expansion outer diameter of the balloon when the umbrella-shaped support inside the balloon expands, so that the balloon obtains an expansion positioning shape more suitable for the implantation site, and the accuracy and close fitting of the heart valve implantation release position are ensured.

[0029] 2. The present application forms an expansion and contraction support for the balloon by the supporting rod and the sliding rocker, and a pressure valve is installed on the front guide pipe, and the supporting rod and the sliding rocker are contracted and pressed to close the valve, so that the supporting rod and the sliding rocker are expanded at the same time to open the pressure valve, so that the balloon obtains a more stable and soft inflation expansion posture when the support expands, which helps to stabilize the shape of the balloon and reduce the damage to the implantation site. BRIEF DESCRIPTION OF DRAWINGS

[0030] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0031] The above and other aspects of the present application will now be described by way of example only, with reference to the accompanying drawings in which:

[0032] Figure 1 is a schematic diagram of the overall structure of the present application;

[0033] Figure 2 is a sectional view of the present application Figure 1 at A-A;

[0034] Figure 3 is a schematic diagram of the internal structure of the balloon expansion of the present application;

[0035] Figure 4 is the cross-sectional view of B-B of the present application Figure 3 ;

[0036] Figure 5 is the structural schematic diagram of the front catheter and the rear catheter of the present application

[0037] Figure 6 is the top plan view of the present application Figure 5 ;

[0038] Figure 7 is the schematic diagram of the hooking rope assembly of the present application in the hooking rope state

[0039] Figure 8 is the structural schematic diagram of the rear catheter of the present application

[0040] Figure 9 is the structural schematic diagram of the front catheter of the present application

[0041] Figure 10 is the structural schematic diagram of the hooking rope assembly of the present application

[0042] Figure 11 is the structural schematic diagram of the pressure valve of the present application

[0043] Figure 12 is the cross-sectional view of C-C of the present application Figure 11 .

[0044] In the figure: 1, catheter; 2, catheter head; 3, rear catheter; 31, sliding rocker; 311, guide rope groove; 32, guide wheel; 33, guide ring; 4, front catheter; 41, hinged seat ring; 42, support rod; 43, pressure valve; 431, valve shell; 432, valve cap; 433, valve core; 434, air inlet channel; 435, air guide groove; 436, communication cavity; 437, valve closing cavity; 438, air filling channel; 44, hooking rope assembly; 441, piston head; 442, connecting rod; 443, hooking rope head; 45, air injection cylinder; 46, air injection pipe; 5, pull rope; 6, balloon; 7, heart valve. DETAILED DESCRIPTION

[0045] In order to better understand the above technical solutions, the above technical solutions will be described in detail below in combination with the drawings of the specification and specific embodiments.

[0046] As shown in Figures 1-12 , a catheter heart valve delivery device comprises:

[0047] a balloon 6 for loading a crimped heart valve 7 in a contracted state and expanding the heart valve 7 in an inflated state; the balloon 6 of the present application is internally provided with an umbrella-shaped stent structure which can assist the expansion of the balloon 6;

[0048] A delivery tube 1 for delivering a balloon 6 loaded with a heart valve 7 to an implantation site in a patient's heart;

[0049] An operating handle connected to a proximal end of the delivery tube 1;

[0050] A delivery head 2 for pre-alignment and penetration into the aortic valve orifice after the balloon 6 passes the aortic arch, the delivery head 2 being connected to a distal end of the balloon 6;

[0051] Further comprising a rear delivery tube 3, a front delivery tube 4 and a pull rope 5, the rear delivery tube 3 passing through the delivery tube 1 to reach the implantation site in the heart, the proximal end of the balloon 6 being connected to the rear delivery tube 3, the front delivery tube 4 being coaxially and slidingly installed inside the rear delivery tube 3, the distal end of the balloon 6 being connected to the front delivery tube 4;

[0052] The proximal end of the balloon 6 is connected to the front delivery tube 4, and the distal end is connected to the rear delivery tube 3, relative sliding of the front delivery tube 4 and the rear delivery tube 3 causes corresponding changes in the vertical connection end of the balloon 6, specifically, the operator pulls the front delivery tube 4, the balloon 6 connection at the front end of the front delivery tube 4 and the balloon 6 connection at the rear end of the rear delivery tube 3 approach each other, thereby enabling the balloon 6 to better form a stable spherical shape;

[0053] The rear delivery tube 3 is circumferentially hinged with a sliding rocker 31, the sliding rocker 31 is internally threaded with a pull rope 5, one end of the pull rope 5 is connected to the inner wall of the maximum outer diameter of the balloon 6, the other end of the pull rope 5 is connected to the rear delivery tube 3; the front delivery tube 4 is hinged with a support rod 42 at one end through a hinge seat ring 41 thereon, the other end of the support rod 42 is hinged to the middle part of the sliding rocker 31, a plurality of hook rope assemblies 44 are also circumferentially installed on the front delivery tube 4, the plurality of hook rope assemblies 44 adjust different sliding strokes through pneumatic adjustment, thereby the rear delivery tube 3 and the front delivery tube 4 sliding away from each other to expand the balloon 6, at the same time, the hook rope assemblies 44 at different positions hook the pull rope 5 to pull the inner wall of the balloon 6, thereby realizing adaptive adjustment of the edge shape of the balloon 6.

[0054] On the rear delivery tube 3, an annular arrangement of hinge structures is arranged, in which a sliding rocker 31 is connected, the sliding rocker 31 is internally threaded with a pull rope 5, one end of the pull rope 5 is connected to the inner wall of the maximum outer diameter of the balloon 6, the other end is fixed to the rear delivery tube 3, thereby when the balloon 6 is inflated, by adjusting the tension of the pull rope 5, the shape and size of the balloon 6 can be effectively controlled;

[0055] The front catheter 4 is connected with one end of the support rod 42 through the hinged seat ring 41 on it, and the other end of the support rod 42 is hinged with the middle part of the sliding rocker 31; in addition, a plurality of hook rope assemblies 44 are installed on the periphery of the front catheter 4, and the sliding stroke of the hook rope assemblies 44 is adjusted by the pneumatic device, so as to fine-tune the shape of the balloon 6; through the above setting, the mutual sliding support between the rear catheter 3 and the front catheter 4, cooperating with the hook rope assemblies 44 at different positions to lock the pull rope 5, can adjust the edge shape of the balloon 6 according to the need of the opening fitting shape of the implantation site when the balloon 6 is inflated; not only enhances the adaptability of the balloon 6, but also ensures the stability and reliability in various implantation scenes.

[0056] As shown in Figure 8 , the rear catheter 3 comprises a sliding rocker 31, a guide wheel 32 and a guide ring 33, a plurality of bottom ends of the sliding rockers 31 are circumferentially hinged on the rear catheter 3, a guide rope groove 311 is opened on the sliding rocker 31 for passing through the pull rope 5, the guide wheel 32 is installed on the lower end side wall of the sliding rocker 31, and a set of guide rings 33 are correspondingly installed on the upper end of the rear catheter 3, the guide rings 33 are two in a group, one guide ring 33 is used for passing through the pull rope 5, and the other guide ring 33 is used for fixing the lower end of the pull rope 5, and the upper end of the pull rope 5 is connected with the inner wall of the balloon 6.

[0057] The guide rope groove 311 on the sliding rocker 31 guides and limits the pull rope 5, and the guide wheel 32 on one side of the sliding rocker 31 is also provided with a universal rotating guide wheel 32, the pull rope 5 passes out of the opening on one side of the sliding rocker 31, and then is adjusted and guided through the universal rotating guide wheel 32, the pull rope 5 extends downward and passes through the two guide rings 33 in turn, and is connected on the distal guide ring 33, the pull rope 5 forms a straight hook rope section between the two guide rings 33, which can be pulled and dragged by the hook rope head 443, so that the hook rope assemblies 44 with different strokes can pull and drag the shape inside the balloon 6, so as to realize the shape adjustment of the balloon 6.

[0058] As shown in Figure 9 , the front catheter 4 comprises a hinged seat ring 41, a support rod 42, a pressure valve 43 and a hook rope assembly 44, the hinged seat ring 41 is installed on the upper end of the front catheter 4, one end of the support rod 42 is hinged with the hinged seat ring 41, the other end of the support rod 42 is hinged with the middle part of the sliding rocker 31, the pressure valve 43 is installed on the front catheter 4, when the front catheter 4 and the rear catheter 3 slide to retract the sliding rocker 31 and the support rod 42, the hinged part of the support rod 42 and the sliding rocker 31 presses downward on the pressure valve 43, and the hook rope assembly 44 is installed on the front catheter 4 and is aligned with the pull rope 5 between the two guide rings 33.

[0059] The pressing valve 43 is pressed by the support rod 42 and the sliding rocker 31 in the initial state, and also provides a certain limiting height, so that the folding range of the support rod 42 and the sliding rocker 31 is limited, thereby ensuring that the support rod 42 and the sliding rocker 31 always retain a certain bending degree after folding, which is convenient for rapid unfolding. If the support rod 42 and the sliding rocker 31 are folded beyond the limit, they are in the same straight line, which may cause the support rod 42 and the sliding rocker 31 to fail to be smoothly unfolded during sliding unfolding, thereby affecting the operation accuracy of the operator.

[0060] As shown in Figure 11 and Figure 12 , the pressing valve 43 comprises a valve shell 431, a valve cap 432 and a valve core 433, the bottom of the valve shell 431 is mounted on the front conduit 4, the bottom end of the inside of the valve shell 431 is provided with the valve core 433, the upper end of the valve core 433 is slidably provided with the valve cap 432, the inside of the valve core 433 is provided with an air inlet channel 434, the bottom end of the air inlet channel 434 is connected with an external air source, the two sides of the top end of the valve core 433 are provided with air guide grooves 435, the bottom end of the valve cap 432 is provided with a communication cavity 436, the upper part of the communication cavity 436 is provided with a valve closing cavity 437 which is slidably matched with the top of the valve core 433, the top end of the air inlet channel 434 is communicated with the communication cavity 436 through the air guide grooves 435, and then communicated with the air filling channel 438 provided at the top of the valve cap 432, and the valve core 433 and the valve cap 432 are slidably reset by a spring.

[0061] In the initial state, the pressing valve 43 is pressed by the support rod 42 and the sliding rocker 31 in the folded state, and then the valve shell 431 at the top of the pressing valve 43 is pressed downward, so that the valve closing cavity 437 in the valve shell 431 is matched with the air guide grooves 435 at the upper end of the valve core 433, thereby making the pressing valve 43 in the closed state; when the folding state of the support rod 42 and the sliding rocker 31 changes to the unfolded state, the valve shell 431 at the top of the pressing valve 43 is released, the internal spring lifts the valve shell 431, the air guide grooves 435 are separated from the valve closing cavity 437, the air guide grooves 435 are communicated with the communication cavity 436, and the air path is communicated in sequence through the air filling channel 438-air guide grooves 435-communication cavity 436-valve closing cavity 437-air filling channel 438, thereby realizing the synchronous inflation of the balloon 6 inside.

[0062] As shown in Figure 4 , Figure 6 and Figure 9 , a plurality of air injection cylinders 45 are circumferentially arranged in the front conduit 4, one end of the air injection cylinder 45 is connected with an air injection pipe 46, the air injection pipe 46 is connected with an external air injection source, and a hook rope assembly 44 is slidably mounted in the air injection cylinder 45. Each air injection cylinder 45 can independently adjust the air injection amount.

[0063] The plurality of air injection cylinders 45 respectively regulate the positions of the inner walls of the plurality of balloons 6 corresponding to the pulling of the plurality of pull ropes 5, and the air injection adjustment mode of the air injection cylinder 45 can adopt a needle cylinder quantitative air injection mode, and a sensitive one-way valve needs to be matched in the air injection pipe 46 to prevent the leakage of the injected adjustment gas; the hook rope assembly 44 presents different hook rope positions under the action of different air volumes in the air injection cylinder 45, thereby changing the shape of the balloon 6 in different adaptive positions.

[0064] As shown in Figures 7-10 The hook rope assembly 44 includes a piston head 441, a connecting rod 442 and a hook rope head 443, the piston head 441 is slidingly installed in the air injection cylinder 45, the bottom end of the piston head 441 is connected with the connecting rod 442, the bottom end of the connecting rod 442 is connected with the hook rope head 443, the front catheter 4 and the rear catheter 3 are both provided with a sliding groove for the hook rope head 443 to slide through, and the hook rope head 443 slides along the sliding groove and hooks the pull rope 5.

[0065] The hook rope assembly 44 adjusts the position of the hook rope head 443 by sliding in the air injection cylinder 45, specifically, the piston head 441 forms a cylinder model in the air injection cylinder 45, and the air injection cylinder 45 is injected with an adjustable air volume, thereby making the piston head 441 slide a certain stroke, thereby changing the position of the hook rope head 443 at the front end of the connecting rod 442, so that when the front catheter 4 and the rear catheter 3 slide close to each other, the hook rope head 443 slides in the sliding groove on them, and the hook rope head 443 at different positions can hook the pull rope 5 to pull and shape the balloon 6 after adjusting to conform to the size of the implantation site, so that the balloon 6 obtains a shape that conforms to the implantation site.

[0066] In the working process of the application, the operator first positions the guide catheter 1 to the heart implantation site through the guide wire, then loads the artificial heart valve 7 into the delivery device, and delivers it to the heart implantation site through the guide catheter 1, and then the operator pulls the front catheter 4, so that the front catheter 4 slides on the rear catheter 3, the sliding of the front catheter 4 makes the support rod 42 on it extrude along the pulling direction, and then the support rod 42 pushes the sliding rocker 31 to rotate and expand, and the front end of the sliding rocker 31 presses the inside of the balloon 6, so that the balloon 6 expands in shape.

[0067] Meanwhile, when the support rod 42 and the sliding rocker 31 are unfolded, the pressure valve 43 is released, and the external air source inflates the balloon 6 through the air inlet channel 434 and the air filling channel 438 in the pressure valve 43, so that the balloon 6 is inflated and expanded under the double action of the stent and the gas; after the balloon 6 is inflated and expanded, the inflation is stopped, and the inner wall of the balloon 6 is reshaped under the traction of the pull rope 5. Specifically, the operator inflates the air cylinder 45 in the front catheter 4 by a small amount, and then the hook rope assembly 44 slides in the air cylinder 45, the hook rope head 443 pulls the pull rope 5 at different positions, and then the pull rope 5 pulls the inner wall of the balloon 6, so as to realize the fine adjustment of the shape of the balloon 6.

[0068] After the transplantation is completed, the operator can pull the rear catheter 3, and then the support rod 42 and the sliding rocker 31 between the front catheter 4 and the rear catheter 3 are mutually contracted and folded. It is worth noting that at this time, the inflation in the balloon 6 needs to be stopped, that is, the inflation source of the pressure valve 43 is disconnected, until the support rod 42 and the sliding rocker 31 are folded and pressed against the pressure valve 43, so that the pressure valve 43 is closed, and finally the catheter delivery device is withdrawn.

[0069] In addition, the operator can measure the opening of the heart valve 7 in advance, and then adjust the sliding stroke of the pull rope 5 assembly in advance. Specifically, the air in the multiple air cylinders 45 is adjusted separately in advance, so that the heads of the pull ropes 5 at different positions have different stroke adjustment amounts, thereby improving the efficiency of the transplantation.

[0070] The description herein is provided so that those of ordinary skill in the art can implement or use the present disclosure. Various modifications to the present disclosure will be apparent to those of ordinary skill in the art, and the general principles defined herein can be applied to other variations without departing from the scope of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but should be given the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A transcatheter heart valve delivery device, comprising: a balloon (6) for loading a crimped heart valve (7) in a deflated state and expanding the heart valve (7) in an inflated state; a delivery catheter (1) for delivering the balloon (6) loaded with the heart valve (7) to an implantation site of a patient's heart; an operating handle connected to a proximal end of the delivery catheter (1); a delivery head (2) for pre-alignment and penetration into aortic valve orifice after the balloon (6) passes through the aortic arch, the delivery head (2) being connected to a distal end of the balloon (6); characterized in that it further comprises a rear catheter (3), a front catheter (4) and a pull rope (5), the rear catheter (3) passing into the delivery catheter (1) and reaching the implantation site of the heart, a proximal end of the balloon (6) being connected to the rear catheter (3), the front catheter (4) being coaxially and slidingly installed inside the rear catheter (3), a distal end of the balloon (6) being connected to the front catheter (4); a plurality of sliding rocker arms (31) are circumferentially hinged to the rear catheter (3), the pull rope (5) is threaded through the sliding rocker arms (31), one end of the pull rope (5) is connected to an inner wall of the balloon (6) at a maximum outer diameter, the other end of the pull rope (5) is connected to the rear catheter (3), the front catheter (4) is hinged to one end of a support rod (42) through a hinged seat ring (41) thereon, the other end of the support rod (42) is hinged to a middle portion of the sliding rocker arms (31), a plurality of hooking rope assemblies (44) are circumferentially installed on the front catheter (4), the hooking rope assemblies (44) are adjusted by gas pressure to have different sliding strokes, so that the rear catheter (3) and the front catheter (4) slide relative to each other to expand the balloon (6), and the hooking rope assemblies (44) at different positions hook the pull rope (5) to pull the inner wall of the balloon (6), thereby achieving adaptive adjustment of the edge shape of the balloon (6).

2. The transcatheter heart valve delivery apparatus of claim 1, wherein: the rear catheter (3) comprises the sliding rocker arms (31), guide wheels (32) and guide rings (33), the bottom ends of the sliding rocker arms (31) are circumferentially hinged to the rear catheter (3), the sliding rocker arms (31) are provided with guide rope grooves (311) for threading the pull rope (5), the guide wheels (32) are installed on the lower end sidewalls of the sliding rocker arms (31), a set of guide rings (33) are correspondingly installed on the rear catheter (3), the guide rings (33) are two in a set, one guide ring (33) is used for threading the pull rope (5), and the other guide ring (33) is used for fixing the lower end of the pull rope (5), the upper end of the pull rope (5) is connected to the inner wall of the balloon (6).

3. The transcatheter heart valve delivery apparatus of claim 2, wherein: The front pipe (4) comprises a hinged seat ring (41), a support rod (42), a pressure valve (43) and a hook rope assembly (44), the hinged seat ring (41) is installed on the upper end of the front pipe (4), one end of the support rod (42) is hinged with the hinged seat ring (41), the other end of the support rod (42) is hinged with the middle part of the sliding rocker (31), the pressure valve (43) is installed on the front pipe (4), when the front pipe (4) and the rear pipe (3) slide to collect the sliding rocker (31) and the support rod (42), the hinged part of the support rod (42) and the sliding rocker (31) presses down the pressure valve (43), the hook rope assembly (44) is installed on the front pipe (4) and is aligned with the pull rope (5) between the two guide rings (33).

4. The transcatheter heart valve delivery apparatus of claim 3, wherein: The pressure valve (43) comprises a valve shell (431), a valve cap (432) and a valve core (433), the bottom of the valve shell (431) is installed on the front pipe (4), the bottom end of the inside of the valve shell (431) is installed with the valve core (433), the upper end of the valve core (433) is slidably installed with the valve cap (432), the inside of the valve core (433) is provided with an air inlet channel (434), the bottom end of the air inlet channel (434) is connected with an external air source, the two sides of the top end of the valve core (433) are provided with air guide grooves (435), the bottom end of the valve cap (432) is provided with a communication cavity (436), the upper part of the communication cavity (436) is provided with a valve closing cavity (437) which is slidably matched with the top part of the valve core (433), the top end of the air inlet channel (434) is communicated with the communication cavity (436) through the air guide grooves (435), and then is communicated with the air inlet channel (438) provided on the top part of the valve cap (432), and the valve core (433) and the valve cap (432) are slidably reset by a spring.

5. The transcatheter heart valve delivery apparatus of claim 2, wherein: A plurality of air injection cylinders (45) are circumferentially arranged in the front pipe (4), one end of the air injection cylinder (45) is connected with an air injection pipe (46), the air injection pipe (46) is connected with an external air injection source, the hook rope assembly (44) is slidably installed in the air injection cylinder (45), and the air injection amount of each air injection cylinder (45) can be adjusted independently.

6. The transcatheter heart valve delivery apparatus of claim 5, wherein: The hook rope assembly (44) comprises a piston head (441), a connecting rod (442) and a hook rope head (443), the piston head (441) is slidably installed in the air injection cylinder (45), the bottom end of the piston head (441) is connected with the connecting rod (442), the bottom end of the connecting rod (442) is connected with the hook rope head (443), the front pipe (4) and the rear pipe (3) are provided with sliding grooves for the sliding of the hook rope head (443), and the hook rope head (443) is hooked with the pull rope (5) along the sliding grooves.

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