A valve delivery device

By designing the translation and curve mechanism separately, combining the perspective window and indicator, and dislocating the hyperbolo tube design, the problem of existing valve conveyors being difficult to accurately locate and quickly release the artificial valve, achieving efficient valve implantation effect.

CN119279859BActive Publication Date: 2025-08-29SHENZHEN SHUNMEI MEDICAL CO LTD
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Patent Information

Application Number
CN202411494564.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-10-24
Publication Date
2025-08-29
Estimated Expiration
2044-10-24

AI Technical Summary

Technical Problem

Existing valve delivery devices are difficult to achieve precise positioning and rapid release of artificial valves, especially alignment and coaxial release at the aortic valve orifice.

Method used

A valve conveyor is designed, using a separate translation mechanism and a curve mechanism to independently control the translation and curve movements, combining the perspective window and indicator to provide real-time feedback. The hyperbolometer adopts misaligned cutting and misaligned hole punching design to adapt to the human aortic structure and ensure visualization using a total development material.

Benefits of technology

The precise positioning and rapid release of artificial valves is achieved, the success rate and safety of the surgery are improved, the risk of damage to blood vessels by hyperboloid tubes is reduced, and the accuracy and visualization of the operation are enhanced.

✦ Generated by Eureka AI based on patent content.

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    Figure CN119279859B_ABST
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Abstract

The present invention discloses a valve delivery device, which realizes precise positioning and rapid release of an artificial valve from the following three aspects: first, the translation mechanism and the bending adjustment mechanism of the valve delivery device are designed separately, and the translation and bending adjustment are independently controlled. The bending adjustment mechanism can support multi-directional bending, while the translation mechanism is responsible for linear movement, so that the doctor can more accurately adjust the position and direction of the valve delivery device during the operation. The combination of the two can realize multi-dimensional precise control, so that the artificial valve remains coaxial with the position of the diseased valve when released; second, the sea wave tube is made of staggered cutting and staggered punching to make the bending of the sea wave tube more consistent with the structure of the human aorta, the force is more uniform, the sea wave tube arch is reduced, and the artificial valve and the diseased valve position are kept coaxial for release; third, the sea wave tube is made of fully developing materials so that the doctor can check whether the artificial valve and the diseased valve position remain coaxial and judge the time of artificial valve implantation.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve delivery device. Background Art

[0002] The heart is an important organ in the human body, providing blood circulation for the human body. Inside the heart, there are four sets of valves that act as one-way valves, controlling the flow of blood from one direction to another and preventing it from flowing back. The valve between the left atrium and the left ventricle is the mitral valve, the valve between the right atrium and the right ventricle is the tricuspid valve, the valve between the left ventricle and the aorta is the aortic valve, and the valve between the right ventricle and the pulmonary artery is the pulmonary valve. Valvular diseases in the heart can affect the normal flow of blood, thereby causing abnormal heart function. The current treatment for valvular diseases is One of the methods is transcatheter valve replacement, which is a new minimally invasive valve treatment method that uses a valve delivery device to deliver an artificial valve to the native valve ring to replace the function of the native valve. The existing valve delivery device includes a handle, a delivery system and a balloon. The handle and the balloon are respectively arranged at both ends of the delivery system. The artificial valve is installed in a curled state at the distal end of the delivery system. The delivery system advances through the patient's blood vessels to the implantation position. The artificial valve at the distal end of the delivery system is supported by the expansion of the balloon. This treatment method can effectively improve treatment efficiency and relieve the patient's pain.

[0003] However, existing valve delivery devices can only adjust the curvature of the delivery system through a handle to adapt to the course of blood vessels. The distal end of the delivery system usually cannot be aligned with the aortic valve orifice, making it difficult to ensure that the artificial valve remains coaxial with the diseased valve position during release, and it is impossible to simultaneously achieve precise positioning and rapid release of the artificial valve. Summary of the Invention

[0004] In order to solve the above-mentioned problems, the present invention provides a valve delivery device, comprising a balloon, a delivery system and a handle connected in sequence along the X-axis direction, the delivery system comprising a translation mechanism and a bending adjustment mechanism, the translation mechanism being arranged at the end of the bending adjustment mechanism away from the balloon along the X-axis direction, and being coaxially arranged with the bending adjustment mechanism; the handle comprising a translation handle and a bending adjustment handle, the translation handle being arranged at the end of the bending adjustment handle away from the balloon along the X-axis direction, and being coaxially arranged with the bending adjustment handle; the translation handle controls the translation mechanism, the bending adjustment handle controls the bending mechanism, the bending adjustment mechanism comprising a perspective window and an indicator, the indicator being fixed at the bottom of the perspective window, and the indicator being fixed to the bending adjustment handle together with the perspective window.

[0005] Preferably, the translation mechanism includes a catheter connector, a translation catheter, a translation center rod, a translation sliding sleeve and a needle hole valve gasket, the catheter connector is fixed to the end of the translation catheter away from the balloon, the translation center rod is sleeved on the translation catheter, the translation sliding sleeve is sleeved on the translation center rod, and the needle hole valve gasket is arranged at the end of the translation center rod close to the balloon.

[0006] Preferably, the bending mechanism includes an inner bending catheter, a hypotube, a spring, a metal ring, an outer bending catheter, a bending center rod, a bending wire, a bending slider and a bending threaded sleeve. The inner bending catheter is sleeved on the translation catheter, the hypotube, the spring and the metal ring are all sleeved on the inner bending catheter and are all arranged in the outer bending catheter. The spring is located at the end of the hypotube away from the balloon, one end of the spring is fixedly connected to the hypotube, the other end of the spring is fixed on the inner bending catheter, the end of the hypotube away from the spring is fixedly connected to the metal ring, and the outer bending catheter The end away from the balloon is sleeved in the bending adjustment center rod, the bending adjustment center rod is arranged at the end of the translation center rod close to the balloon and is fixedly connected to the translation center rod, the pinhole valve gasket is arranged between the bending adjustment center rod and the translation center rod, one end of the bending adjustment wire is sleeved on the sea wave tube, and the other end of the bending adjustment wire passes through the spring and comes out of the through hole on the bending adjustment outer catheter and is fixed on the bending adjustment slider, the bending adjustment slider is arranged in the bending adjustment threaded sleeve and is threadedly connected to the bending threaded sleeve, the bending adjustment slider is sleeved on the bending adjustment center rod and cooperates with the bending center rod through a slide groove.

[0007] Preferably, the sea wave tube includes a tube body, which includes a rear section, a middle section and a front section in sequence along the X-axis direction, and the rear section, the middle section and the front section all include side circumferential surfaces, and the side circumferential surfaces are provided with multiple slits connected to the tube body along the axial direction of the tube body, wherein the width of the slit located in the rear section is less than the width of the slit located in the middle section < the width of the slit located in the front section, and ribs are formed between adjacent slits, and guide holes are provided on the ribs, and any adjacent guide holes are arranged at an angle along the axial direction of the tube body, and in any adjacent guide holes, the guide hole close to one end of the balloon is deflected toward the same side at an equal angle relative to the guide hole close to the handle end in the circumferential direction of the tube body, and the deflection angle of the guide hole opened on the first rib located in the rear section and the guide hole opened on the last rib located in the front section are 0~180°.

[0008] Preferably, the hypotube is made of any one of gold, platinum, platinum-iridium alloy, tungsten, and gold-plated tungsten.

[0009] Preferably, the guide holes are uniformly circular, square, elliptical or other special-shaped holes of the same shape.

[0010] Preferably, the side circumferential surface is further provided with a turning hole, and the turning holes are uniformly circular, square or elliptical.

[0011] Preferably, the extension direction of each slit is set at an angle to the axial direction of the tube body, wherein among any two adjacent slits on the side surface, the slit close to the balloon end is deflected to the same side at an equal angle relative to the slit close to the handle end in the circumferential direction of the sea wave tube.

[0012] Preferably, the translation handle includes a translation handle back cover, a translation handle knob and a translation handle shell. The translation handle back cover is fixedly connected to the translation mechanism sliding sleeve. The catheter connector passes through the translation handle back cover and its movable range is limited by the translation handle back cover. The translation handle knob is sleeved on the translation sliding sleeve and threadedly connected to the translation sliding sleeve. By rotating the translation handle knob, the translation sliding sleeve moves back and forth along the X-axis and thereby drives the balloon to move back and forth. The translation handle shell is sleeved on the translation handle knob and fixedly connected to the bending adjustment center rod.

[0013] Preferably, the bending adjustment handle includes a bending adjustment handle shell, a bending adjustment handle knob and a bending adjustment handle front end cover. The bending adjustment handle shell is mounted on the bending adjustment center rod and fixedly connected to the bending adjustment center rod. The bending adjustment handle front end cover is arranged at one end of the bending adjustment handle shell close to the balloon. The bending adjustment handle knob is arranged between the bending adjustment handle shell and the bending adjustment handle front end cover. The bending adjustment handle knob is fixedly connected to the bending adjustment handle shell and the bending handle front end cover respectively. The bending center rod is threadedly connected to the front end cover of the bending handle close to the balloon.

[0014] The beneficial effects are:

[0015] 1. This application separately designs the translation and bending mechanisms of the valve delivery device, independently controlling the translation and bending movements. This allows the surgeon to more precisely adjust the position and direction of the valve delivery device during surgery. The bending mechanism supports multi-directional bending, while the translation mechanism is responsible for linear movement. The combination of the two enables multi-dimensional precise control. During percutaneous aortic valve implantation, the independent translation and bending mechanisms can help the surgeon quickly align the prosthetic valve on the balloon with the aortic valve orifice, ensuring that the prosthetic valve remains coaxial with the diseased valve position during release, achieving precise positioning and rapid release of the prosthetic valve. During transcatheter mitral valve repair / replacement surgery, the independent translation and bending mechanisms can better cope with the complex left atrial and left ventricular structures, improving the success rate and safety of the surgery. In addition, a transparent window is added to the bending handle to more clearly observe the internal mechanism of the valve delivery device, ensuring operational accuracy. An indicator is added to display the current position and status of the bending mechanism, providing real-time feedback to help the surgeon make quick decisions.

[0016] 2. In order to avoid the damage of blood vessels and inaccurate positioning of the artificial valve caused by the excessive arch of the hypotube, the present application further improves the hypotube by dividing the hypotube into a rear section, a middle section and a front section. The side surface of the hypotube is cut so that the slit width at the rear section is less than the slit width at the middle section and less than the slit width at the front section. Through this gradual slit width design, the hypotube can maintain its overall flexibility while providing necessary rigidity and support. The large slit width of the front section makes the front section more flexible and can better adapt to complex vascular pathways. The small slit width of the rear section makes the rear section more rigid and can provide better support and thrust, which helps to push the entire conveyor forward. The slit width of the middle section is between the front section and the rear section, which plays a transition role, ensuring a smooth transition between the flexibility and rigidity of different parts of the entire hypotube. This gradual slit width design can also ensure that the torque is evenly transmitted along the entire axial direction of the hypotube, reducing the deformation of the hypotube.

[0017] In addition, by staggering the cutting of the hypotube, any two adjacent slits are deflected to the same side at an equal angle in the circumferential direction of the hypotube. In this way, when the bending mechanism is used for bending, the hypotube will compensate for the adduction angle along the staggered empty spiral, making the delivery system more consistent with the structure of the human aorta and making it easier for the artificial valve to remain coaxial with the position of the diseased valve when released; by staggering the drilling of the hypotube, the guide holes on any adjacent ribs are deflected to the same side at an equal angle in the circumferential direction of the hypotube. In this way, when the bending wire passes through the guide holes on all the ribs and then the wire is pulled, the bending force of the hypotube can be more uniform, the nonlinear bending of the hypotube can be reduced, and the bow of the hypotube can be reduced, which can further ensure that the artificial valve and the diseased valve position remain coaxial during release.

[0018] 3. The hypotube used in this application is made of fully developing materials, so that doctors can check whether the artificial valve and the diseased valve are coaxial and determine the time of artificial valve implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0020] Figure 1 Schematic diagram of the overall structure of the valve delivery device;

[0021] Figure 2 is a cross-sectional view of the valve delivery device;

[0022] Figure 3 This is a schematic diagram of the valve delivery device explosion structure;

[0023] Figure 4Schematic diagram of the hypotube structure;

[0024] Figure 5 This is a schematic diagram of the structure of the hypotube after offset cutting and offset punching;

[0025] Figure 6 Schematic diagram of the relative positions of the guide holes on the first and last ribs of the hypotube;

[0026] 1. Balloon;

[0027] 2. Conveying system;

[0028] 21. Translation mechanism; 210. Catheter connector; 211. Translation catheter; 212. Translation sliding sleeve; 213. Translation center rod; 214. Needle valve gasket;

[0029] 22. Bending mechanism;

[0030] 220, bend the inner catheter;

[0031] 221, hypotube; 2211, rear section; 2212, middle section; 2213, front section; 2214, side surface; 2215, slit; 2216, rib; 22161, first rib; 22162, last rib; 2217, guide hole; 2218, turning hole;

[0032] 222. Spring; 223. Metal ring; 224. External bending guide tube; 225. Center bending rod; 226. Bending wire; 227. Bending slider; 228. Bending threaded sleeve; 229. Perspective window; 2291. Indicator;

[0033] 3 handles;

[0034] 31. Translation handle; 310. Translation handle back cover; 311. Translation handle knob; 312. Translation handle housing;

[0035] 32. Bending handle; 320. Bending handle housing; 321. Bending handle knob; 322. Bending handle front end cover. DETAILED DESCRIPTION

[0036] The following diagrams illustrate various embodiments of the present invention. For clarity, many practical details are included in the following description. However, it should be understood that these practical details are not intended to limit the present invention. In other words, in some embodiments of the present invention, these practical details are not essential. Furthermore, to simplify the drawings, some commonly used structures and components are depicted in simplified schematic form.

[0037] It should be noted that all directional indications such as up, down, left, right, front, back, etc. in the embodiments of the present invention are only used to explain the relative position relationship, movement status, etc. between the various components in a certain specific posture as shown in the accompanying drawings. If the specific posture changes, the directional indication will also change accordingly.

[0038] In addition, in the present invention, descriptions such as "first" and "second" are only used for descriptive purposes and do not specifically refer to the order or sequence, nor are they used to limit the present invention. They are only used to distinguish components or operations described with the same technical terms, and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in this field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0039] Example

[0040] An embodiment of the present invention provides a valve delivery device for delivering an artificial valve or valve stent to a patient's heart, comprising a balloon 1, a delivery system 2, and a handle 3 connected in sequence along the X-axis direction; the artificial valve is sleeved on the contracted balloon 1, and the balloon 1 is used to load the curled artificial valve in the contracted state and to expand the artificial valve in the expanded state; the delivery system 2 is used to deliver the balloon 1 loaded with the artificial valve to the implantation position in the patient's heart.

[0041] See also Figure 1 and Figure 2 , Figure 1 This is a schematic diagram of the overall structure of the valve delivery device. Figure 2 This is a cross-sectional view of the valve delivery device. The X-axis is established along the length of the valve delivery device. The delivery system 2 includes a translation mechanism 21 and a bending mechanism 22. The translation mechanism 21 is located along the X-axis at the end of the bending mechanism 22 away from the balloon 1 and is coaxial with the bending mechanism 22. The handle 3 includes a translation handle 31 and a bending handle 32. The translation handle 31 is located along the X-axis at the end of the bending handle 32 away from the balloon 1 and is coaxial with the bending handle 32. The translation handle 31 controls the translation mechanism 21, and the bending handle 32 controls the bending mechanism 22.

[0042] By designing the translation mechanism 21 and the bending mechanism 22 separately, and independently controlling the translation and bending actions, the doctor can more accurately adjust the position and direction of the valve delivery device during the operation. The bending mechanism 22 can support multi-directional bending, and the translation mechanism 21 is responsible for moving the balloon 1 in a straight line. The combination of the two can achieve multi-dimensional precise control. In percutaneous aortic valve implantation surgery, the independent translation mechanism 21 and the bending mechanism 22 can help the doctor quickly align the artificial valve on the balloon with the aortic valve orifice, so that the artificial valve remains coaxial with the diseased valve position when released, thereby achieving precise positioning and rapid release of the artificial valve. In transcatheter mitral valve repair / replacement surgery, the independent translation mechanism 21 and the bending mechanism 22 can better cope with the complex left atrium and left ventricle structure, thereby improving the success rate and safety of the operation.

[0043] Refer back Figure 2 Combined with Figure 3 As shown, Figure 3 This is a schematic diagram of the valve delivery device's exploded structure. The translation mechanism 21 includes a catheter connector 210, a translation catheter 211, a translation sliding sleeve 212, a translation center rod 213, and a needle valve gasket 214. The bending mechanism 22 includes an inner bending catheter 220, a hypotube 221, a spring 222, a metal ring 223, an outer bending catheter 224, a bending center rod 225, a bending wire 226, a bending slider 227, a bending threaded sleeve 228, a perspective window 229, and an indicator 2291. The translation handle 31 includes a translation handle rear cover 310, a translation handle knob 311, and a translation handle housing 312. The bending handle 32 includes a bending handle housing 320, a bending handle knob 321, and a bending handle front cover 322.

[0044] The catheter connector 210 is fixed to the end of the translation catheter 211 away from the balloon 1. The catheter connector 210 and the translation catheter 211 can be fixedly connected by screw connection, clamping, etc. In order to ensure the sealing of the connection, a sealant or a sealing tape can be applied to the connection. The translation center rod 213 is sleeved on the translation catheter 211, and the translation sliding sleeve 212 is sleeved on the translation center rod 213 and fixedly connected to the translation center rod 213.

[0045] The translation handle rear cover 310 is fixedly connected to the translation mechanism sliding sleeve 212 through a slot. A preferred method is to connect the translation handle rear cover 310 and the translation mechanism sliding sleeve 212 through a slot clamp for easy disassembly and maintenance. The catheter connector 210 passes through the translation handle rear cover 310 and is limited in its range of motion by the translation handle rear cover 310. The translation handle knob 311 is sleeved on the translation sliding sleeve 212 and is threadedly connected to the translation sliding sleeve 212. By rotating the translation handle knob 311, the translation sliding sleeve 212 moves forward and backward along the X-axis, thereby driving the balloon 1 to move forward and backward. The translation handle housing 312 It is sleeved on the translation handle knob 311 and fixedly connected to the bending center rod 225. The bending center rod 225 is arranged between the translation handle housing 312 and the bending handle housing 320. The bending center rod 225 includes a rod body and a mounting seat. The rod body is arranged perpendicular to the mounting seat and is integrally formed with the mounting seat. Protrusions are provided on both sides of the mounting seat, and slots corresponding to the positions of the protrusions are provided on the translation handle housing 312 and the bending handle housing 320. By inserting the protrusions into the grooves, the translation handle housing 312 and the bending handle housing 320 can be respectively engaged with the bending center rod 225. This method is convenient for installation and disassembly.

[0046] The inner bend-adjusting catheter 220 is sleeved on the translation catheter 211, and the spring 222, the hypotube 221 and the metal ring 223 are sequentially sleeved on the inner bend-adjusting catheter 220 along the X-axis direction and are all arranged in the outer bend-adjusting catheter 224. The spring 222 is located at the end of the hypotube 221 away from the balloon 1, and one end of the spring 222 is fixedly connected to the hypotube 221, and the other end of the spring 222 is fixed on the inner bend-adjusting catheter 220. The end of the hypotube 221 away from the spring 222 is fixedly connected to the metal ring 223. The hypotube 221 can be welded to the metal ring 223. Both the hypotube 221 and the metal ring 223 can be made of developing materials such as gold, platinum, platinum-iridium alloy, tungsten, and gold-plated tungsten. In this way, the hypotube 221 and the metal ring 223 can be clearly displayed under X-rays, providing doctors with better visualization effects, thereby performing surgical operations more accurately, and helping doctors to achieve accurate positioning and rapid release of artificial valves. The end of the outer bending catheter 224 away from the balloon 1 is sleeved in the inner bending center rod 225. The outer bending catheter 224 includes an inner lining layer made of polyether block amide material, an intermediate reinforcement layer made of nickel titanium alloy material and an outer layer made of polyurethane material. This three-layer structure of the outer bending catheter 224 can not only ensure sufficient pushing force but also has good softness, which is conducive to the rapid passage of the conveyor through complex blood vessels to reach the implantation position, so that the artificial valve can be quickly released. The bending center rod 225 is arranged in a translational manner. The center rod 213 is close to one end of the balloon 1 and is fixedly connected to the translation center rod 213. The needle valve gasket 214 is arranged between the bending center rod 225 and the translation center rod 213. By pressing the bending center rod 225 and the translation center rod 213 toward the middle and fixing them, the needle valve gasket 214 can be used to achieve sealing and control blood flow. One end of the bending wire 226 is sleeved on the hypotube 221, and the other end of the bending wire 226 passes through the spring 222 and comes out of the through hole on the bending outer catheter 224. The bending adjustment slider 227 is fixed on the bending adjustment slider 227. The bending adjustment wire 226 can be made of nickel-titanium alloy. The bending adjustment wire 226 of this material has excellent shape memory effect and super elasticity, which is convenient for doctors to accurately control and helps doctors to achieve accurate positioning and rapid release of artificial valves; the bending adjustment slider 227 is sleeved on the bending adjustment center rod 225 and cooperates with the bending adjustment center rod 225 through a slide groove, the bending adjustment slider 227 is arranged in the bending adjustment thread sleeve 228 and is threadedly connected to the bending thread sleeve 228, and the bending thread sleeve 228 is screwed. The threaded sleeve 228 is provided with a threaded structure inside and outside. The bending adjustment threaded sleeve 228 is fixedly connected to the bending adjustment handle knob 321 near the end of the balloon 1. By rotating the bending adjustment handle knob 321, the bending adjustment threaded sleeve 228 is driven to rotate, thereby causing the bending adjustment slider 227 to move back and forth in the bending adjustment threaded sleeve 228. The bending adjustment slider 227 can be pulled by the bending wire 226 to change the curvature and bending direction of the sea wave tube 221, the translation catheter 211, the bending inner catheter 220, and the bending outer catheter 224.

[0047] The bending handle shell 320 is sleeved on the bending center rod 225 and fixedly connected to the bending center rod 225 through a raised slot. The front end cover 322 of the bending handle is arranged at one end of the bending handle shell 320 close to the balloon 1. The bending handle knob 321 is arranged between the bending handle shell 320 and the front end cover 322 of the bending handle. The bending handle knob 321 is respectively engaged with the bending handle shell 320 and the front end cover 322 of the bending handle. The bending handle shell 320 is also provided with a perspective window 229 for perspective viewing. An indicator 2291 is fixedly connected to the bottom of the window 229, and the bottom of the indicator 2291 is fixed on the bending adjustment threaded sleeve 228. A transparent window 229 is added to the bending adjustment handle 32, so that the internal mechanism movement of the valve delivery device can be observed more clearly to ensure the accuracy of operation. The additional indicator 2291 displays the current position and status of the bending adjustment mechanism 22, provides real-time feedback, and helps doctors make quick decisions; the bending adjustment center rod 225 is threadedly connected to the front end cover 322 of the bending adjustment handle near the end of the balloon 1.

[0048] See also Figure 4 , Figure 4The figure is a schematic diagram of the hypotube structure. The hypotube 221 comprises a slender hollow tubular structure with two open ends, i.e., a tube body. The tube body comprises, in sequence along the X-axis, a rear section 2211, a middle section 2212, and a front section 2213. Each of the rear section 2211, the middle section 2212, and the front section 2213 includes a side surface 2214. The side surface 2214 is provided with a plurality of slits 2215 axially connected to the tube body. The width of the slits 2215 in the rear section 2211 is less than the width of the slits 2215 in the middle section 2212, which is less than the width of the slits 2215 in the front section 2213. Ribs 2216 are formed between adjacent slits 2215. Each rib 2216 has a guide hole 2217 formed therein. The bending adjustment wire 226 passes through these guide holes 2217 and is ultimately secured to the bending adjustment slider 227. In order to prevent the hypotube 221 from damaging blood vessels and causing inaccurate positioning of the artificial valve due to excessive arch height, the hypotube 221 is divided into a rear section 2211, a middle section 2212 and a front section 2213. The side surface of the hypotube is cut so that the width of the slit 2215 in the rear section 2211 is less than the width of the slit 2215 in the middle section 2212 and less than the width of the slit 2215 in the front section 2213. This gradual design of the slit 2215 width can keep the hypotube 221 intact. While being flexible, it also provides necessary rigidity and support. The slit 2215 of the front section 2213 has a large width, which makes the front section 2213 more flexible and can better adapt to complex vascular pathways. The slit 2215 of the rear section 2211 has a small width, which makes the rear section 2211 more rigid and can provide better support and thrust, which helps to push the entire conveyor forward. The slit 2215 of the middle section 2212 has a width between the front section 2213 and the rear section 2211, which plays a transitional role, ensuring that the entire hypotube 221 has a smooth transition between the flexibility and rigidity of different parts. This gradual slit 2215 width design can also ensure that the torque is evenly transmitted axially throughout the hypotube 221, reducing the deformation of the hypotube 221. In addition, during the design, the number of slits 2215 on the hypotube 221 is controlled within 75 to 110 to avoid insufficient rigidity of the hypotube 221 due to too many slits 2215, resulting in poor pushing performance of the hypotube. Or the number of slits 2215 is too small, resulting in poor permeability of the sea wave tube 221 and increasing the risk of trauma, and the number of slits 2215 located in the rear section 2211 is slightly less than or equal to the number of slits 2215 in the middle section 2212, and the number of slits 2215 in the middle section 2212 is slightly less than or equal to the number of slits 2215 in the front section 2213, so as to ensure that the rear section 2211 has higher rigidity and the front section 2213 has higher flexibility and toughness, and the middle section 2212 plays a transitional role.

[0049] See also Figure 5 , Figure 5The diagram is a structural diagram of the hypotube after the offset cutting and offset punching. The extension direction of each slit 2215 is set at an angle to the axial direction of the tube body. Among any two adjacent slits 2215 on the side surface 2214, the slit 2215 near the end of the balloon 1 is deflected to the same side by an equal angle relative to the slit 2215 near the end of the handle 3 in the circumferential direction of the hypotube 221. Figure 5 It can be seen that after the offset cutting, the entire side surface 2214 is spiral on the tube body. In this way, when the bending mechanism 22 is used for bending, the sea wave tube 221 will compensate for the inward angle along the offset empty spiral, so that the delivery system 2 is more in line with the human aorta structure, and it is easier for the artificial valve to remain coaxial with the diseased valve position when released.

[0050] See also Figure 6 , Figure 6 The figure shows the relative positions of the guide holes on the first and last ribs of the hypotube. Any adjacent guide holes 2217 are evenly arranged with a 360° offset along the circumference of the tube. Among any adjacent guide holes 2217, the guide hole 2217 near the end of the balloon 1 is deflected by an equal angle toward the same side relative to the guide hole 2217 near the end of the handle 3 along the circumference of the tube. The guide hole 2217 on the first rib 22161 located at the rear section 2211 and the guide hole 2217 on the last rib 22162 located at the front section 2213 both have a deflection angle of 0 to 180°. Figure 6 As shown, the guide hole 2217 defined on the first rib 22161 located in the rear section 2211 and the guide hole 2217 defined on the last rib 22162 located in the front section 2213 are both deflected at an angle of 180°, preferably 30°, 60°, and 90°. By staggering the holes in the hypotube, the guide holes 2217 on any adjacent ribs 2216 are all deflected at equal angles toward the same side in the circumferential direction of the hypotube 221. This allows the bending wire 226 to be pulled after passing through the guide holes 2217 on all ribs 2216, resulting in more uniform bending force on the hypotube 221, reduced nonlinear bending of the hypotube 221, and lowered bowing times, further ensuring that the artificial valve and the diseased valve maintain coaxial release. The guide holes 2217 are uniformly circular, square, oval or special-shaped holes of the same shape. A circular guide hole 2217 is preferred. The cross-section of the bending wire 226 matching the circular guide hole 2217 must also be circular, that is, the bending wire 226 matching the circular guide hole 2217 is cylindrical, and the cylindrical bending wire 226 is easier to process and bears more uniform force. If the guide hole 2217 adopts other shapes, such as square, then the cross-section of the bending wire 226 must also be square.

[0051] A turning hole 2218 is also provided on the side surface 2214, which can further enhance the flexibility of the hypotube 221, allowing the hypotube 221 to better adapt to vascular structures with complex curvatures and improve the pushing performance of the hypotube 221. When the hypotube 221 passes through a narrowed part of the blood vessel, the local bending through the turning hole 2218 can help the hypotube 221 to move forward more smoothly and reduce jamming. The turning holes 2218 are uniformly circular, square, or elliptical. The different shapes of turning holes 2218 are adapted to different scene requirements. For example, the circular turning hole 2218 can more evenly disperse stress when subjected to force, reducing local concentrated stress that causes cracks or damage to the hypotube 221. The square turning hole 2218 helps to better control the bending direction of the hypotube 221. The elliptical turning hole 2218 can adjust the ratio of the major axis to the minor axis according to actual needs to meet the different bending requirements and mechanical performance requirements of the hypotube 221.

[0052] In summary, the present application discloses a valve delivery device that achieves precise positioning and rapid release of an artificial valve from the following three aspects: first, the translation mechanism 21 and the bending mechanism 22 of the valve delivery device are designed separately to independently control the two actions of translation and bending. The bending mechanism 22 can support multi-directional bending, while the translation mechanism 21 is responsible for linear movement, so that the doctor can more accurately adjust the position and direction of the valve delivery device during the operation. The combination of the two can achieve multi-dimensional precise control, so that the artificial valve remains coaxial with the diseased valve position when released; second, the sea wave tube 221 is cut and punched in an offset manner to make the bending of the sea wave tube 221 more in line with the structure of the human aorta, the force is more uniform, the arch of the sea wave tube 221 is reduced, and the artificial valve and the diseased valve position are ensured to maintain a coaxial release effect; third, the sea wave tube 221 is made of fully developing materials so that the doctor can check whether the artificial valve and the diseased valve position remain coaxial and judge the time of artificial valve implantation.

[0053] The above is merely an embodiment of the present invention and is not intended to limit the present invention. It will be apparent to those skilled in the art that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included within the scope of the claims of the present invention.

Claims

1. A valve delivery device, characterized in that: The invention comprises a balloon (1), a conveying system (2) and a handle (3) connected in sequence along the X-axis direction, wherein the conveying system (2) comprises a translation mechanism (21) and a bending mechanism (22), wherein the translation mechanism (21) is arranged at an end of the bending mechanism (22) away from the balloon (1) along the X-axis direction and is coaxially arranged with the bending mechanism (22); and the handle (3) comprises a translation handle (31) and a bending handle (32), wherein the translation handle (31) is arranged at an end of the bending mechanism (32) away from the balloon (1) along the X-axis direction. The device is located away from one end of the balloon (1) and is coaxially arranged with the bending adjustment handle (32); the translation handle (31) controls the translation mechanism (21), and the bending adjustment handle (32) controls the bending adjustment mechanism (22); the bending adjustment mechanism (22) includes a perspective window (229) and an indicator (2291); the indicator (2291) is fixed to the bottom of the perspective window (229), and the indicator (2291) is fixed to the bending adjustment handle (32) together with the perspective window (229); The translation mechanism (21) includes a catheter connector (210), a translation catheter (211), a translation sliding sleeve (212), a translation center rod (213) and a needle valve gasket (214), wherein the catheter connector (210) is fixed to an end of the translation catheter (211) away from the balloon (1), the translation center rod (213) is sleeved on the translation catheter (211), the translation sliding sleeve (212) is sleeved on the translation center rod (213), and the needle valve gasket (214) is arranged on an end of the translation center rod (213) close to the balloon (1); The bending adjustment mechanism (22) includes an inner bending adjustment tube (220), a sea wave tube (221), a spring (222), a metal ring (223), an outer bending adjustment tube (224), a bending adjustment center rod (225), a bending adjustment wire (226), a bending adjustment slider (227) and a bending adjustment threaded sleeve (228). The inner bending adjustment tube (220) is sleeved on the translation tube (211), and the sea wave tube (221), the spring (222) and the metal ring (223) are all sleeved. The spring (222) is located on the inner bend-adjusting catheter (220) and is disposed in the outer bend-adjusting catheter (224). The spring (222) is located at one end of the hypotube (221) away from the balloon (1). One end of the spring (222) is fixedly connected to the hypotube (221). The other end of the spring (222) is fixed on the inner bend-adjusting catheter (220). The end of the hypotube (221) away from the spring (222) is fixedly connected to the metal ring (223). The end of the outer bending-adjusting catheter (224) away from the balloon (1) is sleeved in the bending-adjusting center rod (225), the bending-adjusting center rod (225) is arranged at the end of the translation center rod (213) close to the balloon (1) and is fixedly connected to the translation center rod (213), the needle valve gasket (214) is arranged between the bending-adjusting center rod (225) and the translation center rod (213), and one end of the bending-adjusting wire (226) is sleeved in the sea wave tube ( 221), the other end of the bending adjustment wire (226) passes through the spring (222) and comes out from the through hole on the bending adjustment outer tube (224) and is fixed on the bending adjustment slider (227), the bending adjustment slider (227) is arranged in the bending adjustment thread sleeve (228) and is threadedly connected to the bending adjustment thread sleeve (228), and the bending adjustment slider (227) is sleeved on the bending adjustment center rod (225) and cooperates with the bending adjustment center rod (225) through a sliding groove; The hypotube (221) comprises a tube body, which comprises a rear section (2211), a middle section (2212) and a front section (2213) in sequence along the X-axis direction, wherein the rear section (2211), the middle section (2212) and the front section (2213) all comprise a side circumferential surface (2214), and the side circumferential surface (2214) is provided with a plurality of slits (2215) in communication with the tube body along the axial direction of the tube body, wherein the width of the slits (2215) located in the rear section (2211) is less than the width of the slits (2215) located in the middle section (2212) and is less than the width of the slits (2215) located in the front section (2213), and ribs (2216) are formed between adjacent slits (2215). The ribs (2216) are all provided with guide holes (2217), and any adjacent guide holes (2217) are arranged at an angle along the circumference of the tube body. Among any adjacent guide holes (2217), the guide hole (2217) close to one end of the balloon (1) is deflected to the same side at an equal angle relative to the guide hole (2217) close to one end of the handle (3) in the circumference of the tube body, wherein the guide hole (2217) provided on the first rib (22161) located at the rear section (2211) and the guide hole (2217) provided on the last rib (22162) located at the front section (2213) have a deflection angle of 0~180°.

2. The valve delivery device according to claim 1, characterized in that The hypotube (221) is made of any one of gold, platinum, platinum-iridium alloy, tungsten, and gold-plated tungsten.

3. The valve delivery device according to claim 1, characterized in that The guide holes (2217) are uniformly circular, square, elliptical or other special-shaped holes of the same shape.

4. The valve delivery device according to claim 1, characterized in that The side circumferential surface (2214) is further provided with a turning hole (2218), and the turning hole (2218) is uniformly circular, square, or elliptical.

5. The valve delivery device according to claim 1, characterized in that The extension direction of each slit (2215) is set at an angle to the axial direction of the tube body, wherein among any two adjacent slits (2215) on the side surface (2214), the slit (2215) close to one end of the balloon (1) is deflected by an equal angle toward the same side relative to the slit (2215) close to one end of the handle (3) in the circumferential direction of the hypotube (221).

6. The valve delivery device according to claim 1, characterized in that The translation handle (31) includes a translation handle back cover (310), a translation handle knob (311) and a translation handle housing (312). The translation handle back cover (310) is fixedly connected to the translation mechanism sliding sleeve (212). The catheter connector (210) passes through the translation handle back cover (310) and its range of movement is limited by the translation handle back cover (310). The translation handle knob (311) is sleeved on the translation sliding sleeve (212) and is threadedly connected to the translation sliding sleeve (212). By rotating the translation handle knob (311), the translation sliding sleeve (212) moves forward and backward along the X-axis, thereby driving the balloon (1) to move forward and backward. The translation handle housing (312) is sleeved on the translation handle knob (311) and is fixedly connected to the bending center rod (225).

7. The valve delivery device according to claim 1, characterized in that: The bending adjustment handle (32) includes a bending adjustment handle housing (320), a bending adjustment handle knob (321) and a bending adjustment handle front end cover (322), wherein the bending adjustment handle housing (320) is sleeved on the bending adjustment center rod (225) and fixedly connected to the bending adjustment center rod (225), the bending adjustment handle front end cover (322) is arranged at one end of the bending adjustment handle housing (320) close to the balloon (1), the bending adjustment handle knob (321) is arranged between the bending adjustment handle housing (320) and the bending adjustment handle front end cover (322), the bending adjustment handle knob (321) is fixedly connected to the bending adjustment handle housing (320) and the bending adjustment handle front end cover (322) respectively, and the bending adjustment center rod (225) is threadedly connected to the bending adjustment handle front end cover (322) at one end close to the balloon (1).

Citation Information

Patent Citations

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    CN118512285A

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