Transcatheter aortic trunk valve delivery system
By introducing a curved structure and axial fine-tuning spiral pair in the transcatheter aortic trunk valve delivery system, the problem of insufficient accuracy when placing valves in the prior art is solved, and higher placement accuracy and surgical reliability are achieved.
Patent Information
- Application Number
- CN202420607252.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-03-27
- Publication Date
- 2025-06-24
- Estimated Expiration
- 2034-03-27
AI Technical Summary
In the prior art, it is difficult to ensure accuracy when placing valves in the transcatheter aortic trunk valve delivery system, resulting in uncertainty in the position of the valves and balloons, affecting the accuracy and safety of the surgery.
A transcatheter aortic trunk valve delivery system is designed, adopting a curved structure and axial fine-tuning spiral pair, which can be bent and axial fine-tuning to ensure that the valve and balloon do not produce relative movement during placement and achieve accurate placement.
Through the curved structure and axial fine-tuning function, the accuracy of dry foliar placement is improved, the relative movement of the instrument during the operation is reduced, and the reliability and efficiency of the operation are improved.
Smart Images
Figure CN223009319U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to a medical device, in particular to a delivery system for an aortic trunk valve in cardiac interventional therapy. Background Art
[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement surgery. By means of catheter intervention, an artificial heart valve is delivered to the position of the aortic valve, thereby completing the implantation of the artificial valve and restoring the valve function. This surgery was initially called transcatheter aortic valve implantation (TAVI). Since the implanted valve functionally replaces the original diseased valve, it is now mostly called transcatheter aortic valve replacement (TAVR).
[0003] The aortic valve is located between the left ventricle and the ascending aorta and acts as a one-way valve. It opens during heart contraction to allow the blood in the left ventricle to smoothly flow into the ascending aorta, and closes during diastole to ensure that the blood in the ascending aorta does not flow back into the left ventricle. If the aortic valve is diseased and its function changes, for example, it cannot fully open during heart contraction (stenosis), it will be difficult for the left ventricle to eject blood, or it cannot fully close during heart diastole (insufficiency), and the blood in the ascending aorta will flow back into the left ventricle, both of which will reduce the heart function and lead to insufficient blood supply throughout the body. The patient will experience dizziness, fatigue, chest tightness, palpitations, etc., and the activity ability will be limited. In severe cases, heart failure, syncope, cardiogenic shock or even sudden death may occur.
[0004] Currently, the main indications for TAVR are aortic stenosis (AS), and a small part is applied to aortic regurgitation (AR). Aortic stenosis is a common heart disease. The aortic valve acts like a "valve" to ensure the unidirectional flow of blood in the heart. When the aortic valve gradually calcifies with age, the passage of the "valve" becomes narrow, resulting in reduced blood flow. The main symptoms include fatigue, shortness of breath, angina pectoris and syncope.
[0005] Before the emergence of TAVR, the main treatment option was surgical aortic valve replacement (SAVR) through thoracotomy. A new artificial heart valve was replaced through surgery to ensure the normal flow of heart blood. The treatment process of traditional thoracotomy is to cut the sternum in the middle of the chest, intubate to establish extracorporeal circulation, stop the heart from beating, and then the doctor directly observes the heart, makes an incision at the aorta, exposes the aortic valve and cuts it off; then implants the artificial valve and sutures it, and the heart is resuscitated, and finally the surgery is completed.
[0006] For patients, the pain brought by surgery persists throughout the process. Many frail patients who are old, physically weak, and have underlying diseases such as diabetes are unable to tolerate such highly challenging open-chest surgeries. Before the emergence of TAVR, such high-risk surgical patients had no chance of treatment. The emergence of TAVR has changed all this. It has now become the main treatment method for aortic stenosis (AS) and has had a certain substitution effect on open-chest valve replacement surgery.
[0007] As the delivery system for transcatheter aortic valve replacement (TAVR), during the treatment process, in order to carry the valve and deliver it from the punctured femoral artery along the guide wire to the aortic valve annulus position, a pressurized balloon is used to place the valve at the annulus.
[0008] Most of the existing aortic valve delivery systems adopt the forms of self-expanding and balloon-expandable valves. The self-expanding valve is made of a superelastic stent formed by laser precision engraving of a nickel-titanium superelastic alloy thin-walled tube. It reaches the lesion through a crimped delivery catheter and self-expands after release of fixation to place the valve at the annulus. The balloon-expandable valve has the valve pre-loaded on the balloon, and the valve is released by balloon dilation.
[0009] When the balloon-expandable valve is released, compared with the self-expanding valve, since the size of the valve frame (stent) can be controlled according to the choice of balloon inflation size and balloon size, and also because the balloon-expandable valve has a greater radial force and stronger adaptability, it can be placed more precisely and controllably, and the valve frame causes less damage to the aortic arch blood vessel wall. Because the valve frame of the balloon-expandable valve is shorter (it can be shorter because it is better positioned), it is easier to pass through the aortic arch, reducing the possibility of scratching the blood vessel wall and causing less damage. Compared with the self-expanding valve, the balloon-expandable valve can increase the valve release height to reduce the postoperative pacemaker implantation rate.
[0010] Compared with the self-expanding valve, the balloon-expandable valve uses balloon dilation to expand the valve, taking into account both stability and precise placement, and can make the valve placement in one step. Theoretically, it is indeed a very good valve release concept.
[0011] For a balloon-expandable valve transcatheter delivery system, it is usually prepared for the glutaraldehyde-treated wet valve (Wet Valve). Before the operation, the wet valve is clamped on the delivery system, and a large amount of preparatory work is required in the operating room before the operation. Its operation is complex and the preoperative preparation is cumbersome. Before entering the valve replacement operation, the valve needs to be cleaned, crimped and assembled many times. This preparation process is cumbersome and easily leads to an increased additional risk of the operation, such as the instability of the crimping rack, which is likely to increase. The residue of long-term storage in glutaraldehyde increases the calcification and toxicity of the biological valve. Taking the delivery system of Edwards Sapien 3 as an example, before the preoperative preparation, the wet valve needs to be cleaned and then clamped in the fixed area. During the operation, the balloon is retracted into the wet valve at the descending aorta. In this way, during the relative movement between the balloon and the valve, the uncertainty of the position of the valve frame and the balloon is likely to occur during the operation, and the uncertainty and risk caused by the inaccurate position and the inability to test.
[0012] At the same time, due to the uncertainty of the positions of the balloon and the valve, it is very difficult to keep the centers of the valve and the balloon consistent with the design values. Perhaps due to the angle between the valve and the balloon, when the balloon supports the valve, it is not easy to accurately place it on the patient's valve. Summary of the Invention
[0013] The purpose of the present invention is to provide a transcatheter aortic valve delivery system, and the technical problem to be solved is to improve the accuracy of dry valve placement.
[0014] To solve the above problems, the present invention is implemented by adopting the following technical solutions: A transcatheter aortic valve delivery system is provided with a tip, a valve stent for placing the valve, and a handle from the distal end to the proximal end. The transcatheter aortic valve delivery system is provided with a bending adjustment structure, so that the transcatheter aortic valve delivery system has the functions of bending and axial fine adjustment.
[0015] The bending adjustment structure of the present invention is provided with an adjusting bending structure and an axial fine adjustment screw pair.
[0016] The adjusting bending structure of the present invention is provided with an adjustable bending tube and a bending adjustment screw. A traction wire is connected between the distal end of the adjustable bending tube and the bending adjustment screw located at the proximal end.
[0017] In the present invention, a bending adjustment knob is connected to the middle of the handle housing with a rotary body shape of the handle, and the bending adjustment knob is threadedly connected to the bending adjustment screw coaxially arranged therein.
[0018] The adjustable bending tube of the present invention is a three-layer tube. A fixing ring is coaxially sleeved outside the inner layer at the distal end of the adjustable bending tube. Along the axial direction of the fixing ring, the distal end of the traction wire is wound around the inner and outer walls of the fixing ring, and the straight section of the traction wire is arranged in the tubular traction channel, and the traction channel is arranged outside the inner layer of the adjustable bending tube.
[0019] The traction wire described in the present utility model passes through the axial inner hole of the bending adjustment screw inside the handle, and the proximal end of the traction wire is fixed with a compression nut at the proximal end of the bending adjustment screw.
[0020] The axial fine adjustment screw pair described in the present utility model is constituted by the axial fine adjustment knob located at the proximal end of the handle being in threaded connection with the axial fine adjustment screw.
[0021] The distal end of the tip of the present utility model is connected to the double - lumen tube. The double - lumen tube passes axially through the valve stent, the adjustable bending tube, the bending adjustment knob, and the inner hole of the handle, and its proximal end extends out to the axial fine adjustment knob connected to the handle.
[0022] An axial fine adjustment screw is arranged inside the handle described in the present utility model. The axial fine adjustment screw is sleeved and connected outside the double - lumen tube, and the axial fine adjustment knob located at the proximal end of the double - lumen tube forms a threaded connection structure with the proximal end of the axial fine adjustment screw.
[0023] The axial movement of the axial fine adjustment screw described in the present utility model is 0 - 2 cm.
[0024] Compared with the prior art, the valve of the present utility model is directly loaded on the balloon, and the transcatheter aortic valve delivery system has a smaller outer contour, so as to ensure that the entire transcatheter aortic valve delivery system has the ability of bending and axial fine adjustment, and during the process of delivering and placing the valve, it is ensured that there is no relative movement between the valve and the balloon, achieving precise placement of the valve at the natural valve of the patient. Description of the Drawings
[0025] Figure 1 is a schematic structural diagram of the handle of the present utility model.
[0026] Figure 2 is a schematic structural diagram of the balloon of the present utility model.
[0027] Figure 3 is a schematic diagram of the balloon and the valve stent of the present utility model.
[0028] Figure 4 is a schematic diagram of the tip and the double - lumen tube of the present utility model.
[0029] Figure 5 is a schematic structural diagram of the adjustable bending tube of the present utility model.
[0030] Figure 6 is Figure 1 the B - B cross - sectional view of
[0031] Figure 7 is Figure 1 the A - A cross - sectional view of
[0032] Figure 8 is Figure 1 the C - C cross - sectional view of
[0033] Figure 9 It is a schematic diagram of the handle structure of the present utility model.
[0034] Figure 10 It is Figure 9 the detail drawing of D of
[0035] Figure 11 It is Figure 9 the enlarged drawing of E of
[0036] Figure 12 It is Figure 9 the detail drawing of E of
[0037] Figure 13 It is Figure 9 the enlarged drawing of F of
[0038] Figure 14 It is Figure 9 the enlarged drawing of F of and the assembly relationship drawing of the double lumen tube Specific embodiments
[0039] The present utility model will be further described in detail below in conjunction with the accompanying drawings and embodiments.
[0040] The transcatheter aortic trunk valve delivery system of the present utility model is provided with a balloon, a valve stent part and a handle.
[0041] As Figure 1 shown, the transcatheter aortic trunk valve delivery system of the present utility model is sequentially connected with a tip 1, a valve stent 32 with a valve 2 placed therein, an adjustable bending tube 3, a bending adjustment knob 6, a handle 7 and an axial fine adjustment knob 8 from the distal end to the proximal end. The tip 1 is connected to the distal end of a double lumen tube 9, and the double lumen tube 9 axially passes through the inner holes of the valve stent 32, the adjustable bending tube 3, the bending adjustment knob 6 and the handle 7, and its proximal end extends out of the axial fine adjustment knob 8 and is connected to a Y-shaped Luer connector 10. The distal end of the bending adjustment knob 6 is connected to a three-way joint 5 through a side tube 4.
[0042] As Figure 7 shown, the proximal end of the bending adjustment knob 6 is threadedly connected to a bending adjustment screw 27 therein, and the proximal end of a traction wire 17 is fixed on the bending adjustment screw 27. A traction wire 17, a bending adjustment screw 27 and a compression nut 29 are arranged in the axial inner hole of the handle 7. The traction wire 17 passes through the axial inner hole of the bending adjustment screw 27 in the handle 7. After the proximal end of the traction wire 17 winds around the outside of the proximal end of the bending adjustment screw 27 for 3 turns, it is then tightened and fixed with the compression nut 29.
[0043] As Figure 8 and Figure 14As shown, an axially fine-tuning screw 28 is disposed inside the handle 7. The axially fine-tuning screw 28 is sleeved and connected outside the double-lumen tube 9. The proximal end of the axially fine-tuning screw 28 is adhesively connected to the double-lumen tube 9 with quick-drying glue. The axially fine-tuning knob 8 located at the proximal end of the double-lumen tube 9 is sleeved outside the axially fine-tuning screw 28, and a threaded connection structure is formed between the fine-tuning knob 8 and the proximal end of the axially fine-tuning screw 28.
[0044] As Figure 2 shown, the tip 1 is connected to the distal end of the double-lumen tube 9. The double-lumen tube 9 is provided with a guide wire channel and a perfusion cavity parallel to its axis. A balloon 14 is sleeved outside the distal end of the double-lumen tube 9. At both ends inside the balloon 14, end marker rings 11 are sleeved on the outer edge of the double-lumen tube 9. An intermediate marker ring 12 is sleeved at the intermediate position between the two marker rings 11. Limiting rings 13 are sleeved on the outer edges of the two marker rings 11. Stopping members are installed on the marker rings 11 and the limiting rings 13, and the stopping members are used to limit the axial movement of the valve pressed on the double-lumen tube 9. A perfusion port is made on the perfusion cavity of the double-lumen tube 9 located at the balloon 14 (the punching design of the balloon double-lumen tube). When the balloon 14 is pressurized through the perfusion cavity of the double-lumen tube 9, it helps the balloon 14 and the valve frame to expand more evenly.
[0045] The tip 1 is adhesively connected to the distal end of the double-lumen tube 9 with silicone glue. The end marker rings 11, the intermediate marker ring 12 and the limiting rings 13 are adhesively connected to the double-lumen tube 9 with quick-drying glue. Both ends of the balloon 14 are welded to the double-lumen tube 9.
[0046] As Figure 3 shown, the valve stent 32 is coaxially sleeved outside the balloon 14. After the balloon 14 expands, its shape is a waist drum shape with larger diameters at both ends and a smaller diameter in the middle. The valve stent 32 is pressed on the outside of the balloon 14 by a valve presser of the prior art. Before the balloon 14 expands, the valve stent 32 is pressed into a straight tube shape with a diameter of 7 mm. When the balloon 14 expands, the valve stent 32 is shaped into a waist drum shape through the shaping of the balloon 14. A valve 2 is loaded and placed outside the valve stent 32.
[0047] As Figure 4 shown, the tip 1 is made of silicone and is a soft component. It is located at the farthest distal end of the entire transcatheter aortic valve delivery system and is the first to contact the blood vessel. Therefore, it needs to be soft to ensure that it will not damage the blood vessel, and at the same time, it should maintain the due guiding property. The radial dimension of the distal end of the tip 1 is smaller than that of the proximal end, and its axial through hole is communicated with the guide wire channel of the double-lumen tube 9 extending into its proximal end. The tip 1 and the double-lumen tube 9 with the balloon 14 are connected together by means of silicone glue Figure 4 The black filled part in
[0048] As Figure 5As shown, the adjustable bent tube 3 is a three-layer tube. One end of the distal end of the traction wire 17 for stretching is sleeved and connected to the fixing ring 16 located at the distal end of the adjustable bent tube 3. By adjusting the other end at the proximal end, the adjustable bent tube 3 is bent. The inner layer of the three-layer tube is the inner lining 22 of the adjustable bent tube 3, which is made of polytetrafluoroethylene (PTFE) material. Its inner surface is smooth and has a small friction coefficient, so that the double lumen tube 9 can slide easily inside, and it is easy to be welded to the outer layers 18, 19, and 20. A fixing ring 16 is coaxially sleeved outside the inner layer at the distal end of the adjustable bent tube 3. Along the axial direction of the fixing ring 16, the distal end of the traction wire 17 is wound around the inner and outer walls of the fixing ring 16. In this embodiment, it is wound around the inner and outer walls once. In this way, the distal end of the traction wire 17 is connected to the fixing ring 16, and the long straight section of the middle part of the traction wire 17 is arranged in the tubular traction channel 30, ensuring that the proximal end of the traction wire 17 can be stretched normally. The traction channel 30 is adhesively arranged outside the inner layer of the adjustable bent tube 3 with quick-drying glue 31 and is parallel to the axis of the adjustable bent tube 3. A metal layer 21 is sleeved outside the traction channel 30. The metal layer 21 can be a braided wire, a metal cutting tube or a spiral spring, providing a certain hardness guarantee for the whole adjustable bent tube 3. The outer layer of the adjustable bent tube 3 is an outer tube, which is composed of a distal outer tube 18, a middle outer tube 19 and a proximal outer tube 20 connected together. The hardness of the outer tube gradually increases from the distal end to the proximal end, and the whole adjustable bent tube 3 is welded together by a tube body welding machine for the three-layer tubes.
[0049] As Figure 6 and Figure 9 shown, the handle head end 23 at the distal end of the handle 7 is adhesively connected to the adjustable bent tube 3 with quick-drying glue. A perfusion port 33 is radially connected to the distal end of the handle 7. A sealing ring 24 is arranged at the connection between the perfusion port 33 and the handle 7 and inside the handle 7. The sealing ring 24 is pressed towards the distal end by the sealing ring pressing screw 25 on the proximal side, ensuring that the liquid entering from the perfusion port 33 will not enter the proximal end of the handle 7. The distal end of the handle housing 26 in the shape of a rotating body is adhesively connected to the outside of the proximal end of the handle head end 23. A bending adjustment knob 6 is connected to the middle of the handle housing 26. The bending adjustment knob 6 is threadedly connected to the bending adjustment screw 27 coaxially arranged inside it. By rotating the bending adjustment knob 6, the bending adjustment screw 27 can move back and forth, thereby driving the traction wire 17 connected thereto, playing a role in stretching and releasing the adjustable bent tube 3 to make the adjustable bent tube 3 bend. The axial fine adjustment screw 28 at the proximal end of the handle 7 is adhesively connected to the proximal end of the double lumen tube 9, so that the handle 7 and the double lumen tube 9 are assembled and connected. The axial fine adjustment knob 8 at the proximal end of the handle 7 is threadedly connected to the axial fine adjustment screw 28 to form a threaded connection member. The threaded connection member can be fixed to the handle housing 26 through the buckle on the axial fine adjustment knob 8. At this time, rotating the axial fine adjustment knob 28 can drive the adjustable bent tube 3 to move back and forth, and the balloon 14 and the valve stent 32 are installed on the double lumen tube 9, that is, it can drive the balloon 14 and the valve stent 32 to move back and forth.
[0050] As Figure 10As shown, after the proximal end of the adjustable bent tube 3 is adhesively connected to the distal end of the handle head 23, the traction wire 17 extends out of the proximal end from within the adjustable bent tube 3, passes through the sealing ring 24, and is fixed to the bending adjustment screw 27. A sealing ring 24 is placed at the proximal end of the handle head 23, and the sealing ring pressing screw 25 presses the sealing ring 24 at the proximal end to ensure that liquid does not enter the proximal handle 7.
[0051] The perfusion port 33 is connected to the three-way joint 5 via the side tube 4 and bonded together with UV glue. During use, we can inject liquid to clean the gap between the double lumen tube 9 and the adjustable bent tube 3. During the operation, the three-way joint 5 can prevent the patient's blood from flowing out.
[0052] As Figure 11 and Figure 12 shown, the traction wire 17 passes through the channel inside the bending adjustment screw 27 from the distal end, winds around the axially protruding post at its proximal end three times, and after pressing the protruding post with the pressing ring 34, it is rotationally tightened by the tightening nut 29 to fix the proximal end of the traction wire 17 to the bending adjustment screw 27.
[0053] As Figure 13 shown, when the axial fine adjustment knob 8 is rotated, the axially moving fine adjustment screw 28 threadedly connected to the axial fine adjustment knob 8 axially moves, driving the double lumen tube 9 to move distally.
[0054] As Figure 14 shown, the double lumen tube 9 and the axially moving fine adjustment screw 28 are adhesively connected with quick-drying glue.
[0055] In the transcatheter aortic trunk valve delivery system of the present utility model, the axial fine adjustment knob 8 located at the proximal end of the handle 7 is threadedly connected to the axially moving fine adjustment screw 28 to form an axial fine adjustment screw pair. By rotating the axial fine adjustment knob 8, the axially moving fine adjustment screw 28 is driven to axially move, thereby improving the accuracy of dry valve placement. The transcatheter aortic trunk valve delivery system of the present utility model can control the axial movement of the dry valve by 0 - 2 cm, with a precise and tiny axial movement of 1 - 2 mm.
[0056] The bending adjustment knob 6 is snap-connected to the handle and can only rotate. The bending adjustment screw 27 is connected to the bending adjustment knob 6 through a screw pair. When the bending adjustment knob 6 rotates, the bending adjustment screw 27 can only perform axial translational motion. The bending of the adjustable bent tube 15 is completed by stretching the metal traction wire 17 at the proximal end of the adjustable bent tube 15.
[0057] The round hole on the fixing ring 16 realizes the folding of the traction wire 17, and the fixing ring 16 is welded to the adjustable bent tube 3 together with the braided wire. That is to say, the traction wire 17 and the adjustable bent tube 3 are combined together, but the traction wire 17 can be pulled within the channel of the adjustable bent tube 3. When the traction wire 17 is pulled, the adjustable bent tube 3 can be bent.
[0058] To realize the pulling of the traction wire 17, first, the adjustable elbow tube 3 and the handle 7 are adhesively connected together. After the traction wire 17 extends from the proximal end of the adjustable elbow tube 3, it passes through the sealing ring 24 and is fixedly connected to the bending adjustment screw 27.
[0059] The traction wire 17 is wound around a small screw of the bending adjustment screw 27, and then the traction wire 17 is tightly pressed and fixed with a gasket and a nut. Therefore, the traction wire 17 will move along with the bending adjustment screw 27. When the bending adjustment knob 6 is rotated, the traction wire 17 can be pulled to realize the bending of the adjustable elbow tube 3.
[0060] The adjustable elbow tube 3, the traction wire 17 and the bending adjustment knob 6 form an adjustable bending structure.
[0061] The axial fine adjustment knob 8 realizes the axial movement of the axial fine adjustment screw 28 through the sliding spiral mechanism composed of the axial fine adjustment knob 8 and the axial fine adjustment screw 28. The axial fine adjustment knob 8 does not move. Therefore, when the axial fine adjustment knob 8 is rotated, the axial fine adjustment screw 28 generates an axial translation movement. At this time, the double lumen tube 9 in the balloon catheter is adhesively connected to the axial fine adjustment screw 28. When the axial fine adjustment screw 28 makes a translation movement, it drives the balloon catheter and the valve on it to make an axial fine adjustment movement. The fine adjustment is determined according to the lead of the thread. In the present utility model, the axial fine adjustment is set between 2 and 5 mm to accurately position the valve during the operation.
[0062] The transcatheter aortic trunk valve delivery system of the present utility model is prepared by the following steps:
[0063] Balloon catheter part
[0064] 1. Blow up the balloon with the balloon material tube.
[0065] 2. After punching perfusion holes on the double lumen tube, install the marker ring 11, the middle marker ring 12, the limit ring 13 and the stop on the marker ring 11 and the limit ring 13 on the double lumen tube.
[0066] 3. Weld the balloon to the double lumen tube.
[0067] 4. Glue the tip 1 in place.
[0068] Adjustable elbow tube part
[0069] 1. Prepare the braided wire, spring or metal cutting tube.
[0070] 2. Assemble the traction wire and the fixing ring.
[0071] 3. Place all the pipes of the adjustable elbow tube (PTFE etched layer tube, middle metal layer, outer tube, traction wire and its connectors).
[0072] 4. Thermally weld the adjustable elbow tube.
[0073] 5. The bendable tube is hydrophilic.
[0074] The handle is integrally installed
[0075] 1. The flushing port is installed on the handle.
[0076] 2. The bendable tube is bonded to the handle.
[0077] 3. The traction wire on the bendable tube is fixed to the bending adjustment screw.
[0078] 4. Install the bending adjustment screw mechanism.
[0079] 5. The balloon catheter is adhesively bonded to the axial fine adjustment screw.
[0080] 6. Install the axial fine adjustment screw mechanism.
[0081] 7. Install the Y-shaped Luer connector 10.
[0082] After the entire transcatheter aortic valve delivery system is assembled, the already sewn valve is loaded onto the balloon of the transcatheter aortic valve delivery system through a valve crimping device, eliminating the step of loading the valve stent onto the balloon, greatly reducing the preoperative preparation time and improving the surgical efficiency.
[0083] The bending adjustment structure composed of the bending adjustment structure and the axial fine adjustment screw pair enables the transcatheter aortic valve delivery system to easily pass through the aortic arch and accurately place the valve. The bendable tube adopts a sheath structure. When the bendable tube is not used for bending adjustment, the transcatheter aortic valve delivery system can easily pass through the aortic arch, and it is easier to pass through the aortic arch by combining the bendable tube or the bendable tube and the axial fine adjustment screw pair.
[0084] The balloon and the valve are fixed together before leaving the factory. When manufacturing the transcatheter aortic valve delivery system and crimping the valve, the valve is placed on the already folded balloon, and the balloon and the valve will fit very well according to the stop. After the balloon is aligned with the position between the valve frame and the native valve, it can be accurately opened and placed on the patient's native valve. Therefore, compared with Sapien 3, no locking device is required to control the relative movement between the balloon and the valve stent. The transcatheter aortic valve delivery system uses fewer components and has a lower cost. Because it can ensure the position of the valve stent loaded on the balloon, the balloon can open the valve more smoothly, reducing the relative movement of the instruments during the operation and making the operation more reliable. At the same time, the problem of the excessive outer diameter size after the valve stent is pre-loaded on the balloon is solved.
[0085] Before leaving the factory, the transcatheter aortic valve delivery system of the present utility model is compressed and held on the balloon, which is a pre-loaded dry valve delivery system. Since it is not necessary to treat the valve with glutaraldehyde, the valve loading time is directly saved. The valve is directly loaded on the valve stent on the balloon. At the same time, the entire transcatheter aortic valve delivery system is ensured to have the functions of bending and axial fine adjustment. And during the process of delivering and placing the valve, it is ensured that there is no relative movement between the valve and the balloon, so as to accurately place the valve at the natural valve of the patient. The punching design of the balloon double lumen tube can make the balloon expand more evenly, and the waist drum-shaped balloon can also better shape the valve for valve placement.
Claims
1. A transcatheter aortic valve delivery system, comprising, from the distal end to the proximal end, a tip (1), a valve support (32) for placing the valve, and a handle (7), characterized in that: The transcatheter aortic trunk valve delivery system is provided with a bending adjustment structure, so that the transcatheter aortic trunk valve delivery system has the functions of bending and axial fine-tuning.
2. The transcatheter aortic valve delivery system according to claim 1, characterized in that: The bending adjustment structure is provided with a bending adjustment structure and an axial fine-tuning spiral pair.
3. The transcatheter aortic valve delivery system according to claim 2, characterized in that: The bending adjustment structure is provided with an adjustable bending tube (3) and a bending adjustment screw (27), and a traction wire (17) is connected between the distal end of the adjustable bending tube (3) and the bending adjustment screw (27) located at the proximal end.
4. The transcatheter aortic valve delivery system according to claim 3, characterized in that: A bending knob (6) is connected to the middle of the handle housing (26) in the shape of a rotating body of the handle (7), and the bending knob (6) is threadedly connected to a bending screw (27) coaxially arranged therein.
5. The transcatheter aortic valve delivery system according to claim 4, characterized in that: The adjustable curved tube (3) is a three-layer tube. A fixed ring (16) is coaxially sleeved outside the inner layer of the distal end of the adjustable curved tube (3). Along the axial direction of the fixed ring (16), the distal end of the traction wire (17) is wrapped around the inner and outer walls of the fixed ring (16). The long straight section of the traction wire (17) is arranged in a tubular traction channel (30), and the traction channel (30) is arranged outside the inner layer of the adjustable curved tube (3).
6. The transcatheter aortic valve delivery system according to claim 4, characterized in that: The traction wire (17) passes through the axial inner hole of the bending adjustment screw (27) in the handle (7), and the proximal end of the traction wire (17) is fixed to the proximal end of the bending adjustment screw (27) by a compression nut (29).
7. The transcatheter aortic valve delivery system according to claim 6, characterized in that: The axial fine-tuning screw pair is composed of an axial fine-tuning knob (8) located at the proximal end of the handle (7) and an axial fine-tuning screw rod (28) which are threadedly connected.
8. The transcatheter aortic valve delivery system according to claim 7, characterized in that: The tip (1) is connected to the distal end of the double-lumen tube (9), and the double-lumen tube (9) passes axially through the valve support (32), the adjustable bend tube (3), the bend adjustment knob (6) and the inner hole of the handle (7), and its proximal end extends out of the axial fine-tuning knob (8) connected to the handle (7).
9. The transcatheter aortic valve delivery system according to claim 8, characterized in that: An axial fine-tuning screw (28) is arranged in the handle (7), and the axial fine-tuning screw (28) is sleeved and connected outside the double-lumen tube (9). The axial fine-tuning knob (8) located at the proximal end of the double-lumen tube (9) forms a threaded connection structure with the proximal end of the axial fine-tuning screw (28).
10. The transcatheter aortic valve delivery system according to claim 9, characterized in that: The axial movement of the axial fine-tuning screw (28) is 0 to 2 cm.