Transcatheter aortic valve expansion and adjustable bend delivery system

Abstract

This invention discloses a transcatheter aortic valve delivery system with adjustable bendability. The system comprises, from distal to proximal, a tip, an adjustable bend, a balloon, a handle, and a double-lumen cannula. The distal end of the adjustable bend is flexible and can be straightened. The balloon is located at the distal end of the double-lumen cannula, with its proximal and distal ends welded to the cannula. The tip is fixed to the distal end of the double-lumen cannula. The balloon communicates with one lumen of the double-lumen cannula. When inflated, the balloon has a wasp-waist structure in its middle. When the balloon is in a folded, contracted state, it is cylindrical, with the aortic valve pre-loaded onto the folded, contracted balloon. Compared to existing technologies, this system directly pre-loads the aortic valve onto the balloon, ensuring the entire system has the ability to bend and finely adjust axially. Furthermore, during valve delivery and placement, the system ensures no relative movement between the valve and the balloon, achieving precise delivery and placement at the patient's natural valve location.

Description

Technical Field

[0001] This invention relates to a medical device, and more particularly to a transcatheter aortic bulb dilatation valve adjustable delivery system for interventional cardiac procedures. Background Technology

[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement surgery that involves inserting an artificial heart valve into the aortic valve area via catheterization, thereby restoring valve function. Originally called transcatheter aortic valve implantation (TAVI), it is now more commonly referred to as TAVR because the implanted valve functionally replaces the original diseased valve.

[0003] The aortic valve, located between the left ventricle and the ascending aorta, acts as a one-way valve. It opens during cardiac contraction to allow blood from the left ventricle to flow smoothly into the ascending aorta, and closes during diastole to prevent blood from flowing back into the left ventricle. If the aortic valve is diseased and its function altered—for example, if it cannot fully open during cardiac contraction (narrowing), the left ventricle will have difficulty ejecting blood; or if it cannot fully close during cardiac diastole (incomplete closure), blood will flow back into the left ventricle. Both conditions impair cardiac function and lead to insufficient blood supply throughout the body. Patients may experience dizziness, fatigue, chest tightness, palpitations, and limited mobility. In severe cases, heart failure, syncope, cardiogenic shock, or even sudden death may occur.

[0004] Currently, TAVR is primarily indicated for aortic stenosis (AS), with a smaller number used for aortic regurgitation (AR). Aortic stenosis is a common heart condition. The aortic valve acts like a valve, ensuring the unidirectional flow of blood within the heart. As the aortic valve calcifies with age, the passage of this valve narrows, leading to reduced blood flow. The main symptoms include fatigue, shortness of breath, angina, and syncope.

[0005] Before the advent of TAVR, the primary treatment option was open-chest surgery for aortic valve replacement (SAVR). This involved surgically replacing the valve with a new artificial one to ensure normal blood flow to the heart. The traditional open-chest surgery procedure involved making an incision in the sternum in the middle of the chest, inserting a cannula to establish cardiopulmonary bypass, stopping the heart, and then the surgeon would make an incision in the aorta to expose and remove the aortic valve. An artificial valve would then be implanted and the incision closed. The heart would then be resuscitated, and the surgery would be completed.

[0006] For patients, the pain of surgery is constant. Many elderly, frail patients, and those with underlying conditions such as diabetes cannot tolerate such challenging open-heart surgery. Before the advent of TAVR, these high-risk patients had no opportunity for treatment. The advent of TAVR changed all that. It has now become the main treatment for aortic stenosis (AS) and has had a certain substitution effect on open-heart valve replacement.

[0007] The transcatheter aortic trunk valve delivery system is used in transcatheter aortic valve replacement (TAVR) procedures. During the procedure, in order to transport the trunk valve from the punctured femoral artery along the guidewire to the aortic valve annulus, a balloon is inflated to place the valve at the annulus.

[0008] Most existing aortic valve delivery systems employ self-expanding or balloon-expanding valves. Self-expanding valves utilize a thin-walled nickel-titanium superelastic alloy tube, precisely laser-engraved into a highly elastic stent. This stent is delivered to the lesion via a gripping delivery catheter, and after release, it self-expands to place the valve at the annulus. Balloon-expanding valves involve pre-loading the valve onto a balloon, which then expands to release the valve.

[0009] Compared to self-expanding valves, bulb-expanding valves offer several advantages during deployment. Firstly, valve size can be controlled by adjusting the balloon inflation pressure and size. Secondly, the greater radial force and self-adaptability of bulb-expanding valves allow for more precise and controllable placement, resulting in less damage to the aortic arch walls. Thirdly, bulb-expanding valves are shorter (due to their easier positioning), making them easier to pass through the aortic arch and reducing the likelihood of abrasion to the vessel walls. Finally, compared to self-expanding valves, bulb-expanding valves allow for a higher valve deployment height, thus reducing the postoperative pacemaker implantation rate.

[0010] Compared to self-expanding valves, balloon-expanded valves use a balloon to expand the valve, balancing stability and precise placement. This allows for one-step valve placement, which is theoretically a very good valve release concept.

[0011] Transcatheter valve delivery systems typically use glutaraldehyde-treated wet valves. Preoperatively, the wet valve is clamped onto the delivery system, requiring extensive preoperative preparation in the operating room. The procedure is complex and the preoperative preparation is tedious. Before valve replacement surgery, the valve needs to undergo multiple cleaning, compression, and assembly processes. This tedious preparation process can easily lead to additional surgical risks, such as unstable compression frames that can cause enlargement. Long-term glutaraldehyde residue increases the calcification and toxicity of bioprosthetic valves. Taking the Edwards Sapien 3 delivery system as an example, preoperative preparation requires cleaning the wet valve before clamping it in a fixed area. During surgery, the balloon retracts into the wet valve at the descending aorta. This relative movement between the balloon and the valve can easily create uncertainty in the position of the valve frame and balloon during surgery, leading to uncertainties and risks due to potentially inaccurate and unverifiable positioning.

[0012] Meanwhile, due to the uncertainty of the positions of the balloon and the valve, it is difficult to keep the center of the valve and the balloon consistent with the design value. Perhaps because there is an angle between the valve and the balloon, it is not easy for the balloon to be accurately placed on the patient's valve when it expands the valve. Summary of the Invention

[0013] The purpose of this invention is to provide a transcatheter aortic bulbar dilatation valve adjustable delivery system. The technical problem to be solved is to simplify the surgical procedure, shorten the surgical preparation time, reduce the uncertainty of loading the valve on the operating table, and improve the accuracy of valve placement.

[0014] To solve the above problems, the present invention adopts the following technical solution: a transcatheter aortic bulb dilatation valve adjustable bend delivery system, which is sequentially connected from distal to proximal end with a tip, an adjustable bend tube, a balloon, a handle, and a double lumen tube;

[0015] The distal end of the adjustable bend is bendable or straight. The adjustable bend is coaxially arranged with the double-lumen tube and sleeved on the outside of the double-lumen tube. The adjustable bend is equipped with a traction wire. The proximal end of the adjustable bend is connected to the distal end of the handle. The proximal end of the traction wire is connected to the handle. The distal end of the double-lumen tube extends from the distal end of the adjustable bend and is connected to the proximal end of the tip. The proximal end of the double-lumen tube passes through the inner hole of the handle. After its proximal end extends out of the handle, it is connected to the Y-shaped Luer connector. The two lumens of the double-lumen tube are respectively connected to the two channels of the Y-shaped Luer connector. There is a gap between the double-lumen tube and the adjustable bend. There is an opening between the distal end of the double-lumen tube and the distal end of the adjustable bend that communicates with the gap. There is an injection port on the handle. The injection port is connected to a tee through a bypass pipe. The injection port communicates with the gap.

[0016] The balloon is located at the distal end of the double-lumen tube. The proximal and distal ends of the balloon are welded to the double-lumen tube, and the tip is fixed to the distal end of the double-lumen tube. The balloon is connected to one of the lumens of the double-lumen tube. After inflation, the middle part of the balloon has a wasp-waist structure. When the balloon is in the folded and contracted state, the whole balloon is cylindrical. The valve is pre-compressed on the balloon in the folded and contracted state.

[0017] Furthermore, the portion of the double-lumen tube located within the balloon has three spaced-apart marking rings fitted onto its outer wall.

[0018] Furthermore, the adjustable bend includes an adjustable bend outer tube, an adjustable bend middle tube, and an adjustable bend inner tube from the outside to the inside. A tubular traction wire channel is embedded between the adjustable bend inner tube and the adjustable bend middle tube. The traction wire channel extends along the axial direction of the adjustable bend, and the traction wire is located in the traction wire channel.

[0019] Furthermore, the adjustable bend intermediate tube is made of braided wire, spring, or metal-cut tube.

[0020] Furthermore, when using a metal-cut tube, the distal end of the adjustable bend intermediate tube is provided with a first hollow hole and a second hollow hole symmetrically cut around the axis of the adjustable bend intermediate tube. The first hollow hole and the second hollow hole are arranged alternately along the axial direction of the adjustable bend intermediate tube.

[0021] Furthermore, a positioning ring is provided at the distal end of the adjustable bend and at the proximal end of the balloon, and the positioning ring is conical in shape.

[0022] Furthermore, the positioning ring is provided with a through hole.

[0023] Furthermore, the handle is provided with a bending adjustment knob, which is threadedly connected to the bending adjustment screw inside it, and the traction wire is fixed to the proximal end of the bending adjustment screw.

[0024] Furthermore, when the distal end of the adjustable bend can be straightened, the distal end of the adjustable bend is provided with a pre-bending section, which is straightened by a traction wire.

[0025] Furthermore, the wall of the cavity in the dual-lumen tube that communicates with the balloon is uniformly provided with liquid outlet holes.

[0026] Compared with the prior art, the present invention preloads the trunk valve directly onto the balloon, while ensuring that the entire catheter aortic trunk valve delivery system has the ability to bend and finely adjust the axis. Furthermore, during the delivery and placement of the trunk valve, it ensures that the trunk valve and the balloon do not move relative to each other, achieving precise delivery and placement at the patient's natural valve. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of the present invention.

[0028] Figure 2 This is a schematic diagram of the balloon structure of the present invention.

[0029] Figure 3 This is a schematic diagram of the balloon and valve of the present invention.

[0030] Figure 4 This is a schematic diagram of the tip and double-lumen tube of the present invention.

[0031] Figure 5 yes Figure 1 BB cross-sectional view.

[0032] Figure 6 yes Figure 1 AA section diagram.

[0033] Figure 7 yes Figure 1 CC section view.

[0034] Figure 8 This is a schematic diagram of the handle structure of the present invention.

[0035] Figure 9 yes Figure 8 Detailed D-image.

[0036] Figure 10 yes Figure 8 Enlarged image of E.

[0037] Figure 11 yes Figure 8 Detailed image of E.

[0038] Figure 12 yes Figure 8 Enlarged F-image.

[0039] Figure 13 This is a schematic diagram of the structure of the balloon of the present invention.

[0040] Figure 14 This is a schematic diagram of the adjustable bend of the present invention.

[0041] Figure 15-1 This is a schematic diagram of the adjustable bend of the present invention.

[0042] Figure 15-2 yes Figure 15-1 A magnified view of the part marked G.

[0043] Figure 15-3 This is a schematic diagram of the internal structure of the adjustable bend tube of the present invention.

[0044] Figure 16 This is a schematic diagram of the structure of the adjustable bend intermediate tube of the present invention.

[0045] Figure 17This is a schematic diagram of the structure of an adjustable bend pipe with a pre-bending section according to the present invention.

[0046] Figure 18 This is a schematic diagram of the positioning ring of the present invention located in the transcatheter aortic trunk valve delivery system.

[0047] Figure 19 This is a schematic cross-sectional view of the internal connection between the positioning ring and the adjustable bend of the present invention.

[0048] Figure 20 This is a schematic diagram of the positioning ring in Example 2.

[0049] Figure 21 This is a schematic diagram of the positioning ring in Example 3.

[0050] Figure 22 This is a schematic diagram of the invention passing through the aortic arch.

[0051] Figure 23 This is a diagram showing the positional relationship between the adjustable bend, the double-lumen tube, and the handle of this invention. Detailed Implementation

[0052] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0053] like Figure 1 , Figure 3 and Figure 4 As shown, this invention discloses a transcatheter aortic bulb dilatation valve adjustable bend delivery system, which is sequentially connected from distal to proximal as follows: a tip 1, an adjustable bend tube 2, a balloon 3, a handle 4, and a double-lumen tube 5, wherein:

[0054] The adjustable bend 2 is coaxially arranged with the double-lumen tube 5 and sleeved on the outside of the double-lumen tube 5. The proximal end of the adjustable bend 2 is connected to the distal end of the handle 4. The distal end of the double-lumen tube 5 extends from the distal end of the adjustable bend 2 and connects to the proximal end of the tip 1. The proximal end of the double-lumen tube 5 passes through the inner hole of the handle 4, and after extending out of the handle 4, it connects to the Y-shaped Luer connector 6. The two lumens of the double-lumen tube 5 are respectively connected to the two channels of the Y-shaped Luer connector 6. There is a gap between the double-lumen tube 5 and the adjustable bend 2. Figure 19 As shown), there is an opening communicating with the gap between the distal end of the double-lumen tube 5 and the distal end of the adjustable bend tube 2. The handle 4 is provided with an injection port 48, which is connected to the tee 8 via the bypass tube 7. The injection port 48 is communicating with the gap to clean and lubricate the gap.

[0055] The balloon 3 is located at the distal end of the double-lumen tube 5. The proximal and distal ends of the balloon 3 are welded to the double-lumen tube 5, and the tip 1 is fixed to the distal end of the double-lumen tube 5.

[0056] In this invention, the handle 4 can be a bending handle used in the prior art for bending conduits.

[0057] Of course, the following structure can also be used, such as Figures 5-12 As shown, the handle 4 is equipped with a bending knob 41, and the near end of the handle 4 is equipped with an axial fine adjustment knob 42. The bending knob 41 is threadedly connected to the bending screw 43 inside it. The traction wire 21 of the adjustable bending tube 2 is fixed to the near end of the bending screw 43. A winding rod 44 is provided at the near end of the bending screw 43. A clamping nut 45 with a threaded connection is provided on the winding rod 44. The traction wire 21 passes through the inner hole of the bending screw 43 inside the handle 4. After the near end of the traction wire 21 is wound around the winding rod 44 multiple times, it is tightened and fixed by the clamping nut 45. During operation, rotating the bending knob 41 causes the bending screw 43 to move back and forth, thereby driving the traction wire 21 connected to it, which plays the role of stretching and releasing the traction wire 21 on the adjustable bending tube 2, so as to bend the adjustable bending tube 2.

[0058] like Figure 5 , Figure 8 , Figure 12 As shown, an axial fine-tuning screw 46 is provided inside the handle 4. The axial fine-tuning screw 46 is sleeved and connected to the proximal end of the double-lumen tube 5. The proximal end of the axial fine-tuning screw 46 is glued to the double-lumen tube 5 with quick-drying adhesive. The axial fine-tuning knob 42 located at the proximal end of the double-lumen tube 5 is sleeved on the axial fine-tuning screw 46. The axial fine-tuning knob 42 and the proximal end of the axial fine-tuning screw 46 form a threaded connection structure.

[0059] like Figure 5 , Figure 6 , Figures 9-11 , Figure 23 As shown, the handle 4 has a handle head 47 at its distal end, which is bonded to the adjustable bend 2 with quick-drying adhesive. The handle head 47 has an inner hole, and a hollow clamping screw 410 is located at the distal end of the handle 4. The inner hole of the handle head 47 communicates with the clamping screw 410, and the handle head 47 is threadedly connected to the clamping screw 410. A filling port 48 communicating with the inner hole of the handle head 47 is located circumferentially on the handle head 47. The proximal end of the adjustable bend 2 is fixed in the inner hole of the handle head 47, and the filling port 48... A tee is connected to the bypass tube 7. A sealing ring 49 is installed between the infusion port 48 and the clamping screw 410 to ensure that the liquid entering through the infusion port 48 does not enter the handle 4, and also to prevent blood or flushing fluid from flowing back into the handle 4. After the proximal end of the adjustable bend tube 2 is bonded to the distal end of the handle head 47, the traction wire 21 extends from the proximal end of the adjustable bend tube 2, passes through the sealing ring 49, and is wound around the winding rod 44. The infusion port 48 and the bypass tube 7, and the bypass tube 7 and the tee 8 are bonded together with UV adhesive. During use, the gap between the double-lumen tube 5 and the adjustable bend tube 2 is cleaned by injecting liquid. During surgery, the tee 8 can prevent the patient's blood from flowing out of the infusion port 48 through the gap between the adjustable bend tube 2 and the double-lumen tube 5.

[0060] like Figure 5 , Figure 9and Figure 23 As shown, the inner hole of the handle head end 47 can be composed of three through holes with different diameters. Two large-diameter through holes are set at the proximal and distal ends of the handle head end 47, and a small-diameter through hole is set at the middle of the handle head end 47. The proximal end of the adjustable bend tube 2 is fixed in the through hole at the distal end. The distal end of the clamping screw 410 is set in the through hole at the proximal end. The double-lumen tube 5 passes through the through holes at the distal end and the middle. The outer diameter of the double-lumen tube 5 is smaller than the diameter of the through hole at the middle, so that the filling port 48 can enter the gap between the double-lumen tube 5 and the adjustable bend tube 2 through the gap between the double-lumen tube 5 and the through hole at the middle. The sealing ring 49 is set in the through hole at the proximal end.

[0061] like Figure 5 As shown, the handle 4 is also provided with a handle head cover 411 in the shape of a rotary body and a handle shell 413. The proximal end of the handle head 47 is bonded to the distal end of the handle shell 413. The proximal end of the bending knob 41 is axially rotatably fixed on the handle shell 413. The axial fine adjustment knob 42 is provided at the proximal end of the handle shell 413. The whole is axially rotatably fixed on the handle shell 413 by the buckle on the axial fine adjustment knob 42. At this time, rotating the axial fine adjustment knob 42 can drive the double cavity tube 5 to move back and forth. The proximal end of the double cavity tube 5 passes through the axial through hole in the handle shell 413 and is bonded and fixed to the distal end of the axial fine adjustment screw 46.

[0062] like Figure 9 , Figure 10 As shown, the traction wire 21 passes through the channel inside the bending screw 43 from the far end, and wraps around the axially protruding winding rod 44 three times at its near end. After the winding rod 44 is pressed down by the pressure ring 412, the pressure nut 45 is rotated to tighten it, and the near end of the traction wire 21 is fixed on the bending screw 43.

[0063] like Figure 5 As shown, when the axial fine adjustment knob 42 is rotated, the axial fine adjustment screw 46, which is threadedly connected to the axial fine adjustment knob 42, moves axially, causing the double-cavity tube 5 to move axially.

[0064] like Figure 2 As shown, three spaced-apart marking rings 9 are fitted onto the outer wall of the portion of the double-lumen tube 5 located within the balloon 3. A limiting ring 91 is provided on the farthest marking ring 9. The marking rings 9 are fixed (using a marking ring applicator) to the outer wall of the double-lumen tube 5. The limiting ring 91 serves to restrict the forward movement of the valve 10.

[0065] In this invention, the stem flap 10 is coaxially fitted outside the balloon 3 in its folded and contracted state.

[0066] like Figure 13As shown, after inflation, the balloon 3 has a wasp-waist structure 31 in its middle part and symmetrical conical structures 32 at both ends. The wasp-waist structure 31 and the conical structure 32 are coaxially arranged. An arc-shaped transition section is provided between the wasp-waist structure 31 and the conical structure 32 to form a shoulder 33. The maximum diameter of the wasp-waist structure 31 is connected to the large end of the conical structure 32. The wasp-waist structure is an arc-shaped section that convexes inward toward the axis of the balloon. The small end of the conical structure 32 faces outward. A cylindrical cylinder 34 is connected to the small end of the conical structure 32.

[0067] like Figure 13 As shown, the balloon 3 of the present invention has a wasp-waist-shaped structure 31 in the middle, which will expand the trunk valve 10 into the same wasp-waist shape. The wasp-waist-shaped trunk valve 10 can better fit the stenosis and calcification at the irregular aortic valve, so as to avoid paravalvular leakage.

[0068] like Figure 1 As shown, in its folded and contracted state, the balloon 3 is cylindrical in shape. Figure 13 As shown, when fully inflated, balloon 3 expands as a whole. The wasp-waist structure 31 and the shoulders 33 of balloon 3 create a height difference, with the wasp-waist structure 31 forming an inward curve. The shoulders 33 of the balloon are positioned against the aortic valve, effectively blocking the aortic valve annulus. After the balloon has fully expanded, it can be further inflated with increased pressure. At this point, the middle portion of the wasp-waist structure continues to expand with the pressure, while the shoulders 33 on both sides do not deform excessively. This design allows the balloon to completely hold the aortic valve in the circumferential direction, thereby reducing paravalvular leakage.

[0069] After the balloon and trunk valve 10 are delivered to the aortic valve region via a transcatheter aortic trunk valve delivery system, the balloon 3 is inflated by perfusion fluid, expanding the trunk valve 10. The wasp-waist structure 31 expands first at both ends, expanding the ends of the trunk valve, followed by expansion in the middle, ensuring that the center point of the trunk valve 10 coincides with the center point of the balloon. When the balloon inflates to its working pressure, the trunk valve 10 is molded into the same shape as the balloon and secured at the natural valve, resulting in better fit. The wasp-waist structure 31 of the balloon covers the edges of the trunk valve 10 and the calcified valve, reducing paravalvular leakage. Furthermore, the wasp-waist structure 31 allows the trunk valve 10 to be better positioned at the natural valve, making it less likely to dislodge from the aortic stenosis.

[0070] like Figure 15-1 As shown, the adjustable bend 2 also includes a traction wire fixing ring 22.

[0071] like Figure 14 , Figure 15-1 , Figure 15-2 and Figure 15-3As shown, the adjustable bend 2 is tubular, and its distal end is bendable. The adjustable bend 2 includes an outer tube 24, a middle tube 25, and an inner tube 26 from the outside to the inside. A tubular traction wire channel 23 is embedded between the inner tube 26 and the middle tube 25. The traction wire channel 23 extends along the axial direction of the adjustable bend 2. A traction wire fixing ring 22 is provided at the distal end of the adjustable bend 2. The traction wire fixing ring 22 is sleeved on the middle tube 25. The traction wire fixing ring 22 is fixed to the middle tube 25 by welding the outer tube 24. The traction wire 21 passes through the traction wire channel 23, and its distal end is connected and fixed to the traction wire fixing ring 22.

[0072] In this invention, the inner tube 26 of the adjustable bend can be made of polytetrafluoroethylene (PTFE), and the middle tube 25 of the adjustable bend is made of a metal material with certain torsional stiffness and bending resilience, such as braided wire, springs, and metal cut tubes, including but not limited to stainless steel and aluminum alloys. The outer tube 24 of the adjustable bend can be made of nylon elastomer (Pebax or nylon) to ensure that the traction wire 21 can move relative to the adjustable bend 2 when pulled, so that the adjustable bend 2 can produce a bending effect. However, this invention is not limited to this; the outer tube 24 of the adjustable bend can be made of the same material or made of different materials in sections. The traction wire 21 and the traction wire fixing ring 22 can be connected and fixed by welding, winding, or other methods.

[0073] like Figure 16 As shown, a first perforated hole 28 and a second perforated hole 29 can be provided on the distal end of the adjustable bending intermediate tube 25, symmetrically cut along the axis of the tube body. The first perforated hole 28 and the second perforated hole 29 are arranged alternately along the axial direction of the adjustable bending intermediate tube 25 to restrict the distal end of the adjustable bending intermediate tube 25 to bend only in two opposite directions within one plane. The cutting direction of the first perforated hole 28 and the second perforated hole 29 is perpendicular to the axis of the adjustable bending intermediate tube 25. The cutting width and cutting interval of the perforated holes can be readjusted and arranged according to the required bending performance.

[0074] By using a metal tube as the base tube and cutting it to create the aforementioned adjustable bending intermediate tube 25, the bending direction of the adjustable bending tube can be restricted to a single plane, causing it to bend in the direction of the traction wire within that plane. The bending performance of the adjustable bending tube under external force, such as the bending position, bending angle, and bending feedback sensitivity, can also be changed by adjusting the width, spacing, and shape of the first and second perforated holes 28 and 29. This gives the adjustable bending tube body bending selectivity; when tension is applied to the traction wire, the distal end of the adjustable bending tube body bends, while the perforated holes restrict the adjustable bending tube body to bending only in the direction of the perforated holes and towards the side where the traction wire is fixed, improving the accuracy of the bending direction and the bending amplitude of the adjustable bending tube.

[0075] Of course, the present invention can also replace the function of the traction wire fixing ring 22 by providing a fixing hole 27 at the distal end of the adjustable bending intermediate tube 25 instead of setting the traction wire fixing ring 22 (e.g. Figure 16 As shown, the traction wire 21 passes through the traction wire channel 23 and is connected and fixed to the fixing hole 27 at the far end of the adjustable bending intermediate tube 25. The fixing hole 27 is set opposite to the first hollow hole 28.

[0076] like Figure 17 As shown, the adjustable bend tube 2 of the present invention can also be pre-bent at its distal end to form a pre-bent section 210, thus ensuring that the adjustable bend tube is in a bent state by default. During use, the tube body can be straightened again by inserting a traction wire 21. The degree of bending of the tube body is adjusted by the depth of insertion of the traction wire 21, thereby meeting the surgical requirements for bending performance. The traction wire 21 is located inside the bending direction of the pre-bent section 210.

[0077] The adjustable bend allows for more precise adjustment of the bend direction and angle, making it easier for the delivery system to reach the designated location. This reduces the number of attempts required for valve placement, thus avoiding potential vascular damage. Simultaneously, it significantly reduces the time required to deliver the valve, thereby shortening the overall surgical time.

[0078] like Figure 2 and Figure 23 As shown, the dual-lumen tube 5 includes a guidewire lumen 51 and a fluid passage lumen 52. The fluid passage lumen 52 is located in the balloon 3. Fluid outlet holes 53, communicating with the interior of the balloon 3, are evenly distributed on the tube wall. The guidewire lumen 51 penetrates the proximal and distal ends of the dual-lumen tube 5. The proximal end of the guidewire lumen 51 communicates with one channel of the Y-shaped Luer connector. The fluid passage lumen 52 (… Figure 23 The proximal end of the section indicated by the dashed line (showing liquid inflow) is connected to another channel of the Y-shaped Luer connector.

[0079] The uniform distribution of the liquid outlet holes 53 allows the liquid to enter the balloon 3 evenly and inflate the balloon 3. Of course, the liquid outlet holes 53 can also be evenly distributed along the axis of the double-lumen tube 5 at the corresponding positions of the liquid passage cavity 52 to further ensure that the liquid enters the balloon 3 evenly.

[0080] like Figure 2 As shown, tip 1 is a soft component made of silicone material, located at the distal end of the entire transcatheter aortic valve delivery system. Because tip 1 is a soft component, it ensures that it will not damage the blood vessel, while also maintaining the necessary guidance. The distal radial dimension of tip 1 is smaller than that of the proximal end, and its axial through-hole communicates with the guidewire lumen 51 of the double-lumen tube 5 extending into it proximally.

[0081] like Figure 18 and Figure 19 As shown, a positioning ring 11 with a protective and pushing function for the valve is provided at the distal end of the adjustable bend 2 and at the proximal end of the balloon 3. The positioning ring 11 is conical in shape, and the diameter of the distal end of the positioning ring 11 is larger than that of the proximal end. A first step 111 is provided on the inner wall of the distal end of the positioning ring 11. The distal end of the first step 111 forms the skirt 112 of the positioning ring. The first step 111 and the skirt 112 limit the proximal end of the valve 10. The proximal end of the positioning ring 11 is provided with a second step 113 that is adapted to and connected to the distal end of the adjustable bend 2. The second step 113 is recessed to form an insertion part 115 that is connected to the adjustable bend 2.

[0082] The positioning ring 11 is fixed to the far end of the adjustable bend 2 by welding.

[0083] like Figure 20 As shown, based on the positioning ring 11 mentioned above, two symmetrically distributed through holes 114 are opened on the outer wall of the positioning ring 11. The through holes 114 are conical in shape, with the large end of the cone facing the far end, and the end of the large end is a section of arc protruding towards the far end.

[0084] like Figure 21 As shown, the through hole 114 can also be a non-circular hole with symmetrical wavy edges on both sides of the hole, and the proximal and distal ends of the hole are convex arcs.

[0085] The axial support force of the positioning ring 11 without through holes is better than that of the positioning ring 11 with through holes 114, but its flexibility is better than that of the positioning ring 11 without through holes.

[0086] like Figure 22As shown, the positioning ring 11 protects and pushes the proximal end of the aortic valve 10. The positioning ring 11 prevents the aortic valve from shifting posteriorly during distalization of the transcatheter aortic valve delivery system (TAVDS), and wraps around the proximal end of the aortic valve to prevent it from scraping the blood vessel as it passes the aortic arch. The inner end face of the positioning ring 11 wraps around the proximal end of the aortic valve, ensuring that the skirt 112 of the positioning ring conforms to the outer periphery of the proximal end of the aortic valve.

[0087] After the entire transcatheter aortic bulb dilatation valve adjustable delivery system is assembled, the pre-sewn valve is loaded onto the balloon of the transcatheter aortic bulb dilatation valve adjustable delivery system using a valve gripper. This eliminates the step of loading the valve onto the balloon before surgery, greatly reducing preoperative preparation time and improving surgical efficiency.

[0088] The adjustable cannula uses a sheath structure, and its bend-adjusting function allows the transcatheter aortic bulbar valve adjustable delivery system to easily pass through the aortic arch. During valve placement, the combination of bend-adjusting and axial fine-tuning functions enables the valve to be delivered to a precise position.

[0089] The transcatheter aortic bulbar dilatation valve adjustable bending delivery system of the present invention pre-loads the valve onto the balloon before shipment, eliminating the need for glutaraldehyde treatment of the valve. This directly saves the pre-operative valve loading time, as the valve is directly loaded onto the balloon. Simultaneously, the system maintains a small outer contour, ensuring that it can achieve bending and axial fine-tuning functions. Furthermore, during valve delivery and placement, the system ensures that there is no relative movement between the valve and the balloon, achieving precise valve placement at the patient's natural valve location.

Claims

1. A transcatheter aortic bulb dilatation valve adjustable delivery system, characterized in that: The tube is connected sequentially from distal to proximal as follows: tip (1), adjustable bend tube (2), balloon (3), handle (4), and double lumen tube (5); The distal end of the adjustable bend (2) is bendable or straight. The adjustable bend (2) is coaxially arranged with the double-lumen tube (5) and sleeved outside the double-lumen tube (5). The adjustable bend (2) is provided with a traction wire (21). The proximal end of the adjustable bend (2) is connected to the distal end of the handle (4). The proximal end of the traction wire (21) is connected to the handle (4). The distal end of the double-lumen tube (5) extends from the distal end of the adjustable bend (2) and is connected to the proximal end of the tip (1). The proximal end of the double-lumen tube (5) passes through the inner hole of the handle (4). The proximal end of the tube extends out of the handle (4) and connects to the Y-shaped Luer connector (6). The two cavities of the double-lumen tube (5) are respectively connected to the two channels of the Y-shaped Luer connector (6). There is a gap between the double-lumen tube (5) and the adjustable bend (2). There is an opening between the distal end of the double-lumen tube (5) and the distal end of the adjustable bend (2) that communicates with the gap. The handle (4) has an injection port (48). The injection port (48) is connected to the tee (8) through the bypass pipe (7). The injection port (48) communicates with the gap. The balloon (3) is located at the distal end of the double-lumen tube (5). The proximal and distal ends of the balloon (3) are welded to the double-lumen tube (5). The tip (1) is fixed to the distal end of the double-lumen tube (5). The balloon (3) is connected to one of the lumens of the double-lumen tube (5). After the balloon (3) is inflated, its middle part has a wasp-waist structure (31). When the balloon (3) is in a folded and contracted state, the balloon (3) is cylindrical in shape. The valve (10) is pre-pressed on the balloon (3) in the folded and contracted state.

2. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 1, characterized in that: The portion of the double-lumen tube (5) located within the balloon (3) has three spaced-apart marking rings (9) fitted onto its outer wall.

3. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 1, characterized in that: The adjustable bend (2) includes an adjustable bend outer tube (24), an adjustable bend middle tube (25), and an adjustable bend inner tube (26) from the outside to the inside. A tubular traction wire channel (23) is embedded between the adjustable bend inner tube (26) and the adjustable bend middle tube (25). The traction wire channel (23) extends along the axial direction of the adjustable bend (2), and the traction wire (21) is located in the traction wire channel (23).

4. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 3, characterized in that: The adjustable bend intermediate tube (25) is made of braided wire, spring or metal cut tube.

5. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 4, characterized in that: When metal cutting tubes are used, the distal tube body of the adjustable bend intermediate tube (25) is provided with a first hollow hole (28) and a second hollow hole (29) symmetrically cut with respect to the tube body axis of the adjustable bend intermediate tube (25). The first hollow hole (28) and the second hollow hole (29) are arranged alternately along the axial direction of the adjustable bend intermediate tube (25).

6. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 3, characterized in that: A positioning ring (11) is provided at the distal end of the adjustable bend (2) and at the proximal end of the balloon (3). The positioning ring (11) is conical in shape.

7. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 6, characterized in that: The positioning ring (11) has a through hole (114).

8. The transcatheter aortic bulb dilatation valve adjustable delivery system according to any one of claims 1-7, characterized in that: The handle (4) is provided with a bending knob (41), which is threadedly connected to the bending screw (43) inside it, and the traction wire (21) is fixed to the proximal end of the bending screw (43).

9. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 8, characterized in that: When the distal end of the adjustable bend (2) can be straightened, the distal end of the adjustable bend (2) is provided with a pre-bending section (210), which is straightened by the traction wire (21).

10. The transcatheter aortic bulb dilatation valve adjustable delivery system according to claim 1, characterized in that: The wall of the cavity in the double-lumen tube (5) that communicates with the balloon (3) is uniformly provided with liquid outlet holes (53).

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