Adjustable structure, and guidewire-assisted transvalvular device comprising same
By designing an adjustable guidewire-assisted transvalvular device, and utilizing the protruding parts of the variable catheter and adjusting tube, the problem of aligning the guidewire through the aortic valve orifice was solved, achieving rapid, safe, and widely applicable guidewire passage, and reducing surgical time and costs.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SHANGHAI HONGLING MEDICAL DEVICE CO LTD
- Filing Date
- 2025-10-31
- Publication Date
- 2026-05-21
AI Technical Summary
In existing technologies, it is difficult to align the guidewire when passing through the aortic valve orifice, especially when the native aortic valve is calcified or not located in the middle. This makes the operation difficult and carries the risk of tissue damage. In particular, in the absence of three-dimensional imaging equipment, existing devices are not suitable for patients whose aortic valve orifice is deviated to the medial side.
Design an adjustable guidewire-assisted transvalvular device, including a variable catheter and an adjustment tube. By adjusting the height difference between the outer and inner protruding sides of the protruding part, the protrusion height of the protruding part can be adjusted to adapt to the aortic valve orifice position of different patients, provide support, and ensure smooth passage of the guidewire.
It enables the guidewire to pass through the aortic valve orifice quickly and safely, accommodates more patients, shortens operation time, reduces patient suffering and lowers usage costs.
Smart Images
Figure CN2025131730_21052026_PF_FP_ABST
Abstract
Description
An adjustable structure and a guidewire-assisted transvalvular device including the same. Technical Field
[0001] This invention belongs to the field of medical devices, specifically relating to an adjustable structure and a guidewire-assisted transvalvular device containing the same. Background Technology
[0002] Transcatheter aortic valve replacement (TAVR) is a technique that involves inserting a catheter containing an aortic valve prosthesis along a guidewire pre-implanted into the left ventricle to implant the aortic valve prosthesis into a pre-defined location.
[0003] To allow the guidewire to pass through the aorta and enter the left ventricle, it needs to be aligned with the native aortic valve orifice. However, a challenge of TAVR is that, in most patients, the native aortic valve is severely calcified, resulting in a small orifice. Furthermore, in some patients, the aortic valve orifice is not located in the middle of the aorta. Especially in the absence of 3D imaging equipment, passing the guidewire through the aortic valve orifice requires a high level of skill from the operator.
[0004] Furthermore, to avoid tissue damage, guidewires are made of soft materials, especially when traversing the tortuous aorta, where positioning and proper orientation can be problematic during guidewire advancement. This issue is more pronounced in the "valve-in-valve" technique (or the simpler VIV). Therefore, the defective valve prosthesis is not removed but used as a support frame to anchor the new prosthetic valve. If the guidewire comes into contact with the defective valve prosthesis during the valve crossing, it may alter the prosthesis's position, potentially causing it to dislodge into the left ventricle, posing a life-threatening risk to the patient.
[0005] As shown in Figures 1A and 1B, this is a guidewire transvalvular assist device designed in the prior art. It uses an expandable basket to move the guidewire away from the outer side of the aortic wall to locate the native aortic valve orifice or defective valve prosthesis with the help of external imaging equipment. However, it is not suitable for patients with certain special conditions, such as those whose aortic valve orifice is deviated to the inner side of the aortic axis.
[0006] In view of the above-mentioned problems in the existing technology, the present invention provides a universal guidewire-assisted transvalvular device that enables the guidewire to pass through the native or defective aortic valve orifice quickly and safely. Summary of the Invention
[0007] A first aspect of the present invention is to provide an adjustable structure comprising: a variable conduit having a protruding portion;
[0008] The protruding portion includes an outer protruding side and an inner protruding side, wherein the protruding height of the outer protruding side is greater than the protruding height of the inner protruding side.
[0009] The outer convex side is the side that needs to be in close contact with the tissue and requires the tissue to provide support, while the inner convex side is the side that does not require the tissue to provide support.
[0010] In a preferred embodiment, the adjustable structure further includes an adjusting tube, which is sleeved inside the variable conduit and its distal end is fixedly connected to the distal end of the variable conduit. Other parts of the adjusting tube can move relative to the variable conduit to change the protrusion height of the protruding part, so that the protruding part is in an expanded state or a contracted state.
[0011] In a preferred embodiment, in the expanded state, along the cross-section of the protruding portion, the outer circumferential length of the outer protruding side is greater than the outer circumferential length of the inner protruding side. Preferably, the protruding height of the inner protruding side is 0.
[0012] In a preferred embodiment, the protrusion is one of a balloon, a woven net, or a basket.
[0013] In a preferred embodiment, the protruding portion is a balloon, which is connected to the outside at its proximal end. During surgery, by injecting fluid such as water into the balloon, the balloon is inflated, thereby changing the lateral position of the central axis of the distal end of the variable catheter with the help of tissue support. Here, lateral refers to the direction perpendicular to the central axis of the variable catheter at its current location.
[0014] In a preferred embodiment, the protrusion is a basket, which includes 3-5 basket bars along the axial direction of the variable conduit.
[0015] In a preferred embodiment, when in the expanded state, along the maximum cross-section of the protruding portion, the central angle α of the arc formed by the basket strips is 60°-270°, preferably 80°-220°, and more preferably 90°-180°.
[0016] In a preferred embodiment, the protrusion height of the protrusion is 3mm-45mm, preferably 4mm-35mm, and more preferably 5mm-30mm.
[0017] Another aspect of the present invention provides a guidewire-assisted transvalvular device, comprising the adjustable structure described in any of the preceding claims.
[0018] In a preferred embodiment, the proximal end of the regulating tube extends out of the variable conduit, and the proximal end of the variable conduit is provided with a fixing seat that can lock the regulating tube.
[0019] The beneficial effects of this invention are:
[0020] 1. By adjusting the height of the protrusion of the protruding part, the distal end of the adjustment tube can be directed toward the aortic valve orifice, allowing the guidewire to pass smoothly through the aortic valve orifice and reach the left ventricle, thus preparing for subsequent surgery.
[0021] 2. Because the cross-sectional shape of the protruding portion is not a regular circle, but rather the protruding height of the outer protruding side is greater than that of the inner protruding side, and there is even no basket or other protruding element on the inner protruding side, for patients with a large aorta, the protruding portion will not bulge too much, causing the adjusting tube to cross the aortic midline, thus preventing the inner protruding portion from compressing the inner aortic side and preventing the outer protruding side from continuing to bulge. In other words, the adjustable structure provided by this invention can not only accommodate more patients with aortic valve disease and be used to assist guidewire crossing the valve during aortic valve replacement surgery, but can also be used for atrial septal puncture surgery.
[0022] 3. The guidewire-assisted transvalvular device provided by the present invention can significantly shorten the operation time and reduce patient pain.
[0023] 4. The adjustable structure and guidewire-assisted transvalvular device provided by the present invention have a simple structure and low production cost, which can reduce the cost of use for patients. Attached Figure Description
[0024] The invention will be more fully understood and appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which:
[0025] Figures 1A and 1B show the usage status of the adjustable structure of the spherical basket structure and the guide wire-assisted cross-lobe device in the prior art.
[0026] Figure 2 is a schematic diagram of the contraction and expansion states of an adjustable structure provided by the present invention.
[0027] Figure 3A shows schematic diagrams of the adjustable structure formed by the net basket;
[0028] Figure 3B is a cross-sectional view of the net basket along C-C' in Figure 3A;
[0029] Figure 4 is a schematic diagram of an adjustable structure formed by woven mesh;
[0030] Figure 5 is a schematic diagram of the adjustable structure formed by the balloon;
[0031] Figure 6 is a schematic diagram of a guidewire-assisted transvalvular device provided by the present invention;
[0032] Figure 7 is a cross-sectional schematic diagram of Figure 6;
[0033] Figure 8 is a schematic diagram of the convergence state of the guidewire-assisted transvalvular device provided by the present invention at the aortic root.
[0034] Figure 9 is a schematic diagram of an expanded state of the translobe device provided by the present invention.
[0035] Figure 10 is a schematic diagram of another expansion state of the translobe device provided by the present invention.
[0036] Among them, 100 is the guidewire-assisted transvalvular device, 101 is the support tube, 102 is the variable ball, 103 is the adjustment tube, 104 is the pigtail catheter, 105 is the fixation seat, 1021 is the basket strip, and 1022 is the variable ball head end. Detailed Implementation
[0037] To more clearly illustrate the embodiments of the present invention, specific implementations will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other implementations can be obtained based on these drawings without any creative effort.
[0038] In this invention, the terms "closed state" and "constricted state" both refer to the delivery state of the protruding part in the conduit or the state in which it expands (opens) without the use of external force.
[0039] Figure 1B illustrates the usage of a prior art guidewire-assisted transvalvular device. Because its distal expandable head expands outwards simultaneously, when the distal central axis of the regulating tube is located in the middle of the aortic valve, the expandable head 111 is pressed against the aortic wall on all sides. In patients with the aortic valve orifice located in the middle of the aorta, the guidewire 112 can pass through the aortic valve orifice into the left ventricle to complete transvalvular passage. However, if the expandable head continues to expand, the forces around the aortic wall cancel each other out. In other words, the prior art guidewire-assisted transvalvular device is not suitable for patients with the aortic valve orifice located medially. To address this problem in the prior art, the present invention proposes the following solution.
[0040] Referring now to Figure 2, a schematic diagram of the contracted and expanded states of an adjustable structure provided by the present invention is shown. The contracted state diagram is used as an example for illustration. The adjustable structure includes a variable conduit 101 and an adjusting tube 103. The adjusting tube 103 is sleeved within the variable conduit 101, and the distal end of the adjusting tube 103 is fixedly connected to the distal end of the variable conduit. In Figure 2, the lower end is the distal end, and the upper end is the proximal end; the proximal end is the end closest to the medical staff during surgery.
[0041] The variable conduit 101 includes a delivery section 1011 and a protruding portion 102. Preferably, the distal end of the variable conduit 101 may also be provided with a converging end 1012, and the two ends of the protruding portion 102 are respectively connected to the delivery section 1011 and the converging end 1012. The distal end of the variable conduit 103 is fixedly connected to the converging end 1012. Other parts of the adjusting tube 103 can move relative to the variable conduit 101, and the proximal end of the adjusting tube 103 extends out of the variable conduit 101. When the proximal end position of the variable conduit 101 is fixed, the adjusting tube 103 is pulled towards the proximal end, and the protruding portion 102 is subjected to a compressive force and moves laterally in the direction perpendicular to the center line of the adjustable structure, that is, laterally. The protruding portion 102 bulges outward to change its protrusion height, so that the protruding portion 102 is in an expanded state.
[0042] To accommodate more patients, as shown in Figure 2, the protruding portion 102 includes an outer protruding side 1023 and an inner protruding side 1024. The protruding height H1 of the outer protruding side 1023 is greater than the protruding height H2 of the inner protruding side. The protruding height refers to the vertical distance from the farthest point of the outer protruding side 1023 and the inner protruding side 1024 to the central axis of the adjusting tube 103. In a preferred embodiment, the protruding height of the protruding portion 102 is 3mm-45mm, preferably 4mm-35mm, and more preferably 5mm-30mm. For example, 8mm, 10mm, 15mm, 18mm, 20mm, 24mm, 26mm, 28mm, 32mm, 38mm, 42mm, 44mm, etc., can meet the needs of most patients.
[0043] In other words, in the expanded state, the outer perimeter length of the outer convex side 1023 of the cross-section of the protruding part 102 (not shown) where points A, O, and B are located in Figure 2 is greater than the outer perimeter length of the inner convex side 1024.
[0044] The function of the protruding part 102 is that when the adjusting tube 103 is pulled back, the protruding part 102 can extend to its surroundings, especially to the outside, and can provide a certain support force. Therefore, the protruding part 102 needs to have both flexibility and strength, and it can be a ball, woven net, or basket.
[0045] As shown in Figure 3A, the variable conduit 101 has a protruding portion 102 in the shape of a basket, which is surrounded by multiple basket strips 1021 extending axially along the variable conduit 101. Further, the number of basket strips 1021 is 3-5. When the protruding portion 102 is in an expanded state, as shown in Figure 3B, along the cross-section where AOB of the protruding portion 102 is located, the central angle α of the arc formed by the basket strips 1021 is 60°-270°, preferably 80°-220°, and more preferably 90°-180°.
[0046] In the embodiments shown in Figures 3A and 3B, the structure of the protruding part 102 is mainly composed of a basket strip 1021. The shape of the basket strip 1021 can be rectangular, S-shaped, or other irregular shapes, as long as it can protrude and provide support.
[0047] In the embodiments shown in Figures 3A and 3B, the protruding portion 102 can be formed by cutting a polymer tube. It can be created at the distal end of the variable conduit 101 by axially cutting the variable conduit 101 and removing several baskets to form a partial slot. Alternatively, it can be made using a single polymer tube. Multiple basket strips are cut along the axial direction of the polymer tube to form the protruding portion 102, which is then welded or bonded to the delivery section 1011 and the receiving section 1012 of the variable conduit 101. The material used to make the basket strips 1021 can be a polymer material, such as PEBAX, PA, PTFE, HDPE, TPU, PEEK, etc. It can also be made using silicone material through injection molding, or multiple basket strips can be formed by weaving.
[0048] As shown in Figure 4, the variable conduit 101 or adjustable structure has a protruding part 102 that is a semi-circular structure formed by a braided mesh. The protruding part 102 can bulge out to one side of the adjusting tube 103 or the variable conduit 101. The braided mesh can be made of polymer material or metal material, and the two ends of the braided mesh are fixed to the distal end of the conveying section 1011 and the proximal end of the receiving end 1012, respectively.
[0049] As shown in Figure 5, the variable catheter 101 or adjustable structure has a protruding portion 102 that is a balloon body communicating proximally with the outside. The balloon body has a semi-circular structure. By injecting liquid into the balloon body, it protrudes outward, thereby changing the relative position of the adjusting tube 103 and the blood vessel. When the protruding portion 102 is a balloon body or balloon, the adjustable structure may also omit the adjusting tube. Instead, water or other liquid is injected into the balloon body or balloon using an external syringe, causing the balloon body or balloon to inflate and protrude. This also changes the lateral position of the central axis of the distal end of the variable catheter 101.
[0050] The adjustable structure provided by this invention can be used in a variety of surgeries, such as guidewire-assisted transvalvular aortic valve replacement and atrial septal puncture.
[0051] The following example, using a guidewire-assisted transvalvular device for aortic valve replacement surgery, illustrates the application of the adjustable structure provided by this invention in surgery.
[0052] As shown in Figures 6 and 7, the guidewire-assisted transvalvular device (other parts not shown) includes any of the aforementioned adjustable structures. The proximal ends of the variable catheter 101 and the adjusting tube 103 of the adjustable structure are respectively provided with fixing seats 105 and 1031. Fixing seat 105 is used to lock the variable catheter 101 and the adjusting tube 103 during surgery and seal the gap between them. Fixing seat 1031 is used to lock the adjusting tube 103 and the pigtail catheter 104 during surgery and seal the gap between them. The proximal end of the adjusting tube 103 extends from the proximal end of the variable catheter 101. Medical personnel can adjust the protrusion height of the protruding part 102 by pulling the adjusting tube 103 proximal to the proximal end.
[0053] In the embodiment shown in Figure 6, the fixing seat 105 has a silicone sealing device inside to seal the gap between the adjusting tube 103 and the variable conduit 101, and the fixing seat 105 has a locking function, which can fix the adjusting tube by rotating or pressing.
[0054] The pigtail catheter 104 may not be included in the guidewire-assisted transvalvular device provided by this invention, and a pigtail catheter commonly available in hospitals may be used instead. It may also not be used in guidewire transvalvular surgery. The intervention of the pigtail catheter 104 is for subsequent TAVR surgery, i.e., by replacing the guidewire with a rigid guidewire suitable for TAVR surgery via the pigtail catheter 104.
[0055] To illustrate the purpose of the guidewire crossing the valve, the pigtail catheter 204 is still used to describe the surgical procedure. As shown in Figures 9-11, during the procedure, the guidewire is first delivered to the aortic root. Then, the crossing device provided by this invention crosses the aortic arch along the guidewire and enters the ascending aorta. Due to the centrifugal force of the guidewire and the crossing device, its distal end, after reaching the ascending aorta, will abut against the lateral aortic wall. This invention, by changing the protrusion height of the protruding part 102, makes the outer protruding side 1023 of the protruding part 102 abut against the lateral aortic wall. As the protrusion height H1 of the protruding part 102 gradually increases, as shown in Figure 9, after the central axis of the adjusting tube 103 is aligned with the aortic valve orifice, the soft guidewire, which has been implanted in the aortic root, crosses the aortic valve orifice along the adjusting tube, completing the guidewire crossing the valve and entering the left ventricle. Then, the distal end of the pigtail catheter 104 is passed through the distal end of the regulating tube 103 and inserted into the left ventricle along the soft guidewire. The soft guidewire is withdrawn, and a rigid guidewire is advanced into the left ventricle along the pigtail catheter 104 to prepare for TAVR surgery. Because the blood vessel is tortuous, the variable catheter 101, regulating tube 102, and pigtail catheter 104 need to have a certain degree of flexibility and bend resistance. Preferably, polymer materials such as PEBAX, PA, PTFE, HDPE, TPU, and PEEK can be used, or the catheter can be made from a composite of the above materials and braided metal wire.
[0056] As shown in Figures 9 and 11, since the protruding part 102 of the guidewire-assisted transvalvular device provided by the present invention is of uneven size when it is in the expanded state, it is not only suitable for patients whose aortic valve orifice is close to the lateral aorta or close to the center of the aorta, but also suitable for patients whose aortic valve orifice is more inclined to the medial side. Therefore, it has a wider range of applicability to patients.
[0057] The following describes the usage process: First, the soft guidewire is inserted through the aorta to the aortic valve orifice. Then, the auxiliary guidewire transvalvular system is advanced along the guidewire to the aortic valve. The adjusting tube is pulled back, causing the variable bulb diameter to change and come into contact with the aortic wall. The variable bulb tip is pressed down to the center of the valve orifice, and the fixing seat is adjusted to lock the adjusting tube. The guidewire is pushed across the valve to the left ventricle. Then, a pigtail catheter is inserted into the adjusting tube and advanced along the guidewire into the left ventricle. The soft guidewire is withdrawn, and a hard guidewire is inserted into the pigtail catheter and advanced along the pigtail catheter into the left ventricle. The fixing knob of the fixing seat is released, and the adjusting tube is pushed forward to reduce the variable bulb diameter, and then withdrawn from the body. The above description is only a preferred embodiment of this patent. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this utility model, and these improvements and modifications should also be considered within the protection scope of this utility model.
Claims
1. An adjustable structure, characterized in that, The adjustable structure includes: A variable conduit, wherein the variable conduit is provided with a protruding portion; The protruding portion includes an outer protruding side and an inner protruding side, wherein the protruding height of the outer protruding side is greater than the protruding height of the inner protruding side.
2. The adjustable structure according to claim 1, characterized in that, The adjustable structure also includes an adjusting tube, which is sleeved inside the variable conduit and its distal end is fixedly connected to the distal end of the variable conduit. Other parts of the adjusting tube can move relative to the variable conduit to change the protrusion height of the protruding part, so that the protruding part is in an expanded state or a contracted state.
3. The adjustable structure according to claim 1, characterized in that, In the expanded state, along the cross-section of the protruding portion, the outer perimeter length of the outer protruding side is greater than the outer perimeter length of the inner protruding side.
4. The adjustable structure according to claim 1, characterized in that, The protruding part can be a balloon, a woven net, or a basket.
5. The adjustable structure according to claim 4, characterized in that, The protruding part is a balloon, and the balloon is connected to the outside at its proximal end.
6. The adjustable structure according to claim 4, characterized in that, The protruding part is a basket, which includes 3-5 basket bars along the axial direction of the variable conduit.
7. The adjustable structure according to claim 5, characterized in that, In the expanded state, along the maximum cross-section of the protruding portion, the central angle α of the arc formed by the basket strips is 60°-270°, preferably 80°-220°, and more preferably 90°-180°.
8. The adjustable structure according to claim 1, characterized in that, The protrusion height of the protruding part is 3mm-45mm, preferably 4mm-35mm, and more preferably 5mm-30mm.
9. A guidewire-assisted transvalvular device, characterized in that, Includes the adjustable structure as described in any one of claims 1-7.
10. The translobe device according to claim 9, characterized in that, The proximal end of the regulating tube extends out of the variable conduit, and the proximal end of the variable conduit is provided with a fixing seat that can lock the regulating tube.