Tube component and vascular intervention catheter with same
By making incisions on the tubular components of the vascular interventional catheter and satisfying a specific cosine function relationship, the problem of stress concentration in tortuous blood vessels is solved, the bending resistance and durability of the catheter are improved, and the stability and safety of the catheter in tortuous blood vessels are ensured.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-11
- Publication Date
- 2026-04-14
AI Technical Summary
When vascular interventional catheters advance through tortuous blood vessels, it is difficult to simultaneously meet the requirements of axial stiffness, radial stiffness, flexural strength, and durability. In particular, stress concentration and plastic deformation are prone to occur when bending.
Cuts are made on the pipe component, with the first and second sides of the cuts positioned opposite each other along the axial direction to satisfy a specific cosine function relationship. These cuts serve as bonding points between the inner and outer pipes, increasing the uniformity and strength of the bonding area. At the same time, the distribution of the cuts reduces stress concentration.
It improves the bending resistance and durability of tubular components, ensures the stability and safety of catheters in tortuous blood vessels, reduces the possibility of plastic deformation, and enhances the uniformity of axial and radial stiffness.
Smart Images
Figure CN121846466A_ABST
Abstract
Description
Technical Field
[0001] This application relates to a vascular interventional medical device, and more particularly to a tubular component and a vascular interventional catheter having the same. Background Technology
[0002] Vascular interventional catheters are commonly used instruments in endovascular interventional therapy. Doctors usually insert vascular interventional catheters into arteries or veins to reach the lesion site through the blood vessels, and then guide other instruments to the target blood vessel location to perform vascular interventional therapy.
[0003] Because of the tortuous and winding vascular pathways, when the vascular interventional catheter advances through the tortuous blood vessels, its inner side is compressed while its outer side is stretched. In order for the vascular interventional catheter to successfully reach the target blood vessel location, it must not only have sufficient axial and radial stiffness to give it good resistance to bending, torsion and support, but also have excellent durability and safety. Summary of the Invention
[0004] To address the aforementioned technical problems, this application proposes a tubular component and a vascular interventional catheter having the same, to meet the requirements for axial stiffness, radial stiffness, flexural strength, and durability of the catheter during endovascular interventional therapy.
[0005] To achieve one of the aforementioned objectives, one embodiment of this application provides a pipe component with a notch. The notch has a first side and a second side, which are arranged opposite to each other along the axial direction of the pipe component. On the unfolded plane of the pipe component, both the first side and the second side are arc-shaped. A coordinate system is established with any point as the origin, a straight line passing through the origin and perpendicular to the axial direction of the pipe component as the X-axis, and a straight line passing through the origin and parallel to the axial direction of the pipe component as the Y-axis.
[0006] The trajectory of the first side satisfies the function:
[0007] The trajectory of the second side satisfies the function:
[0008] And y1≥y2, where a is the maximum width of the cut along the axial direction of the pipe component, and b is the outer perimeter of the pipe component.
[0009] As a further improvement of one embodiment of this application, the number of cuts on the same circumference of the pipe member is at least two.
[0010] As a further improvement of one embodiment of this application, at least two of the cuts are evenly spaced along the circumference of the pipe member on the same circumference.
[0011] As a further improvement to one embodiment of this application, y1-y2≥a / 2.
[0012] As a further improvement of one embodiment of this application, the number of cuts on the same circumference of the pipe member is three. On the unfolded plane of the pipe member, a coordinate system is established with the straight line corresponding to the circumference as the X-axis, the straight line containing one side of the unfolded plane parallel to the axial direction of the pipe member as the Y-axis, and the intersection of the X-axis and the Y-axis as the origin. The trajectories of the first sides of the three cuts all satisfy the function:
[0013]
[0014] The trajectories of the second sides of all three said cuts satisfy the function:
[0015] The x-coordinates of the three cuts satisfy (b / 12+i·b / 3)≤x≤(b / 4+i·b / 3), and the three cuts correspond to i=0, i=1 and i=2 respectively.
[0016] As a further improvement of one embodiment of this application, a is 0.04 to 0.20 mm.
[0017] As a further improvement of one embodiment of this application, on the same circumference of the pipe member, the distance between the ends of two adjacent cuts that are close to each other is 0.03b to 0.08b.
[0018] As a further improvement of one embodiment of this application, the cuts are provided in multiple ways, and adjacent cuts are staggered along the axial direction of the pipe member.
[0019] As a further improvement of one embodiment of this application, the slits are provided in multiple ways, and the multiple slits are arranged in n columns. The n columns of slits are arranged at intervals along the circumference of the pipe member, and each column of slits is spirally arranged along the axial direction of the pipe member; the helix angle α of each column of slits satisfies:
[0020] 180° / n-10°≤α≤180° / n-2°, or 180° / n+2°≤α≤180° / n+10°.
[0021] Where n≥3.
[0022] To achieve one of the above-mentioned objectives, one embodiment of this application provides a vascular interventional catheter, including an inner tube, an outer tube, and an intermediate layer. The outer tube is disposed on the periphery of the inner tube, and the intermediate layer is disposed between the inner tube and the outer tube. The intermediate layer includes tube components as described above, and the inner tube and the outer tube are bonded together through the incision.
[0023] As a further improvement of one embodiment of this application, the vascular interventional catheter includes a support section, and the intermediate layer of the support section is made of the tubular component.
[0024] Compared with the prior art, this application has the following beneficial effects: When the tubular component and the vascular interventional catheter having it advance in the tortuous blood vessel, the tubular component will bend with the bend of the blood vessel, and one side of it will be stretched while the other side will be compressed. The area of maximum stress on the tubular component is mainly on the side that is stretched when bending. By setting an incision on the tubular component, not only can the bending resistance of the tubular component be increased, but when it is applied between the inner and outer tubes of the catheter, the incision can also be used as the bonding point between the inner and outer tubes, so that the bonding area between the inner and outer tubes is more uniformly distributed and the bonding strength is greater. During clinical use, the axial stiffness and radial stiffness will not change significantly, ensuring the durability and safety of the catheter. Furthermore, by setting the trajectories of the first side and the second side to satisfy the cosine functions (1) and (2) respectively, the distribution area of large stress on the tubular component can be increased, thereby reducing the stress concentration on the tubular component, reducing the possibility of plastic deformation of the tubular component, and thus improving the bending resistance, durability and safety of the tubular component. Attached Figure Description
[0025] The accompanying drawings provided herein are intended to illustrate a further understanding of this application and form part of this application. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute an undue limitation of this application. In the drawings:
[0026] Figure 1 This is a schematic diagram of the structure of a pipe component according to an embodiment of this application;
[0027] Figure 2 This is a schematic plan view of a pipe component according to an embodiment of this application;
[0028] Figure 3 This is a structural schematic diagram of a pipe component in the prior art;
[0029] Figure 4 This is a simulation diagram of the bending stress distribution of a pipe component according to an embodiment of this application under a bending state with a bending diameter of 50 mm.
[0030] Figure 5 This is a simulation diagram of the bending stress distribution of a pipe component according to an embodiment of this application under a bending state with a bending diameter of 15mm.
[0031] Figure 6 Pipe components according to an embodiment of this application and Figure 3 The simulation distribution of bending stress in a pipe component under a bending condition with a bending diameter of 50mm is shown in the figure.
[0032] Figure 7 Pipe components according to an embodiment of this application and Figure 3 The simulation distribution of bending stress in a pipe component under a bending state with a bending diameter of 15mm is shown in the figure.
[0033] Figure 8 This is a graph showing the change in hardness of pipe member 100A according to an embodiment of this application and pipe member 100B in the prior art as a function of bending angle.
[0034] Figure 9 This diagram shows the change of the radial outer diameter at the midpoint of the bend as a function of the bending angle for pipe member 100A of an embodiment of this application and pipe member 100B of the prior art. Detailed Implementation
[0035] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.
[0036] In the various figures of this application, for ease of illustration, certain dimensions of structures or parts are enlarged relative to other structures or parts; therefore, they are only used to illustrate the basic structure of the subject matter of this application.
[0037] It should be understood that, unless otherwise expressly specified and limited, in the description of this application, the terms "inner," "outer," etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. Furthermore, the terms "first," "second," "third," and "fourth" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0038] In this application, the terms "distal" and "proximal" should be understood as, from the operator's perspective, the proximal end being the end closer to the operator during operation, while the distal end is the end farther from the operator.
[0039] This application proposes a vascular interventional catheter for endovascular interventional therapy. In use, a physician inserts the vascular interventional catheter into an artery or vein. The vascular interventional catheter reaches the lesion site through the blood vessel and then guides other instruments to the target blood vessel location to perform vascular interventional therapy.
[0040] The vascular interventional catheter includes an inner tube, an outer tube, and an intermediate layer. The outer tube is located around the inner tube, and the intermediate layer is located between the inner tube and the outer tube.
[0041] The intermediate layer includes a pipe component 100A.
[0042] See Figure 1 The tubular component 100A has a slit 1A, which has a first side 11 and a second side 12. The first side 11 and the second side 12 are arranged opposite each other along the axial direction of the tubular component 100A. In this way, the inner tube and the outer tube can be bonded together through the slit 1A on the tubular component 100A. That is, the slit 1A serves as the bonding point between the inner tube and the outer tube, resulting in a more uniform distribution of the bonding area between the inner tube and the outer tube, greater bonding strength, and minimal changes in axial and radial stiffness during clinical use, thus ensuring the durability and safety of the catheter.
[0043] The vascular interventional catheter includes a support section, which is located at the bend in the blood vessel when the vascular interventional catheter travels through the tortuous blood vessel to the target position, and the intermediate layer of the support section adopts the tubular component 100A.
[0044] Combination Figure 2 On the unfolded plane of the tube component 100A, both the first side 11 and the second side 12 are arc-shaped.
[0045] A coordinate system is established with any point on the unfolded plane of the pipe component 100A as the origin, a straight line passing through the origin and perpendicular to the axial direction of the pipe component 100A as the X-axis, and a straight line passing through the origin and parallel to the axial direction of the pipe component 100A as the Y-axis. The trajectory of the first side 11 satisfies the function:
[0046]
[0047] The trajectory of the second side 12 satisfies the function:
[0048]
[0049] And y1≥y2, where a is the maximum width of the cut 1A along the axial direction of the pipe component 100A, and b is the outer perimeter of the pipe component 100A.
[0050] In other words, after determining the maximum width value a of the cut 1A along the axial direction of the pipe component 100A and the diameter of the pipe component 100A, the cut 1A can be formed according to the cosine functions (1) and (2) respectively satisfying the trajectories of the first side 11 and the second side 12.
[0051] As the tube component 100A advances through a tortuous blood vessel, it bends along with the vessel, stretching on one side and compressing on the other. The area of greatest stress on the tube component 100A is primarily on the stretching side. By providing a notch 1A on the tube component 100A, not only can its bending resistance be increased, but when used between the inner and outer tubes of a catheter, the notch 1A can also serve as an adhesion point between the inner and outer tubes, resulting in a more even distribution of the adhesion area between them. The uniformity and stronger bonding strength ensure that the axial and radial stiffness will not change significantly during clinical use, thus guaranteeing the durability and safety of the catheter. Furthermore, by setting the trajectories of the first side 11 and the second side 12 to satisfy the cosine functions (1) and (2) respectively, the distribution area of the stress-prone region on the tube component 100A can be increased, thereby reducing the stress concentration on the tube component 100A, reducing the possibility of plastic deformation of the tube component 100A, and thus improving the flexural strength, durability and safety of the tube component 100A.
[0052] In practical applications, the maximum width value a of the incision 1A along the axial direction of the tubular component 100A and the diameter of the tubular component 100A can be determined in advance based on the application scenario and experience of the tubular interventional catheter.
[0053] Preferably, the number of cuts 1A on the same circumference of the tubular component 100A is at least two, so that the tubular component 100A has both axial stiffness and radial stiffness, and its axial stiffness and radial stiffness can meet the usage requirements during clinical use, ensuring durability and safety.
[0054] Preferably, at least two cuts 1A are evenly spaced along the circumference of the tubular component 100A on the same circumference, thereby ensuring the uniformity of the tubular component 100A's performance in its circumferential direction, facilitating its passage through blood vessels with different curvatures during clinical use, and exhibiting excellent applicability.
[0055] In a preferred embodiment, the trajectories of the first side 11 and the second side 12 satisfy: y1-y2≥a / 2. In this way, while ensuring that the large stress distribution area is large when the pipe component 100A is bent, the distance between adjacent cuts 1A on the same circumference can be increased, thereby improving the strength and support of the pipe component 100A.
[0056] In one specific embodiment, there are three cuts 1A on the same circumference of the pipe member 100A. On the unfolded plane of the pipe member 100A, a coordinate system is established with the straight line corresponding to the circumference as the X-axis, the straight line on the side of the unfolded plane parallel to the axial direction of the pipe member 100A as the Y-axis, and the intersection of the X-axis and the Y-axis as the origin, for example illustration.
[0057] The trajectories of the first edges 11 of the three cuts 1A all satisfy the function:
[0058]
[0059] The trajectories of the second side 12 of all three cuts 1A satisfy the function:
[0060]
[0061] Furthermore, the x-coordinates of the three cuts 1A satisfy the following: (b / 18+i·b / 3)≤x≤(5b / 18+i·b / 3), and the three cuts 1A correspond to i=0, i=1 and i=2 respectively.
[0062] That is, among the three cuts 1A, the x-coordinate of one cut 1A satisfies: b / 18≤x≤5b / 18, the x-coordinate of another cut 1A satisfies: (b / 18+b / 3)≤x≤(5b / 18+b / 3), and the x-coordinate of the third cut 1A satisfies: (b / 18+2b / 3)≤x≤(5b / 18+2b / 3).
[0063] Thus, the three cuts 1A are evenly spaced along the circumferential direction of the tube member 100A.
[0064] Preferably, the three cuts 1A satisfy: (b / 12 + i·b / 3) ≤ x ≤ (b / 4 + i·b / 3), and the three cuts 1A correspond to i = 0, i = 1, and i = 2, respectively. This increases the distance between adjacent cuts 1A on the same circumference while ensuring a large distribution area of high stress when the pipe member 100A is subjected to bending, thereby improving the strength and support of the pipe member 100A.
[0065] Preferably, the maximum width a of the cut 1A along the axial direction of the tubular component 100A is 0.04 to 0.20 mm. Within this range, the axial and radial stiffness of the tubular component 100A can be guaranteed, meeting the requirements for axial and radial stiffness in clinical use, and ensuring durability and safety.
[0066] Preferably, on the same circumference of the tubular member 100A, the distance between the ends of two adjacent cuts 1A that are close to each other is 0.03b to 0.08b. This increases the distance between adjacent cuts 1A on the same circumference while ensuring that the tubular member 100A has a large distribution area of high stress when subjected to bending, thereby improving the strength and support of the tubular member 100A.
[0067] Preferably, multiple cuts 1A are provided, and adjacent cuts 1A are staggered along the axial direction of the pipe member 100A. This can improve the flexural strength of the pipe member 100A along its axial direction.
[0068] Preferably, multiple cuts 1A are provided, and the multiple cuts 1A are arranged in n columns. The n columns of cuts 1A are arranged at intervals along the circumference of the pipe member 100A, and each column of cuts 1A is spirally arranged along the axial direction of the pipe member 100A. This improves the torsional rigidity and bending resistance of the pipe member 100A while ensuring the axial and radial stiffness of the pipe member 100A, and ensures the consistency of axial stiffness and torsional rigidity in the axial direction of the pipe member 100A during bending.
[0069] Furthermore, the helix angle α of each column of the cut 1A satisfies:
[0070] 180° / n-10°≤α≤180° / n-2°, or 180° / n+2°≤α≤180° / n+10°.
[0071] Where n≥3, that is, the plurality of cuts 1A are set to at least three columns.
[0072] The helix angle α is the angle between the helix of each column of the cuts 1A and the axis of the pipe component 100A on the unfolded plane of the pipe component 100A.
[0073] The helix angle α, within the aforementioned range, can not only improve the torsional flexibility and bending resistance of the pipe component 100A, but also enhance the consistency of axial stiffness and torsional flexibility in the axial direction during bending.
[0074] Figure 3 The pipe component 100B in the prior art has a rectangular cutout 1B in its unfolded plane.
[0075] For the pipe component 100A of this application and Figure 3 Simulation analysis was performed on the pipe component 100B, and the simulation distribution of bending stress of the pipe component 100A in this application is shown in the figure below. Figure 4 and Figure 5 As shown, Figure 3The simulation distribution of bending stress in the 100B pipe component is shown in the figure below. Figure 6 and Figure 7 As shown.
[0076] in, Figure 4 and Figure 6 The diagram shows the simulated distribution of bending stress in the tubular component 100A under a bending condition with a bending diameter of 50 mm. Figure 5 and Figure 7 The diagram shows the simulated distribution of bending stress in the tubular component 100B under a bending condition with a bending diameter of 15mm. The bending diameter refers to the diameter of the arc formed at the bend in the tubular component when it is bent.
[0077] In the simulation diagram of bending stress distribution, different colors represent different stress ranges. The stress ranges represented by each color are: red > orange > yellow > green > blue. That is to say, the distribution ranges of red and yellow represent the areas with larger bending stress on the pipe component.
[0078] from Figures 4 to 7 It can be seen that, compared with the prior art pipe component 100B, the stress distribution of the pipe component 100A of this application is more uniform under the bending state with a bending diameter of 50mm; under the bending state with a bending diameter of 15mm, the area of the yellow distribution range of the pipe component 100A of this application is greatly increased, indicating that its large stress distribution range is larger and the stress distribution is more uniform.
[0079] Furthermore, under bending conditions with a bending angle in the range of 0 to 70°, the hardness of the pipe component 100A of this application is increased compared to the pipe component 100B of the prior art; under bending conditions with a bending angle in the range of 40 to 70°, the hardness of the pipe component 100A of this application is significantly increased compared to the pipe component 100B of the prior art.
[0080] The hardness of the pipe component 100A and the radial outer diameter at the midpoint of the bend were tested as a function of the bending angle using the three-point pressing method.
[0081] Figure 8 The graph shows the change in hardness of the pipe components 100A and 100B as a function of bending angle. Figure 9 The diagram shows the change in the radial outer diameter of the midpoint of the bend in the pipe components 100A and 100B as a function of the bend angle.
[0082] Depend on Figure 8 and Figure 9 It can be seen that, compared with the pipe component 100B, the hardness and bending resistance of the pipe component 100A of this application have been greatly improved.
[0083] The shape, rigidity, and frictional force between the vascular interventional catheter and the inner wall of the blood vessel depend on the outer tube, which is made of a polymer material. The inner tube is also made of a polymer material and has an etched layer, which helps reduce the frictional resistance between interventional materials such as balloons and stents and the inner lumen of the catheter.
[0084] Preferably, the outer tube is made of at least one of nylon elastomer, nylon, or polyurethane, and the inner tube is made of at least one of nylon elastomer, nylon, polyurethane, or polytetrafluoroethylene, so that the inner and outer tubes have a certain degree of flexibility and strength to facilitate insertion into blood vessels.
[0085] The tubular component 100A is preferably made of metal, and the incision 1A is formed by cutting, thereby providing axial and radial stiffness to the vascular interventional catheter and preventing the inner lumen of the vascular interventional catheter from collapsing.
[0086] More preferably, the pipe component 100A is made of stainless steel or nickel-titanium alloy.
[0087] In summary, the tubular component 100A and the vascular interventional catheter having it proposed in this application bend as the tubular component 100A advances in a tortuous blood vessel, with its outer portion being stretched and its inner portion being compressed. The area of greatest stress on the tubular component 100A is mainly on the outer portion that is stretched during bending. By setting a notch 1A on the tubular component 100A, not only can the bending resistance of the tubular component 100A be increased, but when applied between an inner tube and an outer tube, the notch 1A can also serve as an adhesion point between the inner and outer tubes. Furthermore, by setting the trajectories of the first side 11 and the second side 12 to satisfy cosine functions (1) and (2) respectively, the distribution area of high stress on the tubular component 100A can be increased, thereby reducing stress concentration on the tubular component 100A, reducing the possibility of plastic deformation of the tubular component 100A, and thus improving the bending resistance, durability and safety of the tubular component 100A.
[0088] It should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This way of describing the specification is only for clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.
[0089] The above description is only a preferred embodiment of this application. It should be noted that for those skilled in the art, several modifications and improvements can be made without departing from the inventive concept of this application, and these all fall within the protection scope of this application.
Claims
1. A pipe component, wherein a notch is provided on the pipe component, characterized in that, The cut has a first side and a second side, which are arranged opposite each other along the axial direction of the pipe component; on the unfolded plane of the pipe component, both the first side and the second side are arc-shaped; a coordinate system is established with any point as the origin, a straight line passing through the origin and perpendicular to the axial direction of the pipe component as the X-axis, and a straight line passing through the origin and parallel to the axial direction of the pipe component as the Y-axis. The trajectory of the first side satisfies the function: The trajectory of the second side satisfies the function: And y1≥y2, where a is the maximum width of the cut along the axial direction of the pipe component, and b is the outer perimeter of the pipe component.
2. The pipe component according to claim 1, characterized in that, The number of cuts on the same circumference of the tubular member is at least two.
3. The pipe component according to claim 2, characterized in that, On the same circumference of the pipe member, at least two of the cuts are evenly spaced along the circumferential direction of the pipe member.
4. The pipe component according to claim 1, characterized in that, y1-y2≥a / 2.
5. The pipe component according to claim 1, characterized in that, The number of cuts on the same circumference of the pipe component is three. On the unfolded plane of the pipe component, a coordinate system is established with the straight line corresponding to the circumference as the X-axis, the straight line containing one side of the unfolded plane parallel to the axial direction of the pipe component as the Y-axis, and the intersection of the X-axis and Y-axis as the origin. The trajectories of the first sides of the three cuts all satisfy the function: The trajectories of the second sides of all three said cuts satisfy the function: The x-coordinates of the three cuts satisfy (b / 12+i·b / 3)≤x≤(b / 4+i·b / 3), and the three cuts correspond to i=0, i=1 and i=2 respectively.
6. The pipe component according to claim 1, characterized in that, a is 0.04 to 0.20 mm.
7. The pipe component according to claim 1, characterized in that, On the same circumference of the tubular member, the distance between the ends of two adjacent cuts that are close to each other is 0.03b to 0.08b.
8. The pipe component according to claim 1, characterized in that, The cuts are provided in multiple ways, and adjacent cuts are staggered along the axial direction of the pipe component.
9. The pipe component according to claim 1, characterized in that, The slits are provided in multiple ways, arranged in n columns. The n columns of slits are spaced apart circumferentially along the pipe member, and each column of slits is spirally arranged axially along the pipe member. The spiral angle α of each column of slits satisfies: 180° / n-10°≤α≤180° / n-2°, or 180° / n+2°≤α≤180° / n+10°. Where n≥3.
10. A vascular interventional catheter, comprising an inner tube, an outer tube, and an intermediate layer, wherein the outer tube is disposed around the periphery of the inner tube, and the intermediate layer is disposed between the inner tube and the outer tube, characterized in that, The intermediate layer includes a tubular component as described in any one of claims 1 to 9, wherein the inner tube and the outer tube are bonded together through the cut.
11. The vascular interventional catheter according to claim 10, characterized in that, The vascular interventional catheter includes a support section, and the intermediate layer of the support section is made of the tubular component.