Balloon dilatation catheter and elastic end thereof
The elastic end of the balloon-diffusion catheter designed with a spiral structure made of metal tube cutting or metal flat strip winding solves the problem of complimentation and resistance to lateral collapse tear in complex blood vessels, and improves the safety and success rate of the surgery.
Patent Information
- Application Number
- CN202422045366.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-21
- Publication Date
- 2025-08-05
- Estimated Expiration
- 2034-08-21
AI Technical Summary
The catheter tip of the existing balloon dilated catheter is prone to form a fish mouth structure when passing through narrow or rough blood vessels, resulting in poor compliance and easily damage to the blood vessel wall, affecting the safety and success rate of the surgery.
The spiral structure design is designed with metal tube cutting or metal flat strip winding to form elastic ends. Combined with laser welding, mechanical grinding and other sharp edge processing techniques, it ensures that the catheter has good flexibility and resistance to lateral collapse and tear when passing through complex blood vessels.
It improves the push performance of the catheter in complex blood vessels, reduces damage to the blood vessels, enhances the tracking and safety of the catheter, and ensures the smooth progress of the operation.
Smart Images
Figure CN223183905U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the technical field of medical devices, and particularly to a balloon dilation catheter and its elastic tip. Background Art
[0002] Balloon dilation catheters are commonly used to treat arterial stenosis or occlusion. For example, they are used to dilate stenotic blood vessels during percutaneous transluminal angioplasty (PTA) to restore blood flow.
[0003] For an ideal balloon dilation catheter, its catheter tip should be able to closely fit the guide wire to minimize the "fish mouth" effect, and have the best resistance to side collapse and tearing when passing through narrow or rough blood vessel surfaces, thereby improving the product's ability to pass through curved blood vessels and complex lesions and ensuring the smooth progress of the operation.
[0004] At present, most of the catheter tips in the market are made of polymer materials. Softer materials can reduce damage to blood vessels, but are easily damaged during transportation to form a "fish mouth" structure, thus affecting the pushing performance of the catheter. While harder materials can resist side collapse and tearing, they have poor flexibility, are likely to damage the blood vessel wall, and also have poor tracking performance. Utility Model Content
[0005] Based on this, an elastic tip for a balloon dilation catheter is provided, which has good flexibility, is not easily formed into a fish mouth structure, has strong resistance to side collapse and tearing, and also has better safety and tracking performance.
[0006] An elastic tip for a balloon dilation catheter, the elastic tip has a spiral structure, the spiral structure is formed by cutting a metal tube or winding a metal flat strip, the axial length of the elastic tip is 2 mm to 10 mm, the pitch of the spiral structure is 0.06 mm to 1 mm, the spiral strip of the spiral structure has a rectangular cross-section, the length of the rectangle is 0.05 mm to 0.5 mm, and the width of the rectangle is 0.04 mm to 0.2 mm.
[0007] The following also provides several optional ways, which are not additional limitations to the above general solution, but only further supplements or optimizations. Without technical or logical contradictions, each optional way can be combined with the above general solution alone, or multiple optional ways can be combined with each other.
[0008] Optionally, the spiral structure is formed by cutting a metal tube, the wall thickness of the metal tube is 0.04 mm to 0.2 mm, the axial length of the spiral structure is 1 mm to 5 mm, the adjacent two cut seams are the spiral strips, the width of the spiral strip is 0.05 mm to 0.5 mm, and the width of the cut seam is 0.01 mm to 0.1 mm.
[0009] Optionally, the wall thickness of the metal tube is 0.06 - 0.08 mm, the axial length of the spiral structure is 3 - 4 mm, the width of the spiral strip is 0.1 - 0.2 mm, and the slit width is 0.01 - 0.05 mm.
[0010] Optionally, the diameter of the elastic end is 0.55 - 0.8 mm.
[0011] Optionally, the spiral structure is formed by winding a metal flat strip, and the spiral structure includes:
[0012] A first section, exposed at the distal end of the balloon dilatation catheter, the axial length of the first section is 1.0 - 5.0 mm, and the pitch of the first section is 0.06 - 0.6 mm;
[0013] A second section, connected to the distal end of the balloon dilatation catheter, the axial length of the second section is 1.0 - 5.0 mm, and the pitch of the second section is 0.15 - 1 mm.
[0014] Optionally, the axial length of the first section is 2.0 - 2.5 mm, and the pitch of the first section is 0.06 - 0.6 mm;
[0015] The axial length of the second section is 1.5 - 2.0 mm, and the pitch of the second section is 0.25 - 0.8 mm.
[0016] Optionally, the diameter of the elastic end gradually increases from the distal end to the proximal end, the diameter of the distal end of the elastic end is 0.45 - 0.60 mm, and the diameter of the proximal end of the elastic end is 0.60 - 0.80 mm.
[0017] Optionally, the cross-section of the metal flat strip is rectangular, the length of the rectangle is 0.15 - 0.2 mm, and the width of the rectangle is 0.06 - 0.08 mm.
[0018] The present application also provides a balloon dilatation catheter, and the elastic end is fixedly connected to the distal end of the balloon dilatation catheter.
[0019] Optionally, in the axial direction of the balloon dilatation catheter, the overlapping length of the elastic end and the distal end of the balloon dilatation catheter is 1 - 2.5 mm.
[0020] The elastic end of the balloon dilatation catheter provided by the present application has good flexibility, is not easy to form a fish mouth structure, and has strong anti-side collapse and tearing performance, and the safety and tracking performance are also better. Description of the Drawings
[0021] Figure 1Schematic diagram of the balloon dilatation catheter of the present application;
[0022] Figure 2 Stereogram of the first embodiment of the elastic end head in the present application;
[0023] Figure 3 Schematic diagram of the first embodiment of the elastic end head in the present application;
[0024] Figure 4 Schematic diagram of the second embodiment of the elastic end head in the present application;
[0025] Figure 5 Cross-sectional schematic diagram of one embodiment of the spiral strip of the elastic end head in the present application;
[0026] Figure 6 Cross-sectional schematic diagram of one embodiment of the spiral strip of the elastic end head in the present application.
[0027] In the figure: 100, balloon dilatation catheter; 110, elastic end head; 111, spiral strip. Detailed implementation mode
[0028] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.
[0029] For better description and illustration of the embodiments of the present application, one or more accompanying drawings may be referred to, but the additional details or examples used to describe the accompanying drawings should not be considered as limiting the scope of any of the inventions, the currently described embodiments or the preferred modes of the present application.
[0030] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.
[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application.
[0032] See Figure 1 、 Figure 2 、 Figure 3 [[ID=Figure 4 As shown, an elastic tip 110 for a balloon dilation catheter 100, the elastic tip 110 having a spiral structure, the spiral structure being formed by winding a metal flat strip or by cutting a metal tube, the axial length L1 of the elastic tip 110 being 2 mm to 10 mm, the pitch of the spiral structure being 0.06 mm to 1 mm, the spiral strip 111 of the spiral structure having a rectangular cross-section, the length L3 of the rectangle being 0.05 mm to 0.5 mm, and the width L4 of the rectangle being 0.04 mm to 0.2 mm.
[0033] In this application, the elastic tip 110 adopts a spiral structure, and there are two ways to prepare this spiral structure. One is by cutting a metal tube, and the other is by winding a metal flat strip.
[0034] The blood vessels at the lesion site are usually relatively fragile and are easily damaged, with a relatively high requirement for the flexibility of the tip. If a spiral structure formed by thinner metal wires is used, its ability to resist longitudinal deformation is weak, resulting in damage to the blood vessels easily due to longitudinal deformation when the catheter is retracted.
[0035] The elastic tip 110 provided in this application is wound with a metal flat strip or formed into a spiral structure by cutting a metal tube. The elastic tip 110 has good flexibility and can fit the guide wire better. When passing through tortuous lesions, it will not produce a fish mouth effect. At the same time, the strength of the spiral strip 111 (i.e., the metal strip) is relatively higher than that of the metal wire, and it has better performance in resisting side collapse and tearing when passing through in-stent restenosis or rough diseased blood vessels.
[0036] The elastic tip 110 provided in this application has a high strength against unwinding. When the elastic tip 110 encounters resistance, it is not easy to lose its elasticity due to unwinding deformation. The elastic tip made of a metal material has X-ray imaging properties, which can enable doctors to visualize the distal part of the balloon catheter during the operation, improving the safety and accuracy of the operation.
[0037] The materials of the metal tube and the metal flat strip are each selected from stainless steel, nitinol alloy, platinum-iridium alloy or other medically applicable metal materials. Whether by cutting a metal tube or winding a metal flat strip, it is necessary to process the sharp edges left after cutting or winding to make them smooth to avoid damaging the blood vessels after the balloon dilation catheter 100 enters the body. The specific method of processing the sharp edges can be laser welding, mechanical grinding, sandblasting, etc.
[0038] See Figure 5 、 Figure 6 As shown, due to the processing of the sharp edges, the cross-section of the spiral strip is not a standard rectangle in the geometric sense, but has rounded chamfers at the four corners of the rectangle. However, the cross-section of the spiral strip is still close to the shape of a rectangle. For the length L3 and width L4 of the rectangle,Figure 5 , Figure 6 It is marked in the manner defined in, and the same understanding shall be applied wherever the rectangle and its size description are involved in other parts of this application.
[0039] The pitch of the spiral structure is the axial distance that any point moves along the spiral line for one turn. In Figure 3 , the pitch is L2. In Figure 4 , the pitches are L22 and L21, and the lengths of L2, L22, and L21 are 0.1 mm to 1 mm.
[0040] See Figure 2 , Figure 3 As shown, the spiral structure is formed by cutting a metal tube. The wall thickness L4 of the metal tube is 0.04 mm to 0.2 mm, the axial length L1 of the spiral structure is 1 mm to 5 mm, the spiral strips 111 are between adjacent cut seams, and the width L3 of the spiral strips 111 is 0.05 mm to 0.5 mm, and the cut seam width L5 is 0.01 mm to 0.1 mm.
[0041] The wall thickness L4 of the metal tube is the width of the rectangular cross-section of the spiral strip 111, and they have the same value range. The width L3 of the spiral strip 111 formed by cutting is the length of the rectangular cross-section of the spiral strip 111, and they have the same value range.
[0042] In the preferred range, the wall thickness L4 of the metal tube is 0.06 to 0.08 mm, the axial length L1 of the spiral structure is 3 mm to 4 mm, the width L3 of the spiral strips 111 is 0.1 mm to 0.2 mm, and the cut seam width L5 is 0.01 mm to 0.05 mm.
[0043] See Figure 4 As shown, the spiral structure is formed by winding a metal flat strip. The spiral structure includes:
[0044] The first section (i.e., the area spanned by L6), which is exposed at the distal end of the balloon dilation catheter 100. The axial length L6 of the first section is 1.0 mm to 5.0 mm, and the pitch L21 of the first section is 0.06 mm to 0.6 mm;
[0045] The second section (i.e., the area spanned by L7), which is connected to the distal end of the balloon dilation catheter 100. The axial length L7 of the second section is 1.0 mm to 5.0 mm, and the pitch L22 of the second section is 0.15 mm to 1 mm.
[0046] The winding of the first section is relatively tight and is exposed at the distal end of the balloon dilation catheter 100. The winding of the second section is relatively sparse and is mainly used for fixedly connecting to the distal end of the balloon dilation catheter 100.
[0047] Preferably, the axial length L6 of the first section is 2.0 mm to 2.5 mm, and the pitch L21 of the first section is 0.06 mm to 0.6 mm;
[0048] The axial length L7 of the second section is 1.5 mm to 2.0 mm, and the pitch L22 of the second section is 0.25 mm to 0.8 mm.
[0049] See Figure 3 As shown, the diameter L8 of the elastic end 110 is 0.55 mm to 0.8 mm.
[0050] See Figure 4 As shown, the diameter of the elastic end 110 gradually increases from the distal end to the proximal end. The diameter L9 of the distal end of the elastic end 110 is 0.45 mm to 0.60 mm, and the diameter L10 of the proximal end of the elastic end 110 is 0.60 mm to 0.80 mm.
[0051] See Figure 4 As shown, the cross-section of the metal flat strip is rectangular. The length L3 of the rectangle is 0.15 mm to 0.2 mm, and the width L4 of the rectangle is 0.06 mm to 0.08 mm.
[0052] See Figure 1 As shown, for a balloon dilatation catheter 100, the elastic end 110 is fixedly connected to the distal end of the balloon dilatation catheter 100. In the axial direction of the balloon dilatation catheter 100, the overlapping length L11 between the elastic end 110 and the distal end of the balloon dilatation catheter 100 is 1 mm to 2.5 mm.
[0053] The balloon dilatation catheter 100 can be of the over-the-wire (OTW) type or the rapid exchange (RX) type. The elastic end 110 is sleeved on the inner tube of the balloon dilatation catheter 100 and placed in the pin at the distal end of the balloon. The distal pin covers the second section of the elastic end 110 and can also extend to a small area of the first section. The distal pin of the balloon, the inner tube, and the elastic end 110 are welded into a whole by laser welding or hot air welding.
[0054] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.
[0055] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can be made, and these all fall within the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.
Claims
1. An elastic tip for a balloon dilatation catheter, characterized in that: The elastic end head has a spiral structure, which is formed by cutting a metal tube or winding a metal flat bar. The axial length of the elastic end head is 2mm to 10mm, the pitch of the spiral structure is 0.06mm to 1mm, and the spiral strip of the spiral structure has a rectangular cross-section, the length of the rectangle is 0.05mm to 0.5mm, and the width of the rectangle is 0.04mm to 0.2mm.
2. The elastic tip for a balloon dilatation catheter according to claim 1, characterized in that: The spiral structure is formed by cutting a metal tube, the wall thickness of the metal tube is 0.04mm-0.2mm, the axial length of the spiral structure is 1mm-5mm, the spiral strip is between two adjacent slits, the width of the spiral strip is 0.05mm-0.5mm, and the slit width is 0.01mm-0.1mm.
3. The elastic tip for a balloon dilatation catheter according to claim 2, characterized in that: The wall thickness of the metal tube is 0.06-0.08 mm, the axial length of the spiral structure is 3-4 mm, the width of the spiral strip is 0.1-0.2 mm, and the slit width is 0.01-0.05 mm.
4. The elastic tip for a balloon dilatation catheter according to claim 3, characterized in that: The diameter of the elastic end is 0.55mm to 0.8mm.
5. The elastic tip for a balloon dilatation catheter according to claim 1, characterized in that: The spiral structure is formed by winding a metal flat bar, and the spiral structure includes: a first section, exposed at the distal end of the balloon dilatation catheter, wherein the axial length of the first section is 1.0 mm to 5.0 mm, and the pitch of the first section is 0.06 mm to 0.6 mm; The second section is connected to the distal end of the balloon dilatation catheter. The axial length of the second section is 1.0 mm to 5.0 mm, and the pitch of the second section is 0.15 mm to 1 mm.
6. The elastic tip for a balloon dilatation catheter according to claim 5, characterized in that: The axial length of the first section is 2.0 mm to 2.5 mm, and the pitch of the first section is 0.06 mm to 0.6 mm; The axial length of the second section is 1.5 mm to 2.0 mm, and the pitch of the second section is 0.25 mm to 0.8 mm.
7. The elastic tip for a balloon dilatation catheter according to claim 6, characterized in that: The diameter of the elastic end gradually increases from the distal end to the proximal end. The diameter of the distal end of the elastic end is 0.45 mm to 0.60 mm, and the diameter of the proximal end of the elastic end is 0.60 mm to 0.80 mm.
8. The elastic tip for a balloon dilatation catheter according to any one of claims 5 to 7, characterized in that: The cross section of the metal flat bar is rectangular, the length of the rectangle is 0.15 mm to 0.2 mm, and the width of the rectangle is 0.06 mm to 0.08 mm.
9. A balloon dilatation catheter, characterized in that: The distal end of the balloon dilatation catheter is fixedly connected to the elastic tip according to any one of claims 1 to 8.
10. The balloon dilatation catheter according to claim 9, characterized in that: In the axial direction of the balloon dilatation catheter, the overlapping length between the elastic end and the distal end of the balloon dilatation catheter is 1 mm to 2.5 mm.