Method of processing a multi-segment tube and balloon catheter

Abstract

The application provides a processing method of a multi-section tube and a balloon catheter, and the processing method is used for processing an inner cavity tube or an outer tube of the balloon catheter, and the method comprises the following steps: providing a plurality of tube materials, wherein the plurality of tube materials at least comprise a first tube material and a second tube material; butting a first end of the first tube material and a second end of the second tube material; providing a polymer material layer, and arranging the polymer material layer on the outer surface of the butting position of the first tube material and the second tube material; and connecting the polymer material layer with the first tube material and the second tube material into an integrated whole through thermal processing. The method is simple, can guarantee the gradual change of the overall flexibility of the balloon catheter, and improves the pushing property and the in-place ability of the balloon catheter in a tortuous blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a method for processing a multi-segment tube and a balloon catheter. Background Technology

[0002] Ischemic stroke is mainly caused by stenosis or occlusion of blood vessels, changes in hemodynamics or blood composition, leading to insufficient oxygen and nutrient carrying capacity or reduced ability to clear metabolic products, resulting in the death of neurons or glial cells and blood vessels in the brain. Ischemic stroke accounts for about 80% of cerebrovascular diseases, among which cerebral vascular stenosis is an important cause and risk factor for ischemic cerebrovascular disease. The main treatment methods for cerebral vascular stenosis at present are: (i) drug therapy, combined with antiplatelet aggregation or lipid-lowering drugs to slow the progression of carotid artery stenosis and improve cerebral vascular reactivity; (ii) intracranial and extracranial bypass: for patients with symptomatic intracranial stenosis with severe hemodynamic disturbances, intracranial and extracranial bypass may improve brain tissue ergonomics or reduce the stroke recurrence rate; (iii) endovascular treatment: for symptomatic intracranial stenosis of ≥70% that is unresponsive to optimal drug therapy or has poor collateral circulation compensation, balloon angioplasty or stent implantation is used to dilate the stenotic vessels, thereby restoring vascular access. Intracranial stenosis is usually caused by tortuous and complex blood vessels with small diameters and thin walls, making them prone to spasm and dissection during surgery. The stenosis is often located at a distal point in the blood vessel, such as C6 and C7 (ocular segment and communicating segment), M1 and M2 (horizontal segment of the middle cerebral artery (postorbital segment) and the turning segment of the middle cerebral artery (sula segment)). Therefore, for balloon angioplasty, the balloon catheter needs to have good delivery and positioning capabilities so that the surgeon can successfully deliver the balloon catheter to the lesion site.

[0003] To improve the delivery and positioning capabilities of balloon catheters, besides reducing the outer diameter of the catheter and designing the size and rigidity of the distal end, different rigidity inner or outer tubing is often used to achieve a smooth transition between the two. This ensures good passage through diseased blood vessels while improving the overall delivery from the proximal to the distal end of the balloon catheter. However, when connecting tubing of different rigidities, the connection point needs to have sufficiently high connection strength to avoid risks such as catheter bending and breakage. To improve connection strength, tubing of different rigidities is often overlapped and welded. This welding method increases the outer diameter and rigidity of the weld point, affecting the transition between the inner and outer tubing, and consequently impacting the overall delivery and positioning capabilities of the balloon catheter. Summary of the Invention

[0004] To address the problems in the prior art, the present invention aims to provide a method for processing multi-segment tubes and a balloon catheter, ensuring the overall flexibility of the balloon catheter and improving its delivery and positioning capabilities in tortuous blood vessels.

[0005] This invention provides a method for processing multi-segment tubes for processing the inner or outer tube of a balloon catheter. The method includes the following steps:

[0006] S100: Provide a plurality of pipes, wherein the plurality of pipes includes at least a first pipe and a second pipe;

[0007] S200: Connect the first end of the first pipe and the second end of the second pipe;

[0008] S300: Provide a polymer material layer, and dispose of the polymer material layer on the outer surface of the mating position of the first pipe and the second pipe;

[0009] S400: The polymer material layer is welded to the first pipe and the second pipe to form a whole.

[0010] In some embodiments, the polymer material layer is made of silicone, polyethylene terephthalate (PET), perfluoroethylene propylene (FEP), or polyetheramide (Pebax).

[0011] In some embodiments, step S300 includes the following steps:

[0012] In some embodiments, one or more cracks are created on the surface of the polymer material layer along the circumferential direction of the pipe. The cracks extend along the axial direction of the pipe on the surface of the polymer material layer. The number of cracks is 1 to 6, and they are evenly arranged along the circumferential direction of the pipe.

[0013] In some embodiments, the width of the crack is less than or equal to 1.2 mm.

[0014] In some embodiments, creating one or more cracks on the surface of the polymer material layer includes cutting or slicing one or more cracks on the surface of the polymer material layer.

[0015] In some embodiments, the thermal processing in step S400 includes laser welding or hot pressing:

[0016] In some embodiments, the polymer material layer is arc-shaped.

[0017] In some embodiments, the circumferential curvature of the arc-shaped material is 30° to 360°.

[0018] In some embodiments, at least two of the plurality of pipes have different hardnesses.

[0019] This invention provides a method for processing multi-segment tubes for processing the inner or outer tube of a balloon catheter. The method includes the following steps:

[0020] S10: Provide a plurality of pipes, wherein the plurality of pipes includes at least a first pipe and a second pipe;

[0021] S20: Overlap and connect the first end of the first pipe and the second end of the second pipe;

[0022] S30: In step S20, the overlapping portion is heat-processed to connect the first pipe and the second pipe into one unit.

[0023] In some embodiments, step S20 includes the following steps:

[0024] The second end of the second pipe is fitted onto the first end of the first pipe, and one or more cracks are made at the first end of the second pipe along the circumferential direction of the first end of the second pipe.

[0025] In some embodiments, the cracks extend along the axial direction of the first pipe, and the number of cracks is 1 to 6, and they are evenly arranged along the circumferential direction of the first pipe.

[0026] In some embodiments, the width of the crack is less than or equal to 1.2 mm.

[0027] In some embodiments, creating one or more cracks at the second end of the second pipe includes cutting or slicing one or more cracks at the first end of the first pipe.

[0028] In some embodiments, the thermal processing in step S30 includes laser welding or hot pressing.

[0029] In some embodiments, at least two of the plurality of pipes have different hardnesses.

[0030] The present invention provides a balloon catheter, comprising an inner lumen and an outer tube, wherein the inner lumen or the outer tube is obtained by the multi-segment tube processing method described above.

[0031] In some embodiments, the inner tube is a cylindrical tube comprising at least three coaxial layers, wherein the second layer of the inner tube is sleeved outside the first layer of the inner tube, and the third layer of the inner tube is sleeved outside the second layer of the inner tube.

[0032] In some embodiments, the first layer of the inner lumen tube is made of polyethylene, polyoxymethylene, or polytetrafluoroethylene; the second layer of the inner lumen tube is made of polyethylene; and the third layer of the inner lumen tube is made of polyamide, nylon, or a polymer containing at least nylon and polyamide.

[0033] The multi-segment tube processing method and balloon catheter provided by this invention have the following advantages:

[0034] The multi-segment tube processing method provided by this invention is used to process the inner lumen and outer tube of a balloon catheter, which can ensure the gradual change in the overall flexibility of the balloon catheter and improve the pushing and positioning ability of the balloon catheter in tortuous blood vessels. Attached Figure Description

[0035] Other features, objects, and advantages of the invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings.

[0036] Figure 1 This is a schematic flowchart of a multi-segment tube processing method according to an embodiment of the present invention;

[0037] Figure 2 This is a schematic flowchart of a multi-segment tube processing method according to an embodiment of the present invention;

[0038] Figure 3 This is a schematic diagram of a balloon catheter according to an embodiment of the present invention;

[0039] Figure 4 This is a cross-sectional view of the inner lumen tube according to an embodiment of the present invention;

[0040] Figure 5 This is a schematic diagram of the inner cavity tube processed by the multi-segment tube processing method of Embodiment 1 of the present invention;

[0041] Figure 6 This is a schematic diagram of the inner cavity tube processed by the multi-segment tube processing method of Embodiment 2 of the present invention.

[0042] Figure label:

[0043] 10 Balloon Catheter

[0044] 11. Globe-like body

[0045] 12 Inner lumen tube

[0046] 121 Distal end-lumen tube

[0047] 122 Proximal endplate

[0048] 123 The position of the distal and proximal endplates overlapping.

[0049] 124 Cracks

[0050] 125 Polymer Material Layer

[0051] 13 End

[0052] 14 Outer tube

[0053] 15. Stress-diffusing tube

[0054] 16 seats

[0055] 112 Distal part of the balloon body

[0056] 113 Proximal end of the balloon body Detailed Implementation

[0057] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided so that the invention will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted. The words “or” and “or” in the specification may mean “and” or “or”.

[0058] like Figure 1 As shown, this invention provides a method for processing multi-segment tubes for manufacturing the inner lumen and / or outer tube of a balloon catheter. The inner lumen and / or outer tube comprises multiple tubes, at least two of which have different hardnesses. To ensure the strength of the connection point when multiple segments of different hardness are connected together, and to prevent an increase in the outer diameter and hardness of the connection point, the method includes the following steps:

[0059] S10: Provide a plurality of pipes, wherein the plurality of pipes includes at least a first pipe and a second pipe;

[0060] S20: Overlap and connect the first end of the first pipe and the second end of the second pipe;

[0061] S30: In step S20, the overlapping portion is heat-processed to connect the first pipe and the second pipe into one unit.

[0062] Specifically, when pipes of different hardness are stacked and welded, in order to avoid increasing the outer diameter and hardness of the weld joint, step S20 preferably includes the following steps:

[0063] One or more cracks are made at the second end of the second pipe along the circumferential direction of the second end of the second pipe.

[0064] The second end of the second pipe with the created crack is fitted onto the first end of the first pipe.

[0065] like Figure 2As shown, the present invention also provides a method for processing multi-segment tubes for processing the inner lumen and / or outer tube of a balloon catheter, wherein the inner lumen and / or the outer tube comprises multiple tubes, at least two of which have different hardnesses. To ensure the strength of the connection points of the multi-segment tubes with different hardnesses, and without causing an increase in the outer diameter and hardness of the connection points, the processing method includes the following steps:

[0066] S100: Provide a plurality of pipes, wherein the plurality of pipes includes at least a first pipe and a second pipe;

[0067] S200: Connect the first end of the first pipe and the second end of the second pipe;

[0068] S300: A polymer material layer is provided, and the polymer material layer is disposed on the outer surface of the mating position of the first pipe and the second pipe;

[0069] S400: The polymer material layer is connected to the first pipe and the second pipe as a whole through heat treatment.

[0070] Specifically, the polymer material layer is made of silicone, polyethylene terephthalate (PET), perfluoroethylene propylene (FEP), or polyetheramide. The polymer material layer is an arc-shaped polymer material layer. Preferably, in step S300, the arc-shaped polymer material layer is fitted onto the outer surface of the mating position between the first pipe and the second pipe.

[0071] like Figure 3 As shown, the present invention also provides a balloon catheter, wherein the inner or outer tube of the balloon catheter is obtained using the multi-segment tube processing method described above. From Figure 3 As can be seen, the balloon catheter 10 includes: a distal end 13, a balloon body 11, an inner lumen 12, an outer tube 14, a stress-diffusing tube 15, a hypotube between the outer tube 14 and the stress-diffusing tube 15, and a seat 16. The distal end 112 of the balloon body 11 is fixed to the inner lumen 12, and the proximal end 113 of the balloon body 11 is fixed to the outer tube 14. The inner lumen 12 is a cylindrical tube comprising at least three coaxial layers, with the second layer of the inner lumen 12 sleeved outside the first layer, and the third layer sleeved outside the second layer.

[0072] Figure 4 This is a cross-sectional view of the inner lumen tube. From Figure 3As can be seen, the inner lumen tube 12 comprises three layers: an inner layer 12a, a middle layer 12b, and an outer layer 12c. The inner layer 12a is a polymer, preferably a fluoropolymer such as high-density polyethylene, polyoxymethylene, or polytetrafluoroethylene with a low coefficient of friction, to ensure smooth guidewire movement within the lumen during balloon catheter delivery. The middle layer 12b is linear low-density polyethylene. The outer layer 12c is a polymer, which can be polyamide, nylon, or a mixture of at least both polyamide and nylon with the same or different hardness. Preferably, the outer layer 12c of the inner lumen tube 12 is made of polyamide or nylon with different hardnesses, and the inner lumen tubes 12 of different hardnesses are connected into a single unit by laser welding. The processing method of the multi-segment tube of the present invention will be explained and described in detail below with reference to specific embodiments.

[0073] Example 1

[0074] Figure 5 This is a schematic diagram of the inner cavity tube manufactured using a multi-segment tube processing method in this embodiment. From Figure 5 As can be seen, the inner tube 12 comprises two sections of tubing, including a proximal inner tube 122 and a distal inner tube 121, wherein the hardness of the proximal inner tube 122 is greater than the hardness of the distal inner tube 121. The processing steps for connecting the two inner tube sections into a single tube in this embodiment are as follows:

[0075] S10: Provides a distal lumen tube 121 and a proximal lumen tube 122;

[0076] S20: Overlap and connect the first end of the proximal inner lumen tube 122 and the second end of the distal inner lumen tube 121;

[0077] S30: In step S20, the overlapping portion is heat-processed to connect the distal inner tube 121 and the proximal inner tube 122 into one unit.

[0078] Before step S20, the method further includes the following step: creating one or more cracks at the second end of the second pipe along the circumferential direction of the second end of the second pipe.

[0079] In this embodiment, the crack 124 can be created by mechanical cutting, laser cutting, or other cutting processes. The crack 124 extends along the axial direction of the proximal inner tube 122. The number of cracks 124 is one or more, preferably one to six, and they are evenly arranged along the circumferential direction of the first end of the proximal inner tube 122. The width of the crack 124 is 0 mm to 1.2 mm. Adding cracks has the advantage that during the heating process, the polymer material at the proximal and distal inner tube sleeves is in a molten state, possessing a certain degree of fluidity. This allows the uncut portion of the polymer material to flow to the location of the crack 124, thereby sealing the entire welding area and increasing the strength of the connection point without excessively increasing its outer diameter. In this embodiment, the connection strength of the welded point in the overlapping welding method is 2N to 3N higher than that of the un-overlapped welded point, and the outer diameter of the welded point in the trimmed overlapping method is 0.0005 inches to 0.0001 inches smaller than that in the untrimmed overlapping method. Uncutting stacking is usually because the inner and outer diameters of the proximal inner tube 122 and the distal inner tube 121 are close, so one end needs to be flared before stacking. During flaring, uneven deformation of the flared section is easy to cause, which affects the stacking welding.

[0080] Example 2

[0081] Figure 6 This is a schematic diagram of an inner cavity tube processed using another multi-segment tube processing method according to this embodiment. From Figure 6 As can be seen, the inner lumen tube includes a distal inner lumen tube 121 and a proximal inner lumen tube 122. A polymer layer 125 is attached to the outer surfaces of both the distal and proximal inner lumen tubes 121 as a welding material. In this embodiment, the outer layer of the proximal inner lumen tube 122 is made of nylon, Pebax 72D (Pebax, polyether block polyamide, where D represents a Shore hardness unit, and the meaning of D hereafter is the same as in this context), or Pebax 70D. Correspondingly, the outer layer of the distal inner lumen tube 121 is made of Pebax 72D, Pebax 63D, or Pebax 70D. The proximal inner lumen tube 122 has a higher hardness than the distal inner lumen tube 121. The welding steps for the distal inner lumen tube 121 and the proximal inner lumen tube 122 in this embodiment are as follows:

[0082] S100: Provides a distal lumen tube 121 and a proximal lumen tube 122;

[0083] S200: Connect the first end of the proximal lumen tube 122 and the second end of the distal lumen tube 121;

[0084] S300: The arc-shaped polymer material layer 125 is disposed on the outer surface of the junction of the proximal inner tube 122 and the distal inner tube 121.

[0085] S400: Welding is performed at the location where the arc-shaped polymer material layer 125 is provided, and the polymer material layer 125 is integrated with the proximal inner lumen tube 122 and the distal inner lumen tube 121 by heat processing. The heat processing includes laser welding or hot pressing.

[0086] In this embodiment, the surface of the polymer material layer is provided with multiple cracks 124, therefore step S300 further includes the following steps:

[0087] One or more cracks 124 are formed on the surface of the polymer material layer along the circumferential direction of the distal inner tube 121, and the cracks are formed by cutting or trimming. The cracks 124 extend along the axial direction of the proximal inner tube 122, and the number of cracks 124 is one or more, preferably one to six, and they are evenly arranged along the circumferential direction of the first end of the proximal inner tube 122. The width of the cracks 124 is 0 mm to 1.2 mm.

[0088] In this embodiment, the arc of the arc-shaped polymer sheet 125 is preferably 30° to 360°. This method can ensure good compatibility between the sheet and the inner cavity tube at the near and far ends, thus achieving good bonding. At the same time, the connection strength at the near and far ends can be improved by axial and radial double fixing, without excessively increasing the outer diameter of the entire weld point circumference, thus achieving good dimensional and mechanical transition.

[0089] In other embodiments, the polymer material layer 125 is made of silicone tubing, PET, FEP, or polyetheramide, meaning the polymer material layer has a curvature of 360°. When the polymer material layer 125 is a heat shrink tubing, if the wall thickness of the heat shrink tubing is 0.0001 inches, it is equivalent to increasing the outer diameter of the weld joint by only 0.0002 inches, or 0.5 μm, based on the butt welding of the proximal and distal inner tubes. Connecting the distal and proximal inner tubes through heat shrink tubing can improve the connection strength of the proximal and distal inner tubes in both axial and radial directions, with a smaller increase in the outer diameter at the connection point.

[0090] In other embodiments, the outer tube of the balloon catheter can also be welded using the above welding method to achieve welding of outer tubes with different hardness, ensuring a good transition.

[0091] To further confirm the changes in the strength and outer diameter of the inner tube when polymer material is added, the outer diameter and tensile force at the connection point of the inner tube with and without polymer material were compared. The comparison results are shown in the table below:

[0092]

[0093] As shown in the table above, without the addition of a polymer material layer, the average outer diameter at the weld joint of the two types of inner tubes is 0.023 inches, and the average tensile force is 1.3687 N. When a Pebax polymer material layer with a radius of 180° is added, the average outer diameter at the weld joint is 0.0231 inches, which is not much different from the outer diameter at the weld joint without the addition of polymer material. However, the tensile force at the weld joint increases to 4.6723 N, and the strength increases by about 3.3 N.

[0094] In summary, the multi-segment tube processing method and balloon catheter provided by the present invention have the following advantages: The multi-segment tube processing method is used to process and connect outer tubes or inner tubes with different hardness. It can improve the connection strength of the welding point of the inner tube or outer tube, and will not affect the overall transition of the balloon catheter due to the increase in the outer diameter and hardness of the welding point. It ensures the gradual change in the overall flexibility of the balloon catheter and improves the balloon catheter's delivery and positioning ability in tortuous blood vessels.

[0095] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. A method of processing a multi-segment tube, characterized by, A method for processing a lumen tube or an outer tube of a balloon catheter, the method comprising the steps of: S100: providing a plurality of tubes, the plurality of tubes comprising at least a first tube and a second tube; S200: butting a first end of the first tube and a second end of the second tube; S300: providing a layer of polymer material, disposing the layer of polymer material on an outer surface of a butting position of the first tube and the second tube; and making one or more slits on a surface of the layer of polymer material along a circumferential direction of the tubes; S400: connecting the layer of polymer material with the first tube and the second tube into one body by heat processing.

2. The method of processing a multi-segment tube according to claim 1, wherein, The material of the layer of polymer material is silica gel, polyethylene terephthalate, polytetrafluoroethylene, or polyether amide.

3. The method of processing a multi-segment tube according to claim 1, wherein, The slits extend along an axial direction of the first tube, the number of the slits is 1-6, and the slits are arranged uniformly along a circumferential direction of the first end of the first tube.

4. The method of processing a multi-segment tube according to claim 1, wherein, The width of the slits is less than or equal to 1.2 mm.

5. The method of processing a multi-segment tube according to claim 1, wherein, The making of the one or more slits on the surface of the layer of polymer material comprises cutting or slicing one or more slits on the surface of the layer of polymer material.

6. The method of processing a multi-segment tube according to claim 1, wherein, The heat processing in the S400 step comprises laser welding or hot pressing.

7. The method of processing a multi-segment tube according to claim 1, wherein, The layer of polymer material has an arc shape.

8. The method of processing a multi-segment tube according to claim 7, wherein, The circumferential arc of the arc shape is 30°-360°.

9. The method of processing a multi-segment tube according to claim 1, wherein, The hardness of at least two tubes of the plurality of tubes is different from each other.

10. A method of processing a multi-segment tube, characterized by, A method for processing a lumen tube or an outer tube of a balloon catheter, the method comprising the steps of: S10: providing a plurality of tubes, the plurality of tubes comprising at least a first tube and a second tube; S20: butting a first end of the first tube and a second end of the second tube; the second end of the second tube is sleeved on the first end of the first tube, and one or more slits are made on the second end of the second tube along a circumferential direction of the second end of the second tube; S30: connecting the first tube and the second tube into one body at a sleeved position in the S20 step by heat processing.

11. The method of processing a multi-segment tube according to claim 10, wherein, The slits extend along an axial direction of the second tube, the number of the slits is 1-6, and the slits are arranged uniformly along a circumferential direction of the second tube.

12. The method of processing a multi-segment tube according to claim 10, wherein, The width of the slits is less than or equal to 1.2 mm.

13. The method of processing a multi-segment tube according to claim 10, wherein, The making of the one or more slits on the second end of the second tube comprises cutting or slicing one or more slits on the second end of the second tube.

14. The method of Claim 10, wherein The heat processing in the S30 step comprises laser welding or hot pressing.

15. The method of Claim 10, wherein The hardness of at least two tubes of the plurality of tubes is different from each other.

16. A balloon catheter characterized by, A balloon catheter comprising a lumen tube and an outer tube, the lumen tube or the outer tube is obtained by the processing method of the multi-segment tube according to any one of claims 1-15.

17. The balloon catheter of claim 16, wherein, The lumen tube comprises at least three coaxial cylindrical tubes, a second tube of the lumen tube is sleeved on an outer portion of a first tube of the lumen tube, and a third tube of the lumen tube is sleeved on an outer portion of the second tube of the lumen tube.

18. The balloon catheter of claim 16, wherein, The material of the first layer tube of the inner lumen tube is polyethylene, polyoxymethylene or polytetrafluoroethylene; the material of the second layer tube of the inner lumen tube is polyethylene; and the material of the third layer tube of the inner lumen tube is polyamide, nylon or a high molecular polymer containing at least nylon and polyamide.

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