Methods for fabricating balloon catheter structures, balloon catheter assemblies, and core wire structures

Abstract

This invention provides a balloon catheter structure, comprising: an elastic sheath, the two ends of which are a first opening and a second opening, respectively; a balloon having a distal end and a proximal end, the distal end being adjacent to the second opening; an outer tube adjacent to the proximal end; and a core wire comprising a straight segment and a spring segment connected end to end, the spring segment passing through the outer tube and continuing to penetrate the balloon from the proximal end, the spring segment being a core wire wound spring structure; the straight segment extending from the distal end into the elastic sheath, the straight segment being a variable diameter core wire, and the diameter of the variable diameter core wire decreasing from the distal end toward the first opening, satisfying the requirements for the working channel of an ultra-thin ureteroscope.

Description

Technical Field

[0001] This invention relates to the field of endoscopic auxiliary devices, specifically to a method for manufacturing a balloon catheter structure, a balloon catheter assembly, and a core wire structure. Background Technology

[0002] With the increasing popularity of disposable flexible ureteroscopy, the demand for balloon dilation under flexible ureteroscopy is growing rapidly. It can be used not only for dilation of ureteral strictures, but also for dilation of the ureteral orifice under flexible ureteroscopy for ureteral stones or ureteral examinations, so as to facilitate instrument entry and reduce direct insertion injury. However, existing ureteral balloon catheters are limited by catheter structure and size and cannot meet the requirements of working channels through ultra-thin ureteroscopes, such as 1mm (3Fr) and 1.2mm (3.6Fr). Summary of the Invention

[0003] The technical problem solved by this invention is to provide a method for manufacturing a balloon catheter structure, a balloon catheter assembly, and a core wire structure, thereby improving the adaptability of balloon catheters.

[0004] To solve the above-mentioned technical problems, the present invention provides a balloon catheter structure, including: an elastic sheath, with a first opening and a second opening at its two ends; a balloon having a distal end and a proximal end, the distal end being adjacent to the second opening; an outer tube adjacent to the proximal end; and a core wire including a straight segment and a spring segment connected end to end, the spring segment passing through the outer tube and continuing to penetrate the balloon from the proximal end, the spring segment being a core wire spring-wound structure; the straight segment extending from the distal end into the elastic sheath, the straight segment being a variable-diameter core wire, and the diameter of the variable-diameter core wire decreasing from the distal end toward the first opening.

[0005] Optionally, the distal end is tightly wrapped around the outer periphery of the spring segment, and the proximal end is tightly wrapped around the outer periphery of the outer tube.

[0006] Optionally, the spring segment has a first diameter and a second diameter, the first diameter being smaller than the second diameter, the spring segment inside the balloon having the first diameter, and the spring segment inside the outer tube having the second diameter.

[0007] Optionally, a radiopaque ring is provided between the distal end and the second opening, and the outer tube increases in diameter from the first tube diameter to the second tube diameter in the direction from the distal end to the proximal end, and the proximal end tightly covers the outer periphery of the outer tube of the first tube diameter.

[0008] Optionally, a metal ball is connected to the front end of the straight segment, the metal ball is sealed in the first opening, and the elastic sheath includes a spring tube and a plastic coating layer covering the outer periphery of the spring tube, and the spring tube is fixedly connected to the straight segment.

[0009] Optionally, the material of the coating layer is selected from at least one of TPU, PEBAX and PA, and a hydrophilic coating is applied to the outer periphery of the coating layer.

[0010] The present invention also provides a balloon catheter assembly, comprising: a balloon catheter structure as described above; a stress tube connected to the end of the balloon catheter structure; a connector connected to the end of the stress tube; and a two-way valve connected to the end of the connector. The balloon catheter structure, the stress tube, the connector, and the two-way valve are sequentially connected to each other so as to control the degree of fluid filling in the balloon by controlling the opening of the two-way valve. The fluid enters the balloon catheter structure from the outside of the balloon catheter assembly through the two-way valve, the connector, and the stress tube in sequence.

[0011] The technical solution of the present invention also provides a method for manufacturing a core wire structure for the balloon catheter structure described above, comprising: providing an initial core wire having a connected straight segment and a spring material segment, the spring material segment being a straight structure, the diameter of the spring material segment being the same as the maximum diameter of the straight segment; spirally winding the spring material segment from one end where the spring material segment is connected to the straight segment to the end of the spring material segment to form a spring segment, thereby forming the core wire.

[0012] Optionally, after the core wire is formed, a metal ball is fixedly connected to the front end of the straight segment.

[0013] Optionally, the spring material segment includes a first diameter segment and a second diameter segment connected end to end. The diameter of the first diameter segment is smaller than the diameter of the second diameter segment. The first diameter segment is spirally wound around the first diameter segment with a first pitch, and the second diameter segment is spirally wound around the second diameter segment with a second pitch. The first pitch is larger than the second pitch.

[0014] Compared with the prior art, the technical solution of the present invention has the following beneficial effects: The balloon catheter structure, balloon catheter assembly, and mandrel structure manufacturing method provided by the technical solution of the present invention include an elastic sheath with a first opening and a second opening at its two ends; a balloon with a distal end and a proximal end, the distal end being adjacent to the second opening; an outer tube adjacent to the proximal end; and a mandrel comprising a straight segment and a spring segment connected end to end, the spring segment passing through the outer tube and continuing to penetrate the balloon from the proximal end, the spring segment being a mandrel spring-wound structure. The straight segment extends from the distal end into the elastic sheath, the straight segment being a variable-diameter mandrel, and the diameter of the variable-diameter mandrel decreases from the distal end towards the first opening. Therefore, the straight segment keeps the distal end of the mandrel slender, while the spring segment increases the cross-sectional area of ​​the mandrel, improving the strength of the balloon catheter structure. Thus, the balloon catheter structure can be used with various flexible and rigid ureteroscopes to complete the dilation of any part of the ureter.

[0015] The method for manufacturing the balloon catheter assembly and core wire structure provided by the technical solution of the present invention is a solution corresponding to the above-mentioned balloon catheter structure. Therefore, it also has all the technical effects of the above-mentioned balloon catheter structure, and will not be repeated here. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of a balloon catheter structure according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the core wire structure according to an embodiment of the present invention; Figure 3 This is a schematic diagram of an elastic sheath according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the core wire structure according to another embodiment of the present invention; Figure 5 This is a schematic diagram of a balloon catheter assembly according to an embodiment of the present invention.

[0017] Explanation of reference numerals in the attached figures: Elastic sheath-1; Bourdon tube-11; Plastic coating-12; Balloon-2; Distal-21; Proximal-22; Outer pipe -3; First pipe diameter -d1; Second pipe diameter -d2; Core wire-4; Straight section-41; Spring section-42; First diameter section-421; Second diameter section-422; Development ring -5; Metal ball-6; Stress tube-7; Connector-8; Two channels - 9. Detailed Implementation

[0018] As described in the background section, existing ureteral balloon catheters are limited by issues such as catheter structure and size, and cannot meet the requirements for working through an ultra-thin ureteroscope.

[0019] To solve the above-mentioned technical problems, the present invention provides a method for manufacturing a balloon catheter structure, a balloon catheter assembly, and a core wire structure. The balloon catheter structure includes an elastic sheath with a first opening and a second opening at its two ends. The balloon has a distal end and a proximal end, with the distal end adjacent to the second opening. An outer tube is adjacent to the proximal end. The core wire includes a straight segment and a spring segment connected end-to-end. The spring segment passes through the outer tube and continues to penetrate the balloon from the proximal end. The spring segment is a core wire spring-wound structure. The straight segment extends from the distal end into the elastic sheath. The straight segment is a variable-diameter core wire, and the diameter of the variable-diameter core wire decreases from the distal end towards the first opening. Therefore, the straight segment keeps the distal end of the core wire slender, while the spring segment increases the cross-sectional area of ​​the core wire, improving the strength of the balloon catheter structure. This allows the balloon catheter structure to be used with various flexible and rigid ureteroscopes to dilate any part of the ureter.

[0020] To make the above-mentioned objectives, features, and beneficial effects of the present invention more apparent and understandable, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] The terms “first,” “second,” “third,” “fourth,” etc. (if present) in the specification, claims, and drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a particular order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms “comprising” and “having,” and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus. Additionally, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as they are shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure and downward or lower directions pointing towards the bottom of the corresponding figure.

[0022] [First Embodiment] Figure 1 This is a schematic diagram of a balloon catheter structure according to an embodiment of the present invention.

[0023] Please refer to the reference. Figure 1 and Figure 2 The balloon catheter structure includes: an elastic sheath 1, a balloon 2, an outer tube 3, and a core wire 4.

[0024] Specifically, the elastic sheath 1 has a first opening (not shown) and a second opening (not shown) at its two ends. The balloon has a distal end 21 and a proximal end 22, with the distal end 21 adjacent to the second opening. The outer tube 3 is adjacent to the proximal end 22. The core wire 4 includes a straight segment 41 connected end to end and a spring segment 42. The spring segment 42 passes through the outer tube 3 and continues to penetrate the balloon 2 from the proximal end 22. The spring segment 42 is a core wire spring-wound structure. The straight segment 41 extends from the distal end 21 into the elastic sheath 1. The straight segment 41 is a variable-diameter core wire, and the diameter of the variable-diameter core wire decreases from the distal end 21 toward the first opening. This variable-diameter core wire structure can effectively improve the toughness of the core wire tip.

[0025] Furthermore, the material of the outer tube 3 can be selected from at least one of PEEK, nylon, PE, PEBAX and TPU.

[0026] The balloon catheter structure includes an elastic sheath 1, with a first opening and a second opening at its two ends; a balloon 2 having a distal end 21 and a proximal end 22, with the distal end 21 adjacent to the second opening; an outer tube 3 adjacent to the proximal end 22; and a core wire 4 including a straight section 41 and a spring section 42 connected end-to-end. The spring section 42 passes through the outer tube 3 and continues to penetrate the balloon 2 from the proximal end 22. The spring section 42 is a core wire spring-wound structure. The straight section 41 extends from the distal end 21 into the elastic sheath 1. The straight section 41 is a variable-diameter core wire, and the diameter of the variable-diameter core wire decreases from the distal end 21 towards the first opening. Therefore, the straight section 41 keeps the front end of the core wire 4 slender, while the spring section 42 increases the cross-sectional area of ​​the core wire 4, improving the strength of the balloon catheter structure. Thus, the balloon catheter structure can be used with various flexible and rigid ureteroscopes to complete the dilation of any part of the ureter.

[0027] For further details, please refer to the following references. Figure 1 and Figure 2 The distal end 21 tightly covers the outer periphery of the spring section 42, forming a fixed and sealed connection, while the proximal end 22 tightly covers the outer periphery of the outer tube 3.

[0028] For further information, please refer to the following: Figure 1 A contrast ring 5 is provided between the distal end 21 and the second opening to serve a positioning function. From the distal end 21 toward the proximal end 22, the outer tube 3 increases in diameter from the first tube diameter d1 to the second tube diameter d2, and the proximal end 22 tightly covers the outer periphery of the outer tube with the first tube diameter d1, reducing the size of the connection point of the balloon catheter structure and facilitating the passage of the balloon catheter structure through a smaller channel space.

[0029] For further details, please refer to... Figure 3 The front end of the straight segment 41 is connected to a metal ball 6, which seals the first opening. The elastic sheath 1 includes a spring tube 11 and a plastic coating layer 12 covering the outer periphery of the spring tube 11. The spring tube 1 is fixedly connected to the straight segment 41. The spring tube 1 is tightly arranged and wrapped around the outer layer of the straight segment 41 to improve the strength of the core wire tip, making it easier for the balloon catheter structure to pass through narrow and tortuous parts. At the same time, the structure of the metal ball 6 reduces the risk of puncturing tissue.

[0030] In this embodiment, both the front-end spring tube 1 and the metal ball 6 are welded to the straight segment 41.

[0031] Furthermore, the material of the plastic coating layer 12 is selected from at least one of TPU, PEBAX and PA, and a hydrophilic coating is applied to the outer periphery of the plastic coating layer 12 to reduce contact friction and facilitate the entry of the catheter tip into a smaller channel.

[0032] [Second Embodiment] Please refer to Figure 4 and Figure 5 Furthermore, the spring segment 42 has a first diameter 421 and a second diameter 422, the first diameter 421 being smaller than the second diameter 422, the spring segment 42 inside the balloon 3 having the first diameter 421, and the spring segment 42 inside the outer tube 3 having the second diameter 422.

[0033] Please refer to Figure 5 Furthermore, the spring segment 42 has a first pitch and a second pitch, with the first pitch being greater than the second pitch. The spring segment 42 inside the balloon 2 has the first pitch, and the spring segment 42 inside the outer tube 3 has the second pitch. The spring segments 42 with the second pitch have tightly arranged springs in each coil to improve the structural strength of this part. Therefore, a thin-walled outer tube 3 can be used to wrap the spring segment 42 at this location to improve the toughness of the balloon catheter structure.

[0034] Furthermore, the spring segment 42 with the first pitch 421 still retains a gap to meet the requirement that the fluid can quickly inflate the balloon 2.

[0035] Furthermore, the stiffness of the spring segment 42 can be adjusted by changing the size of the first pitch.

[0036] Please refer to Figure 5 The present invention also provides a balloon catheter assembly, comprising: a balloon catheter structure, a stress tube 7, a connector 8, and two ports 9.

[0037] Specifically, the stress tube 7 is connected to the end of the balloon catheter structure; the connector 8 is connected to the end of the stress tube 7; and the two-way valve 9 is connected to the end of the connector 8. The balloon catheter structure, the stress tube 7, the connector 8, and the two-way valve 9 are connected in sequence. By applying pressure to the two-way valve 9 and simultaneously controlling the opening of the valve of the two-way valve 9, the degree of fluid filling in the balloon 2 is controlled. The fluid enters the balloon catheter structure from the outside of the balloon catheter assembly through the two-way valve 9, the connector 8, and the stress tube 7 in sequence.

[0038] Furthermore, the balloon catheter structure, stress tube 7, connector 8, and two ports 9 are connected in a sealed manner.

[0039] In this embodiment, the fluid is a liquid.

[0040] In other embodiments, the fluid may also be a gas.

[0041] The present invention also provides a method for manufacturing a core wire structure for use in the balloon catheter structure described above, comprising: An initial core wire is provided, having a connected straight section 41 and a spring material section (not shown). The spring material section is a straight structure, and the diameter of the spring material section is the same as the maximum diameter of the straight section. The spring material section is spirally wound around the spring material section from one end where it connects to the straight section to the end of the spring material section to form the spring section 42, thereby forming the core wire 4.

[0042] Furthermore, after forming the core wire 4, a metal ball 6 is fixedly connected to the front end of the straight segment 41.

[0043] Furthermore, the spring material segment includes a first diameter segment 421 and a second diameter segment 422 connected end to end. The diameter of the first diameter segment 421 is smaller than the diameter of the second diameter segment 422. The first diameter segment 421 is spirally wound around the first diameter segment 421 with a first pitch, and the second diameter segment 422 is spirally wound around the second diameter segment 422 with a second pitch. The first pitch is greater than the second pitch.

[0044] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A balloon catheter structure, characterized in that, include: An elastic sheath, wherein the two ends of the elastic sheath are a first opening and a second opening, respectively; A balloon having a distal end and a proximal end, the distal end being adjacent to the second opening; The outer tube is adjacent to the proximal end; The core wire includes a straight segment and a spring segment connected end to end. The spring segment passes through the outer tube and continues to penetrate the balloon from the proximal end. The spring segment is a core wire wound spring structure. The straight segment extends from the distal end into the elastic sheath. The straight segment is a variable diameter core wire, and the diameter of the variable diameter core wire decreases from the distal end toward the first opening.

2. The balloon catheter structure according to claim 1, characterized in that, The distal end tightly covers the outer periphery of the spring segment, and the proximal end tightly covers the outer periphery of the outer tube.

3. The balloon catheter structure according to claim 2, characterized in that, The spring segment has a first diameter and a second diameter, the first diameter being smaller than the second diameter; the spring segment inside the balloon has the first diameter, and the spring segment inside the outer tube has the second diameter.

4. The balloon catheter structure according to claim 2, characterized in that, There is a radiopaque ring between the distal end and the second opening. From the distal end toward the proximal end, the outer tube increases in diameter from the first tube diameter to the second tube diameter, and the proximal end tightly covers the outer periphery of the outer tube with the first tube diameter.

5. The balloon catheter structure according to claim 1, characterized in that, The front end of the straight segment is connected to a metal ball, which is sealed in the first opening. The elastic sheath includes a spring tube and a plastic coating layer covering the outer periphery of the spring tube. The spring tube is fixedly connected to the straight segment.

6. The balloon catheter structure according to claim 5, characterized in that, The material of the plastic coating layer is selected from at least one of TPU, PEBAX and PA, and a hydrophilic coating is applied to the outer periphery of the plastic coating layer.

7. A balloon catheter assembly, characterized in that, include: The balloon catheter structure as described in any one of claims 1 to 6; A stress tube is connected to the end of the balloon catheter structure; A connector is attached to the end of the stress tube; Two valves are connected to the end of the connector. The balloon catheter structure, the stress tube, the connector, and the two valves are connected in sequence to control the degree of fluid filling in the balloon by controlling the opening of the two valves. The fluid enters the balloon catheter structure from the outside of the balloon catheter assembly through the two valves, the connector, and the stress tube in sequence.

8. A method for fabricating a core wire structure, used in the balloon catheter structure as described in any one of claims 1 to 6, characterized in that, include: An initial core wire is provided, having a connected straight segment and a spring material segment, wherein the spring material segment is a straight structure and the diameter of the spring material segment is the same as the maximum diameter of the straight segment; The spring segment is formed by spiraling around the spring material segment from one end where it connects to the straight segment until the end of the spring material segment, thereby forming the core wire.

9. The method for manufacturing the core wire structure according to claim 8, characterized in that, After the core wire is formed, a metal ball is fixedly connected to the front end of the straight segment.

10. The method for manufacturing the core wire structure according to claim 8, characterized in that, The spring material segment comprises a first diameter segment and a second diameter segment connected end to end. The diameter of the first diameter segment is smaller than the diameter of the second diameter segment. The first diameter segment is spirally wound around the first diameter segment with a first pitch, and the second diameter segment is spirally wound around the second diameter segment with a second pitch. The first pitch is larger than the second pitch.

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