Balloon Catheter

Abstract

The present invention discloses a balloon catheter, comprising a tube seat, a tube body and a balloon, wherein the proximal section of the tube body is connected to the tube seat, the distal section of the tube body is connected to the balloon, the tube body comprises an inner layer, an intermediate layer and an outer layer which are stacked in sequence from the inside to the outside, the outer layer comprises a first core wire and a second core wire, the cross-sectional area of ​​the first core wire is larger than the cross-sectional area of ​​the second core wire, the first core wire is configured to tightly cover the second core wire after melting, and to form a firm connection after cooling to fix the second core wire on the outer surface of the intermediate layer and form a spiral pattern protruding outward under the action of the second core wire. The present invention sets the outer layer as the first core wire and the second core wire on the basis of retaining the original structure of the catheter intermediate layer, so that there is no need to set an additional protruding structure on the outer surface of the catheter intermediate layer, thereby simplifying the overall structure, while ensuring the uniformity and consistency of the spiral pattern, thereby significantly improving the ability of the balloon catheter to pass through complex vascular paths.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter. Background Art

[0002] Balloon catheters are usually composed of a soft catheter with excellent maneuverability and one or more expandable balloons at the distal end of the catheter. This combination allows doctors to perform precise operations at specific locations in the patient's body, such as filling and dilating stenosis to restore or improve blood flow, or temporarily blocking a section of a blood vessel to create a stable environment for interventional surgery.

[0003] In order to ensure that the balloon can reach the target location smoothly, the catheter must have good enough maneuverability. This is not only to cope with the complex vascular paths in the human body, but also to protect the surrounding tissues from damage. For example, Chinese utility model patent CN209827933U proposes a design concept of gradual hardness, that is, the hardness of the catheter gradually decreases from the proximal end to the distal end, thereby improving the flexibility of the distal end of the catheter, making it easier for the balloon catheter to pass through the tortuous vascular path. This design optimizes the propulsion performance of the balloon catheter while maintaining the necessary control accuracy.

[0004] For another example, Chinese invention patent CN115253018A sets a series of regularly arranged protrusion structures on the middle layer of the catheter. After these protrusion structures come into contact with the outer layer of the catheter, spiral patterns are formed on the outer surface, similar to the design of a drill bit. This design enhances the forward efficiency of the catheter by optimizing the mechanical properties during rotation and provides additional forward thrust. However, it is worth noting that setting a protrusion structure on the middle layer of the catheter woven from braided wire will not only increase the structural complexity of the middle layer of the catheter, but may also cause the spiral patterns formed by the protrusion structure to be uneven, thereby affecting the overall passing performance and control accuracy of the catheter. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a balloon catheter through the above-mentioned defects in the prior art, by improving the outer layer structure to avoid setting additional protrusions on the outer surface of the middle layer, thereby simplifying the overall structure and ensuring the uniformity and consistency of the spiral texture.

[0006] According to the present invention, a balloon catheter is provided, comprising a tube seat, a tube body and a balloon, wherein the proximal section of the tube body is connected to the tube seat, and the distal section of the tube body is connected to the balloon, the tube body comprises an inner layer, an intermediate layer and an outer layer which are stacked in sequence from the inside to the outside, the outer layer comprises a first core wire and a second core wire, the cross-sectional area of ​​the first core wire is larger than the cross-sectional area of ​​the second core wire, the first core wire is configured to tightly cover the second core wire after melting, and to form a firm connection after cooling to fix the second core wire on the outer surface of the intermediate layer and form a spiral pattern protruding outward under the action of the second core wire.

[0007] Furthermore, the first core wire and the second core wire are closely alternately arranged along the length direction of the middle layer and are spirally wound around the outer surface of the middle layer, and the first core wire is deformed in all directions in a molten state to completely cover the second core wire.

[0008] Furthermore, the first core wire and the second core wire are coaxially arranged from outside to inside and after being coaxially combined, they are spirally wound around the outer surface of the middle layer along the length direction of the middle layer. The first core wire is maintained at the outer position of the second core wire in a molten state and undergoes appropriate deformation to tightly wrap the second core wire.

[0009] Furthermore, the cross-sectional area of ​​the first core wire is S1, the cross-sectional area of ​​the second core wire is S2, and 2≤S1 / S2≤5.

[0010] Furthermore, the melting point of the first core wire is lower than the melting point of the second core wire.

[0011] Furthermore, the first core wire is a plastic core wire, and the second core wire is a plastic core wire or a metal core wire.

[0012] Furthermore, the distal end section of the tube body is provided with a developing wire, which is extended along the distal end section of the second core wire and is coated in the first core wire.

[0013] Furthermore, the second core wire is a hollow wire, the interior of the second core wire forms a balloon filling channel for balloon filling and is connected to the interior of the balloon, and the interior of the inner layer forms a guidewire channel for the guidewire to pass through.

[0014] Furthermore, the tube seat is provided with a guidewire interface for accessing the guidewire channel and a filling interface for accessing the balloon filling channel. The two ends of the proximal section of the tube body are respectively sealed and fixedly connected to the interior of the tube seat. The side of the proximal section of the tube body is provided with an incision that passes through the interior of the second core wire. The incision is connected to the filling interface, and the inner layer is connected to the guidewire interface.

[0015] Furthermore, the cross section of the second core wire is circular, elliptical, triangular or half-moon shaped.

[0016] Compared with the prior art, the present invention retains the original structure of the catheter middle layer and sets the outer layer as the first core wire and the second core wire. The first core wire is tightly wrapped around the second core wire after melting treatment and fixed to the outer surface of the middle layer to naturally form a spiral pattern. In this way, there is no need to set an additional protrusion structure on the outer surface of the catheter middle layer, thereby simplifying the overall structure and ensuring the uniformity and consistency of the spiral pattern, optimizing the mechanical properties of the balloon catheter during rotation, providing better propulsion force and control performance, and thus significantly improving the ability of the balloon catheter to pass through complex vascular pathways. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A more complete understanding of the invention and its attendant advantages and features will be more readily appreciated by referring to the following detailed description taken in conjunction with the accompanying drawings.

[0018] Figure 1 It is a schematic diagram of the overall structure of the first embodiment of the present invention.

[0019] Figure 2 It is a schematic cross-sectional structural diagram of the first embodiment of the present invention.

[0020] Figure 3 yes Figure 2 Enlarged schematic diagram at point A in the middle.

[0021] Figure 4 It is a schematic diagram of the overall structure of the second core wire in the tube body in the first embodiment of the present invention.

[0022] Figure 5 It is a partial cross-sectional view of the tube body in the first embodiment of the present invention.

[0023] Figure 6 It is a partial cross-sectional view of the tube body in the second embodiment of the present invention.

[0024] Figure 7 It is a partial cross-sectional view of the tube body in the third embodiment of the present invention.

[0025] In the accompanying drawings: 10 is a tube seat, 11 is a guide wire interface, 12 is a filling interface; 20 is a tube body, 21 is an inner layer, 22 is a middle layer, 23 is an outer layer, 231 is a first core wire, 232 is a second core wire, 24 is an incision; 30 is a balloon.

[0026] It should be noted that the drawings are used to illustrate the present invention, rather than to limit the present invention. Note that the drawings showing the structures may not be drawn to scale. In addition, in the drawings, the same or similar elements are marked with the same or similar reference numerals. DETAILED DESCRIPTION

[0027] In order to make the contents of the present invention clearer and easier to understand, the contents of the present invention are described in detail below in conjunction with specific embodiments and drawings.

[0028] The "proximal end" and "distal end" referred to in the present invention should be understood as being viewed from the direction of the attending physician. The "proximal end" refers to the end close to the attending physician, which corresponds to the "left end" referred to in the reference drawings, and the "distal end" refers to the end away from the attending physician, which corresponds to the "right end" referred to in the reference drawings. Similarly, the "proximal segment" refers to a segment or a specific area close to the attending physician, and the "distal segment" refers to a segment or a specific area away from the attending physician.

[0029] Embodiment 1: Figures 1 to 5As shown, the balloon catheter of this embodiment includes a tube seat 10, a tube body 20 and a balloon 30, the proximal section of the tube body 20 is connected to the tube seat 10, and the distal section of the tube body 20 is connected to the balloon 30, so that the tube seat 10, the tube body 20 and the balloon 30 are sequentially connected from the proximal end to the distal end to form a balloon catheter. The tube body 20 includes an inner layer 21, an intermediate layer 22 and an outer layer 23 which are sequentially stacked from the inside to the outside, the inner layer 21 and the intermediate layer 22 are both existing structures, the outer layer 23 includes a first core wire 231 and a second core wire 232, the cross-sectional area of ​​the first core wire 231 is larger than the cross-sectional area of ​​the second core wire 232, the first core wire 231 is configured to tightly cover the second core wire 232 after melting treatment, and form a firm connection after cooling to fix the second core wire 232 on the outer surface of the intermediate layer 22 and form a spiral pattern protruding outward under the action of the second core wire 232. Since the outer layer 23 is composed of two different cross-sectional areas, the first core wire 231 has a larger cross-section and a lower melting point than the second core wire 232, that is, the second core wire 232 is not melted during the melting process of the first core wire 231, so under specific temperature conditions, the first core wire 231 can melt and tightly cover the second core wire 232, and form a firm connection after cooling, fixing the second core wire 232 to the outer surface of the middle layer 22, and naturally forming a spiral pattern in the process. This process not only fixes the second core wire 232 to the outer surface of the middle layer 22, but also naturally forms a spiral pattern protruding outward under the action of the second core wire 232. In this way, it is avoided to set an additional protruding structure on the outer surface of the middle layer 22, simplifying the overall structure while ensuring the uniformity and consistency of the spiral pattern, thereby optimizing the mechanical properties of the balloon catheter during rotation, providing better propulsion and control performance, and significantly improving the ability of the balloon catheter to pass through complex vascular paths.

[0030] Specifically, the first core wire 231 and the second core wire 232 are closely arranged alternately along the length direction of the middle layer 22 and are wound in a spiral form on the outer surface of the middle layer 22, that is, the two core wires are wound alternately, one core wire goes around the other core wire once, and then the latter goes around the former, and so on. In each round of winding, the first core wire 231 and the second core wire 232 are closely attached to the outer surface of the middle layer 22. As the winding process progresses, the core wire gradually forms a spiral shape, and each turn of winding can provide additional support to enhance the torsional stiffness of the catheter. The first core wire 231 is a plastic core wire for easy melting, and the second core wire 232 is a plastic core wire or a metal core wire for providing a stronger support force. The first core wire 231 is deformed in all directions in the molten state to completely cover the second core wire 232 and form a spiral pattern under the support of the second core wire 232. The cross-sectional area of ​​the first core wire 231 is S1, and the cross-sectional area of ​​the second core wire 232 is S2. In order to ensure the compatibility of the two, the cross-sectional area ratio S1 / S2 of the first core wire 231 and the second core wire 232 is set to be between 2 and 5. In this embodiment, the value is 3. Of course, in other embodiments, S1 / S2 can also be 2, 2.5, 3.5, 4, 4.5 or 5, as long as 2≤S1 / S2≤5 is satisfied. The selection within this ratio range ensures that the first core wire 231 can be fully deformed and wrap the second core wire 232 in the molten state, and does not affect the generation of the spiral pattern. If S1 / S2 is less than 2, the first core wire 231 may not be able to completely cover the second core wire 232 in the molten state; if S1 / S2 is greater than 5, the formation of the spiral pattern may be affected.

[0031] The first core wire 231 is a solid wire, and the second core wire 232 is a hollow wire, and its cross-sectional shape is circular. The hollow structure allows the second core wire 232 to form a balloon filling channel for filling the balloon 30 and communicate with the interior of the balloon 30, which simplifies the balloon filling mechanism. The distal end of the second core wire 232 can directly penetrate the outer layer 23 and directly connect to the interior of the balloon, or it can be indirectly connected to the interior of the balloon through an additional connecting tube. In addition, the interior of the inner layer 21 is smooth and forms a guidewire channel for the guidewire to pass through. Correspondingly, the tube seat 10 is provided with a guidewire interface 11 for accessing the guidewire channel and a filling interface 12 for accessing the balloon filling channel. The guidewire interface 11 and the filling interface 12 are separately arranged and the two are roughly formed into a Y shape after being combined with the tube seat 10. After the proximal section of the tube body 20 extends into the interior of the tube seat 10, the two ends of the proximal section of the tube body 20 are respectively sealed and fixedly connected to the interior of the tube seat 10, and a cutout 24 is provided on the side of the proximal section of the tube body 20 that penetrates the interior of the second core wire 232. The cutout 24 is connected to the filling interface 12 so that the filling interface 12 is connected to the balloon filling channel formed inside the second core wire 232, and the inner layer 21 is connected to the guidewire interface 11 so that the guidewire interface 11 is connected to the guidewire channel, thereby ensuring that the guidewire and the filling medium can smoothly pass through the guidewire interface 11 and the filling interface 12 and enter their respective channels.

[0032] Considering the importance of precise positioning during surgery, the distal section of the tube body 20 is provided with a developing wire, which extends along the distal section of the second core wire 232 and is wrapped in the first core wire 231. It can be clearly seen under X-ray fluoroscopy, helping doctors to accurately find the target position.

[0033] In summary, the balloon catheter of this embodiment cleverly combines the first core wire 231 and the second core wire 232, and tightly wraps them around the outer surface of the middle layer 22 in an alternating winding manner. After the first core wire 231 is melted, it tightly covers the second core wire 232 and cools to form a firm connection, naturally forming a uniform spiral pattern, optimizing the mechanical properties during rotation, and providing better propulsion and control performance. At the same time, the second core wire 232 is hollow in design, and a balloon filling channel for balloon filling is formed inside, which simplifies the filling mechanism and improves flexibility and passability, significantly improving the ability of the balloon catheter to pass through complex vascular pathways.

[0034] Embodiment 2: Different from Embodiment 1, Figure 6 As shown, the cross-sectional shape of the second core wire 232 is an ellipse. The other structures of this embodiment are consistent with those of the first embodiment, and will not be described again.

[0035] Embodiment 3: Different from Embodiment 1, Figure 7 As shown, the cross-sectional shape of the second core wire 232 is a triangle. Other structures of this embodiment are consistent with those of the first embodiment, and will not be described again.

[0036] It is understandable that the cross-sectional shape of the second core wire 232 can be designed to be a half-moon shape or other geometric shapes according to actual needs, as long as it does not form filling resistance and affect the filling of the balloon.

[0037] Embodiment 4: Different from Embodiment 1, the arrangement of the first core wire 231 and the second core wire 232 of this embodiment is different. The first core wire 231 and the second core wire 232 are coaxially arranged from outside to inside, and the two are coaxially combined and wound in a spiral form on the outer surface of the middle layer 22 along the length direction of the middle layer 22. The first core wire 231 is kept in the outer position of the second core wire 232 in the molten state and deforms appropriately to tightly cover the second core wire 232. This coaxial arrangement facilitates the outer layer 23 to be wound on the outer surface of the middle layer 22, and also ensures that the first core wire 231 can tightly cover the second core wire 232 and form a spiral pattern after being molten.

[0038] The other structures of this embodiment are consistent with those of the first embodiment and will not be described again here.

[0039] It is to be understood that, although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A balloon catheter, comprising a tube seat, a tube body and a balloon, wherein the proximal end of the tube body is connected to the tube seat, the distal end of the tube body is connected to the balloon, the tube body comprises an inner layer, an intermediate layer and an outer layer stacked in sequence from inside to outside, characterized in that: The outer layer includes a first core wire and a second core wire, the cross-sectional area of ​​the first core wire is larger than the cross-sectional area of ​​the second core wire, the melting point of the first core wire is lower than the melting point of the second core wire, the first core wire is configured to tightly cover the second core wire after melting, and to form a firm connection after cooling to fix the second core wire on the outer surface of the middle layer and form a spiral pattern protruding outward under the action of the second core wire, wherein the first core wire is fully deformed in a molten state and wraps the second core wire; The first core wire and the second core wire are closely alternately arranged along the length direction of the middle layer and are wound around the outer surface of the middle layer in a spiral form, and the first core wire is deformed in all directions in a molten state to completely cover the second core wire; or, the first core wire and the second core wire are coaxially arranged from outside to inside and the two are coaxially combined and wound around the outer surface of the middle layer in a spiral form along the length direction of the middle layer, and the first core wire is maintained in an external position of the second core wire in a molten state and is appropriately deformed to tightly cover the second core wire.

2. The balloon catheter according to claim 1, characterized in that: The cross-sectional area of ​​the first core wire is S1, the cross-sectional area of ​​the second core wire is S2, and 2≤S1 / S2≤5.

3. The balloon catheter according to claim 1, characterized in that: The first core wire is a plastic core wire, and the second core wire is a plastic core wire or a metal core wire.

4. The balloon catheter according to claim 1, characterized in that: The distal end section of the tube body is provided with a developing wire, which is extended along the distal end section of the second core wire and is covered in the first core wire.

5. The balloon catheter according to claim 1, characterized in that: The second core wire is a hollow wire, the interior of the second core wire forms a balloon filling channel for balloon filling and is connected to the interior of the balloon, and the interior of the inner layer forms a guidewire channel for the guidewire to pass through.

6. The balloon catheter according to claim 5, characterized in that: The tube seat is provided with a guidewire interface for accessing the guidewire channel and a filling interface for accessing the balloon filling channel. The two ends of the proximal section of the tube body are respectively sealed and fixedly connected to the inside of the tube seat. The side of the proximal section of the tube body is provided with an incision that passes through the inside of the second core wire. The incision is connected to the filling interface, and the inner layer is connected to the guidewire interface.

7. The balloon catheter according to claim 5, characterized in that: The cross section of the second core wire is circular, elliptical, triangular or half-moon shaped.

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