Catheter tip and forming method thereof

Abstract

The invention relates to a catheter tip and a forming method thereof. The catheter tip comprises a tip body smoothly connected with a catheter body, and a cavity penetrates through the tip body in the axial direction; a linear reinforcing component with deformability is formed in the tip body, and the linear reinforcing component is embedded into the tip wall of the tip body and extends from the head of the tip body to the joint of the tip body and the catheter body so as to provide supporting strength and deformability for the tip body. The invention has the beneficial effects that: the linear reinforcing component is arranged, so that the tip of the catheter has high flexibility and can easily conform to natural bending of a target part or other in-vivo pipelines, and the risk of damage to tissues is reduced. Meanwhile, by means of the design, the guide wire tracking and guiding capacity of the catheter in a complex anatomical structure is enhanced, and operation is more accurate and smoother.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a catheter tip and a molding method thereof. Background Art

[0002] In standard stent delivery systems, the proximal portion of the catheter is made of a material that makes it relatively stiff or inflexible, which allows the catheter to be sufficiently pushable. In contrast, the distal portion of the catheter is made quite flexible to allow the stent to be adequately delivered through tortuous blood vessels to the desired target.

[0003] The design of the medical catheter tip structure is critical, as it directly affects the performance of the catheter, the ease of operation, and the safety of the patient. The catheter tip can have different shapes and characteristics to suit the needs of various medical application scenarios.

[0004] However, the structure of the catheter tip in the prior art is generally made of a single material, which causes the tip to be easily deformed or even bent after encountering an obstruction in the blood vessel, resulting in functional failure; some catheter tips are provided with a composite layer to enhance the strength of the tip, but the strength of the composite layer is limited or the hardness is high, and it is impossible to perform a small range of bending and deformation according to the target position, which brings inconvenience to the operation. Summary of the invention

[0005] In order to solve the above problems existing in the prior art, the present invention provides a catheter tip and a molding method thereof.

[0006] The above-mentioned problem of the present invention is solved by the following technical solutions: A catheter tip comprises a tip body smoothly connected to a catheter body, wherein a cavity is axially penetrated in the tip body; A linear reinforcing component with deformation capability is formed in the tip body, embedded in the tip wall of the tip body, and extends from the head of the tip body to the connecting part between the tip body and the catheter body to provide support strength and deformation capability to the tip body.

[0007] The above technical solution is further configured as follows: the linear reinforcing component is elastic.

[0008] The above technical solution is further configured as follows: the linear reinforcing component is a braid or a coil.

[0009] The above technical solution is further configured as follows: the linear enhancement component is a spiral structure.

[0010] The above technical solution is further configured as follows: the tip body is configured as a tip portion and a connecting portion in sequence from the head, and the connecting portion is connected to the catheter body; The inner diameter of the tip portion gradually increases or decreases from the head portion to the connecting portion.

[0011] The above technical solution is further configured as follows: the inner diameter of the spiral structure is consistent with the inner diameter of the tip portion.

[0012] The above technical solution is further configured as follows: the spiral density of the spiral structure is configured to gradually increase or gradually decrease along the axial direction of the catheter tip.

[0013] A method for forming a catheter tip, used for forming the above-mentioned catheter tip, comprises the following steps: Step 1, material preparation: preparation of linear reinforcement components and polymer materials, and design and manufacture of suitable molds; Step 2, preheating the mold: preheating the mold according to the biological characteristics of the polymer material; Step 3, placing materials: positioning the linear reinforcement component into the molding cavity of the mold; Step 4, filling the mold: injecting the molten polymer material into the mold; Step 5, pressurizing: applying pressure to the molding cavity of the mold to ensure that the polymer material completely wraps the linear reinforcement component; Step 6, cooling and curing: cooling the mold to room temperature to solidify the polymer material; Step 7, demoulding and post-processing: The molded catheter tip is removed from the mold and the surface of the catheter tip is visually inspected.

[0014] The above technical solution is further configured as follows: in step 2, the preheating temperature is 150°C to 200°C.

[0015] The above technical solution is further configured as follows: in step 3, a positioning structure is provided in the molding cavity of the mold or on the linear reinforcing component so that the linear reinforcing component is placed in a set position of the molding cavity.

[0016] Compared with the prior art, the present invention has the following beneficial effects: 1. The linear reinforcement component is set to make the catheter tip highly flexible, which can easily conform to the natural curvature of the target site or other internal tubes, reducing the risk of tissue damage. At the same time, this design also enhances the catheter's ability to "track" the guide wire in complex anatomical structures, making the operation more precise and smooth; 2. Placing the linear enhancement component inside the catheter tip can reduce damage to the blood vessel wall and improve the accuracy of surgical operations, which can effectively reduce the incidence of complications such as bleeding, blood vessel rupture or catheter displacement, thereby improving operational safety; The elastic properties of the linear reinforcement component provide the necessary support for the catheter tip, ensuring that it can effectively overcome resistance during the pushing process, especially when passing through narrow or tortuous paths; this design helps to reduce "slipping" during the advancement process and ensures that the catheter tip can accurately reach the treatment area. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A schematic diagram of the structure of one of the catheter tips.

[0018] Figure 2 for Figure 1 Schematic diagram of the cross-sectional structure of the catheter tip.

[0019] Figure 3 A schematic diagram of the structure of another catheter tip.

[0020] Figure 4 for Figure 3 Schematic diagram of the cross-sectional structure of the catheter tip.

[0021] Markings on the attached drawings: 100, tip portion; 200, connecting portion; 300, linear reinforcing component. DETAILED DESCRIPTION

[0022] In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the specific implementation mode, structure, characteristics and effects of the present invention are described in detail below in combination with the accompanying drawings and preferred embodiments.

[0023] Example 1 like Figure 1-Figure 4 As shown, this embodiment discloses a catheter tip.

[0024] A catheter tip comprises a tip body smoothly connected to a catheter body, wherein a cavity is axially penetrated in the tip body; a linear reinforcing component 300 with deformation capability is formed in the tip body, wherein the linear reinforcing component 300 is embedded in the tip wall of the tip body and extends from the head of the tip body to the connecting portion between the tip body and the catheter body to provide support strength and deformation capability to the tip body.

[0025] The above is the basic solution of this embodiment.

[0026] Specific reference Figure 1-Figure 4 As shown, the catheter tip is an integrally formed structure, the head is inserted into the target site, the tail is smoothly connected to the catheter body, and the connection between the catheter tip and the catheter body can be integrally formed by heat setting; the cavity of the catheter tip and the cavity of the catheter body are connected.

[0027] The head is embedded with a linear reinforcing component 300 , and the linear reinforcing component 300 and the catheter tip are integrally formed, that is, the tube wall of the catheter tip completely covers the linear reinforcing component 300 .

[0028] In this embodiment, the linear reinforcing component 300 completely penetrates the catheter tip, that is, the first end of the linear reinforcing component 300 extends to the head of the catheter tip, and the second end extends to the connection portion between the catheter tip and the catheter body.

[0029] Compared with ordinary catheter tips or catheter tips reinforced by composite layers, the interface of this embodiment should be able to be firmly bonded and effectively transfer stress to avoid delamination or cracks at the interface. The linear reinforcement component 300 and the polymer material adopt covalent bonding, mechanical interlocking and other methods to enhance the interface bonding force, ensuring that the linear reinforcement component 300 and the catheter body maintain a stable connection during repeated bending and stretching.

[0030] At the same time, the linear reinforcement component 300 is integrally formed with the catheter tip to optimize stress distribution, avoid stress concentration, and reduce local damage. The fatigue resistance of the catheter can be effectively improved by predicting and optimizing stress distribution through simulation software; uniform distribution of stress at the interface is crucial to maintaining the structural integrity and service life of the catheter tip.

[0031] Based on the above settings, the catheter tip has a high degree of flexibility, which can easily conform to the natural curvature of the target site or other internal tubes, reducing the risk of tissue damage. At the same time, this design also enhances the catheter's ability to "track" the guide wire in complex anatomical structures, making the operation more precise and smooth; Disposing the linear enhancement component 300 inside the catheter tip can reduce damage to the blood vessel wall and improve the accuracy of surgical operations, which can effectively reduce the incidence of complications such as bleeding, blood vessel rupture or catheter displacement, thereby improving operational safety.

[0032] Preferably, in this embodiment, the linear reinforcing component 300 is elastic.

[0033] In order to enable the catheter tip to bend and deform to a certain extent according to operational requirements after entering the target position, in this embodiment, the linear reinforcement component 300 is made of an elastic material or is set to an elastic structure, so that the catheter tip can still be flexible and will not cause accidents such as breakage during the bending process.

[0034] The elastic properties of the linear reinforcement component 300 provide the necessary support for the catheter tip, ensuring that resistance can be effectively overcome during the pushing process, especially when passing through narrow or tortuous paths. This design helps to reduce the "slippage" phenomenon during the pushing process and ensures that the catheter tip can accurately reach the treatment area.

[0035] It should be noted that, in this embodiment, the bending of the linear reinforcing component 300 has linear flexibility, and its bending degree can be adjusted as needed; in this embodiment, a bending control structure can be provided at the tip of the catheter to control the bending degree.

[0036] The bending control structure is a conventional arrangement in the prior art and will not be described in detail here.

[0037] Preferably, in this embodiment, the linear reinforcing component 300 is a braid or a coil.

[0038] In this embodiment, in order to ensure the bending structure described above, a woven fabric or coil structure is used so that when the linear reinforcement component 300 is bent, the entire structure is bent rather than a certain part. While ensuring the bending state, no large stress is generated at a certain position of the linear reinforcement part, thereby ensuring the integrity of the linear reinforcement component 300.

[0039] Preferably, in this embodiment, the linear reinforcing component 300 is a spiral structure.

[0040] Preferably, in this embodiment, the linear reinforcing component 300 is configured as a spring.

[0041] Based on the above settings, the spring structure has excellent anti-fatigue performance and can maintain its structural integrity even under cyclic loads of repeated bending and stretching, thereby extending the service life of the catheter and reducing the frequency of catheter replacement due to catheter damage during surgery. At the same time, since the spring-reinforced catheter tip can more flexibly adjust its shape and direction, the position of the catheter can be more accurately controlled during operation, which is particularly critical for targeted drug delivery, sampling or performing precision surgical operations.

[0042] The shape, material, density and layout of the spring can be customized to meet the specific requirements of different surgical or treatment scenarios. For example, the spring can be designed with a specific pre-bent shape to fit the needs of a specific target area.

[0043] In this embodiment, the tip body is sequentially configured as a tip portion 100 and a connecting portion 200 from the head, and the connecting portion 200 is connected to the catheter body; The inner diameter of the tip portion 100 gradually increases or decreases from the head portion to the connecting portion 200 .

[0044] Specific reference Figure 1 and Figure 2 As shown, the inner diameter of the tip portion 100 of the tip body gradually increases from the head portion to the connecting portion 200, that is, the tip portion 100 is configured to be in a constricted shape; Figure 3 and Figure 4In the figure, the inner diameter of the tip portion 100 of the tip body gradually decreases from the head to the connecting portion 200, that is, the tip portion 100 is configured to be flared; to ensure the firmness of the connection between the linear reinforcement component 300 and the tip body, the inner diameter of the portion of the linear reinforcement component 300 located at the tip portion 100 is consistent with the structure of the tip portion 100, and the inner diameter of the portion located at the connecting portion 200 is consistent with the structure of the connecting portion 200.

[0045] In addition, according to the strength requirements of the tip portion 100 , the helical density of the linear reinforcing component 300 can be set to a gradual structure, so that the bending strength of the catheter tip from the head to the connecting portion 200 gradually increases or decreases.

[0046] Example 2 This embodiment also provides a method for forming a catheter tip, which is used to form the catheter tip described in Example 1.

[0047] A method for forming a catheter tip, used for forming the catheter tip described in Example 1, comprising the following steps: Step 1, material preparation: preparation of the linear reinforcement component 300 and polymer materials, and design and manufacture of a suitable mold; Step 2, preheating the mold: preheating the mold according to the biological characteristics of the polymer material; Step 3, placing materials: positioning the linear reinforcement component 300 into the molding cavity of the mold; Step 4, filling the mold: injecting the molten polymer material into the mold; Step 5, pressurizing: applying pressure to the molding cavity of the mold to ensure that the polymer material completely wraps the linear reinforcing component 300; Step 6, cooling and curing: cooling the mold to room temperature to solidify the polymer material; Step 7, demoulding and post-processing: The molded catheter tip is removed from the mold and the surface of the catheter tip is visually inspected.

[0048] Preferably, in step 2, the preheating temperature is 150°C to 200°C.

[0049] In order to ensure that the reinforcing component can be positioned and placed at the set position so that the polymer material can completely cover the linear reinforcing component 300, in this embodiment, in step 3, a positioning structure is set in the molding cavity of the mold or on the linear reinforcing component 300, so that the linear reinforcing component 300 is placed in the set position of the molding cavity.

[0050] Preferably, in this embodiment, the linear reinforcing component 300 can be a spiral structure formed of stainless steel or nickel-titanium alloy, such as a finished spring; these materials have good elasticity and biocompatibility.

[0051] In this embodiment, the polymer material may be polyurethane (PU), polyethylene (PE), etc. These materials have good flexibility and biocompatibility.

[0052] In this embodiment, the injection cavity in the mold is consistent with the outer structure of the catheter tip.

[0053] In this embodiment, the preheating temperature of the mold is at least the melting temperature of the polymer material. In this way, when the polymer material is injected into the molding cavity, it is in a flowing state and can completely cover the linear reinforcement component 300, thereby achieving the bonding strength between the catheter tip and the linear reinforcement component 300.

[0054] In this embodiment, the cooling temperature is preferably 20° C. to 25° C. Too high a temperature will result in a slow solidification speed and deformation during the solidification process; too low a temperature will cause the catheter tip to solidify quickly and produce defects such as fractures.

[0055] In this embodiment, in step 7, the tip of the catheter is checked for bubbles or cracks.

[0056] In this embodiment, for the positioning of the linear reinforcing component 300 in the mold, a positioning structure can be set in the mold to ensure the position of the linear reinforcing component 300; or the linear reinforcing component 300 can be pre-treated and coated with an adhesive to increase the bonding force between the linear reinforcing component 300 and the polymer material.

[0057] In step 4, vacuum-assisted technology is used to ensure that the polymer material completely fills the mold and avoids the generation of bubbles and voids.

[0058] In step 5, appropriate pressure is applied to the injection molding material so that the polymer material can evenly wrap the linear reinforcing component 300 to avoid displacement of the linear reinforcing component 300 during the molding process and the production of defective products.

[0059] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technical personnel in this field can make some changes or modify the technical contents disclosed above into equivalent embodiments without departing from the scope of the technical solution of the present invention. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A catheter tip, comprising a tip body smoothly connected to a catheter body, wherein a cavity is axially penetrated in the tip body; Features: A linear reinforcing component (300) with deformation capability is formed in the tip body. The linear reinforcing component (300) is embedded in the tip wall of the tip body and extends from the head of the tip body to the connection position between the tip body and the catheter body to provide support strength and deformation capability to the tip body.

2. The catheter tip according to claim 1, characterized in that: The linear reinforcing component (300) has elasticity.

3. The catheter tip according to claim 2, characterized in that: The linear reinforcing component (300) is a braid or a coil.

4. The catheter tip according to any one of claims 1 to 3, characterized in that: The linear reinforcing component (300) is a spiral structure.

5. The catheter tip according to claim 4, characterized in that: The tip body is sequentially arranged from the head to include a tip portion (100) and a connecting portion (200), and the connecting portion (200) is connected to the catheter body; The inner diameter of the tip portion (100) gradually increases or decreases from the head portion to the connecting portion (200).

6. The catheter tip according to claim 5, characterized in that: The inner diameter of the spiral structure is consistent with the inner diameter of the tip portion (100).

7. The catheter tip according to claim 4, characterized in that: The helical density of the helical structure is arranged to gradually increase or gradually decrease along the axial direction of the catheter tip.

8. A method for forming a catheter tip, used for forming the catheter tip according to claim 1, characterized in that: The following steps are included: Step 1, material preparation: preparation of the linear reinforcement component (300) and polymer materials, and designing and manufacturing a suitable mold; Step 2, preheating the mold: preheating the mold according to the biological characteristics of the polymer material; Step 3, placing materials: positioning the linear reinforcement component (300) into the molding cavity of the mold; Step 4, filling the mold: injecting the molten polymer material into the mold; Step 5, pressurizing: applying pressure to the molding cavity of the mold to ensure that the polymer material completely wraps the linear reinforcing component (300); Step 6, cooling and curing: cooling the mold to room temperature to solidify the polymer material; Step 7, demoulding and post-processing: The molded catheter tip is removed from the mold and the surface of the catheter tip is visually inspected.

9. The method for forming a catheter tip according to claim 8, characterized in that: In step 2, the preheating temperature is 150°C to 200°C.

10. The method for forming a catheter tip according to claim 8, characterized in that: In step 3, a positioning structure is provided in the molding cavity of the mold or on the linear reinforcing component (300) so that the linear reinforcing component (300) is placed at a set position in the molding cavity.

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