Retractable high polymer material developing ring for medical catheter and mounting method thereof

Abstract

The invention discloses a contractile high polymer material developing ring for a medical catheter and an installation method thereof, the contractile high polymer material developing ring comprises an inner layer, a middle layer and an outer layer which are arranged from inside to outside in a joint mode, and an installation space for the catheter to be placed in is formed in the inner layer; the middle layer is made of the blend of the shrinkable high polymer material and the developing heavy metal particles, so that the middle layer has the developing property, the inner layer and the outer layer are made of the shrinkable high polymer material, the manufacturing process is simpler, the production cost is reduced, the production efficiency is improved, and the falling risk is avoided.

Description

Technical Field

[0001] The invention relates to the technical field of medical catheters, in particular to a shrinkable polymer material developing ring for a medical catheter and a mounting method thereof. Background Art

[0002] Medical catheter metal developing rings, also known as marker rings or developing markers, are metal rings or spiral wires embedded in catheters to provide catheter location information under X-ray or other imaging techniques. This metal usually has a high density, such as platinum-iridium alloy, gold, platinum, tungsten or barium-containing polymers, etc. They produce obvious contrast in imaging, allowing doctors to track the position of the catheter in the body in real time, which is crucial for interventional surgery, angiography, catheter insertion and other procedures.

[0003] Currently, metal developing rings for medical catheters have been widely used in a variety of medical catheter products on the market, including but not limited to cardiovascular catheters: used for interventional treatment of cardiovascular vessels, such as coronary angiography, coronary stent implantation, etc.

[0004] Neurovascular catheters: used for diagnosis and treatment of cerebrovascular diseases; Urology catheter: used for interventional treatment of the kidney, bladder and other urinary systems; Digestive tract catheters: used for gastrointestinal diagnosis and treatment, such as endoscopic retrograde cholangiopancreatography (ERCP); Oncology catheters: chemotherapy catheters, radioactive particle implantation catheters, etc. used for cancer treatment.

[0005] Features: High developing property: ensure clear visibility under X-ray; Biocompatibility: The materials used must be harmless to the human body and avoid causing allergic reactions or inflammation; Stability: It maintains its position in the body for a long time and is not easy to fall off or shift; Flexibility: Matches the flexibility of the catheter and does not affect the overall performance of the catheter.

[0006] Although the use of metal rings in medical catheters has greatly improved the safety and effectiveness of surgery, there are also some potential problems: 1. Increased costs: The addition of metal rings will increase the production cost of the catheter, which may be passed on to consumers, leading to higher medical costs; 2. Potential biocompatibility issues: Although most metal materials have good biocompatibility, a very small number of patients may be allergic to certain metal components; 3. Image interference: In some cases, the metal development ring may produce artifacts that affect image quality, especially in non-X-ray imaging techniques such as MRI; 4. Impact on catheter performance: The addition of metal rings may slightly affect the flexibility and maneuverability of the catheter, especially when the catheter needs to pass through complex anatomical pathways; 5. Risk of falling off: Although rare, the metal imaging ring may fall off the catheter and enter the body, causing accidental injury. Summary of the invention

[0007] In order to solve the technical problems existing in the background technology, the present invention provides a shrinkable polymer material developing ring for a medical catheter and a method for installing the same.

[0008] The technical solution adopted by the present invention to solve the technical problem is as follows: A shrinkable polymer material developing ring for a medical catheter comprises an inner layer, an intermediate layer, and an outer layer which are arranged by inner and outer bonding, wherein an installation space for inserting a catheter is formed on the inner layer; The middle layer is made of a blend of shrinkable polymer material and developing heavy metal particles, so that the middle layer has developing properties, and the inner layer and the outer layer are made of shrinkable polymer material.

[0009] Preferably, the inner layer and the outer layer are joined and wrapped around the periphery of the middle layer. Through the above improvements, the inner layer is tightly wrapped around the bottom of the middle layer to form a tight physical bond, and the top of the middle layer is wrapped by the outer layer to also form a physical bond. At the same time, the inner layer and the outer layer are joined so that the middle layer is between the inner and outer layers, ensuring the integrity and stability of the entire structure.

[0010] Preferably, an abutment protrusion that abuts the catheter is formed on the inner layer, and the abutment protrusion extends axially. Through the above improvements, when the developing ring is sleeved on the catheter and heated and shrunk, the abutment protrusion can further increase the friction force with the contact area of ​​the catheter, thereby greatly increasing the reliability of the developing ring installation.

[0011] Preferably, extended protrusions for connecting to the catheter are extended on both sides of the inner layer, and connecting grooves for connecting to the catheter are formed on the extended protrusions. Through the above improvements, the extended protrusions are utilized to increase the axial contact area between the developing ring and the catheter, and the connecting grooves can be used to cooperate with the catheter to improve the stability of the developing ring installation.

[0012] Preferably, a first guide arc surface is formed on the extended protrusion, a second guide arc surface is formed on the connection area between the extended protrusion and the inner layer, and a third guide arc surface is formed on the outer layer. Through the above improvements, the first guide arc surface, the second guide arc surface, and the third guide arc surface are coordinated to increase the smoothness of the catheter during use and reduce the risk of the developing ring falling off.

[0013] Preferably, the polymer material of the middle layer is TPU material, and the developing heavy metal particles are tungsten powder. Through the above improvements, the tungsten powder provides a developing effect, making the catheter visible under X-rays, and the polymer material is used to ensure biocompatibility and flexibility.

[0014] Preferably, the inner layer, the middle layer, and the outer layer are extruded simultaneously using a multi-cavity extrusion device. Through the above improvement, a multi-cavity extruder is used to extrude the inner layer, the middle layer, and the outer layer materials simultaneously to form an integrated "sandwich" structure developing ring, which can not only ensure the developing effect, but also ensure biocompatibility and flexibility.

[0015] A method for installing a developing ring comprises the following steps: S1 assembly: placing the developing ring sleeve in an uncontracted state at a predetermined position of the catheter; S2 Heating: Using a heating device, the developing ring is heated so that the polymer material shrinks in response to temperature changes; S3 shrinkage and fixation: As the temperature rises, the developing ring gradually shrinks and tightly wraps around the outer circumference of the catheter, so that the developing ring is fixed on the catheter; S4 Cooling: After the developing ring is cooled, it maintains its contracted state and forms a close physical connection with the catheter.

[0016] Preferably, extended protrusions for connecting to the conduit are extended on both sides of the inner layer, and connecting grooves for connecting to the conduit are formed on the extended protrusions, and connecting holes arranged opposite to the connecting grooves are formed on the conduit. Through the above improvements, the extended protrusions can be utilized to increase the contact area with the conduit, thereby improving the reliability of the development ring installation.

[0017] Preferably, after S4, step S5 is also included: perfusion connection, in which a certain amount of polymer material is injected into the connecting groove, and the polymer material flows into the connecting hole through the connecting groove. After the polymer material solidifies, the polymer material connects the extended protrusion with the catheter. Through the above improvements, the polymer material can be injected into the connecting groove, and the polymer material flows into the connecting hole through the connecting groove. After the polymer material solidifies, the connection between the developing ring and the catheter is achieved, thereby ensuring the reliability of the connection.

[0018] Compared with the prior art, the present invention has the following advantages and beneficial effects: By using a blend of shrinkable polymer material and developing heavy metal particles as the material of the middle layer, and using the shrinkable polymer material as the material of the inner layer and the outer layer, the inner layer, the middle layer, and the outer layer are joined in sequence from the inside to the outside, thereby forming a shrinkable developing ring with a developing effect. Compared with conventional developing rings, allergic reactions can be reduced, the manufacturing process is simpler, production costs are reduced, and production efficiency is improved. In addition, the developing ring made of polymer material can maintain long-term stability and reliability in the in vivo environment, will not lose developing performance due to corrosion or wear, and avoids the risk of falling off. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the overall structure of the first embodiment of the present invention; Figure 2 It is an axial projection view of the entire embodiment 1 of the present invention; Figure 3 It is a cross-sectional view of the overall structure of the first embodiment of the present invention; Figure 4 It is a structural schematic diagram of the development ring installation of the first embodiment of the present invention; Figure 5 It is a structural schematic diagram of Embodiment 2 of the present invention; Figure 6 This is a schematic diagram of the structure of Embodiment 3 of the present invention; In the figure: 1. inner layer; 2. middle layer; 3. outer layer; 4. installation space; 5. abutment protrusion; 6. extension protrusion; 7. connection groove; 8. conduit; 1.1. first guide arc surface; 1.2. second guide arc surface; 1.3. third guide arc surface; 1.4. connection hole. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] It should be understood that although the terms upper, middle, lower, top, end, etc. appear in this article to describe various elements, these elements are not limited by these terms. These terms are only used to distinguish elements from each other for easy understanding, and are not used to define any direction or order limitation.

[0022] Embodiment 1: Figure 1-4As shown, a shrinkable polymer developing ring for a medical catheter comprises an inner layer 1, an intermediate layer 2, and an outer layer 3 which are arranged by inner and outer bonding. An installation space 4 for inserting a catheter 8 is formed on the inner layer 1. The developing ring is sleeved on the catheter 8, and the catheter 8 is inserted into the installation space 4. The developing ring is fixed on the catheter 8 after heat shrinkage.

[0023] Specifically, the middle layer 2 adopts a blend of shrinkable polymer materials and developing heavy metal particles to make the middle layer 2 have developing properties, and the inner layer 1 and the outer layer 3 adopt shrinkable polymer materials. The inner layer 1, the middle layer 2, and the outer layer 3 are joined to form a shrinkable developing ring with a developing effect.

[0024] Compared with conventional developing rings, it has the following advantages: 1. Reduce allergic reactions: polymer materials generally have good biocompatibility, which means they are less likely to cause allergic reactions or inflammation in patients, compared to some metal materials, such as nickel, which may cause allergies in a small number of people; 2. Reduce the risk of metal toxicity: Avoid direct contact between the human body and metal materials, thereby reducing potential metal ion release and metal toxicity problems; 3. Low-cost manufacturing: The developer ring made of polymer materials can be mass-produced through simple processes such as extrusion molding, and the processing cost is lower than that of metal rings; 4. Reduce material waste: polymer materials are usually easy to process, and waste materials generated during the production process can be recycled and reused, further reducing costs; 5. Better maneuverability: The softness of the polymer material developing ring is closer to the material of the catheter 8 itself, which helps to improve the overall flexibility and maneuverability of the catheter 8, making the catheter 8 easier to manipulate in complex anatomical pathways; 6. Improvement of gyroscopic effect: The polymer material developing ring and the catheter 8 are more integrated, which can significantly reduce the gyroscopic effect of the catheter 8 during transportation and improve the positioning accuracy; 7. Optimize the development effect: By precisely controlling the content and distribution of heavy metal particles in polymer materials, the development effect can be optimized to ensure sufficient contrast under various imaging techniques without generating excessive artifacts or affecting image quality; 8. Simplified manufacturing process: The manufacturing and assembly process of polymer developer rings is simpler and does not require complicated metal processing steps such as cutting, welding or grinding, which not only reduces production costs but also improves production efficiency; 9. Long-term stability: The developing ring made of polymer materials can maintain long-term stability and reliability in the in vivo environment and will not lose its developing performance due to corrosion or wear; 10. Reduce the risk of falling off: The heat shrinkage property allows the developing ring to be more firmly attached to the guide tube 8, reducing the risk of falling off during use.

[0025] For example, the polymer material of the middle layer 2 is TPU, and the developing heavy metal particles are tungsten powder. The tungsten powder and TPU material are mixed through extrusion molding to form a uniform blend. The tungsten powder provides a developing effect, making the catheter 8 visible under X-rays, and the polymer material is used to ensure biocompatibility and flexibility.

[0026] Furthermore, the inner layer 1, the middle layer 2, and the outer layer 3 are extruded synchronously by a multi-cavity extrusion device to form an integrated "sandwich" structure developing ring, which can not only ensure the developing effect, but also ensure the biocompatibility and flexibility.

[0027] like Figure 4 As shown, as a further explanation of the development ring installation, the following steps are included: S1: assembling: placing the developing ring sleeve in an uncontracted state at a predetermined position of the guide tube 8; S2 Heating: Use a heating device (such as a heat gun, infrared lamp or hot water bath) to heat the developing ring so that the polymer material shrinks in response to temperature changes; S3 shrinkage and fixing: as the temperature rises, the developing ring gradually shrinks and tightly wraps around the guide tube 8, so that the developing ring is fixed on the guide tube 8; S4 Cooling: After the developing ring is cooled, it maintains its contracted state and forms a close physical connection with the guide tube 8.

[0028] In some other embodiments, extended protrusions 6 for connecting to the conduit 8 are extended on both sides of the inner layer 1, and connecting grooves 7 for connecting to the conduit 8 are formed on the extended protrusions 6. Connecting holes 1.4 arranged opposite to the connecting grooves 7 are formed on the conduit 8. The extended protrusions 6 can be used to increase the contact area with the conduit 8 to improve the reliability of the development ring installation.

[0029] Specifically, after S4, step S5 is also included: perfusion connection, injecting a certain amount of polymer material into the connecting groove 7, the polymer material flows into the connecting hole 1.4 through the connecting groove 7, and after the polymer material solidifies, the polymer material connects the extension protrusion 6 with the conduit 8, thereby realizing the connection between the extension protrusion 6 and the conduit 8, thereby further improving the reliability of the development ring installation.

[0030] Preferably, after cooling is completed, it is necessary to check and confirm that the developing ring is firmly fixed on the guide tube 8 to ensure that there is no twisting or looseness, so as to ensure the reliability of the installation.

[0031] Preferably, a first guiding arc surface 1.1 is formed on the extended protrusion 6, a second guiding arc surface 1.2 is formed on the connecting area between the extended protrusion 6 and the inner layer 1, and a third guiding arc surface 1.3 is formed on the outer layer 3. The first guiding arc surface 1.1, the second guiding arc surface 1.2, and the third guiding arc surface 1.3 are coordinated to increase the smoothness of the catheter 8 during use and reduce the risk of the developing ring falling off.

[0032] Embodiment 2: Figure 5 As shown, the difference between this embodiment and embodiment 1 lies in that, among the inner layer 1, the middle layer 2, and the outer layer 3, the inner layer 1 and the outer layer 3 are joined and wrapped around the periphery of the middle layer 2, thereby completely isolating the middle layer 2 and preventing the middle layer 2 from directly contacting the human body, thereby reducing potential metal ion release and metal toxicity problems.

[0033] Specifically, the inner layer 1 is tightly wrapped around the bottom of the middle layer 2 to form a tight physical bond, and the top of the middle layer 2 is wrapped by the outer layer 3 to also form a physical bond. At the same time, the inner layer 1 and the outer layer 3 are bonded so that the middle layer 2 is between the inner and outer layers 3, ensuring the integrity and stability of the entire structure.

[0034] Embodiment 3: Figure 6 As shown, the difference between this embodiment and the first embodiment is that an abutting protrusion 5 abutting the catheter 8 is formed on the inner layer 1, and the abutting protrusion 5 extends axially. When the developing ring is sleeved on the catheter 8 and heated and shrunk, the abutting protrusion 5 can further increase the friction force of the contact area with the catheter 8, thereby greatly increasing the reliability of the developing ring installation.

[0035] Preferably, a plurality of notches may be provided on the abutting protrusion 5, so that a plurality of abutting protrusions are formed on the abutting protrusion 5, further increasing the reliability of the installation of the developing ring.

[0036] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. A shrinkable polymer material developing ring for medical catheters, characterized in that: It comprises an inner layer (1), an intermediate layer (2), and an outer layer (3) which are arranged by inner and outer bonding, and an installation space (4) for placing a catheter (8) is formed on the inner layer (1); The middle layer (2) is made of a blend of shrinkable polymer material and developing heavy metal particles, so that the middle layer (2) has developing properties, and the inner layer (1) and the outer layer (3) are made of shrinkable polymer material.

2. The shrinkable polymer material developing ring for medical catheter according to claim 1, characterized in that: The inner layer (1) and the outer layer (3) are joined and wrapped around the outer periphery of the middle layer (2).

3. The shrinkable polymer material developing ring for medical catheter according to claim 1, characterized in that: The inner layer (1) is provided with an abutting protrusion (5) abutting against the catheter (8), and the abutting protrusion (5) extends in the axial direction.

4. The shrinkable polymer material developing ring for medical catheter according to claim 1, characterized in that: Extended protrusions (6) for connecting to the conduit (8) are extended on both sides of the inner layer (1), and connecting grooves (7) for connecting to the conduit (8) are formed on the extended protrusions (6).

5. The shrinkable polymer material developing ring for medical catheter according to claim 4, characterized in that: A first guiding arc surface (1.1) is formed on the extended protrusion (6), a second guiding arc surface (1.2) is formed on the connection area between the extended protrusion (6) and the inner layer (1), and a third guiding arc surface (1.3) is formed on the outer layer (3).

6. The shrinkable polymer material developing ring for medical catheter according to claim 1, characterized in that: The polymer material of the intermediate layer (2) is TPU material, and the developing heavy metal particles are tungsten powder.

7. The shrinkable polymer material developing ring for medical catheter according to claim 1, characterized in that: The inner layer (1), the middle layer (2), and the outer layer (3) are extruded synchronously using a multi-cavity extrusion device.

8. A method for installing a developing ring, comprising the shrinkable polymer developing ring for a medical catheter as claimed in any one of claims 1 to 7, characterized in that: The following steps are involved: S1: assembling: placing the developing ring sleeve in an uncontracted state at a predetermined position of the guide tube (8); S2 Heating: Using a heating device, the developing ring is heated so that the polymer material shrinks in response to temperature changes; S3 shrinkage and fixation: as the temperature rises, the developing ring gradually shrinks and tightly wraps around the outer circumference of the conduit (8), so that the developing ring is fixed on the conduit (8); S4 Cooling: After the developing ring is cooled, it maintains its contracted state and forms a close physical connection with the guide tube (8).

9. A method for installing a developing ring according to claim 8, characterized in that: Extended protrusions (6) for connecting to the conduit (8) are extended on both sides of the inner layer (1), and connecting grooves (7) for connecting to the conduit (8) are formed on the extended protrusions (6), and connecting holes (1.4) arranged opposite to the connecting grooves (7) are formed on the conduit (8).

10. The method for installing a developing ring according to claim 8, characterized in that: After S4, step S5 is also included: perfusion connection, in which a certain amount of polymer material is injected into the connection groove (7), and the polymer material flows into the connection hole (1.4) through the connection groove (7). After the polymer material solidifies, the polymer material connects the extension protrusion (6) and the catheter (8).

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