Shrinkable Polymer Material Imaging Ring for Medical Catheter and Its Installation Method

Abstract

The present invention discloses a shrinkable polymer material imaging ring for a medical catheter and its installation method, which includes an inner layer, an intermediate layer, and an outer layer that are arranged in an inner and outer connection manner. An installation space for inserting the catheter is formed on the inner layer; the intermediate layer is made of a blend of a shrinkable polymer material and imaging heavy metal particles, so that the intermediate layer has imaging properties, and the inner layer and the outer layer are made of a shrinkable polymer material. The manufacturing process is simpler, the production cost is reduced, the production efficiency is improved, and the risk of detachment is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical catheters, and particularly to a contractible polymer material imaging ring for medical catheters and its installation method. Background Art

[0002] The metal imaging ring of a medical catheter, also known as a marker ring or imaging marker, is a metal ring or helix embedded in the catheter for providing the position information of the catheter under X-ray or other imaging techniques. This kind of metal usually has a high density, such as platinum-iridium alloy, gold, platinum, tungsten or barium-containing polymer, etc. They produce obvious contrast in imaging, enabling doctors to track the position of the catheter in the body in real time, which is crucial for procedures such as interventional surgery, angiography, catheterization, etc.

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

[0004] Neurovascular catheters: for the diagnosis and treatment of cerebrovascular diseases;

[0005] Urological catheters: for interventional treatment of the urinary system such as the kidneys and bladder;

[0006] Digestive tract catheters: for the diagnosis and treatment of the gastrointestinal tract, such as endoscopic retrograde cholangiopancreatography (ERCP);

[0007] Oncology catheters: for chemotherapy catheters, radioactive seed implantation catheters, etc. in cancer treatment.

[0008] Product Features:

[0009] High imaging property: Ensure clear visibility under X-ray;

[0010] Biocompatibility: The materials used must be harmless to the human body to avoid causing allergic reactions or inflammation;

[0011] Stability: Maintain the position unchanged in the body for a long time, and it is not easy to fall off or shift;

[0012] Flexibility: Match the flexibility of the catheter without affecting the overall performance of the catheter.

[0013] Although the application of metal imaging rings in medical catheters has greatly improved the safety and effectiveness of surgeries, there are also some potential problems:

[0014] 1. Cost increase: The addition of metal imaging rings will increase the production cost of catheters, which may be passed on to consumers, resulting in an increase in medical expenses;

[0015] 2. Potential biocompatibility issues: Although most metal materials have good biocompatibility, a very small number of patients may be allergic to certain metal components;

[0016] 3. Image interference: In some cases, the metal imaging ring may generate artifacts, affecting image quality, especially in non-X-ray imaging technologies such as MRI;

[0017] 4. Influence on catheter performance: The addition of the metal ring may slightly affect the flexibility and maneuverability of the catheter, especially when the catheter needs to pass through complex anatomical paths;

[0018] 5. Risk of detachment: Although rare, the metal imaging ring has the potential to detach from the catheter and enter the body, causing accidental injury. Summary of the Invention

[0019] To solve the technical problems existing in the background art, the present invention proposes a shrinkable polymer material imaging ring for medical catheters and its installation method.

[0020] The technical solutions adopted by the present invention to solve its technical problems are as follows:

[0021] The shrinkable polymer material imaging ring for medical catheters includes an inner layer, a middle layer, and an outer layer that are internally and externally joined. An installation space for the catheter to be inserted is formed on the inner layer;

[0022] The middle layer is a blend of a shrinkable polymer material and imaging heavy metal particles, so that the middle layer has imaging properties, and the inner layer and the outer layer are made of shrinkable polymer materials.

[0023] Preferably, the inner layer and the outer layer are joined and wrapped around the outer periphery of the middle layer. Through the above improvement, the inner layer tightly wraps around the bottom of the middle layer, forming a tight physical joint, and the top of the middle layer is wrapped by the outer layer, also forming a physical joint. 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.

[0024] Preferably, a contact convex portion for abutting against the catheter is formed on the inner layer, and the contact convex portion extends axially. Through the above improvement, after the imaging ring is sleeved on the catheter and heated and shrunk, the contact convex portion can further increase the friction force in the contact area with the catheter, thereby greatly increasing the reliability of the installation of the imaging ring.

[0025] Preferably, extension convex portions for connecting the catheter extend from both sides of the inner layer, and connection grooves for connecting the catheter are formed on the extension convex portions. Through the above improvement, the extension convex portions are used to increase the axial contact area between the imaging ring and the catheter, and the connection can be made with the catheter through the connection grooves to improve the stability of the installation of the imaging ring.

[0026] Preferably, a first guiding arc surface is formed on the extending convex portion, a second guiding arc surface is formed in the connection area between the extending convex portion and the inner layer, and a third guiding arc surface is formed on the outer layer. Through the above improvements, by cooperating with the first guiding arc surface, the second guiding arc surface, and the third guiding arc surface, the smoothness of the catheter during use is increased, and at the same time, the risk of the imaging ring falling off is reduced.

[0027] Preferably, the polymer material of the intermediate layer is TPU material, and the imaging heavy metal particles are tungsten powder. Through the above improvements, the tungsten powder provides an imaging effect, making the catheter visible under X-rays, and using the polymer material to ensure biocompatibility and flexibility.

[0028] Preferably, the inner layer, the intermediate layer, and the outer layer are synchronously extruded by a multi-cavity extrusion device. Through the above improvements, a multi-cavity extruder is used to simultaneously extrude the inner layer, the intermediate layer, and the outer layer materials to form an integrated "sandwich" structure imaging ring, which can not only ensure the imaging effect but also ensure biocompatibility and flexibility.

[0029] An installation method of an imaging ring includes the following steps:

[0030] S1 Assembly: Sleeving the imaging ring in the unshrunk state on a predetermined position of the catheter;

[0031] S2 Heating: Using a heating device to heat the imaging ring so that the polymer material shrinks in response to the temperature change;

[0032] S3 Shrinking and fixing: As the temperature rises, the imaging ring gradually shrinks and tightly wraps around the outer periphery of the catheter to fix the imaging ring on the catheter;

[0033] S4 Cooling: After the imaging ring cools down, it maintains its shrunk state and forms a tight physical bond with the catheter.

[0034] Preferably, extending convex portions for connecting the catheter extend from both sides of the inner layer, and connection grooves for connecting the catheter are formed on the extending convex portions. Connection holes opposite to the connection grooves are formed on the catheter. Through the above improvements, the extending convex portions can increase the contact area with the catheter to improve the reliability of the installation of the imaging ring.

[0035] Preferably, after S4, there is also a step S5: perfusion connection. A quantitative polymer material is injected into the connection groove. The polymer material flows into the connection hole through the connection groove. After the polymer material solidifies, the polymer material connects the extending convex portion and the catheter. Through the above improvements, the polymer material can be injected into the connection groove, and the polymer material flows into the connection hole through the connection groove. After the polymer material solidifies, the connection between the imaging ring and the catheter is realized, ensuring the reliability of the connection.

[0036] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0037] By using a blend of a shrinkable polymer material and a developer heavy metal particle as the material for the intermediate layer, and the shrinkable polymer material as the material for the inner layer and the outer layer, the inner layer, the intermediate layer, and the outer layer are sequentially joined from the inside out, thereby forming a developable and shrinkable developing ring with a developing effect. Compared with the conventional developing ring, it can reduce allergic reactions, the manufacturing process is simpler, the production cost is reduced, and the 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 its developing performance due to corrosion or wear, and avoids the risk of detachment. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic structural diagram of the whole of the first embodiment of the present invention;

[0039] Figure 2 It is an axially projected view of the whole of the first embodiment of the present invention;

[0040] Figure 3 It is a cross-sectional view of the whole structure of the first embodiment of the present invention;

[0041] Figure 4 It is a schematic structural diagram of the installation of the developing ring of the first embodiment of the present invention;

[0042] Figure 5 It is a schematic structural diagram of the second embodiment of the present invention;

[0043] Figure 6 It is a schematic structural diagram of the third embodiment of the present invention;

[0044] In the figure: 1, inner layer; 2, intermediate layer; 3, outer layer; 4, installation space; 5, abutting convex portion; 6, extending convex portion; 7, connecting groove; 8, catheter; 1.1, first guiding arc surface; 1.2, second guiding arc surface; 1.3, third guiding arc surface; 1.4, connecting hole. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0045] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0046] It should be understood that although terms such as upper, middle, lower, top, one end, etc. appear in this text to describe various components, these components are not limited by these terms. These terms are only used to distinguish the components from each other for easy understanding, rather than to define any directional or sequential limitations.

[0047] Example 1: As Figure 1-4 shown, the shrinkable polymer material imaging ring for medical catheter includes an inner layer 1, a middle layer 2, and an outer layer 3 which are arranged with internal and external joints. An installation space 4 for inserting the catheter 8 is formed on the inner layer 1. The imaging ring is sleeved on the catheter 8, and the catheter 8 is inserted into the installation space 4. After heat shrinking, the imaging ring is fixed on the catheter 8.

[0048] Specifically, the middle layer 2 adopts a blend of a shrinkable polymer material and imaging heavy metal particles, so that the middle layer 2 has imaging 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 imaging ring with imaging effect.

[0049] Compared with the conventional imaging ring, it has the following advantages:

[0050] 1. Reducing allergic reactions: Polymer materials usually have good biocompatibility, which means they are less likely to cause allergic reactions or inflammation in patients. Compared with some metal materials, such as nickel, which may cause allergies in a small number of people;

[0051] 2. Reducing the risk of metal toxicity: Avoiding direct contact between the human body and metal materials, thus reducing potential metal ion release and metal toxicity problems;

[0052] 3. Low-cost manufacturing: The imaging ring made of polymer materials can be mass-produced by simple processes such as extrusion molding, with lower processing costs compared to metal rings;

[0053] 4. Reducing material waste: Polymer materials usually have good processability, and the waste generated during the production process can be recycled and reused, further reducing costs;

[0054] 5. Stronger maneuverability: The softness of the polymer material imaging 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 paths;

[0055] 6. Improving the gyroscopic effect: The imaging ring made of polymer materials has a higher integration with the catheter 8, which can significantly reduce the gyroscopic effect of the catheter 8 during transportation and improve the positioning accuracy;

[0056] 7. Optimize the development effect: By precisely controlling the content and distribution of development heavy metal particles in the polymer material, the development effect can be optimized to ensure sufficient contrast under various imaging techniques without generating excessive artifacts or affecting image quality;

[0057] 8. Simplify the manufacturing process: The manufacturing and assembly process of the polymer development ring is simpler and does not require complex metal processing steps such as cutting, welding, or grinding. This not only reduces production costs but also improves production efficiency;

[0058] 9. Long-term stability: The development ring made of polymer material can maintain long-term stability and reliability in the in-vivo environment and will not lose its development performance due to corrosion or wear;

[0059] 10. Reduce the risk of detachment: The heat-shrinkable property enables the development ring to adhere more firmly to the catheter 8, reducing the risk of detachment during use.

[0060] For example, the polymer material of the intermediate layer 2 is TPU, and the development heavy metal particles are tungsten powder. Through extrusion molding, the tungsten powder and the TPU material are mixed to form a uniform blend. The tungsten powder provides the development effect, making the catheter 8 visible under X-rays, and the polymer material is used to ensure biocompatibility and flexibility.

[0061] Furthermore, the inner layer 1, the intermediate layer 2, and the outer layer 3 are synchronously extruded using a multi-layer extrusion device to form an integrated "sandwich" structure development ring, which can not only ensure the development effect but also ensure biocompatibility and flexibility.

[0062] As Figure 4 shown, for further explanation of the installation of the development ring, the following steps are included:

[0063] S1 Assembly: Set the unshrunk development ring on the predetermined position of the catheter 8;

[0064] S2 Heating: Use a heating device (such as a hot air gun, an infrared lamp, or a hot water bath) to heat the development ring so that the polymer material shrinks in response to the temperature change;

[0065] S3 Shrinkage fixation: As the temperature rises, the development ring gradually shrinks and tightly wraps around the catheter 8 to fix the development ring on the catheter 8;

[0066] S4 Cooling: After the development ring cools down, it maintains its shrunk state and forms a tight physical bond with the catheter 8.

[0067] In some other embodiments, extension protrusions 6 for connecting the catheter 8 extend on both sides of the inner layer 1, and connection grooves 7 for connecting the catheter 8 are formed on the extension protrusions 6. Connection holes 1.4 are formed on the catheter 8 and are arranged opposite to the connection grooves 7. The use of the extension protrusions 6 can increase the contact area with the catheter 8 to improve the reliability of the installation of the imaging ring.

[0068] Specifically, after S4, there is also step S5: perfusion connection. A quantitative polymer material is injected into the connection groove 7. 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, realizing the joint of the extension protrusion 6 and the catheter 8, thereby further improving the reliability of the installation of the imaging ring.

[0069] Preferably, after cooling is completed, it is necessary to check and confirm that the imaging ring is firmly fixed on the catheter 8 to ensure that there is no twisting or loosening to ensure the reliability of the installation.

[0070] Preferably, a first guiding arc surface 1.1 is formed on the extension protrusion 6, a second guiding arc surface 1.2 is formed in the connection area between the extension protrusion 6 and the inner layer 1, and a third guiding arc surface 1.3 is formed on the outer layer 3. The cooperation of the first guiding arc surface 1.1, the second guiding arc surface 1.2, and the third guiding arc surface 1.3 increases the smoothness of the catheter 8 during use and reduces the risk of the imaging ring falling off at the same time.

[0071] Embodiment 2: As Figure 5 shown, the difference between this embodiment and Embodiment 1 is that for the inner layer 1, the intermediate layer 2, and the outer layer 3, the inner layer 1 and the outer layer 3 are joined and wrap around the outer periphery of the intermediate layer 2, thus completely isolating the intermediate layer 2 and preventing the intermediate layer 2 from directly contacting the human body, thereby reducing potential metal ion release and metal toxicity problems.

[0072] Specifically, the inner layer 1 tightly wraps around the bottom of the intermediate layer 2 to form a tight physical joint, and the top of the intermediate layer 2 is wrapped by the outer layer 3 to also form a physical joint. At the same time, the inner layer 1 and the outer layer 3 are joined, placing the intermediate layer 2 between the inner and outer layers 1 and 3, ensuring the integrity and stability of the entire structure.

[0073] Embodiment 3: As Figure 6 shown, the difference between this embodiment and Embodiment 1 is that an abutting protrusion 5 for abutting against the catheter 8 is formed on the inner layer 1, and the abutting protrusion 5 extends axially. After the imaging ring is sleeved on the catheter 8 and heated and shrunk, the abutting protrusion 5 can further increase the friction force in the contact area with the catheter 8, thereby greatly increasing the reliability of the installation of the imaging ring.

[0074] Preferably, a plurality of notches may be provided on the abutting convex portion 5, so that a plurality of abutting convex points are formed on the abutting convex portion 5, further increasing the reliability of the development ring installation.

[0075] This specific embodiment is only an interpretation of the present invention, and it is not a limitation of the present invention. After reading this specification, those skilled in the art can make modifications to this embodiment that do not contribute creatively as needed, but 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), a middle layer (2), and an outer layer (3) which are connected from the inside to the outside, and an installation space (4) for placing a catheter (8) is formed on the inner layer (1); The intermediate layer (2) is made of a blend of a polymer material that can shrink thermally and maintain shrinkage after cooling and developing heavy metal particles, so that the intermediate layer (2) has developability, and the inner layer (1) and the outer layer (3) are made of a polymer material that can shrink thermally and maintain shrinkage after cooling.

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 respectively joined and coated on the middle layer (2), and the inner layer (1) is tightly wrapped around the bottom of the middle layer (2), and the top of the middle layer (2) is wrapped by the outer layer (3).

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.

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