Variable-rigidity vascular intervention catheter and manufacturing method therefor

Abstract

A variable-rigidity vascular intervention catheter and a manufacturing method therefor. The variable-rigidity vascular intervention catheter comprises an outer-layer guide tube and an inner-layer guide tube, a working channel being formed inside the inner-layer guide tube, and a low-melting-point alloy having a melting point of 43-45°C being sealed between the outer-layer guide tube and the inner-layer guide tube. The rigidity of the variable-rigidity vascular intervention catheter can be adjusted by means of injecting into the working channel normal saline having different temperatures, so as to adapt to different operations during surgeries, thus facilitating normal operation of surgeries.

Description

A variable stiffness vascular intervention catheter and its manufacturing method Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a variable-rigidity vascular intervention catheter and a manufacturing method thereof. Background Art

[0002] Vascular catheters are tools used for medical diagnosis and treatment by placing flexible tubes inside the human body. These catheters are usually soft and flexible and can be inserted into the patient's vascular system for manipulation. The use of vascular catheters can reduce trauma, increase surgical precision, and shorten patient recovery time. The following are some common uses of vascular catheters:

[0003] Angioplasty: A vascular interventional catheter can be used to treat narrowed or blocked arteries, commonly in the treatment of coronary artery disease and peripheral artery disease. The catheter carries a balloon that, when it reaches the narrowed area, is inflated, helping to dilate the vessel and increase blood flow.

[0004] Stent implantation: In cases of vascular stenosis, a stent can be placed at the narrowed area to maintain the patency of the blood vessel. The stent is carried by a catheter, and once the catheter reaches the narrowed area, the stent deploys and stabilizes within the blood vessel, preventing reocclusion.

[0005] Embolization therapy: Vascular interventional catheters are used to treat tumors, vascular malformations, abnormal bleeding, or to dissolve blood clots. Through the catheter, doctors can deliver embolic materials (such as tiny particles or coils) into abnormal blood vessels to block blood flow, or deliver dissolving drugs into the blood vessels to dissolve blood clots and restore blood flow.

[0006] Minimally invasive surgery using vascular interventional catheters offers many advantages. Minimally invasive interventional surgery requires only a small incision or puncture. Compared to traditional open surgery, patients experience smaller wounds, less tissue damage and bleeding, less surgical trauma, less pain and discomfort, and a shorter recovery time. Due to the smaller incisions, minimally invasive interventional surgery has a lower risk of infection and fewer postoperative complications. It only requires local anesthesia or mild general anesthesia, reducing the use of anesthesia and its associated risks compared to larger open surgeries. In recent decades, minimally invasive vascular interventional surgery has developed rapidly and has become one of the main clinical methods for treating vascular diseases.

[0007] However, current vascular intervention catheters are usually rigid or soft, which is not convenient for surgical operation.

[0008] Summary of the Invention

[0009] In order to solve the defect that the existing catheter is inconvenient for the normal operation, the present invention proposes a variable stiffness vascular intervention catheter and a manufacturing method thereof, which can change the stiffness of the catheter during the operation to facilitate the operation.

[0010] The present invention proposes a variable stiffness vascular intervention catheter, comprising an outer catheter and an inner catheter, wherein a working channel is formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter.

[0011] Preferably, the inner layer conduit is arranged inside the outer layer conduit, and the inner layer conduit and the outer layer conduit have the same center.

[0012] Preferably, the inner diameter of the inner tube is 1 mm and the outer diameter is 1.6 mm; the inner diameter of the outer tube is 2.4 mm and the outer diameter is 3 mm, and the average gap between the inner and outer tubes is 0.4 mm.

[0013] Preferably, the low melting point alloy is a bismuth-indium-lead-tin-cadmium alloy.

[0014] Preferably, the proportions of each element in the low-melting-point alloy are: bismuth accounts for 45%, indium accounts for 19%, lead accounts for 23%, tin accounts for 8%, and cadmium accounts for 5%.

[0015] Preferably, the variable stiffness vascular intervention catheter includes a soft state and a rigid state. The variable stiffness vascular intervention catheter includes a soft state, a rigid state and an intermediate state. The soft state is formed by injecting physiological saline with a temperature of 45 degrees or above into the working channel. The rigid state is formed by injecting physiological saline with a temperature of 43 degrees or below into the working channel. The intermediate state is a state in which the stiffness is between the soft state and the rigid state. The intermediate state is formed by adjusting the temperature of the physiological saline injected into the working channel.

[0016] The present invention also proposes a method for manufacturing a variable stiffness vascular intervention catheter, comprising: inserting an inner catheter into an outer catheter; sealing a first end of the interlayer between the outer catheter and the inner catheter using a silicone sealant; heating a low-melting-point alloy with a melting point of 43-45 degrees in a water bath until it is liquid; injecting the liquid low-melting-point alloy into the interlayer between the outer catheter and the inner catheter; and sealing a second end of the interlayer between the outer catheter and the inner catheter using a silicone sealant.

[0017] The present invention also proposes a variable stiffness vascular intervention catheter, comprising at least two catheter segments, each catheter segment comprising an outer catheter and an inner catheter, a working channel formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees sealed between the outer catheter and the inner catheter; the melting point of the low-melting-point alloy of each catheter segment is different.

[0018] The present invention also proposes a variable stiffness vascular intervention catheter, comprising a first catheter and a second catheter, wherein the first catheter comprises an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the second catheter comprises a catheter in a rigid state.

[0019] The present invention also proposes a variable stiffness vascular intervention catheter, comprising a first catheter and a second catheter, wherein the first catheter comprises an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the second catheter comprises a catheter in a soft state.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] In existing solutions, catheters with excessive rigidity may cause trauma to the vascular endothelium when traversing curved or narrow blood vessels, leading to bleeding, hematoma, vascular damage, spasm, etc. Catheters with insufficient rigidity may bend when passing through bends in blood vessels and be unable to pass smoothly, and the working channel inside the catheter may be deformed or blocked, thereby affecting the normal progress of the surgery. In other words, the rigidity of existing single vascular intervention catheters cannot adapt to the anatomical structure and pathological conditions of the blood vessels. It can be seen that vascular intervention catheters in existing solutions are usually rigid or soft, which makes surgical operations inconvenient. The solution of this application proposes a variable rigidity vascular intervention catheter, which includes an outer catheter and an inner catheter, with a working channel formed in the middle of the inner catheter. A low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer and inner catheters. In this solution, a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer and inner catheters. The rigidity of the catheter can be adjusted by injecting saline solutions of different temperatures into the working channel, thereby adapting to different operations during the surgery and facilitating the normal progress of the surgery. For example, physiological saline with a temperature of 45 degrees or above can be injected into the working channel to convert the low-melting-point alloy in the variable stiffness vascular interventional catheter into a liquid state, thereby making the variable stiffness vascular interventional catheter soft, so that the catheter will not cause trauma to the vascular endothelium when passing through curved or narrow blood vessels, thereby facilitating the operation. Physiological saline with a temperature of 43 degrees or below can also be injected into the working channel to convert the low-melting-point alloy in the variable stiffness vascular interventional catheter into a solid state, thereby making the variable stiffness vascular interventional catheter soft; so that the catheter can pass smoothly through the bends in the blood vessels, and the working channel inside the catheter will not be squeezed, deformed or blocked, thereby facilitating the normal operation. The stiffness of the catheter can also be adjusted by continuously adjusting the temperature of the physiological saline injected into the working channel to make the catheter adapt to different needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention is described in detail below with reference to the embodiments and accompanying drawings, in which:

[0023] FIG1 is a schematic structural diagram of a variable stiffness vascular intervention catheter;

[0024] FIG2 is a schematic diagram showing the change in stiffness of a variable stiffness vascular intervention catheter at different temperatures;

[0025] FIG3 is a schematic diagram of a method for manufacturing a variable stiffness vascular intervention catheter. DETAILED DESCRIPTION

[0026] To make the objectives, technical solutions, and advantages of the present invention more apparent, embodiments of the present invention will be described in further detail below with reference to the accompanying drawings. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar components or components having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0027] In existing solutions, catheters with excessive rigidity may cause trauma to the vascular endothelium when passing through curved or narrow blood vessels, leading to bleeding, hematoma or vascular damage, spasm, etc. Catheters with too little rigidity may bend when passing through the bends of the blood vessels and may not pass smoothly, and the working channel inside the catheter may be deformed or blocked, thereby affecting the normal progress of the operation. That is, the rigidity of the existing single vascular intervention catheter cannot adapt to the anatomical structure and pathological conditions of the blood vessels. It can be seen that the vascular intervention catheters in existing solutions are usually rigid or soft, which is not convenient for the normal progress of the operation.

[0028] The present invention proposes a variable stiffness vascular interventional catheter, as shown in Figure 1 . The catheter comprises an outer catheter and an inner catheter, with a working channel formed in the middle of the inner catheter. A low-melting-point alloy with a melting point of 43-45°C is sealed between the outer and inner catheters. Specifically, as an optional embodiment, the inner catheter is disposed within the outer catheter, with the inner and outer catheters centered at the same center. The centers of the inner and outer catheters may also differ, depending on specific requirements. Specifically, as an optional embodiment, the inner catheter has an inner diameter of 1 mm and an outer diameter of 1.6 mm; the outer catheter has an inner diameter of 2.4 mm and an outer diameter of 3 mm. The gap between the inner and outer catheters averages 0.4 mm. It should be noted that the above dimensions are only one option for this embodiment; different dimensions can be set as needed to accommodate different types of blood vessels. Furthermore, to prevent the gap between the outer and inner catheters from being too small, a support member can be provided within the interlayer to provide support and prevent the gap from being too small.

[0029] Specifically, as an optional embodiment, the low melting point alloy is a bismuth, indium, lead, tin, and cadmium alloy. Specifically, as an optional embodiment, the proportions of each element in the low melting point alloy are: bismuth (element symbol: Bi) accounts for 45%, indium (element symbol: In) accounts for 19%, lead (element symbol: Pb) accounts for 23%, tin (element symbol: Sn) accounts for 8%, and cadmium (element symbol: Cd) accounts for 5%.

[0030] As the variable stiffness vascular interventional catheter changes state, the state of the variable stiffness vascular interventional catheter can be divided into a soft state, a rigid state, and an intermediate state. Specifically, as an optional embodiment, the variable stiffness vascular interventional catheter includes a soft state, a rigid state, and an intermediate state. The soft state is achieved by injecting saline solution at a temperature of 45 degrees Celsius or above into the working channel. The rigid state is achieved by injecting saline solution at a temperature of 43 degrees Celsius or below into the working channel. The intermediate state is a state with a stiffness between the soft and rigid states, and the intermediate state is achieved by adjusting the temperature of the saline solution injected into the working channel.

[0031] In this solution, a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter. The stiffness of the catheter can be adjusted by injecting physiological saline of different temperatures into the working channel, thereby adapting to different operations during the operation and facilitating the normal progress of the operation. For example, as shown in Figure 2, physiological saline of 43 degrees or below can be injected into the working channel to convert the low-melting-point alloy in the variable stiffness vascular intervention catheter into a solid state, thereby increasing the stiffness of the variable stiffness vascular intervention catheter and making the catheter soft; so that the catheter can pass smoothly through the bends in the blood vessels, and the working channel inside the catheter will not be squeezed, deformed or blocked, thereby facilitating the normal progress of the operation. The stiffness of the catheter can also be adjusted by continuously adjusting the temperature of the physiological saline injected into the working channel to make the catheter adapt to different needs. Physiological saline at a temperature of 45 degrees or above can also be injected into the working channel to convert the low-melting-point alloy in the variable stiffness vascular intervention catheter into a liquid state, thereby reducing the stiffness of the variable stiffness vascular intervention catheter and making the catheter soft. This prevents the catheter from causing trauma to the vascular endothelium when passing through curved or narrow blood vessels, thereby facilitating the operation.

[0032] In addition, in this solution, the thermal conductivity of the inner and outer catheters can be changed by changing the material, thickness and other indicators of the inner and outer catheters, so that when physiological saline of the same temperature is passed through the working channels of different sections of the catheter, the different sections of the catheter have different stiffnesses, which is convenient for adapting to the needs of the operation. For example, the catheter can be divided into five sections, and the thickness of the inner catheter of the second section can be reduced, so that the low-melting-point alloy corresponding to the second section of the catheter softens faster, making it easier for the second section of the catheter to bend to change the direction of the first section of the catheter. In addition, some solutions can also provide an extension tube, which can be extended into the working channel of the inner catheter, so that the temperature of the inner catheter can be changed by adding liquids of different temperatures into the extension tube. The thermal conductivity of different sections of the corresponding extension tube can also be different, which can be set according to the needs.

[0033] Based on the above embodiments, the present application also provides a method for manufacturing a variable stiffness vascular intervention catheter, as shown in FIG3 . The method includes the following steps: Step 1: inserting the inner catheter into the outer catheter; Step 2: sealing the first end of the interlayer between the outer and inner catheters with a silicone sealant; Step 3: heating a low-melting-point alloy with a melting point of 43-45 degrees in a water bath until it is liquid; Step 4: injecting the liquid low-melting-point alloy into the interlayer between the outer and inner catheters; Step 5: sealing the second end of the interlayer between the outer and inner catheters with a silicone sealant. In this solution, auxiliary components can also be provided to facilitate the completion of the manufacturing method, such as a bracket to support the inner and outer catheters so that the interlayer between the inner and outer catheters maintains the desired gap. Equipment for automated catheter packaging, automated heating, and alloy injection equipment can also be provided to facilitate the implementation of the solution of the present application.

[0034] The variable stiffness vascular intervention catheter of the present application can also be composed of multiple catheter segments with different melting points. Specifically, as an optional embodiment, the present application also provides a variable stiffness vascular intervention catheter, including at least two catheter segments, each of which includes an outer catheter and an inner catheter, with a working channel formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees sealed between the outer and inner catheters; the low-melting-point alloy of each catheter segment has a different melting point. The different melting points of the low-melting-point alloy of each catheter segment result in different stiffnesses when physiological saline of the same temperature is passed through the working channels of different catheter segments of the catheter, thereby facilitating adaptation to surgical needs.

[0035] The variable stiffness vascular intervention catheter of the present application can also be connected to a rigid catheter to meet different needs. Specifically, as an optional embodiment, the present application also provides a variable stiffness vascular intervention catheter, comprising a first catheter and a second catheter. The first catheter comprises an outer catheter and an inner catheter, wherein a working channel is formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer and inner catheters; the second catheter comprises a rigid catheter. One or more sections of the variable stiffness vascular intervention catheter can be connected to one or more sections of the rigid catheter to meet different needs.

[0036] The variable stiffness vascular intervention catheter of the solution of the present application can also be connected with a catheter in a soft state to meet different needs. Specifically, as an optional embodiment, the present application also provides a variable stiffness vascular intervention catheter, which is characterized in that it includes a first catheter and a second catheter, the first catheter includes an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the second catheter includes a catheter in a soft state. One or more sections of variable stiffness vascular intervention catheters can be connected with one or more sections of flexible state catheters to meet different needs. One or more sections of variable stiffness vascular intervention catheters can also be connected with one or more sections of rigid state catheters and one or more sections of flexible state catheters to meet different needs.

[0037] In this specification, the use of terms such as "Embodiment 1," "this embodiment," and "in one embodiment" indicates that the specific features, structures, materials, or characteristics described in conjunction with that embodiment or example are included in the invention or at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example; furthermore, the specific features, structures, materials, or characteristics described may be appropriately combined in any one or more embodiments or examples.

[0038] In the description of this specification, the terms "connect," "install," "fix," "dispose," and "have" are to be understood in a broad sense. For example, "connect" can mean a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0039] In the description of this specification, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises", "comprising" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising the element.

[0040] The above description of the embodiments is to facilitate ordinary technicians in this technical field to understand and apply the technology of this case. People familiar with the technology in this field can obviously make various modifications to these examples easily and apply the general principles described here to other embodiments without having to go through creative work. Therefore, this case is not limited to the above embodiments. Modifications to the following situations should all be within the scope of protection of this case: ① A new technical solution implemented based on the technical solution of the present invention and combined with existing common knowledge, the technical effect produced by the new technical solution does not exceed the technical effect of the present invention; ② The equivalent replacement of some features of the technical solution of the present invention with the known technology, the technical effect produced is the same as the technical effect of the present invention; ③ The technical solution of the present invention is expandable, and the substantive content of the expanded technical solution does not exceed the technical solution of the present invention; ④ The equivalent transformation made by the content of the description and drawings of the present invention is directly or indirectly applied to other related technical fields.

Claims

1. A variable stiffness vascular intervention catheter, characterized in that: It comprises an outer conduit and an inner conduit, a working channel is formed in the middle of the inner conduit, and a low melting point alloy with a melting point of 43-45 degrees is sealed between the outer conduit and the inner conduit.

2. The variable stiffness vascular intervention catheter according to claim 1, characterized in that: The inner layer conduit is arranged in the outer layer conduit, and the inner layer conduit and the outer layer conduit have the same center.

3. The variable stiffness vascular intervention catheter according to claim 1, characterized in that: The inner diameter of the inner catheter is 1 mm and the outer diameter is 1.6 mm; the inner diameter of the outer catheter is 2.4 mm and the outer diameter is 3 mm. The gap between the inner and outer catheters is 0.4 mm on average.

4. The variable stiffness vascular intervention catheter according to claim 1, characterized in that: The low melting point alloy is bismuth, indium, lead, tin, and cadmium alloy.

5. The variable stiffness vascular intervention catheter according to claim 4, characterized in that: The proportions of each element in the low melting point alloy are: bismuth accounts for 45%, indium accounts for 19%, lead accounts for 23%, tin accounts for 8%, and cadmium accounts for 5%.

6. The variable stiffness vascular intervention catheter according to claim 1, characterized in that: The variable stiffness vascular intervention catheter includes a soft state, a rigid state and an intermediate state. The soft state is formed by injecting physiological saline with a temperature of 45 degrees or above into the working channel, the rigid state is formed by injecting physiological saline with a temperature of 43 degrees or below into the working channel, and the intermediate state is a state in which the stiffness is between the soft state and the rigid state, and the intermediate state is formed by adjusting the temperature of the physiological saline injected into the working channel.

7. A method for manufacturing a variable stiffness vascular intervention catheter, characterized in that: include: inserting the inner catheter into the outer catheter; Using a silicone sealant to seal a first end of the sandwich between the outer conduit and the inner conduit; Heat the low melting point alloy with a melting point of 43-45 degrees in a water bath until it is liquid; Injecting a liquid low melting point alloy into the interlayer between the outer conduit and the inner conduit; The second end of the sandwich layer between the outer conduit and the inner conduit is sealed using silicone sealant.

8. A variable stiffness vascular intervention catheter, characterized in that: It comprises at least two conduit sections, each of which comprises an outer conduit and an inner conduit, a working channel is formed in the middle of the inner conduit, a low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer conduit and the inner conduit; the melting point of the low-melting-point alloy of each conduit section is different.

9. A variable stiffness vascular intervention catheter, characterized in that: It comprises a first conduit and a second conduit. The first conduit comprises an outer conduit and an inner conduit. A working channel is formed in the middle of the inner conduit. A low melting point alloy with a melting point of 43-45 degrees is sealed between the outer conduit and the inner conduit. The second conduit comprises a rigid conduit.

10. A variable stiffness vascular intervention catheter, characterized in that: It comprises a first conduit and a second conduit. The first conduit comprises an outer conduit and an inner conduit. A working channel is formed in the middle of the inner conduit. A low melting point alloy with a melting point of 43-45 degrees is sealed between the outer conduit and the inner conduit. The second conduit comprises a conduit in a soft state.

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