CN117298412A - Variable-rigidity vascular intervention catheter and manufacturing method thereof - Google Patents

Variable-rigidity vascular intervention catheter and manufacturing method thereof Download PDF

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Publication number
CN117298412A
CN117298412A CN202311231724.2A CN202311231724A CN117298412A CN 117298412 A CN117298412 A CN 117298412A CN 202311231724 A CN202311231724 A CN 202311231724A CN 117298412 A CN117298412 A CN 117298412A
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China
Prior art keywords
catheter
variable
melting point
rigidity
low
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Pending
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CN202311231724.2A
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Chinese (zh)
Inventor
徐天添
杜世伟
陈志强
邱明
王姝
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Shenzhen Institute of Advanced Technology of CAS
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Shenzhen Institute of Advanced Technology of CAS
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Priority to CN202311231724.2A priority Critical patent/CN117298412A/en
Publication of CN117298412A publication Critical patent/CN117298412A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0054Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to a variable-rigidity vascular interventional catheter and a manufacturing method thereof, wherein the variable-rigidity vascular interventional catheter comprises an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; in the scheme, the low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer-layer catheter and the inner-layer catheter, and the rigidity of the catheter can be adjusted by injecting physiological saline with different temperatures into the working channel, so that the catheter is suitable for different operations in the operation process and is convenient for normal operation of the operation.

Description

Variable-rigidity vascular intervention catheter and manufacturing method thereof
Technical Field
The invention relates to the technical field of medical treatment, in particular to a variable-rigidity vascular interventional catheter and a manufacturing method thereof.
Background
Vascular interventional catheters are a tool for medical diagnosis and treatment by placing flexible tubing inside the body. These catheters are typically flexible and can be inserted into the vascular system of a patient for manipulation. The use of vascular interventional catheters may reduce trauma, improve surgical accuracy, and reduce patient recovery time. The following are some common uses for vascular interventional catheters:
angioplasty: vascular interventional catheters are useful for treating arterial stenosis or obstruction, commonly used in the treatment of coronary artery disease and peripheral arterial disease. The catheter carries an inflatable balloon which is inflated when the catheter reaches the stenosed site, helping to dilate the vessel and increase blood flow.
And (3) implantation of a bracket: in the case of a stenosis of a blood vessel, a stent may be placed at the stenosis to maintain the patency of the blood vessel. The catheter carries a stent which expands once it reaches the stenosed site, stabilizes in the vessel, and prevents reocclusion.
Embolic treatment: vascular interventional catheters are used for the treatment of tumors, vascular malformations, abnormal bleeding or thrombolysis. Through catheter guidance, the physician may deliver an embolic material (e.g., tiny particles or coils) into the abnormal blood vessel, occlude its blood flow, or deliver a lytic drug into the blood vessel to lyse the thrombus, restoring blood flow.
Minimally invasive surgery using vascular interventional catheters has many advantages. Compared with the traditional open operation, the minimally invasive operation requires only a small incision or puncture, the wound of the patient is smaller, the tissue injury and bleeding are less, the operation wound is smaller, the pain and discomfort felt by the patient are also less, and the recovery time is shorter; because the incision is smaller, the infection risk of the interventional minimally invasive surgery is lower, and postoperative complications are fewer; only local or mild general anesthesia is required, reducing the use of anesthesia and associated risks compared to larger open surgery. In recent decades, vascular-mediated minimally invasive surgery has progressed rapidly, and has become one of the main clinical approaches to treating vascular diseases.
However, current vascular interventional catheters are often rigid or flexible, which is inconvenient for surgical procedures.
Disclosure of Invention
In order to solve the defect that the conventional catheter is inconvenient for normal operation, the invention provides the variable-rigidity vascular intervention catheter and the manufacturing method thereof, which can change the rigidity of the catheter in the operation process and facilitate the operation of the operation.
The invention provides a variable-rigidity vascular interventional catheter which comprises an outer catheter and an inner catheter, wherein a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter.
Preferably, the inner layer catheter is arranged in the outer layer catheter, and the center of the inner layer catheter is the same as that of the outer layer catheter.
Preferably, the inner diameter of the inner layer catheter is 1mm, and the outer diameter is 1.6mm; the inner diameter of the outer layer catheter is 2.4mm, the outer diameter is 3mm, and the gap between the interlayer of the inner layer catheter and the outer layer catheter is 0.4mm on average.
Preferably, the low melting point alloy is bismuth indium lead tin cadmium alloy.
Preferably, the ratio of each element in the low-melting-point alloy is as follows: 45% of bismuth, 19% of indium, 23% of lead, 8% of tin and 5% of cadmium.
Preferably, the variable stiffness vascular access catheter includes a soft state formed by injecting physiological saline at a temperature of 45 degrees and above in the working channel, a stiff state formed by injecting physiological saline at a temperature of 43 degrees and below in the working channel, and an intermediate state in which stiffness is in a state between the soft state and the stiff state, the intermediate state being formed by adjusting the temperature of the physiological saline injected in the working channel.
The invention also provides a manufacturing method of the variable-rigidity vascular interventional catheter, which comprises the following steps: inserting the inner catheter into the outer catheter; sealing a first end of the interlayer between the outer layer catheter and the inner layer catheter with a silicone sealant; heating the low-melting-point alloy with the melting point of 43-45 ℃ to be in a liquid state in water bath; injecting a liquid low melting point alloy into the interlayer between the outer layer catheter and the inner layer catheter; the second end of the interlayer between the outer layer catheter and the inner layer catheter is sealed using a silicone sealant.
The invention also provides a variable-rigidity vascular interventional catheter, which comprises at least two catheter sections, wherein each catheter section comprises an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the low melting point alloy of each tube segment has a different melting point.
The invention also provides a variable-rigidity vascular interventional catheter, which comprises 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 low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the second conduit comprises a rigid state conduit.
The invention also provides a variable-rigidity vascular interventional catheter, which comprises 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 low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the second conduit comprises a conduit in a flexible state.
Compared with the prior art, the invention has the following beneficial effects:
in the existing scheme, when a catheter with excessive rigidity passes through a bent or narrow blood vessel, the catheter can cause trauma to the intima of the blood vessel, so that bleeding, hematoma or vascular injury, spasm and the like are caused. The catheter with too low rigidity may be bent to pass through the bent portion of the blood vessel, and the working channel inside the catheter may be deformed or blocked, thereby affecting the normal operation. I.e. the rigidity of the existing single vessel interventional catheter cannot conform to the anatomy and lesion of the vessel. It can be seen that the vascular access catheters of the prior art are often rigid or flexible, which is inconvenient for the surgical procedure. The scheme of the application provides a variable-rigidity vascular intervention catheter which comprises an outer catheter and an inner catheter, wherein a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter. In the scheme, the low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer-layer catheter and the inner-layer catheter, and the rigidity of the catheter can be adjusted by injecting physiological saline with different temperatures into the working channel, so that the catheter is suitable for different operations in the operation process and is convenient for normal operation of the operation. For example, physiological saline with the temperature of 45 degrees or more can be injected into the working channel, so that the low-melting-point alloy in the variable-rigidity vascular interventional catheter is converted into a liquid state, and the variable-rigidity vascular interventional catheter is changed into a soft state, so that the vascular interventional catheter can not cause trauma to the intima of the blood vessel when passing through a bent or narrow blood vessel, and the operation is convenient to carry out. Physiological saline with the temperature of 43 ℃ or below can be injected into the working channel, so that the low-melting-point alloy in the variable-rigidity vascular interventional catheter is converted into a solid state, and the variable-rigidity vascular interventional catheter is converted into a soft state; the catheter can smoothly pass through the vascular bending position, and the working channel inside the catheter can not be extruded, deformed or blocked, so that the normal operation is facilitated. The rigidity of the catheter can be adjusted by continuously adjusting the temperature of the physiological saline injected into the working channel, so that the catheter is suitable for different requirements.
Drawings
The invention is described in detail below with reference to examples and figures, wherein:
FIG. 1 is a schematic illustration of the structure of a variable stiffness vascular interventional catheter;
FIG. 2 is a schematic illustration of the variation in stiffness of a variable stiffness vascular interventional catheter at different temperatures;
fig. 3 is a schematic illustration of a method of making a variable stiffness vascular interventional catheter.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, the embodiments of the present invention will be described in further detail with reference to the accompanying drawings. Examples of the embodiments are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements throughout, or elements having like or similar functionality. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the invention.
In the existing scheme, when a catheter with excessive rigidity passes through a bent or narrow blood vessel, the catheter can cause trauma to the intima of the blood vessel, so that bleeding, hematoma or vascular injury, spasm and the like are caused. The catheter with too low rigidity may be bent to pass through the bent portion of the blood vessel, and the working channel inside the catheter may be deformed or blocked, thereby affecting the normal operation. I.e. the rigidity of the existing single vessel interventional catheter cannot conform to the anatomy and lesion of the vessel. It can be seen that the vascular access catheters of the prior art are generally rigid or flexible, which is inconvenient for the normal operation.
The scheme of the application provides a variable-rigidity vascular interventional catheter, which 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 catheter and the inner catheter as shown in figure 1. Specifically, as an alternative embodiment, the inner layer catheter is disposed in the outer layer catheter, and the center of the inner layer catheter is the same as that of the outer layer catheter. The circle centers of the inner-layer catheter and the outer-layer catheter can be different, and the arrangement can be specifically carried out according to the requirements. Specifically, as an alternative embodiment, the inner diameter of the inner catheter is 1mm and the outer diameter is 1.6mm; the inner diameter of the outer layer catheter is 2.4mm, the outer diameter is 3mm, and the gap between the interlayer of the inner layer catheter and the outer layer catheter is 0.4mm on average. It should be noted that the above dimensions are only an alternative of the present solution, and different dimensions may be set according to the requirements to correspond to different types of blood vessels, etc. In addition, optionally, in order to avoid too small a gap between the outer layer catheter and the inner layer catheter, a supporting piece can be arranged in the interlayer to support, so that the too small a gap is prevented.
Specifically, as an alternative embodiment, the low melting point alloy is bismuth indium lead tin cadmium alloy. Specifically, as an alternative embodiment, the low melting point alloy comprises the following elements in percentage: 45% of bismuth (Bi), 19% of indium (In), 23% of lead (Pb), 8% of tin (Sn) and 5% of cadmium (Cd).
The state of the variable stiffness vascular access catheter may be divided into a soft state, a rigid state, an intermediate state, and the like as the state of the variable stiffness vascular access catheter changes. Specifically, as an alternative embodiment, the variable stiffness vascular interventional catheter includes a soft state formed by injecting physiological saline at a temperature of 45 degrees and above in the working channel, a rigid state formed by injecting physiological saline at a temperature of 43 degrees and below in the working channel, and an intermediate state between the soft state and the rigid state, the intermediate state being formed by adjusting the temperature of the physiological saline injected in the working channel.
In the scheme, the low-melting-point alloy with the melting point of 43-45 degrees is sealed between the outer-layer catheter and the inner-layer catheter, and the rigidity of the catheter can be adjusted by injecting physiological saline with different temperatures into the working channel, so that the catheter is suitable for different operations in the operation process and is convenient for normal operation of the operation. For example, as shown in fig. 2, physiological saline at 43 degrees or below can be injected into the working channel, so that the low-melting-point alloy in the variable-rigidity vascular interventional catheter is converted into a solid state, and the rigidity of the variable-rigidity vascular interventional catheter is increased, and the catheter is in a soft state; the catheter can smoothly pass through the vascular bending position, and the working channel inside the catheter can not be extruded, deformed or blocked, so that the normal operation is facilitated. The rigidity of the catheter can be adjusted by continuously adjusting the temperature of the physiological saline injected into the working channel, so that the catheter is suitable for different requirements. Physiological saline with the temperature of 45 degrees or more can be injected into the working channel, so that the low-melting-point alloy in the variable-rigidity vascular intervention catheter is converted into a liquid state, the rigidity of the variable-rigidity vascular intervention catheter is reduced, the catheter is changed into a soft state, and the catheter cannot cause trauma to the intima of the blood vessel when passing through a bent or narrow blood vessel, thereby facilitating the operation.
In addition, in the scheme, the heat conductivity of the inner-layer catheter and the outer-layer catheter can be changed by changing the indexes of the material, the thickness and the like of the inner-layer catheter and the outer-layer catheter, so that when the physiological saline at the same temperature is introduced into the working channels in different sections of the catheter, different sections of the catheter have different rigidities, and the requirement of an operation is met conveniently. For example, the catheter can be divided into five sections, so that the thickness of the inner catheter of the second section can be reduced, the low-melting-point alloy corresponding to the second section of the catheter is softer, and the second section of the catheter is convenient to bend to change the orientation of the first section of the catheter. In addition, part of the proposal can be provided with an extension pipe which can extend into the working channel of the inner-layer conduit, thereby changing the temperature of the inner-layer conduit by adding liquids with different temperatures into the extension pipe. The thermal conductivity of the different sections of the corresponding extension tube can also be different, and can be set according to the requirements.
On the basis of the above embodiment, the embodiment of the present application further provides a method for manufacturing a variable stiffness vascular interventional catheter, as shown in fig. 3, where the method includes: step 1, inserting an inner layer catheter into an outer layer catheter; step 2, sealing a first end of an interlayer between the outer layer catheter and the inner layer catheter by using an organosilicon sealant; step 3, heating the low-melting-point alloy with the melting point of 43-45 ℃ in water bath to be in a liquid state; step 4, injecting liquid low-melting-point alloy into an interlayer between the outer-layer catheter and the inner-layer catheter; and 5, sealing the second end of the interlayer between the outer layer catheter and the inner layer catheter by using a silicone sealant. In this embodiment, an auxiliary assembly for facilitating the completion of the manufacturing method may be provided, such as a stent may be provided to support the inner and outer catheters so that the sandwich of the inner and outer catheters maintains a desired gap. Equipment for automatically packaging the catheter, equipment for automatically heating and injecting alloy and the like can also be arranged, so that the scheme of the application is convenient to realize.
The variable-rigidity vascular interventional catheter of the scheme of the application can also consist of a plurality of catheter sections with different melting points, and specifically, as an optional embodiment, the application also provides a variable-rigidity vascular interventional catheter which comprises at least two catheter sections, wherein each catheter section 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 the melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the low melting point alloy of each tube segment has a different melting point. The low-melting-point alloy of each catheter section has different melting points, so that when the working channels in different catheter sections of the catheter are filled with physiological saline at the same temperature, the different catheter sections have different rigidities, thereby being convenient for adapting to the requirements of the operation.
The variable-stiffness vascular interventional catheter of the scheme of the application can be connected with a catheter in a rigid state so as to adapt to different requirements, and particularly, as an optional embodiment, the application also provides a variable-stiffness vascular interventional catheter which comprises 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 conduit comprises a rigid state conduit. One or more sections of variable stiffness vascular access catheters may be connected to one or more sections of catheters in a rigid state to accommodate the need.
The variable-stiffness vascular interventional catheter according to the scheme of the application can be connected with a catheter in a soft state so as to adapt to different requirements, and particularly, as an optional embodiment, the application also provides a variable-stiffness vascular interventional catheter, which is characterized by 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 conduit comprises a conduit in a flexible state. One or more sections of variable stiffness vascular access catheters may be connected to one or more sections of catheters in a flexible state to accommodate the need. The one or more sections of variable stiffness vascular interventional catheters may also be connected to one or more sections of catheters in a rigid state and one or more sections of catheters in a flexible state to accommodate the need.
In the description of the present specification, the terms "embodiment," "present embodiment," "in one embodiment," and the like, if used, mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in 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 embodiments or examples; furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
In the description of the present specification, the terms "connected," "mounted," "secured," "disposed," "having," and the like are to be construed broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art as the case may be.
In the description of this specification, relational terms such as "first" and "second", and the like, are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The embodiments have been described so as to facilitate a person of ordinary skill in the art in order to understand and apply the present technology, it will be apparent to those skilled in the art that various modifications may be made to these examples and that the general principles described herein may be applied to other embodiments without undue burden. Therefore, the present application is not limited to the above embodiments, and modifications to the following cases should be within the scope of protection of the present application: (1) the technical scheme of the invention is taken as the basis and combined with the new technical scheme implemented by the prior common general knowledge, and the technical effect produced by the new technical scheme is not beyond that of the invention; (2) equivalent replacement of part of the characteristics of the technical scheme of the invention by adopting the known technology produces the technical effect the same as that of the invention; (3) the technical scheme of the invention is taken as a basis for expanding, and the essence of the expanded technical scheme is not beyond the technical scheme of the invention; (4) equivalent transformation made by the content of the specification and the drawings of the invention is directly or indirectly applied to other related technical fields.

Claims (10)

1. The variable-rigidity vascular interventional catheter is characterized by comprising an outer catheter and an inner catheter, wherein a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter.
2. The variable stiffness vascular interventional catheter of claim 1, wherein the inner catheter is disposed within the outer catheter, the inner catheter having a center that is the same as the outer catheter.
3. The variable stiffness vascular interventional catheter of claim 1, wherein the inner catheter has an inner diameter of 1mm and an outer diameter of 1.6mm; the inner diameter of the outer layer catheter is 2.4mm, the outer diameter is 3mm, and the gap between the interlayer of the inner layer catheter and the outer layer catheter is 0.4mm on average.
4. The variable stiffness vascular access catheter of claim 1, wherein the low melting point alloy is bismuth indium lead tin cadmium alloy.
5. The variable stiffness vascular interventional catheter of claim 4, wherein the low melting point alloy comprises the following elements in percentage: 45% of bismuth, 19% of indium, 23% of lead, 8% of tin and 5% of cadmium.
6. The variable stiffness vascular access catheter of claim 1, comprising a soft state formed by injecting physiological saline at a temperature of 45 degrees and above in the working channel, a stiff state formed by injecting physiological saline at a temperature of 43 degrees and below in the working channel, and an intermediate state in which stiffness is in a state between the soft state and the stiff state, the intermediate state being formed by adjusting the temperature of the physiological saline injected in the working channel.
7. A method for manufacturing a variable stiffness vascular interventional catheter, comprising:
inserting the inner catheter into the outer catheter;
sealing a first end of the interlayer between the outer layer catheter and the inner layer catheter with a silicone sealant;
heating the low-melting-point alloy with the melting point of 43-45 ℃ to be in a liquid state in water bath;
injecting a liquid low melting point alloy into the interlayer between the outer layer catheter and the inner layer catheter;
the second end of the interlayer between the outer layer catheter and the inner layer catheter is sealed using a silicone sealant.
8. The variable-rigidity vascular interventional catheter is characterized by comprising at least two catheter sections, wherein each catheter section comprises an outer catheter and an inner catheter, a working channel is formed in the middle of the inner catheter, and low-melting-point alloy with a melting point of 43-45 degrees is sealed between the outer catheter and the inner catheter; the low melting point alloy of each tube segment has a different melting point.
9. The variable-rigidity vascular interventional catheter is characterized by 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 conduit comprises a rigid state conduit.
10. The variable-rigidity vascular interventional catheter is characterized by 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 conduit comprises a conduit in a flexible state.
CN202311231724.2A 2023-09-22 2023-09-22 Variable-rigidity vascular intervention catheter and manufacturing method thereof Pending CN117298412A (en)

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Application Number Priority Date Filing Date Title
CN202311231724.2A CN117298412A (en) 2023-09-22 2023-09-22 Variable-rigidity vascular intervention catheter and manufacturing method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202311231724.2A CN117298412A (en) 2023-09-22 2023-09-22 Variable-rigidity vascular intervention catheter and manufacturing method thereof

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