CN116492013A - Cardiovascular and cerebrovascular intervention micro device and processing method - Google Patents

Cardiovascular and cerebrovascular intervention micro device and processing method Download PDF

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Publication number
CN116492013A
CN116492013A CN202310491553.0A CN202310491553A CN116492013A CN 116492013 A CN116492013 A CN 116492013A CN 202310491553 A CN202310491553 A CN 202310491553A CN 116492013 A CN116492013 A CN 116492013A
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China
Prior art keywords
flexible substrate
deformation
flexible
cardiovascular
electric heating
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CN202310491553.0A
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Chinese (zh)
Inventor
任仲靖
李承阳
谢可才
孙首禹
徐阳
王敬凯
闫鹏
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Shandong University
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Shandong University
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Priority to CN202310491553.0A priority Critical patent/CN116492013A/en
Publication of CN116492013A publication Critical patent/CN116492013A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/0001Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D99/00Subject matter not provided for in other groups of this subclass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2075/00Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Manufacturing & Machinery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The invention relates to a cardiovascular intervention microdevice and a processing method thereof, comprising a banded flexible substrate, wherein the upper surface of the flexible substrate is provided with a plurality of deformation sheets, the deformation sheets are made of shape memory alloy materials, the deformation sheets are arranged in parallel and distributed along the length direction of the flexible substrate, the long axes of the deformation sheets form a set acute angle with the long axes of the flexible substrate, the periphery of the area where the deformation sheets are positioned is provided with an electric heating loop fixed on the flexible substrate, and the electric heating loop is used for being connected with a power supply to generate heat after being electrified.

Description

Cardiovascular and cerebrovascular intervention micro device and processing method
Technical Field
The invention relates to the technical field of medical equipment, in particular to a cardiovascular and cerebrovascular intervention micro-device and a processing method thereof
Background
The statements herein merely provide background information related to the present disclosure and may not necessarily constitute prior art.
Currently, there is a need for a more effective and rapid way to save the life of patients for the treatment of ischemic stroke (also known as "stroke") disease. In recent years, interventional thrombolysis technologies based on medical instruments such as microcatheters, thrombolytic stents and the like have proved to have great potential in the treatment of ischemic stroke patients.
In the existing cardiovascular and cerebrovascular interventional operation device, the device needs to be guided to a lesion position through a micro-guide wire or a micro-catheter. Wherein, adopt initiative seal wire, pipe can realize controllable crooked, avoided the risk of scratching the blood vessel that the bending caused with the help of the friction with the vascular wall. In the existing active guide wire and guide tube designs, common driving methods comprise wire pulling driving, magnetic driving, hydraulic driving and the like, but the active guide tube manufactured based on the method can generate buckling in the using process. In addition, the thrombus taking support is often required to be folded and then embedded into the micro-catheter, and released from the micro-catheter after reaching the target position along with the micro-catheter, and passively unfolded by virtue of the super elasticity of the support, so that the operation is complex and the manufacturing and processing are complex.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide a cardiovascular and cerebrovascular intervention micro device which can realize the active guiding and thrombus taking functions.
In order to achieve the above object, the present invention is realized by the following technical scheme:
in a first aspect, an embodiment of the present invention provides a cardiovascular intervention microdevice, including a strip-shaped flexible substrate, where the upper surface of the flexible substrate is provided with a plurality of deformation sheets, the deformation sheets are made of a shape memory alloy material, the deformation sheets are arranged in parallel and distributed along the length direction of the flexible substrate, the long axes of the deformation sheets and the long axes of the flexible substrate form a set acute angle, and an electric heating loop fixed on the flexible substrate is arranged at the periphery of an area where the deformation sheets are located, and the electric heating loop is used for being connected with a power supply to generate heat after being electrified.
Optionally, the flexible substrate is made of thermoplastic polyurethane elastomer rubber material.
Optionally, the electric heating loop is made of an electric heating wire, and an insulating layer is coated on the surface of the electric heating wire.
Optionally, the electric heating loop adopts a U-shaped structure, and two ends of the electric heating loop are used for being connected with a power supply.
Optionally, the periphery above the electric heating loop and the deformation sheet is encapsulated by an encapsulation layer, the encapsulation layer is fixed with the upper surface of the flexible substrate, the electric heating loop and the deformation sheet are located in the encapsulation layer, and the thickness of the encapsulation layer is greater than that of the flexible substrate so that the deformation edge is arranged in a biased manner relative to the center of the overall structure formed by the encapsulation layer and the flexible substrate.
Optionally, the encapsulation layer is made of thermoplastic polyurethane elastomer rubber.
Optionally, the device further comprises an interventional catheter, and one end of the flexible substrate extends into the interventional catheter and is fixedly connected with the interventional catheter.
In a second aspect, an embodiment of the present invention provides a method for processing a cardiovascular and cerebrovascular intervention micro-device according to the first aspect, including the following steps:
preparing a flexible matrix;
manufacturing a plurality of deformation sheets on the upper surface of the flexible matrix;
placing an electric heating loop on the upper surface of the flexible substrate, wherein the electric heating loop is positioned at the periphery of the area where the plurality of deformation sheets are positioned;
and packaging the flexible matrix by using a liquid packaging material to form a packaging layer, wherein the packaging layer packages the deformation sheet and the electric heating loop inside the packaging layer.
Optionally, injecting the liquid thermoplastic polyurethane elastomer rubber material into a mold, standing for a set time, and curing the liquid thermoplastic polyurethane elastomer rubber material to obtain the flexible matrix.
Alternatively, a micro-sodium processing method is used to manufacture a plurality of deformed sheets on the surface of the flexible substrate.
The beneficial effects of the invention are as follows:
1. the cardiovascular intervention microdevice is characterized in that a plurality of deformation sheets are arranged on a flexible substrate, the long axes of the deformation sheets and the long axis of the flexible substrate form a set acute angle, the deformation sheets are made of shape memory alloy materials, the deformation sheets can generate thermal shrinkage deformation after being heated, so that the flexible substrate generates bending coupling deformation, the steering of the flexible substrate is realized, the rigidity of the flexible substrate is improved after the bending coupling deformation is generated, and the thrombus can be taken out, so that the device has the functions of active guiding and thrombus taking, a micro-guide wire and an active catheter are not required, buckling phenomenon is avoided, the operation is simple and convenient, the flexible substrate and the deformation sheets are in contact with the thrombus surface when the thrombus is grasped, the capturing capability of the thrombus is strong, and the thrombus taking effect is good.
2. The cardiovascular intervention micro device is provided with the packaging layer, so that the deformation sheet, the electric heating loop and the external blood flow environment are isolated, and the safety of electric heating driving in the cardiovascular intervention process is improved.
3. According to the cardiovascular and cerebrovascular intervention micro device, the surface of the metal wire is coated with the insulating layer, so that the short circuit of the metal wire in a distal passage catheter or a suction catheter caused by contact is avoided.
4. After the flexible matrix is prepared, the deformation sheet is manufactured on the surface of the flexible matrix, and the flexible matrix can be packaged after the electric heating loop is placed, so that the cardiovascular and cerebrovascular intervention micro device is finished, and the manufacturing process is simple and convenient to manufacture.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention.
FIG. 1 is a plan view showing the construction of a thrombus-catching portion according to embodiment 1 of the present invention;
FIG. 2 is a front view showing the construction of a thrombus-catching section according to embodiment 1 of the present invention;
FIG. 3 is a schematic overall structure of embodiment 1 of the present invention;
FIG. 4 is a schematic illustration of the use of embodiment 1 of the present invention;
FIG. 5 is a schematic view of the process flow of example 2 of the present invention;
wherein, 1, a thrombus catching part, 2, an interventional catheter, 3, a blood vessel and 4, thrombus;
101. flexible matrix, 2, deformation sheet, 103, electrothermal circuit, 104, wire, 105, encapsulation layer.
Detailed Description
Example 1
The embodiment provides a cardiovascular and cerebrovascular intervention micro-device, which comprises an intervention catheter 2 and a thrombus capture part 1, wherein the thrombus capture part 1 comprises a flexible substrate 101, a deformation sheet 102, an electric heating circuit 103 and a packaging layer 105, as shown in fig. 1-3.
The flexible substrate 101 adopts a belt structure, one end of the flexible substrate 101 extends into the medium conduit 2 and is fixedly connected with the intervention conduit 2, in this embodiment, the flexible substrate 101 and the intervention conduit 2 are fixed by bonding or other modes, and the flexible substrate 101 and the intervention conduit 2 can be set according to actual needs by those skilled in the art.
In this embodiment, the flexible substrate 101 has a strip-shaped structure, one end of the flexible substrate 101 is used for being connected with the interventional catheter 2, the other end of the flexible substrate is in an arc-shaped structure, the flexible substrate 101 is made of thermoplastic polyurethane elastomer (TPU) material, and the flexible substrate has thermoplasticity and can shrink after being heated.
The upper surface of the flexible substrate 101 is provided with a deformation sheet fixing area, the deformation sheet fixing area is provided with a plurality of deformation sheets 102, the deformation sheets 102 are of strip-shaped structures and are made of shape memory alloy, and preferably, the deformation sheets are made of nickel-titanium shape memory alloy.
The deformation sheets 102 are arranged in parallel, the deformation sheets 102 are distributed along the length direction of the flexible substrate, and the long axis of the deformation sheet 102 and the long axis of the flexible substrate 101 are arranged at a set acute angle.
The periphery of deformation piece fixed zone is provided with electric heat return circuit 103, in this embodiment, electric heat return circuit 103 adopts the heating wire of U type, and the heating wire sets up in the periphery of deformation piece fixed zone, and its both ends are used for stretching into in the intervention pipe and are connected with wire 104, can be connected with the power through wire 104, and wire 104 adopts electrically conductive metallic material to make, and the heating wire can produce heat after the circular telegram, and then gives the heat transfer to the deformation piece.
In order to avoid short-circuiting of the heating wire in the distal access catheter or the suction catheter due to contact, the outer surface of the heating wire is coated with an insulating layer, which is made of an insulating material with good biocompatibility, preferably, the insulating layer is made of a silica gel material.
The upper surface of the flexible substrate 101 is encapsulated by the encapsulation layer 105, the electric heating wires and the deformation sheet 102 are encapsulated in the encapsulation layer 105, the encapsulation layer 105 is made of thermoplastic polyurethane elastomer rubber (TPU), and has certain thermoplasticity, and the deformation sheet and the electric heating wires are isolated from the external blood flow environment by the encapsulation layer, so that the safety of electric heating driving in the cardiovascular and cerebrovascular intervention process is improved.
The thickness of the encapsulation layer 105 is greater than the thickness of the flexible substrate 101 such that the deformation sheet 102 is disposed offset with respect to the center of the overall structure formed by the encapsulation layer 105 and the flexible substrate 101.
Through the offset distance of the center of the integral structure formed by the deformation sheet 102, the packaging layer 105 and the flexible substrate 101, the included angle between the long axis of the deformation sheet 102 and the long axis of the flexible substrate 101 and the geometric dimension of the deformation sheet 102, the bending-torsion coupling deformation capacity of the whole interventional micro-device can be adjusted, and then the functional requirements of active guidance and thrombus capture in the vascular interventional process are met.
The working process of the embodiment is as follows:
as shown in fig. 4, when a thrombus exists in a diseased vessel, the interventional catheter 2 needs to be turned when being fed to the bifurcation of the vessel 3, an external power supply is used for electrifying an electric heating wire, the electric heating wire is electrified to pass through, joule heat is generated, the joule heat is transmitted to the deformation sheets 102 through heat conduction, the deformation sheets 102 are driven to shrink, the flexible matrix 101 is further driven to generate bending deformation, the flexible matrix 101 is bent and deformed into a spiral structure, the turning is completed, after the complete active guidance at the bifurcation of the vessel, the forward feeding is continued, and as the flexible matrix 101 becomes into the spiral structure, the rigidity is increased, the interventional catheter can be inserted into the thrombus, the flexible matrix 101 is inserted into the thrombus 4 to complete the capture of the thrombus 4, and then the thrombus 4 is removed, so as to complete the thrombus taking process.
The interventional micro device of the embodiment realizes the functions of active guidance and thrombus removal simultaneously, does not need to adopt a micro guide wire and an active catheter, avoids buckling phenomenon, and has simple and convenient operation and strong functionality.
The flexible matrix is deformed into a spiral structure, so that the flexible matrix is in surface contact with thrombus, the catching capability on the thrombus is strong, and the thrombus taking effect is good.
Example 2
The present embodiment provides a method for processing a cardiovascular and cerebrovascular access micro device according to embodiment 1, as shown in fig. 5, comprising the following steps:
step 1: a flexible substrate 101 is prepared.
A liquid thermoplastic polyurethane elastomer rubber (TPU) material is injected into a mold, left for a set time, and the band thermoplastic polyurethane elastomer rubber material is cured and then demolded to obtain a band-shaped flexible substrate 101.
Step 2: a plurality of deformation sheets 102 are fabricated on the upper surface of the flexible substrate.
The micro-nano processing technology is adopted to deposit and manufacture a plurality of deformation sheets 102 on the upper surface of the flexible substrate, the micro-nano processing technology is adopted by the existing technological method, and the specific steps are not described in detail here.
Step 3: an electrothermal circuit 103 is arranged on the upper surface of the flexible matrix, and the electrothermal circuit 103 is positioned at the periphery of the area where the plurality of deformation sheets are positioned.
The electric heating loop 103 adopts a U-shaped electric heating wire, and the surface of the electric heating wire is coated with a silica gel insulating layer and then is placed at the periphery of a deformation sheet fixing area on the upper surface of the flexible substrate.
Step 4: the flexible substrate 101 with the deformation sheet and the electrothermal circuit 103 is packaged with liquid thermoplastic polyurethane elastomer rubber material on the upper surface, the packaging layer 105 is manufactured, the deformation sheet 102 and the electrothermal wire are packaged in the packaging layer 105, the two ends of the electrothermal wire are connected with the metal wires 104, and the electrothermal wire can be connected with a power supply through the metal wires.
And 5, stretching the metal wire into the medium conduit, and bonding and fixing the end part of the flexible matrix 101 and the medium conduit 2 to finish the processing of the whole cardiovascular and cerebrovascular access micro device.
The interventional device and the processing method of the embodiment have the advantages of simple structure, easy processing and manufacturing, high action execution rate, integration of functions of the micro-guide wire, the micro-catheter and the thrombus extractor, obvious advantages in the aspects of functional integrated design and miniaturization of the cerebral vascular interventional device, and the like, can be oriented to multiple clinical application requirements, and reasonably designs and optimizes processing materials, structural dimensions and driving design of the micro-device, and has wide application scenes.
The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the same, but rather, various modifications and variations may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims (10)

1. The utility model provides a cardiovascular and cerebrovascular intervenes micro-device, its characterized in that includes banded flexible base member, and flexible base member upper surface is provided with a plurality of deformation piece, and the deformation piece adopts shape memory alloy material to make, and a plurality of deformation piece parallel arrangement just distribute along the length direction of flexible base member, and the long axis of deformation piece is the settlement acute angle with the long axis of flexible base member, and the periphery in the region that a plurality of deformation pieces are located is equipped with the electric heat return circuit of fixing at flexible base member, and the electric heat return circuit is used for being connected with the power in order to realize the heat that produces after the circular telegram.
2. The cardiovascular intervention microdevice of claim 1, wherein the flexible substrate is made of a thermoplastic polyurethane elastomer rubber material.
3. The cardiac and cerebral vascular interventional micro device of claim 1, wherein the electrothermal circuit is made of electrothermal wire, and the surface of the electrothermal wire is coated with an insulating layer.
4. The cardiac and cerebral vascular interventional micro device of claim 1, wherein the electrothermal circuit has a U-shaped structure with two ends for connection to a power source.
5. The cardiovascular intervention microdevice as recited in claim 1, wherein the upper periphery of the electrothermal circuit and the deformable strip are encapsulated by an encapsulation layer, the encapsulation layer is fixed to the upper surface of the flexible substrate, the electrothermal circuit and the deformable strip are positioned in the encapsulation layer, and the thickness of the encapsulation layer is greater than that of the flexible substrate so that the deformed edge is offset with respect to the center of the integrated structure formed by the encapsulation layer and the flexible substrate.
6. The cardiovascular intervention microdevice of claim 1, wherein the encapsulation layer is made of a thermoplastic polyurethane elastomer rubber material.
7. The cardiovascular interventional micro device of claim 1, further comprising an interventional catheter, wherein one end of the flexible substrate extends into the interventional catheter and is fixedly connected thereto.
8. A method of manufacturing a cardiovascular and cerebrovascular interventional microdevice as claimed in any one of claims 1 to 7, comprising the steps of:
preparing a flexible matrix;
manufacturing a plurality of deformation sheets on the upper surface of the flexible matrix;
placing an electric heating loop on the upper surface of the flexible substrate, wherein the electric heating loop is positioned at the periphery of the area where the plurality of deformation sheets are positioned;
and packaging the flexible matrix by using a liquid packaging material to form a packaging layer, wherein the packaging layer packages the deformation sheet and the electric heating loop inside the packaging layer.
9. The method of claim 8, wherein the liquid thermoplastic polyurethane elastomer rubber material is injected into a mold, and after the liquid thermoplastic polyurethane elastomer rubber material is cured after a set time, a flexible matrix is obtained.
10. The method of claim 8, wherein the plurality of deformed pieces are formed on the surface of the flexible substrate by a micro-sodium process.
CN202310491553.0A 2023-04-26 2023-04-26 Cardiovascular and cerebrovascular intervention micro device and processing method Pending CN116492013A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310491553.0A CN116492013A (en) 2023-04-26 2023-04-26 Cardiovascular and cerebrovascular intervention micro device and processing method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310491553.0A CN116492013A (en) 2023-04-26 2023-04-26 Cardiovascular and cerebrovascular intervention micro device and processing method

Publications (1)

Publication Number Publication Date
CN116492013A true CN116492013A (en) 2023-07-28

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202310491553.0A Pending CN116492013A (en) 2023-04-26 2023-04-26 Cardiovascular and cerebrovascular intervention micro device and processing method

Country Status (1)

Country Link
CN (1) CN116492013A (en)

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