CN116899072B - Nerve microcatheter with improved kink resistance - Google Patents

Nerve microcatheter with improved kink resistance Download PDF

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Publication number
CN116899072B
CN116899072B CN202310978877.7A CN202310978877A CN116899072B CN 116899072 B CN116899072 B CN 116899072B CN 202310978877 A CN202310978877 A CN 202310978877A CN 116899072 B CN116899072 B CN 116899072B
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inner tube
nerve
microcatheter
tube
mixture
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CN116899072A (en
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姜贤男
潘国立
舒小娟
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Shanghai Kindly Medical Devices Co ltd
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Shanghai Kindly Medical Devices Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements 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
    • A61B2017/22079—Implements 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 suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081—Soft tip

Abstract

The invention relates to a nerve micro-catheter with improved bending resistance, which comprises an inner tube and an outer tube, wherein the inner tube and the outer tube are coaxially arranged, a hollow inner channel extending along the axial direction is formed in the inner tube, and the outer surface of the inner tube and the inner surface of the outer tube are tightly crosslinked, adhered and fixed together; the inner diameter r of the inner tube 1 With the outer diameter r of the outer tube 2 Satisfies the fitting relation of the difference between the inner diameter and the outer diameter. The invention adopts three materials of polyglycolic acid, deacetylated chitin and polybutyl lactam to manufacture the inner tube, thereby improving the bending resistance of the inner tube.

Description

Nerve microcatheter with improved kink resistance
Technical Field
The invention relates to the technical field of microcatheters, in particular to a nerve microcatheter with improved bending resistance.
Background
Cerebral stroke (stroke), also known as stroke, cerebrovascular accident (Cerebral Vascular Accident, CVA), is an acute cerebrovascular disease, a group of diseases that cause damage to brain tissue due to sudden rupture of cerebral vessels or failure of blood to flow into the brain due to vessel occlusion, including ischemic and hemorrhagic strokes. The incidence rate of ischemic stroke is higher than that of hemorrhagic stroke, and the ischemic stroke accounts for 60-70% of the total cerebral stroke. The occlusion and stenosis of the carotid and vertebral arteries can cause ischemic stroke, with ages above 40 years, with men more than women, and severe cases can cause death. The cerebral apoplexy has the characteristics of high morbidity, high mortality and high disability rate.
A nerve microcatheter is a medical device for treating cerebral stroke (cerebral neurovascular embolism). Since cerebral infarction is a cerebrovascular disease in which cerebral tissue is damaged due to a thrombus caused by a blockage of a cerebral blood vessel, a nerve microcatheter (thrombus-absorbing catheter) can be used to recanalize blood flow by placing the catheter into a cerebral blood vessel from the root of a foot.
The applicant found during the development that the nerve microcatheter, when entering into the common carotid artery and intracranial anatomy, is prone to not advance normally due to insufficient kink resistance due to resistance caused by tortuosity and diameter of the blood vessel. Once the driving force applied to the nerve microcatheter becomes greater, it can cause undesirable bending of the nerve microcatheter, affecting proper treatment.
Disclosure of Invention
The present invention aims to provide a nerve microcatheter with improved kink resistance, and the technical problem to be solved includes how to improve the kink resistance of the nerve microcatheter, and avoid the nerve microcatheter from generating undesirable bending when entering the common carotid artery and intracranial anatomy.
The invention aims to solve the defects of the prior art and provide a nerve micro-catheter with improved bending resistance, which comprises an inner tube and an outer tube, wherein the inner tube and the outer tube are coaxially arranged, a hollow inner channel extending along the axial direction is formed in the inner tube, and the outer surface of the inner tube is tightly crosslinked, adhered and fixed with the inner surface of the outer tube; the inner diameter r of the inner tube 1 With the outer diameter r of the outer tube 2 The fitting relation of the difference values of the inner diameter and the outer diameter is satisfied, wherein the fitting relation of the difference values of the inner diameter and the outer diameter is:
wherein a is the thickness of the pipe wall of the inner pipe;
b is the thickness of the pipe wall of the outer pipe;
K 1 is the bending stiffness of the inner tube;
K 2 is the bending stiffness of the outer tube.
Preferably, the preparation method of the inner tube comprises the following steps: mixing polyglycolic acid and deacetylated chitin according to the mass ratio of 7:3 to obtain a first mixture, mixing the first mixture and polybutylece lactam according to the mass ratio of 20:1 to obtain a second mixture, placing the second mixture into a freezing chamber, regulating the temperature to minus 20 ℃, and cooling for more than 36 hours; drying the cooled second mixture at a constant temperature of 45 ℃ for 9 hours, then feeding the cooled second mixture into a double-screw extruder for melt blending, cooling a sample obtained after melt blending, granulating by a granulator, preparing a sample strip by an injection molding machine, pressing the sample strip into a sheet material by a roll pressing machine, winding the sheet material on the outer surface of a bar composed of water-soluble polymers by a tube winding machine to obtain an inner tube blank with a plurality of layers of sheet materials wound on the outer surface of the bar, soaking the inner tube blank in deionized water for more than 72 hours, dissolving and washing the bar composed of the water-soluble polymers by the deionized water, simultaneously enabling the deionized water to promote tight adhesion between the plurality of layers of sheet materials of the inner tube blank, and drying the inner tube blank after soaking and washing at 50-55 ℃ for 3 hours to obtain the inner tube with a hollow inner channel 103 extending along the axial direction.
Preferably, the average molecular weight of the polyglycolic acid is 20000 to 145000.
Preferably, the deacetylated chitin has an average molecular weight of 65000 to 170000.
Preferably, the polybutyl lactam has an average molecular weight of 15000 to 35000.
Preferably, the temperature of the melt blending of the twin-screw extruder is in accordance with a blending temperature curve, the blending temperature curve satisfies a blending temperature relational expression, and the blending temperature relational expression is:
wherein T is the temperature of the double-screw extruder for melt blending, and the unit is the temperature; t is the time in minutes for the second mixture to enter the twin screw extruder.
Preferably, the rotating speed of the double-screw extruder is 60r/min.
Preferably, the injection pressure of the injection molding machine is 5.8MPa to 6.5MPa.
Preferably, the preparation method of the outer tube comprises the following steps: mixing polycaprolactone and dichloromethane to prepare a first solution with the mass concentration of 15-20%, adding sodium alginate accounting for 25-30% of the mass of the first solution into the first solution, mechanically stirring for 1 hour to form an intermediate mixture, immersing an inner tube into the intermediate mixture, controlling the inner tube to rotate in the intermediate mixture at the rotating speed of 20r/min for 15 minutes, taking out the inner tube, and drying in a dryer for 20 minutes; the inner tube is again immersed in the intermediate mixture and the immersing, spinning and drying steps are repeated at least 5 times.
Preferably, the drying temperature of the dryer accords with a drying temperature curve, the drying temperature curve satisfies a drying temperature relation, and the drying temperature relation is:
wherein T is 1 The unit is the drying temperature of the dryer; t is t 1 The time in minutes for the inner tube to enter the dryer is given.
In a preferred embodiment, the nerve microcatheter with improved bending resistance further comprises a catheter seat, a catheter seat sheath and a guiding sheath, wherein the outer peripheral wall of the outer tube is tightly wound with a spring-shaped woven mesh layer, the outer peripheral wall of the spring-shaped woven mesh layer is tightly wound with a grid-shaped woven mesh layer, the outer peripheral wall of the grid-shaped woven mesh layer is tightly wound with an outer Pebax tube layer, and the guiding sheath is slidably sleeved on the outer peripheral wall of the outer Pebax tube layer; the inside of the catheter seat is provided with a catheter channel which is fixedly connected with the inner tube through the catheter seat light, so that the catheter channel is communicated with the hollow inner channel of the inner tube; the catheter seat sheath is wrapped outside the catheter seat light fixture and wraps at least the catheter seat and a part of the inner tube; the free end of the catheter hub is provided with an opening through which the catheter passageway and the hollow interior passageway of the inner tube can be accessed.
Preferably, the outer Pebax tube layer is coated with a hydrophilic coating on its peripheral wall.
The nerve microcatheter also comprises a mandrel, and the mandrel is inserted into the hollow inner channel of the inner tube.
Preferably, the mesh-shaped woven mesh layer is diamond-shaped mesh.
Preferably, the length of the inner tube is 150 cm, 155 cm or 160 cm.
The inner diameter of the inner tube is 0.38 mm, 0.43 mm, 0.53 mm or 0.69 mm.
The outer layer Pebax tube layer is characterized in that a smooth transition layer is tightly wrapped on the peripheral wall of the outer layer Pebax tube layer, and the smooth transition layer comprises a plurality of segments with different hardness, thickness and length.
Preferably, the smooth transition layer includes a first smooth transition layer, a second smooth transition layer, a third smooth transition layer, a fourth smooth transition layer, a fifth smooth transition layer, a sixth smooth transition layer, a seventh smooth transition layer, an eighth smooth transition layer and a ninth smooth transition layer, wherein the hardness of the first smooth transition layer is 80D, the hardness of the second smooth transition layer is 81D, the hardness of the third smooth transition layer is 83D, the hardness of the fourth smooth transition layer is 89D, the hardness of the fifth smooth transition layer is 85D, the hardness of the sixth smooth transition layer is 84D, the hardness of the seventh smooth transition layer is 87D, the hardness of the eighth smooth transition layer is 86D, and the hardness of the ninth smooth transition layer is 82D.
Further preferably, the first smooth transition layer has a thickness M 1 The thickness of the second section smooth transition layer is M 2 The thickness of the third smooth transition layer is M 3 The thickness of the fourth smooth transition layer is M 4 The thickness of the fifth smooth transition layer is M 5 The thickness of the sixth smooth transition layer is M 6 The thickness of the seventh smooth transition layer is M 7 The thickness of the eighth smooth transition layer is M 8 The thickness of the ninth smooth transition layer is M 9 The thickness of each smooth transition layer meets a thickness difference formula, wherein the thickness difference formula is as follows:
wherein n=1, 2, … …,8;
A 1 the cross section area of the grid-shaped woven mesh layer is the cross section area;
A 2 is the cross-sectional area of the hollow inner passage;
p is the limited number of turns of the spring contained in the spring-shaped woven mesh layer within the length range of the nth section smooth transition layer;
t is the shear elastic modulus of a spring contained in the spring-shaped woven mesh layer;
θ is the thermal expansion coefficient of the latticed woven mesh layer;
R 1 the diameter of the latticed woven mesh layer is the diameter of the latticed woven mesh layer;
R 2 is the diameter of the spring-shaped woven mesh layer.
Further preferably, the length L of the t-th smooth transition layer t Satisfies a length relation, wherein the length relation is as follows:
wherein t=1, 2, … …,9;
μ 1 an axial spacing of springs contained in the spring-like woven mesh layer;
c 1 a spring winding ratio included in the spring-shaped woven mesh layer;
M t the thickness of the smooth transition layer of the t section;
b is the area of a single grid contained in the grid-shaped woven mesh layer;
alpha is the helix angle of the springs contained in the spring-like woven mesh layer.
Advantageous effects
Compared with the prior art, the invention has the beneficial effects that:
the invention creatively provides an inner diameter difference fitting relation, and the results of verification experiments show that under the condition of the same test conditions, the bending resistance of the nerve microcatheter meeting the inner diameter difference fitting relation is improved by at least 42.3% compared with that of a 'SOFIAFLOW Plus' thrombus absorbing catheter of Japanese Tal metallocene Co, at least 51.6% compared with that of a 3Max model reperfusion catheter of Penumbera company in the United states, at least 50.3% compared with that of a 4Max model reperfusion catheter, and at least 45.9% compared with that of a 5Max model reperfusion catheter.
The bending resistance of the inner tube manufactured by adopting the polyglycolic acid, the deacetylated chitin and the polybutyl lactam is improved by at least 3.6 times compared with that of the inner tube manufactured by adopting the polyglycolic acid alone, the bending resistance of the inner tube manufactured by adopting the deacetylated chitin alone is improved by at least 27.9 times compared with that of the inner tube manufactured by adopting the polybutyl lactam alone, and the bending resistance of the inner tube manufactured by adopting the polybutyl lactam alone is improved by at least 2.7 times.
The invention also creatively provides a blending temperature relation, and the results of verification tests show that under the condition of the same test conditions, the blending temperature relation provided by the application is adopted to control the temperature of the double-screw extruder for melt blending, and compared with the double-screw extruder heated at constant temperature, the bending resistance of the finally manufactured inner pipe is improved by at least 12.3 times.
The nerve microcatheter with improved bending resistance can find the best balance point between the bending resistance and the torque transmission capability of the nerve microcatheter by simultaneously arranging the spring-shaped woven mesh layer and the grid-shaped woven mesh layer, and the bending resistance and the torque transmission capability are both considered, so that the comprehensive performance of the nerve microcatheter is greatly improved. The spring-shaped woven mesh layer can increase the flexibility of the nerve micro-catheter (namely, flexibility means that the nerve micro-catheter can enter into a more tortuous blood vessel), the grid-shaped woven mesh layer can increase the pushing force of the nerve micro-catheter, and meanwhile, the spring-shaped woven mesh layer and the grid-shaped woven mesh layer can increase the pushing force of the nerve micro-catheter and simultaneously increase the control of the nerve micro-catheter and reduce the discount of the nerve micro-catheter.
In addition, the nerve microcatheter is provided with the smooth transition layer on the peripheral wall of the outer layer Pebax pipe layer, and the smooth transition layer comprises a plurality of segments with different hardness, thickness and length. The nerve microcatheter has the characteristics of being most suitable for the region of the nerve blood vessel due to the fact that the hardness, the thickness and the length of each section are different, each section of the smooth transition layer can stay in the region of the nerve blood vessel during positioning, and therefore the overall stress state of the nerve microcatheter can be greatly improved, and the tendency of the nerve microcatheter to retract towards the aorta is avoided.
Drawings
The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate and do not limit the invention.
Fig. 1 is a radial view of a nerve microcatheter with improved kink resistance according to the present invention.
Fig. 2 is an axial view of a nerve microcatheter with improved kink resistance according to the present invention.
Fig. 3 is a schematic structural view of another embodiment of the nerve microcatheter of the present invention.
FIG. 4 is a schematic view of the overall structure of a tubular embryo in a nerve microcatheter according to the present invention.
FIG. 5 is an enlarged partial schematic view of the tube blank shown in FIG. 4.
Fig. 6 is a schematic structural view of a further embodiment of the nerve microcatheter of the present invention.
Detailed Description
The present invention is described in more detail below to facilitate an understanding of the present invention.
As shown in fig. 1 to 2, the nerve micro-catheter according to the present invention comprises an inner tube 101 and an outer tube 102, wherein the inner tube 101 and the outer tube 102 are coaxially arranged, a hollow inner channel 103 extending along an axial direction is formed inside the inner tube 101, and an outer surface of the inner tube 101 is tightly crosslinked, adhered and fixed with an inner surface of the outer tube 102; the inner diameter r of the inner tube 101 1 And the outer tube102 outer diameter r 2 The fitting relation of the difference values of the inner diameter and the outer diameter is satisfied, wherein the fitting relation of the difference values of the inner diameter and the outer diameter is:
wherein a is the thickness of the pipe wall of the inner pipe;
b is the thickness of the pipe wall of the outer pipe;
K 1 is the bending stiffness of the inner tube;
K 2 is the bending stiffness of the outer tube.
The fitting relation between the inner diameter and the outer diameter is obtained through experiments and numerical simulation and is obtained through SCILAB numerical fitting, and the results of verification experiments show that under the condition that the test conditions are the same, the bending resistance of the nerve microcatheter meeting the fitting relation between the inner diameter and the outer diameter is improved by at least 42.3% compared with that of a 'SOFIAFLOW Plus' thrombus absorbing catheter of Japanese Talcum Co., ltd., at least 51.6% compared with that of a 3Max type reperfusion catheter of Penumbra company in the United states, at least 50.3% compared with that of a 4Max type reperfusion catheter, and at least 45.9% compared with that of a 5Max type reperfusion catheter.
Preferably, the preparation method of the inner tube 101 is as follows: mixing polyglycolic acid and deacetylated chitin according to the mass ratio of 7:3 to obtain a first mixture, mixing the first mixture and polybutylece lactam according to the mass ratio of 20:1 to obtain a second mixture, placing the second mixture into a freezing chamber, regulating the temperature to minus 20 ℃, and cooling for more than 36 hours; the longer the storage time in the freezer compartment, the higher the mechanical stability; drying the cooled second mixture at a constant temperature of 45 ℃ for 9 hours, then feeding the cooled second mixture into a double-screw extruder for melt blending, cooling a sample obtained after melt blending, granulating by a granulator, preparing a sample strip by an injection molding machine, pressing the sample strip into a sheet material by a roll pressing machine, winding the sheet material on the outer surface of a bar composed of water-soluble polymers by a tube winding machine to obtain an inner tube blank with a plurality of layers of sheet materials wound on the outer surface of the bar, soaking the inner tube blank in deionized water for more than 72 hours, dissolving and washing the bar composed of the water-soluble polymers by the deionized water, simultaneously, tightly adhering the plurality of layers of sheet materials of the inner tube blank by the deionized water (the inner tube blank can not be separated again after drying), and drying the inner tube blank after soaking and washing at 50 ℃ to 55 ℃ for 3 hours to obtain the inner tube 101 with the hollow inner channel 103 extending along the axial direction.
Preferably, the average molecular weight of the polyglycolic acid is 20000 to 145000.
Preferably, the deacetylated chitin has an average molecular weight of 65000 to 170000.
Preferably, the polybutyl lactam has an average molecular weight of 15000 to 35000.
The average molecular weight of polyglycolic acid, deacetylated chitin and polybutyl lactam is selected mainly by considering the fusion degree of the polyglycolic acid, the deacetylated chitin and the polybutyl lactam and the processing difficulty of a double-screw extruder and an injection molding machine. Experimental results show that if the average molecular weight of polyglycolic acid is less than 20000, the average molecular weight of deacetylated chitin is less than 65000, the average molecular weight of polybutylece lactam is less than 15000, the hardness of the mixture formed after mixing is low, the desired shape cannot be formed when processed by a twin screw extruder and an injection molding machine, even if the mixture is forcibly wound on a bar composed of a water-soluble polymer, after the bar composed of a water-soluble polymer is dissolved out and washed away by deionized water, the inner tube 101 in which the hollow inner channel 103 extending in the axial direction is formed cannot be obtained due to insufficient hardness, and collapse is easy. If the average molecular weight of polyglycolic acid is higher than 145000, the average molecular weight of deacetylated chitin is higher than 170000, the average molecular weight of polybutyl lactam is higher than 35000, the fusion degree of the three is very low, and the formed inner tube is easy to crack. However, if the inner tube is made of a single material, the experimental results show that the inner tube made of a single polyglycolic acid, deacetylated chitin or polybutylectam is not ideal in terms of bending resistance. The bending resistance of the inner tube made of the three materials of polyglycolic acid, deacetylated chitin and polybutyl lactam is improved by at least 3.6 times compared with that of the inner tube made of the polyglycolic acid alone, the bending resistance of the inner tube made of the deacetylated chitin alone is improved by at least 27.9 times, and the bending resistance of the inner tube made of the polybutyl lactam alone is improved by at least 2.7 times.
Preferably, the temperature of the melt blending of the twin-screw extruder is in accordance with a blending temperature curve, the blending temperature curve satisfies a blending temperature relational expression, and the blending temperature relational expression is:
wherein T is the temperature of the double-screw extruder for melt blending, and the unit is the temperature; t is the time in minutes for the second mixture to enter the twin screw extruder.
The blending temperature relational expression is obtained by fitting test data and using SCILAB values, and the results of verification tests show that under the condition of the same test conditions, the blending temperature relational expression provided by the application is adopted to control the temperature of the double-screw extruder for melt blending, and compared with the double-screw extruder heated at constant temperature, the bending resistance of the finally manufactured inner tube is improved by at least 12.3 times.
The rotating speed of the double-screw extruder is 60r/min.
The injection pressure of the injection molding machine is 5.8MPa to 6.5MPa.
Preferably, the preparation method of the outer tube 102 is as follows: mixing polycaprolactone and dichloromethane to prepare a first solution with the mass concentration of 15-20%, adding sodium alginate accounting for 25-30% of the mass of the first solution into the first solution, mechanically stirring for 1 hour to form an intermediate mixture, immersing an inner tube into the intermediate mixture, controlling the inner tube to rotate in the intermediate mixture at the rotating speed of 20r/min for 15 minutes, taking out the inner tube, and drying in a dryer for 20 minutes; the inner tube is again immersed in the intermediate mixture and the immersing, spinning and drying steps are repeated at least 5 times.
Preferably, the drying temperature of the dryer accords with a drying temperature curve, the drying temperature curve satisfies a drying temperature relation, and the drying temperature relation is:
wherein T is 1 The unit is the drying temperature of the dryer; t is t 1 The time in minutes for the inner tube to enter the dryer is given.
The result of the verification test shows that under the condition of the same test condition, the drying temperature is controlled by adopting the drying temperature curve provided by the application, and compared with the constant-temperature drying, the bending resistance of the finally manufactured nerve microcatheter is improved by at least 4.3 times.
The applicant also found during the development that the nerve microcatheter is contradictory between buckling resistance and torque transmission capability during the insertion into a blood vessel, that is, the nerve microcatheter in the prior art has strong buckling resistance and generally has poor torque transmission capability; the torque transmission capability is strong and the bending resistance is generally poor. The contradiction between bending resistance and torque transmission capability can not be well solved in the field, and an optimal balance point can not be found between the bending resistance and the torque transmission capability.
In addition, in clinical use, the applicant has found that the prior art nerve microcatheters have a tendency to retract toward the aorta when they are advanced into the common carotid artery and intracranial anatomy due to resistance caused by tortuosity and diameter of the blood vessels. At this point the physician needs to divert his attention from the treatment site (i.e., where the thrombus is located) to repositioning the neuromicrocatheter, often requiring the physician to adjust the angiographic field of view to a location away from the intracranial vasculature. In some clinical settings, encountering this condition also requires the physician to remove the neuromicrocatheter, and reselect the neurovascular branch vessel from the aorta for interventional procedures. In many cases, the problem of nerve microcatheter retraction is repeatedly addressed by the physician during a single treatment procedure, greatly affecting the efficiency of the treatment.
Applicant's analysis found that the main cause of nerve microcatheter retraction was due to the limited length of nerve microcatheters and their greater flexibility, so that prior art nerve microcatheters tended to reside in the proximal neurovascular system (relatively straight vessel). This position makes the nerve microcatheter necessary to resist the posteriorly directed forces transmitted from the common carotid artery and intracranial anatomy. Additionally, because the prior art nerve microcatheters have flexible contours that are not optimally designed for intracranial access, they tend to retract when subjected to rearward forces transmitted from the common carotid artery and intracranial anatomy.
Another aspect of the present application is therefore to solve the technical problem of finding an optimal balance between kink resistance and torque transmission capability and providing greater support to avoid the tendency of the nerve microcatheter to retract.
In order to solve the above-mentioned technical problems, in another embodiment of the present application, as shown in fig. 3 and 4, the present invention further provides a nerve micro-catheter with improved bending resistance, including an inner tube 101 and an outer tube 102, other features are the same as those of the embodiment shown in fig. 1 and 2, except that the nerve micro-catheter in this embodiment further includes a catheter hub 1, a catheter hub sheath 2 and a guiding sheath 3, the outer peripheral wall of the outer tube 102 is tightly wound with a spring-shaped woven mesh layer 42, the outer peripheral wall of the spring-shaped woven mesh layer 42 is tightly wound with a mesh-shaped woven mesh layer 43, the outer peripheral wall of the mesh-shaped woven mesh layer 43 is tightly wound with an outer Pebax (block polyether amide resin) tube layer 44, and the guiding sheath 3 is slidably sleeved on the outer peripheral wall of the outer Pebax tube layer 44; a conduit channel is arranged in the conduit seat 1 and is fixedly connected with the inner tube 101 through conduit seat light, so that the conduit channel is communicated with the hollow inner channel 103 of the inner tube 101; the catheter seat sheath 2 wraps the light-cured outside of the catheter seat and wraps at least the catheter seat 1 and a part of the inner tube 101; the free end of the catheter hub 1 is provided with an opening 11 through which opening 11 the catheter passage and the hollow inner passage 103 of the inner tube 101 can be accessed.
The guide sheath 3 is slidably sleeved on the outer peripheral wall of the outer Pebax pipe layer 44. Since the front end of the microcatheter is soft, the front end of the microcatheter may be bent and deformed or may not be inserted due to insufficient supporting force when the device is accessed. The guiding sheath has better supporting force, and the guiding sheath has the function of establishing a channel before the micro-catheter is inserted into the instrument, so that the micro-catheter is convenient to insert. The guiding sheath can be withdrawn after the microcatheter is inserted into the device.
Preferably, the outer Pebax tube layer 44 is coated with a hydrophilic coating 6 on its outer peripheral wall.
The nerve microcatheter further comprises a mandrel 5, wherein the mandrel 5 is inserted into the hollow inner channel 103 of the inner tube 101.
The mandrel 5 is used to prevent unwanted buckling of the nerve microcatheter during packaging. The mandrel 5 is pulled out when in use.
Preferably, the mesh-like woven mesh layer 43 has a diamond mesh shape.
The hydrophilic coating 6 can improve the traceability (trackability) of the nerve microcatheter; the inner tube 101 facilitates pushing the micro-spring emboli through the nerve microcatheter.
The spring-shaped woven mesh layer 42 can increase the flexibility of the nerve microcatheter (flexibility means that the nerve microcatheter can enter into a more tortuous blood vessel), the grid-shaped woven mesh layer 43 can increase the pushing force of the nerve microcatheter, meanwhile, the spring-shaped woven mesh layer 42 and the grid-shaped woven mesh layer 43 can increase the pushing force of the nerve microcatheter and simultaneously increase the control of the nerve microcatheter and reduce the bending of the nerve microcatheter, and a large number of experimental results show that the optimal balance point can be found between the bending resistance and the torque transmission capability of the nerve microcatheter by simultaneously arranging the spring-shaped woven mesh layer 42 and the grid-shaped woven mesh layer 43, so that the bending resistance and the torque transmission capability are both considered, and the comprehensive performance of the nerve microcatheter is greatly improved.
Preferably, the length L of the inner tube 101 is 150 cm, 155 cm or 160 cm.
The inner diameter of the inner tube 101 is 0.38 mm, 0.43 mm, 0.53 mm or 0.69 mm.
The above specific values of the length and the inner diameter are only preferred values of the present invention, but do not constitute a specific limitation on the scope of the present invention, and those skilled in the art may reasonably change the specific values of the length and the inner diameter on the basis of the present invention, and such changes are also within the scope of the present invention.
The invention further provides a nerve microcatheter in one embodiment, which aims at solving the problem that the nerve microcatheter in the prior art tends to retract towards the aorta due to resistance caused by tortuosity of blood vessels and diameters of blood vessels when the nerve microcatheter enters the carotid artery and intracranial anatomy.
In the embodiment shown in fig. 6, the outer Pebax pipe layer 44 is further tightly wrapped with a smooth transition layer 8 on the outer peripheral wall, and the smooth transition layer 8 includes a plurality of segments having different hardness, thickness and length.
Although the steps are formed between the adjacent segments due to the different thicknesses shown in fig. 6, in reality, fig. 6 is an enlarged process of the smooth transition layer 8, and since the diameter of the nerve micro-catheter itself is small, no obvious step is felt on the different segments of the smooth transition layer 8, and the smooth transition layer 8 is still smooth on the whole, but the difference in the small thickness and the variation in the hardness and the length can greatly improve the overall stress state of the nerve micro-catheter, so as to avoid the tendency of the nerve micro-catheter to retract toward the aorta.
Preferably, the smooth transition layer 8 includes a first smooth transition layer 8a, a second smooth transition layer 8b, a third smooth transition layer 8c, a fourth smooth transition layer 8D, a fifth smooth transition layer 8e, a sixth smooth transition layer 8f, a seventh smooth transition layer 8g, an eighth smooth transition layer 8h and a ninth smooth transition layer 8i, wherein the hardness of the first smooth transition layer 8a is 80D, the hardness of the second smooth transition layer 8b is 81D, the hardness of the third smooth transition layer 8c is 83D, the hardness of the fourth smooth transition layer 8D is 89D, the hardness of the fifth smooth transition layer 8e is 85D, the hardness of the sixth smooth transition layer 8f is 84D, the hardness of the seventh smooth transition layer 8g is 87D, the hardness of the eighth smooth transition layer 8h is 86D, and the hardness of the ninth smooth transition layer 8i is 82D.
Further preferably, the first smooth transition layer 8a has a thickness M 1 The second smooth transition layer 8b has a thickness M 2 The thickness of the third smooth transition layer 8c is M 3 The fourth smooth transition layer 8d has a thickness M 4 The thickness of the fifth smooth transition layer 8e is M 5 The thickness of the sixth smooth transition layer 8f is M 6 The thickness of the seventh smooth transition layer 8g is M 7 The thickness of the eighth smooth transition layer 8h is M 8 The ninth smooth transition layer 8i has a thickness M 9 The thickness of each smooth transition layer meets a thickness difference formula, wherein the thickness difference formula is as follows:
wherein n=1, 2, … …,8;
A 1 the cross section area of the grid-shaped woven mesh layer is the cross section area;
A 2 is the cross-sectional area of the hollow interior passage 103;
p is the limited number of turns of the spring contained in the spring-shaped woven mesh layer within the length range of the nth section smooth transition layer;
t is the shear elastic modulus of a spring contained in the spring-shaped woven mesh layer;
θ is the thermal expansion coefficient of the latticed woven mesh layer;
R 1 the diameter of the latticed woven mesh layer is the diameter of the latticed woven mesh layer;
R 2 is the diameter of the spring-shaped woven mesh layer.
Further preferably, the length L of the t-th smooth transition layer t Satisfy the length relation, whatThe length relation is as follows:
wherein t=1, 2, … …,9;
μ 1 an axial spacing of springs contained in the spring-like woven mesh layer;
c 1 a spring winding ratio included in the spring-shaped woven mesh layer;
M t the thickness of the smooth transition layer of the t section;
b is the area of a single grid contained in the grid-shaped woven mesh layer;
alpha is the helix angle of the springs contained in the spring-like woven mesh layer.
The applicant of the present application obtains the above thickness difference formula and length relation through a great number of experiments and numerical simulation, and the hardness of each segment of the smooth transition layer 8 and each segment is also the best value obtained through a great number of experiments, and because the hardness, thickness and length of each segment are different, the property of the nerve microcatheter of the present invention is most suitable for the area of the nerve blood vessel, and each segment of the smooth transition layer 8 can stay in the area of the nerve blood vessel during positioning, so that the overall stress state of the nerve microcatheter can be greatly improved, and the tendency of the nerve microcatheter to retract towards the aorta is avoided.
The smooth transition layer 8 is made of Pebax or polyurethane, and the first section of smooth transition layer 8a, the second section of smooth transition layer 8b, the third section of smooth transition layer 8c, the fourth section of smooth transition layer 8d, the fifth section of smooth transition layer 8e and the sixth section of smooth transition layer 8f are made of Pebax or polyurethane, so that the smooth transition layer has enough flexibility and kink resistance; the seventh, eighth and ninth smooth transition layers 8g, 8h and 8i are made of nylon materials to provide sufficient supporting force. The hydrophilic coating can be polyvinylpyrrolidone or polyacrylamide.
Preferably, a developing ring 7 is further disposed between the first smooth transition layer 8a and the outer tube 102, and the developing ring 7 is doped with a radiopaque material, such as barium sulfate.
Further preferably, a plurality of developing rings, for example, two developing rings, including a first developing ring and a second developing ring, may be disposed between the first smooth transition layer 8a and the outer tube 102, the first developing ring being spaced from the outlet of the outer tube 102 by 0.6mm, and the second developing ring being spaced from the first developing ring by 30mm, and the two developing rings may serve to measure a distance during an operation.
The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations to the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.

Claims (9)

1. The nerve micro-catheter with improved bending resistance performance is characterized by comprising an inner tube and an outer tube, wherein the inner tube and the outer tube are coaxially arranged, a hollow inner channel extending along the axial direction is formed inside the inner tube, and the outer surface of the inner tube is tightly crosslinked, adhered and fixed with the inner surface of the outer tube; the inner diameter r of the inner tube 1 With the outer diameter r of the outer tube 2 The fitting relation of the difference values of the inner diameter and the outer diameter is satisfied, wherein the fitting relation of the difference values of the inner diameter and the outer diameter is:
wherein a is the thickness of the pipe wall of the inner pipe;
b is the thickness of the pipe wall of the outer pipe;
K 1 is the bending stiffness of the inner tube;
K 2 is the bending stiffness of the outer tube;
the preparation method of the inner tube comprises the following steps: mixing polyglycolic acid and deacetylated chitin according to the mass ratio of 7:3 to obtain a first mixture, mixing the first mixture and polybutylece lactam according to the mass ratio of 20:1 to obtain a second mixture, placing the second mixture into a freezing chamber, regulating the temperature to minus 20 ℃, and cooling for more than 36 hours; drying the cooled second mixture at a constant temperature of 45 ℃ for 9 hours, then feeding the cooled second mixture into a double-screw extruder for melt blending, cooling a sample obtained after melt blending, granulating by a granulator, preparing a sample strip by an injection molding machine, pressing the sample strip into a sheet material by a roll pressing machine, winding the sheet material on the outer surface of a bar composed of water-soluble polymers by a tube winding machine to obtain an inner tube blank with a plurality of layers of sheet materials wound on the outer surface of the bar, soaking the inner tube blank in deionized water for more than 72 hours, dissolving and washing the bar composed of the water-soluble polymers by the deionized water, simultaneously enabling the deionized water to promote tight adhesion between the plurality of layers of sheet materials of the inner tube blank, and drying the inner tube blank after soaking and washing at 50-55 ℃ for 3 hours to obtain the inner tube with a hollow inner channel 103 extending along the axial direction.
2. The nerve microcatheter with improved kink resistance as in claim 1, wherein the average molecular weight of the polyglycolic acid is 20000 to 145000.
3. The nerve microcatheter with improved kink resistance according to claim 1, wherein the deacetylated chitin has an average molecular weight of 65000 to 170000.
4. The nerve microcatheter with improved kink resistance according to claim 1, wherein the polybutyl lactam has an average molecular weight of 15000 to 35000.
5. The nerve microcatheter with improved kink resistance of claim 1 wherein the temperature at which the twin screw extruder is melt blended conforms to a blending temperature profile that satisfies a blending temperature relationship:
wherein T is the temperature of the double-screw extruder for melt blending, and the unit is the temperature; t is the time in minutes for the second mixture to enter the twin screw extruder.
6. The nerve microcatheter with improved kink resistance of claim 1 wherein the twin screw extruder is at a speed of 60r/min.
7. The nerve microcatheter with improved kink resistance of claim 1 wherein the injection pressure of the injection molding machine is 5.8MPa to 6.5MPa.
8. The nerve microcatheter with improved kink resistance of claim 1 wherein the outer tube is prepared by the process of: mixing polycaprolactone and dichloromethane to prepare a first solution with the mass concentration of 15-20%, adding sodium alginate accounting for 25-30% of the mass of the first solution into the first solution, mechanically stirring for 1 hour to form an intermediate mixture, immersing an inner tube into the intermediate mixture, controlling the inner tube to rotate in the intermediate mixture at the rotating speed of 20r/min for 15 minutes, taking out the inner tube, and drying in a dryer for 20 minutes; the inner tube is again immersed in the intermediate mixture and the immersing, spinning and drying steps are repeated at least 5 times.
9. The nerve microcatheter with improved kink resistance of claim 8 wherein the dryer has a drying temperature that meets a drying temperature profile that satisfies a drying temperature relationship:
wherein T is 1 The unit is the drying temperature of the dryer; t is t 1 The time in minutes for the inner tube to enter the dryer is given.
CN202310978877.7A 2023-08-04 2023-08-04 Nerve microcatheter with improved kink resistance Active CN116899072B (en)

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