CN113197620B - Nerve micro-catheter - Google Patents
Nerve micro-catheter Download PDFInfo
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- CN113197620B CN113197620B CN202110482120.XA CN202110482120A CN113197620B CN 113197620 B CN113197620 B CN 113197620B CN 202110482120 A CN202110482120 A CN 202110482120A CN 113197620 B CN113197620 B CN 113197620B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
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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
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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
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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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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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
- A61M25/0043—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
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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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
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Abstract
The invention relates to a nerve micro-catheter, which comprises a catheter seat, a catheter seat sheath, a guide sheath and a nerve micro-catheter tube blank, wherein the nerve micro-catheter tube blank comprises an inner-layer PTFE tube layer, a middle-layer stainless steel woven mesh and an outer-layer Pebax tube layer, the middle-layer stainless steel woven mesh comprises a spring-shaped woven mesh layer and a grid-shaped woven mesh layer, the inner-layer PTFE tube layer is a hollow tube body, and the spring-shaped woven mesh layer is tightly wound on the outer peripheral wall of the inner-layer PTFE tube layer; the latticed woven mesh layer is tightly wound on the outer peripheral wall of the spring-shaped woven mesh layer; the outer Pebax tube layer is tightly wrapped on the outer peripheral wall of the latticed woven net layer; the guide sheath is slidably sleeved on the outer peripheral wall of the nerve micro-catheter tube blank; a catheter channel is arranged in the catheter seat and is optically connected with the nerve micro-catheter tube blank through the catheter seat; the catheter base jacket is wrapped outside the catheter base light-cured part; the free end of the catheter hub is provided with an opening through which the hollow tube body of the catheter channel and the inner PTFE tube layer can be accessed.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a nerve micro-catheter.
Background
The nerve micro-catheter is a medical apparatus for treating cerebral neurovascular embolism, also known as cerebral apoplexy, cerebral thrombosis and cerebral apoplexy, which are classified into hemorrhagic stroke (cerebral hemorrhage or subarachnoid hemorrhage) and ischemic stroke (cerebral infarction and cerebral thrombosis), wherein the ischemic stroke is the most common one, has acute morbidity and high mortality and disability rate.
According to statistics, 250 ten thousand new stroke diseases per year, about 150 ten thousand dead people, account for 22.45 percent of death cases of various diseases, and show a rising trend year by year. According to the mortality rate of 240 diseases in China in 1990-2013 published in "Lancet" in 2015: a systematic analysis of the provincial level of the study of global disease burden in 2013 survey showed that stroke has become the most lethal disease. Among the surviving patients, about three-quarters are disabled to different degrees, the severe disabled accounts for about 40%, and the treatment cost for the disease in 2014 reaches more than 100 billion yuan.
Therapeutic methods for stroke typically include drug thrombolysis and mechanical embolectomy. The drug thrombolytic is the first used method for treating cerebral apoplexy, common thrombolytic drugs comprise alteplase, butylphthalide, rivaroxaban, etoxaban-p-toluenesulfonate and the like, wherein the alteplase is the only thrombolytic drug approved by FDA for ischemic cerebral apoplexy and is the national class B medical insurance drug at present, 20mg price 2402.4 yuan is recommended in Hubei in 2013, 50mg price 5443.34 yuan is recommended in Hubei, generally more than 50mg can be used by one patient, 100mg can be used at most, and 7000 and 8000 yuan can be estimated to be spent by each patient on average. The alteplase belongs to a second generation thrombolytic drug, has fibrin selectivity compared with urokinase and streptokinase which are first generation thrombolytic drugs, and does not cause the phenomenon of systemic fibrinolysis. The disadvantage is that the half-life is relatively short as with the first generation thrombolytic drugs and the risk of causing bleeding is high.
If the thrombolytic drug is directly injected or orally taken, the drug utilization rate is low, and the action speed is slow, so with the mature development of guide wire and catheter technologies, a plurality of products are not directly injected or orally taken any more at present, but the drug is coated on the surface of the balloon or stent, and the balloon or stent coated with the drug is delivered to the thrombus for release through an operation, so that the effect is better, and the effect is faster.
The main methods of mechanical thrombus extraction include intravascular thrombus extraction, thrombus suction, mechanical thrombus breaking, thrombus entrapment and latest stent-like thrombus extraction. Most of these devices are in animal testing and preclinical research. Since the first generation of mechanical embolectomy devices did not achieve satisfactory results in terms of recanalization rate and prognosis, a second generation of embolectomy devices based on the stent-sampling embolectomy (stenriever) technique has emerged in recent years. Stentriever is shaped like a stent and collects blood clots on the stent, pulling the stent along with the blood clots away from the vessel. The device is soft in trunk, can easily pass through intracranial tortuous vessels, and is specially used for acute occlusion of the vessels caused by thrombosis of the large vessels. The currently most clinically used products mainly include "sofafilow Plus" thrombus-absorbing catheter from talmopene corporation of japan, TronFX thrombectomy stents from delmopene corporation, and Penumbra max series reperfusion catheters from Penumbra corporation of america.
Cerebral infarction is a cerebrovascular disease in which brain tissue is damaged due to thrombus caused by the blockage of blood vessels in the brain. The thrombus-absorbing catheter is a medical instrument that is inserted into a cerebral blood vessel from the foot root to suck thrombus and to allow the blood to flow back. The thrombus-absorbing catheter "soffiafwow Plus" of tylocene corporation, japan is a large-diameter catheter suitable for thrombus recovery, and can rapidly reach a diseased site even in a highly tortuous cerebral blood vessel.
The stent-type thrombus removal device is a medical instrument which is attached to a stent (a mesh tube made of metal) at the tip of a catheter and can lock thrombus in a cerebral vessel and allow blood to pass through. A Tronfx thrombus-removal stent of Delmopo corporation is a stent-type thrombus removal device for treating acute cerebral infarction, and because of its improved flexibility, stents having a diameter of 2mm are used in a unified manner, and thrombus in a thinner peripheral blood vessel can be easily recovered.
Penumbra Max series reperfusion catheters of Penumbra company in America are a device for recanalizing blood vessels of patients suffering from acute ischemic stroke secondary to large vessel obstructive disease, and the specific models of the catheters comprise 3Max, 4Max and 5 Max. The 3Max and 4Max systems employ maximum tracking technology that allows for ease of use by individual guidewires, while the 5Max has Max series of tracking capabilities and greater throughput.
Research shows that the bending resistance and the torque transmission capacity of the nerve micro-catheter are contradictory in the process of inserting the nerve micro-catheter into a blood vessel, namely, the nerve micro-catheter in the prior art has strong bending resistance and generally has poor torque transmission capacity; the torque transmission capability is strong, and the bending resistance is generally poor. The art has not been able to solve the contradiction between the bending resistance and the torque transmission capability well and find an optimal balance point between the two.
In addition, in clinical use, the applicant has found that the nerve microcatheter in the prior art tends to retract back towards the aorta when entering the common carotid artery and intracranial anatomical structures due to resistance caused by the tortuosity and diameter of the blood vessels. The physician needs to divert attention from the treatment site (i.e., where the thrombus is) to repositioning the neuro-microcatheter, often requiring the physician to adjust the angiographic field of view to a location away from the intracranial vasculature. In some clinical settings, this condition may be met by removing the nerve microcatheter and reselecting a branch of the neurovascular from the aorta for interventional procedures. In many cases, the problem of nerve microcatheter retraction needs to be repeatedly addressed by the physician during a single treatment procedure, greatly affecting the efficiency of the treatment.
The applicant has analyzed that the main reason for the retraction of the nerve microcatheter is that the nerve microcatheter of the prior art tends to stay in the proximal neurovascular system (relatively straight blood vessels) due to its limited length and greater flexibility. This location requires the nerve microcatheter to resist the rearward forces transmitted from the common carotid artery and intracranial anatomy. In addition, because the prior art neuro-microcatheters have flexible profiles that are not optimally designed for entry into the cranium, they are prone to recoil when subjected to rearward forces transmitted from the common carotid artery and intracranial anatomy.
Disclosure of Invention
The invention aims to provide a nerve micro-catheter, and the technical problems to be solved comprise how to find the optimal balance point between the bending resistance and the torque transmission capacity and provide greater supporting force to avoid the tendency of the nerve micro-catheter to retract.
The invention aims to solve the defects of the prior art and provides a nerve micro-catheter which comprises a catheter seat, a catheter seat sheath, a guide sheath and a nerve micro-catheter tube blank, wherein the nerve micro-catheter tube blank comprises an inner-layer PTFE tube layer, a middle-layer stainless steel woven net and an outer-layer Pebax tube layer, the middle-layer stainless steel woven net comprises a spring-shaped woven net layer and a grid-shaped woven net layer, the inner-layer PTFE tube layer is a hollow tube body, and the spring-shaped woven net layer is tightly wound on the outer peripheral wall of the inner-layer PTFE tube layer; the latticed woven mesh layer is tightly wound on the outer peripheral wall of the spring-shaped woven mesh layer; the outer Pebax tube layer is tightly wrapped on the outer peripheral wall of the latticed woven net layer; the guide sheath is slidably sleeved on the outer peripheral wall of the nerve micro-catheter tube blank; a catheter channel is arranged in the catheter seat and is optically connected with the nerve micro-catheter tube blank through the catheter seat, so that the catheter channel is communicated with the hollow tube body of the inner PTFE tube layer; the catheter base sheath is wrapped outside the catheter base and at least wraps the catheter base and a part of the nerve micro-catheter tube blank; the free end of the catheter hub is provided with an opening through which the catheter channel and the hollow tube of the inner PTFE tube layer can be accessed.
Preferably, the outer Pebax tube layer has a hydrophilic coating on its outer peripheral wall.
The nerve micro-catheter also comprises a mandrel, and the mandrel is inserted into the hollow tube body of the inner PTFE tube layer.
Preferably, the shape of the latticed woven mesh layer is a rhombic grid.
Preferably, the length of the nerve micro-catheter tube blank is 150 cm, 155 cm or 160 cm.
The inner diameter of the inner PTFE tube layer is 0.38 millimeters, 0.43 millimeters, 0.53 millimeters, or 0.69 millimeters.
The outer Pebax tube layer is characterized in that the outer peripheral wall of the outer Pebax tube layer is tightly wrapped with a smooth transition layer, and the smooth transition layer comprises a plurality of sections 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, where 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 thickness of the first smooth transition layer is M1The thickness of the second smooth transition layer is M2The thickness of the third smooth transition layer is M3The thickness of the fourth smooth transition layer is M4The thickness of the fifth smooth transition layer is M5The thickness of the sixth smooth transition layer is M6The thickness of the seventh smooth transition layer is M7The thickness of the eighth smooth transition layer is M8The thickness of the ninth smooth transition layer is M9The thickness of each smooth transition layer satisfies a thickness difference formula, wherein the thickness difference formula is as follows:
wherein n is 1,2, … …, 8;
A1the cross section area of the grid-shaped woven net layer is the cross section area of the grid-shaped woven net layer;
A2the cross-sectional area of the inner PTFE tube layer;
p is the limited number of the spring contained in the spring-shaped woven net layer within the length range of the nth section of the smooth transition layer;
t is the shear elastic modulus of the spring contained in the spring-like woven mesh layer;
theta is the thermal expansion coefficient of the latticed knitted net layer;
R1the diameter of the grid-shaped woven net layer;
R2the diameter of the spring-like woven mesh layer.
Further preferably, the length L of the t-th section smooth transition layertThe length relation is satisfied, and the length relation is as follows:
wherein t is 1,2, … …, 9;
μ1axial spacing of springs contained for said spring-like woven mesh layer;
c1a spring winding ratio of the spring included in the spring-like knitted mesh layer;
Mtthe thickness of the smooth transition layer at the t section;
b is the area of a single grid contained in the grid-shaped woven net layer;
alpha is the helix angle of the spring contained in the spring-like braided mesh layer.
Advantageous effects
Compared with the prior art, the invention has the beneficial effects that:
the nerve micro-catheter is provided with the spring-shaped woven net layer and the grid-shaped woven net layer simultaneously, so that an optimal balance point can be found between the bending resistance and the torque transmission capacity of the nerve micro-catheter, the bending resistance and the torque transmission capacity are both considered, and the comprehensive performance of the nerve micro-catheter is greatly improved. The spring-shaped woven net layer can increase flexibility of the nerve micro-catheter (flexibility means that the nerve micro-catheter can enter a more tortuous blood vessel), the grid-shaped woven net layer can increase pushing force of the nerve micro-catheter, and the spring-shaped woven net layer and the grid-shaped woven net layer can increase pushing force of the nerve micro-catheter, increase control of the nerve micro-catheter and reduce folding of the nerve micro-catheter.
In addition, the nerve micro-catheter is arranged on the outer peripheral wall of the outer Pebax tube layer and is provided with a smooth transition layer, and the smooth transition layer comprises a plurality of sections with different hardness, thickness and length. Because the hardness, the thickness and the length of each section are different, the property of the nerve micro-catheter is most suitable for the area of the neurovascular, and each section of the smooth transition layer can stay in the area of the neurovascular during positioning, so that the overall stress state of the nerve micro-catheter can be greatly improved, and the nerve micro-catheter is prevented from generating the tendency of retracting to the aorta.
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 embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention.
Fig. 1 is a schematic structural view of a nerve micro-catheter according to the present invention.
FIG. 2 is a schematic diagram of the overall structure of the tube embryo in the nerve microcatheter of the present invention.
FIG. 3 is an enlarged partial schematic view of the blank shown in FIG. 2.
Fig. 4 is a schematic structural view of another embodiment of the nerve micro-catheter according to 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 3, the neuro-microcatheter of the present invention comprises a catheter holder 1, a catheter holder sheath 2, a guiding sheath 3 and a neuro-microcatheter tube blank 4, wherein the neuro-microcatheter tube blank 4 comprises an inner PTFE (polytetrafluoroethylene) tube layer 41, a middle stainless steel woven mesh and an outer Pebax (block polyether amide resin) tube layer 44, the middle stainless steel woven mesh comprises a spring-like woven mesh layer 42 and a grid-like woven mesh layer 43, the inner PTFE tube layer 41 is a hollow tube, and the spring-like woven mesh layer 42 is tightly wound on the outer circumferential wall of the inner PTFE tube layer 41; the grid-shaped woven net layer 43 is tightly wound on the outer peripheral wall of the spring-shaped woven net layer 42; the outer Pebax tube layer 44 is tightly wrapped on the outer peripheral wall of the latticed woven mesh layer 43; the guide sheath 3 is slidably sleeved on the outer peripheral wall of the nerve micro-catheter tube blank 4; a catheter channel is arranged in the catheter base 1, and the catheter channel is optically connected with the nerve micro-catheter tube blank 4 through the catheter base, so that the catheter channel is communicated with the hollow tube body of the inner PTFE tube layer 41; the catheter base sheath 2 is wrapped outside the catheter base and at least wraps the catheter base 1 and a part of the nerve micro-catheter tube blank 4; the free end of the catheter hub 1 is provided with an opening 11 through which opening 11 the catheter channel and the hollow tube of the inner PTFE tube layer 41 can be accessed.
The guide sheath 3 is slidably sleeved on the peripheral wall of the nerve micro-catheter tube blank 4. Since the tip of the microcatheter is flexible, the tip of the microcatheter may bend or become non-insertable during insertion into the device due to insufficient support. The guide sheath has better supporting force, and the function of the guide sheath is to establish a channel before the micro catheter is inserted into the instrument, so that the micro catheter can be conveniently inserted. The guide sheath can be withdrawn after the micro-catheter is inserted into the instrument.
Preferably, the outer Pebax tube layer 44 has a hydrophilic coating 6 on its outer peripheral wall.
The nerve micro-catheter also comprises a mandrel 5, and the mandrel 5 is inserted into the hollow tube body of the inner PTFE tube layer 41.
The mandrel 5 serves to prevent the nerve microcatheter from undesirably bending during packaging. When in use, the mandrel 5 is drawn out.
Preferably, the shape of the mesh-like woven net layer 43 is a diamond mesh.
The hydrophilic coating 6 can improve the trackability (trackability) of the nerve micro-catheter; the inner PTFE tube layer 41 facilitates the pushing of the microspring emboli through the nerve microcatheter.
The spring-shaped woven mesh layer 42 can increase flexibility of the nerve microcatheter (flexibility means that the nerve microcatheter can enter a more tortuous blood vessel), the grid-shaped woven mesh layer 43 can increase pushing force of the nerve microcatheter, and the spring-shaped woven mesh layer 42 and the grid-shaped woven mesh layer 43 can increase control of the nerve microcatheter and reduce bending of the nerve microcatheter while increasing the pushing force of the nerve microcatheter, and a large number of experimental results show that by arranging the spring-shaped woven mesh layer 42 and the grid-shaped woven mesh layer 43 at the same time, an optimal balance point can be found between bending resistance and torque transmission capacity of the nerve microcatheter, bending resistance and torque transmission capacity are both considered, and comprehensive performance of the nerve microcatheter is greatly improved.
Preferably, the length L of the nerve micro-catheter tube blank 4 is 150 cm, 155 cm or 160 cm.
The inner diameter of the inner PTFE tube layer 41 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 specific limitations to the scope of the present invention, and those skilled in the art can reasonably change the specific values of the length and the inner diameter based on the present invention, and such changes also fall within the scope of the present invention.
Aiming at the problem that the nerve micro-catheter in the prior art tends to retract towards the aorta due to resistance caused by the tortuosity and the diameter of the blood vessel when entering the common carotid artery and the intracranial anatomical structure, the invention also provides the nerve micro-catheter of the following embodiment.
In the embodiment shown in fig. 4, the outer Pebax tube layer 44 further has a smooth transition layer 8 tightly wrapped around the outer peripheral wall, and the smooth transition layer 8 includes a plurality of segments with different hardness, thickness and length.
Although the adjacent segments shown in fig. 4 have step portions due to different thicknesses, actually fig. 4 is an enlarged view of the smooth transition layer 8, and since the diameter of the nerve microcatheter itself is small, the obvious step portions cannot be felt on the different segments of the smooth transition layer 8, and the smooth transition layer 8 is still smooth as a whole, but the small thickness difference and the change of hardness and length can greatly improve the overall stress state of the nerve microcatheter and avoid the tendency of the nerve microcatheter to retract into the aorta.
Preferably, the smooth transition layer 8 comprises a first section of smooth transition layer 8a, a second section of smooth transition layer 8b, a third section of smooth transition layer 8c, a fourth section of smooth transition layer 8d, a fifth section of smooth transition layer 8e, a sixth section of smooth transition layer 8f, a seventh section of smooth transition layer 8g, an eighth section of smooth transition layer 8h and a ninth section of smooth transition layer 8i, 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 thickness of the first smooth transition layer 8a is M1The thickness of the second smooth transition layer 8b is M2The thickness of the third smooth transition layer 8c is M3The thickness of the fourth smooth transition layer 8d is M4The thickness of the fifth smooth transition layer 8e is M5The thickness of the sixth smooth transition layer 8f is M6The thickness of the seventh smooth transition layer 8g is M7The thickness of the eighth smooth transition layer 8h is M8The ninth smooth transition layer 8i has a thickness M9The thickness of each smooth transition layer satisfies a thickness difference formula, wherein the thickness difference formula is as follows:
wherein n is 1,2, … …, 8;
A1the cross section area of the grid-shaped woven net layer is the cross section area of the grid-shaped woven net layer;
A2the cross-sectional area of the inner PTFE tube layer 41;
p is the limited number of the spring contained in the spring-shaped woven net layer within the length range of the nth section of the smooth transition layer;
t is the shear elastic modulus of the spring contained in the spring-like woven mesh layer;
theta is the thermal expansion coefficient of the latticed knitted net layer;
R1the diameter of the grid-shaped woven net layer;
R2the diameter of the spring-like woven mesh layer.
Further preferably, the length L of the t-th section smooth transition layertThe length relation is satisfied, and the length relation is as follows:
wherein t is 1,2, … …, 9;
μ1axial spacing of springs contained for said spring-like woven mesh layer;
c1a spring winding ratio of the spring included in the spring-like knitted mesh layer;
Mtthe thickness of the smooth transition layer at the t section;
b is the area of a single grid contained in the grid-shaped woven net layer;
alpha is the helix angle of the spring contained in the spring-like braided mesh layer.
The applicant of the present application obtains the above thickness difference formula and length relation formula through a large number of experiments and numerical simulation, the hardness of each segment of the smooth transition layer 8 and the hardness of each segment are also the optimal values obtained through a large number of experiments, and the hardness, thickness and length of each segment are different, so that the property of the nerve micro-catheter of the present invention is most suitable for the region of the neurovascular, and each segment of the smooth transition layer 8 can stay in the region of the neurovascular during the positioning, thereby greatly improving the overall stress state of the nerve micro-catheter and avoiding the tendency of the nerve micro-catheter to retract to the aorta.
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 flexible and anti-kink performance is sufficient; the seventh section of smooth transition layer 8g, the eighth section of smooth transition layer 8h and the ninth section of smooth transition layer 8i are made of nylon material to provide sufficient supporting force. The hydrophilic coating can be selected from polyvinylpyrrolidone or polyacrylamide.
Preferably, a development ring 7 is further arranged between the first section of smooth transition layer 8a and the nerve micro-catheter blank 4, and the development ring 7 is doped with a radiopaque material, such as barium sulfate.
Further preferably, a plurality of developing rings may be disposed between the first smooth transition layer 8a and the nerve micro duct blank 4, for example, two developing rings are disposed, including a first developing ring and a second developing ring, the first developing ring is 0.6mm away from the outlet of the nerve micro duct blank 4, and the second developing ring is 30mm away from the first developing ring, and the two developing rings may play a role of measuring the distance during the operation.
The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations of the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.
Claims (7)
1. The nerve micro-catheter is characterized by comprising a catheter holder, a catheter holder sheath, a guide sheath and a nerve micro-catheter tube blank, wherein the nerve micro-catheter tube blank comprises an inner-layer PTFE tube layer, a middle-layer stainless steel woven mesh and an outer-layer Pebax tube layer, the middle-layer stainless steel woven mesh comprises a spring-shaped woven mesh layer and a grid-shaped woven mesh layer, the inner-layer PTFE tube layer is a hollow tube body, and the spring-shaped woven mesh layer is tightly wound on the outer peripheral wall of the inner-layer PTFE tube layer; the latticed woven mesh layer is tightly wound on the outer peripheral wall of the spring-shaped woven mesh layer; the outer Pebax tube layer is tightly wrapped on the outer peripheral wall of the latticed woven net layer; the guide sheath is slidably sleeved on the outer peripheral wall of the nerve micro-catheter tube blank; a catheter channel is arranged in the catheter seat and is connected with the nerve micro-catheter tube blank through the catheter seat in a photocuring mode, so that the catheter channel is communicated with the hollow tube body of the inner PTFE tube layer; the catheter base sheath is wrapped outside the catheter base photocuring connection position and at least wraps the catheter base and a part of the nerve micro-catheter tube blank; the free end of the catheter seat is provided with an opening, and the hollow pipe body of the catheter channel and the inner PTFE pipe layer can enter through the opening;
a hydrophilic coating is coated on the outer peripheral wall of the outer Pebax tube layer;
the outer peripheral wall of the outer Pebax tube layer is also tightly wrapped with a smooth transition layer, and the smooth transition layer comprises a plurality of sections with different hardness, thickness and length;
the smooth transition layer comprises a first section of smooth transition layer, a second section of smooth transition layer, a third section of smooth transition layer, a fourth section of smooth transition layer, a fifth section of smooth transition layer, a sixth section of smooth transition layer, a seventh section of smooth transition layer, an eighth section of smooth transition layer and a ninth section of smooth transition layer;
the thickness of the first section of smooth transition layer is M1The thickness of the second smooth transition layer is M2The thickness of the third smooth transition layer is M3The thickness of the fourth smooth transition layer is M4The thickness of the fifth smooth transition layer is M5The thickness of the sixth smooth transition layer is M6The thickness of the seventh smooth transition layer is M7The thickness of the eighth smooth transition layer is M8The thickness of the ninth smooth transition layer is M9The thickness of each smooth transition layer satisfies a thickness difference formula, wherein the thickness difference formula is as follows:
wherein n is 1,2, … …, 8;
A1the cross section area of the grid-shaped woven net layer is the cross section area of the grid-shaped woven net layer;
A2the cross-sectional area of the inner PTFE tube layer;
p is the limited number of the spring contained in the spring-shaped woven net layer within the length range of the nth section of the smooth transition layer;
t is the shear elastic modulus of the spring contained in the spring-like woven mesh layer;
theta is the thermal expansion coefficient of the latticed knitted net layer;
R1the diameter of the grid-shaped woven net layer;
R2the diameter of the spring-like woven mesh layer.
2. The nerve microcatheter of claim 1, further comprising a mandrel inserted into the hollow tube of the inner PTFE tube layer.
3. The nerve microcatheter of claim 1, wherein the lattice shape of the lattice-like woven mesh layer is a diamond-shaped lattice.
4. The nerve microcatheter of claim 1, wherein the nerve microcatheter blank has a length of 150 cm, 155 cm or 160 cm.
5. The nerve microcatheter of claim 1, wherein the inner PTFE tube layer has an inner diameter of 0.38 mm, 0.43 mm, 0.53 mm, or 0.69 mm.
6. The nerve micro-catheter according to claim 1, 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.
7. The nerve microcatheter of claim 1, wherein the length L of the t-th smooth transition layertThe length relation is satisfied, and the length relation is as follows:
wherein t is 1,2, … …, 9;
μ1axial spacing of springs contained for said spring-like woven mesh layer;
c1a spring winding ratio of the spring included in the spring-like knitted mesh layer;
Mtthe thickness of the smooth transition layer at the t section;
b is the area of a single grid contained in the grid-shaped woven net layer;
alpha is the helix angle of the spring contained in the spring-like braided mesh layer.
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|---|---|---|---|
| CN202110482120.XA CN113197620B (en) | 2021-04-30 | 2021-04-30 | Nerve micro-catheter |
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| CN202110482120.XA CN113197620B (en) | 2021-04-30 | 2021-04-30 | Nerve micro-catheter |
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| CN113197620B true CN113197620B (en) | 2022-03-11 |
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| CN116899072B (en) * | 2023-08-04 | 2024-03-15 | 上海璞康医疗器械有限公司 | Nerve microcatheter with improved kink resistance |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7905877B1 (en) * | 2006-05-12 | 2011-03-15 | Micrus Design Technology, Inc. | Double helix reinforced catheter |
| CN106913949A (en) * | 2015-12-28 | 2017-07-04 | 威海维心医疗设备有限公司 | Ganglioside GM_3 microtubular |
| CN107376101B (en) * | 2017-02-24 | 2024-03-08 | 苏州恒瑞迪生医疗科技有限公司 | Microcatheter for Transcatheter Arterial Chemoembolization (TACE) |
| EP3536371B1 (en) * | 2018-03-06 | 2023-01-25 | Phenox Ltd. | Catheter with catheter hub |
| CN109173003B (en) * | 2018-10-10 | 2024-04-09 | 江苏尼科医疗器械有限公司 | Intermediate catheter |
| CN209884980U (en) * | 2018-12-19 | 2020-01-03 | 深圳市业聚实业有限公司 | Novel micro-catheter |
| CN110652645A (en) * | 2019-08-13 | 2020-01-07 | 上海沃比医疗科技有限公司 | Multilayer catheter body and catheter assembly therefor |
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