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CN109173003B - Intermediate catheter - Google Patents

Intermediate catheter Download PDF

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Publication number
CN109173003B
CN109173003B CN201811176634.7A CN201811176634A CN109173003B CN 109173003 B CN109173003 B CN 109173003B CN 201811176634 A CN201811176634 A CN 201811176634A CN 109173003 B CN109173003 B CN 109173003B
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Prior art keywords
catheter
section
distal
far
layer
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CN109173003A (en
Inventor
余永毅
范叔奇
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Jiangsu Nico Medical Equipment Co ltd
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Jiangsu Nico Medical Equipment Co ltd
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Priority to CN201811176634.7A priority Critical patent/CN109173003B/en
Publication of CN109173003A publication Critical patent/CN109173003A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • A61L29/041Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • A61L29/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0012Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0008Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

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

Abstract

The invention provides an intermediate catheter, which comprises a seat, a stress release tube and a catheter which are sequentially arranged from a proximal end to a distal end; the main improvement is that the catheter is axially distributed with a near-end pushing section, a middle-end supporting section, a far-end torsion control section and an ultra-far-end tracking section from near to far; the tip of the catheter is coaxially connected with the ultra-distal tracking section; the duct of the seat and the inner cavity of the catheter are coaxially connected to form a guide cavity; the catheter is distributed with an inner liner layer, a middle reinforcing layer and an outer cladding layer from inside to outside along the radial direction, and the middle reinforcing layer is respectively connected with the inner liner layer and the outer cladding layer. The invention can provide excellent pushing property of the near section, good vascular support property of the middle section, torque control property of the far section with high torque response and complicated tortuosity vascular trafficability of the ultra-far section, and is convenient for a catheter to pass through an intracranial far-end vascular or convey other instruments to a farther-end vascular.

Description

Intermediate catheter
Technical Field
The invention relates to an intermediate catheter, in particular to an intermediate catheter for diagnosing or treating cerebrovascular lesions by a nerve intervention method, and belongs to the technical field of medical appliances.
Background
The cerebral apoplexy is commonly called as "apoplexy" or "cerebrovascular accident", which is an acute cerebrovascular disease, and is a disease of brain tissue injury caused by the failure of normal blood supply to the brain due to sudden rupture of cerebral nerve blood vessels or blood vessel blockage, including ischemic and hemorrhagic apoplexy. The incidence rate of ischemic stroke accounts for 60% -70% of the total cerebral stroke. The most common cause of cerebral stroke is arterial embolism, i.e. ischemic stroke, caused by small emboli on the inner wall of blood vessels supplying the brain. Coronary heart disease is accompanied by atrial fibrillation, and heart valves of the coronary heart disease are easy to generate wall-attached thrombus, cerebral vessels can be blocked after embolic precipitation, and ischemic stroke can be caused. Other factors include hypertension, diabetes, hyperlipidemia, etc. The investigation shows that cerebral apoplexy is a syndrome characterized by acute onset of neurological deficit, reflects disorder of the central nervous system, is a result of brain circulation disorder, becomes a primary cause of death and disability of adults in China, and has the characteristics of high morbidity, high mortality and high disability rate. The middle cerebral artery is the most frequent part of cerebral apoplexy, branches of the middle cerebral artery are easy to break and bleed, and extracranial emboli are most easy to enter the M1 section of the middle cerebral artery and branches of the middle cerebral artery, so that cerebral infarction or cerebral embolism of the area is caused.
The middle catheter is a novel distal pass-through catheter which is used for diagnosis, conveying appliances or treatment and extends to the carotid artery and even the cerebral artery after penetrating into the aortic arch from the femoral artery based on the principle of the mediated minimally invasive treatment. In the prior art, the common methods for cerebral apoplexy treatment operation comprise venous thrombolysis and cerebral nerve vascular mechanical thrombolysis, and the appearance of an intermediate catheter provides a new thought for diagnosing and treating the intracranial vascular acute and chronic occlusion or carotid artery lesions with the tortuosity of more than medium.
Similar products in the current market have Envoy DA catheters of the Qiangsheng company, and an end-to-end metal braiding structure is adopted, so that the length of a flexible section at the far end of the catheter is increased, and the flexible section can be pushed to a rock section in the neck to a cavernous sinus section. The Sofia DAC/Plus adopts a structure of a spring inner core and a braided outer sheath, is provided with a particularly soft tip, and improves the capability of passing through tortuous vessels. However, most of the middle catheters have the limitations of self structures, such as insufficient pushing force at the proximal end and insufficient torque response at the distal end, so that the distal end of the catheter can only be conveyed to the neck section or the rock section in the neck, and cannot pass through the spongy sinus section in the neck to reach a more distant position, such as the middle cerebral artery M1 section with high incidence of cerebral apoplexy, and the limitation relatively influences the application of the middle catheter.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and provides an intermediate catheter which can provide excellent pushing property of a near section, good vascular support property of a middle section, torque control property of a far section high torque response and complicated tortuosity vascular trafficability of an ultra-far section, and is convenient for the catheter to pass through an intracranial far-end vascular or convey other instruments to a farther-end vascular. The technical scheme adopted by the invention is as follows:
an intermediate catheter comprises a seat, a stress relief tube and a catheter which are sequentially arranged from a proximal end to a distal end; the main improvement is that,
the catheter is axially distributed with a proximal pushing section, a middle-end supporting section, a distal torsion control section and an ultra-distal tracking section from near to far; the tip of the catheter is coaxially connected with the ultra-distal tracking section; the duct of the seat and the inner cavity of the catheter are coaxially connected to form a guide cavity;
the catheter is distributed with an inner liner layer, a middle reinforcing layer and an outer cladding layer from inside to outside along the radial direction, and the middle reinforcing layer is respectively connected with the inner liner layer and the outer cladding layer.
Further, the lining layer is made of PTFE, and the extensibility is 5% -80%. Further, the extensibility of the lining layer is 40% -50% and the thickness range is 0.005-0.03 mm.
Further, the middle strengthening layer of the near-end pushing section adopts a strengthening woven net; the reinforced woven mesh comprises oblique woven wires and axial reinforcing wires.
Furthermore, the reinforced woven mesh is additionally provided with axial reinforcing wires on the basis of the woven mesh formed by 2x2 oblique woven wires, so as to form the reinforced woven mesh with a three-way structure; the axial reinforcing wires are axially distributed along the catheter, and pass through the middle of the two oblique braided wires at the intersection of the two oblique braided wires; the pitch d1 of the reinforced woven mesh is gradually increased from near to far along the axial direction;
the pitch d1 of the reinforced woven mesh is 0.05 mm-0.7 mm, and the pitch d1 of the reinforced woven mesh is gradually increased from 0.05mm to 0.7mm from near to far along the axial direction.
Further, an included angle alpha 2 formed by the inclined braiding wires of the reinforced braided net and the radial direction of the catheter is 30-65 degrees.
Further, the middle reinforcing layer of the middle end supporting section is sleeved with an elastic net by adopting a spiral line, or the middle reinforcing layer of the middle end supporting section comprises an axial reinforcing wire extending from the near end pushing section reinforcing woven net and a spiral coil to form a reinforcing spiral coil, or the elastic net is sleeved with the reinforcing spiral line.
Further, elastic meshes are distributed on the elastic net, the shape of the elastic meshes is elliptical, a crisscross or diamond-shaped structure is embedded in the ellipse, the long axis and the short axis of the embedded shape are respectively overlapped with the long axis and the short axis of the ellipse, the long axis direction is uniformly distributed along the axial direction of the catheter, and the short axis direction is uniformly distributed along the circumferential direction of the catheter.
Further, the pitch d2 of the elastic mesh in the axial direction of the catheter is in the range of 0.15 to 0.9mm, the width of the elastic mesh in the circumferential direction of the catheter is in the range of 0.1 to 0.3mm, and the wall thickness of the elastic mesh is in the range of 0.01 to 0.1mm.
The pitch range of the spiral coil of the middle end support section is 0.1 mm-0.7 mm, and the pitch of the spiral coil of the middle end support section is gradually decreased from near to far along the axial direction of the catheter; consistent with the helical coil of the distal torque control section.
Further, the strengthening layers of the far-end torsion control section and the ultra-far-end tracking section adopt spiral coils, or the strengthening layers (308) of the far-end torsion control section (303) and the ultra-far-end tracking section (304) comprise strengthening spiral coils formed by the spiral coils and axial strengthening wires extending from a strengthening woven net of the near-end supporting section (301); the interstices of the spiral coil are filled with a highly elastic polymer, and the inner and/or outer layers of the spiral coil are coated with a highly elastic polymer coating having compatibility with said highly elastic polymer.
Further, the high elastic polymer is a copolymer type thermoplastic elastomer or a mechanical blending type thermoplastic elastomer; wherein the shore hardness of the high-elasticity polymer of the remote torsion control section is 30D-55D; the Shore hardness of the high-elasticity polymer of the ultra-far tracking section is 40A-85A;
the high-elasticity polymer coating is made of a copolymerization type thermoplastic elastomer;
when the high-elasticity polymer coating is only coated on the outer layer of the spiral coil, the thickness range is 0.01-0.1 mm; when the coating is only coated on the inner layer of the spiral coil, the thickness range is 0.001-0.02 mm; when the spiral coil is coated on the inner layer and the outer layer of the spiral coil, the thickness of the coating coated on the outer layer ranges from 0.001 mm to 0.03mm, and the thickness of the coating coated on the inner layer ranges from 0.001 mm to 0.01mm;
the pitch range of the spiral coil of the remote torsion control section is 0.1 mm-0.7 mm, and the pitch of the spiral coil of the remote torsion control section is gradually decreased from near to far along the axial direction of the catheter;
the pitch range of the spiral coil of the ultra-far end tracking section is 0.01 mm-0.5 mm, and the pitch of the spiral coil of the ultra-far end tracking section is gradually decreased from near to far along the axial direction.
Further, the outer wrapping layer is blended by adopting a copolymerization type thermoplastic elastomer and a lubrication additive;
the elastic body of the outer cladding comprises PEBAX of a proximal pushing section, a middle supporting section and a distal torsion control section, and polyurethane of a super-distal tracking section;
PEBAX hardness of the proximal pushing section is 63D-74D; the PEBAX hardness of the middle end supporting section is 55D-63D; the PEBAX hardness of the distal torsion control section is 40D-55D; the polyurethane hardness of the ultra-far end tracking section is 60A-85A;
the hardness of the outer wrapping layer from the proximal end to the distal end is gradually decreased in a multi-section manner;
the thickness of the outer cladding is in the range of 0.01-0.2 mm.
Further, the tip of the catheter is made of linear flexible polymer copolymerization modified polyurethane; the catheter tip is shaped as a straight cone or a long curve.
Further, the distal end of the ultra-distal tracking section is provided with a developing ring or the distal and proximal ends of the ultra-distal tracking section are each provided with a developing ring.
The developing ring adopts a hollow ring structure with regular rectangular holes arranged along the axial direction or a rectangular toothed structure is arranged outside the developing ring.
Further, the PTFE material of the lining layer is heated to 270 ℃ to 320 ℃ at constant temperature, annealed at constant cooling rate of 10 ℃ to 20 ℃ per minute, and then axially stretched at rated speed of 10mm to 80mm per minute and rated stress of 5N to 40N, and the extensibility after stretching is controlled at 5 percent to 80 percent.
Compared with the prior art, the invention has the following advantages:
1. according to the invention, the inner liner is heated to be close to the melting point of Polytetrafluoroethylene (PTFE) at a constant temperature, and is subjected to annealing treatment at a constant cooling rate, and then is subjected to axial stretching by applying rated speed and stress, so that the C-C chain of the crystalline polymer PTFE is highly oriented along the axial direction, the overall crystallinity of the inner liner can be reduced, and the tensile strength and the axial distribution uniformity of the inner liner in the axial direction are enhanced; through the control of ductility, reduce the thickness of inside lining, increase the internal diameter of guide chamber, promote the axial trafficability characteristic of apparatus in the guide chamber.
2. According to the reinforced woven mesh, the axial reinforcing wires are added on the basis of the 2X2 oblique woven wires to form the reinforced woven mesh with a three-way structure, so that interaction and migration of the oblique woven wires are restrained to a certain extent, radial rigidity and axial tensile strength of the woven mesh are improved, the catheter has excellent radial supporting performance and axial pushing performance at a proximal pushing section, a tubular body can be protected from bearing larger pressure, and proximal pushing force is better transferred; by selecting the optimal angle of the braiding angle, the optimization of the radial rigidity and the axial tensile strength of the braided net is realized.
3. According to the elastic net, the metal pipe is cut into a porous, multi-branch and thin-wall net structure by adopting laser, and the radial support and elasticity of the elastic net can be adjusted according to the selection of materials and the design of mesh shape; the elastic net adopts the structural design of oval embedded crisscross or irregular diamond: the long axis and the short axis of the embedded shape are respectively overlapped with the long axis and the short axis of the ellipse, the long axis direction is uniformly distributed along the axial direction of the catheter, the short axis direction is uniformly distributed along the circumferential direction of the catheter, and the joint of the embedded shape and the ellipse is subjected to rounding treatment. The structural design ensures that the elastic net can be well adapted to the natural bending of the blood vessel in the long axis direction, and can provide enough support for the catheter in the short axis direction so as to prevent the collapse or bending of the catheter body. When the elastic net is sleeved on the spiral coil or the reinforced spiral coil which is reinforced in the axial direction, the elastic net is favorable for providing good axial compliance and radial support for the middle end support section of the catheter, so that the elastic net can better adapt to physiological bending of a large blood vessel (such as an aortic arch with complex and changeable shape), is attached to the inner wall of the blood vessel, and reduces complications such as vasospasm.
4. The gap of the spiral coil is filled with a blending or copolymerization type thermoplastic elastomer, and the inner layer and/or the outer layer of the elastic coil are/is coated with a copolymerization type thermoplastic elastomer coating. The flexibility and high elasticity of the distal torsion control section and the ultra-distal tracking section of the catheter are improved by changing the material and pitch of the spiral coil, the material of the filling polymer, adding the high-elasticity polymer coating of the inner layer or the outer layer and changing the thickness of the coating, so that the excellent kink resistance of the distal torsion control section and the excellent flexibility of the ultra-distal tracking section are realized. The high-elasticity polymer coating and the filled high-elasticity polymer or the inner liner layer have good compatibility in material selection, and migration or sliding layers between the coating and the filler or the inner liner layer are prevented. Such designs ensure that the soft, ultra-distal tracking segment more easily traverses the complex tortuosity of the intracranial distal (particularly the C3 siphon bend and C4 cavernous sinus segment in the neck to the M1 segment of the cerebral artery where ischemic stroke is highly developed) and aids in guiding other instruments (e.g., microcatheters, embolectomy instruments, etc.) in the lumen to the more distal vessel. The kink resistant distal torque control segment provides good torque response preventing kinking of the catheter in complex tortuous vessels.
5. The axial reinforcing wire can extend from the proximal pushing section to one or more of the tube body sections of the middle-end supporting section, the distal torsion control section or the ultra-distal tracking section, and forms a reinforcing spiral coil with the spiral coil. The structure has the advantages that deformation of the spiral coil in the axial stretching or compressing process is greatly limited, and simultaneously, the whole torsion control property, flexibility or high elasticity of the section of tube body is not influenced, namely, the axial excessive compression/stretching deformation of the tube body, which is generated by a series of acting forces such as continuous pushing/withdrawing force of a proximal pushing section, resistance of a tortuous vessel, bending force of the compliance vessel of the tube body, and the like, of the tube body of the spiral coil part is reduced when the tube body passes through the intracranial distal complex tortuous vessel, the inner diameter of the tube cavity of the tube is prevented from being changed, and good expected use of the tube is ensured.
6. When the developing ring is sleeved on the spiral coil or the reinforced spiral coil at the far end or the near end of the ultra-far end tracking section by adopting a regular rectangular pore, a thin-wall hollow structure or a rectangular tooth-shaped structure which are axially arranged, compared with the developing ring with a uniform cylindrical structure, the developing ring can conform to the axial/radial change of the spiral coil, does not influence the overall flexibility of the ultra-far end tracking section, ensures that the position of the whole ultra-far end tracking section 304 in an intracranial blood vessel can be accurately positioned under the X-ray condition, and realizes the whole-course visual operation when the ultra-far end tracking section 304 passes through a complex tortuous blood vessel.
Drawings
Fig. 1 is a schematic structural view of an intermediate catheter according to the present invention.
Fig. 2 is a schematic view of the length of each section of the intermediate conduit according to the present invention.
Fig. 3a and 3b are schematic structural views of a proximal pushing section, a middle supporting section, a distal torsion control section and a super distal tracking section according to the present invention, respectively showing two structures of elastic mesh of the middle supporting section.
FIG. 3c is a schematic view of the axial reinforcement wire of the present invention extending to a middle support section, a distal torque control section or a super distal tracking section.
Fig. 4 is a schematic view of the D-D cross-section of fig. 3a, 3b according to the present invention.
Fig. 5a, 5b, 5c and 5d are respectively four cross-sectional views of the reinforced woven wire of the present invention.
FIG. 6 is a schematic view of the cross section C-C of FIGS. 3a and 3b according to the present invention.
Fig. 7a, 7B, 7c are schematic cross-sectional views A-A, B-B of fig. 3a, 3B, respectively, showing three embodiments of the high elastic polymer coating of the present invention.
Fig. 8a, 8b, 8c are three cross-sectional schematic views of a reinforcement layer filled with a distal torque control segment and a super distal tracking segment of a highly elastic polymer.
Fig. 9a and 9b are schematic views of two structures of the developing ring, respectively.
Detailed Description
The invention will be further described with reference to the following specific drawings and examples.
As shown in fig. 1, the intermediate catheter provided by the invention comprises a seat 1, a stress relief tube 2 and a catheter 3 which are sequentially arranged from the proximal end to the distal end.
The catheter 3 is provided with a proximal pushing section 301, a middle supporting section 302, a distal torsion control section 303 and an ultra-distal tracking section 304 which are distributed from near to far along the axis; wherein the proximal end and the distal end of the ultra-distal tracking section 304 are respectively provided with a developing ring 305, and the catheter tip 4 is coaxially connected with the ultra-distal tracking section 304; the bore of the seat 1 is coaxially connected with the lumen of the catheter 3 to form a guide lumen 1301.
As shown in fig. 2, the length L6 of the proximal pushing section 301 is 50-100cm, the length L5 of the middle supporting section 302 is 20-50cm, the length L4 of the distal twisting control section 303 is 5-18cm, and the length L3 of the ultra-distal tracking section 304 is 1-8cm; l1 is the total length of the middle catheter (120-160 cm), and L2 is the effective length of the middle catheter; l2=l3+l4+l5+l6. The inner diameter of the catheter 3 is in the range of 1.1-1.8mm and the outer diameter is in the range of 1.3-2.2mm.
As shown in fig. 4, the catheter 3 is distributed with an inner liner 309, an intermediate reinforcing layer 308 and an outer cladding 306 from inside to outside in the radial direction; the intermediate reinforcing layer 308 is connected to the inner liner 309 and the outer cladding 306, respectively.
The material of the inner liner 309 is Polytetrafluoroethylene (PTFE), which is a crystalline polymer with better lubrication performance; heating the material of the lining layer 309 to 270-320 ℃ at a constant temperature, approaching to the melting point 327 ℃ of PTFE, annealing at a constant cooling rate of 10-20 ℃/min, applying a rated speed of 10-80 mm/min and a rated stress of 5-40N for axial stretching, controlling the extensibility after stretching to 5-80%, and reducing the overall crystallinity and thickness of the PTFE lining; the extensibility is 40-50% of the optimal range; the annealed and axially stretched lining PTFE aims at improving the axial orientation of C-C molecular chains in PTFE by reducing the crystallinity of the whole material, thereby achieving the purpose of increasing the axial tensile strength and the distribution uniformity of the lining. Through the control of ductility, reduce the thickness of inner liner, reach the guide chamber internal diameter of increase middle pipe, promote the purpose of the axial trafficability characteristic of apparatus.
As shown in fig. 3a, 3b, and 4, the middle reinforcement layer 308 of the proximal push section 301 is a reinforcement braid 3011; the reinforced woven mesh is characterized in that axial reinforcing wires are added on the basis of a woven mesh formed by weaving 2x2 oblique woven wires; forming a reinforced woven net with a three-way structure; as shown in fig. 5a, 5b, 5c, 5d, an axial reinforcement wire 3011a is routed axially along the catheter 3, passing between two diagonal filaments 3011b, 3011c at the intersection of the two diagonal filaments; the reinforced knitted net 3011 is made of 304 stainless steel, nickel-titanium alloy or copper. The reinforced woven mesh 3011 with the three-way structure is beneficial to improving the radial rigidity and the axial tensile strength of the proximal pushing section 301 of the middle catheter, so that the catheter has excellent radial supporting performance and axial pushing performance in the proximal pushing section. The catheter is beneficial to better transmitting the proximal pushing force of the intermediate catheter and provides pushing support for the ultra-distal tracking section to reach the blood vessel at the farther end.
The included angle α2 formed by the oblique woven wires of the reinforced woven wire 3011 and the radial direction of the catheter is 30-80 degrees, and the included angle α2 is 30-65 degrees, which is the optimal angle. The pitch d1 of the reinforcement mesh 3011 (the distance between adjacent diagonal filaments in the axial direction) is 0.05 to 0.7mm, and the pitch d1 of the reinforcement mesh 3011 gradually increases from 0.05mm to 0.7mm from near to far in the axial direction. By selecting the optimal angle of the braiding angle alpha 2, the optimization of the radial rigidity and the axial tensile strength of the braided net is realized.
The diameters of the bias braided wires 3011b and 3011c and the axial reinforcing wires 3011a are 0.05mm to 0.15mm.
As shown in fig. 5a, 5b, 5c, 5d, respectively, the cross-sectional shapes of the bias braided wires 3011b, 3011c, and the axial reinforcing wires 3011a may be semicircular, trapezoidal, rectangular, circular, or regular hexagonal.
As shown in fig. 3a, 3b, 3c and 6, the middle reinforcement layer 308 of the middle support section 302 is formed by sleeving elastic nets 3021a and 3021b with spiral coils 3031 consistent with the distal torsion control section 303, or the middle reinforcement layer 308 of the middle support section 302 comprises axial reinforcement wires extending from the reinforced braided net of the proximal push section 301 and spiral coils to form reinforced spiral coils, and the elastic nets are sleeved on the reinforced spiral coils.
The elastic nets 3021a and 3021b are porous, multi-branched and thin-wall elastic nets which are formed by integrally cutting metal pipes by laser; elastic meshes are distributed on the elastic net, the pitch d2 of the elastic meshes along the axial direction of the catheter ranges from 0.15mm to 0.9mm, and the width of the elastic meshes along the circumferential direction of the catheter ranges from 0.1mm to 0.3mm; the wall thickness of the elastic net ranges from 0.01mm to 0.2mm. The elastic net is made of 304 stainless steel or nickel-titanium alloy; the elastic webs 3021a, 3021b differ in the shape of the elastic mesh insert.
The elastic mesh is elliptical in shape, and a crisscrossed or diamond-shaped structure is embedded in the ellipse; the joint of the crisscross or diamond and the ellipse is rounded.
The long axis and the short axis of the embedded shape are respectively overlapped with the long axis and the short axis of the ellipse, the long axis direction is uniformly distributed along the axial direction of the catheter, and the short axis direction is uniformly distributed along the circumferential direction of the catheter. The structural design ensures that the middle end supporting section of the catheter where the elastic net is located can be well adapted to physiological bending of a large blood vessel in the axial direction, can also provide enough supporting performance for the catheter in the radial direction, is well attached to the inner wall of the blood vessel, prevents the tube body from collapsing or bending through the bending part of the large blood vessel (such as the aortic arch position in the blood vessel), and is beneficial to providing good axial compliance and radial supporting performance for the middle end supporting section of the catheter.
The pitch range of the spiral coils of the middle end support section 302 is 0.1 mm-0.7 mm, and the pitch of the spiral coils of the middle end support section is gradually decreased from near to far along the axial direction of the catheter; consistent with helical coil 3031 of distal torque control section 303.
As shown in fig. 3a, 3b, 7a, 7b, 7c, the stiffening layer 308 of the distal torsion control section 303 and the ultra-distal tracking section 304 employs helical coils 3031, 3041; the spiral coils 3031 and 3041 are formed by winding metal wires with S-shaped spiral structures, wherein the diameter or thickness range of the metal wires is 0.05-0.3 mm; the radial included angle alpha 1 between the spiral coil and the catheter is 30-80 degrees.
The pitch of the helical coil 3031 of the distal torque control section 303 ranges from 0.1mm to 0.7mm, with the pitch decreasing from proximal to distal along the catheter axis at the distal torque control section 303.
The pitch of the helical coils 3041 of the super-distal tracking section 304 ranges from 0.01mm to 0.5mm, with the pitch decreasing axially from near to far in the super-distal tracking section 304.
Alternatively, as shown in FIG. 3c, the reinforcing layers 308 of the distal torsion control section 303 and the ultra-distal tracking section 304 are formed as reinforcing helical coils 3032, 3042 using axial reinforcing filaments extending from a reinforcing mesh and helical coils 3031, 3041, respectively. Wherein the axial reinforcing wires may extend to one or more of the middle support section 302, the distal torque control section 303, or the ultra-distal tracking section 304.
As shown in fig. 8a, 8b, 8c, the gap of the spiral coil is filled with a highly elastic polymer 308a; the high elastic polymer 308a is made of a copolymer thermoplastic elastomer such as polyurethane (TPU), polystyrene (S-TPE), polyester (TPEE), polyolefin (TPO), organofluorine (TPF), polysiloxane (SiO-TPE), polyamide (TPEE), or a mechanical blend thermoplastic elastomer modified by blending ethylene propylene diene monomer (EDPM) with polypropylene (PP) and blending nitrile rubber (NBR) with PP. When the polyurethane elastomer is preferably used as the filler, the Shore hardness is controlled to be 40A-85A or 30D-55D. The polyurethane shore hardness of the distal torsion control section 303 is preferably 30D-55D, and the polyurethane shore hardness of the ultra-distal tracking section is preferably 40A-85A.
As shown in fig. 7a, 7b and 7c, the inner layer and/or the outer layer of the spiral coil is/are coated with a high elastic polymer coating 307, the high elastic polymer coating 307 is made of a copolymerization type thermoplastic elastomer, and the coating has good compatibility with the filled high elastic polymer 308 a.
By varying the thickness (in the range of 0.001-0.05 mm) of the highly elastic polymer coating 307, flexibility and high elasticity of the distal torsion control section and the super distal tracking section are achieved. When the high elastic polymer coating 307 is coated only on the outer layers of the spiral coils 3031 and 3041, the preferable thickness range is 0.01 to 0.1mm; when coated only on the inner layers of helical coils 3031 and 3041, the preferred thickness range is 0.001 to 0.02mm; when the inner and outer layers of the spiral coils 3031 and 3041 are coated, the thickness of the coating layer coated on the outer layer is preferably in the range of 0.001 to 0.03mm, and the thickness of the coating layer coated on the inner layer is preferably in the range of 0.001 to 0.01mm.
The flexibility and high elasticity of the distal torsion control section and the ultra-distal tracking section of the catheter are improved by changing the material and pitch of the spiral coil, the material of the filling polymer, adding the high-elasticity polymer coating of the inner layer or the outer layer and changing the thickness of the coating, so that the excellent kink resistance of the distal torsion control section and the excellent flexibility of the ultra-distal tracking section are realized. Such a configuration ensures that the flexible, ultra-distal tracking section of the intermediate catheter is more likely to traverse the complex tortuous vessels of the intracranial distal end and aids in guiding other instruments (e.g., microcatheters, embolectomy instruments, guide catheters, etc.) within the lumen to the more distal vessels. The kink resistant distal torque control segment provides good torque response preventing kinking of the catheter in complex tortuous vessels.
The outer wrapping layer 306 is prepared by blending a copolymerization type thermoplastic elastomer and a lubrication additive, and extruding the mixture through a double-screw extruder to obtain the outer wrapping layer with a certain lubrication effect; the lubricating additive is hydrophilic polymer additive, polyethylene glycol stearate material or self-lubricating polymer material. The elastomer of the outer wrapping layer is preferably a block polyether amide elastomer (PEBAX) of Almar France or Caesarean De Caesarean Germany, and the Shore hardness is controlled to be 30-80D; polyurethane is preferred, and the Shore hardness is controlled to be 50-90A. The elastic body of the outer cladding comprises PEBAX of a proximal pushing section, a middle supporting section and a distal torsion control section, and polyurethane of a super-distal tracking section; wherein the PEBAX hardness of the proximal pushing section is 63D-74D; the PEBAX hardness of the middle end supporting section is 55D-63D; the PEBAX hardness of the distal torsion control section is 40D-55D; the polyurethane hardness of the ultra-far end tracking section is 60A-85A; the hardness of the outer cladding 306 from the proximal end to the distal end is reduced in multiple segments of 4-40 segments. The thickness of the outer cladding is in the range of 0.01-0.2 mm.
As shown in fig. 1, 9a, 9b, the developing ring 305 adopts methods such as laser cutting and machining to form regular rectangular holes arranged along the axial direction, a thin-walled hollow ring structure 3051 or a rectangular tooth-shaped structure 3052 arranged outside the developing ring, when being sleeved on a spiral coil or a reinforced spiral coil at the far end or near end of the ultra-far end tracking section, compared with a developing ring with a uniform cylindrical structure, the developing ring can conform to the axial/radial change of the spiral coil, does not affect the overall flexibility of the ultra-far end tracking section, ensures that the position of the whole ultra-far end tracking section 304 in an intracranial blood vessel can be accurately positioned under the condition of X-rays, and realizes the whole-course visual operation of the ultra-far end tracking section 304 when passing through a complex tortuous blood vessel.
The catheter tip 4 is made of linear flexible high polymer copolymerization modified polyurethane, long carbon chain branches are introduced on the basis of the molecular structure of polyurethane, and the structure is beneficial to increasing the flexibility and softness of the material. The Shore hardness of the catheter can be bent by a specific angle under the influence of heat and mechanics, and particularly, the tip of the catheter can be shaped by steam, and a certain bending angle is preset, so that the tip of the catheter can pass through a complicated tortuous vessel. The catheter tip is shaped as a straight cone or a long curve.
In a specific embodiment, to obtain a "cavity wall thin" intermediate conduit, the thickness of liner 309 is controlled to be in the range of 0.005-0.03 mm by selecting the annealing rate and the stress-stretching rate to provide a liner having an elongation of preferably 50% during fabrication of liner 309. In the process of manufacturing the intermediate reinforcing layer 308, the materials of the spiral coils 3031 and 3041 of the middle end supporting section 302, the distal end torsion control section 303 and the ultra-distal end tracking section 304 are preferably nickel-titanium alloy, the radial included angle alpha 1 is preferably 45 degrees and 60 degrees respectively, and the pitches are preferably 0.25-0.4 mm and 0.08-0.2 mm respectively; the shore hardness of the high-elastic polymer 308a of the distal torsion control section 303 and the ultra-distal tracking section 304 is preferably 35D and 80A polyurethane, respectively, and the high-elastic polymer coating 307 is coated on the inner layers of the spiral coils 3031 and 3041, and the material is preferably organic fluorine polymer elastomer (TPF), and the thickness is preferably 0.006-0.008 mm. The coating has good compatibility with the inner liner 309 (PTFE), which ensures the firmness and reliability of the layer-to-layer connection, prevents migration or slip layers, and increases the flexibility of the section of pipe. The material of the 2x2 woven mesh of the proximal pushing section 301 is preferably 304 stainless steel, the weaving angle alpha 2 is preferably 60 degrees, wherein the axial reinforcing wire 3011a of the proximal pushing section 301 is preferably a semicircular structure, the material is preferably 304 stainless steel, and the diameter is preferably 0.07-0.09 mm; the middle end support section 302 is preferably a structure of reinforcing a structure of sleeving an elastic net outside the spiral coil, wherein the elastic net is preferably made of nickel-titanium alloy, and the embedded shape of the elastic net hole is preferably a diamond structure. The PEBAX hardness of the outer cladding 306 on the proximal push section 301 is preferably 63-74D, the PEBAX hardness of the middle support section 302 is preferably 55-63D, the PEBAX hardness of the distal twist control section 303 is preferably 40-55D, and the polyurethane hardness of the ultra-distal tracking section 304 is preferably 60-85A. The thickness of the outer cladding is preferably 0.08-0.12 mm.
In this embodiment, the maximum value of the inner diameters of the proximal pushing section 301 and the middle supporting section 302 of the middle catheter can reach 1.65-1.70 mm, and the maximum value of the outer diameter is controlled to be 1.8-2.2 mm; the maximum value of the inner diameter of the distal torsion control section 303 and the ultra-distal tracking section 304 can reach 1.40-1.52 mm, and the maximum value of the outer diameter is controlled to be 1.95-2.1 mm. From clinical data, the internal vessel diameter of the region from the challenging endocervical cavernous sinus segment (C4 segment) to the middle cerebral artery segment M1 was in the range of 2.5-3.5 mm. Therefore, the outer diameter of the middle catheter meets the basic condition of penetrating through a distal blood vessel to reach the M1 section, and the three-way structure woven mesh of the proximal pushing section 301 has excellent radial support and axial pushing performance; the middle end supporting section 302 adopts a structure that an elastic net is sleeved outside an axially reinforced spiral coil (reinforced spiral coil), has excellent folding resistance and supporting property, and can be well attached to the inner wall of a blood vessel; the distal torsion control section 303 and the ultra-distal tracking section 304 enable the distal torsion control section 303 to have excellent torsion resistance and flexibility by means of adjusting the pitch of the spiral coil, the material and the hardness of the filling polymer, adding an inner layer high-elasticity polymer coating, adjusting the thickness of the coating and the like, and the ultra-distal tracking section 304 has excellent flexibility and can realize the purpose of crossing an intracranial complex tortuous vessel (particularly crossing an intra-cervical C3 siphon bend and a C4 sponge sinus section) by matching with a soft catheter tip capable of being steam shaped. The upper limit value of the inner diameter of the middle catheter can reach 1.70mm (5.1F), and the cavity can be matched with and convey most microcatheters and thrombus removing devices (such as intracranial stents, blood flow reconstruction devices and the like) on the market to intracranial blood vessels at the M1 section or more of the middle cerebral artery, so as to assist in completing diagnosis or treatment of cerebrovascular diseases.
According to an application feature of the present invention, an intermediate catheter for rapidly removing intracranial arterial vessel thrombosis for treating acute ischemic stroke is provided. In one embodiment, the intermediate catheter and the external suction pump form a catheter system for aspiration of thrombus, designed for use in a variety of different blood vessels (e.g., internal carotid artery, middle cerebral artery segments M1, M2, basilar artery, vertebral artery, etc.), thereby providing a means for an operator to accomplish thrombus removal without the aid of or introduction of an embolic instrument. Thus, the physician does not have to expend time in the extra steps of operating the thrombectomy device or using other catheters (e.g., using balloon-guided catheters requiring pre-evacuation, filling and deflation of the balloon) as is required for typical mechanical thrombectomy (mechanical thrombectomy using intracranial stents, etc.). Thus, the aspiration thrombotic catheter system provides a physician with a rapid and effective means of treating acute ischemic stroke. The procedure is shown in the following table:
in this embodiment, the use of an intermediate catheter to aspirate the thrombus of the target vessel saves surgical procedures and time in the treatment of acute ischemic stroke compared to typical mechanical thrombectomy, and reduces the use of instruments during the procedure (e.g., the use of a thrombus removal device, balloon guide catheter, microcatheter, guidewire to direct the balloon guide catheter, etc.) and saves economic costs to the patient.

Claims (9)

1. An intermediate catheter comprises a seat (1), a stress release tube (2) and a catheter (3) which are sequentially arranged from a proximal end to a distal end; it is characterized in that the method comprises the steps of,
the catheter (3) is axially distributed with a proximal pushing section (301), a middle-end supporting section (302), a distal torsion control section (303) and an ultra-distal tracking section (304) from near to far; the catheter tip (4) is coaxially connected with the ultra-distal tracking section (304); the pore canal of the seat (1) and the inner cavity of the catheter (3) are coaxially connected to form a guide cavity (1301);
the catheter (3) is provided with an inner lining layer (309), an intermediate reinforcing layer (308) and an outer cladding layer (306) from inside to outside in the radial direction, and the intermediate reinforcing layer (308) is respectively connected with the inner lining layer (309) and the outer cladding layer (306);
the middle strengthening layer of the near-end pushing section (301) adopts a strengthening woven net (3011); the reinforced woven mesh (3011) comprises oblique woven wires and axial reinforcing wires which are woven;
the middle reinforcement layer (308) of the middle end support section (302) comprises an axial reinforcement wire and a spiral coil which extend from the reinforced woven mesh of the near end pushing section (301) to form a reinforced spiral coil, and an elastic mesh is sleeved on the reinforced spiral coil; elastic meshes are distributed on the elastic net, the shape of each elastic mesh is an ellipse, a crisscross or diamond-shaped structure is embedded in the ellipse, the long axis and the short axis of the embedded shape are respectively overlapped with the long axis and the short axis of the ellipse, the long axis direction is uniformly distributed along the axial direction of the catheter, and the short axis direction is uniformly distributed along the circumferential direction of the catheter;
the strengthening layer (308) of the far-end torsion control section (303) and the ultra-far-end tracking section (304) comprises a strengthening spiral coil formed by the spiral coil and axial strengthening wires extending from the strengthening woven mesh of the near-end supporting section (301); the gaps of the spiral coil are filled with a high-elasticity polymer (308 a), and the inner layer and/or the outer layer of the spiral coil are/is coated with a high-elasticity polymer coating (307) which has compatibility with the high-elasticity polymer (308 a);
the pitch range of the spiral coil (3031) of the distal torsion control section (303) is 0.1 mm-0.7 mm, and the pitch of the distal torsion control section (303) is gradually decreased from near to far along the axial direction of the catheter;
the pitch range of the spiral coil (3041) of the ultra-far end tracking section (304) is 0.01 mm-0.5 mm, and the pitch of the spiral coil is gradually decreased from near to far along the axial direction of the ultra-far end tracking section (304);
the high elastic polymer (308 a) adopts a copolymerization type thermoplastic elastomer or a mechanical blending type thermoplastic elastomer; wherein, the shore hardness of the high-elasticity polymer (308 a) of the far-end torsion control section (303) is 30D-55D; the shore hardness of the high-elasticity polymer (308 a) of the ultra-far end tracking section (304) is 40A-85A;
the high-elasticity polymer coating (307) is made of a copolymerization type thermoplastic elastomer;
when the high-elasticity polymer coating (307) is only coated on the outer layer of the spiral coil, the thickness range is 0.01-0.1 mm; when the coating is only coated on the inner layer of the spiral coil, the thickness range is 0.001-0.02 mm; when the spiral coil is coated on the inner layer and the outer layer of the spiral coil, the thickness of the coating coated on the outer layer ranges from 0.001 mm to 0.03mm, and the thickness of the coating coated on the inner layer ranges from 0.001 mm to 0.01mm.
2. The intermediary catheter of claim 1, wherein the intermediate catheter is configured to,
the lining layer (309) is made of PTFE, the extensibility is 40% -50% and the thickness range is 0.005-0.03 mm.
3. The intermediary catheter of claim 1, wherein the intermediate catheter is configured to,
the reinforced woven mesh (3011) is formed by adding axial reinforcing wires on the basis of a woven mesh formed by weaving 2x2 oblique woven wires; the axial reinforcing wires (3011 a) are axially distributed along the catheter (3), and pass through the middle of the two oblique braided wires at the intersection of the two oblique braided wires (3011 b, 3011 c); the pitch d1 of the reinforced woven mesh (3011) gradually increases from near to far along the axial direction;
the pitch d1 of the reinforced knitted net (3011) is 0.05 mm-0.7 mm, and the pitch d1 of the reinforced knitted net (3011) is gradually increased from 0.05mm to 0.7mm from near to far along the axial direction.
4. An intermediate catheter as in claim 3, wherein,
the included angle alpha 2 formed by the oblique braiding wires of the reinforced braided net (3011) and the radial direction of the catheter is 30-65 degrees.
5. The intermediary catheter of claim 1, wherein the intermediate catheter is configured to,
the distance d2 of the elastic mesh along the axial direction of the catheter is 0.15-0.9 mm, the width of the elastic mesh along the circumferential direction of the catheter is 0.1-0.3 mm, and the wall thickness of the elastic mesh is 0.01-0.2 mm.
6. An intermediate catheter as in any of claims 1-3,
the outer wrapping layer (306) is blended by adopting a copolymerization type thermoplastic elastomer and a lubrication additive;
the elastic body of the outer cladding comprises PEBAX of a proximal pushing section, a middle supporting section and a distal torsion control section, and polyurethane of a super-distal tracking section;
PEBAX hardness of the proximal pushing section is 63D-74D; the PEBAX hardness of the middle end supporting section is 55D-63D; the PEBAX hardness of the distal torsion control section is 40D-55D; the polyurethane hardness of the ultra-far end tracking section is 60A-85A;
the hardness of the outer cladding (306) from the proximal end to the distal end is gradually decreased in a multi-stage manner;
the thickness of the outer cladding is in the range of 0.01-0.2 mm.
7. An intermediate catheter as in any of claims 1-3,
the catheter tip (4) is made of linear flexible polymer copolymerization modified polyurethane; the catheter tip is shaped as a straight cone or a long curve.
8. An intermediate catheter as in any of claims 1-3,
the distal end of the ultra-distal tracking section (304) is provided with a developing ring (305) or the distal end and the proximal end of the ultra-distal tracking section (304) are respectively provided with a developing ring (305);
the developing ring (305) adopts a hollow ring structure (3051) with regular rectangular holes arranged along the axial direction or a rectangular toothed structure (3052) is arranged outside the developing ring.
9. An intermediate catheter as in any of claims 1-2,
PTFE material of the lining layer (309) is heated to 270-320 ℃ at constant temperature, annealed at constant cooling rate of 10-20 ℃/min, and then axially stretched at rated speed of 10-80 mm/min and rated stress of 5-40N, and the stretching rate is controlled at 5-80%.
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