CN116139388A - Flexible support catheter - Google Patents

Flexible support catheter Download PDF

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Publication number
CN116139388A
CN116139388A CN202211718121.0A CN202211718121A CN116139388A CN 116139388 A CN116139388 A CN 116139388A CN 202211718121 A CN202211718121 A CN 202211718121A CN 116139388 A CN116139388 A CN 116139388A
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CN
China
Prior art keywords
layer
support
connecting member
nylon
support catheter
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Pending
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CN202211718121.0A
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Chinese (zh)
Inventor
王思维
请求不公布姓名
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Shanghai Changde Medical Technology Co ltd
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Shanghai Changde Medical Technology Co ltd
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Priority to CN202211718121.0A priority Critical patent/CN116139388A/en
Publication of CN116139388A publication Critical patent/CN116139388A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0141Tip steering devices having flexible regions as a result of using materials with different mechanical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0059Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention provides a bendable support catheter which comprises a support member, a sheath member, a first connecting member, a second connecting member and a lining core, wherein one end of the sheath member is sleeved on one end of the support member, the other end of the sheath member is detachably connected with the first connecting member, one end of the lining core is detachably connected with the second connecting member, the other end of the lining core is inserted into the support member, and the lining core can be bent. According to the invention, the support catheter provided by the invention has the advantages that the support catheter is provided with the flexible lining core matched with the support member, the sheath member, the first connecting member and the second connecting member, so that the practicability of the support catheter is improved, and a doctor can perform bending adjustment according to clinical actual conditions, so that the support catheter is particularly suitable for treating tortuous vascular occlusion diseases.

Description

Flexible support catheter
Technical Field
The invention belongs to the technical field of medical catheter design, and relates to a bendable support catheter.
Background
In the treatment of occlusive disease caused by thrombosis, embolism, atherosclerosis, etc., it is often difficult to pass a guidewire alone through a lesion, particularly a complex CTO lesion. The support catheter can provide good support and puncture for the guide wire, is often used for establishing a good vascular access, and is convenient for carrying out subsequent treatment such as guide wire exchange, balloon placement, stent and the like.
At present, the existing support catheter is usually subjected to bending adjustment in advance in a heat setting mode so as to meet the use requirement of a specific scene. If the clinical scenes are more, the support catheters with different angles and various specifications are required to be prepared, the lower limb blood vessel is complicated to bend, the blood vessel branches are more, the limitation of the support catheter with the conventional specific angle is larger, and the use is inconvenient. Therefore, there is a need to design and develop a flexible support catheter that overcomes the drawbacks of the prior art while meeting the practical needs.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide the bendable support catheter, and in the invention, the support catheter is provided with the bendable lining core matched with the support member, the sheath member, the first connecting member and the second connecting member, so that the practicability of the support catheter is improved, a doctor can perform bending adjustment according to the clinical actual situation, and the support catheter is particularly suitable for treating the tortuous vessel occlusion diseases.
To achieve the purpose, the invention adopts the following technical scheme:
the invention provides a bendable support catheter which comprises a support member, a sheath member, a first connecting member, a second connecting member and a lining core, wherein one end of the sheath member is sleeved on one end of the support member, the other end of the sheath member is detachably connected with the first connecting member, one end of the lining core is detachably connected with the second connecting member, the other end of the lining core is inserted into the support member, and the lining core can be bent.
According to the invention, the support catheter provided by the invention has the advantages that the support catheter is provided with the flexible lining core matched with the support member, the sheath member, the first connecting member and the second connecting member, so that the practicability of the support catheter is improved, and a doctor can perform bending adjustment according to clinical actual conditions, so that the support catheter is particularly suitable for treating tortuous vascular occlusion diseases.
The support catheter of the present invention can be used for the treatment of occlusive diseases caused by thrombus, embolism, atherosclerosis and the like.
As a preferable technical scheme of the invention, the supporting member is of a tubular structure, the supporting member comprises a main body member, one end of the main body member is connected to the first connecting member, and the other end of the main body member is sequentially provided with a plastic member and a head end member along a direction away from the first connecting member.
Preferably, the body member includes a tube and a composite layer disposed on an outer surface of the tube.
Preferably, the plastic member is sleeved on the surface of the composite layer, and a coating layer is arranged on the surface of the plastic member away from the composite layer.
It should be noted that the coating of the present invention provides a smooth frontal surface and natural rheology.
Preferably, the head end component comprises a developing component, and the developing component is sleeved on the surface of the composite layer.
Preferably, the pipeline is a flexible lined pipeline.
Preferably, the composite layer is any one or a combination of two or more of a first bonding layer, a rigid supporting layer, a second bonding layer, a woven layer, a longitudinal supporting wire and a polymer wrapping material.
It should be noted that, the conventional support catheter is bent in advance by a heat setting mode, and only can meet the requirement of a specific vascular use scene that a plurality of use scenes require preparation of support catheters with a plurality of bending angles; the support catheter is different from the existing support catheter, a rigid support layer is added outside the braiding layer, so that the support catheter has stronger support performance and is easier to pass through a CTO lesion part; further, the conventional support catheter is composed of a lining, a braiding layer and a polymer outer layer, the lining is only subjected to etching treatment, the connection strength between the lining and the outer layer is weak, and in the process of passing through a guide wire, the inner layer is wrinkled or even falls off, so that surgical instruments need to be replaced. According to the support catheter disclosed by the invention, a layer of bonding layer is respectively added among the polymer outer layer, the rigid support layer and the flexible lining pipeline, so that the adhesive property is excellent, the support catheter is not easy to wrinkle and fall off, and the support property and the torque of the support catheter are also greatly improved.
Preferably, the material of the coating layer is the same as the material of the polymer coating material.
In a preferred embodiment of the present invention, the length of the main body member is 60 to 160cm, for example, 60cm, 70cm, 80cm, 90cm, 100cm, 110cm, 120cm, 130cm, 140cm, 150cm, 160cm, but the present invention is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned range are applicable.
The length of the main body member is limited to 60-160 cm, so that the risk that the length of the catheter is insufficient in the operation process and treatment time is delayed if the length of the catheter is not in the range and the catheter reaches the lesion position in various access modes can be met. It should be noted that the main body member of the present invention may have a certain flexibility and support, and the specific structure and material of the present invention are not particularly limited, and those skilled in the art may adapt according to the actual situation.
Preferably, the flexible lining pipe is made of any one of polytetrafluoroethylene, polyether-ether-ketone, fluorinated ethylene-propylene copolymer and ethylene-tetrafluoroethylene copolymer, and more preferably polytetrafluoroethylene.
It should be noted that polytetrafluoroethylene is preferred for the flexible lining pipe in the present invention because the coefficient of friction of the surface is low, and no scraps are generated.
Preferably, the surface of the flexible lining pipe is modified.
Preferably, the modification treatment mode comprises sodium naphthalene etching and plasma treatment.
It should be noted that, when the flexible lining pipeline is used, the surface of the flexible lining pipeline is subjected to modification treatment, so that the treated lining has good hydrophilic performance.
Preferably, the material of the first adhesive layer is any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon and fluorine-containing adhesive.
It should be noted that, in the present invention, the first adhesive layer may effectively bond the flexible lining pipe and the rigid supporting layer. The fluorine-containing binder in the present invention may be polyvinylidene fluoride, fluorine-containing polyacrylate, or the like.
Preferably, the rigid supporting layer is made of polyimide or stainless steel.
It should be noted that, the rigid supporting layer in the present invention can further enhance the supporting strength of the whole supporting catheter.
Preferably, the material of the second adhesive layer is any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon, and more preferably nylon.
It should be noted that the second adhesive layer in the invention can tightly bond the rigid supporting layer, the woven layer and the polymer packaging material, so that the pipe is not easy to delaminate in the using process, and the nylon hot melt adhesive can be used for bonding.
Preferably, the material of the braiding layer is any one of stainless steel, nickel titanium and polymer monofilament.
It should be noted that, the supporting property and the torque related parameter of the braid in the present invention can be adjusted according to the actual situation, and those skilled in the art do not limit the structure, shape and material thereof in particular.
Preferably, the braiding layer comprises braiding wires, and the braiding wires are round wires or flat wires.
It should be noted that, the shape handle of the braided wire in the present invention is limited to round wire or flat wire, and it is the protection scope of the present invention for the braiding layer preparation in the present application, and those skilled in the art should know.
Preferably, the braiding density of the braiding layer is 60-120 PPI, for example, 60PPI, 70PPI, 80PPI, 90PPI, 100PPI, 110PPI, 120PPI, but not limited to the listed values, and other non-listed values in the range of values are equally applicable.
Preferably, the number of the longitudinal support wires is 1 to 8, for example, 1, 2, 3, 4, 5, 6, 7, 8, but not limited to the recited values, and other non-recited values within the range are equally applicable.
Preferably, the longitudinal supporting wires are uniformly distributed circumferentially.
Preferably, the polymer wrapping material is any one of nylon-11, nylon-12 and polyether amide.
It should be noted that, in the present invention, the materials of the polymer coating material may be materials with different hardness, and the nylon-11, nylon-12 and polyether amide are only preferred examples of the present invention, and those skilled in the art may adapt according to the actual situation.
In a preferred embodiment of the present invention, the thickness of the flexible lining pipe is 15 to 20. Mu.m, for example, 15. Mu.m, 15.5. Mu.m, 16. Mu.m, 16.5. Mu.m, 17. Mu.m, 17.5. Mu.m, 18. Mu.m, 18.5. Mu.m, 19. Mu.m, 19.5. Mu.m, 20. Mu.m, but the flexible lining pipe is not limited to the above-mentioned values, and other values not shown in the above-mentioned numerical ranges are equally applicable.
The thickness of the flexible lining pipe is preferably 15 to 20 μm in the present invention, and the operation effect can be improved in this range, and the flexible lining pipe is not limited to this range, and can be adaptively adjusted according to the actual situation by those skilled in the art.
The thickness of the first adhesive layer is preferably 5 to 10 μm, and may be, for example, 5 μm, 5.5 μm, 6 μm, 6.5 μm, 7 μm, 7.5 μm, 8 μm, 8.5 μm, 9 μm, 9.5 μm, or 10 μm, but is not limited to the listed values, and other values not listed in the range of values are equally applicable.
In the present invention, the thickness of the first adhesive layer is preferably 5 to 10 μm, and the operation effect can be improved within this range, and the present invention is not limited to this range, and the present invention can be suitably adjusted according to the actual situation by those skilled in the art.
The thickness of the rigid support layer is preferably 40 to 50 μm, and may be, for example, 40 μm, 41 μm, 42 μm, 43 μm, 44 μm, 45 μm, 46 μm, 47 μm, 48 μm, 49 μm, 50 μm, but is not limited to the recited values, and other non-recited values within the range of values are equally applicable.
In the present invention, the thickness of the rigid support layer is preferably 40 to 50. Mu.m, and the operation effect can be improved in this range, and the present invention is not limited to this range, and the present invention can be suitably adjusted according to the actual situation by those skilled in the art.
The inner diameter of the longitudinal support wire is preferably 0.01 to 0.1mm, and may be, for example, 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, or 0.1mm, but is not limited to the values recited, and other values not recited in the numerical range are equally applicable.
The thickness of the polymer coating material is preferably 50 to 150. Mu.m, for example, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, but the thickness is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned numerical range are applicable.
In the present invention, the thickness of the polymer coating material is preferably 50 to 150. Mu.m, and the operation effect can be improved in this range, and the present invention is not limited to this range, and the present invention can be suitably adjusted according to the actual situation by those skilled in the art.
The thickness of the coating layer is preferably 20 to 30 μm, and may be, for example, 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, 26 μm, 27 μm, 28 μm, 29 μm, or 30 μm, but is not limited to the listed values, and other non-listed values within the range are equally applicable.
As a preferred embodiment of the invention, the plastic component is bendable.
The bending angle of the plastic member is preferably 0 to 60 °, for example, 0 °,1 °, 5 °, 10 °, 20 °, 30 °, 40 °, 50 °, 60 °, but the bending angle is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned numerical range are equally applicable.
The plastic member of the present invention needs to have a certain degree of flexibility, be bendable at 0 to 60 degrees without bending, and be bendable repeatedly a plurality of times, so that the technical effects of the present application can be achieved.
Preferably, the plastic member is made of any one of stainless steel, titanium and nickel.
Preferably, the plastic component is annealed.
The annealing treatment is preferably performed at a temperature of 500 to 1100 ℃, and may be performed at 500 ℃, 600 ℃, 700 ℃, 800 ℃, 900 ℃, 1000 ℃, 1100 ℃, for example, but the annealing treatment is not limited to the values listed, and other values not listed in the range are applicable.
Preferably, the surface of the plastic member is provided with a plating layer.
The plating on the surface of the plastic component can make the plastic component more flexible, visualize the treatment process and increase the operability.
Preferably, the plating layer is made of any one of gold, platinum iridium and tantalum.
The thickness of the plastic member is preferably 40 to 50 μm, and may be, for example, 40 μm, 41 μm, 42 μm, 43 μm, 44 μm, 45 μm, 46 μm, 47 μm, 48 μm, 49 μm, 50 μm, but is not limited to the recited values, and other non-recited values within the range of values are equally applicable.
The thickness of the plastic member is preferably 40 to 50 μm in the present invention, and the operation effect can be improved in this range, and the present invention is not limited to this range, and the plastic member can be suitably adjusted according to the actual situation by those skilled in the art.
As a preferable embodiment of the present invention, the developing member includes an organic polymer and a doping material doped in the organic polymer.
The developing device of the present invention must have a certain developing property, and the advancing of the support catheter after bending in the blood vessel can be seen.
The doping amount of the doping material is preferably 20 to 40%, and may be, for example, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, but is not limited to the values recited, and other values not recited in the range are equally applicable.
The doping amount of the doping material is preferably 20 to 40% in the present invention, and the operation effect can be improved in this range, and the present invention is not limited to this range, and the present invention can be adaptively adjusted according to the actual situation by those skilled in the art.
Preferably, the doping materials are tungsten, bismuth oxide and BaSO 4 Any one of the following.
Preferably, the material of the organic polymer is the same as that of the coating layer.
Preferably, an end of the head end member remote from the sheath member is tapered.
The head end member of the present invention has flexibility and is not likely to cause damage to blood vessels during the tortuosity of the blood vessels.
The taper angle of the taper structure is preferably 3 to 30 °, for example, 3 ℃, 5 ℃, 7 ℃, 10 ℃, 14 ℃, 16 ℃, 18 ℃, 20 ℃, 22 ℃, 24 ℃, 26 ℃, 28 ℃, 30 ℃, but is not limited to the above-mentioned values, and other values not shown in the above-mentioned range are applicable, and more preferably 10 to 20 °.
The angle of the cone structure is preferably 3-30 degrees, the operation effect can be better in the range, the range is not limited, and the person skilled in the art can adapt according to the actual situation.
As a preferable technical scheme of the invention, the sheath member is made of any one of nylon-11, nylon-12 and polyether amide.
Preferably, the sheath member is a hollow cylindrical structure.
The sheath member of the present invention is combined with one end of the support member by a fusion reflow soldering or bonding process, so that the support catheter is more stable as a whole.
As a preferable technical scheme of the invention, the first connecting member is a luer connector, one end of the first connecting member is used for being connected with an instrument, and the other end of the first connecting member is detachably connected with the supporting member.
It should be noted that, the detachable connection in the present invention may be a bolt connection, a bayonet connection, etc., and those skilled in the art should know that the manner of satisfying the detachable connection in the present invention is all the protection scope of the present invention.
Preferably, the first connecting member is made of any one of polyether amide, polyethylene, polycarbonate and polypropylene.
As a preferable technical scheme of the invention, the lining core is made of any one of nylon-11, nylon-12 and polyether amide.
Preferably, the end of the core remote from the second connecting member is of conical configuration or provided with a cut-out.
The taper angle of the taper structure is preferably 30 to 45 °, and may be, for example, 30 ℃, 31 ℃, 32 ℃, 33 ℃, 34 ℃, 35 ℃, 36 ℃, 37 ℃, 38 ℃, 39 ℃, 40 ℃, 42 ℃, 45 ℃, but is not limited to the above-mentioned values, and other values not mentioned in the above-mentioned value range are equally applicable.
The taper angle of the taper structure is preferably 30 to 45 degrees in the present invention, and the operation effect can be improved in this range, and the present invention is not limited to this range, and the present invention can be adaptively adjusted according to the actual situation by those skilled in the art.
As a preferred embodiment of the present invention, the second connecting member is bonded to the core.
It should be noted that, the second connecting member and the core are bonded by adopting a bonding manner, so that the second connecting member and the core are convenient to be movably connected, and the movable connection can be the extending and the extracting of the second connecting member and the core.
Preferably, the material of the second connecting member is any one of polyether amide, polyethylene, polycarbonate and polypropylene.
Compared with the prior art, the invention has the beneficial effects that:
according to the invention, the support catheter provided by the invention has the advantages that the support catheter is provided with the flexible lining core matched with the support member, the sheath member, the first connecting member and the second connecting member, so that the practicability of the support catheter is improved, and a doctor can perform bending adjustment according to clinical actual conditions, so that the support catheter is particularly suitable for treating tortuous vascular occlusion diseases.
Drawings
FIG. 1 is a schematic view of a support catheter according to an embodiment of the present invention;
FIG. 2 is a schematic view of a structure of a second connecting member and a core in a support catheter according to an embodiment of the present invention;
FIG. 3 is a schematic view of a support member in a support catheter according to an embodiment of the present invention;
FIG. 4 is a cross-sectional view of a support catheter according to one embodiment of the present invention;
FIG. 5 is a schematic view of a plastic component according to one embodiment of the present invention;
FIG. 6 is a schematic diagram II of a plastic component according to an embodiment of the present invention;
wherein 1-the support member; 11-a body member; 12-a plastic component; 13-coating layer; 14-a head end member; 111-flexible lined tubing; 112-a first tie layer; 113-a rigid support layer; 114-a second tie layer; 115-braiding layer; 116-polymer coating; 117-longitudinal support wires;
2-a sheath member; 3-a first connecting member; 4-lining core; 5-a second connecting member.
Detailed Description
It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus are not to be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
It should be noted that, in the description of the present invention, unless explicitly specified and limited otherwise, the terms "disposed," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art in a specific case.
It will be appreciated by those skilled in the art that the present invention necessarily includes the necessary piping, conventional valves and general pumping equipment for achieving the process integrity, but the foregoing is not a major inventive aspect of the present invention, and that the present invention is not particularly limited thereto as the layout may be added by themselves based on the process flow and the equipment configuration options.
The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.
The invention provides a bendable support catheter, which comprises a support member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4, wherein one end of the sheath member 2 is sleeved on one end of the support member 1, the other end of the sheath member 2 is detachably connected with the first connecting member 3, one end of the lining core 4 is detachably connected with the second connecting member 5, the other end is inserted into the support member 1, and the lining core 4 is bendable, as shown in fig. 1 to 6.
According to the invention, the support catheter provided by the invention is provided with the support member 1, the sheath member 2, the first connecting member 3 and the second connecting member 5 in a matched manner through the bendable lining core 4, so that the practicability of the support catheter is improved, and a doctor can perform bending adjustment according to clinical actual conditions, so that the support catheter is particularly suitable for treating the tortuous vascular occlusion disease. The support catheter of the present invention can be used for the treatment of occlusive diseases caused by thrombus, embolism, atherosclerosis and the like.
The supporting member 1 is a tubular structure, the supporting member 1 comprises a main body member 11, one end of the main body member 11 is connected to the first connecting member 3, the other end of the main body member 11 is sequentially provided with a plastic member 12 and a head end member 14 along a direction away from the first connecting member 3, and the main body member 11 comprises a pipeline and a composite layer arranged on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and the surface of the plastic member 12 away from the composite layer is provided with a coating layer 13. It should be noted that the coating layer 13 of the present invention can provide a smooth frontal surface and natural rheology. The head end component 14 comprises a developing component, the developing component is sleeved on the surface of a composite layer, the pipeline is a flexible lining pipeline 111, the composite layer is any one or a combination of two or more of a first bonding layer 112, a rigid supporting layer 113, a second bonding layer 114, a woven layer 115, a longitudinal supporting wire 117 and a polymer wrapping material 116, and the material of the wrapping layer 13 is the same as the material of the polymer wrapping material 116.
The length of the main body member 11 is 60-160 cm, the flexible lining pipeline 111 is made of any one of polytetrafluoroethylene, polyether-ether-ketone, fluorinated ethylene-propylene copolymer and ethylene-tetrafluoroethylene copolymer, and further the surface of the flexible lining pipeline 111 is modified by polytetrafluoroethylene, wherein the modification method comprises sodium naphthalene etching and plasma treatment. It should be noted that, when the flexible lining pipe 111 of the present invention is used, the surface needs to be modified, so that the treated lining has good hydrophilic performance.
The first adhesive layer 112 is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon and fluorine-containing adhesive. It should be noted that, in the present invention, the first adhesive layer 112 may effectively bond the flexible lining pipe 111 and the rigid supporting layer 113; the rigid support layer 113 is made of polyimide or stainless steel. It should be noted that, the rigid support layer 113 in the present invention may further enhance the support strength of the whole support catheter.
The second adhesive layer 114 is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon, further nylon, the braid 115 is made of any one of stainless steel, nickel titanium and polymer monofilaments, the braid 115 comprises braided filaments, and the shape of the braided filaments is round filaments or flat filaments. It should be noted that, the shape handle of the braided wire in the present invention is limited to round wire or flat wire, and it is the protection scope of the present invention for the braiding layer preparation in the present application, and those skilled in the art should know. The braiding density of the braiding layer 115 is 60-120 PPI, 1-8 longitudinal supporting wires 117 are arranged, the longitudinal supporting wires 117 are uniformly distributed circumferentially, and the polymer wrapping material 116 is made of any one of nylon-11, nylon-12 and polyether amide.
The thickness of the flexible lining pipe 111 is 15-20 μm, the thickness of the first adhesive layer 112 is 5-10 μm, the thickness of the rigid support layer 113 is 40-50 μm, the inner diameter of the longitudinal support wire 117 is 0.01-0.1 mm, the thickness of the polymer wrapping 116 is 50-150 μm, and the thickness of the wrapping layer 13 is 20-30 μm.
The plastic component 12 is bendable, the bending angle of the plastic component 12 is 0-60 degrees, the plastic component 12 is made of any one of stainless steel, titanium and nickel, the plastic component 12 is subjected to annealing treatment, the annealing treatment temperature is 500-1100 ℃, a plating layer is arranged on the surface of the plastic component 12, the plating layer is made of any one of gold, platinum iridium and tantalum, and the thickness of the plastic component 12 is 40-50 mu m.
The material of the developing member includes an organic polymer and a doping material doped in the organic polymer. The developing device of the present invention must have a certain developing property, and the advancing of the support catheter after bending in the blood vessel can be seen. The doping amount of the doping material is 20-40%. The doping materials are tungsten, bismuth oxide and BaSO 4 The material of the organic polymer is the same as that of the coating layer 13, and one end of the head end member 14, which is far away from the sheath member 2, is in a conical structure. The cone angle of the cone structure is 3-30 degrees.
The sheath member 2 is made of any one of nylon-11, nylon-12 and polyether amide, and the sheath member 2 is of a hollow cylindrical structure. The first connecting member 3 is a luer connector, one end of the first connecting member 3 is used for being connected with an instrument, and the other end of the first connecting member 3 is detachably connected with the supporting member 1. It should be noted that, the detachable connection in the present invention may be a bolt connection, a bayonet connection, etc., and those skilled in the art should know that the manner of satisfying the detachable connection in the present invention is all the protection scope of the present invention.
The first connecting member 3 is made of any one of polyether amide, polyethylene, polycarbonate and polypropylene. The lining core 4 is made of any one of nylon-11, nylon-12 and polyether amide. The end of the core 4 remote from the second connecting member 5 is of a conical structure or provided with a cut, the conical angle of the conical structure being 30-45 °. The second connecting member 5 is bonded to the core 4, and the second connecting member 5 is made of any one of polyether amide, polyethylene, polycarbonate and polypropylene.
Example 1
The present embodiment provides a flexible support catheter wherein:
the support catheter comprises a support member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4, one end of the sheath member 2 is sleeved on one end of the support member 1, the other end of the sheath member 2 is detachably connected with the first connecting member 3, one end of the lining core 4 is detachably connected with the second connecting member 5, the other end of the lining core 4 is inserted into the support member 1, and the lining core 4 is bendable.
The supporting member 1 is a tubular structure, the supporting member 1 comprises a main body member 11, one end of the main body member 11 is connected to the first connecting member 3, the other end of the main body member 11 is sequentially provided with a plastic member 12 and a head end member 14 along a direction away from the first connecting member 3, and the main body member 11 comprises a pipeline and a composite layer arranged on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and the surface of the plastic member 12 away from the composite layer is provided with a coating layer 13. The head end component 14 comprises a developing component, the developing component is sleeved on the surface of a composite layer, the pipeline is a flexible lining pipeline 111, the composite layer is sequentially provided with a first bonding layer 112, a rigid supporting layer 113, a second bonding layer 114, a woven layer 115, a longitudinal supporting wire 117 and a polymer packaging material 116, and the material of the packaging layer 13 is the same as that of the polymer packaging material 116.
The length of the main body member 11 is 60cm, the material of the flexible lining pipeline 111 is polytetrafluoroethylene, and the surface of the flexible lining pipeline 111 is modified in a sodium naphthalene etching mode.
The first adhesive layer 112 is made of ethylene-vinyl acetate copolymer. The rigid support layer 113 is made of polyimide. The second adhesive layer 114 is made of ethylene-vinyl acetate copolymer, the braid 115 is made of stainless steel, the braid 115 comprises braided filaments, and the braided filaments are round filaments. The braiding density of the braiding layer 115 is 60PPI, 3 longitudinal supporting wires 117 are provided, the longitudinal supporting wires 117 are uniformly circumferentially distributed, and the polymer wrapping material 116 is nylon-11.
The thickness of the flexible lining tubing 111 was 15 μm, the thickness of the first adhesive layer 112 was 5 μm, the thickness of the rigid support layer 113 was 40 μm, the inner diameter of the longitudinal support wire 117 was 0.01mm, the thickness of the polymer wrapping 116 was 50 μm, and the thickness of the cladding layer 13 was 20 μm.
The plastic member 12 is bendable, the bending angle of the plastic member 12 is 20 degrees, the plastic member 12 is made of stainless steel, the plastic member 12 is required to be annealed, and the annealing temperature is 1100 ℃. The surface of the plastic member 12 is provided with a plating layer made of gold, and the thickness of the plastic member 12 is 40 μm.
The material of the developing member includes an organic polymer and a doping material doped in the organic polymer. The doping amount of the doping material is 20%. The doped material is tungsten, the material of the organic polymer is the same as that of the coating layer 13, and one end of the head end member 14, which is far away from the sheath member 2, is in a conical structure. The cone angle of the cone structure is 3 degrees.
The sheath member 2 is made of nylon-11, and the sheath member 2 is of a hollow cylindrical structure. The first connecting member 3 is a luer connector, one end of the first connecting member 3 is used for being connected with an instrument, and the other end of the first connecting member 3 is detachably connected with the supporting member 1.
The first connecting member 3 is made of polyether amide. The lining core 4 is made of nylon-11. The end of the core 4 remote from the second connecting member 5 is of a conical configuration with a taper angle of 30 °. The second connecting member 5 is bonded with the lining core 4, and the material of the second connecting member 5 is polyether amide.
Example 2
The present embodiment provides a flexible support catheter wherein:
the support catheter comprises a support member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4, one end of the sheath member 2 is sleeved on one end of the support member 1, the other end of the sheath member 2 is detachably connected with the first connecting member 3, one end of the lining core 4 is detachably connected with the second connecting member 5, the other end of the lining core 4 is inserted into the support member 1, and the lining core 4 is bendable.
The supporting member 1 is a tubular structure, the supporting member 1 comprises a main body member 11, one end of the main body member 11 is connected to the first connecting member 3, the other end of the main body member 11 is sequentially provided with a plastic member 12 and a head end member 14 along a direction away from the first connecting member 3, and the main body member 11 comprises a pipeline and a composite layer arranged on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and the surface of the plastic member 12 away from the composite layer is provided with a coating layer 13. The head end component 14 comprises a developing component, the developing component is sleeved on the surface of a composite layer, the pipeline is a flexible lining pipeline 111, the composite layer is sequentially provided with a first bonding layer 112, a rigid supporting layer 113, a braiding layer 115, a longitudinal supporting wire 117 and a polymer packing material 116, and the material of the packing layer 13 is the same as that of the polymer packing material 116.
The length of the main body member 11 is 100cm, the material of the flexible lining pipe 111 is polyether-ether-ketone, and the surface of the flexible lining pipe 111 is modified by plasma treatment.
The first adhesive layer 112 is made of thermoplastic polyurethane elastomer rubber. The rigid support layer 113 is made of stainless steel. The material of the braid 115 is nickel titanium, the braid 115 includes braid wires, and the shape of the braid wires is flat wires. The braiding density of the braiding layer 115 is 100PPI, 5 longitudinal supporting wires 117 are provided, the longitudinal supporting wires 117 are uniformly distributed circumferentially, and the polymer wrapping material 116 is nylon-12.
The thickness of the flexible lining tubing 111 was 18 μm, the thickness of the first adhesive layer 112 was 8 μm, the thickness of the rigid support layer 113 was 45 μm, the inner diameter of the longitudinal support filaments 117 was 0.05mm, the thickness of the polymer wrapper 116 was 100 μm, and the thickness of the cladding layer 13 was 25 μm.
The plastic member 12 is bendable, the bending angle of the plastic member 12 is 30 degrees, the plastic member 12 is made of titanium, the plastic member 12 is subjected to annealing treatment at 550 ℃, a plating layer is arranged on the surface of the plastic member 12, the plating layer is made of platinum iridium, and the thickness of the plastic member 12 is 45 μm.
The material of the developing member includes an organic polymer and a doping material doped in the organic polymer. The doping amount of the doping material is 30%. The doped material is bismuth oxide, the material of the organic polymer is the same as that of the coating layer 13, and one end of the head end component 14, which is far away from the sheath component 2, is in a conical structure. The cone angle of the cone structure is 20 degrees.
The sheath member 2 is made of nylon-12, and the sheath member 2 is of a hollow cylindrical structure. The first connecting member 3 is a luer connector, one end of the first connecting member 3 is used for being connected with an instrument, and the other end of the first connecting member 3 is detachably connected with the supporting member 1.
The first connecting member 3 is made of polyethylene. The lining core 4 is made of nylon-12. The end of the core 4 remote from the second connecting member 5 is provided with a cut. The second connecting member 5 is bonded to the core 4, and the second connecting member 5 is made of polyethylene.
Example 3
The present embodiment provides a flexible support catheter wherein:
the support catheter comprises a support member 1, a sheath member 2, a first connecting member 3, a second connecting member 5 and a lining core 4, one end of the sheath member 2 is sleeved on one end of the support member 1, the other end of the sheath member 2 is detachably connected with the first connecting member 3, one end of the lining core 4 is detachably connected with the second connecting member 5, the other end of the lining core 4 is inserted into the support member 1, and the lining core 4 is bendable.
The supporting member 1 is a tubular structure, the supporting member 1 comprises a main body member 11, one end of the main body member 11 is connected to the first connecting member 3, the other end of the main body member 11 is sequentially provided with a plastic member 12 and a head end member 14 along a direction away from the first connecting member 3, and the main body member 11 comprises a pipeline and a composite layer arranged on the outer surface of the pipeline. The plastic member 12 is sleeved on the surface of the composite layer, and the surface of the plastic member 12 away from the composite layer is provided with a coating layer 13. The head end component 14 comprises a developing component, the developing component is sleeved on the surface of the composite layer, the pipeline is a flexible lining pipeline 111, the composite layer is sequentially provided with a first bonding layer 112, a rigid supporting layer 113, a second bonding layer 114 and a polymer packaging material 116, and the material of the packaging layer 13 is the same as that of the polymer packaging material 116.
The length of the main body member 11 is 160cm, the flexible lining pipe 111 is made of fluorinated ethylene propylene copolymer, and the surface of the flexible lining pipe 111 is modified by plasma treatment.
The first adhesive layer 112 is made of nylon. The rigid support layer 113 is made of polyimide. The second adhesive layer 114 is nylon, and the polymer wrapping material 116 is polyether amide.
The thickness of the flexible lining tubing 111 was 20 μm, the thickness of the first adhesive layer 112 was 10 μm, the thickness of the rigid support layer 113 was 50 μm, the thickness of the polymer wrapper 116 was 150 μm, and the thickness of the cladding layer 13 was 30 μm.
The plastic member 12 is bendable, the bending angle of the plastic member 12 is 60 degrees, the plastic member 12 is made of stainless steel, the plastic member 12 is subjected to annealing treatment at 1100 ℃, a plating layer is arranged on the surface of the plastic member 12, the plating layer is made of tantalum, and the thickness of the plastic member 12 is 50 mu m.
The material of the developing member includes an organic polymer and a doping material doped in the organic polymer. The doping amount of the doping material is 40%. The doping material is BaSO 4 The material of the organic polymer is the same as that of the coating layer 13, and one end of the head end member 14, which is far away from the sheath member 2, is in a conical structure. The cone angle of the cone structure is 30 degrees.
The sheath member 2 is made of polyether amide, and the sheath member 2 is of a hollow cylindrical structure. The first connecting member 3 is a luer connector, one end of the first connecting member 3 is used for being connected with an instrument, and the other end of the first connecting member 3 is detachably connected with the supporting member 1.
The first connecting member 3 is made of polypropylene. The material of the lining core 4 is polyether amide. The end of the core 4 remote from the second connecting member 5 is of a conical configuration with a conical angle of 45 °. The second connecting member 5 is bonded to the core 4, and the second connecting member 5 is made of polypropylene.
Example 4
This example provides a flexible support catheter, which differs from example 1 in that the plastic member 12 has a thickness of 30 μm, and other parameters and conditions are the same as in example 1.
Example 5
This example provides a flexible support catheter, which differs from example 1 in that the plastic member 12 has a thickness of 55 μm, and other parameters and conditions are the same as in example 1.
The flexibility of the support catheter of examples 1-3 is superior to that of the support catheters of examples 4, 5 because the thickness of the plastic member 12 in the present invention is 40-50 μm, the plastic member is smaller than 40 μm, and the plastic member is easily bent under force; the shaping member is greater than 50um, which can result in an oversized maximum outer diameter of the tubing, affecting the passability of the catheter.
The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and it should be apparent to those skilled in the art that any changes or substitutions that fall within the technical scope of the present invention disclosed herein are within the scope of the present invention.

Claims (10)

1. The flexible support catheter is characterized by comprising a support member, a sheath member, a first connecting member, a second connecting member and a lining core, wherein one end of the sheath member is sleeved on one end of the support member, the other end of the sheath member is detachably connected with the first connecting member, one end of the lining core is detachably connected with the second connecting member, the other end of the lining core is inserted into the support member, and the lining core is flexible.
2. The support catheter of claim 1, wherein the support member is a tubular structure, the support member comprising a main body member having one end connected to the first connection member and the other end provided with a plastic member and a head end member in this order in a direction away from the first connection member;
preferably, the main body member comprises a pipeline and a composite layer arranged on the outer surface of the pipeline;
preferably, the plastic component is sleeved on the surface of the composite layer, and a coating layer is arranged on the surface of the plastic component far away from the composite layer;
preferably, the head end component comprises a developing component, and the developing component is sleeved on the surface of the composite layer;
preferably, the pipeline is a flexible lined pipeline;
preferably, the composite layer is any one or a combination of two or more of a first bonding layer, a rigid supporting layer, a second bonding layer, a braiding layer, a longitudinal supporting wire and a polymer wrapping material;
preferably, the material of the coating layer is the same as the material of the polymer coating material.
3. The support catheter of claim 2, wherein the body member has a length of 60-160 cm;
preferably, the flexible lining pipeline is made of any one of polytetrafluoroethylene, polyether-ether-ketone, fluorinated ethylene propylene copolymer and ethylene-tetrafluoroethylene copolymer, and more preferably polytetrafluoroethylene;
preferably, the surface of the flexible lining pipeline is subjected to modification treatment;
preferably, the modification treatment mode comprises sodium naphthalene etching and plasma treatment;
preferably, the first adhesive layer is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber, nylon and fluorine-containing adhesive;
preferably, the rigid supporting layer is made of polyimide or stainless steel;
preferably, the second adhesive layer is made of any one of ethylene-vinyl acetate copolymer, thermoplastic polyurethane elastomer rubber and nylon, and more preferably nylon;
preferably, the material of the braiding layer is any one of stainless steel, nickel titanium and polymer monofilament;
preferably, the braiding layer comprises braiding wires, and the braiding wires are round wires or flat wires;
preferably, the braiding density of the braiding layer is 60-120 PPI;
preferably, 1 to 8 longitudinal support wires are arranged;
preferably, the longitudinal supporting wires are uniformly distributed circumferentially;
preferably, the polymer wrapping material is any one of nylon-11, nylon-12 and polyether amide.
4. The support catheter of claim 2, wherein the flexible liner conduit has a thickness of 15-20 μιη;
preferably, the thickness of the first adhesive layer is 5-10 μm;
preferably, the thickness of the rigid support layer is 40-50 μm;
preferably, the inner diameter of the longitudinal support wire is 0.01-0.1 mm;
preferably, the thickness of the polymer coating material is 50-150 mu m;
preferably, the thickness of the coating layer is 20 to 30 μm.
5. The support catheter of claim 2, wherein the plastic member is bendable;
preferably, the bending angle of the plastic member is 0 to 60 °;
preferably, the plastic member is made of any one of stainless steel, titanium and nickel;
preferably, the plastic component is subjected to an annealing treatment;
preferably, the temperature of the annealing treatment is 500-1100 ℃;
preferably, the surface of the plastic member is provided with a plating layer;
preferably, the plating layer is made of any one of gold, platinum iridium and tantalum;
preferably, the thickness of the plastic member is 40 to 50 μm.
6. The support catheter of any one of claims 1-5, wherein the material of the developing component comprises an organic polymer and a doping material doped in the organic polymer;
preferably, the doping amount of the doping material is 20-40%;
preferably, the doping materials are tungsten, bismuth oxide and BaSO 4 Any one of them;
preferably, the material of the organic polymer is the same as that of the coating layer;
preferably, an end of the head end member remote from the sheath member is tapered;
preferably, the cone angle of the cone structure is 3-30 °, more preferably 10-20 °.
7. The support catheter of any one of claims 1-6, wherein the sheath member is any one of nylon-11, nylon-12, and polyether amide;
preferably, the sheath member is a hollow cylindrical structure.
8. The support catheter of any one of claims 1-7, wherein the first connection member is a luer fitting, one end of the first connection member being for connection with an instrument, the other end being detachably connected to the support member;
preferably, the first connecting member is made of any one of polyether amide, polyethylene, polycarbonate and polypropylene.
9. The support catheter of any one of claims 1-8, wherein the core is any one of nylon-11, nylon-12, and polyether amide;
preferably, the end of the lining core far away from the second connecting member is in a conical structure or is provided with a notch;
preferably, the taper angle of the taper structure is 30-45 °.
10. The support catheter of any one of claims 1-9, wherein the second connection member and the core are bonded;
preferably, the material of the second connecting member is any one of polyether amide, polyethylene, polycarbonate and polypropylene.
CN202211718121.0A 2022-12-29 2022-12-29 Flexible support catheter Pending CN116139388A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202211718121.0A CN116139388A (en) 2022-12-29 2022-12-29 Flexible support catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202211718121.0A CN116139388A (en) 2022-12-29 2022-12-29 Flexible support catheter

Publications (1)

Publication Number Publication Date
CN116139388A true CN116139388A (en) 2023-05-23

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
CN (1) CN116139388A (en)

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