WO2018121019A1 - 一种非血管腔道导丝 - Google Patents

一种非血管腔道导丝 Download PDF

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Publication number
WO2018121019A1
WO2018121019A1 PCT/CN2017/107643 CN2017107643W WO2018121019A1 WO 2018121019 A1 WO2018121019 A1 WO 2018121019A1 CN 2017107643 W CN2017107643 W CN 2017107643W WO 2018121019 A1 WO2018121019 A1 WO 2018121019A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
ball head
outer diameter
layer
guidewire
Prior art date
Application number
PCT/CN2017/107643
Other languages
English (en)
French (fr)
Inventor
郑忠伟
黄云腾
袁庆
王攀
严航
Original Assignee
上海英诺伟医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海英诺伟医疗器械有限公司 filed Critical 上海英诺伟医疗器械有限公司
Priority to CN201780002806.6A priority Critical patent/CN108064180B/zh
Priority to EP17889065.3A priority patent/EP3560542A4/en
Priority to JP2019555533A priority patent/JP2020506021A/ja
Priority to US16/473,252 priority patent/US20200147352A1/en
Publication of WO2018121019A1 publication Critical patent/WO2018121019A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • the present invention relates to the field of medical device technology, and more particularly to a non-vascular lumen guidewire.
  • the guide wire When a catheter is inserted into a lumen of a living body such as a digestive tract, a urinary tract, or a trachea, the guide wire can be used to guide the catheter to a target site of the living body lumen.
  • the role of the guidewire in medical procedures is usually the advancement and proper positioning of the auxiliary catheter and other medical devices within the body cavity.
  • a guide wire inserted into the lumen of the endoscope is guided to a target site such as a living body lumen.
  • a guidewire is used when inserting a catheter into the lumen, the guidewire is first inserted into the lumen, and the catheter is advanced along the guidewire such that the guidewire can guide the catheter to the lesion.
  • the metal guide wire has poor affinity with the inner wall of the cavity, has large frictional resistance, low lubricity, and is inconvenient to insert.
  • the doctor needs to observe the traveling state of the guide wire through a medical X-ray machine or an endoscope.
  • the doctor judges the contact between the guide wire and the inner wall of the cavity through the image, but the ordinary guide wire is not favorable for observation under the endoscope and the X-ray machine.
  • it is very important to accurately determine the contact between the guide wire and the inner wall of the cavity. It can prevent the guide wire from exerting excessive force on the human tissue. If the force is too large, the inner wall of the cavity may be stabbed.
  • a number of documents in the prior art such as reference 1 (CN103623495A), disclose a zebra guidewire having a polytetrafluoroethylene layer disposed on the surface of the metal core of the delivery mandrel and a lower polytetrafluoroethylene layer.
  • the friction coefficient reduces the resistance generated by the guide wire delivery process, and the surface of the Teflon layer on the surface of the metal core is a spiral stripe not in the same plane, which is easy to handle while reducing the resistance, and the PTFE layer is further improved.
  • the operability of the zebra guide wire is further improved.
  • a polymeric sleeve is placed over the surface of the guidewire of the zebra guidewire, and the surface of the polymeric sleeve is pre-coated with a hydrophilic coating to reduce the guidewire and other instruments or lumens during use.
  • the friction of the inner wall makes the zebra guide wire have better maneuverability and super-slip at the same time.
  • an improved zebra guidewire comprising a core with an elastic metal body attached to the top of the inner core, the length of the elastic metal body being 0.5 cm to 3 cm, and the outer diameter of the elastic metal body being The outer diameter of the core is 0.1 mm, and an overmold layer is wrapped around the outer side of the elastic metal body and the inner core.
  • the program can improve the deficiencies of the prior art, and can achieve uncompromising and super-slip during the operation process, and the doctor can clearly observe the puncture site reached at the front end of the zebra guide wire in the image, so that the operation can be smoothly performed. Health care workers reduce psychological stress and bring convenience to the success of the operation.
  • both zebra guide wires are covered with spiral strips on the surface, which can be inserted under the observation of the endoscope, but the distal end of the guide wire is pointed, relatively sharp, even if it is visible.
  • it is also easy to smash the catheter or scratch the inner wall of the cavity causing the use of the product to be ineffective, causing pain to the patient, becoming a new lesion or causing complications.
  • the spiral stripe plastic coating layer is easy to fall off, or the plastic coated body at the distal end of the guide wire is easily rolled up during the insertion process.
  • a guide wire is disclosed in Reference 3 (CN105343984A), which solves the problem that the contact force cannot be accurately determined when the guide wire is in contact with the blood vessel in the prior art.
  • the guide wire of the utility model comprises a guide wire tip end, a fiber optic sensor disposed in the lumen of the guide wire, a spring, a fixing member; the spring is fixed between the fixing member and the tip end of the guide wire; the optical fiber sensor passes through the fixing member
  • the inner cavity and the spring are internally fixed to the tip end of the guide wire, and the grating portion of the fiber sensor is located at the end of the spring and the guide wire.
  • the grating of the fiber sensor is located at the end of the spring and the guide wire.
  • the deformation of the obtained grating and the coefficient obtained in advance can accurately determine the force of the tip end of the guide wire. This can effectively avoid stabbing the wall of the cavity, but the structure of the guide wire is complicated, and the cost is high, which is not suitable for a wide range of applications.
  • Reference 4 discloses a urinary power tube insertion guide wire comprising a guide wire guide body; the distal end of the insertion guide wire body is a rounded end, and the proximal end of the insertion guide wire body
  • the positioning handle has a positioning handle for inserting the distal end of the auxiliary guide wire into the urinary power tube and just in contact with the top of the balloon of the urinary power tube.
  • the urinary power tube insertion guide wire can prevent the distal end of the balloon from piercing the urinary power test tube after inserting the urinary power test tube, thereby avoiding the failure of the use of the urinary power test tube.
  • a positioning handle in addition to the round end, a positioning handle must be provided to achieve the function of the puncture-proof balloon, resulting in a complicated structure of the guide wire, an increase in cost, an increase in operational difficulty, and no mention of how to avoid the thorn. Injury Body wall.
  • Reference 5 discloses a ball-end guide wire comprising a flexible mandrel having flexibility, a tip end of the wire at the head of the mandrel and a cover made of a flexible material, which is coated outside the mandrel. a coating layer, and a head tube made of a developed polymer material, the head tube is connected to the coating layer and the tip end of the guide wire, and the tip end of the guide wire is an inner hollow sphere made of a highly elastic material.
  • the outer surface of the guide wire has a hydrophilic layer, and the tip end of the guide wire is integrated with the cover layer.
  • the invention has the advantages that the perforation of the wall of the lumen is not caused, the tip end of the guide wire can smoothly pass through the lumen, and the operation risk is small.
  • the guide wire tip end is an inner hollow sphere made of a highly elastic material, and the outer surface of the guide wire has a hydrophilic layer, and the tip end of the guide wire is integrated with the coating layer.
  • Highly elastic materials such as polyurethane, modified nylon and other elastic materials.
  • the ball head made of a high molecular polymer can effectively prevent the inner wall from being stabbed, the hollow ball head made of the high polymer has low strength, poor guiding property, and is inconvenient to insert.
  • the technical problem to be solved by the present invention is to provide a non-vascular lumen guide wire which has strong visibility under the endoscope and X-ray, simple structure, does not stab the inner wall of the cavity, and can prevent the plastic layer from falling off or curling. .
  • the non-vascular lumen guide wire comprises a mandrel and a ball head prepared from a metal material, the outer diameter of the insertion end of the mandrel is smaller than the outer diameter of the non-insertion end, and the ball is inserted at the insertion end of the mandrel.
  • the head, the mandrel jacket is provided with a plastic coating layer, the outer diameter of the ball head is larger than the outer diameter of the insertion end of the plastic layer, and the outer diameter of the ball head is not larger than the outer diameter of the non-inserted end of the plastic coating layer.
  • the outer diameter of the ball head is 1.1 to 3 times the outer diameter of the insertion end of the plastic layer.
  • the overmold layer is coated with an ultra-smooth hydrophilic coating.
  • the overmold layer is sleeved outside the mandrel, and the overmold layer is made of one or more materials selected from the group consisting of polytetrafluoroethylene, polyurethane or nylon elastomer.
  • the plastic coating layer is sleeved outside the mandrel, and the plastic coating layer is composed of a first plastic coating layer close to the ball head and a second plastic coating layer away from the ball head, and the hardness of the second plastic coating layer is greater than that of the first plastic coating layer.
  • the plastic coating layer is sleeved outside the mandrel, and the plastic coating layer is composed of a first plastic coating layer close to the ball head and a second plastic coating layer away from the ball head, and the hardness of the second plastic coating layer is greater than that of the first plastic coating layer.
  • the first plastic layer has a Shore A hardness of 30 to 90
  • the second plastic layer has a Shore D hardness of 50 to 100.
  • the first overmold layer is made of a material selected from the group consisting of polytetrafluoroethylene, polyurethane or nylon elastomer.
  • the second overmold layer is made of a material selected from the group consisting of polytetrafluoroethylene or polyurethane.
  • mandrel and the ball head are made of a nickel-titanium alloy material or a stainless steel material.
  • the ball head is seamlessly coupled to the mandrel.
  • the guide wire is a straight guide wire or an elbow guide wire.
  • the outer diameter of the guide wire ball head of the present invention is larger than the outer diameter of the insertion end of the plastic coated layer, which overcomes the prior art that the guide wire with the plastic coated layer is easy to fall off during actual use, or is inserted. In the process, the plastic coating layer is easily rolled up due to the resistance of the distal end.
  • the ball head of the guide wire is made of a metal material, and the developability is much better than that of the plastic under the X-ray machine.
  • the outer diameter of the ball head is larger than the plastic coating layer, and can be clearly observed under the X-ray machine and the endoscope. At the ball head, the doctor can clearly observe the puncture site reached at the front end of the guide wire, and the effect of preventing the guide wire head from piercing the inner wall of the cavity can be achieved without the need for a positioning device.
  • FIG. 1 is a schematic cross-sectional view of a straight guide wire according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic cross-sectional view of a straight guide wire according to Embodiment 2 of the present invention.
  • FIG. 3 is a schematic cross-sectional view of a curved guide wire provided by the present invention.
  • FIG. 4 is a schematic cross-sectional view of a zebra guide wire of Comparative Example 1;
  • Figure 5 is a schematic cross-sectional view of a hybrid guide wire of Comparative Example 2.
  • proximal or tail of a guidewire is the guidewire segment that extends closest to the physician on the outside of the body, ie, the non-inserted end.
  • distal or front end of the guidewire is the guidewire segment that is furthest from the entrance site within the body lumen, ie, the insertion end.
  • the full length of the guide wire is not shown.
  • the length of the guidewire can vary depending on the type of interventional procedure, but typically the length of the guidewire is in the range of 30 to 800 centimeters (cm).
  • the typical length of the guidewire for the intervention of the coronary, peripheral, and neural vessels may range from 170 to 300 cm.
  • the non-vascular lumen guide wire provided by the present invention comprises a mandrel 1 and a ball head 2 prepared from a metal material, and an outer diameter of the insertion end of the mandrel 1 is smaller than an outer diameter of the non-insertion end.
  • the insertion end of the mandrel 1 is connected with a ball head 2, and the mandrel 1 is provided with a plastic coating layer 3.
  • the outer diameter of the ball head 2 is larger than the outer diameter of the insertion end of the plastic layer 3.
  • the outer diameter of the ball head 2 is not greater than the plastic coating layer. 3 OD of the non-inserted end.
  • the diameter of the ball head 2 is slightly larger than the outer diameter of the insertion end of the plastic coating layer 3, it is possible to effectively prevent the plastic coating layer 3 in the guide wire from falling off during actual use, or the insertion end of the plastic molding layer 3 is easy during the insertion process.
  • the outer diameter of the ball head 2 needs to be no larger than the outer diameter of the non-inserted end of the plastic coated layer 3, thereby avoiding the excessively large size of the guide wire and requiring more instrument passages.
  • the guide wire head has a spherical head shape, has a smooth appearance and is not easy to stab the inner wall of the cavity; and has a diameter larger than the outer diameter of the insertion end of the plastic coated layer 3, and the size is larger than that of the prior art guide wire head, and relies on the excellent developability of the metal itself.
  • the ball head 2 can be clearly observed under the endoscope and the X-ray, and the doctor can clearly observe the insertion of the guide wire, and can prevent the guide wire from piercing the inner wall of the cavity without the need of the positioning device. .
  • the person skilled in the art can adjust the size of the ball head 2 according to actual needs.
  • the outer diameter of the ball head 2 can be preferably 1.1 to 3 times the outer diameter of the insertion section of the plastic layer 3.
  • the size of the ball head 2 is too small, and the visibility under the X-ray machine and the endoscope is weakened. Therefore, even if the guide wire head is in the shape of a ball, the area of the force when it contacts the inner wall of the cavity is still small, If the operator cannot clearly observe the position of the guide wire, once the operator cares, the inner wall may be stabbed; the size of the ball head 2 is too large, and the insertion resistance is increased, which may increase the difficulty of insertion of the guide wire.
  • the overmold layer 3 is coated with an ultra-slip hydrophilic coating, which can adsorb and retain the liquid, reduce the frictional resistance of the surface of the guide wire, and further increase the insertion performance of the guide wire.
  • the overmold layer 3 is a plastic sleeve sleeved outside the mandrel, and the overmold layer 3 may be selected from materials having good flexibility (such as soft materials, elastic materials, etc.), and the specific material is not special.
  • the invention may be selected from polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, and the like.
  • One or more of various rubber materials such as fluoropolymer (PTFE, ETFE, PFA, etc.) or composite materials of these materials, latex rubber, silicone rubber, nylon elastomer, and the like.
  • the overmold layer 3 is most preferably made of one or more materials of polytetrafluoroethylene, polyurethane or nylon elastomer; the polytetrafluoroethylene material has low surface friction and good lubricity, and can improve the conductivity.
  • the overmold layer 3 is sleeved outside the mandrel, and the overmold layer 3 is composed of a first overmold layer 31 adjacent to the ball head 2 and a second overmold layer 32 remote from the ball head, The hardness of the second overmold 32 is greater than that of the first overmold layer 31.
  • the presence of the overmolding layer 3 is mainly for increasing the biocompatibility of the guide wire and the inner wall of the cavity, or for lubricating, reducing the resistance when the guide wire is inserted; and at the same time, the flexibility of the mandrel may be lowered due to the presence of the overmold layer 3.
  • the flexibility and bendability of the guide wire head can be improved, facilitating the guiding property in a relatively complicated cavity;
  • the first plastic coating layer 31 is soft, and the ball head 2 can be further prevented from stabbing the inner wall of the cavity; by setting the end away from the ball head 2 to the harder second plastic coating layer 32, the strength of the guide wire can be ensured and improved. Insertability.
  • the first plastic layer 31 has a Shore A hardness of 30 to 90
  • the second plastic layer 32 has a Shore D hardness of 50 to 100.
  • the Shore hardness of the first overmold layer 31 and the second overmold layer 32 is within this range, that is, the stab resistance of the ball guide wire can be further improved, and the insertion performance of the ball guide wire can be sufficiently ensured.
  • the first overmold layer 31 is made of a material selected from a polytetrafluoroethylene, polyurethane or nylon elastomer having a lower hardness, more preferably a polyurethane material, the polyurethane having high strength and the human body It has good biocompatibility and high flexibility at body temperature.
  • the first overmold layer 31 is mainly composed of a urethane-based resin, the flexibility of the tip end portion of the guide wire is further improved, so that when the cavity is inserted into the cavity, the inner wall of the cavity can be more reliably prevented from being damaged, and the operation is improved. safety.
  • the second plastic layer 32 is made of a high hardness polytetrafluoroethylene or polyurethane material, preferably polytetrafluoroethylene, which has high strength, low surface friction and good lubricity, and can improve the insertability of the guide wire.
  • the mandrel 1 is made of a metal material, and for example, various metal materials such as stainless steel and an alloy (including a superelastic alloy) exhibiting pseudoelasticity can be used, and a nickel-titanium alloy material is preferable.
  • the constituent material of the mandrel 1 in the guide wire is made of a metal material, and is not particularly limited, and a metal material which is common in the art can be selected, for example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430) can be used.
  • a metal material which is common in the art can be selected, for example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430) can be used.
  • Various metal materials such as SUS434, SUS444, SUS429, SUS430F, and SUS302, which exhibit pseudoelasticity (including a superelastic alloy), and preferably a superelastic alloy.
  • the guide wire made of the superelastic alloy as the mandrel has a sufficient bending softness and elastic recovery capability at the front end portion, which can improve the insertion of a complicated, curved cavity. Performance, and can obtain more excellent operability, and even if the guide wire undergoes repeated bending deformation, the guide wire does not cause permanent bending deformation due to the excellent elastic recovery ability of the guide wire, so that the guide wire can be avoided in use because The occurrence of bending causes a decrease in operability.
  • the superelastic alloy is preferably a nickel-titanium alloy
  • the guide wire using the nickel-titanium alloy as the mandrel has excellent pushability, torque transmission property, and good operability, and has good at the distal end.
  • the softness and restorability improve the followability and safety of the cavity, further reducing the risk of piercing the inner wall of the cavity.
  • the ball head 2 is seamlessly coupled to the mandrel, and the ball head 2 is preferably integrally formed with the mandrel 1 and seamlessly coupled to the mandrel 1, thereby reducing the risk of the ball head 2 falling off.
  • the ball head 2 may be coated with a functional coating such as one or more of a hydrophilic coating, a hydrophobic coating or a bioactive coating, and the hydrophilic coating may attract water molecules to form on the surface thereof.
  • the hydrophilic coating material is not specifically limited, and the coating is preferably formed of a material having a small frictional resistance.
  • it is preferably made of polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyacrylamide, polyacrylic acid, sodium polyacrylate, poly(2-hydroxyethyl methacrylate), maleic anhydride copolymer, ethylene vinyl alcohol.
  • Copolymer 2-methacryloyloxyethylphosphocholine or its copolymer, (2-hydroxyethyl methacrylate)-styrene block copolymer, various synthetic peptides, collagen, hyaluronate One or more of cellulose-based copolymers.
  • the ball head 2 may also be coated with a hydrophobic coating.
  • the hydrophobic coating material is not particularly limited, and one or more of silicone, polytetrafluoroethylene or fluorinated ethylene propylene copolymer may be used, and hydrophobic coating may be employed.
  • the layer can inhibit the formation of "flaky" surface of water molecules, reduce friction and increase the tracking performance of the guide wire.
  • the above-mentioned functional coating layer may also be coated on the overmold layer 3 according to the cost.
  • the guide wire can be a straight guide wire or an elbow guide wire.
  • the straight guide wire is widely used and is suitable for most percutaneous cannula insertion operations; as shown in Fig. 3, the guide wire in the present invention can also be an elbow guide wire, and the front end of the elbow guide wire is curved, and the advantage is When the cannula encounters a curved and deformed cavity tube, the front end of the guide wire does not protrude on the inner wall of the cavity, and further effectively prevents damage to the inner wall of the cavity.
  • the plastic coating layer 3 may be provided with a marking portion, which can further improve the visibility of the guide wire under the endoscope, and combine the ball head 2 to further avoid stabbing the inner wall of the cavity.
  • the structure of the above-mentioned marking portion is not particularly limited as long as it is observed under an endoscope or an X-ray machine, and the marking portion may be an alternating spiral stripe of two or more colors, alternating rings or alternating Vertical stripes, through the contrast of contrasting colors, can clearly see the insertion of the guide wire under the endoscope.
  • the alternating spiral stripe may be black and white stripes, black and blue stripes, black and green stripes, yellow and green stripes, black and red stripes, red and green stripes, red and blue stripes, or black and yellow stripes, etc., but is not specifically limited to color contrast. Distinct, easy to observe by endoscopy.
  • the marking portion may also be an X-ray development marking ring, a point, a line, etc. disposed near the distal end of the guide wire, further ensuring the visibility of the guide wire under the X-ray machine, facilitating the operation of the doctor, and effectively preventing the guide wire from piercing the cavity.
  • the condition of the inner wall may also be an X-ray development marking ring, a point, a line, etc. disposed near the distal end of the guide wire, further ensuring the visibility of the guide wire under the X-ray machine, facilitating the operation of the doctor, and effectively preventing the guide wire from piercing the cavity.
  • the ball zebra guide wire, the mandrel 1 and the ball head 2 made of a metal material
  • the plastic layer D has a Shore D of 60
  • the ball head 2 has a size of 0.7 mm
  • the overmold layer 3 is inserted.
  • the outer diameter of the end is 0.35 mm
  • the outer diameter of the non-inserted end of the plastic coated layer 3 is 0.89 mm.
  • the ball-head mixing guide wire as shown in FIG. 2 is different from Embodiment 1 only in that the overmold layer 3 includes a first overmold layer 31 and a second overmold layer 32, and the first overmold layer 31 has a Shore hardness of The Shore A hardness is 75, and the second plastic layer 32 has a Shore D hardness of 60.
  • the zebra guide wire shown in Fig. 4 differs from the first embodiment only in that it does not contain the ball head 2.
  • the insertion end of the mandrel 1 is completely covered by the overmold layer 3, and the outer diameter of the guide wire insertion end is 0.35 mm.
  • the hybrid guide wire shown in Fig. 5 differs from the second embodiment only in that it does not contain the ball head 2.
  • the insertion end of the mandrel 1 is completely covered by the first plastic mold 31 layer, and the outer diameter of the guide wire insertion end is 0.35 mm. .
  • the guide wire was clamped using a microcomputer-controlled electronic universal testing machine.
  • the guide wire was passed through a plastic tube with an inner diameter of 1.67 mm (5 F), and the aluminum foil (aluminum foil thickness 0.07 mm) was pierced at a speed of 3 inches/min and a 90 degree angle, and the tip was worn. The force required to break the aluminum foil. Repeat the test 5 times and take the average.
  • Microcomputer control electronic universal testing machine purchased from Shanghai Hualong Testing Instrument Co., Ltd., model: WDW-5;
  • Plastic tube purchased from Shanghai Yanke Precision Extrusion Technology Co., Ltd., model: 1.67mm (5F);
  • Aluminum foil purchased from Shanghai Shenhuo Aluminum Foil Co., Ltd., model: thickness is 0.07mm.
  • Example 1 Example 2 Comparative example 1 Comparative example 2 Ball head zebra guide wire Ball jointed guide wire Zebra guide wire Mixed guide wire 0.352N 0.562N 0.169N 0.221N
  • Example 1 and Comparative Example 1 when the ball is inserted at the insertion end of the guide wire, the force required to insert the ball zebra guide wire into the aluminum foil is significantly increased, that is, the stab-resistant cavity of the ball guide wire. The performance has been greatly improved. Further, in Embodiment 2, by dividing the overmold layer into a softer first overmold layer and a harder second overmold layer, the ball is close to the ball head The guide wire at one end is more flexible, and the force required to insert the guide wire into the aluminum foil is increased to 0.562 N, which further improves the stab resistance of the guide wire.
  • the guidewire of the present invention can be used in any interventional, diagnostic, and/or therapeutic procedure, including directing other devices, such as catheters, stents, and/or balloons, to a target site within a patient, and the like.
  • the outer diameter of the ball head in the guide wire according to the invention is larger than the outer diameter of the plastic coating layer, which can effectively prevent the guide wire from falling off during the actual use, or the defect that the distal end of the plastic coated layer is easy to be rolled up during the insertion process. .
  • the mandrel and the ball head of the guide wire are made of a metal material, and the developability under the X-ray machine is much better than that of the plastic, and the outer diameter of the ball head is slightly larger than the plastic coating layer, and the X-ray machine and the endoscope can be Obviously observing the ball head, the doctor can clearly observe the puncture site reached at the front end of the guide wire, and the effect of preventing the guide wire head from piercing the inner wall of the cavity can be achieved without the need for a positioning device.

Abstract

一种非血管腔道导丝，包括由金属材料制备的芯轴（1）和球头（2），芯轴（1）插入端的外径小于非插入端的外径，芯轴（1）插入端连接有球头（2），芯轴（1）外套设有包塑层（3），球头（2）的外径大于包塑层（3）插入端的外径，球头（2）的外径不大于包塑层（3）非插入端的外径。导丝通过在远端采用直径略大于包塑层（3）的球头（2），可以有效避免导丝在实际使用过程中脱落，或是在插入过程中远端的包塑层（3）容易卷起等缺陷。球头（2）由金属材料制成，外径较大，在内镜和X光下可视性强，医生可清晰地观察到导丝前端达到的穿刺部位，在不需要定位装置的情况下就可以实现防止导丝头刺破腔体内壁的效果。

Description

一种非血管腔道导丝 技术领域
本发明涉及医疗器械技术领域，具体地说，是一种非血管腔道导丝。
背景技术
在将导管插入非血管腔道如消化管、泌尿道、气管等生物体管腔内时，为了将该导管引导至生物体管腔的目标部位，可以使用导丝。导丝在医疗手术中的作用，通常是辅助导管和其他医疗装置在体腔内的前进和正确定位。另外，在使用内窥镜观察、治疗的生物体管腔等的情况下，也使用导丝，将该插入到内窥镜的管腔中的导管引导至生物体管腔等的目标部位。在腔体中插入导管时使用导丝，首先将导丝插入腔体中，然后使导管沿导丝前进，这样导丝可以将导管引导至病变部。
在现有技术中，金属导丝与腔体内壁亲和性差，摩擦阻力大，润滑性低，不便于插入。并且当导丝在患者体内处于行进状态时，医生需要通过医用X光机或内窥镜对导丝的行进状态进行观察。医生通过图像对导丝与腔体内壁接触情况进行判断，但是普通的导丝在内窥镜和X光机下面都不利于观察。而对于医生来说，准确的判断导丝与腔体内壁的接触情况非常重要，可以避免导丝对人体组织施加力过大，若施加力过大可能会刺伤腔体内壁。对于可以采用内窥镜观察的情况下，为了方便内镜直视下观察导丝的移动，尽量避免刺伤腔体内壁，需要在导丝上设置可识性标识。针对于导丝的标识各个公司设计的略有不同，但都是以方便医生容易观察导丝的移动为标准。目前多以螺旋形条纹为主，所以，称之为“斑马导丝”。
例如，现有技术中多篇文献如参考文献1(CN103623495A)中公开了一种斑马导丝，由于输送芯轴的金属芯表面设置了聚四氟乙烯层，而聚四氟乙烯层具有较低的摩擦系数，减小了导丝递送过程产生的阻力，同时金属芯表面的聚四氟乙烯层表面为不在同一平面的螺旋条纹，减小阻力的同时易于操控，该聚四氟乙烯层进一步提高了斑马导丝的可操控性。另外，在斑马导丝的导丝头表面设置了聚合物套管，且聚合物套管表面预涂有亲水性涂层，使斑马导丝在使用时降低了导丝头与其它器械或腔体内壁的摩擦力，从而使所述斑马导丝同时具有较好的可操控性与超滑性。
参考文献2(CN204521931U)中同样公开了一种改进的斑马导丝，包括芯，在内芯的顶部连接有弹性金属体，弹性金属体的长度为0.5cm～3cm，弹性金属体的外径比内芯的外径大0.1mm，在弹性金属体和内芯的外侧包裹有包塑层。该方案能够改进现有技术的不足，在手术过程中能做到不折不弯曲，超滑，同时在影像下医生可清晰地观察到斑马导丝前端达到的穿刺部位，使手术顺利进行，给医护工作者减轻了心理压力并为手术成功带来方便。
总的来说，上述两种斑马导丝都在表面包覆了螺旋条纹，可以有利于在内窥镜的观察下插入，但是导丝的远端为尖端，比较锋利，即使是在可视的情况下也容易捅破导管或者是划伤腔体内壁，造成产品使用的失效，给病人造成痛苦，成为新的病灶或者是引起并发症。在实际使用过程中还存在螺旋条纹包塑层容易脱落，或者是在插入过程中导丝远端的包塑体容易卷起等缺陷。并且在使用医用X光机来观察时，由于X光机显示的图像是二维图，斑马条纹并不能提高其在X光机下的可视性，因此，上述技术方案还是存在导丝刺伤内壁的可能。
参考文献3(CN105343984A)中公开了一种导丝，解决现有技术中导丝与血管接触时接触力无法准确判断的问题。该实用新型中的导丝包括导丝头端、设置在导丝内腔中的光纤传感器、弹簧、固定件；所述弹簧固定在固定件与导丝头端之间；光纤传感器穿过固定件内腔和弹簧内部固接于导丝头端，光纤传感器的光栅部分位于弹簧和导丝头端部。通过该技术方案提供的导丝，可以实现导丝与血管接触力的准确判断。简单来说，其通过在导丝的头端近端设置了固定件与弹簧，弹簧固定于固定件与头端之间，光纤传感器的光栅位于弹簧和导丝头端部。当导丝头端与腔体内壁的组织接触时，因为外力使得腔体内壁的组织与导丝头端相互挤压，头端受力使得弹簧发生形变，光栅也发生形变，通过前期的实验可以获得弹簧与光栅形变之间的系数，以及弹簧发生形变与受力之间的系数，通过获得的光栅的形变以及提前获知的系数就可以准确的判断导丝头端的受力大小。这样可以有效避免刺伤腔体管壁，但是该导丝结构复杂，造价成本较高，不适宜大范围的应用。
参考文献4(CN204193262U)中公开了一种尿动力管助插导丝，其包括助插导丝主体；所述助插导丝主体远端为圆头端，所述助插导丝主体近端一体成型有一个用于使助插导丝主体远端插入尿动力管后与尿动力管的球囊顶部恰好接触配合的定位把手。该尿动力管助插导丝能够避免其远端在插入尿动力测试管后刺破尿动力测试管的球囊，避免造成尿动力测试管使用的失效。在该文献中除了圆头端外还必须得设有定位把手才能实现防刺破球囊的功能，导致该导丝的结构复杂，成本升高，操作难度增大，也没有提及如何避免刺伤腔 体内壁。
参考文献5(CN103316416A)中公开了一种球头导丝，包括具有挠性的长条状芯轴，位于芯轴头部的导丝头端和包覆于芯轴外、由柔性材料制成的包覆层，以及由显影高分子材料制成的头部管，头部管连接包覆层与导丝头端，所述的导丝头端为由高弹性材料制成的内部中空的球体，导丝的外表面具有亲水层，导丝头端与包覆层一体。本发明具有不会导致腔道壁穿孔，导丝头端能够顺利通过腔道，手术风险小的优点。其说明书中还公开了所述的导丝头端为由高弹性材料制成的内部中空的球体，导丝的外表面具有亲水层，导丝头端与包覆层一体。高弹性材料如聚氨酯，改性尼龙等弹性材料。但是采用高分子聚合物制成的球头虽然能够有效避免刺伤内壁，但是该高分子聚合物制得的空心球头强度较低，导向性差，不便于插入。
因此，提供一种可视性强、结构简单、不会刺伤腔体内壁，还能避免包塑层脱落或卷曲的非血管腔道导丝成为本医疗领域急待解决的问题。
发明内容
本发明要解决的技术问题是提供一种在内镜和X光下可视性强、结构简单、不会刺伤腔体内壁，同时能避免包塑层脱落或卷曲的非血管腔道导丝。
为解决上述技术问题，本发明所提供的非血管腔道导丝，包括由金属材料制备的芯轴和球头，芯轴插入端的外径小于非插入端的外径，芯轴插入端连接有球头，芯轴外套设有包塑层，球头的外径大于包塑层插入端的外径，球头的外径不大于包塑层非插入端的外径。
进一步地，球头的外径为包塑层插入端的外径的1.1-3倍。
进一步地，包塑层外涂有超滑亲水涂层。
进一步地，包塑层套设于芯轴外，包塑层由选自聚四氟乙烯、聚氨酯或尼龙弹性体中的一种或几种材料制成。
进一步地，包塑层套设于芯轴外，包塑层由靠近球头的第一包塑层和远离球头的第二包塑层组成，第二包塑层的硬度大于第一包塑层。
进一步地，第一包塑层的邵氏硬度A为30～90，第二包塑层的邵氏硬度D为50～100。
进一步地，第一包塑层由选自聚四氟乙烯、聚氨酯或尼龙弹性体中的一种材料制成。
进一步地，第二包塑层由选自聚四氟乙烯或聚氨酯中的一种材料制成。
进一步地，芯轴和球头采用镍钛合金材料或不锈钢材料制成。
进一步地，球头无缝连接于芯轴上。
进一步地，导丝为直头导丝或弯头导丝。
综上，本发明所涉及的导丝球头的外径大于包塑层插入端的外径，克服了现有技术中带有包塑层的导丝容易在实际使用过程中脱落，或者是在插入过程中，包塑层由于远端的阻力容易卷起等缺陷。另一个方面，导丝的球头由金属材料制成，在X光机下显影性远好于塑料，球头的外径大于包塑层，在X光机和内窥镜下都可以明显观察到球头，医生可清晰地观察到导丝前端达到的穿刺部位，在不需要定位装置的情况下就可以实现防止导丝头刺破腔体内壁的效果。
附图说明
下面结合附图和具体实施方式对本发明作进一步详细的说明：
图1为本发明所提供的实施例1的直头导丝的剖面示意图；
图2为本发明所提供的实施例2的直头导丝的剖面示意图；
图3为本发明所提供的弯头导丝的剖面示意图；
图4为对比例1的斑马导丝的剖面示意图；
图5为对比例2的混合导丝的剖面示意图。
元件标号如下：
1-芯轴
2-球头
3-包塑层
31-第一包塑层
32-第二包塑层
具体实施方式
现在结合附图，详细介绍本发明的较佳实施方式。虽然本发明的描述将结合各个实施方式一起介绍，但这并不代表此发明的特征仅限于该几种实施方式。恰恰相反，结合实施方式作发明介绍的目的是为了覆盖基于本发明的权利要求而有可能延伸出的其它选择或改造。为了提供对本发明的深度了解，以下描述中将包含许多具体的细节。本发明也可以不使用这些细节实施。此外，为了避免混乱或模糊本发明的重点，有些具体细节将在描述中被省略。
另外，在以下的说明中所使用的“上”、“下”、“左”、“右”、“顶”、“底”，是为了更 好地描述本发明的较佳实施方式而设定的，不应理解为对本发明的限制。
用在本文中的术语，导丝的“近端”或“尾端”是在身体外侧延伸最接近医生的导丝段，即非插入端。导丝的“远端”或“前端”是在体腔内距离入口部位最远的导丝段，即插入端。
在下面的附图中，并没有示出导丝的全长。导丝的长度能根据介入手术的类型而改变，但是典型地导丝的长度在30到800厘米(cm)的范围内。用于冠状、外周和神经脉管的介入的导丝的通常长度可能在170到300cm的范围内。
实施例
本发明的技术方案如图1所示，本发明所提供的非血管腔道导丝，包括由金属材料制备的芯轴1和球头2，芯轴1插入端的外径小于非插入端的外径，芯轴1插入端连接有球头2，芯轴1外套设有包塑层3，球头2的外径大于包塑层3插入端的外径，球头2的外径不大于包塑层3非插入端的外径。由于球头2直径略大于包塑层3插入端的外径，这样可以有效的避免导丝中的包塑层3在实际使用过程中脱落，或者是在插入过程中包塑层3的插入端容易卷起等缺陷，球头2的外径需要不能大于包塑层3非插入端的外径，避免了导丝头的尺寸过大而需求更大的器械通道。导丝头为球头状，外表光滑，不易刺伤腔体内壁；并且直径大于包塑层3插入端的外径，尺寸大于现有技术中的导丝头，依靠金属本身优异的显影性，在内镜和X光下都可以明显的观察到该球头2，医生可清晰地观察到导丝的插入情况，在不需要定位装置的情况下就可以实现防止导丝刺破腔体内壁的效果。
进一步地，本领域技术人员可以根据实际需要调节球头2的尺寸，例如，可以优选球头2的外径为包塑层3插入段外径的1.1-3倍。球头2尺寸过小，在X光机和内窥镜下的可视性减弱，因此，即使导丝头部为球头状，其与腔体内壁接触时的受力面积依旧较小，在操作人员不能清楚观察到导丝头所在位置的情况下，一旦操作人员大意，可能还是会刺伤内壁；球头2尺寸过大，插入阻力增大，会增加导丝插入的困难。
进一步地，包塑层3外涂有超滑亲水涂层，该超滑亲水涂层能吸附并保存液体,使导丝表面摩擦阻力降低,进一步增加导丝的插入性能。
进一步地，包塑层3是套设于芯轴外的塑料套筒，包塑层3可以选自具有较好柔软性的材料(如软质材料、弹性材料等)，具体的材料没有特别的限定，可以选自聚乙烯、聚丙烯等聚烯烃、聚氯乙烯、聚酯(PET、PBT等)、聚酰胺、聚酰亚胺、聚氨酯、聚苯乙烯、聚碳酸酯、有机硅树脂、含氟聚合物(PTFE、ETFE、PFA等)或者这些材料的复合材料、胶乳橡胶、硅氧橡胶、尼龙弹性体等各种橡胶材料中的一种或几种。
更进一步地，包塑层3最优选由聚四氟乙烯、聚氨酯或尼龙弹性体中的一种或几种材料制成；聚四氟乙烯材料，表面摩擦力低，润滑性好，可以提高导丝的插入性；聚氨酯材料和尼龙弹性体生物相容性高，可以减少导丝对腔体内壁组织的刺激。
优选地，如图2所示，包塑层3套设与芯轴外，包塑层3由靠近球头2的第一包塑层31和远离球头的第二包塑层32组成，第二包塑层32硬度大于第一包塑层31。包塑层3的存在主要是为了增加导丝和腔体内壁的生物相容性，或起润滑作用，减少导丝插入时的阻力；同时由于包塑层3的存在可能会降低芯轴的柔性和可弯曲性，通过将靠近球头2的一端设置为较软的第一包塑层31，可以提升导丝头的柔性和可弯曲性，有利于在较为复杂的腔体中的导向性；并且第一包塑层31较软，可以进一步避免球头2刺伤腔体内壁；通过将远离球头2的一端设置为较硬的第二包塑层32，可以保证导丝的强度，提升插入性。优选地，第一包塑层31的邵氏硬度A为30～90，第二包塑层32的邵氏硬度D为50～100。第一包塑层31和第二包塑层32的邵氏硬度在该范围内，即可以进一步提升球头导丝的防刺伤性能，又可以充分的保证球头导丝的插入性能。
更优选地，第一包塑层31由硬度较低的选自聚四氟乙烯、聚氨酯或尼龙弹性体中的一种材料制成，更优选为聚氨酯材料制成，聚氨酯具有高强度、与人体有良好的生物相容性，并且在人体温度下有较高的柔韧性。在第一包塑层31主要由聚氨酯类树脂构成的情况下，导丝的前端部的柔软性进一步提高，因此在插入腔体内时，能够更加可靠地防止损伤腔体内壁等，提高了操作的安全性。第二包塑层32由硬度较高的聚四氟乙烯或聚氨酯材料制成，优选为聚四氟乙烯，其强度高，表面摩擦力低，润滑性好，可以提高导丝的插入性。
进一步地，芯轴1由金属材料构成，例如能够使用不锈钢、呈现伪弹性的合金(包含超弹性合金)等各种金属材料，优选镍钛合金材料。
导丝中芯轴1的构成材料由金属材料构成，没有特殊的限定，可以选择本领域中常见的金属材料，例如能够使用不锈钢(例如SUS304、SUS303、SUS316、SUS316L、SUS316J1、SUS316J1L、SUS405、SUS430、SUS434、SUS444、SUS429、SUS430F、SUS302等)、呈现伪弹性的合金(包含超弹性合金)等各种金属材料，优选超弹性合金。由于超弹性合金比较柔软且具有复原性，所以由超弹性合金作为芯轴的导丝，其前端部分具有充分的弯曲的柔软性和弹性回复能力，能够提高对复杂的、弯曲的腔体的插入性能，并能够得到更优异的操作性，而且即使导丝发生反复的弯曲变形，由于导丝优异的弹性回复能力，导丝也不会产生永久的弯曲形变，所以能够避免导丝在使用中因为发生弯曲而导致操作性降低的情况。
进一步地，超弹合金优选采用镍钛合金，采用镍钛合金作为芯轴的导丝在具有优异的推入性、转矩传递性，进而具有良好的操作性的同时，在远端具有良好的柔软性、复原性，进而对腔体的追随性、安全性提高，进一步降低了刺破腔体内壁的风险。
进一步地，球头2无缝连接于芯轴上，球头2优选与芯轴1一体成型，无缝连接于芯轴1上，以此可以减少球头2脱落的风险。
球头2上可以涂覆有功能性涂层，如亲水性涂层、疏水涂层或生物活性涂层中的一种或多种，亲水性涂层可以吸引水分子在其表面形成“凝胶状”表面，降低导丝的通过阻力。对于亲水涂层材料并没有具体的限定，涂层优选由摩擦阻力小的材料形成。例如优选由聚乙烯醇、聚乙烯吡咯烷酮、聚乙二醇、聚丙烯酰胺、聚丙烯酸、聚丙烯酸钠、聚(甲基丙烯酸2-羟基乙酯)、马来酸酐系共聚物、乙烯-乙烯醇共聚物、2-甲基丙烯酰氧乙基磷酸胆碱或其共聚物、(甲基丙烯酸2-羟基乙酯)-苯乙烯嵌段共聚物、各种合成多肽、胶原蛋白、透明质酸盐、纤维素系共聚物中的一种或多种。
球头2上还可以涂覆有疏水涂层，对于疏水涂层材料并没有具体的限定，可以采用硅酮、聚四氟乙烯或氟化乙烯丙烯共聚物中的一种或多种，疏水涂层可以抑制水分子形成“腊状”表面，减少摩擦，增加导丝的跟踪性能。
进一步地，根据成本的需要，包塑层3上也可以涂覆有上述的功能性性涂层。
进一步地，导丝可以为直头导丝或弯头导丝。直头导丝用途甚广，适用于绝大多数经皮穿刺插管操作；如图3所示，本发明中的导丝也可以是弯头导丝，弯头导丝前端弯曲，其优点是插管时遇到弯曲变形的腔体管，导丝前端不会顶在腔体内壁上，进一步有效的防止损伤腔体内壁。
进一步地，包塑层3上可以设置有标识部，可以进一步提高导丝在内窥镜下的可视性，结合球头2，进一步避免刺伤腔体内壁。
上述对上述标识部的结构没有特别的限定，以便于在内窥镜或X光机下观察为准，标识部可以为两种或两种以上颜色的交替螺旋条纹、交替的圆环或交替的竖直条纹，通过间隔对比鲜明的颜色，可以清楚的在内窥镜下观察到导丝的插入情况。
进一步地，交替螺旋条纹可以为黑白条纹、黑蓝条纹、黑绿条纹、黄绿条纹、黑红条纹、红绿条纹、红蓝条纹或黑黄条纹等，但是并没有具体的限定，以颜色对比鲜明，便于内窥镜观察为准。
标识部还可以是设置在导丝远端附近的X光显影标记环、点、线等，进一步保证了导丝在X光机下的可视性，便于医生操作，有效避免导丝刺破腔体内壁的情况。
为了进一步证明本发明的技术效果，以下结合实施例进行进一步说明：
实施例1
如图1所示的球头斑马导丝，由金属材料制备的芯轴1和球头2，包塑层3的邵氏硬度D为60，球头2尺寸为0.7mm，包塑层3插入端的外径为0.35mm，包塑层3非插入端的外径为0.89mm。
实施例2
如图2所示的球头混合导丝，与实施例1的区别仅在于，包塑层3包括第一包塑层31和第二包塑层32，第一包塑层31邵氏硬度为邵氏硬度A为75，第二包塑层32的邵氏硬度D为60。
对比例1
如图4所示的斑马导丝，与实施例1的区别仅在于不含有球头2，芯轴1的插入端由包塑层3完全包覆，导丝插入端外径为0.35mm。
对比例2
如图5所示的混合导丝，与实施例2的区别仅在于不含有球头2，芯轴1的插入端由第一包塑31层完全包覆，导丝插入端外径为0.35mm。
测试方法
使用微机控制电子万能试验机夹持导丝，导丝穿过一根内径为1.67mm(5F)塑料管，以速度3英寸/分钟和90度角穿刺铝箔(铝箔厚0.07mm)，记录尖端穿破铝箔所需的力。重复测试5次，取其平均值。
实验设备
1.微机控制电子万能试验机，购自上海华龙测试仪器有限公司，型号：WDW-5；
2.塑料管，购自上海翊科精密挤出技术有限公司，型号：1.67mm(5F)；
3.铝箔，购自上海神火铝箔有限公司公司，型号：厚度为0.07mm。
实施例1-2和对比例1-2的实验结果如下表1所示：
实施例1 实施例2 对比例1 对比例2
球头斑马导丝 球头混合导丝 斑马导丝 混合导丝
0.352N 0.562N 0.169N 0.221N
从实施例1和对比例1中可以看出，当在导丝的插入端增加球头过后，球头斑马导丝插入铝箔所需要的力显著增加，即球头导丝的防刺伤腔体的性能得到了极大的提升。进一步地，实施例2中通过将包塑层分为较软的第一包塑层和较硬的第二包塑层，使靠近球头 的一端导丝柔性更好，导丝插入铝箔所需要的力增加到了0.562N，进一步提升了导丝的防刺伤性能。本发明的导丝可以被用于任何介入、诊断、和/或治疗手术，包括将其他装置(比如导管、支架、和/或球囊)引导到患者体内的目标部位等。
本发明所涉及的导丝中球头的外径大于包塑层的外径，可以有效的避免导丝在实际使用过程中脱落，或者是在插入过程中包塑层远端容易卷起等缺陷。并且该导丝的芯轴和球头由金属材料制成，在X光机下显影性远好于塑料，球头的外径略大于包塑层，在X光机和内窥镜都下可以明显观察到球头，医生可清晰地观察到导丝前端达到的穿刺部位，在不需要定位装置的情况下就可以实现防止导丝头刺破腔体内壁的效果。
上述的说明是本发明中具体实施方式的实施例，用于更清楚地说明本发明的发明构思，但其并非是用于对本发明的权利要求范围的限定。根据本发明的发明构思，本领域技术人员能够容易变型和修改上述的实施例，这些属于本发明的发明构思内的变型和修改均包含在本发明后附的权利要求的范围之内。

Claims (11)

  1. 一种非血管腔道导丝，其特征在于，包括由金属材料制备的芯轴和球头，所述芯轴插入端的外径小于非插入端的外径，所述芯轴插入端连接有所述球头，所述芯轴外套设有包塑层，所述球头的外径大于所述包塑层插入端的外径，所述球头的外径不大于所述包塑层非插入端的外径。
  2. 如权利要求1所述的非血管腔道导丝，其特征在于，所述球头的外径为所述包塑层插入端的外径的1.1-3倍。
  3. 如权利要求1所述的非血管腔道导丝，其特征在于，所述包塑层外涂有超滑亲水涂层。
  4. 如权利要求1所述的非血管腔道导丝，其特征在于，所述包塑层套设于所述芯轴外，所述包塑层由选自聚四氟乙烯、聚氨酯或尼龙弹性体中的一种或几种材料制成。
  5. 如权利要求1所述的非血管腔道导丝，其特征在于，所述包塑层套设于所述芯轴外，所述包塑层由靠近球头的第一包塑层和远离球头的第二包塑层组成，所述第二包塑层的硬度大于所述第一包塑层。
  6. 如权利要求5所述的非血管腔道导丝，其特征在于，所述第一包塑层的邵氏硬度A为30～90，所述第二包塑层的邵氏硬度D为50～100。
  7. 如权利要求5所述的非血管腔道导丝，其特征在于，所述第一包塑层由选自聚四氟乙烯、聚氨酯或尼龙弹性体中的一种材料制成。
  8. 如权利要求5所述的非血管腔道导丝，其特征在于，所述第二包塑层由选自聚四氟乙烯或聚氨酯中的一种材料制成。
  9. 如权利要求1所述的非血管腔道导丝，其特征在于，所述芯轴和所述球头采用镍钛合金材料或不锈钢材料制成。
  10. 如权利要求1所述的非血管腔道导丝，其特征在于，所述球头无缝连接于所述芯轴上。
  11. 如权利要求1所述的非血管腔道导丝，其特征在于，所述导丝为直头导丝或弯头导丝。
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CN109481828B (zh) * 2018-12-27 2024-04-12 肖恒军 一种新型导丝及其应用
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