WO2019165623A1 - 压力导丝 - Google Patents

压力导丝 Download PDF

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Publication number
WO2019165623A1
WO2019165623A1 PCT/CN2018/077748 CN2018077748W WO2019165623A1 WO 2019165623 A1 WO2019165623 A1 WO 2019165623A1 CN 2018077748 W CN2018077748 W CN 2018077748W WO 2019165623 A1 WO2019165623 A1 WO 2019165623A1
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WO
WIPO (PCT)
Prior art keywords
pressure
intermediate portion
woven
head end
layers
Prior art date
Application number
PCT/CN2018/077748
Other languages
English (en)
French (fr)
Inventor
张立喆
Original Assignee
北京佰为深科技发展有限公司
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 北京佰为深科技发展有限公司 filed Critical 北京佰为深科技发展有限公司
Priority to US16/977,186 priority Critical patent/US11849929B2/en
Priority to EP18907946.0A priority patent/EP3760272B1/en
Priority to PCT/CN2018/077748 priority patent/WO2019165623A1/zh
Priority to JP2020545715A priority patent/JP7195017B2/ja
Publication of WO2019165623A1 publication Critical patent/WO2019165623A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02154—Measuring pressure in heart or blood vessels by means inserted into the body by optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D11/00—Double or multi-ply fabrics not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00305—Constructional details of the flexible means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0462—Apparatus with built-in sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits
    • 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
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09191—Guide wires made of twisted wires

Definitions

  • the present disclosure relates to the field of medical devices, and in particular to a medical pressure guidewire.
  • Medical pressure guidewires can be used for minimally invasive interventional procedures in vascular and non-vascular lumens, which typically include a proximal portion, a distal portion. Wherein a portion of the proximal portion is external to the body and is manipulated by an operator to advance the guidewire along the lumen, the proximal portion being generally a relatively rigid tubular structure to provide good pushability and torsion .
  • the distal portion typically has a soft tip portion to avoid damage to the blood vessel.
  • an intermediate portion may also be provided between the proximal end portion and the distal end portion of the pressure guide wire, the intermediate portion requiring both a good push Performance, torque control performance, also requires good flexibility.
  • One type of pressure guidewire configuration is present in which the proximal, intermediate and distal portions are constructed of a unitary tube structure wherein at the intermediate portion the tube structure is cut into a pattern to achieve compliance.
  • the pushability, torsion, and compliance of the pressure guidewire are relatively general, and there is a strong mutual exclusion relationship between the pushability, torsion, and compliance of the pressure guidewire. It is impossible to further improve the pushability, twistability and flexibility at the same time.
  • non-integral pressure guidewire construction comprising sections of different materials, and one or more sections may comprise outer and inner layers of different properties and/or different materials, etc., in order to achieve various parts Different mechanical properties of the segment.
  • the structure of such a pressure guide wire is complicated, and there are serious problems of adhesion reliability when different materials are bonded together.
  • the present solution proposes a novel pressure guide wire for the problems and needs mentioned above, which has good pushability, torque control, flexibility, and other advantages due to the following features.
  • a pressure guidewire comprising: a proximal portion; an intermediate portion comprised of one or more woven layers, wherein each woven layer comprises a plurality of woven wires; the distal portion includes A sensor housing of the pressure sensor, and a head end assembly including a development spring and a head end core nested within the development spring.
  • the braided wire is too thin in size, and the helical structure formed by it is too small to provide sufficient supporting performance, so there has never been an attempt to form a middle portion of the pressure guide wire by using a braided wire.
  • the structure formed by the "weaving" method is often considered not to have sufficient strength and airtightness, and thus has never been used for the section of the pressure guide wire.
  • this patent teaches the use of a plurality of braided filaments to form one or more helical braid layers, each braid layer comprising a plurality of braided filaments such that a very fine braided filament forms a braided structure of greater intercept. It has been experimentally verified that such a woven structure has both good flexibility and support.
  • such a woven structure has a very outstanding support performance, even more than 10 times that of the conventional weaving method, and is far superior to other existing support structures.
  • the woven structure has much more flexibility than the existing one, so that it can adapt to more complicated lesion areas and better meet the diagnosis and treatment. demand.
  • the intermediate part of the existing structure for example, a structural scheme for achieving flexibility by cutting a steel pipe into a pattern, in order to achieve the support performance of the present solution, the flexibility of the intermediate portion must be greatly sacrificed, and the mechanical mechanism of the pressure guide wire is seriously affected. Performance; and its softness is more different than this one.
  • the braided wire itself and the weaving process are both inexpensive, the solution can reduce the cost of the entire pressure guidewire.
  • each of the woven layers is formed of a plurality of woven wires that are arranged in parallel in close contact with each other and spirally wound.
  • the plurality of braided wires are closely attached together by pre-stressing.
  • a plurality of woven wires are arranged in parallel in close contact with each other and spirally wound to form a woven layer, which avoids complicated manufacturing processes and is easy to implement compared to the prior art described above.
  • each of the braid layers comprises 6 to 12 braided wires.
  • the braided wire has a diameter in the range of 0.01 mm to 0.1 mm.
  • each of the braided wires has an intercept of 0.1 mm to 1 mm.
  • the intermediate portion comprises at least two braid layers, and wherein the helical direction of the braided filaments of each adjacent two braid layers is different.
  • the intermediate portion comprises at least two braid layers, and wherein the different braid layers are formed from different numbers of braided wires.
  • the scheme of weaving silk weaving has great flexibility because it can adjust the number and intercept of the braided yarn of each braid layer, the winding direction of each braid layer, and the respective braid layers.
  • the overall arrangement, the number of braids, etc. change the flexibility and support of the entire braided structure to suit different application needs.
  • the different helical directions of the braided wires of the adjacent two braid layers can give the pressure guiding ribbon a better handling performance, and the operator can more easily control the advancing direction of the pressure guide wire.
  • the intermediate portion comprises at least two woven layers, and wherein adjacent woven layers are in close contact.
  • the solution further ensures the impermeability of the woven structure and makes the woven structure easy to manufacture and saves cost.
  • the maximum outer diameters of the proximal portion, the intermediate portion and the distal portion are each no greater than 0.36 mm.
  • the pressure sensor is a fiber optic pressure sensor that includes an optical fiber coupled to the pressure sensor through the proximal portion, the intermediate portion, and the sensor housing.
  • the head end assembly is connected to the sensor housing by a connector, wherein the connector is a cylindrical structure having a thick intermediate middle end, one end of which is inserted into the developing spring, and the other end is inserted into the sensor housing.
  • the connector is a cylindrical structure having a thick intermediate middle end, one end of which is inserted into the developing spring, and the other end is inserted into the sensor housing.
  • the proximal portion, the intermediate portion, the sensor housing, the connector, the head end assembly are constructed of similar or identical materials and are in turn welded.
  • the proximal portion, the intermediate portion, the sensor housing, the connector, and the head end assembly are constructed of stainless steel.
  • the head end core wire and the developing spring have a taper of about 0.124 degrees.
  • the pressure guide wire can be made to have better puncture ability and more excellent ability to pass complex lesions.
  • the head end core wire is made of a memory metal.
  • the operator can pre-set the shape of the head end core wire according to the traveling environment of the pressure guide wire, so that the pressure guide wire can more easily pass through a specific position.
  • Figure 1 is a side elevational view of an exemplary embodiment of a pressure guidewire
  • Figure 3 is a side elevational view of the sensor housing
  • Figure 4 is a side elevational view of the connector
  • 5A-C are exemplary embodiments of intermediate portions having a single layer woven structure, each of which shows a cross-sectional view and a side view of the intermediate portion;
  • Figure 6 is an exemplary embodiment of an intermediate portion having a two-layer woven structure showing a cross-sectional view and a side view of the intermediate portion;
  • Figure 7 is an exemplary embodiment of an intermediate portion having a two-layer woven structure showing a cross-sectional view and a side view of the intermediate portion;
  • Figure 8 is an exemplary embodiment of an intermediate portion having a three-layer woven structure showing a cross-sectional view and a side view of the intermediate portion;
  • Figure 9 is an exemplary embodiment of an intermediate portion having a three-layer woven structure showing a cross-sectional view and a side view of the intermediate portion;
  • Figure 10 is a schematic view of a developing spring
  • 11A and 11B are schematic views of the head end core wire inserted into the inside of the developing spring.
  • a pressure guidewire mainly includes a proximal portion 1, an intermediate portion 2, and a distal portion 12.
  • the distal end portion 12 mainly includes a sensor housing 4 that houses the pressure sensor 5, a head end assembly including a developing spring 9 and a head end core wire 11, and a connector 8 that connects the sensor housing 4 and the head end assembly.
  • the proximal portion 1 is an elongated tubular structure. During the diagnosis and treatment, a portion thereof is located outside the body, and the operator manipulates the pressure guide wire through the proximal portion to make it along the blood vessel or non-vascular lumen of the human body. Go on.
  • the proximal portion 1 has a length of 1500 mm, an outer diameter of no greater than 0.36 mm, such as 0.355 mm, and an inner diameter of between 0.13 mm and 0.17 mm.
  • the proximal portion 1 is preferably made of stainless steel, such as medical 304v stainless steel. The proximal portion 1 having the above features has good pushability and torsion.
  • the intermediate portion 2 is also an elongated tubular structure and is disposed coaxially with the proximal portion 1.
  • the length of the intermediate portion 2 is less than 300 mm, for example 280 mm.
  • the inner and outer diameters of the intermediate portion 2 are preferably the same as the proximal portion 1, i.e., the outer diameter is no greater than 0.36 mm, such as 0.355 mm, and the inner diameter is between 0.13 mm and 0.17 mm.
  • the intermediate portion 2 is preferably made of a material similar or identical to the proximal portion 1, for example also made of stainless steel, such as medical 304v stainless steel. This coaxial and equal arrangement of the intermediate portion 2 and the proximal portion 1 and the selection of similar/identical materials enable the two to be easily welded.
  • the intermediate portion 2 is preferably constructed of one or more woven layers, wherein each woven layer is formed from a plurality of woven wires that are arranged in close contact with each other and spirally wound.
  • each of the braid layers may include 6 to 12 braided wires, for example, 6, 8, or 12, and the like.
  • each of the braided wires has a diameter in the range of 0.01 mm to 0.1 mm.
  • the intercept of the braided wire is made approximately 0.1 mm to 1 mm, more preferably 0.4 mm.
  • the braided wire is too small in size, and the helical structure formed by the mesh is too small to provide sufficient supporting performance. Therefore, the braided wire has never been used to form the middle portion of the pressure guide wire. try. At the same time, the structure formed by the "weaving" method is often considered not to have sufficient strength and airtightness, and thus has never been used for the section of the pressure guide wire. While this patent teaches the use of a plurality of braided filaments to form one or more helical braid layers, each braid layer comprising a plurality of braided filaments such that a very fine braided filament forms a braided structure of greater intercept.
  • such a woven structure has both good flexibility and support.
  • supportability according to the late support force test, such a woven structure has a very outstanding support performance, even more than 10 times that of the conventional weaving method, and is far superior to other existing support structures.
  • flexibility due to the soft and soft characteristics of the woven wire itself and the characteristics of the spiral weaving method, the woven structure has much more flexibility than the existing one, so that it can adapt to more complicated lesion areas and better meet the diagnosis and treatment. demand.
  • the flexibility of the intermediate portion must be greatly sacrificed, and the mechanical mechanism of the pressure guide wire is seriously affected. Performance; and its softness is more different than this one.
  • the present scheme using braided wire weaving is also extremely flexible compared to the prior art, since the number and the intercept of the braided yarn of each braid layer, the winding direction of each braid layer, The overall arrangement of the individual braid layers, the number of braid layers, and the like, change the flexibility and support of the entire braided structure to suit different application needs.
  • the braided wire itself and the weaving process are both inexpensive, the solution can reduce the cost of the entire pressure guidewire.
  • the intermediate portion 2 may include one or more woven layers each composed of a plurality of woven wires.
  • the different braid layers may be formed from the same or different numbers of braided wires.
  • the winding direction of the braided wire of each of the braid layers may be left-handed or right-handed.
  • the direction of the braided wire may be left-handed or right-handed.
  • the winding directions of the different braid layers may be the same or different.
  • the helical directions of the braided wires of the two braid layers are made different. More preferably, the helical directions of the braided wires of each adjacent two knitted layers are made different, that is, the knitting directions from the innermost layer to the outermost layer are sequentially changed.
  • Figures 5-9 illustrate various embodiments of the intermediate portion 2.
  • 5A-C shows an intermediate portion having only one woven layer, wherein in the embodiment of 5A, the woven layer is formed by spirally winding six parallel woven wires, and in the embodiment of 5B, the woven layer is composed of 8
  • the root-parallel braided wire is formed by spiral winding, and in the 5C embodiment, the braid is formed by spirally winding 12 parallel braided wires.
  • Figures 6-7 illustrate an intermediate portion having two braided layers, wherein in the embodiment of Figure 6, the inner braided layer and the outer braided layer are each formed by helically winding six parallel braided filaments; In the embodiment, the inner braid layer is formed by spirally winding eight parallel braided wires, and the outer braid layer is also spirally wound by six parallel braided wires.
  • the inner braid has a different weave direction than the outer braid.
  • Figure 8 illustrates an intermediate portion having three braid layers, wherein the three braid layers from the inside to the outside are formed of 12, 8 and 6 braided wires, respectively, for which it is preferred to have at least one pair of adjacent braids
  • the weaving direction of the layers is different; more preferably, the weaving direction from the innermost layer to the outermost layer is sequentially changed.
  • Figure 9 shows an intermediate portion having four braid layers, each of which is formed by helically winding six braided wires.
  • the weaving directions of adjacent woven layers are different. More preferably, the weaving direction from the innermost layer to the outermost layer is sequentially changed. According to the later tests, the pressure guide wire having such a configuration is superior in handling performance.
  • a plurality of braided wires which are arranged in parallel and spirally wound are closely fitted to each other such that adjacent knitting wires do not have a gap with each other.
  • This close fitting effect can be achieved by the pre-stress introduced during the braiding process. That is, when forming the braid layer, a mandrel is provided, and a plurality of braided wires arranged in parallel are tightly wound on the mandrel, and a pre-stress which is twisted around itself is introduced into each of the braided wires in the winding, so that the mandrel is removed Thereafter, the adjacent braided wires are closely attached together under the action of the pre-stress.
  • adjacent woven layers are arranged in close fit.
  • This close fitting effect can be achieved by an over-tightening process of the braided wire, that is, after a braided layer (referred to as a first braided layer) has been formed, it is tightly wound on the braided layer for forming
  • a braided wire of a woven layer (referred to as a second woven layer) is such that a pre-stress of shrinkage tends to form in the woven wire of the second woven layer such that the second woven layer is tightly wound around the first woven layer.
  • the sensor housing 4 is also of a generally cylindrical configuration with an outer diameter that is close to the proximal portion 1 and the intermediate portion 2, i.e., no greater than 0.36 mm, such as 0.355 mm, and an inner diameter of no greater than 0.28 mm.
  • the length of the sensor housing 4 is preferably no more than 2.5 mm, for example 1.6 mm.
  • the sensor housing 4 is preferably made of a material similar or identical to the intermediate portion 2, for example also made of stainless steel, such as medical 304v stainless steel, to ensure soldering reliability with the intermediate portion 2.
  • the pressure sensor 5 is disposed within the sensor housing 4.
  • the pressure sensor 5 is preferably a fiber optic pressure sensor and has an optical fiber as a sensor communication device that passes through the proximal portion 1, the intermediate portion 2, the sensor housing 4 to be connected to the pressure sensor 5.
  • the sensor housing 4 is provided with a sensing window 7 through which blood pressure is applied to the sensor 5 to measure the pressure of blood in the blood vessel.
  • the sensing window 7 is a square opening, preferably having a length of 0.5 mm, a width of 0.27 mm, a chamfer of R 0.02 mm, and the sensing window 7 is located no more than 0.6 mm from the proximal end portion of the developing spring 9.
  • the sensor housing 4 can also be provided with an opening 6 which can be used as an operating opening for mounting and fixing the pressure sensor 5, for example, during the manufacture of the mounting pressure guide wire, the pressure sensor 5 can be passed through the glue with the opening 6 It is fixed to the sensor housing 4 by means of adhesion or the like.
  • the opening 6 is a substantially circular opening having a diameter of preferably not more than 0.2 mm.
  • the center of the opening 6 is located no more than 1.5 mm from the developing spring 9.
  • the center of the opening 6 and the center of the sensing window 7 are different by about 90 degrees in the circumferential direction of the sensor housing.
  • the head end assembly includes a developing spring 9, a head end core wire 11 nested inside the developing spring 9, and a head end portion 10 welded to the developing spring 9 and the head end core wire 11.
  • the developing spring 9 is used to position the pressure guidewire in the blood vessel to improve the visibility of the guidewire in the diseased blood vessel or body cavity during treatment.
  • the developing spring 9 may be composed of a developing material or coated with a developing material.
  • the spring structure of the developing spring 9 has an excellent ability to pass through a complex lesion area, and can improve the shaping ability and shape retention of the tip end of the guide wire.
  • FIG. 10 shows an exemplary embodiment of the developing spring 9.
  • the developing spring 9 is a tapered coil spring having a length of preferably 35 mm and an outer diameter of not more than 0.36 mm, for example, 0.355 mm.
  • the head end core wire 11 is nested by the developing spring, and is preferably made of a memory metal, so that the operator can preliminarily preset the shape of the head end core wire according to the traveling environment of the pressure guide wire, so that the pressure guide wire can more easily pass through the specific position.
  • the head end core wire 11 is in an elongated and tapered configuration.
  • the developing spring 9 and the head end wire 11 are designed to have a taper of 0.124 degrees to give the pressure wire a certain puncture capability and a superior ability to pass complex lesions.
  • the head end wire 11 has a head end portion 10 integral with the head end core wire, or the head end portion 10 can be later welded to the head end core wire 11.
  • the head end portion 10 is shown in Figure 1 and has a rounded transitional shape, such as a streamlined, parabolic, staged, smooth transition type, etc., to facilitate passage of the tortuous path.
  • the head end assembly having the above characteristics, the head end of the pressure guide wire is softer, the shape retaining force is better, and the permanent deformation is not easily generated after the force is applied, thereby ensuring that the pressure guide wire can be applied to more lesions, effectively Reduced the economic pressure on patients.
  • the developing spring 9 and the sensor housing 4 are welded together using a connector 8.
  • the connector 8 is a cylindrical structure having a thin intermediate portion at both ends, one end portion of which is inserted and welded to the developing spring 9, and the other end portion is inserted and welded to the sensor housing 4.
  • the use of the connector 8 of this particular configuration enables the welding of the sensor housing 4 and the developing spring 9 to be simple and reliable, and if the developing spring 9 is directly welded to the sensor housing 4, there is a problem that the welding is not strong.
  • the connector 8 has a length of 0.8 mm and an inner diameter of 0.14 mm, wherein the end for connecting the developing spring has a length of 0.5 mm and an outer diameter of 0.21 mm and is used for connecting the end of the sensor housing.
  • the length is 0.2 mm and the outer diameter is 0.27 mm.
  • the outer diameter of the intermediate portion is not more than 0.36 mm.
  • the maximum outer diameters of the proximal portion, the intermediate portion, and the distal portion are preferably substantially equal, and are each no greater than 0.36 mm.
  • the proximal portion, the intermediate portion, the sensor housing, the connector, and the head end assembly are constructed of similar or identical materials, preferably stainless steel, and are sequentially welded together. This makes it possible to obtain a pressure guide wire which is easy to weld and has a more extended use.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Textile Engineering (AREA)
  • Vascular Medicine (AREA)
  • Physiology (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种压力导丝，包括近端部分（1）、中间部分（2）和远端部分（12），中间部分（2）由一个或多个编织层构成，其中每个编织层包括多根编织丝，远端部分（12）包括容纳有压力传感器（5）的传感器壳体（4）和头端组件（11），头端组件（11）包括显影弹簧（9）以及嵌套于显影弹簧（9）内的头端芯丝（11）。具有这样结构的压力导丝兼具良好的柔顺性和支撑性，同时由于编织丝本身及编织工艺成本低廉，从而能够降低压力导丝的成本。

Description

压力导丝 技术领域
本公开涉及医疗器械领域，具体涉及一种医用压力导丝。
背景技术
医用压力导丝可用于血管腔道和非血管腔道的微创介入诊疗，其通常包括近端部分、远端部分。其中，近端部分的一部分位于体外，操作者对其进行操控，以使导丝沿腔道行进，所述近端部分通常为较为刚性的管状结构，以提供良好的可推性和可扭转性。远端部分通常具有柔软的头端部分，以避免损伤血管。
为了提高压力导丝通过各种迂曲的腔道而达到病变位置的适航性能，还可在压力导丝的近端部分和远端部分之间设置中间部分，该中间部分既需要具有良好的推送性能、扭控性能，还需要良好的柔顺性。
目前存在的一种压力导丝构造是，其近端、中间和远端部分由一体式管结构构成，其中在中间部分处，管结构被切割出图案，以实现柔顺性。然而，对于这样的方案，其压力导丝的可推性、可扭转性与柔顺性均较为一般，且由于压力导丝的可推性、可扭转性与柔顺性之间具有强烈的互斥关系，无法同时将可推性、可扭转性与柔顺性进一步提高。
目前还存在非一体的压力导丝构造，其包括不同材料构成的部段，且一个或多个部段可包括不同性能和/或不同材料构成的外层和内层，等，以便实现各个部段的不同的机械性能。然而，这种压力导丝的结构复杂，且不同材料粘合在一起时存在严重的粘结可靠性问题。
发明内容
本方案针对上文提到的问题和需求，提出一种新型的压力导丝，其由于具有以下特征而具有良好的可推送性、可扭控性、柔顺性，且具有其他优势。
首先，本公开提出了一种压力导丝，其包括：近端部分；中间部分，其由一个或多个编织层构成，其中每个编织层包括多根编织丝；远端部分，包 括容纳有压力传感器的传感器壳体、和头端组件，所述头端组件包括显影弹簧以及嵌套于显影弹簧内的头端芯丝。
在传统认知中，编织丝由于本身的尺寸过细，其形成的螺旋结构截距过小，无法提供足够的支撑性能，因此从未有过采用编织丝来形成压力导丝的中间部分的尝试。同时，“编织”方式形成的结构往往被认为不具有足够的强度和密闭性，因此也从未用于压力导丝的部段。而本专利提出了，采用了多根编织丝形成一个或多个螺旋编织层，每个编织层包括多根编织丝，这样，以非常细的编织丝形成了较大截距的编织结构。经实验验证，这样的编织结构兼具良好的柔顺性和支撑性。其中，在支撑性方面，根据后期支撑力测试，这样的编织结构具有的支撑性能非常突出，甚至是普通编织方法的编织丝的10倍以上，且也远优于现有的其他支撑结构。同时，在柔顺性方面，由于编织丝本身的细软特性和螺旋编织方式的特征，所述编织结构具有远优于现有方案的柔顺性，从而能适应更复杂的病变区域，更好地满足诊疗需求。对于现有结构的中间部分，例如通过将钢管切割出图案而实现柔软性的结构方案，若要达到本方案的支撑性能，则必须极大地牺牲中间部分的柔顺性，严重影响压力导丝的机械性能；而其柔软性相比于本方案则差别更大。另外，由于编织丝本身以及编织工艺均是成本低廉的，从而，该方案能够降低整个压力导丝的成本。
优选地，每个编织层由彼此紧密贴合地平行布置且螺旋式缠绕的多根编织丝形成。
优选地，所述多根编织丝通过预应力紧密贴合在一起。
将多根编织丝彼此紧密贴合地平行布置并进行螺旋式缠绕从而形成编织层，该形成方案相比于前文所述的现有方案而言，还避免了复杂的制造工艺简单并易于实现。
优选地，其中每个编织层包括6至12根编织丝。
优选地，所述编织丝的直径在0.01mm至0.1mm的范围内。
优选地，其中每一根编织丝的截距为0.1mm至1mm。
通过将多个编织丝同时编织，实现了以非常细的编织丝形成了较大截距的编织结构，从而克服了传统认知中无法采用编织丝实现压力导丝的中间部分的技术偏见，而通过上述参数更使得实现的编织结构兼具良好的柔顺性和 支撑性。
优选地，所述中间部分包括至少两个编织层，且其中每相邻两个编织层的编织丝的螺旋方向不同。
优选地，所述中间部分包括至少两个编织层，且其中不同的编织层由不同数量的编织丝形成。
相比于现有方案，采用编织丝编织的方案具有极大的灵活性，因为可以通过调整每个编织层的编织丝的根数和截距、每个编织层的缠绕方向、各个编织层的总体布置、编织层数量等来改变整个编织结构的柔顺性和支撑性，以适用于不同的应用场合需求。根据后期试验证实，使得相邻两个编织层的编织丝的螺旋方向不同能够给压力导丝带来更优的操控性能，操作者更容易控制压力导丝的前进方向。
优选地，其中中间部分包括至少两个编织层，且其中相邻的编织层紧密贴合。
该方案进一步保障了编织结构的不透性，且使得编织结构易于制造，节约成本。
优选地，其中近端部分、中间部分和远端部分的最大外直径均不大于0.36mm。
通过该方案，能够获得整体上粗细均匀的压力导丝，且不大于0.36mm的尺寸使得压力导丝的应用范围更广。
优选地，所述压力传感器为光纤压力传感器，其包括穿过近端部分、中间部分和传感器壳体而连接到压力传感器的光纤。
优选地，头端组件通过连接器连接到传感器壳体，其中所述连接器为两端细中间粗的筒状结构，其一端插入显影弹簧，另一端插入传感器壳体。
该特定构造的连接器的使用能够使得传感器壳体与显影弹簧的焊接简单且可靠，而若将显影弹簧直接和传感器壳体焊接在一起，则存在焊接不牢的问题。
优选地，所述近端部分、中间部分、传感器壳体、连接器、头端组件由相似或相同材料构成，且依次焊接连接。
优选地，所述近端部分、中间部分、传感器壳体、连接器、头端组件由不锈钢构成。
上述方案避免了在采用不同材料形成压力导丝的现有技术中存在的不同材料之间焊接不牢问题。
优选地，其中头端芯丝和显影弹簧具有约0.124度锥度。
通过该方案，能够使得压力导丝具有更佳的穿刺能力和具有更优异的通过复杂病变的能力。
优选地，所述头端芯丝由记忆金属制成。
通过该方案，操作者可以根据压力导丝的行进环境提前预设头端芯丝的形状，以使得压力导丝更容易地通过特定位置。
下文中将结合附图对实施本公开的最优实施例进行更详尽的描述，以便能容易地理解本公开的特征和优点。
附图说明
为了更清楚地说明本专利实施例的技术方案，下文中将对本专利实施例的附图进行简单介绍。其中，附图仅仅用于展示本专利的一些实施例，而非将本专利的全部实施例限制于此。
图1是压力导丝的一个示例性实施例的侧视图；
图2是传感器壳体的俯视示意图；
图3是传感器壳体的侧视示意图；
图4是连接器的侧视示意图；
图5A-C是具有单层编织结构的中间部分的示例性实施例，其每幅图均展示了中间部分的截面视图和侧视图；
图6是具有双层编织结构的中间部分的一个示例性实施例，其展示了中间部分的截面视图和侧视图；
图7是具有双层编织结构的中间部分的一个示例性实施例，其展示了中间部分的截面视图和侧视图；
图8是具有三层编织结构的中间部分的一个示例性实施例，其展示了中间部分的截面视图和侧视图；
图9是具有三层编织结构的中间部分的一个示例性实施例，其展示了中间部分的截面视图和侧视图；
图10是显影弹簧的示意图；
图11A和11B是插入显影弹簧内部的头端芯丝的示意图。
具体实施方式
为了使得本专利的技术方案的目的、技术方案和优点更加清楚，下文中将结合本专利具体实施例的附图，对本专利实施例的技术方案进行清楚、完整地描述。附图中相同的附图标记代表相同的部件。需要说明的是，所描述的实施例是本专利的一部分实施例，而不是全部的实施例。基于所描述的本专利的实施例，本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例，都属于本专利保护的范围。
除非另作定义，此处使用的技术术语或者科学术语应当为本专利所属领域内具有一般技能的人士所理解的通常意义。本专利申请说明书以及权利要求书中使用的“第一”、“第二”以及类似的词语并不表示任何顺序、数量或者重要性，而只是用来区分不同的组成部分。同样，“一个”或者“一”等类似词语也不必然表示数量限制。“包括”或者“包含”等类似的词语意指出现该词前面的元件或物件涵盖出现在该词后面列举的元件或者物件及其等同，而不排除其他元件或者物件。“连接”或者“相连”等类似的词语并非限定于物理的或者机械的连接，而是可以包括电性的连接，不管是直接的还是间接的。“上”、“下”、“左”、“右”等仅用于表示相对位置关系，当被描述对象的绝对位置改变后，则该相对位置关系也可能相应地改变。
如图1所示，根据示例性实施例的压力导丝主要包括近端部分1、中间部分2、和远端部分12。所述远端部分12主要包括：容纳有压力传感器5的传感器壳体4、包括显影弹簧9及头端芯丝11的头端组件，以及连接传感器壳体4和头端组件的连接器8。
如图1所示，近端部分1为细长的管状结构，在诊疗过程中，其部分位于体外，操作者通过该近端部分操控压力导丝，使其沿人体的血管或非血管腔道行进。优选地，近端部分1的长度为1500mm，外直径为不大于0.36mm，例如为0.355mm，内直径在0.13mm至0.17mm之间。近端部分1优选采用不锈钢制成，例如医用304v不锈钢。具有如上特征的近端部分1具有良好的可推送性和可扭转性。
中间部分2也为细长的管状结构，且和近端部分1同轴布置。优选地， 中间部分2的长度小于300mm，例如为280mm。中间部分2的内外直径优选和近端部分1相同，即外直径不大于0.36mm，例如为0.355mm，内直径在0.13mm至0.17mm之间。中间部分2优选采用与近端部分1相似或相同的材料制成，例如也采用不锈钢制成，例如医用304v不锈钢。中间部分2和近端部分1的这种同轴同径的布置以及相似/相同材料的选择使得二者能够容易地焊接连接。
中间部分2优选由一个或多个编织层构成，其中每个编织层由彼此紧密贴合地平行布置且螺旋式缠绕的多根编织丝形成。
具体地，每个编织层可包括6至12根编织丝，例如6根、8根或12根等。其中，每一根编织丝的直径在0.01mm至0.1mm的范围内。优选地，使得编织丝的截距为大致0.1mm至1mm，更优选为0.4mm。
其中，在传统认知中，编织丝由于本身的尺寸过细，其形成的螺旋结构截距过小，无法提供足够的支撑性能，因此从未有过采用编织丝来形成压力导丝的中间部分的尝试。同时，“编织”方式形成的结构往往被认为不具有足够的强度和密闭性，因此也从未用于压力导丝的部段。而本专利提出了，采用了多根编织丝形成一个或多个螺旋编织层，每个编织层包括多根编织丝，这样，以非常细的编织丝形成了较大截距的编织结构。经实验验证，这样的编织结构兼具良好的柔顺性和支撑性。其中，在支撑性方面，根据后期支撑力测试，这样的编织结构具有的支撑性能非常突出，甚至是普通编织方法的编织丝的10倍以上，且也远优于现有的其他支撑结构。同时，在柔顺性方面，由于编织丝本身的细软特性和螺旋编织方式的特征，所述编织结构具有远优于现有方案的柔顺性，从而能适应更复杂的病变区域，更好地满足诊疗需求。对于现有结构的中间部分，例如通过将钢管切割出图案而实现柔软性的结构方案，若要达到本方案的支撑性能，则必须极大地牺牲中间部分的柔顺性，严重影响压力导丝的机械性能；而其柔软性相比于本方案则差别更大。此外，相比于现有方案，采用编织丝编织的本方案还具有极大的灵活性，因为可以通过调整每个编织层的编织丝的根数和截距、每个编织层的缠绕方向、各个编织层的总体布置、编织层数量等来改变整个编织结构的柔顺性和支撑性，以适用于不同的应用场合需求。而且，由于编织丝本身以及编织工艺均是成本低廉的，从而，该方案能够降低整个压力导丝的成本。
根据本公开的提出的上述理念，中间部分2可包括一个或多个编织层，每个编织层由多个编织丝构成。其中，对于包括至少两个编织层的方案，其中不同的编织层可由相同或不同数量的编织丝形成。
根据本公开的提出的上述理念，每个编织层的编织丝的缠绕方向可为左旋或右旋。其中，对于单层的编织结构，其编织丝的方向可为左旋或右旋。而对于包括至少两个编织层的方案，不同编织层的缠绕方向可以相同或不同。优选地，使得其中两个编织层的编织丝的螺旋方向不同。更优选地，使得每相邻两个编织层的编织丝的螺旋方向都不同，即，从最内层到最外层的编织方向依次改变。
图5-9展示了中间部分2的多个具体实施例。其中5A-C展示了仅具有一个编织层的中间部分，其中在5A的实施例中，编织层由6根并行的编织丝进行螺旋式缠绕而形成，在5B的实施例中，编织层由8根并行的编织丝进行螺旋式缠绕而形成，在5C的实施例中，编织层由12根并行的编织丝进行螺旋式缠绕而形成。图6-7展示了具有两个编织层的中间部分，其中在图6的实施例中，内部编织层和外部编织层均由6根并行的编织丝进行螺旋式缠绕而形成；而在图7的实施例中，内部编织层由8根并行的编织丝进行螺旋式缠绕而形成，外部编织层也由6根并行的编织丝进行螺旋式缠绕而形成。对于图6-7展示的方案，优选地，内部编织层与外部编织层的编织方向不同。图8展示了具有三个编织层的中间部分，其中从内向外的三个编织层分别由12根、8根和6根编织丝形成，对于该方案，优选地，使得至少一对相邻编织层的编织方向不同；更优选地，从最内层到最外层的编织方向依次改变。图9展示了具有四个编织层的中间部分，其中四个编织层均由6根编织丝进行螺旋式缠绕而形成。对于该方案，优选地，使得相邻的编织层的编织方向不同。更优选地，从最内层到最外层的编织方向依次改变。根据后期试验证实，具有此种构造的压力导丝的操控性能更优。
其中，平行布置且螺旋式缠绕的多根编织丝彼此紧密地贴合，使得相邻编织丝彼此之间不存在缝隙。这种紧密贴合的布置效果可以通过编织丝缠绕过程中引入的预应力而实现。即，在形成编织层时，提供一心轴，并在心轴上紧密地缠绕多根并行布置的编织丝，在缠绕中将绕自身扭转的预应力引入到每一根编织丝，使得在去除心轴后，相邻的编织丝在所述预应力的作用下 紧密地贴合在一起。
对于包括两个或两个以上编织层的中间部分，相邻的编织层紧密贴合地布置。这种紧密贴合的布置效果可以通过编织丝的过紧缠绕过程而实现，即，在已形成一个编织层(称为第一编织层)后，在该编织层上紧密地缠绕用于形成又一编织层(称为第二编织层)的编织丝，使得在第二编织层的编织丝中形成收缩趋势的预应力，从而该第二编织层紧密地缠绕于第一编织层。
图2和图3分别以不同视角展示了传感器壳体4的示例性实施例。传感器壳体4也为大致筒状结构，其外直径与近端部分1和中间部分2接近，即不大于0.36mm，例如为0.355mm，其内直径不大于0.28mm。传感器壳体4的长度优选不大于2.5mm，例如为1.6mm。传感器壳体4优选采用与中间部分2相似或相同的材料制成，例如也采用不锈钢制成，例如医用304v不锈钢，以保证与中间部分2的焊接可靠性。
压力传感器5设置在传感器壳体4内。所述压力传感器5优选为光纤压力传感器，且具有作为传感器通信装置的光纤，所述光纤穿过近端部分1、中间部分2、传感器壳体4从而连接到压力传感器5。
传感器壳体4设置有感测窗口7，血压通过感测窗口7施加在传感器5上，以测量血管中的血液的压力。优选地，感测窗口7为方形开口，其尺寸优选为长0.5mm，宽0.27mm，倒角为R0.02mm，该感测窗口7位于距显影弹簧9近端部分不大于0.6mm处。
传感器壳体4还可设置有开口6，所述开口6可用作安装和固定压力传感器5的操作开口，例如，在安装压力导丝的制造过程中，可以利用开口6将压力传感器5通过胶粘等方式固定到传感器壳体4。优选地，开口6为大致圆形的开口，其直径优选为不大于0.2mm。开口6的中心位于距显影弹簧9不大于1.5mm处。优选地，开口6的中心与感测窗口7的中心在传感器壳体的周向方向上相差90度左右。
头端组件包括显影弹簧9、嵌套于显影弹簧9内的头端芯丝11，以及焊接到显影弹簧9和头端芯丝11的头端部10。
显影弹簧9用于定位血管中的压力导丝，以提高治疗过程中导丝在病变血管或体腔中的可视性。为此，显影弹簧9可由显影材料构成，或涂覆有显影材料。同时，显影弹簧9的弹簧结构具有优异的通过复杂病变区域的能力， 且能够提升导丝头端的塑形能力和塑形保持力。图10展示了显影弹簧9的示例性实施例。显影弹簧9渐缩式的螺旋弹簧，其长度优选为35mm，外直径不大于0.36mm，例如为0.355mm。
头端芯丝11被显影弹簧嵌套，且优选由记忆金属制成，从而操作者可以根据压力导丝的行进环境提前预设头端芯丝的形状，以使得压力导丝更容易地通过特定位置。在图11A-11B所示的示例性构造中，头端芯丝11呈细长且渐缩的构造。优选地，显影弹簧9及头端芯丝11设计为具有0.124度的锥度，以让压力导丝具有一定的穿刺能力和具有更优异的通过复杂病变的能力。
头端芯丝11具有与该头端芯丝一体的头端部10，或头端部10可后期焊接到头端芯丝11。头端部10在图1中示出，其具有圆滑过渡的外形，例如为流线型、抛物线型、分阶段圆滑过渡型等，以方便通过迂曲的腔道。
通过具有上述特征的头端组件，使压力导丝的头端更柔软，塑形保持力更好，受力后不容易产生永久形变，因而保证了压力导丝可以应用到更多的病变，有效减轻了病患的经济压力。
根据优选实施例，采用连接器8将显影弹簧9和传感器壳体4焊接在一起。如图4所示，连接器8为两端细中间粗的筒状结构，其一个端部插入并焊接到显影弹簧9，另一个端部插入并焊接到传感器壳体4。该特定构造的连接器8的使用能够使得传感器壳体4与显影弹簧9的焊接简单且可靠，而若将显影弹簧9直接和传感器壳体4焊接在一起，则存在焊接不牢的问题。
根据优选实施例，连接器8的长度为0.8mm，内直径为0.14mm，其中用于连接显影弹簧的端部长度为0.5mm，外直径为0.21mm，且用于连接传感器壳体的端部长度为0.2mm，外直径为0.27mm。中间部分的外直径为不大于0.36mm。
根据上述内容可知，根据本公开，优选地使得近端部分、中间部分和远端部分的最大外直径大致相等，且均不大于0.36mm。此外，所述近端部分、中间部分、传感器壳体、连接器、头端组件由相似或相同材料(优选为不锈钢)构成，并依次焊接连接。这样可以获得易于焊接制造，且具有更扩展用途的压力导丝。
上文中参照优选的实施例详细描述了本专利所提出的压力导丝的示范性实施方式，然而本领域技术人员可理解的是，在不背离本专利理念的前提下， 可以对上述具体实施例做出多种变型和改型，且可以对本专利提出的各种技术特征、结构进行多种组合，而不超出本专利的保护范围，本专利的保护范围由所附的权利要求确定。
附图标记列表
1      近端部分
2      中间部分
3      光纤
4      传感器壳体
5      传感器
6      开口
7      感测窗口
8      连接器
9      显影弹簧
10     头端部
11     头端芯丝
12     远端部分

Claims (16)

  1. 一种压力导丝，其特征在于，包括：
    近端部分；
    中间部分，其由一个或多个编织层构成，其中每个编织层包括多根编织丝；
    远端部分，包括容纳有压力传感器的传感器壳体、和头端组件，所述头端组件包括显影弹簧以及嵌套于显影弹簧内的头端芯丝。
  2. 如权利要求1所述的压力导丝，其特征在于，每个编织层由彼此紧密贴合地平行布置且螺旋式缠绕的多根编织丝形成。
  3. 如权利要求2所述的压力导丝，其特征在于，所述多根编织丝通过预应力紧密贴合在一起。
  4. 如权利要求1所述的压力导丝，其特征在于，其中每个编织层包括6至12根编织丝。
  5. 如权利要求1所述的压力导丝，其特征在于，所述编织丝的直径在0.01mm至0.1mm的范围内。
  6. 如权利要求1所述的压力导丝，其特征在于，其中每一根编织丝的截距为0.1mm至1mm。
  7. 如权利要求1所述的压力导丝，其特征在于，所述中间部分包括至少两个编织层，且其中每相邻两个编织层的编织丝的螺旋方向不同。
  8. 如权利要求1所述的压力导丝，其特征在于，所述中间部分包括至少两个编织层，且其中不同的编织层由不同数量的编织丝形成。
  9. 如权利要求1所述的压力导丝，其特征在于，其中中间部分包括至少两个编织层，且其中相邻的编织层紧密贴合。
  10. 如权利要求1所述的压力导丝，其特征在于，其中近端部分、中间部分和远端部分的最大外直径均不大于0.36mm。
  11. 如权利要求1所述的压力导丝，其特征在于，所述压力传感器为光纤压力传感器，其包括穿过近端部分、中间部分和传感器壳体而连接到压力传感器的光纤。
  12. 如权利要求1所述的压力导丝，其特征在于，头端组件通过连接器连接到传感器壳体，其中所述连接器为两端细中间粗的筒状结构，其一端插入显 影弹簧，另一端插入传感器壳体。
  13. 如权利要求12所述的压力导丝，其特征在于，所述近端部分、中间部分、传感器壳体、连接器、头端组件由相似或相同材料构成，且依次焊接连接。
  14. 如权利要求12所述的压力导丝，其特征在于，所述近端部分、中间部分、传感器壳体、连接器、头端组件由不锈钢构成。
  15. 如权利要求1所述的压力导丝，其特征在于，其中头端芯丝和显影弹簧具有约0.124度锥度。
  16. 如权利要求1所述的压力导丝，其特征在于，所述头端芯丝由记忆金属制成。
PCT/CN2018/077748 2018-03-01 2018-03-01 压力导丝 WO2019165623A1 (zh)

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PCT/CN2018/077748 WO2019165623A1 (zh) 2018-03-01 2018-03-01 压力导丝
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