WO2020228053A1 - 鞘管组件、超声探头及其组装方法 - Google Patents

鞘管组件、超声探头及其组装方法 Download PDF

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Publication number
WO2020228053A1
WO2020228053A1 PCT/CN2019/087865 CN2019087865W WO2020228053A1 WO 2020228053 A1 WO2020228053 A1 WO 2020228053A1 CN 2019087865 W CN2019087865 W CN 2019087865W WO 2020228053 A1 WO2020228053 A1 WO 2020228053A1
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WO
WIPO (PCT)
Prior art keywords
sheath
plug
assembly
connection
tube
Prior art date
Application number
PCT/CN2019/087865
Other languages
English (en)
French (fr)
Inventor
刘长庚
严航
Original Assignee
声索生物科技(上海)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 声索生物科技(上海)有限公司 filed Critical 声索生物科技(上海)有限公司
Priority to US16/611,479 priority Critical patent/US11696742B2/en
Publication of WO2020228053A1 publication Critical patent/WO2020228053A1/zh
Priority to US18/303,587 priority patent/US20230255593A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00105—Constructional details of the endoscope body characterised by modular construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112—Connection or coupling means
    • A61B1/00121—Connectors, fasteners and adapters, e.g. on the endoscope handle
    • A61B1/00128—Connectors, fasteners and adapters, e.g. on the endoscope handle mechanical, e.g. for tubes or pipes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112—Connection or coupling means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00142—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with means for preventing contamination, e.g. by using a sanitary sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4422—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to hygiene or sterilisation

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a sheath tube assembly, an ultrasonic probe and an assembly method thereof.
  • Ultrasound endoscope is a commonly used medical device. Its ultrasound probe can enter the body to be examined through natural orifices of the human body, such as the urinary tract, or surgical incision, to directly observe the pathological conditions of the relevant parts to assist in obtaining clear images .
  • the fiber-type ultrasound endoscope in the ultrasound endoscope has a slender ultrasound probe, so that the ultrasound transducer fixed at one end of the ultrasound probe can penetrate deep into the human body; in addition, the ultrasound transducer is through a coaxial cable It is connected with the driving and imaging system at the other end of the ultrasound probe. Under the drive of an external motor, the ultrasound transducer can rotate freely in the ultrasound probe to generate a vertical axial tissue cross-sectional ring image or cross-sectional image.
  • the purpose of the present invention is to provide a sheath assembly, an ultrasound probe with the sheath assembly, and an assembly method of the ultrasound probe, so as to avoid the problem of cross-infection caused by the overall repeated use of the ultrasound probe in the prior art, At the same time reduce the cost of treatment.
  • the sheath assembly of the present invention includes a plug part and a sheath part, one end of the plug part is used to connect with the connection butting part of the ultrasound probe in a detachable and fixed connection manner, the plug The other end of the part is fixedly connected with one end of the sheath part, and the inside of the plug part communicates with the inside of the sheath part to accommodate the torque transmission part of the ultrasonic probe.
  • the beneficial effect of the sheath assembly of the present invention is that one end of the plug part is used to connect to the connection butting part of the ultrasonic probe in a detachable and fixed connection manner, so that after the ultrasonic probe is used, the plug The connecting and docking parts can be separated.
  • the connecting and docking parts fixed with the torque transmission part are reserved for subsequent application processes, which is beneficial to reduce the treatment cost; on the other hand, the after-use Since the sheath assembly has directly contacted human tissues and has low cost, it can be directly discarded, avoiding cross-infection problems caused by repeated use.
  • the plug portion includes a groove, and the inner side wall of the groove has a first thread structure, and the detachable and fixed connection is realized by screwing with the connection butting portion by the thread.
  • the beneficial effect is that the detachable and fixed connection of the plug part and the connection butting part can be quickly realized by screwing.
  • the bottom of the groove is provided with a first locking part
  • the inside of the first locking part is communicated with the inside of the sheath tube part
  • the outer side wall of the first locking part can be connected to the connection butting part.
  • the inner side wall is attached so that the first locking portion is accommodated in the connecting butting portion.
  • the first locking portion has a first inner diameter for accommodating the torque transmission portion, and the first inner diameter is greater than or equal to 0.5 mm and greater than the outer diameter of the torque transmission portion.
  • the beneficial effect is that the torque transmission part can rotate freely in the first locking part to obtain good image information.
  • the outer side wall of the first locking portion has a taper, so that the first locking portion is housed in the connecting and docking portion, and is fixedly connected to the connecting docking portion in a taper self-locking manner.
  • the taper is 3 degrees to 6 degrees, so that the sheath tube assembly can withstand at least 1 atmosphere for at least 30 seconds.
  • the beneficial effect is that the strength of the sheath tube assembly is further improved.
  • the plug part has a sealing part for detachably and fixedly connecting with the first locking part.
  • the beneficial effect is that it facilitates sealing after the subsequent injection of liquid into the sheath tube assembly, so as to facilitate the storage or transportation of the sheath tube assembly.
  • the other end of the sheath tube portion has a sealing head structure.
  • the beneficial effect is that it is convenient to contain the liquid in the sheath part during the subsequent use of the ultrasonic probe, so that the ultrasonic transducer of the torque transmission part can achieve a good signal transmission function.
  • the sheath tube part has a first sheath tube and a second sheath tube connected to each other, one end of the first sheath tube is fixedly connected to the sheath tube connection part of the plug part, and the first sheath tube
  • the Shore hardness is greater than the Shore hardness of the second sheath.
  • the beneficial effect is that the Shore hardness of the first sheath tube connected to the sheath tube connection part is greater than the Shore hardness of the second sheath tube at the distal end, which is beneficial to enhance the strength of the sheath tube part and facilitate
  • the sheath tube part smoothly carries out the pushing process in the body; on the other hand, the second sheath tube with lower Shore hardness directly contacts the human tissue, which can reduce the damage to the human tissue, and is also convenient to bend to enter more complex narrow In the cavity.
  • the sheath tube portion further has a third sheath tube, the Shore hardness of the third sheath tube is greater than or equal to the Shore hardness of the first sheath tube, and the third sheath tube is at least partially sheathed in the first sheath The outer part of the tube to enhance the strength of the sheath tube part.
  • the beneficial effect is that it is convenient for the sheath tube part to smoothly carry out the pushing process in the body.
  • one end of the third sheath is fixedly connected to the sheath connecting portion, and is sleeved on the outside of the first sheath, and the length of the third sheath is smaller than that of the first sheath The length of the tube.
  • the Shore hardness of the first sheath is 50D-90D
  • the Shore hardness of the second sheath is 30D-75D
  • the Shore hardness of the third sheath is 50D-90D.
  • the third sheath tube is a metal spring sleeve, and the metal spring sleeve is movably sleeved on the outside of the sheath connection part and part of the outside of the first sheath.
  • the ultrasonic probe of the present invention includes a connection and docking part, a torque transmission part, and the sheath tube assembly.
  • the sheath tube assembly has a plug part and a sheath tube part connected to each other; the connection and docking part is detachably fixedly connected The fixed end of the torque transmission part is fixedly connected in the connection butt part, and the transducer end of the torque transmission part penetrates the connection butt part and the plug part to enter the In the sheath section.
  • the beneficial effect of the ultrasonic probe of the present invention is that the connection butting portion of the ultrasonic probe is connected to the plug portion in a detachable and fixed connection manner, so that after the ultrasonic probe is used, the plug portion and the connection The docking portion can be separated.
  • the connecting docking portion with the torque transmission portion is retained for subsequent application processes, which is beneficial to reduce the treatment cost;
  • the sheath assembly after use is directly It has been in contact with human tissues, and the cost is low, and it can be discarded directly, avoiding cross-infection problems caused by repeated use.
  • connection butting portion has a first connection portion
  • first connection portion has a second inner diameter
  • second inner diameter is used to accommodate the torque transmission portion
  • the second inner diameter is greater than or equal to 0.5 mm, and Larger than the outer diameter of the torque transmission part.
  • connection butting portion further has a second connection portion, and the second connection portion and the first connection portion are coaxially connected in a detachable and fixed connection manner, and a part of the second connection portion is The surface is provided with a second thread structure, which is locked by screwing with the plug part.
  • the plug portion has a first locking portion
  • the second connecting portion accommodates the first locking portion so that the inside of the connection butting portion communicates with the inside of the sheath assembly, and the first The inner side walls of the two connecting parts are attached to the outer side walls of the first locking part.
  • the inner side wall of the second connecting portion has a taper to accommodate the first locking portion, and the second connecting portion and the first locking portion are connected in a taper self-locking manner.
  • the beneficial effect is that on the basis of further improving the sealing performance, the strength of the ultrasonic component is strengthened.
  • the Shore hardness of the first locking portion is less than the Shore hardness of the second connecting portion.
  • the beneficial effect is that the sealing performance can be further enhanced through the combination of soft and hard.
  • the sheath tube assembly, the catheter and the liquid injection device are provided.
  • the sheath tube assembly includes a plug part and a sheath part connected to each other. One end of the catheter is fed into the Using the liquid injection device to inject liquid into the sheath part through the other end of the catheter;
  • connection butt part Provide the connection butt part to which the torque transmission part is fixed, insert the transducer end of the torque transmission part from the plug part into the sheath part, and then connect the plug part with the The connection butting part is locked and connected to complete the assembly of the ultrasonic probe.
  • the advantageous effect of the assembling method of the ultrasonic probe of the present invention is that the assembling of the ultrasonic probe can be completed by locking and connecting the plug part and the connection butting part, which facilitates the subsequent disassembly process,
  • retaining the connecting and docking portion fixed with the torque transmission portion for subsequent application processes is beneficial to reduce treatment costs;
  • the sheath assembly after use has directly contacted human tissues, and Low cost, can be directly discarded, avoiding cross-infection problems caused by repeated use.
  • the plug part is provided with a sealing part
  • the step S1 further includes: removing the sealing part to inject the liquid into the sheath part through the catheter and the liquid injection device.
  • step S3 after the ultrasonic probe is used, unlock the connection butting portion and the plug portion, then break the sealing structure of the sheath portion, and then pull the The connecting butt part is used to draw the torque transmission part away from the sheath assembly.
  • the beneficial effect is that after unlocking the connecting and docking part from the plug part, the sealing structure of the sheath tube part is broken, so that the connecting and docking part can be pulled to draw the torque transmission part away from the sheath tube.
  • the distal end of the sheath tube part has a sealing head structure
  • the distal end of the sheath tube part has a sealing head structure.
  • the outer side wall of the sheath portion is broken to break the sealing structure of the sheath portion.
  • Fig. 1 is a schematic structural diagram of a first sheath assembly according to Embodiment 1 of the present invention
  • Figure 2 is a longitudinal sectional view of the plug portion shown in Figure 1;
  • FIG. 3 is a schematic diagram of the assembly of the third sheath tube and the sheath tube connection part in Embodiment 2 of the present invention.
  • FIG. 4 is a schematic diagram of the structure of the spring sleeve of Embodiment 3 of the present invention.
  • Figure 5a is a schematic structural diagram of a sealing sleeve according to Embodiment 4 of the present invention.
  • Fig. 5b is a schematic diagram of an exploded structure of another sealing sleeve according to embodiment 4 of the present invention.
  • FIG. 6 is a schematic structural diagram of a first ultrasonic probe according to Embodiment 5 of the present invention.
  • FIG. 7 is a schematic structural diagram of the first socket part shown in FIG. 6;
  • FIG. 8 is a schematic structural diagram of the second socket part shown in FIG. 6;
  • Embodiment 9 is a schematic diagram of the structure of the torque transmission part of Embodiment 5 of the present invention.
  • FIG. 10 is a schematic diagram of the structure of the plug part of Embodiment 6 of the present invention.
  • Fig. 11 is a longitudinal sectional view of the plug portion shown in Fig. 10.
  • embodiments of the present invention provide a sheath assembly and a method for preparing the sheath assembly.
  • the sheath tube assembly is applied to an ultrasound probe.
  • the sheath tube assembly has a plug part and a sheath tube part.
  • the proximal end of the sheath part is fixedly connected to the sheath connection part of the plug part, and the proximal end is defined as the end close to the plug part.
  • One end of the plug part is used to connect to the connection butting part of the ultrasound probe in a detachable and fixed connection manner, the sheath tube connection part is fixedly connected to one end of the sheath tube part, and the inside of the plug part is connected with The inside of the sheath tube part communicates to accommodate the torque transmission part of the ultrasonic probe.
  • At least part of the outer surface of the sheath tube portion is hydrophilic.
  • the preparation method of the sheath tube assembly includes:
  • the open end of the sheath tube part is fixedly connected with the sheath tube connecting part of the plug part to form the sheath tube assembly.
  • At least part of the outer surface of the sheath portion to be processed is hydrophilically treated along the radial direction of the sheath portion to be processed , To form the sheath part.
  • the area on the outer surface of the sheath portion to be processed that needs to be subjected to the hydrophilic treatment includes an area directly in contact with human tissue, so as to improve the biocompatibility of the sheath portion.
  • the embodiment of the present invention also provides an ultrasonic probe and an assembling method of the ultrasonic probe.
  • the ultrasonic probe is composed of the sheath tube assembly, a connection butting part and a torque transmission part.
  • the transducer end of the torque transmission part is fixed with an ultrasonic transducer, the other end of the ultrasonic transducer is a fixed end, and the fixed end is fixedly connected to the inside of the connection butting part.
  • the connection and docking portion is connected to the plug portion in a detachable and fixed connection manner, and the transducer end of the torque transmission portion penetrates the connection docking portion and the plug portion to enter the sheath tube portion.
  • the assembling method of the ultrasonic probe includes the following steps:
  • the sheath tube assembly, the catheter and the liquid injection device are provided.
  • the sheath tube assembly includes a plug part and a sheath part connected to each other. One end of the catheter is fed into the Using the liquid injection device to inject liquid into the sheath part through the other end of the catheter;
  • connection butt part Provide the connection butt part to which the torque transmission part is fixed, insert the transducer end of the torque transmission part from the plug part into the sheath part, and then connect the plug part with the The connection butting part is locked and connected to complete the assembly of the ultrasonic probe.
  • the plug part is provided with a sealing part
  • the step S1 further includes: removing the sealing part, so as to inject the sheath into the sheath part through the catheter and the liquid injection device. ⁇ Said liquid.
  • the assembling method further includes step S3.
  • step S3 after the ultrasonic probe is used, the connecting and docking part is unlocked from the plug part, and then the sheath is broken. Part of the sealing structure, and then pull the connection butting part to draw the torque transmission part away from the sheath assembly.
  • the distal end of the sheath tube part has a sealing head structure
  • the distal end of the sheath tube part has a sealing head structure.
  • the outer side wall of the sheath portion is broken to break the sealing structure of the sheath portion.
  • a through hole is opened on the outer side wall of the sheath tube part or the outer side wall of the sheath tube part is cut to break the sealing structure of the sheath tube part.
  • This embodiment provides a first sheath tube assembly having a first plug part and a sheath tube part.
  • FIG. 1 is a schematic diagram of the structure of the first sheath assembly of Embodiment 1 of the present invention.
  • Fig. 2 is a longitudinal sectional view of the first plug part shown in Fig. 1.
  • the first sheath assembly 1 has a first plug part 11 and a sheath part 12.
  • the first plug portion 11 has a first locking portion 111 and a first sheath connecting portion 112.
  • the sheath portion 12 has a first sheath 121 and a second sheath 122.
  • the first plug portion 11 has a cylindrical fixing portion 114, one end of the fixing portion 114 is provided with a first groove 1141, and the first groove 1141 is a cylindrical groove.
  • the first locking portion 111 has an internal hollow structure, and communicates with the interior of the first sheath connecting portion 112 through a passage inside the fixing portion 114 to accommodate a torque transmission portion (not shown in the figure). One end of the first locking portion 111 is fixed to the bottom of the first groove 1141.
  • the first sheath tube connecting portion 112 is a hollow structure, and has an extension tube 1122 and a conical joint tube 1121 connected in sequence.
  • One end of the extension tube 1122 is fixed to the other end of the fixing portion 114, and the conical joint tube 1121 is fixedly connected to one end of the first sheath tube 121.
  • the center line of the first locking portion 111 and the center line of the first sheath connecting portion 112 both coincide with the center line 13 of the fixing portion 114.
  • the first locking portion 111 is a truncated cone structure, and the longitudinal cross-sectional shape is an isosceles trapezoid, that is, the outer side wall of the first locking portion 111 has a taper so as to be accommodated in the connecting butt portion (in the figure) (Not marked) inside, and fixedly connected to the connection butting portion (not marked in the figure) in a taper self-locking manner.
  • the taper self-locking fixing method is beneficial to enhance the sealing and strength of the ultrasonic probe assembled by the sheath assembly 1.
  • the sheath tube assembly 1 When the sheath tube assembly 1 is filled with liquid and assembled into an ultrasonic probe, the sheath tube assembly 1 can withstand at least 30 seconds under at least 1 atmosphere without leakage of the liquid.
  • the taper is the ratio between the absolute value of the difference between the side lengths of the two bases of the isosceles trapezoid and the height of the isosceles trapezoid.
  • the taper is 3 to 6 degrees.
  • the sheath tube assembly 1 can withstand at least 30 s under at least 3 atmospheres without the liquid leakage.
  • the first sheath tube 121 is a hollow tube structure with open ends, and one end is bonded and fixed to the inner wall of the tapered joint of the first sheath tube connecting portion 112 by epoxy glue, and the other One end and one end of the second sheath tube 122 are fixed by heat fusion.
  • the distal end of the second sheath tube 122 has a hemispherical sealing head structure.
  • the inner side wall of the first groove 1141 has a first thread structure 1142.
  • the first inner diameter of the first locking portion 111 is greater than or equal to 0.5 mm and greater than the outer diameter of the torque transmission portion to accommodate the torque transmission portion. In some specific embodiments of the present invention, the first inner diameter is any one of 0.5 mm, 1.0 mm, 1.2 mm, and 1.4 mm.
  • first sheath tube 121 and the second sheath tube 122 have the same inner diameter and the same outer diameter.
  • the length of the first sheath tube 121 is greater than the length of the second sheath tube 122. In some specific embodiments of the present invention, the length of the first sheath tube 121 is 175 cm, and the length of the second sheath tube 122 is 5 cm.
  • the sheath tube portion 12 only has the second sheath tube 122, and one end of the second sheath tube 122 is fixedly connected to the conical connector tube 1121.
  • the second sheath 122 is a hollow tube structure with open ends, that is, the distal end of the second sheath 122 does not have the sealing head structure.
  • the constituent materials of the first sheath 121 and the second sheath 122 are both plastics.
  • the constituent material of the plastic is polyetheramide elastomer, high density polyethylene or nylon.
  • the Shore hardness of the first sheath tube 121 is greater than the Shore hardness of the second sheath tube 122.
  • the Shore hardness of the first sheath tube 121 is 75D
  • the Shore hardness of the second sheath tube 122 is 50D.
  • the Shore hardness of the first sheath tube 121 connected to the first sheath tube connecting portion 112 is greater than the Shore hardness of the second sheath tube 122, which enhances the strength of the sheath tube portion 12. It is beneficial to the advancement process of the sheath portion 12 in the human tissue; on the other hand, the second sheath 122 with a lower Shore hardness directly contacts the human tissue, which can reduce the damage to the human tissue.
  • the Shore hardness of the first sheath 121 is 50D-90D, and the Shore hardness of the second sheath 122 is 30D-75D. In some specific embodiments of the present invention, the Shore hardness of the first sheath 121 is any one of 60D, 70D, 75D, 80D, and 85D, and the Shore hardness of the second sheath 122 is 30D, Any one of 40D, 45D, 55D, 60D, 65D, 70D and 75D.
  • the hydrophilic treatment is performed along the radial direction of the sheath tube portion 12, so that at least part of the surface of the sheath tube portion 12 is formed Hydrophilic modification layer.
  • the liquid is injected into the sheath tube part using a liquid injection device containing a liquid inside.
  • the liquid injection device has an injection syringe and a catheter, and the inside of the injection syringe is filled with the liquid. 1 and 2, insert a catheter (not marked in the figure) into the sheath portion 12 through the first locking part 111, and make one end of the catheter (not marked in the figure) reach the At the bottom of the second sheath portion 122, the other end of the catheter extends out of the first locking portion 111. Insert an injection syringe (not shown in the figure) into the catheter (not shown in the figure), and then slowly inject the liquid into the sheath portion 12, and slowly pass through the liquid while injecting the liquid.
  • An injection syringe (not marked in the figure) draws the catheter (not marked in the figure) away from the first locking portion 111 to ensure that no bubbles are generated in the sheath portion 12.
  • the catheter (not marked in the figure) is withdrawn, and then a sealing part (not marked in the figure) is used to seal the first locking part 111.
  • the outer diameter of the catheter is smaller than the inner diameter of the first locking portion 111 and smaller than the inner diameter of the sheath portion 12, and the composition material of the catheter is plastic.
  • the liquid injected into the sheath portion can at least immerse the ultrasonic transducer of the torque transmission portion, so as to facilitate the signal transmission of the ultrasonic transducer to obtain a clear image.
  • the liquid is any one of physiological saline or silicone oil.
  • the plastic is polyetheretherketone (PEEK).
  • This embodiment provides a second sheath tube assembly.
  • the difference between the second sheath tube assembly and the first sheath tube assembly in Embodiment 1 of the present invention is that the sheath tube part further has a third sheath tube, and the The third sheath is a hollow tube.
  • Fig. 3 is a schematic diagram of assembling the third sheath and the connecting part of the sheath in the embodiment. 1 and 3, the outer diameter of the hollow tube 31 is adapted to the diameter of the hollow tube 1133 inside the first sheath tube connecting portion 112.
  • One end of the hollow tube 31 extends to the inside of the hollow pipe 1133, and is bonded and fixed to the inner wall of the conical joint tube 1121 by epoxy glue, so as to be sheathed outside the first sheath tube 121.
  • One end of the first sheath tube 121 is fixed to the inner wall of the first sheath tube connecting portion 112 by epoxy resin glue or thermal fusion.
  • the length of the hollow tube 31 is smaller than the length of the first sheath tube 121.
  • the outer diameter of the first sheath tube 121 is adapted to the inner diameter of the hollow tube 31.
  • the Shore hardness of the hollow tube 31 is greater than or equal to the Shore hardness of the first sheath tube 121.
  • the Shore hardness of the hollow tube 31 is 50D-90D.
  • the Shore hardness of the third sheath 31 is any one of 50D, 60D, 65D, 70D, 75D, and 80D.
  • This embodiment provides a third sheath tube assembly.
  • the difference between the third sheath assembly and the second sheath assembly of Embodiment 2 of the present invention is that the third sheath is a metal spring sleeve.
  • the metal spring sleeve is movably sleeved on the outside of the sheath connection part and part of the outside of the first sheath, so as to strengthen the connection relationship between the sheath connection part and the sheath part.
  • the metal spring sleeve 4 is a schematic diagram of the structure of the metal spring sleeve of the third embodiment.
  • the metal spring sleeve 4 has a first sleeve 41, a tapered sleeve 42, and a second sleeve 43 connected in sequence.
  • the length of the first sleeve 41 is equal to the length of the extension tube 1122, and the inner diameter is adapted to the outer diameter of the extension tube 1122.
  • the length of the tapered sleeve 42 is equal to the length of the tapered joint pipe 1121, and the shape of the inner wall is the same as the shape of the outer wall of the tapered joint pipe 1121.
  • the length of the second sleeve 43 is smaller than the length of the first sheath 121, and the inner diameter of the second sleeve 43 is compatible with the outer diameter of the third sheath 31.
  • the metal spring sleeve 4 is a movable sleeve and can move along the radial direction of the first sheath tube 121.
  • This embodiment provides a fourth sheath assembly.
  • the difference between the fourth sheath assembly and the third sheath assembly of Embodiment 3 of the present invention is that the fourth sheath assembly further has a sealing portion, and the sealing portion is a sealing sleeve.
  • FIG. 5a is a schematic diagram of the structure of a sealing sleeve of Embodiment 4.
  • the first sealing sleeve 51 is a hollow structure with one end open.
  • the outer side wall of the first sealing sleeve 51 has a first locking thread 511 to engage with the first thread structure 1142.
  • the inner side wall of the first sealing sleeve 51 has a taper to accommodate the first locking portion 111, and the outer side wall of the first locking portion 111 is self-locking with the first sealing sleeve 51 in a tapered manner. Fit the inner wall.
  • the bottom of the first sealing sleeve 51 is tightly attached to the end surface of the first locking portion 111 to seal the first locking portion 111.
  • FIG. 5b is a schematic diagram of an exploded structure of another sealing sleeve of Embodiment 4.
  • the second sealing sleeve 52 has a sealing tube 521 and a sealing head 522.
  • the sealing plug 522 is a cylindrical structure with a middle groove (not marked in the figure) at one end. The bottom of the middle groove (not marked in the figure) has a plug 5221.
  • the sealing tube 521 is a hollow structure with open ends. Part of the outer side wall of one end of the sealing tube 521 has the first locking thread 511, and a part of the inner side wall has a taper to accommodate the first locking portion 111, and the outer side wall of the first locking portion 111 is The taper self-locking method fits part of the inner side wall of the second sealing sleeve 52. Another part of the inner side wall of the sealing tube 521 is used to receive the plug 5221, and the inner side wall of the intermediate groove (not shown in the figure) is combined with a part of the outer side wall of the sealing tube 521 to connect the
  • the sealing head 522 is detachably and fixedly connected to the sealing tube 521.
  • This embodiment provides a first ultrasonic probe, which is composed of the first sheath assembly, a connection butt portion, and a torque transmission portion.
  • the connection butting portion has a first connection portion and a second connection portion, and the first connection portion and the second connection portion are coaxially connected in a detachable and fixed connection manner.
  • the second connecting portion is detachably and fixedly connected to the first sheath assembly.
  • the first connecting portion and the second connecting portion realize the coaxial connection in a concave-convex butt joint and pin fixation.
  • the constituent material of the connection butting portion is metal, and the constituent material of the plug portion is polymer.
  • the constituent material of the connection butting portion is stainless steel or copper, and the constituent material of the plug portion is polypropylene.
  • the first ultrasonic probe has a metal jacket, the metal jacket is sleeved on the outer surface of the connecting butting portion, and the outer surface of the connecting butting portion is attached to the inner surface of the metal jacket. Together, it is beneficial to strengthen the signal transmission effect of the torque transmission part.
  • the first ultrasonic probe further has an insulating jacket sheathed outside the metal jacket to increase surface friction, and the inner surface of the insulating jacket fits the outer surface of the metal jacket .
  • FIG. 6 is a schematic structural diagram of a first ultrasonic probe according to Embodiment 5 of the present invention.
  • FIG. 7 is a schematic diagram of the structure of the first connecting portion shown in FIG. 6.
  • FIG. 8 is a schematic diagram of the structure of the second connecting portion shown in FIG. 6.
  • the first ultrasonic probe 6 has a first connecting portion 61, a second connecting portion 62, and the first sheath assembly 1, which are connected in sequence, and the second socket portion 62 and the first plug
  • the part 11 is detachable and fixedly connected.
  • the first connecting portion 61 has a spring core 611, a bearing 613, a rotating portion 614, a sealing member 615, and a protective shell 616 that are connected in sequence and communicate with each other, and a first connecting portion 61 disposed at the bottom of the protective shell 616
  • the positioning pin 617 and the second positioning pin 618 have the same structure as the second positioning pin 618.
  • the sealing ring 612 is sleeved on the outer surface of the spring inner core 611.
  • the inner diameter of the sealing ring 612 is compatible with the outer diameter of the spring inner core 611, and the outer diameter of the sealing ring 612 is smaller than the outer diameter of the bearing 613.
  • the first connecting portion 61 has a second inner diameter for accommodating the torque transmission portion, and the second inner diameter is greater than or equal to 0.5 mm and greater than the outer diameter of the torque transmission portion.
  • the inner diameter of the spring inner core 611 is the second inner diameter.
  • the second inner diameter is any one of 0.5mm, 1.0mm, 1.2mm or 1.4mm.
  • the inner spring core 611, the bearing 613, the rotating part 614 and the sealing member 615 have the same inner diameter.
  • the second connecting portion 62 has a second locking portion 621 and a mating portion 622 that are both hollow cylindrical structures and communicate with each other inside.
  • a part of the outer surface of the proximal end of the second locking portion 621 has a second thread structure 6211.
  • the first threaded structure 1142 and the second threaded structure 6211 can be engaged with each other, and the inner side wall of the second locking portion 621 has a tapered structure to accommodate the first locking portion 111 and interact with the first locking portion.
  • the outer side wall of 111 is attached in a tapered self-locking manner.
  • the first locking part 111 is a hollow cylinder, and the inner diameter of the second locking part 621 is adapted to the outer diameter of the first locking part 111 to accommodate the first locking part 111. ⁇ 111.
  • the inner diameter of the second locking portion 621 is 3-6 mm, and the length of the first locking portion 111 is equal to the length of the second locking portion 621.
  • the length of the second locking portion 621 is equal to the length of the spring inner core 611.
  • the inner side wall of the mating portion 622 has an annular groove structure (not marked in the figure) that cooperates with the sealing ring 612, the bearing 613, the rotating portion 614, and the sealing member 615 to realize the first
  • a connecting portion 61 is detachably fixedly connected to the second connecting portion 62.
  • FIG. 9 is a schematic diagram of the structure of the torque transmission part of Embodiment 5 of the present invention.
  • the torque transmission part 9 has a flexible sleeve 91, a metal protective tube 92, a coaxial cable 93 and an ultrasonic transducer 94.
  • the flexible sleeve 91 is a hollow metal spiral tube structure, and the coaxial cable 93 passes through the inside of the flexible sleeve 91.
  • One end of the metal protection tube 92 is fixed to the flexible sleeve 91 by welding, and the signal line (not shown in the figure) and the shielding line (not shown in the figure) of the coaxial cable 93 are welded or bonded The way is fixedly connected with the two electrodes (not marked in the figure) of the ultrasonic transducer 94.
  • a mounting groove (not marked in the figure) is opened on one side of the metal protection tube 92 for installing the ultrasonic transducer 94.
  • the fixed end of the torque transmission part 9 penetrates the spring inner core 611 and the bearing 613 to be fixed inside the rotating part 614.
  • the rotation of the rotating portion 614 drives the first positioning pin 617 and the second positioning pin 618 to rotate, so that the torque transmission portion 9 transmits torque.
  • This embodiment provides a second plug part.
  • the second plug part has a main body part, a third locking part and a second sheath connection part.
  • FIG. 10 is a schematic diagram of the structure of the second plug part of this embodiment, and FIG. 11 is a longitudinal cross-sectional view of the second plug part shown in FIG. 10.
  • the second plug portion 10 has a main body portion 101, a second sheath connecting portion 102 and a third locking portion 103, one end of the main body portion 101 is provided with a second groove 1011, the second The bottom of the groove 1011 is provided with the third locking portion 103 with a hollow structure.
  • a silicone sealing ring 1014 is fixed inside the main body 101.
  • the outer side wall of the main body 101 has four anti-skid members 1012.
  • the inner side wall of the second groove 1011 is provided with a third thread structure 1013.
  • the inside of the main body part 101 communicates with the inside of the second sheath connecting part 102.
  • a part of the second sheath connecting portion 102 is housed inside the main body 101, and one end is tightly attached to the silicone sealing ring 1014; the first sheath 121 One end of is fixed inside the second sheath connecting portion 102.
  • the second locking part 621 can be locked with the third locking part 103.
  • the second sheath tube Part of the outer side wall of the connecting portion 102 closely fits with part of the inner side wall of the main body 101 and can rotate relative to the main body 101, so that the second sheath connecting portion 102 is rotated when the main body 101 is rotated. The rotation can not occur, and the problem of twisting and deformation of the first sheath tube 121 is avoided.

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Abstract

一种鞘管组件（1），包括相互连接的插头部（10,11）和鞘管部（12），该鞘管组件（1）的插头部（10,11）的一端用于以可拆卸固定连接的方式与超声探头（6）的连接对接部（622）连接，使得该超声探头（6）使用完毕后，该插头部（10,11）和该连接对接部（622）能够分离，一方面保留了固定有扭矩传输部（9）的该连接对接部（622）以用于后续的应用过程，有利于降低治疗成本；另一方面，使用后的该鞘管组件（1）由于直接接触过人体组织，且成本低，能够直接丢弃，避免了由于重复使用造成的交叉感染问题。还提供了包括鞘管组件（1）的超声探头（6），以及超声探头（6）的组装方法。

Description

鞘管组件、超声探头及其组装方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及鞘管组件、超声探头及其组装方法。
背景技术
超声内窥镜是常用的医疗器械，其超声探头能够经人体的天然孔道，例如泌尿腔道，或者手术切口进入人体内的待检查器官，直接窥视有关部位的病变情况，以辅助获得清晰的图像。
超声内窥镜中的纤维式超声内窥镜，具有细长的超声探头，使得固定在超声探头一端的超声换能器能够深入人体内部较深的部位；另外，超声换能器通过同轴电缆与超声探头另一端的驱动以及成像系统连接，在外部的马达驱动下，超声换能器能够在超声探头内自由旋转，以产生垂直轴向的组织截面环形影像或剖面影像。
然而，现有技术中的大多数纤维式超声内窥镜为一体式结构，由于超声换能器的成本高，每次临床应用过程完毕后，多采用对超声探头中直接接触人体组织的部分进行清洗消毒后继续应用于下次的临床使用，容易产生交叉感染的问题；而每次临床应用后抛弃整个超声探头的做法，使得治疗成本大幅度增加。
因此，有必要开发一种新型的超声探头以避免现有技术中存在的上述问题。
发明内容
本发明的目的在于提供鞘管组件、具有所述鞘管组件的超声探头以及所述超声探头的组装方法，避免现有技术中由于对超声探头的整体重复使用造成的容 易产生交叉感染的问题，同时降低治疗成本。
为实现上述目的，本发明的所述鞘管组件包括插头部和鞘管部，所述插头部的一端用于以可拆卸固定连接的方式与所述超声探头的连接对接部连接，所述插头部的另一端与所述鞘管部的一端固定连接，所述插头部的内部与所述鞘管部的内部相通，以收容所述超声探头的扭矩传输部。
本发明所述鞘管组件的有益效果在于：所述插头部的一端用于以可拆卸固定连接的方式与所述超声探头的连接对接部连接，使得所述超声探头使用完毕后，所述插头部和所述连接对接部能够分离，一方面保留了固定有所述扭矩传输部的所述连接对接部以用于后续的应用过程，有利于降低治疗成本；另一方面，使用后的所述鞘管组件由于直接接触过人体组织，且成本低，能够直接丢弃，避免了由于重复使用造成的交叉感染问题。
优选的，所述插头部包括凹槽，所述凹槽的内侧壁具有第一螺纹结构，以与所述连接对接部以所述螺纹旋合的方式实现所述可拆卸固定连接。其有益效果在于：通过螺纹旋合的方式能够快速实现所述插头部和所述连接对接部的可拆卸固定连接。
进一步优选的，所述凹槽的底部设置有第一锁定部，所述第一锁定部内部与所述鞘管部的内部相通，所述第一锁定部的外侧壁能够与所述连接对接部的内侧壁贴合，以使所述第一锁定部收容在所述连接对接部的内部。其有益效果在于：有利于进一步提高所述插头部和所述连接对接部之间的密封性能。
优选的，所述第一锁定部具有用于收容所述扭矩传输部的第一内径，所述第一内径大于等于0.5mm，且大于所述扭矩传输部的外径。其有益效果在于：有利于所述扭矩传输部在所述第一锁定部内能够进行自由旋转，以获得良好的图像信息。
进一步优选的，所述第一锁定部的外侧壁具有锥度，以使所述第一锁定部收容在所述连接对接部内部，且以锥度自锁的方式与所述连接对接部固定连接。
进一步优选的，所述锥度为3度-6度，以使所述鞘管组件能够在至少30s的时间承受至少1个大气压。其有益效果在于：进一步提高所述鞘管组件的强度。
更进一步优选的，所述插头部具有密封部，用于与所述第一锁定部可拆卸固定连接。其有益效果在于：有利于后续向所述鞘管组件中注入液体后进行密封，以便于所述鞘管组件的储存或运输。
优选的，所述鞘管部的另一端具有密封头结构。其有益效果在于：便于在后续的所述超声探头使用过程中，收容所述鞘管部内的液体，以利于所述扭矩传输部的超声换能器实现良好的信号传输功能。
优选的，所述鞘管部具有相互连接的第一鞘管和第二鞘管，所述第一鞘管的一端与所述插头部的鞘管连接部固定连接，所述第一鞘管的邵氏硬度大于所述第二鞘管的邵氏硬度。其有益效果在于：与所述鞘管连接部相连的所述第一鞘管的邵氏硬度大于远端的第二鞘管的邵氏硬度，有利于增强所述鞘管部的强度，便于所述鞘管部顺利地在体内进行推送过程；另一方面邵氏硬度较低的所述第二鞘管直接接触人体组织，能够减小对人体组织的损伤，也便于弯曲以进入更复杂窄小的腔道内。
进一步优选的，所述鞘管部还具有第三鞘管，所述第三鞘管的邵氏硬度大于等于所述第一鞘管的邵氏硬度，且至少部分套设在所述第一鞘管的外部，以增强所述鞘管部的强度。其有益效果在于：便于所述鞘管部顺利地在体内进行推送过程。
更进一步优选的，所述第三鞘管的一端与所述鞘管连接部固定连接，且套设在所述第一鞘管的外部，所述第三鞘管的长度小于所述第一鞘管的长度。
更进一步优选的，所述第一鞘管的邵氏硬度为50D-90D，所述第二鞘管的邵氏硬度为30D-75D，所述第三鞘管的邵氏硬度为50D-90D。
更进一步优选的，所述第三鞘管为金属弹簧套管，所述金属弹簧套管活动套接在所述鞘管连接部的外部以及部分所述第一鞘管的外部。
本发明的所述超声探头，包括连接对接部、扭矩传输部以及所述鞘管组件，所述鞘管组件具有相互连接的插头部和鞘管部；所述连接对接部以可拆卸固定连接的方式与所述插头部连接；所述扭矩传输部的固定端固定连接在所述连接对接部内，所述扭矩传输部的换能器端贯穿所述连接对接部和所述插头部，以进入所述鞘管部内。
本发明所述超声探头的有益效果在于：所述超声探头的连接对接部以可拆卸固定连接的方式与所述插头部连接，使得所述超声探头使用完毕后，所述插头部和所述连接对接部能够分离，一方面保留了固定有所述扭矩传输部的所述连接对接部以用于后续的应用过程，有利于降低治疗成本；另一方面，使用后的所述鞘管组件由于直接接触过人体组织，且成本低，能够直接丢弃，避免了由于重复使用造成的交叉感染问题。
优选的，所述连接对接部具有第一连接部，所述第一连接部具有第二内径，所述第二内径用于收容所述扭矩传输部，所述第二内径大于等于0.5mm，且大于所述扭矩传输部的外径。其有益效果在于：有利于所述扭矩传输部在所述第一连接部内能够进行自由旋转，以获得良好的图像信息。
进一步优选的，所述连接对接部还具有第二连接部，所述第二连接部与所述第一连接部以可拆卸固定连接的方式实现同轴连接，所述第二连接部的部分外表面具有第二螺纹结构，以与所述插头部以螺纹旋合的方式进行锁定。
进一步优选的，所述插头部具有第一锁定部，所述第二连接部收容所述第一锁定部，以使所述连接对接部的内部与所述鞘管组件的内部相通，所述第二连接部的内侧壁与所述第一锁定部的外侧壁贴合。其有益效果在于：进一步提高所述插头部和所述连接对接部之间的密封性能。
更进一步优选的，所述第二连接部的内侧壁具有锥度，以收容所述第一锁定部，所述第二连接部与所述第一锁定部以锥度自锁的方式连接。其有益效果在于：在进一步提高密封性能的基础上，加强所述超声组件的强度。
更进一步优选的，所述第一锁定部的邵氏硬度小于所述第二连接部的邵氏硬度。其有益效果在于：通过软硬结合的方式达到进一步加强密封性能。
本发明的所述超声探头的组装方法，其特征在于，包括以下步骤：
S1：提供所述鞘管组件、导液管和液体注射装置，所述鞘管组件包括相互连接的插头部和鞘管部，将所述导液管的一端通过所述插头部送入所述鞘管部内的底部，使用所述液体注射装置通过所述导液管的另一端向所述鞘管部内注入液体；
S2：提供固定有所述扭矩传输部的所述连接对接部，将所述扭矩传输部的换能器端从所述插头部插入至所述鞘管部内，然后将所述插头部与所述连接对接部锁定连接，以完成所述超声探头的组装。
本发明所述超声探头的组装方法的有益效果在于：由于通过将所述插头部与所述连接对接部锁定连接，就能完成所述超声探头的组装，有利于在后续的拆解过程中，一方面保留固定有所述扭矩传输部的所述连接对接部以用于后续的应用过程，有利于降低治疗成本；另一方面，使用后的所述鞘管组件由于直接接触过人体组织，且成本低，能够直接丢弃，避免了由于重复使用造成的交叉感染问题。
优选的，所述插头部设置有密封部，所述步骤S1还包括：拆除所述密封部，以通过所述导液管和所述液体注射装置向所述鞘管部内注入所述液体。
优选的，还包括步骤S3，所述步骤S3中，所述超声探头使用完毕后，将所述连接对接部与所述插头部解锁定，然后打破所述鞘管部的密封结构，再拉动所述连接对接部以将所述扭矩传输部抽离所述鞘管组件。其有益效果在于：将所述连接对接部与所述插头部解锁定后，打破所述鞘管部的密封结构，便于拉动所述连接对接部以将所述扭矩传输部抽离所述鞘管组件。
进一步优选的，所述鞘管部远端具有密封头结构，所述鞘管部远端具有密封头结构，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，切除所述 密封头结构，以打破所述鞘管部的密封结构。
进一步优选的，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，破坏所述鞘管部的外侧壁，以打破所述鞘管部的密封结构。
附图说明
图1为本发明实施例1的第一鞘管组件的结构示意图；
图2为图1所示的插头部的纵剖面图；
图3为本发明实施例2中的第三鞘管与鞘管连接部的装配示意图；
图4为本发明实施例3的弹簧套管的结构示意图；
图5a为本发明实施例4的一种密封套头的结构示意图；
图5b为本发明实施例4的另一种密封套头的爆炸结构示意图；
图6为本发明实施例5的第一超声探头的结构示意图；
图7为图6所示的第一插座部的结构示意图；
图8为图6所示的第二插座部的结构示意图；
图9为本发明实施例5的扭矩传输部的结构示意图；
图10为本发明实施例6的插头部的结构示意图；
图11为图10所示的插头部的纵剖面图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本 领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。除非另外定义，此处使用的技术术语或者科学术语应当为本发明所属领域内具有一般技能的人士所理解的通常意义。本文中使用的“包括”等类似的词语意指出现该词前面的元件或者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。
针对现有技术存在的问题，本发明实施例提供了一种鞘管组件以及所述鞘管组件的制备方法。所述鞘管组件应用于超声探头。
所述鞘管组件具有插头部和鞘管部。所述鞘管部的近端与所述插头部的鞘管连接部固定连接，定义近端为靠近所述插头部的一端。所述插头部的一端用于以可拆卸固定连接的方式与所述超声探头的连接对接部连接，所述鞘管连接部与所述鞘管部的一端固定连接，所述插头部的内部与所述鞘管部的内部相通，以收容所述超声探头的扭矩传输部。
本发明一些实施例中，所述鞘管部的至少部分外表面具有亲水性。
所述鞘管组件的制备方法包括：
提供所述插头部和待加工鞘管部，对所述待加工鞘管部的一端进行封头处理，以形成所述密封头结构；
对所述待加工鞘管部的至少部分外表面进行亲水处理，以形成所述鞘管部；
将所述鞘管部的开口端与所述插头部的鞘管连接部固定连接，以形成所述鞘管组件。
本发明一些实施例中，自所述密封头结构的远端点为起始点，沿所述待加工鞘管部的径向方向对所述待加工鞘管部的至少部分外表面进行亲水处理，以形成所述鞘管部。
本发明一些实施例中，所述待加工鞘管部外表面的需要进行所述亲水处理的区域包括直接与人体组织接触的区域，以提高所述鞘管部的生物相容性。
本发明实施例还提供了一种超声探头以及所述超声探头的组装方法。
所述超声探头由所述鞘管组件、连接对接部和扭矩传输部组成。所述扭矩传输部的换能器端固定有超声换能器，所述超声换能器的另一端为固定端，所述固定端固定连接在所述连接对接部的内部。所述连接对接部以可拆卸固定连接的方式与所述插头部连接，所述扭矩传输部的换能器端贯穿所述连接对接部和所述插头部，以进入所述鞘管部内。
所述超声探头的组装方法包括以下步骤：
S1：提供所述鞘管组件、导液管和液体注射装置，所述鞘管组件包括相互连接的插头部和鞘管部，将所述导液管的一端通过所述插头部送入所述鞘管部内的底部，使用所述液体注射装置通过所述导液管的另一端向所述鞘管部内注入液体；
S2：提供固定有所述扭矩传输部的所述连接对接部，将所述扭矩传输部的换能器端从所述插头部插入至所述鞘管部内，然后将所述插头部与所述连接对接部锁定连接，以完成所述超声探头的组装。
本发明一些实施例中，所述插头部设置有密封部，所述步骤S1还包括：拆除所述密封部，以通过所述导液管和所述液体注射装置向所述鞘管部内注入所述液体。
本发明一些实施例中，所述组装方法还包括步骤S3，所述步骤S3中，所述超声探头使用完毕后，将所述连接对接部与所述插头部解锁定，然后打破所述鞘管部的密封结构，再拉动所述连接对接部以将所述扭矩传输部抽离所述鞘管组件。
本发明一些实施例中，所述鞘管部远端具有密封头结构，所述鞘管部远端具有密封头结构，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，切除所述密封头结构，以打破所述鞘管部的密封结构。
本发明一些实施例中，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，破坏所述鞘管部的外侧壁，以打破所述鞘管部的密封结构。
本发明一些具体的实施例中，通过在所述鞘管部的外侧壁开设通孔或划破所述鞘管部的外侧壁，以打破所述鞘管部的密封结构。
以下通过实施例1-6对本发明的技术方案进行详细的叙述。
实施例1
本实施例提供了第一鞘管组件，所述第一鞘管组件具有第一插头部和鞘管部。
图1为本发明实施例1的第一鞘管组件的结构示意图。图2为图1所示的第一插头部的纵剖面图。
参照图1和图2，第一鞘管组件1具有第一插头部11和鞘管部12。所述第一插头部11具有第一锁定部111和第一鞘管连接部112。所述鞘管部12具有第一鞘管121和第二鞘管122。
参照图1和图2，所述第一插头部11具有圆柱体的固定部114，所述固定部114的一端开设有第一凹槽1141，所述第一凹槽1141为圆柱形凹槽。所述第一锁定部111具有内部中空结构，通过所述固定部114内部的通道与所述第一鞘管连接部112的内部相通，以收容扭矩传输部(图中未标示)。所述第一锁定部111的一端固定在所述第一凹槽1141的底部。所述第一鞘管连接部112为空心结构，具有依次相连的延伸管1122和圆锥接头管1121。所述延伸管1122的一端固定在所述固定部114的另一端，所述圆锥接头管1121与所述第一鞘管121的一端固定连接。所述第一锁定部111的中心线和所述第一鞘管连接部112的中心线均与所述固定部114的中心线13重合。
参照图1和图2，所述第一锁定部111为圆台结构，纵剖面形状为等腰梯形，即所述第一锁定部111的外侧壁具有锥度，以便于收容在连接对接部(图中未标示)内部，并以锥度自锁的方式与所述连接对接部(图中未标示)固定连接。锥度自锁的固定方式有利于增强由所述鞘管组件1组装成的超声探头的密封性 以及强度。当所述鞘管组件1中注入液体且组装成超声探头，所述鞘管组件1能够在至少1个大气压下承受至少30s的时间而不发生所述液体泄漏的情况。所述锥度为所述等腰梯形两个底边边长之差的绝对值与所述等腰梯形的高度之间的比值。
本发明一些具体的实施例中，所述锥度为3度-6度。所述鞘管组件1能够在至少3个大气压下承受至少30s的时间而不发生所述液体泄漏的情况。
参照图1和图2，所述第一鞘管121为两端开口的空心管结构，一端通过环氧树脂胶与所述第一鞘管连接部112的锥形接头的内壁粘接固定，另一端与所述第二鞘管122的一端以热熔合的方式固定。所述第二鞘管122的远端为半球形的密封头结构。所述第一凹槽1141的内侧壁具有第一螺纹结构1142。
本发明一些实施例中，所述第一锁定部111的第一内径为大于等于0.5mm，且大于所述扭矩传输部的外径，以收容所述扭矩传输部。本发明一些具体的实施例中，所述第一内径为0.5mm、1.0mm、1.2mm和1.4mm中的任意一种。
本实施例中，所述第一鞘管121和所述第二鞘管122具有相同的内径和相同的外径。所述第一鞘管121的长度大于所述第二鞘管122的长度。本发明一些具体的实施例中，所述第一鞘管121的长度为175cm，所述第二鞘管122的长度为5cm。
本发明一些实施例中，参照图2，所述鞘管部12仅具有所述第二鞘管122，所述第二鞘管122的一端与所述圆锥接头管1121固定连接。
本发明一些实施例中，所述第二鞘管122为两端开口的空心管结构，即所述第二鞘管122的远端不具有所述密封头结构。
本发明一些实施例中，所述第一鞘管121和所述第二鞘管122的组成材料均为塑料。本发明一些具体的实施例中，所述塑料的组成材料为聚醚酰胺弹性体、高密度聚乙烯或尼龙。
本实施例中，参照图1和图2，所述第一鞘管121的邵氏硬度大于所述第二 鞘管122的邵氏硬度。所述第一鞘管121的邵氏硬度为75D，所述第二鞘管122的邵氏硬度为50D。一方面，与所述第一鞘管连接部112连接的所述第一鞘管121的邵氏硬度大于所述第二鞘管122的邵氏硬度，增强了所述鞘管部12的强度，有利于所述鞘管部12在人体组织内的推进过程；另一方面邵氏硬度较低的所述第二鞘管122直接接触人体组织，能够减小对人体组织的损伤。
本发明一些实施例中，所述第一鞘管121的邵氏硬度为50D-90D，所述第二鞘管122的邵氏硬度为30D-75D。本发明一些具体的实施例中，所述第一鞘管121的邵氏硬度为60D、70D、75D、80D和85D中的任意一种，所述第二鞘管122的邵氏硬度为30D、40D、45D、55D、60D、65D、70D和75D中的任意一种。
参照图1，以所述第二鞘管122的密封头结构的端点为起点，沿所述鞘管部12的径向方向进行亲水处理，以使至少部分所述鞘管部12的表面形成亲水修饰层。
利用内部装有液体的液体注射装置向所述鞘管部内注入所述液体。所述液体注射装置具有注射针筒和导液管，所述注射针筒的内部装有所述液体。参照图1和图2，将导液管(图中未标示)经所述第一锁定部111插入所述鞘管部12，并使所述导液管(图中未标示)的一端到达所述第二鞘管部122内的底部，所述导液管的另一端伸出所述第一锁定部111的外部。将注射针筒(图中未标示)插入所述导液管(图中未标示)，然后向所述鞘管部12内缓慢注入所述液体，且在注入所述液体的同时缓慢通过所述注射针筒(图中未标示)将所述导液管(图中未标示)抽离所述第一锁定部111，以确保所述鞘管部12内部没有气泡产生。所述注射针筒(图中未标示)中的所述液体注射完毕后，抽出所述导液管(图中未标示)，然后使用密封部(图中未标示)密封所述第一锁定部111。
本实施例中，所述导液管的外径小于所述第一锁定部111的内径，且小于所述鞘管部12的内径，所述导液管的组成材料为塑料。
本发明一些实施例中，注入所述鞘管部的所述液体至少能够浸没所述扭矩传输部的超声换能器，以有利于所述超声换能器的信号传输，以获得清晰图像。
本发明一些实施例中，所述液体为生理盐水或硅油中的任意一种。所述塑料为聚醚醚酮(Polyetheretherketone，PEEK)。
实施例2
本实施例提供了第二鞘管组件，所述第二鞘管组件与本发明实施例1的所述第一鞘管组件的区别在于：所述鞘管部还具有第三鞘管，所述第三鞘管为空心管。
图3为实施例中的第三鞘管与鞘管连接部的装配示意图。参照图1和图3，空心管31的外径与所述第一鞘管连接部112内部的空心管道1133的直径相适应。所述空心管31的一端延伸至所述空心管道1133的内部，通过环氧树脂胶与所述圆锥接头管1121的内壁粘接固定，以套设在所述第一鞘管121的外部。所述第一鞘管121的一端通过环氧树脂胶或热熔合的方式固定在所述第一鞘管连接部112的内壁。所述空心管31的长度小于所述第一鞘管121的长度。
本发明一些实施例中，所述第一鞘管121的外径与所述空心管31的内径相适应。
本实施例中，所述空心管31的邵氏硬度大于等于所述第一鞘管121的邵氏硬度。所述空心管31的邵氏硬度为50D-90D。本发明一些具体的实施例中，所述第三鞘管31的邵氏硬度为50D、60D、65D、70D、75D和80D中的任意一种。
实施例3
本实施例提供了第三鞘管组件。所述第三鞘管组件与本发明实施例2的所述第二鞘管组件的区别在于：所述第三鞘管为金属弹簧套管。所述金属弹簧套管活动套接在所述鞘管连接部的外部以及部分所述第一鞘管的外部，以加强所述鞘管连接部和所述鞘管部之间的连接关系。
图4为实施例3的金属弹簧套管的结构示意图。参照图2、图3和图4，金 属弹簧套管4具有依次连接的第一套管41、锥型套管42和第二套管43。所述第一套管41的长度与所述延伸管1122的长度相等，且内径与所述延伸管1122的外径相适应。所述锥形套管42的长度与所述圆锥接头管1121的长度相等，且内壁形状与所述圆锥接头管1121的外壁形状相同。所述第二套管43的长度小于所述第一鞘管121的长度，所述第二套管43的内径与所述第三鞘管31的外径相适应。所述金属弹簧套管4为活动套管，能够沿所述第一鞘管121的径向运动。
实施例4
本实施例提供了第四鞘管组件。所述第四鞘管组件与本发明实施例3的所述第三鞘管组件的区别在于：所述第四鞘管组件还具有密封部，所述密封部为密封套头。
图5a为实施例4的一种密封套头的结构示意图。参照图2和图5a，第一密封套头51为一端开口的中空结构。所述第一密封套头51的外侧壁具有第一锁定螺纹511，以与所述第一螺纹结构1142相啮合。所述第一密封套头51的内侧壁具有锥度，以收容所述第一锁定部111，且使所述第一锁定部111的外侧壁以锥度自锁的方式与所述第一密封套头51的内侧壁贴合。所述第一密封套头51的底部与所述第一锁定部111的端面紧密贴合，以密封所述第一锁定部111。
图5b为实施例4的另一种密封套头的爆炸结构示意图。参照图2和图5b，第二密封套头52具有密封管521和密封头522。所述密封堵头522为一端具有中间凹槽(图中未标示)的圆柱体结构。所述中间凹槽(图中未标示)的底部具有堵头5221。
所述密封管521为两端开口的中空结构。所述密封管521的一端的部分外侧壁具有所述第一锁定螺纹511，且部分内侧壁具有锥度，以收容所述第一锁定部111，且使所述第一锁定部111的外侧壁以锥度自锁的方式与所述第二密封套头52的部分内侧壁贴合。所述密封管521的另一部分内侧壁用于收容所述堵头 5221，且所述中间凹槽(图中未标示)的内侧壁与所述密封管521的部分外侧壁结合，以将所述密封头522与所述密封管521可拆卸固定连接。
实施例5
本实施例提供了第一超声探头，所述第一超声探头由所述第一鞘管组件、连接对接部和扭矩传输部组成。所述连接对接部具有第一连接部和第二连接部，所述第一连接部与所述第二连接部以可拆卸固定连接的方式实现同轴连接。所述第二连接部与所述第一鞘管组件可拆卸固定连接。
本发明一些实施例中，所述第一连接部与所述第二连接部以凹凸对接和销钉固定的方式实现所述同轴连接。
本发明一些实施例中，所述连接对接部的组成材料为金属，所述插头部的组成材料为聚合物。本发明一些具体的实施例中，所述连接对接部的组成材料为不锈钢或铜，所述插头部的组成材料为聚丙烯。
本发明一些实施例中，所述第一超声探头具有金属外套，所述金属外套套设在所述连接对接部的外表面，所述连接对接部的外表面与所述金属外套的内表面贴合，有利于加强所述扭矩传输部的信号传输效果。
本发明一些实施例中，所述第一超声探头还具有套设在所述金属外套外部的绝缘外套，以增加表面摩擦力，所述绝缘外套的内表面与所述金属外套的外表面贴合。
图6为本发明实施例5的第一超声探头的结构示意图。图7为图6所示的第一连接部的结构示意图。图8为图6所示的第二连接部的结构示意图。
参照图1和图6，第一超声探头6具有依次连接的第一连接部61、第二连接部62和所述第一鞘管组件1，所述第二插座部62与所述第一插头部11可拆卸固定连接。
参照图7，所述第一连接部61具有依次连接且内部相通的弹簧内芯611、轴 承613、旋转部614、密封件615和保护外壳616，以及设置在所述保护外壳616底部的第一定位针617和第二定位针618，所述第一定位针617的结构与所述第二定位针618的结构相同。所述密封圈612套设在所述弹簧内芯611的外表面。所述密封圈612的内径与所述弹簧内芯611的外径相适应，所述密封圈612的外径小于所述轴承613的外径。
本实施例中，所述第一连接部61具有第二内径，用于收容所述扭矩传输部，所述第二内径大于等于0.5mm，且大于所述扭矩传输部的外径。参照图7，所述弹簧内芯611的内径为所述第二内径。
本发明一些具体的实施例中，所述第二内径为0.5mm、1.0mm、1.2mm或1.4mm中的任意一种。
本发明一些实施例中，所述弹簧内芯611、所述轴承613、所述旋转部614和所述密封件615具有相同的内径。
参照图2和图8，所述第二连接部62具有均为空心圆柱体结构且内部相通的第二锁定部621和对接部622。所述第二锁定部621的近端的部分外表面具有第二螺纹结构6211。所述第一螺纹结构1142与所述第二螺纹结构6211能够相互啮合，所述第二锁定部621的内侧壁具有锥度结构，以收容所述第一锁定部111且与所述第一锁定部111的外侧壁以锥度自锁的方式贴合。
本发明一些实施例中，所述第一锁定部111为空心的圆柱体，所述第二锁定部621的内径与所述第一锁定部111的外径相适应，以收容所述第一锁定部111。
本发明一些实施例中，所述第二锁定部621的内径为3-6mm，所述第一锁定部111的长度与第二锁定部621的长度相等。
参照图7和图8，所述第二锁定部621的长度与所述弹簧内芯611的长度相等。所述对接部622的内侧壁具有与所述密封圈612、所述轴承613、所述旋转部614和所述密封件615相配合的环形槽结构(图中未标示)，以实现所述第一连接部61与所述第二连接部62的可拆卸固定连接。
图9为本发明实施例5的扭矩传输部的结构示意图。参照图9，扭矩传输部9具有柔性套管91、金属保护管92、同轴电缆93和超声换能器94。所述柔性套管91为中空的金属螺旋管结构，所述同轴电缆93穿过在所述柔性套管91的内部。所述金属保护管92的一端以焊接的方式与所述柔性套管91固定，所述同轴电缆93的信号线(图中未标示)和屏蔽线(图中未标示)以焊接或粘接的方式与所述超声换能器94的两个电极(图中未标示)固定连接。所述金属保护管92的一侧开设有安装槽(图中未标示)，用于设置所述超声换能器94。
参照图1、图6和图9，所述扭矩传输部9的固定端贯穿所述弹簧内芯611和所述轴承613，以固定在所述旋转部614的内部。所述旋转部614的转动带动所述第一定位针617和所述第二定位针618转动，以使所述扭矩传输部9传输扭矩。
实施例6
本实施例提供了第二插头部。所述第二插头部具有主体部、第三锁定部和第二鞘管连接部。
图10为本实施例的第二插头部的结构示意图，图11为图10所示的第二插头部的纵剖面图。
参照图10和图11，第二插头部10具有主体部101、第二鞘管连接部102和第三锁定部103，所述主体部101的一端开设有第二凹槽1011，所述第二凹槽1011的底部设置有中空结构的所述第三锁定部103。所述主体部101的内部固定有硅胶密封圈1014。所述主体部101的外侧壁具有4个防滑件1012。所述第二凹槽1011的内侧壁开设有第三螺纹结构1013。所述主体部101的内部与所述第二鞘管连接部102的内部相通。
参照图1、图8和图11，所述第二鞘管连接部102的一部分收容在所述主体部101的内部，一端与所述硅胶密封圈1014紧密贴合；所述第一鞘管121的一端固定在所述第二鞘管连接部102的内部。一方面通过握住所述防滑件1012旋 转所述主体部101，就能够实现所述第二锁定部621与所述第三锁定部103的锁定连接，另一方面，由于所述第二鞘管连接部102的部分外侧壁与所述主体部101的部分内侧壁紧密贴合且能够相对所述主体部101做旋转运动，使得所述第二鞘管连接部102在所述主体部101转动时能够不发生转动，避免了所述第一鞘管121发生扭曲形变的问题。
虽然在上文中详细说明了本发明的实施方式，但是对于本领域的技术人员来说显而易见的是，能够对这些实施方式进行各种修改和变化。但是，应理解，这种修改和变化都属于权利要求书中所述的本发明的范围和精神之内。而且，在此说明的本发明可有其它的实施方式，并且可通过多种方式实施或实现。

Claims (24)

  1. 一种鞘管组件，应用于超声探头，其特征在于，所述鞘管组件包括插头部和鞘管部，所述插头部的一端用于以可拆卸固定连接的方式与所述超声探头的连接对接部连接，所述鞘管连接部与所述鞘管部的一端固定连接，所述插头部的内部与所述鞘管部的内部相通，以收容所述超声探头的扭矩传输部。
  2. 根据权利要求1所述的鞘管组件，其特征在于，所述插头部包括凹槽，所述凹槽的内侧壁具有第一螺纹结构，以与所述连接对接部以所述螺纹旋合的方式实现所述可拆卸固定连接。
  3. 根据权利要求2所述的鞘管组件，其特征在于，所述凹槽的底部设置有第一锁定部，所述第一锁定部内部与所述鞘管部的内部相通，所述第一锁定部的外侧壁能够与所述连接对接部的内侧壁贴合，以使所述第一锁定部收容在所述连接对接部的内部。
  4. 根据权利要求3所述的鞘管组件，其特征在于，所述第一锁定部具有用于收容所述扭矩传输部的第一内径，所述第一内径大于等于0.5mm，且大于所述扭矩传输部的外径。
  5. 根据权利要求3所述的鞘管组件，其特征在于，所述第一锁定部的外侧壁具有锥度，以使所述第一锁定部收容在所述连接对接部内部，且以锥度自锁的方式与所述连接对接部固定连接。
  6. 根据权利要求5所述的鞘管组件，其特征在于，所述锥度为3度-6度，以使所述鞘管组件能够在至少30s的时间承受至少1个大气压。
  7. 根据权利要求3所述的鞘管组件，其特征在于，所述插头部具有密封部，用于与所述第一锁定部可拆卸固定连接。
  8. 根据权利要求1所述的鞘管组件，其特征在于，所述鞘管部的另一端具有密封头结构。
  9. 根据权利要求1所述的鞘管组件，其特征在于，所述鞘管部具有相互连接的第一鞘管和第二鞘管，所述第一鞘管的一端与所述插头部的鞘管连接部固定连接，所述第一鞘管的邵氏硬度大于所述第二鞘管的邵氏硬度。
  10. 根据权利要求9所述的鞘管组件，其特征在于，所述鞘管部还具有第三鞘管，所述第三鞘管的邵氏硬度大于等于所述第一鞘管的邵氏硬度，且至少部分套设在所述第一鞘管的外部，以增强所述鞘管部的强度。
  11. 根据权利要求10所述的鞘管组件，其特征在于，所述第三鞘管的一端与所述鞘管连接部固定连接，且套设在所述第一鞘管的外部，所述第三鞘管的长度小于所述第一鞘管的长度。
  12. 根据权利要求11所述的鞘管组件，其特征在于，所述第一鞘管的邵氏硬度为50D-90D，所述第二鞘管的邵氏硬度为30D-75D，所述第三鞘管的邵氏硬度为50D-90D。
  13. 根据权利要求10所述的鞘管组件，其特征在于，所述第三鞘管为金属弹簧套管，所述金属弹簧套管活动套接在所述鞘管连接部的外部以及部分所述第一鞘管的外部。
  14. 一种超声探头，其特征在于，包括连接对接部、扭矩传输部以及如权利要求1所述的鞘管组件，所述鞘管组件具有相互连接的插头部和鞘管部；
    所述连接对接部以可拆卸固定连接的方式与所述插头部连接；
    所述扭矩传输部的固定端固定连接在所述连接对接部内，所述扭矩传输部的换能器端贯穿所述连接对接部和所述插头部，以进入所述鞘管部内。
  15. 根据权利要求14所述的超声探头，其特征在于，所述连接对接部具有第一连接部，所述第一连接部具有第二内径，所述第二内径用于收容所述扭矩传输部，所述第二内径大于等于0.5mm，且大于所述扭矩传输部的外径。
  16. 根据权利要求15所述的超声探头，其特征在于，所述连接对接部还具有第二连接部，所述第二连接部与所述第一连接部以可拆卸固定连接的方式实现同 轴连接，所述第二连接部的部分外表面具有第二螺纹结构，以与所述插头部以螺纹旋合的方式进行锁定。
  17. 根据权利要求16所述的超声探头，其特征在于，所述插头部具有第一锁定部，所述第二连接部收容所述第一锁定部，以使所述连接对接部的内部与所述鞘管组件的内部相通，所述第二连接部的内侧壁与所述第一锁定部的外侧壁贴合。
  18. 根据权利要求17所述的超声探头，其特征在于，所述第二连接部的内侧壁具有锥度，以收容所述第一锁定部，所述第二连接部与所述第一锁定部以锥度自锁的方式连接。
  19. 根据权利要求17所述的超声探头，其特征在于，所述第一锁定部的邵氏硬度小于所述第二连接部的邵氏硬度。
  20. 一种如权利要求14所述的超声探头的组装方法，其特征在于，包括以下步骤：
    S1：提供所述鞘管组件、导液管和液体注射装置，所述鞘管组件包括相互连接的插头部和鞘管部，将所述导液管的一端通过所述插头部送入所述鞘管部内的底部，使用所述液体注射装置通过所述导液管的另一端向所述鞘管部内注入液体；
    S2：提供固定有所述扭矩传输部的所述连接对接部，将所述扭矩传输部的换能器端从所述插头部插入至所述鞘管部内，然后将所述插头部与所述连接对接部锁定连接，以完成所述超声探头的组装。
  21. 根据权利要求20所述的组装方法，其特征在于，所述插头部设置有密封部，所述步骤S1还包括：
    拆除所述密封部，以通过所述导液管和所述液体注射装置向所述鞘管部内注入所述液体。
  22. 根据权利要求20所述的组装方法，其特征在于，还包括步骤S3，所述步骤 S3中，所述超声探头使用完毕后，将所述连接对接部与所述插头部解锁定，然后打破所述鞘管部的密封结构，再拉动所述连接对接部以将所述扭矩传输部抽离所述鞘管组件。
  23. 根据权利要求22所述的组装方法，其特征在于，所述鞘管部远端具有密封头结构，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，切除所述密封头结构，以打破所述鞘管部的密封结构。
  24. 根据权利要求22所述的组装方法，其特征在于，所述步骤S3中，将所述连接对接部与所述插头部解锁定后，破坏所述鞘管部的外侧壁，以打破所述鞘管部的密封结构。
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WO2013133356A1 (ja) * 2012-03-09 2013-09-12 テルモ株式会社 カテーテル
CN104185450A (zh) * 2012-04-09 2014-12-03 圣犹达医疗用品电生理部门有限公司 用于医疗装置的多方向柔性线束
CN107080604A (zh) * 2016-02-16 2017-08-22 微创心脉医疗科技（上海）有限公司 快接接头组件、输送系统及其应用方法
CN107260221A (zh) * 2017-08-04 2017-10-20 深圳英美达医疗技术有限公司 一种超声内窥镜及其旋转连接机构

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CN110115599B (zh) 2021-09-24

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