WO2013063968A1 - 一次性腹腔镜用的可视穿刺器制造方法及实施该方法的穿刺器 - Google Patents

一次性腹腔镜用的可视穿刺器制造方法及实施该方法的穿刺器 Download PDF

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Publication number
WO2013063968A1
WO2013063968A1 PCT/CN2012/080092 CN2012080092W WO2013063968A1 WO 2013063968 A1 WO2013063968 A1 WO 2013063968A1 CN 2012080092 W CN2012080092 W CN 2012080092W WO 2013063968 A1 WO2013063968 A1 WO 2013063968A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
puncture
needle
sheath
cavity
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2012/080092
Other languages
English (en)
French (fr)
Inventor
沈振权
勾成俊
颜志坦
黄振宁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY Co Ltd
Original Assignee
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY Co Ltd
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 DONGGUAN MICROVIEW MEDICAL TECHNOLOGY Co Ltd filed Critical DONGGUAN MICROVIEW MEDICAL TECHNOLOGY Co Ltd
Priority to US14/002,739 priority Critical patent/US9247862B2/en
Priority to EP12845699.3A priority patent/EP2774558A4/en
Publication of WO2013063968A1 publication Critical patent/WO2013063968A1/zh
Anticipated expiration legal-status Critical
Priority to US14/738,945 priority patent/US20150327886A1/en
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • 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
    • A61B1/0011—Manufacturing of endoscope parts
    • 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
    • A61B1/012—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 characterised by internal passages or accessories therefor
    • A61B1/018—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 characterised by internal passages or accessories therefor for receiving instruments
    • 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
    • A61B1/04—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 combined with photographic or television appliances
    • A61B1/05—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 combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00907—Material properties transparent or translucent for light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a method for manufacturing a visual puncture device for a disposable laparoscope and a puncture device for carrying out the method.
  • Minimally invasive surgery represented by laparoscopy, has developed rapidly in recent years. In developed countries, the amount of surgery has exceeded that of traditional surgery. Minimally invasive treatment techniques characterized by minor surgery and small trauma have gradually been recognized by doctors.
  • the cannula puncturing device is an essential tool for establishing a surgical channel and an observation channel in laparoscopic surgery.
  • the existing casing puncturing device has no visual function, that is, the "blind insertion" method is adopted.
  • blindness during the puncture, he can not directly look at or touch the arteries of the retroperitoneal large blood vessels, the blood vessels of the abdominal wall, etc. The operation is very inconvenient, and the damage is often fatal.
  • an object of the present invention is to provide a method for manufacturing a visual puncturing device for a disposable laparoscopic machine which is simple in process, easy to implement, high in efficiency, and high in safety and effectiveness.
  • the present invention provides a technical solution of:
  • a method for manufacturing a visual trocar for a disposable laparoscopic machine comprising the steps of:
  • the step (2) specifically includes the following steps: (2.1) Preparing a needle sleeve;
  • a sleeve portion corresponding to the needle sleeve is disposed on the front side wall of the handle, and the tail end of the needle sleeve is sleeved on the sleeve portion of the handle, and the first end of the needle sleeve forms a single slope a cutting edge, the inclined surface of the cutting edge has an inclination angle of 20 to 70 degrees;
  • a mounting bracket adapted to the camera module is mounted at the head end of the protection rod, and a mounting position adapted to the transparent cover is reserved on the head end of the mounting bracket;
  • a boss is arranged in the middle of the protection rod, the return spring is sleeved on the tail end of the protection rod, and then the tail end of the protection rod is inserted into the needle sleeve, and penetrates into the handle through the sleeve portion, so that the protection One end of the return spring on the rod abuts against the sleeve portion, and the other end abuts against the boss, and a clip for preventing it from withdrawing from the handle is provided at the end of the protection rod to obtain a puncture needle.
  • the step (2) described further includes the following steps:
  • the protection mechanism is disposed in the handle of the puncture needle, and can prevent the transparent cover from retracting into the needle sleeve when the puncture needle is not used, and automatically activates the protection function when the puncture needle is matched with the positioning puncture sleeve. , to prevent the needle sleeve from accidentally injuring the internal organs when it is inserted into the abdominal cavity.
  • the outer edge of the gasket is provided with a buckle portion, the middle portion is conically convex toward one side, and the center of the protrusion is provided with a through hole adapted to the needle sleeve The through hole is interference fit with the needle sleeve;
  • (3.2) Prepare a check valve made of flexible material.
  • the check valve has a hook portion on the outer edge and two resist plates in the middle.
  • the two resist plates are oppositely arranged, and are gradually close together to make them close.
  • An elongated slit is formed between the two end faces, and the inner side of the two resisting plates is symmetrically provided with a rib which can strengthen the structural strength thereof; the rib is long in the needle sleeve
  • the two end faces of the two resisting plates can be closely contacted to prevent the high pressure gas in the abdominal cavity from leaking;
  • a two-way valve is prepared, the two-way valve is fixed to the cannula sheath, and the two-way valve is communicated with the cavity of the cannula sheath to obtain a positioning puncture cannula.
  • the transparent cover is a circular tube body closed at one end, and the closed portion of the circular tube body has a slope shape, a spherical shape, a conical shape or a polygonal pyramid shape, wherein when the closed portion of the circular tube body has a slope shape, The slope of the slope is 20 to 70 degrees.
  • a puncturing device for manufacturing the visual puncturing device for disposable laparoscopic comprising: a camera module with a light source, a puncture needle and a positioning puncture sleeve adapted to the puncture needle;
  • the camera module is disposed at a front end of the puncture needle, and a transparent cover capable of covering the camera module is disposed on the first end of the puncture needle, and the puncture needle is inserted into the positioning puncture sleeve, and
  • the transparent cover on the tip end of the puncture needle is slightly extended beyond the positioning puncture cannula.
  • the puncture needle comprises a needle sleeve, a handle, a protection rod and a return spring, and a sleeve portion adapted to the needle sleeve is arranged on the front side wall of the handle, and the tail end of the needle sleeve is sleeved
  • the first end of the needle sleeve forms a single beveled blade edge
  • the inclined surface of the blade edge has an inclination angle of 20 to 70 degrees
  • the first end of the protection rod is mounted with the camera module.
  • a mounting bracket the mounting end of the mounting bracket is provided with a mounting position adapted to the transparent cover; a middle portion of the protection rod is provided with a boss, the tail end of the protection rod is inserted into the needle sleeve, and extends into the handle through the sleeve portion And a clamping end of the protection rod is provided with a cap for preventing it from withdrawing from the handle, the return spring is sleeved at the tail end of the protection rod, and one end of the return spring abuts against the sleeve portion, and the other end abuts against the boss .
  • the puncture needle further includes a protection mechanism, the protection mechanism includes a spring arm, the first end of the elastic arm is fixed in the handle, and the middle portion is provided to prevent the transparent cover from retracting the needle when the needle is not used when the puncture needle is not used.
  • a card slot in the sleeve the tail end extending from the front side wall of the handle, forming a dial that can resist the withdrawal of the card position from the card cap on the positioning puncture sleeve when the puncture needle is adapted to the positioning puncture sleeve sheet.
  • the positioning puncture sleeve comprises a sleeve sheath, an upper cover, a gasket, a check valve and a two-way valve, the outer edge of the gasket is provided with a buckle portion, and the middle portion is conical to one side a protrusion, and a center of the protrusion is provided with a through hole adapted to the needle sleeve, the through hole is interference fit with the needle sleeve, and an outer edge of the check valve is provided with a hook portion.
  • the inner side surfaces of the two resisting plates are symmetrically provided with a rib capable of reinforcing the structural strength thereof, and the tail portion of the sleeve sheath forms a check valve with the check valve a cavity having a contoured contour, the head of the sleeve sheath extending along the axial direction thereof, and having a tapered tapered protrusion on an outer side thereof, the leading end of the sleeve sheath being tapered a return valve is disposed in the cavity of the casing sheath, and the hook portion of the check valve is snapped onto the opening of the cavity, the gasket is disposed on the opening of the cavity, and the gasket of the gasket
  • the buckle is buckled on the hook portion of the check valve, the upper cover is fastened to the opening of the cavity, and the gasket and the check valve are positioned in the cavity of the sleeve sheath.
  • the two-way valve is fixed to
  • the transparent cover is a circular tube body closed at one end, and the closed portion of the circular tube body has a slope shape, a spherical shape, a conical shape or a polygonal pyramid shape, wherein when the closed portion of the circular tube body has a slope shape, The slope of the slope is 20 to 70 degrees.
  • the invention has the following advantages: the method provided by the invention is simple in process, easy to implement, and has high production efficiency; the puncture device provided by the invention has ingenious design and reasonable structure, and realizes surgical operation under visible conditions through the camera module, thereby preventing In the case of blind vision, accidentally injure normal tissues or internal organs, effectively improve the safety of puncture surgery, reduce the occurrence of medical accidents; and operate in a visible state, which can greatly shorten the operation time, reduce patient suffering, simple operation, low cost, and reduce The dependence of doctors on technology improves the accuracy and success rate of surgery.
  • the casing sheath is provided with a node-shaped conical protrusion, which is not easy to slip off, and eliminates the traditional safety accident caused by slippage, and the leading end of the casing sheath is tapered, which not only reduces the resistance during puncture, but also reduces the resistance during puncture. Easy to operate, it can further reduce the damage to the incision and achieve minimally invasive effect.
  • the overall structure is simple, easy to implement, low in cost, and used once, avoiding cross-infection and ensuring the safety of use.
  • the first end of the needle sleeve forms a single bevel-shaped cutting edge, and the inclined surface of the cutting edge has an inclination angle of 20 to 70 degrees, and the cutting edge can be effectively used to cut the tissue, and then the reaming is performed along the inclined angle, and the damage is small and effective. Improve the safety and effectiveness of puncture surgery.
  • Figure 1 is a schematic perspective view of the present invention
  • Figure 2 is a schematic cross-sectional view of the A-A of Figure 1;
  • Figure 3 is a cross-sectional view showing the structure of the puncture needle A-A of Figure 1;
  • Figure 4 is a cross-sectional view showing the puncture needle B-B of Figure 1;
  • Figure 5 is a cross-sectional view showing the positioning puncture sleeve A-A of Figure 1;
  • Figure 6 is a schematic structural view of the check valve of Figure 1;
  • Figure 7 is a schematic view showing the state of the structure when the present invention is used;
  • Figure 8 is a schematic structural view 1 of the transparent cover of Figure 1;
  • Figure 9 is a schematic structural view of the transparent cover of Figure 1 2;
  • Figure 10 is a schematic structural view 3 of the transparent cover of Figure 1.
  • an embodiment of the present invention provides a method for manufacturing a visual trocar for a disposable laparoscope, which includes the following steps:
  • the camera module 1 is mounted on the first end of the puncture needle 2, and corresponding to the first end of the puncture needle 2 is provided with a transparent cover 4 capable of covering the camera module 1;
  • the step (2) specifically includes the following steps:
  • a sleeve portion 221 corresponding to the needle sleeve 21 is disposed on the front side wall of the handle 22, and the tail end of the needle sleeve 21 is sleeved on the sleeve portion 221 of the handle 22, and the needle sleeve 21 is made
  • the first end of the blade 211 has a single bevel-shaped cutting edge 211, and the inclined angle a of the inclined surface of the cutting edge 211 is 20 to 70 degrees;
  • a mounting bracket 231 adapted to the camera module 1 is mounted at the head end of the protection rod 23, and a mounting position adapted to the transparent cover 4 is reserved on the head end of the mounting bracket 231;
  • a boss 232 is disposed in the middle of the protection rod 23, and the return spring 24 is sleeved on the tail end of the protection rod 23. Then, the tail portion of the protection rod 23 is inserted into the needle sleeve 21, and extends through the sleeve portion 221 The handle spring 22 is inserted into the handle 22 so that one end of the return spring 24 on the protection rod 23 abuts against the socket portion 221, and the other end abuts against the boss 232, and a rear end of the protection rod 23 is provided to prevent it from being removed from the handle 22.
  • the puncture needle 2 is made by withdrawing the card cap 25.
  • the protection mechanism 5 is disposed in the handle 22 of the puncture needle 2 and can prevent penetration when the puncture needle 2 is not used
  • the cover 4 is retracted into the needle cover 21, and when the puncture needle 2 is used in conjunction with the positioning puncture cannula 3, the protection function is automatically activated to prevent the needle cover 21 from accidentally injuring the internal organs when it is inserted into the abdominal cavity.
  • a gasket 31 is prepared.
  • the outer edge of the gasket 31 is provided with a buckle portion 311, and the central portion has a conical protrusion 312 toward one side, and the center of the protrusion 312 is provided with a needle sleeve 21 a matching through hole 313, the through hole 313 is interference fit with the needle sleeve 21;
  • the gasket 31 is disposed on the opening of the cavity 331, and the buckle portion 311 of the gasket 31 is snapped on the hook portion 321 of the check valve 32;
  • the transparent cover 4 is a circular tube body 41 closed at one end, and the closed portion 42 of the circular tube body 41 has a slope shape, a spherical shape, a conical shape or a polygonal pyramid shape, wherein the closed portion of the circular tube body 41 When the shape of the inclined surface 42 is 42, the inclined angle b of the inclined surface is 20 to 70 degrees.
  • a puncturing device for manufacturing the visual puncturing device for disposable laparoscopic comprising a camera module with a light source, a puncture needle 2 and a positioning puncture adapted to the puncture needle 2 a sleeve 3, the camera module 1 is disposed at a front end of the puncture needle 2, and a transparent cover 4 capable of covering the camera module 1 is disposed on the first end of the puncture needle 2, the puncture needle 2 is inserted into the positioning puncture cannula 3, and the transparent cover 4 on the tip end of the puncture needle 2 is slightly extended beyond the positioning puncture cannula 3.
  • the transparent cover 4 is a circular tube body 41 closed at one end, and the circular tube body 41
  • the closed portion 42 has a bevel shape, a spherical shape, a conical shape or a polygonal pyramid shape.
  • the inclined angle b of the inclined surface is 20 to 70 degrees.
  • the puncture needle 2 includes a needle sleeve 21, a handle 22, a protection rod 23 and a return spring 24.
  • the front side wall of the handle 22 is provided with a sleeve portion 221 adapted to the needle sleeve 21,
  • the tail end of the needle sleeve 21 is sleeved on the sleeve portion 221 of the handle 22.
  • the first end of the needle sleeve 21 forms a single beveled blade edge 211.
  • the inclined surface of the blade edge 211 has an inclination angle of £ to 70 degrees.
  • the mounting end of the protection rod 23 is mounted with a mounting bracket 231 adapted to the camera module 1.
  • the mounting end of the mounting bracket 231 is provided with a mounting position adapted to the transparent cover 4;
  • the boss 232, the tail of the protection rod 23 is inserted into the needle sleeve 21, and extends into the handle 22 through the sleeve portion 221, and a cap 25 for preventing the withdrawal from the handle 22 is provided at the end of the protection rod 23, and is reset.
  • the spring 24 is sleeved on the tail end of the protection rod 23, and one end of the return spring 24 abuts against the socket portion 221, and the other end abuts against the boss 232.
  • the leading end of the needle sleeve 21 forms a single bevel-shaped cutting edge 211.
  • the inclined surface of the cutting edge 211 has an inclination angle of 20 to 70 degrees, and can effectively cut the tissue by the cutting edge 211 thereon, and then re-expand the hole along the inclined angle.
  • the damage is small, which effectively improves the safety and effectiveness of the puncture operation.
  • the puncture needle 2 further includes a protection mechanism 5, and the protection mechanism 5 includes a spring arm 51.
  • the first end of the elastic arm 51 is fixed in the handle 22, and the middle portion is provided to be able to resist the cap when the puncture needle 2 is not used. 25 prevents the transparent cover 4 from retracting into the card seat 21, and the tail end protrudes from the front side wall of the handle 22 to form a puncture in the positioning puncture needle 2 when it is fitted with the positioning puncture sleeve 3 A paddle on the sleeve 3 that allows the card to be withdrawn from the card cap 25.
  • the positioning puncture sleeve 3 includes a sleeve sheath 33, an upper cover 34, a gasket 31, a check valve 32 and a two-way valve 35.
  • the outer edge of the gasket 31 is provided with a buckle portion 311.
  • the central portion has a conical protrusion 312 toward one side, and a central portion of the protrusion 312 is provided with a through hole 313 adapted to the needle sleeve 21, and the through hole 313 is interference fit with the needle sleeve 21,
  • the outer edge of the check valve 32 is provided with a hook portion 321 , and the middle portion is provided with two resisting plates 322 .
  • the two resisting plates 322 are oppositely disposed, and are formed in a gradually close-to-close manner to form a needle and the needle between the opposite end faces.
  • a pair of 21-shaped elongated slits 324 are formed, and the inner side surfaces of the two resisting plates 322 are symmetrically provided with a rib 323 capable of reinforcing the structural strength thereof, and the tail portion of the sleeve sheath 33 forms a check valve with the check valve
  • the contour of the sleeve 32 is adapted to the cavity 331, the head portion of the sleeve sheath 33 extends along the axial direction thereof, and has a node-shaped tapered protrusion 332 on the outer side surface thereof, and the leading end of the sleeve sheath 33 is formed Conical, the check valve 32 is disposed in the cavity 331 of the sleeve sheath 33, and the hook portion 321 of the check valve 32 is buckled.
  • the opening of the cavity 331 is disposed on the opening of the cavity 331, and the latching portion 311 of the sealing pad 31 is snapped on the hook portion 321 of the check valve 32, the upper cover 34 is fastened to the opening of the cavity 331 and positions the gasket 31 and the check valve 32 in the cavity 331 of the sleeve sheath 33, and the two-way valve 35 is fixed to the sleeve sheath 33, and the two-way valve 35 is in communication with the cavity 331 of the sleeve sheath 33.
  • the paddle on the elastic arm 51 is rotated at a certain angle with the connection of the elastic arm 51 and the handle 22 under the pressure of the upper cover 34 of the positioning puncture sleeve 3, so that the latching position on the elastic arm 51 is
  • the card cap 25 is withdrawn from the direction of movement of the protection lever 23, and the card cap 25 on the protection lever 23 is movable toward one side of the handle 22.
  • the transparent cover 4 on the puncture needle 2 is retracted into the needle cover 21 against the elastic force of the return spring 24 under the action of the skin resistance, thereby exposing the blade edge 211 of the needle cover 21, at which time the skin is cut by the blade 211. Tissue, allowing the needle 2 to slowly enter the tissue.
  • the camera module 1 can transmit the entire process image of the puncture tissue into the abdominal cavity in real time through the video connection line 6 to the display device 7, and can effectively directly view the arteries such as the retroperitoneal large blood vessels and the abdominal wall blood vessels. It is easy to operate and avoids accidents caused by surgery, thus effectively improving the safety and effectiveness of the puncture operation.
  • the node-shaped conical projection 332 of the cannula sheath 33 enters the abdominal cavity, and the conical contraction protrusion 332 and the contraction force formed by the expansion of the incision cooperate to securely fix the cannula sheath 33 to the abdominal wall.
  • gas can be introduced into the abdominal cavity to maintain the air pressure in the abdomen during surgery.
  • the main body of the puncture device is made of polymer material and can be used at one time to avoid cross infection, which ensures the safety of use.
  • the transparent cover 4 is a circular tube body 41 closed at one end.
  • the closed portion 42 of the circular tube body 41 has a sloped shape, the slope of the inclined surface is 20 to 70 degrees. Both puncture and protection functions.
  • the closed portion 42 of the circular tube body 41 can be arranged in a conical shape or a polygonal pyramid shape according to the use requirement, instead of the cutting edge 211 on the needle sleeve 21, directly used. For puncture. Referring to FIG.
  • the closed portion 42 of the circular tube body 41 is disposed in a spherical shape, which can effectively prevent the puncture device from easily injuring the normal tissue such as the internal organs when extending into the abdominal cavity, and avoiding the laparoscope.
  • Surgical complications such as vascular injury, intestinal damage, bladder injury, etc., ensure the safety and effectiveness of the operation.

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种一次性腹腔镜用的可视穿刺器制造方法及其实施该制造方法制得的穿刺器，其中该制造方法包括如下步骤：1）预备摄像模组（1）；2）预备穿刺针（2）；3）预备定位穿刺套管（3）；4）将摄像模组（1）安装在穿刺针（2）上；5）将穿刺针（2）插置在定位穿刺套管（3）内，且使透明罩（4）略伸出定位穿刺套管（3）。上述制造方法工序简单，易于实现，生产效率高；由该方法制得的穿刺器结构合理，可通过摄像模组（1）实现在可视情况下进行手术操作，能有效提高穿刺手术的安全性，减少医疗事故的发生；而且，在可视状态下操作简单，能减少对医生技术的依赖，提高手术的准确性和成功率。

Description

一次性腹腔镜用的可视穿刺器制造方法及实施该方法的穿刺器 技术领域
本发明涉及医疗器械领域技术， 特别涉及一种一次性腹腔镜用的可视穿刺器制造方 法及实施该方法的穿刺器。
背景技术
以腹腔镜为代表的微创手术在最近几年迅速发展， 在发达国家其手术量已经超过了 传统手术。 小手术、 小创伤为特征的微创治疗技术逐步得到广大医生的认可。 套管穿刺 器是腹腔镜手术中用于建立手术通道、 观察通道的必备器械。 但是现有的套管穿刺器无 可视功能， 即采用 "盲插"方式。 医生在手术时， 全凭其经验操作， 由于是盲视， 在穿 刺过程中， 无法直视或触及到腹膜后大血管、 腹壁的血管等动脉血管， 操作很不方便， 一旦发生损伤往往引起致命的大出血， 造成手术事故。 另外， 在套管穿刺器伸入腹腔内 时极容易误伤内脏器官等正常组织， 如血管损伤、 肠损伤、 膀胱损伤等， 存在着腹腔镜 手术并发症的隐患， 难以保证手术的安全性和有效性。
发明内容
针对上述的不足， 本发明目的之一在于， 提供一种工序简单， 易于实现， 效率高且 安全性和有效性高的一次性腹腔镜用的可视穿刺器制造方法。
本发明的目的还在于， 提供一种结构设计合理、 手术全程实时可视， 操作方便的穿 刺器。
本发明为实现上述目的， 所提供的技术方案是：
一种一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 其包括如下步骤：
( 1 ) 预备一带有光源的摄像模组；
(2) 预备一穿刺针；
( 3 ) 预备一与所述穿刺针相适配的定位穿刺套管；
( 4)将摄像模组安装在穿刺针的首端， 并对应于该穿刺针的首端上套设有一能将摄 像模组罩住的透明罩；
( 5 )将穿刺针插置在定位穿刺套管内， 且使该穿刺针首端上的透明罩略伸出所述定 位穿刺套管，制得一次性腹腔镜用的可视穿刺器。
所述步骤 （2) 具体包括如下步骤： (2.1 ) 预备一针套；
(2.2) 预备一手柄；
(2.3) 预备一保护杆；
(2.4) 预备一复位弹簧；
(2.5) 于手柄的前侧壁设有一与针套相适配的套接部， 将针套的尾端套设在手柄的 套接部上， 并使该针套的首端形成一单斜面形的刀刃， 该刀刃的斜面的倾斜角度为 20〜 70度；
(2.6) 在保护杆的首端安装有与摄像模组相适配的安装架， 该安装架的首端上预留 有与透明罩相适配的安装位；
(2.7) 在保护杆的中部设有一凸台， 将复位弹簧套设在保护杆的尾端， 然后将该保 护杆的尾部插入针套内， 并贯穿套接部伸入手柄内， 使该保护杆上的复位弹簧的一端抵 触在套接部上， 另一端抵触在凸台上， 且在保护杆的尾端设有一防止其从手柄内退出的 卡帽， 制得穿刺针。
所述的步骤 （2) 还包括以下步骤：
(2.8) 预备一保护机构；
(2.9) 该保护机构设置在穿刺针的手柄内， 并能在不使用穿刺针时防止透明罩縮回 针套内， 而在穿刺针与定位穿刺套管相适配使用时， 自动启动保护功能， 防止针套在伸 入腹腔内时误伤内脏器官。
所述的步骤 （3) 具体包括以下步骤：
(3.1 ) 预备一密封垫， 该密封垫的外缘设有一卡扣部， 中部向一侧呈圆锥形凸起， 且该凸起的中心位置设有一与所述针套相适配的通孔， 该通孔与所述针套过盈配合；
(3.2) 预备一由柔性材料制成的止回阀， 该止回阀的外缘设有一卡勾部， 中部设有 两抵触板， 两抵触板相对设置， 且呈逐渐靠拢状使其相近的两端面之间形成一与所述针 套相适配的长条形缝， 两抵触板的内侧面对称各设一能加强其结构强度的凸筋； 该凸筋 在所述针套退出长条形缝时能使两抵触板相近的两端面紧密抵触， 防止腹腔内的高压气 体泄漏；
(3.3) 预备一采用高分子材料制成的套管鞘， 该套管鞘的尾部形成一与所述止回阀 的外形轮廓相适配的空腔， 该套管鞘的首部沿其轴向延伸， 并在其外侧面上设有节状锥 形凸起， 该套管鞘的首端成锥形；
(3.4) 将所述止回阀放置在该套管鞘的空腔内， 并使该止回阀的卡勾部卡扣在该空 腔的开口上；
(3.5) 将所述密封垫设置在空腔的开口上， 并且该密封垫的卡扣部卡扣在止回阀的 卡勾部上；
(3.6) 预备一上盖， 将所述上盖扣合在所述空腔的开口上， 进而将所述密封垫、 止 回阀定位在套管鞘的空腔内；
(3.7) 预备一二通阀， 将该二通阀固定在所述套管鞘上， 且使该二通阀与所述套管 鞘的空腔相连通， 制得定位穿刺套管。
所述透明罩为一端封闭的圆形管体， 该圆形管体的封闭部分呈斜面形状、 球面形状、 圆锥形状或多棱锥面状， 其中该圆形管体的封闭部分呈斜面形状时， 其斜面的倾斜角度 为 20〜70度。
一种实施上述一次性腹腔镜用的可视穿刺器制造方法制得的穿刺器， 其包括一带有 光源的摄像模组、 一穿刺针及一与该穿刺针相适配的定位穿刺套管， 所述摄像模组设置 在穿刺针的首端， 并对应于该穿刺针的首端上套设有一能将摄像模组罩住的透明罩， 所 述穿刺针插置在定位穿刺套管内， 且使该穿刺针首端上的透明罩略伸出所述定位穿刺套 管。
所述穿刺针包括一针套、 一手柄、 一保护杆及一复位弹簧， 在所述手柄的前侧壁设 有一与针套相适配的套接部， 所述针套的尾端套设在手柄的套接部上， 该针套的首端形 成一单斜面形的刀刃， 该刀刃的斜面的倾斜角度为 20〜70度， 保护杆的首端安装有与摄 像模组相适配的安装架， 该安装架的首端上设有与透明罩相适配的安装位； 保护杆的中 部设有一凸台， 保护杆的尾部插入针套内， 并贯穿套接部伸入手柄内， 且在保护杆的尾 端设有一防止其从手柄内退出的卡帽， 复位弹簧套设在保护杆的尾端， 且该复位弹簧的 一端抵触在套接部上， 另一端抵触在凸台上。
所述穿刺针还包括一保护机构， 该保护机构包括一弹臂， 该弹臂的首端固定在手柄 内， 中部设有能在不使用穿刺针时抵触在卡帽上防止透明罩縮回针套内的卡位， 尾端从 手柄的前侧壁伸出， 形成一能在穿刺针与定位穿刺套管相适配时抵触在该定位穿刺套管 上使卡位从卡帽上退出的拨片。
所述定位穿刺套管包括一套管鞘、 一上盖、 一密封垫、 一止回阀和一二通阀， 所述 密封垫的外缘设有一卡扣部， 中部向一侧呈圆锥形凸起， 且该凸起的中心位置设有一与 所述针套相适配的通孔， 该通孔与所述针套过盈配合， 所述止回阀的外缘设有一卡勾部， 中部设有两抵触板， 两抵触板相对设置， 且呈逐渐靠拢状使其相近的两端面之间形成一 与所述针套相适配的长条形缝，两抵触板的内侧面对称各设一能加强其结构强度的凸筋， 所述套管鞘的尾部形成一与所述止回阀的外形轮廓相适配的空腔， 该套管鞘的首部沿其 轴向延伸， 并在其外侧面上设有节状锥形凸起， 该套管鞘的首端成锥形， 所述止回阀设 置在套管鞘的空腔内， 并使该止回阀的卡勾部卡扣在该空腔的开口上， 所述密封垫设置 在空腔的开口上， 并且该密封垫的卡扣部卡扣在止回阀的卡勾部上， 所述上盖扣合在所 述空腔的开口上， 并将所述密封垫、 止回阀定位在套管鞘的空腔内， 所述二通阀固定在 所述套管鞘上， 且使该二通阀与所述套管鞘的空腔相连通。
所述透明罩为一端封闭的圆形管体， 该圆形管体的封闭部分呈斜面形状、 球面形状、 圆锥形状或多棱锥面状， 其中该圆形管体的封闭部分呈斜面形状时， 其斜面的倾斜角度 为 20〜70度。
本发明的有益效果为： 本发明提供的方法工序简单， 易于实现， 生产效率高； 本发 明提供的穿刺器设计巧妙， 结构合理， 通过摄像模组实现在可视情况下进行手术操作， 防止在盲视情况下误伤正常组织或内脏， 有效提高穿刺手术的安全性， 减少医疗事故的 发生； 而且在可视状态下操作， 可以大大縮短手术时间， 减少患者痛苦， 操作简单， 费 用低， 减少对医生技术的依赖， 提高手术的准确性和成功率。
套管鞘设有节状锥形凸起， 固定性好不易滑脱， 杜绝传统因易滑脱而导致安全事故 的现象， 而且套管鞘的首端成锥形， 不仅能减小穿刺时的阻力， 方便操作， 还能进一步 减小对切口损伤， 实现微创效果。 另外， 整体结构简单， 易于实现， 成本低， 且为一次 性使用， 避免交叉感染， 保证使用的安全性。
针套的首端形成一单斜面形的刀刃， 该刀刃的斜面的倾斜角度为 20〜70度， 能有效 利用其上的刀刃切开组织， 然后沿倾斜角度进行再扩孔， 损伤小， 有效提高了穿刺手术 的安全性和有效性。
下面结合附图与实施例， 对本发明进一步说明。
附图说明
图 1是本发明的立体结构示意图；
图 2是图 1的 A-A剖视结构示意图；
图 3是图 1中的穿刺针 A-A剖视结构示意图；
图 4是图 1中的穿刺针 B-B剖视结构示意图；
图 5是图 1中的定位穿刺套管 A-A剖视结构示意图；
图 6是图 1中的止回阀结构示意图； 图 7是本发明使用时的状态结构示意图；
图 8是图 1中的透明罩的结构示意图 1 ;
图 9是图 1中的透明罩的结构示意图 2;
图 10是图 1中的透明罩的结构示意图 3。
具体实施方式
实施例：参见图 1至图 6，本发明实施例提供一种一次性腹腔镜用的可视穿刺器制造 方法， 其特征在于， 其包括如下步骤：
( 1 ) 预备一带有光源的摄像模组 1 ;
(2) 预备一穿刺针 2;
( 3 ) 预备一与所述穿刺针 2相适配的定位穿刺套管 3;
( 4)将摄像模组 1安装在穿刺针 2的首端， 并对应于该穿刺针 2的首端上套设有一 能将摄像模组 1罩住的透明罩 4;
( 5 )将穿刺针 2插置在定位穿刺套管 3内， 且使该穿刺针 2首端上的透明罩 4略伸 出所述定位穿刺套管 3，制得一次性腹腔镜用的可视穿刺器。
所述步骤 （2) 具体包括如下步骤：
(2.1 ) 预备一针套 21 ;
(2.2) 预备一手柄 22;
(2.3 ) 预备一保护杆 23;
(2.4) 预备一复位弹簧 24;
(2.5 )于手柄 22的前侧壁设有一与针套 21相适配的套接部 221， 将针套 21的尾端 套设在手柄 22的套接部 221上，并使该针套 21的首端形成一单斜面形的刀刃 211，该刀 刃 211的斜面的倾斜角度 a为 20〜70度；
(2.6) 在保护杆 23的首端安装有与摄像模组 1相适配的安装架 231， 该安装架 231 的首端上预留有与透明罩 4相适配的安装位；
(2.7 )在保护杆 23的中部设有一凸台 232，将复位弹簧 24套设在保护杆 23的尾端， 然后将该保护杆 23的尾部插入针套 21内， 并贯穿套接部 221伸入手柄 22内， 使该保护 杆 23上的复位弹簧 24的一端抵触在套接部 221上， 另一端抵触在凸台 232上， 且在保 护杆 23的尾端设有一防止其从手柄 22内退出的卡帽 25， 制得穿刺针 2。
(2.8 ) 预备一保护机构 5;
(2.9)该保护机构 5设置在穿刺针 2的手柄 22内，并能在不使用穿刺针 2时防止透 明罩 4縮回针套 21内， 而在穿刺针 2与定位穿刺套管 3相适配使用时， 自动启动保护功 能， 防止针套 21在伸入腹腔内时误伤内脏器官。
所述的步骤 （3 ) 具体包括以下步骤：
( 3.1 )预备一密封垫 31， 该密封垫 31的外缘设有一卡扣部 311， 中部向一侧呈圆锥 形凸起 312， 且该凸起 312的中心位置设有一与所述针套 21相适配的通孔 313， 该通孔 313与所述针套 21过盈配合；
( 3.2) 预备一由柔性材料制成的止回阀 32， 该止回阀 32的外缘设有一卡勾部 321， 中部设有两抵触板 322，两抵触板 322相对设置，且呈逐渐靠拢状使其相近的两端面之间 形成一与所述针套 21相适配的长条形缝 324， 两抵触板 322的内侧面对称各设一能加强 其结构强度的凸筋 323;该凸筋 323在所述针套 21退出长条形缝 324时能使两抵触板 322 相近的两端面紧密抵触， 防止腹腔内的高压气体泄漏；
( 3.3 ) 预备一采用高分子材料制成的套管鞘 33， 该套管鞘 33的尾部形成一与所述 止回阀 32的外形轮廓相适配的空腔 331，该套管鞘 33的首部沿其轴向延伸，并在其外侧 面上设有节状锥形凸起 332， 该套管鞘 33的首端成锥形；
( 3.4)将所述止回阀 32放置在该套管鞘 33的空腔 331内，并使该止回阀 32的卡勾 部 321卡扣在该空腔 331的开口上；
( 3.5 ) 将所述密封垫 31设置在空腔 331的开口上， 并且该密封垫 31的卡扣部 311 卡扣在止回阀 32的卡勾部 321上；
( 3.6) 预备一上盖 34， 将所述上盖 34扣合在所述空腔 331的开口上， 进而将所述 密封垫 31、 止回阀 32定位在套管鞘 33的空腔 331内；
( 3.7 )预备一二通阀 35， 将该二通阀 35固定在所述套管鞘 33上， 且使该二通阀 35 与所述套管鞘 33的空腔 331相连通， 制得定位穿刺套管 3。
所述透明罩 4为一端封闭的圆形管体 41，该圆形管体 41的封闭部分 42呈斜面形状、 球面形状、 圆锥形状或多棱锥面状， 其中该圆形管体 41的封闭部分 42呈斜面形状时， 其斜面的倾斜角度 b为 20〜70度。
一种实施上述一次性腹腔镜用的可视穿刺器制造方法制得的穿刺器， 其包括一带有 光源的摄像模组 1、 一穿刺针 2及一与该穿刺针 2相适配的定位穿刺套管 3， 所述摄像模 组 1设置在穿刺针 2的首端， 并对应于该穿刺针 2的首端上套设有一能将摄像模组 1罩 住的透明罩 4，所述穿刺针 2插置在定位穿刺套管 3内，且使该穿刺针 2首端上的透明罩 4略伸出所述定位穿刺套管 3。 所述透明罩 4为一端封闭的圆形管体 41， 该圆形管体 41 的封闭部分 42呈斜面形状、 球面形状、 圆锥形状或多棱锥面状， 其中该圆形管体 41的 封闭部分 42呈斜面形状时， 其斜面的倾斜角度 b为 20〜70度。
所述穿刺针 2包括一针套 21、 一手柄 22、 一保护杆 23及一复位弹簧 24， 在所述手柄 22的前侧壁设有一与针套 21相适配的套接部 221，所述针套 21的尾端套设在手柄 22的套接 部 221上， 该针套 21的首端形成一单斜面形的刀刃 211， 该刀刃 211的斜面的倾斜角度 £1为 20〜70度， 保护杆 23的首端安装有与摄像模组 1相适配的安装架 231， 该安装架 231的首端 上设有与透明罩 4相适配的安装位； 保护杆 23的中部设有一凸台 232， 保护杆 23的尾部插 入针套 21内， 并贯穿套接部 221伸入手柄 22内， 且在保护杆 23的尾端设有一防止其从手柄 22内退出的卡帽 25， 复位弹簧 24套设在保护杆 23的尾端， 且该复位弹簧 24的一端抵触在 套接部 221上， 另一端抵触在凸台 232上。 针套 21的首端形成一单斜面形的刀刃 211， 该刀 刃 211的斜面的倾斜角度为 20〜70度， 能有效利用其上的刀刃 211切开组织， 然后沿倾斜 角度进行再扩孔， 损伤小， 有效提高了穿刺手术的安全性和有效性。
所述穿刺针 2还包括一保护机构 5， 该保护机构 5包括一弹臂 51， 该弹臂 51的首端 固定在手柄 22内， 中部设有能在不使用穿刺针 2时抵触在卡帽 25上防止透明罩 4縮回 针套 21内的卡位，尾端从手柄 22的前侧壁伸出，形成一能在穿刺针 2与定位穿刺套管 3 相适配时抵触在该定位穿刺套管 3上使卡位从卡帽 25上退出的拨片。
所述定位穿刺套管 3包括一套管鞘 33、 一上盖 34、 一密封垫 31、 一止回阀 32和一 二通阀 35， 所述密封垫 31的外缘设有一卡扣部 311， 中部向一侧呈圆锥形凸起 312， 且 该凸起 312的中心位置设有一与所述针套 21相适配的通孔 313， 该通孔 313与所述针套 21过盈配合， 所述止回阀 32的外缘设有一卡勾部 321， 中部设有两抵触板 322， 两抵触 板 322相对设置，且呈逐渐靠拢状使其相近的两端面之间形成一与所述针套 21相适配的 长条形缝 324， 两抵触板 322的内侧面对称各设一能加强其结构强度的凸筋 323， 所述套 管鞘 33的尾部形成一与所述止回阀 32的外形轮廓相适配的空腔 331， 该套管鞘 33的首 部沿其轴向延伸， 并在其外侧面上设有节状锥形凸起 332， 该套管鞘 33的首端成锥形， 所述止回阀 32设置在套管鞘 33的空腔 331内，并使该止回阀 32的卡勾部 321卡扣在该 空腔 331的开口上， 所述密封垫 31设置在空腔 331的开口上， 并且该密封垫 31的卡扣 部 311卡扣在止回阀 32的卡勾部 321上， 所述上盖 34扣合在所述空腔 331的开口上， 并将所述密封垫 31、止回阀 32定位在套管鞘 33的空腔 331内，所述二通阀 35固定在所 述套管鞘 33上， 且使该二通阀 35与所述套管鞘 33的空腔 331相连通。
参见图 7， 在穿刺前， 将视频连接线 6的电源插头插上供电系统的电源插座， 视频连 接线 6的一端与穿刺针 2上的摄像模组 1相连接，视频连接线 6的另一端接入显示装置 7 的输入端口。 穿刺针 2插入所述定位穿刺套管 3内， 使穿刺针 2与定位穿刺套管 3相适 配。 这时， 弹臂 51上的拨片在定位穿刺套管 3的上盖 34压力下， 以弹臂 51与手柄 22 的连接处为轴心转动一定角度， 进而使弹臂 51上的卡位从卡帽 25上退出离开保护杆 23 的运动方向， 保护杆 23上的卡帽 25即可向手柄 22的一侧方向运动。
在穿刺时，穿刺针 2上的透明罩 4在皮肤阻力的作用下克服复位弹簧 24的弹力縮入 针套 21内， 进而露出针套 21的刀刃 211， 这时， 利用该刀刃 211切开皮肤组织， 使穿刺 针 2慢慢进入组织。 在光源的照明下， 摄像模组 1可以实时将整个穿刺组织进入腹腔的 过程图像经视频连接线 6传输到显示装置 7上， 能有效地直视到腹膜后大血管、 腹壁的 血管等动脉血管， 操作方便， 避免出现造成手术事故， 从而有效提高了穿刺手术的安全 性和有效性。
刺穿时， 由于透明罩 4上的阻力消失， 透明罩 4在复位弹簧 24的弹簧力的作用下重 新复位， 恢复透明罩 4略伸出所述定位穿刺套管 3的状态， 即实现保护的功效。 这时， 即使因误操作继续往腹腔穿刺， 在透明罩 4的作用下， 可防止针套 21上的刀刃 211误伤 内脏器官， 从而大大提高了穿刺手术的安全性和有效性。 同时， 套管鞘 33的节状锥形凸 起 332进入腹腔， 在节状锥形凸起 332和切口扩张形成的收縮力的共同作用下， 从而实 现将套管鞘 33牢固地固定在腹壁上。 通过二通阀 35与气腹机相连， 即可将气体输入腹 腔， 维持手术时腹部的气压。 另外， 穿刺器主体采用高分子材料制成， 一次性使用， 避 免交叉感染， 保证了使用的安全性。
本实施例中， 所述透明罩 4为一端封闭的圆形管体 41， 该圆形管体 41的封闭部分 42呈斜面形状时， 其斜面的倾斜角度为 20〜70度。兼有穿刺以及保护功能。其它实施例 中， 参见图 8和图 9， 可根据使用需求， 将该圆形管体 41的封闭部分 42设置呈圆锥形状 或多棱锥面状， 可取代针套 21上的刀刃 211， 直接用于穿刺。 参见图 10， 或者根据使用 需求将该圆形管体 41的封闭部分 42设置呈球面形状， 能有效杜绝穿刺器在伸入腹腔内 时极容易误伤内脏器官等正常组织的现象， 避免出现腹腔镜手术并发症， 如血管损伤、 肠损伤、 膀胱损伤等， 保证手术的安全性和有效性。
如本发明上述实施例所述， 采用与其相同或相似结构而得到的其它穿刺器及其制造 方法， 均在本发明保护范围内。

Claims

权 利 要 求 书
1、 一种一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 其包括如下步骤：
( 1 ) 预备一带有光源的摄像模组；
(2) 预备一穿刺针；
( 3) 预备一与所述穿刺针相适配的定位穿刺套管；
( 4)将摄像模组安装在穿刺针的首端， 并对应于该穿刺针的首端上套设有一能将摄 像模组罩住的透明罩；
( 5 )将穿刺针插置在定位穿刺套管内， 且使该穿刺针首端上的透明罩略伸出所述定 位穿刺套管，制得一次性腹腔镜用的可视穿刺器。
2、 根据权利要求 1所述的一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 所 述步骤 （2) 具体包括如下步骤：
(2.1 ) 预备一针套；
(2.2) 预备一手柄；
(2.3) 预备一保护杆；
(2.4) 预备一复位弹簧；
(2.5) 于手柄的前侧壁设有一与针套相适配的套接部， 将针套的尾端套设在手柄的 套接部上， 并使该针套的首端形成一单斜面形的刀刃， 该刀刃的斜面的倾斜角度为 20〜 70度；
(2.6) 在保护杆的首端安装有与摄像模组相适配的安装架， 该安装架的首端上预留 有与透明罩相适配的安装位；
(2.7) 在保护杆的中部设有一凸台， 将复位弹簧套设在保护杆的尾端， 然后将该保 护杆的尾部插入针套内， 并贯穿套接部伸入手柄内， 使该保护杆上的复位弹簧的一端抵 触在套接部上， 另一端抵触在凸台上， 且在保护杆的尾端设有一防止其从手柄内退出的 卡帽， 制得穿刺针。
3、 根据权利要求 2所述的一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 所 述的步骤 （2) 还包括以下步骤：
(2.8) 预备一保护机构；
(2.9) 该保护机构设置在穿刺针的手柄内， 并能在不使用穿刺针时防止透明罩縮回 针套内， 而在穿刺针与定位穿刺套管相适配使用时， 自动启动保护功能， 防止针套在伸 入腹腔内时误伤内脏器官。
4、 根据权利要求 3所述的一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 所 述的步骤 （3) 具体包括以下步骤：
(3.1 ) 预备一密封垫， 该密封垫的外缘设有一卡扣部， 中部向一侧呈圆锥形凸起， 且该凸起的中心位置设有一与所述针套相适配的通孔， 该通孔与所述针套过盈配合；
(3.2) 预备一由柔性材料制成的止回阀， 该止回阀的外缘设有一卡勾部， 中部设有 两抵触板， 两抵触板相对设置， 且呈逐渐靠拢状使其相近的两端面之间形成一与所述针 套相适配的长条形缝， 两抵触板的内侧面对称各设一能加强其结构强度的凸筋； 该凸筋 在所述针套退出长条形缝时能使两抵触板相近的两端面紧密抵触， 防止腹腔内的高压气 体泄漏；
(3.3) 预备一采用高分子材料制成的套管鞘， 该套管鞘的尾部形成一与所述止回阀 的外形轮廓相适配的空腔， 该套管鞘的首部沿其轴向延伸， 并在其外侧面上设有节状锥 形凸起， 该套管鞘的首端成锥形；
(3.4) 将所述止回阀放置在该套管鞘的空腔内， 并使该止回阀的卡勾部卡扣在该空 腔的开口上；
(3.5) 将所述密封垫设置在空腔的开口上， 并且该密封垫的卡扣部卡扣在止回阀的 卡勾部上；
(3.6) 预备一上盖， 将所述上盖扣合在所述空腔的开口上， 进而将所述密封垫、 止 回阀定位在套管鞘的空腔内；
(3.7) 预备一二通阀， 将该二通阀固定在所述套管鞘上， 且使该二通阀与所述套管 鞘的空腔相连通， 制得定位穿刺套管。
5、 根据权利要求 4所述的一次性腹腔镜用的可视穿刺器制造方法， 其特征在于， 所 述透明罩为一端封闭的圆形管体， 该圆形管体的封闭部分呈斜面形状、 球面形状、 圆锥 形状或多棱锥面状，其中该圆形管体的封闭部分呈斜面形状时，其斜面的倾斜角度为 20〜 70度。
6、 一种实施权利要求 1所述一次性腹腔镜用的可视穿刺器制造方法制得的穿刺器， 其特征在于， 其包括一带有光源的摄像模组、 一穿刺针及一与该穿刺针相适配的定位穿 刺套管， 所述摄像模组设置在穿刺针的首端， 并对应于该穿刺针的首端上套设有一能将 摄像模组罩住的透明罩， 所述穿刺针插置在定位穿刺套管内， 且使该穿刺针首端上的透 明罩略伸出所述定位穿刺套管。
7、 根据权利要求 6所述的穿刺器， 其特征在于， 所述穿刺针包括一针套、 一手柄、 一保护杆及一复位弹簧， 在所述手柄的前侧壁设有一与针套相适配的套接部， 所述针套 的尾端套设在手柄的套接部上， 该针套的首端形成一单斜面形的刀刃， 该刀刃的斜面的 倾斜角度为 20〜70度， 保护杆的首端安装有与摄像模组相适配的安装架， 该安装架的首 端上设有与透明罩相适配的安装位； 保护杆的中部设有一凸台， 保护杆的尾部插入针套 内， 并贯穿套接部伸入手柄内， 且在保护杆的尾端设有一防止其从手柄内退出的卡帽， 复位弹簧套设在保护杆的尾端， 且该复位弹簧的一端抵触在套接部上， 另一端抵触在凸 台上。
8、 根据权利要求 7所述的穿刺器， 其特征在于， 所述穿刺针还包括一保护机构， 该 保护机构包括一弹臂， 该弹臂的首端固定在手柄内， 中部设有能在不使用穿刺针时抵触 在卡帽上防止透明罩縮回针套内的卡位， 尾端从手柄的前侧壁伸出， 形成一能在穿刺针 与定位穿刺套管相适配时抵触在该定位穿刺套管上使卡位从卡帽上退出的拨片。
9、 根据权利要求 8所述的穿刺器， 其特征在于， 所述定位穿刺套管包括一套管鞘、 一上盖、 一密封垫、 一止回阀和一二通阀， 所述密封垫的外缘设有一卡扣部， 中部向一 侧呈圆锥形凸起， 且该凸起的中心位置设有一与所述针套相适配的通孔， 该通孔与所述 针套过盈配合， 所述止回阀的外缘设有一卡勾部， 中部设有两抵触板， 两抵触板相对设 置， 且呈逐渐靠拢状使其相近的两端面之间形成一与所述针套相适配的长条形缝， 两抵 触板的内侧面对称各设一能加强其结构强度的凸筋， 所述套管鞘的尾部形成一与所述止 回阀的外形轮廓相适配的空腔， 该套管鞘的首部沿其轴向延伸， 并在其外侧面上设有节 状锥形凸起， 该套管鞘的首端成锥形， 所述止回阀设置在套管鞘的空腔内， 并使该止回 阀的卡勾部卡扣在该空腔的开口上， 所述密封垫设置在空腔的开口上， 并且该密封垫的 卡扣部卡扣在止回阀的卡勾部上， 所述上盖扣合在所述空腔的开口上， 并将所述密封垫、 止回阀定位在套管鞘的空腔内， 所述二通阀固定在所述套管鞘上， 且使该二通阀与所述 套管鞘的空腔相连通。
10、 根据权利要求 9所述的穿刺器， 其特征在于， 所述透明罩为一端封闭的圆形管 体， 该圆形管体的封闭部分呈斜面形状、 球面形状、 圆锥形状或多棱锥面状， 其中该圆 形管体的封闭部分呈斜面形状时， 其斜面的倾斜角度为 20〜70度。
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