WO2020103350A1 - 一种医用连接装置 - Google Patents

一种医用连接装置

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Publication number
WO2020103350A1
WO2020103350A1 PCT/CN2019/076046 CN2019076046W WO2020103350A1 WO 2020103350 A1 WO2020103350 A1 WO 2020103350A1 CN 2019076046 W CN2019076046 W CN 2019076046W WO 2020103350 A1 WO2020103350 A1 WO 2020103350A1
Authority
WO
WIPO (PCT)
Prior art keywords
connection device
spiral tube
pitch
proximal end
distal end
Prior art date
Application number
PCT/CN2019/076046
Other languages
English (en)
French (fr)
Inventor
唐志
范茗侨
解欢
沙德青
李常青
冷德嵘
刘春俊
Original Assignee
南微医学科技股份有限公司
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 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to KR2020217000029U priority Critical patent/KR200497247Y1/ko
Priority to JP2021600062U priority patent/JP3235996U/ja
Priority to US17/289,017 priority patent/US20220000344A1/en
Priority to AU2019383529A priority patent/AU2019383529A1/en
Priority to DE212019000387.7U priority patent/DE212019000387U1/de
Priority to ES202190026A priority patent/ES2836537B2/es
Publication of WO2020103350A1 publication Critical patent/WO2020103350A1/zh

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    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
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    • 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
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Definitions

  • the invention relates to a medical connection device in the field of medical instruments, in particular to an endoscope attachment device integrating functions of electric conduction, liquid passing, powder spraying, negative pressure suction, sealing, insulation and support.
  • Endoscopy technology has been born for more than 50 years, and has gone from the stage of disease diagnosis to disease treatment. It has been very effective and reliable for the treatment of some digestive diseases, and has even become the first choice for treatment.
  • endoscopic technology endoscopic tissue biopsy, endoscopic mucosal resection (EMR), and endoscopic mucosal dissection (Endoscopic submucosal dissection (ESD) have been widely used. Treatment of tract bleeding, polypectomy, and early cancer are gradually becoming the first choice. Among them, ESD has played a key role in the detection, diagnosis and resection of early cancer.
  • Endoscopic submucosal dissection refers to the use of high-frequency instruments to perform submucosal dissection on lesions larger than 2 cm. Due to the large area of ESD resection of the mucosa, the surgical procedure is complicated and generally takes a long time, and the operation needs to be performed under endoscopic guidance.
  • the endoscope first enters the human body to find the diseased tissue, then the high-frequency incision knife enters the human body through the endoscopic forceps, marks the lesion, then exits the device after the marking, and the injection needle is used for submucosal injection.
  • the connecting tube for traditional endoscope accessories has a relatively simple performance, can only achieve some functions, and is not versatile.
  • the connecting tube for injection needles is generally made of polymer materials, which can realize the function of liquid passing, but can not realize the function of conduction.
  • connection tubes for high-frequency incision knives some of which use stainless steel tubes, although the function of conducting fluid is achieved, but the overall structure is consistent, the hardness of the front end is large, and it is difficult to bend through the endoscope; if the connection tube for hemostatic forceps is generally used Solid stainless steel wire or stainless steel wire rope can only realize the conductive function, but can not realize the liquid-passing function; as the existing coated spring tube is generally made of spring wire, the whole product is consistent, and cannot coexist with flexibility and rigidity.
  • the end close to the operator is defined as the proximal end, and the end remote from the operator is defined as the distal end.
  • a medical connection device having a proximal end and a distal end, including an insulating layer and a spiral tube, the insulating layer covering the outermost layer of the entire device; the spiral tube is a conductive hollow tubular structure, located inside the entire device Layer, the helical tube has a helical structure, the helical structure having a gradual pitch from proximal to distal direction. The pitch can be gradually reduced from the proximal end to the distal end. The relatively small pitch of the distal end makes it flexible and easy to pass through the bend of the medical device.
  • the relatively large pitch of the proximal end has support and is convenient for pushing to the distal end Medical devices; the pitch can also gradually increase from the proximal end to the distal end, the distal end has a relatively large pitch, and the proximal end has a relatively small pitch; the pitch can also increase from the proximal end to the distal end first and then change Small, or from the proximal end to the distal direction to become smaller and then larger, or adopt the structure of equal pitch.
  • the gap between the spiral structures is ⁇ 0.003mm, and the pitch of each thread is ⁇ 0.03mm.
  • the spiral tube is a material having electrical conductivity.
  • the spiral tube has a spiral structure from the proximal end to the distal end. It is also possible that the proximal end and the distal end of the helical tube may have partial non-helical structure regions separately or simultaneously.
  • the pitch of the spiral tube can adopt an equal pitch structure, a gradual pitch structure, a combination of multiple equal pitch structures, and a structure combining equal pitch and gradual pitch.
  • the medical connection device of the present invention further includes one or more seals that are connected to the distal or proximal end of the spiral tube or to the proximal and distal ends of the spiral tube at the same time.
  • the seal has a non-planar structure, which can be concave-convex, concave, convex.
  • the protrusions of the non-planar structure can be semicircular, rectangular, trapezoidal, or toothed.
  • the insulating layer of the present invention is made of polymer material, and its thickness is ⁇ 0.03mm.
  • the polymer material is polytetrafluoroethylene, fluoroethylene propylene copolymer, and polyethylene.
  • the insulating layer covers the outer surface of the spiral tube by means of heat shrinking, welding, and pasting.
  • the medical connecting device of the present invention includes: an insulating layer, located on the outer layer of the device, which realizes the function of insulation protection and at the same time plays a sealing effect; the spiral tube plays a conductive function, and at the same time provides a cavity, which can realize functions such as liquid injection.
  • the spiral tube contains a spiral structure, the direction of the spiral structure is not fixed, and different pitches can be designed according to different needs, and can be used for liquid injection, powder spraying, negative pressure suction sampling, etc.
  • the small-pitch end of the medical connection device has flexibility and is easy to pass through the endoscope forceps, and the large-pitch end is relatively rigid and has support performance.
  • the distal and proximal ends have partial non-helical structure areas.
  • the seal When the non-helical structure area is relatively short, the length of the rigid section of the product can be shortened.
  • the seal has a non-planar structure, which can be concave and convex, concave, convex and other structures. It can be connected to the spiral tube to achieve the sealing function.
  • the seal When the non-helical structure area of one end of the spiral pipe is long, the seal can be connected only at the other end of the spiral pipe.
  • the seal When the length of the non-helical structure area at both ends is the same or the gap is not large, the seal can be connected to both ends of the spiral pipe .
  • the insulating layer covers the outside of the seal, and the pressure gradually decreases through the non-planar structure of the seal, improving the sealing effect.
  • the insulating layer is located in the outermost layer of the entire device; the spiral tube is a hollow tubular structure made of a conductive material and is located in the inner layer of the entire device.
  • the spiral tube contains a spiral structure.
  • the insulating layer is made of high molecular material, covering the surface of the spiral tube and the seal.
  • the material is not limited to polytetrafluoroethylene (PTFE), fluoroethylene propylene copolymer (FEP), polyethylene (PE), etc.
  • the thickness is not less than 0.03mm .
  • the insulation layer is attached to the surface of the spiral tube by heat shrinking, welding, pasting, etc.
  • the insulating layer makes the product have good voltage resistance, its insulation withstand voltage is not less than 300Vp, and also has good sealing performance, can withstand a pressure of not less than 2atm.
  • the spiral tube adopts conductive materials, which can realize the conductive function, and at the same time provide the cavity to realize liquid injection and powder spraying.
  • One end of the hollow structure is connected to the energizable parts of the instrument, such as electrodes, forceps, needle-like structures, etc., to realize the functions of product cutting and blood coagulation.
  • the outer diameter of the spiral tube is not less than 0.3mm, and the wall thickness is not less than 0.05mm. Because the wall thickness of the spiral tube is small, it can provide a large lumen space. Because the spiral tube has a relatively small outer diameter, the outer diameter of the entire instrument can be reduced to facilitate operation, and at the same time, the product can be adapted to a smaller endoscope cavity.
  • the spiral tube has a relatively small resistance value compared to a conventionally wound spring tube, and the resistance value is not greater than 20 ⁇ , which increases the current flowing through the device under the same voltage and can provide working efficiency.
  • the outer layer of the spiral tube is covered with an insulating layer, which can effectively protect and prevent the user from being injured by electric shock.
  • the spiral tube adopts a hollow tubular structure to provide a channel, which can realize the functions of liquid passing, powder spraying or negative pressure suction. In the clinic, it can achieve the product of saline, indigo rouge injection, powder product spraying or negative pressure suction sampling, etc.
  • the spiral tube has a spiral structure.
  • the pitch of the distal end of the spiral tube is small and elastic, and the better the bending performance, the better the product can pass through the endoscope bend.
  • the pitch of the proximal end of the spiral tube is large, and the supporting performance is good.
  • the pitch of the thread can be adjusted to meet the needs of different products.
  • the pitch of each thread of the spiral tube can adopt an equal pitch structure, a gradual pitch structure (the pitch can be an unequal number series), a combination of multiple equal pitch structures, a combination of equal pitch and gradual pitch, etc. According to needs, design other different spiral structures.
  • a structure combining equal pitch and gradual pitch can be selected.
  • FIG. 1A is a schematic diagram of the distal end and the proximal end of the spiral tube of the device of the present invention respectively connected to a seal.
  • FIG. 1B is a schematic diagram of the distal end of the spiral tube of the device of the present invention connected to a seal.
  • FIG. 2 is a schematic diagram of the device of the present invention applied to a high-frequency cutting knife.
  • Fig. 3 is a schematic diagram of applying the device of the present invention to an ultrasound suction biopsy needle.
  • Fig. 4 is a schematic diagram of the device of the present invention applied to a hemostat.
  • Fig. 5 is a schematic view of the structure of the seal of the device of the present invention.
  • the device of the present invention can be used in the following embodiments but not limited to the following embodiments, and can also be used in other endoscope consumables, such as combined instruments of incision knife and hemostatic forceps, bipolar probes, combined instruments of probe and injection needle, etc.
  • the medical connection device can adopt different size structures, and the medical connection device of multiple sizes can also be combined and matched in the same product.
  • the medical connection device of the present invention includes a spiral tube 2, a sealing member 1, and an insulating layer 3 covering the outer surfaces of the spiral tube 2 and the sealing member 1.
  • the spiral tube 2 includes a spiral structure, and different pitches can be designed according to different requirements.
  • the helical tube 2 includes a distal non-helical structure region 4, a proximal non-helical structure region 6 and an intermediate spiral structure region 5, including a spiral structure 8 near the proximal end is designed to have an equal pitch structure, near the distal spiral structure region 7 has a gradual pitch that gradually decreases from the proximal end to the distal end.
  • the intermediate spiral structure region 5 can also be designed as a gradual pitch that gradually decreases from the proximal end to the distal direction, and can also adopt a combination of a variety of equal pitch structures from the proximal end to the distal end pitch from large to small and then to large. , The structure design of the combination of equal pitch and gradual pitch, and other different spiral structures (not shown in the figure) can also be designed according to requirements.
  • the distal non-helical structure area has a shorter length and shortens the length of the rigid section of the product.
  • the distal pitch is small and flexible. It is easy to pass through medical devices such as endoscope bends.
  • the proximal end has a large pitch and good support.
  • the non-helical structure area at the end has a long length and is convenient for pushing.
  • the middle end and the proximal end are relatively rigid and have support performance; the spiral tube 2 can play a conductive function, and at the same time provide a cavity to realize liquid injection and other functions.
  • seals 1 may be added at both ends of the spiral tube 2.
  • FIG. 1B when the proximal non-helical structure region 6 of the spiral tube 2 is longer, the spiral tube 2 is connected to the seal 1 only at the distal end.
  • FIG. 5 is a schematic diagram of the structure of the seal.
  • the seal is a non-planar structure, which is of a concave-convex, concave, convex and other structures.
  • the protrusion of the non-planar structure can be semicircular, rectangular, trapezoidal, or toothed.
  • the sealing member 1 can be connected with the spiral tube 2 to realize the sealing function.
  • the high-frequency incision knife includes an electrode portion 110, a conveying portion 120, and an operating portion 130.
  • the electrode 111 includes a hollow tubular portion and a protrusion.
  • the shape of the electrode is not limited to this structure, but can also be other structures including a hollow tubular portion.
  • the hollow tubular portion of the electrode can pass liquid, powder, cut, etc .; the limiter 121 At the same time, it plays the role of insulation.
  • the limiter 121 adopts a tubular structure, made of heat-resistant and insulating materials such as zirconia, and is fixedly connected to the distal end of the outer tube 125 to limit the extension of the distal end of the electrode 111 And retracted, and the inner hole size is larger than the outer diameter of the hollow tubular portion of the electrode;
  • the sealing member 122 is made of a conductive material, the concave-convex structure is conducive to sealing, and is fixedly connected to the proximal end of the electrode 111, and cooperates with the limiter 121 to limit the electrode 111
  • the extended length of the insulating layer 123 is made of PTFE and other insulating materials, covering the surface of the sealing member 122 and the spiral tube 124 for sealing and insulating purposes;
  • the spiral tube 124 is made of a conductive material, which is relatively common to a wound spring In terms of tube, the resistance is small, the current through the circuit is large when the current path is formed, and the cutting efficiency of the
  • the helical tube 123 provides a lumen at the same time. With the same outer diameter, due to the small wall thickness, it can provide a relatively large lumen space for liquid injection or powder spraying; the outer tube 125 extends from the proximal end to the distal end to support Internal connection device, convenient for pushing electrodes, the distal end is connected to the limiter 121, and the proximal end is fixedly connected to the positioning structure 131; the positioning structure 131 includes a luer connector 1311, which is an input port for liquid or powder products; The slider 133 can move back and forth along the core rod 132; the slider 133 is connected to the proximal end of the spiral tube 124, and the spiral electrode 124 is controlled to extend or retract the active electrode 111.
  • the slider 133 also has a conductive connector 1331 and a luer
  • the luer connector 1332 and the conductive connector 1331 are connected to an external high-frequency generator.
  • the luer connector 1332 is an input port for liquid or powder products.
  • the spiral tube 124 adopts a structure combining a gradual pitch and an equal pitch, and is designed to gradually decrease the pitch from the proximal end to the distal end.
  • the pitch near the distal electrode is small, the flexibility is good, and it is convenient for high frequency
  • the incision knife passes through the endoscope bend, and the screw pitch near the proximal operation part 130 is relatively large to maintain better rigidity and supportability, and it is convenient for medical personnel to insert the product into the endoscope cavity.
  • the spiral tube can also be provided with an equal pitch structure, a gradual pitch structure or a combination of multiple equal pitch structures according to requirements.
  • the slider 133 In use, pull the slider 133, retract the electrode 111 to the end face of the limiter 121, and then insert the high-frequency incision knife into the endoscope forceps. Because the high-frequency incision knife spiral tube 124 has a small pitch at the distal end, the high frequency The incision knife can smoothly pass through the bending structure of the distal end of the endoscope.
  • the spiral pitch of the proximal end of the spiral tube 124 is relatively large and relatively rigid, and the medical staff can push the high-frequency incision knife to the distal end of the endoscope.
  • the seal 122 and the spiral tube 124 have a conductive function, the high-frequency current can be transmitted to the electrode part 110 To mark.
  • the slider 133 is pushed, and with the help of the pushing performance of the non-helical structure area at the proximal end of the spiral tube 124, the electrode 111 is extended to perform cutting and peeling.
  • you need to inject liquid to bulge the mucosal tissue you can connect a syringe to the Luer connector 1332 to inject to bulge the tissue, and form a liquid buffer layer under the mucosa, that is, the "water pad", which is in the muscle layer.
  • FIG. 3 is a schematic diagram of the application of the device of the present invention to an ultrasound suction biopsy needle.
  • the ultrasound suction biopsy needle includes a puncture part 210, a delivery part 220, and an operation part 230.
  • 211 is a puncture needle, which adopts a hollow tubular structure and contains a needle tip for puncture sampling;
  • 221 is a seal, a non-planar structure is conducive to sealing, and is fixedly connected to the puncture needle 211;
  • an insulating layer 222 covers the seal 221 and the spiral
  • the surface of the tube 223 plays a sealing role;
  • the outer tube 224 extends from the proximal end to the distal end and supports the internal connection device to facilitate pushing the puncture needle 211;
  • the core rod 231 is connected to the proximal end of the outer tube 224, and the slider 232 can be along the core
  • the rod 231 moves, and the slider 232 includes a Luer connector 2321.
  • the spiral tube 223 adopts a structure combining a gradual pitch and an equal pitch.
  • the pitch near the distal puncture needle 211 is small and the flexibility is good to facilitate the entire biopsy needle to pass through the endoscope bend.
  • the spiral tube 223 is operated near the proximal end
  • the screw pitch on one side of the portion 230 is large, and the support is good, so that the medical staff can insert the ultrasound biopsy needle into the endoscope cavity.
  • the threaded tube close to the side of the slider retains part of the non-helical structure area to facilitate puncture.
  • the spiral tube can also be provided with an equal pitch structure, a gradual pitch structure or a combination of multiple equal pitch structures according to requirements.
  • the biopsy needle When in use, first insert the biopsy needle into the endoscopic forceps. Ultrasound attracts the biopsy needle's distal spiral tube with a small pitch, which can facilitate the product to pass through the endoscope's distal bending structure. The medical staff pushes the product to the distal end of the endoscope. When ultrasound draws the biopsy needle into the field of view of the endoscope, the length of the puncture needle 211 extending out of the outer tube 224 can be controlled by adjusting the slider 232. During the puncture, a negative pressure device is connected to the luer connector by using the channel of the spiral tube 223 to draw tissue into the puncture needle for sampling.
  • the hemostatic forceps includes a gripping part 310, a conveying part 320, and an operating part 330.
  • 311 is a forceps head, the shape of which is not limited to this structure, but can also be in the shape of scissors, zigzag, used for electrocoagulation to stop bleeding or cutting, and can be movably connected to the fixing base 312; the fixing base 312 uses a conductive material It is made to support the pliers head 311 and can smoothly open and close the pliers head 311.
  • the seal 321 is made of a conductive material, and the non-planar structure is conducive to sealing ,
  • the proximal end of the sealing member 321 is connected to the fixing seat 312;
  • 322 is an insulating layer, which is made of PTFE and other insulating materials, covering the surface of the sealing member 321 and the spiral tube 323 for sealing and insulation;
  • the spiral tube 323 is electrically conductive Compared with ordinary coiled spring tubes, due to the low resistance of the conductive material, when forming a current path, the current through the circuit is large, which can have high efficiency.
  • a relatively small outer diameter can be achieved, so that the hemostatic forceps can fit a smaller endoscope cavity;
  • 324 is the cable ,
  • the distal end is connected to the pull rod 313, which can be a steel wire rope or a steel wire, which is used to drive the opening or closing of the jaw 311;
  • 331 is a positioning structure, and a conductive connector 3311 is connected to the proximal end, which is used to connect with a high-frequency power supply.
  • the high-frequency current flows to the end of the forceps through the spiral tube 323, and the forceps 311 is closed for electrocoagulation to stop bleeding; 332 is a core rod, and the slider 333 can move along the core rod 332, and the slider 333 can be pushed and pulled along the core rod. Open and close the pliers head 311.
  • the spiral tube 323 adopts a structure combining a gradual pitch and an equal pitch. The pitch near the distal end is small and the flexibility is good to facilitate the entire hemostatic forceps to pass through the endoscope bend.
  • the thread pitch of the threaded pipe 323 near the proximal end Larger and better supporting, it is convenient for medical staff to insert the hemostatic forceps into the endoscope cavity.
  • the threaded tube close to the side of the slider end retains part of the non-helical structure area for easy pushing.
  • the spiral tube can also be provided with an equal pitch structure, a gradual pitch structure or a combination of multiple equal pitch structures according to requirements.
  • the proximal spiral tube has a large pitch and is relatively rigid, which facilitates medical personnel to push the product to the distal end of the endoscope.
  • the forceps 311 is closed to perform electrocoagulation and hemostasis, and the outer insulating layer 322 can play an insulating and protective role.
  • the hollow cavity of the spiral tube 323 and the cable 324 can be used to inject fluid through the luer connector 3312 to the syringe to irrigate the blood at the bleeding site.

Abstract

一种医用连接装置，其具有近端和远端，医用连接装置包括绝缘层（3, 123, 222, 322）和螺旋管（2, 124, 223, 323），绝缘层（3, 123, 222, 322）覆于整个装置的最外层；螺旋管（2, 124, 223, 323）为可导电空心管状结构，螺旋管（2, 124, 223, 323）具有螺旋结构，螺旋结构具有从近端到远端方向渐变的螺距。该医用连接装置能够实现导电、通液、粉末喷洒、负压吸引、密封、绝缘、支撑等功能于一体。

Description

一种医用连接装置 技术领域
本发明涉及医疗器械领域的一种医用连接装置，特别是一种集导电、通液、粉末喷洒、负压吸引、密封、绝缘、支撑等功能于一体的内窥镜附件用装置。
背景技术
内镜技术诞生50多年来，经历了从疾病诊断到疾病治疗的阶段，对于治疗一些消化疾病已经十分有效和可靠，甚至成为治疗的首选疗法。近年来随着内镜技术的发展，内镜下组织活检、内镜下黏膜切除术(Endoscopic mucosal resection，EMR)、内镜下黏膜剥离术(Endoscopic submucosal dissection，ESD)得到广泛应用，其对消化道出血、息肉切除和早癌症的治疗，正逐渐成为首选的治疗手段。其中，尤其是ESD对早癌的发现、诊断和切除起到了关键作用。
在临床各科中，对各种病态进行以诊断、判定治疗结果、决定治疗方针等为目的的体腔内的直接观察及处置。以往，这些都需要通过开腹或开胸等侵害大的手术方式来进行。但是，随着近年来内窥镜下手术器具的普及，可以在切开创伤更小的腹腔镜和胸腔镜等内窥镜下来进行。
内镜黏膜下剥离术(ESD)是指利用高频器械对大于2cm的病变进行黏膜下剥离的内镜微创技术。由于ESD切除粘膜面积大，手术过程繁杂，一般耗时很长，且需在内镜引导下进行手术。内窥镜先进入人体发现病变组织，然后高频切开刀通过内窥镜钳道进入人体，进行病变标记，标记后退出器械，换用注射针进行粘膜下层注射，注射后再用适合的高频切开刀进行切割剥离，术中如有出血，还需更换止血钳进行电凝止血，大约1～2个小时左右才能成功切除一个3cm左右的早癌病变。手术中需要频繁更换器械，延长了手术时间，给患者带来了痛苦。在针对内窥镜下这类比较复杂的手术时，需要有一种集标记、冲洗、注射、切割、凝血等功能于一体的产品，因此对该产品用连接管的功能要求比较高，否则需要频繁更换器械，延长手术时间。
而传统内窥镜附件用连接管性能比较单一，仅能够实现部分功能，不具有通用性，如注射针用连接管，一般选用高分子材料制成，可实现通液功能，但无法实现导电功能；如高频切开刀用连接管，有些采用不锈钢管，虽实现了导 电通液功能，但整体结构一致，前端硬度大，通过内窥镜弯道困难；如止血钳用连接管，一般选用实心不锈钢丝或不锈钢丝绳，仅能实现导电功能，而无法实现通液功能；如现有的涂层弹簧管，一般由弹簧丝绕制而成，整个产品前后一致，无法柔性与刚性共存。为了更好的实现内窥镜附件产品的功能，需要开发一种能够实现多种功能的医疗连接装置，可实现导电、通液、粉末喷洒、负压吸引、绝缘、密封、支撑等多种功能，同时又具有柔性和刚性并存等性能特点。
发明内容
将靠近操作者的一端为近端，远离操作者的一端定义为远端。
一种医用连接装置，其具有近端和远端，包括绝缘层和螺旋管，所述绝缘层覆于整个装置的最外层；所述螺旋管为可导电空心管状结构，位于整个装置的内层，所述螺旋管具有螺旋结构，所述螺旋结构具有从近端到远端方向渐变的螺距。螺距可以从近端到远端方向逐渐变小，远端相对较小的螺距使其具有柔性，易于通过医疗装置的弯道，近端相对较大的螺距，具有支撑性，方便向远端推送医疗器械；螺距还可以从近端到远端方向逐渐变大，远端相对较大的螺距，而近端具有相对较小的螺距；螺距还可以从近端到远端方向先变大再变小，或者从近端到远端方向先变小再变大，或者采用等螺距的结构。螺旋结构间的缝隙≥0.003mm，每道螺纹的螺距≥0.03mm。优选地，螺旋管为具有导电性的材料。
螺旋管从近端到远端整根具有螺旋结构。也可螺旋管的近端和远端可分别或同时具有部分非螺旋结构区域。螺旋管的螺距可采用等螺距结构，渐变螺距结构，多种等螺距结构相结合，等螺距与渐变螺距相结合的结构。
本发明的医用连接装置还包括一个或多个密封件，所述密封件与螺旋管远端或近端或与螺旋管的近端和远端同时相连。密封件为非平面结构，可以为凹凸型，内凹型，凸起型。非平面结构的突出部分可以为半圆形，矩形，梯形，齿形。
本发明的绝缘层采用高分子材料制成，其厚度≥0.03mm。高分子材料为聚四氟乙烯、氟乙烯丙烯共聚物、聚乙烯。绝缘层以热缩、焊接、粘贴等方式覆在螺旋管的外表面。
本发明的医用连接装置包括：绝缘层，位于装置的外层，实现绝缘保护功 能，同时起到密封效果；螺旋管，起导电功能，同时提供腔道，能够实现注液等功能。螺旋管包含有螺旋结构，螺旋结构的方向不固定，且可根据不同需求设计不同螺距，可用于液体注射、粉末喷洒、负压吸引取样等。医用连接装置螺距较小端具有柔性，易于通过内窥镜钳道，螺距较大端相对刚性，具有支撑性能。远端和近端末端具有部分非螺旋结构区域，非螺旋结构区域相对较短时，可减短产品刚性段的长度。非螺旋结构区域相对较长时，方便推送；密封件，呈非平面结构，可以为凹凸型，内凹型、凸起型等多种结构，可与螺旋管连接，实现密封功能。当螺旋管一端非螺旋结构区域较长时，可只在螺旋管的另一端连接密封件，当两端非螺旋结构区域长度相同或差距不大时，可在螺旋管的两端均连接密封件。绝缘层覆在密封件外侧，压力经密封件的非平面结构逐渐减小，改善密封效果。
绝缘层位于整个装置的最外层；螺旋管采用具有导电性的材料制成的空心管状结构，位于整个装置的内层，螺旋管包含螺旋结构。
绝缘层材质采用高分子材料，覆于螺旋管与密封件的表面，材料不限于聚四氟乙烯(PTFE)、氟乙烯丙烯共聚物(FEP)、聚乙烯(PE)等，厚度不小于0.03mm。绝缘层以热缩、焊接、粘贴等方式附在螺旋管的表面。绝缘层使得产品具有良好的耐压性能，其绝缘耐压不低于300Vp，同时具有良好的密封性能，能够承受不低于2atm的压力。
螺旋管采用具有导电性的材料，能够实现导电功能，同时提供腔道能够实现注液、粉末喷洒。空心结构一端与器械可通电部件连接，例如电极、钳头、针状结构等，实现产品的切割、凝血等功能。螺旋管外径为不小于0.3mm，壁厚不小于0.05mm。由于螺旋管的壁厚较小，可以提供较大的管腔空间。由于螺旋管具有比较小的外径尺寸，可以缩小整个器械的外径，方便操作，同时使得产品可以适配更小的内窥镜腔道。此外，螺旋管相对普通绕制的弹簧管，阻值较小，阻值不大于20Ω，在相同电压下使得流通器械的电流增大，能够提供工作效率。在螺旋管外层外覆绝缘层，能够有效防护，防止使用者受到电击伤害。
螺旋管采用空心管状结构从而提供通道，能够实现通液、粉末喷洒或负压吸引等功能。在临床中可以实现产品的生理盐水、靛胭脂注射、粉末产品喷洒或负压吸引取样等。螺旋管上具有螺旋结构，优选地，螺旋管远端的螺距较小，具有弹性，过弯性能越好，可以使产品更好地通过内窥镜弯道。螺旋管近端的 螺距较大，支撑性能好。此外，还能根据对柔韧性需求的不同，可以调整螺纹的螺距，以适应不同产品的需求。其中，螺旋管的每道螺纹间的螺距可采用等螺距结构、渐变螺距结构(螺距可成等差数列)、多种等螺距结构相结合、等螺距与渐变螺距相结合的结构等，亦可根据需求，设计其它不同的螺旋结构。优选地，可以选用等螺距与渐变螺距相结合的结构。
附图说明
图1A本发明的装置的螺旋管远端和近端分别连接密封件的示意图。
图1B本发明的装置的螺旋管远端连接密封件的示意图。
图2本发明的装置应用于高频切开刀的示意图。
图3本发明的装置应用于超声吸引活检针的示意图。
图4本发明的装置应用于止血钳的示意图。
图5本发明的装置的密封件结构示意图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施方式，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施方式仅用以解释本发明，并不用于限定本发明。本申请的范围并不受这些实施方式的限定，乃以申请专利的范围为准。而为提供更清楚的描述及使熟悉该项技艺者能理解本申请的申请内容，图示内各部分并不一定依照其相对的尺寸而绘图，某些尺寸与其他相关尺度的比例会被凸显而显得夸张，且不相关或不重要的细节部分亦未完全绘出，以求图示的简洁。
本发明的装置可用于以下实施方式但不限于以下实施方式，亦可用于其它内窥镜耗材，如切开刀与止血钳组合器械、双极探头、探头与注射针组合器械等。同样，该医用连接装置可采用不同的尺寸结构，在同一产品，也可以使用多种尺寸的该医用连接装置进行组合搭配。
如图1A和1B所示，本发明的医用连接装置包括：螺旋管2，密封件1，以及覆于螺旋管2和密封件1的外表面的绝缘层3。螺旋管2包含有螺旋结构，可根据不同需求设计不同螺距。优选地，螺旋管2包括远端非螺旋结构区域4，近端非螺旋结构区域6以及中间螺旋结构区域5，在靠近近端包含螺旋结构8设计为具有等螺距结构，靠近远端螺旋结构区域7具有由近端到远端逐渐变小的渐变螺距。也可以中间螺旋结构区域5设计为从近端到远端方向螺距逐渐变小 的渐变螺距，还可采用从近端到远端螺距从大先变小再变大、多种等螺距结构相结合、等螺距与渐变螺距相结合的结构等设计，亦可根据需求，设计其它不同的螺旋结构(图中未示出)。远端非螺旋结构区域，长度较短，减短产品刚性段的长度，远端螺距较小具有柔性，易于通过医疗装置如内窥镜弯道，近端螺距较大，支撑性较好，近端非螺旋结构区域，长度较长，方便推送，中间端及近端相对刚性，具有支撑性能；螺旋管2能起导电功能，同时提供腔道实现注液等功能。如图1A所示，当远端非螺旋结构区域4和近端非螺旋结构区域6长度差距不大时，螺旋管2两端可加密封件1。如图1B所示，当螺旋管2近端非螺旋结构区域6较长时，螺旋管2仅在远端连接密封件1。螺旋管2和密封件1的外表面覆有绝缘层3，实现绝缘保护功能，同时起到密封效果。图5是密封件结构示意图，密封件是非平面结构，呈凹凸型，内凹型、凸起型等多种结构，非平面结构的突出部分可以为半圆形，矩形，梯形，齿形。密封件1可与螺旋管2连接，实现密封功能。
实施例一：
如图2为本发明的装置应用于高频切开刀的示意图。高频切开刀包括电极部110、输送部120和操作部130。其中，电极111包括空心管状部和凸起，电极形状不限于这种结构，亦可是其它包含有空心管状部的结构，电极的空心管状部可以通液、通粉末、切割等；限位件121同时起到绝缘的作用，限位件121采用管状结构，由氧化锆等具有耐热性和绝缘性的材料制成，与外管125远端固定连接，用于限制电极111远端的伸出和缩回，且其内孔尺寸大于电极空心管状部的外径；密封件122采用具有导电性的材料，凹凸结构利于密封，与电极111近端固定连接，与限位件121配合限制电极111的伸出长度；绝缘层123采用PTFE等具有绝缘性的材料，覆在密封件122和螺旋管124表面，起密封和绝缘作用；螺旋管124采用具有导电性的材料，相对普通绕制的弹簧管而言，电阻较小，形成电流通路时通过电路的电流较大，高频切开刀切割效率较高。螺旋管123同时提供腔道，相同外径的情况下，由于壁厚较小，可以提供比较大的管腔空间，用于液体注射或粉末喷洒；外管125从近端向远端延伸，支撑内部连接装置，方便推送电极，远端与限位件121连接，近端与定位结构131固定连接；定位结构131包含有鲁尔接头1311，为液体或粉末产品的输入口；132为芯杆，滑块133可沿芯杆132前后移动；滑块133与螺旋管124近端相连 接，通过控制螺旋管124以伸出或缩回活性电极111，滑块133上还具有导电连接器1331和鲁尔接头1332，导电连接器1331与外接的高频发生器连接，鲁尔接头1332为液体或粉末状产品的输入口。其中，螺旋管124采用渐变螺距与等螺距相结合的结构，设计为从近端到远端方向螺距逐渐变小的渐变螺距，靠近远端电极的螺距较小，柔韧性较好，方便高频切开刀通过内窥镜弯道，靠近近端操作部130的螺距较大，以保持较好的刚性和支撑性，方便医护人员将产品插入内窥镜腔道。其中靠近滑块133，保留部分非螺旋结构区域，方便推送，用于伸缩电极111。上述螺旋管也可以根据需求，将螺纹设置为等螺距结构、渐变螺距结构或多种等螺距结构相结合的螺纹结构。
使用时，拉动滑块133，将电极111收回至限位件121端面，然后将高频切开刀插入内窥镜钳道，因高频切开刀螺旋管124远端螺距较小，高频切开刀可以顺利通过内窥镜远端弯曲结构。螺旋管124近端螺距较大，相对刚性，医护人员可以将高频切开刀向内窥镜远端推送。当将高频切开刀送入内窥镜视野时，此时，通过导电连接器接通高频电，由于密封件122和螺旋管124具有导电功能，能够将高频电流传送到电极部110，以进行标记。标记完成后，推动滑块133，借助螺旋管124近端非螺旋结构区域的推送性能，将电极111伸出，进行切割剥离。切割剥离过程中，如需注射液体隆起黏膜组织，可以在鲁尔接头1332处外接注射器，进行注射以隆起组织，并在黏膜下形成液体缓冲层即“水垫”，“水垫”在肌层和病变间形成有效隔离，同时也有效阻止了热传导，使手术视野更清晰，血管受到水垫的挤压封闭，出血的风险显著降低。若遇组织出血，可通过螺旋管124的空心管状部腔道或者绝缘层123与外管125间形成的间隙腔道，通过鲁尔接头1332或1311外接注射器进行液体注射或喷洒止血粉，实现对出血部位的清洗或止血。
实施例二：
如图3为本发明的装置应用于超声吸引活检针的示意图。超声吸引活检针包括穿刺部210、输送部220和操作部230。其中，211为穿刺针，采用空心管状结构，并包含有针尖，用于穿刺取样；221为密封件，非平面结构利于密封，与穿刺针211固定连接；绝缘层222覆在密封件221和螺旋管223表面，起密封作用；外管224，从近端向远端延伸，支撑内部连接装置，方便推送穿刺针211；芯杆231与外管224近端相连接，滑块232可以沿着芯杆231运动，滑块 232上包含有鲁尔接头2321。螺旋管223采用渐变螺距与等螺距相结合的结构，靠近远端穿刺针211的螺距较小，柔韧性较好，以方便整个活检针通过内窥镜弯道，其中螺旋管223靠近近端操作部230的一侧的螺距较大，支撑性较好，方便医护人员将超声吸引活检针插入内窥镜腔道。而靠近滑块端一侧的螺纹管，保留部分非螺旋结构区域，方便穿刺。上述螺旋管也可以根据需求，将螺纹设置为等螺距结构、渐变螺距结构或多种等螺距结构相结合的螺纹结构。
使用时，先将活检针插入内窥镜钳道，超声吸引活检针远端螺旋管螺距较小，可以方便产品通过内窥镜远端弯曲结构，近端螺旋管螺距较大，相对刚性，方便医护人员将产品向内窥镜远端推送。当超声吸引活检针进入内窥镜视野时，可通过调节滑块232控制穿刺针211伸出外管224的长度。穿刺时，利用螺旋管223的通道，在鲁尔接头处连接负压装置，将组织吸入穿刺针内部，进行取样。
实施例三：
如图4为本发明的装置应用于止血钳的示意图。止血钳包括夹持部310、输送部320和操作部330。其中，311为钳头，其形状不限于这种结构，亦可是如剪刀状，锯齿状，用于电凝止血或切割，可活动的与固定座312连接；固定座312采用具有导电性的材料制成，用于支撑钳头311，并可以使钳头311顺利张开和闭合，其内孔尺寸大于拉杆313的外径；密封件321采用具有导电性的材料制成，非平面结构利于密封，密封件321近端与固定座312相连接；322为绝缘层，采用PTFE等具有绝缘性的材料，覆在密封件321和螺旋管323表面，起密封和绝缘作用；螺旋管323采用具有导电性的材料，相对普通绕制的弹簧管而言，由于导电材料的电阻较小，形成电流通路时，通过电路的电流较大，能够具有较高的效率。在同内径的情况下，由于具有比较小的壁厚，相对其它同类产品而言，可以实现比较小的外径尺寸，这样止血钳可以适配更小的内窥镜腔道；324为拉索，远端与拉杆313相连接，可为钢丝绳，亦可为钢丝，用于驱动打开或闭合钳头311；331为定位结构，近端接有导电连接器3311，用于与高频电源连接，经螺旋管323将高频电流流通至钳头端，闭合钳头311，用于电凝止血；332为芯杆，滑块333可以沿着芯杆332运动，沿芯杆推拉滑块333，可以打开和闭合钳头311。螺旋管323采用渐变螺距与等螺距相结合的结构，靠近远端的螺距较小，柔韧性较好，以方便整个止血钳通过内窥镜弯道，其中螺纹 管323靠近近端一侧的螺距较大，支撑性较好，方便医护人员将止血钳插入内窥镜腔道。而靠近滑块端一侧的螺纹管，保留部分非螺旋结构区域，方便推送。上述螺旋管也可以根据需求，将螺纹设置为等螺距结构、渐变螺距结构或多种等螺距结构相结合的螺纹结构。
在使用时，拉动滑块333，闭合钳头311，然后将止血钳远端插入内窥镜钳道，因止血钳远端螺旋管螺距较小，可以方便产品通过内窥镜远端弯曲结构，近端螺旋管螺距较大，相对刚性，方便医护人员将产品向内窥镜远端推送。当将止血钳送入内窥镜视野时，此时，可通过导电连接器3311接通高频电，利用螺旋管323的导电功能，将高频电流传送到钳头部，向近端拉动滑块333以闭合钳头311，进行电凝止血，外部绝缘层322可以起到绝缘保护作用。当出血点较严重影响手术视野时，可通过螺旋管323的空心管状部与拉索324形成的间隙腔道，通过鲁尔接头3312外接注射器进行液体注射冲洗出血部位的血液。
上所述仅是本申请的优选实施方式，使本领域技术人员能够理解或实现本申请的发明。对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本申请的精神或范围的情况下，在其他实施例中实现。因此，本申请将不会被限制在本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (13)

  1. 一种医用连接装置，其具有近端和远端，其特征在于，所述医用连接装置包括绝缘层和螺旋管，所述绝缘层覆于整个装置的最外层；所述螺旋管为可导电空心管状结构，所述螺旋管具有螺旋结构，所述螺旋结构具有从近端到远端方向渐变的螺距。
  2. 根据权利要求1所述的医用连接装置，其特征在于，所述螺距从近端到远端方向逐渐变小，远端相对较小的螺距使其具有柔性，易于通过医疗装置的弯道，近端相对较大的螺距，具有支撑性，方便向远端推送医疗器械。
  3. 根据权利要求1所述的医用连接装置，其特征在于，所述螺距从近端到远端方向由大逐渐变小再逐渐变大。
  4. 根据权利要求1所述的医用连接装置，其特征在于，所述螺距从近端到远端方向逐渐变大。
  5. 根据权利要求1所述的医用连接装置，其特征在于，所述螺旋管为具有导电性的材料。
  6. 根据权利要求1所述的医用连接装置，其特征在于，所述螺旋管从近端到远端整根具有螺旋结构。
  7. 根据权利要求1所述的医用连接装置，其特征在于，所述螺旋管的近端和远端可分别或同时具有部分非螺旋结构区域。
  8. 根据权利要求1所述的医用连接装置，其特征在于，所述连接装置还包括一个或多个密封件，所述密封件与所述螺旋管的远端或近端或与螺旋管的近端和远端同时相连。
  9. 根据权利要求8所述的医用连接装置，其特征在于，所述密封件为非平面结构。
  10. 根据权利要求9所述的医用连接装置，其特征在于，所述非平面结构为凹凸型，内凹型，凸起型，所述非平面结构的突出部分可以为半圆形，矩形，梯形，齿形。
  11. 根据权利要求1所述的医用连接装置，其特征在于，所述绝缘层采用高分子材料制成。
  12. 根据权利要求11所述的医用连接装置，其特征在于，所述高分子材料为聚四氟乙烯、氟乙烯丙烯共聚物、聚乙烯。
  13. 根据权利要求1所述的医用连接装置，其特征在于，所述绝缘层以热缩、焊接、粘贴等方式覆在螺旋管的外表面。
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