WO2024067296A1 - 双定位静脉曲张闭合手术输送装置、手术系统及方法 - Google Patents

双定位静脉曲张闭合手术输送装置、手术系统及方法 Download PDF

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Publication number
WO2024067296A1
WO2024067296A1 PCT/CN2023/120067 CN2023120067W WO2024067296A1 WO 2024067296 A1 WO2024067296 A1 WO 2024067296A1 CN 2023120067 W CN2023120067 W CN 2023120067W WO 2024067296 A1 WO2024067296 A1 WO 2024067296A1
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WO
WIPO (PCT)
Prior art keywords
tube
injection
positioning
intervention
optical fiber
Prior art date
Application number
PCT/CN2023/120067
Other languages
English (en)
French (fr)
Inventor
王思维
李佩鸿
苗铮华
Original Assignee
上海畅德医疗科技有限公司
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Application filed by 上海畅德医疗科技有限公司 filed Critical 上海畅德医疗科技有限公司
Publication of WO2024067296A1 publication Critical patent/WO2024067296A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00008—Vein tendon strippers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/091—Guide wires having a lumen for drug delivery or suction

Definitions

  • the present application belongs to the field of medical technology and relates to varicose vein closure surgery, for example, to a dual-positioning varicose vein closure surgery delivery device, a surgery system and a method.
  • varicose vein intracavitary closure surgical system in related technologies has a single instrument structure, usually requiring the use of ultrasound and other equipment for positioning, or the use of dilatation catheters to pass through narrow lesions.
  • the surgical cost is high, which is not conducive to product promotion.
  • the present application provides a dual-positioning varicose vein closure surgical delivery device, surgical system and method, which can use a dual-positioning structure to accurately deliver drugs, improve surgical effects, and meet various complex pathology treatment requirements, reducing the surgical costs for patients, especially complex patients, and has high safety, stability and reliability.
  • the present application provides a dual-position varicose vein closure surgery delivery device, the dual-position varicose vein closure surgery delivery device comprising a delivery unit and an injection unit;
  • the conveying unit includes a first positioning module and a second positioning module, the first positioning module includes an intervention tube and an optical fiber assembly, and the second positioning module includes a label tube, and a plurality of positioning marks are arranged on the surface of the label tube;
  • the injection unit is configured to inject medicine into the intervention tube, and the intervention tube is connected to the optical fiber assembly and then inserted into the label tube for dual positioning transmission.
  • the present application provides a dual-positioning varicose vein closure surgical system, wherein the surgical system comprises the dual-positioning varicose vein closure surgical delivery device described in the first aspect.
  • the present application provides a dual-positioning varicose vein closure surgical method, wherein the surgical method uses the dual-positioning varicose vein closure surgical system described in the second aspect to perform the surgery.
  • FIG1 is a schematic structural diagram of a dual-positioning varicose vein closure surgical system provided in Example 1 of the present application;
  • FIG2 is a schematic diagram of the structure of a first positioning module provided in Example 1 of the present application.
  • FIG3 is a schematic diagram of the internal structure of the interventional tube provided in Example 1 of the present application.
  • FIG4 is a schematic diagram of the connection between the glue gun, the first positioning module and the second positioning module provided in Example 1 of the present application;
  • FIG5 is a schematic diagram of the connection between the label tube and the expansion tube provided in Example 1 of the present application.
  • FIG6 is a schematic diagram of the structure of a glue gun provided in Example 1 of the present application.
  • FIG. 7 is a schematic diagram of a dual-positioning varicose vein closure surgical method provided in an embodiment of the present application.
  • 1-glue gun 11-push mechanism; 12-withdrawal mechanism; 13-drive trigger; 14-glue gun body; 2-first positioning module; 21-first fastening assembly; 22-control switch; 23-housing; 24-control power supply; 25-second fastening assembly; 26-intervention tube; 261-injection cavity; 262-optical fiber cavity; 263-light inlet; 27-light-emitting mechanism; 28-fixed sleeve; 29-optical fiber; 3-expansion tube; 31-third fastening assembly; 4-label tube; 41-positioning mark; 5-guide wire; 6-first syringe; 7-second syringe; 8-first needle; 9-second needle.
  • the terms “disposed”, “connected”, and “connected” should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components.
  • the specific meanings of the above terms in this application can be understood by specific circumstances.
  • the present application provides an efficient and easy-to-operate dual-positioning varicose vein closure surgical delivery device, including a delivery unit and an injection unit.
  • the delivery unit includes a first positioning module 2 and a second positioning module, the first positioning module 2 includes an intervention tube 26 and an optical fiber assembly, the second positioning module includes a label tube 4, and a plurality of positioning marks 41 are arranged on the surface of the label tube 4.
  • the injection unit is configured to inject a drug into the intervention tube 26, and the intervention tube 26 is connected to the optical fiber assembly and then inserted into the label tube 4 for dual-positioning transmission.
  • the dual-positioning varicose vein closure surgical delivery device in the present application is provided with two positioning modules, which form a positioning light spot in the interventional tube 26 through the optical fiber component, and a positioning mark 41 on the surface of the label tube 4, thereby realizing a dual-positioning structure and accurately delivering drugs, making the doctor's surgery clearer and helping to improve surgical efficiency.
  • the first positioning module 2 includes a housing 23, the intervention tube 26 is inserted in the housing 23, and the optical fiber assembly is fixed in the housing 23.
  • the two ends of the housing 23 are respectively provided with a first fastening assembly 21 and a second fastening assembly 25, the first fastening assembly 21 fixes the intervention tube 26 and the injection unit, and the second fastening assembly 25 fixes the intervention tube 26 and the label tube 4.
  • the first end of the interventional tube 26 is located in the shell 23, and the second end of the interventional tube 26 extends out of the shell 23.
  • the first fastening component 21 is configured to fixedly connect the injection unit and the portion of the interventional tube 26 located in the shell 23, and the second fastening component 25 is configured to fixedly connect the label tube 4 and the portion of the interventional tube 26 extending out of the shell 23.
  • the present application does not make any special requirements or specific limitations on the first fastening component and the second fastening component.
  • the first fastening component 21 can adopt a screw joint
  • the second fastening component 25 can adopt a screw cap.
  • the optical fiber assembly includes a light emitting mechanism 27 and an optical fiber filament 29 , and two ends of the optical fiber filament 29 are respectively connected to the light emitting mechanism 27 and the interventional tube 26 .
  • the optical fiber assembly further includes a fixed sleeve 28, and the optical fiber 29 passes through the fixed sleeve 28 and is connected to the light-emitting mechanism 27.
  • the head of the optical fiber 29 is fixed by the fixed sleeve 28, and the position of the optical fiber 29 with the light-emitting mechanism 27 is fixed, ensuring that the optical fiber 29 can transmit the maximum brightness to the interventional Tube 26 head end.
  • a control power supply 24 and a control switch 22 are further disposed in the housing 23, and the control switch 22 is electrically connected to the control power supply 24 and the light emitting mechanism 27.
  • the control switch 22 in the housing 23 is turned on, and the control power supply 24 provides energy to enable the light emitting mechanism 27 to start emitting light, which is transmitted to the head end of the intervention tube 26 through the optical fiber filament 29 to form a positioning light spot.
  • the intervention tube 26 is provided with an injection cavity 261 and an optical fiber cavity 262 which are independent of each other along the length direction, the injection cavity 261 runs through the intervention tube 26, the two ends of the optical fiber cavity 262 are blocked, and the injection cavity 261 is connected to the injection unit.
  • a light inlet 263 is provided on the side wall of the intervention tube 26, the light inlet 263 is connected to the optical fiber cavity 262, and the optical fiber assembly is connected to the light inlet 263. The end of the optical fiber filament 29 away from the light emitting mechanism 27 extends into the light inlet 263.
  • the injection cavity 261 and the optical fiber cavity 262 in the interventional tube 26 of the present application are independent of each other.
  • the injection cavity 261 passes through the interventional tube 26, and is configured to deliver the medicine injected by the injection unit to the diseased part; and both ends of the optical fiber cavity 262 are blocked, and the optical fiber filament 29 enters the optical fiber cavity 262 through the light inlet 263 opened on the side wall of the interventional tube 26, forming a positioning light spot, which can prevent the optical fiber filament 29 from contacting the blood in the blood vessel, thereby affecting the injection of the medicine.
  • the surface of the label tube 4 of the present application is provided with equidistant positioning marks 41, and a bright interventional tube 26 is inserted into the label tube 4.
  • the operator can position through the positioning marks 41 on the label tube 4, and at the same time position through the positioning light spot at the head end of the optical fiber 29, so as to achieve double positioning and improve the accuracy of drug delivery.
  • the delivery unit includes an expansion tube 3, the expansion tube 3 includes a tip portion and an expansion portion, and the expansion tube 3 extends from the tip portion into the label tube 4.
  • a third fastening component 31 is also provided at the joint between the tip portion and the expansion portion.
  • a fixing portion is provided at one end of the label tube 4, and the fixing portion is configured to fix the label tube 4 and the intervention tube 26, or fix the label tube 4 and the expansion tube 3.
  • the transport unit further includes a guide wire 5, and the guide wire 5 is configured to guide the label tube 4 into the diseased part.
  • the present application inserts the guide wire 5 into the human body and passes through the lesion site, the expansion tube 3 is inserted into the label tube 4, the third fastening component 31 on the expansion tube 3 is fixed with the label tube 4, and both enter the human body along the guide wire 5 at the same time. After the label tube 4 reaches the designated position, it stops entering. If a stenotic site is encountered, the expansion part of the expansion tube 3 can be passed through the site to dilate the blood vessels to ensure smooth passage.
  • the injection unit includes a glue gun 1 and at least two first injection components, the first injection components are detachably connected to the intervention tube 26, the first injection components are configured to contain medicine, and the glue gun 1 is configured to drive and discharge the medicine in the first injection components.
  • the glue gun 1 includes a glue gun main
  • the glue gun body 14 is provided with a placement groove, and the first injection assembly is placed in the placement groove.
  • the first injection component can be at least two groups. After the injection is completed, there is no need to adjust other accessories.
  • the first injection component can be directly replaced using a set of instruments, which can treat multiple groups of lesions at the same time and save surgical costs.
  • the dual-positioning varicose vein closure surgical delivery device provided in the present application is equipped with multiple sets of first injection components.
  • the same set of delivery devices can be used in the same operation.
  • Different first injection components can be directly replaced to continue the operation, which improves the surgical effect, reduces the surgical cost, and has higher stability.
  • the first injection assembly includes a detachably connected first syringe 6 and a first needle 8, the first syringe 6 is placed in the placement slot, and the first needle 8 extends into the intervention tube 26 to inject medicine.
  • the first syringe 6 is connected to the intervention tube 26 via the first fastening assembly 21.
  • the first needle 8 is assembled on the first syringe 6, and a certain amount of medicine is drawn and placed in the placement groove.
  • the first syringe 6 is connected to the intervention tube 26 through the first fastening component 21 of the shell 23, and the glue gun 1 provides a driving force to push the medicine in the first syringe 6 into the intervention tube 26.
  • the glue gun body 14 is also provided with a pushing mechanism 11, a retraction mechanism 12 and a driving trigger 13.
  • the pushing mechanism 11 is arranged at one end of the placement slot.
  • the pushing mechanism 11 pushes the first injection component to discharge the medicine into the interventional tube 26.
  • the pushing mechanism 11 is respectively connected to the driving trigger 13 and the retraction mechanism 12 through a rack.
  • the driving trigger 13 is pressed, the pushing mechanism 11 pushes the first injection component to move toward the interventional tube 26.
  • the retraction mechanism 12 is pressed, the pushing mechanism 11 moves away from the first injection component.
  • the present application provides a slide groove on the glue gun body 14, and the push mechanism 11 can reciprocate in the slide groove.
  • An active rack and a driven rack are provided in the glue gun body 14, and the active rack is respectively connected to the push mechanism 11 and the driving trigger 13, and the driven rack is respectively connected to the push mechanism 11 and the withdrawal mechanism 12.
  • the driving trigger 13 is pulled, the push mechanism 11 moves toward the direction close to the first injection component, pushing the first injection component to extrude the medicine.
  • the withdrawal mechanism 12 is pressed to withdraw the push mechanism 11, so as to facilitate the installation and removal of the first injection component.
  • the present application provides a dual-positioning varicose vein closure surgical system, wherein the surgical system includes the dual-positioning varicose vein closure surgical delivery device described in the first aspect.
  • the surgical system further includes a second injection assembly, which includes a detachably connected second syringe 7 and a second needle 9.
  • the volume of the second syringe 7 is smaller than the volume of the first syringe 6 of the injection unit, and the diameter of the second needle 9 is smaller than that of the first needle 8. diameter.
  • the surgical system of the present application includes a dual-positioning varicose vein closure surgical delivery device.
  • the first injection component plays the main role of delivering drugs to the diseased area.
  • the second injection component can be used to directly inject the diseased area for treatment, thereby improving the success rate of the operation.
  • the surgical system of the present application integrates functions such as precise positioning and delivery, injection of drugs, vascular dilation and closure effect inspection. It does not require equipment such as ultrasound or dilation catheters, which reduces the cost of surgery and helps to improve the success rate of surgery.
  • the present application provides a dual-positioning varicose vein closure surgical method, wherein the surgical method uses the dual-positioning varicose vein closure surgical system described in the second aspect to perform surgery, as shown in FIG7 , and the surgical method includes:
  • the label tube 4 is implanted into the diseased part, the medicine is injected into the intervention tube 26, the optical fiber is sent into the intervention tube 26 to form a positioning light spot, and then the intervention tube 26 is inserted into the label tube 4. According to the positioning mark 41 on the surface of the label tube 4, the medicine is injected into the affected area to close the blood vessels.
  • the surgical method specifically comprises the following steps:
  • the guide wire 5 is sent to the lesion part, and the dilation tube 3 is inserted into the label tube 4, and enters the human body along the guide wire 5 and moves to the lesion part;
  • the dilation tube 3 is taken out, and the control switch 22 in the housing 23 is turned on to start the light-emitting mechanism 27, which is transmitted through the optical fiber filament 29 and enters the optical fiber cavity 262 of the intervention tube 26 through the light inlet hole 263, so that a positioning light spot appears at the tip of the intervention tube 26;
  • the pushing mechanism of the glue gun 1 is pressed multiple times at regular intervals to inject the medicine into the diseased part.
  • the blood vessel is pressed to close it, and the label tube 4 is moved in the opposite direction of the injection to inject the next diseased part.
  • the spacing between the label tube surfaces and the pressing force of the glue gun push mechanism are The number of presses is determined according to the parameters evaluated before surgery, and depends on the cross-sectional area and length of the patient's diseased blood vessels. For different patients, the spacing can be set the same or different, and the number of presses can be the same or different.
  • the driving mechanism of the glue gun 1 that presses multiple times in the present invention refers to a driving mechanism that presses the glue gun 1 at least once.
  • the surgical method further comprises: after the injection is completed, a second injection component is used to perform a supplementary injection to the incompletely closed lesion.
  • a second injection component is used to directly inject the lesion into the lesion to improve the success rate of the operation.
  • the supplementary injection is performed by a glue gun injection or subcutaneous injection.
  • each blood vessel compression lasts for 10-20 seconds.
  • the time for pressing the blood vessel each time is 10-20 seconds, for example, it can be 10 seconds, 11 seconds, 12 seconds, 13 seconds, 14 seconds, 15 seconds, 16 seconds, 17 seconds, 18 seconds, 19 seconds or 20 seconds, but is not limited to the listed values, and other unlisted values within the numerical range are also applicable.
  • the system refers to an equipment system, a device system or a production device.
  • the pharmaceutical agent includes a binder.
  • the present embodiment provides a dual-positioning varicose vein closure surgery system, including a dual-positioning varicose vein closure surgery delivery device.
  • the dual-positioning varicose vein closure surgery delivery device includes an injection unit and a delivery unit, and the injection unit is configured to inject an adhesive into the delivery unit.
  • the delivery unit includes a first positioning module 2 and a second positioning module.
  • the first positioning module 2 includes a housing 23 and an intervention tube 26, and the intervention tube 26 is inserted into the housing 23.
  • the housing 23 has a first fastening component 21 and a second fastening component 25 at both ends, the first fastening component 21 is a screw joint, and the second fastening component 25 is a screw cap.
  • the housing 23 is provided with an optical fiber assembly, a control power supply 24 and a control switch 22.
  • the optical fiber assembly includes a light-emitting mechanism 27, an optical fiber filament 29 and a fixed sleeve 28.
  • the optical fiber filament 29 passes through the fixed sleeve 28 and is connected to the light-emitting mechanism 27.
  • the insertion tube 26 is provided with an injection cavity 261 and a light cavity 262 which are independent of each other along its length.
  • the fiber cavity 262 and the injection cavity 261 penetrate the intervention tube 26. Both ends of the fiber cavity 262 are blocked, and the injection cavity 261 is connected to the injection unit.
  • a light inlet 263 is provided on the side wall of the intervention tube 26. The light inlet 263 is connected to the fiber cavity 262.
  • the second positioning module includes a label tube 4, and a plurality of positioning marks 41 are equidistantly arranged on the surface of the label tube 4.
  • a fixing portion is arranged at one end of the label tube 4, and the intervention tube 26 is connected to the optical fiber assembly and inserted into the label tube 4, and is fixedly connected to the fixing portion by the second fastening assembly 25. Positioning is performed by the positioning mark 41 on the label tube 4 and the positioning light spot at the head end of the optical fiber filament 29, so as to achieve dual positioning.
  • the delivery unit also includes a guide wire 5 and an expansion tube 3.
  • the expansion tube 3 includes a tip portion and an expansion portion.
  • a third fastening component 31 is also provided at the joint between the tip portion and the expansion portion.
  • the expansion tube 3 extends from the tip portion into the label tube 4 and is fixedly connected to the fixing portion of the label tube 4 by the third fastening component 31.
  • the third fastening component 31 adopts a screw cap.
  • the guide wire 5 penetrates into the human body and passes through the lesion site.
  • the expansion tube 3 penetrates into the label tube 4, and both enter the human body along the guide wire 5 at the same time.
  • the injection unit includes a glue gun 1 and two groups of first injection components.
  • the glue gun 1 includes a glue gun body 14, and a placement groove is provided on the glue gun body 14.
  • the first injection component includes a detachably connected first syringe 6 and a first needle 8. The first syringe 6 is placed in the placement groove, and the first needle 8 extends into the intervention tube 26 and is fixedly connected by a first fastening component 21.
  • the glue gun body 14 is also provided with a pushing mechanism 11, a retracting mechanism 12 and a driving trigger 13.
  • the pushing mechanism 11 is provided at one end of the placement slot and is provided to push the first syringe 6 to discharge the adhesive into the intervention tube 26.
  • a slide groove is provided on the glue gun body 14, and the pushing mechanism 11 can reciprocate in the slide groove.
  • An active rack and a driven rack are provided in the glue gun body 14. The active rack is respectively connected to the pushing mechanism 11 and the driving trigger 13 in a transmission manner, and the driven rack is respectively connected to the pushing mechanism 11 and the retracting mechanism 12 in a transmission manner.
  • the pushing mechanism 11 moves in a direction close to the first syringe 6, and pushes the adhesive in the first syringe 6 to the intervention tube 26.
  • the retracting mechanism 12 is pressed, the pushing mechanism 11 moves in a direction away from the first syringe 6.
  • the surgical system further includes a second injection assembly, which is composed of a detachably connected second syringe 7 and a second needle 9.
  • the volume of the second syringe 7 is smaller than that of the first syringe 6, and the diameter of the second needle 9 is smaller than that of the first needle 8.
  • the first syringe 6 plays the main role of delivering the adhesive to the lesion site.
  • the second syringe 7 can be used to directly inject the lesion site for treatment, thereby improving the success rate of the operation.
  • the dual-positioning varicose vein closure surgery system provided in the embodiment is used to perform varicose vein closure surgery, which specifically includes the following steps:

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Abstract

一种双定位静脉曲张闭合手术输送装置、手术系统及方法，双定位静脉曲张闭合手术输送装置包括输送单元与注射单元，输送单元包括第一定位模块（2）与第二定位模块，第一定位模块（2）包括介入管（26）与光纤组件，第二定位模块包括标签管（4），标签管（4）的表面设置有多个定位标记（41），注射单元设置为向介入管（26）内注入药剂，介入管（26）连接光纤组件后插入标签管（4）内进行双定位传输。

Description

双定位静脉曲张闭合手术输送装置、手术系统及方法
本申请要求申请日为2022年9月26日、申请号为202211176245.0的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请属于医疗技术领域，涉及静脉曲张闭合手术，例如涉及一种双定位静脉曲张闭合手术输送装置、手术系统及方法。
背景技术
由于人们生活习惯的改变，静脉曲张的患者越来越多，医院的静脉曲张治疗手术量也逐年增长。但相关技术中的静脉曲张腔内闭合手术系统器械结构单一，通常需要借助超声等设备定位，或借助扩张导管穿过狭窄病变，手术成本较高，不利于产品推广。
发明内容
本申请提供了一种双定位静脉曲张闭合手术输送装置、手术系统及方法，能够采用双定位结构精准输送药剂，提高手术效果，且能满足各种复杂病理治疗要求，降低了病人，尤其是复杂病人的手术成本，具有较高的安全性、稳定性及可靠性。
第一方面，本申请提供了一种双定位静脉曲张闭合手术输送装置，所述双定位静脉曲张闭合手术输送装置包括输送单元与注射单元；
所述输送单元包括第一定位模块与第二定位模块，所述第一定位模块包括介入管与光纤组件，所述第二定位模块包括标签管，所述标签管的表面设置有多个定位标记；
所述注射单元设置为向所述介入管内注入药剂，所述介入管连接所述光纤组件后插入所述标签管内进行双定位传输。
第二方面，本申请提供了一种双定位静脉曲张闭合手术系统，所述手术系统包括第一方面所述的双定位静脉曲张闭合手术输送装置。
第三方面，本申请提供的一种双定位静脉曲张闭合手术方法，所述手术方法采用第二方面所述的双定位静脉曲张闭合手术系统进行手术，所述手术方法 包括：
将标签管植入至病变部分；向介入管内注入药剂；将光纤送入介入管内形成定位光点；将介入管插入至标签管内，并根据标签管表面的定位标记，将药剂注入患处后进行血管闭合。
附图说明
图1为本申请实施例1提供的双定位静脉曲张闭合手术系统的结构示意图；
图2为本申请实施例1提供的第一定位模块的结构示意图；
图3为本申请实施例1提供的介入管的内部结构示意图；
图4为本申请实施例1提供的胶枪、第一定位模块与第二定位模块的连接示意图；
图5为本申请实施例1提供的标签管与扩张管的连接示意图；
图6为本申请实施例1提供的胶枪的结构示意图；
图7是本申请一实施例提供的双定位静脉曲张闭合手术方法的示意图。
其中，1-胶枪；11-推送机构；12-回撤机构；13-驱动扳机；14-胶枪主体；2-第一定位模块；21-第一紧固组件；22-控制开关；23-壳体；24-控制电源；25-第二紧固组件；26-介入管；261-注射腔；262-光纤腔；263-进光孔；27-发光机构；28-固定管套；29-光纤丝；3-扩张管；31-第三紧固组件；4-标签管；41-定位标记；5-导引导丝；6-第一注射器；7-第二注射器；8-第一针头；9-第二针头。
具体实施方式
需要理解的是，在本申请的描述中，术语“中心”、“上”、“下”、“前”、“后”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”等的特征可以明示或者隐含地包括一个或者更多个该特征。在本申请的描述中，除非另有说明，“多个”的含义是 两个或两个以上。
需要说明的是，在本申请的描述中，除非另有明确的规定和限定，术语“设置”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以通过具体情况理解上述术语在本申请中的具体含义。
下面结合附图并通过具体实施方式来进一步说明本申请的技术方案。
在一个具体实施方式中，本申请提供了一种高效的、便于操作的双定位静脉曲张闭合手术输送装置，包括输送单元与注射单元。所述输送单元包括第一定位模块2与第二定位模块，所述第一定位模块2包括介入管26与光纤组件，所述第二定位模块包括标签管4，所述标签管4的表面设置有多个定位标记41，所述注射单元设置为向所述介入管26内注入药剂，所述介入管26连接所述光纤组件后插入所述标签管4内进行双定位传输。
本申请中的双定位静脉曲张闭合手术输送装置，设置两种定位模块，通过光纤组件在介入管26内形成定位光点，以及标签管4表面的定位标记41，实现双定位结构，精准输送药剂，使得医生手术更加清晰，有利于提高手术效率。
在一些实施方式中，所述第一定位模块2包括壳体23，所述介入管26插设于所述壳体23内，所述光纤组件固定于所述壳体23内。所述壳体23的两端分别设置有第一紧固组件21与第二紧固组件25，所述第一紧固组件21固定所述介入管26与所述注射单元，所述第二紧固组件25固定所述介入管26与所述标签管4。
本申请中介入管26的第一端位于壳体23内，介入管26的第二端伸出壳体23，第一紧固组件21设置为固定连接注射单元与介入管26位于壳体23的部分，第二紧固组件25设置为固定连接标签管4与介入管26伸出壳体23的部分。
本申请对于第一紧固组件与第二紧固组件不作特殊要求或具体限定，在一些实施方式中，第一紧固组件21可采用螺旋接头，第二紧固组件25可采用螺旋帽。
在一些实施方式中，所述光纤组件包括发光机构27与光纤丝29，所述光纤丝29的两端分别连接所述发光机构27与所述介入管26。
在一些实施方式中，所述光纤组件还包括固定管套28，所述光纤丝29穿过所述固定管套28后连接所述发光机构27。光纤丝29头部通过固定管套28进行固定，且与发光机构27的位置是固定的，确保光纤丝29能将最大光亮传递到介入 管26头端。
在一些实施方式中，所述壳体23内还设置有控制电源24与控制开关22，所述控制开关22分别电性连接所述控制电源24与所述发光机构27。本申请中打开壳体23内的控制开关22，控制电源24提供能量，以使得发光机构27开启发光，通过光纤丝29传递到介入管26的头端，形成定位光点。
在一些实施方式中，所述介入管26内沿长度方向设置有相互独立的注射腔261与光纤腔262，所述注射腔261贯穿所述介入管26，所述光纤腔262的两端封堵，所述注射腔261连通所述注射单元。所述介入管26的侧壁开设有进光孔263，所述进光孔263连通所述光纤腔262，所述光纤组件接入所述进光孔263。所述光纤丝29远离所述发光机构27的一端伸入所述进光孔263内。
本申请的介入管26内的注射腔261与光纤腔262相互独立，注射腔261贯通介入管26，设置为将由注射单元注入的药剂输送至病变部分；而光纤腔262的两端封堵，光纤丝29通过介入管26侧壁开设的进光孔263进入到光纤腔262内，形成定位光点，能够避免光纤丝29与血管血液接触，进而影响注射药剂。
本申请的标签管4表面设置等距的定位标记41，且带有光亮的介入管26插入到标签管4内，术者可通过标签管4上定位标记41进行定位，同时通过光纤丝29头端的定位光点进行定位，以实现双重定位，提高药剂输送的精准度。
在一些实施方式中，所述输送单元包括扩张管3，所述扩张管3包括尖端部与扩张部，所述扩张管3由所述尖端部伸入所述标签管4内。所述尖端部与所述扩张部的对接处还设置有第三紧固组件31。所述标签管4的一端设置有固定部，所述固定部设置为固定所述标签管4与所述介入管26，或固定所述标签管4与所述扩张管3。
在一些实施方式中，所述输送单元还包括导引导丝5，所述导引导丝5设置为引导所述标签管4进入病变部分。
在注射药剂前，本申请将导引导丝5穿进人体中，并穿过病变部位，扩张管3穿进标签管4中，扩张管3上的第三紧固组件31与标签管4固定，两者同时沿着导引导丝5进入人体，标签管4到达指定位置后，停止穿进。若遇到狭窄部位，可通过扩张管3的扩张部穿过该部位进行血管扩张，保证顺利通过。
在一些实施方式中，所述注射单元包括胶枪1与至少两组第一注射组件，所述第一注射组件可拆卸连接所述介入管26，所述第一注射组件设置为容纳药剂，所述胶枪1设置为驱动排出所述第一注射组件内的药剂。所述胶枪1包括胶枪主 体14，所述胶枪主体14上设置有放置槽，所述第一注射组件置于所述放置槽内。
本申请中第一注射组件可以为至少两组，在注射结束后，无需调整其他附件，使用一套器械，直接将第一注射组件进行更换，能够同时治疗多组病变部位，节省手术成本。
本申请提供的双定位静脉曲张闭合手术输送装置配备有多组第一注射组件，可在同一台手术中，利用同一套输送装置，另外，对多条病变血管同时进行手术时，无需更换胶枪1，可直接替换不同的第一注射组件继续进行手术，提高了手术效果，降低手术成本，且具有较高的稳定性。
在一些实施方式中，所述第一注射组件包括可拆卸连接的第一注射器6与第一针头8，所述第一注射器6置于所述放置槽内，所述第一针头8伸入所述介入管26内注入药剂。所述第一注射器6通过所述第一紧固组件21连接所述介入管26。
本申请将第一针头8组装在第一注射器6上，抽取一定量的药剂后置于放置槽内，第一注射器6通过壳体23的第一紧固组件21连接介入管26，胶枪1提供推动力将在第一注射器6内的药剂推送至介入管26内。
在一些实施方式中，所述胶枪主体14上还设置有推送机构11、回撤机构12与驱动扳机13，所述推送机构11设置于所述放置槽的一端，所述推送机构11推动所述第一注射组件向所述介入管26内排出药剂，所述推送机构11分别与所述驱动扳机13与所述回撤机构12通过齿条连接，按压所述驱动扳机13，所述推送机构11推动所述第一注射组件向靠近所述介入管26的方向移动，按压所述回撤机构12，所述推送机构11向远离所述第一注射组件的方向移动。
本申请在胶枪主体14上开设滑槽，推送机构11可在滑槽内进行往复运动。胶枪主体14内设置主动齿条与从动齿条，主动齿条分别与推送机构11和驱动扳机13传动连接，从动齿条分别与推送机构11和回撤机构12传动连接。扣动驱动扳机13，推送机构11向靠近第一注射组件的方向移动，推动第一注射组件挤出药剂，在结束注射后，按动回撤机构12，将推送机构11回撤，方便安装及取出第一注射组件。
在另一个具体实施方式中，本申请提供了一种双定位静脉曲张闭合手术系统，所述手术系统包括第一方面所述的双定位静脉曲张闭合手术输送装置。
在一些实施方式中，所述手术系统还包括第二注射组件，所述第二注射组件包括可拆卸连接的第二注射器7与第二针头9。所述第二注射器7的容积小于所述注射单元的第一注射器6的容积，所述第二针头9的直径小于所述第一针头8的 直径。
本申请的手术系统包括双定位静脉曲张闭合手术输送装置，在手术过程中，第一注射组件起到主要输送药剂到病变部位的作用，在手术结束前，医生检查手术效果时，若发现未完全闭合的部位，可采用第二注射组件对病变部位直接注射治疗，提高了手术成功率。
需要说明的是，本申请的手术系统集成了精准定位输送、注射药剂、扩张血管和闭合效果检查等功能，无需配备超声等设备或扩张导管，降低了手术成体，同时有利于提高手术成功率。
在另一个具体实施方式中，本申请提供的一种双定位静脉曲张闭合手术方法，所述手术方法采用第二方面所述的双定位静脉曲张闭合手术系统进行手术，如图7所示，所述手术方法包括：
将标签管4植入至病变部分，向介入管26内注入药剂，将光纤送入介入管26内形成定位光点，再将介入管26插入至标签管4内，根据标签管4表面的定位标记41，将药剂注入患处后进行血管闭合。
在一些实施方式中，所述手术方法具体包括如下步骤：
(1)将导引导丝5送至病变部分，并将扩张管3插入标签管4内，沿着导引导丝5进入人体并移动至病变部分；
(2)利用第一注射组件抽取药剂，按压胶枪1的回撤机构12，将装有药剂的第一注射组件置于放置槽内，并连接介入管26，向所述介入管26内注射药剂，排出介入管26内的空气；
(3)随后取出所述扩张管3，开启壳体23内的控制开关22，启动发光机构27，通过光纤丝29传递，并由进光孔263进入所述介入管26的光纤腔262内，使得介入管26的头端呈现定位光点；
(4)将介入管26插入标签管4内，在定位光点的引导下，沿导引导丝5，将所述介入管26移动至病变部分，随后固定所述介入管26与所述标签管4，并取出导引导丝5；
(5)根据所述标签管4表面的定位标记41，每隔一定间距，按压多次的胶枪1的推动机构，将药剂注入病变部分，注射结束后，按压血管进行闭合，将标签管4沿注射相反方向移动，进行下一个病变部分的注射。
需要说明的是，步骤(5)中，标签管表面的间距，以及胶枪推动机构的按 压次数根据手术前评估的参数决定，取决于患者病变血管的截面积及长度，针对不同的患者，间距的设置可相同，也可不同，同时按压次数可相同，也可不同。本发明中所述的按压多次的胶枪1的推动机构是指进行至少一次按压胶枪1的推动机构。
在一些实施方式中，所述手术方法还包括：在注射完成后，采用第二注射组件向未完全闭合的病变部分进行补充注射。在手术结束前，医生检查手术效果时，若发现未完全闭合的部位，采用第二注射组件对病变部位直接注射治疗，提高了手术成功率。所述补充注射为采用胶枪注射或皮下注射。
在一些实施方式中，每次按压血管的时间为10-20s。
在一实施例中，每次按压血管的时间为10-20s，例如可以是10s、11s、12s、13s、14s、15s、16s、17s、18s、19s或20s，但并不仅限于所列举的数值，该数值范围内其他未列举的数值同样适用。
所述系统是指设备系统、装置系统或生产装置。
在一些实施方式中，所述药剂包括粘合剂。
本申请提供的一种双定位静脉曲张闭合手术输送装置、手术系统及方法，设置两种定位模块，通过光纤组件在介入管26内形成定位光点，以及标签管4表面的定位标记41，实现双定位结构，精准输送药剂，使得医生手术更加清晰，有利于提高手术效率，能满足多种复杂病理治疗要求，降低了病人，尤其是复杂病人的手术成本。
实施例1
本实施例提供了一种双定位静脉曲张闭合手术系统，包括双定位静脉曲张闭合手术输送装置。如图1所示，双定位静脉曲张闭合手术输送装置包括注射单元与输送单元，注射单元设置为向输送单元注入粘合剂。输送单元包括第一定位模块2与第二定位模块。
如图2所示，第一定位模块2包括壳体23与介入管26，介入管26插设于壳体23内。壳体23的两端分别设置有第一紧固组件21与第二紧固组件25，第一紧固组件21为螺旋接头，第二紧固组件25为螺旋帽。
壳体23内设置有光纤组件、控制电源24与控制开关22。光纤组件包括发光机构27、光纤丝29与固定管套28，光纤丝29穿过固定管套28后连接发光机构27。
如图3所示，介入管26内沿自身长度方向设置有相互独立的注射腔261与光 纤腔262，注射腔261贯穿介入管26，光纤腔262的两端封堵，注射腔261连通注射单元。介入管26的侧壁开设有进光孔263，进光孔263连通光纤腔262，打开壳体23内的控制开关22，控制电源24提供能量，以使得发光机构27开启发光，通过光纤丝29由进光孔263传递到光纤腔262，形成定位光点。
如图4所述，第二定位模块包括标签管4，标签管4表面等距设置有多个定位标记41。标签管4的一端设置有固定部，介入管26连接光纤组件后插入标签管4内，并通过第二紧固组件25固定连接固定部。通过标签管4上定位标记41，以及光纤丝29头端的定位光点进行定位，以实现双重定位。
如图1和图5所示，输送单元还包括导引导丝5与扩张管3，扩张管3包括尖端部与扩张部，尖端部与扩张部的对接处还设置有第三紧固组件31。扩张管3由尖端部伸入标签管4内，并通过第三紧固组件31进行固定连接标签管4的固定部，第三紧固组件31采用螺旋帽。导引导丝5穿进人体中，并穿过病变部位，扩张管3穿进标签管4中，两者同时沿着导引导丝5进入人体。
如图1和图6所示，注射单元包括胶枪1与两组第一注射组件，胶枪1包括胶枪主体14，胶枪主体14上设置有放置槽，第一注射组件包括可拆卸连接的第一注射器6与第一针头8，第一注射器6置于放置槽内，第一针头8伸入介入管26内，并通过第一紧固组件21固定连接。
胶枪主体14上还设置有推送机构11、回撤机构12与驱动扳机13，推送机构11设置于放置槽的一端，设置为推动第一注射器6向介入管26内排出粘合剂。在胶枪主体14上开设滑槽，推送机构11可在滑槽内进行往复运动。胶枪主体14内设置主动齿条与从动齿条，主动齿条分别与推送机构11和驱动扳机13传动连接，从动齿条分别与推送机构11和回撤机构12传动连接。扣动驱动扳机13，推送机构11向靠近第一注射器6的方向移动，将在第一注射器6内的粘合剂推送至介入管26，按压回撤机构12，推送机构11向远离第一注射器6的方向移动。
如图1所示，手术系统还包括第二注射组件，第二注射组件由可拆卸连接的第二注射器7与第二针头9组成。第二注射器7的容积小于第一注射器6的容积，第二针头9的直径小于第一针头8的直径。在手术过程中，第一注射器6起到主要输送粘合剂到病变部位的作用，在手术结束前，医生检查手术效果时，若发现未完全闭合的部位，可采用第二注射器7对病变部位直接注射治疗，提高了手术成功率。
应用例1
本应用例中采用实施例提供的双定位静脉曲张闭合手术系统进行静脉曲张闭合手术，具体包括如下步骤：
(1)将导引导丝5植入人体内，并穿过病变部位，将扩张管3插入标签管4内，通过第三紧固组件31(螺旋帽)进行固定，同时沿着导引导丝5进入人体并移动至病变部分，标签管4到达指定位置后，停止穿进；
(2)利用第一注射器6抽取粘合剂，组装第一针头8，按压胶枪1的回撤机构12，将装有粘合剂的第一注射器6置于放置槽内，并连接介入管26，通过第一紧固组件21(螺旋接头)固定，向介入管26内注射粘合剂，排出介入管26内的空气；
(3)松开第三紧固组件31，随后取出扩张管3；
(4)开启壳体23内的控制开关22，启动发光机构27，通过光纤丝29传递，并由进光孔263进入介入管26的光纤腔262内，使得介入管26的头端呈现定位光点；
(5)将介入管26插入标签管4内，在定位光点的引导下，沿导引导丝5，将介入管26移动至病变部分，随后利用第二紧固组件25固定介入管26与标签管4，并取出导引导丝5；
(6)根据标签管4表面的定位标记41，每隔3cm的间距，按压胶枪1的推动机构两次，将粘合剂注入病变部分，注射结束后，按压血管15s进行闭合，将标签管4沿注射相反方向移动，进行下一个病变部分的注射；
(7)在注射完成后，组装第二注射器7与第二针头9，并抽取粘合剂，采用第二注射器7向未完全闭合的病变部分进行皮下注射。

Claims (10)

  1. 一种双定位静脉曲张闭合手术输送装置，包括：
    输送单元，所述输送单元包括第一定位模块与第二定位模块，所述第一定位模块包括介入管与光纤组件，所述第二定位模块包括标签管，所述标签管的表面设置有多个定位标记；
    注射单元，所述注射单元设置为向所述介入管内注入药剂，所述介入管连接所述光纤组件后插入所述标签管内进行双定位传输。
  2. 根据权利要求1所述的双定位静脉曲张闭合手术输送装置，其中，所述第一定位模块包括壳体，所述介入管插设于所述壳体内，所述光纤组件固定于所述壳体内；
    所述壳体的两端分别设置有第一紧固组件与第二紧固组件，所述第一紧固组件设置为固定所述介入管与所述注射单元，所述第二紧固组件设置为固定所述介入管与所述标签管；
    所述光纤组件包括发光机构与光纤丝，所述光纤丝的两端分别连接所述发光机构与所述介入管；
    所述光纤组件还包括固定管套，所述光纤丝穿过所述固定管套后连接所述发光机构；
    所述壳体内还设置有控制电源与控制开关，所述控制开关分别电性连接所述控制电源与所述发光机构。
  3. 根据权利要求2所述的双定位静脉曲张闭合手术输送装置，其中，所述介入管内沿长度方向设置有相互独立地注射腔与光纤腔，所述注射腔贯穿所述介入管，所述光纤腔的两端封堵，所述注射腔连通所述注射单元；
    所述介入管的侧壁开设有进光孔，所述进光孔连通所述光纤腔，所述光纤组件接入所述进光孔；
    所述光纤丝远离所述发光机构的一端伸入所述进光孔内。
  4. 根据权利要求1-3任一项所述的双定位静脉曲张闭合手术输送装置，其中，所述输送单元包括扩张管，所述扩张管包括尖端部与扩张部，所述扩张管由所述尖端部伸入所述标签管内；
    所述尖端部与所述扩张部的对接处还设置有第三紧固组件；
    所述标签管的一端设置有固定部，所述固定部设置为固定所述标签管与所述介入管，或固定所述标签管与所述扩张管；
    所述输送单元还包括导引导丝，所述导引导丝设置为引导所述标签管进入 病变部分。
  5. 根据权利要求1-4任一项所述的双定位静脉曲张闭合手术输送装置，其中，所述注射单元包括胶枪与至少两组第一注射组件，所述第一注射组件可拆卸连接所述介入管，所述第一注射组件设置为容纳药剂，所述胶枪设置为驱动排出所述第一注射组件内的药剂；
    所述胶枪包括胶枪主体，所述胶枪主体上设置有放置槽，所述第一注射组件置于所述放置槽内；
    所述第一注射组件包括可拆卸连接的第一注射器与第一针头，所述第一注射器置于所述放置槽内，所述第一针头伸入所述介入管内注入药剂；
    所述第一注射器通过所述第一紧固组件连接所述介入管。
  6. 根据权利要求5所述的双定位静脉曲张闭合手术输送装置，其中，所述胶枪主体上还设置有推送机构、回撤机构与驱动扳机；
    所述推送机构设置于所述放置槽的一端，所述推送机构设置为推动所述第一注射组件向所述介入管内排出药剂；
    所述推送机构分别与所述驱动扳机和所述回撤机构通过齿条连接，所述推送机构设置为当按压所述驱动扳机时，推动所述第一注射组件向靠近所述介入管的方向移动，所述推送机构设置为当按压所述回撤机构时，向远离所述第一注射组件的方向移动。
  7. 一种双定位静脉曲张闭合手术系统，包括权利要求1-6任一项所述的双定位静脉曲张闭合手术输送装置。
  8. 根据权利要求7所述的手术系统，还包括第二注射组件，所述第二注射组件包括可拆卸连接的第二注射器与第二针头；
    所述第二注射器的容积小于所述注射单元的第一注射器的容积，所述第二针头的直径小于所述第一针头的直径。
  9. 一种双定位静脉曲张闭合手术方法，所述手术方法采用权利要求7或8所述的双定位静脉曲张闭合手术系统进行手术，所述手术方法包括：
    将标签管植入至病变部分；
    向介入管内注入药剂；
    将光纤送入所述介入管内形成定位光点；
    将所述介入管插入至所述标签管内，并根据所述标签管表面的定位标记，将药剂注入至病变部分后进行血管闭合。
  10. 根据权利要求9所述的手术方法，其中，所述手术方法具体包括如下步骤：
    所述将标签管植入至病变部分包括：将导引导丝送至病变部分，并将扩张管插入标签管内，沿着导引导丝进入人体并移动至病变部分；
    所述向介入管内注入药剂包括：利用第一注射组件抽取药剂，按压胶枪的回撤机构，将装有药剂的第一注射组件置于放置槽内，并连接介入管，向所述介入管内注射药剂，排出介入管内的空气；
    所述将光纤送入所述介入管内形成定位光点包括：取出所述扩张管，开启壳体内的控制开关，启动发光机构，通过光纤丝传递，并通过进光孔进入所述所述介入管的光纤腔内，使得所述介入管的头端呈现定位光点；
    将所述介入管插入所述标签管内，在定位光点的引导下，沿导引导丝，将所述所述介入管移动至病变部分，固定所述所述介入管与所述标签管，并取出所述导引导丝；
    根据所述标签管表面的定位标记，每隔预设间距，按压多次胶枪的推动机构，将药剂注入病变部分，注射结束后，按压血管进行闭合，将所述标签管沿注射相反方向移动，进行下一个病变部分的注射；及
    在注射完成后，采用第二注射组件向未完全闭合的病变部分进行补充注射；
    其中，所述补充注射为采用所述胶枪注射或皮下注射；每次按压血管的时间为10-20s；所述药剂包括粘合剂。
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