WO2023005082A1 - 一种用于阴道的负压治疗装置及其制造方法 - Google Patents

一种用于阴道的负压治疗装置及其制造方法 Download PDF

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Publication number
WO2023005082A1
WO2023005082A1 PCT/CN2021/134050 CN2021134050W WO2023005082A1 WO 2023005082 A1 WO2023005082 A1 WO 2023005082A1 CN 2021134050 W CN2021134050 W CN 2021134050W WO 2023005082 A1 WO2023005082 A1 WO 2023005082A1
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drainage
tube
strip
negative pressure
distal end
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PCT/CN2021/134050
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English (en)
French (fr)
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万绵水
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万绵水
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    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/14—Female reproductive, genital organs
    • A61M2210/1475—Vagina

Definitions

  • the invention relates to the technical field of medical devices, in particular to a negative pressure therapy device for vagina and a manufacturing method thereof.
  • Vaginal laceration refers to the tearing injury of the perineum and vagina caused by various reasons. Vaginal lacerations are more common in two situations: one is caused by obstetric delivery, and the other is caused by trauma and other reasons. Vaginal lacerations caused by vaginal delivery in obstetrics are more common, which can occur during natural childbirth or damage caused by some instrument manipulation during childbirth. Childbirth is the main cause of vulva and vaginal trauma; poor vaginal development, rough sexual intercourse , can also cause vaginal opening and vaginal laceration; trauma to other parts such as pelvic injury can also affect the bladder, urethra, vagina or vulva.
  • Vulvar wounds are often bandaged under pressure after surgery, and the vagina is stuffed with oily gauze. Patients often complain of pain. Pain relief should be given as directed by the doctor. Give active treatment and keep the vulva clean and dry.
  • wounds on the human body surface caused by trauma, surgery or other reasons, after bandaging and treatment of this type of wound, the wound will not heal immediately, but need to go through necrosis, exudation, and healing period.
  • the traditional method is to use medical supplies such as cotton gauze to bandage the wound.
  • the bandaged wound can resist bacterial infection to a certain extent, the environment with poor air permeability is not conducive to wound repair, and the wound surface will be damaged during the repair process.
  • the metabolites and secretions in the wound cannot be drained and eliminated in time, which will affect the wound repair and delay the wound healing cycle.
  • Vacuum Sealing Drainage refers to a technique originally developed by Dr. W Fleischman in Germany in the early 1990s and applied to soft tissue wounds. The drained area is closed with a permeable adhesive film to isolate it from the outside world, and a high negative pressure source is connected to form an efficient drainage system.
  • the present invention provides a negative pressure treatment device for the vagina to solve the problem of uneven drainage and drug administration in the prior art when using negative pressure drainage to treat vaginal lacerations and affecting the therapeutic effect.
  • the present invention also provides a manufacturing method for a vaginal negative pressure treatment device, which is used for manufacturing the above device.
  • the present invention provides a negative pressure therapy device for vagina, comprising:
  • a drainage strip, the two ends of the drainage strip are respectively covered with a layer of impermeable membrane;
  • Drainage tube the proximal end of the drainage tube has a drainage section, the drainage section is inserted into the drainage strip from the far end to drain the drainage strip, and the distal end of the drainage tube is externally connected to a negative pressure device;
  • a supply tube the proximal end of the supply tube has a drug delivery segment, the drug delivery segment is inserted into the drainage strip from the distal end for administering drugs to the drainage strip, and the distal end of the supply tube is externally connected to a drug delivery device.
  • the distal end of the drainage strip is provided with a blind hole along its axial direction, the drainage section of the drainage tube is inserted into the blind hole, and a plurality of drainage holes are opened on the wall of the drainage section of the drainage tube;
  • It also includes a support tube, the support tube is coaxially arranged in the drainage section of the drainage tube, the distal end of the support tube passes through the tube wall of the drainage tube, and several diameters are arranged between the drainage section of the drainage tube and the support tube.
  • a connecting tube with the outer end tilted far away, and the two ends of the connecting tube respectively pass through the tube walls of the drainage tube and the support tube;
  • the supply pipe is installed in the support pipe, and the distal end of the supply pipe passes through the distal end of the support pipe.
  • shunt pipes whose radially outer ends are inclined to the far side.
  • the ends of the shunt pipes are provided with cone tips, and each of the shunt pipes penetrates into each of the connecting pipes in one-to-one correspondence.
  • the distal end of the support pipe is provided with a first joint
  • the first joint is provided with a first external thread
  • the supply pipe is provided with a second joint near the first joint
  • the second A second external thread is provided on the outside of the joint, and the first external thread and the second external thread have opposite directions of rotation
  • An adjusting nut is also included, and the adjusting nut is sleeved on the outside of the first joint and the second joint, and is threadedly engaged with the first external thread and the second external thread respectively.
  • drainage tube, support tube and connection tube are integrally injection-molded with silica gel
  • supply tube and shunt tube are integrally injection-molded with silica gel.
  • a tapered surface is provided on the side of the connecting tube facing the proximal end.
  • the soft rubber plug body includes a sleeve and a retaining ring integrally connected to the distal end of the sleeve, the sleeve is sleeved outside the drainage tube, and passes through the drainage tube at the same time.
  • the water-impermeable membrane at the far end of the drainage strip is inserted into the drainage strip, and the retaining ring is close to the outside of the water-impermeable membrane at the end.
  • the soft rubber plug body is made of silica gel.
  • the drainage strip adopts polyvinyl alcohol foam sponge.
  • the present invention provides a method for manufacturing a negative pressure therapy device for the vagina, which is used to manufacture the above-mentioned negative pressure therapy device for the vagina, including the steps of manufacturing a drainage strip, manufacturing a drainage tube-support tube-supply tube steps and assembly steps;
  • the manufacturing steps of the drainage strip are as follows: apply a release agent on the inner wall of a rectangular mold, and then apply a layer of silica gel coating on the inner walls of the two sides of the rectangular mold, and the distance between the two sides coated with the silica gel coating Equal to the design length of the drainage strip, then pour the reaction solution into the rectangular mold for curing to obtain a sponge block, and at the same time, the silica gel solidifies on both sides of the sponge block to form an impermeable film; after demoulding, wash the sponge block repeatedly until the pH is 4 ⁇ 5; Cut the cleaned sponge block into a drainage strip; use a sponge punching device to process a blind hole at one end of the drainage strip;
  • the manufacturing steps of the drainage tube-support tube-supply tube are: integral injection molding of the drainage tube, support tube and connecting tube; integral injection molding of the supply tube and shunt tube; inserting the injection-molded supply tube into the support tube, and placing each shunt tube one by one Correspondingly insert each connecting pipe;
  • the assembly steps are as follows: put a soft rubber plug body on the assembled drainage tube-support tube-supply tube; insert the drainage tube-support tube-supply tube into the blind hole of the formed drainage strip; put the soft rubber The sleeve of the plug body is pressed between the drainage tube and the inner wall of the blind hole until the retaining ring of the soft rubber plug body is against the water-impermeable membrane at the end of the drainage strip; the supply tube is pulled to the far end so that the supply tube is opposite to the support tube Move until the shunt outside the supply tube passes through the drain and inserts the drain strip.
  • the sponge perforating device includes:
  • a punching mechanism includes a guide rail, a motor base, a motor and a drill rod
  • the guide rail is fixed on the base
  • the motor base is slidably installed on the guide rail
  • the motor is fixed on the motor base
  • the drill rod is coaxially fixed to the output end of the motor
  • a positioning mechanism the positioning mechanism includes a base and an upper cover, the base is fixed on the base, the upper cover is covered on the base, and a limit for fixing the drainage strip is formed between the base and the upper cover cavity, and the side wall at one end of the limiting cavity is provided with a relief hole through which the drill rod passes.
  • the beneficial effect of the present invention is reflected in: when the application treats vaginal wounds, the drainage strip is placed in the vagina, and since the two ends of the drainage strip are sealed by a water-impermeable membrane, the liquid cannot pass through the two ends of the drainage strip.
  • the drainage tube is externally connected Negative pressure device, the negative pressure device drains the drainage strip through the drainage tube, and a negative pressure is formed in the drainage strip, and the liquid exuded from the vaginal wall wound can only be drained out through the peripheral surface of the drainage strip, so as to ensure uniform drainage.
  • the tube is externally connected with a drug delivery device, and the drug delivery device supplies drugs to the drainage strip through the supply tube, and the supplied medicinal solution can be transported to the vaginal wall through the peripheral surface of the drainage strip, so as to ensure uniform drug administration. Therefore, the present application solves the problem of uneven drainage and drug administration and affecting the therapeutic effect when negative pressure drainage is used to treat vaginal lacerations in the prior art.
  • Fig. 1 is the three-dimensional structure schematic diagram of the embodiment of the present invention.
  • Fig. 2 is an internal cross-sectional view of a drainage strip according to an embodiment of the present invention.
  • Fig. 3 is the cross-sectional view of connecting pipe of the embodiment of the present invention.
  • Fig. 4 is the structural representation of the rectangular mold of the embodiment of the present invention.
  • Fig. 5 is the structural representation of the sponge block after the embodiment of the present invention molding
  • Fig. 6 is a schematic structural view of a sponge punching device according to an embodiment of the present invention.
  • 100-drainage strip 110-impermeable membrane; 120-blind hole; 200-drainage tube; 210-drainage section; 220-drainage hole; 300-supply tube; ;330-second joint; 400-support pipe; 410-connecting pipe; 411-tapered surface; 420-first joint; 500-adjusting nut; 600-soft rubber plug; Ring; 700-rectangular mold; 710-silicone coating; 800-sponge block; 900-sponge punching device; 910-punching mechanism; 911-guide rail; 912-motor seat; 913-motor; - positioning mechanism; 921 - base; 922 - upper cover; 923 - limiting cavity; 924 - relief hole.
  • an embodiment of the present invention provides a negative pressure therapy device for vagina, including a drainage strip 100 , a drainage tube 200 and a supply tube 300 .
  • the drainage strip 100 is preferably made of polyvinyl alcohol foam sponge, and can also be made of other drainage carrier materials.
  • the water-impermeable membrane 110 can be made of silica gel or other water-impermeable film materials attached to both ends of the drainage strip 100 .
  • the proximal end of the drainage tube 200 has a drainage section 210, and the drainage section 210 is inserted into the drainage strip 100 from the distal end for drainage of the drainage strip 100, and the distal end of the drainage tube 200 is externally connected with a negative pressure device (not shown).
  • the proximal end of the supply tube 300 has a drug delivery section 310.
  • the drug delivery section 310 is inserted into the drainage strip 100 from the distal end for administering medicine to the drainage strip 100.
  • the distal end of the supply tube 300 is externally connected with a drug delivery device (not shown in the figure).
  • the drainage strip 100 When this application treats vaginal wounds, the drainage strip 100 is placed in the vagina. Since the two ends of the drainage strip 100 are sealed by the water-impermeable membrane 110, the liquid cannot pass through the two ends of the drainage strip 100.
  • the drainage tube 200 is externally connected to a negative pressure device. , the negative pressure device drains the drainage strip 100 through the drainage tube 200, a negative pressure is formed in the drainage strip 100, and the liquid exuded from the vaginal wall wound can only be drained out through the peripheral surface of the drainage strip 100, thereby ensuring uniform drainage.
  • the supply tube 300 is externally connected with a drug delivery device, and the drug delivery device supplies medicine to the drainage strip 100 through the supply tube 300, and the supplied medicinal solution can be transported to the vaginal wall through the peripheral surface of the drainage strip 100, thereby ensuring uniform drug administration. Therefore, the present application solves the problem of uneven drainage and drug administration and affecting the therapeutic effect when negative pressure drainage is used to treat vaginal lacerations in the prior art.
  • the distal end of the drainage strip 100 is provided with a blind hole 120 along its axial direction, and the drainage section 210 of the drainage tube 200 is inserted into the blind hole 120.
  • the above-mentioned negative pressure treatment device also includes a support tube 400, the support tube 400 is coaxially arranged in the drainage section 210 of the drainage tube 200, the distal end of the support tube 400 passes through the wall of the drainage tube 200, and the drainage section 210 of the drainage tube 200 between the support tube 400, there are several connecting tubes 410 whose radially outer ends are inclined to the far side.
  • the support tube 400 and the connecting tube 410 are preferably integrally injection-molded with silica gel.
  • the supply tube 300 is installed in the support tube 400, and the distal end of the supply tube 300 passes through the distal end of the support tube 400.
  • a number of shunt tubes 320 with radial outer ends inclined far side are arranged outside the tube wall of the supply tube 300.
  • the end of the shunt tube 320 is provided with a tapered tip, and each shunt pipe 320 is inserted into each connecting pipe 410 one by one.
  • the supply pipe 300 and the shunt pipe 320 are integrally injection-molded with silica gel.
  • the end of the shunt tube 320 outside the supply tube 300 is retracted in the connecting tube 410, and after the drainage tube 200 is inserted, the supply tube 300 is pulled to the far end to supply
  • the tube 300 and the support tube 400 move relative to each other, so that the ends of the shunt tubes 320 outside the supply tube 300 pass through the connecting tube 410 and inserted into the drainage strip 100, and finally lock the supply tube 300 and the support tube 400 to complete the assembly, which is convenient to assemble , fast, and the depth of the shunt tube 320 inserted into the drainage strip 100 is adjustable, and the assembled drainage tube 200 is not easy to pull out from the blind hole 120 of the drainage strip 100 .
  • the administration section 310 of the supply tube 300 is coaxially arranged in the drainage section 210 of the drainage tube 200.
  • the supplied liquid medicine is dispersed into the drainage strip 100 through the shunt tube 320 distributed on its periphery and supplied to the vaginal wall.
  • the liquid exuded from the wound surface of the vaginal wall is directly sucked away through the drainage hole 220 on the tube wall of the drug delivery section 310, so that only one tube needs to be led out of the drainage strip 100 to realize drug administration and drainage, and the drainage strip 100 can be reduced.
  • the opening of the water-impermeable membrane 110 at the distal end facilitates the sealing of the distal end of the drainage strip 100 .
  • the distal end of the support tube 400 is provided with a first joint 420, and the first joint 420 is provided with a first external thread, and the supply pipe 300 is provided with a second joint 330 near the first joint 420, and the second joint 330 is provided with a second joint 330.
  • the negative pressure treatment device also includes an adjustment nut 500, the adjustment nut 500 is sleeved outside the first joint 420 and the second joint 330, and The threads are matched with the first external thread and the second external thread respectively.
  • first external thread on the first joint 420 and the second external thread on the second joint 330 have opposite directions of rotation, when the adjusting nut 500 is turned, the first joint 420 and the second joint 330 will move relative to each other, thereby pulling The relative displacement of the supply pipe 300 and the support pipe 400 achieves the purpose of passing the end of each branch pipe 320 out of or retracting into the connecting pipe 410 .
  • the connecting tube 410 is provided with a conical surface 411 on the side facing the proximal end.
  • the aspirated clot can be cut through the conical surface 411 of the connecting tube 410 to prevent the aspirated clot from depositing on the connecting tube. 410 towards the proximal side to cause blockage.
  • the negative pressure therapy device further includes a soft rubber plug body 600
  • the soft rubber plug body 600 includes a sleeve 610 and a retaining ring 620 integrally connected to the distal end of the sleeve 610, the sleeve 610 is sleeved outside the drainage tube 200, At the same time, pass through the water-impermeable membrane 110 at the distal end of the drainage strip 100 and insert it into the drainage strip 100, the retaining ring 620 is close to the outside of the water-impermeable membrane 110 at this end, and the soft rubber plug body 600 is preferably made of silica gel.
  • the sealing performance between the drainage tube 200 and the water-impermeable membrane 110 at the distal end of the drainage strip 100 can be improved by providing the soft rubber plug body 600 .
  • the embodiment of the present invention also provides a method for manufacturing a negative pressure therapy device for the vagina, which is used to manufacture the above-mentioned negative pressure therapy device for the vagina, including the manufacturing steps of the drainage strip 100, Drain tube 200-support tube 400-supply tube 300 manufacturing steps and assembly steps.
  • the manufacturing steps of the drainage strip 100 are as follows: apply a release agent on the inner wall of a rectangular mold 700, and then apply a layer of silicone coating 710 (as shown in Figure 4 ) on the inner walls of the two sides of the rectangular mold 700.
  • the distance between the two sides of the layer 710 is equal to the design length of the drainage strip 100, and then the reaction solution is poured into the rectangular mold 700 for curing to obtain the sponge block 800, and the silica gel is cured on both sides of the sponge block 800 to form an impervious Membrane 110 (as shown in Figure 5); After demoulding, repeatedly wash the sponge block 800 until the pH is 4 to 5; cut the cleaned sponge block 800 into drainage strips 100; A blind hole 120 is processed at one end.
  • the manufacture method of above-mentioned reaction liquid comprises dissolving step and synthesis reaction, is specifically:
  • Dissolution Weigh the raw materials polyvinyl alcohol and carboxymethyl chitosan according to the prescription amount, add appropriate amount of purified water, put them in a jacketed pot, stir and heat, and control the temperature at 90°C to 100°C. When polyvinyl alcohol and carboxymethyl chitosan When the sugar has all dissolved into a clear solution, turn off the heat.
  • Synthesis reaction transfer the polyvinyl alcohol-carboxymethyl chitosan mixed solution into the stirring pot according to the prescription amount, start the stirring, when the solution is cooled to room temperature, add the sulfuric acid solution, stir for 10-15 minutes, then add the formaldehyde solution into the reaction solution and stirred for 30-40 minutes.
  • the above sponge punching device 900 specifically includes a punching mechanism 910 and a positioning mechanism 920 .
  • Punching mechanism 910 comprises guide rail 911, motor base 912, motor 913 and drill rod 914, guide rail 911 is fixed on the base, motor base 912 is slidably installed on the guide rail 911, motor 913 is fixed on the motor base 912, drill rod 914 is the same as The shaft is fixed at the output end of the motor 913 .
  • the positioning mechanism 920 includes a base 921 and an upper cover 922, the base 921 is fixed on the base, the upper cover 922 covers the base 921, and a limiting cavity 923 for fixing the drainage bar 100 is formed between the base 921 and the upper cover 922
  • the sidewall of one end of the limiting cavity 923 is provided with a relief hole 924 through which the drill rod 914 passes.
  • drainage tube 200-support tube 400-supply tube 300 The manufacturing steps of drainage tube 200-support tube 400-supply tube 300 are: integral injection molding of drainage tube 200, support tube 400 and connecting tube 410; integral injection molding of supply tube 300 and shunt tube 320; inserting injection-molded supply tube 300 into support tube 400 , and insert each branch pipe 320 into each connecting pipe 410 one by one.
  • the assembly steps are: put a soft rubber plug body 600 on the outside of the assembled drainage tube 200-support tube 400-supply tube 300; In the hole 120; press the sleeve 610 of the soft rubber plug body 600 between the drainage tube 200 and the inner wall of the blind hole 120 until the stop ring 620 of the soft rubber plug body 600 is against the water-impermeable membrane 110 at the end of the drainage strip 100; The supply tube 300 is pulled distally so that the supply tube 300 and the support tube 400 move relative to each other until the shunt tube 320 outside the supply tube 300 passes through the drainage tube 200 and is inserted into the drainage strip 100 .
  • the drainage strip 100 and the drainage tube 200-support tube 400-supply tube 300 are manufactured separately, and then assembled together after the manufacturing is completed, so that the manufacturing efficiency is high;
  • a silica gel impermeable film 110 can be formed on both sides of the sponge block 800, and then the sponge block 800 is cut and processed, namely A plurality of drainage strips 100 with water-impermeable membranes 110 at both ends can be obtained, and finally the cut and shaped drainage strips 100 can be punched.
  • the manufacturing efficiency of the drainage strips 100 is high and the cost is low.

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Abstract

一种用于阴道的负压治疗装置及其制造方法，该装置包括引流条（100）、引流管（200）和供给管（300）；引流条（100）的两端各覆盖有一层不透水膜（110）；引流管（200）的近端具有引流段（210），引流段（210）从远端插入引流条（100）用于对引流条（100）引流，引流管（200）的远端外接负压装置；供给管（300）的近端具有给药段（310），给药段（310）从远端插入引流条（100）用于对引流条（100）给药，供给管（300）的远端外接给药装置。该负压治疗装置解决了现有技术采用负压引流治疗阴道裂伤时引流和给药不均匀、影响治疗效果的问题。

Description

一种用于阴道的负压治疗装置及其制造方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种用于阴道的负压治疗装置及其制造方法。
背景技术
阴道裂伤是指会阴及阴道因为各种原因导致阴道撕裂性损伤。阴道裂伤多见于两种情况：一种是产科分娩引起，另一种是外伤和其他原因引起。产科中的阴道分娩引起的阴道裂伤较多见，可以是自然分娩时发生，也可以是分娩时一些器械操作导致的损害，分娩是导致外阴、阴道创伤的主要原因；阴道发育差，粗暴性交，也可使阴道口及阴道裂伤；其他部位创伤如骨盆损伤也可波及膀胱、尿道、阴道或外阴。
外阴创伤术后伤口常加压包扎，阴道内油纱条填塞，病人常主诉疼痛，应遵医嘱给予止痛，阴道纱条取出或外阴包扎松解后需密切观察有无再次出血情况，如有应给予积极处理，并保持外阴清洁干燥。
通常情况下，外伤、外科手术或者其它原因造成的人体体表创面伤口，这一类型的伤口在进行包扎和治疗之后，伤口不会立即痊愈复原，而是需要经过坏死，渗出，愈合期。传统的做法是利用棉纱等一类的医疗用品对伤口进行包扎，包扎的伤口虽然能够在一定程度上抵御细菌感染，但是透气性不强的环境不利于伤口的修复，而且在修复过程中创面伤口的代谢产物和分泌物也无法及时引流排除，反而会影响伤口修复，从而拖延了创面康复周期。
传统的阴道内油纱条填塞，不能对创面伤口进行药物输注或者液体冲洗是现有创面伤口修复技术中存在的不足。
负压封闭引流术(Vacuum Sealing Drainage，VSD)，是指由德国的WFleischman医师于20世纪90年代初原创并用于软组织创面的技术，该技术 利用医用泡沫包裹多侧孔引流管后置入被引流区，再用透性粘贴薄膜封闭被引流区使之与外界隔绝，接通高负压源，形成一个高效引流系统。
近年来，负压封闭引流术在阴道裂伤中的应用越来越广泛，治疗过程中，可通过引流条进行引流或给药，然而，现有技术中，液体不仅可以从引流条的周面进出，还可以从引流条的两端进出，导致引流和给药不均匀，影响治疗效果。
发明内容
针对现有技术中的缺陷，本发明提供了一种用于阴道的负压治疗装置，以解决现有技术采用负压引流治疗阴道裂伤时引流和给药不均匀、影响治疗效果的问题，本发明还提供了一种用于阴道的负压治疗装置的制造方法，用于制造上述装置。
一方面，本发明提供了一种用于阴道的负压治疗装置，包括：
引流条，所述引流条的两端各覆盖有一层不透水膜；
引流管，所述引流管的近端具有引流段，所述引流段从远端插入所述引流条用于对引流条引流，引流管的远端外接负压装置；
供给管，所述供给管的近端具有给药段，所述给药段从远端插入所述引流条用于对引流条给药，供给管的远端外接给药装置。
进一步地，所述引流条的远端沿其轴向开设有一盲孔，所述引流管的引流段插入所述盲孔内，引流管的引流段的管壁上开设有若干引流孔；
还包括支撑管，所述支撑管同轴设于所述引流管的引流段内，支撑管的远端从引流管的管壁穿出，引流管的引流段与支撑管之间设置有若干径向外端向远侧倾的连接管，所述连接管的两端分别贯穿所述引流管和支撑管的管壁；
所述供给管穿设于所述支撑管内，供给管的远端从支撑管的远端穿出，所述供给管的管壁外设置有若干径向外端向远侧倾的分流管，所述分流管的 末端设有锥尖，各所述分流管一一对应穿入各所述连接管。
进一步地，所述支撑管的远端设有第一接头，所述第一接头外设置有第一外螺纹，所述供给管外靠近所述第一接头设置有第二接头，所述第二接头外设置有第二外螺纹，所述第一外螺纹和第二外螺纹的旋向相反；
还包括调节螺帽，所述调节螺帽套在所述第一接头和第二接头外，并分别与第一外螺纹和第二外螺纹螺纹配合。
进一步地，所述引流管、支撑管和连接管采用硅胶一体注塑成型，所述供给管和分流管采用硅胶一体注塑成型。
进一步地，所述连接管朝向近端的一侧设有锥形面。
进一步地，还包括软胶塞体，所述软胶塞体包括套管以及一体连接于所述套管远端外的挡环，所述套管套在所述引流管外，同时穿过所述引流条远端的不透水膜并插入所述引流条内，所述挡环紧贴该端的不透水膜外。
进一步地，所述软胶塞体采用硅胶制成。
进一步地，所述引流条采用聚乙烯醇泡沫海绵。
另一方面，本发明提供了一种用于阴道的负压治疗装置的制造方法，用于制造上述用于阴道的负压治疗装置，包括引流条制造步骤、引流管-支撑管-供给管制造步骤和组装步骤；
所述引流条制造步骤为：在一矩形模具的内壁涂脱模剂，再在该矩形模具的两侧边的内壁涂抹一层硅胶涂层，涂有硅胶涂层的两侧边之间的距离等于引流条的设计长度，然后将反应液倒入该矩形模具内进行固化，得到海绵块，同时硅胶固化在海绵块的两侧形成不透水膜；脱模后，反复洗海绵块至pH为4～5；将清洗后的海绵块切割成引流条；采用海绵打孔装置在引流条的一端加工盲孔；
所述引流管-支撑管-供给管制造步骤为：一体注塑引流管、支撑管和连接管；一体注塑供给管和分流管；将注塑成型的供给管插入支撑管，并将各分流管一一对应插入各连接管；
所述组装步骤为：将一软胶塞体套在组装好的引流管-支撑管-供给管外；将引流管-支撑管-供给管穿入成型的引流条的盲孔内；将软胶塞体的套管压入引流管与盲孔的内壁之间至软胶塞体的挡环抵在引流条该端的不透水膜外；向远端拉动供给管，使得供给管与支撑管发生相对移动，直至供给管外的分流管穿出引流管并插入引流条。
进一步地，所述海绵打孔装置包括：
打孔机构，所述打孔机构包括导轨、电机座、电机和钻杆，所述导轨固定于基座上，所述电机座滑动安装于所述导轨上，所述电机固定于所述电机座上，所述钻杆同轴固定于所述电机的输出端；
定位机构，所述定位机构包括底座和上盖，所述底座固定于基座上，所述上盖盖在所述底座上，底座和上盖之间形成用于对引流条进行固定的限位腔，所述限位腔一端的侧壁设有共所述钻杆穿过的让位孔。
本发明的有益效果体现在：本申请治疗阴道创伤时，引流条置于阴道内，由于引流条的两端通过不透水膜封闭，液体不能从引流条的两端通过，引流时，引流管外接负压装置，负压装置通过引流管对引流条引流，引流条内形成负压，阴道壁创面渗出的液体只能通过引流条的周面引流出去，从而确保引流均匀，给药时，供给管外接给药装置，给药装置通过供给管向引流条给药，供给的药液中能通过引流条的周面输送到阴道壁，从而确保给药均匀。因此，本申请解决了现有技术采用负压引流治疗阴道裂伤时引流和给药不均匀、影响治疗效果的问题。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍。在所有附图中，类似的元件或部分一般由类似的附图标记标识。附图中，各元件或部分并不一定按照实际的比例绘制。
图1为本发明实施例的立体结构示意图；
图2为本发明实施例引流条的内部剖视图；
图3为本发明实施例连接管的横断面图；
图4为本发明实施例矩形模具的结构示意图；
图5为本发明实施例成型后的海绵块的结构示意图；
图6为本发明实施例海绵打孔装置的结构示意图。
附图中，100-引流条；110-不透水膜；120-盲孔；200-引流管；210-引流段；220-引流孔；300-供给管；310-给药段；320-分流管；330-第二接头；400-支撑管；410-连接管；411-锥形面；420-第一接头；500-调节螺帽；600-软胶塞体；610-套管；620-挡环；700-矩形模具；710-硅胶涂层；800-海绵块；900-海绵打孔装置；910-打孔机构；911-导轨；912-电机座；913-电机；914-钻杆；920-定位机构；921-底座；922-上盖；923-限位腔；924-让位孔。
具体实施方式
下面将结合附图对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚地说明本发明的技术方案，因此只作为示例，而不能以此来限制本发明的保护范围。
需要注意的是，除非另有说明，本申请使用的技术术语或者科学术语应当为本发明所属领域技术人员所理解的通常意义。
如图1-图3所示，本发明实施例提供了一种用于阴道的负压治疗装置，包括引流条100、引流管200和供给管300。
引流条100的两端各覆盖有一层不透水膜110，以对引流条100的两端进行封闭。本实施例中，引流条100优选采用聚乙烯醇泡沫海绵，也可以使用其它引流载体材料制成。不透水膜110可以采用贴附于引流条100两端的硅胶或其它不透水的薄膜材料。
引流管200的近端具有引流段210，引流段210从远端插入引流条100用 于对引流条100引流，引流管200的远端外接负压装置(图中未示出)。
供给管300的近端具有给药段310，给药段310从远端插入引流条100用于对引流条100给药，供给管300的远端外接给药装置(图中未示出)。
本申请治疗阴道创伤时，引流条100置于阴道内，由于引流条100的两端通过不透水膜110封闭，液体不能从引流条100的两端通过，引流时，引流管200外接负压装置，负压装置通过引流管200对引流条100引流，引流条100内形成负压，阴道壁创面渗出的液体只能通过引流条100的周面引流出去，从而确保引流均匀，给药时，供给管300外接给药装置，给药装置通过供给管300向引流条100给药，供给的药液中能通过引流条100的周面输送到阴道壁，从而确保给药均匀。因此，本申请解决了现有技术采用负压引流治疗阴道裂伤时引流和给药不均匀、影响治疗效果的问题。
在一优选的实施例中，引流条100的远端沿其轴向开设有一盲孔120，引流管200的引流段210插入盲孔120内，引流管200的引流段210的管壁上开设有若干引流孔220。上述负压治疗装置还包括支撑管400，支撑管400同轴设于引流管200的引流段210内，支撑管400的远端从引流管200的管壁穿出，引流管200的引流段210与支撑管400之间设置有若干径向外端向远侧倾的连接管410，连接管410的两端分别贯穿引流管200和支撑管400的管壁，本实施例中，引流管200、支撑管400和连接管410优选采用硅胶一体注塑成型。供给管300穿设于支撑管400内，供给管300的远端从支撑管400的远端穿出，供给管300的管壁外设置有若干径向外端向远侧倾的分流管320，分流管320的末端设有锥尖，各分流管320一一对应穿入各连接管410，本实施例中，供给管300和分流管320采用硅胶一体注塑成型。
采用上述结构，将引流管200插入引流条100的盲孔120时，供给管300外的分流管320的末端缩在连接管410内，引流管200插入后，向远端拉动供给管300，供给管300与支撑管400发生相对移动，使得供给管300外的各分流管320的末端穿出连接管410并插入引流条100，最后锁定供给管300和 支撑管400，即可完成组装，组装方便、快捷，且分流管320插入引流条100的深度可调，组装后的引流管200不易从引流条100的盲孔120拔出。
上述供给管300的给药段310同轴设于引流管200的引流段210内，给药时，供给的药液通过分布在其外周的分流管320分散进入引流条100并供至阴道壁，引流时，阴道壁创面渗出的液体直接通过给药段310管壁上的引流孔220吸走，这样引流条100内只需引出一条管道，即可实现给药和引流，能够减少引流条100远端不透水膜110的开孔，有利于引流条100远端的密封。
优选地，支撑管400的远端设有第一接头420，第一接头420外设置有第一外螺纹，供给管300外靠近第一接头420设置有第二接头330，第二接头330外设置有第二外螺纹，第一外螺纹和第二外螺纹的旋向相反；该负压治疗装置还包括调节螺帽500，调节螺帽500套在第一接头420和第二接头330外，并分别与第一外螺纹和第二外螺纹螺纹配合。由于第一接头420外的第一外螺纹和第二接头330外的第二外螺纹的旋向相反，拧动调节螺帽500时，第一接头420和第二接头330发生相对移动，进而拉动供给管300和支撑管400发生相对位移，达到将各分流管320的末端穿出或缩回连接管410的目的。
优选地，连接管410朝向近端的一侧设有锥形面411，在引流时，可通过连接管410的锥形面411对吸出的凝块进行切割，避免吸出的凝块沉积在连接管410朝向近端的一侧而造成堵塞。
优选地，该负压治疗装置还包括软胶塞体600，软胶塞体600包括套管610以及一体连接于套管610远端外的挡环620，套管610套在引流管200外，同时穿过引流条100远端的不透水膜110并插入引流条100内，挡环620紧贴该端的不透水膜110外，软胶塞体600优选采用硅胶制成。通过设置软胶塞体600，能够提高引流管200与引流条100远端的不透水膜110之间的密封性。
如图1-图6所示，本发明实施例还提供了一种用于阴道的负压治疗装置 的制造方法，用于制造上述用于阴道的负压治疗装置，包括引流条100制造步骤、引流管200-支撑管400-供给管300制造步骤和组装步骤。
引流条100制造步骤为：在一矩形模具700的内壁涂脱模剂，再在该矩形模具700的两侧边的内壁涂抹一层硅胶涂层710(如图4所示)，涂有硅胶涂层710的两侧边之间的距离等于引流条100的设计长度，然后将反应液倒入该矩形模具700内进行固化，得到海绵块800，同时硅胶固化在海绵块800的两侧形成不透水膜110(如图5所示)；脱模后，反复洗海绵块800至pH为4～5；将清洗后的海绵块800切割成引流条100；采用海绵打孔装置900在引流条100的一端加工盲孔120。
上述反应液的制造方法包括溶解步骤和合成反应，具体为：
溶解：按处方量称取原料聚乙烯醇和羧甲基壳聚糖、加入适量纯化水，置于夹层锅内，搅拌加热，温度控制在90℃～100℃，当聚乙烯醇和羧甲基壳聚糖全部溶解成澄清溶液时，停止加热。
合成反应：按处方量将聚乙烯醇-羧甲基壳聚糖混合溶液移置搅拌锅内，开启搅拌，当溶液冷却到室温时，加入硫酸溶液，搅拌10～15分钟后，将甲醛溶液加入到反应液中，搅拌30～40min。
上述海绵打孔装置900具体包括打孔机构910和定位机构920。打孔机构910包括导轨911、电机座912、电机913和钻杆914，导轨911固定于基座上，电机座912滑动安装于导轨911上，电机913固定于电机座912上，钻杆914同轴固定于电机913的输出端。定位机构920包括底座921和上盖922，底座921固定于基座上，上盖922盖在底座921上，底座921和上盖922之间形成用于对引流条100进行固定的限位腔923，限位腔923一端的侧壁设有共钻杆914穿过的让位孔924。打孔时，引流条100置于限位腔923内，电机913驱动钻杆914转动，然后推动电机座912沿导轨911滑动，钻杆914通过让位孔924钻入引流条100，以对引流条100进行钻孔。
引流管200-支撑管400-供给管300制造步骤为：一体注塑引流管200、 支撑管400和连接管410；一体注塑供给管300和分流管320；将注塑成型的供给管300插入支撑管400，并将各分流管320一一对应插入各连接管410。
组装步骤为：将一软胶塞体600套在组装好的引流管200-支撑管400-供给管300外；将引流管200-支撑管400-供给管300穿入成型的引流条100的盲孔120内；将软胶塞体600的套管610压入引流管200与盲孔120的内壁之间至软胶塞体600的挡环620抵在引流条100该端的不透水膜110外；向远端拉动供给管300，使得供给管300与支撑管400发生相对移动，直至供给管300外的分流管320穿出引流管200并插入引流条100。
上述制造方法至少具备如下优点：
(1)引流条100和引流管200-支撑管400-供给管300分开制造，制造完成后再组装在一起，制造效率高；
(2)通过在矩形模具700的两侧边涂硅胶涂层710，一次性浇筑反应液，就可在海绵块800的两侧形成硅胶不透水膜110，再对海绵块800进行切割加工，即可得到多个两端具有不透水膜110的引流条100，最后再对切割成型的引流条100进行打孔即可，引流条100的制造效率高，成本低。
(3)采用上述方式将引流管200-支撑管400-供给管300与引流条100组装在一起，组装方便、快捷。
最后应说明的是：以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围，其均应涵盖在本发明的权利要求和说明书的范围当中。

Claims (10)

  1. 一种用于阴道的负压治疗装置，其特征在于，包括：
    引流条，所述引流条的两端各覆盖有一层不透水膜；
    引流管，所述引流管的近端具有引流段，所述引流段从远端插入所述引流条用于对引流条引流，引流管的远端外接负压装置；
    供给管，所述供给管的近端具有给药段，所述给药段从远端插入所述引流条用于对引流条给药，供给管的远端外接给药装置。
  2. 根据权利要求1所述的用于阴道的负压治疗装置，其特征在于，所述引流条的远端沿其轴向开设有一盲孔，所述引流管的引流段插入所述盲孔内，引流管的引流段的管壁上开设有若干引流孔；
    还包括支撑管，所述支撑管同轴设于所述引流管的引流段内，支撑管的远端从引流管的管壁穿出，引流管的引流段与支撑管之间设置有若干径向外端向远侧倾的连接管，所述连接管的两端分别贯穿所述引流管和支撑管的管壁；
    所述供给管穿设于所述支撑管内，供给管的远端从支撑管的远端穿出，所述供给管的管壁外设置有若干径向外端向远侧倾的分流管，所述分流管的末端设有锥尖，各所述分流管一一对应穿入各所述连接管。
  3. 根据权利要求2所述的用于阴道的负压治疗装置，其特征在于，所述支撑管的远端设有第一接头，所述第一接头外设置有第一外螺纹，所述供给管外靠近所述第一接头设置有第二接头，所述第二接头外设置有第二外螺纹，所述第一外螺纹和第二外螺纹的旋向相反；
    还包括调节螺帽，所述调节螺帽套在所述第一接头和第二接头外，并分别与第一外螺纹和第二外螺纹螺纹配合。
  4. 根据权利要求2所述的用于阴道的负压治疗装置，其特征在于，所述引流管、支撑管和连接管采用硅胶一体注塑成型，所述供给管和分流管采用硅胶一体注塑成型。
  5. 根据权利要求2所述的用于阴道的负压治疗装置，其特征在于，所述连 接管朝向近端的一侧设有锥形面。
  6. 根据权利要求2所述的用于阴道的负压治疗装置，其特征在于，还包括软胶塞体，所述软胶塞体包括套管以及一体连接于所述套管远端外的挡环，所述套管套在所述引流管外，同时穿过所述引流条远端的不透水膜并插入所述引流条内，所述挡环紧贴该端的不透水膜外。
  7. 根据权利要求6所述的用于阴道的负压治疗装置，其特征在于，所述软胶塞体采用硅胶制成。
  8. 根据权利要求1所述的用于阴道的负压治疗装置，其特征在于，所述引流条采用聚乙烯醇泡沫海绵。
  9. 一种用于阴道的负压治疗装置的制造方法，用于制造如权利要求6所述的用于阴道的负压治疗装置，其特征在于，包括引流条制造步骤、引流管-支撑管-供给管制造步骤和组装步骤；
    所述引流条制造步骤为：在一矩形模具的内壁涂脱模剂，再在该矩形模具的两侧边的内壁涂抹一层硅胶涂层，涂有硅胶涂层的两侧边之间的距离等于引流条的设计长度，然后将反应液倒入该矩形模具内进行固化，得到海绵块，同时硅胶固化在海绵块的两侧形成不透水膜；脱模后，反复洗海绵块至pH为4～5；将清洗后的海绵块切割成引流条；采用海绵打孔装置在引流条的一端加工盲孔；
    所述引流管-支撑管-供给管制造步骤为：一体注塑引流管、支撑管和连接管；一体注塑供给管和分流管；将注塑成型的供给管插入支撑管，并将各分流管一一对应插入各连接管；
    所述组装步骤为：将一软胶塞体套在组装好的引流管-支撑管-供给管外；将引流管-支撑管-供给管穿入成型的引流条的盲孔内；将软胶塞体的套管压入引流管与盲孔的内壁之间至软胶塞体的挡环抵在引流条该端的不透水膜外；向远端拉动供给管，使得供给管与支撑管发生相对移动，直至供给管外的分流管穿出引流管并插入引流条。
  10. 根据权利要求9所述的用于阴道的负压治疗装置的制造方法，其特征在于，所述海绵打孔装置包括：
    打孔机构，所述打孔机构包括导轨、电机座、电机和钻杆，所述导轨固定于基座上，所述电机座滑动安装于所述导轨上，所述电机固定于所述电机座上，所述钻杆同轴固定于所述电机的输出端；
    定位机构，所述定位机构包括底座和上盖，所述底座固定于基座上，所述上盖盖在所述底座上，底座和上盖之间形成用于对引流条进行固定的限位腔，所述限位腔一端的侧壁设有共所述钻杆穿过的让位孔。
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