WO2011116691A1 - 医用负压封闭引流装置 - Google Patents

医用负压封闭引流装置 Download PDF

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Publication number
WO2011116691A1
WO2011116691A1 PCT/CN2011/072066 CN2011072066W WO2011116691A1 WO 2011116691 A1 WO2011116691 A1 WO 2011116691A1 CN 2011072066 W CN2011072066 W CN 2011072066W WO 2011116691 A1 WO2011116691 A1 WO 2011116691A1
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WO
WIPO (PCT)
Prior art keywords
tube
sealing
drainage
elastic
porous foam
Prior art date
Application number
PCT/CN2011/072066
Other languages
English (en)
French (fr)
Inventor
宋九宏
Original Assignee
武汉维斯第医用科技有限公司
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
Priority claimed from CN201010132585A external-priority patent/CN101829388A/zh
Priority claimed from CN2010202525406U external-priority patent/CN201744062U/zh
Priority claimed from CN2010102215692A external-priority patent/CN101904768B/zh
Priority claimed from CN2011200053867U external-priority patent/CN201959394U/zh
Priority to RU2012144010/14A priority Critical patent/RU2559184C2/ru
Priority to EP11758801.2A priority patent/EP2550990B1/en
Application filed by 武汉维斯第医用科技有限公司 filed Critical 武汉维斯第医用科技有限公司
Priority to BR112012024080-3A priority patent/BR112012024080B1/pt
Priority to CA2793955A priority patent/CA2793955C/en
Priority to MX2012011001A priority patent/MX335970B/es
Priority to SG2012069688A priority patent/SG184164A1/en
Priority to JP2013500321A priority patent/JP2013521954A/ja
Priority to KR1020127027131A priority patent/KR101484047B1/ko
Publication of WO2011116691A1 publication Critical patent/WO2011116691A1/zh
Priority to US13/625,024 priority patent/US20130023842A1/en

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Classifications

    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • 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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • 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
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus

Definitions

  • the invention relates to a medical vacuum sealing drainage device. It is a negative pressure closed drainage for the treatment of human body surface tissue or body cavity lesions. Background technique
  • Vacuum sealing drainage was initiated in 1992 by Dr. Wim Fleischman of ULM University in Germany, and formed a theoretical prototype for the drainage of limbs.
  • Professor Yan Huade of China applied the application of vacuum sealing technology for the first time. Yupu Surgery pioneered the application of negative pressure closed drainage technology in general surgery.
  • Professor Wang Yanfeng and Prof. Hua Huade were granted the patent CN 2236350 on March 17, 1997, which is the first patent for vacuum sealing drainage technology.
  • the basic configuration of the existing VSD technology includes a negative pressure source (including medical suction machine, central vacuum device used in hospital or negative pressure drainage bottle, etc.), drainage tube, polyvinyl alcohol foam or other medical porous foam, sponge or gauze (below Referred to as a porous foam cushion), it can be attached with a sealing film and a drainage container.
  • the negative pressure source is drained, and oozing, exudate, liquefied necrotic tissue fragments, and liquefied substances such as pus are drained into the drainage container.
  • the porous foam cushion is placed on the wound surface or the wound cavity, and then the porous foam cushion and the outlet end of the drainage tube are tightly sealed by the sealing film to be insulated from the outside, and the drainage container is connected, and then the negative pressure is connected.
  • the source forms a drainage system. Since the pores in the porous foam cushion are interconnected and elastic, the negative pressure can reach every point of the target drainage zone to form a full-scale drainage.
  • the larger, less rigid block extracts are divided and shaped into pellets under the action of negative pressure, and enter the drainage tube through the pores of the porous foam cushion or the interpenetrating pores, and then quickly sucked into the drainage container.
  • the large extracts that may block the draft tube are blocked by the porous foam cushion and can only adhere to the surface of the porous foam cushion, leaving the body together with the porous foam cushion when removing or replacing the drain.
  • the sealing effect of the sealing film is the key to maintaining the negative pressure of the guiding force, and it is also the key to the isolation of the drainage area from the outside, effectively preventing pollution and cross-infection.
  • the object of the present invention is to solve the unreasonableness of the above-mentioned conventional vacuum sealing drainage device, and to provide a sealing effect, simple structure and convenient use, which is suitable for drainage of body surface wounds and for body cavity.
  • the medical negative pressure sealing drainage device of the present invention comprises a porous foam cushion, a drainage tube disposed in the porous foam cushion and extending outside the porous foam cushion at the tail end, and the outer side of the porous foam cushion
  • the elastic sealing film extending from the pipe system is provided, and the elastic sealing film has a sealing mouth extending from the pipe system, and the diameter D of the mouth of the sealing port is smaller than the outer diameter of the corresponding protruding pipe.
  • the elastic sealing film on the upper tube of the sealing mouth is a circular hole, the diameter of the circular hole is smaller than the corresponding outer diameter of the protruding tube 0. 3 ⁇ 4
  • the sealing hole of the tube of the elastic sealing film is a tube hole, the diameter of the mouth of the tube hole is smaller than the outer diameter of the corresponding protruding tube 0. 3 2
  • the tube hole is inverted trumpet, the diameter of the mouth of the tube hole is smaller than the outer diameter of the corresponding protruding tube, and the diameter of the bottom of the tube hole is larger than Corresponding outer tube outer diameter 2 6mm
  • the angle a between the sealing port and the elastic sealing film body is 15 to 90°.
  • the side wall of the drainage tube is arranged with a plurality of small holes.
  • the drainage tube has one or more uniform rows. When multiple rows are arranged, the distance between two adjacent ones is 25 35. When there are multiple drainage tubes, the multiple ends are connected with a multi-pass joint.
  • the negative pressure sealing drainage device is provided with an irrigation tube in the drainage tube, one end of the irrigation tube extends into the drainage tube, and the other end of the irrigation tube is led out from the side wall of the tail end of the drainage tube, and the end of the irrigation tube has a sealing cover .
  • the negative pressure sealing drainage device for orthopedics of the present invention comprises a porous foam cushion, a drainage tube disposed in the porous foam cushion and extending outside the porous foam cushion at the tail end, and the first elastic sealant is disposed outside the porous foam cushion Membrane, the first elastic sealing film has a sealing mouth extending from the drainage tube, and the diameter D of the mouth of the sealing port is smaller than the outer diameter of the corresponding drainage tube, and the second and third portions are arranged at the needle connecting the external fixation device of the orthopedics Elastomeric sealant film, the second and third elastic sealant films have vertical tube hole-shaped sealing ports, and the two vertical tube-shaped sealing mouths on the second and third elastic sealant films are sleeved on the two needles The second and third elastic sealant films are placed on the first elastic sealant film or directly placed on the porous foam cushion to cover the seal.
  • the sealing opening of the first elastic sealing film on the drainage tube is a tubular hole
  • the angle a between the tubular hole and the elastic sealing film body
  • the tube hole of the vertical tube hole-shaped sealing port on the second and third elastic sealing film is inverted trumpet shape, and the diameter of the mouth of the tube hole is smaller than the outer diameter of the needle. 0. 3 2
  • the diameter of the bottom of the tube hole is larger than Corresponding piercing outer diameter 2 6
  • the orthopaedic negative pressure sealing drainage device is provided with an irrigation tube in the drainage tube, one end of the irrigation tube extends into the drainage tube, and the other end of the irrigation tube is from the tail end side of the drainage tube
  • the wall is led out and the end of the flushing tube has a sealing cap.
  • the vacuum sealing drainage device for the perineal portion of the present invention comprises a porous foam cushion, a drainage tube disposed in the porous foam cushion and extending outside the porous foam cushion at the tail end, and a drainage tube outside the porous foam cushion
  • An extended first elastic sealing film the first elastic sealing film has a sealing mouth extending from the drainage tube, the mouth diameter D of the sealing opening is smaller than the outer diameter of the corresponding drainage tube, and an anus insertion catheter is also included
  • the fourth elastic sealing film is disposed at the position of the negative pressure zone of the anus plugging conduit through the negative pressure sealing drainage device, the fourth elastic sealing film has a vertical tube hole sealing mouth, and the vertical tube hole sealing mouth is sleeved in the anal cutting catheter
  • the fourth elastic sealant film is placed on the first elastic sealant film or directly on the porous foam cushion to cover the seal.
  • An annular inflatable or liquid-filled capsule is disposed on the outer side of the front end of the anal insertion catheter, and a gas guiding or liquid guiding tube is arranged in parallel with the anal insertion catheter, and the gas guiding or catheter leading end and the inflation or flushing capsule
  • the rear end extends to the rear end of the tubular body, and the gas guide or the rear end of the liquid guiding tube is provided with a sealing cover.
  • the negative pressure closed drainage device for the perineal portion is provided with an irrigation tube in the drainage tube, one end of the irrigation tube extends into the drainage tube, and the other end of the irrigation tube is led out from the side wall of the tail end of the drainage tube, and the irrigation tube is There is a sealing cover at the end.
  • the device is suitable for both body surface drainage and body cavity drainage. Two sets of different drainage devices for drainage of existing body surface wounds and drainage of body cavity wounds are unified into one device.
  • the elastic sealing film on the protruding part of the drainage tube has sealed the extension of the drainage tube, making the sealing of the sealing film easier and easier;
  • the internal wound surface uses VSD technology, the structure is complex, and the doctor's workload is large.
  • the body cavity is drained, it provides an effective support (carrier) for the sealing film, avoiding radical mastectomy, rectal cancer, vaginal tumor radical surgery, osteomyelitis lavage drainage, perineal blast injury
  • the film is attached, there is no support at the drainage tube film and the crucible has to be used.
  • the elastic sealant film can also cover the porous foam cushion by increasing the area of the adhesive film to prevent the sealing film from being directly attached to the porous foam.
  • the moisture in the porous foam cushion is volatilized by the sealing film, which makes the porous foam cushion hard. The hardening of the porous foam cushion will cause the negative pressure closed drainage to fail.
  • a plurality of drainage tubes are connected to the conduit through a multi-pass joint, and a plurality of rows of small holes in the side wall of the drainage tube increase the absorption area, and the outlet of each outlet tube can serve as both a drainage port and a tube plugging. Flushing, drainage and flushing are all very convenient.
  • a special flushing tube to flush and block, and there will be no "retrograde infection".
  • a special flushing tube can also dilute, soak, and soften the drainage in the porous foam cushion in a timely manner, which is more convenient for drainage. It shortens the operation time, reduces the pain of the patient, and shortens the time for the wound healing of the patient.
  • the negative pressure closed drainage device for orthopedics of the present invention changes the operation rules and principles of the traditional orthopedic external fixation technique, and combines sealing and fixing operations, and the sealing of the orthopedic external fixation device is very strict, and the leakage is eliminated.
  • the failure of the negative pressure closed drainage treatment or the effect is reduced, and the infection at the needle insertion is eliminated, and the key technology for applying the negative pressure closed drainage device to the orthopedic trauma is solved, and the infection of the orthopedic trauma needle is basically eliminated.
  • the situation that the frequent infections extend along the needle into the bone cavity is completely eliminated, which greatly reduces the patient's treatment risk, reduces the patient's pain, effectively protects the treatment effect, and greatly reduces the patient's disability rate. .
  • the negative pressure closed drainage device for the perineum of the present invention increases the insertion catheter of the perineum, and does not affect the normal physiological excretion of the patient during the VSD treatment, effectively avoids the overflow of the excrement and contaminates the wound, and effectively reduces the infection.
  • the rate effectively reduces the incidence of infection and shortens the healing time of the wound.
  • FIG. 1 is a schematic view showing the overall structure of a first basic negative pressure closed drainage device according to the present invention.
  • FIG. 2 is a schematic view showing the overall structure of a second most basic negative pressure closed drainage device according to the present invention.
  • Fig. 3 is a schematic view of Fig. 1 when it is used in vivo.
  • Figure 4 is a schematic view of the sealing port of the elastic sealant film being a circular hole.
  • Figure 5 is a schematic view showing the sealing port of the elastic sealant film as a pipe hole.
  • Figure 6 is a cross-sectional view showing the structure of A-A of Figure 5;
  • Figure 7 is a schematic illustration of a flexible sealant film with a vertical tube hole seal.
  • Fig. 8 is a schematic view showing the structure of the draft tube and the two-way joint mechanism of the two draft tubes.
  • Figure 9 is a schematic view showing the arrangement of four drainage tubes and a four-way joint in a porous foam cushion.
  • Fig. 10 is a schematic view showing the overall structure of a negative pressure closed drainage device for orthopedics.
  • Figure 11 is a schematic longitudinal sectional view of Figure 10;
  • Fig. 12 is a schematic view showing the overall structure of a negative pressure closed drainage device for a perineal portion.
  • Figure 13 is a schematic view of the structure of the anal insertion catheter. detailed description
  • FIG. 1 is a schematic view showing the overall structure of a first basic negative pressure closed drainage device according to the present invention:
  • the utility model comprises a porous foam cushion 1 , a drainage tube 2 disposed in the porous foam cushion 1 and extending outside the porous foam cushion 1 at the tail end, and an elastic sealing film protruding from the tube system is arranged outside the porous foam cushion 1 3.
  • the elastic sealing film 3 has a sealing opening 3a extending from the drainage tube 2, and the sealing opening 3a is a circular hole.
  • Figure 4 is a schematic view of the elastic sealing film: the diameter D of the sealing hole 3a is smaller than the outer diameter of the corresponding drainage tube 2 0. 3
  • the sealing hole 3a is tightly sealed on the draft tube 2.
  • the sealing film 8 is resealed on the elastomeric sealant film 3 and the porous foam pad 1.
  • the tail end of the draft tube 2 is connected through a conduit 4 draining vessel 5 and a negative pressure source 6.
  • the trailing end of the draft tube 2 projects from the upper side of the porous foam cushion 1.
  • An irrigation tube 7 is disposed in the drainage tube 2, one end of the irrigation tube 7 extends into the drainage tube 2, and the other end of the irrigation tube 7 is led out from the side wall of the tail end of the drainage tube 2, and the end of the irrigation tube 7 has a sealing cover 7a.
  • FIG. 2 is a schematic view showing the overall structure of the second most basic vacuum sealing drainage device of the present invention: the basic structure is identical to that of the first type, except that the sealing port 3a of the drainage tube 2 on which the drainage tube 2 protrudes is a tube hole, and the tube 3 2 ⁇ The diameter of the mouth of the hole is smaller than the outer diameter of the corresponding extension tube 0. 3 2mm
  • the sealing port 3a of the elastic sealing film 3 is formed by a tube hole shape, and the tube hole has an inverted horn shape, and the mouth diameter dl of the tube hole is smaller than the outer diameter of the drainage tube 2.
  • the diameter of the bottom d2 of the tube hole is larger than the outer diameter of the drainage tube 2 6
  • the angle a between the sealing port 3a and the body of the elastic sealing film 3 is 15 ⁇ 90°, preferably 30 45°
  • Fig. 7 is a schematic view of the elastic sealing film with a vertical tube hole sealing port: the angle a between the sealing port 3a and the body of the elastic sealing film 3 is 90°.
  • This embodiment is suitable for vertical piping use.
  • Figure 8 is a schematic view of the diversion tube structure and the two-way joint mechanism of the two drainage tubes
  • Figure 9 is a schematic diagram of four or two drainage tubes and a four-way joint mechanism in the porous foam cushion:
  • the side wall of the drainage tube 2 is arranged with a plurality of small holes 2a.
  • Multiple drainage tubes are connected to the multi-way connector 2b, and multiple connections The head 2b is connected to the catheter 4.
  • Multiple drainage tubes are suitable for large areas of trauma. After the plurality of drainage tubes 2 are connected through the multi-pass joint, they merge into one drainage container 5, which is simple and convenient. For in vivo use, a tube is taken out and the wound is small.
  • the above structure solves the sealing problem and thus maintains a stable negative pressure closed drainage.
  • the sealing opening 3a is made due to the elasticity of the elastic sealing film.
  • the tightening is sealed on the drainage tube 2 to provide a sealing function.
  • the porous foam pad 1 and the elastic sealant film 3 are sealed by a sealing film 8 to seal the porous foam pad 1 to the body surface.
  • the elastic sealing film can be covered with the porous foam cushion by increasing the area of the elastic sealing film 3, thereby avoiding the porous foam generated by directly sealing the sealing film 3 on the porous foam cushion 1.
  • the moisture in the cushion is volatilized by the sealing film, which makes the porous foam cushion hard. The hardening of the porous foam cushion will cause the negative pressure closure to fail to drain.
  • Figure 3 is a schematic diagram when used in vivo:
  • a structure in which one end of the drainage tube 2 is located in the porous foam cushion 1 and the other end of the drainage tube 2 is taken out from the upper end of the porous foam cushion 1 is used.
  • the elastic sealant film 3 is attached to the outside of the body, providing an effective support (carrier) for the sealing film 8, which is made by the elasticity of the sealing port 3a. Tightly clamped on the drainage tube 2 to provide a sealing function.
  • the elastic sealing film 3 is covered with a sealing film 8, and the periphery of the elastic sealing film 3 is sealed with the body surface.
  • the negative pressure system When the small hole of the drainage tube 2 is clogged, the negative pressure system is closed, and the sealing cover 7a at the end of the irrigation tube 7 is opened, the irrigator is connected, the physiological saline is injected, and the blood clot is diluted and dissolved. After the flushing is stopped, the negative pressure is turned on, and the diluted blood clot or the like is taken out.
  • the commonly used rinsing methods are as follows: (1) A rubber tube is placed on the wound surface, but the "film-based method” is also required to seal the lead-out position of the rubber tube, which increases the possibility of "leakage” and the difficulty of sealing; (2) Retrograde injection of irrigation fluid from the original drainage tube may introduce the exuded exudate into the wound surface, causing "retrograde infection”; (3) injecting the irrigation fluid from the porous foam cushion, which is required to be in the porous foam. Re-attach the sealing film at the hole in the cushion to increase the difficulty of operation.
  • the invention facilitates the flushing of the tube, and does not cause "retrograde infection", and does not cause the flushing tube to occupy the space of the drainage tube.
  • the end of the flushing pipe 7 has a sealing cover 7a, and the sealing cap is tightly closed when not in use to ensure the normal operation of the drainage pipe 2.
  • the flushing tube 7 can also be used as a sampling port to test the drainage solution as a reference for doctors.
  • the plurality of drainage tubes 2 are connected by a multi-pass joint. When one drainage tube is blocked, it can be conveniently observed from the catheter joint, so that it can be flushed through the irrigation tube in time, and other drainage tubes can continue to drain, and no drainage tube will be blocked. After that, the negative pressure closed drainage does not work properly.
  • FIG 10 and Figure 11 are schematic diagrams showing the overall structure of the negative pressure closed drainage device for orthopedics:
  • the structure of the negative pressure closed drainage device for orthopedics is basically the same as that of the above basic negative pressure sealing drainage device, including a porous foam cushion 1, a drainage tube 2 disposed inside the porous foam cushion 1 and extending outside the porous foam cushion 1 at the tail end.
  • a first elastic sealing film 3 is disposed on the outer side of the porous foam pad 1.
  • the first elastic sealing film 3 has a sealing opening 3a extending from the drainage tube 2.
  • the diameter D of the sealing opening 3a is smaller than the corresponding drainage tube.
  • the outer diameter of 2 is provided with a second and third elastic sealing film 3 at the needle 9a of the orthopedic external fixation device 9, and the second and third elastic sealing films 3 are provided with a vertical tube-like sealing opening 3a.
  • Two vertical tube-shaped sealing openings 3a on the second and third elastic sealing films 3 are sleeved on the two needles 9a, and the second and third elastic sealing films 3 are placed on the first elastic sealing film 3. Or directly placed on the porous foam pad 1 to cover the seal.
  • An irrigation tube 7 is disposed in the drainage tube 2, one end of the irrigation tube 7 extends into the drainage tube 2, and the other end of the irrigation tube 7 is led out from the side wall of the tail end of the drainage tube 2, and the end of the irrigation tube 7 has a sealing cover 7a.
  • the second and third elastic sealant films 3 are provided to accommodate the change in the distance between the two needles 9a.
  • the sealing opening 3a of the first elastic sealant film 3 is a tubular hole
  • the angle a between the tubular hole and the body of the elastic sealing film 3 is 15 to 90°, preferably 30 to 45. ° .
  • the tube-shaped sealing port 3a is preferably an inverted horn shape, and the mouth diameter dl of the tube hole is smaller than the outer diameter 1 ⁇ 2 of the draft tube 2, and the bottom diameter d2 of the tube hole is larger than the outer diameter 2 ⁇ 6 of the corresponding draft tube 2. hidden.
  • the sealing port 3a on the second and third elastic sealant films 3 has a vertical tube-like sealing opening 3a as shown in FIG. 7, and the angle between the tubular hole and the body of the elastic sealing film 3 is 90°.
  • the hole-shaped sealing port 3a is an inverted trumpet shape, and the mouth diameter dl of the pipe hole is smaller than the outer diameter of the needle 9a, and the bottom diameter d2 of the pipe hole is larger than the outer diameter 2 to 6 of the corresponding needle 9a.
  • the orthopedics use negative pressure closed drainage device to change the operation rules and principles of traditional orthopedic external fixation technology, and combine sealing and fixation operations.
  • the sealing of orthopedic external fixation device is very strict, and the negative pressure closed drainage treatment caused by air leakage is prevented. The failure or the effect is reduced.
  • Figure 12 is a schematic view showing the overall structure of a negative pressure closed drainage device for the perineal portion:
  • the negative pressure closed drainage device has substantially the same structure as the basic negative pressure closed drainage device, and comprises a porous foam cushion 1 disposed in the porous foam cushion 1 and a drainage tube 2 extending from the outer end of the porous foam cushion 1 at the tail end,
  • the first elastic sealing film 3 is disposed on the outer side of the porous foam pad 1.
  • the first elastic sealing film 3 has a sealing opening 3a extending from the drainage tube 2, and the diameter D of the opening of the sealing opening 3a is smaller than that of the corresponding drainage tube 2.
  • the path further includes an anal insertion catheter 11 having a fourth elastic sealing film 3 disposed at a position of a negative pressure region of the negative pressure sealing drainage device, and a fourth elastic sealing film 3 having a vertical tube hole shape
  • the sealing port 3a, the vertical tube hole-shaped sealing port 3a is sleeved on the anal insertion tube 11, and the fourth elastic sealing film 3 is placed on the first elastic sealing film 3 or directly placed on the porous foam pad 1 to cover and seal.
  • An irrigation tube 7 is disposed in the drainage tube 2, one end of the irrigation tube 7 extends into the drainage tube 2, and the other end of the irrigation tube 7 From the side wall of the trailing end of the draft tube 2, the end of the flushing tube 7 has a sealing cover 7a.
  • the tube-shaped sealing opening 3a of the fourth elastic sealing film 3 is preferably an inverted horn shape, the mouth diameter dl of the tube hole is smaller than the outer diameter l ⁇ 2 mm of the anal insertion catheter 11, and the bottom diameter d2 of the tube hole is larger than the corresponding anus
  • the outer diameter of the insertion duct 11 is 2 to 6 mm.
  • an annular inflated or liquid-filled capsule la la is disposed outside the front end of the anal insertion catheter 11 , and a gas guiding or liquid guiding tube 1 ib is provided in parallel with the anal insertion catheter 11 , and the air guiding or guiding tube is provided.
  • the front end of the ib communicates with the inflation or flushing capsule 11a, the rear end extends to the rear end of the tubular body 11, and the rear end of the air guiding or liquid guiding tube l ib is provided with a sealing cover 111.
  • the catheter l ib can also be placed in the inner wall of the anal insertion catheter 11. In the treatment of VSD, the anal insertion catheter is increased, which does not affect the normal physiological excretion of the patient, effectively avoiding the overflow of contaminated wounds, effectively reducing the incidence of infection and shortening the wound healing time of the patient.
  • the core of the present invention utilizes the elasticity of the elastic material to seal the pipe-piercing portion of the vacuum-tight closed drainage system, and skillfully solves the problem of air leakage that has not been solved for a long time.
  • a set of negative pressure closed drainage devices one or more can be used as needed, and the size and shape can be used interchangeably, which is extremely flexible. Therefore, any changes or modifications made without departing from the principles of the invention are intended to be within the scope of the invention.

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  • Health & Medical Sciences (AREA)
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Description

医用负压封闭引流装置 技术领域
本发明涉及一种医用负压封闭引流装置。 它是一种适用于人体体表组织或体腔病变 治疗用的负压封闭引流。 背景技术
负压封闭引流技术 (vacuum sealing drainage, 简称 VSD) 是德国 ULM大学 Wim Fleischman博士于 1992年首创， 并形成理论雏形， 用于四肢创面的引流； 1994年中国 裘华德教授首次将负压封闭引流技术应用于普外科， 开创了负压封闭引流技术在普外科 应用的先河，王彦峰、裘华德教授在中国于 1997年 3月 17日得到授权的专利 CN 2236350， 为负压封闭引流技术的第一个专利。
现有的 VSD技术基本配置包括负压源（包括医用吸引机、医院使用的中心负压装置 或负压引流瓶等）， 引流管、聚乙烯醇泡沫或其它医用多孔泡沫、海绵或纱布（以下简称 多孔泡沫软垫）、可粘贴密封薄膜、 引流容器组成。接通负压源引流， 将人体组织内的渗 血、 渗液、 液化坏死的组织碎片以及脓液等液化物质引流至引流容器内。
实际应用中， 将多孔泡沫软垫放置在创面上或创腔内， 再用密封薄膜将多孔泡沫软 垫和引流管出口端严密封闭， 使之与外界隔绝， 连接引流容器， 再接通负压源， 形成了 一个引流系统。 由于多孔泡沫软垫内的孔泡互相连通且富有弹性， 负压可以到达目标引 流区的每一点， 形成一个全方位的引流。 较大的、 质地不太硬的块状引出物在负压作用 下会被分割和塑型成颗粒状， 经过多孔泡沫软垫的孔隙或相互贯通的孔泡进入引流管， 再被迅速吸入引流容器内； 而可能堵塞引流管的大块引出物则被多孔泡沫软垫阻挡， 只 能附着在多孔泡沫软垫表面， 在去除或更换引流物时与多孔泡沫软垫一起离开机体。 密 封薄膜的封闭的好坏是作为引流动力的负压得以维持的关键， 同时也是被引流区与外界 隔绝， 有效地防止了污染和交叉感染的关键。
但是现有的 VSD技术仍存在很多的问题： ①密封不方便， 密封薄膜与引流管穿过部 分之间封闭不严密。 常用的密封方法包括： 戳孔法、 "系膜"法、 缝合法及 "包饺子"法 等。 但上述的密封方法在实际的操作中均非常繁琐， 手术医生均需要进行反复的操作和 练习才能掌握。而密封不牢固，往往是漏气最主要的原因，从而造成因漏气而导致的 VSD 系统治疗效果的削弱甚至失败。 ② VSD 材料在长时间负压状态下会缺水变干、 变硬。 ③ 对于外固定器穿针或会阴部插管时， 难以密封。 良好的密封是保证引流效果的关键， 也是整个负压封闭引流操作中最困难之处。 发明内容
本发明的目的是为了解决上述现有负压封闭引流装置的不合理之处，而提供了一种 密封效果好， 结构简单， 使用方便， 既适用于体表创面的引流， 又适用于体腔内作负压 封闭引流的医用负压封闭引流装置。
本发明的目的技术方案： 本发明的医用负压封闭引流装置包括多孔泡沫软垫， 布置 在多孔泡沫软垫内、 尾端伸出多孔泡沫软垫外侧的引流管， 所述多孔泡沫软垫外侧设有 管系伸出的弹性密封胶膜， 弹性密封胶膜上有管系伸出的密封口， 密封口的口部直径 D 小于对应的伸出管的外径。
所述的弹性密封胶膜上管系伸出的密封口是个圆孔， 圆孔的直径小于对应的伸出管 的外径 0. 3~4
所述的弹性密封胶膜上管系伸出的密封口是个管孔， 管孔的口部直径小于对应的伸 出管的外径 0. 3 2
所述的弹性密封胶膜上管系伸出的密封口是个管孔时， 管孔是倒喇叭形， 管孔的口 部直径小于对应的伸出管的外径 1 2 管孔的底部直径大于对应的伸出管的外径 2 6mm
所述的弹性密封胶膜上引流管伸出的密封口为管孔时， 密封口与弹性密封胶膜本体 之间的夹角 a为 15~90°
所述的引流管的侧壁排列有多个小孔。
所述的引流管为 1根或多根均匀排列， 多根排列时， 相邻两根的间距为 25 35 引流管为多根时， 多根尾端连接多通接头。
所述的负压封闭引流装置， 在引流管内设置冲洗管， 所述冲洗管的一端伸至引流管 内， 冲洗管的另一端从引流管的尾端侧壁引出， 冲洗管的尾端有密封盖。
本发明的骨科用负压封闭引流装置包括多孔泡沫软垫， 布置在多孔泡沫软垫内、 尾 端伸出多孔泡沫软垫外侧的引流管， 所述多孔泡沫软垫外侧设第一弹性密封胶膜， 第一 弹性密封胶膜上有引流管伸出的密封口，密封口的口部直径 D小于对应的引流管的外径， 在连接骨科外固定装置的穿针处设第二、 第三弹性密封胶膜， 第二、 第三弹性密封胶膜 上带有垂直管孔状密封口， 第二、 第三弹性密封胶膜上的两个垂直管孔状密封口套在两 个穿针上， 第二、 第三弹性密封胶膜置于第一弹性密封胶膜上或直接置于多孔泡沫软垫 上覆盖密封。 所述的第一弹性密封胶膜上引流管伸出的密封口为管状孔时， 管状孔与弹性密封胶 膜本体之间的夹角 a为 15 90°
所述的第二、 第三弹性密封胶膜上的垂直管孔状密封口的管孔是倒喇叭形， 管孔的 口部直径小于穿针的外径 0. 3 2 管孔的底部直径大于对应的穿针的外径 2 6 所述的骨科用负压封闭引流装置， 在引流管内设置冲洗管， 所述冲洗管的一端伸至 引流管内， 冲洗管的另一端从引流管的尾端侧壁引出， 冲洗管的尾端有密封盖。
本发明的用于会阴部的负压封闭引流装置包括多孔泡沫软垫， 布置在多孔泡沫软垫 内、 尾端伸出多孔泡沫软垫外侧的引流管， 所述多孔泡沫软垫外侧设引流管伸出的第一 弹性密封胶膜， 第一弹性密封胶膜上有引流管伸出的密封口， 密封口的口部直径 D小于 对应的引流管的外径， 还包括有肛门扦插导管， 所述肛门扦插导管穿越负压封闭引流装 置的负压区的位置设第四弹性密封胶膜， 第四弹性密封胶膜带有垂直管孔状密封口， 垂 直管孔状密封口套在肛门扦插导管上， 第四弹性密封胶膜置于第一弹性密封胶膜上或直 接置于多孔泡沫软垫上覆盖密封。
所述的肛门扦插导管前端外侧设置有环状的充气或充液胶囊， 还设有与肛门扦插导 管并行的导气或导液管， 所述导气或导液管前端与充气或冲液胶囊连通， 后端延伸至管 体后端外， 所述导气或导液管后端设有密封盖。
所述的用于会阴部的负压封闭引流装置， 在引流管内设置冲洗管， 所述冲洗管的一 端伸至引流管内， 冲洗管的另一端从引流管的尾端侧壁引出， 冲洗管的尾端有密封盖。 本发明有如下优点：
( 1 ) 彻底解决了引流管伸出部分的漏气问题， 保障了负压的稳定和成功， 攻克了 负压引流的关键技术， 使用效果更好， 大大降低了 VSD系统发生 "漏气" 的可能性， 即 将现有漏气率由 60%降低为 5%
( 2 ) 有了弹性密封胶膜， 使得本装置既适用于体表创面引流， 又适用于体腔内引 流。 将现有的体表创面引流和体腔创面引流的二套不同的引流装置统一为一套装置。
( 3)操作更方便， 无论是在体腔内的创面还是在体表创面， 引流管伸出部分有弹性 密封胶膜已经将引流管伸出部分密封， 使得密封薄膜密封更简单容易； 解决了体腔内创 面使用 VSD技术， 结构复杂， 医生的工作量大等缺点。 体腔创面引流时， 为密封薄膜提 供了一个有效的支撑处（载体）， 避免在如乳腺癌根治术、 直肠癌 Miles术、 阴道肿瘤根 治术、 骨髓炎开窗灌洗引流术、 会阴部爆炸伤等手术中， 贴膜时引流管贴膜无支撑处而 不得不采用对贴法的尴尬。 仅需要将密封薄膜密封在弹性密封胶膜的四周即可， 使体腔 创面引流操作简单、 密封效果好。 避免了使用 "系膜"法时操作人员的繁琐性和戳孔法 对患者正常机体组织的伤害； 避免了在侧出孔引流时对周围正常组织的压迫。
( 4 ) 在体表创面使用时， 弹性密封胶膜除提供贴膜支撑面外， 还可通过增大胶膜 的面积，使弹性密封胶膜覆盖多孔泡沫软垫，避免密封薄膜直接张贴在多孔泡沫软垫上， 而产生的因多孔泡沫软垫内的水分通过密封薄膜挥发， 使多孔泡沫软垫变硬的可能， 多 孔泡沫软垫变硬将使负压封闭引流失败。
( 5 )多根引流管通过多通接头与导管连接，引流管侧壁得多排小孔增大了吸收面积， 每根引出管的出口既可以作为引流口， 又可以作为发生堵管时的冲洗口， 引流和冲洗都 非常方便。
( 6 )有专用的冲洗管冲洗堵塞， 不会产生"逆行感染"。 有专用的冲洗管还可适时 地稀释、 浸泡、 软化多孔泡沫软垫内引流物， 更方便引流。 縮短了手术的时间， 并减轻 了病人的痛苦， 縮短了患者创面愈合的时间。
( 7 )本发明的用于骨科的负压封闭引流装置改变了传统的骨科外固定技术的操作规 程及原则， 将密封和固定操作结合起来， 对于骨科外固定装置的密封非常严密， 杜绝因 漏气而导致负压封闭引流治疗的失败或效果降低， 更杜绝了穿针处的感染， 解决了将负 压封闭引流装置应用于骨科创伤的关键技术， 基本杜绝了骨科创伤穿针处的感染， 使经 常发生的感染顺着穿针一直延伸至骨腔内的情况完全杜绝， 极大地降低了病人的治疗风 险、 减轻了病人的痛苦， 有效地保障了治疗效果， 大大降低了病人的致残率。
( 8 ) 本发明的用于会阴部的负压封闭引流装置， 增加会阴部的扦插导管， 在 VSD 治疗中， 不影响患者正常的生理排泄， 有效避免排泄物溢出污染创面， 有效降低了感染 发生率， 有效降低了感染发生率， 縮短了病人创面愈合时间。 附图说明
图 1为本发明第一种最基本的负压封闭引流装置总体结构示意图。
图 2为本发明第二种最基本的负压封闭引流装置总体结构示意图。
图 3为图 1用于体内时的示意图。
图 4为弹性密封胶膜的密封口是圆孔的示意图。
图 5为弹性密封胶膜的密封口是管孔的示意图。
图 6是图 5的 A-A剖视结构示意图。
图 7是弹性密封胶膜带垂直管孔密封口的示意图。
图 8为引流管结构及两根引流管的二通接头机构的示意图。 图 9为在多孔泡沫软垫内设四两根引流管及四通接头机构示意图。
图 10为骨科用负压封闭引流装置总体结构示意图。
图 11为图 10的纵向剖视结构示意图。
图 12是用于会阴部的负压封闭引流装置总体结构示意图。
图 13是肛门扦插导管结构示意图。 具体实施方式
下面结合附图详细说明本发明的实施方式， 但它们并不构成对本发明的限定。
图 1为本发明第一种最基本的负压封闭引流装置总体结构示意图：
包括多孔泡沫软垫 1， 布置在多孔泡沫软垫 1内、 尾端伸出多孔泡沫软垫 1外侧的 引流管 2， 所述多孔泡沫软垫 1外侧设有管系伸出的弹性密封胶膜 3， 弹性密封胶膜 3 上有引流管 2伸出的密封口 3a， 密封口 3a是圆孔.
图 4为弹性密封胶膜的示意图:密封孔 3a的直径 D小于对应的引流管 2的外径 0. 3
4mm
由于弹性密封胶膜的弹性， 使密封孔 3a紧箍在引流管 2上密封。使用时， 将密封薄 膜 8在弹性密封胶膜 3和多孔泡沫软垫 1上再密封。 引流管 2的尾端通过导管 4引流容 器 5、 负压源 6连接。 所述的引流管 2的尾端从多孔泡沫软垫 1的上侧伸出。
引流管 2内设置冲洗管 7， 所述冲洗管 7的一端伸至引流管 2内， 冲洗管 7的另一 端从引流管 2的尾端侧壁引出， 冲洗管 7的尾端有密封盖 7a
图 2为本发明第二种最基本的负压封闭引流装置总体结构示意图： 基本结构与第一 种完全相同，只是弹性密封胶膜 3上引流管 2伸出的密封口 3a是管孔，管孔的口部直径 小于对应的伸出管的外径 0. 3 2mm
如图 5、 图 6所示： 弹性密封胶膜 3上管系伸出的密封口 3a是个管孔状， 管孔是倒 喇叭形， 管孔的口部直径 dl小于引流管 2的外径 0. 3 2 管孔的底部 d2直径大于引 流管 2的外径 2 6 密封口 3a与弹性密封胶膜 3本体之间的夹角 a为 15~90° ，最佳 30 45°
图 7是弹性密封胶膜带垂直管孔密封口的示意图：密封口 3a与弹性密封胶膜 3本体 之间的夹角 a为 90° 。 本实施例适于垂直管系使用。
图 8为引流管结构及两根引流管的二通接头机构的示意图， 图 9为在多孔泡沫软垫 内设四两根引流管及四通接头机构示意图：
所述引流管 2的侧壁排列有多个小孔 2a。 多根引流管与多通接头 2b连接， 多通接 头 2b与导管 4连接。多根引流管适用于大面积创伤。将多个引流管 2通过多通接头连接 后， 汇合进入一个引流容器 5， 简单方便。 对于体内使用， 一根管引出， 创伤小。
上述结构解决了密封问题， 从而能够保持稳定的负压封闭引流。
在体表创面使用时， 如图 1、 图 2, 将多孔泡沫软垫 1置于创面后， 由于引流管 2 伸出处设弹性密封胶膜 3， 由于弹性密封胶膜的弹性， 使密封口 3a紧箍在引流管 2上密 封， 起到密封作用。 再用密封薄膜 8将多孔泡沫软垫 1和弹性密封胶膜 3盖上密封， 使 多孔泡沫软垫 1与体表密封。除达到密封效果外，还可通过增大弹性密封胶膜 3的面积， 使弹性密封胶膜覆盖多孔泡沫软垫， 避免因密封薄膜 3直接张贴在多孔泡沫软垫 1上而 产生的因多孔泡沫软垫内的水分通过密封薄膜挥发， 使多孔泡沫软垫变硬的可能， 多孔 泡沫软垫变硬将使负压封闭引流失败。
图 3为用于体内时的示意图：
本实施例采用引流管 2的一端位于多孔泡沫软垫 1内， 引流管 2的另一端从多孔泡 沫软垫 1的上端引出的结构形式。 在体腔内使用时， 将多孔泡沫软垫 1置于体腔内后， 弹性密封胶膜 3附在体外， 为密封薄膜 8提供了一个有效的支撑处 （载体）， 由密封口 3a的弹性使其紧箍在引流管 2上， 起到密封作用。 再用密封薄膜 8将弹性密封胶膜 3盖 上， 将弹性密封胶膜 3的四周与体表密封即可。
当引流管 2的小孔堵塞时， 将负压系统关闭， 打开冲洗管 7尾端的有密封盖 7a， 接 上冲洗器， 注入生理盐水， 瘀血块等被稀释溶化。 停止冲洗后， 打开负压， 被稀释的瘀 血块等被抽出。
现常用的冲洗方法为： （1 ) 在创面上另置一根橡胶管， 但也需要用 "系膜法"密封 橡胶管的引出位置， 增加了"漏气" 的可能性和密封的难度； （2 ) 从原引流管逆行注入 冲洗液， 可能会将引流出的渗液从新注入创面上， 造成"逆行感染"； （3 )从多孔泡沫软 垫上戳孔注入冲洗液， 单需要在多孔泡沫软垫上的破孔处重新粘贴密封薄膜， 增加了操 作的难度。
本发明方便冲洗堵管， 不会发生"逆行感染"， 且不会产生冲洗管占用引流管空间的 情况。 冲洗管 7的尾端有密封盖 7a， 不用时将密封盖盖严， 保证引流管 2正常工作。 冲 洗管 7还可以作为取样口， 将引流溶液进行化验， 作为医生用药时的参考。
多个引流管 2通过多通接头连接方式， 当一个引流管堵塞时， 可很方便地从导管接 头进行观察， 便于及时通过冲洗管冲洗， 其它引流管可继续引流， 不会发生一个引流管 堵塞后， 负压封闭引流不能正常工作的情况。
图 10、 图 11为骨科用负压封闭引流装置总体结构示意图： 骨科用负压封闭引流装置结构与上述基本负压封闭引流装置结构基本相同， 包括多 孔泡沫软垫 1， 布置在多孔泡沫软垫 1内、尾端伸出多孔泡沫软垫 1外侧的引流管 2， 所 述多孔泡沫软垫 1外侧设第一弹性密封胶膜 3， 第一弹性密封胶膜 3上有引流管 2伸出 的密封口 3a， 密封口 3a的口部直径 D小于对应的引流管 2的外径， 在连接骨科外固定 装置 9的穿针 9a处设第二、 第三弹性密封胶膜 3， 第二、 第三弹性密封胶膜 3上带有垂 直管孔状密封口 3a， 第二、 第三弹性密封胶膜 3上的两个垂直管孔状密封口 3a套在两 个穿针 9a上，第二、第三弹性密封胶膜 3置于第一弹性密封胶膜 3上或直接置于多孔泡 沫软垫 1上覆盖密封。 在引流管 2内设置冲洗管 7， 所述冲洗管 7的一端伸至引流管 2 内， 冲洗管 7的另一端从引流管 2的尾端侧壁引出， 冲洗管 7的尾端有密封盖 7a。 设第 二、第三弹性密封胶膜 3是为了适应两根穿针 9a的距离变化。 所述第一弹性密封胶膜 3 上引流管 2伸出的密封口 3a为管状孔时， 管状孔与弹性密封胶膜 3本体之间的夹角 a 为 15~90° ， 最佳 30〜45° 。
管孔状密封口 3a是倒喇叭形较佳，管孔的口部直径 dl小于引流管 2的外径 1〜2隱， 管孔的底部直径 d2大于对应的引流管 2的外径 2〜6隱。
第二、 第三弹性密封胶膜 3上的密封口 3a如图 7所示的垂直管孔状密封口 3a， 属 于管状孔与弹性密封胶膜 3本体之间的夹角 a为 90° 的实施例， 用于其它管系密封。 管 孔状密封口 3a是倒喇叭形， 管孔的口部直径 dl小于穿针 9a的外径 1〜2隱， 管孔的底 部直径 d2大于对应的穿针 9a的外径 2〜6隱。骨科用负压封闭引流装置改变了传统的骨 科外固定技术的操作规程及原则， 将密封和固定操作结合起来， 对于骨科外固定装置的 密封非常严密， 杜绝因漏气而导致负压封闭引流治疗的失败或效果降低。
图 12是用于会阴部的负压封闭引流装置总体结构示意图：
负压封闭引流装置与上述基本负压封闭引流装置结构基本相同， 包括多孔泡沫软垫 1， 布置在多孔泡沫软垫 1内、 尾端伸出多孔泡沫软垫 1外侧的引流管 2， 所述多孔泡沫 软垫 1外侧设第一弹性密封胶膜 3，第一弹性密封胶膜 3上有引流管 2伸出的密封口 3a， 密封口 3a的口部直径 D小于对应的引流管 2的外径， 还包括有肛门扦插导管 11， 所述 肛门扦插导管 11穿越负压封闭引流装置的负压区的位置设第四弹性密封胶膜 3，第四弹 性密封胶膜 3带有垂直管孔状密封口 3a，垂直管孔状密封口 3a套在肛门扦插导管 11上， 第四弹性密封胶膜 3置于第一弹性密封胶膜 3上或直接置于多孔泡沫软垫 1上覆盖密封。 在引流管 2内设置冲洗管 7， 所述冲洗管 7的一端伸至引流管 2内， 冲洗管 7的另一端 从引流管 2的尾端侧壁引出， 冲洗管 7的尾端有密封盖 7a。
第四弹性密封胶膜 3的管孔状密封口 3a是倒喇叭形较佳， 管孔的口部直径 dl小于 肛门扦插导管 11的外径 l〜2mm， 管孔的底部直径 d2大于对应的肛门扦插导管 11的外 径 2〜6mm。
如图 13:肛门扦插导管 11前端外侧设置有环状的充气或充液胶囊 l la，还设有与肛 门扦插导管 11并行的导气或导液管 l ib,所述导气或导液管 l ib前端与充气或冲液胶囊 11a连通， 后端延伸至管体 11后端外， 所述导气或导液管 l ib后端设有密封盖 l lc。 导 液管 l ib也可以设在肛门扦插导管 11内壁内。在 VSD治疗中， 增加肛门扦插导管， 不影 响患者正常的生理排泄， 有效避免排泄物溢出污染创面， 有效降低了感染发生率， 縮短 了病人创面愈合时间。
综上所述，本发明的核心是利用弹性材料的弹性，对负压封闭引流系统穿管部位进行 密封， 巧妙地解决了长期以来无法解决的漏气难题。 在一套负压封闭引流装置中， 可以 根据需要使用一个或多个， 大小、 不同形状可以交叉使用， 极其灵活。 因此， 在不改变 本发明原理的前提下， 所作出的任何改变或变形， 均属于本发明的保护范围。

Claims

权 利 要 求 书
1. 一种医用负压封闭引流装置， 包括多孔泡沫软垫（1)， 布置在多孔泡沫软垫（1) 内、尾端伸出多孔泡沫软垫（1)外侧的引流管（2)，其特征在于： 所述多孔泡沫软垫（1) 外侧设有管系伸出的弹性密封胶膜（3)，弹性密封胶膜（3)上有管系伸出的密封口（3a 密封口 （3a) 的口部直径 D小于对应的伸出管的外径。
2. 根据权利要求 1所述的医用负压封闭引流装置， 其特征在于： 弹性密封胶膜（3) 上管系伸出的密封口 （3a) 是个圆孔， 圆孔的直径小于对应的伸出管的外径 0.3~4
3. 根据权利要求 1所述的医用负压封闭引流装置， 其特征在于： 弹性密封胶膜（3) 上管系伸出的密封口 （3a) 是个管孔， 管孔的口部直径小于对应的伸出管的外径 0.3〜 2mm
4. 根据权利要求 3所述的医用负压封闭引流装置， 其特征在于： 弹性密封胶膜（3) 上管系伸出的密封口 （3a) 是个管孔时， 管孔是倒喇叭形， 管孔的口部直径小于对应的 伸出管的外径 1〜2 管孔的底部直径大于对应的伸出管的外径 2〜6
5. 根据权利要求 3或 4所述的医用负压封闭引流装置， 其特征在于： 所述弹性密封 胶膜 （3) 上引流管 （2) 伸出的密封口 （3a) 为管孔时， 密封口 （3a) 与弹性密封胶膜
(3) 本体之间的夹角 a为 15~90°
6. 根据权利要求 1或 2所述的负压封闭引流装置， 其特征在于： 所述引流管 （2) 的侧壁排列有多个小孔 （2a)。
7.根据权利要求 3或 4所述的医用负压封闭引流装置，其特征在于：所述引流管（2) 的侧壁排列有多个小孔 （2a)。
8. 根据权利要求 1或 2所述的医用负压封闭引流装置， 其特征在于： 引流管 （2) 为 1根或多根均匀排列， 多根排列时， 相邻两根的间距为 25〜35mm， 弓 |流管 （2) 为多 根时， 多根尾端连接多通接头 （2b)。
9. 根据权利要求 3或 4所述的医用负压封闭引流装置， 其特征在于： 引流管 （2) 为 1根或多根均匀排列， 多根排列时， 相邻两根的间距为 25〜35mm， 弓 |流管 （2) 为多 根时， 多根尾端连接多通接头 （2b)。
10. 根据权利要求 1或 2所述的医用负压封闭引流装置，其特征在于：在引流管（2) 内设置冲洗管 （7)， 所述冲洗管 （7) 的一端伸至引流管 （2) 内， 冲洗管 （7) 的另一端 从引流管 （2) 的尾端侧壁引出， 冲洗管 （7) 的尾端有密封盖 （7a)。
11.根据权利要求 3或 4所述的医用负压封闭引流装置，其特征在于：在引流管（2) 内设置冲洗管 （7)， 所述冲洗管 （7) 的一端伸至引流管 （2) 内， 冲洗管 （7) 的另一端 从引流管 （2) 的尾端侧壁引出， 冲洗管 （7) 的尾端有密封盖 （7a)。
12.一种骨科用负压封闭引流装置，包括多孔泡沫软垫（1)，布置在多孔泡沫软垫（1) 内、尾端伸出多孔泡沫软垫（1)外侧的引流管（2)，其特征在于： 所述多孔泡沫软垫（1) 外侧设第一弹性密封胶膜 （3)， 第一弹性密封胶膜 （3) 上有引流管 （2) 伸出的密封口
(3a), 密封口 （3a) 的口部直径 D小于对应的引流管 （2) 的外径， 在连接骨科外固定 装置（9)的穿针（9a)处设第二、第三弹性密封胶膜（3)， 第二、第三弹性密封胶膜（3) 上带有垂直管孔状密封口 （3a)， 第二、 第三弹性密封胶膜 （3) 上的两个垂直管孔状密 封口 （3a)套在两个穿针 （9a)上， 第二、 第三弹性密封胶膜 （3)置于第一弹性密封胶 膜 （3) 上或直接置于多孔泡沫软垫 （1) 上覆盖密封。
13. 根据权利要求 12所述的骨科用负压封闭引流装置， 其特征在于： 所述第一弹性 密封胶膜 （3) 上引流管 （2) 伸出的密封口 （3a) 为管状孔时， 管状孔与弹性密封胶膜
(3) 本体之间的夹角 a为 15〜90° 。
14. 根据权利要求 12或 13所述的骨科用负压封闭引流装置， 其特征在于： 第二、 第三弹性密封胶膜（3)上的垂直管孔状密封口 （3a) 的管孔是倒喇叭形， 管孔的口部直 径小于穿针 （9a) 的外径 0.3〜2mm， 管孔的底部直径大于对应的穿针 （9a) 的外径 2〜 6mm。
15. 根据权利要求 12或 13所述的骨科用负压封闭引流装置， 其特征在于： 在引流 管 （2) 内设置冲洗管 （7)， 所述冲洗管 （7) 的一端伸至引流管 （2) 内， 冲洗管 （7) 的另一端从引流管 （2) 的尾端侧壁引出， 冲洗管 （7) 的尾端有密封盖 （7a)。
16. 一种用于会阴部的负压封闭引流装置， 包括多孔泡沫软垫 （1)， 布置在多孔泡 沫软垫 （1) 内、 尾端伸出多孔泡沫软垫 （1) 外侧的引流管 （2)， 其特征在于： 所述多 孔泡沫软垫 （1) 外侧设引流管 （2) 伸出的第一弹性密封胶膜 （3)， 第一弹性密封胶膜
(3)上有引流管 （2)伸出的密封口 （3a)， 密封口 （3a) 的口部直径 D小于对应的引流 管 （2) 的外径， 还包括有肛门扦插导管 （11)， 所述肛门扦插导管 （11) 穿越负压封闭 引流装置的负压区的位置设第四弹性密封胶膜（3)， 第四弹性密封胶膜（3)带有垂直管 孔状密封口 （3a)， 垂直管孔状密封口 （3a)套在肛门扦插导管 （11)上， 第四弹性密封 胶膜 （3) 置于第一弹性密封胶膜 （3) 上或直接置于多孔泡沫软垫 （1) 上覆盖密封。
17. 根据权利要求 16所述的用于会阴部的负压封闭引流装置， 其特征在于： 肛门扦 插导管（11)前端外侧设置有环状的充气或充液胶囊（lla)，还设有与肛门扦插导管（11) 并行的导气或导液管 （lib), 所述导气或导液管 （lib) 前端与充气或冲液胶囊 （11a) 连通， 后端延伸至管体（11)后端外， 所述导气或导液管（lib)后端设有密封盖（llc)。
18. 根据权利要求 16或 17所述的用于会阴部的负压封闭引流装置， 其特征在于： 在引流管 （2) 内设置冲洗管 （7)， 所述冲洗管 （7) 的一端伸至引流管 （2) 内， 冲洗管
(7) 的另一端从引流管 （2) 的尾端侧壁引出， 冲洗管 （7) 的尾端有密封盖 （7a)。
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