WO2020186729A1 - 无缝线闭合皮肤创口的负压引流及清洗系统 - Google Patents

无缝线闭合皮肤创口的负压引流及清洗系统 Download PDF

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Publication number
WO2020186729A1
WO2020186729A1 PCT/CN2019/109565 CN2019109565W WO2020186729A1 WO 2020186729 A1 WO2020186729 A1 WO 2020186729A1 CN 2019109565 W CN2019109565 W CN 2019109565W WO 2020186729 A1 WO2020186729 A1 WO 2020186729A1
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Prior art keywords
negative pressure
skin
wound
subcutaneous
catheter
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Application number
PCT/CN2019/109565
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English (en)
French (fr)
Inventor
陈伟
Original Assignee
景润(上海)医疗器械有限公司
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 CN201910208814.7A external-priority patent/CN111714171B/zh
Priority claimed from CN201910414748.9A external-priority patent/CN111939333A/zh
Application filed by 景润(上海)医疗器械有限公司 filed Critical 景润(上海)医疗器械有限公司
Priority to US17/593,218 priority Critical patent/US20220218891A1/en
Priority to EP19919593.4A priority patent/EP3943130A4/en
Publication of WO2020186729A1 publication Critical patent/WO2020186729A1/zh

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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
    • 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
    • A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
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    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
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    • 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
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
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    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0208—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
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    • 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
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    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0258—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
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    • A61B2017/081—Tissue approximator
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/80—Implements for cleaning or washing the skin of surgeons or patients
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/00—General characteristics of the apparatus
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    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate

Definitions

  • the application relates to the field of medical devices, and in particular to a negative pressure drainage and cleaning system for closing skin wounds with seamless threads.
  • the purpose of this application is to provide a sutureless sutureless vacuum drainage and cleaning system for skin wounds, which is used to solve the problem that the suture of the incision after the operation in the prior art is easy to leave traces and fluid accumulation. The problem is difficult to discharge.
  • the first aspect of this application provides a vacuum drainage and cleaning system for sutureless closure of skin wounds, including: a flushing device, including a delivery pump and a part of the subcutaneous wound cavity
  • the first catheter with a depth is used to deliver the cleaning solution to the predetermined depth of the subcutaneous wound cavity through the first catheter;
  • the negative pressure device includes a negative pressure source and partially penetrates into the predetermined depth of the subcutaneous wound cavity
  • the second catheter is used to generate negative pressure to force the cavity of the subcutaneous wound to be closed during the healing process and to drain the effusion in the cavity of the subcutaneous wound through the second catheter; control device, electrical
  • the flushing device and the negative pressure device are connected to control the output pressure or flow rate of the flushing device and the negative pressure device according to the received feedback to maintain the vacuum degree of the cavity of the subcutaneous wound.
  • the flushing device includes: a cleaning solution container storing a cleaning solution for flushing the inner cavity of the subcutaneous wound, and communicating with the delivery pump through the first conduit;
  • the first pressure sensor is used to feed back the fluid pressure value of the first catheter between the delivery pump and the subcutaneous wound cavity to the control device to adjust the speed of the delivery pump to control the cleaning fluid
  • the output pressure is used to sense the vacuum of the first conduit between the delivery pump and the cleaning liquid container to monitor the exhausted state of the cleaning liquid in the cleaning liquid container.
  • the flushing device includes an alarm device for outputting an alarm signal when the first vacuum sensor detects that the cleaning liquid in the cleaning liquid container is exhausted.
  • the delivery pump is a diaphragm pump.
  • the negative pressure device includes: a collection container for collecting the fluid drained from the subcutaneous wound cavity by the second catheter; and a second pressure sensor To sense the fluid resistance of the second conduit between the negative pressure source and the collection container to monitor the full state of the collection container; the second vacuum sensor is used to sense the negative pressure source The degree of vacuum between the second catheter and the cavity of the subcutaneous wound is fed back to the control device to adjust the power of the negative pressure source to control the generated negative pressure.
  • the negative pressure source is a diaphragm pump.
  • the predetermined depth is the depth from the superficial skin fascia to the fat layer and the deep fascia layer in the skin tissue.
  • the first or second catheter partially penetrates through a predetermined position of the skin wound to a predetermined depth of the lumen of the subcutaneous wound; or The first or second catheter passes through the skin and subcutaneous tissue through a predetermined position away from the skin wound to partially penetrate into the predetermined depth of the lumen of the subcutaneous wound.
  • the first catheter and the second catheter are integrally formed or the second catheter is sheathed in the first catheter.
  • a plurality of through holes are provided on the tube wall of the part where the first or second catheter penetrates into the skin wound at a predetermined depth.
  • a one-way valve is provided on the first or second conduit.
  • the one-way valve is a duckbill valve or a fan valve.
  • the negative pressure device is also used to maintain a stable tissue position on the surface of the skin wound and its peripheral area by the generated negative pressure.
  • the negative pressure device includes: a sealing film for adhering to the skin and covering the skin wound surface to form a sealed space; a negative pressure channel communicating with the Negative pressure source, through the negative pressure generated by the negative pressure source to make the sealing film provide contraction force to drive the skin wound to contract towards each other.
  • the sealing film is bonded to the surface of the skin through its adhesive layer relative to the surface of the skin, and the material of the adhesive layer includes acrylic adhesive coated Polyurethane is a flexible impermeable material.
  • the sealing film is provided with an observation window made of a light-transmitting material.
  • the negative pressure device includes a humidity detection component for providing the detected humidity information in the sealed space to the negative pressure source to facilitate the negative pressure Source control negative pressure output.
  • the second catheter includes a subcutaneous drainage hole and a supracutaneous negative pressure hole, and the subcutaneous drainage hole is set in the second catheter to penetrate into the skin wound.
  • the present application has the beneficial effects that: the sutureless sutureless vacuum drainage and cleaning system of the present application is forced by the negative pressure drainage device to make the subcutaneous wound cavity in the healing process Keep closed, maintain the dissected tissues in a fit state, and maintain the bleeding and exudate in the wound cavity to be cleared in time through continuous negative pressure suction; on this basis, the liquid drug is delivered to the subcutaneously through the intermittent cleaning system
  • the wound cavity moisturizes the clotted blood clots in the subcutaneous wound cavity to facilitate removal, and dilutes the bacterial community that has the potential to reach colonization concentration, and is drained and removed with the irrigation fluid to maintain a clean state in the wound cavity;
  • negative pressure can be generated through negative pressure drainage to maintain the stable tissue position of the skin wound and its peripheral area, thereby facilitating tissue healing.
  • this application can assist in the seamless closure of the full-thickness tissue above the deep fascia of the skin, avoiding lateral scars (commonly known as "centipede feet") on the skin surface caused by suture compression/cutting, and in the superficial fascia There are no suture knots left, which eliminates the important factors that cause bacterial colonization and the main cause of recurrence of incision infection.
  • Fig. 1 shows a schematic diagram of an embodiment of the negative pressure drainage and cleaning system for closing skin wounds with seamless threads of this application.
  • Fig. 2 shows a schematic diagram of an embodiment of the application of the vacuum drainage and cleaning system for sutureless skin wound closure.
  • Fig. 3 is a schematic diagram of an embodiment of the alarm device in the negative pressure drainage and cleaning system for closing skin wounds with seamless thread according to the present application.
  • Fig. 4 is a schematic diagram showing an embodiment of the first or second catheter in this application partially penetrated from a predetermined position of the skin wound to the predetermined depth of the cavity of the subcutaneous wound.
  • Fig. 5 is a schematic diagram showing an embodiment of the first or second catheter passing through the skin and subcutaneous tissue through a predetermined position away from the skin wound in this application.
  • FIG. 6 shows a schematic diagram of an embodiment of the flushing device in this application.
  • FIG. 7 shows a schematic diagram of an embodiment of the negative pressure device in this application.
  • Fig. 8 shows a schematic diagram of the structure of the closure member in the wound closure device in an embodiment of the present application.
  • Fig. 9 shows a schematic diagram of an embodiment of the combination of a closure element and a wound in an embodiment of the present application.
  • Fig. 10 shows a schematic diagram of the closure member of the wound closure device in this application in another embodiment.
  • Fig. 11 is a schematic diagram showing the application of the closure member and auxiliary member of the wound closure device of the present application in an embodiment.
  • Fig. 12 shows a schematic diagram of the structure of the closure member in the wound closure device of this application in another embodiment.
  • Fig. 13 shows a schematic diagram of an embodiment of the first and second duct structures of this application.
  • Fig. 14 shows a schematic diagram of another embodiment of the first and second duct structures of this application.
  • FIG. 15 shows a schematic diagram of the sealing and force-receiving structure of the negative pressure device in an embodiment of this application.
  • FIG. 16 shows a schematic diagram of an embodiment of the second catheter in this application.
  • FIG. 17 shows a schematic diagram of an application embodiment of this application.
  • first, second, etc. are used herein to describe various elements or parameters in some examples, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one or parameter from another or parameter.
  • the first catheter may be referred to as the second catheter, and similarly, the second catheter may be referred to as the first catheter without departing from the scope of the various described embodiments. Both the first catheter and the second catheter describe one catheter, but unless the context clearly indicates otherwise, they are not the same catheter.
  • A, B or C or "A, B and/or C” means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C” .
  • An exception to this definition will only occur when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way.
  • superficial fascia refers to the skin epidermis, dermis and subcutaneous fat tissue.
  • superficial fascia is the continuation of the superficial fascia of the anterior and lateral areas with the superficial fascia of the neck, abdomen and upper limbs, and contains fat, superficial Blood vessels, lymphatic vessels, cutaneous nerves and breast.
  • Deep fascia refers to the fibrous connective tissue that separates the skin and muscle tissue. Surgical procedures usually require layered suture of the superficial fascia and the deep fascia during the skin suture stage. The sequence is to suture the deep fascia first, then suture the subcutaneous tissue, and finally suture the skin.
  • layered suture The significance of layered suture is to use suture to resist skin tension layer by layer, thereby improving the quality of healing. Because skin sutures can cause local tissue ischemia, scars in the direction perpendicular to the incision can be formed at the suture site after surgery, commonly known as "centipede feet", which is an inevitable result of traditional suture methods. In addition, conventional skin sutures will inevitably leave a large number of thread knots in the superficial subcutaneous fascia layer. The presence of thread knots often leads to incision complications: such as incision infection, fat liquefaction, etc., causing serious consequences and affecting the quality of life of patients.
  • the reduced-pressure dressing assembly includes a pillow body with a closing member formed of a closed pillow material. When dressing a pillow, the closing member can generate an inward closing force. In some cases, the assembly also includes a wicking material that has fluid flow paths for removing fluid.
  • this method still needs to suture the wound during the application process, which can only help suture and help healing, and cannot completely replace the suture step, so it still leaves suture marks on the patient's skin.
  • the closing force generated in this structure can only act on the surface layer.
  • the deep subcutaneous muscle tissue cannot be forced into a closed state, and the wicking material can only treat the liquid exuded from the skin surface.
  • the inability to deal with the subcutaneous fluid (such as bleeding, exudate, etc.) in time is not conducive to wound recovery.
  • the present application provides a negative pressure drainage and cleaning system for closing skin wounds without stitches, in order to achieve the control of the environment in and around the skin wound to facilitate the healing of the skin wound.
  • the negative pressure drainage and cleaning system for sutureless skin wound closure of the present application includes: a flushing device, a negative pressure device, and a control device.
  • the irrigation device includes a delivery pump and a first catheter, wherein the first catheter partially penetrates into the predetermined depth of the lumen of the subcutaneous wound, and the delivery pump delivers cleaning fluid to the first catheter to clean the lumen of the subcutaneous wound. At the same time, cleaning fluid can be delivered to the cavity of the subcutaneous wound to promote the healing of the cavity of the subcutaneous wound.
  • the negative pressure device includes a negative pressure source and a second catheter, the second catheter partially penetrates the subcutaneous wound cavity to a predetermined depth, and the negative pressure source is connected to the second catheter to generate negative pressure to force the subcutaneous wound
  • the inner cavity is closed during the healing process, and at the same time, it can also drain the effusion in the subcutaneous wound cavity to ensure the health of the subcutaneous wound cavity environment.
  • the control device is electrically connected to the flushing device and the negative pressure device, thereby controlling the flushing device and the negative pressure device, and at the same time adjusting the flushing device and the negative pressure device through the information fed back from the flushing device and the negative pressure device, thereby adjusting the output of the flushing device Pressure or flow and negative pressure device.
  • the negative pressure drainage and cleaning system for sutureless skin wound closure of the present application uses a negative pressure device to keep the subcutaneous wound cavity in a closed state during the healing and rehabilitation process, maintain the disconnected tissue in a fit state, and continue to Negative pressure suction keeps blood and exudate in the wound cavity cleared in time.
  • the present application can also use the negative pressure generated by the negative pressure device to maintain the stable tissue position of the skin wound and its peripheral area, thereby facilitating tissue healing.
  • liquid medicine is intermittently delivered to the lumen of the subcutaneous wound through a flushing device, so that the clotted blood in the lumen of the subcutaneous wound is moistened to facilitate removal, and the bacterial community that has the potential to reach colonization concentration is diluted , With the flushing fluid drainage to remove, so as to maintain a clean state in the wound cavity.
  • the third aspect of the present application controls the flushing device and the negative pressure device through the feedback mechanism of the control device to ensure the strength, flow, and intensity of the negative pressure to ensure that the patient will not be adversely affected and the subcutaneous wound cavity is maintained The degree of vacuum.
  • the subcutaneous wound cavity can be closed to assist in the sutureless closure of the full-thickness tissue above the deep fascia of the skin, avoiding lateral scars on the skin surface caused by suture compression/cutting, and in the superficial tendons There are no suture knots left in the membrane, thereby eliminating important factors that cause bacterial colonization and the main cause of recurrence of incision infection.
  • the skin wounds include all skins or other tissues where the continuity is formed by interruption, and broadly refers to incisions, wounds, defects or other therapeutic targets located on or in tissues . It should be noted that most of the skin wounds are caused by surgery, but in some cases, the skin wounds may also be caused by accidents such as cuts or collisions.
  • the healing of skin wounds needs to fit the two sections of the subcutaneous wound cavity, for example, it can be achieved by means of suture in the prior art.
  • the gas in the subcutaneous wound cavity is drawn out by negative pressure, so that the subcutaneous wound cavity maintains a certain degree of vacuum, so that the two sections of the subcutaneous wound cavity are attached inwardly, thereby realizing a skin wound The closure.
  • the tissue includes, but is not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament.
  • the wound may include, for example, chronic, acute, traumatic, subacute and dehiscence wounds; partial cortical burns, ulcers (such as diabetic ulcers, pressure ulcers or venous insufficiency ulcers), skin flaps, and grafts.
  • tissue site can also refer to any tissue area that is not necessarily injured or defective, but is an area where it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure can be applied to the tissue site to grow additional tissue that can be harvested and transplanted.
  • the seamless thread mentioned in this application refers to the superficial skin fascia part (ie skin epidermis, dermis and subcutaneous fat tissue part) or the aforementioned superficial skin fascia layer in the treatment of closed skin wounds or in the skin
  • other treatments such as cleaning, disinfection, and application of skin wounds are not used to suture the superficial fascia of the skin, and suture needles are not used in these processes Therefore, after the skin wound is healed, there is no process for removing foreign bodies in the wound or superficial fascia of the skin, such as removing or removing the suture or removing the thread.
  • FIG. 1 shows a schematic diagram of an embodiment of a vacuum drainage and cleaning system for closing skin wounds with seamless threads.
  • the seamless The negative pressure drainage and cleaning system for thread-closing skin wounds includes: flushing device 1, negative pressure device 2, control device 3.
  • FIG. 2 shows a schematic diagram of an embodiment of the application of the vacuum drainage and cleaning system for sutureless skin wound closure.
  • the irrigation device 1 includes a delivery pump 103 and a first catheter 105 partially penetrated into the subcutaneous wound cavity 8 to a predetermined depth, and is used to deliver cleaning fluid to the subcutaneous wound through the first catheter 105 The preset depth of the cavity 8.
  • the subcutaneous wound cavity 8 refers to the cavity formed by the internal incision under the wound during the operation.
  • the cavity includes the gap formed by the continuity of all skin or other tissue parts.
  • the biological tissue has elasticity or stretch properties.
  • the cavity 8 of the subcutaneous wound that is, the cleft gap may not be visually presented as a cavity state or a hollow state. Therefore, the shape of the gap gap And the size is not limited in the examples provided in this application.
  • the “conduit” disclosed in this application refers to that components can be fluidly coupled to each other in order to provide a path for transferring fluid (ie, liquid and/or gas) between these components.
  • these components may be fluidly coupled by fluid guides such as tubes.
  • Catheter as used herein broadly includes tubes, pipes, hoses, catheters, or other structures having one or more lumens adapted to convey fluid between two ends.
  • the tube is an elongated cylindrical structure with some flexibility, but the geometry and rigidity can vary.
  • multiple components may also be coupled by physical proximity, become a single structure as a whole, or be formed from the same piece of material.
  • some fluid guides may be molded into other parts or otherwise integrated with other parts.
  • the preset depth is the depth from the superficial skin fascia to the fat layer and the deep fascia layer in the skin tissue.
  • the predetermined depth position is at the junction of the fat layer and the deep fascia layer in the skin tissue.
  • the skin tissue includes blood vessel network, superficial fascia layer, fat, deep fascia layer, muscle and bone in sequence. Therefore, the preset depth in this embodiment includes the depth interval from the superficial fascia layer to the fat and deep fascia layer.
  • the cleaning fluid includes distilled water, hydrogen peroxide, physiological saline, etc., which can be used to clean the wound.
  • the cleaning solution may also include liquid medicines, which are determined according to different causes and different types of subcutaneous wound cavities. For example, when there is a bacterial infection in the wound, it can be cleaned Antibiotics are added to the liquid. When there is inflammation in the wound, liquid medicine with anti-inflammatory ingredients can be added to the cleaning liquid. In other embodiments, the solid medicine can also be dissolved in the cleaning solution to be delivered to the subcutaneous wound cavity 8.
  • FIG. 6 shows a schematic diagram of an embodiment of the flushing device in this application.
  • the flushing device 1 further includes: a cleaning liquid container 101, a first pressure sensor 104.
  • the first vacuum sensor 102 is a sensor that detects the first vacuum.
  • the washing liquid container 101 stores washing liquid for washing the inner cavity 8 of the subcutaneous wound, and is connected to the delivery pump 103 through the first conduit 105.
  • the first catheter 105 is used to deliver the cleaning solution to the predetermined depth of the subcutaneous wound cavity 8 to facilitate the healing of the subcutaneous wound cavity 8.
  • the washing device 1 can be controlled to deliver the washing solution to the subcutaneous wound cavity 8 in an intermittent manner, so that the clotted blood clots, tissue liquid clots, etc. in the subcutaneous wound cavity 8 can be moistened to facilitate migration. It removes, and dilutes the bacterial community that has the potential to reach the colonization concentration, and is drained and removed with the washing fluid, thereby maintaining the clean state of the subcutaneous wound cavity 8.
  • the intermittentity is, for example, the delivery frequency in hours, or the delivery of drugs in days.
  • the cleaning liquid container 101 and the delivery pump 103 can also be replaced with a drug delivery device or a drug delivery machine including devices such as a micro pump or a syringe.
  • skin wounds may secrete blood, tissue fluids or other body fluids to form fluid accumulation. If the fluid is not drained in time, it may cause infection, inflammation and even suppuration. In some cases, the effusion that has not been cleared in time may coagulate in the cavity 8 of the subcutaneous wound, forming blood clots and other difficult-to-remove objects. After being moistened by the cleaning fluid, the blood clots can be dissolved or carried by the pressure of the liquid. It is beneficial to the recovery of the subcutaneous wound.
  • Surgical site infection is a clinical problem worldwide. After the skin is incised/cracked, the deep tissues of the human body will come into contact with the outside world, and there will be opportunities for contamination by pathogenic bacteria. When the bacterial content in the tissue exceeds 10 5 /g, bacterial colonization occurs and cannot be controlled by the human immune system. With the exponential proliferation of bacteria, tissue necrosis and inflammation gradually appear at the infected site, and local symptoms of redness, swelling, heat, and pain appear; due to the incubation period of bacteria colonization to the appearance of infection symptoms, SSI is usually difficult to be effective at an early stage Identification and timely processing. A typical wound infection usually occurs 7-10 days after surgery, starting from local redness, tenderness, and then ulceration and pus.
  • the irrigation device 1 can deliver the cleaning solution to the subcutaneous wound cavity 8 through the first conduit 105 for diluting the bacterial infection that may or has occurred in the subcutaneous wound cavity 8, thereby making The infection foci with potential colonization concentration are diluted; at the same time, the cleaning solution delivered by the washing device 1 can also achieve the purpose of washing the infected part in the subcutaneous wound cavity 8. After washing is completed, pass the negative The drainage function of the pressure device 2 sucks away the cleaning fluid in the cavity 8 of the subcutaneous wound, thereby draining and removing bacteria, so that the cavity 8 of the subcutaneous wound is kept clean.
  • the amount of cleaning fluid in the flushing device 1 can be controlled, the time for diluting the bacterial infection part, the frequency of flushing of the cleaning fluid, and the amount of cleaning fluid can be controlled according to the judgment of the patient’s subcutaneous wound cavity 8 infection.
  • the time for the washing device 1 to wash the subcutaneous wound cavity 8 with the washing solution is, for example, 2 to 3 days.
  • the cleaning solution container 101 and the delivery pump 103 can also be replaced with a drug delivery device or a drug delivery machine including a micro pump or a syringe, when a syringe or other drug delivery device that requires manual control is used, it can also be operated The personnel manually control the flushing time, frequency, intensity and other parameters.
  • the delivery pump 103 is a diaphragm pump, and the diaphragm pump is a water pump.
  • the diaphragm pump also known as the diaphragm pump and the control pump, is the main type of actuator, and changes the fluid flow by receiving the control signal output by the adjustment control unit and using power operation.
  • the diaphragm pump is used to receive the control signal of the regulator or computer during the control process, change the flow of the adjusted medium, and maintain the adjusted parameter within the required range, so as to realize the control of the parameters such as temperature, pressure, and flow during the working process. , Adjustment and control of liquid level, etc.
  • the first pressure sensor 104 is used to feed back the fluid pressure value of the first conduit 105 between the delivery pump 103 and the subcutaneous wound cavity 8 to the control
  • the device 3 adjusts the speed of the delivery pump 103 to control the output pressure of the cleaning liquid.
  • the fluid pressure is too large, it will cause secondary injury to the wound and cause pain to the patient.
  • the fluid pressure is too small, the washing effect will be unsatisfactory, and the effusion in the subcutaneous wound cavity 8 cannot be washed away, resulting in the effusion remaining in the subcutaneous wound cavity 8, which is not conducive to wound healing .
  • a first pressure sensor 104 is provided on the first catheter 105 between the delivery pump 103 and the subcutaneous wound cavity 8.
  • the fluid pressure value sensed by the first pressure sensor 104 reflects The fluid pressure value at the output end of the first pipe 105 feeds back the fluid pressure value sensed by the first pressure sensor 104 to the control device 3, so that the control device 3 adjusts the speed of the delivery pump 103 , So as to control the output pressure of the cleaning liquid.
  • the feedback means that the first pressure sensor 104 provides the control device 3 with the fluid pressure value of the sensing pair, so that the control device 3 adjusts the delivery pump 103 based on a preset desired pressure value. Speed, thereby controlling the output pressure of the cleaning fluid.
  • This process is realized by feedback control, that is, the output information of the system is sent back to the input terminal, compared with the input information, and the difference between the two is used for control.
  • the feedback control refers to comparing the actual results after a certain action and task is completed, so as to affect the progress of the next action and play a control role.
  • the first pressure sensor 104 or the second pressure sensor 203 adopts a pressure sensor including but not limited to a model MPXH6300A.
  • the first vacuum sensor 102 is used to sense the vacuum degree of the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 to monitor the vacuum in the cleaning liquid container 101 The exhausted state of the cleaning fluid. After the cleaning solution in the cleaning solution container 101 is used up, it is necessary to stop the infusion or replenish the cleaning solution in time, which will cause air to enter the cavity 8 of the subcutaneous wound.
  • the first vacuum sensor 102 on the first pipe 105 between the delivery pump 103 and the cleaning liquid container 101, the vacuum degree of the first pipe 105 between the delivery pump 103 and the cleaning liquid container 101 can be reflected Whether the cleaning liquid in the cleaning liquid container 101 is used up.
  • the detection result is fed back to the control device 3 so that the control device 3 turns off the delivery pump 103 , So as to prevent the delivery pump 103 from continuing to work.
  • the location of the first vacuum sensor 102 is on the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101. Therefore, the degree of vacuum detected by the first vacuum sensor 102 reflects the degree of vacuum of the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101.
  • the vacuum in the first duct 105 between the delivery pump 103 and the cleaning liquid container 101 is zero or close to Zero, but when there is no liquid or very little liquid flowing through the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101, it means that the cleaning liquid in the cleaning liquid container 101 has been used up or is nearly used up At this time, the vacuum degree of the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 will increase significantly.
  • the vacuum degree value detected by the first vacuum sensor 102 can be used to determine whether the cleaning liquid container 101 is Whether the cleaning solution is used up or is about to be used up, that is, the cleaning solution in the cleaning solution container 101 is exhausted.
  • FIG. 3 shows a schematic diagram of an embodiment of an alarm device in a negative pressure drainage and cleaning system for sutureless skin wound closure of this application.
  • the flushing The device 1 further includes an alarm device 9 for outputting an alarm signal when the first vacuum sensor 102 detects that the cleaning liquid in the cleaning liquid container 101 is exhausted.
  • the alarm device can be used 9 to alarm to remind the replenishment of cleaning fluid or stop the operation of the washing device 1.
  • the alarm device 9 is a device that can receive the control signal of the control device 3 to emit a sound to achieve the alarm function, which includes but is not limited to a buzzer, a voice alarm system, a sound and light alarm, etc.
  • the flushing device 1 includes a delivery pump 103, a first pipe 105, a cleaning liquid container 101, a first pressure sensor 104, and a first vacuum sensor 102.
  • the cleaning liquid container 101 is provided with a cleaning liquid for washing the inner cavity 8 of the subcutaneous wound.
  • the delivery pump 103 is used to deliver the cleaning liquid in the cleaning liquid container 101 and control the flow rate and strength of the liquid and other parameters.
  • One end of the first pipe 105 is connected to the cleaning solution container 101, and the other end of the first pipe 105 is partially penetrated into the subcutaneous wound cavity 8 to a predetermined depth, so as to transport the cleaning solution in the cleaning solution container 101 to the subcutaneous wound cavity 8 .
  • the first pressure sensor 104 is arranged on the first catheter 105 between the delivery pump 103 and the subcutaneous wound cavity 8, thereby feeding back the fluid pressure value to the control device 3, so that the control device 3
  • the rotation speed of the delivery pump 103 is adjusted to control the output pressure of the cleaning liquid.
  • the first vacuum sensor 102 is arranged on the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101, so as to determine the cleaning liquid in the cleaning liquid container 101 by the vacuum degree value detected by the first vacuum sensor 102 Whether it is exhausted or is about to be exhausted.
  • the control device 3 can trigger the alarm device 9 to alarm or the control device 3 can turn off the delivery pump 103.
  • the negative pressure device 2 includes a negative pressure source 202 and a second catheter 205 partially penetrated into the subcutaneous wound cavity 8 to a predetermined depth.
  • the negative pressure device 2 is used to generate negative pressure.
  • the second catheter 205 In order to force the subcutaneous wound lumen 8 to be closed during the healing process, and the second catheter 205 to drain the effusion of the subcutaneous wound lumen 8.
  • the second catheter 205 is used to generate negative pressure to force the subcutaneous wound cavity 8 to be closed during the healing process, to maintain the dissected tissues in a fit state, and to maintain the bleeding and bleeding in the wound cavity through continuous negative pressure suction. The fluid is cleared in time.
  • the second catheter 205 of the negative pressure device 2 penetrates into the subcutaneous wound cavity 8 and generates negative pressure to force the tissues on both sides of the subcutaneous wound cavity 8 to tend to Facing each other (in the direction indicated by the arrows on both sides of the arrow subcutaneous wound in Fig. 2) to eliminate the subcutaneous wound cavity 8 and the closure of the subcutaneous wound cavity 8 facilitates wound healing. It should be understood that during this process, the part of the second catheter 205 in the subcutaneous wound cavity 8 does not affect the growth of tissues on both sides of the subcutaneous wound cavity 8.
  • skin wounds may secrete blood, tissue fluids or other body fluids to form fluid accumulation. If the fluid is not drained in time, it may cause infection, inflammation and even suppuration.
  • the negative pressure is used to discharge the effusion in the cavity 8 of the subcutaneous wound, which can avoid the occurrence of unfavorable conditions such as wound infection, inflammation or suppuration, thereby facilitating wound healing.
  • FIG. 7 shows a schematic diagram of an embodiment of the negative pressure device in this application.
  • the negative pressure device 2 further includes: a collection container 204, a second pressure The sensor 203 and the second vacuum sensor 201.
  • the collection container 204 is used to collect the effusion drained by the second catheter 205 from the cavity 8 of the subcutaneous wound.
  • the collection container 204 includes, but is not limited to, a liquid collection bottle, a liquid collection tank, and other containers that can be used to store liquid.
  • the second catheter 205 collects the effusion drained from the subcutaneous wound cavity 8 in the collection container 204. When the collection container 204 is full, the collection container 204 can be replaced or the liquid accumulation in the collection container 204 can be removed.
  • control part of the control device 3 is integrated with the cleaning liquid container 101 and the collection container 204
  • the control part (including the control device, the delivery pump, and the negative pressure source) of the control device 3 is configured in the first housing
  • the cleaning liquid container 101 and the collection container 204 Is configured in a second housing
  • the cleaning liquid container 101 and the collection container 204 are physically separated in the second housing, and each container has an independent and disconnected space.
  • the casing is provided with conduit ports respectively connecting the cleaning liquid container 101 and the collecting container 204, which are used to communicate with the respective conduits, that is, the collecting container 204 is connected to the second conduit 205, and the cleaning liquid container 101 is connected to the first conduit. ⁇ 105 ⁇ 105.
  • the cleaning liquid container 101 and the collection container 204 are connected to the housing through a detachable structure, which is convenient for replacement or maintenance.
  • the lotion container 101 and the collection container 204 may also be separately arranged in their respective housings, for example, the control device 3
  • the control part (including the control device, the delivery pump, and the negative pressure source) is configured in the first housing
  • the cleaning liquid container 101 is configured in the second housing
  • the collection container 204 is configured in the third housing Body.
  • the second pressure sensor 203 is used to sense the fluid resistance of the second conduit 205 between the negative pressure source 202 and the collection container 204 to monitor the collection container 204 Full state.
  • a second pressure sensor 203 is provided on the second conduit 205 between the negative pressure source 202 and the collection container 204.
  • the fluid resistance in the second conduit 205 between the negative pressure source 202 and the collection container 204 will increase significantly, and the second pressure sensor 203 can detect the fluid resistance in the second conduit 205 between the negative pressure source 202 and the collection container 204 to determine whether the collection container 204 is full or is about to be full, so as to determine whether the collection container 204 is full Full state.
  • fluid resistance is generally divided into: the flow of fluid in the pipeline system can be divided into flow in a uniform straight pipe, which produces along-the-way resistance mainly due to surface friction; and in various pipes such as valves, elbows,
  • the flow in the inlet and outlet of the equipment due to the change of the direction of the flow channel, the change of the cross-sectional area, and the bifurcation and confluence of the flow channel, produce local resistance mainly due to the reverse pressure difference or eddy current.
  • the fluid in the second conduit 205 receives resistance from the liquid in the collection container 204 and cannot continue to flow into the collection container 204.
  • the negative pressure device 2 further includes an alarm device 9 for outputting when the second pressure sensor 203 detects that the effusion in the collection container 204 is full or is about to be full. Alarm.
  • the alarm device can be used 9 to call the police to prompt to replace and clean the collection container 204.
  • the second pressure sensor 203 arranged on the second conduit 205 between the negative pressure source 202 and the collection container 204 detects that the collection container 204 is full or about to be full
  • the second pressure sensor 203 can also feed back the information to the control device 3 so that the control device 3 sends a stop signal to the negative pressure device 2 to close the negative pressure device 2.
  • the second vacuum sensor 201 is used to feed back the vacuum degree of the second conduit 205 between the negative pressure source 202 and the subcutaneous wound cavity 8 to the control device. 3 Make it adjust the power of the negative pressure source 202 to control the negative pressure generated.
  • a second vacuum sensor 201 is provided on the second catheter 205 between the negative pressure source 202 and the subcutaneous wound cavity 8, because the second catheter 205 partially penetrates the subcutaneous wound
  • the inner cavity 8 has a preset depth, so when the negative pressure in the second catheter 205 is too high, it will cause secondary damage to the subcutaneous wound cavity 8; when the negative pressure in the second catheter 205 is too small, the closure cannot be reached.
  • the effects of the subcutaneous wound cavity 8 and drainage of fluid accumulation in the subcutaneous wound cavity 8 are described. Therefore, it is necessary to maintain the negative pressure in the second duct 205 within an appropriate value range.
  • the vacuum degree in the second duct 205 between the negative pressure source 202 and the subcutaneous wound cavity 8 is zero or close to zero.
  • a second vacuum sensor 201 is provided on the second conduit 205 between the negative pressure source 202 and the subcutaneous wound cavity 8 so that the second vacuum sensor 201 can reflect the difference between the negative pressure source 202 and the subcutaneous wound cavity 8
  • the degree of vacuum in the second catheter 205 further reflects whether the negative pressure applied to the cavity 8 of the subcutaneous wound is within an ideal range.
  • the second vacuum sensor 201 feeds back the acquired vacuum degree of the second catheter 205 between the negative pressure source 202 and the subcutaneous wound cavity 8 to the control device 3, and the control device 3 according to the The data fed back by the second vacuum sensor 201 adjusts the output power of the negative pressure source 202, thereby controlling the negative pressure generated by the negative pressure source 202, and avoiding excessive negative pressure to damage the wound or insufficient negative pressure to prevent fluid accumulation The clean-up situation occurs.
  • the negative pressure source 202 is a diaphragm pump, and the diaphragm pump is an air pump.
  • the diaphragm pump also known as the diaphragm pump and the control pump, is the main type of actuator, and changes the fluid flow by receiving the control signal output by the adjustment control unit and using power operation.
  • the diaphragm pump is used to receive the control signal from the regulator or the computer 7 during the control process, change the flow rate of the adjusted medium, and maintain the adjusted parameters within the required range, so as to realize the control of the parameters such as temperature, pressure, Adjustment and control of flow, liquid level, etc.
  • the negative pressure source 202 can be an air reservoir under negative pressure, or can be a manually or electrically driven device that can reduce the pressure in the sealed volume, such as a vacuum pump, a suction pump, It can be used for wall suction ports, or micro pumps, syringes or static negative pressure devices in many healthcare facilities, or any suitable active or passive suction source.
  • the negative pressure supply may be contained in other components or used in combination with these other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment.
  • the negative pressure source 202 may be combined with other components to form a treatment unit.
  • the negative pressure supply may also have one or more supply ports configured to facilitate coupling and coupling of the negative pressure supply to one or more distribution components.
  • the "negative pressure” disclosed in this application generally refers to a pressure less than the local environmental pressure, such as the environmental pressure in the local environment outside the sealed treatment environment provided by the dressing.
  • the local environmental pressure can also be the atmospheric pressure where the tissue site is located.
  • the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site.
  • the pressure values stated here are gauge pressures.
  • reference to an increase in negative pressure typically refers to a decrease in absolute pressure
  • a decrease in negative pressure typically refers to an increase in absolute pressure.
  • the pressure is generally a low vacuum, which is also commonly referred to as a rough vacuum, between -5mm Hg (-667Pa) and -500mm Hg( -66.7kPa).
  • the common treatment range is between -75mm Hg (-9.9kPa) and -300mm Hg (-39.9kPa).
  • control device 3 is electrically connected to the flushing device 1 and the negative pressure device 2, for controlling the output pressure or flow rate of the flushing device 1 and the negative pressure according to the received feedback
  • the device 2 maintains the vacuum degree of the cavity 8 of the subcutaneous wound.
  • the washing device 1 outputs the cleaning liquid through the delivery pump 103, and the pressure of the output cleaning liquid and the flow rate of the output cleaning liquid can be adjusted through the delivery pump 103.
  • the output pressure is too small, the subcutaneous wound cavity 8 cannot be effectively flushed, and when the output pressure is too large, it may cause secondary injury to the subcutaneous wound or increase the patient’s pain. .
  • the output flow is too small, too little cleaning fluid will also affect the cleaning effect of the subcutaneous wound cavity 8.
  • the output flow is too large, it will increase the output pressure, causing secondary damage to the subcutaneous wound or The patient has increased pain. Therefore, it is necessary to control the output pressure and flow rate of the flushing device 1 within an ideal range to ensure the cleaning effect while not causing new adverse effects on the subcutaneous wound and the patient.
  • the degree of vacuum refers to the lean degree of gas in a vacuum state. If the pressure in the tested equipment is lower than atmospheric pressure, the pressure measurement requires a vacuum gauge. The value read from the vacuum gauge is called the degree of vacuum.
  • the degree of vacuum can indirectly reflect the size of the cavity 8 of the subcutaneous wound. For example, when the degree of vacuum is high, it reflects that there is still a large gap between the two sections of the cavity 8 of the subcutaneous wound, indicating that negative pressure is possible.
  • the closing force on the subcutaneous wound cavity 8 may not be enough; on the contrary, when the vacuum degree is zero or close to zero, it reflects that the two sections of the subcutaneous wound cavity 8 have no gap or the gap is small, indicating that the negative pressure may be
  • the ideal range may be too high, and when the negative pressure is too high, it may cause secondary injury to the subcutaneous wound or bring pain to the patient.
  • the negative pressure is kept within the ideal range, it is more conducive to the healing of the subcutaneous wound. Therefore, maintaining the vacuum degree of the subcutaneous wound cavity 8 in an ideal range can help close the subcutaneous wound cavity 8 without causing secondary injury to the subcutaneous wound or causing pain to the patient, and helping the subcutaneous wound to recover better.
  • the degree of vacuum is mainly detected by a vacuum sensor, which includes, but is not limited to, a vacuum sensor with a model of MPXV6115VC6U.
  • control device 3 can control the output pressure and output flow of the irrigation device 1 through the signals fed back from the irrigation device 1 to ensure that the output pressure of the irrigation device 1 will not cause damage to the subcutaneous wound and at the same time, the subcutaneous wound cavity 8
  • the negative pressure intensity of the negative pressure device 2 can be controlled by the feedback signal of the negative pressure device 2, so as to ensure that the subcutaneous wound will not be damaged, and the subcutaneous wound cavity 8 The effusion is drained and the cavity 8 of the subcutaneous wound is closed to maintain the vacuum degree of the cavity 8 of the subcutaneous wound within an ideal range.
  • the negative pressure device 2 can generate a vacuum degree of 70% to 80%, such as 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%. , 78%, 79%, 80%, so as to maintain the vacuum degree of the subcutaneous wound cavity 8 in an ideal range.
  • the negative pressure device 2 includes a collection container 204, a second pressure sensor 203, a negative pressure source 202, a second vacuum sensor 201 and a second conduit 205.
  • one end of the second catheter 205 is partially penetrated into the subcutaneous wound cavity 8 to a predetermined depth, and the other end of the second catheter 205 is connected to the collection container 204 through a negative pressure source 202, and the negative pressure source 202 is connected to the collection container 204.
  • a second pressure sensor 203 is provided on the second conduit 205 between the containers 204 to determine whether the collection container 204 is full by detecting the resistance.
  • a second vacuum sensor 201 is provided on the second conduit 205 between the negative pressure source 202 and the subcutaneous wound cavity 8 for detecting the vacuum degree of the subcutaneous wound cavity 8 to determine the magnitude of the negative pressure in the subcutaneous wound cavity 8 .
  • the control device 3 is respectively connected to the second pressure sensor 203 and the second vacuum sensor 201 through an A/D module, namely a digital-to-analog signal conversion module, and the second pressure sensor 203 feeds back the resistance information sensed to The control device 3 allows the control device 3 to adjust the opening and closing of the negative pressure source 202 or to control the alarm device 9 to alarm.
  • the flushing device 1 includes a cleaning liquid container 101, a first pipe 105, a first vacuum sensor 102, a delivery pump 103 and a first pressure sensor 104.
  • one end of the first conduit 105 is partially penetrated into the subcutaneous wound cavity 8 to a preset depth, and the other end of the first conduit 105 is connected to the cleaning solution container 101 through a delivery pump 103, which is connected to the subcutaneous wound.
  • a first pressure sensor 104 is provided on the first pipe 105 between the cavities 8 to detect the output pressure of the delivery pump 103.
  • a first vacuum sensor 102 is provided on the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 to determine the exhaustion of the cleaning liquid in the cleaning liquid container 101 by detecting the degree of vacuum.
  • the control device 3 is respectively connected to the first vacuum sensor 102 and the first pressure sensor 104 through an A/D module, that is, a digital-to-analog signal conversion module, and the first vacuum sensor 102 feeds back the vacuum degree it senses to
  • the control device 3 allows the control device 3 to control the control alarm device 9 to alarm or to control the opening and closing of the delivery pump 103, and the first pressure sensor 104 feeds back the pressure sensed by it to the control device 3 for
  • the control device 3 controls the output pressure of the delivery pump 103 through the duty ratio.
  • a wound closure device 4 may be used to help the negative pressure device 2 to close the subcutaneous wound cavity 8.
  • the wound closure device 4 can squeeze the skin edge to make the exposed ends of the skin wound close, and under the pressure and assistance of the negative pressure device 2, the subcutaneous wound cavity 8 can be kept closed during the healing and rehabilitation process, and the subcutaneous wound can be sucked
  • the fluid accumulation in the lumen 8 can also be flushed and delivered to the subcutaneous wound lumen 8 through the irrigation device 1 and liquid medicine can be used to dilute and clean the potential infection foci in the subcutaneous wound lumen 8 that reach colonization concentration.
  • the wound closure device 4 is used to squeeze the skin edge to make the skin wound in a closed state during the healing process. At the same time, squeezing the skin edge can reduce the bleeding of the subdermal vascular network of the skin, which is beneficial to Wound recovery.
  • the wound closure device 4 is arranged on the peripheral side of the skin wound. In some embodiments, the wound closure device 4 is arranged on the peripheral side of the skin wound by means of adhesion. In some embodiments, the wound closure device 4 includes at least two closure elements 41, and the at least two closure elements 41 are respectively arranged on both sides of the skin wound. The closure 41 is combined to keep the skin wound in a closed state during the healing process. In practical applications, the number of closure elements 41 can be determined by the length of the wound and the specific form of closure elements 41.
  • FIG. 8 shows a schematic structural diagram of the closure member in the wound closure device in an embodiment of the present application.
  • the wound closure device 4 further includes a micropore covering the closure member 41
  • the covering member 40 (not shown), the microporous covering member 40 conforms to the shape and structure of the closing member 41 and is combined on the closing member 41 to form an integral body with the closing member 41 to facilitate absorption or suction from the skin wound
  • the secretion liquid that oozes out and stays on the closure member 41 or the medical liquid that remains on the closure member 41.
  • the microporous covering member 40 and the closing member 41 are integrally formed.
  • the microporous covering member 40 is combined with the closure member 41 by a process such as bonding, so that the microporous covering member 40 is bonded to the closure member 41 in conformity with the shape and structure of the closure member 41 .
  • the closure member 41 includes a flexible body 410, and the flexible body 410 indicates that the elastic/flexible flexible body 410 material can have an ultimate elongation greater than 100% and a significant rebound amount.
  • the resilience of a material refers to the ability of a material to recover from elastic deformation.
  • the material of the elastic/flexible flexible body 410 may include, but is not limited to, natural rubber, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene Rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, copolyester and silicone, etc.
  • the closing member 41 may also be a silicone material, a resin material, or a silicone resin material.
  • the material of the microporous covering member 40 is medical cotton, degreasing cotton, foam, mesh, gauze, sponge, or porous biocompatible material.
  • the member 40 has the properties of air permeability and moisture absorption, and is used to absorb the fluid that may be secreted by the skin wound during the healing process or the moisture of the drug residue that is not absorbed by the tissue.
  • the closure member 41 includes a flexible body 410 and a rigid curved needle 411.
  • the flexible body 410 is adhered to the skin surface at the periphery of the skin wound; in this embodiment, the flexible body 410 is made of silicone material, resin material, or silicone resin material.
  • the flexible body 410 is adhered to the skin surface at the periphery of the skin wound by an adhesive.
  • the adhesive is, for example, a medical adhesive, for example, the main body includes methyl cyanoacrylate. Fast adhesive etc.
  • at least two of the flexible bodies 410 are respectively adhered to the skin surfaces on opposite sides of the skin wound periphery.
  • the rigid curved needle 411 includes a root and a curved needle.
  • the root of the rigid curved needle 411 is buried in the flexible body 410 and is firmly arranged on the flexible body 410.
  • the curved needle part is exposed outside the flexible body 410.
  • the root of the rigid curved needle 411 is firmly set in the flexible body 410 through a deformed structural design, such as a hook-shaped structure or a T-shaped structure. Wait.
  • FIG. 9 shows a schematic diagram of an embodiment of combining a closure element and a wound in an embodiment of this application.
  • the rigid curved needle 411 is exposed outside the The curved needle part outside the flexible body 410 pierces one side of the skin wound to squeeze the skin edge to keep the skin wound closed during the healing process.
  • the doctor needs to make the wound first. Operate the skin (align the edges of the skin, prevent inversion of the edges and prevent poor skin healing), and then insert the curved needle part of the rigid curved needle 411 from one side of the skin wound, as In the state shown in Fig.
  • the rigid curved needles 411 of the closure member 41 on both sides of the skin wound pierce the healthy tissue on the side edge of the wound to squeeze the skin edge to reduce the bleeding of the subdermal vascular network of the skin, which is beneficial to the wound. Recovery, thereby making the skin wound in a closed state.
  • the curved needle part of the rigid curved needle 411 exposed outside the flexible body 410 pierces the other side of the skin wound, and uses the curved needle part to hook the skin.
  • the other side of the skin wound is such that the two sides of the skin wound are connected to each other, and at the same time, the healthy tissues on the opposite sides of the skin wound are also connected to each other to close the skin wound.
  • the curved needle part of the rigid curved needle 411 exposed outside the flexible body 410 partially penetrates into the flexible body 410 provided on the other side of the skin wound, so that it is located
  • the flexible bodies 410 on both sides of the skin wound are joined to each other, and at the same time, the healthy tissues on the opposite sides of the skin wound are driven to join each other to close the skin wound.
  • the tissue under the skin 11 includes vascular network, superficial fascia layer, fat, deep fascia layer, muscle and bone in sequence.
  • the suture depth in this embodiment is in the superficial fascia layer.
  • the problem of concern in this application is the seamless operation of the superficial fascia portion of the skin (ie, the skin epidermis, dermis, and subcutaneous fat tissue).
  • the rigid curved needle 411 is exposed outside the curved needle of the flexible body 410
  • the penetration depth of the part includes the skin epidermis, dermis and subcutaneous fat tissue of the superficial fascia part of the skin.
  • the number and length of the rigid curved needles 411 provided on the flexible body 410 may present different implementation states.
  • the rigid curved pins 411 are arranged on the elongated flexible body 410 in an equidistantly distributed arrangement.
  • FIG. 10 shows a schematic diagram of the closure member of the wound closure device in this application in another embodiment.
  • the closure member 41 further includes a clamping member 42.
  • the holding member 42 is used to hold the flexible body 410 of the closure member 41 adhered to both sides of the skin wound.
  • the flexible body 410 provides opposing force under the action of the holding member 42 to squeeze the skin edge to ensure the skin The wound was closed during the healing process.
  • the clamping member 42 is a component such as a medical clip.
  • FIG. 11 shows an application schematic diagram of the closing member and auxiliary member of the wound closure device of the present application in an embodiment.
  • FIG. 12 shows a schematic structural diagram of the closure member in the wound closure device of this application in another embodiment.
  • the The closure 41 includes a first flexible body 4100 and a second flexible body 4101.
  • the first flexible body 4100 is bonded to the skin surface at the periphery of the skin wound, the first flexible body 4100 has a first bonding portion; the second flexible body 4101 is bonded to the skin surface at the periphery of the skin wound
  • the second flexible body 4101 has a second coupling part corresponding to the first coupling part.
  • the combination of the first joining part and the second joining part provides opposing forces applied to the flexible body 410 on both sides of the skin wound, thereby squeezing the skin edge to keep the skin wound in a closed state during the healing process.
  • the first and second flexible bodies 4101 are made of silicone material, resin material, or silicone resin material.
  • the first and second flexible bodies 4101 are bonded to the skin surface on opposite sides of the skin wound by an adhesive.
  • the adhesive is, for example, a medical adhesive, for example, including cyanide. Fast adhesives based on methyl acrylate, etc.
  • the first coupling portion is a groove structure or a snap structure
  • the second coupling portion is a protruding structure that can be limited to the groove structure or a snap hole corresponding to the snap Or card hook structure.
  • a plurality of grooves are provided on the first coupling portion
  • a protrusion structure corresponding to the plurality of grooves is provided on the second coupling portion.
  • the grooves on the first coupling portion can be replaced with snap structures.
  • the protruding structure on the second coupling portion can be replaced with snap holes or hook structures corresponding to the snaps; but it is not limited to this.
  • Other coupling structures that can realize the mutual coupling of the first flexible body 4100 and the second flexible body 4101 can achieve the purpose of this embodiment, such as the combination of a groove or a hole and a protrusion structure.
  • the wound closure device 4 further includes an auxiliary member 412, the auxiliary member 412 is used to assist the adhesion between the closure member 41 and the skin surface, and to provide the closure member 41 The contractile force for closing the skin wound.
  • the auxiliary member 412 is adhered to the peripheral side of the skin wound and faces the The closing element 41 exerts a force in a second direction perpendicular to the first direction. This force is called contraction force in the present embodiment, thereby assisting the closing element 41 to close the skin wound.
  • the auxiliary member 412 is adhered to the surface of the skin through its adhesive layer opposite to the surface of the skin.
  • the material of the adhesive layer is, for example, a tape including polyurethane coated with an acrylic adhesive.
  • the auxiliary member 412 of the tape may be designed as a belt-like structure extending from the center to opposite sides, and the belt-like structures extending on both sides may be separated or integrated.
  • the belt-like structure is suitable for manual stretching.
  • the first or second catheter partially penetrates into the predetermined depth of the subcutaneous wound cavity 8 through a predetermined position of the skin wound; or the first or second catheter The two catheters pass through the skin and subcutaneous tissue through a predetermined position away from the skin wound to partially penetrate into the predetermined depth of the cavity 8 of the subcutaneous wound.
  • FIG. 4 shows the implementation of the first or second catheter in this application from a predetermined position of the skin wound to the predetermined depth of the subcutaneous wound cavity
  • Example schematic diagram shows the implementation of the first or second catheter in this application from a predetermined position of the skin wound to the predetermined depth of the subcutaneous wound cavity
  • the first or second catheter partially penetrates into the predetermined depth of the subcutaneous wound cavity 8 through a predetermined position of the skin wound, thereby generating negative pressure to ensure that the subcutaneous wound
  • the cavity 8 is in a closed state during the healing process, and at the same time, it drains the effusion in the subcutaneous wound cavity 8 so as to maintain the dissected tissues in a fit state, and maintain the bleeding in the wound cavity through continuous negative pressure suction.
  • the exudate is removed in time, so that the effusion such as blood and/or exudate in the subcutaneous wound cavity 8 can be removed in time, thereby eliminating the living space or environment of bacteria.
  • the preset position may be any position on the wound, and it is more conducive to wound recovery when it is set at a position close to the edge of the wound.
  • the first or second catheter passes through the skin and subcutaneous tissue through a predetermined position away from the skin wound to partially penetrate To the preset depth of the subcutaneous wound cavity 8, which can generate negative pressure to ensure that the subcutaneous wound cavity 8 is in a closed state during the healing process, and at the same time suck the effusion of the subcutaneous wound cavity 8, so that the subcutaneous wound can be cleared in time
  • the fluid accumulation in the cavity 8 eliminates the living space or environment of bacteria.
  • FIG. 5 shows a schematic diagram of an embodiment in which the first or second catheter passes through the skin and subcutaneous tissue through a predetermined position away from the skin wound in this application.
  • the first or second catheter passes through the skin and subcutaneous tissue through a preset position far away from the skin wound (the position shown at A in FIG. 5) to partially penetrate into the preset subcutaneous wound cavity 8 depth.
  • the distance refers to a preset position away from the skin wound (the position shown at A in Figure 5).
  • the first or second The second catheter does not penetrate into the subcutaneous wound cavity 8 through the skin wound, but passes through the skin and subcutaneous tissue from another position, that is, a preset position away from the skin wound, to partially penetrate into the subcutaneous wound Cavity 8, this embodiment is particularly suitable for the elongated wound as shown in FIG. 5.
  • first duct 105 and the second duct 205 are integrally formed.
  • FIG. 13 shows a schematic diagram of an embodiment of the first and second duct structures of this application.
  • the first duct 105 and the second duct 205 are integrally formed by This can reduce the number of buried pipes.
  • the integrally formed pipe includes two pipes that are isolated from each other and not connected to each other.
  • the first pipe forms the first pipe 105
  • the second pipe forms the Second conduit 205.
  • the second tube 205 may also be sleeved in the first tube 105.
  • FIG. 14 shows a schematic diagram of another embodiment of the first and second duct structures of this application.
  • the first duct 105 and the second duct 205 are integrally formed.
  • the first pipe 105 and the second pipe 205 are integrally formed into two pipes that are not connected to each other, wherein the second pipe 205 is sleeved on the first pipe 105 Inside, the diameter of the first tube 105 is larger than the diameter of the second tube 205. Since the thinner tube is sheathed in the thicker tube, this does not increase the number of tubes without increasing the overall tube diameter.
  • a plurality of through holes are provided on the tube wall of the part where the first catheter 105 penetrates into the skin wound at a predetermined depth.
  • a plurality of through holes 1050 are provided on the first pipe 105, and the first pipe 105 is connected to the cleaning liquid container 101, so as to transport cleaning in the first pipe 105
  • the cleaning solution in the liquid container 101 reaches the preset depth of the subcutaneous wound cavity 8
  • the plurality of through holes 1050 are evenly distributed on the tube wall of the part where the first catheter 105 penetrates into the skin wound at a predetermined depth, especially for narrow and long wounds.
  • the wound cavity formed under the skin of the narrow wound is usually also a long cavity or gap, so as to ensure that each of the long cavity or gap can be cleaned by the cleaning liquid in the first pipe or transported medicine;
  • the multiple through holes 1050 on the first catheter 105 may also be designed to have unequal intervals (ie, multiple through holes). The holes are unevenly distributed in a manner in which the first catheter 105 penetrates into the wall of the skin wound at a predetermined depth).
  • a plurality of through holes are provided on the wall of the part where the second conduit 205 penetrates into the skin wound at a predetermined depth, and the second conduit 205 is connected to the negative pressure source 202 to generate negative pressure.
  • the multiple through holes on the second conduit 205 can help to absorb the gas and liquid in the cavity 8 of the subcutaneous wound, thereby increasing the suction area and location, and is more conducive to the healing of the subcutaneous wound.
  • the plurality of through holes are evenly distributed on the wall of the part where the second catheter 205 penetrates into the skin wound at a predetermined depth at intervals, especially for narrow and long wounds.
  • the wound cavity formed under the skin of the narrow wound is usually also a long cavity or gap, in order to ensure that the effusion or residual liquid secreted in each of the long cavity or gap is sucked by the second conduit 205
  • the multiple through holes on the second conduit 205 can also be designed with unequal intervals (ie, multiple through The holes are unevenly distributed in a manner in which the second conduit 205 penetrates into the wall of the skin wound at a predetermined depth).
  • the shape and structure of the first catheter 105 and the second catheter 205 that penetrate into the skin wound at a predetermined depth can also be designed according to actual needs, for example, according to the desired penetration into the skin wound.
  • the inner depth is different or the tissue structure is different, the thickness of the first catheter 105 and the second catheter 205 are different or the flexibility is different, for example, the thickness of the same catheter at different parts is different, or the material of the same catheter at different parts is different, more Or the same catheter has different flexibility in different parts.
  • a one-way valve is provided on the first or second conduit.
  • the one-way valve is, for example, a duckbill valve, a fan valve, or a cone valve, but it is not limited to rubber parts.
  • the valve assembly using mechanical or electrical control is also applicable to this embodiment.
  • the shape of the duckbill valve is similar to a duckbill, so it is called a duckbill valve.
  • the duckbill valve is made of elastic material, so when there is no internal pressure, the duckbill outlet is closed under the action of its own elasticity. When the internal pressure of the duckbill valve gradually increases, the duckbill outlet gradually increases to keep the liquid discharged at a high flow rate.
  • the outlet of the sector valve has a sector structure.
  • the sector valve is made of elastic material, so when there is no internal pressure, the sector outlet is closed under the action of its own elasticity.
  • the internal pressure of the fan-shaped valve gradually increases, the fan-shaped outlet gradually increases to keep the liquid discharged at a high flow rate.
  • valve core sealing surface of the cone valve is a cone surface.
  • the conical valve is equipped with a conical valve core at the end of the flow passage, and all its moving parts are arranged outside the flow passage of the valve, so that the flow passage inside the valve body is smooth and smooth, with large flow and low pressure drop loss. Cavitation and vibration will not occur in the entire working range, and it still has a good flow control effect at small flow rates.
  • the negative pressure device 2 is also used to maintain a stable tissue position on the surface of the skin wound and its peripheral area by the generated negative pressure, thereby facilitating wound recovery.
  • the negative pressure device 2 includes: a sealing film 12 for adhering to the skin and covering the skin wound surface to form a sealed space 13; a negative pressure channel communicating with the negative pressure
  • the source 202 uses the negative pressure generated by the negative pressure source 202 to provide the sealing film 12 with contraction force to drive the skin wound to contract.
  • the negative pressure passage is communicated with the negative pressure source 202 through the second conduit 205, and the negative pressure passage is connected to the sealed space 13, thereby forming the sealed space 13.
  • the negative pressure generated by the negative pressure device 2 compresses the sealed space 13 so that the local tissue can be maintained to close toward the wound position.
  • the negative pressure generated by the negative pressure device 2 also exerts force on the deep tissue under the wound, so as to close the potential dead space and promote wound healing.
  • the pressure range of the sealed space 13 formed by the sealing film 12 adhered to the skin can be set between about 0.001 and about 1 atmosphere.
  • the negative pressure value generated by the negative pressure device 2 can be controlled according to the degree of wound healing.
  • the negative pressure value can be appropriately reduced according to the degree of skin wound healing, or according to the degree of skin wound healing.
  • secreted effusion for example, in the case of increased secretion of effusion, the negative pressure value can be appropriately increased to increase the strength of sucking the effusion.
  • FIG. 15 shows a schematic diagram of the sealing and stress structure of an embodiment of the negative pressure device in this application.
  • the sealing film 12 adheres to the skin And cover the wound surface of the skin, thus forming a sealed space 13.
  • the sealed space 13 inside the sealing film 12 forms an inward force.
  • the force is in the direction of the arrow shown in Figure 15 while maintaining the local tissue position fixed, pressure can also be applied to the deep tissue, thereby closing the potential dead space.
  • the sealing film 12 bypasses the skin wound to form a sealing area, and the sealing area forms a sealing space 13.
  • the sealing film 12 is adhered to the skin surface
  • the adhesive layer is bonded to the surface of the skin, and the material of the adhesive layer is, for example, a flexible impermeable material including polyurethane coated with an acrylic adhesive.
  • the sealing film 12 is provided with an observation window made of light-transmitting material.
  • the sealing film 12 may be made of a transparent material.
  • the sealing film 12 made of the transparent material can facilitate the clinician to visually observe the healing condition of the skin wound so as to carry out timely intervention.
  • FIG. 17 shows a schematic diagram of an application embodiment of this application.
  • the operator connects the first tube 105 of the irrigation device 1 and the second tube 205 of the negative pressure device 2
  • the subcutaneous tissue of the skin is embedded, and the first catheter 105 and the second catheter 205 are extended into the cavity 8 of the subcutaneous wound.
  • the negative pressure device 2 can drain the effusion secreted by the subcutaneous wound lumen 8 through the second conduit 205, and at the same time, the negative pressure forces the wound lumen to converge/merge, so that the tissues on both sides are joined together.
  • the flushing device 1 can also deliver cleaning fluid and liquid drugs to the cavity 8 of the subcutaneous wound through the first catheter 105 to facilitate healing.
  • the closure member 41 removes the wound on both sides of the wound. The skin is folded inward to keep the skin wound closed during the healing process. The squeezing effect of the closure member 41 on the skin edge can reduce the bleeding of the subdermal vascular network of the skin.
  • the negative pressure of the negative pressure device 2 can assist in the subcutaneous wound cavity. 8 is closed. The operator continues to cover the microporous cover 40 on the wound surface to ensure that the secretions on the wound surface can be absorbed in time during the healing process.
  • the sealing film 12 is pumped through the negative pressure channel of the negative pressure device 2 to make the skin
  • the tissue in the wound and its peripheral area tightens towards the wound.
  • the negative pressure generated by the negative pressure device 2 can also exert a certain degree of pressure on the deep tissues to close the potential dead space, which accelerates the healing speed of the skin wound. It is also a treatment method that does not use needles to suture the superficial fascia of the skin, and does not use medical tools such as suture needles and sutures.
  • the negative pressure device 2 includes a humidity detection component (not shown) for providing the detected humidity information in the sealed space 13 to the negative pressure source 202 to facilitate The negative pressure source 202 regulates negative pressure output.
  • the sensor of the humidity detection component is arranged in the sealed space 13 formed by the sealing film 12, and the information output port of the humidity detection component is connected to the control device 3, thereby providing the detected humidity information to the control pressure device to control the negative
  • the pressure device 2 regulates the output negative pressure.
  • the humidity detection component is, for example, a humidity sensor.
  • FIG. 16 shows a schematic diagram of an embodiment of the second catheter in this application.
  • the second catheter 205 includes a subcutaneous drainage hole 2050 and a supracutaneous negative pressure hole 2051.
  • the subcutaneous drainage holes 2050 are multiple through holes provided on the wall of the part where the second catheter 205 penetrates into the skin wound at a predetermined depth; the subcutaneous negative pressure hole 2051 communicates with the sealed space 13 to The sealed space 13 applies negative pressure.
  • the second conduit 205 is connected to a negative pressure source 202, and the negative pressure source 202 provides negative pressure for the second conduit 205.
  • the subcutaneous drainage hole 2050 of the second catheter 205 is located on the wall of the part where the second catheter 205 penetrates into the skin wound at a predetermined depth, and the negative pressure generated by the negative pressure source 202 forces the cavity of the subcutaneous wound 8 is in a closed state during the healing process, and the effusion in the subcutaneous wound cavity 8 is drained through the second catheter 205.
  • the subcutaneous negative pressure hole 2051 of the second conduit 205 is located in the sealed space 13 on the skin, and is used to communicate with the sealed space 13 to apply negative pressure to the sealed space 13 so as to maintain the surface of the skin wound and its periphery The regional organization position is stable.
  • the negative pressure drainage and cleaning system for sutureless skin wound closure further includes a computer 7, which is connected to the control device 3, and the connection method includes But it is not limited to communication connection via USB interface connection or Bluetooth or wireless network connection.
  • the user can set a program on the computer 7 to set the working time and working mode of the washing device 1 and the negative pressure device 2.
  • the driving parameters of the washing device 1 and the negative pressure device 2 can be set according to different diseases, different treatment methods, or according to the actual condition or the characteristics of the wound.
  • the negative pressure drainage and cleaning system for sutureless skin wound closure further includes an interactive device 6.
  • the interactive device 6 includes but is not limited to a touch screen, a display screen, and Operation keyboard, etc.
  • the user can manually set the control system through the interactive device, so as to control the working status, working time, working mode, etc. of the negative pressure device 2 and the flushing device 1, and understand the negative pressure device in real time through the information fed back on the display screen 2 and the working status, working time, working mode of the flushing device 1.
  • the negative pressure drainage and cleaning system for sutureless skin wound closure further includes a storage module 5.
  • the storage module 5 includes but is not limited to a storage chip such as an SD card Or cloud storage.
  • the storage module 5 can store the operating information set by the user, the operating program downloaded from the computer 7, and the data during actual use.
  • the first aspect of the vacuum drainage and cleaning system for sutureless skin wound closure of the present application is forced by the negative pressure device 2, so that the subcutaneous wound cavity 8 remains closed during the healing and rehabilitation process, and remains disconnected.
  • the tissues of the wound are kept in a fit state, and through continuous negative pressure suction, the bleeding and exudate in the wound cavity are kept in a timely manner;
  • the second aspect is to intermittently deliver the cleaning fluid to the subcutaneous wound cavity 8 to make the subcutaneous wound cavity
  • the coagulated blood clot in 8 is moistened to facilitate removal, and the bacterial community that has the potential to reach colonization concentration is diluted, and drained and removed with the cleaning solution, thereby maintaining a clean state in the wound cavity.
  • the cleaning solution can also be added or replaced with drugs, so as to be delivered to the subcutaneous wound cavity 8 to help the subcutaneous wound heal;
  • the third aspect is through the feedback control of the negative pressure device 2, the flushing device 1 and the control device 3, so that the control device 3
  • the negative pressure of the negative pressure device 2 and the flushing pressure and flow rate of the flushing device 1 can be controlled in real time, so as to ensure that the negative pressure of the negative pressure device 2 can achieve better closure and drainage, and the flushing device 1 can perform better.
  • the good flushing effect will not negatively affect the subcutaneous wound.
  • control device 3 can trigger the alarm device 9 to alarm based on the feedback information of the vacuum sensor and the pressure sensor to remind the operator to replenish the cleaning liquid or replace the collection container 204 in time.
  • the negative pressure generated by the negative pressure device 2 can also maintain the stable tissue position of the skin wound and its peripheral area, thereby facilitating tissue healing.
  • the application can realize seamless closure of the entire tissue above the deep fascia of the skin, avoiding lateral scars (commonly known as "centipede feet") caused by suture compression/cutting on the skin surface, and there is no suture in the superficial fascia. The suture knot is left, thereby eliminating the important factors that cause bacterial colonization and the main cause of recurrence of incision infection.
  • the negative pressure drainage and cleaning system for the sutureless skin wound closure of the present application can keep the subcutaneous wound cavity 8 in the closed state during the healing and rehabilitation process without using sutures, which has not only accelerated
  • the healing speed of skin wounds is a treatment method that does not use needles to suture the skin, and does not use medical tools such as suture needles and sutures. Therefore, after the skin wound is healed, there is no treatment to remove foreign bodies in the wound or wound.
  • the process of removing or removing the suture or removing the thread and the operation process thereby eliminating the key link and important inducement of bacterial colonization, and ensuring that the wound after healing will not leave a "centipede" on the surface of the skin.
  • the suture marks of the “foot” ensure the beauty of the surgical incision site, thereby solving the problems in the prior art that the incision after the operation is easy to leave traces and the effusion is difficult to drain.
  • the skin superficial fascia of the present application is closed without suture Surgical auxiliary equipment for skin wounds is especially suitable for the field of aesthetic medicine.

Abstract

一种无缝线闭合皮肤创口的负压引流及清洗系统，包括：冲洗装置（1），包括一输送泵（103）及部分探入皮下创口内腔（8）预设深度的第一导管（105），用于通过第一导管（105）输送清洗液至所述皮下创口内腔（8）的预设深度；负压装置（2），包括一负压源（202）及部分探入皮下创口内腔（8）预设深度的第二导管（205），用于产生负压以迫使皮下创口内腔（8）在愈合过程中呈闭合状态以及通过第二导管（205）对皮下创口内腔（8）的积液进行引流；控制装置（3），电性连接冲洗装置（1）及负压装置（2），用于依据接收的反馈控制冲洗装置（1）的输出压力或流量以及负压装置（2）以维持皮下创口内腔（8）的真空度。该系统可辅助实现皮肤深筋膜以上全层组织的无缝线闭合，避免了皮肤表面因风险压迫/切割引起的横向瘢痕，并且在浅筋膜内无遗留缝线结，从而消除了引起细菌定殖的重要因素和切口感染复发的主要诱因。

Description

无缝线闭合皮肤创口的负压引流及清洗系统 技术领域
本申请涉及医疗器械领域，尤其涉及一种无缝线闭合皮肤创口的负压引流及清洗系统。
背景技术
众所周知，人类在进化过程中逐渐丧失了机体再生的能力，应对创伤造成的组织破坏主要靠瘢痕愈合。因而，外科缝合与组织愈合之间存在密切的关系，在一定程度上缝合的质量可以决定组织愈合的质量。外科缝合多以弯针携带缝线穿过离断组织，再通过打结的方式收紧、固定缝线，令离断的组织紧密贴合，从而为愈合创造有利条件。理想的外科缝合应满足张力适中、切口边缘对合良好、不留死腔、无永久或仅少量缝合痕迹的要求。针对不同组织的结构、生理特点，外科缝合要求不尽相同，缝合材料、方式的选择对手术效果有很大的影响。当组织实现愈合、并恢复功能性强度后，缝合材料就失去了功能意义。此时，在体表的缝线就应当被拆除，大量的临床医疗证明，因缝合带来的遗留于深部组织内的缝线在创口愈合后很难拆除，其结局是被瘢痕组织所包裹，或在一定时间内降解吸收，这些遗留在深部组织内的线结有时会对人体造成影响。另外，传统的外科缝合造成的显著瘢痕对美观性也产生了较大影响。
消除皮肤表面缝线瘢痕的方式目前有以下几类：1，皮内缝合方式，外科医生在完成浅筋膜缝合后，用缝线在真皮浅层做连续皮内缝合，拉紧缝线对合皮缘；2，组织胶水方式，同样是在完成浅筋膜缝合后，用丙烯酸甲酯类组织胶水粘合皮缘；3，皮肤减张器(俗称皮肤拉链)，完成浅筋膜缝合后，用带锁止结构的减张胶带拉合皮肤、对紧皮缘。但是，当前的几类解决方案仍然需要在皮肤浅筋膜层进行大量的缝合，无法避免因缝线残留造成的系列安全问题。安全、美观的闭合皮肤切口已经成为本领域人员期待解决的技术问题。
发明内容
鉴于以上所述现有技术的缺点，本申请的目的在于提供一种无缝线闭合皮肤创口的负压引流及清洗系统，用于解决现有技术中手术后切口缝合易留下痕迹且积液难以排出的问题。
为实现上述目的及其他相关目的，本申请的第一方面提供一种无缝线闭合皮肤创口的负压引流及清洗系统，包括：冲洗装置，包括一输送泵及部分探入皮下创口内腔预设深度的第一导管，用于通过所述第一导管输送清洗液至所述皮下创口内腔的预设深度；负压装置，包括一负压源及部分探入皮下创口内腔预设深度的第二导管，用于产生负压以迫使所述皮下创 口内腔在愈合过程中呈闭合状态以及通过所述第二导管对所述皮下创口内腔的积液进行引流；控制装置，电性连接所述冲洗装置及负压装置，用于依据接收的反馈控制所述冲洗装置的输出压力或流量以及所述负压装置以维持所述皮下创口内腔的真空度。
在本申请的第一方面的某些实施方式中，所述冲洗装置包括：清洗液容器，存储有用于冲洗所述皮下创口内腔的清洗液，通过所述第一导管连通所述输送泵；第一压力传感器，用于将感测的所述输送泵与所述皮下创口内腔之间第一导管的流体压力值反馈给所述控制装置使其调节所述输送泵的转速以控制清洗液的输出压力；第一真空传感器，用于将感测的所述输送泵与清洗液容器之间第一导管的真空度以监测所述清洗液容器中清洗液的用尽状态。
在本申请的第一方面的某些实施方式中，所述冲洗装置包括报警装置，用于在所述第一真空传感器监测到所述清洗液容器中清洗液的用尽时输出报警信号。
在本申请的第一方面的某些实施方式中，所述输送泵为膜片泵。
在本申请的第一方面的某些实施方式中，所述负压装置包括：收集容器，用于收集所述第二导管自所述皮下创口内腔引流的积液；第二压力传感器，用于将感测的所述负压源与所述收集容器之间第二导管的流体阻力以监测所述收集容器的装满状态；第二真空传感器，用于将感测的所述负压源与皮下创口内腔之间第二导管的真空度以反馈给所述控制装置使其调节所述负压源的功率以控制产生的负压。
在本申请的第一方面的某些实施方式中，所述负压源为膜片泵。
在本申请的第一方面的某些实施方式中，所述预设深度为皮肤组织中所述皮肤浅筋膜至脂肪层与深筋膜层的区间深度。
在本申请的第一方面的某些实施方式中，所述第一或第二导管经由所述皮肤创口的一预设位置部分探入至所述皮下创口内腔的预设深度；或者所述第一或第二导管经由远离所述皮肤创口的一预设位置穿过皮肤及皮下组织以部分探入至所述皮下创口内腔的预设深度。
在本申请的第一方面的某些实施方式中，所述第一导管及第二导管一体成型或所述第二导管套设于所述第一导管内。
在本申请的第一方面的某些实施方式中，所述第一或第二导管探入皮肤创口内预设深度的部分的管壁上设置有多个通孔。
在本申请的第一方面的某些实施方式中，所述第一或第二导管上设置有单向阀。
在本申请的第一方面的某些实施方式中，所述单向阀为鸭嘴阀或扇形阀。
在本申请的第一方面的某些实施方式中，所述负压装置还用于藉由产生的负压维持皮肤创口表面及其周缘区域的组织位置稳定。
在本申请的第一方面的某些实施方式中，所述负压装置包括：密封膜，用于粘合于皮肤 上并覆盖所述皮肤创口表面以形成密封空间；负压通道，连通所述负压源，通过将所述负压源产生的负压以使所述密封膜提供收缩力驱使所述皮肤创口相向收缩。
在本申请的第一方面的某些实施方式中，所述密封膜通过其相对于皮肤表面的粘合层与皮肤的表面粘接，所述粘合层的材料包括涂有丙烯酸粘合剂的聚氨酯的柔性不渗透材料。
在本申请的第一方面的某些实施方式中，所述密封膜开设有为透光材料的观察窗。
在本申请的第一方面的某些实施方式中，所述负压装置包括湿度检测部件，用于将检测的所述密封空间内的湿度信息提供给所述负压源以利所述负压源调控负压输出。
在本申请的第一方面的某些实施方式中，所述第二导管包括皮下引流孔及皮上负压孔，所述皮下引流孔为设置在所述第二导管探入皮肤创口内预设深度的部分的管壁上的多个通孔；所述皮上负压孔连通所述密封空间以向所述密封空间施加负压。
本申请同现有技术相比，其有益效果在于：本申请的无缝线闭合皮肤创口的负压引流及清洗系统第一方面在负压引流装置迫使下，使皮下创口内腔在愈合康复过程中保持闭合，维持离断的组织保持贴合状态，并通过持续负压吸引保持创腔内渗血、渗液得到及时的清除；在此基础上，通过清洗系统的间歇性输送液态药物至皮下创口内腔，使皮下创口内腔中凝固的血块得到湿润，以利于移除，并令潜在的达到定殖浓度的细菌群落得到稀释，随冲洗液引流清除，从而维持创腔内清洁状态；第二方面通过负压引流可产生负压以维持所述皮肤创口及其周缘区域的组织位置稳定，从而利于组织愈合。此外，通过本申请可以辅助实现皮肤深筋膜以上全层组织的无缝线闭合，避免了皮肤表面因缝线压迫/切割引起的横向瘢痕(俗称“蜈蚣脚”)，并且在浅筋膜内无遗留缝线结，从而消除了引起细菌定殖的重要因素和切口感染复发的主要诱因。
附图说明
图1显示为本申请的无缝线闭合皮肤创口的负压引流及清洗系统的一实施例示意图。
图2显示为本申请的无缝线闭合皮肤创口的负压引流及清洗系统在应用时的一实施例示意图。
图3显示为本申请无缝线闭合皮肤创口的负压引流及清洗系统中报警装置的一实施例示意图。
图4显示为本申请中第一或第二导管从皮肤创口的一预设位置部分探入至所述皮下创口内腔的预设深度的实施例示意图。
图5显示为本申请中第一或第二导管经由远离所述皮肤创口的一预设位置穿过皮肤及皮下组织的实施例示意图。
图6显示为本申请中冲洗装置的一实施例示意图。
图7显示为本申请中负压装置的一实施例示意图。
图8显示为本申请在一实施例中创口闭合装置中闭合件的结构示意图。
图9显示为本申请在一实施例中的闭合件与创口结合的实施例示意图。
图10显示为本申请中创口闭合装置的闭合件在又一个实施例中的示意图。
图11显示为在本申请创口闭合装置的闭合件及辅助件在一实施例中的应用示意图。
图12显示为本申请创口闭合装置中的闭合件在再一实施例中的结构示意图。
图13显示为本申请的第一和第二导管结构的一实施例示意图。
图14显示为本申请的第一和第二导管结构的另一实施例示意图。
图15显示为本申请中负压装置在一实施例中的密封及受力结构示意图。
图16显示为本申请中第二导管的一实施例示意图。
图17显示为本申请的一应用实施例示意图。
具体实施方式
以下由特定的具体实施例说明本申请的实施方式，熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本申请的其他优点及功效。
在下述描述中，参考附图，附图描述了本申请的若干实施例。应当理解，还可使用其他实施例，并且可以在不背离本公开的精神和范围的情况下进行机械组成、结构、电气以及操作上的改变。下面的详细描述不应该被认为是限制性的，并且本申请的实施例的范围仅由公布的专利的权利要求书所限定。这里使用的术语仅是为了描述特定实施例，而并非旨在限制本申请。空间相关的术语，例如“上”、“下”、“左”、“右”、“下面”、“下方”、“下部”、“上方”、“上部”等，可在文中使用以便于说明图中所示的一个元件或特征与另一元件或特征的关系。
虽然在一些实例中术语第一、第二等在本文中用来描述各种元件或参数，但是这些元件或参数不应当被这些术语限制。这些术语仅用来将一个或参数件与另一个或参数进行区分。例如，第一导管可以被称作第二导管，并且类似地，第二导管可以被称作第一导管，而不脱离各种所描述的实施例的范围。第一导管和第二导管均是在描述一个导管，但是除非上下文以其他方式明确指出，否则它们不是同一个导管。
再者，如同在本文中所使用的，单数形式“一”、“一个”和“该”旨在也包括复数形式，除非上下文中有相反的指示。应当进一步理解，术语“包含”、“包括”表明存在所述的特征、步骤、操作、元件、组件、项目、种类、和/或组，但不排除一个或多个其他特征、 步骤、操作、元件、组件、项目、种类、和/或组的存在、出现或添加。此处使用的术语“或”和“和/或”被解释为包括性的，或意味着任一个或任何组合。因此，“A、B或C”或者“A、B和/或C”意味着“以下任一个：A；B；C；A和B；A和C；B和C；A、B和C”。仅当元件、功能、步骤或操作的组合在某些方式下内在地互相排斥时，才会出现该定义的例外。
外科医生习惯上将皮肤分为浅筋膜与深筋膜两层。所谓浅筋膜指的是皮肤表皮、真皮及皮下脂肪组织，具体地说，浅筋膜是胸前、外侧区的浅筋膜与颈、腹部和上肢浅筋膜相延续，内含脂肪、浅血管、淋巴管、皮神经和乳腺。深筋膜指的是分隔皮肤与肌肉组织之间的纤维结缔组织。外科手术在皮肤缝合阶段通常要对浅筋膜与深筋膜进行分层缝合，顺序为首先缝合深筋膜，然后缝合皮下组织，最后缝合皮肤。分层缝合的意义在于以缝合方式逐层对抗皮肤张力，从而提高愈合质量。由于皮肤缝线可造成局部组织的缺血，手术后在缝线部位可形成垂直切口的方向的瘢痕，俗称“蜈蚣脚”，这是传统缝合方式带来的必然结果。此外，常规的皮肤缝合也必然在皮下浅筋膜层遗留大量的线结，常常因线结的存在导致切口并发症：如切口感染、脂肪液化等等，造成严重的后果，影响患者生活质量。
针对病人(患者)在手术中不可避免造成的创口(业界亦称切口或手术切口、伤口等)的处理多采用缝合处理以助于病人创口的愈合，在这一治疗过程中，即针线缝合创口之后，为利于创口的愈合，业界在应用闭合力中使用的减压敷料组件，该减压敷料组件包括由闭合垫枕材料形成的具有闭合构件的垫枕主体，当在减压之下放置闭合敷料垫枕时，闭合构件可产生内向闭合力。在一些情况下，该组件还包括芯吸材料，芯吸材料具有用于除去流体的流体流动通路。但是，这种方式在应用过程中仍然需要缝合伤口，只能起到帮助缝合及帮助愈合的作用，并无法完全取代缝合步骤，因此依然会在患者皮肤上留下缝合痕迹。另外，该结构中产生的闭合力仅能作用于表层，当伤口较深时，皮下较深处的肌肉组织等无法受力呈闭合状态，且芯吸材料只能处理皮肤表面渗出的液体，无法对皮下的积液(例如渗血、渗液等)进行及时处理，不利于伤口的恢复。
有鉴于此，本申请提供一种无缝线闭合皮肤创口的负压引流及清洗系统，以期达到通过对皮肤创口内和皮肤创口周围环境的控制以利于皮肤创口的愈合。在以下提供的实施例中，本申请的无缝线闭合皮肤创口的负压引流及清洗系统包括：冲洗装置、负压装置、控制装置。所述冲洗装置包括输送泵和第一导管，其中所述第一导管部分探入皮下创口内腔的预设深度，所述输送泵向第一导管输送清洗液，从而在清洗皮下创口内腔的同时可输送清洗液至皮下创口内腔，促进皮下创口内腔的愈合。所述负压装置包括一负压源及第二导管，所述第二导管部分探入皮下创口内腔预设深度，所述负压源连通第二导管从而产生负压以迫使所述皮下创口内腔在愈合过程中呈闭合状态，同时还可对皮下创口内腔的积液进行引流，保证皮下创口 内腔环境的健康。所述控制装置电性连接所述冲洗装置及负压装置，从而控制冲洗装置和负压装置，同时通过冲洗装置和负压装置反馈的信息调整冲洗装置和负压装置，从而调整冲洗装置的输出压力或流量以及负压装置。
本申请的无缝线闭合皮肤创口的负压引流及清洗系统第一方面通过负压装置使皮下创口内腔在愈合康复过程中保持闭合状态，维持离断的组织保持贴合状态，并通过持续负压吸引保持创腔内渗血、渗液得到及时的清除。同时，本申请还可通过负压装置产生的负压以维持所述皮肤创口及其周缘区域的组织位置稳定，从而利于组织愈合。本申请的第二方面通过冲洗装置间歇性输送液态药物至皮下创口内腔，使皮下创口内腔中凝固的血块得到湿润，以利于移除，并令潜在的达到定殖浓度的细菌群落得到稀释，随冲洗液引流清除，从而维持创腔内清洁状态。本申请的第三方面通过控制装置的反馈机制控制冲洗装置和负压装置，保证冲洗的力度、流量和负压的强度，以确保不会对病患造成不利影响并维持所述皮下创口内腔的真空度。此外，通过本申请还可以藉由闭合皮下创口内腔以辅助实现皮肤深筋膜以上全层组织的无缝线闭合，避免了皮肤表面因缝线压迫/切割引起的横向瘢痕，并且在浅筋膜内无遗留缝线结，从而消除了引起细菌定殖的重要因素和切口感染复发的主要诱因。
应当理解，本申请所涉及的实施例中，所述皮肤创口包括一切皮肤或其他组织部位连续性中断所形成的裂口，广泛地指位于组织上或组织内的切口、伤口、缺损或其他治疗靶。应需说明的是，所述皮肤创口大多情况下是由于手术造成的，但在一些状况下，所述皮肤创口也可能是比如割伤或碰撞等事故的原因造成的。
应当理解，皮肤创口的愈合需要将皮下创口内腔的两个断面贴合，例如可通过现有技术中的缝合等手段实现。而本实施例中通过负压将皮下创口内腔中的气体抽出，以使皮下创口内腔保持一定的真空度，从而将皮下创口内腔的两个断面向内贴合，由此实现皮肤创口的闭合。
在一些实施例中，所述组织包括但不限于骨组织、脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、肌腱或韧带。所述伤口可以包括例如慢性、急性、外伤性、亚急性以及裂开的伤口；部分皮层烧伤、溃疡(诸如糖尿病性溃疡、压力性溃疡或静脉功能不全溃疡)、皮瓣、以及移植物。术语“组织部位”还可以是指不一定受伤或缺损的任何组织区域，而是为在其中可能希望增加或促进另外的组织生长的区域。例如，可以将负压施加到组织部位上以使可以获取并移植的另外的组织进行生长。
应当理解，本申请中所述的无缝线是指在皮肤浅筋膜部分(即皮肤表皮、真皮及皮下脂肪组织部分)或者上述的皮肤浅筋膜层在闭合皮肤创口的治疗中或者在皮肤创口愈合的过程中或者在手术后对皮肤创口进行例如比如清洗、消毒、敷药等其他处理中不使用针线对皮肤 浅筋膜进行缝合(suture)的治疗手段，在这些过程中不使用缝合针和缝合线等医疗工具，因此在皮肤创口愈合后，也没有去除创口或皮肤浅筋膜的创面内异物的处理的过程例如拆除或拆掉缝线或取出线头的步骤和操作过程。
在一个示例性的实施例中，请参阅图1，图1显示为本申请的无缝线闭合皮肤创口的负压引流及清洗系统的一实施例示意图，如图所示，本申请的无缝线闭合皮肤创口的负压引流及清洗系统包括：冲洗装置1、负压装置2、控制装置3。
在一个示例性的实施例中，请参阅图2，其显示为本申请的无缝线闭合皮肤创口的负压引流及清洗系统在应用时的一实施例示意图。如图所示，所述冲洗装置1包括一输送泵103及部分探入皮下创口内腔8预设深度的第一导管105，用于通过所述第一导管105输送清洗液至所述皮下创口内腔8的预设深度。
应当理解，所述皮下创口内腔8是指在手术中创口下的内部切口形成的腔体，所述腔体包括一切皮肤或其他组织部位连续性中断所形成的裂口间隙，由于人体或动物体的生物体组织具有弹性或伸缩性能，在实际的状态之中，所述皮下创口内腔8即裂口间隙不一定被直观地呈现为空腔状态或空洞状态，因此，所述的裂口间隙的形状及大小在本申请提供的实施例中不作限定。
应当理解，本申请中所公开的“导管”指的是部件可以彼此流体联接，以便提供用于在这些部件之间传递流体(即液体和/或气体)的路径。例如，这些部件可以通过流体导器(诸如管)而流体联接。如在此使用的“导管”广泛地包括管、管道、软管、导管或具有被适配成在两个末端之间传送流体的一个或多个管腔的其他结构。典型地，管是具有一些柔性的细长圆柱形结构，但是几何形状和刚性可以改变。在一些实施例中，多个部件还可以凭借物理接近而联接、在整体上成为单一结构、或者由同一件材料形成。此外，一些流体导器可以被模制到其他部件中或以其他方式与其他部件整体组合。
所述预设深度为皮肤组织中所述皮肤浅筋膜至脂肪层与深筋膜层的区间深度。其中，在较佳的实施例中，所述预设深度位置在皮肤组织中脂肪层与深筋膜层的结合处。应当理解，皮肤组织下依次包括了血管网、浅筋膜层、脂肪、深筋膜层、肌肉和骨骼。因此，本实施例中的预设深度即包括从浅筋膜层至脂肪及深筋膜层这段深度区间。
在一个示例性的实施例中，所述清洗液包括蒸馏水、双氧水、生理盐水等可以被用于清洗伤口的液体。在某些实施例中，所述清洗液中还可包括液体药物，所述液体药物根据不同的病因、不同的皮下创口内腔8类型而确定，例如当创口内有细菌感染时，可在清洗液中添加抗生素，当创口内有炎症时，可在清洗液中添加消炎成分的液体药物等。在另一些实施例中，也可将固体药物溶解于清洗液中从而被输送到皮下创口内腔8。
在一个示例性的实施例中，请参阅图6，其显示为本申请中冲洗装置的一实施例示意图，如图所示，所述冲洗装置1还包括：清洗液容器101，第一压力传感器104、第一真空传感器102。
其中，所述清洗液容器101存储有用于冲洗所述皮下创口内腔8的清洗液，通过所述第一导管105连通所述输送泵103。所述第一导管105用于输送清洗液至所述皮下创口内腔8的预设深度以利于所述皮下创口内腔8的愈合。在本实施例的一种方式中，可以通过控制冲洗装置1采用间歇性的方式输送清洗液至皮下创口内腔8，使皮下创口内腔8中凝固的血块、组织液块等得到湿润以利于移除，并令潜在的达到定殖浓度的细菌群落得到稀释，随冲洗液引流清除，从而维持皮下创口内腔8保持清洁状态。在本实施例中，因应不同的病情、治疗方案及患者体质，所述间隙性例如为以小时为单位的输送频率，再或者以天为单位输送药物。在具体的实施状态下，所述清洗液容器101及输送泵103也可被替换为包括微型泵或注射器等装置的给药设备或给药机。
应当理解，皮肤创口在愈合过程中可能会分泌血液、组织液或其他体液，形成积液。如果未及时将这些积液排出，则可能会引起感染、发炎甚至化脓。在一些情况下，未被及时清除的积液可能会在皮下创口内腔8中凝固，形成血块等难以清除的物体，通过清洗液的湿润后，可将血块溶解或以液体的压力将其带出，从而利于皮下创口的恢复。
外科手术部位感染(surgical site infection，简称SSI)是世界范围内的临床难题。皮肤切开/裂开后，人体深部组织将与外界接触，出现被致病细菌污染的机会。组织内细菌含量超过10 5/g时，就会发生细菌定殖，无法被人体免疫系统控制。随着细菌的指数型增殖，感染部位逐渐出现组织坏死和炎症反应，局部出现红、肿、热、痛症状；由于细菌定殖到感染症状出现存在潜伏期，因此，SSI通常很难在早期得到有效识别和及时处理。典型的切口感染通常发生在术后7-10天，由局部红肿、触痛开始，进而出现破溃、流脓。由于外科缝线容易被细菌定殖，SSI发生后，尽可能的移除皮下缝合的所有缝线线结十分重要，也是预防SSI复发的关键，这是因为复发的SSI感染源往往来自残留缝线线结。
在愈合过程中，所述冲洗装置1可以通过第一导管105输送清洗液至所述皮下创口内腔8，用于稀释所述皮下创口内腔8内可能产生或已经产生的细菌感染，进而使得潜在的达到定殖浓度的感染灶得到稀释；同时，所述冲洗装置1输送的清洗液还可以达到冲洗所述皮下创口内腔8中感染部位的目的，待冲洗完成后，再通过所述负压装置2的引流作用，将所述皮下创口内腔8内的清洗液吸走，进而将细菌引流清除，使皮下创口内腔8保持清洁状态。
在实际的临床治疗中，可以根据判断的患者皮下创口内腔8的感染情况，控制所述冲洗装置1的清洗液量，控制稀释细菌感染部分的时间，控制清洗液的冲洗频率，以及控制所述 负压装置2的工作频率等等。比如，在一个示例性的实施例中，所述冲洗装置1对所述皮下创口内腔8中进行清洗液冲洗的时间例如为2～3天。由于所述清洗液容器101及输送泵103也可被替换为包括微型泵或注射器等装置的给药设备或给药机，因此当采用注射器等需要人工控制的给药设备时，也可通过操作人员手动控制冲洗的时间、频率、力度等参数。
在一个示例性的实施例中，所述输送泵103为膜片泵，所述膜片泵为水泵。
应当理解，所述膜片泵又称隔膜泵和控制泵，是执行器的主要类型，通过接受调节控制单元输出的控制信号，借助动力操作而改变流体流量。膜片泵在控制过程中用以接受调节器或计算机的控制信号，改变被调介质的流量，使被调参数维持在所要求的范围内，从而实现对工作过程中参数如温度、压力、流量、液位等的调节控制。
在一个示例性的实施例中，所述第一压力传感器104用于将感测的所述输送泵103与所述皮下创口内腔8之间第一导管105的流体压力值反馈给所述控制装置3使其调节所述输送泵103的转速以控制清洗液的输出压力。在冲洗装置1对所述皮下创口内腔8清洗的过程中，如果流体压力过大，则会导致对创口的二次伤害，并会给患者带来疼痛感。反之，如果流体压力过小，则会导致冲洗效果不理想，无法将皮下创口内腔8中的积液等冲洗干净，导致积液仍然会存留在皮下创口内腔8中，不利于创口的愈合。为避免上述情况发生，通过在输送泵103与所述皮下创口内腔8之间的第一导管105上设置第一压力传感器104，所述第一压力传感器104所感测到的流体压力值反映了所述第一导管105输出端的流体压力值，将第一压力传感器104感测的所述的流体压力值反馈给所述控制装置3，以使所述控制装置3调节所述输送泵103的转速，从而控制清洗液的输出压力。
应当理解，所述反馈指所述第一压力传感器104通过其感测对的流体压力值提供给所述控制装置3，以便所述控制装置3基于预设的期望压力值来调整输送泵103的转速，从而控制清洗液的输出压力。该过程通过反馈控制来实现，即将系统的输出信息返送到输入端，与输入信息进行比较，并利用二者的偏差进行控制的过程。具体地说，所述反馈控制是指在某一行动和任务完成之后，将实际结果进行比较，从而对下一步行动的进行产生影响，起到控制的作用。其可对计划决策在实施过程中的每一步骤所引起的客观效果，能够及时做出反应，并据此调整、修改下一步的实施方案，使计划决策的实施与原计划本身在动态中达到协调。所述第一压力传感器104或第二压力传感器203采用包括但不限于型号为MPXH6300A的压力传感器。
在一个示例性的实施例中，所述第一真空传感器102用于将感测的所述输送泵103与清洗液容器101之间第一导管105的真空度以监测所述清洗液容器101中清洗液的用尽状态。当清洗液容器101内的清洗液使用完毕后，需要及时停止输液或补充清洗液，则会导致空气 进入皮下创口内腔8。在此，通过在输送泵103与清洗液容器101之间的第一导管105上设置第一真空传感器102，通过检测输送泵103与清洗液容器101之间的第一导管105的真空度可反映所述清洗液容器101中的清洗液是否用尽。
在一个示例性的实施例中，当检测到清洗液容器101中的清洗液用尽或即将用尽时，将检测结果反馈给所述控制装置3，以便所述控制装置3将输送泵103关闭，从而避免输送泵103继续工作。
应当理解，所述第一真空传感器102的设置位置在输送泵103与清洗液容器101之间的第一导管105上。因此所述第一真空传感器102所检测到的真空度反映了输送泵103与清洗液容器101之间的第一导管105的真空度。当输送泵103与清洗液容器101之间的第一导管105中充满液体或有大量液体通过时，输送泵103与清洗液容器101之间的第一导管105内的真空度为零或接近于零，但当输送泵103与清洗液容器101之间的第一导管105中没有液体流过或流过的液体非常少时，表示所述清洗液容器101内的清洗液已用尽或接近用尽，此时输送泵103与清洗液容器101之间的第一导管105的真空度会明显上升。因此，通过在检测输送泵103与清洗液容器101之间的第一导管105上设置第一真空传感器102后，可通过第一真空传感器102检测的真空度数值来判断所述清洗液容器101中的清洗液是否用尽或即将用尽，即所述清洗液容器101中清洗液的用尽状态。
在一个示例性的实施例中，请参阅图3，图3显示为本申请无缝线闭合皮肤创口的负压引流及清洗系统中报警装置的一实施例示意图，如图所示，所述冲洗装置1还包括报警装置9，用于在所述第一真空传感器102监测到所述清洗液容器101中清洗液的用尽时输出报警信号。在此，当设置在输送泵103与清洗液容器101之间的第一导管105上的第一真空传感器102检测到清洗液容器101内的清洗液用尽或即将用尽时，可通过报警装置9来报警以提示补充清洗液或停止冲洗装置1的工作。
应当理解，报警装置9为能够接收所述控制装置3的控制信号以发出声音以达到警报功能的设备，其包括但不限于蜂鸣器、语音报警系统、声光报警器等。
在一个示例性的实施例中，所述冲洗装置1包括输送泵103、第一导管105、清洗液容器101、第一压力传感器104、第一真空传感器102。其中，所述清洗液容器101内设有用于冲洗所述皮下创口内腔8的清洗液。所述输送泵103用于输送清洗液容器101内的清洗液并控制液体的流量和力度等参数。所述第一导管105一端连接清洗液容器101，所述第一导管105另一端部分探入皮下创口内腔8预设深度，从而将清洗液容器101中的清洗液输送至皮下创口内腔8。所述第一压力传感器104设置在输送泵103与所述皮下创口内腔8之间的第一导管105上，由此将流体压力值反馈给所述控制装置3，以使所述控制装置3调节所述输送泵 103的转速，从而控制清洗液的输出压力。所述第一真空传感器102设置于输送泵103与清洗液容器101之间的第一导管105上，从而通过第一真空传感器102检测的真空度数值来判断所述清洗液容器101中的清洗液是否用尽或即将用尽。当检测到清洗液容器101中的清洗液已用尽或即将用尽时，可通过所述控制装置3触发报警装置9报警或通过控制装置3将所述输送泵103关闭。
在一个示例性的实施例中，所述负压装置2包括一负压源202及部分探入皮下创口内腔8预设深度的第二导管205，所述负压装置2用于产生负压以迫使所述皮下创口内腔8在愈合过程中呈闭合状态以及通过所述第二导管205对所述皮下创口内腔8的积液进行引流。所述第二导管205用于产生负压以迫使皮下创口内腔8在愈合过程中呈闭合状态，维持离断的组织保持贴合状态，并通过持续负压吸引保持创腔内渗血、渗液得到及时的清除，在实际的实施过程中，通过所述负压装置2的第二导管205探入到皮下创口内腔8中，通过产生负压迫使皮下创口内腔8两侧的组织趋向相向(诚如图2中箭头皮下创口两侧箭头所示的方向)贴合以消除所述皮下创口内腔8，皮下创口内腔8的闭合利于创口的愈合。应当理解的，在这一过程中，所述第二导管205在皮下创口内腔8中的部分不影响所述皮下创口内腔8两侧的组织的生长。
应当理解，皮肤创口在愈合过程中可能会分泌血液、组织液或其他体液，形成积液。如果未及时将这些积液排出，则可能会引起感染、发炎甚至化脓。通过负压将皮下创口内腔8中的积液排出，可避免创口感染、发炎或化脓等不利情况的发生，从而利于创口的愈合。
在一个示例性的实施例中，请参阅图7，其显示为本申请中负压装置的一实施例示意图，如图所示，所述负压装置2还包括：收集容器204、第二压力传感器203和第二真空传感器201。
其中，所述收集容器204用于收集所述第二导管205自所述皮下创口内腔8引流的积液。所述收集容器204包括但不限于集液瓶、集液罐等可用于存储液体的容器。所述第二导管205将从皮下创口内腔8引流的积液收集在所述收集容器204中。当所述收集容器204集满时，可更换收集容器204或将收集容器204内的积液清除。
为保证清洗液容器101和所述收集容器204保持在无菌工作环境下，在一个示例性的实施例中，所述控制装置3的控制部分与清洗液容器101和所述收集容器204集成在不同的设备壳体中，比如，所述控制装置3的控制部分(包括控制装置、输送泵、负压源)被配置在第一壳体中，所述清洗液容器101和所述收集容器204被配置在第二壳体中，所述清洗液容器101和所述收集容器204在所述第二壳体内物理隔离，每个容器均具有一个独立且彼此不相连通的空间，所述第二壳体上设有分别连接所述清洗液容器101和所述收集容器204的导 管接口，用于连通各自的导管，即，所述收集容器204连通第二导管205，清洗液容器101连通第一导管105。在实施例中，所述清洗液容器101和所述收集容器204通过可拆卸式的结构与壳体连接，便于更换或维护。
在另一个示例性的实施例中，在临床中，为了灵活安置，所述洗液容器101和所述收集容器204也可以分别独立地设置在各自的壳体中，比如，所述控制装置3的控制部分(包括控制装置、输送泵、负压源)被配置在第一壳体中，所述清洗液容器101被配置在第二壳体中，所述收集容器204被配置在第三壳体中。在一个示例性的实施例中，所述第二压力传感器203用于将感测的所述负压源202与所述收集容器204之间第二导管205的流体阻力以监测所述收集容器204的装满状态。请继续参阅图1，如图所示，在负压源202与所述收集容器204之间第二导管205上设有第二压力传感器203。当所述收集容器204内的液体装满或即将装满时，所述负压源202与所述收集容器204之间第二导管205内的流体阻力会明显增大，所述第二压力传感器203可检测所述负压源202与所述收集容器204之间第二导管205内的流体阻力，以判断所述收集容器204是否已经装满或即将装满，从而判断所述收集容器204的装满状态。
应当理解，流体阻力通常分为：流体在管路系统中的流动可以分为在均匀直管中的流动，产生以表面摩擦为主的沿程阻力；以及在各种管件象阀门、弯管、设备进出口等中的流动，由于流道变向、截面积变化、流道分叉汇合等产生以逆压差或涡流为主的局部阻力。当收集容器204内的液体装满时，第二导管205内的流体则受到来自收集容器204内液体的阻力，无法继续流入收集容器204内。
在一个示例性的实施例中，所述负压装置2还包括报警装置9，用于在所述第二压力传感器203监测到所述收集容器204中的积液装满或即将装满时输出报警信号。在此，当设置在负压源202与所述收集容器204之间第二导管205上的第二压力传感器203检测到收集容器204内的积液装满或即将装满时，可通过报警装置9来报警以提示更换、清理收集容器204。在另一些情况下，当设置在负压源202与所述收集容器204之间第二导管205上的第二压力传感器203检测到收集容器204内的积液装满或即将装满时，所述第二压力传感器203还可将该信息反馈给控制装置3，从而使控制装置3向所述负压装置2发出停止工作的信号以关闭负压装置2。
在一个示例性的实施例中，所述第二真空传感器201用于将感测的所述负压源202与皮下创口内腔8之间第二导管205的真空度以反馈给所述控制装置3使其调节所述负压源202的功率以控制产生的负压。请继续参阅图1，如图所示，所述负压源202与皮下创口内腔8之间第二导管205上设有第二真空传感器201，由于所述第二导管205部分探入皮下创口内 腔8预设深度，因此当第二导管205内的负压过高时，会对皮下创口内腔8造成二次伤害；当第二导管205内的负压过小时，则无法达到闭合所述皮下创口内腔8及引流皮下创口内腔8积液的效果。因此，需要将第二导管205内的负压保持在合适的数值范围内。同时，当皮下创口内腔8已处于闭合状态或接近闭合状态时，所述负压源202与皮下创口内腔8之间第二导管205内的真空度为零或接近于零，因此，通过在所述负压源202与皮下创口内腔8之间第二导管205上设置第二真空传感器201，可使第二真空传感器201反映所述负压源202与皮下创口内腔8之间第二导管205内的真空度，进而反映对皮下创口内腔8施加的负压是否在理想范围内。进一步地，所述第二真空传感器201将获取的所述负压源202与皮下创口内腔8之间第二导管205的真空度反馈给所述控制装置3，所述控制装置3根据所述第二真空传感器201反馈的数据调整所述负压源202的输出功率，从而控制所述负压源202产生的负压大小，避免负压过大对创口的伤害或负压不足无法将积液抽净的情况发生。
在一个示例性的实施例中，所述负压源202为膜片泵，所述膜片泵为气泵。
应当理解，所述膜片泵又称隔膜泵和控制泵，是执行器的主要类型，通过接受调节控制单元输出的控制信号，借助动力操作而改变流体流量。膜片泵在控制过程中用以接受调节器或计算机7的控制信号，改变被调介质的流量，使被调参数维持在所要求的范围内，从而实现对工作过程中参数如温度、压力、流量、液位等的调节控制。
在某些实施例中，所述负压源202可以是处于负压下的空气储存器，或可以是可降低密封体积中的压力的手动或电力驱动的装置，例如像真空泵、抽吸泵、可用于许多医疗保健设施中的壁吸端口、或微型泵、注射器或者静止负压器件等或者是任何适当的主动或被动抽吸源。负压供给可以被容纳在其他部件内或可以与这些其他部件结合使用，这些其他部件是例如传感器、处理单元、报警指示器、存储器、数据库、软件、显示设备、或进一步利于治疗的用户接口。例如，在一些实施例中，负压源202可以与其他部件组合成治疗单元。负压供给还可以具有一个或多个供给口，供给口被配置成利于将负压供给联接至且耦合至一个或多个分配部件。
应当理解，本申请中所公开的“负压”通常是指小于局部环境压力的压力，局部环境压力诸如在由敷料提供的密封治疗环境外部的局部环境中的环境压力。在许多情况下，局部环境压力还可以是组织部位所处位置的大气压。可替代地，压力可以小于与组织部位处的组织相关联的流体静压。除非另外说明，否则在此所陈述的压力的值是表压。类似地，提及负压的增加典型地指绝对压力的降低，而负压的降低典型地指绝对压力的增加。尽管施加到组织部位上的负压的量和性质可以根据治疗要求而变化，但压力总体上是低真空的，也通常被称为粗真空，在-5mm Hg(-667Pa)与-500mm Hg(-66.7kPa)之间。常见治疗范围在-75mm Hg (-9.9kPa)与-300mm Hg(-39.9kPa)之间。
在一个示例性的实施例中，所述控制装置3电性连接所述冲洗装置1及负压装置2，用于依据接收的反馈控制所述冲洗装置1的输出压力或流量以及所述负压装置2以维持所述皮下创口内腔8的真空度。
应当理解，冲洗装置1通过输送泵103输出清洗液，通过输送泵103可调整输出清洗液的压力以及输出清洗液的流量。当输出的压力过小时，则无法对皮下创口内腔8起到较好的冲洗作用，而当输出的压力过大时，则可能会造成对皮下创口的二次伤害或者增加病患的疼痛感。同时，当输出的流量过小时，过少的清洗液也会影响皮下创口内腔8的清洗效果，而当输出的流量过大时，会增加输出的压力，对皮下创口造成二次伤害或者为病患增加疼痛感。因此，需要将冲洗装置1的输出压力和流量控制在理想范围内，以保证清洗效果的同时不会对皮下创口和病患造成新的不良影响。
应当理解，真空度是指处于真空状态下的气体稀薄程度。若所测设备内的压强低于大气压强，其压力测量需要真空表。从真空表所读得的数值称真空度。真空度数值是表示出系统压强实际数值低于大气压强的数值，即：真空度＝大气压强-绝对压强，绝对压强＝大气压+表压(-真空度)。在本实施例中，真空度可间接反映所述皮下创口内腔8的大小，例如：当真空度较高时，反映皮下创口内腔8的两个断面仍有较大空隙，表示负压可能偏低，对皮下创口内腔8的闭合作用力可能不够；反之当真空度为零或接近于零时，反映皮下创口内腔8的两个断面没有空隙或空隙很小，表示负压可能在理想范围或者偏高，而当负压偏高时，可能会对皮下创口造成二次伤害或为病患带来疼痛感，当负压保持在理想范围内时，更利于皮下创口的愈合。因此，将皮下创口内腔8的真空度维持在理想范围可在帮助闭合皮下创口内腔8的同时不给皮下创口造成二次伤害或为病患造成疼痛感，帮助皮下创口更好的康复。在本申请中，主要通过真空传感器来检测真空度，所述真空传感器包括但不限于型号为MPXV6115VC6U的真空传感器。
所述控制装置3一方面可通过感应冲洗装置1反馈的信号控制冲洗装置1的输出压力和输出流量，保证冲洗装置1的输出压力不会对皮下创口造成损伤的同时能够将皮下创口内腔8的积液、杂质等清除，另一方面可通过感应负压装置2反馈的信号控制负压装置2的负压强度，从而保证不会对皮下创口造成损伤的同时将皮下创口内腔8中的积液引流，并闭合所述皮下创口内腔8，维持所述皮下创口内腔8的真空度在理想范围内。
在一个示例性的实施例中，所述负压装置2可产生70％～80％的真空度，如70％、71％、72％、73％、74％、75％、76％、77％、78％、79％、80％，从而维持所述皮下创口内腔8的真空度在理想范围内。
在一个示例性的实施例中，请继续参阅图3，所述负压装置2包括收集容器204、第二压力传感器203、负压源202、第二真空传感器201以及第二导管205。其中，所述第二导管205一端部分探入皮下创口内腔8预设深度，所述第二导管205另一端通过负压源202连接收集容器204，在所述负压源202与所述收集容器204之间第二导管205上设有第二压力传感器203，用以通过检测阻力大小以判断收集容器204内是否装满。所述负压源202与皮下创口内腔8之间第二导管205上设有第二真空传感器201，用以通过检测皮下创口内腔8的真空度以判断皮下创口内腔8的负压大小。所述控制装置3分别通过一A/D模块即数字模拟信号转换模块与第二压力传感器203和所述第二真空传感器201相连接，所述第二压力传感器203将感应到的阻力信息反馈给控制装置3以便控制装置3调整负压源202的启闭或控制报警装置9报警。同时，所述第二真空传感器201将感应到的真空度信息反馈给控制装置3以便控制装置3通过占空比调整负压源202的转速和流量。所述冲洗装置1包括清洗液容器101、第一导管105、第一真空传感器102、输送泵103和第一压力传感器104。其中，所述第一导管105一端部分探入皮下创口内腔8预设深度，所述第一导管105另一端通过输送泵103连接清洗液容器101，所述输送泵103与所述皮下创口内腔8之间的第一导管105上设有第一压力传感器104，用以检测输送泵103的输出压力。所述输送泵103与所述清洗液容器101之间的第一导管105上设有第一真空传感器102，用以通过检测真空度而判断所述清洗液容器101内清洗液的用尽情况。所述控制装置3分别通过一A/D模块即数字模拟信号转换模块与所述第一真空传感器102和第一压力传感器104连接，所述第一真空传感器102将其感应到的真空度反馈给所述控制装置3以便所述控制装置3控制控制报警装置9报警或控制所述输送泵103的启闭，所述第一压力传感器104将其感应到的压力大小反馈给所述控制装置3以便所述控制装置3通过占空比控制输送泵103的输出压力大小。
在一个示例性的实施例中，可采用创口闭合装置4以帮助所述负压装置2闭合所述皮下创口内腔8。创口闭合装置4可挤压皮缘以使皮肤创口暴露的两端紧贴，并在负压装置2迫使及辅助下，使皮下创口内腔8在愈合康复过程中保持闭合状态，在吸取皮下创口内腔8的积液的同时还可通过通过冲洗装置1冲洗并输送液态药物至皮下创口内腔8，进而对皮下创口内腔8中潜在的达到定殖浓度的感染灶得到稀释及清洗。
在本申请提供的实施例中，所述创口闭合装置4用于挤压皮缘以使皮肤创口在愈合过程中呈闭合状态，同时，挤压皮缘可减少皮肤真皮下血管网的出血，利于创口恢复。所述创口闭合装置4设置在皮肤创口的周侧，在某些实施例中，所述创口闭合装置4通过粘合的方式设置在皮肤创口的周侧。在某些实施例中，所述创口闭合装置4包括至少两个闭合件41，所述的至少两个闭合件41分别设置在所述皮肤创口的两侧边缘，在实施过程中，通过两个闭合 件41的结合来保持皮肤创口在愈合过程中呈闭合状态。在实际应用中，可通过创口的长度和闭合件41的具体形式来确定闭合件41的数量。
请参阅图8，其显示为本申请在一实施例中创口闭合装置中闭合件的结构示意图，如图所示，在实施例中，所述创口闭合装置4还包括覆盖闭合件41的微孔覆件40(未予以图示)，所述微孔覆件40顺应闭合件41的外形结构结合于闭合件41上，用以和所述闭合件41形成一个整体以利于吸附或吸取自皮肤创口渗出并滞留在所述闭合件41上的分泌液体或者存留在所述闭合件41上的药物液体。在一个示例性的实施例中，所述微孔覆件40与闭合件41为一体成型结构。在另一个示例性的实施例中，比如通过黏合等工艺使得所述微孔覆件40与闭合件41结合，使所述微孔覆件40顺应闭合件41的外形结构结合于闭合件41上。
在某些实施例中，所述闭合件41包括柔性本体410，所述柔性本体410表示具有弹性/柔性柔性本体410材料可以具有大于100％的极限伸长和显著的回弹量。材料的回弹是指材料从弹性变形恢复的能力。弹性/柔性柔性本体410材料的例如可以包括，但不局限于天然橡胶、聚异戊二烯、丁苯橡胶、氯丁二烯橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、乙烯丙烯二烯单体、氯磺化聚乙烯、聚硫橡胶、聚氨酯、EVA膜、共聚酯和硅酮类等。
在一个示例性的实施例中，所述闭合件41还可以为硅胶材料、树脂材料，或者硅胶树脂材料。
在一个示例性的实施例中，所述微孔覆件40的材料为医用棉花、脱脂棉(degreasing cotton)、泡沫、网状物、纱布、海绵、或者多孔生物相容材料，所述微孔覆件40具有透气性能以及吸附水分的特性，用于吸附皮肤创口在愈合过程中可能分泌的积液或者存留在皮肤创口未被组织吸收的药物残液的水分。
在本实施例中，所述闭合件41包括：柔性本体410以及刚性曲针411。
所述柔性本体410粘合于所述皮肤创口周缘的皮肤表面；在本实施例中，所述柔性本体410为硅胶材料、树脂材料，或者硅胶树脂材料。所述柔性本体410通过粘合剂粘合于所述皮肤创口周缘的皮肤表面上，在一些实施例中，所述粘合剂例如为医用粘合剂，例如包括氰基丙烯酸甲酯为主体的快速粘合剂等。在具体的实施过程中，至少两个所述柔性本体410分别被粘合于所述皮肤创口周缘的相对两侧的皮肤表面上。
所述刚性曲针411包括根部及曲形针部，所述刚性曲针411的根部埋于所述柔性本体410中，被牢固地设置在所述柔性本体410上，所述刚性曲针411的曲形针部外露于所述柔性本体410外。在一个示例性的实施例中，所述刚性曲针411的根部通过变形的结构设计被牢固地设置在所述柔性本体410中，所述变形的结构设计比如呈勾状结构或者T字形结构等等。
在一个示例性的实施例中，请参阅图9，其显示为本申请在一实施例中的闭合件与创口 结合的实施例示意图，如图所示，所述刚性曲针411外露于所述柔性本体410外的曲形针部部分刺入所述皮肤创口的一侧以挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态，在具体的实施过程中，医生需要先进行创口对皮(把皮肤皮缘对齐，另外防止皮缘内翻，避免皮肤愈合不良)操作，然后通过将所述刚性曲针411的曲形针部从所述皮肤创口的一侧刺入，诚如图9所示的状态，由于所述皮肤创口两侧的闭合件41的刚性曲针411刺入创口侧缘的健康组织，以挤压皮缘以可减少皮肤真皮下血管网的出血，利于创口恢复，进而使得所述皮肤创口呈闭合状态。
在另一个示例性的实施例中，所述刚性曲针411外露于所述柔性本体410外的曲形针部部分刺入所述皮肤创口的另一侧，并利用其曲形针部勾住所述皮肤创口的另一侧，使得位于所述皮肤创口两侧相向结合，同时带动皮肤创口的相对两侧的健康组织也相向结合进而闭合所述皮肤创口。
在再一个示例性的实施例中，所述刚性曲针411外露于所述柔性本体410外的曲形针部部分刺入设置在所述皮肤创口另一侧的柔性本体410内，使得位于所述皮肤创口两侧的柔性本体410相向结合，同时带动皮肤创口的相对两侧的健康组织也相向结合进而闭合所述皮肤创口。
呈如图9所示，皮肤11组织下依次包括了血管网、浅筋膜层、脂肪、深筋膜层、肌肉和骨骼。本实施例中的缝合深度即在浅筋膜层中。在本申请中关注的问题是对皮肤浅筋膜部分(即皮肤表皮、真皮及皮下脂肪组织部分)的无缝线操作，所述刚性曲针411外露于所述柔性本体410外的曲形针部部分刺入的深度包括皮肤浅筋膜部分的皮肤表皮、真皮及皮下脂肪组织部分。
在某些实施例中，依据适用的皮肤创口的长度或者宽度不同，所述柔性本体410上设置的刚性曲针411的数量和长度可以呈现不同的实施状态，在一些实施例中，当所述柔性本体410上设置的刚性曲针411为多个时，该些刚性曲针411呈等距分布的排列在为长条状的柔性本体410上。
请参阅图10，显示为本申请中创口闭合装置的闭合件在又一个实施例中的示意图，如图所示，在本实施例中，所述闭合件41还包括夹持件42，该夹持件42用于夹持粘合于所述皮肤创口两侧的闭合件41的柔性本体410，所述柔性本体410在夹持件42的作用下提供了相向力以挤压皮缘，保证皮肤创口在愈合过程中呈闭合状态。在具体的实施中，所述夹持件42为医用夹子等部件。
在上述采用包括柔性本体410以及刚性曲针411的闭合件41的各实施例中，还可以辅助采用一些辅助件412，所述辅助件412用于辅助闭合件41与皮肤表面之间粘接，并向闭合件 41提供使皮肤创口闭合的收缩力，请参阅图11，显示为在本申请创口闭合装置的闭合件及辅助件在一实施例中的应用示意图。
在另一个示例性的实施例中，请参阅图12，其显示为本申请创口闭合装置中的闭合件在再一实施例中的结构示意图，如图所示，在本实施例中，所述闭合件41包括：第一柔性本体4100及第二柔性本体4101。
所述第一柔性本体4100粘合于所述皮肤创口周缘的皮肤表面，所述第一柔性本体4100具有第一结合部；所述第二柔性本体4101粘合于所述皮肤创口周缘的皮肤表面，所述第二柔性本体4101具有对应结合于所述第一结合部的第二结合部。所述第一结合部与第二结合部的结合提供施加于所述皮肤创口两侧的柔性本体410的相向力，由此挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态。在本实施例中，所述第一及第二柔性本体4101为硅胶材料、树脂材料，或者硅胶树脂材料。所述第一及第二柔性本体4101通过粘合剂粘合于所述皮肤创口相对两侧的皮肤表面上，在一些实施例中，所述粘合剂例如为医用粘合剂，例如包括氰基丙烯酸甲酯为主体的快速粘合剂等。
在一些示例性的实施例中，所述第一结合部为凹槽结构或卡扣结构，所述第二结合部为可限于所述凹槽结构内突起结构或对应所述卡扣的卡孔或卡勾结构。比如，在第一结合部上设有若干凹槽，在第二结合部上设有与该若干凹槽相对应的突起结构。第一结合部上的若干凹槽可替换为卡扣结构，相对应地，第二结合部上的突起结构可替换为对应卡扣的卡孔或卡勾结构；但并不局限于此，凡其他可以实现第一柔性本体4100与第二柔性本体4101相互结合的结合结构均可实现本实施例的目的，比如凹槽或孔与突起结构的结合等方式。
在某些实施例中，请继续参阅图12，所述创口闭合装置4还包括辅助件412，所述辅助件412用于辅助闭合件41与皮肤表面之间粘接，并向闭合件41提供使皮肤创口闭合的收缩力，在一个示例性的实施例中，如果皮肤创口为在第一方向上的切口，则所述辅助件412粘合在所述皮肤创口的周侧，并向所述闭合件41施加垂直于第一方向的第二方向上的力，这个力在本实施例中被称之为收缩力，进而辅助闭合件41提供使皮肤创口闭合。在本实施例中，所述辅助件412通过其相对于皮肤表面的粘合层与皮肤的表面粘接，所述粘合层的材料例如为包括涂有丙烯酸粘合剂的聚氨酯的胶布。
在本实施例中，为所述胶布的辅助件412可以被设计为从中心向相对的两侧延伸的带状结构，所述两侧延伸的带状结构可以是分离的，也可以是一体的，为增加病人/患者的舒适度，所述带状结构适于人工伸展。
在一个示例性的实施例中，所述第一或第二导管经由所述皮肤创口的一预设位置部分探入至所述皮下创口内腔8的预设深度；或者所述第一或第二导管经由远离所述皮肤创口的一 预设位置穿过皮肤及皮下组织以部分探入至所述皮下创口内腔8的预设深度。
在一个示例性的实施例中，请参阅图4，其显示为本申请中第一或第二导管从皮肤创口的一预设位置部分探入至所述皮下创口内腔的预设深度的实施例示意图。如图所示，所述第一或第二导管经由所述皮肤创口的一预设位置部分探入至所述皮下创口内腔8的预设深度，由此可产生负压，保证皮下创口内腔8在愈合过程中呈闭合状态，并同时对皮下创口内腔8的积液起到引流作用，进而维持离断的组织保持贴合状态，并通过持续负压吸引保持创腔内渗血、渗液得到及时的清除，使得由于能够及时清除皮下创口内腔8的例如渗血和/或渗液等积液，消除了细菌的生存空间或环境。在本实施例中，所述预设位置可以是所述创口上的任一位置，其中设置在靠创口边缘的位置时更利于伤口恢复。
在另一个示例性的实施例中，请继续参阅图2，如图所示，所述第一或第二导管经由远离所述皮肤创口的一预设位置穿过皮肤及皮下组织以部分探入至皮下创口内腔8的预设深度，由此可产生负压保证皮下创口内腔8在愈合过程中呈闭合状态的同时吸取皮下创口内腔8的积液，使得由于能够及时清除皮下创口内腔8的积液，消除了细菌的生存空间或环境。在本实施例中，请参阅图5，其显示为本申请中第一或第二导管经由远离所述皮肤创口的一预设位置穿过皮肤及皮下组织的实施例示意图。所述第一或第二导管经由远离所述皮肤创口的一预设位置(如图5中A处所示的位置)穿过皮肤及皮下组织以部分探入至皮下创口内腔8的预设深度。所述的远离是指在离所述皮肤创口一预设的位置(如图5中A处所示的位置)，为了利于对所述皮肤创口的闭合处理以及表面处理，所述第一或第二导管非通过所述皮肤创口探入到皮下创口内腔8中，而是从另外的位置，即远离所述皮肤创口的一预设位置穿过皮肤及皮下组织以部分探入至皮下创口内腔8，本实施例特别适用于如图5所示的狭长型创口。
在一个示例性的实施例中，所述第一导管105及第二导管205一体成型。
在本实施例中，请参阅图13，其显示为本申请的第一和第二导管结构的一实施例示意图，如图所示，所述第一导管105及第二导管205一体成型，由此可减少埋管数量，所述的一体成型为在一根导管中包含两个相互隔离并相互不连通的管道，其中第一个管道形成所述第一导管105，第二个管道形成所述第二导管205。
在另一个示例性的实施例中，所述第二导管205还可套设于所述第一导管105内。
在本实施例中，请参阅图14，其显示为本申请的第一和第二导管结构的另一实施例示意图，如图所示，所述第一导管105及第二导管205一体成型，由此可减少埋管数量，所述的一体成型为所述第一导管105与第二导管205为两根相互不连通的管道，其中所述第二导管205套设于所述第一导管105内，第一导管105的直径大于第二导管205的直径，由于较细的导管套设在较粗的导管中，此在不增加导管的数量的同时，也可以不增加整体导管的直径。
在一个示例性的实施例中，所述第一导管105探入皮肤创口内预设深度的部分的管壁上设置有多个通孔。请继续参阅图13～图14，如图所示，在所述第一导管105上设有多个通孔1050，所述第一导管105连接清洗液容器101，从而在第一导管105输送清洗液容器101中的清洗液至皮下创口内腔8的预设深度的同时，通过第一导管105上的通孔1050流出到皮下创口的各个部位，从而对皮下创口的更多部位进行清洗或输送药物。在一个示例性的实施例中，所述多个通孔1050成间距均匀地分布在所述第一导管105探入皮肤创口内预设深度的部分的管壁上，特别是针对狭长创口而言，形成在该狭长创口皮下的创口内腔通常也为长形空腔或间隙，以确保所述长形空腔或间隙每一处均能被第一管道中的清洗液所清洗或输送药物；在另一个示例性的实施例中，适用于不同类型的皮肤创口或者不同目的手术，所述第一导管105上的多个通孔1050也可以被设计为呈间距不等(即，多个通孔成间距不均匀地分布在所述第一导管105探入皮肤创口内预设深度的部分的管壁上)的方式。
在一个示例性的实施例中，所述第二导管205探入皮肤创口内预设深度的部分的管壁上设置有多个通孔，所述第二导管205连接负压源202从而产生负压，第二导管205上的多个通孔可助于吸取所述皮下创口内腔8的气体及液体，从而提高吸取的面积和部位，更利于皮下创口的愈合。在一个示例性的实施例中，所述多个通孔成间距均匀地分布在所述第二导管205探入皮肤创口内预设深度的部分的管壁上，特别是针对狭长创口而言，形成在该狭长创口皮下的创口内腔通常也为长形空腔或间隙，为了确保所述长形空腔或间隙每一处分泌的积液或残余的药液被所述第二导管205汲取；在另一个示例性的实施例中，适用于不同类型的皮肤创口或者不同目的手术，所述第二导管205上的多个通孔也可以被设计为呈间距不等(即，多个通孔成间距不均匀地分布在所述第二导管205探入皮肤创口内预设深度的部分的管壁上)的方式。
在再一个示例性的实施例中，探入皮肤创口内预设深度的部分的第一导管105和第二导管205的形状和结构也可以根据实际的需求被设计，比如依据期望探入皮肤创口内的深度不同或者组织结构不同，第一导管105和第二导管205的粗细不同或者柔弱性能不同，比如同一根导管在不同部位的粗细不同，又或者同一根导管在不同部位的材料不同，更或者同一根导管在不同部位的柔弱性能不同等。
在一个示例性的实施例中，所述第一或第二导管上设置有单向阀。以避免吸入到导管中的气体或者积液回流从而不利于皮肤创口的愈合，在实施例中，所述单向阀例如为鸭嘴阀或者扇形阀或者锥形阀等橡胶件，但并不局限于此，利用机械或者电气控制的阀组件也适用本实施例。
应当理解，所述鸭嘴阀的形状类似鸭嘴，故称鸭嘴阀。鸭嘴阀采用弹性材质，故在内部 无压力情况下，鸭嘴出口在本身弹性作用下合拢。当鸭嘴阀内部压力逐渐增加时，鸭嘴出口逐渐增大，保持液体能在高流速下排出。
应当理解，所述扇形阀的出口为扇形结构。所述扇形阀采用弹性材质，故在内部无压力情况下，扇形出口在本身弹性作用下合拢。当扇形阀内部压力逐渐增加时，扇形出口逐渐增大，保持液体能在高流速下排出。
应当理解，所述锥形阀的阀芯密封面为锥形面。锥形阀在流道终端设置有锥形阀芯，其所有运动部件均设置在阀门的过流通道外部，使得阀体内部流道通畅顺滑，流量大而压降损耗少，锥形阀在整个工作范围内不会产生气蚀及振动，在小流量时仍具有良好的流量控制效果。
在一个示例性的实施例中，所述负压装置2还用于藉由产生的负压维持皮肤创口表面及其周缘区域的组织位置稳定，进而利于创口恢复。
在一个示例性的实施例中，所述负压装置2包括：密封膜12，用于粘合于皮肤上并覆盖所述皮肤创口表面以形成密封空间13；负压通道，连通所述负压源202，通过将所述负压源202产生的负压以使所述密封膜12提供收缩力驱使所述皮肤创口相向收缩。在本实施例中，所述负压通道通过第二导管205与负压源202连通，将负压通道连通密封空间13，由此形成密封空间13。
在本实施例中，所述负压装置2产生的负压使密封空间13压缩，从而可维持局部组织趋向创口位置合拢。同时，负压装置2产生的负压对创口下的深部组织也产生作用力，使潜在的死腔闭合，促进创口愈合。在本实施例中，所述密封膜12粘合于皮肤上形成的密封空间13的压力值的范围可以设置在大约0.001与约1个大气压之间。在实际的实施过程中，可以根据创口的愈合程度来控制所述负压装置2产生的负压值，比如随着皮肤创口的愈合程度可以适当地减小所述负压值，或者根据皮肤创口分泌的积液的情况，例如分泌积液增多的情况下，可以适当地增加所述负压值以加大吸取所述积液的力度。
在一个示例性的实施例中，请参阅图15，其显示为本申请中负压装置在一实施例中的密封及受力结构示意图，如图所示，所述密封膜12粘合于皮肤上并覆盖皮肤创口表面，由此形成一个密封空间13，通过负压装置2抽压后，密封膜12内部密封空间13形成向内的作用力，受力如图15所示的箭头方向，在维持局部组织位置固定的同时还可对深部组织施加压力，由此闭合潜在死腔。在本实施例中，所述密封膜12绕过皮肤创口形成一个密封区，并使得所述密封区形成密封空间13，在本实施例中，所述密封膜12通过其相对于皮肤表面的粘合层与皮肤的表面粘接，所述粘合层的材料例如为包括涂有丙烯酸粘合剂的聚氨酯的柔性不渗透材料。
在一个示例性的实施例中，所述密封膜12开设有为透光材料的观察窗。在此，所述密封膜12可以由透明材料制成。为所述透明材料的密封膜12可以有利于临床医师目测所述皮肤创口的愈合情况，以便进行及时的干预。
上述实施例的具体操作步骤请参阅图17，其显示为本申请的一应用实施例示意图，如图所示，操作人员将冲洗装置1的第一导管105及负压装置2的第二导管205埋入皮肤的皮下组织，并使第一导管105和第二导管205伸入皮下创口内腔8。负压装置2可通过第二导管205引流皮下创口内腔8分泌的积液，同时由于负压作用迫使创口内腔趋向收拢/合并，使得两侧的组织相向结合。另外，冲洗装置1还可通过第一导管105输送清洗液和液体药物至所述皮下创口内腔8利于愈合，此为第一方面；在第二方面，通过闭合件41将创口外两侧的皮肤向内收拢，使皮肤创口在愈合过程中保持闭合状态，闭合件41对皮缘的挤压作用可减少皮肤真皮下血管网的出血，负压装置2的负压可辅助使皮下创口内腔8闭合。操作人员继续将微孔覆件40覆盖在创口表面，保证愈合过程中创口表面的分泌物可被及时吸收。再在微孔附件外盖上密封膜12以包裹整个创口及创口上的微孔覆件40；第三方面，通过负压装置2的负压通道将密封膜12内抽压，使得所述皮肤创口及其周缘区域的组织向创口收紧，另外，负压装置2产生的负压还可对深部组织施加一定程度的压力，使潜在的死腔闭合，如此使得加快了皮肤创口的愈合速度，更是不使用针线对皮肤浅筋膜部分进行缝合(suture)的治疗手段，不使用缝合针和缝合线等医疗工具。
在一个示例性的实施例中，所述负压装置2包括湿度检测部件(未予以图示)，用于将检测的所述密封空间13内的湿度信息提供给所述负压源202以利所述负压源202调控负压输出。将湿度检测部件的传感器设置于密封膜12形成的密封空间13内，并将湿度检测部件的信息输出端口与控制装置3连接，由此将检测到的湿度信息提供给控制压装置，以控制负压装置2调控输出的负压大小。在本实施例中，所述湿度检测部件例如为湿度传感器。
在一个示例性的实施例中，请参阅图16，其显示为本申请中第二导管的一实施例示意图，所述第二导管205包括皮下引流孔2050及皮上负压孔2051，所述皮下引流孔2050为设置在所述第二导管205探入皮肤创口内预设深度的部分的管壁上的多个通孔；所述皮上负压孔2051连通所述密封空间13以向所述密封空间13施加负压。所述第二导管205连接负压源202，所述负压源202为所述第二导管205提供负压。所述第二导管205的皮下引流孔2050位于所述第二导管205探入皮肤创口内预设深度的部分的管壁上，藉由负压源202产生的负压迫使所述皮下创口内腔8在愈合过程中呈闭合状态并通过所述第二导管205对所述皮下创口内腔8的积液进行引流。所述第二导管205的皮上负压孔2051位于皮上部分的密封空间13内，用以连通所述密封空间13以向所述密封空间13施加负压，从而维持皮肤创口表面及其周缘 区域的组织位置稳定。
在一个示例性的实施例中，请继续参阅图1，所述无缝线闭合皮肤创口的负压引流及清洗系统还包括计算机7，所述计算机7与所述控制装置3连接，连接方式包括但不限于通过USB接口连接或蓝牙或无线网络连接等方式通讯连接。用户可在计算机7上设置程序，以设定所述冲洗装置1和负压装置2的工作时间、工作模式等。例如，可根据不同的疾病、不同的处理方法或根据实际的病情或创口的特点来设置所述冲洗装置1和负压装置2的驱动参数。
在一个示例性的实施例中，请继续参阅图1，所述无缝线闭合皮肤创口的负压引流及清洗系统还包括交互装置6，所述交互装置6包括但不限于触摸屏、显示屏与操作键盘等。用户通过交互装置可人工对控制系统进行设定，从而控制所述负压装置2和冲洗装置1的工作状态、工作时间、工作模式等，并通过反馈在显示屏上的信息实时了解负压装置2和冲洗装置1的工作状态、工作时间、工作模式等。
在一个示例性的实施例中，请继续参阅图1，所述无缝线闭合皮肤创口的负压引流及清洗系统还包括存储模块5，所述存储模块5包括但不限于SD卡等存储芯片或云端存储。所述存储模块5可保存用户设置的操作信息和从计算机7上下载的操作程序，以及实际使用过程中的数据等。
综上所述，本申请的无缝线闭合皮肤创口的负压引流及清洗系统第一方面在负压装置2迫使下，使皮下创口内腔8在愈合康复过程中保持闭合状态，维持离断的组织保持贴合状态，并通过持续的负压吸引保持创腔内渗血、渗液得到及时的清除；第二方面，通过间歇性输送清洗液至皮下创口内腔8，使皮下创口内腔8中凝固的血块得到湿润，以利于移除，并令潜在的达到定殖浓度的细菌群落得到稀释，随清洗液引流清除，从而维持创腔内清洁状态。同时，清洗液中还可添加或替换为药物，从而输送至皮下创口内腔8帮助皮下创口愈合；第三方面通过负压装置2、冲洗装置1与控制装置3的反馈控制，使控制装置3能够实时控制所述负压装置2的负压大小以及冲洗装置1的冲洗压力及流量，从而保证负压装置2的负压能够起到较好的闭合和引流作用、冲洗装置1能够起到较好的冲洗作用的同时不会对皮下创口产生负面影响。且在使用过程中，所述控制装置3基于真空传感器和压力传感器的反馈信息可触发报警装置9报警，以提醒操作人员及时补充清洗液或更换收集容器204。负压装置2产生的负压还可以维持所述皮肤创口及其周缘区域的组织位置稳定，从而利于组织愈合。此外，通过本申请可以实现皮肤深筋膜以上全层组织的无缝线闭合，避免了皮肤表面因缝线压迫/切割引起的横向瘢痕(俗称“蜈蚣脚”)，并且在浅筋膜内无遗留缝线结，从而消除了引起细菌定殖的重要因素和切口感染复发的主要诱因。
因此，本申请的无缝线闭合皮肤创口的负压引流及清洗系统，可以在不使用缝合的情况 下使皮下创口内腔8在愈合康复过程中始终保持闭合状态，由此以来，不但加快了皮肤创口的愈合速度，更是不使用针线对皮肤进行缝合(suture)的治疗手段，不使用缝合针和缝合线等医疗工具，因此在皮肤创口愈合后，也没有去除创口或创面内异物的处理的过程例如拆除或拆掉缝线或取出线头的步骤和操作过程，进而消除了细菌定殖的关键环节和重要诱因，更是保证了愈合之后的创口不会在皮肤的表面留下例如“蜈蚣脚”的缝线痕迹，保证了手术切口部位的美观，进而解决了现有技术中手术后切口缝合易留下痕迹且积液难以排出等难题，本申请的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备尤其适用于美容医疗领域。
上述实施例仅例示性说明本申请的原理及其功效，而非用于限制本申请。任何熟悉此技术的人士皆可在不违背本申请的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本申请所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本申请的权利要求所涵盖。

Claims (18)

  1. 一种无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，包括：
    冲洗装置，包括一输送泵及部分探入皮下创口内腔预设深度的第一导管，用于通过所述第一导管输送清洗液至所述皮下创口内腔的预设深度；
    负压装置，包括一负压源及部分探入皮下创口内腔预设深度的第二导管，用于产生负压以迫使所述皮下创口内腔在愈合过程中呈闭合状态以及通过所述第二导管对所述皮下创口内腔的积液进行引流；
    控制装置，电性连接所述冲洗装置及负压装置，用于依据接收的反馈控制所述冲洗装置的输出压力或流量以及所述负压装置以维持所述皮下创口内腔的真空度。
  2. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述冲洗装置包括：
    清洗液容器，存储有用于冲洗所述皮下创口内腔的清洗液，通过所述第一导管连通所述输送泵；
    第一压力传感器，用于将感测的所述输送泵与所述皮下创口内腔之间第一导管的流体压力值反馈给所述控制装置使其调节所述输送泵的转速以控制清洗液的输出压力；
    第一真空传感器，用于将感测的所述输送泵与清洗液容器之间第一导管的真空度以监测所述清洗液容器中清洗液的用尽状态。
  3. 根据权利要求2所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述冲洗装置包括报警装置，用于在所述第一真空传感器监测到所述清洗液容器中清洗液的用尽时输出报警信号。
  4. 根据权利要求1或2所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述输送泵为膜片泵。
  5. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述负压装置包括：
    收集容器，用于收集所述第二导管自所述皮下创口内腔引流的积液；
    第二压力传感器，用于将感测的所述负压源与所述收集容器之间第二导管的流体阻力以监测所述收集容器的装满状态；
    第二真空传感器，用于将感测的所述负压源与皮下创口内腔之间第二导管的真空度以 反馈给所述控制装置使其调节所述负压源的功率以控制产生的负压。
  6. 根据权利要求5所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述负压源为膜片泵。
  7. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述预设深度为皮肤组织中所述皮肤浅筋膜至脂肪层与深筋膜层的区间深度。
  8. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述第一或第二导管经由所述皮肤创口的一预设位置部分探入至所述皮下创口内腔的预设深度；或者所述第一或第二导管经由远离所述皮肤创口的一预设位置穿过皮肤及皮下组织以部分探入至所述皮下创口内腔的预设深度。
  9. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述第一导管及第二导管一体成型或所述第二导管套设于所述第一导管内。
  10. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述第一或第二导管探入皮肤创口内预设深度的部分的管壁上设置有多个通孔。
  11. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述第一或第二导管上设置有单向阀。
  12. 根据权利要求11所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述单向阀为鸭嘴阀或扇形阀。
  13. 根据权利要求1所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述负压装置还用于藉由产生的负压维持皮肤创口表面及其周缘区域的组织位置稳定。
  14. 根据权利要求13所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述负压装置包括：
    密封膜，用于粘合于皮肤上并覆盖所述皮肤创口表面以形成密封空间；
    负压通道，连通所述负压源，通过将所述负压源产生的负压以使所述密封膜提供收缩力驱使所述皮肤创口相向收缩。
  15. 根据权利要求14所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述密封膜通过其相对于皮肤表面的粘合层与皮肤的表面粘接，所述粘合层的材料包括涂有丙烯酸粘合剂的聚氨酯的柔性不渗透材料。
  16. 根据权利要求14所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述密封膜开设有为透光材料的观察窗。
  17. 根据权利要求14所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述负压装置包括湿度检测部件，用于将检测的所述密封空间内的湿度信息提供给所述负压源以利所述负压源调控负压输出。
  18. 根据权利要求14所述的无缝线闭合皮肤创口的负压引流及清洗系统，其特征在于，所述第二导管包括皮下引流孔及皮上负压孔，所述皮下引流孔为设置在所述第二导管探入皮肤创口内预设深度的部分的管壁上的多个通孔；所述皮上负压孔连通所述密封空间以向所述密封空间施加负压。
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1887369A (zh) * 2006-07-20 2007-01-03 陈少全 粘贴式多功能负压引流器
WO2007142688A1 (en) * 2006-06-02 2007-12-13 Bengtson Bradley P Assemblies, systems, and methods for vacuum assisted internal drainage during wound healing
US20080294147A1 (en) * 2003-08-28 2008-11-27 Boehringer Technologies, L.P. Device for treating a wound
CN103732266A (zh) * 2011-07-07 2014-04-16 美德乐控股公司 具有降低的反压力的胸部引流设备
CN103961195A (zh) * 2013-01-24 2014-08-06 谢有富 负压伤口治疗用于防治手术缝合伤口瘢痕增生
CN104941015A (zh) * 2015-07-21 2015-09-30 兰州大学 三腔负压伤口冲洗引流管
CN107050628A (zh) * 2017-03-31 2017-08-18 张明亮 一种乳腺炎性疾病冲洗、引流两用管
CN206792720U (zh) * 2017-01-20 2017-12-26 上海拜瑞曼克生物科技有限公司 一种创口护理装置

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3825010A (en) * 1973-04-23 1974-07-23 Donald B Mc Surgical apparatus for closing wounds
US7759538B2 (en) * 1997-05-27 2010-07-20 Wilhelm Fleischmann Process and device for application of active substances to a wound surface
US7520872B2 (en) * 2002-09-13 2009-04-21 Neogen Technologies, Inc. Closed wound drainage system
GB0403969D0 (en) * 2004-02-24 2004-03-31 Huntleigh Technology Plc Tissue treatment device
EP2114508A4 (en) * 2007-02-09 2014-05-07 Twin Star Medical Inc METHOD AND SYSTEM FOR USING HOLLOW FIBER CATHETERS IN TOPICAL APPLICATIONS
AT505614B1 (de) * 2007-11-06 2009-03-15 Walter Milacek Medizinisches gerät in form eines katheters zum zu-, insbesondere jedoch abführen von fluid in, insbesondere aus körperhöhlen, insbesondere dem pleuraraum
RU2011107114A (ru) * 2008-10-03 2012-11-10 КейСиАй Лайсензинг, Инк. (US) Система и способ использования микроэлектромеханических систем (мэмс) для заживления ран
EP2626049B1 (de) * 2012-02-11 2018-07-25 Paul Hartmann AG Wundtherapievorrichtung
DK2879636T3 (da) * 2012-08-01 2017-06-19 Smith & Nephew Sårbandage
RU2015142877A (ru) * 2013-03-14 2017-04-18 СМИТ ЭНД НЕФЬЮ ПиЭлСи Сжимаемые наполнители раны и системы и способы их применения в лечении ран с применением отрицательного давления
CN104815385A (zh) * 2015-04-23 2015-08-05 广州新诚生物科技有限公司 多功能负压引流系统
CN205055157U (zh) * 2015-10-13 2016-03-02 杨超 可抽取式深部创面负压封闭引流装置
EP3661571A1 (en) * 2017-07-27 2020-06-10 KCI Licensing, Inc. Wound therapy system with fluid instillation and removal
US20210008259A1 (en) * 2018-04-04 2021-01-14 Kci Licensing, Inc. Systems and methods for controlling negative pressure therapy with fluid instillation therapy and cleansing
WO2020051273A1 (en) * 2018-09-05 2020-03-12 Kci Licensing, Inc. Systems and methods for scheduling and controlling wound therapy

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080294147A1 (en) * 2003-08-28 2008-11-27 Boehringer Technologies, L.P. Device for treating a wound
WO2007142688A1 (en) * 2006-06-02 2007-12-13 Bengtson Bradley P Assemblies, systems, and methods for vacuum assisted internal drainage during wound healing
CN1887369A (zh) * 2006-07-20 2007-01-03 陈少全 粘贴式多功能负压引流器
CN103732266A (zh) * 2011-07-07 2014-04-16 美德乐控股公司 具有降低的反压力的胸部引流设备
CN103961195A (zh) * 2013-01-24 2014-08-06 谢有富 负压伤口治疗用于防治手术缝合伤口瘢痕增生
CN104941015A (zh) * 2015-07-21 2015-09-30 兰州大学 三腔负压伤口冲洗引流管
CN206792720U (zh) * 2017-01-20 2017-12-26 上海拜瑞曼克生物科技有限公司 一种创口护理装置
CN107050628A (zh) * 2017-03-31 2017-08-18 张明亮 一种乳腺炎性疾病冲洗、引流两用管

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3943130A4 *

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