WO2020186728A1 - 皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备 - Google Patents

皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备 Download PDF

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Publication number
WO2020186728A1
WO2020186728A1 PCT/CN2019/109564 CN2019109564W WO2020186728A1 WO 2020186728 A1 WO2020186728 A1 WO 2020186728A1 CN 2019109564 W CN2019109564 W CN 2019109564W WO 2020186728 A1 WO2020186728 A1 WO 2020186728A1
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WIPO (PCT)
Prior art keywords
skin
wound
negative pressure
closing
fascia
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Application number
PCT/CN2019/109564
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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
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Filing date
Publication date
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 US17/593,209 priority Critical patent/US20220125429A1/en
Priority to EP19920078.3A priority patent/EP3943145A4/en
Publication of WO2020186728A1 publication Critical patent/WO2020186728A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • 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
    • A61M1/91—Suction aspects of the dressing
    • A61M1/916—Suction aspects of the dressing specially adapted for deep wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0645—Surgical staples, i.e. penetrating the tissue being elastically deformed for insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • This application relates to the field of medical devices, and in particular to a surgical auxiliary device for closing skin wounds with seamless lines in the superficial skin fascia.
  • the purpose of this application is to provide a surgical auxiliary device for closing skin wounds without sutures in the superficial fascia of the skin, which is used to solve the problem that the suture of the incision in the prior art may leave traces The problem that the effusion is difficult to drain.
  • the first aspect of the present application provides surgical aids for closing skin wounds without sutures in the superficial fascia of the skin, including: a subcutaneous negative pressure drainage device, including a partial penetration into the subcutaneous wound cavity preset A deep catheter is used to generate negative pressure to force the cavity of the subcutaneous wound to be closed during the healing process; a wound closure device is arranged on the peripheral side of the skin wound and is used to squeeze the skin edge to make the skin The wound is kept closed during the healing process; a negative pressure device on the skin is arranged on the periphery of the skin wound to generate negative pressure to maintain the stable tissue position of the skin wound and its peripheral area.
  • the catheter partially penetrates into the predetermined depth of the lumen of the subcutaneous wound through a predetermined position of the skin wound.
  • the catheter penetrates 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 catheter is also used to drain the effusion in the lumen of the subcutaneous wound through the negative pressure generated.
  • the subcutaneous negative pressure drainage device further includes a negative pressure device for generating and controlling negative pressure, and the negative pressure device is connected to the catheter.
  • the catheter is also used to deliver liquid medicine to a preset depth of the lumen of the subcutaneous wound.
  • the surgical auxiliary device for closing skin wounds without sutures in the superficial fascia of the skin further includes a drug delivery device for delivering liquid medicine to the place through the catheter. Describe the preset depth of the cavity of the subcutaneous wound.
  • the drug delivery device is used to intermittently deliver and deliver liquid medicine through the catheter to a predetermined depth of the lumen of the subcutaneous wound.
  • 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 predetermined depth is the junction of the fat layer and the deep fascia layer in the skin tissue.
  • the conduit includes a first conduit and a second conduit isolated from the first conduit, the first conduit communicates with the negative pressure device, and the second conduit The catheter communicates with the drug delivery device.
  • the first catheter and the second catheter are integrally formed.
  • 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 catheter penetrates into the skin wound at a predetermined depth.
  • the wound closure device includes at least two closure members, which are respectively arranged on both sides of the skin wound, for squeezing the skin edge to make the skin wound Keep closed during the healing process.
  • the wound closure device further includes a microporous covering member covering the closure member and the skin wound to absorb fluid secreted from the skin wound.
  • the microporous covering member is bonded to the closure member in conformity with the external structure of the closure member.
  • the microporous covering member and the closure member are integrally formed.
  • the material of the microporous covering member is foam, mesh, gauze, sponge, or porous biocompatible material.
  • the closure member includes: a flexible body adhered to the skin surface on one side of the skin wound; and a rigid curved needle, the root of which is provided on the flexible body The curved needle part is exposed outside the flexible body, and is used to pierce one side of the skin wound to squeeze the skin edge to keep the skin wound in a closed state during the healing process.
  • the closure member further includes a clamping member for clamping the flexible body adhered to both sides of the skin wound to provide opposing force to squeeze the skin edge to make The skin wound remains closed during the healing process.
  • the flexible body is a resin/silicone material.
  • the closure member includes: a first coupling portion formed on a flexible body; a second coupling portion corresponding to the first coupling portion formed on another On the flexible body; the first joint and the second joint are combined to provide opposing forces applied to the flexible body on both sides of the skin wound to squeeze the skin edge to keep the skin wound during the healing process Closed state.
  • the first coupling portion is a groove structure or a snap structure
  • the second coupling portion is a protrusion structure that can be limited to the groove structure or corresponds to the The hole or hook structure of the buckle.
  • the wound closure device further includes an auxiliary member for adhering to the at least two closure members and the surface of the skin, and for attaching to the at least two closure members Provides contraction force to close skin wounds.
  • the auxiliary member includes adhesive tape.
  • the supradermal negative pressure device includes: a sealing film for adhering to the skin and covering the wound closure device to form a sealed space; a negative pressure channel communicating A negative pressure device, by applying the negative pressure generated by the negative pressure device to the sealing film to provide contraction force to drive the skin wound to contract to assist the wound closure device to close the skin wound.
  • 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 on the skin includes a humidity detection component for providing the detected humidity information in the sealed space to the negative pressure device to facilitate the The negative pressure device regulates the negative pressure output.
  • the supradermal negative pressure device is also used to generate negative pressure to cause the sealing membrane to apply pressure to the skin tissue to assist in forcing the subcutaneous The cavity of the wound was closed during the healing process.
  • the supracutaneous negative pressure device and the subcutaneous negative pressure drainage device share a negative pressure device.
  • the catheter includes a subcutaneous drainage hole and a subcutaneous negative pressure hole, and the subcutaneous drainage hole is provided at a portion where the catheter penetrates into the skin wound at a predetermined depth.
  • the surgical auxiliary device for closing skin wounds in the superficial skin fascia of the present application uses a wound closure device to close the exposed ends of the skin wound.
  • the wound closure device can close the wound at the same time. Play the role of squeezing the skin edge, thereby reducing the bleeding of the subdermal vascular network of the skin;
  • the subcutaneous negative pressure drainage device is forced to keep the cavity of the subcutaneous wound in a closed state during the healing and rehabilitation process and maintain the disconnection
  • the tissues of the wound are kept in a fit state, and the bleeding and exudation in the wound cavity are cleared in time through continuous negative pressure suction; on this basis, the liquid medicine is intermittently delivered to the subcutaneous wound cavity to make the subcutaneous wound cavity
  • the coagulated blood clot is moistened to facilitate removal, and the potential bacterial community that reaches the colonization concentration is diluted, and it is drained and removed with the washing fluid, thereby maintaining a clean state in the wound cavity;
  • the third aspect can be produced by a negative pressure device
  • the surgical auxiliary device of the present application can realize 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 shallow There are no suture knots left in the fascia, 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 a surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia of the present application.
  • Fig. 2 shows a schematic diagram of an embodiment of the subcutaneous negative pressure drainage device of this application.
  • Fig. 3 shows a schematic diagram of the subcutaneous negative pressure drainage device of the surgical auxiliary equipment of this application in another embodiment.
  • Fig. 4 is a schematic diagram of the catheter in Fig. 3 passing through the skin and subcutaneous tissue from a preset position away from the skin wound to partially penetrate into the elongated wound.
  • Fig. 5 shows a schematic structural view of the closure member of the wound closure device in this application in an embodiment.
  • Fig. 6 is a schematic diagram showing the combination of the closure member and the wound of the wound closure device in this application in another embodiment.
  • Fig. 7 shows a schematic diagram of the closure member of the wound closure device in this application in another embodiment.
  • Fig. 8 is a schematic diagram showing the application of the auxiliary element in an embodiment of the closure element of the wound closure device of the present application.
  • FIG. 9 shows a schematic diagram of an embodiment of the catheter structure of this application.
  • FIG. 10 shows a schematic diagram of another embodiment of the catheter structure of this application.
  • Fig. 11 shows a schematic view of the structure of the closure member of the wound closure device in this application in another embodiment.
  • FIG. 12 shows a schematic diagram of the sealing and force-receiving structure of an embodiment of the negative pressure device on the skin in this application.
  • Fig. 13 shows a schematic diagram of another embodiment of the surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia of the present application.
  • Fig. 14 shows a schematic diagram of a surgical auxiliary device for closing skin wounds without sutures in the superficial fascia of the skin in another embodiment of the present 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 the subcutaneous tissue, and finally 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 oozing, exudate, etc.) in time is not conducive to wound recovery.
  • the present application provides a surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia, in order to replace the traditional stitching method for the superficial skin fascia and realize the purpose of closing the skin wound.
  • the surgical auxiliary equipment for closing skin wounds without sutures in the superficial skin fascia of the present application includes: a subcutaneous negative pressure drainage device, a wound closure device, and a supracutaneous negative pressure device for closing through the wound
  • the device squeezes the edge of the skin and is forced by the subcutaneous negative pressure drainage device to keep the subcutaneous wound cavity closed during the healing and rehabilitation process.
  • the subcutaneous negative pressure drainage device can also deliver liquid while draining the effusion in the subcutaneous wound cavity.
  • the medicine is applied to the cavity of the subcutaneous wound to ensure that the environment of the cavity of the subcutaneous wound is maintained in a state conducive to wound recovery.
  • the supradermal negative pressure device can generate force through the action of negative pressure to keep the tissue position of the skin wound and its peripheral area in a stable state, thereby achieving the purpose of closing the skin wound without suture in the superficial fascia of the skin.
  • the surgical auxiliary device for closing skin wounds without sutures in the superficial fascia of the skin of the present application uses a wound closing device to close the exposed ends of the skin wound, which can squeeze while closing the wound.
  • the role of the skin edge which can reduce the bleeding of the subdermal vascular network of the skin;
  • the subcutaneous negative pressure drainage device is forced to keep the subcutaneous wound cavity closed during the healing and rehabilitation process, and the broken tissue can be kept attached.
  • the surgical auxiliary device of the present application can realize seamless 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 leaving no sutures in the superficial fascia Therefore, the important factors that cause bacterial colonization and the main cause of recurrence of incision infection are eliminated.
  • 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 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 the surgical aid device of the present application. As shown in the figure, the skin is closed by sutureless lines in the superficial fascia of the present application.
  • Surgical auxiliary equipment for wounds includes: subcutaneous negative pressure drainage device 1, wound closure device 2, supracutaneous negative pressure device 3.
  • FIG. 2 shows a schematic diagram of an embodiment of the subcutaneous negative pressure drainage device of the surgical auxiliary equipment of this application.
  • the subcutaneous negative pressure drainage device 1 includes A catheter 10 partially penetrated into the subcutaneous wound lumen 4 at a preset depth, and the catheter 10 is used to generate negative pressure to force the subcutaneous wound lumen 4 to be closed during the healing process, and to maintain the dissected tissue in a fit state, and Through continuous negative pressure suction, the bleeding and exudate in the wound cavity are kept cleared in time.
  • the catheter 10 of the subcutaneous negative pressure drainage device 1 is inserted into the subcutaneous wound lumen 4, and the The negative pressure forces the tissues on both sides of the subcutaneous wound cavity 4 to face each other (as shown by the arrows on both sides of the subcutaneous wound 4 in Figure 2) to eliminate the subcutaneous wound cavity 4, the subcutaneous wound cavity 4 Closure facilitates wound healing. It should be understood that during this process, the part of the catheter 10 in the subcutaneous wound lumen 4 does not affect the growth of tissues on both sides of the subcutaneous wound lumen 4.
  • the catheter 10 partially penetrates into the predetermined depth of the subcutaneous wound cavity 4 through a predetermined position of the skin wound. Therefore, negative pressure can be generated to ensure that the subcutaneous wound cavity 4 is closed during the healing process, and at the same time, it can drain the fluid accumulation in the subcutaneous wound cavity 4, thereby maintaining the dissected tissues in a fit state, and Continuous negative pressure suction keeps the bleeding and exudate in the wound cavity cleared in time, so that the effusion such as blood and/or exudate in the subcutaneous wound cavity 4 can be removed in time, 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.
  • FIG. 3 shows a schematic diagram of the subcutaneous negative pressure drainage device of the surgical auxiliary device of the present application in another embodiment.
  • the catheter 10 passes away from A preset position of the skin wound (the position shown at A in FIG. 3) penetrates the skin and subcutaneous tissue to partially penetrate to the preset depth of the cavity 4 of the subcutaneous wound, thereby generating negative pressure to ensure the subcutaneous
  • the wound cavity 4 is in a closed state during the healing process while sucking the effusion of the subcutaneous wound cavity 4, so that the effusion of the subcutaneous wound cavity 4 can be cleared in time, eliminating the living space or environment of bacteria.
  • the term “far away” refers to a preset position away from the skin wound (the position shown at A in Fig. 3).
  • the catheter 10 does not penetrate into the subcutaneous wound cavity 4 through the skin wound, but penetrates the skin and subcutaneous tissue from another position, that is, a preset position away from the skin wound, to partially penetrate into the subcutaneous tissue.
  • the wound cavity 4, this embodiment is particularly suitable for the elongated wound as shown in FIG. 4.
  • the surgical auxiliary equipment squeezes the skin edge through the wound closure device 2 to make the exposed ends of the skin wound 4 closely adhere, and is forced and assisted by the subcutaneous negative pressure drainage device 1 to make The subcutaneous wound cavity 4 remains closed during the healing and rehabilitation process. While sucking the effusion in the subcutaneous wound cavity 4, it can also deliver liquid medicine to the subcutaneous wound cavity 4, thereby determining the potential of the subcutaneous wound cavity 4
  • the infection foci with the reproductive concentration are diluted and cleaned; at the same time, the negative pressure generated by the supradermal negative pressure device 3 can maintain the tissue position of the skin wound and its peripheral area to remain stable, thereby facilitating wound recovery.
  • the subcutaneous wound cavity 4 refers to the cavity formed by the internal incision under the wound during the operation, and the cavity includes the gap formed by the continuity of all skin or other tissue parts, due to the human or animal body
  • the biological tissue has elastic or stretch properties.
  • the cavity 4 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.
  • a plurality of through holes are provided on the tube wall of the part where the catheter 10 penetrates into the skin wound at a predetermined depth, so as to help form the suction of gas and liquid from the cavity 4 of the subcutaneous wound.
  • the plurality of through holes are evenly distributed at intervals on the tube wall of the part where the catheter 10 penetrates into the skin wound at a predetermined depth, especially for narrow and long wounds.
  • the subcutaneous wound lumen of a narrow wound is usually also a long cavity or gap, in order to ensure that the effusion or residual liquid secreted at each of the long cavity or gap is sucked by the catheter 10; in another example In a sexual embodiment, it is suitable for different types of skin wounds or operations for different purposes.
  • the multiple through holes on the catheter 10 can also be designed to have unequal intervals (that is, the multiple through holes are unevenly spaced. The catheter 10 penetrates into the wall of the skin wound at a predetermined depth).
  • the shape and structure of the catheter 10 that penetrates into the skin wound at a predetermined depth can also be designed according to actual needs, for example, depending on the desired penetration depth or tissue structure of the skin wound.
  • the thickness or flexibility of the catheter 10 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, or the flexibility of the same catheter at different parts is different.
  • the predetermined depth at which the catheter 10 partially penetrates into the cavity 4 of the subcutaneous wound refers to the depth from the superficial skin fascia layer to 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 subcutaneous negative pressure drainage device 1 further includes a negative pressure device, the negative pressure device is used to generate and control negative pressure, the negative pressure device is connected with the catheter 10, thereby The negative pressure in the catheter 10 can be adjusted by the negative pressure device to avoid damage to the wound caused by excessive negative pressure or insufficient negative pressure to drain the effusion.
  • the catheter 10 connected with the negative pressure device is provided with a one-way valve to prevent the gas or fluid inhaled into the catheter 10 from flowing back into the cavity 4 of the subcutaneous wound, which is not conducive to skin wounds. heal.
  • the one-way valve is, for example, a rubber part such as a duckbill valve or a cone valve, but it is not limited to this, and a valve assembly using mechanical or electrical control is also applicable to this application.
  • the negative pressure supply of the negative pressure device 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,
  • vacuum pumps, suction pumps, wall suction ports that can be used in many healthcare facilities, or micro pumps, syringes, or static negative pressure devices, 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 can 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).
  • 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 surgical auxiliary device for closing skin wounds with sutureless lines in the superficial skin fascia of the present application further includes a drug delivery device (not shown).
  • the device is used to deliver liquid medicine to the preset depth of the subcutaneous wound cavity 4 to facilitate the healing of the subcutaneous wound cavity 4.
  • the drug delivery device includes, for example, a micro pump or a syringe. The drug delivery equipment or drug delivery machine.
  • the drug delivery device can be controlled to deliver liquid medicine to the subcutaneous wound cavity intermittently, so that the clotted blood clots in the subcutaneous wound cavity 4 can be moistened to facilitate removal, and the potential The bacterial community that has reached the colonization concentration is diluted and drained and removed with the washing fluid, thereby maintaining the clean state of the cavity 4 of the subcutaneous wound.
  • the intermittentity is, for example, the delivery frequency in hours, or the delivery of drugs in days.
  • the drug delivery device can deliver liquid drugs to the subcutaneous wound lumen 4 through its connected catheter for diluting the bacterial infection that may or has occurred in the subcutaneous wound lumen 4, thereby making The infection foci with the potential to reach colonization concentration are diluted; at the same time, the liquid medicine delivered by the drug delivery device can also achieve the purpose of washing the infected part in the subcutaneous wound cavity 4, and then pass the subcutaneous wound after washing is completed.
  • the drainage effect of the catheter of the negative pressure drainage device 1 sucks away the liquid medicine in the cavity 4 of the subcutaneous wound, thereby draining and removing bacteria, and the cavity 4 of the subcutaneous wound is in a clean state.
  • the dosage of the drug delivery device can be controlled, the time for diluting the bacterial infection part, the washing frequency of liquid medicine, and the control The working frequency of the subcutaneous negative pressure drainage device 1 and so on.
  • the time for the drug delivery device to rinse the lumen 4 of the subcutaneous wound with liquid medicine is, for example, 2-3 days, and the drug delivery device can use an integrated machine (Such as drug delivery machines and other equipment) to control.
  • the liquid medicine includes but is not limited to hydrogen peroxide, physiological saline and the like.
  • the catheter may be a catheter integrated with two catheters, or two independent catheters.
  • the catheter 10 includes a first catheter 101 and a first catheter 101.
  • An isolated second conduit 102, the first conduit 101 is connected to the negative pressure device, and is used to suck the effusion in the subcutaneous wound cavity 4; the second conduit 102 is connected to the drug delivery device and is used to deliver liquid medicine to the place The preset depth of the cavity 4 of the subcutaneous wound is described.
  • FIG. 9 shows a schematic diagram of an embodiment of the catheter structure of this application.
  • the first catheter 101 and the second catheter 102 are integrally formed, thereby
  • the integral molding is to include two isolated and disconnected pipes in one pipe, wherein the first pipe forms the first pipe 101, and the second pipe forms the second pipe.
  • the catheter 102 wherein the first catheter 101 is provided with a plurality of through holes 1010, the first catheter 101 is used for connecting a negative pressure device, and the second catheter 102 is used for connecting a drug delivery device.
  • FIG. 10 shows a schematic diagram of another embodiment of the catheter structure of this application.
  • the first catheter 101 and the second catheter 102 are integrally formed, thereby The number of buried pipes can be reduced.
  • the first pipe 101 and the second pipe 102 are integrally formed as two pipes that are not connected to each other, and the second pipe 102 is sleeved in the first pipe 101, Since the thinner tube 102 is sheathed in the thicker tube 101, this does not increase the number of tubes, but also does not increase the diameter of the overall tube.
  • the thicker tube 101 is provided with multiple through holes 1010.
  • the thicker catheter 101 is used to connect a negative pressure device, and the thinner catheter 102 is connected to a drug delivery device.
  • the first catheter 101 is connected to a negative pressure device to generate negative pressure
  • the first catheter 101 provided in the second catheter 102 is connected to the drug delivery device
  • the second catheter 102 is provided with multiple There are two through holes 1010 to help suck gas and liquid in the cavity 4 of the subcutaneous wound.
  • the wound closure device 2 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 2 is arranged on the peripheral side of the skin wound. In some embodiments, the wound closure device 2 is arranged on the peripheral side of the skin wound by means of adhesion. In some embodiments, the wound closure device 2 includes at least two closure elements, and the at least two closure elements are respectively arranged on both sides of the skin wound. During the implementation process, the two closure elements Combination to keep the skin wound closed during the healing process. In practical applications, the number of closures can be determined by the length of the wound and the specific form of the closures.
  • FIG. 5 shows a schematic structural diagram of the closure member 21 in the wound closure device 2 in an embodiment of the present application.
  • the wound closure device 2 further includes a covering member 21
  • the secretion liquid on the closure member 21 or the medical liquid remaining on the closure member 21 are integrally formed.
  • the microporous covering member 20 is combined with the closure member 21 by a process such as bonding, so that the microporous covering member 20 is bonded to the closure member 21 in conformity with the shape and structure of the closure member 21 .
  • the closure member 21 includes a flexible body, and the flexible body means that the elastic/flexible flexible body material can have an ultimate elongation greater than 100% and a significant amount of rebound.
  • the resilience of a material refers to the ability of a material to recover from elastic deformation.
  • elastic/flexible flexible body materials may include, but are not limited to, natural rubber, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, and ethylene propylene rubber. , Ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, copolyester and silicone, etc.
  • the closing member 21 may also be a silicone material, a resin material, or a silicone resin material.
  • the material of the microporous covering 20 is medical cotton, degreasing cotton, foam, mesh, gauze, sponge, or porous biocompatible material.
  • the member 20 has the properties of air permeability and moisture absorption, and is used for absorbing the effusion 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 21 includes a flexible body 210 and a rigid curved needle 211.
  • the flexible body 210 is adhered to the skin surface at the periphery of the skin wound; in this embodiment, the flexible body 210 is made of silicone material, resin material, or silicone resin material.
  • the flexible body 210 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 210 are respectively adhered to the skin surface on opposite sides of the skin wound periphery.
  • the rigid curved needle 211 includes a root and a curved needle.
  • the root of the rigid curved needle 211 is buried in the flexible body 210 and is firmly arranged on the flexible body 210.
  • the curved needle part is exposed outside the flexible body 210.
  • the root of the rigid curved needle 211 is firmly set in the flexible body 210 through a deformed structural design, such as a hook-shaped structure or a T-shaped structure. Wait.
  • FIG. 6 shows a schematic diagram of an embodiment of the closure member and wound in an embodiment of the present application.
  • the rigid curved needle 211 The curved needle part exposed outside the flexible body 210 pierces one side of the skin wound to squeeze the skin edge to keep the skin wound closed during the healing process.
  • the doctor It is necessary to perform the operation of wound to the skin (align the skin edge of the skin, and prevent the skin edge from turning inward to avoid poor skin healing), and then puncture the curved needle part of the rigid curved needle 211 from one side of the skin wound
  • the rigid curved needles 211 of the closure member 21 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 conducive to wound recovery, thereby making the skin wound in a closed state.
  • the curved needle part of the rigid curved needle 211 exposed outside the flexible body 210 pierces the other side of the skin wound, and the curved needle part is used 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 211 exposed outside the flexible body 210 partially penetrates into the flexible body 210 provided on the other side of the skin wound, so that it is located
  • the flexible bodies 210 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 skin 50 includes a vascular network 51, a superficial fascia layer 52, fat 53, a deep fascia layer 54, muscle 55 and bone 56 in order.
  • the stitch depth in this embodiment is in the superficial fascia layer 52.
  • 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 211 is exposed outside the curved needle of the flexible body 210
  • 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 211 provided on the flexible body 210 may present different implementation states according to the length or width of the applicable skin wound. In some embodiments, when the When there are multiple rigid curved pins 211 provided on the flexible body 210, the rigid curved pins 211 are arranged on the elongated flexible body 210 in an equidistant distribution.
  • FIG. 7 shows a schematic diagram of the closure member of the wound closure device in this application in another embodiment.
  • the closure member further includes a clamping member 22.
  • the member 22 is used to clamp the flexible body of the closure member 21 adhered to both sides of the skin wound.
  • the flexible body provides opposing force under the action of the clamping member to squeeze the skin edge to ensure that the skin wound is healing.
  • the middle is closed.
  • the clamping member 22 is a component such as a medical clip.
  • FIG. 8 shows a schematic diagram of the application of the auxiliary element in an embodiment of the closure element of the wound closure device of the present application.
  • FIG. 11 shows a schematic structural diagram of the closure member in the wound closure device of this application in another embodiment.
  • the The closure 21 includes a first flexible body 2100 and a second flexible body 2101.
  • the first flexible body 2100 is bonded to the skin surface at the periphery of the skin wound, the first flexible body 2100 has a first bonding portion; the second flexible body 2101 is bonded to the skin surface at the periphery of the skin wound , The second flexible body 2101 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 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 2101 are made of silicone material, resin material, or silicone resin material.
  • the first and second flexible bodies 2101 are adhered to the skin surface on opposite sides of the skin wound by an adhesive.
  • the adhesive is, for example, a medical adhesive, such as 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 2100 and the second flexible body 2101 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 2 further includes an auxiliary member 212, the auxiliary member 212 is used to assist the adhesion between the closure member 21 and the skin surface, and to provide the closure member 21 The contractile force for closing the skin wound.
  • the auxiliary member 212 is adhered to the peripheral side of the skin wound and faces the The closing element 21 exerts a force in a second direction perpendicular to the first direction, and this force is called contraction force in this embodiment, thereby assisting the closing element 21 to close the skin wound.
  • the auxiliary member 212 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 212 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 supradermal negative pressure device 3 includes a sealing membrane and a negative pressure channel.
  • FIG. 12 shows a schematic diagram of the sealing and stress structure of an embodiment of the supradermal negative pressure device in this application.
  • the sealing film 30 is adhered to the skin and covers the wound closure device 2 Therefore, a sealed space 32 is formed.
  • the sealed space inside the sealing film forms an inward force. The force is applied in the direction of the arrow as shown in Figure 12, which can maintain the local tissue position while maintaining a fixed position. Apply pressure to deep tissues, thereby closing the potential dead space.
  • the sealing film 30 bypasses the skin wound and the wound closure device 2 arranged on the skin wound forms a sealed area, and makes the sealed area form a sealed space 32.
  • the sealing film 30 is adhered to the surface of the skin through its adhesive layer relative to the surface of the skin.
  • the material of the adhesive layer is, for example, a flexible impermeable material including polyurethane coated with an acrylic adhesive.
  • the sealing film 30 may be made of a transparent material.
  • the sealing film 30 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.
  • the sealing film 30 is provided with an observation window made of light-transmitting material to facilitate the clinician to observe the healing of the skin wound and take corresponding medical measures.
  • the operator embeds the catheter 10 of the subcutaneous negative pressure diversion device into the subcutaneous tissue of the skin, and makes the catheter 10 extend into the cavity 4 of the subcutaneous wound.
  • the subcutaneous negative pressure diversion device can drain the effusion secreted by the subcutaneous wound lumen 4 through the catheter 10, 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, and the liquid can also be delivered through the catheter
  • the squeezing effect on the skin edge can reduce the bleeding of the subdermal vascular network of the skin, and the negative pressure of the subcutaneous negative pressure diversion device can assist in closing the cavity 4 of the subcutaneous wound.
  • the operator continues to cover the microporous cover 20 on the wound surface to ensure that the secretions on the wound surface can be absorbed in time during the healing process.
  • the negative pressure generated by the negative pressure device on the skin can also exert a certain degree of pressure on the deep tissues to close the potential dead space, thus speeding up the skin.
  • the healing speed of the wound is not to use needles to suture the superficial fascia of the skin, and do not use medical tools such as suture needles and sutures.
  • the negative pressure passage 31 communicates with a negative pressure device through a pipe, and the negative pressure passage 31 is connected to the sealed space, thereby providing a negative pressure source to form a sealed space.
  • the negative pressure generated by the negative pressure device compresses the sealed space, so that the local tissue can be maintained to close toward the wound position.
  • the negative pressure generated by the negative pressure device also exerts force on the deep tissue under the wound to close the potential dead space and assist the wound closure device 2 to close the skin wound and promote wound healing.
  • the pressure range of the sealed space formed by the sealing film 30 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 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 skin wound secretion In the case of effusion, for example, when the secretion effusion is increased, the negative pressure value can be appropriately increased to increase the strength of sucking the effusion.
  • a one-way valve is provided on the conduit connecting the negative pressure channel 31 and a negative pressure device to prevent the gas or fluid inhaled into the conduit from flowing back into the sealed space, which is not conducive to skin wounds.
  • the one-way valve is, for example, a rubber piece such as a duckbill valve or a cone valve, but it is not limited to this.
  • the valve assembly using mechanical or electrical control is also applicable to this embodiment.
  • the negative pressure supply of the negative pressure device 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,
  • vacuum pumps, suction pumps, wall suction ports that can be used in many healthcare facilities, or micro pumps, syringes, or static negative pressure devices, 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 can 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.
  • FIG. 13 shows a schematic diagram of another embodiment of a surgical auxiliary device for closing skin wounds in the superficial fascia of the skin of this application, as shown in FIG. 13, so
  • the supradermal negative pressure device can share a negative pressure source 6 with the subcutaneous negative pressure drainage device, which is connected to the same negative pressure source through two different catheters, namely the catheter connected to the enclosed space 32 on the skin and the communication station.
  • the catheter in the lumen of the subcutaneous wound is two different catheters.
  • FIG. 14 shows a schematic diagram of a surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia of the present application.
  • the upper skin The pressure device can share a negative pressure source 6 with the subcutaneous negative pressure drainage device, and the subcutaneous wound cavity 4 and the enclosed space 32 on the skin are respectively connected through a catheter, wherein the catheter 10 includes a subcutaneous drainage hole 1010 and a subcutaneous drainage hole 1010.
  • the negative pressure hole 60, the subcutaneous drainage hole is a plurality of through holes 1010 arranged on the tube wall of the part where the catheter penetrates into the skin wound at a predetermined depth; the negative pressure hole on the skin communicates with the sealed space to A negative pressure is applied to the sealed space.
  • the negative pressure device 3 on the skin further includes a humidity detection component (not shown), the sensor of the humidity detection component is arranged in the sealed space formed by the sealing film 30, and the humidity is detected
  • the information output port of the component is connected to the negative pressure device, thereby providing the detected humidity information to the negative pressure device to control the negative pressure device to regulate the output negative pressure.
  • the humidity detection component is, for example, a humidity sensor.
  • the surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia of the present application in the first aspect uses a wound closure device to close the exposed two ends of the skin wound, and the wound closure device closes the wound at the same time It can squeeze the skin edge, thereby reducing the bleeding of the subdermal vascular network of the skin;
  • the subcutaneous negative pressure drainage device is forced to keep the subcutaneous wound cavity in a closed state during the healing and rehabilitation process, and maintain the separation
  • the broken tissues are kept in a fit state, and the bleeding and exudate in the wound cavity are cleared in time through continuous negative pressure suction; on this basis, liquid medicine is intermittently delivered to the subcutaneous wound cavity to make the subcutaneous wound cavity
  • the coagulated blood clot is moistened to facilitate removal, and the potential bacterial community that reaches the colonization concentration is diluted, and it is drained and removed with the washing fluid, thereby maintaining a clean state in the wound cavity;
  • the third aspect can be achieved by a negative pressure device on the skin.
  • Negative pressure is generated to maintain the stable tissue position of the skin wound and its peripheral area, thereby facilitating tissue healing.
  • the surgical auxiliary device of the present application can realize 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 shallow There are no suture knots left in the fascia, which eliminates the important factors that cause bacterial colonization and the main cause of recurrence of incision infection.
  • the surgical auxiliary device for closing skin wounds without sutures in the superficial skin fascia of the present application can keep the subcutaneous wound cavity 4 in a closed state during the healing and rehabilitation process without using sutures. It speeds up the healing speed of skin wounds. It 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, the wound or foreign bodies in the wound are not removed.
  • the process of treatment such as 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 such as on the surface of the skin.
  • the suture marks of the "centipede 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 seamless
  • the surgical auxiliary equipment for closing skin wounds with thread is especially suitable for the field of aesthetic medicine.

Abstract

一种皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，包括：皮下负压引流装置（1），包括部分探入皮下创口内腔（4）预设深度的导管（10），用于产生负压以使皮下创口内腔（4）在愈合过程中闭合；创口闭合装置（2），设在皮肤创口周侧，用于挤压皮缘以使皮肤创口在愈合过程中保持闭合状态；皮上负压装置（3），设置在皮肤创口的周缘，用于产生负压以维持皮肤创口及其周缘区域的组织位置稳定。该外科辅助设备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，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

皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备 技术领域
本申请涉及医疗器械领域，尤其涉及一种皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备。
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皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，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的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备包括：皮下负压引流装置，包括部分探入皮下创口内腔预设深度的导 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；创口闭合装置，设置在所述皮肤创口的周侧，用于挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态；皮上负压装置，设置在所述皮肤创口的周缘，用于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。
在本申请的第一方面的某些实施方式中，所述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。
在本申请的第一方面的某些实施方式中，所述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，所述导管还用于通过产生的负压以引流所述皮下创口内腔的积液。
在本申请的第一方面的某些实施方式中，所述皮下负压引流装置还包括一用以产生并控制负压压力的负压装置，所述负压装置连通所述导管。
在本申请的第一方面的某些实施方式中，所述导管还用于输送液态药物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，所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备还包括一给药装置，用于通过所述导管输送液态药物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，所述给药装置，用于通过所述导管间歇性输送输送液态药物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，所述预设深度为皮肤组织中脂肪层与深筋膜层的结合处。
在本申请的第一方面的某些实施方式中，所述导管包括第一导管及与所述第一导管隔离的第二导管，所述第一导管连通所述负压装置，所述第二导管连通所述给药装置。
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。
在本申请的第一方面的某些实施方式中，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，所述创口闭合装置包括至少两个闭合件，分别设置在所述皮肤创口的两侧边缘，用于挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状 态。
在本申请的第一方面的某些实施方式中，所述创口闭合装置还包括覆盖所述闭合件及所述皮肤创口的微孔覆件以吸附自所述皮肤创口分泌的积液。
在本申请的第一方面的某些实施方式中，所述微孔覆件顺应所述闭合件的外形结构结合于所述闭合件上。
在本申请的第一方面的某些实施方式中，所述微孔覆件与所述闭合件为一体成型构造。
在本申请的第一方面的某些实施方式中，所述微孔覆件的材料为泡沫、网状物、纱布、海绵、或者多孔生物相容材料。
在本申请的第一方面的某些实施方式中，所述闭合件包括：柔性本体，粘合于所述皮肤创口一侧的皮肤表面上；刚性曲针，其根部设置在所述柔性本体上，其曲形针部外露于所述柔性本体外，用于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。
在本申请的第一方面的某些实施方式中，所述闭合件还包括夹持件，用于夹持粘合于所述皮肤创口两侧的柔性本体以提供相向力挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态。
在本申请的第一方面的某些实施方式中，所述柔性本体为树脂/硅胶材料。
在本申请的第一方面的某些实施方式中，所述闭合件包括：第一结合部，形成在一柔性本体上；对应结合所述第一结合部的第二结合部，形成在另一柔性本体上；藉由所述第一结合部与第二结合部的结合以提供施加于所述皮肤创口两侧的柔性本体的相向力以挤压皮缘使所述皮肤创口在愈合过程中保持闭合状态。
在本申请的第一方面的某些实施方式中，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。
在本申请的第一方面的某些实施方式中，所述创口闭合装置还包括辅助件，用于粘合于所述至少两个闭合件及皮肤表面，用于向所述至少两个闭合件提供使皮肤创口闭合的收缩力。
在本申请的第一方面的某些实施方式中，所述辅助件包括胶布。
在本申请的第一方面的某些实施方式中，所述皮上负压装置包括：密封膜，用于粘合于皮肤上并覆盖所述创口闭合装置以形成密封空间；负压通道，连通一负压装置，通过将所述负压装置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收缩以辅助所述创口闭合装置闭合所述皮肤创口。
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，所述皮上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装置以利所述负压装置调控负压输出。
在本申请的第一方面的某些实施方式中，所述皮上负压装置还用于藉由产生的负压以使所述密封膜向所述皮肤组织施加压力以辅助以迫使所述皮下创口内腔在愈合过程中呈闭合状态。
在本申请的第一方面的某些实施方式中，所述皮上负压装置及皮下负压引流装置共用负压装置。
在本申请的第一方面的某些实施方式中，所述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。
如上所述，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第一方面通过创口闭合装置使皮肤创口暴露的两端紧贴，所述创口闭合装置在闭合创口的同时可起到挤压皮缘的作用，由此可减少皮肤真皮下血管网的出血；第二方面在皮下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；在此基础上，通过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；第三方面通过皮上负压装置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，通过本申请的外科辅助设备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。
附图说明
图1显示为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在一实施例中的示意图。
图2显示为本申请的皮下负压引流装置在一实施例中的示意图。
图3显示为本申请的外科辅助设备的皮下负压引流装置在另一实施例中的示意图。
图4显示为图3中导管从远离皮肤创口一预设位置穿过皮肤及皮下组织以部分探入至狭长型创口的示意图。
图5显示为本申请中创口闭合装置的闭合件在一实施例中的结构示意图。
图6显示为本申请中创口闭合装置的闭合件与创口结合在另一实施例中示意图。
图7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8显示为在本申请创口闭合装置的闭合件在一实施例中辅助件的应用示意图。
图9显示为本申请的导管结构的一实施例示意图。
图10显示为本申请的导管结构的另一实施例示意图。
图11显示为本申请中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12显示为本申请中皮上负压装置在一实施例中的密封及受力结构示意图。
图13显示为本申请皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备在另一实施例中的示意图。
图14其显示为本申请皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备在再一实施例中的示意图。
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，本申请提供一种皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，以期替代传统的针对皮肤浅筋膜的针线缝合方式并可实现闭合皮肤创口的目的。在以下提供的实施例中，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包括：皮下负压引流装置、创口闭合装置、以及皮上负压装置，用以通过创口闭合装置挤压皮缘，并在皮下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状态，皮下负压引流装置在引流皮下创口内腔的积液的同时还可输送液态药物至皮下创口内腔，确保皮下创口内腔的环境保持在利于创口恢复的状态。同时，皮上负压装置可通过负压作用产生作用力，使皮肤创口及其周缘区域的组织位置保持稳定状态，进而实现皮肤浅筋膜内无缝线闭合皮肤创口的目的。
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第一方面通过创口闭合装置 使皮肤创口暴露的两端紧贴，所述创口闭合装置在闭合创口的同时可起到挤压皮缘的作用，由此可减少皮肤真皮下血管网的出血；第二方面在皮下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；在此基础上，通过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；第三方面通过皮上负压装置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，通过本申请的外科辅助设备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，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。
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显示为本申请的外科辅助设备在一实施例中的示意图，如图所示，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包括：皮下负压引流装置1、创口闭合装置2、皮上负压装置3。
在一个示例性的实施例中，请参阅图2，显示为本申请的外科辅助设备的皮下负压引流装置在一实施例中的示意图，如图所示，所述皮下负压引流装置1包括部分探入皮下创口内 腔4预设深度的导管10，所述导管10用于产生负压以迫使皮下创口内腔4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，通过所述皮下负压引流装置1的导管10探入到皮下创口内腔4中，通过产生负压迫使皮下创口内腔4两侧的组织趋向相向(诚如图2中箭头皮下创口4两侧箭头所示的方向)贴合以消除所述皮下创口内腔4，皮下创口内腔4的闭合利于创口的愈合。应当理解的，在这一过程中，所述导管10在皮下创口内腔4中的部分不影响所述皮下创口内腔4两侧的组织的生长。
在另一个示例性的实施例中，请继续参阅图2，如图所示，所述导管10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4的预设深度，由此可产生负压，保证皮下创口内腔4在愈合过程中呈闭合状态，并同时对皮下创口内腔4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4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，请参阅图3，其显示为本申请的外科辅助设备的皮下负压引流装置在另一实施例中的示意图，如图所示，所述导管10经由远离所述皮肤创口的一预设位置(如图3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4的预设深度，由此可产生负压保证皮下创口内腔4在愈合过程中呈闭合状态的同时吸取皮下创口内腔4的积液，使得由于能够及时清除皮下创口内腔4的积液，消除了细菌的生存空间或环境。在本实施例中，所述的远离是指在离所述皮肤创口一预设的位置(如图3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，所述导管10非通过所述皮肤创口探入到皮下创口内腔4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4，本实施例特别适用于如图4所示的狭长型创口。
在图1所示的实施例中，所述外科辅助设备通过创口闭合装置2挤压皮缘以使皮肤创口4暴露的两端紧贴，并在皮下负压引流装置1迫使及辅助下，使皮下创口内腔4在愈合康复过程中保持闭合状态，在吸取皮下创口内腔4的积液的同时还可输送液态药物至皮下创口内腔4，进而对皮下创口内腔4中潜在的达到定殖浓度的感染灶得到稀释及清洗；同时，皮上负压装置3可通过产生的负压来维持皮肤创口及其周缘区域的组织位置保持稳定，进而利于伤口恢复。
应当理解，所述皮下创口内腔4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4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。
在某些实施例中，所述导管10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，以助于形成吸取所述皮下创口内腔4的气体及液体，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导管10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导管10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，所述导管10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导管10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导管10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，导管10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。
在某些实施例中，所述导管10部分探入皮下创口内腔4的预设深度是指：皮肤组织中所述皮肤浅筋膜层至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，所述皮下负压引流装置1还包括负压装置，所述负压装置用于产生并控制负压压力，所述负压装置与导管10相连通，由此可通过负压装置调整导管10内的负压大小，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。
在本实施例中，所述负压装置连通的导管10上设置有单向阀，以避免吸入到导管10中 的气体或者积液回流到所述皮下创口内腔4中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申请。
在本实施例中，所述负压装置的负压供给，诸如负压源，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。
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。
为此，在本申请中一个示例性的实施例中，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还包括一给药装置(未予以图示)，所述给药装置用于输送液态药物至所述皮下创口内腔4的预设深度以利于所述皮下创口内腔4的愈合，在具体的实施状态下，所述给药装置例如包括微型泵或注射器等装置的给药设备或称给药机。在本实施例的一种方式中， 可以通过控制给药装置通过间歇性的输送液态药物至皮下创口内腔，使皮下创口内腔4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，从而维持皮下创口内腔4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。
在愈合过程中，所述给药装置可以通过其连通的导管输送液体药物至所述皮下创口内腔4，用于稀释所述皮下创口内腔4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，所述给药装置输送的液体药物还可以达到冲洗所述皮下创口内腔4中感染部位的目的，待冲洗完成后，再通过所述皮下负压引流装置1的导管的引流作用，将所述皮下创口内腔4内的液体药物吸走，进而将细菌引流清除，皮下创口内腔4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的感染情况，控制所述给药装置的给药量，控制稀释细菌感染部分的时间，控制液体药物的冲洗频率，以及控制所述皮下负压引流装置1的工作频率等等。比如，在一个示例性的实施例中，所述给药装置对所述皮下创口内腔4中进行液体药物冲洗的时间例如为2-3天，所述给药装置可藉由一体化的机器(比如给药机等设备)进行控制。
在实施例中，所述液体药物包括但不限于为双氧水、生理盐水等。
所述导管可以是有两根导管集成为一体的导管，也可以为两根相互独立的导管，比如在一个示例性的实施例中，所述导管10包括第一导管101及与第一导管101隔离的第二导管102，所述第一导管101连通所述负压装置，用于吸取皮下创口内腔4的积液；所述第二导管102连通给药装置，用于输送液态药物至所述皮下创口内腔4的预设深度。
在一个示例性的实施例中，请参阅图9，其显示为本申请的导管结构的一实施例示意图，如图所示，所述第一导管101及第二导管102一体成型，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101，第二个管道形成所述第二导管102，其中第一导管101上开设有多个通孔1010，第一导管101用于连接负压装置，第二导管102用于连接给药装置。
在一个示例性的实施例中，请参阅图10，其显示为本申请的导管结构的另一实施例示意图，如图所示，所述第一导管101及第二导管102一体成型，由此可减少埋管数量，所述的一体成型为所述第一导管101与第二导管102为两根相互不连通的管道，其中所述第二导管102套设于所述第一导管101内，由于较细的导管102套设在较粗的导管101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，所述较粗的导管101上开设有多个通孔1010，所述较粗的导管101用于连接负压装置，较细的导管102连接给药装置。
在某些实施例中，所述第一导管101连接负压装置以产生负压，设在第二导管102内的第一导管101连接给药装置，在所述第二导管102上设有多个通孔1010，以助于吸取所述皮下创口内腔4的气体及液体。
在本申请提供的实施例中，所述创口闭合装置2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2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2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2包括至少两个闭合件，所述的至少两个闭合件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的具体形式来确定闭合件的数量。
请参阅图5，其显示为本申请在一实施例中创口闭合装置2中闭合件21的结构示意图，如图所示，在实施例中，所述创口闭合装置2还包括覆盖闭合件21的微孔覆件20，所述微孔覆件20顺应闭合件21的外形结构结合于闭合件21上，用以和所述闭合件21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21上的分泌液体或者存留在所述闭合件21上的药物液体。在一个示例性的实施例中，所述微孔覆件20与闭合件21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20与闭合件21结合，使所述微孔覆件20顺应闭合件21的外形结构结合于闭合件21上。
在某些实施例中，所述闭合件21包括柔性本体，所述柔性本体表示具有弹性/柔性柔性本体材料可以具有大于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21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20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20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21包括：柔性本体210以及刚性曲针211。
所述柔性本体210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210为硅胶材料、树脂材料，或者硅胶树脂材料。所述柔性本体210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210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211包括根部及曲形针部，所述刚性曲针211的根部埋于所述柔性本体210中，被牢固地设置在所述柔性本体210上，所述刚性曲针211的曲形针部外露于所述柔性本体210外。在一个示例性的实施例中，所述刚性曲针211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210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6并结合图5，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211外露于所述柔性本体210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211的曲形针部从所述皮肤创口的一侧刺入，呈如图6示的状态，由于所述皮肤创口两侧的闭合件21的刚性曲针211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211外露于所述柔性本体210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211外露于所述柔性本体210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210内，使得位于所述皮肤创口两侧的柔性本体210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6所示，皮肤50组织下依次包括了血管网51、浅筋膜层52、脂肪53、深筋膜层54、肌肉55和骨骼56。本实施例中的缝合深度即在浅筋膜层52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211外露于所述柔性本体210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210上设置的刚性曲针211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210上设置的刚性曲针211为多个时，该些刚性曲针211呈等距分布的排列在为长条状的柔 性本体210上。
请参阅图7，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，所述闭合件还包括夹持件22，该夹持件22用于夹持粘合于所述皮肤创口两侧的闭合件21的柔性本体，所述柔性本体在夹持件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22为医用夹子等部件。
在上述采用包括柔性本体210以及刚性曲针211的闭合件21的各实施例中，还可以辅助采用一些辅助件，所述辅助件用于辅助闭合件21与皮肤表面之间粘接，并向闭合件21提供使皮肤创口闭合的收缩力，请参阅图8，显示为在本申请创口闭合装置的闭合件在一实施例中辅助件的应用示意图。
在另一个示例性的实施例中，请参阅图11，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21包括：第一柔性本体2100及第二柔性本体2101。
所述第一柔性本体2100粘合于所述皮肤创口周缘的皮肤表面，所述第一柔性本体2100具有第一结合部；所述第二柔性本体2101粘合于所述皮肤创口周缘的皮肤表面，所述第二柔性本体2101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2101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2101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2100与第二柔性本体2101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11，所述创口闭合装置2还包括辅助件212，所述辅助件212用于辅助闭合件21与皮肤表面之间粘接，并向闭合件21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212粘合在所述皮肤创口的周侧，并向所述闭合件21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21提供使皮肤创口闭合。在本实施例中，所述辅助件212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212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。
在某些实施例中，所述皮上负压装置3包括密封膜和负压通道。请参阅图12，其显示为本申请中皮上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30粘合于皮肤上并覆盖创口闭合装置2，由此形成一个密封空间32，通过负压装置抽压后，密封膜内部密封空间形成向内的作用力，受力如图12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30绕过皮肤创口以及设置在所述皮肤创口上的创口闭合装置2形成一个密封区，并使得所述密封区形成密封空间32，在本实施例中，所述密封膜30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30可以由透明材料制成。为所述透明材料的密封膜30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。
在一个示例性的实施例中，所述密封膜30开设有为透光材料的观察窗，以方便临床医师观察所述皮肤创口的愈合情况来采取相应的医疗措施。
上述实施例的具体操作步骤请参阅图1，如图所示，操作人员将皮下负压导流装置的导管10埋入皮肤的皮下组织，并使导管10伸入皮下创口内腔4。皮下负压导流装置可通过导管10引流皮下创口内腔4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，另外还可通过导管输送液体药物至所述皮下创口内腔4利于愈合，此为第一方面；在第二方面，通过闭合件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，闭合件对皮缘的挤压作用可减少皮肤真皮下血管网的出血，皮下负压导流装置的负压可辅助使皮下创口内腔4闭合。操作人员继续将微孔覆件20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30以包裹整个创口及创口上的微孔覆件20；第三方面，通过皮上负压装置3的负压通道31将密封膜30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，皮上负压装置同时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。
在本实施例中，所述负压通道31通过导管与一负压装置连通，将负压通道31连通密封空间，由此提供负压源，形成密封空间。
在本实施例中，所述负压装置产生的负压使密封空间压缩，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，辅助创口闭合装置2闭合皮肤创口进而促进创口愈合。在本实施例中，所述密封膜30粘合于皮肤上形成的密封空间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。
在本实施例中，所述负压通道31与一负压装置连通的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到所述密封空间内进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。
在本实施例中，所述负压装置的负压供给，诸如负压源，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。
在一个示例性的实施例中，请参阅图13，其显示为本申请皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备在另一实施例中的示意图，如图13所示，所述皮上负压装置可以与皮下负压引流装置共用一个负压源6，通过两根不同的导管分别连接到同一个负压源，即连通所述皮上的密闭空间32的导管以及连通所述皮下创口内腔的导管为两根不同的导管。
请参阅图14，其显示为本申请皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备在再一实施例中的示意图，如图所示，在本实施例中，所述皮上负压装置可以与皮下负压引流装置共用一个负压源6，通过一导管分别连通所述皮下创口内腔4以及皮上的密闭空间32，其中，所述导管10包括皮下引流孔1010及皮上负压孔60，所述皮下引流孔为设置在所述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1010；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。
在一个示例性的实施例中，所述皮上负压装置3还包括湿度检测部件(未予以图示)，将湿度检测部件的传感器设置于密封膜30形成的密封空间内，并将湿度检测部件的信息输出端口与负压装置连接，由此将检测到的湿度信息提供给负压装置，以控制负压装置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。
综上所述，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第一方面通过创口闭合装置使皮肤创口暴露的两端紧贴，所述创口闭合装置在闭合创口的同时可起到挤压皮缘的作用，由此可减少皮肤真皮下血管网的出血；第二方面在皮下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；在此基础上，通过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；第三方面通过皮上负压装置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，通过本申请的外科辅助设备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，本申请的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，可以在不使用缝合的情况下使皮下创口内腔4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 (32)

  1. 一种皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，包括：
    皮下负压引流装置，包括部分探入皮下创口内腔预设深度的导管，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；
    创口闭合装置，设置在所述皮肤创口的周侧，用于挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态；
    皮上负压装置，设置在所述皮肤创口的周缘，用于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。
  2. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述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。
  3. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述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。
  4. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述导管还用于通过产生的负压以引流所述皮下创口内腔的积液。
  5. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述皮下负压引流装置还包括一用以产生并控制负压压力的负压装置，所述负压装置连通所述导管。
  6. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述导管还用于输送液态药物至所述皮下创口内腔的预设深度。
  7. 根据权利要求6所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，还包括一给药装置，用于通过所述导管输送液态药物至所述皮下创口内腔的预设深度。
  8. 根据权利要求1、2、3、6或7所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，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。
  9. 根据权利要求8所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述预设深度为皮肤组织中脂肪层与深筋膜层的结合处。
  10. 根据权利要求7所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述导管包括第一导管及与所述第一导管隔离的第二导管，所述第一导管连通所述负压装置，所述第二导管连通所述给药装置。
  11. 根据权利要求10所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述第一导管及第二导管一体成型。
  12. 根据权利要求10所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述第二导管套设于所述第一导管内。
  13. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述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。
  14. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述创口闭合装置包括至少两个闭合件，分别设置在所述皮肤创口的两侧边缘，用于挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态。
  15. 根据权利要求14所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述创口闭合装置还包括覆盖所述闭合件及所述皮肤创口的微孔覆件以吸附自所述皮肤创口分泌的积液。
  16. 根据权利要求15所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述微孔覆件顺应所述闭合件的外形结构结合于所述闭合件上。
  17. 根据权利要求15所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述微孔覆件与所述闭合件为一体成型构造。
  18. 根据权利要求15所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于， 所述微孔覆件的材料为泡沫、网状物、纱布、海绵、或者多孔生物相容材料。
  19. 根据权利要求14所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述闭合件包括：
    柔性本体，粘合于所述皮肤创口一侧的皮肤表面上；
    刚性曲针，其根部设置在所述柔性本体上，其曲形针部外露于所述柔性本体外，用于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。
  20. 根据权利要求19所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述闭合件还包括夹持件，用于夹持粘合于所述皮肤创口两侧的柔性本体以提供相向力挤压皮缘以使所述皮肤创口在愈合过程中保持闭合状态。
  21. 根据权利要求19所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述柔性本体为树脂/硅胶材料。
  22. 根据权利要求14所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述闭合件包括：
    第一结合部，形成在一柔性本体上；
    对应结合所述第一结合部的第二结合部，形成在另一柔性本体上；
    藉由所述第一结合部与第二结合部的结合以提供施加于所述皮肤创口两侧的柔性本体的相向力以挤压皮缘使所述皮肤创口在愈合过程中保持闭合状态。
  23. 根据权利要求22所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，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。
  24. 根据权利要求14所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述创口闭合装置还包括辅助件，用于粘合于所述至少两个闭合件及皮肤表面，用于向所述至少两个闭合件提供使皮肤创口闭合的收缩力。
  25. 根据权利要求24所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于， 所述辅助件包括胶布。
  26. 根据权利要求1所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述皮上负压装置包括：
    密封膜，用于粘合于皮肤上并覆盖所述创口闭合装置以形成密封空间；
    负压通道，连通一负压装置，通过将所述负压装置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收缩以辅助所述创口闭合装置闭合所述皮肤创口。
  27. 根据权利要求26所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，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。
  28. 根据权利要求26所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述密封膜开设有为透光材料的观察窗。
  29. 根据权利要求26所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述皮上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装置以利所述负压装置调控负压输出。
  30. 根据权利要求26所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述皮上负压装置还用于藉由产生的负压以使所述密封膜向所述皮肤组织施加压力以辅助以迫使所述皮下创口内腔在愈合过程中呈闭合状态。
  31. 根据权利要求26所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述皮上负压装置及皮下负压引流装置共用负压装置。
  32. 根据权利要求31所述的皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述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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