WO2020186730A1 - 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备 - Google Patents

四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备 Download PDF

Info

Publication number
WO2020186730A1
WO2020186730A1 PCT/CN2019/109572 CN2019109572W WO2020186730A1 WO 2020186730 A1 WO2020186730 A1 WO 2020186730A1 CN 2019109572 W CN2019109572 W CN 2019109572W WO 2020186730 A1 WO2020186730 A1 WO 2020186730A1
Authority
WO
WIPO (PCT)
Prior art keywords
skin
wound
negative pressure
subcutaneous
drainage
Prior art date
Application number
PCT/CN2019/109572
Other languages
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
Priority claimed from CN201910585716.5A external-priority patent/CN112168256A/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 EP19920290.4A priority Critical patent/EP3943020A4/en
Priority to US17/439,167 priority patent/US20220160951A1/en
Publication of WO2020186730A1 publication Critical patent/WO2020186730A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • 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
    • A61M1/915—Constructional details of the pressure distribution manifold
    • 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
    • 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
    • A61B17/085—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • 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
    • 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
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00561—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
    • A61B2017/00566—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum fixation of form upon application of vacuum
    • 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
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/081—Tissue approximator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains

Definitions

  • the present application relates to the field of medical devices, and in particular to a surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities.
  • Closing skin cracks by sutures will cause changes in skin tension and affect blood circulation in the skin. After the suture passes through the tissue, the knot is tightened, which can cause the tissue to move and bring squeezing force to the local tissue.
  • This squeezing force has a dual effect: on the one hand, it can eliminate the dead space of the resection margin and reduce the bleeding of the skin edge, which is conducive to tissue healing; on the other hand, the squeeze caused by the suture can cause relative ischemia of the skin edge tissue, causing The risk of tissue necrosis and scarring.
  • the sutures are gathered and knotted and the local tissues move to the incisal margin, which can increase the tension of the peripheral skin, and increase the risk of ischemic necrosis of soft tissues in certain parts, especially when the volume of soft tissues of the limbs of the human body is limited.
  • the anti-swelling ability of the site is relatively weak, and there is a higher risk of soft tissue ischemic necrosis.
  • the purpose of this application is to provide a surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities, which is used to solve the problem that the suturing of the incision in the prior art may leave traces
  • the problem that the effusion is difficult to drain, especially the soft tissues and skin wounds of the human limbs have higher ischemia and hypoxia.
  • the present application provides a surgical aid for closing skin wounds without sutures in the deep fascia of the extremities, including: a subcutaneous negative pressure drainage device, the subcutaneous negative pressure drainage device includes a part of the subcutaneous drainage device A catheter with a preset depth of the wound cavity 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 In order to keep the skin wound in a closed state 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; more
  • the root drainage needle is used to pierce the deep fascia of the subcutaneous soft tissue from the peripheral side of the skin wound to drain the fluid in the deep fascia of the subcutaneous soft tissue.
  • the drainage needle includes a needle formed on the The drainage part, when the drainage needle penetrates the deep fascia of the subcutaneous soft tissue
  • the needle body of the drainage needle is a hollow structure, and the drainage portion is at least one drainage hole formed on the hollow structure.
  • the drainage needle includes a needle head, a hollow needle body, and a needle tip, the at least one drainage hole is formed on the hollow needle body, and the needle head has a connection with the hollow needle.
  • the through hole of the needle body, or/and the needle tip portion has a through hole communicating with the hollow needle body.
  • the needle body of the drainage needle is a solid structure, and the drainage portion is a drainage groove formed on the needle body.
  • the multiple drainage needles are arranged on a flexible substrate, and the multiple drainage needles on the flexible substrate penetrate the deep fascia of the subcutaneous soft tissue to provide contraction force to squeeze the skin edge. In order to keep the skin wound closed during the healing process.
  • the flexible substrate includes resin material or silicone material.
  • the catheter is partially penetrated to the predetermined depth of the lumen of the subcutaneous wound through a predetermined position of the skin wound, or the catheter is passed through a predetermined depth away from the skin wound.
  • the preset position penetrates the skin and subcutaneous tissue to partially penetrate to the preset depth of the cavity of the subcutaneous wound.
  • 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 for passing the generated negative pressure. To drain the effusion in the cavity of the subcutaneous wound.
  • it further includes a drug delivery device for delivering liquid medicine through the catheter to a predetermined depth of the lumen of the subcutaneous wound.
  • 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 communicates with the Drug delivery device.
  • the first catheter and the second catheter are integrally formed, and the second catheter is sheathed in the first catheter.
  • 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.
  • 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 so that the skin wound is in the healing process. Keep it closed.
  • 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 combined with the closure member in conformity with the outer structure of the closure member; or 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 includes: a flexible body, which is adhered to the skin surface on the side of the skin wound; a rigid curved needle, the root of which is arranged on the flexible body, and its curved shape The needle is exposed outside the flexible body and is used to penetrate 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 Keep closed during the healing process.
  • the flexible body is made of resin material or silicone material.
  • the closure member includes: a first coupling portion formed on a flexible body; and a second coupling portion corresponding to the first coupling portion and formed on another flexible body; 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 to squeeze the skin edge to keep the skin wound in a closed state during the healing process.
  • the first coupling portion is a groove structure or a buckle structure
  • the second coupling portion is a protruding structure that can be limited to the groove structure or a buckle corresponding to the buckle. Hole or hook structure.
  • the wound closure device further includes an auxiliary member for adhering to the at least two closure members and the skin surface, and for providing the at least two closure members to make the skin wound. Closed contraction force.
  • 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 with a negative pressure device , By applying the negative pressure generated by the negative pressure device to provide the contraction force of the sealing film to drive the skin wound to contract to assist the wound closure device to close the skin wound.
  • the sealing film is adhered 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 the flexible non-flexibility of polyurethane coated with acrylic adhesive. Infiltration material.
  • the sealing film is provided with an observation window made of 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 regulation of the negative pressure device. 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 wound cavity in It 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 on the tube wall of the portion where the catheter penetrates into the skin wound at a predetermined depth.
  • the surgical auxiliary equipment for closing skin wounds in the deep fascia of the extremities of the present application includes a subcutaneous negative pressure drainage device, a wound closure device, a supracutaneous negative pressure device and multiple drainage needles for passing through multiple
  • the drainage needle drains the effusion in the subcutaneous soft tissue, so as to keep the effusion in the subcutaneous soft tissue to be discharged in time; at the same time, the present application also squeezes the skin edge through the wound closure device, and is forced by the subcutaneous negative pressure drainage device to make the subcutaneous wound
  • the inner cavity is kept closed during the healing and rehabilitation process.
  • the subcutaneous negative pressure drainage device can drain the effusion in the subcutaneous wound cavity while delivering liquid medicine to the subcutaneous wound cavity to ensure that the environment of the subcutaneous wound cavity is maintained in favor of 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 seamlessly closing the skin wound.
  • Fig. 1 shows a schematic diagram of a surgical auxiliary device for closing skin wounds without sutures in deep fascia of extremities of the present application.
  • Fig. 2 shows a schematic diagram of the subcutaneous negative pressure drainage device of the surgical auxiliary equipment of this application in an embodiment.
  • 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 is a schematic diagram showing the structure of the closure member in the wound closure device in an embodiment of the present application.
  • Fig. 6 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. 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 diagram of the structure of the closure in another embodiment of the wound closure device of the present application.
  • 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 deep fascia of the extremities of the present application.
  • Fig. 14 shows a schematic diagram of a surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities in another embodiment of the present application.
  • FIG. 15 shows a schematic diagram of the application of the drainage needle of this application in an embodiment.
  • FIG. 16 shows a schematic diagram of the application of the drainage needle in this application in another embodiment.
  • FIGS 17 to 18 show schematic diagrams of the structure of the drainage needle of this application in an embodiment.
  • FIGS 19-20 show schematic diagrams of the structure of the drainage needle of this application in another embodiment.
  • FIGS 21-22 show schematic structural diagrams of the drainage needle of this application in another embodiment.
  • FIG. 23 shows a schematic diagram of the application structure of the drainage needle in another embodiment of this application.
  • FIG. 24 shows a schematic diagram of an application embodiment of multiple drainage needles in 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.
  • 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.
  • This tissue edema caused by inflammation can cause the pressure of the deep tissue compartment to increase, forming a compartment syndrome, leading to necrosis of the limbs.
  • severe tissue swelling can also cause blood flow disorders in the skin and soft tissues, resulting in skin non-healing, skin border necrosis, and extensive skin ischemic necrosis.
  • the present application provides a surgical aid for closing skin wounds with seamless sutures in the deep fascia of the extremities, in order to replace the traditional needle suture method for skin and soft tissues and realize the closure of skin wounds and the prevention of fluid accumulation in subcutaneous soft tissues.
  • the purpose of drainage is a surgical aid for closing skin wounds with seamless sutures in the deep fascia of the extremities, in order to replace the traditional needle suture method for skin and soft tissues and realize the closure of skin wounds and the prevention of fluid accumulation in subcutaneous soft tissues.
  • the purpose of drainage is a surgical aid for closing skin wounds with seamless sutures in the deep fascia of the extremities, in order to replace the traditional needle suture method for skin and soft tissues and realize the closure of skin wounds and the prevention of fluid accumulation in subcutaneous soft tissues. The purpose of drainage.
  • the surgical auxiliary equipment for closing skin wounds without sutures in the deep fascia of the extremities of the present application includes: a subcutaneous negative pressure drainage device, a wound closure device, a supracutaneous negative pressure device, and multiple drainage needles, It is used to drain the effusion in the deep fascia of the subcutaneous soft tissue through the hollow structure and drainage holes through multiple drainage needles, so as to keep the effusion in the deep fascia of the subcutaneous soft tissue to be discharged in time and maintain the environment in the subcutaneous soft tissue in a healthy state status.
  • the present application also squeezes the skin edge through the wound closure device and is forced by the subcutaneous negative pressure drainage device to keep the subcutaneous wound cavity closed during the healing process.
  • the subcutaneous negative pressure drainage device drains the subcutaneous wound cavity.
  • Liquid medicine can be delivered to the lumen of the subcutaneous wound while effusion, ensuring that the environment of the lumen of the subcutaneous wound is maintained in a state that is 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 seamlessly closing the skin wound.
  • the surgical auxiliary device for closing skin wounds in the deep fascia of the extremities of the present application allows the exposed ends of the skin wound to be close to each other.
  • the wound closure device 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 pressure drainage device exerts a force to gather the skin tissue in the direction of the wound, thereby facilitating the recovery of the skin wound.
  • 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.
  • the deep fascia is also called fascia intestinal.
  • the deep fascia is composed of dense connective tissue and is located on the deep surface of the superficial fascia. It covers the body wall and the muscles of the limbs. And blood vessels and nerves.
  • the relationship between deep fascia and muscle is very close, and it is layered with the layering of muscles.
  • the deep fascia stretches between the muscle groups and is attached to the bones to form a muscle interval; and the deep fascia surrounding the muscle groups constitutes a fascial sheath; the deep fascia also surrounds blood vessels and nerves to form a vascular nerve sheath; It can also provide muscle attachment or as a starting point for muscles.
  • the deep fascia also refers to all the dense fibrous layers that interact with muscles in an orderly arrangement; the deep fascia connects different components of the skeletal muscle system and transmits muscle contraction force to a distance.
  • the matrix wavy collagen fibers coexist with a few elastin fibers.
  • the collagen fibers in the matrix have three different directions: oblique, longitudinal, and transverse.
  • the fascia there is the most extensive continuity and strong elasticity. It wraps tightly on the surface of the muscle to prevent excessive expansion of the muscle belly caused by muscle contraction. When muscles contract, in order to avoid friction between adjacent muscles, it plays a role in assisting sliding.
  • the deep fascia sometimes separates the muscle from other encased structures, and then combines with another membrane.
  • fascias are connected to other fascias.
  • the insertion of muscle fibers forms an attachment part. Assist the continuity of periosteum, perichondrium, ligaments, etc. It supports blood vessels, nerves, and lymphatic vessels, and has mechanical functions that allow them to pass through.
  • FIG. 1 shows a schematic diagram of an embodiment of the surgical assist device of the present application.
  • the deep fascia of the extremities of the present application is sutured to close the skin
  • Surgical auxiliary equipment for wounds includes: subcutaneous negative pressure drainage device 1, wound closure device 2, supracutaneous negative pressure device 3, and multiple drainage needles 4.
  • the multiple drainage needles 4 of the surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities of the present application are used to penetrate from the peripheral side of the skin wound to the deep subcutaneous soft tissue.
  • the fascia is used to drain the effusion in the deep fascia of the subcutaneous soft tissue
  • the drainage needle 4 includes a drainage portion 41 formed on the needle body, and the drainage needle 4 penetrates the deep fascia of the subcutaneous soft tissue.
  • a part of the drainage part 41 is located outside the skin surface; at the same time, the force (negative pressure) of the supracutaneous negative pressure device 1 is also applied to the multiple drainage needles 4 through its drainage part 41, While the needle 4 absorbs the fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the drainage needle 4 to pierce the part of the peripheral tissue under the influence of the negative pressure exerted by the supracutaneous negative pressure device 3 towards each other. Together, under the combined action of multiple drainage needles, it is helpful to assist the wound closure device 2 and the subcutaneous negative pressure drainage device 1 to apply force to the skin tissue to draw the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • the subcutaneous soft tissue refers to the soft tissue located in the lower layer of human skin, including muscles, tendons, ligaments, joint capsules, synovial sacs, nerves, blood vessels, and the like.
  • the subcutaneous soft tissue When the subcutaneous soft tissue is uncontrollably damaged, it will cause subcutaneous hemorrhage and other conditions, causing swelling in the subcutaneous soft tissue. If the swelling is not removed in time, it will cause tissue necrosis and seriously affect the patient's recovery.
  • the drainage needle 4 is arranged on the peripheral side of the skin wound to drain the effusion in the deep fascia of the subcutaneous soft tissue.
  • the human body does not leave a wound on the surface of the skin, such as fractures and other subcutaneous soft tissue damage.
  • the drainage needle 4 can be set at a position corresponding to the deep fascia of the injured subcutaneous soft tissue, or near the deep fascia of the injured subcutaneous soft tissue or other parts that require drainage. Therefore, the drainage needle 4 in the present application is particularly suitable for damage to the deep fascia of the subcutaneous soft tissue of the human limbs or fractures.
  • the drainage needle 4 is a component used to drain the fluid in the deep fascia of the subcutaneous soft tissue to the outside of the human body. In order to allow the drainage needle 4 to drain the fluid in the deep fascia of the subcutaneous soft tissue out of the body, drain The drainage part of the needle 4 is exposed outside the skin surface.
  • the drainage needle 4 has a drainage part 41, and the drainage part 41 is a part arranged on the needle body of the drainage needle 4 to help drain the subcutaneous fluid.
  • the shape of the drainage needle 4 can be cylindrical or other special-shaped structures, and any shape that can pierce the skin and be able to provide a drainage part 41 on the needle body of the drainage needle 4 for drainage can be applied. In the present invention.
  • the subcutaneous part of the drainage needle 4 does not affect the growth of the tissue on both sides of the subcutaneous wound cavity 7. After the wound is healed, the needle holes left on the skin and subcutaneous soft tissue after the drainage needle 4 is removed can heal by itself.
  • the needle body of the drainage needle 4 is a hollow structure
  • the drainage portion 41 is at least one drainage hole formed on the hollow structure
  • the hollow structure and the drainage portion 41 Work with each other to drain the fluid in the deep fascia of the subcutaneous soft tissue.
  • FIGS. 17-18 show a schematic structural diagram of an embodiment of the drainage needle of this application.
  • the needle body of the drainage needle 4 is a hollow structure, so The needle body of the drainage needle 4 is evenly distributed with 4 drainage holes to form a drainage portion 41.
  • the drainage holes are respectively located on the front, left, right, and back sides of the needle body, and the hollow cavity 42 of the hollow structure Connect with the drainage hole.
  • the drainage needle 4 After the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, it cooperates with the drainage portion 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; at the same time, the supracutaneous negative pressure device
  • the force (negative pressure) of 1 is also applied to the plurality of drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also Under the influence of the negative pressure exerted by the supracutaneous negative pressure device 3, the peripheral tissues of the penetrating part of the drainage needle 4 are forced to adhere to each other. Under the combined action of multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous
  • the negative pressure drainage device 1 exerts a force to draw the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • FIGS. 19-20 show a schematic structural diagram of the drainage needle of this application in another embodiment.
  • the needle body of the drainage needle 4 is a hollow structure
  • a drainage hole is uniformly distributed on the needle body of the drainage needle 4 to form a drainage portion 41, and the cavity 42 of the hollow structure is communicated with the drainage hole.
  • the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, it cooperates with the drainage portion 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; at the same time, the supracutaneous negative pressure device
  • the force (negative pressure) of 1 is also applied to the plurality of drainage needles 4 through its drainage part 41.
  • the drainage needle 4 absorbs fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also Under the influence of the negative pressure exerted by the supracutaneous negative pressure device 3, the peripheral tissues of the penetrating part of the drainage needle 4 are forced to adhere to each other. Under the combined action of multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous The negative pressure drainage device 1 exerts a force to draw the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • FIGS. 21-22 show a schematic structural diagram of the drainage needle of this application in another embodiment.
  • the needle body of the drainage needle 4 is a hollow structure
  • the needle body of the drainage needle 4 is evenly distributed with three drainage holes to form a drainage portion 41, and the cavity 42 of the hollow structure communicates with the drainage holes.
  • the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, it cooperates with the drainage portion 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; at the same time, the supracutaneous negative pressure device
  • the force (negative pressure) of 1 is also applied to the plurality of drainage needles 4 through its drainage part 41.
  • the drainage needle 4 absorbs fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also Under the influence of the negative pressure exerted by the supracutaneous negative pressure device 3, the peripheral tissues of the penetrating part of the drainage needle 4 are forced to adhere to each other. Under the combined action of multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous The negative pressure drainage device 1 exerts a force to draw the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • the number of the drainage holes may be 1, 2, 3, 4 or more.
  • the arrangement of the drainage holes can be a single-row regular arrangement as shown in FIGS. 17-22, or other arrangements, such as multi-row arrangement, irregular arrangement, etc.
  • the shape of the drainage hole includes not limited to the elongated shape shown in Figs. 17-22, and may also be round, square and other shapes.
  • FIG. 15 shows an application schematic diagram of the drainage needle of this application in an embodiment.
  • the drainage needle 4 includes a needle head 44, a hollow needle body, And a needle tip portion 43, the at least one drainage hole is formed on the hollow needle body, the needle head has a through hole communicating with the hollow needle body, or/and the needle tip portion 43 has a hollow needle body connected to it Of through holes.
  • the needle tip 43 it is defined that one end of the drainage needle 4 piercing the skin is the needle tip 43, and the other end is the needle head 44.
  • the needle body of the drainage needle is a hollow structure
  • the needle head 44 has a through hole communicating with the hollow needle body
  • the needle body of the drainage needle 4 Two drainage holes are provided on the upper part. The drainage holes and the through holes of the needle head 44 together form a drainage part for drainage.
  • the two The drainage holes are all located under the skin, and the needle head is located on the skin, so that the drainage hole on the hollow needle body sucks the fluid in the deep fascia of the subcutaneous soft tissue to the cavity 42 of the hollow structure, and the needle head 44
  • the through hole is discharged; the through hole of the needle head 44 is located in a sealed space formed by the sealing film adhered to the skin and covering the wound closure device, thereby making the force (negative pressure) of the supracutaneous negative pressure device 1 It is applied to the drainage needle 4 through the drainage part 41.
  • FIG. 16 shows a schematic diagram of the application of the drainage needle in this application in another embodiment.
  • the needle body of the drainage needle 4 is a hollow structure
  • the needle tip portion 43 has a through hole communicating with the hollow needle body, and the needle body of the drainage needle 4 is provided with a drainage hole, and the drainage hole and the through hole of the needle tip portion 43 together form a drainage for drainage Part, the cavity 42 of the hollow needle body communicates with the drainage hole.
  • the middle and lower parts of the needle body of the drainage needle 4 and the middle and lower parts of the drainage hole are located under the skin, and the needle head 44 and the upper part of the drainage hole are outside the skin surface. Therefore, on the first aspect, the effusion in the deep fascia of the subcutaneous soft tissue can be sucked into the cavity 42 through the through hole of the needle tip part 43, and on the other hand, the deep fascia of the subcutaneous soft tissue can be sucked into the deep fascia of the subcutaneous soft tissue through the drainage hole located under the skin.
  • the effusion in the cavity 42 is discharged through the upper part of the drainage hole; the upper part of the drainage hole is located in the sealing film bonded to the skin and covering the wound closure device to form a sealed space Therefore, the force (negative pressure) of the supracutaneous negative pressure device 1 can be applied to the drainage needle 4 through the drainage portion 41.
  • the needle tip portion 43 and the needle head portion 44 each have a through hole communicating with the hollow needle body.
  • the drainage needle 4 penetrates the skin 50 through the needle tip portion 43 to the depth of the subcutaneous soft tissue
  • the drainage holes on the needle body are all located under the skin, and the needle head is located on the skin.
  • the through hole of the needle head 44, the through hole of the needle tip part 43 and the drainage hole together form a drainage part for drainage. Therefore, on the first aspect, the through hole of the needle tip portion 43 is used to draw the effusion in the deep fascia of the subcutaneous soft tissue to the cavity 42, on the other hand, the drainage hole on the needle body is used to draw the effusion in the deep fascia of the subcutaneous soft tissue.
  • the needle head 44 is located in a sealed space that is adhered to the skin by a sealing film and covers the wound closure device, Thereby, the force (negative pressure) of the supracutaneous negative pressure device 1 can be applied to the drainage needle 4 through the drainage portion 41.
  • FIG. 23 shows a schematic diagram of the application structure of the drainage needle in this application in another embodiment.
  • the needle body of the drainage needle 4 is a physical structure.
  • the drainage portion 41 is a drainage groove formed on the needle body.
  • the drainage portion 41 is designed as a drainage groove formed on the needle body, and the physical structure indicates that the structure of the drainage needle 4 is designed as a solid structure without a cavity, and is only provided in the drainage needle 4
  • the drainage groove on the needle body realizes drainage; the drainage groove is located in a sealed space where the sealing film is adhered to the skin and covers the wound closure device, thereby making the force of the supracutaneous negative pressure device 1 (negative pressure ) It is applied to the drainage needle 4 through the drainage part 41.
  • the needle body of the drainage needle 4 is provided with two drainage holes to form a drainage portion 41. After the drainage needle 4 is pierced into the deep fascia of the subcutaneous soft tissue through the needle tip portion 43, The drainage hole in the lower part sucks the effusion in the deep fascia of the subcutaneous soft tissue to the cavity 42 and discharges it through the upper part of the drainage groove.
  • the number of the drainage grooves may be 1, 2, 3, 4 or more.
  • the arrangement of the drainage grooves may be a symmetrical arrangement as shown in FIG. 23, or other arrangements, such as irregular arrangements.
  • the shape of the drainage groove includes not limited to the elongated shape shown in Figs. 17-22, and may also be round, square and other shapes.
  • the multiple drainage needles 4 are arranged on a flexible substrate, and the multiple drainage needles 4 on the flexible substrate penetrate the deep fascia of the subcutaneous soft tissue to provide contraction force to squeeze the skin.
  • the edge keeps the skin wound closed during the healing process, and the auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 exert a force to shrink the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • FIG. 24 shows a schematic diagram of an application embodiment of multiple drainage needles in this application.
  • multiple drainage needles 4 are arranged on the flexible substrate. Piercing the multiple drainage needles 4 on the flexible substrate into the deep fascia of the subcutaneous soft tissue, the multiple drainage needles 4 can help drain the fluid in the deep fascia of the subcutaneous soft tissue in the first aspect, thereby reducing hematoma and edema, As a result, the tension of the skin is reduced, which is beneficial to the recovery of soft tissues; on the other hand, a contraction force is provided to squeeze the skin edge, so that the skin wound remains closed during the healing process.
  • the arrangement of the multiple drainage needles 4 on the flexible substrate can be set according to actual needs, including but not limited to the multiple rows and multiple columns shown in FIG. 24, or one row, multiple columns, or multiple rows.
  • One row and one column can also be arranged irregularly, and the arrangement of the multiple drainage needles 4 on the flexible substrate can be selected according to the specific conditions of the site to be drained.
  • the flexible substrate is a component used to place a plurality of drainage needles 4 on it.
  • the flexible substrate is made of a flexible material, such as a resin material or a silicone material. .
  • the subcutaneous negative pressure drainage device 1 includes a catheter 10 partially protruding into the cavity 7 of the subcutaneous wound to a predetermined depth, and the catheter 10 is used to generate negative pressure to force the subcutaneous wound into The cavity 7 is closed during the healing process.
  • 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 7 to a preset depth.
  • the catheter 10 is used to generate negative pressure to force the subcutaneous wound lumen 7 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 penetrates into the subcutaneous wound cavity 7 and generates The negative pressure forces the tissues on both sides of the subcutaneous wound cavity 7 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 7 and the subcutaneous wound cavity 7 Closure facilitates wound healing. It should be understood that during this process, the part of the catheter 10 in the subcutaneous wound cavity 7 does not affect the growth of tissues on both sides of the subcutaneous wound cavity 7.
  • the catheter 10 partially penetrates into the predetermined depth of the subcutaneous wound cavity 7 through a predetermined position of the skin wound. Therefore, negative pressure can be generated to ensure that the subcutaneous wound cavity 7 is closed during the healing process, and at the same time, it can drain the fluid accumulation in the subcutaneous wound cavity 7, 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 7 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 D in FIG. 3) penetrates the skin and subcutaneous tissue to partially penetrate to the preset depth of the subcutaneous wound cavity 7, thereby generating negative pressure to ensure the subcutaneous
  • the wound cavity 7 is in a closed state during the healing process while sucking the effusion of the subcutaneous wound cavity 7 so that the effusion of the subcutaneous wound cavity 7 can be cleared in time, eliminating the living space or environment of bacteria.
  • the “distance” refers to a preset position away from the skin wound (the position shown at D in Fig.
  • the catheter 10 does not penetrate into the subcutaneous wound cavity 7 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 tissue.
  • the wound cavity 7, this embodiment is particularly suitable for the elongated (narrow-shaped) 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 close, and is forced and assisted by the subcutaneous negative pressure drainage device 1 to make the skin
  • the wound cavity 7 remains closed during the healing and rehabilitation process. It can also deliver liquid medicine to the subcutaneous wound cavity 7 while sucking the effusion in the subcutaneous wound cavity 7, thereby potentially colonizing the subcutaneous wound cavity 7
  • the concentrated infection foci are diluted and cleaned; at the same time, the negative pressure generated by the supracutaneous negative pressure device 3 can maintain the tissue position of the skin wound and its peripheral area to remain stable, thereby facilitating wound recovery.
  • a plurality of drainage needles 4 are pierced from the peripheral side of the skin wound to the deep fascia of the subcutaneous soft tissue, thereby draining the fluid in the deep fascia of the subcutaneous soft tissue.
  • the supercutaneous negative pressure device 3 generates The negative pressure can also help the drainage needle 4 to drain the effusion in the deep fascia of the subcutaneous soft tissue; at the same time, the force (negative pressure) of the supracutaneous negative pressure device 1 is also applied to all the fluids through its drainage part 41
  • the drainage needle 4 absorbs the fluid around the deep fascia of the subcutaneous soft tissue through its drainage portion 41, it can also force the drainage needle 4 to puncture under the influence of the negative pressure of the supracutaneous negative pressure device 3
  • the tissues on the peripheral side of the inlet part tend to fit each other, and under the combined action of multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous negative pressure drainage device 1 to apply force to the skin tissue to gather in the direction of the wound. So as to assist in wound closure.
  • the subcutaneous wound cavity 7 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 elasticity.
  • the cavity 7 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 1010 are provided on the tube wall of the part where the catheter 10 penetrates into the skin wound at a predetermined depth to help form the suction of gas and liquid from the cavity 7 of the subcutaneous wound.
  • the plurality of through holes 1010 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 wound cavity under the skin of the narrow wound is usually 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 drawn by the catheter 10;
  • the multiple through holes 1010 on the catheter 10 can also be designed to have unequal intervals (that is, the multiple through holes 1010 constitute The spacing is unevenly distributed on the tube wall of the part where the catheter 10 penetrates into 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 the subcutaneous wound cavity 7 refers to the depth of the interval from the superficial fascia layer to the deep fascia layer of the skin 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 generated can be used to drain the effusion in the cavity of the subcutaneous wound, and 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 prevent the effusion The clean-up situation occurs.
  • 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 7 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 in the deep fascia of the limbs of the present application further includes a drug delivery device (not shown).
  • the device is used to deliver liquid medicine to the predetermined depth of the subcutaneous wound cavity 7 through the catheter to facilitate the healing of the subcutaneous wound cavity 7.
  • the drug delivery device includes, for example, a micro pump Or a drug delivery device such as a syringe or a 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 7 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 irrigation fluid, thereby maintaining the clean state of the inner cavity 7 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 cavity 7 through its connected catheter, which is used to dilute the bacterial infection that may or has occurred in the subcutaneous wound cavity 7, 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 7. After washing is completed, pass the subcutaneous The drainage effect of the catheter of the negative pressure drainage device 1 sucks away the liquid medicine in the cavity 7 of the subcutaneous wound, thereby draining and removing bacteria, and the cavity 7 of the subcutaneous wound is clean.
  • 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 flush the liquid medicine in the subcutaneous wound cavity 7 is, for example, 2-3 days, and the drug delivery device can be used by 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 10 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 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 7; the second conduit 102 is connected to the drug delivery device and is used to deliver liquid medicine to The preset depth of the cavity 7 of the subcutaneous wound.
  • 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 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 21, and the at least two closure elements 21 are respectively provided on both sides of the skin wound.
  • the closure element 21 is combined to squeeze the skin edge to keep the skin wound in a closed state during the healing process. In practical applications, the number of closure elements 21 can be determined by the length of the wound and the specific form of closure elements 21.
  • 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 (degreasing cotton)
  • the microporous covering 20 has air permeability and moisture absorption characteristics, and is used to absorb fluid that may be secreted by the skin wound during the healing process. Or the water left in the skin wound and 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 combining a closure element and a wound in an embodiment of this application.
  • the rigid curved needle 211 is exposed outside the The curved needle part 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 needs to make the wound first. Operate the skin (align the edges of the skin, and prevent the edges of the skin from turning inward to avoid poor skin healing), and then pierce the curved needle part of the rigid curved needle 211 from one side of the skin wound.
  • Figure 6 shows the state, because 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 beneficial for wound recovery , In turn, the skin wound is closed.
  • 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.
  • some auxiliary members 212 can also be used to assist the adhesion between the closure member 21 and the skin surface. It also provides the closing member 21 with a contractile force for closing the skin wound.
  • FIG. 8 shows a schematic diagram of the application of the auxiliary member in an embodiment of the closing member 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 negative pressure device 3 on the skin includes a sealing film 30 and a negative pressure channel 31.
  • 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.
  • the force (negative pressure) of the supracutaneous negative pressure device 1 is also applied to the multiple drainage needles 4 through its drainage part 41, While the needle 4 absorbs the fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the drainage needle 4 to pierce the part of the peripheral tissue under the influence of the negative pressure exerted by the supracutaneous negative pressure device 3 towards each other. Together, under the combined action of multiple drainage needles, it is helpful to assist the wound closure device 2 and the subcutaneous negative pressure drainage device 1 to apply force to the skin tissue to draw the skin tissue in the direction of the wound, thereby assisting the wound closure.
  • 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 7 of the subcutaneous wound.
  • the subcutaneous negative pressure diversion device can drain the effusion secreted by the subcutaneous wound lumen 7 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 combined together, and liquid can also be delivered through the catheter
  • the medicine to the subcutaneous wound cavity 7 facilitates healing.
  • the squeezing effect of the member 21 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 subcutaneous wound cavity 7;
  • the third aspect is to pierce through multiple drainage needles 4 After the deep fascia of the subcutaneous soft tissue is drained, the effusion in the deep fascia of the subcutaneous soft tissue can be drained, which can eliminate subcutaneous hemorrhage and other effusions, reduce edema, reduce skin tension, avoid infection, improve circulation, and facilitate wound recovery.
  • the systolic pressure provided by the multiple drainage needles 4 can also squeeze the edge of the skin, so that the skin wound can be kept closed during the healing process.
  • the operator continues to cover the microporous covering 20 on the wound surface to ensure that the secretions on the wound surface and the effusion drained by the drainage needle 4 can be absorbed in time during the healing process. Then cover the microporous accessory with a sealing film 30 to wrap the entire wound and the microporous covering 20 on the wound; in the fourth aspect, the negative pressure channel 31 of the skin negative pressure device 3 draws pressure inside the sealing film 30, so that The skin wound and the tissues in the peripheral area tighten to the wound.
  • the negative pressure generated by the supracutaneous negative pressure device can also exert a certain degree of pressure on the deep subcutaneous tissues, so that the potential dead space is closed, which speeds up
  • the healing speed of skin wounds is 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 generated by the supracutaneous negative pressure device can also provide negative pressure for the drainage needle 4 to help the deep fascia drainage of the subcutaneous soft tissue.
  • 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 a surgical auxiliary device for closing skin wounds in the deep fascia of the extremities of this application in another embodiment, 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 1, and are respectively connected to the same negative pressure source through two different catheters, that is, the catheter connected to the sealed space 32 on the skin and the connection
  • the catheters of the subcutaneous wound cavity 7 are two different catheters.
  • FIG. 14 shows a schematic diagram of a surgical auxiliary device for closing skin wounds in the deep fascia of the extremities of this application in another embodiment.
  • the skin is negative
  • the pressure device can share a negative pressure source 6 with the subcutaneous negative pressure drainage device 1, and respectively communicate with the subcutaneous wound cavity 7 and the sealed space 32 on the skin through a catheter, wherein the catheter 10 includes a subcutaneous drainage hole 1010 and a skin
  • the upper negative pressure hole 60, the subcutaneous drainage hole is a plurality of through holes 1010 provided 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 apply negative pressure 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 in the deep fascia of the extremities of the present application can be realized to a certain extent to achieve safe closure in the deep fascia of the extremities; and the present application uses active drainage to improve the existing
  • the passive drainage method in the technology can promptly treat the effusion of the subcutaneous tissue, especially the deep fascia (such as oozing, exudate, etc.), which is beneficial to the recovery of the wound.
  • the surgical assistant device of the present application uses a seamless thread to close the skin wound.
  • the exposed ends of the skin wound are closely adhered by the wound closure device.
  • the wound closure device can squeeze the skin edge while closing the wound, thereby reducing bleeding of the subdermal vascular network of the skin.
  • the second aspect is forced by the subcutaneous negative pressure drainage device to keep the cavity of the subcutaneous wound closed during the healing and rehabilitation process, maintain the dissected tissues in a fit state, and maintain the bleeding and seepage in the wound cavity through continuous negative pressure suction.
  • the liquid is cleared in time; on this basis, the intermittent delivery of liquid drugs to the cavity of the subcutaneous wound will moisturize the coagulated blood clots in the cavity of the subcutaneous wound to facilitate removal and allow the potential to reach colonization concentration of bacteria
  • the colony is diluted and drained and removed with the irrigation fluid, thereby maintaining a clean state in the wound cavity.
  • the negative pressure can be generated by the negative pressure device on the skin to maintain the stable tissue position of the skin wound and its peripheral area, thereby facilitating tissue healing.
  • the force (negative pressure) of the supradermal negative pressure device is also applied to the multiple drainage needles through its drainage part, and the drainage needle absorbs fluid around the deep fascia of the subcutaneous soft tissue through its drainage part.
  • the peripheral tissues of the piercing part of the drainage needle can be forced to adhere to each other.
  • the subcutaneous negative pressure drainage device 1 exerts a force to gather the skin tissue in the direction of the wound, so as to assist the wound closure.
  • multiple drainage needles can drain the effusion in the deep fascia of the subcutaneous soft tissue, thereby avoiding infection, reducing edema, and reducing skin tension.
  • the multiple drainage needles can also apply pressure to the skin after piercing the skin, and the effect of squeezing the skin edge is realized by the contraction force, which is beneficial to the recovery of the patient.
  • the negative pressure generated by the supracutaneous negative pressure device can help the drainage needle achieve better drainage effect through the negative pressure.
  • 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 of the present application can also drain the fluid in the deep fascia of the subcutaneous soft tissue, which is suitable for wound closure of limbs or fractures.
  • the surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities of the present application can keep the cavity of the subcutaneous wound closed during the healing and rehabilitation process without using sutures, and continue to deepen the subcutaneous soft tissue.
  • the fascia is drained.
  • it is also 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 is not removed.
  • the process of handling foreign bodies in the wound also eliminates the key link and important inducement of bacterial colonization, and ensures that the wound after healing will not be on the skin.
  • the suture marks of the “centipede foot” are left on the surface of the “centipede”, which ensures the beauty of the surgical incision site, thereby solving the problems in the prior art that the suture of the incision after the operation is easy to leave marks and the fluid accumulation is difficult to drain.
  • the surgical auxiliary device for closing skin wounds in the deep fascia of the extremities of the present application also solves the problems of swelling and infection caused by the deep fascia effusion of the subcutaneous soft tissue.
  • the surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the extremities of the present application is also suitable for the field of aesthetic medicine.

Abstract

一种四肢深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）和多根引流针（4）。多根引流针（4）将皮下软组织内的积液引流，从而保持皮下软组织内的积液能够及时排出；创口闭合装置（2）挤压皮缘，并在皮下负压引流装置（1）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（1）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；并且，皮上负压装置（3）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，进而实现无缝线闭合皮肤创口的目的。

Description

四肢深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，尤其涉及一种四肢深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。
通过缝合闭合皮肤裂口会造成皮肤张力改变，影响皮肤血液循环。缝线穿过组织后收紧打结，可使组织发生位移，并给局部组织带来挤压力。这种挤压力具有双重效应：一方面可以消除切缘死腔，并减少皮缘渗血，利于组织愈合；另一方面，缝线造成的挤压可造成皮缘组织相对缺血，带来组织坏死和瘢痕增生的风险。此外，缝线收拢打结另局部组织向切缘移动，可增加外周皮肤的张力，在特定部位可增加软组织缺血坏死的风险，特别是人体的四肢的肢体软组织容积有限的情况下，尤其该部位的抗肿胀的能力比较弱，具有软组织缺血坏死更高的风险。
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四肢深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，特别是人体四肢部分的软组织及皮肤创口具有更高缺血缺氧带来的问题。
为实现上述目的及其他相关目的，本申请提供一种四肢深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，所述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；多根引流针，用于自所述皮肤创口的周侧刺入至皮下软组织深筋膜以对所述皮下软组织深筋膜内的积液进行引流，所述引流针包括形成于其针体上的引 流部，所述引流针刺入皮下软组织深筋膜时所述引流部的一部分位于所述皮肤表面之外。
在本申请的某些实施方式中，所述引流针的针体为中空结构，所述引流部为形成于所述中空结构上的至少一个引流孔。
在本申请的某些实施方式中，所述引流针包括针头部、中空针体、以及针尖部，所述至少一个引流孔形成于所述中空针体上，所述针头部具有连通所述中空针体的通孔，或者/以及所述针尖部具有连通所述中空针体的通孔。
在本申请的某些实施方式中，所述引流针的针体为实体结构，所述引流部为形成于所述针体上的引流槽。
在本申请的某些实施方式中，所述多根引流针排列设置在一柔性基板上，所述柔性基板上的多根引流针刺入皮下软组织深筋膜时以提供收缩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。
在本申请的某些实施方式中，所述柔性基板包括树脂材质或硅胶材质。
在本申请的某些实施方式中，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，或者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，用于通过产生的负压以引流所述皮下创口内腔的积液。
在本申请的某些实施方式中，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。
在本申请的某些实施方式中，所述第一导管及第二导管一体成型，并且所述第二导管套设于所述第一导管内。
在本申请的某些实施方式中，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；或者所述微孔覆件与所述闭合件为一体成型构造。
在本申请的某些实施方式中，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。
在本申请的某些实施方式中，所述柔性本体为树脂材料或硅胶材料。
在本申请的某些实施方式中，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。
在本申请的某些实施方式中，所述辅助件包括胶布。
在本申请的某些实施方式中，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，本申请的四肢深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、皮上负压装置和多根引流针，用以通过多根引流针将皮下软组织内的积液引流，从而保持皮下软组织内的积液能够及时排出；同时，本申请还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；并且，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，进而实现无缝线闭合皮肤创口的目的。
附图说明
图1显示为本申请的四肢深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。
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显示为本申请在一实施例中创口闭合装置中闭合件的结构示意图。
图6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显示为本申请四肢深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显示为本申请四肢深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。
图15显示为本申请的引流针在一实施例中的应用示意图。
图16显示为本申请中的引流针在另一实施例中的应用示意图。
图17～图18显示为本申请的引流针在一实施例中的结构示意图。
图19～图20显示为本申请的引流针在另一实施例中的结构示意图。
图21～图22显示为本申请的引流针在又一实施例中的结构示意图。
图23显示为本申请中引流针在又一实施例中的应用结构示意图。
图24显示为本申请中多根引流针的应用实施例示意图。
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。
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。
特别是在四肢创伤治疗中，软组织张力一直是影响愈合的重要因素。创伤带来局部组织炎症反应，使得血管通透性增加，造成组织水肿；组织内大量液体积聚，可使局部组织张力增加、组织缺氧，形成恶性循环(vicious cycle)，导致广泛的组织坏死。这种由于炎症引起的组织水肿，可以造成深部组织筋膜间室压力升高，形成筋膜间室综合征，导致肢体坏死。在皮肤软组织层，严重的组织肿胀也会另皮肤软组织血运障碍，造成皮肤不愈合、皮缘坏死以及广泛的皮肤缺血坏死等。皮肤软组织坏死将导致骨外露、肌腱外露或者是内固定钢板外露等，可继发慢性感染(骨髓炎)、骨折不愈合等严重问题，使得治疗费用显著增加、治疗周期明显延长。有效对抗组织水肿、保护皮肤软组安全、美观的闭合四肢创伤后皮肤切口已经成为本领域人员期待解决的技术问题。
另外，针对四肢部位的软组织中，如果深筋膜下产生水肿更易造成炎症，即，由于水肿挤压血管流通会造成组织缺血，使得组织坏死进而造成缺氧，形成恶性循环(vicious cycle)；再者，在常见的四肢骨折病患的处理中，常需要将四肢部位比如小腿部位切开以对骨折处进行固定处理，再将切口闭合，由于人体四肢的肢体软组织容积有限，该部位抗肿胀的能力比较弱，肿胀会造成更为严重的问题。
有鉴于此，本申请提供一种四肢深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软组织的针线缝合方式并可实现闭合皮肤创口、对皮下软组织内的积液进行引流的目的。在以下提供的实施例中，本申请的四肢深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、皮上负压装置、以及多根引流针，用以通过多根引流针藉由中空结构和引流孔将皮下软组织深筋膜内的积液进行引流，从而保持皮下软组织深筋膜内的积液能够及时排出，维持皮下软组织内的环境处于健康状态。同时，本 申请还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。并且，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，进而实现无缝线闭合皮肤创口的目的。
本申请的四肢深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。第四方面通过多根引流针可对皮下软组织深筋膜内的积液进行引流，消除皮下积血及其他组织液，在多根引流针的共同作用下，有助于辅助创口闭合装置以及皮下负压引流装置对皮肤组织施以向创口方向收拢的作用力，从而利于皮肤创口的恢复。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。
应当理解，在一些情况下，所述深筋膜亦被称为固有筋膜，所述深筋膜是由致密结缔组织构成，位于浅筋膜的深面，它包被体壁、四肢的肌肉和血管神经等。深筋膜与肌肉的关系非常密切，随肌肉的分层而分层。在四肢，深筋膜伸人肌肉群之间，并附着于骨，构成肌肉间隔；与包绕肌肉群的深筋膜构成筋膜鞘；深筋膜还包绕血管、神经形成血管神经鞘；还可提供肌肉的附着或作为肌肉的起点。
所述深筋膜还指所有与肌肉相互作用的排列有序的致密纤维层；深筋膜连接不同的骨骼肌系统成分，并将肌肉收缩力向远处传递。基质中，波状胶原纤维与少许的弹性蛋白纤维共同存在。在深筋膜中，基质中的胶原纤维有3种不同方向：斜方向、纵方向、横方向。在筋膜中，存在最具广泛连续性，具有很强的弹性。紧致的包裹在肌肉的表面，防止由于肌肉的收缩引起的肌腹的过度膨胀。肌肉收缩的时候，为了避免邻近肌肉之间产生摩擦力，起到助滑的作用。深筋膜有时肌肉与其他包裹的构造物相分离，会再与另一层膜相结合。由此，有些筋膜与其他筋膜相连接。有肌纤维的插入形成附着部分的部位。协助骨膜与软骨膜，韧带等的连续性。支持血管与神经以及淋巴管，且具备使其通过这些的机械性功能。
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，本申请的四肢深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、多根引流针4。
在图1所示的实施例中，本申请的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备的多根引流针4用于自所述皮肤创口的周侧刺入至皮下软组织深筋膜以对所述皮下软组织深筋膜内的积液进行引流，所述引流针4包括形成于其针体上的引流部41，所述引流针4刺入皮下软组织深筋膜时所述引流部41的一部分位于所述皮肤表面之外；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
应当理解，皮下软组织指位于人体皮肤下层的软组织，包括肌肉、肌腱、韧带、关节囊、滑膜囊、神经、血管等。当皮下软组织受到不可控的损伤后，会引起皮下积血等情况，引起 皮下软组织内的肿胀，如果不及时去除肿胀，则会引起组织坏死，对患者的康复造成严重影响。
在本实施例中，所述引流针4通过设置在皮肤创口的周侧，对皮下软组织深筋膜内的积液进行引流。在另一些实施例中，人体所受伤害未在皮肤表面留下创口，例如骨折等皮下软组织受损的情况，此时同样需要对皮下软组织深筋膜内的积液进行引流，以消除水肿，避免组织进一步坏死。在这种情况下，可依据实际需求，将引流针4设置在对应受伤皮下软组织深筋膜位置处的部位，或设置在受伤的皮下软组织深筋膜位置附近或其他需要引流的部位等。因此，本申请中的引流针4尤其适用于人体四肢或骨折处的皮下软组织深筋膜受损中。
应当理解，所述引流针4是用于将皮下软组织深筋膜内的积液进行引流到人体外的部件，为使引流针4能够将皮下软组织深筋膜内的积液引流出体外，引流针4的引流部暴露于皮肤表面之外。所述引流针4上具有引流部41，引流部41为设置在所述引流针4的针体上帮助引流皮下积液的部位。
应当理解，所述引流针4的形状可以是圆柱形也可以是其他异形结构，任何可穿刺皮肤并能够在引流针4针体上设置引流部41以起到引流作用的形状，均可被应用在本发明中。
应当理解，在通过将多根引流针4刺入皮下软组织深筋膜引流的这一过程中，所述引流针4在皮下的部分不影响所述皮下创口内腔7两侧的组织的生长。且在创口愈合后，拆除引流针4后在皮肤上及皮下软组织留下的针孔可自行愈合。
在一个示例性的实施例中，所述引流针4的针体为中空结构，所述引流部41为形成于所述中空结构上的至少一个引流孔，所述中空结构与所述引流部41相互配合以引流皮下软组织深筋膜内的积液。
在一个示例性的实施例中，请参阅图17～图18，其显示为本申请的引流针在一实施例中的结构示意图，如图所示，引流针4的针体为中空结构，所述引流针4的针体上均布有4个引流孔以形成引流部41，所述引流孔分别位于针体的前侧、左侧、右侧及后侧，所述中空结构的空腔42与引流孔相连通。所述引流针4刺入皮肤至皮下软组织深筋膜后，通过所述中空结构与所述引流部41相互配合以引流皮下软组织深筋膜内的积液；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
在另一个示例性的实施例中，请参阅图19～图20，其显示为本申请的引流针在另一实施 例中的结构示意图，如图所示，引流针4的针体为中空结构，所述引流针4的针体上均布有1个引流孔以形成引流部41，所述中空结构的空腔42与引流孔相连通。所述引流针4刺入皮肤至皮下软组织深筋膜后，通过所述中空结构与所述引流部41相互配合以引流皮下软组织深筋膜内的积液；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
在又一个示例性的实施例中，请参阅图21～图22，其显示为本申请的引流针在又一实施例中的结构示意图，如图所示，引流针4的针体为中空结构，所述引流针4的针体上均布有3个引流孔以形成引流部41，所述中空结构的空腔42与引流孔相连通。所述引流针4刺入皮肤至皮下软组织深筋膜后，通过所述中空结构与所述引流部41相互配合以引流皮下软组织深筋膜内的积液；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
应当理解，所述引流孔的数量可以为1个，2个，3个，4个或更多。所述引流孔的排布形式可以为图17～图22所示的单行规则排布形式，也可以为其他排布形式，如多行排布、不规则排布等。所述引流孔的形状包括不限于为图17～图22所示的长条状，还可以为圆形、方形等形状。
在一个示例性的实施例中，请参阅图15，其显示为本申请的引流针在一实施例中的应用示意图，如图所示，所述引流针4包括针头部44、中空针体、以及针尖部43，所述至少一个引流孔形成于所述中空针体上，所述针头部具有连通所述中空针体的通孔，或者/以及所述针尖部43具有连通所述中空针体的通孔。在此，定义所述引流针4刺入皮肤的一端为针尖部43，另一端为针头部44。
在一个示例性的实施例中，请继续参阅图15，所述引流针的针体为中空结构，所述针头部44具有连通所述中空针体的通孔，所述引流针4的针体上设有两个引流孔，所述引流孔与针头部44的通孔共同形成用以引流的引流部，将引流针4通过针尖部43刺入至皮下软组织深筋膜后，所述两个引流孔均位于皮下，而针头部位于皮上，由此藉由中空针体上的引流孔汲取皮下软组织深筋膜中的积液至所述中空结构的空腔42，并由针头部44的通孔排出；所 述针头部44的通孔位于密封膜粘合于皮肤上并覆盖创口闭合装置形成一个密封空间中，藉此可以使得所述皮上负压装置1的作用力(负压)通过引流部41施加于所述引流针4上。
在另一个示例性的实施例中，请参阅图16，其显示为本申请中的引流针在另一实施例中的应用示意图，如图所示，所述引流针4的针体为中空结构，所述针尖部43具有连通所述中空针体的通孔，所述引流针4的针体上设有一个引流孔，所述引流孔与针尖部43的通孔共同形成用以引流的引流部，所述中空针体的空腔42与引流孔相连通。当引流针4刺入皮肤50至皮下软组织深筋膜后，引流针4针体的中下部以及引流孔的中下部均位于皮肤之下，针头部44及引流孔的上部位于皮肤表面之外，由此可在第一方面通过针尖部43的通孔汲取皮下软组织深筋膜中的积液至所述空腔42，另一方面通过位于皮肤之下部分的引流孔汲取皮下软组织深筋膜中的积液至所述空腔42，所述空腔42内的积液通过引流孔的上部排出；所述引流孔的上部位于密封膜粘合于皮肤上并覆盖创口闭合装置形成一个密封空间中，藉此可以使得所述皮上负压装置1的作用力(负压)通过引流部41施加于所述引流针4上。
在又一个示例性的实施例中，所述针尖部43与所述针头部44均分别具有一与中空针体连通的通孔，当引流针4通过针尖部43刺入皮肤50至皮下软组织深筋膜后，所述针体上的引流孔均位于皮下，而针头部位于皮上，所述针头部44的通孔、针尖部43的通孔与引流孔共同形成用以引流的引流部，由此在第一方面藉由针尖部43的通孔汲取皮下软组织深筋膜中的积液至所述空腔42，另一方面通过针体上的引流孔汲取皮下软组织深筋膜中的积液至所述空腔42，所述空腔42内的积液由针头部44的通孔排出；所述针头部44位于密封膜粘合于皮肤上并覆盖创口闭合装置形成一个密封空间中，藉此可以使得所述皮上负压装置1的作用力(负压)通过引流部41施加于所述引流针4上。
在一个示例性的实施例中，请参阅图23，其显示为本申请中引流针在又一实施例中的应用结构示意图，如图所示，所述引流针4的针体为实体结构，所述引流部41为形成于所述针体上的引流槽。在此，引流部41被设计为形成于所述针体上的引流槽，所述实体结构表示所述引流针4的结构被设计为不具有空腔的实心结构，仅通过设置在引流针4针体上的引流槽实现引流；所述引流槽位于密封膜粘合于皮肤上并覆盖创口闭合装置形成一个密封空间中，藉此可以使得所述皮上负压装置1的作用力(负压)通过引流部41施加于所述引流针4上。
在本实施例中，所述引流针4的针体上设有两个引流孔以形成引流部41，将引流针4通过针尖部43刺入至皮下软组织深筋膜后，藉由位于皮肤之下部分的引流孔汲取皮下软组织深筋膜中的积液至所述空腔42，并通过引流槽的上部排出。
应当理解，所述引流槽的数量可以为1个，2个，3个，4个或更多。所述引流槽的排布形式可以为图23所示的对称排布形式，也可以为其他排布形式，如不规则排布等。所述引流 槽的形状包括不限于为图17～图22所示的长条状，还可以为圆形、方形等形状。
在一个示例性的实施例中，所述多根引流针4排列设置在一柔性基板上，所述柔性基板上的多根引流针4刺入皮下软组织深筋膜时以提供收缩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，并且辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
在本实施例中，请参阅图24，其显示为本申请中多根引流针的应用实施例示意图，如图所示，在所述柔性基板上排布有多根引流针4。将所述柔性基板上的多根引流针4刺入皮下软组织深筋膜，所述多根引流针4在第一方面可帮助引流皮下软组织深筋膜中的积液，从而减轻血肿和水肿，由此减少了皮肤的张力，利于软组织恢复；另一方面还提供了收缩力挤压皮缘，使得所述皮肤创口在愈合过程中保持闭合状态。
应当理解，所述多根引流针4在所述柔性基板上的排列方式可按照实际需要进行设置，其包括但不限于图24中所示的多行多列方式，也可是一行多列或者多行一列，也可以是不规则排布形式，可依据需要引流的部位的具体情况来选择多根引流针4在所述柔性基板上的排列方式。
应当理解，所述柔性基板为用来将多根引流针4设置于其上的部件，为保证其与皮肤之间的贴合性，所述柔性基板采用柔性材质，例如树脂材质或硅胶材质等。
在图1所示的实施例中，所述皮下负压引流装置1包括部分探入皮下创口内腔7预设深度的导管10，所述导管10用于产生负压以迫使所述皮下创口内腔7在愈合过程中呈闭合状态。
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7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7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7中，通过产生负压迫使皮下创口内腔7两侧的组织趋向相向(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7，皮下创口内腔7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7中的部分不影响所述皮下创口内腔7两侧的组织的生长。
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7的预设深度，由此可产生负压，保证皮下创口内腔7在愈合过程中呈闭合状态，并同时对皮下创口内腔7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7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D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7的预设深度，由此可产生负压保证皮下创口内腔7在愈合过程中呈闭合状态的同时吸取皮下创口内腔7的积液，使得由于能够及时清除皮下创口内腔7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D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7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7，本实施例特别适用于如图4所示的狭长型(狭长形)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7在愈合康复过程中保持闭合状态，在吸取皮下创口内腔7的积液的同时还可输送液态药物至皮下创口内腔7，进而对皮下创口内腔7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。另外，多根引流针4自所述皮肤创口的周侧刺入至皮下软组织深筋膜，从而对所述皮下软组织深筋膜内的积液进行引流，在此，皮上负压装置3产生的负压也可帮助引流针4对所述皮下软组织深筋膜内的积液引流；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
应当理解，所述皮下创口内腔7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7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1010，以助于形成吸取所述皮下创口内腔7的气体及液体，在一个示例性的实施例中，所述多个通孔1010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的手术，所述导管10上的多个通孔1010也可以被设计为呈间距不等(即，多个通孔1010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7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，由此可通过产生的负压以引流所述皮下创口内腔的积液，并藉由负压装置调整导管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7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，本申请的四肢深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)，所述给药装置用于通过所述导管输送液态药物至所述皮下创口内腔7的预设深度以利于所述皮下创口内腔7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7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7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7，用于稀释所述皮下创口内腔7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7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7内的液体药物吸走，进而将细菌引流清除，皮下创口内腔7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7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10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7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7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21，所述的至少两个闭合件21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21的结合来挤压皮缘，以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21的具体形式来确定闭合件21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，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，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。
在图1所示的实施例中，所述皮上负压装置3包括密封膜30和负压通道31。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；同时，所述皮上负压装置1的作用力(负压)通过其引流部41还被施加于所述多根引流针4上，在引流针4通过其引流部41吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置3作用的负压影响下迫使引流针4刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置2以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
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7。皮下负压导流装置可通过导管10引流皮下创口内腔7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7利于愈合，此为第一方面；在第二方面，通过闭合件21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21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7闭合；第三方面，通过多根引流针4刺入皮下软组织深筋膜后对皮下软组织深筋膜内的积液进行引流，可消除皮下的积血和其他积液，减轻水肿，减少皮肤张力，同时避免感染，改善循环，利于创口的恢复，与此同时，多根引流针4提供的收缩压也可起到挤压皮缘的作用，以使所述皮肤创口在愈合过程中保持闭合状态。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以及引流针 4引流出的积液可被及时吸收。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；第四方面，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皮下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。同时，皮上负压装置产生的负压还可为引流针4提供负压，帮助皮下软组织深筋膜引流。
应当理解，无论是采用传统的缝合手段或是采用本申请中的闭合件使皮肤创口闭合时，均会给缝合处的周边皮肤带来额外的张力，从而引起张力性缺血。同时，对于缝合处的皮下部分也会造成压缩性缺血。本申请藉由皮上负压装置使得所述皮肤创口及其周缘区域的组织向创口收紧的同时，还藉由多根引流针4及柔性基板朝创口方向施加了收缩力(如图12箭头所示)且不会对切缘造成额外的压力，从而避免了张力性缺血和压缩性缺血。
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，其显示为本申请四肢深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1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封空间32的导管以及连通所述皮下创口内腔7的导管为两根不同的导管。
请参阅图14，其显示为本申请四肢深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1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7以及皮上的密封空间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，本申请的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，在一定程度上实现可以实现四肢深筋膜内安全闭合；且本申请采用主动引流进而改善了现有技术中被动引流的方式，能够及时地对皮下组织尤其是深筋膜的积液(例如渗血、渗液等)进行及时处理，进而利于伤口的恢复。由于本申请的外科辅助设备采用无缝线的方式闭合皮肤创口。
在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。
第四方面所述皮上负压装置的作用力(负压)通过其引流部还被施加于所述多根引流针上，在引流针通过其引流部吸收皮下软组织深筋膜周围的积液的同时，也能在皮上负压装置 作用的负压影响下迫使引流针刺入部分的周侧的组织趋向相向贴合，在多根引流针的共同作用下，有助于辅助创口闭合装置以及皮下负压引流装置1对皮肤组织施以向创口方向收拢的作用力，从而起到辅助创口闭合的作用。
第五方面通过多根引流针可对皮下软组织深筋膜内的积液进行引流，从而避免感染、减轻水肿、减少皮肤张力。同时，多根引流针刺入皮肤后还可对皮肤施以压力，并藉由此收缩力实现挤压皮缘的效果，利于患者的恢复。并且，所述皮上负压装置所产生的负压可帮助引流针藉由负压达到更好的引流效果。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。并且，通过本申请的外科辅助设备还可对皮下软组织深筋膜内的积液进行引流，适用于四肢或骨折处的创口闭合。
因此，本申请的四肢深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在愈合康复过程中始终保持闭合状态，并持续对皮下软组织深筋膜进行引流。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，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，也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。
同时，本申请的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备也解决了由于皮下软组织深筋膜积液而引起的肿胀和感染的问题。本申请的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备还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. 一种四肢深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；
    多根引流针，用于自所述皮肤创口的周侧刺入至皮下软组织深筋膜以对所述皮下软组织深筋膜内的积液进行引流，所述引流针包括形成于其针体上的引流部，所述引流针刺入皮下软组织时所述引流部的一部分位于所述皮肤表面之外。
  2. 根据权利要求1所述的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述引流针的针体为中空结构，所述引流部为形成于所述中空结构上的至少一个引流孔。
  3. 根据权利要求2所述的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述引流针包括针头部、中空针体、以及针尖部，所述至少一个引流孔形成于所述中空针体上，所述针头部具有连通所述中空针体的通孔，或者/以及所述针尖部具有连通所述中空针体的通孔。
  4. 根据权利要求1所述的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述引流针的针体为实体结构，所述引流部为形成于所述针体上的引流槽。
  5. 根据权利要求1所述的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述多根引流针排列设置在一柔性基板上，所述柔性基板上的多根引流针刺入皮下软组织深筋膜时以提供收缩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。
  6. 根据权利要求5所述的四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备，其特征在于，所述柔性基板包括树脂材质或硅胶材质。
  7. 根据权利要求1所述的四肢深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，或者 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。
  8. 根据权利要求1所述的四肢深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，用于通过产生的负压以引流所述皮下创口内腔的积液。
  9. 根据权利要求8所述的四肢深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。
  10. 根据权利要求9所述的四肢深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所述的四肢深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，并且所述第二导管套设于所述第一导管内。
  12. 根据权利要求1所述的四肢深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。
  13. 根据权利要求12所述的四肢深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。
  14. 根据权利要求1所述的四肢深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。
  15. 根据权利要求1所述的四肢深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。
  16. 根据权利要求15所述的四肢深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。
  17. 根据权利要求16所述的四肢深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；或者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17所述的四肢深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15所述的四肢深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所述的四肢深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所述的四肢深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材料或硅胶材料。
  22. 根据权利要求15所述的四肢深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所述的四肢深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15所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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所述的四肢深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。
PCT/CN2019/109572 2019-03-19 2019-09-30 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备 WO2020186730A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP19920290.4A EP3943020A4 (en) 2019-03-19 2019-09-30 SURGICAL ASSISTANT DEVICE FOR SEAMLESS WOUND CLOSURE OF SKIN WOUNDS IN DEEP CONNECTIVE TISSUE OF LIMBS
US17/439,167 US20220160951A1 (en) 2019-03-19 2019-09-30 Surgical auxiliary equipment for sutureless closed skin incision in deep fascia limbs

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN201910208814.7 2019-03-19
CN201910208814.7A CN111714171B (zh) 2019-03-19 2019-03-19 皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备
CN201910414748.9 2019-05-17
CN201910414748.9A CN111939333A (zh) 2019-05-17 2019-05-17 无缝线闭合皮肤创口的负压引流及清洗系统
CN201910585716.5 2019-07-01
CN201910585716.5A CN112168256A (zh) 2019-07-01 2019-07-01 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备

Publications (1)

Publication Number Publication Date
WO2020186730A1 true WO2020186730A1 (zh) 2020-09-24

Family

ID=72519647

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2019/109572 WO2020186730A1 (zh) 2019-03-19 2019-09-30 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备

Country Status (3)

Country Link
US (1) US20220160951A1 (zh)
EP (1) EP3943020A4 (zh)
WO (1) WO2020186730A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040039415A1 (en) * 2002-08-21 2004-02-26 Kci Licensing, Inc. Medical closure screen device and method
CN102046118A (zh) * 2008-05-30 2011-05-04 凯希特许有限公司 具有可膨胀的囊的伤口敷料
CN105147344A (zh) * 2015-10-19 2015-12-16 张新平 皮肤伤口辅助愈合装置
CN205215293U (zh) * 2015-10-19 2016-05-11 张新平 皮肤伤口愈合装置
WO2016168081A1 (en) * 2015-04-13 2016-10-20 Mayo Foundation For Medical Education And Research Magnetic wound closure systems
CN107260241A (zh) * 2016-04-07 2017-10-20 浙江海创医疗器械有限公司 创口负压对合装置

Family Cites Families (12)

* 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
US5047047A (en) * 1988-10-26 1991-09-10 Inbae Yoon Wound closing device
US6071267A (en) * 1998-02-06 2000-06-06 Kinetic Concepts, Inc. Medical patient fluid management interface system and method
US7520872B2 (en) * 2002-09-13 2009-04-21 Neogen Technologies, Inc. Closed wound drainage system
WO2008098207A2 (en) * 2007-02-09 2008-08-14 Twin Star Medical, Inc. Method and system for the use of hollow fiber catheters in topical applications
WO2009021047A2 (en) * 2007-08-06 2009-02-12 Ohio Medical Corporation Wound treatment system and suction regulator for use therewith
WO2009070905A1 (de) * 2007-12-07 2009-06-11 Medela Holding Ag Wundabdeckungs-verbindungsvorrichtung
US8721629B2 (en) * 2008-12-02 2014-05-13 Kci Licensing, Inc. System and method for mechanical closure of wounds
US10751050B2 (en) * 2012-06-15 2020-08-25 University Of Washington Microstructure-based wound closure devices
WO2014121051A1 (en) * 2013-02-01 2014-08-07 The Brigham And Women's Hospital, Inc. Swellable adhesive needles
AU2014229749B2 (en) * 2013-03-14 2018-09-20 Smith & Nephew Plc Compressible wound fillers and systems and methods of use in treating wounds with negative pressure
US10123789B1 (en) * 2014-08-22 2018-11-13 James Woodfin Kennedy Variable compressible wound closure device and method

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040039415A1 (en) * 2002-08-21 2004-02-26 Kci Licensing, Inc. Medical closure screen device and method
CN102046118A (zh) * 2008-05-30 2011-05-04 凯希特许有限公司 具有可膨胀的囊的伤口敷料
WO2016168081A1 (en) * 2015-04-13 2016-10-20 Mayo Foundation For Medical Education And Research Magnetic wound closure systems
CN105147344A (zh) * 2015-10-19 2015-12-16 张新平 皮肤伤口辅助愈合装置
CN205215293U (zh) * 2015-10-19 2016-05-11 张新平 皮肤伤口愈合装置
CN107260241A (zh) * 2016-04-07 2017-10-20 浙江海创医疗器械有限公司 创口负压对合装置

Also Published As

Publication number Publication date
EP3943020A4 (en) 2022-12-14
EP3943020A1 (en) 2022-01-26
US20220160951A1 (en) 2022-05-26

Similar Documents

Publication Publication Date Title
US11793679B2 (en) Super-absorbent, reduced-pressure wound dressing and systems
WO2009109351A3 (de) Vorrichtung und verfahren zur überwachung eines zugangs zu einem patienten, insbesondere eines gefässzugangs bei einer extrakorporalen blutbehandlung
CN212415804U (zh) 皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备
WO2020186728A1 (zh) 皮肤浅筋膜内无缝线闭合皮肤创口的外科辅助设备
CN212439529U (zh) 医用引流管及适用的负压引流及清洗系统、外科辅助设备
WO2020186730A1 (zh) 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备
CN211356991U (zh) 无缝线闭合皮肤创口的负压引流及清洗系统
CN211355669U (zh) 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备
WO2020186729A1 (zh) 无缝线闭合皮肤创口的负压引流及清洗系统
CN215079130U (zh) 皮肤浅筋膜内无缝线闭合皮肤创口的外科设备
CN112168256A (zh) 四肢深筋膜内无缝线闭合皮肤创口的外科辅助设备
CN212439530U (zh) 负压引流及清洗系统
CN111939333A (zh) 无缝线闭合皮肤创口的负压引流及清洗系统
Marks et al. Principles and aplications of vacuum-assisted closure (VAC)
AU2013257419B2 (en) Super-absorbent, reduced-pressure wound dressing and systems
Negosanti et al. World Journal of
Benjamin et al. Negative Pressure Wound Therapy for Soft Tissue Infections

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19920290

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2019920290

Country of ref document: EP

Effective date: 20211019