Surgical auxiliary equipment for sutureless closure of skin wounds in the deep fascia of the limbs

Abstract

The present application discloses a surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of limbs, comprising a subcutaneous negative pressure drainage device, a wound closure device, an above-the-skin negative pressure device and a plurality of drainage needles, for draining the accumulated fluid in the subcutaneous soft tissue through the plurality of drainage needles, thereby keeping the accumulated fluid in the subcutaneous soft tissue able to be discharged in time; at the same time, the present application also squeezes the skin edge through the wound closure device, and under the compulsion of the subcutaneous negative pressure drainage device, keeps the subcutaneous wound cavity in a closed state during the healing and rehabilitation process; the subcutaneous negative pressure drainage device can also deliver liquid medicine to the subcutaneous wound cavity while draining the accumulated fluid in the subcutaneous wound cavity, ensuring that the environment of the subcutaneous wound cavity is maintained in a state conducive to wound recovery; and the above-the-skin negative pressure device can generate a force through the negative pressure effect, so that the tissue position of the skin wound and its peripheral area remains in a stable state, thereby achieving the purpose of sutureless closure of the skin wound.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a surgical auxiliary device for closing skin wounds in the deep fascia of limbs without sutures. Background Art

[0002] As we all know, humans have gradually lost their ability to regenerate during the evolution process, and they rely mainly on scar healing to deal with tissue damage caused by trauma. Therefore, there is a close relationship between surgical suturing and tissue healing, and the quality of suturing can determine the quality of tissue healing to a certain extent. Surgical suturing usually uses a curved needle to carry the suture through the severed tissue, and then tightens and fixes the suture by tying knots, so that the severed tissue fits tightly, thereby creating favorable conditions for healing. Ideal surgical suturing should meet the requirements of moderate tension, good incision edge alignment, no dead space, and no permanent or only a small amount of suture marks.

[0003] Closing skin lacerations by suturing will cause changes in skin tension and affect skin blood circulation. After the sutures pass through the tissue, they are tightened and knotted, which can cause the tissue to shift and bring squeezing pressure to the local tissue. This squeezing pressure has a dual effect: on the one hand, it can eliminate the dead space at the incision edge and reduce bleeding at the skin edge, which is beneficial to tissue healing; on the other hand, the squeezing caused by the sutures can cause relative ischemia of the skin edge tissue, bringing the risk of tissue necrosis and scar hyperplasia. In addition, the tightening and knotting of the sutures can cause the local tissue to move toward the incision edge, which can increase the tension of the peripheral skin and increase the risk of soft tissue ischemia and necrosis in specific parts, especially when the soft tissue volume of the limbs of the human body is limited, and the ability of this part to resist swelling is relatively weak, which has a higher risk of soft tissue ischemia and necrosis. Summary of the invention

[0004] In view of the shortcomings of the prior art mentioned above, the purpose of the present application is to provide a surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs, which is used to solve the problems in the prior art that postoperative incision sutures are prone to leave marks and the accumulated fluid is difficult to drain, especially the problems caused by higher ischemia and hypoxia in the soft tissues and skin wounds of the human limbs.

[0005] To achieve the above-mentioned purpose and other related purposes, the present application provides a surgical auxiliary equipment for sutureless closure of skin wounds in the deep fascia of limbs, including: a subcutaneous negative pressure drainage device, the subcutaneous negative pressure drainage device includes a catheter that partially penetrates into the inner cavity of the subcutaneous wound to a preset depth, and is used to generate negative pressure to force the inner cavity of the subcutaneous wound to be in a closed state during the healing process; a wound closure device, arranged on the peripheral side of the skin wound, and is used to squeeze the skin edge so that the skin wound remains in a closed state during the healing process; an supraskin negative pressure device, arranged on the peripheral edge of the skin wound, and is used to generate negative pressure to maintain the stability of the tissue position of the skin wound and its peripheral area; a plurality of drainage needles, which are used to penetrate from the peripheral side of the skin wound into the deep fascia of the subcutaneous soft tissue to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue, the drainage needle including a drainage portion formed on its needle body, and a portion of the drainage portion is located outside the skin surface when the drainage needle penetrates the deep fascia of the subcutaneous soft tissue.

[0006] In certain embodiments of the present application, 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.

[0007] In certain embodiments of the present application, 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, the needle head has a through hole connected to the hollow needle body, and / or the needle tip has a through hole connected to the hollow needle body.

[0008] In certain embodiments of the present application, the needle body of the drainage needle is a solid structure, and the drainage portion is a drainage groove formed on the needle body.

[0009] In certain embodiments of the present application, the plurality of drainage needles are arranged on a flexible substrate, and when the plurality of drainage needles on the flexible substrate penetrate into the deep fascia of the subcutaneous soft tissue, they provide a contraction force to squeeze the skin edge so that the skin wound remains closed during the healing process.

[0010] In some embodiments of the present application, the flexible substrate includes a resin material or a silicone material.

[0011] In certain embodiments of the present application, the catheter partially penetrates to a preset depth of the subcutaneous wound cavity through a preset position of the skin wound, or the catheter passes through the skin and subcutaneous tissue through a preset position away from the skin wound to partially penetrate to a preset depth of the subcutaneous wound cavity.

[0012] In certain embodiments of the present application, the subcutaneous negative pressure drainage device also includes a negative pressure device for generating and controlling negative pressure, wherein the negative pressure device is connected to the catheter and is used to drain the accumulated fluid in the subcutaneous wound cavity by generating negative pressure.

[0013] In certain embodiments of the present application, a drug delivery device is further included for delivering liquid medicine to a preset depth of the subcutaneous wound cavity through the catheter.

[0014] In certain embodiments of the present application, the catheter includes a first catheter and a second catheter isolated from the first catheter, the first catheter is connected to the negative pressure device, and the second catheter is connected to the drug delivery device.

[0015] In certain embodiments of the present application, the first catheter and the second catheter are integrally formed, and the second catheter is sleeved inside the first catheter.

[0016] In certain embodiments of the present application, the preset depth is the depth of the interval from the superficial fascia of the skin to the fat layer and the deep fascia layer in the skin tissue.

[0017] In certain embodiments of the present application, the preset depth is the junction of the fat layer and the deep fascia layer in the skin tissue.

[0018] In certain embodiments of the present application, a plurality of through holes are provided on the wall of the portion of the catheter that penetrates into the skin wound to a preset depth.

[0019] In certain embodiments of the present application, the wound closure device includes at least two closing members, which are respectively arranged on the two side edges of the skin wound, and are used to squeeze the skin edges to keep the skin wound in a closed state during the healing process.

[0020] In certain embodiments of the present application, the wound closure device further comprises a microporous covering member covering the closure member and the skin wound to absorb the accumulated fluid secreted from the skin wound.

[0021] In certain embodiments of the present application, the microporous covering is combined with the closure member in accordance with the outer shape structure of the closure member; or the microporous covering and the closure member are integrally formed.

[0022] In certain embodiments of the present application, the material of the microporous covering is foam, mesh, gauze, sponge, or porous biocompatible material.

[0023] In certain embodiments of the present application, the closure member includes: a flexible body, adhered to the skin surface on one side of the skin wound; a rigid curved needle, a root of which is arranged on the flexible body, and a curved needle portion of which is exposed outside the flexible body, for piercing one side of the skin wound to squeeze the skin edge so that the skin wound remains in a closed state during the healing process.

[0024] In certain embodiments of the present application, the closure member further comprises a clamping member for clamping the flexible body bonded to both sides of the skin wound to provide opposite forces to squeeze the skin edges so that the skin wound remains in a closed state during the healing process.

[0025] In certain embodiments of the present application, the flexible body is made of resin material or silicone material.

[0026] In certain embodiments of the present application, the closing member includes: a first combining portion, formed on a flexible body; a second combining portion corresponding to the first combining portion, formed on another flexible body; the first combining portion and the second combining portion are combined to provide opposite forces of the flexible body applied to both sides of the skin wound to squeeze the skin edge so that the skin wound remains in a closed state during the healing process.

[0027] In certain embodiments of the present application, the first combining portion is a groove structure or a buckle structure, and the second combining portion is a protrusion structure that can be confined in the groove structure or a hole or hook structure corresponding to the buckle.

[0028] In certain embodiments of the present application, the wound closure device further comprises an auxiliary component, which is used to adhere to the at least two closure components and the skin surface, and is used to provide a contraction force to the at least two closure components to close the skin wound.

[0029] In certain embodiments of the present application, the auxiliary component includes adhesive tape.

[0030] In certain embodiments of the present application, the skin negative pressure device includes: a sealing film, which is used to adhere to the skin and cover the wound closure device to form a sealed space; a negative pressure channel, which is connected to a negative pressure device, and the negative pressure generated by the negative pressure device is used to cause the sealing film to provide a contraction force to drive the skin wound to contract, thereby assisting the wound closure device to close the skin wound.

[0031] In certain embodiments of the present application, the sealing film is bonded to the surface of the skin via its adhesive layer opposite to the skin surface, and the material of the adhesive layer comprises a flexible impermeable material of polyurethane coated with an acrylic adhesive.

[0032] In certain embodiments of the present application, the sealing film is provided with an observation window made of a light-transmitting material.

[0033] In certain embodiments of the present application, the skin negative pressure device includes a humidity detection component for providing the detected humidity information in the sealed space to the negative pressure device so as to facilitate the negative pressure device to regulate the negative pressure output.

[0034] In certain embodiments of the present application, the skin negative pressure device is also used to generate negative pressure so that the sealing film applies pressure to the skin tissue to assist in forcing the inner cavity of the subcutaneous wound to be in a closed state during the healing process.

[0035] In certain embodiments of the present application, the supracutaneous negative pressure device and the subcutaneous negative pressure drainage device share a negative pressure device.

[0036] In certain embodiments of the present application, the catheter includes subcutaneous drainage holes and supracutaneous negative pressure holes, the subcutaneous drainage holes are multiple through holes arranged on the tube wall of the portion of the catheter that penetrates into the skin wound to a preset depth; the supracutaneous negative pressure holes are connected to the sealed space to apply negative pressure to the sealed space.

[0037] As described above, the surgical auxiliary equipment for sutureless closure of skin wounds in the deep fascia of the limbs of the present application includes a subcutaneous negative pressure drainage device, a wound closure device, an supracutaneous negative pressure device and multiple drainage needles, which are used to drain the accumulated fluid in the subcutaneous soft tissue through the multiple drainage needles, so as to keep the accumulated fluid in the subcutaneous soft tissue discharged in time; at the same time, the present application also squeezes the skin edge through the wound closure device, and under the force of the subcutaneous negative pressure drainage device, the subcutaneous wound cavity is kept in a closed state during the healing and rehabilitation process. The subcutaneous negative pressure drainage device can drain the accumulated fluid in the subcutaneous wound cavity while also delivering liquid drugs to the subcutaneous wound cavity, ensuring that the environment of the subcutaneous wound cavity is maintained in a state conducive to wound recovery; and the supracutaneous negative pressure device can generate a force through the action of negative pressure, so that the tissue position of the skin wound and its surrounding area remains in a stable state, thereby achieving the purpose of sutureless closure of the skin wound. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 Shown is a schematic diagram of an embodiment of a surgical auxiliary device for sutureless closure of skin wounds within the deep fascia of a limb according to the present application.

[0039] Figure 2 Shown is a schematic diagram of a subcutaneous negative pressure drainage device of the surgical auxiliary equipment of the present application in one embodiment.

[0040] Figure 3 Shown is a schematic diagram of a subcutaneous negative pressure drainage device of the surgical auxiliary equipment of the present application in another embodiment.

[0041] Figure 4 Display as Figure 3 A schematic diagram of a middle catheter passing through the skin and subcutaneous tissue from a preset position away from the skin wound to partially penetrate into the narrow and long wound.

[0042] Figure 5 Shown is a schematic structural diagram of a closing member in a wound closure device in one embodiment of the present application.

[0043] Figure 6 Shown is a schematic diagram of an embodiment of the present application in which a closure member is combined with a wound.

[0044] Figure 7 The diagram shows a further embodiment of a closure member of the wound closure device of the present application.

[0045] Figure 8 It is a schematic diagram showing the application of an auxiliary member in one embodiment of a closing member of the wound closure device of the present application.

[0046] Fig. 9 Shown is a schematic diagram of an embodiment of a catheter structure of the present application.

[0047] Fig.10 Shown is a schematic diagram of another embodiment of the catheter structure of the present application.

[0048] Fig.11 Shown is a schematic structural diagram of a closing member in the wound closure device of the present application in yet another embodiment.

[0049] Fig.12 Shown is a schematic diagram of the sealing and force-bearing structure of the supra-skin negative pressure device in one embodiment of the present application.

[0050] Fig.13 Shown is a schematic diagram of another embodiment of the surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of limbs of the present application.

[0051] Fig.14 Shown is a schematic diagram of yet another embodiment of the surgical auxiliary device for sutureless closure of skin wounds within the deep fascia of limbs of the present application.

[0052] Fig.15 Shown is a schematic diagram of the application of the drainage needle of the present application in one embodiment.

[0053] Fig.16 Shown is a schematic diagram of the application of the drainage needle in the present application in another embodiment.

[0054] Figure 17-18 Shown is a schematic structural diagram of a drainage needle of the present application in one embodiment.

[0055] Figure 19-20 Shown is a schematic structural diagram of the drainage needle of the present application in another embodiment.

[0056] Figure 21-22 Shown is a schematic structural diagram of a drainage needle of the present application in yet another embodiment.

[0057] Fig.23 Shown is a schematic diagram of the application structure of the drainage needle in another embodiment of the present application.

[0058] Fig.24 Shown is a schematic diagram of an application example of multiple drainage needles in this application. DETAILED DESCRIPTION

[0059] The following is an explanation of the implementation of the present application by means of specific embodiments. People familiar with the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0060] In the following description, with reference to the accompanying drawings, several embodiments of the present application are described. It should be understood that other embodiments may also be used, and mechanical composition, structure, electrical and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims of the published patents. The terms used here are only to describe specific embodiments and are not intended to limit the present application. Spatially related terms, such as "upper", "lower", "left", "right", "below", "below", "lower", "above", "upper", etc., may be used in the text to facilitate the description of the relationship between an element or feature shown in the figure and another element or feature.

[0061] Although the terms first, second, etc. are used to describe various elements or parameters in some instances, 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. For example, the first conduit can be referred to as the second conduit, and similarly, the second conduit can be referred to as the first conduit without departing from the scope of the various described embodiments. The first conduit and the second conduit are both describing a conduit, but unless the context otherwise clearly indicates, they are not the same conduit.

[0062] Furthermore, as used in this article, the singular forms "one", "an" and "the" are intended to include plural forms as well, unless there is an indication to the contrary in the context. It should be further understood that the terms "comprise", "include" indicate the presence of the described features, steps, operations, elements, components, projects, kinds, and / or groups, but do not exclude the presence, occurrence or addition of one or more other features, steps, operations, elements, components, projects, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Therefore, "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". Exceptions to this definition will only occur when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way.

[0063] The treatment of the wound (also called incision or surgical incision, wound, etc.) inevitably caused by the patient during the operation is mostly done by suturing to help the patient's wound heal. In this treatment process, that is, after the wound is sutured with needle and thread, in order to facilitate the healing of the wound, the industry uses a decompression dressing assembly in the application of closing force. The decompression dressing assembly includes a cushion body with a closing component formed by a closing cushion material. When the closing dressing cushion is placed under decompression, the closing component can generate an inward closing force. In some cases, the assembly also includes a wicking material, which has a fluid flow path for removing fluid. However, this method still requires suturing the wound during the application process, which can only help suturing and healing, and cannot completely replace the suturing step, so it will still leave suture marks on the patient's skin. In addition, the closing force generated in this structure can only act on the surface. When the wound is deep, the muscle tissue deeper under the skin cannot be forced to be closed. The wicking material can only handle the liquid seeping from the skin surface, but cannot deal with the accumulated fluid under the skin (such as bleeding, exudate, etc.) in time, which is not conducive to wound recovery.

[0064] Especially in the treatment of limb trauma, soft tissue tension has always been an important factor affecting healing. Trauma brings about local tissue inflammatory response, which increases vascular permeability and causes tissue edema; a large amount of fluid accumulation in the tissue can increase local tissue tension and tissue hypoxia, forming a vicious cycle, leading to extensive tissue necrosis. This tissue edema caused by inflammation can cause increased pressure in the deep tissue fascia compartment, forming fascia compartment syndrome, leading to limb necrosis. In the skin and soft tissue layer, severe tissue swelling can also cause blood flow obstruction to the skin and soft tissue, causing skin non-healing, skin edge necrosis, and extensive skin ischemic necrosis. Skin and soft tissue necrosis will lead to bone exposure, tendon exposure, or internal fixation plate exposure, which can lead to serious problems such as chronic infection (osteomyelitis) and fracture non-healing, which significantly increases the cost of treatment and significantly prolongs the treatment cycle. Effectively combating tissue edema, protecting skin and soft tissue safety, and beautifully closing skin incisions after limb trauma have become technical problems that people in this field are looking forward to solving.

[0065] In addition, if edema occurs under the deep fascia in the soft tissues of the limbs, it is more likely to cause inflammation. That is, edema squeezes blood vessels and causes tissue ischemia, which leads to tissue necrosis and hypoxia, forming a vicious cycle. Furthermore, in the treatment of common limb fractures, it is often necessary to make incisions in limbs, such as the calf, to fix the fracture and then close the incision. Since the soft tissue volume of the human limbs is limited, the ability of this part to resist swelling is relatively weak, and swelling will cause more serious problems.

[0066] In view of this, the present application provides a surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures, in order to replace the traditional needle and thread suturing method for skin soft tissue and achieve the purpose of closing skin wounds and draining the accumulated fluid in the subcutaneous soft tissue. In the embodiments provided below, the surgical auxiliary device for closing skin wounds in the deep fascia of the limbs of the present application without sutures includes: a subcutaneous negative pressure drainage device, a wound closure device, an upper skin negative pressure device, and a plurality of drainage needles, which are used to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue through the hollow structure and the drainage holes through the plurality of drainage needles, so as to keep the accumulated fluid in the deep fascia of the subcutaneous soft tissue discharged in time and maintain the environment in the subcutaneous soft tissue in a healthy state. At the same time, the present application also squeezes the skin edge through the wound closure device, and under the pressure of the subcutaneous negative pressure drainage device, the subcutaneous wound cavity is kept in a closed state during the healing process. The subcutaneous negative pressure drainage device can also deliver liquid drugs to the subcutaneous wound cavity while draining the effusion in the subcutaneous wound cavity, ensuring that the environment of the subcutaneous wound cavity remains in a state conducive to wound recovery. In addition, the skin negative pressure device can generate a force through the negative pressure effect to keep the tissue position of the skin wound and its peripheral area stable, thereby achieving the purpose of closing the skin wound without sutures.

[0067] The surgical auxiliary equipment for sutureless closure of skin wounds in the deep fascia of the limbs of the present application, on the one hand, makes the exposed two ends of the skin wound close together through the wound closure device, and the wound closure device can squeeze the skin edge while closing the wound, thereby reducing the bleeding of the subdermal vascular network of the skin; on the other hand, under the pressure of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound is kept in a closed state during the healing and recovery process, the severed tissue is kept in a fitted state, and the bleeding and exudate in the wound cavity are kept cleared in time through continuous negative pressure suction; on this basis, by intermittently delivering liquid drugs to the inner cavity of the subcutaneous wound, the coagulated blood clots in the inner cavity of the subcutaneous wound are moistened to facilitate removal, and the potential bacterial community that has reached the colonization concentration is diluted and removed with the drainage of the flushing fluid, thereby maintaining the clean state of the wound cavity; on the third hand, negative pressure can be generated by the skin negative pressure device to maintain the stable position of the tissues of the skin wound and its surrounding area, thereby facilitating tissue healing. Fourthly, multiple drainage needles can be used to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue, eliminate subcutaneous blood and other tissue fluids, and under the joint action of multiple drainage needles, it helps the auxiliary wound closure device and the subcutaneous negative pressure drainage device to exert a force on the skin tissue to close in the direction of the wound, thereby facilitating the recovery of the skin wound. In addition, the surgical auxiliary device of the present application can achieve suture-free closure of the entire layer of tissue above the deep fascia of the skin, avoiding transverse scars on the skin surface caused by suture compression / cutting, and no suture knots are left in the superficial fascia, thereby eliminating the important factors causing bacterial colonization and the main cause of recurrence of incisional infection.

[0068] It should be understood that in the embodiments of the present application, the skin wound includes any tear formed by the interruption of the continuity of the skin or other tissue parts, and broadly refers to the incision, wound, defect or other treatment target located on or in the tissue. It should be noted that the skin wound is mostly caused by surgery, but in some cases, the skin wound may also be caused by accidents such as cuts or collisions.

[0069] In some embodiments, 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 ruptured wounds; partial thickness burns, ulcers (such as diabetic ulcers, pressure ulcers or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" may also refer to any tissue area that is not necessarily injured or defective, but rather an area in which it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that may be harvested and transplanted.

[0070] It should be understood that the sutureless mentioned in the present application refers to a treatment method in which the superficial fascia of the skin (i.e., the epidermis, dermis and subcutaneous fat tissue of the skin) or the above-mentioned superficial fascia of the skin is not sewed (sutured) with needles and threads in the treatment of closing skin wounds or in the process of skin wound healing or in other treatments of skin wounds after surgery, such as cleaning, disinfection, and dressing. Medical tools such as suture needles and sutures are not used in these processes. Therefore, after the skin wound is healed, there is no process for removing foreign bodies from the wound or the superficial fascia of the skin, such as the steps and operations of removing or removing sutures or taking out thread ends.

[0071] It should be understood that in some cases, the deep fascia is also called the fascia propria. The deep fascia is composed of dense connective tissue and is located deep to the superficial fascia. It covers the muscles, blood vessels, nerves, etc. of the body wall and limbs. The deep fascia has a very close relationship with the muscles and is layered according to the layers of the muscles. In the limbs, the deep fascia extends between the muscle groups and attaches to the bones to form the muscle intervals; it forms a fascial sheath with the deep fascia that surrounds the muscle groups; the deep fascia also surrounds the blood vessels and nerves to form a vascular nerve sheath; it can also provide muscle attachment or serve as the starting point of the muscle.

[0072] The deep fascia also refers to all the orderly arranged dense fiber layers that interact with muscles; the deep fascia connects different components of the skeletal muscle system and transmits muscle contraction force to distant places. In the matrix, wavy collagen fibers coexist with a small amount of elastin fibers. In the deep fascia, the collagen fibers in the matrix have three different directions: oblique, longitudinal, and transverse. Among the fascia, it has the most extensive continuity and strong elasticity. It is tightly wrapped on the surface of the muscle to prevent excessive expansion of the muscle belly caused by muscle contraction. When the muscle contracts, in order to avoid friction between adjacent muscles, it plays a role in helping slippage. Sometimes the deep fascia separates from other wrapped structures and combines with another layer of membrane. As a result, some fascia are connected to other fascia. There are areas where muscle fibers are inserted to form attachment parts. Assist the continuity of periosteum, perichondrium, ligaments, etc. Support blood vessels, nerves and lymphatic vessels, and have the mechanical function to allow them to pass through them.

[0073] In an exemplary embodiment, see Figure 1 , Figure 1 Shown is a schematic diagram of a surgical auxiliary device of the present application in one embodiment. As shown in the figure, the surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs of the present application includes: a subcutaneous negative pressure drainage device 1, a wound closure device 2, a supracutaneous negative pressure device 3, and multiple drainage needles 4.

[0074] exist Figure 1 In the embodiment shown, the surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs of the present application has multiple drainage needles 4 used to penetrate from the peripheral side of the skin wound to the deep fascia of the subcutaneous soft tissue to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue, and the drainage needle 4 includes a drainage portion 41 formed on the needle body thereof, and a portion of the drainage portion 41 is located outside the skin surface when the drainage needle 4 penetrates 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 the multiple drainage needles 4 through the drainage part 41. When the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through the drainage part 41, the negative pressure of the subcutaneous negative pressure device 3 can force the tissues around the pierced part of the drainage needle 4 to tend to fit together. Under the joint action of the multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous negative pressure drainage device 1 to apply a force to the skin tissue to retract toward the wound, thereby playing a role in assisting the wound closure.

[0075] It should be understood that subcutaneous soft tissue refers to the soft tissue located under the human skin, including muscles, tendons, ligaments, joint capsules, synovial capsules, nerves, blood vessels, etc. When the subcutaneous soft tissue is damaged uncontrollably, it will cause subcutaneous blood accumulation and swelling in the subcutaneous soft tissue. If the swelling is not removed in time, it will cause tissue necrosis, which will have a serious impact on the patient's recovery.

[0076] In the present embodiment, the drainage needle 4 is arranged on the peripheral side of the skin wound to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue. In other embodiments, the injury to the human body does not leave a wound on the skin surface, such as in the case of damage to the subcutaneous soft tissue such as fractures. At this time, it is also necessary to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue to eliminate edema and avoid further necrosis of the tissue. In this case, the drainage needle 4 can be set at the position corresponding to the position of the injured deep fascia of the subcutaneous soft tissue, or near the position of the injured deep fascia of the subcutaneous soft tissue or other parts that need drainage, etc., according to actual needs. Therefore, the drainage needle 4 in the present application is particularly suitable for the damage of the deep fascia of the subcutaneous soft tissue in the limbs or fractures of the human body.

[0077] It should be understood that 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 enable the drainage needle 4 to drain the fluid in the deep fascia of the subcutaneous soft tissue out of the body, the drainage part of the drainage needle 4 is exposed outside the skin surface. The drainage needle 4 has a drainage part 41, which is a part arranged on the needle body of the drainage needle 4 to help drain the subcutaneous fluid.

[0078] It should be understood that the shape of the drainage needle 4 can be cylindrical or other special-shaped structures. Any shape that can puncture the skin and can provide a drainage portion 41 on the needle body of the drainage needle 4 to perform a drainage function can be applied in the present invention.

[0079] It should be understood that in the process of drainage by inserting multiple drainage needles 4 into the deep fascia of the subcutaneous soft tissue, the subcutaneous portion of the drainage needles 4 does not affect the growth of tissues on both sides of the subcutaneous wound cavity 7. After the wound heals, the needle holes left on the skin and subcutaneous soft tissue after the drainage needles 4 are removed can heal themselves.

[0080] In an exemplary embodiment, 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, and the hollow structure and the drainage portion 41 cooperate with each other to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue.

[0081] In an exemplary embodiment, see Figure 17-18, which is a schematic structural diagram of the drainage needle of the present application in one embodiment. As shown in the figure, the needle body of the drainage needle 4 is a hollow structure, and four drainage holes are evenly distributed on the needle body of the drainage needle 4 to form a drainage part 41, and the drainage holes are respectively located on the front side, left side, right side and rear side of the needle body, and the cavity 42 of the hollow structure is connected to the drainage hole. After the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, the hollow structure cooperates with the drainage part 41 to drain the accumulated fluid 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 the multiple drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the tissues around the inserted part of the drainage needle 4 to tend to fit together under the influence of the negative pressure of the supracutaneous negative pressure device 3. Under the joint action of the multiple drainage needles, it helps the auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 to exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0082] In another exemplary embodiment, see Figure 19-20 , which shows a schematic structural diagram of the drainage needle of the present application in another embodiment. As shown in the figure, the needle body of the drainage needle 4 is a hollow structure, and a drainage hole is evenly distributed on the needle body of the drainage needle 4 to form a drainage part 41, and the cavity 42 of the hollow structure is connected to the drainage hole. After the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, the hollow structure cooperates with the drainage part 41 to drain the accumulated fluid 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 the multiple drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the tissues around the inserted part of the drainage needle 4 to tend to fit together under the influence of the negative pressure of the supracutaneous negative pressure device 3. Under the joint action of the multiple drainage needles, it helps the auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 to exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0083] In yet another exemplary embodiment, see Figure 21-22, which is a schematic structural diagram of the drainage needle of the present application in another embodiment. As shown in the figure, the needle body of the drainage needle 4 is a hollow structure, and three drainage holes are evenly distributed on the needle body of the drainage needle 4 to form a drainage part 41, and the cavity 42 of the hollow structure is connected to the drainage hole. After the drainage needle 4 penetrates the skin to the deep fascia of the subcutaneous soft tissue, the hollow structure cooperates with the drainage part 41 to drain the accumulated fluid 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 the multiple drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the tissues around the inserted part of the drainage needle 4 to tend to fit together under the influence of the negative pressure of the supracutaneous negative pressure device 3. Under the joint action of the multiple drainage needles, it helps the auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 to exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0084] It should be understood that the number of the drainage holes can be 1, 2, 3, 4 or more. The arrangement of the drainage holes can be Figure 17 to Figure 22 The single row regular arrangement shown in the figure may also be other arrangements, such as multiple rows, irregular arrangements, etc. The shape of the drainage holes includes but is not limited to: Figure 17 to Figure 22 The strip shape shown can also be round, square or other shapes.

[0085] In an exemplary embodiment, see Fig.15 , which is a schematic diagram of the application of the drainage needle of the present application in one embodiment. As shown in the figure, the drainage needle 4 includes a needle head 44, a hollow needle body, and a needle tip 43. The at least one drainage hole is formed on the hollow needle body, and the needle head has a through hole connected to the hollow needle body, or / and the needle tip 43 has a through hole connected to the hollow needle body. Here, the end of the drainage needle 4 that pierces the skin is defined as the needle tip 43, and the other end is defined as the needle head 44.

[0086] In an exemplary embodiment, please refer to Fig.15The needle body of the drainage needle is a hollow structure, and the needle head 44 has a through hole connected to the hollow needle body. The needle body of the drainage needle 4 is provided with two drainage holes, and the drainage holes and the through hole of the needle head 44 together form a drainage part for drainage. After the drainage needle 4 is inserted into the deep fascia of the subcutaneous soft tissue through the needle tip 43, the two drainage holes are both located under the skin, and the needle head is located on the skin, thereby drawing the accumulated fluid in the deep fascia of the subcutaneous soft tissue into the cavity 42 of the hollow structure through the drainage holes on the hollow needle body, and discharged from the through hole of the needle head 44; the through hole of the needle head 44 is located in a sealed space formed by the sealing film bonded to the skin and covering the wound closure device, thereby allowing the force (negative pressure) of the above-skin negative pressure device 1 to be applied to the drainage needle 4 through the drainage part 41.

[0087] In another exemplary embodiment, see Fig.16 , which shows a schematic diagram of the application of the drainage needle in the present application in another embodiment. As shown in the figure, the needle body of the drainage needle 4 is a hollow structure, the needle tip 43 has a through hole connected to the hollow needle body, and a drainage hole is provided on the needle body of the drainage needle 4. The drainage hole and the through hole of the needle tip 43 together form a drainage part for drainage, and the cavity 42 of the hollow needle body is connected to the drainage hole. When the drainage needle 4 penetrates the skin 50 to the deep fascia of the subcutaneous soft tissue, 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 both located under the skin, and the needle head 44 and the upper part of the drainage hole are located outside the skin surface. Therefore, on the one hand, the accumulated fluid in the deep fascia of the subcutaneous soft tissue can be drawn to the cavity 42 through the through hole of the needle tip 43, and on the other hand, the accumulated fluid in the deep fascia of the subcutaneous soft tissue can be drawn to the cavity 42 through the drainage hole located under the skin, and the accumulated fluid in the cavity 42 is discharged through the upper part of the drainage hole; the upper part of the drainage hole is located in a sealed space formed by the sealing film bonded to the skin and covering the wound closure device, thereby allowing the force (negative pressure) of the subcutaneous negative pressure device 1 to be applied to the drainage needle 4 through the drainage part 41.

[0088] In another exemplary embodiment, the needle tip 43 and the needle head 44 each have a through hole connected to the hollow needle body. When the drainage needle 4 penetrates the skin 50 through the needle tip 43 to the deep fascia of the subcutaneous soft tissue, the drainage holes on the needle body are all located subcutaneously, while the needle head is located above the skin. The through hole of the needle head 44, the through hole of the needle tip 43 and the drainage hole together form a drainage portion for drainage, thereby, on the first hand, the accumulated fluid in the deep fascia of the subcutaneous soft tissue is drawn into the cavity 42 through the through hole of the needle tip 43, and on the other hand, the accumulated fluid in the deep fascia of the subcutaneous soft tissue is drawn into the cavity 42 through the drainage hole on the needle body, and the accumulated fluid in the cavity 42 is discharged from the through hole of the needle head 44; the needle head 44 is located in a sealed space formed by a sealing film bonded to the skin and covering the wound closure device, thereby allowing the force (negative pressure) of the subcutaneous negative pressure device 1 to be applied to the drainage needle 4 through the drainage portion 41.

[0089] In an exemplary embodiment, see Fig.23 , which shows a schematic diagram of the application structure of the drainage needle in another embodiment of the present application. As shown in the figure, the needle body of the drainage needle 4 is a solid structure, and the drainage portion 41 is a drainage groove formed on the needle body. Here, the drainage portion 41 is designed as a drainage groove formed on the needle body, and the solid structure means that the structure of the drainage needle 4 is designed as a solid structure without a cavity, and drainage is achieved only by the drainage groove set on the needle body of the drainage needle 4; the drainage groove is located in a sealed space formed by the sealing film being bonded to the skin and covering the wound closure device, thereby allowing the force (negative pressure) of the skin negative pressure device 1 to be applied to the drainage needle 4 through the drainage portion 41.

[0090] In this embodiment, two drainage holes are provided on the needle body of the drainage needle 4 to form a drainage portion 41. After the drainage needle 4 is inserted into the deep fascia of the subcutaneous soft tissue through the needle tip 43, the accumulated fluid in the deep fascia of the subcutaneous soft tissue is drawn into the cavity 42 through the drainage hole located under the skin, and discharged through the upper part of the drainage groove.

[0091] It should be understood that the number of the drainage grooves can be 1, 2, 3, 4 or more. The arrangement of the drainage grooves can be Fig.23 The symmetrical arrangement shown in the figure may also be other arrangements, such as irregular arrangements, etc. The shape of the drainage groove includes but is not limited to: Figure 17 to Figure 22 The strip shape shown can also be round, square or other shapes.

[0092] In an exemplary embodiment, the multiple drainage needles 4 are arranged on a flexible substrate. When the multiple drainage needles 4 on the flexible substrate penetrate into the deep fascia of the subcutaneous soft tissue, they provide a contraction force to squeeze the skin edge so that the skin wound remains closed during the healing process. The auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0093] In this example, see Fig.24 , which is a schematic diagram of an application embodiment of multiple drainage needles in the present application. As shown in the figure, multiple drainage needles 4 are arranged on the flexible substrate. The multiple drainage needles 4 on the flexible substrate are inserted into the deep fascia of the subcutaneous soft tissue. The multiple drainage needles 4 can help drain the effusion in the deep fascia of the subcutaneous soft tissue, thereby reducing hematoma and edema, thereby reducing the tension of the skin and facilitating the recovery of the soft tissue; on the other hand, they also provide a contraction force to squeeze the skin edge, so that the skin wound remains closed during the healing process.

[0094] It should be understood that the arrangement of the plurality of drainage needles 4 on the flexible substrate can be set according to actual needs, including but not limited to: Fig.24 The multiple rows and columns shown in the figure may also be one row and multiple columns or multiple rows and one column, or may be an irregular arrangement. The arrangement of the multiple drainage needles 4 on the flexible substrate may be selected according to the specific conditions of the parts that need drainage.

[0095] It should be understood that the flexible substrate is a component for arranging the plurality of drainage needles 4 thereon. To ensure its fit with the skin, the flexible substrate is made of a flexible material, such as a resin material or a silicone material.

[0096] exist Figure 1 In the illustrated embodiment, the subcutaneous negative pressure drainage device 1 comprises a catheter 10 partially inserted into the subcutaneous wound cavity 7 to a preset depth, and the catheter 10 is used to generate negative pressure to force the subcutaneous wound cavity 7 to be in a closed state during the healing process.

[0097] In an exemplary embodiment, see Figure 2, which is a schematic diagram of a subcutaneous negative pressure drainage device of a surgical auxiliary device of the present application in one embodiment. As shown in the figure, the subcutaneous negative pressure drainage device 1 includes a catheter 10 partially inserted into a preset depth of a subcutaneous wound cavity 7. The catheter 10 is used to generate negative pressure to force the subcutaneous wound cavity 7 to be closed during the healing process, maintain the severed tissue in a fitted state, and keep the bleeding and exudate in the wound cavity cleared in time through continuous negative pressure suction. In the actual implementation process, the catheter 10 of the subcutaneous negative pressure drainage device 1 is inserted into the subcutaneous wound cavity 7, and the tissues on both sides of the subcutaneous wound cavity 7 are forced to move toward each other by generating negative pressure (as shown in FIG. 1 ). Figure 2 The middle arrow (in the direction indicated by the arrows on both sides of the subcutaneous wound 4) fits to eliminate the subcutaneous wound cavity 7. The closure of the subcutaneous wound cavity 7 is conducive to wound healing. It should be understood that in this process, the portion 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.

[0098] In another exemplary embodiment, please continue to refer to Figure 2 As shown in the figure, the catheter 10 partially penetrates into the preset depth of the subcutaneous wound cavity 7 through a preset position of the skin wound, thereby generating negative pressure to ensure that the subcutaneous wound cavity 7 is in a closed state during the healing process, and at the same time drains the accumulated fluid in the subcutaneous wound cavity 7, thereby maintaining the separated tissue in a fitted state, and maintaining the bleeding and exudate in the wound cavity through continuous negative pressure suction to be promptly removed, so that the living space or environment of bacteria can be eliminated because the accumulated fluid such as bleeding and / or exudate in the subcutaneous wound cavity 7 can be promptly removed. In this embodiment, the preset position can 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.

[0099] In another exemplary embodiment, see Figure 3 , which is a schematic diagram of a subcutaneous negative pressure drainage device of the surgical auxiliary equipment of the present application in another embodiment. As shown in the figure, the catheter 10 passes through a preset position (such as Figure 3 The position shown at D in the figure) 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 that the subcutaneous wound cavity 7 is closed during the healing process while absorbing the accumulated fluid in the subcutaneous wound cavity 7, so that the accumulated fluid in the subcutaneous wound cavity 7 can be removed in time, eliminating the living space or environment of bacteria. In this embodiment, the distance refers to a preset position (such as Figure 3In order to facilitate the closure and surface treatment of the skin wound, the catheter 10 does not penetrate into the subcutaneous wound cavity 7 through the skin wound, but penetrates the skin and subcutaneous tissue from another position, that is, a preset position away from the skin wound, to partially penetrate into the subcutaneous wound cavity 7. This embodiment is particularly suitable for Figure 4 The elongated (narrow) wound shown.

[0100] exist Figure 1 In the illustrated embodiment, the surgical auxiliary device squeezes the skin edge through the wound closure device 2 to make the two exposed ends of the skin wound close together, and under the compulsion and assistance of the subcutaneous negative pressure drainage device 1, the subcutaneous wound cavity 7 is kept in a closed state during the healing and rehabilitation process, while absorbing the accumulated fluid in the subcutaneous wound cavity 7, liquid medicine can also be delivered to the subcutaneous wound cavity 7, thereby diluting and cleaning the potential infection foci in the subcutaneous wound cavity 7 that have reached the colonization concentration; at the same time, the skin negative pressure device 3 can maintain the stable tissue position of the skin wound and its surrounding area through the generated negative pressure, thereby facilitating wound recovery. In addition, multiple drainage needles 4 are inserted from the peripheral side of the skin wound into the deep fascia of the subcutaneous soft tissue, thereby draining the accumulated fluid in the deep fascia of the subcutaneous soft tissue. Here, the negative pressure generated by the supracutaneous negative pressure device 3 can also help the drainage needles 4 to drain the accumulated fluid 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 the multiple drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the tissues around the inserted part of the drainage needle 4 to tend to fit together under the influence of the negative pressure of the supracutaneous negative pressure device 3. Under the joint action of multiple drainage needles, it helps the auxiliary wound closure device 2 and the subcutaneous negative pressure drainage device 1 to exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0101] It should be understood that the subcutaneous wound cavity 7 refers to the cavity formed by the internal incision under the wound during surgery, and the cavity includes all the gaps formed by the interruption of the continuity of the skin or other tissue parts. Since the biological tissues of the human body or animal body have elastic or stretchable properties, in actual conditions, the subcutaneous wound cavity 7, i.e., the gap, may not be intuitively presented as a cavity or a hollow state. Therefore, the shape and size of the gap are not limited in the embodiments provided in this application.

[0102] It should be understood that the "conduit" disclosed in this application refers to the fact that components can be fluidly connected to each other so as to provide a path for transferring fluid (i.e., liquid and / or gas) between these components. For example, these components can be fluidly connected by a fluid conductor (such as a tube). As used herein, "conduit" broadly includes tubes, pipes, hoses, catheters, or other structures having one or more lumens adapted to transfer fluid between two ends. Typically, the tube is an elongated cylindrical structure with some flexibility, but the geometry and rigidity can be changed. In some embodiments, multiple components can also be connected by physical proximity, become a single structure as a whole, or be formed by the same material. In addition, some fluid conductors can be molded into other components or otherwise combined with other components as a whole.

[0103] In some embodiments, a plurality of through holes 1010 are provided on the tube wall of the portion of the catheter 10 that penetrates into the skin wound to a preset depth, so as to help form a gas and liquid for absorbing the subcutaneous wound cavity 7. In an exemplary embodiment, the plurality of through holes 1010 are evenly distributed at intervals on the tube wall of the portion of the catheter 10 that penetrates into the skin wound to a preset depth. In particular, for narrow and long wounds, the wound cavity formed under the skin of the narrow and long wound is usually also a long cavity or gap, in order to ensure that the accumulated fluid or residual liquid medicine secreted in each part of the long cavity or gap is absorbed by the catheter 10; in another exemplary embodiment, suitable for different types of skin wounds or surgeries for different purposes, the plurality of through holes 1010 on the catheter 10 can also be designed to be unequally spaced (that is, the plurality of through holes 1010 are unevenly distributed at intervals on the tube wall of the portion of the catheter 10 that penetrates into the skin wound to a preset depth).

[0104] In another exemplary embodiment, the shape and structure of the portion of the catheter 10 that penetrates into the skin wound to a preset depth can also be designed according to actual needs. For example, the thickness or flexibility of the catheter 10 can be different according to the desired depth of penetration into the skin wound or the different tissue structures. For example, the thickness of the same catheter can be different at different locations, or the materials of the same catheter can be different at different locations, or the flexibility of the same catheter can be different at different locations, etc.

[0105] In some embodiments, the preset depth of the catheter 10 partially probing into the subcutaneous wound cavity 7 refers to: the depth of the interval from the superficial fascia layer to the deep fascia layer in the skin tissue. Among them, in a preferred embodiment, the preset depth position is at the junction of the fat layer and the deep fascia layer in the skin tissue. It should be understood that the skin tissue includes the vascular 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 layers.

[0106] In an exemplary embodiment, the subcutaneous negative pressure drainage device 1 also includes a negative pressure device, which is used to generate and control negative pressure. The negative pressure device is connected to the catheter 10, so that the negative pressure generated can be used to drain the accumulated fluid in the inner 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 due to excessive negative pressure or insufficient negative pressure to drain the accumulated fluid.

[0107] In this embodiment, a one-way valve is provided on the catheter 10 connected to the negative pressure device to prevent the gas or fluid sucked into the catheter 10 from flowing back into the subcutaneous wound cavity 7 and hindering the healing of the skin wound. In the embodiment, the one-way valve is a rubber part such as a duckbill valve or a cone valve, but is not limited thereto, and a valve assembly controlled mechanically or electrically is also applicable to the present application.

[0108] In the present embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, can be an air reservoir under negative pressure, or can be a manual or electrically driven device that can reduce the pressure in the sealed volume, such as a vacuum pump, a suction pump, a wall suction port that can be used in many health care facilities, or a micro pump, a syringe or a static negative pressure device, etc., or any suitable active or passive suction source. The negative pressure supply can be contained in other components or can be used in combination with these other components, and these other components are, for example, sensors, processing units, alarm indicators, memories, databases, software, display devices, or user interfaces that are further beneficial to treatment. For example, in some embodiments, the negative pressure source can be combined with other components into a treatment unit. The negative pressure supply can also have one or more supply ports, and the supply port is configured to facilitate the negative pressure supply to be connected to and coupled to one or more distribution components.

[0109] It should be understood that the "negative pressure" disclosed in the present application generally refers to a pressure less than the local environmental pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by the dressing. In many cases, the local environmental pressure can also be the atmospheric pressure at the location of the tissue site. Alternatively, the pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the value of the pressure stated herein is a gauge pressure. Similarly, the increase in negative pressure is typically referred to as a decrease in absolute pressure, while the decrease in negative pressure is typically referred to as an increase in absolute pressure. Although the amount and nature of the negative pressure applied to the tissue site can vary according to the treatment requirements, the pressure is generally a low vacuum, 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).

[0110] Surgical site infection (SSI) is a clinical problem worldwide. After the skin is cut / split, the deep tissue of the human body will come into contact with the outside world and there is a chance of contamination by pathogenic bacteria. 5 / g, bacterial colonization will occur and cannot be controlled by the human immune system. With the exponential proliferation of bacteria, tissue necrosis and inflammatory response gradually occur at the infected site, and local symptoms of redness, swelling, heat and pain appear; because there is a latent period from bacterial colonization to the onset of infection symptoms, SSI is usually difficult to effectively identify and treat in a timely manner in the early stage. Typical incision infection usually occurs 7-10 days after surgery, starting with local redness, swelling and tenderness, followed by ulceration and pus discharge. Since surgical sutures are easily colonized by bacteria, it is very important to remove all suture knots of subcutaneous sutures as much as possible after SSI occurs. This is also the key to preventing SSI recurrence, because the source of recurrent SSI infection often comes from residual suture knots.

[0111] To this end, in an exemplary embodiment of the present application, the surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs of the present application also includes a drug delivery device (not shown), which is used to deliver liquid drugs to the preset depth of the subcutaneous wound cavity 7 through the catheter to facilitate the healing of the subcutaneous wound cavity 7. In a specific implementation state, the drug delivery device, for example, includes a drug delivery device or a drug delivery machine of a device such as a micro pump or a syringe. In one mode of this embodiment, the drug delivery device can be controlled to intermittently deliver liquid drugs to the subcutaneous wound cavity, so that the coagulated blood clots in the subcutaneous wound cavity 7 are moistened to facilitate removal, and the potential bacterial community that reaches the colonization concentration is diluted and removed with the drainage of the flushing fluid, thereby maintaining the subcutaneous wound cavity 7 in a clean state. In this embodiment, in response to different conditions, treatment plans and patient constitutions, the intermittent delivery frequency is, for example, in hours, or the drug is delivered in days.

[0112] During the healing process, the drug delivery device can deliver liquid medicine to the subcutaneous wound cavity 7 through its connected catheter, so as to dilute the bacterial infection that may occur or has occurred in the subcutaneous wound cavity 7, thereby diluting the potential infection focus that has reached the colonization concentration; at the same time, the liquid medicine delivered by the drug delivery device can also achieve the purpose of flushing the infected area in the subcutaneous wound cavity 7. After the flushing is completed, the liquid medicine in the subcutaneous wound cavity 7 is sucked away through the drainage effect of the catheter of the subcutaneous negative pressure drainage device 1, and then the bacteria are drained and removed, and the subcutaneous wound cavity 7 is in a clean state.

[0113] In actual clinical treatment, the drug administration amount of the drug administration device can be controlled according to the infection condition of the subcutaneous wound cavity of the patient, the time for diluting the bacterial infection part can be controlled, the flushing frequency of the liquid drug can be controlled, and the working frequency of the subcutaneous negative pressure drainage device 1 can be controlled. For example, in an exemplary embodiment, the time for the drug administration device to flush the subcutaneous wound cavity 7 with liquid drug is, for example, 2-3 days, and the drug administration device can be controlled by an integrated machine (such as a drug administration machine and other equipment).

[0114] In an embodiment, the liquid medicine includes but is not limited to hydrogen peroxide, physiological saline, etc.

[0115] The catheter 10 may be a catheter integrated with two catheters, or may be two independent catheters. For example, in an exemplary embodiment, the catheter 10 includes a first catheter 101 and a second catheter 102 isolated from the first catheter 101. The first catheter 101 is connected to the negative pressure device for absorbing the accumulated fluid in the subcutaneous wound cavity 7; the second catheter 102 is connected to the drug delivery device for delivering liquid medicine to a preset depth in the subcutaneous wound cavity 7.

[0116] In an exemplary embodiment, see Fig. 9 , which is a schematic diagram of an embodiment of the catheter structure of the present application. As shown in the figure, the first catheter 101 and the second catheter 102 are integrally formed, thereby reducing the number of buried tubes. The integral forming is that two mutually isolated and mutually unconnected pipes are included in one catheter, wherein the first pipe forms the first catheter 101, and the second pipe forms the second catheter 102, wherein the first catheter 101 is provided with a plurality of through holes 1010, the first catheter 101 is used to connect to the negative pressure device, and the second catheter 102 is used to connect to the drug delivery device.

[0117] In an exemplary embodiment, see Fig.10 , which is a schematic diagram of another embodiment of the catheter structure of the present application. As shown in the figure, the first catheter 101 and the second catheter 102 are integrally formed, thereby reducing the number of buried tubes. The integral forming is that the first catheter 101 and the second catheter 102 are two mutually unconnected pipes, wherein the second catheter 102 is sleeved in the first catheter 101. Since the thinner catheter 102 is sleeved in the thicker catheter 101, the number of catheters does not increase, and the diameter of the entire catheter may not be increased. The thicker catheter 101 is provided with a plurality of through holes 1010. The thicker catheter 101 is used to connect to a negative pressure device, and the thinner catheter 102 is connected to a drug delivery device.

[0118] In the embodiments provided in the present application, the wound closure device 2 is used to squeeze the skin edge so that the skin wound is in a closed state during the healing process. At the same time, squeezing the skin edge can reduce bleeding of the vascular network under the skin dermis, 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 bonding. In some embodiments, the wound closure device 2 includes at least two closure members 21, and the at least two closure members 21 are respectively arranged on the two side edges of the skin wound. During the implementation process, the skin edge is squeezed by combining the two closure members 21 to keep the skin wound in a closed state during the healing process. In practical applications, the number of closure members 21 can be determined by the length of the wound and the specific form of the closure member 21.

[0119] See also Figure 5 , which is a schematic diagram of the structure of the closure member 21 in the wound closure device 2 in one embodiment of the present application. As shown in the figure, in the embodiment, the wound closure device 2 also includes a microporous covering 20 covering the closure member 21, and the microporous covering 20 is combined with the closure member 21 in accordance with the external structure of the closure member 21, so as to form a whole with the closure member 21 to facilitate the adsorption or absorption of the secretion liquid that seeps out of the skin wound and stays on the closure member 21 or the drug liquid that stays on the closure member 21. In an exemplary embodiment, the microporous covering 20 and the closure member 21 are an integrally formed structure. In another exemplary embodiment, the microporous covering 20 and the closure member 21 are combined, for example, by bonding or other processes, so that the microporous covering 20 conforms to the external structure of the closure member 21 and is combined with the closure member 21.

[0120] In some embodiments, the closure 21 includes a flexible body, which means that the flexible body material has an elastic / flexible flexible body material that can have an ultimate elongation greater than 100% and a significant amount of rebound. The rebound of a material refers to the ability of a material to recover from elastic deformation. Examples of elastic / flexible flexible body materials can include, but are not limited to, natural rubber, polyisoprene, styrene-butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene-propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, copolyester and silicones, etc.

[0121] In an exemplary embodiment, the closing member 21 may also be made of silicone material, resin material, or silicone resin material.

[0122] In an exemplary embodiment, the material of the microporous covering 20 is medical cotton, degreasing cotton, foam, mesh, gauze, sponge, or porous biocompatible material. The microporous covering 20 has air permeability and moisture absorption properties, and is used to absorb moisture from the accumulated fluid that may be secreted by the skin wound during the healing process or the residual drug solution that remains in the skin wound and is not absorbed by the tissue.

[0123] In this embodiment, the closing member 21 includes a flexible body 210 and a rigid curved needle 211 .

[0124] The flexible body 210 is bonded to the skin surface around the skin wound; in this embodiment, the flexible body 210 is a silicone material, a resin material, or a silicone resin material. The flexible body 210 is bonded to the skin surface around the skin wound by an adhesive. In some embodiments, the adhesive is, for example, a medical adhesive, such as a quick adhesive including methyl cyanoacrylate as a main body. In a specific implementation process, at least two flexible bodies 210 are respectively bonded to the skin surfaces on opposite sides of the skin wound.

[0125] The rigid curved needle 211 includes a root portion and a curved needle portion, the root portion of the rigid curved needle 211 is buried in the flexible body 210 and is firmly disposed on the flexible body 210, and the curved needle portion of the rigid curved needle 211 is exposed outside the flexible body 210. In an exemplary embodiment, the root portion of the rigid curved needle 211 is firmly disposed in the flexible body 210 through a deformed structural design, and the deformed structural design is, for example, a hook-shaped structure or a T-shaped structure.

[0126] In an exemplary embodiment, see Figure 6 , which is a schematic diagram of an embodiment of the combination of a closure member and a wound in one embodiment of the present application. As shown in the figure, the curved needle portion of the rigid curved needle 211 exposed outside the flexible body 210 partially penetrates into one side of the skin wound to squeeze the skin edge so that the skin wound remains closed during the healing process. In the specific implementation process, the doctor needs to first perform the wound skin alignment operation (align the skin edge, prevent the skin edge from turning inward, and avoid poor skin healing), and then penetrate the curved needle portion of the rigid curved needle 211 from one side of the skin wound to form a closed wound. Figure 6 In the state shown, the rigid curved needles 211 of the closure member 21 on both sides of the skin wound penetrate into the healthy tissue at the side edge of the wound to squeeze the skin edge to reduce bleeding of the subdermal vascular network of the skin, which is beneficial to wound recovery, thereby making the skin wound in a closed state.

[0127] In another exemplary embodiment, the curved needle portion of the rigid curved needle 211 exposed outside the flexible body 210 partially penetrates into the other side of the skin wound, and uses its curved needle portion to hook the other side of the skin wound, so that the two sides of the skin wound are combined with each other, and at the same time, the healthy tissues on the opposite sides of the skin wound are also combined with each other to close the skin wound.

[0128] In another exemplary embodiment, the curved needle portion of the rigid curved needle 211 exposed outside the flexible body 210 is inserted into the flexible body 210 disposed on the other side of the skin wound, so that the flexible bodies 210 located on both sides of the skin wound are combined with each other, and at the same time, the healthy tissues on the opposite sides of the skin wound are also driven to combine with each other to close the skin wound.

[0129] Present as Figure 6 As shown, the skin 50 tissue includes a vascular network 51, a superficial fascia layer 52, fat 53, a deep fascia layer 54, muscles 55 and bones 56 in sequence. The suture depth in this embodiment is in the superficial fascia layer 52. The issue of concern in this application is the sutureless operation of the superficial fascia part of the skin (i.e., the epidermis, dermis and subcutaneous fat tissue part of the skin), and the depth of penetration of the curved needle part of the rigid curved needle 211 exposed outside the flexible body 210 includes the epidermis, dermis and subcutaneous fat tissue part of the superficial fascia part of the skin.

[0130] In some embodiments, depending on the length or width of the applicable skin wound, the number and length of the rigid curved needles 211 provided on the flexible body 210 may present different implementation states. In some embodiments, when there are multiple rigid curved needles 211 provided on the flexible body 210, the rigid curved needles 211 are arranged equidistantly on the long strip-shaped flexible body 210.

[0131] See also Figure 7 , which is a schematic diagram of a closure member of the wound closure device in the present application in another embodiment. As shown in the figure, in this embodiment, the closure member further includes a clamping member 22, which is used to clamp the flexible body of the closure member 21 bonded to both sides of the skin wound. Under the action of the clamping member, the flexible body provides a relative force to squeeze the skin edge to ensure that the skin wound is in a closed state during the healing process. In a specific implementation, the clamping member 22 is a medical clip or other component.

[0132] In the above-mentioned embodiments of the closure member 21 including the flexible body 210 and the rigid curved needle 211, some auxiliary members 212 may be used to assist the closure member 21 in bonding with the skin surface and provide the closure member 21 with a contraction force to close the skin wound, see Figure 8, which is a schematic diagram showing the application of an auxiliary component in an embodiment of a closing component of a wound closure device of the present application.

[0133] In another exemplary embodiment, see Fig.11 , which is a schematic structural diagram of a closure member in the wound closure device of the present application in yet another embodiment. As shown in the figure, in this embodiment, the closure member 21 includes: a first flexible body 2100 and a second flexible body 2101.

[0134] The first flexible body 2100 is bonded to the skin surface around the skin wound, and the first flexible body 2100 has a first bonding portion; the second flexible body 2101 is bonded to the skin surface around the skin wound, and the second flexible body 2101 has a second bonding portion corresponding to the first bonding portion. The combination of the first bonding portion and the second bonding portion provides a relative force applied to the flexible bodies on both sides of the skin wound, thereby squeezing the skin edge so that the skin wound remains in a closed state during the healing process. In this embodiment, the first and second flexible bodies 2101 are silicone materials, resin materials, or silicone resin materials. The first and second flexible bodies 2101 are bonded to the skin surfaces on opposite sides of the skin wound by an adhesive. In some embodiments, the adhesive is, for example, a medical adhesive, such as a quick adhesive including methyl cyanoacrylate as a main body.

[0135] In some exemplary embodiments, the first combining portion is a groove structure or a buckle structure, and the second combining portion is a protrusion structure that can be limited to the groove structure or a buckle hole or a hook structure corresponding to the buckle. For example, a plurality of grooves are provided on the first combining portion, and a protrusion structure corresponding to the plurality of grooves is provided on the second combining portion. The plurality of grooves on the first combining portion can be replaced with a buckle structure, and correspondingly, the protrusion structure on the second combining portion can be replaced with a buckle hole or a hook structure corresponding to the buckle; however, it is not limited to this, and any other combining structure that can realize the mutual combination 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 with a protrusion structure.

[0136] In some embodiments, please refer to Fig.11The wound closure device 2 further includes an auxiliary member 212, which is used to assist the closure member 21 in bonding with the skin surface and provide the closure member 21 with a contraction force to close the skin wound. In an exemplary embodiment, if the skin wound is an incision in a first direction, the auxiliary member 212 is bonded to the peripheral side of the skin wound and applies a force in a second direction perpendicular to the first direction to the closure member 21. This force is referred to as a contraction force in this embodiment, thereby assisting the closure member 21 in providing the skin wound closure. In this embodiment, the auxiliary member 212 is bonded to the skin surface through its adhesive layer relative to the skin surface, and the material of the adhesive layer is, for example, an adhesive tape comprising polyurethane coated with an acrylic adhesive.

[0137] In this embodiment, the auxiliary part 212 of the adhesive tape can be designed as a belt-like structure extending from the center to opposite sides. The belt-like structures extending on both sides can be separate or integrated. In order to increase the comfort of the patient, the belt-like structure is suitable for artificial stretching.

[0138] exist Figure 1 In the embodiment shown, the above-skin negative pressure device 3 includes a sealing film 30 and a negative pressure channel 31. Fig.12 , which is a schematic diagram of the sealing and force structure of the skin negative pressure device in one embodiment of the present application. As shown in the figure, the sealing film 30 is adhered to the skin and covers the wound closure device 2, thereby forming a sealed space 32. After the negative pressure device is pumped, the sealed space inside the sealing film forms an inward force, and the force is as follows: Fig.12 In the direction of the arrow shown, while maintaining the local tissue position fixed, pressure can also be applied to the deep tissue, thereby closing the potential dead space; at the same time, the force (negative pressure) of the subcutaneous negative pressure device 1 is also applied to the multiple drainage needles 4 through its drainage part 41. While the drainage needle 4 absorbs the accumulated fluid around the deep fascia of the subcutaneous soft tissue through its drainage part 41, it can also force the tissues around the pierced part of the drainage needle 4 to tend to fit together under the influence of the negative pressure applied by the subcutaneous negative pressure device 3. Under the joint action of the multiple drainage needles, it helps to assist the wound closure device 2 and the subcutaneous negative pressure drainage device 1 to apply a force to the skin tissue to retract in the direction of the wound, thereby playing a role in assisting the wound closure.

[0139] In this embodiment, the sealing film 30 bypasses the skin wound and the wound closure device 2 arranged on the skin wound to form a sealing area, and the sealing area forms a sealed space 32. In this embodiment, the sealing film 30 is bonded to the surface of the skin through its adhesive layer relative to the skin surface. The material of the adhesive layer is, for example, a flexible impermeable material including polyurethane coated with acrylic adhesive.

[0140] In an exemplary embodiment, the sealing film 30 may be made of a transparent material. The sealing film 30 made of the transparent material may help clinicians visually inspect the healing status of the skin wound so as to perform timely intervention.

[0141] In an exemplary embodiment, the sealing film 30 is provided with an observation window made of a light-transmitting material, so as to facilitate clinicians to observe the healing condition of the skin wound and take corresponding medical measures.

[0142] For the specific operation steps of the above embodiment, please refer to Figure 1 As shown in the figure, the operator buries the catheter 10 of the subcutaneous negative pressure diversion device into the subcutaneous tissue of the skin and extends the catheter 10 into the subcutaneous wound cavity 7. The subcutaneous negative pressure diversion device can drain the accumulated fluid secreted by the subcutaneous wound cavity 7 through the catheter 10. At the same time, due to the negative pressure, the wound cavity is forced to shrink / merge, so that the tissues on both sides are combined towards each other. In addition, liquid medicine can be delivered to the subcutaneous wound cavity 7 through the catheter to facilitate healing. This is the first aspect; in the second aspect, the skin on both sides outside the wound is gathered inward by the closure 21, so that the skin wound remains in a closed state during the healing process. The squeezing effect of the closure 21 on the skin edge can reduce 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; in the third aspect, after multiple drainage needles 4 are inserted into the deep fascia of the subcutaneous soft tissue, the accumulated fluid in the deep fascia of the subcutaneous soft tissue is drained, which can eliminate subcutaneous blood and other accumulated fluid, reduce edema, reduce skin tension, avoid infection, improve circulation, and facilitate the recovery of the wound. At the same time, the systolic pressure provided by the multiple drainage needles 4 can also play a role in squeezing the skin edge, so that the skin wound remains in a closed state during the healing process. The operator continues to cover the wound surface with the microporous cover 20 to ensure that the secretions on the wound surface and the accumulated fluid drained by the drainage needle 4 during the healing process can be absorbed in time. Then, a sealing film 30 is covered on the outside of the microporous attachment to wrap the entire wound and the microporous cover 20 on the wound; fourthly, the sealing film 30 is compressed through the negative pressure channel 31 of the skin negative pressure device 3, so that the skin wound and the tissues in the peripheral area are tightened toward the wound. In addition, the negative pressure generated by the skin negative pressure device can also apply a certain degree of pressure to the deep subcutaneous tissue to close the potential dead space, thereby accelerating the healing speed of the skin wound. It is a treatment method that does not use needles and threads to suture the superficial fascia of the skin, and does not use medical tools such as suture needles and sutures. At the same time, the negative pressure generated by the skin negative pressure device can also provide negative pressure for the drainage needle 4 to help drain the deep fascia of the subcutaneous soft tissue.

[0143] It should be understood that whether the skin wound is closed by traditional suturing means or by the closure member of the present application, additional tension will be applied to the skin around the suture, thereby causing tension ischemia. At the same time, compression ischemia will also be caused to the subcutaneous part of the suture. The present application uses the negative pressure device on the skin to tighten the tissue of the skin wound and its surrounding area toward the wound, and also applies a contraction force (such as suturing force) toward the wound by means of multiple drainage needles 4 and the flexible substrate. Fig.12 The above results suggest that the resection of the esophageal carcinoma can be effectively controlled (arrowhead) without causing additional pressure on the resection edge, thus avoiding tension ischemia and compressive ischemia.

[0144] In this embodiment, the negative pressure channel 31 is connected to a negative pressure device through a conduit, and the negative pressure channel 31 is connected to the sealed space, thereby providing a negative pressure source to form a sealed space.

[0145] In this embodiment, the negative pressure generated by the negative pressure device compresses the sealed space, thereby maintaining the local tissue to close toward the wound position. At the same time, the negative pressure generated by the negative pressure device also exerts a force on the deep tissue under the wound, closing the potential dead space, assisting the wound closure device 2 to close the skin wound and promoting wound healing. In this embodiment, the range of the pressure value of the sealed space formed by the sealing film 30 adhering to the skin can be set between about 0.001 and about 1 atmosphere. In the actual implementation process, the negative pressure value generated by the negative pressure device can be controlled according to the degree of wound healing. For example, the negative pressure value can be appropriately reduced as the degree of skin wound healing increases, or according to the situation of the accumulation of fluid secreted by the skin wound, for example, when the secretion of the accumulation of fluid increases, the negative pressure value can be appropriately increased to increase the force of absorbing the accumulation of fluid.

[0146] In this embodiment, a one-way valve is provided on the catheter connected to a negative pressure device through the negative pressure channel 31 to prevent the gas or accumulated fluid inhaled into the catheter from flowing back into the sealed space, which is not conducive to the healing of the skin wound. In the embodiment, the one-way valve is a rubber part such as a duckbill valve or a conical valve, but is not limited to this. A valve assembly using mechanical or electrical control is also applicable to this embodiment.

[0147] In the present embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, can be an air reservoir under negative pressure, or can be a manual or electrically driven device that can reduce the pressure in the sealed volume, such as a vacuum pump, a suction pump, a wall suction port that can be used in many health care facilities, or a micro pump, a syringe or a static negative pressure device, etc., or any suitable active or passive suction source. The negative pressure supply can be contained in other components or can be used in combination with these other components, and these other components are, for example, sensors, processing units, alarm indicators, memories, databases, software, display devices, or user interfaces that are further beneficial to treatment. For example, in some embodiments, the negative pressure source can be combined with other components into a treatment unit. The negative pressure supply can also have one or more supply ports, and the supply port is configured to facilitate the negative pressure supply to be connected to and coupled to one or more distribution components.

[0148] In an exemplary embodiment, see Fig.13 , which is a schematic diagram of another embodiment of the surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures in the present application, such as Fig.13 As shown, the supracutaneous negative pressure device can share a negative pressure source 6 with the subcutaneous negative pressure drainage device 1, and be connected to the same negative pressure source through two different catheters, that is, the catheter connecting the sealed space 32 on the skin and the catheter connecting the subcutaneous wound cavity 7 are two different catheters.

[0149] See also Fig.14 , which shows a schematic diagram of a surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs of the present application in another embodiment. As shown in the figure, in this embodiment, the supracutaneous negative pressure device can share a negative pressure source 6 with the subcutaneous negative pressure drainage device 1, and connect the subcutaneous wound cavity 7 and the sealed space 32 on the skin through a catheter, respectively, wherein the catheter 10 includes a subcutaneous drainage hole 1010 and an supracutaneous negative pressure hole 60, and the subcutaneous drainage hole is a plurality of through holes 1010 arranged on the tube wall of the part of the catheter that penetrates into the skin wound at a preset depth; the supracutaneous negative pressure hole is connected to the sealed space to apply negative pressure to the sealed space.

[0150] In an exemplary embodiment, the skin negative pressure device 3 further includes a humidity detection component (not shown), a sensor of the humidity detection component is arranged in the sealed space formed by the sealing film 30, and the information output port of the humidity detection 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 adjust the output negative pressure. In this embodiment, the humidity detection component is, for example, a humidity sensor.

[0151] In summary, the surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures in the present application can achieve safe closure in the deep fascia of the limbs to a certain extent; and the present application adopts active drainage to improve the passive drainage method in the prior art, and can timely treat the accumulation of fluid (such as bleeding, exudate, etc.) in the subcutaneous tissue, especially the deep fascia, which is beneficial to the recovery of the wound. Because the surgical auxiliary device of the present application closes the skin wound in a sutureless manner.

[0152] In the first aspect, the two exposed ends of the skin wound are tightly attached by a wound closure device, and the wound closure device can squeeze the skin edge while closing the wound, thereby reducing bleeding of the blood vessel network under the dermis of the skin.

[0153] Secondly, under the pressure of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound remains closed during the healing process, the severed tissues are kept in contact, and the bleeding and exudate in the wound cavity are cleared in time through continuous negative pressure suction; on this basis, by intermittently delivering liquid drugs to the inner cavity of the subcutaneous wound, the coagulated blood clots in the inner cavity of the subcutaneous wound are moistened to facilitate their removal, and the potential bacterial community that has reached the colonization concentration is diluted and removed with the drainage of the flushing fluid, thereby maintaining the cleanliness of the wound cavity.

[0154] On the third aspect, negative pressure can be generated by the skin negative pressure device to maintain the stability of the tissue position of the skin wound and its surrounding area, thereby facilitating tissue healing.

[0155] In the fourth aspect, the force (negative pressure) of the supracutaneous negative pressure device is also applied to the multiple drainage needles through its drainage part. While the drainage needles absorb the accumulated fluid around the deep fascia of the subcutaneous soft tissue through their drainage parts, the negative pressure of the supracutaneous negative pressure device can also force the tissues around the insertion part of the drainage needles to tend to fit together. Under the joint action of the multiple drainage needles, the auxiliary wound closure device and the subcutaneous negative pressure drainage device 1 can exert a force on the skin tissue to retract toward the wound, thereby playing a role in assisting wound closure.

[0156] In the fifth aspect, multiple drainage needles can be used to drain the effusion in the deep fascia of the subcutaneous soft tissue, thereby avoiding infection, reducing edema, and reducing skin tension. At the same time, after multiple drainage needles are inserted into the skin, pressure can be applied to the skin, and the contraction force can be used to squeeze the skin edge, which is beneficial to the patient's recovery. In addition, the negative pressure generated by the skin negative pressure device can help the drainage needle achieve a better drainage effect by negative pressure. In addition, the surgical auxiliary device of the present application can achieve seamless closure of the entire layer of tissue above the deep fascia of the skin, avoiding the transverse scar (commonly known as "centipede feet") caused by suture compression / cutting on the skin surface, and there are no residual suture knots in the superficial fascia, thereby eliminating the important factors causing bacterial colonization and the main cause of recurrence of incisional infection. In addition, the surgical auxiliary device of the present application can also drain the effusion in the deep fascia of the subcutaneous soft tissue, which is suitable for wound closure at the limbs or fractures.

[0157] Therefore, the surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the limbs of the present application can keep the inner cavity of the subcutaneous wound in a closed state during the healing and rehabilitation process without using sutures, and continuously drain the deep fascia of the subcutaneous soft tissue. Therefore, not only the healing speed of the skin wound is accelerated, but also a treatment method that does not use needles and threads to suture the skin, and does not use medical tools such as suture needles and sutures. Therefore, after the skin wound is healed, there is no process of removing foreign bodies from the wound or wound surface, such as the steps and operations of removing or removing sutures or taking out thread ends, which also eliminates the key links and important inducements of bacterial colonization, and ensures that the wound after healing will not leave suture marks such as "centipede feet" on the surface of the skin, ensuring the beauty of the surgical incision site, thereby solving the problems of the prior art that the postoperative incision suture is easy to leave marks and the effusion is difficult to discharge.

[0158] At the same time, the surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the limbs of the present application also solves the problem of swelling and infection caused by effusion in the deep fascia of the subcutaneous soft tissue. The surgical auxiliary device for closing skin wounds without sutures in the deep fascia of the limbs of the present application is also applicable to the field of cosmetic medicine.

[0159] The above embodiments are merely illustrative of the principles and effects of the present application and are not intended to limit the present application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed in the present application shall still be covered by the claims of the present application.

Claims

1. A surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures, characterized in that: include: A subcutaneous negative pressure drainage device, comprising a catheter partially inserted into a subcutaneous wound cavity to a preset depth, for generating negative pressure to force the subcutaneous wound cavity 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 so that the skin wound remains in a closed state during the healing process; the wound closure device comprises at least two closing members, which are respectively arranged on the two side edges of the skin wound, and are used to squeeze the skin edge so that the skin wound remains in a closed state during the healing process; An on-skin negative pressure device, arranged at the periphery of the skin wound, for generating negative pressure to maintain the stability of the tissue position of the skin wound and its periphery; The skin negative pressure device comprises: a sealing film for adhering to the skin and covering the wound closing device to form a sealed space, and a negative pressure channel connected to a negative pressure device, wherein the negative pressure channel drives the skin wound to contract by providing a contraction force to the sealing film through the negative pressure generated by the negative pressure device to assist the wound closing device in closing the skin wound; A plurality of drainage needles are used to penetrate into the deep fascia of the subcutaneous soft tissue from the peripheral side of the skin wound to drain the accumulated fluid in the deep fascia of the subcutaneous soft tissue. The drainage needle includes a drainage portion formed on its needle body. When the drainage needle penetrates the subcutaneous soft tissue, a portion of the drainage portion is located outside the skin surface.

2. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: 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.

3. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 2, characterized in that: The drainage needle comprises a needle head, a hollow needle body, and a needle tip, the at least one drainage hole is formed on the hollow needle body, the needle head has a through hole connected to the hollow needle body, or / and the needle tip has a through hole connected to the hollow needle body.

4. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The needle body of the drainage needle is a solid structure, and the drainage portion is a drainage groove formed on the needle body.

5. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The multiple drainage needles are arranged on a flexible substrate. When the multiple drainage needles on the flexible substrate penetrate into the deep fascia of the subcutaneous soft tissue, they provide a contraction force to squeeze the skin edge so that the skin wound remains in a closed state during the healing process.

6. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 5, characterized in that: The flexible substrate comprises a resin material or a silicone material.

7. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The catheter partially penetrates to a preset depth of the subcutaneous wound cavity via a preset position of the skin wound, or the catheter penetrates the skin and subcutaneous tissue via a preset position away from the skin wound to partially penetrate to a preset depth of the subcutaneous wound cavity.

8. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The subcutaneous negative pressure drainage device also includes a negative pressure device for generating and controlling negative pressure. The negative pressure device is connected to the catheter and is used to drain the accumulated fluid in the subcutaneous wound cavity by generating negative pressure.

9. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 8, characterized in that: It also includes a drug delivery device for delivering liquid medicine to a preset depth of the inner cavity of the subcutaneous wound through the catheter.

10. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 9, characterized in that: The catheter includes a first catheter and a second catheter isolated from the first catheter, the first catheter is connected to the negative pressure device, and the second catheter is connected to the drug delivery device.

11. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 10, characterized in that: The first conduit and the second conduit are integrally formed, and the second conduit is sleeved inside the first conduit.

12. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The preset depth is the depth of the interval from the superficial fascia of the skin to the fat layer and the deep fascia layer in the skin tissue.

13. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 12, characterized in that: The preset depth is the junction of the fat layer and the deep fascia layer in the skin tissue.

14. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: A plurality of through holes are arranged on the wall of the portion of the catheter that penetrates into the skin wound to a preset depth.

15. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The wound closure device further comprises a microporous covering member covering the closure member and the skin wound to absorb the accumulated fluid secreted from the skin wound.

16. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 15, characterized in that: The microporous covering member is combined with the closing member in accordance with the outer shape structure of the closing member; Alternatively, the microporous covering member and the closing member are integrally formed.

17. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 16, characterized in that: The material of the microporous covering is foam, mesh, gauze, sponge, or porous biocompatible material.

18. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The closure element comprises: A flexible body, bonded to the skin surface on one side of the skin wound; A rigid curved needle, whose root is arranged on the flexible body and whose curved needle part is exposed outside the flexible body, is used to pierce one side of the skin wound to squeeze the skin edge so that the skin wound remains in a closed state during the healing process.

19. The surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs according to claim 18, characterized in that: The closure member also includes a clamping member for clamping the flexible body bonded to both sides of the skin wound to provide opposite forces to squeeze the skin edges so that the skin wound remains in a closed state during the healing process.

20. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 18, characterized in that: The flexible body is made of resin material or silicone material.

21. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The closure element comprises: A first joint portion is formed on a flexible body; A second combining portion corresponding to the first combining portion is formed on another flexible body; The first combining portion and the second combining portion are combined to provide the opposite forces of the flexible body applied to both sides of the skin wound to squeeze the skin edge so that the skin wound remains in a closed state during the healing process.

22. The surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs according to claim 21, characterized in that: The first combining portion is a groove structure or a buckle structure, and the second combining portion is a protrusion structure that can be confined in the groove structure or a hole or hook structure corresponding to the buckle.

23. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The wound closure device also includes an auxiliary component, which is used to adhere to the at least two closure components and the skin surface, and is used to provide a contraction force to the at least two closure components to close the skin wound.

24. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 23, characterized in that: The auxiliary component includes adhesive tape.

25. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The sealing film is bonded to the surface of the skin through its adhesive layer opposite to the skin surface, and the material of the adhesive layer comprises a flexible impermeable material of polyurethane coated with an acrylic adhesive.

26. The surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs according to claim 1, characterized in that: The sealing film is provided with an observation window made of light-transmitting material.

27. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 1, characterized in that: The skin negative pressure device includes a humidity detection component, which is used to provide the detected humidity information in the sealed space to the negative pressure device so that the negative pressure device can adjust the negative pressure output.

28. The surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of the limbs according to claim 1, characterized in that: The subcutaneous negative pressure device is also used to generate negative pressure so that the sealing film applies pressure to the skin tissue to assist in forcing the inner cavity of the subcutaneous wound to be in a closed state during the healing process.

29. The surgical auxiliary device for sutureless closure of skin wounds in the deep fascia of limbs according to claim 1, characterized in that: The supracutaneous negative pressure device and the subcutaneous negative pressure drainage device share a negative pressure device.

30. The surgical auxiliary device for closing skin wounds in the deep fascia of the limbs without sutures according to claim 29, characterized in that: The catheter includes subcutaneous drainage holes and supracutaneous negative pressure holes. The subcutaneous drainage holes are multiple through holes arranged on the tube wall of the part of the catheter that penetrates into the skin wound to a preset depth; the supracutaneous negative pressure holes are connected to the sealed space to apply negative pressure to the sealed space.

Images