CN211356991U - Negative pressure drainage and cleaning system for suture-free closed skin wound - Google Patents

Abstract

The application discloses negative pressure drainage and cleaning system of closed skin wound of no suture, it relates to the medical instrument field. This application makes subcutaneous wound inner chamber keep closed in the healing rehabilitation process under the force of negative pressure drainage device, maintains the tissue of disjunctor and keeps the laminating state to keep wound intracavity oozing blood, sepage to obtain timely cleaing away through lasting negative pressure suction. Meanwhile, the cleaning system intermittently conveys the liquid medicine to the inner cavity of the subcutaneous wound, so that the blood clots coagulated in the inner cavity of the subcutaneous wound are wetted to be removed, and the potential bacterial community reaching the colonization concentration is diluted and removed along with the drainage of the flushing liquid, thereby maintaining the clean state in the wound cavity. The application can assist in realizing the seamless closure of the whole layer of tissue above the deep fascia of the skin, avoids the transverse scar caused by suture compression/cutting on the surface of the skin, and has no suture knot left in the shallow fascia, thereby eliminating the important factors causing bacterial colonization and the main inducement of the recurrence of the incision infection.

Description

Negative pressure drainage and cleaning system for suture-free closed skin wound

Technical Field

The application relates to the field of medical equipment, in particular to a negative pressure drainage and cleaning system for closing skin wounds by using a seamless thread.

Background

It is well known that human beings gradually lose the ability of regenerating the body in the course of evolution, and the tissue damage caused by the wound is mainly healed by the scar. Thus, there is a close relationship between surgical sutures and tissue healing, and to some extent the quality of the suture may determine the quality of tissue healing. Surgical suture mostly uses a curved needle to carry a suture to pass through a separated tissue, and then the suture is tightened and fixed in a knotting mode, so that the separated tissue is tightly attached, and favorable conditions are created for healing. An ideal surgical suture should meet the requirements of moderate tension, good apposition of the incision edges, no dead space, no permanent or only a small amount of suture marking. Aiming at the structural and physiological characteristics of different tissues, the surgical suture requirements are different, and the selection of suture materials and modes has great influence on the surgical effect. When the tissue heals and functional strength is restored, the suture material loses functional significance. At this time, the suture on the body surface should be removed, and a large number of clinical medical treatments prove that the suture left in the deep tissue due to the suture is difficult to remove after the wound is healed, the suture is wrapped by scar tissue or degraded and absorbed within a certain time, and the knots left in the deep tissue sometimes influence the human body. In addition, significant scarring from conventional surgical sutures can have a major impact on aesthetics.

The following categories of methods for removing scars from skin surface sutures currently exist: 1, an intradermal suture mode, wherein after a surgeon finishes suturing a superficial fascia, continuous intradermal suture is performed on a superficial dermis by using a suture, and the suture is tensioned to close a skin edge; 2, tissue glue mode, namely, adhering the leather margin by methyl acrylate tissue glue after completing superficial fascia suture; and 3, a skin tension reducer (commonly called as a skin zipper) is used for closing the skin and tightly tightening the skin edge by using a tension reducing adhesive tape with a locking structure after the superficial fascia is sutured. However, several current solutions still require extensive suturing in the superficial fascia layer of the skin, and cannot avoid the series of safety problems caused by residual suture. Safe, aesthetically pleasing closure of skin incisions has been a technical problem that those skilled in the art expect to solve.

Disclosure of Invention

In view of the above disadvantages of the prior art, an object of the present application is to provide a negative pressure drainage and cleaning system for closing a skin wound without suture, which is used to solve the problems in the prior art that the incision suture is easy to leave traces and the effusion is difficult to discharge after the operation.

To achieve the above and other related objects, a first aspect of the present application provides a negative pressure drainage and cleansing system for seamlessly closing a skin wound, comprising: the flushing device comprises a delivery pump and a first catheter, wherein part of the first catheter extends into the inner cavity of the subcutaneous wound to a preset depth, and the first catheter is used for delivering cleaning liquid to the preset depth of the inner cavity of the subcutaneous wound; the negative pressure device comprises a negative pressure source and a second catheter partially extending into the inner cavity of the subcutaneous wound by a preset depth, and is used for generating negative pressure to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process and draining effusion in the inner cavity of the subcutaneous wound through the second catheter; and the control device is electrically connected with the flushing device and the negative pressure device and is used for controlling the output pressure or flow of the flushing device and the negative pressure device according to the received feedback so as to maintain the vacuum degree of the subcutaneous wound inner cavity.

In certain embodiments of the first aspect of the present application, the irrigation device comprises: the cleaning liquid container is used for storing cleaning liquid for flushing the inner cavity of the subcutaneous wound and is communicated with the delivery pump through the first catheter; the first pressure sensor is used for feeding back the sensed fluid pressure value of the first catheter between the delivery pump and the inner cavity of the subcutaneous wound to the control device so as to adjust the rotating speed of the delivery pump and control the output pressure of the cleaning liquid; and the first vacuum sensor is used for sensing the vacuum degree of a first conduit between the delivery pump and the cleaning liquid container so as to monitor the exhaustion state of the cleaning liquid in the cleaning liquid container.

In certain embodiments of the first aspect of the present application, the flushing device comprises an alarm device for outputting an alarm signal when the first vacuum sensor detects exhaustion of the cleaning liquid in the cleaning liquid container.

In certain embodiments of the first aspect of the present application, the delivery pump is a diaphragm pump.

In certain embodiments of the first aspect of the present application, the negative pressure device comprises: the collection container is used for collecting the effusion drained from the inner cavity of the subcutaneous wound by the second catheter; a second pressure sensor for sensing a fluid resistance of a second conduit between the negative pressure source and the collection container to monitor a full state of the collection container; and the second vacuum sensor is used for feeding back the sensed vacuum degree of the second conduit between the negative pressure source and the inner cavity of the subcutaneous wound to the control device so as to adjust the power of the negative pressure source to control the generated negative pressure.

In certain embodiments of the first aspect of the present application, the negative pressure source is a diaphragm pump.

In certain embodiments of the first aspect of the present application, the predetermined depth is the depth in the skin tissue between the superficial fascia of the skin to the adipose layer and the deep fascia layer.

In certain embodiments of the first aspect of the present application, the first or second catheter is partially advanced to a predetermined depth of the subcutaneous wound lumen via a predetermined location of the skin wound; or the first or second catheter is passed through the skin and subcutaneous tissue via a predetermined location remote from the skin wound to partially penetrate to a predetermined depth within the lumen of the subcutaneous wound.

In certain embodiments of the first aspect of the present application, the first and second conduits are integrally formed or the second conduit is nested within the first conduit.

In certain embodiments of the first aspect of the present application, the first or second catheter is provided with a plurality of through holes in the wall of the portion of the tube that extends to a predetermined depth within the skin incision.

In certain embodiments of the first aspect of the present application, a one-way valve is disposed on the first or second conduit.

In certain embodiments of the first aspect of the present application, the one-way valve is a duckbill valve or a sector valve.

In certain embodiments of the first aspect of the present application, the negative pressure device is further adapted to maintain the tissue position of the skin wound surface and its peripheral region stable by means of the generated negative pressure.

In certain embodiments of the first aspect of the present application, the negative pressure device comprises: a sealing film for adhering to the skin and covering the skin wound surface to form a sealed space; and the negative pressure channel is communicated with the negative pressure source, and the sealing film provides a contractile force to drive the skin wounds to contract oppositely by the negative pressure generated by the negative pressure source.

In certain embodiments of the first aspect of the present application, the sealing membrane is adhered to the surface of the skin by an adhesive layer thereof opposite the skin surface, the material of the adhesive layer comprising a flexible impermeable material of polyurethane coated with an acrylic adhesive.

In certain embodiments of the first aspect of the present application, the sealing film is provided with a viewing window of a light transmissive material.

In certain embodiments of the first aspect of the present application, the negative pressure device comprises a humidity detection component for providing detected humidity information within the sealed space to the negative pressure source to facilitate the negative pressure source to regulate the negative pressure output.

In certain embodiments of the first aspect of the present application, the second catheter comprises a subcutaneous drainage hole and an intradermal negative pressure hole, the subcutaneous drainage hole being a plurality of through holes disposed in a wall of a portion of the second catheter that protrudes a predetermined depth into the skin wound; the skin negative pressure hole is communicated with the sealed space to apply negative pressure to the sealed space.

Compared with the prior art, the application has the beneficial effects that: the negative pressure drainage and cleaning system for the suture-free closed skin wound has the advantages that on the first hand, under the force of the negative pressure drainage device, the inner cavity of the subcutaneous wound is kept closed in the healing and rehabilitation process, the separated tissue is kept in a joint state, and the blood seepage and the seepage in the wound cavity are kept to be timely removed through continuous negative pressure suction; on the basis, the liquid medicine is intermittently conveyed to the inner cavity of the subcutaneous wound through the cleaning system, so that blood clots coagulated in the inner cavity of the subcutaneous wound are moistened to be removed conveniently, and a potential bacterial community reaching the colonization concentration is diluted and removed along with drainage of a flushing liquid, so that the cleaning state in the wound cavity is maintained; in a second aspect, negative pressure may be generated by negative pressure drainage to maintain the tissue position of the skin wound and its peripheral region stable, thereby facilitating tissue healing. In addition, the application can assist in realizing the seamless line closure of the whole layer of tissue above the deep fascia of the skin, avoid the transverse scar (commonly called as 'centipede feet') on the surface of the skin caused by suture compression/cutting, and have no remained suture knot in the shallow fascia, thereby eliminating the important factors causing bacterial colonization and the main inducement of the recurrence of the incision infection.

Drawings

FIG. 1 is a schematic view of one embodiment of the present negative pressure drainage and cleansing system for suture-free closure of skin wounds.

Fig. 2 shows a schematic view of an embodiment of the application of the negative pressure drainage and cleansing system for suture-free closure of skin wounds.

Fig. 3 is a schematic view of an embodiment of the alarm device in the negative pressure drainage and cleansing system for sutureless closure of skin wounds according to the present application.

Fig. 4 is a schematic view of an embodiment of the present application in which the first or second catheter is partially advanced from a predetermined location of the skin wound to a predetermined depth within the lumen of the subcutaneous wound.

FIG. 5 is a schematic view of an embodiment of the present application where the first or second catheter is passed through the skin and subcutaneous tissue via a predetermined location away from the skin incision.

Fig. 6 is a schematic view of an embodiment of the flushing device of the present application.

Fig. 7 is a schematic view of an embodiment of the negative pressure device of the present application.

Fig. 8 shows a schematic view of the closure element of the wound closure device of an embodiment of the present application.

Fig. 9 shows a schematic view of an embodiment of the present application in combination with a closure and a wound in one embodiment.

Fig. 10 shows a schematic view of an occlusive member of the wound closure device of the present application in a further embodiment.

Fig. 11 is a schematic view of the application of the closure member and the auxiliary member of the wound closure device of the present application in one embodiment.

Fig. 12 shows a schematic view of a closure element in a wound closure device according to the present application in a further embodiment.

Figure 13 shows a schematic view of an embodiment of the first and second conduit structures of the present application.

Figure 14 shows a schematic view of another embodiment of the first and second conduit structures of the present application.

FIG. 15 is a schematic view of a sealing and force-bearing structure of the negative pressure device according to an embodiment of the present disclosure.

FIG. 16 is a schematic view of an embodiment of a second catheter in the present application.

Fig. 17 is a schematic diagram of an embodiment of the present application.

Detailed Description

The following description of the embodiments of the present application is provided for illustrative purposes, and other advantages and capabilities of the present application will become apparent to those skilled in the art from the present disclosure.

In the following description, reference is made to the accompanying drawings that describe several embodiments of the application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description is not to be taken in a limiting sense, and the scope of embodiments of the present application is defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatially relative terms, such as "upper," "lower," "left," "right," "lower," "below," "lower," "above," "upper," and the like, may be used herein to facilitate describing one element or feature's relationship to another element or feature as illustrated in the figures.

Although the terms first, second, etc. may be used herein 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 element or parameter from another element or parameter. For example, a first conduit may be referred to as a second conduit, and similarly, a second conduit may be referred to as a first conduit, without departing from the scope of the various described embodiments. The first conduit and the second conduit are both describing one conduit, but they are not the same conduit unless the context clearly dictates otherwise.

Also, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes" and/or "including," when used in this specification, specify the presence of stated features, steps, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, steps, operations, elements, components, species, and/or groups thereof. The terms "or" and/or "as used herein are to be construed as inclusive or meaning any one or any combination. Thus, "A, B or C" or "A, B and/or C" means "any of the following: a; b; c; a and B; a and C; b and C; A. b and C ". An exception to this definition will occur only when a combination of elements, functions, steps or operations are inherently mutually exclusive in some way.

Surgeons routinely separate the skin into two layers, a superficial fascia and a deep fascia. The superficial fascia refers to the epidermis, dermis and subcutaneous adipose tissue of the skin, and specifically, the superficial fascia is the continuation of the superficial fascia of the anterior and lateral regions of the chest, the neck, abdomen and upper limbs, which contains fat, superficial blood vessels, lymphatic vessels, cutaneous nerves and mammary glands. Deep fascia refers to fibrous connective tissue that separates skin from muscle tissue. Surgery typically involves suturing the superficial and deep fascia together in layers during the skin suturing phase, in the order of first suturing the deep fascia, then suturing the subcutaneous tissue, and finally suturing the skin. The meaning of layered suturing is to resist skin tension layer by layer in a sutured manner, thereby improving the quality of healing. Because the skin suture can cause the ischemia of local tissues, scars which are perpendicular to the direction of an incision can be formed at the suture position after the operation, which is commonly called as centipede feet, and the inevitable result brought by the traditional suture mode is achieved. In addition, conventional skin sutures also entail leaving behind a large number of knots in the subcutaneous superficial fascia layer, often with the presence of knots leading to incision complications: such as incision infection, liquefaction of fat, etc., with serious consequences that affect the quality of life of the patient.

The treatment of wounds (also referred to in the art as incisions or surgical incisions, wounds, etc.) that are unavoidable during surgery on a patient (e.g., a patient) often employs a suture treatment to facilitate healing of the wound on the patient, in which a reduced-pressure dressing assembly is used in the industry to apply a closing force, the reduced-pressure dressing assembly including a bolster body formed from a closing bolster material having a closing member that generates an inward closing force when the closing dressing bolster is placed under reduced pressure. In some cases, the assembly further includes a wicking material having a fluid flow path for removal of fluid. However, this method still requires suturing the wound during application, only serves to assist in suturing and healing, and does not completely replace the suturing step, thereby still leaving a suture mark on the skin of the patient. In addition, the closing force generated in the structure only acts on the surface layer, when the wound is deep, muscle tissues and the like at the deep subcutaneous part cannot be stressed to be in a closed state, and the wicking material can only treat liquid seeped from the surface of the skin, cannot timely treat subcutaneous effusion (such as blood seepage, liquid seepage and the like) and is not beneficial to wound recovery.

In view of the above, the present application provides a negative pressure drainage and cleansing system for closing a skin wound without suture, so as to control the environment inside and around the skin wound to facilitate the healing of the skin wound. In the embodiments provided below, the negative pressure drainage and cleansing system for suture-free closure of skin wounds of the present application comprises: flushing device, negative pressure device, controlling means. The flushing device comprises a delivery pump and a first catheter, wherein the first catheter is partially inserted into the preset depth of the inner cavity of the subcutaneous wound, and the delivery pump delivers cleaning fluid to the first catheter, so that the cleaning fluid can be delivered to the inner cavity of the subcutaneous wound while the inner cavity of the subcutaneous wound is cleaned, and the healing of the inner cavity of the subcutaneous wound is promoted. The negative pressure device comprises a negative pressure source and a second catheter, wherein the second catheter partially extends into the inner cavity of the subcutaneous wound to a preset depth, the negative pressure source is communicated with the second catheter to generate negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process, and meanwhile, effusion in the inner cavity of the subcutaneous wound can be drained, so that the health of the environment of the inner cavity of the subcutaneous wound is ensured. The control device is electrically connected with the flushing device and the negative pressure device so as to control the flushing device and the negative pressure device, and simultaneously adjusts the flushing device and the negative pressure device through information fed back by the flushing device and the negative pressure device so as to adjust the output pressure or flow of the flushing device and the negative pressure device.

The negative pressure drainage and cleaning system of the closed skin wound of no suture of this application makes subcutaneous wound inner chamber keep the closure state in the recovered process of healing through negative pressure device in the first aspect, maintains the tissue that breaks and keeps the laminating state to it obtains timely cleaing away to keep creating intracavity oozing blood, sepage through lasting negative pressure attraction. Meanwhile, the negative pressure generated by the negative pressure device can be used for maintaining the stable tissue position of the skin wound and the peripheral area thereof, so that the tissue healing is facilitated. The second aspect of this application passes through washing unit intermittent type nature transport liquid medicine to subcutaneous wound inner chamber, makes the blood clot of solidifying in the subcutaneous wound inner chamber obtain moist to do benefit to and remove, and make the latent bacterial community that reaches colonizing concentration obtain diluting, clear away along with the flush fluid drainage, thereby maintain the clean state in the wound cavity. The third aspect of the application controls the flushing device and the negative pressure device through the feedback mechanism of the control device, and ensures the flushing force, flow and negative pressure strength so as to ensure that the patient is not adversely affected and the vacuum degree of the subcutaneous wound inner cavity is maintained. In addition, the application can also help realize the seamless line closure of the whole layer of tissue above the deep fascia of the skin by closing the inner cavity of the subcutaneous wound, avoid the transverse scar caused by suture compression/cutting on the surface of the skin, and have no suture knot left in the shallow fascia, thereby eliminating the important factors causing bacterial colonization and the main inducement of the recurrence of the infection of the incision.

It should be understood that in embodiments of the present application, the skin incision includes any breach of skin or other tissue site by a continuous discontinuity, broadly referred to as an incision, wound, defect, or other therapeutic target in or on the tissue. It should be noted that the skin wounds are mostly due to surgery, but in some cases, the skin wounds may also be the cause of accidents such as cuts or collisions.

It will be appreciated that healing of a skin wound requires the apposition of two sections of the subcutaneous wound lumen, for example by means of sutures and the like as is known in the art. In the embodiment, the gas in the inner cavity of the subcutaneous wound is pumped out through negative pressure so as to keep the inner cavity of the subcutaneous wound at a certain vacuum degree, so that two sections of the inner cavity of the subcutaneous wound are attached inwards, and the skin wound is closed.

In some embodiments, the tissue includes, but is not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. The wound may include, for example, chronic, acute, traumatic, subacute, and dehiscent wounds; partial cortical burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" may also refer to any area of tissue that is not necessarily wounded or defective, but is an area in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to the tissue site to grow additional tissue that may be harvested and transplanted.

It should be understood that the suture-free line described in the present application refers to a treatment means for suturing (suturee) the superficial fascia of the skin without using a needle line in the treatment of closing the skin wound or in the process of healing the skin wound or in other treatments such as washing, disinfecting, dressing, etc. to the skin wound after an operation, and thus, there is no process for removing the foreign matter in the wound or the wound surface of the superficial fascia of the skin, such as a step and a procedure for removing or detaching a suture or an outlet, after the skin wound is healed.

In an exemplary embodiment, referring to fig. 1, fig. 1 is a schematic view of an embodiment of the vacuum drainage and cleansing system for a skin wound closed by a suture, as shown in the drawings, the vacuum drainage and cleansing system for a skin wound closed by a suture comprises: a flushing device 1, a negative pressure device 2 and a control device 3.

In an exemplary embodiment, please refer to fig. 2, which shows a schematic view of an embodiment of the vacuum drainage and cleansing system for suture-free closed skin wounds of the present application in use. As shown, the flushing device 1 comprises a delivery pump 103 and a first conduit 105 partially extending into the subcutaneous wound cavity 8 to a predetermined depth, for delivering a cleaning solution to the subcutaneous wound cavity 8 through the first conduit 105 to the predetermined depth.

It should be understood that the subcutaneous wound lumen 8 refers to a cavity formed by an internal incision under a wound in an operation, the cavity includes a breach gap formed by continuous interruption of all skin or other tissue parts, and due to the elasticity or elasticity of the living tissue of a human or animal body, in an actual state, the subcutaneous wound lumen 8, i.e. the breach gap, is not necessarily intuitively present in a cavity state or a cavity state, and therefore, the shape and size of the breach gap are not limited in the embodiments provided in the present application.

It should be understood that "conduit" as disclosed herein refers to components that may be fluidly coupled to one another so as to provide a path for transferring fluid (i.e., liquid and/or gas) between the components. For example, the components may be fluidly coupled by a fluid conductor (such as a tube). "catheter" as used herein broadly includes a tube, pipe, hose, conduit or other structure having one or more lumens adapted to convey fluid between two ends. Typically, the tube is an elongated cylindrical structure with some flexibility, but the geometry and rigidity may vary. In some embodiments, multiple components may also be coupled by physical proximity, integrated into a single structure, or formed from the same piece of material. Further, some fluid conductors may be molded into or otherwise integrally combined with other components.

The preset depth is the depth from the skin superficial fascia to the fat layer and the deep fascia layer in the skin tissue. Wherein, in a preferred embodiment, the predetermined depth is at the junction of the adipose layer and the deep fascia layer in the skin tissue. It is understood that the underlying skin tissue includes, in order, the vascular network, the superficial fascia layer, fat, the deep fascia layer, muscle, and bone. Therefore, the predetermined depth in this embodiment includes the depth interval from the superficial fascia layer to the fat and deep fascia layer.

In an exemplary embodiment, the cleaning solution includes distilled water, hydrogen peroxide, physiological saline, etc. which may be used to clean the wound. In some embodiments, the cleaning fluid may also include a liquid medicament that is determined by different etiologies and different types of the inner lumen 8 of the subcutaneous wound, for example, antibiotics may be added to the cleaning fluid when there is a bacterial infection in the wound, liquid medicaments of anti-inflammatory composition may be added to the cleaning fluid when there is an inflammation in the wound, etc. In other embodiments, solid drugs may also be dissolved in the cleansing solution and delivered to the subcutaneous wound lumen 8.

In an exemplary embodiment, please refer to fig. 6, which is a schematic diagram of an embodiment of the flushing device of the present application, and as shown in the drawing, the flushing device 1 further includes: a cleaning solution container 101, a first pressure sensor 104, and a first vacuum sensor 102.

Wherein the cleaning liquid container 101 stores cleaning liquid for washing the subcutaneous wound cavity 8, and the delivery pump 103 is communicated with the first conduit 105. The first conduit 105 is used to deliver a cleansing fluid to a predetermined depth of the subcutaneous wound lumen 8 to facilitate healing of the subcutaneous wound lumen 8. In a mode of this embodiment, can adopt intermittent type nature mode to carry the washing liquid to subcutaneous wound inner chamber 8 through control washing unit 1, make blood clot, tissue liquid piece etc. of solidification in subcutaneous wound inner chamber 8 obtain moist in order to do benefit to and remove to make the latent bacterial community that reaches colonizing concentration obtain diluting, clear away along with the flush fluid drainage, thereby maintain subcutaneous wound inner chamber 8 and keep clean state. In this embodiment, the intermittent delivery of the drug is performed in response to different conditions, treatment regimens and patient constitutions, such as the delivery frequency in hours or days. In a specific embodiment, the cleaning solution container 101 and the transfer pump 103 may be replaced with a drug delivery device or a drug delivery machine including a micro-pump, a syringe, or the like.

It will be appreciated that skin wounds may secrete blood, interstitial or other body fluids during the healing process, forming fluid pools. If these fluid collections are not discharged in a timely manner, they may cause infection, inflammation, and even suppuration. In some cases, the effusion which is not removed in time may be coagulated in the inner cavity 8 of the subcutaneous wound to form blood clots and other objects which are difficult to remove, and the blood clots can be dissolved or taken out by the pressure of the liquid after being wetted by the cleaning liquid, thereby being beneficial to the recovery of the subcutaneous wound.

Surgical Site Infection (SSI) is a worldwide clinical problem. After the skin is cut/cracked, the deep tissues of the human body will contact with the outside, and the chance of contamination by pathogenic bacteria appears. The bacteria content in the tissue exceeds 10⁵At/g, bacterial colonization occurs and cannot be controlled by the human immune system. Along with the exponential proliferation of bacteria, tissue necrosis and inflammatory reaction gradually occur at the infected part, and symptoms of redness, swelling, heat and pain appear locally; SSI is often difficult to identify and manage effectively at an early stage due to the latency of bacterial colonization to the appearance of infectious symptoms. Typical incision infections usually occur 7-10 days after surgery, starting with localized redness, tenderness, and ulceration, purulence. Since surgical sutures are easily colonized by bacteria, it is important to remove as much of all suture knots subcutaneously sutured as possible after SSI has occurred, and is also critical to prevent the recurrence of SSI, since the source of the recurrent SSI infection often comes from residual suture knots.

During the healing process, the flushing device 1 can deliver a cleaning fluid to the subcutaneous wound lumen 8 through the first conduit 105 for diluting bacterial infections that may or may have been produced in the subcutaneous wound lumen 8, thereby diluting the potential foci of infection to a colonizing concentration; meanwhile, the cleaning fluid conveyed by the flushing device 1 can also achieve the purpose of flushing the infected part in the inner cavity 8 of the subcutaneous wound, and after the flushing is finished, the cleaning fluid in the inner cavity 8 of the subcutaneous wound is sucked away through the drainage effect of the negative pressure device 2, so that bacteria are drained and removed, and the inner cavity 8 of the subcutaneous wound is kept in a clean state.

In actual clinical treatment, the amount of the cleaning liquid of the flushing device 1, the time for diluting the bacteria-infected part, the flushing frequency of the cleaning liquid, the operating frequency of the negative pressure device 2, and the like can be controlled according to the judged infection condition of the subcutaneous wound cavity 8 of the patient. For example, in an exemplary embodiment, the washing device 1 washes the cleaning solution in the subcutaneous wound inner cavity 8 for 2 to 3 days, for example. Since the cleaning solution container 101 and the delivery pump 103 may be replaced with a medication administering device or a medication administering machine including a micro pump, a syringe, or the like, parameters such as time, frequency, force, and the like of flushing may be manually controlled by an operator when a medication administering device such as a syringe, which requires manual control, is used.

In an exemplary embodiment, the transfer pump 103 is a diaphragm pump, which is a water pump.

It should be understood that the diaphragm pump, also known as a diaphragm pump and a control pump, is the main type of actuator that is operated by power to vary the fluid flow by receiving a control signal that regulates the output of the control unit. The diaphragm pump is used for receiving a control signal of a regulator or a computer in the control process, changing the flow rate of the regulated medium and maintaining the regulated parameters within a required range, thereby realizing the regulation and control of parameters such as temperature, pressure, flow rate, liquid level and the like in the working process.

In an exemplary embodiment, the first pressure sensor 104 is used to feed back the sensed value of the fluid pressure in the first conduit 105 between the delivery pump 103 and the subcutaneous wound lumen 8 to the control device 3 to adjust the rotational speed of the delivery pump 103 to control the output pressure of the cleansing fluid. In the process of cleaning the subcutaneous wound inner cavity 8 by the flushing device 1, if the fluid pressure is too high, secondary injury to the wound can be caused, and pain can be brought to a patient. On the contrary, if the fluid pressure is too low, the flushing effect is not ideal, the effusion and the like in the subcutaneous wound inner cavity 8 cannot be flushed completely, and the effusion still remains in the subcutaneous wound inner cavity 8 and is not beneficial to healing of the wound. In order to avoid the above situation, a first pressure sensor 104 is arranged on the first conduit 105 between the delivery pump 103 and the subcutaneous wound cavity 8, the fluid pressure value sensed by the first pressure sensor 104 reflects the fluid pressure value at the output end of the first conduit 105, and the fluid pressure value sensed by the first pressure sensor 104 is fed back to the control device 3, so that the control device 3 adjusts the rotation speed of the delivery pump 103, thereby controlling the output pressure of the cleaning solution.

It should be understood that the feedback means that the fluid pressure value of the pair sensed by the first pressure sensor 104 is provided to the control device 3, so that the control device 3 adjusts the rotation speed of the delivery pump 103 based on a preset desired pressure value, thereby controlling the output pressure of the cleaning liquid. The process is realized by feedback control, namely, the output information of the system is returned to the input end, compared with the input information, and the process of controlling by utilizing the deviation of the output information and the input information is carried out. Specifically, the feedback control is a function of comparing actual results after a certain action and a task are completed, thereby affecting the progress of the next action and playing a role of control. The method can timely react to the objective effect caused by each step in the implementation process of the planning decision, and adjust and modify the implementation scheme of the next step according to the objective effect, so that the implementation of the planning decision is coordinated with the original plan in a dynamic state. The first pressure sensor 104 or the second pressure sensor 203 is a pressure sensor including, but not limited to, model number MPXH 6300A.

In an exemplary embodiment, the first vacuum sensor 102 is configured to sense a vacuum level in the first conduit 105 between the transfer pump 103 and the cleaning solution container 101 to monitor a use-up condition of the cleaning solution in the cleaning solution container 101. When the cleaning liquid in the cleaning liquid container 101 is used up, infusion needs to be stopped or the cleaning liquid needs to be supplemented in time, and air enters the subcutaneous wound cavity 8. Here, by providing the first vacuum sensor 102 on the first conduit 105 between the transfer pump 103 and the cleaning liquid container 101, whether the cleaning liquid in the cleaning liquid container 101 is used up can be reflected by detecting the degree of vacuum of the first conduit 105 between the transfer pump 103 and the cleaning liquid container 101.

In an exemplary embodiment, when it is detected that the cleaning liquid in the cleaning liquid container 101 is used up or is about to be used up, the detection result is fed back to the control device 3, so that the control device 3 turns off the delivery pump 103, thereby preventing the delivery pump 103 from continuing to operate.

It should be understood that the first vacuum sensor 102 is disposed on the first conduit 105 between the transfer pump 103 and the cleaning solution container 101. The vacuum level detected by the first vacuum sensor 102 is therefore a reflection of the vacuum level in the first conduit 105 between the transfer pump 103 and the cleaning solution container 101. When the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 is filled with liquid or a large amount of liquid passes through, the vacuum degree in the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 is zero or close to zero, but when there is no liquid or very little liquid flowing through the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101, it indicates that the cleaning liquid in the cleaning liquid container 101 is used up or nearly used up, and at this time, the vacuum degree in the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 will be obviously increased. Therefore, after the first vacuum sensor 102 is disposed on the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101, whether the cleaning liquid in the cleaning liquid container 101 is used up or is about to be used up, that is, the used-up state of the cleaning liquid in the cleaning liquid container 101, can be determined according to the value of the vacuum degree detected by the first vacuum sensor 102.

In an exemplary embodiment, referring to fig. 3, fig. 3 is a schematic diagram of an alarm device in the negative pressure drainage and cleaning system for sutureless closure of a skin wound according to the present application, and as shown in the figure, the irrigation device 1 further includes an alarm device 9 for outputting an alarm signal when the first vacuum sensor 102 detects the exhaustion of the cleaning liquid in the cleaning liquid container 101. Here, when the first vacuum sensor 102 provided on the first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 detects that the cleaning liquid in the cleaning liquid container 101 is used up or is about to be used up, an alarm may be given by the alarm device 9 to prompt replenishment of the cleaning liquid or stop the operation of the flushing device 1.

It should be understood that the alarm device 9 is a device capable of receiving the control signal of the control device 3 to sound for the alarm function, and includes, but is not limited to, a buzzer, a voice alarm system, an audible and visual alarm, etc.

In an exemplary embodiment, the flushing device 1 comprises a delivery pump 103, a first conduit 105, a cleaning liquid container 101, a first pressure sensor 104, a first vacuum sensor 102. Wherein, the cleaning liquid container 101 is internally provided with a cleaning liquid for washing the inner cavity 8 of the subcutaneous wound. The delivery pump 103 is used for delivering the cleaning liquid in the cleaning liquid container 101 and controlling parameters such as flow rate, force and the like of the liquid. One end of the first conduit 105 is connected with the cleaning solution container 101, and the other end part of the first conduit 105 extends into the subcutaneous wound cavity 8 by a preset depth, so that the cleaning solution in the cleaning solution container 101 is delivered to the subcutaneous wound cavity 8. The first pressure sensor 104 is arranged on the first conduit 105 between the delivery pump 103 and the subcutaneous wound lumen 8, whereby a fluid pressure value is fed back to the control device 3, so that the control device 3 adjusts the rotational speed of the delivery pump 103 to control the output pressure of the cleansing liquid. The first vacuum sensor 102 is disposed on the first conduit 105 between the transfer pump 103 and the cleaning solution container 101, so that whether the cleaning solution in the cleaning solution container 101 is used up or is about to be used up is determined by the value of the vacuum degree detected by the first vacuum sensor 102. When it is detected that the cleaning liquid in the cleaning liquid container 101 is used up or is about to be used up, the alarm device 9 can be triggered by the control device 3 to alarm or the delivery pump 103 can be switched off by the control device 3.

In an exemplary embodiment, the negative pressure device 2 comprises a negative pressure source 202 and a second catheter 205 partially extending into the subcutaneous wound cavity 8 to a predetermined depth, and the negative pressure device 2 is used for generating negative pressure to force the subcutaneous wound cavity 8 to be in a closed state during healing and draining effusion in the subcutaneous wound cavity 8 through the second catheter 205. The second conduit 205 is used for generating negative pressure to force the subcutaneous wound inner cavity 8 to be in a closed state in the healing process, maintaining the detached tissues to be in a joint state, and maintaining the blood seepage and the liquid seepage in the wound cavity to be removed in time through continuous negative pressure suction, in the actual implementation process, the second conduit 205 of the negative pressure device 2 is inserted into the subcutaneous wound inner cavity 8, the tissues on two sides of the subcutaneous wound inner cavity 8 are forced to be in opposite directions (directions shown by arrows on two sides of the scalp lower wound in fig. 2) to be jointed through the generated negative pressure to eliminate the subcutaneous wound inner cavity 8, and the closure of the subcutaneous wound inner cavity 8 is favorable for the healing of the wound. It will be appreciated that in this process, the portion of the second conduit 205 in the subcutaneous wound lumen 8 does not affect the growth of tissue on either side of the subcutaneous wound lumen 8.

It will be appreciated that skin wounds may secrete blood, interstitial or other body fluids during the healing process, forming fluid pools. If these fluid collections are not discharged in a timely manner, they may cause infection, inflammation, and even suppuration. The accumulated liquid in the inner cavity 8 of the subcutaneous wound is discharged through negative pressure, so that the adverse conditions of wound infection, inflammation or suppuration and the like can be avoided, and the healing of the wound is facilitated.

In an exemplary embodiment, referring to fig. 7, which is a schematic view of an embodiment of the negative pressure device in the present application, as shown, the negative pressure device 2 further includes: a collection vessel 204, a second pressure sensor 203, and a second vacuum sensor 201.

Wherein the collection container 204 is used for collecting the effusion drained from the subcutaneous wound cavity 8 by the second catheter 205. The collection container 204 includes, but is not limited to, a liquid collection bottle, a liquid collection tank, and the like, which can be used to store liquid. The second catheter 205 collects the effusion drained from the subcutaneous wound lumen 8 in the collection container 204. When the collection container 204 is full, the collection container 204 may be replaced or the collection container 204 may be purged of liquid.

To ensure that the cleaning solution container 101 and the collection container 204 are maintained in an aseptic working environment, in an exemplary embodiment, the control part of the control device 3 is integrated with the cleaning solution container 101 and the collection container 204 in different equipment housings, for example, the control part of the control device 3 (including control device, delivery pump, negative pressure source) is configured in a first housing, the cleaning solution container 101 and the collection container 204 are configured in a second housing, the cleaning solution container 101 and the collection container 204 are physically isolated in the second housing, each container has an independent and non-communicating space, the second housing is provided with a conduit interface for connecting the cleaning solution container 101 and the collection container 204, respectively, for communicating with the respective conduits, that is, the collection container 204 communicates with a second conduit 205, the cleaning solution container 101 communicates with a first conduit 105. In an embodiment, the cleaning solution container 101 and the collection container 204 are detachably connected to the housing for easy replacement or maintenance.

In another exemplary embodiment, in a clinical setting, the washing solution container 101 and the collection container 204 may be disposed in respective housings independently for flexible arrangement, for example, the control part (including the control device, the delivery pump, and the negative pressure source) of the control device 3 is disposed in a first housing, the washing solution container 101 is disposed in a second housing, and the collection container 204 is disposed in a third housing. In an exemplary embodiment, the second pressure sensor 203 is used to monitor the full state of the collection container 204 by sensing the fluid resistance of the second conduit 205 between the negative pressure source 202 and the collection container 204. With continued reference to fig. 1, a second pressure sensor 203 is shown disposed on a second conduit 205 between the negative pressure source 202 and the collection container 204. When the liquid in the collection container 204 is full or about to be full, the fluid resistance in the second conduit 205 between the negative pressure source 202 and the collection container 204 is significantly increased, and the second pressure sensor 203 can detect the fluid resistance in the second conduit 205 between the negative pressure source 202 and the collection container 204 to determine whether the collection container 204 is full or about to be full, thereby determining the full state of the collection container 204.

It should be understood that the fluid resistance is generally divided into: the flow of fluid in the pipeline system can be divided into the flow in the uniform straight pipe, and the on-way resistance mainly based on surface friction is generated; and the flow in various pipe fittings such as valves, bent pipes, equipment inlets and outlets, etc., and local resistance mainly based on inverse pressure difference or vortex is generated due to flow passage direction change, sectional area change, flow passage branching and merging, etc. When the collection container 204 is full of liquid, the fluid in the second conduit 205 is prevented from flowing into the collection container 204 by the resistance from the liquid in the collection container 204.

In an exemplary embodiment, the negative pressure device 2 further includes an alarm device 9 for outputting an alarm signal when the second pressure sensor 203 detects that the liquid loading in the collection container 204 is full or is about to be full. Here, when the second pressure sensor 203 disposed on the second conduit 205 between the negative pressure source 202 and the collection container 204 detects that the liquid loading in the collection container 204 is full or is about to be full, an alarm device 9 can be used to give an alarm to prompt the collection container 204 to be replaced or cleaned. In other cases, when the second pressure sensor 203 arranged on the second conduit 205 between the negative pressure source 202 and the collection container 204 detects that the liquid loading in the collection container 204 is full or is about to be full, the second pressure sensor 203 can also feed back this information to the control device 3, so that the control device 3 signals the negative pressure device 2 to stop working to close the negative pressure device 2.

In an exemplary embodiment, the second vacuum sensor 201 is used to feed back the sensed vacuum level of the second conduit 205 between the negative pressure source 202 and the subcutaneous wound lumen 8 to the control device 3 to adjust the power of the negative pressure source 202 to control the generated negative pressure. Referring to fig. 1, as shown in the figure, a second vacuum sensor 201 is disposed on the second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8, and since the second conduit 205 partially protrudes into the subcutaneous wound inner cavity 8 by a preset depth, when the negative pressure in the second conduit 205 is too high, a secondary injury may be caused to the subcutaneous wound inner cavity 8; when the negative pressure in the second catheter 205 is too small, the effects of closing the subcutaneous wound cavity 8 and draining the effusion in the subcutaneous wound cavity 8 cannot be achieved. Therefore, it is necessary to maintain the negative pressure in the second conduit 205 within a suitable range of values. Meanwhile, when the subcutaneous wound inner cavity 8 is in a closed state or close to the closed state, the vacuum degree in the second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8 is zero or close to zero, so that by arranging the second vacuum sensor 201 on the second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8, the second vacuum sensor 201 can reflect the vacuum degree in the second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8, and further reflect whether the negative pressure applied to the subcutaneous wound inner cavity 8 is in an ideal range. Further, the second vacuum sensor 201 feeds back the acquired vacuum degree of the second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8 to the control device 3, and the control device 3 adjusts the output power of the negative pressure source 202 according to the data fed back by the second vacuum sensor 201, so as to control the negative pressure generated by the negative pressure source 202, and avoid the situation that the wound is damaged by excessive negative pressure or the effusion cannot be completely pumped due to insufficient negative pressure.

In an exemplary embodiment, the negative pressure source 202 is a diaphragm pump, which is an air pump.

It should be understood that the diaphragm pump, also known as a diaphragm pump and a control pump, is the main type of actuator that is operated by power to vary the fluid flow by receiving a control signal that regulates the output of the control unit. The diaphragm pump is used for receiving a control signal of a regulator or a computer 7 in the control process, changing the flow rate of the regulated medium and maintaining the regulated parameters within a required range, thereby realizing the regulation control of parameters such as temperature, pressure, flow rate, liquid level and the like in the working process.

In certain embodiments, the negative pressure source 202 may be an air reservoir under negative pressure, or may be a manually or electrically powered device that can reduce the pressure in the sealed volume, such as, for example, a vacuum pump, a suction pump, a wall suction port that may be used in many healthcare facilities, or a micro-pump, syringe, or stationary negative pressure device, or the like, or any suitable active or passive suction source. The negative pressure supply may be housed within or used in conjunction with other components such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 202 may be combined with other components into a therapy unit. The negative pressure supply can also have one or more supply ports configured to facilitate coupling of the negative pressure supply to and to the one or more distribution members.

It should be understood that "negative pressure" as disclosed herein generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside of the sealed therapeutic environment provided by the dressing. In many cases, the local ambient pressure may also be the atmospheric pressure at the location of the tissue site. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise stated, the values of pressure stated herein are gauge pressures. Similarly, reference to an increase in negative pressure typically refers to a decrease in absolute pressure, while a decrease in negative pressure typically refers to an increase in absolute pressure. While the amount and nature of the negative pressure applied to the tissue site may vary depending on the treatment requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between-5 mm Hg (-667Pa) and-500 mm Hg (-66.7 kPa). A common treatment range is between-75 mm Hg (-9.9kPa) and-300 mm Hg (-39.9 kPa).

In an exemplary embodiment, the control device 3 is electrically connected to the irrigation device 1 and the negative pressure device 2, and is configured to control the output pressure or flow of the irrigation device 1 and the negative pressure device 2 according to the received feedback to maintain the vacuum level of the subcutaneous wound lumen 8.

It should be understood that the washing apparatus 1 outputs the washing liquid by the delivery pump 103, and the pressure of the output washing liquid and the flow rate of the output washing liquid can be adjusted by the delivery pump 103. When the output pressure is too low, the subcutaneous wound inner cavity 8 cannot be well flushed, and when the output pressure is too high, secondary damage to the subcutaneous wound or pain of a patient may be caused. Meanwhile, when the output flow is too small, too little cleaning liquid can also affect the cleaning effect of the inner cavity 8 of the subcutaneous wound, and when the output flow is too large, the output pressure can be increased, secondary damage is caused to the subcutaneous wound or pain is increased for a patient. Therefore, it is desirable to control the output pressure and flow rate of the irrigation device 1 within a desired range to ensure a cleansing effect without causing new adverse effects on the subcutaneous wound and the patient.

It should be understood that the degree of vacuum refers to the degree of rareness of the gas in a vacuum state. If the pressure in the device under test is below atmospheric pressure, a vacuum gauge is required for its pressure measurement. The value read from the vacuum gauge is called the vacuum degree. The vacuum value is a value indicating that the actual value of the system pressure is lower than the atmospheric pressure, that is: the vacuum degree is atmospheric pressure-absolute pressure, and the absolute pressure is atmospheric pressure + gauge pressure (-vacuum degree). In this embodiment, the vacuum level may indirectly reflect the size of the subcutaneous wound lumen 8, for example: when the vacuum degree is higher, the two sections reflecting the inner cavity 8 of the subcutaneous wound still have larger gaps, which means that the negative pressure is possibly lower and the closing acting force on the inner cavity 8 of the subcutaneous wound is possibly insufficient; on the contrary, when the vacuum degree is zero or close to zero, the two sections reflecting the inner cavity 8 of the subcutaneous wound have no gap or small gaps, which means that the negative pressure is probably in an ideal range or is higher, and when the negative pressure is higher, the negative pressure can cause secondary damage to the subcutaneous wound or bring pain to a patient, and when the negative pressure is kept in the ideal range, the healing of the subcutaneous wound is more facilitated. Therefore, maintaining the vacuum degree of the subcutaneous wound inner cavity 8 in an ideal range can help close the subcutaneous wound inner cavity 8 without causing secondary damage to the subcutaneous wound or pain to a patient, and help the subcutaneous wound to recover better. In the present application, the vacuum level is primarily detected by a vacuum sensor, including but not limited to a vacuum sensor model MPXV6115VC 6U.

The output pressure and the output flow of signal control washing unit 1 of controlling means 3 accessible response washing unit 1 feedback on the one hand can clear away the hydrops, impurity etc. of subcutaneous wound inner chamber 8 when guaranteeing that washing unit 1's output pressure can not cause the damage to the subcutaneous wound, on the other hand accessible response negative pressure device 2 feedback signal control negative pressure apparatus 2's negative pressure intensity to guarantee not causing the hydrops drainage in the subcutaneous wound inner chamber 8 when damaging to the subcutaneous wound, and close subcutaneous wound inner chamber 8, maintain the vacuum of subcutaneous wound inner chamber 8 is in ideal scope.

In an exemplary embodiment, the negative pressure device 2 may generate a vacuum of 70% to 80%, such as 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, to maintain the vacuum of the subcutaneous wound lumen 8 within a desired range.

In an exemplary embodiment, continuing to refer to fig. 3, the negative pressure device 2 includes a collection container 204, a second pressure sensor 203, a negative pressure source 202, a second vacuum sensor 201, and a second conduit 205. One end of the second conduit 205 extends into the subcutaneous wound cavity 8 to a preset depth, the other end of the second conduit 205 is connected to the collection container 204 through the negative pressure source 202, and a second pressure sensor 203 is arranged on the second conduit 205 between the negative pressure source 202 and the collection container 204 for detecting the resistance to determine whether the collection container 204 is full. A second vacuum sensor 201 is arranged on a second conduit 205 between the negative pressure source 202 and the subcutaneous wound inner cavity 8, and is used for detecting the vacuum degree of the subcutaneous wound inner cavity 8 to judge the negative pressure of the subcutaneous wound inner cavity 8. The control device 3 is respectively connected with the second pressure sensor 203 and the second vacuum sensor 201 through an A/D module, namely a digital-analog signal conversion module, and the second pressure sensor 203 feeds back the sensed resistance information to the control device 3 so that the control device 3 can adjust the on-off of the negative pressure source 202 or control the alarm device 9 to give an alarm. Meanwhile, the second vacuum sensor 201 feeds back the sensed vacuum degree information to the control device 3 so that the control device 3 adjusts the rotating speed and the flow rate of the negative pressure source 202 through the duty ratio. The flushing device 1 comprises a cleaning liquid container 101, a first conduit 105, a first vacuum sensor 102, a delivery pump 103 and a first pressure sensor 104. One end of the first conduit 105 extends into the subcutaneous wound inner cavity 8 by a preset depth, the other end of the first conduit 105 is connected with the cleaning solution container 101 through the delivery pump 103, and the first conduit 105 between the delivery pump 103 and the subcutaneous wound inner cavity 8 is provided with a first pressure sensor 104 for detecting the output pressure of the delivery pump 103. A first vacuum sensor 102 is disposed on a first conduit 105 between the delivery pump 103 and the cleaning liquid container 101 for detecting a vacuum degree to determine the exhaustion of the cleaning liquid in the cleaning liquid container 101. The control device 3 is connected with the first vacuum sensor 102 and the first pressure sensor 104 through an a/D module, i.e. a digital-to-analog signal conversion module, the first vacuum sensor 102 feeds back the sensed vacuum degree to the control device 3, so that the control device 3 controls the alarm device 9 to give an alarm or controls the on/off of the delivery pump 103, and the first pressure sensor 104 feeds back the sensed pressure to the control device 3, so that the control device 3 controls the output pressure of the delivery pump 103 through the duty ratio.

In an exemplary embodiment, a wound closure device 4 may be employed to assist the negative pressure device 2 in closing the subcutaneous wound lumen 8. The wound closing device 4 can extrude the skin edge to enable the two exposed ends of the skin wound to be attached tightly, the subcutaneous wound inner cavity 8 is kept in a closed state in the healing and rehabilitation process under the forcing and assisting of the negative pressure device 2, the effusion of the subcutaneous wound inner cavity 8 can be sucked, meanwhile, the flushing device 1 can be used for flushing and conveying liquid medicine to the subcutaneous wound inner cavity 8, and then the infection focus which potentially reaches the colonization concentration in the subcutaneous wound inner cavity 8 is diluted and cleaned.

In the embodiment provided by the present application, the wound closure device 4 is used for pressing the skin margin to make the skin wound in a closed state in the healing process, and meanwhile, the pressing of the skin margin can reduce the bleeding of the blood vessel network under the skin dermis, which is beneficial to wound recovery. The wound closure device 4 is arranged on the circumference of the skin wound, in some embodiments the wound closure device 4 is arranged on the circumference of the skin wound by means of adhesive. In some embodiments, the wound closure device 4 comprises at least two closure elements 41, the at least two closure elements 41 are respectively arranged at two side edges of the skin wound, and in the implementation process, the skin wound is kept in a closed state in the healing process through the combination of the two closure elements 41. In practice, the number of closure members 41 may be determined by the length of the wound and the particular form of the closure member 41.

Referring to fig. 8, which is a schematic structural view of the closure element in the wound closure device of the present application in one embodiment, as shown in the figure, in one embodiment, the wound closure device 4 further includes a microporous cover 40 (not shown) covering the closure element 41, and the microporous cover 40 is combined on the closure element 41 to conform to the shape structure of the closure element 41 so as to form an integral body with the closure element 41 to facilitate adsorbing or sucking secreted liquid exuded from the skin wound and retained on the closure element 41 or drug liquid retained on the closure element 41. In an exemplary embodiment, the microporous cover 40 is a unitary structure with the closure 41. In another exemplary embodiment, the microporous cover 40 is bonded to the closure element 41, such as by bonding or the like, such that the microporous cover 40 conforms to the contours of the closure element 41 and is bonded to the closure element 41.

In certain embodiments, the closure 41 includes a flexible body 410, the flexible body 410 representing that a material having an elastic/flexible body 410 can have an ultimate elongation of greater than 100% and a significant amount of spring back. Rebound of a material refers to the ability of the material to recover from elastic deformation. Examples of the elastic/flexible body 410 material may include, but are not limited to, natural rubber, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, copolyester, silicone, and the like.

In an exemplary embodiment, the closure member 41 may also be a silicone material, a resin material, or a silicone resin material.

In an exemplary embodiment, the material of the microporous cover 40 is medical cotton, cotton wool (cotton wool)

cotton), foam, mesh, gauze, sponge, or porous biocompatible material, and the microporous cover 40 has air permeability and moisture adsorption properties for adsorbing effusion that may be secreted during the healing process of the skin wound or moisture remaining in the drug residue that is not absorbed by the tissue of the skin wound.

In the present embodiment, the closure member 41 includes: a flexible body 410 and a rigid curved needle 411.

The flexible body 410 is adhered to the skin surface at the periphery of the skin wound; in this embodiment, the flexible body 410 is made of a silicone material, a resin material, or a silicone resin material. The flexible body 410 is adhered to the skin surface of the skin wound periphery by an adhesive, such as, in some embodiments, a medical adhesive, such as a quick-stick adhesive including methyl cyanoacrylate as a main body, or the like. In a specific implementation, at least two of the flexible bodies 410 are adhered to the skin surface on opposite sides of the skin wound periphery.

The rigid curved needle 411 includes a root portion and a curved needle portion, the root portion of the rigid curved needle 411 is embedded in the flexible body 410 and is firmly disposed on the flexible body 410, and the curved needle portion of the rigid curved needle 411 is exposed outside the flexible body 410. In an exemplary embodiment, the root of the rigid curved needle 411 is securely disposed in the flexible body 410 by a deformed structural design, such as a hook-like structure or a T-shaped structure, etc.

In an exemplary embodiment, referring to fig. 9, which shows a schematic view of a closure element and a wound combination according to an embodiment of the present application, as shown in the drawing, the curved needle portion of the rigid curved needle 411 exposed out of the flexible body 410 penetrates into one side of the skin wound to squeeze the skin edge so as to keep the skin wound in a closed state during a healing process, in a specific implementation, a doctor needs to perform a wound-to-skin (aligning the skin edge and preventing the skin edge from being turned inwards to avoid poor skin healing) operation, and then penetrates the curved needle portion of the rigid curved needle 411 from one side of the skin wound so as to squeeze the skin edge to reduce bleeding of the hypodermic blood network of the skin as the rigid curved needles 411 of the closure elements 41 on both sides of the skin wound penetrate into healthy tissue on the side edge of the wound, is beneficial to wound recovery, and further enables the skin wound to be in a closed state.

In another exemplary embodiment, the curved needle portion of the rigid curved needle 411 exposed outside the flexible body 410 penetrates into the other side of the skin wound, and hooks the other side of the skin wound with the curved needle portion, so that the two sides of the skin wound are combined in an opposite manner, and the healthy tissues on the two opposite sides of the skin wound are also combined in an opposite manner, thereby closing the skin wound.

In another exemplary embodiment, the curved needle portion of the rigid curved needle 411 exposed out of the flexible body 410 penetrates into the flexible body 410 disposed at the other side of the skin wound, such that the flexible bodies 410 at the two sides of the skin wound are combined oppositely, and the healthy tissues at the two opposite sides of the skin wound are also combined oppositely, thereby closing the skin wound.

As shown in fig. 9, the skin 11 includes, in sequence, a vascular network, a superficial fascia layer, fat, a deep fascia layer, muscle and bone. The depth of the stitching in this example is in the superficial fascia layer. A problem of concern in the present application is a seamless operation of the superficial fascia portion of the skin (i.e., the epidermis, dermis and subcutaneous adipose tissue portions of the skin), and the depth of penetration of the curved needle portion of the rigid curved needle 411 exposed outside the flexible body 410 includes the epidermis, dermis and subcutaneous adipose tissue portions of the superficial fascia portion of the skin.

In some embodiments, the number and length of the rigid curved needles 411 disposed on the flexible body 410 may be different according to the length or width of the applicable skin wound, and in some embodiments, when there are a plurality of rigid curved needles 411 disposed on the flexible body 410, the rigid curved needles 411 are arranged on the elongated flexible body 410 in an equidistant manner.

Referring to fig. 10, which is a schematic view of a closure member of the wound closure device of the present application in a further embodiment, as shown in the figure, in the present embodiment, the closure member 41 further comprises a holding member 42, the holding member 42 is used for holding a flexible body 410 of the closure member 41 adhered to two sides of the skin wound, and the flexible body 410 provides an opposite force to press the skin edges under the action of the holding member 42 to ensure that the skin wound is in a closed state during the healing process. In a specific implementation, the clip 42 is a medical clip or the like.

In the embodiments using the closure member 41 including the flexible body 410 and the rigid curved needle 411, it is also possible to use some auxiliary members 412, and the auxiliary members 412 are used for assisting the adhesion between the closure member 41 and the skin surface and providing the closure member 41 with the contraction force for closing the skin wound, please refer to fig. 11, which is a schematic view of the application of the closure member and the auxiliary members of the wound closure device of the present application in one embodiment.

In another exemplary embodiment, referring to fig. 12, which is a schematic structural view of a closure element in the wound closure device of the present application, in yet another embodiment, as shown, in this embodiment, the closure element 41 comprises: a first flexible body 4100 and a second flexible body 4101.

The first flexible body 4100 is adhered to a skin surface of the skin wound periphery, the first flexible body 4100 having a first bonding portion; the second flexible body 4101 is adhered to the skin surface of the skin wound periphery, and the second flexible body 4101 has a second combining portion correspondingly combined to the first combining portion. The combination of the first and second junctions provides opposing forces to the flexible bodies 410 applied to both sides of the skin wound, thereby compressing the edges to maintain the skin wound in a closed state during healing. In this embodiment, the first and second flexible bodies 4101 are made of silicone material, resin material, or silicone resin material. The first and second flexible bodies 4101 are adhered to the skin surface on opposite sides of the skin incision with an adhesive, such as in some embodiments a medical adhesive, such as a quick adhesive comprising methyl cyanoacrylate as a main body, or the like.

In some exemplary embodiments, the first coupling portion is a groove structure or a snap structure, and the second coupling portion is a protrusion structure or a snap hole or a hook structure corresponding to the snap structure. For example, the first combining portion is provided with a plurality of grooves, and the second combining portion is provided with a plurality of protruding structures corresponding to the grooves. The grooves on the first combining part can be replaced by buckle structures, and correspondingly, the protruding structures on the second combining part can be replaced by clamping holes or clamping hook structures corresponding to the buckles; however, the present invention is not limited thereto, and any other combination structure that can combine the first flexible body 4100 and the second flexible body 4101 can achieve the purpose of the present embodiment, such as combination of the groove or the hole and the protrusion structure.

In some embodiments, with continued reference to fig. 12, the wound closure device 4 further comprises an auxiliary element 412 for assisting in the adhesion between the closure element 41 and the skin surface and providing a constricting force to the closure element 41 for closing the skin wound, in an exemplary embodiment, if the skin wound is an incision in a first direction, the auxiliary element 412 is adhered to the periphery of the skin wound and applies a force to the closure element 41 in a second direction perpendicular to the first direction, in this embodiment referred to as a constricting force, and the auxiliary closure element 41 provides for closing the skin wound. In this embodiment, the auxiliary element 412 is attached to the surface of the skin by means of its adhesive layer against the skin surface, for example an adhesive plaster comprising polyurethane coated with an acrylic adhesive.

In this embodiment, the auxiliary element 412, which is the adhesive, may be designed as a strip-like structure extending from the center to two opposite sides, which may be separate or integrated, and which is adapted to be stretched manually for increasing the comfort of the patient.

In an exemplary embodiment, the first or second catheter is partially advanced to a predetermined depth of the subcutaneous wound lumen 8 via a predetermined location of the skin wound; or the first or second catheter is passed through the skin and subcutaneous tissue via a predetermined location remote from the skin wound to partially reach the predetermined depth of the subcutaneous wound lumen 8.

In an exemplary embodiment, please refer to fig. 4, which is a schematic diagram of an embodiment of the present application in which the first or second catheter is partially advanced from a predetermined location of the skin wound to a predetermined depth of the lumen of the subcutaneous wound. As shown in the figure, the first or second catheter partially extends into the preset depth of the inner cavity 8 of the subcutaneous wound through a preset position of the skin wound, so that negative pressure can be generated, the inner cavity 8 of the subcutaneous wound is ensured to be in a closed state in the healing process, and meanwhile, effusion of the inner cavity 8 of the subcutaneous wound is drained, so that the detached tissue is maintained to be in a fit state, and the blood seepage and the effusion in the wound are kept to be cleared away in time through continuous negative pressure suction, so that the effusion such as the blood seepage and/or the effusion and the like of the inner cavity 8 of the subcutaneous wound can be cleared away in time, and the living space or the environment of bacteria is eliminated. In this embodiment, the predetermined position may be any position on the wound, where placement against the edge of the wound is more conducive to wound healing.

In another exemplary embodiment, referring to fig. 2, as shown, the first or second catheter is passed through the skin and the subcutaneous tissue via a predetermined position away from the skin wound to partially protrude to a predetermined depth of the inner cavity 8 of the subcutaneous wound, so as to generate a negative pressure to ensure that the inner cavity 8 of the subcutaneous wound is closed during the healing process and simultaneously suck the effusion from the inner cavity 8 of the subcutaneous wound, so that the living space or environment of bacteria is eliminated due to the timely removal of the effusion from the inner cavity 8 of the subcutaneous wound. In this embodiment, please refer to FIG. 5, which is a schematic diagram of the first or second catheter passing through the skin and subcutaneous tissue at a predetermined location away from the skin wound. The first or second catheter is passed through the skin and subcutaneous tissue via a predetermined location remote from the skin incision (the location shown at a in figure 5) to partially reach a predetermined depth within the subcutaneous incision lumen 8. By remote is meant a predetermined location from the skin incision (such as the location shown at a in fig. 5), and in order to facilitate closure and surface treatment of the skin incision, the first or second catheter does not protrude through the skin incision into the subcutaneous incision lumen 8, but instead protrudes through the skin and subcutaneous tissue from another location, such as a predetermined location remote from the skin incision, to partially protrude into the subcutaneous incision lumen 8, this embodiment being particularly suitable for use with an elongated incision as shown in fig. 5.

In an exemplary embodiment, the first conduit 105 and the second conduit 205 are integrally formed.

In this embodiment, referring to fig. 13, which is a schematic view of an embodiment of the first and second conduit structures of the present application, as shown in the drawings, the first conduit 105 and the second conduit 205 are integrally formed, so that the number of pipe laying can be reduced, the integrally formed conduit includes two conduits which are isolated from each other and not communicated with each other, wherein the first conduit forms the first conduit 105, and the second conduit forms the second conduit 205.

In another exemplary embodiment, the second conduit 205 may also be nested within the first conduit 105.

In the present embodiment, please refer to fig. 14, which shows a schematic view of another embodiment of the first and second conduit structures of the present application, as shown in the drawings, the first conduit 105 and the second conduit 205 are integrally formed, so that the number of buried pipes can be reduced, the integrally formed first conduit 105 and the second conduit 205 are two pipes which are not communicated with each other, wherein the second conduit 205 is sleeved in the first conduit 105, the diameter of the first conduit 105 is larger than that of the second conduit 205, and since the thinner conduit is sleeved in the thicker conduit, the diameter of the entire conduit can not be increased while the number of conduits is not increased.

In an exemplary embodiment, a plurality of through holes are formed in the wall of the portion of the first catheter 105 that extends to a predetermined depth into the skin incision. Referring to fig. 13 to 14, as shown in the figure, a plurality of through holes 1050 are formed on the first conduit 105, the first conduit 105 is connected to the cleaning solution container 101, so that the cleaning solution in the cleaning solution container 101 is delivered to the preset depth of the inner cavity 8 of the subcutaneous wound by the first conduit 105, and simultaneously flows out to each part of the subcutaneous wound through the through holes 1050 on the first conduit 105, thereby cleaning or delivering more medicine to the subcutaneous wound. In an exemplary embodiment, the plurality of through holes 1050 are uniformly distributed at intervals on the wall of the portion of the first catheter 105 extending into the skin wound to a predetermined depth, especially for a long and narrow wound, the wound lumen formed under the long and narrow wound is usually also an elongated cavity or gap, so as to ensure that the elongated cavity or gap can be cleaned or used for delivering the medicine by the cleaning solution in the first conduit at each position; in another exemplary embodiment, the plurality of through holes 1050 of the first catheter 105 may be designed to be unequally spaced (i.e., the plurality of through holes are unevenly spaced on the wall of the portion of the first catheter 105 that protrudes to a predetermined depth into the skin lesion) for different types of skin lesions or for different purposes.

In an exemplary embodiment, a plurality of through holes are formed in the wall of the portion of the second catheter 205 which protrudes into the skin wound by a predetermined depth, the second catheter 205 is connected to the negative pressure source 202 to generate negative pressure, and the plurality of through holes in the second catheter 205 can help to suck the gas and liquid in the inner cavity 8 of the subcutaneous wound, so as to increase the sucking area and the sucking position, and further help to heal the subcutaneous wound. In an exemplary embodiment, the through holes are uniformly distributed at intervals on the wall of the portion of the second conduit 205 that protrudes into the skin wound to a predetermined depth, especially for a narrow wound, the wound lumen formed under the narrow wound is also usually an elongated cavity or gap, in order to ensure that the effusion or residual medical liquid secreted from each of the elongated cavity or gap is drawn by the second conduit 205; in another exemplary embodiment, the plurality of through holes on the second catheter tube 205 may be designed to be unequally spaced (i.e., the plurality of through holes are unevenly spaced on the wall of the portion of the second catheter tube 205 that protrudes to a predetermined depth into the skin lesion) for different types of skin lesions or different purposes.

In yet another exemplary embodiment, the shape and structure of the first and second catheters 105 and 205 penetrating into the skin wound at a predetermined depth may also be designed according to actual requirements, such as different thicknesses or different tissue structures of the skin wound according to the expected penetration depth, different flexibility of the first and second catheters 105 and 205, such as different thicknesses of the same catheter at different positions, different materials of the same catheter at different positions, different flexibility of the same catheter at different positions, and the like.

In an exemplary embodiment, a one-way valve is disposed on the first or second conduit. In order to avoid the backflow of the gas or effusion sucked into the catheter, which is not beneficial to the healing of the skin wound, in the embodiment, the one-way valve is a rubber member such as a duckbill valve, a fan valve or a cone valve, but is not limited to this, and the embodiment is also applicable to the valve assembly controlled by a machine or an electricity.

It should be understood that the duckbill valve is shaped like a duckbill, and is referred to as a duckbill valve. The duckbill valve is made of elastic materials, so that the duckbill outlet is folded under the elastic action of the duckbill valve under the condition of no internal pressure. When the internal pressure of the duckbill valve is gradually increased, the duckbill outlet is gradually increased, and liquid can be discharged at a high flow speed.

It should be understood that the outlet of the sector valve is of a sector configuration. The sector valve is made of elastic materials, so that the sector outlet is folded under the elastic action of the sector outlet under the condition of no internal pressure. When the pressure inside the fan-shaped valve is gradually increased, the fan-shaped outlet is gradually increased, and the liquid can be discharged at a high flow rate.

It should be understood that the spool sealing surface of the conical valve is a conical surface. The cone valve is provided with the cone valve core at the flow channel terminal, and all moving parts of the cone valve are arranged outside the flow channel of the valve, so that the flow channel inside the valve body is smooth and smooth, the flow is large, the pressure drop loss is low, the cone valve cannot generate cavitation erosion and vibration in the whole working range, and the cone valve still has a good flow control effect when in small flow.

In an exemplary embodiment, the negative pressure device 2 is further used for maintaining the tissue position of the skin wound surface and its peripheral region stable by the generated negative pressure, thereby facilitating wound healing.

In an exemplary embodiment, the negative pressure device 2 includes: a sealing film 12 for adhering to the skin and covering the skin wound surface to form a sealed space 13; and the negative pressure channel is communicated with the negative pressure source 202, and the skin wounds are driven to contract oppositely by the contraction force provided by the sealing film 12 due to the negative pressure generated by the negative pressure source 202. In the present embodiment, the negative pressure passage communicates with the negative pressure source 202 through the second conduit 205, communicating the negative pressure passage with the sealed space 13, thereby forming the sealed space 13.

In this embodiment, the negative pressure generated by the negative pressure device 2 compresses the sealed space 13, so as to maintain the local tissue close to the wound site. Meanwhile, the negative pressure generated by the negative pressure device 2 also generates acting force on deep tissues under the wound, so that potential dead spaces are closed, and the wound healing is promoted. In the present embodiment, the pressure value of the sealed space 13 formed by the sealing film 12 adhered to the skin may be set to a range between about 0.001 and about 1 atmosphere. In an actual implementation process, the negative pressure value generated by the negative pressure device 2 may be controlled according to the healing degree of the wound, for example, the negative pressure value may be appropriately decreased according to the healing degree of the skin wound, or the negative pressure value may be appropriately increased according to the situation of the effusion secreted by the skin wound, for example, the effusion is increased, so as to increase the force of sucking the effusion.

In an exemplary embodiment, referring to fig. 15, which shows a schematic view of a sealing and force-applying structure of the negative pressure device in an embodiment of the present application, as shown in the figure, the sealing membrane 12 is adhered to the skin and covers the wound surface of the skin, thereby forming a sealed space 13, and after being pumped and compressed by the negative pressure device 2, the sealed space 13 inside the sealing membrane 12 is inwardly applied with a force, as shown by the arrow in fig. 15, to apply pressure to the deep tissue while maintaining the local tissue position fixed, thereby closing the potential dead space. In this embodiment the sealing membrane 12 forms a sealing zone around the skin wound and such that the sealing zone forms a sealed space 13, in this embodiment the sealing membrane 12 is bonded to the surface of the skin by its adhesive layer, e.g. a flexible impermeable material comprising polyurethane coated with an acrylic adhesive, against the skin surface.

In an exemplary embodiment, the sealing film 12 is provided with a viewing window of a light transmissive material. Here, the sealing film 12 may be made of a transparent material. The sealing membrane 12, being a transparent material, may facilitate the clinician in visualizing the healing of the skin wound for timely intervention.

Referring to fig. 17, which is a schematic view of an application example of the present application, as shown in the figure, the operator embeds the first catheter tube 105 of the flushing device 1 and the second catheter tube 205 of the negative pressure device 2 into the subcutaneous tissue of the skin, and extends the first catheter tube 105 and the second catheter tube 205 into the subcutaneous wound inner cavity 8. The negative pressure device 2 can drain the effusion secreted by the subcutaneous wound lumen 8 through the second catheter 205, and meanwhile, the wound lumen tends to be folded/combined due to the negative pressure, so that the tissues on the two sides are combined oppositely. In addition, the flushing device 1 can also deliver cleaning solution and liquid medicine to the subcutaneous wound inner cavity 8 through the first conduit 105 for healing, which is the first aspect; in the second aspect, the closing part 41 is used for folding the skin on the two sides outside the wound inwards, so that the skin wound is kept in a closed state in the healing process, the closing part 41 can squeeze the skin edge to reduce the bleeding of the hypodermic blood pipe network of the skin, and the negative pressure of the negative pressure device 2 can assist in closing the inner cavity 8 of the subcutaneous wound. The operator continues to place the microporous covering 40 over the wound surface to ensure that secretions on the wound surface are absorbed in time during the healing process. Then covering a sealing film 12 outside the micropore accessory to wrap the whole wound and the micropore covering piece 40 on the wound; in the third aspect, the sealing membrane 12 is pumped and pressed through the negative pressure channel of the negative pressure device 2, so that the skin wound and the tissues in the peripheral area of the skin wound are tightened, in addition, the negative pressure generated by the negative pressure device 2 can also apply a certain degree of pressure on the deep tissues to close the potential dead space, so that the healing speed of the skin wound is accelerated, and in addition, the treatment means of suturing (suture) the superficial fascia part of the skin without using a needle and a suture line and other medical tools are not used.

In an exemplary embodiment, the negative pressure device 2 includes a humidity detection component (not shown) for providing the detected humidity information in the sealed space 13 to the negative pressure source 202 to facilitate the negative pressure source 202 to regulate the negative pressure output. The sensor of the humidity detection component is arranged in a sealed space 13 formed by a sealing film 12, and an information output port of the humidity detection component is connected with the control device 3, so that the detected humidity information is provided for the control pressure device to control the negative pressure device 2 to regulate and control the output negative pressure. In this embodiment, the humidity detection component is, for example, a humidity sensor.

In an exemplary embodiment, referring to fig. 16, which is a schematic view of an embodiment of the second catheter in the present application, the second catheter 205 includes a subcutaneous drainage hole 2050 and a subcutaneous negative pressure hole 2051, the subcutaneous drainage hole 2050 is a plurality of through holes disposed on the wall of the portion of the second catheter 205 that protrudes a predetermined depth into the skin wound; the on-skin negative pressure hole 2051 communicates with the sealed space 13 to apply negative pressure to the sealed space 13. The second conduit 205 is connected to a negative pressure source 202, and the negative pressure source 202 provides negative pressure to the second conduit 205. The subcutaneous drainage hole 2050 of the second catheter 205 is located on the wall of the part of the second catheter 205 which extends into the skin wound by a preset depth, the subcutaneous wound inner cavity 8 is forced to be in a closed state in the healing process by the negative pressure generated by the negative pressure source 202, and the effusion of the subcutaneous wound inner cavity 8 is drained through the second catheter 205. The subcutaneous negative pressure hole 2051 of the second catheter 205 is positioned in the sealed space 13 of the subcutaneous part and is used for communicating with the sealed space 13 to apply negative pressure to the sealed space 13, so as to maintain the tissue position of the skin wound surface and the peripheral area thereof stable.

In an exemplary embodiment, with continuing reference to fig. 1, the negative pressure drainage and cleansing system for sutureless closed skin wounds further comprises a computer 7, wherein the computer 7 is connected to the control device 3 in a communication manner, such as but not limited to, a USB interface connection, a bluetooth connection, or a wireless network connection. The user can set a program on the computer 7 to set the working time, working mode, etc. of the flushing device 1 and the negative pressure device 2. For example, the drive parameters of the irrigation device 1 and the negative pressure device 2 may be set according to different diseases, different treatment methods or according to the characteristics of the actual condition or wound.

In an exemplary embodiment, with continuing reference to fig. 1, the negative pressure drainage and cleansing system for a sutureless closed skin wound further comprises an interactive device 6, wherein the interactive device 6 includes, but is not limited to, a touch screen, a display screen, an operation keyboard, and the like. The user can manually set the control system through the interaction device, so that the working state, the working time, the working mode and the like of the negative pressure device 2 and the flushing device 1 are controlled, and the working state, the working time, the working mode and the like of the negative pressure device 2 and the flushing device 1 are known in real time through information fed back on the display screen.

In an exemplary embodiment, with continuing reference to fig. 1, the negative pressure drainage and cleansing system for a sutureless closed skin wound further comprises a memory module 5, wherein the memory module 5 includes, but is not limited to, a memory chip such as an SD card or cloud storage. The storage module 5 can store operation information set by a user, an operation program downloaded from the computer 7, data during actual use, and the like.

In summary, the negative pressure drainage and cleaning system for the suture-free closed skin wound of the application makes the inner cavity 8 of the subcutaneous wound keep a closed state in the healing and rehabilitation process under the force of the negative pressure device 2, maintains the detached tissue to keep a joint state, and keeps the blood and the exudate in the wound cavity to be removed in time through continuous negative pressure suction; in the second aspect, the cleaning solution is intermittently delivered to the inner cavity 8 of the subcutaneous wound, so that the blood clots coagulated in the inner cavity 8 of the subcutaneous wound are wetted to be removed, and the potential bacterial community reaching the colonization concentration is diluted and removed along with the drainage of the cleaning solution, thereby maintaining the cleaning state in the wound cavity. Meanwhile, medicines can be added or replaced in the cleaning solution, so that the cleaning solution is conveyed to the subcutaneous wound inner cavity 8 to help the subcutaneous wound to heal; in the third aspect, the control device 3 can control the negative pressure of the negative pressure device 2 and the flushing pressure and flow of the flushing device 1 in real time through the feedback control of the negative pressure device 2, the flushing device 1 and the control device 3, so that the negative pressure of the negative pressure device 2 can play a good role in closing and drainage, and the flushing device 1 can play a good role in flushing without generating negative influence on subcutaneous wounds. And in the using process, the control device 3 can trigger the alarm device 9 to alarm based on the feedback information of the vacuum sensor and the pressure sensor so as to remind an operator to replenish the cleaning liquid or replace the collecting container 204 in time. The negative pressure generated by the negative pressure device 2 can also maintain the stable tissue position of the skin wound and the peripheral area thereof, thereby being beneficial to tissue healing. In addition, the application can realize the seamless line closure of the whole layer of tissue above the deep fascia of the skin, avoid the transverse scar (commonly called as 'centipede feet') caused by suture compression/cutting on the surface of the skin, and has no remained suture knot in the shallow fascia, thereby eliminating the important factors causing bacterial colonization and the main inducement of the relapse of the infection of the incision.

Therefore, the negative pressure drainage and cleaning system for closing the skin wound without the suture can keep the inner cavity 8 of the subcutaneous wound in a closed state all the time in the healing and rehabilitation process without using suture, thereby not only accelerating the healing speed of the skin wound, but also not using a treatment means of suturing (suture) the skin without using a needle and medical tools such as a suture and a suture line, so that after the skin wound is healed, the process of removing the wound or foreign matters in the wound surface, such as the step of removing or detaching the suture or taking out the thread head and the operation process, further eliminating the key link and the important inducement of bacterial colonization, ensuring the wound after healing not to leave the suture trace such as 'centipede' on the surface of the skin, ensuring the beauty of the operation incision part, further solving the problems that the incision suture after the operation is easy to leave the trace and the effusion is difficult to discharge and the like in the prior art, the surgical auxiliary equipment for closing the skin wound without the suture line in the skin superficial fascia is particularly suitable for the field of beauty treatment.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical concepts disclosed in the present application shall be covered by the claims of the present application.

Claims (18)

1. A negative pressure drainage and cleaning system for closing skin wounds without sutures, comprising:

the flushing device comprises a delivery pump and a first catheter, wherein part of the first catheter extends into the inner cavity of the subcutaneous wound to a preset depth, and the first catheter is used for delivering cleaning liquid to the preset depth of the inner cavity of the subcutaneous wound;

the negative pressure device comprises a negative pressure source and a second catheter partially extending into the inner cavity of the subcutaneous wound by a preset depth, and is used for generating negative pressure to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process and draining effusion in the inner cavity of the subcutaneous wound through the second catheter;

and the control device is electrically connected with the flushing device and the negative pressure device and is used for controlling the output pressure or flow of the flushing device and the negative pressure device according to the received feedback so as to maintain the vacuum degree of the subcutaneous wound inner cavity.

2. The negative pressure drainage and cleansing system for closing skin wounds with a suture-free line of claim 1, wherein the irrigation device comprises:

the cleaning liquid container is used for storing cleaning liquid for flushing the inner cavity of the subcutaneous wound and is communicated with the delivery pump through the first catheter;

the first pressure sensor is used for feeding back the sensed fluid pressure value of the first catheter between the delivery pump and the inner cavity of the subcutaneous wound to the control device so as to adjust the rotating speed of the delivery pump and control the output pressure of the cleaning liquid;

and the first vacuum sensor is used for sensing the vacuum degree of a first conduit between the delivery pump and the cleaning liquid container so as to monitor the exhaustion state of the cleaning liquid in the cleaning liquid container.

3. The negative pressure drainage and cleaning system for closing a skin wound with a suture-free thread as claimed in claim 2, wherein the flushing device comprises an alarm device for outputting an alarm signal when the first vacuum sensor detects the exhaustion of the cleaning liquid in the cleaning liquid container.

4. The negative pressure drainage and cleansing system for closing skin wounds without sutures according to claim 1 or 2, characterized in that the delivery pump is a diaphragm pump.

5. The negative pressure drainage and cleansing system for closing skin wounds with no suture of claim 1, wherein the negative pressure device comprises:

the collection container is used for collecting the effusion drained from the inner cavity of the subcutaneous wound by the second catheter;

a second pressure sensor for sensing a fluid resistance of a second conduit between the negative pressure source and the collection container to monitor a full state of the collection container;

and the second vacuum sensor is used for feeding back the sensed vacuum degree of the second conduit between the negative pressure source and the inner cavity of the subcutaneous wound to the control device so as to adjust the power of the negative pressure source to control the generated negative pressure.

6. The negative pressure drainage and cleansing system for closing skin wounds with a suture-free thread according to claim 5, wherein the negative pressure source is a diaphragm pump.

7. The negative pressure drainage and cleansing system for a suture-free closed skin wound of claim 1, wherein the predetermined depth is the depth of the interval from the superficial fascia to the adipose layer and the deep fascia layer in the skin tissue.

8. The negative pressure drainage and cleansing system for suture-free closure of skin wounds of claim 1, wherein the first or second catheter is partially advanced to a predetermined depth of the subcutaneous wound lumen via a predetermined location of the skin wound; or the first or second catheter is passed through the skin and subcutaneous tissue via a predetermined location remote from the skin wound to partially penetrate to a predetermined depth within the lumen of the subcutaneous wound.

9. The negative pressure drainage and cleansing system for closing skin wounds with no suture of claim 1, wherein the first and second catheters are integrally formed or the second catheter is sleeved inside the first catheter.

10. The negative pressure drainage and cleansing system for closing skin wounds with no suture as claimed in claim 1, wherein a plurality of through holes are provided on the wall of the portion of the first or second catheter that protrudes to a predetermined depth into the skin wound.

11. The negative pressure, suture-free, closed skin wound drainage and cleansing system of claim 1, wherein the first or second catheter is provided with a one-way valve.

12. The negative pressure drainage and cleansing system for closing skin wounds without sutures according to claim 11, wherein the one-way valve is a duckbill valve or a fan valve.

13. The negative pressure drainage and cleansing system for suture-free closure of skin wounds of claim 1, wherein the negative pressure device is further configured to maintain the tissue position of the skin wound surface and its peripheral region stable by the generated negative pressure.

14. The negative pressure drainage and cleansing system for closing skin wounds with no suture of claim 13, wherein the negative pressure device comprises:

a sealing film for adhering to the skin and covering the skin wound surface to form a sealed space;

and the negative pressure channel is communicated with the negative pressure source, and the sealing film provides a contractile force to drive the skin wounds to contract oppositely by the negative pressure generated by the negative pressure source.

15. The negative pressure, suture-free, closed skin wound drainage and cleansing system of claim 14, wherein the sealing membrane is adhered to the surface of the skin by an adhesive layer opposite the skin surface, the adhesive layer comprising a flexible, impermeable material such as polyurethane coated with an acrylic adhesive.

16. The negative pressure, suture-free, closed skin wound drainage and cleansing system of claim 14, wherein the sealing membrane is provided with a viewing window of a light-transmitting material.

17. The negative pressure drainage and cleansing system for closing skin wounds with a suture-free thread according to claim 14, wherein the negative pressure device comprises a humidity detection component for providing detected humidity information in the sealed space to the negative pressure source to facilitate the negative pressure source to regulate the negative pressure output.

18. The negative pressure drainage and cleansing system for closing skin wounds without sutures according to claim 14, characterized in that the second catheter comprises a subcutaneous drainage hole and an intradermal negative pressure hole, the subcutaneous drainage hole being a plurality of through holes provided on the wall of the portion of the second catheter that protrudes into the skin wound by a predetermined depth; the skin negative pressure hole is communicated with the sealed space to apply negative pressure to the sealed space.

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