CN212439529U - Medical drainage tube and negative pressure drainage and cleaning system and surgical auxiliary equipment suitable for same - Google Patents

Abstract

The application relates to the technical field of medical equipment, specifically provides a medical drainage tube and negative pressure drainage and cleaning system, surgery auxiliary assembly who is suitable for, includes: the hose body is used for draining effusion at the periphery or the inner cavity of the wound through the generated negative pressure; and a first supporting part which is arranged in the hose body or formed on the hose body and is used for supporting the hose body. This application can be at the drainage in-process, by the effect of first supporting part under, even the hose body receives external force to buckle at the pipeline section that has first supporting part, also can not make the hose body build the choke and collapse and influence the fluid and pass through, guaranteed the unobstructed nature of drainage process. Simultaneously, the hose body is under the effect of second supporting part, when being located the pipeline section of on-skin negative pressure device and receiving seal membrane and negative pressure effect, because the holding power of second supporting part can not make the hose body produce great deformation to drainage effect has been guaranteed.

Description

Medical drainage tube and negative pressure drainage and cleaning system and surgical auxiliary equipment suitable for same

Technical Field

The application relates to the technical field of medical instruments, in particular to a medical drainage tube, a negative pressure drainage and cleaning system applicable to the medical drainage tube and surgical auxiliary equipment.

Background

Surgical drainage is used for discharging redundant liquid or gas at the affected part or in the body of a patient out of the body, and avoids complications such as infection and the like caused by excessive accumulation of effusion or gas, wherein the effusion comprises residual pus, blood, bile and the like in cavities and gaps in the body. In still other cases, drainage may also include placement of a gastric tube for gastrointestinal decompression, placement of a urinary catheter for catheterization, and the like. For drainage of a surgical site, excess fluid or gas is usually drained away by some conduit left on the patient's body.

Since the drainage tube usually needs to be left in the patient for a long time, the body of the patient inevitably presses the drainage tube during the activity, and the drainage tube is bent to influence the fluid passing.

Disclosure of Invention

In view of the above-mentioned shortcomings of the prior art, the present application aims to provide a medical drainage tube, which is used for solving the problem of poor drainage caused by easy deformation of the drainage tube in the prior art.

To achieve the above and other related objects, a first aspect of the present application provides a medical drainage tube comprising: the hose body is used for draining effusion at the periphery or the inner cavity of the wound through the generated negative pressure; and a first supporting part which is arranged in the hose body or formed on the hose body and is used for supporting the hose body.

In certain embodiments of the first aspect of the present application, the first support is a continuous support of a predetermined length.

In certain embodiments of the first aspect of the present application, the first support is a spacer support of a predetermined length.

In certain embodiments of the first aspect of the present application, the first support is a filler filled in the hose body, the filler includes a plurality of microparticles having a gap therebetween, through which the effusion flows.

In certain embodiments of the first aspect of the present application, the outer surface of the microparticles has at least one curved or folded surface.

In certain embodiments of the first aspect of the present application, the microparticles are hard materials.

In certain embodiments of the first aspect of the present application, the microparticles are of a polymeric plastic material.

In certain embodiments of the first aspect of the present application, the hose body is provided with a fixing structure for fixing the filler.

In certain embodiments of the first aspect of the present application, the securing structure is integrally formed on an inner wall of the hose body.

In certain embodiments of the first aspect of the present application, the securing structure is snap-fitted to an inner wall of the hose body.

In certain embodiments of the first aspect of the present application, the first support is a steel wire disposed on an inner wall of the hose body and disposed in compliance with a length direction of the hose body.

In certain embodiments of the first aspect of the present application, the steel wires are arranged in a circumferential direction of the cross-section of the hose body and are at least 3 in number.

In certain embodiments of the first aspect of the present application, the first support is a threaded tube.

In certain embodiments of the first aspect of the present application, the hose body includes two end engaging portions and a middle portion located between the two end engaging portions, and the first supporting portion is located at least one predetermined position of the middle portion.

In certain embodiments of the first aspect of the present application, a second support portion is provided within the tube of the joint portion of at least one end of the hose body.

In certain embodiments of the first aspect of the present application, the second support is a spring.

In certain embodiments of the first aspect of the present application, the hose body further includes a negative pressure hole adjacent to the second supporting portion for maintaining the tissue position of the wound and the peripheral region thereof stable by the generated negative pressure.

In certain embodiments of the first aspect of the present application, the medical drainage tube further comprises a position limiting structure for fixing the medical drainage tube.

In certain embodiments of the first aspect of the present application, the device further comprises an irrigation tube for delivering the liquid drug to a predetermined depth of the wound periphery or lumen.

In certain embodiments of the first aspect of the present application, the irrigation tube is integrally formed with the hose body, or the irrigation tube is nested within the hose body.

The second aspect of the present application also provides a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin, comprising: the subcutaneous negative pressure drainage device comprises a catheter, a drainage tube and a drainage tube, wherein part of the catheter extends into the inner cavity of a subcutaneous wound by a preset depth and is used for generating negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process; the catheter is a medical drain according to any one of the first aspect of the present application; the wound closing device is arranged on the peripheral side of the skin wound and used for pressing the skin edges to keep the skin wound in a closed state in the healing process; the skin negative pressure device is arranged at the periphery of the skin wound and used for generating negative pressure to maintain the stable tissue position of the skin wound and the peripheral area thereof.

A third aspect of the present application also provides a negative pressure drainage and cleansing system for closing a skin wound with a suture, 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 which partially extends 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, wherein the second catheter is the medical drainage tube in any one of the first 18 aspects of the application; 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.

A fourth aspect of the present application also provides a surgical aid for the seamless closure of skin wounds in the deep fascia of a limb, comprising: the subcutaneous negative pressure drainage device comprises a catheter, a drainage tube and a drainage tube, wherein part of the catheter extends into the inner cavity of a subcutaneous wound by a preset depth and is used for generating negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process; the catheter is a medical drain according to any one of the first aspect of the present application; the wound closing device is arranged on the peripheral side of the skin wound and used for pressing the skin edges to keep the skin wound in a closed state in the healing process; the skin negative pressure device is arranged at the periphery of the skin wound and is used for generating negative pressure to maintain the stable tissue position of the skin wound and the peripheral area of the skin wound; the drainage needles are used for penetrating into the deep fascia of the subcutaneous soft tissue from the peripheral sides of the skin wound so as to drain the effusion in the deep fascia of the subcutaneous soft tissue, each drainage needle comprises a drainage part formed on a needle body of the drainage needle, and one part of the drainage part is positioned outside the surface of the skin when the drainage needle penetrates into the subcutaneous soft tissue.

As mentioned above, the medical drainage tube, the negative pressure drainage and cleaning system and the surgical auxiliary equipment which are suitable for the medical drainage tube have the following beneficial effects:

according to the application, firstly, a drainage part is cleaned through a cleaning pipe by a drug delivery device, so that possible or generated bacterial infection is diluted by utilizing a cleaning solution; secondly, the drainage part is drained through the hose body by the negative pressure source, so that accumulated liquid, cleaning liquid and the like in the drainage part are discharged through negative pressure; in addition, the air in the sealing film is extracted through the negative pressure hole, so that the sealing film applies pressure to the skin to facilitate the closing of the wound. In whole drainage process, the hose body is by under the effect of first supporting part, even the hose body receives external force to buckle at the pipeline section that has first supporting part, also can not make the hose body hold out the smooth nature that collapses and influence the fluid and pass through, has guaranteed drainage process. Simultaneously, the hose body is under the effect of second supporting part, when being located the pipeline section of on-skin negative pressure device and receiving seal membrane and negative pressure effect, because the holding power of second supporting part can not make the hose body produce great deformation to drainage effect has been guaranteed.

Drawings

FIG. 1 is a schematic structural view of a medical drainage tube according to an embodiment of the present invention.

FIG. 2 is a schematic view of another embodiment of a medical drain according to the present application.

FIG. 3 is a schematic view of another embodiment of a medical drain according to the present application.

FIG. 4 is a schematic structural view of a medical drainage tube according to still another embodiment of the present application.

FIG. 5 is a schematic structural view of a fixing structure of a medical drainage tube according to an embodiment of the present application.

FIG. 6 is a schematic view showing a fixing structure of a medical drainage tube according to another embodiment of the present application.

FIG. 7 is a schematic view showing the structure of a medical drainage tube according to still another embodiment of the present application.

FIG. 8 is a schematic view showing an embodiment of a catheter structure of a medical drainage tube according to the present application.

FIG. 9 is a schematic view showing another embodiment of a catheter structure of a medical drainage tube according to the present application.

FIG. 10 is a schematic view of an embodiment of a medical drain in accordance with the present application.

FIG. 11 is a schematic view showing a structure of a hose body of a medical drainage tube according to an embodiment of the present application.

FIG. 12 is a schematic view of a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application in one embodiment.

Fig. 13 shows a schematic view of a subcutaneous negative pressure drainage device of the surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application in one embodiment.

Fig. 14 shows a schematic view of a subcutaneous negative pressure drainage device of a surgical aid for sutureless closure of a skin wound within the superficial fascia of the skin of the present application in another embodiment.

Fig. 15 is a schematic view of the catheter of fig. 14 being passed through the skin and subcutaneous tissue from a predetermined location away from the skin incision to partially penetrate the elongated incision.

Fig. 16 is a schematic view of a closure member of an embodiment of a wound closure device of the surgical assistance apparatus for sutureless closure of a skin wound in superficial fascia of the skin of the present application.

Fig. 17 is a schematic view of an embodiment of an occlusive member in combination with a wound in an embodiment of a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application.

FIG. 18 shows a schematic view of an occlusive member of a wound occluding device in a surgical aid for sutureless occlusion of a skin wound in the superficial fascia of the skin of the present application, in yet another embodiment.

FIG. 19 shows a schematic view of an occlusive member of a wound closure device in one embodiment of a surgical adjunct for sutureless closure of a skin wound in the superficial fascia of the skin of the present application.

FIG. 20 is a schematic view of an embodiment of a catheter structure of a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application.

FIG. 21 is a schematic view of another embodiment of a catheter structure of a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application.

Fig. 22 shows a schematic view of a closure element in a wound closure device of the present surgical aid for the sutureless closure of a skin wound in the superficial fascia of the skin, in a further embodiment.

FIG. 23 is a schematic view of a sealing and force-bearing structure of a vacuum device on skin in the surgical aid for sutureless closure of a skin wound in superficial fascia of skin according to an embodiment of the present application.

FIG. 24 is a schematic view of a surgical aid for the sutureless closure of a skin wound in the superficial fascia of the skin of the present application in another embodiment.

FIG. 25 is a schematic view of a surgical aid for the sutureless closure of a skin wound in the superficial fascia of the skin of the present application in a further embodiment.

FIG. 26 is a schematic view of an embodiment of the negative pressure drainage and cleansing system for suture-free closure of skin wounds of the present application.

Fig. 27 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. 28 shows a schematic view of an embodiment of the alarm device in the negative pressure drainage and cleansing system for suture-free closure of skin wounds according to the present application.

Fig. 29 is a schematic view of an embodiment of the present application of the negative pressure drainage and cleansing system for suture-free closure of a skin wound, wherein the first and second catheters are partially advanced from a predetermined location of the skin wound to a predetermined depth within the lumen of the subcutaneous wound.

Fig. 30 shows a schematic view of an embodiment of the first and second catheters of the vacuum drainage and cleansing system for suture-free closure of a skin wound of the present application passing through the skin and subcutaneous tissue via a predetermined location away from the skin wound.

Fig. 31 shows a schematic view of an embodiment of an irrigation device in the negative pressure drainage and cleansing system for suture-free closure of skin wounds according to the present application.

Fig. 32 is a schematic view of an embodiment of a negative pressure device in the negative pressure drainage and cleansing system for closing skin wounds without sutures according to the present application.

Fig. 33 is a schematic view of a sealing and force-bearing structure of a negative pressure device in the negative pressure drainage and cleansing system for closing skin wounds without sutures according to an embodiment of the present invention.

FIG. 34 shows a schematic view of an embodiment of a first catheter in the negative pressure drainage and cleansing system for suture-free closure of skin wounds of the present application.

Fig. 35 shows a schematic view of an embodiment of an application of the negative pressure drainage and cleansing system for suture-free closure of skin wounds according to the present application.

FIG. 36 shows a schematic view of a surgical aid for sutureless closure of skin wounds in the deep fascia of an extremity of the present application in one embodiment.

Fig. 37 is a schematic view showing an application structure of a drainage needle in the surgical assistant device for closing skin wounds without stitches in deep fascia of limbs of the application in still another embodiment.

Fig. 38 shows a schematic view of an application example of a plurality of drainage needles in the surgical aid for sutureless closure of skin wounds in the deep fascia of limbs according to the present application.

FIG. 39 is a schematic view of the sealing and force-bearing structure of the vacuum device on the skin of the surgical aid for sutureless closure of skin wounds in the deep fascia of limbs according to the present application.

FIG. 40 shows a schematic view of a surgical aid for the sutureless closure of skin wounds in the deep fascia of an extremity of the present application in another embodiment.

FIG. 41 is a schematic view of a surgical aid for the sutureless closure of skin wounds in the deep fascia of an extremity of the present application in a further embodiment.

Fig. 42 shows a schematic view of the application of the drainage needle in the surgical aid for sutureless closure of skin wounds in the deep fascia of the limbs of the application in one embodiment.

Fig. 43 shows a schematic view of the application of the drainage needle in the surgical aid for the sutureless closure of skin wounds in the deep fascia of the limbs of the application in another embodiment.

Fig. 44-45 show a schematic view of the structure of the drainage needle in the surgical auxiliary device for closing skin wound without suture in deep fascia of limbs according to the application in one embodiment.

Fig. 46 to 47 show a schematic structural view of a drainage needle in a surgical aid for closing a skin wound without a suture in deep fascia of limbs according to another embodiment of the present application.

Fig. 48 to 49 show a schematic configuration of a drainage needle in a surgical aid for closing a skin wound without a suture in the deep fascia of an extremity according to the present application in a further embodiment.

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 in some instances, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. 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 conduit are both describing one conduit, but they are not the same conduit unless the context clearly dictates otherwise. The similar situation also includes the first supporting part and the second supporting part.

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.

As described in the background, surgical drainage is used to drain excess fluid or gas from the affected area or body of a patient, and to avoid complications such as infection due to accumulation of excessive fluid or gas, including pus, blood, bile, etc. remaining in the body cavity. The drainage also comprises stomach tube for gastrointestinal decompression, urinary catheter for catheterization and the like. For drainage of a surgical site, excess fluid or gas is usually drained away by some conduit left on the patient's body.

For example, in some cases, suture treatments are often used to treat wounds (also referred to in the industry as incisions or surgical incisions, wounds, etc.) that are unavoidably created by a patient (patient) during surgery, and to facilitate healing of the wound during such treatment, i.e., after suture of the wound with a needle or suture, the industry may use a reduced pressure dressing assembly that includes a bolster body formed from a closing bolster material with 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, the closing force generated in the structure can only act on the surface layer, when the wound is deep, muscle tissues and the like at the deep subcutaneous part cannot be forced to be in a closed state, and the wicking material can only treat liquid seeped from the surface of the skin, so that subcutaneous effusion (such as blood seepage, liquid seepage and the like) cannot be treated in time, and the recovery of the wound is not facilitated. In this case, the drainage can discharge the excess liquid or gas from the affected part or body of the patient, which is beneficial to the healing of the wound of the patient. However, since the drainage tube is usually required to be retained in the patient for a certain period of time, the patient inevitably presses the drainage tube during the movement of the drainage tube, so that the drainage tube is bent to influence the fluid passing.

In view of this, the present application provides a medical drainage tube, so as to achieve the purpose of solving the problem that fluid is difficult to pass through when the drainage tube is bent by providing a support part on the drainage tube. In the embodiments provided below, the medical drain of the present application comprises: the hose comprises a hose body and a first supporting part arranged in the hose body or formed on the hose body. The hose body is used for draining effusion around the periphery of the wound or in the inner cavity through the generated negative pressure, and the first supporting part is used for supporting the hose body.

The medical drainage tube of this application can make the hose body when taking place to buckle, still by first supporting part support hose body to make the fluid still can pass through the hose body smoothly under the condition that the hose body took place to buckle inside, also avoided the not smooth scheduling problem of drainage that leads to because of the hose body buckles when the aspect patient moves about. The hose body can be used for any part needing drainage, and is not limited to effusion at the periphery of a wound or in an inner cavity.

It should be understood that "hose body" as disclosed herein means that components can 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). As used herein, "hose body" 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 material of the hose body includes, but is not limited to: TPE (Thermoplastic Elastomer), silicone, latex, and the like.

One end of the hose body is connected with the negative pressure source, and the other end of the hose body is arranged at the periphery of the wound or in the inner cavity of the wound, so that the effusion at the periphery of the wound or in the inner cavity of the wound can be drained by the negative pressure generated by the negative pressure source. Wherein the effusion includes, but is not limited to, pus, blood, bile and the like remained in the periphery or the inner cavity of the wound.

In this embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, may be an air reservoir at negative pressure, or may be a manually or electrically driven 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 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).

It should be understood that in embodiments of the present application, the wound includes any breach created by a continuous interruption of a skin or other tissue site, 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. Wherein the wound periphery includes tissue adjacent the wound. The wound lumen is a cavity formed by an internal incision under a wound in an operation, and the cavity comprises a cleft gap (or body cavity gap) formed by continuous interruption of all skin or other tissue parts. Since the living tissue of the human or animal body has elasticity or elasticity, the wound lumen, i.e. the breach gap, is not necessarily intuitively present in a cavity state or a cavity state in an actual state, and thus, the shape and size of the breach gap are not limited in the embodiments provided in this application.

Wherein the tissue includes, but is not limited to, bone tissue, adipose tissue, muscle tissue, nerve 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 tissue region that is not necessarily wounded or defective, but is an area in which it may be desirable to add or promote additional tissue growth or to be drained. For example, negative pressure may be applied to the tissue site to grow additional tissue that may be harvested and transplanted, and the like.

In some embodiments, the first support may be disposed inside the hose body, i.e., inside the hose tube. In some embodiments, the first support may be formed on the hose body, that is, the first support is a part of the hose body. By means of the first supporting portion, the corresponding pipe section can still keep a certain fluid space inside when being bent under the action of external force, and smooth drainage is guaranteed.

In an exemplary embodiment, please refer to fig. 1, which is a schematic structural diagram of a medical drainage tube according to an embodiment of the present application, and as shown in the drawing, the medical drainage tube includes: a hose body 101, and a first support portion 1011 provided in the hose body 101 or formed on the hose body 101.

In an exemplary embodiment, referring to fig. 2, which is another structural schematic view of the medical drainage tube of the present application in one embodiment, as shown in the drawing, the first supporting portion 1011 is a continuous supporting body with a preset length. In this embodiment, the first supporting portion 1011 is disposed in the hose body 101 or on the hose body 101 without interruption, that is, the first supporting portion 1011 is disposed in the hose body 101 or on a continuous section of the hose body 101.

Wherein, the preset length can be determined according to the actual requirement. In some embodiments, the preset length may be configured to be the same as the length of the hose body, that is, the first supporting portion 1011 is provided in all the sections of the hose body 101 or on all the sections of the hose body 101, so as to ensure that any position of the hose body 101 does not affect the drainage effect when being bent. In other embodiments, considering that the hose body far away from the human body of the patient has a small bending probability, the preset length may be configured to correspond to a portion of the hose body that is easily touched by the human body of the patient, for example, 50CM to 100CM, so as to ensure that the hose body 101 near the human body of the patient or all the pipe sections of the hose body 101 have the first supporting portion 1011, so that the hose body 101 near the human body of the patient does not affect the drainage effect when being bent.

In another exemplary embodiment, please refer to fig. 3, which is a schematic structural view of a medical drainage tube according to an embodiment of the present application, and as shown in the drawing, the first supporting portion 101 is a spacing supporting body with a predetermined length. In this embodiment, the first supporting portions 1011 are spaced apart from each other in the hose body 101 or on the hose body 101, that is, the first supporting portions are provided in a part of the hose body 101 or on the hose body 101, and the first supporting portions are not provided in a part of the hose body 101 or on the hose body 101.

The setting position of the first supporting part and the preset length can be determined according to actual requirements. In some embodiments, the first support may be configured to provide the first support at a portion of the pipe segment that is susceptible to bending. For example, if there is a difference in height between the installation height of the negative pressure source and the position of the patient, the hose body may be easily bent at the connection section between the hose body and the negative pressure source, and the first support portion may be provided in the hose body or on the hose body at this section. If the patient is in motion, the hose body is easily pressed by the patient to be bent, so that the first supporting part can be arranged in the hose body near the patient or on the hose body, and the hose body of the part near the human body of the patient cannot influence the drainage effect when being bent. The preset length may be determined according to a position where the first support is disposed and a corresponding requirement, and in some embodiments, when the first support is disposed in or on a hose body of a connection section portion of the hose body and a negative pressure source, the preset length may be configured to correspond to the connection section portion length, for example, 10 to 30CM or the like. In some further embodiments, when the first support is located near the human body of the patient, the preset length may be configured to correspond to a length of a portion accessible to the human body of the patient, for example, 50CM to 100 CM.

It should be understood that the support portion refers to a member provided in the hose body so as to act on an inner wall of the hose body to form a supporting force; or a part which is formed on the hose body and still keeps the internal fluid path smooth under the action of negative pressure. For this purpose, the support portion includes, but is not limited to, a filler filled in the hose body, a support member supported on an inner wall of the hose body, or a structure which is a part of the hose body and can be bent while still maintaining an open internal fluid path under a negative pressure.

In an exemplary embodiment, the first support 1011 is a filler filled in the hose body, and the filler includes a plurality of micro-particles, and the micro-particles have gaps therebetween for flowing the liquid. Wherein, the micro-particle is the particulate matter that the diameter is less than 5mm, the micro-particle can be hard materials such as polymer plastic material to can not produce deformation when receiving the negative pressure effect. The polymer plastic material includes, but is not limited to, polypropylene, polyethylene, polyvinyl chloride, polystyrene, polyester, polyurethane, and the like. The gap formed between the outer surface structures of the micro particles can allow fluid to pass through, meanwhile, the micro particles filled in the hose body form supporting force on the inner wall of the hose body, when the hose body is bent after receiving pressure, the micro particles can also displace along with the pressure, so that the bending of the hose body is not influenced, but the micro particles are still in a passage state under the supporting effect, and the smoothness of a drainage process is ensured.

In an exemplary embodiment, to allow fluid to pass through the gaps between the microparticles, the outer surface of the microparticles has at least one curved or folded surface, for example, the microparticles have a spherical, ellipsoidal, irregular polyhedral shape, or the like. In some embodiments, the plurality of microparticles may all be the same shape, e.g., all are spheres or ellipsoids, etc. In other embodiments, as shown in fig. 3, the plurality of microparticles may have different shapes, such as a part of the plurality of microparticles being spherical, another part of the plurality of microparticles being hexahedral, and another part of the plurality of microparticles being octahedral. Wherein the diameter of the plurality of microparticles may or may not be equal, for example, in some embodiments, the diameter of each of the plurality of microparticles is 0.6 mm; in other embodiments, a portion of the plurality of microparticles has a diameter of 0.8mm, another portion has a diameter of 1mm, and so forth.

In an exemplary embodiment, to prevent the filler from escaping under the negative pressure inside the hose body, the hose body is provided with a fixing structure for fixing the filler. It will be appreciated that during drainage a negative pressure will be created in the hose body, the force of which will to some extent affect the position of the filling. In order to limit the position of the filler at the position of the preset first supporting part, the filler can be limited in the fixed structure by arranging the fixed structure on the hose body, so that the filler is prevented from escaping along with the acting force of negative pressure to influence the supporting effect.

In some embodiments, referring to fig. 5, which is a schematic structural view of an embodiment of the fixing structure of the medical drainage tube of the present application, as shown in the drawings, the fixing structure 1013 is integrally formed on the inner wall of the hose body 101. Here, the fixing structure 1013 is configured as an integral structure with the hose body 101, that is, the fixing structure 1013 is provided on the inner wall of the hose body corresponding to the position of the first support 1011, so that the filler is limited within the range surrounded by the fixing structure 1013, and the filler is prevented from escaping. The fixing structure 1013 may be a blocking part integrally formed on the inner wall of the hose body, for example, as shown in fig. 5, a filter net is provided at the boundary of two ends corresponding to the position of the first supporting part, and the diameter of the filter hole of the filter net is smaller than the diameter of the filler, so that the filler is prevented from passing through the filter net and is limited in the space limited by the filter nets at two ends, that is, the first supporting part 1011 is formed.

In still other embodiments, please refer to fig. 6, which is a schematic structural view illustrating a fixing structure of a medical drainage tube according to another embodiment of the present application, as shown in the figure, the fixing structure 1013 is engaged with an inner wall of the hose body 101. Here, the fixing structure 1013 is configured to be a separate structure from the hose body 101, that is, the fixing structure 1013 and the hose body 101 are detachable structures, and the filler is limited within a range surrounded by the fixing structure 1013, so that the filler is prevented from escaping. For example, as shown in fig. 6, the fixing structure is a sieve, the sieve is inserted into the hose body 101 at corresponding positions, that is, at both ends of the filler filling portion, so that the filler in the hose body 101 can be limited, and since the diameter of the filter holes of the sieve is smaller than that of the filler, the filler can be prevented from passing through the sieve so as to be limited in the space limited by the sieve at both ends, that is, the first supporting portion 1011 is formed.

In an exemplary embodiment, referring to fig. 4, which is a schematic structural view of a medical drainage tube according to the present application in yet another embodiment, the first supporting portion 1011 is a steel wire disposed on an inner wall of the hose body 101 and configured to conform to a length direction of the hose body 101. Because the steel wire can be buckled into the deformation state of expectation by the manpower, nevertheless can not produce deformation by the negative pressure effect for the drainage, consequently when hose body 101 takes place to buckle, the steel wire can cooperate hose body 101 to produce deformation, nevertheless can not lead to flat collapsing because of the negative pressure to can play the supporting role for hose body 101, guarantee the drainage effect.

The steel wire may be disposed on an outer wall of the hose body 101, or may be disposed on an outer wall of the hose body 101. In this embodiment, in order to ensure the body feeling when the hose contacts the skin of a patient during use, the hose is provided on the inner wall of the hose body 101. Meanwhile, the steel wire is disposed in conformity with the length direction of the hose body 101. It should be understood that the hose body is usually a slender structure, so the axial direction thereof is a length direction, that is, the steel wire is arranged in conformity with the axial direction of the hose body, so that the steel wire can be deformed in cooperation with the hose body when the hose body is bent.

In some embodiments, the wires are arranged in a circumferential direction of the cross-section of the hose body and are at least 3 in number. It will be appreciated that if the number of wires is small and thin, the support for the hose body is limited and the negative pressure is high, which may still cause the hose to collapse and affect the flow of fluid therethrough. Therefore, the hose body can be supported at each radial position of the hose body by arranging a plurality of steel wires in the hose body; or by increasing the width of the wire to increase the contact surface of the wire with the hose body to increase the supporting force. Here, when the steel wires are arranged in the circumferential direction of the cross section of the hose body and the number is at least 3, the supporting force to the hose body can be secured even when the diameter of the steel wires is thin.

In an exemplary embodiment, referring to fig. 7, which is a schematic structural view of a medical drainage tube according to the present application in another embodiment, as shown in the drawings, the first support portion 1011 is a threaded tube. When the first supporting part is a continuous supporting body with a preset length, the hose body is a threaded pipe, or a certain section of the hose body is a threaded pipe; when the first support part is a spacing support body with a preset length, namely, at least two parts of pipe sections of the hose body are threaded pipes. Here, the threaded pipe is made of plastic, and the threaded pipe can be easily bent under an external force but cannot be collapsed under the negative pressure generated by a negative pressure source connected with the hose body, so that the fluid circulation is ensured during drainage, and the threaded pipe includes but is not limited to: polyethylene (PE), flexible ABS plastic, etc. Wherein the flexible ABS plastic is a terpolymer of acrylonitrile, butadiene and styrene.

In the use, when needs buckle hose body 101, the screwed pipe can buckle by its structural characteristic cooperation hose body, and because the plastic material of screwed pipe can not be in the produced negative pressure effect of the negative pressure source of hose body coupling takes place flat and collapses down, consequently under the effect of negative pressure in hose body 101, the screwed pipe still can guarantee hose body's drainage unobstructed nature.

In some embodiments, to better ensure the support of the threaded pipe, the threaded pipe may further be a steel wire threaded pipe, and the steel wire threaded pipe has a three-layer structure. The inner layer and the outer layer of the three-layer structure are made of plastic materials, for example: PVC (polyvinyl chloride), etc.; the middle layer is a steel wire reinforced structure, such as a spiral steel wire. Therefore, the steel wire reinforcing structure can ensure that the threaded pipe cannot collapse under the action of negative pressure to a greater extent, the supporting force is enhanced, and the fluid circulation is ensured.

In an exemplary embodiment, the hose body 101 includes two end joints and a middle part between the two end joints, and the first supporting part 1011 is located at least one predetermined position of the middle part. Here, the hose body 101 is divided into two end joining portions and a middle portion. One end of the two end joining parts is connected with a negative pressure source, the other end of the two end joining parts is positioned in the inner cavity of the wound or the peripheral area of the wound, and the middle part is positioned between the two end joining parts. Since the pipe section, which is easily bent in practical applications, is usually located in the middle, the first support 1011 is configured to be located at least one predetermined position of the middle. The position of the first supporting portion 1011, i.e. the predetermined position, is explained in the foregoing, and therefore, will not be described in detail.

In another exemplary embodiment, referring to fig. 10, which is a schematic view of an application of the medical drainage tube of the present application, as shown in the drawing, a second supporting portion 1012 is provided in the tube of the coupling portion of at least one end of the hose body 101.

It will be appreciated that suture treatments are often used to treat wounds that are unavoidably created during surgery on a patient (patient) to aid in the healing of the wound on the patient, and that during such treatment, i.e., after the suture is applied to the wound, a reduced pressure dressing assembly may be used to aid in the healing of the wound. In some embodiments, a reduced-pressure dressing set, also referred to as a sub-dermal negative pressure device, includes a sealing membrane 30, a microporous cover 20, which is adhered to the skin to form a sealed space, and an inward force is created within the sealed space of the sealing membrane after suction is applied by the negative pressure device to maintain the local tissue site stationary while applying pressure to the deeper tissue, thereby closing potential dead spaces. In this embodiment, the sealing membrane 30 is adhered to the surface of the skin by its adhesive layer against the skin surface, the material of the adhesive layer being, for example, a flexible impermeable material comprising polyurethane coated with an acrylic adhesive. The material of the microporous covering member 20 is medical cotton, absorbent cotton (absorbent cotton), foam, mesh, gauze, sponge, or porous biocompatible material, and the microporous covering member 20 has air permeability and water adsorption characteristics, and is used for adsorbing effusion possibly secreted in the healing process of the skin wound or water of residual drug liquid left in the skin wound and not absorbed by tissues. In the drainage process, one part of the medical drainage tube is positioned in the sealing film 30, and under the condition, the part of the medical drainage tube positioned in the sealing film 30 is simultaneously subjected to negative pressure acting force and acting force generated by the sealing film 30 on the medical drainage tube under the action of negative pressure, so that the medical drainage tube is very easy to deform and the drainage effect is influenced. Therefore, by providing the second support portion 1012 in the engaging tube at the end of the hose body 101 close to the vacuum skin device, the portion of the hose body 101 located in the sealing membrane 30 can be prevented from being deformed by the negative pressure.

In an exemplary embodiment, the second support portion 1012 may be disposed in the hose body 101 or formed on the hose body 101. When the second supporting portion 1012 is disposed in the hose body 101, the second supporting portion 1012 includes, but is not limited to, a spring, for example. The spring can still keep the supporting state in the hose body under the action of negative pressure and the action force generated by the sealing membrane, so that the fluid passage is kept smooth. When the second supporting part 1012 is formed on the hose body 101, the second supporting part 1012 includes, but is not limited to, a wire thread tube, for example. The steel wire screwed pipe is three-layer structure, the two-layer plastics material of inside and outside three-layer structure, for example: PVC (Polyvinyl chloride), polyethylene (PE for short), flexible ABS plastic, and the like; the middle layer is a steel wire reinforced structure, such as a spiral steel wire. Therefore, the steel wire reinforcing structure can ensure that the threaded pipe cannot be shrunken or collapsed under the action of negative pressure and the action of the sealing film on the threaded pipe to a greater extent, so that the supporting force is enhanced, and the fluid circulation is ensured.

In an exemplary embodiment, please refer to fig. 11, which is a schematic structural view of a hose body of a medical drainage tube according to an embodiment of the present application. As shown in the figure, the hose body 101 is further provided with a negative pressure hole, which is adjacent to the second supporting portion 1012, for maintaining the tissue position of the wound and the peripheral region thereof stable by the generated negative pressure. Here, when the vacuum device on the skin is used to help the healing of the wound, the hose body 101 further includes a vacuum hole 60 and a drainage hole 1010. The drainage holes 1010 are through holes arranged on the tube wall of the wound periphery or the wound inner cavity 7, and are used for draining gas or effusion at the wound periphery or the wound inner cavity 7; the negative pressure hole communicates with the sealed space to apply negative pressure to the sealed space by a negative pressure source 6.

Here, the number of the through holes may be one or more, in some embodiments, the through holes are uniformly distributed on the wall of the portion of the hose body which protrudes into the skin wound at intervals, 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 effusion or residual medical liquid secreted at each position of the elongated cavity or gap is sucked by the hose body; in other embodiments, the plurality of through holes on the hose body 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 hose body protruding into the skin wound) for different types of skin wounds or different purposes.

In an exemplary embodiment, the medical drainage tube further comprises an irrigation tube for delivering the liquid drug to a predetermined depth of the periphery of the wound or the lumen. Wherein, the preset depth refers to: the depth of the region from the superficial fascia layer to the deep fascia layer of the skin 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.

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. When the bacterial content in the tissue exceeds 105/g, bacterial colonization can occur 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.

To this end, in an exemplary embodiment of the present application, the present application further includes a drug delivery device (not shown) for delivering liquid drug to the wound periphery or inner cavity to facilitate the healing of the wound, and in a specific implementation state, the drug delivery device is, for example, a drug delivery apparatus or a drug delivery machine including a micro pump or a syringe. In one mode of this embodiment, the device may be controlled to maintain the wound periphery or cavity in a clean state by intermittently delivering the liquid drug to the wound periphery or cavity to wet the blood clots that may have coagulated in the wound periphery or cavity for removal, and to dilute the bacterial flora that may have reached a colonizing concentration for removal by draining the irrigation fluid. 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.

During the healing process, the administration device can deliver liquid medicine to the wound periphery or the inner cavity through the flushing pipe to dilute bacterial infection which may be produced or is produced in the wound periphery or the inner cavity, so that potential infection focus reaching the colonization concentration is diluted; meanwhile, the liquid medicine delivered by the administration device can also achieve the purpose of flushing the infected part in the wound periphery or the inner cavity, and after flushing is finished, the liquid medicine at the wound periphery or the inner cavity is sucked away through the drainage effect of the hose body, so that bacteria are drained and removed, and the clean state of the wound periphery or the inner cavity is kept.

In actual clinical treatment, the dosage of the administration device, the time for diluting the bacterial infection part, the flushing frequency of the liquid medicine, the working frequency of the negative pressure source and the like can be controlled according to the judged infection condition of the inner cavity of the subcutaneous wound of the patient. For example, in an exemplary embodiment, the time period for the administration device to flush the liquid drug into the wound periphery or lumen is, for example, 2-3 days, and the administration device may be controlled by an integrated machine (e.g., an administration machine or the like). The liquid medicine includes but is not limited to hydrogen peroxide, physiological saline and the like.

In an exemplary embodiment, the flushing pipe is integrally formed with the hose body, or the flushing pipe is sleeved within the hose body. Here, the flushing pipe and the hose body may be integrated, or may be two separate pipes. In an exemplary embodiment, the irrigation tube is isolated from the hose body, which is communicated with the negative pressure source 6 for sucking the effusion or gas from the wound periphery or the inner cavity; the flushing pipe is communicated with the drug delivery device and is used for delivering liquid drugs to the preset depth of the periphery of the wound or the inner cavity.

In an exemplary embodiment, referring to fig. 8, which is a schematic view of a catheter structure of a medical drainage catheter of the present application, as shown in the drawings, the hose body 101 and the irrigation tube 102 are integrally formed, so that the number of embedded tubes can be reduced, the integrally formed catheter includes two isolated and non-communicated tubes, wherein the first tube forms the hose body 101, the second tube forms the irrigation tube 102, the hose body 101 is provided with a plurality of through holes 1010, the hose body 101 is used for connecting a negative pressure source, and the irrigation tube 102 is used for connecting a drug administration device.

In an exemplary embodiment, please refer to fig. 9, which is a schematic view illustrating a catheter structure of a medical drainage catheter according to the present application, as shown in the drawings, the hose body 101 and the flushing tube 102 are integrally formed, so that the number of embedded catheters can be reduced, the integrally formed hose body 101 and the flushing tube 102 are two tubes which are not communicated with each other, wherein the flushing tube 102 is sleeved in the hose body 101, since the thinner catheter is sleeved in the thicker catheter, the diameter of the whole catheter can not be increased while the number of catheters is not increased, the thicker catheter 101 is provided with a plurality of through holes 1010, the thicker catheter is used for connecting a negative pressure source, and the thinner catheter is connected with a drug delivery device.

In some embodiments, the hose body 101 is connected to a negative pressure source to generate negative pressure, the irrigation tube 102 disposed in the hose body 101 is connected to a drug delivery device, and a plurality of through holes 1010 are disposed on the hose body 101 to assist in sucking up the gas and liquid in the subcutaneous wound cavity 4.

In an exemplary embodiment, the medical drainage tube further comprises a limiting structure for fixing the medical drainage tube. Wherein, limit structure is used for fixing the hose body on the patient or on the clothing or around the patient etc to reduce the influence to hose body position when the patient moves about. The limiting structure includes but is not limited to: adhesive means, clips or the like, for example, which are adhered 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, which may be designed as a band-like structure extending from the centre to opposite sides, which may be separate or integrated, which is adapted to be stretched manually for increased patient/patient comfort. In some embodiments, the clamping member includes a clamping arm, a transmission shaft, and a clamping portion, the clamping member controls the opening and closing of the clamping portion through the clamping arm, the clamping portion can fix the hose body with the target object, and the fixing portion is disposed on the first supporting portion, so as to prevent the deformation of the hose body due to the clamping force from affecting the drainage effect. In application, the clamping arm drives the clamping part to open and clamp through the transmission shaft, so that the hose body is fixed with a target object, wherein the target object can be objects on clothes of a patient or around the patient.

Referring to fig. 10 in conjunction with fig. 11, in practical application, an operator first connects one end of the hose body 101 to the negative pressure source 6, and the other end of the hose body extends into the subcutaneous wound cavity 7 or is placed at the periphery of a wound or other parts requiring drainage. Wherein, one end of the hose body which is inserted into the inner cavity 7 of the subcutaneous wound or is arranged at the periphery of the wound or other parts needing drainage is positioned in the sealing membrane 30 of the subcutaneous negative pressure device. In this embodiment, the site to be drained is located in the subcutaneous wound lumen 7 of the skin 50, and therefore, the hose body in this embodiment protrudes into the subcutaneous wound lumen 7. Meanwhile, one end of the cleaning pipe is connected with a cleaning device. According to the application, firstly, a drainage part is cleaned through a cleaning pipe by a drug delivery device, so that possible or generated bacterial infection is diluted by utilizing a cleaning solution; secondly, the drainage part is drained through the hose body 101 by the negative pressure source 6, so that accumulated liquid, cleaning liquid and the like at the drainage part are discharged through negative pressure; in addition, the present application also draws air from the sealing membrane 30 through the negative pressure holes 60 to allow the sealing membrane 30 to apply pressure to the skin to facilitate wound closure. In whole drainage process, hose body 101 is by under the effect of first supporting part 1011, and even hose body 101 receives external force to buckle at the pipeline section that has first supporting part 1011, can not make hose body 101 hold out the collapse influence fluid and pass through, has guaranteed drainage process's unobstructed nature yet. Meanwhile, when the hose body 101 is under the action of the second supporting part 1012 and the pipe section in the skin negative pressure device is under the action of the sealing membrane 30 and the negative pressure, the hose body 101 cannot be greatly deformed due to the supporting force of the second supporting part 1012, so that the drainage effect is ensured.

Embodiments of a second aspect of the present application provide a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin.

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.

As described above, suture treatment is often used for treating wounds (also referred to as incisions or surgical incisions, wounds, etc.) inevitably caused by a patient (patient) during surgery, and in order to facilitate the healing of the wounds during the treatment process, i.e., after suture of the wounds with needle threads, reduced pressure dressing assemblies used in applying a closing force, which include a bolster body formed of 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, in the embodiment of the second aspect of the present application, a surgical auxiliary device for closing a skin wound without a suture line in the superficial fascia of the skin is provided, so as to replace the traditional needle suture mode for the superficial fascia of the skin and achieve the purpose of closing the skin wound. In the examples provided below, the surgical aid for the sutureless closure of a skin wound in the superficial fascia of the skin of the present application comprises: the device comprises a subcutaneous negative pressure drainage device, a wound closing device and a subcutaneous negative pressure device, wherein the wound closing device is used for extruding a skin edge, and the subcutaneous negative pressure drainage device is used for forcing the subcutaneous negative pressure drainage device to be in a closed state in the healing and rehabilitation process, the subcutaneous negative pressure drainage device can drain effusion in the subcutaneous wound inner cavity and also can convey liquid medicine to the subcutaneous wound inner cavity, and the environment of the subcutaneous wound inner cavity is kept in a state beneficial to wound recovery. Meanwhile, the skin negative pressure device can generate acting force through the negative pressure effect to keep the skin wound and the tissue position of the peripheral area thereof in a stable state, thereby realizing the purpose of closing the skin wound without a suture line in the skin shallow fascia. The subcutaneous negative pressure drainage device comprises a catheter, a drainage tube and a drainage tube, wherein part of the catheter extends into the inner cavity of a subcutaneous wound by a preset depth and is used for generating negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process; the catheter is the medical drainage tube according to any one of the embodiments of the first aspect of the surgical aid for sutureless closure of skin wounds in the superficial fascia of the skin of the application. The wound closing device is arranged on the peripheral side of the skin wound and used for pressing the skin edges to keep the skin wound in a closed state in the healing process. The skin negative pressure device is arranged at the periphery of the skin wound and used for generating negative pressure to maintain the stable tissue position of the skin wound and the peripheral area of the skin wound.

According to the surgical auxiliary equipment for closing the skin wound without the suture line in the skin superficial fascia, on the first hand, the exposed two ends of the skin wound are tightly attached through the wound closing device, and the wound closing device can play a role of extruding a skin margin while closing the wound, so that the bleeding of a blood vessel network under the skin dermis can be reduced; the second aspect is that under the force of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound is kept in a closed state in the healing and rehabilitation process, the detached tissue is kept in a joint state, and the blood seepage and the seepage in the wound cavity are kept to be removed in time through continuous negative pressure suction; on the basis, the liquid medicine is intermittently conveyed to the inner cavity of the subcutaneous wound, so that blood clots coagulated in the inner cavity of the subcutaneous wound are wetted to be removed conveniently, and potential bacterial communities reaching the colonization concentration are diluted and removed along with drainage of flushing fluid, so that the cleaning state in the wound cavity is maintained; in a third aspect, negative pressure may be generated by a negative pressure device on the skin to maintain the tissue position of the skin wound and its peripheral region stable, thereby facilitating tissue healing. In addition, through the surgical auxiliary equipment of this application can realize the seamless line closure of skin deep fascia above the full layer tissue, avoided the skin surface because of the horizontal scar that suture oppression/cutting arouses to no remains the suture knot in shallow fascia, thereby eliminated the main cause that causes the important factor of bacterial colonization and incision infection relapse.

It should be understood that embodiments of the surgical aid for sutureless closure of a skin incision in the superficial fascia of the skin of the present application are directed to a wound that includes a break formed by a continuous interruption in the skin or other tissue site, 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.

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 in the surgical aid for closing a skin wound in the skin superficial fascia (i.e., skin epidermis, dermis and subcutaneous adipose tissue portions) of the present application refers to a therapeutic means for suturing (sutureing) the skin superficial fascia without using a needle thread in the treatment for closing the skin wound or in the process of healing the skin wound or in other treatments for the skin wound after an operation, such as cleaning, disinfection, dressing, etc., wherein medical tools such as a suture needle and a suture thread are not used, and thus, after the skin wound is healed, there is no process for removing foreign substances in the wound or the wound surface of the skin superficial fascia, such as a step and a procedure for removing or removing a suture or a thread head.

In an exemplary embodiment, referring to fig. 12, which is a schematic view of an embodiment of the present surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin, there is shown a surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application comprising: a subcutaneous negative pressure drainage device 1, a wound closing device 2 and an epithelial negative pressure device 3.

In an exemplary embodiment, referring to fig. 13, which is a schematic view of a subcutaneous negative pressure drainage device of the surgical auxiliary equipment for closing a skin wound without a suture line in the superficial fascia of the skin of the present application, as shown in the figure, the subcutaneous negative pressure drainage device 1 comprises a catheter 100 partially extending into the inner cavity 7 of the subcutaneous wound by a preset depth, the catheter 100 is used for generating negative pressure to force the inner cavity 7 of the subcutaneous wound to be in a closed state during a healing process, maintaining the detached tissues in a fit state, and maintaining the blood and the exudate in the wound cavity to be timely removed through continuous negative pressure suction, in an actual implementation, the catheter 100 of the subcutaneous negative pressure drainage device 1 extends into the inner cavity 7 of the subcutaneous wound to force the tissues at two sides of the inner cavity 7 of the subcutaneous wound to be in a fit towards each other (in directions shown by arrows at two sides of the lower scalp wound 7 of fig. 13) to eliminate the inner cavity 7 of the subcutaneous wound, the closure of the subcutaneous wound lumen 7 facilitates the healing of the wound. It will be appreciated that the portion of the catheter 100 in the subcutaneous wound lumen 7 does not affect the growth of tissue on either side of the subcutaneous wound lumen 7 during this process.

In another exemplary embodiment, please continue to refer to fig. 13, as shown in the figure, the catheter 100 partially protrudes into the preset depth of the inner cavity 7 of the subcutaneous wound through a preset position of the skin wound, so as to generate a negative pressure, ensure that the inner cavity 7 of the subcutaneous wound is in a closed state during the healing process, and simultaneously drain the effusion in the inner cavity 7 of the subcutaneous wound, so as to maintain the detached tissue in a bonded state, and maintain the blood and the effusion in the wound to be removed in time through continuous negative pressure suction, so that the living space or the environment of bacteria can be eliminated due to the timely removal of the effusion, such as the blood and/or the effusion, in the inner cavity 7 of the subcutaneous wound. 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. 14, which is a schematic view of the subcutaneous negative pressure drainage device of the surgical auxiliary equipment for closing a skin wound without a suture line in the superficial fascia of the skin of the present application in another exemplary embodiment, as shown in the figure, the catheter 100 penetrates the skin and the subcutaneous tissue via a preset position (the position shown as D in fig. 14) far away from the skin wound to partially penetrate into the preset depth of the inner cavity 7 of the subcutaneous wound, so as to generate a negative pressure to ensure that the inner cavity 7 of the subcutaneous wound is closed during the healing process and simultaneously suck the effusion in the inner cavity 7 of the subcutaneous wound, so that the living space or environment of bacteria is eliminated due to the timely removal of the effusion in the inner cavity 7 of the subcutaneous wound. In this embodiment, the far away refers to a predetermined position (the position shown as D in fig. 14) away from the skin wound, and in order to facilitate the closing treatment and surface treatment of the skin wound, the catheter 100 is not inserted into the subcutaneous wound inner cavity 7 through the skin wound, but is inserted through the skin and subcutaneous tissue from another position, i.e. a predetermined position away from the skin wound, to be partially inserted into the subcutaneous wound inner cavity 7, which is particularly suitable for the narrow-length wound shown in fig. 15.

In the embodiment shown in fig. 12, the surgical auxiliary equipment presses the skin edge through the wound closing device 2 to enable the two exposed ends of the skin wound 4 to be tightly attached, the subcutaneous wound inner cavity 7 is kept in a closed state in the healing and rehabilitation process under the force and the assistance of the subcutaneous negative pressure drainage device 1, liquid medicine can be conveyed to the subcutaneous wound inner cavity 7 while the effusion in the subcutaneous wound inner cavity 7 is sucked, and then the infection focus which reaches the colonization concentration in the subcutaneous wound inner cavity 7 is diluted and cleaned; meanwhile, the skin negative pressure device 3 can maintain the tissue position of the skin wound and the peripheral area thereof to be stable through the generated negative pressure, thereby being beneficial to wound recovery.

It should be understood that the subcutaneous wound lumen 7 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 7, 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.

In some embodiments, the wall of the part of the catheter extending into the skin wound to a predetermined depth is provided with a plurality of through holes to help form a suction for the gas and liquid in the subcutaneous wound lumen 7, and in an exemplary embodiment, the plurality of through holes are uniformly distributed on the wall of the part of the catheter 100 extending into the skin wound to a predetermined depth at intervals, especially for a long wound, the wound lumen formed below the long wound is also a generally long cavity or gap, in order to ensure that the effusion or residual medical liquid secreted from each of the long cavity or gap is sucked by the catheter 100; in another exemplary embodiment, the plurality of through holes on the catheter 100 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 catheter 100 that protrudes to a predetermined depth into the skin lesion) for different types of skin lesions or for different purposes.

In yet another exemplary embodiment, the shape and structure of the catheter 100 extending into the skin incision at a predetermined depth may also be designed according to actual requirements, such as different thicknesses or different weakening properties of the catheter 100, for example, different thicknesses or different materials of the same catheter at different positions, different weakening properties of the same catheter at different positions, etc. according to the desired depth or different tissue structures extending into the skin incision.

In some embodiments, the predetermined depth of partial penetration of the catheter 100 into the subcutaneous wound lumen 7 is: the depth of the region from the superficial fascia layer to the deep fascia layer of the skin 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 subcutaneous negative pressure drainage device 1 further comprises a negative pressure device, the negative pressure device is used for generating and controlling negative pressure, the negative pressure device is communicated with the catheter 100, so that the negative pressure in the catheter 100 can be adjusted through the negative pressure device, and the condition that the wound is injured by excessive negative pressure or the accumulated liquid cannot be completely pumped due to insufficient negative pressure is avoided.

In this embodiment, the conduit 100 connected to the negative pressure device is provided with a one-way valve to prevent the gas or effusion sucked into the conduit 100 from flowing back into the subcutaneous wound cavity 7 and thus not being beneficial to healing of the skin wound. In the embodiment, the check valve is a rubber member such as a duckbill valve or a cone valve, but is not limited thereto, and a valve assembly using mechanical or electrical control is also applicable to the present application.

In this embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, may be an air reservoir at negative pressure, or may be a manually or electrically driven 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 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).

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. When the bacterial content in the tissue exceeds 105/g, bacterial colonization can occur 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.

To this end, in an exemplary embodiment of the present application, the surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application further includes a drug delivery device (not shown) for delivering a liquid drug to a predetermined depth of the inner cavity 7 of the subcutaneous wound to facilitate healing of the inner cavity 7 of the subcutaneous wound, and in a specific implementation state, the drug delivery device is, for example, a drug delivery device or a drug delivery machine including a micro pump or a syringe. In one mode of this embodiment, the administration device can be controlled to intermittently deliver the liquid drug to the inner cavity of the subcutaneous wound, so that the blood clots coagulated in the inner cavity 7 of the subcutaneous wound can be moistened to facilitate removal, and the bacterial colonies which potentially reach the colonization concentration can be diluted and removed along with the drainage of the flushing fluid, thereby maintaining the inner cavity 7 of the subcutaneous wound in a 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.

During the healing process, the administration device can deliver liquid medicine to the subcutaneous wound inner cavity 7 through the connected catheter, so as to dilute bacterial infection which may be generated or is generated in the subcutaneous wound inner cavity 7, and further dilute potential infection focus reaching the colonization concentration; meanwhile, the liquid medicine delivered by the administration device can also achieve the purpose of flushing the infected part in the inner cavity 7 of the subcutaneous wound, and after the flushing is finished, the liquid medicine in the inner cavity 7 of the subcutaneous wound is sucked away through the drainage effect of the catheter of the subcutaneous negative pressure drainage device 1, so that the bacteria are drained and removed, and the inner cavity 7 of the subcutaneous wound is clean.

In actual clinical treatment, the dosage of the administration device, the time for diluting the bacterial infection portion, the frequency of flushing the liquid medicine, the frequency of operating the subcutaneous negative pressure drainage device 1, and the like can be controlled according to the judged infection condition of the internal cavity of the subcutaneous wound of the patient. For example, in an exemplary embodiment, the time period for the administration device to flush the liquid drug into the subcutaneous wound lumen 7 is, for example, 2-3 days, and the administration device may be controlled by an integrated machine (e.g., an administration machine).

In this embodiment, the liquid medicine includes, but is not limited to, hydrogen peroxide, physiological saline, and the like.

The catheter can be a catheter integrated by two catheters or two catheters independent from each other, for example, in an exemplary embodiment, the catheter 100 includes a first catheter 101 and a second catheter 102 isolated from the first catheter 101, the first catheter 101 is communicated with the negative pressure device for sucking the effusion from the subcutaneous wound cavity 7; the second conduit 102 communicates with a drug delivery device for delivering a liquid drug to a predetermined depth in the lumen 7 of the subcutaneous wound.

In an exemplary embodiment, referring to fig. 20, which shows a schematic view of a catheter structure of the surgical aid for sutureless closure of skin wounds in superficial fascia of the skin of the present application, as shown in the drawing, the first catheter 101 and the second catheter 102 are integrally formed, thereby reducing the number of embedded tubes, the integrally formed catheter includes two isolated and non-communicating tubes, wherein the first tube forms the first catheter 101, the second tube forms the second catheter 102, the first catheter 101 is provided with a plurality of through holes 1010, the first catheter 101 is used for connecting a negative pressure device, and the second catheter 102 is used for connecting a drug delivery device.

In an exemplary embodiment, referring to fig. 21, another exemplary embodiment of a catheter structure of a surgical aid for closing a skin wound without sutures in the superficial fascia of the skin of the present application is shown, as shown in the drawings, the first catheter 101 and the second catheter 102 are integrally formed, so that the number of embedded tubes can be reduced, the integrally formed first catheter 101 and the second catheter 102 are two tubes which are not communicated with each other, wherein the second catheter 102 is sleeved in the first catheter 101, since the thinner catheter 102 is sleeved in the thicker catheter 101, the diameter of the integral catheter can not be increased while the number of catheters is not increased, the thicker catheter 101 is provided with a plurality of through holes 1010, the thicker catheter 101 is used for connecting a negative pressure device, and the thinner catheter 102 is connected with a drug delivery device.

In some embodiments, the first catheter 101 is connected to a negative pressure device to generate negative pressure, the second catheter 102 disposed in the first catheter 101 is connected to a drug delivery device, and a plurality of through holes 1010 are formed in the first catheter 101 to assist in sucking up gas and liquid from the subcutaneous wound lumen 7.

In the embodiment provided by the application, the wound closing device 2 is used for pressing the skin margin to enable the skin wound to be in a closed state in the healing process, and meanwhile, the bleeding of the blood vessel network under the skin dermis can be reduced by pressing the skin margin, so that the wound recovery is facilitated. The wound closure device 2 is arranged on the circumference of the skin wound, in some embodiments the wound closure device 2 is arranged on the circumference of the skin wound by means of adhesive. In some embodiments, the wound closure device 2 comprises at least two closure elements 21, the at least two closure elements 21 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 21. In practice, the number of closure members 21 may be determined by the length of the wound and the particular form of closure member 21.

Referring to fig. 16, which is a schematic view showing the structure of the closure element in the wound closure device of the surgical aid for closing a skin wound without sutures in the superficial fascia of the skin of the application, in one embodiment, as shown in the drawing, the wound closure device 2 further includes a microporous cover 20 covering the closure element 21, and the microporous cover 20 is combined on the closure element 21 to conform to the shape structure of the closure element 21 and to form an integral body with the closure element 21 so as to facilitate adsorbing or sucking secretion liquid seeping from the skin wound and retained on the closure element 21 or medicine liquid retained on the closure element 21. In an exemplary embodiment, the microporous cover 20 is a unitary structure with the closure 21. In another exemplary embodiment, the microporous cover 20 is bonded to the closure element 21, such as by bonding or the like, such that the microporous cover 20 conforms to the contours of the closure element 21 and is bonded to the closure element 21.

In certain embodiments, the closure 21 comprises a flexible body, meaning that a material having an elastic/flexible body 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 elastic/flexible body materials 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, silicones, and the like.

In an exemplary embodiment, the closure member 21 may also be a silicone material, a resin material, or a silicone resin material.

In an exemplary embodiment, the material of the microporous cover 20 is medical cotton, absorbent cotton (degreasingcotton), foam, mesh, gauze, sponge, or porous biocompatible material, and the microporous cover 20 has air permeability and moisture absorption properties for absorbing effusion possibly secreted by the skin wound during the healing process or moisture remaining in the drug residue not absorbed by the tissue of the skin wound.

In the present embodiment, the closure 21 includes: a flexible body 210 and a rigid curved needle 211.

The flexible body 210 is adhered to the skin surface at the periphery of the skin wound; in this embodiment, the flexible body 210 is made of a silicone material, a resin material, or a silicone resin material. The flexible body 210 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 210 are adhered to the skin surface on opposite sides of the skin wound periphery.

The rigid curved needle 211 comprises a root portion and a curved needle portion, the root portion of the rigid curved needle 211 is embedded in the flexible body 210 and is firmly disposed on the flexible body 210, and the curved needle portion of the rigid curved needle 211 is exposed out of the flexible body 210. In an exemplary embodiment, the root of the rigid curved needle 211 is securely disposed in the flexible body 210 by a deformed structural design, such as a hook-like structure or a T-shaped structure, etc.

In an exemplary embodiment, referring to fig. 17, which shows a closure and wound combination of the surgical auxiliary device for closing a skin wound without sutures in superficial fascia of skin of the present application, as shown in the figure, the curved needle portion exposed outside the flexible body is partially inserted into one side of the skin wound to squeeze the skin edges so as to keep the skin wound in a closed state during healing, in the specific implementation, a doctor needs to perform a wound-to-skin (aligning the skin edges and preventing the skin edges from turning inwards to avoid poor healing of the skin) operation, and then inserts the curved needle portion of the rigid curved needle into one side of the skin wound to be in a state shown in fig. 17, since the rigid curved needles of the closure 21 on both sides of the skin wound are inserted into healthy tissues on the side edges of the wound so as to squeeze the skin edges so as to reduce bleeding of the subcutaneous blood network of the skin, 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 exposed outside the flexible body 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 two sides of the skin wound are combined in an opposite manner, and healthy tissues on 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 exposed out of the flexible body penetrates into the flexible body disposed at the other side of the skin wound, so that the flexible bodies 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 to close the skin wound.

As shown in FIG. 17, the skin 50 includes, in order, a vascular network 51, a superficial fascia layer 52, fat 53, a deep fascia layer 54, muscle 55, and bone 56. The depth of the stitching in this embodiment is in the superficial fascia layer 52. A problem of concern in the embodiments of the second aspect of the present application is the 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 211 exposed out of the flexible body 210 includes the epidermis, dermis and subcutaneous adipose tissue portions of the skin of the superficial fascia portion.

In some embodiments, the number and length of the rigid curved needles 211 disposed on the flexible body 210 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 211 disposed on the flexible body 210, the rigid curved needles 211 are arranged on the elongated flexible body 210 in an equidistant manner.

Referring to fig. 18, which is a schematic view of a closure member of a wound closure device in the surgical aid for closing a skin wound without sutures in the superficial fascia of the skin of the application in a further embodiment, in this embodiment, the closure member further comprises a clamping member 22, the clamping member 22 is used for clamping a flexible body of the closure member 21 adhered to two sides of the skin wound, and the flexible body provides an opposite force to press a skin edge under the action of the clamping member so as to ensure that the skin wound is in a closed state during a healing process. In a specific implementation, the clip 22 is a medical clip or the like.

Referring to fig. 19, which is a schematic view showing the application of the closure member of the wound closure device in the surgical assistant device for closing a skin wound without a suture line in the superficial fascia of the skin of the present application, in one embodiment, the application of the assistant member 212 may be additionally adopted in each of the above-mentioned embodiments using the closure member 21 including the flexible body and the rigid curved needle, and the assistant member 212 is used for assisting the adhesion between the closure member 21 and the skin surface and providing the closure member 21 with a contractive force for closing the skin wound.

In another exemplary embodiment, referring to fig. 22, there is shown a schematic structural view of a closure element in a wound closure device of the surgical assistance device for sutureless closure of a skin wound in the superficial fascia of the skin of the present application in yet another embodiment, as shown, in this embodiment, the closure element 21 comprises: a first flexible body 2100 and a second flexible body 2101.

The first flexible body 2100 is adhered to the skin surface of the skin wound periphery, the first flexible body 2100 having a first bond; the second flexible body 2101 is adhered to the skin surface of the skin wound periphery, the second flexible body 2101 having a second bond corresponding to the first bond. The combination of the first and second junctions provides opposing forces to the flexible bodies applied to both sides of the skin wound, thereby squeezing the edges to maintain the skin wound in a closed state during healing. In this embodiment, the first and second flexible bodies 2101 are made of silicone, resin, or silicone resin. The first and second flexible bodies 2101 are adhered to the skin surface on opposite sides of the skin incision with an adhesive, such as, in some embodiments, a medical adhesive, for example, 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 2100 and the second flexible body 2101 with each other can achieve the purpose of the present embodiment, such as combination of a groove or a hole with a protrusion structure.

In some embodiments, with continued reference to fig. 22, the wound closure device 2 further comprises an auxiliary element 212, the auxiliary element 212 being adapted to assist in the adhesion between the closure element 21 and the skin surface and to provide a constricting force to the closure element 21 for closing the skin wound, in an exemplary embodiment, if the skin wound is an incision in a first direction, the auxiliary element 212 is adhered to the periphery of the skin wound and a force is applied to the closure element 21 in a second direction perpendicular to the first direction, which force is referred to as a constricting force in this embodiment, and the auxiliary closure element 21 provides for closing the skin wound. In this embodiment, the auxiliary element 212 is adhered 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 212, which is an 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 certain embodiments, the subcutaneous negative pressure device 3 includes a sealing membrane 30 and a negative pressure channel 31. Referring to fig. 23, which is a schematic view of a sealing and force-applying structure of the present invention for a vacuum device on skin in a surgical assistant for closing a skin wound without a suture line in the superficial fascia of the skin, as shown in the figure, the sealing membrane 30 is adhered to the skin and covers the wound closing device 2, thereby forming a sealed space 32, and after being pumped by the vacuum device, the sealed space inside the sealing membrane forms an inward acting force, and the force is applied in the direction of the arrow shown in fig. 23, and can apply pressure to deep tissues while maintaining the position of local tissues, thereby closing potential dead space. In this embodiment the sealing membrane 30 forms a sealing zone around the skin wound and the wound closure device 2 placed over the skin wound, and such that the sealing zone forms a sealed space 32, in this embodiment the sealing membrane 30 is adhered to the surface of the skin by its adhesive layer to the skin surface, for example a flexible impermeable material comprising polyurethane coated with an acrylic adhesive.

In an exemplary embodiment, the sealing film 30 may be made of a transparent material. Sealing membrane 30, which is a transparent material, may facilitate the clinician in visualizing the healing of the skin wound for timely intervention.

In an exemplary embodiment, the sealing film 30 is provided with an observation window made of a transparent material so as to facilitate a clinician to observe the healing condition of the skin wound for taking corresponding medical measures.

Referring to fig. 12, as shown in the figure, the operator embeds the catheter 100 of the subcutaneous negative pressure drainage device into the subcutaneous tissue of the skin and extends the catheter 100 into the subcutaneous wound cavity 7. The subcutaneous negative pressure flow guide device can guide effusion secreted by the subcutaneous wound inner cavity 7 through the catheter 100, meanwhile, the wound inner cavity tends to be folded/combined due to the negative pressure effect, so that tissues on two sides are combined oppositely, and in addition, liquid medicine can be conveyed to the subcutaneous wound inner cavity 7 through the catheter to be beneficial to healing; in the second aspect, the skin on the two sides of the outer side of the wound is folded inwards through the closing part, so that the skin wound is kept in a closed state in the healing process, the bleeding of a hypodermal blood vessel network of the skin can be reduced under the extrusion effect of the closing part on the skin edge, and the negative pressure of the subcutaneous negative pressure flow guide device can assist in closing the inner cavity 7 of the subcutaneous wound. The operator continues to place the microporous covering 20 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 30 outside the micropore accessory to wrap the whole wound and the micropore covering piece 20 on the wound; in a third aspect, the sealing membrane 30 is pumped through the negative pressure channel 31 of the vacuum device 3, so that the skin wound and the tissue in the peripheral region thereof are tightened, and in addition, the negative pressure generated by the vacuum device can apply a certain degree of pressure to the deep tissue to close the potential dead space, so that the healing speed of the skin wound is accelerated, and in addition, the treatment means for suturing (suture) the superficial fascia part of the skin without using a needle or a suture thread is adopted, and medical tools such as a suture needle and a suture thread are not used.

In this embodiment, the negative pressure channel 31 is communicated with a negative pressure device through a conduit, and the negative pressure channel 31 is communicated with the sealed space, so that a negative pressure source is provided to form the sealed space.

In this embodiment, the negative pressure generated by the negative pressure device compresses the sealed space, thereby maintaining the local tissue toward the wound site. Meanwhile, the negative pressure generated by the negative pressure device also generates acting force on deep tissues under the wound, so that the potential dead space is closed, and the wound closing device 2 is assisted to close the skin wound so as to promote the wound healing. In the present embodiment, the pressure value of the sealed space formed by the sealing film 30 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 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 condition 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 this embodiment, the conduit of the negative pressure channel 31 communicating with a negative pressure device is provided with a one-way valve to prevent the gas or effusion sucked into the conduit from flowing back into the sealed space and further being unfavorable for healing of the skin wound.

In this embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, may be an air reservoir at negative pressure, or may be a manually or electrically driven 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 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.

In an exemplary embodiment, referring to fig. 24, which is a schematic view of the surgical aid for sutureless closure of a skin wound in the superficial fascia of the skin of the present application in another embodiment, as shown in fig. 24, the subcutaneous negative pressure drainage device and the supracutaneous negative pressure device may share a negative pressure source 6, and the two different catheters are connected to the same negative pressure source, respectively, i.e., the catheter communicating with the closed space 32 on the skin and the catheter communicating with the lumen 7 of the subcutaneous wound are two different catheters.

Referring to fig. 25, which is a schematic view of a surgical auxiliary apparatus for closing a skin wound without sutures in the superficial fascia of the skin according to the present application in yet another embodiment, as shown in the figure, in this embodiment, the subcutaneous negative pressure device and the subcutaneous negative pressure drainage device can share a negative pressure source 6, and the subcutaneous wound inner chamber 7 and the subcutaneous closed space 32 are respectively communicated through a catheter, wherein the catheter 100 includes a subcutaneous drainage hole 1010 and an intradermal negative pressure hole 60, and the intradermal drainage hole is a plurality of through holes 1010 disposed on the wall of a portion of the catheter extending 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.

In an exemplary embodiment, the vacuum device 3 further comprises a humidity detection component (not shown), a sensor of the humidity detection component is disposed in the sealed space formed by the sealing film 30, and an information output port of the humidity detection component is connected to the vacuum device, so that the detected humidity information is provided to the vacuum device to control the vacuum device to regulate the output vacuum. In this embodiment, the humidity detection component is, for example, a humidity sensor.

In summary, in the surgical auxiliary device for closing a skin wound without a suture line in a superficial fascia of skin in the second aspect of the present application, in the first aspect, the exposed two ends of the skin wound are tightly attached by the wound closing device, and the wound closing device can play a role of squeezing a skin margin while closing the wound, so that bleeding of a blood vessel network under skin dermis can be reduced; the second aspect is that under the force of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound is kept in a closed state in the healing and rehabilitation process, the detached tissue is kept in a joint state, and the blood seepage and the seepage in the wound cavity are kept to be removed in time through continuous negative pressure suction; on the basis, the liquid medicine is intermittently conveyed to the inner cavity of the subcutaneous wound, so that blood clots coagulated in the inner cavity of the subcutaneous wound are wetted to be removed conveniently, and potential bacterial communities reaching the colonization concentration are diluted and removed along with drainage of flushing fluid, so that the cleaning state in the wound cavity is maintained; in a third aspect, negative pressure may be generated by a negative pressure device on the skin to maintain the tissue position of the skin wound and its peripheral region stable, thereby facilitating tissue healing. In addition, the surgical auxiliary equipment can realize the seamless closure of the whole layer of tissue above the deep fascia of the skin, avoid transverse scars (commonly called as centipede feet) caused by suture compression/cutting on the surface of the skin, and have no remained suture knots in the shallow fascia, thereby eliminating important factors causing bacterial colonization and main inducement of the recurrence of incision infection.

Therefore, the surgical auxiliary equipment for closing the skin wound without the suture in the skin superficial fascia can keep the inner cavity 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 sewing the skin by using a needle, and not using medical tools such as a suture needle, a suture line and the like, 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 and the operation process of removing or detaching the suture line or a line outlet head, is not needed, the key links and important inducements of bacteria colonization are eliminated, the wound after healing can not leave the suture traces such as 'centipede feet' on the surface of the skin, the beauty of the operation incision part is ensured, and the problems that the traces are easy to leave and the effusion is difficult to discharge after the operation in the prior art are solved, 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.

In embodiments of a third aspect of the present application, a negative pressure drainage and cleansing system for closing a skin wound with a suture is provided.

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, embodiments of the third aspect of the present application provide a negative pressure drainage and cleansing system for suture-free closure of a skin wound, which is intended to facilitate healing of the skin wound by controlling the environment inside and around 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 washing device is used for conveying the cleaning liquid to the preset depth of the inner cavity of the subcutaneous wound through the first conduit, and comprises a conveying pump and a first conduit, wherein the first conduit partially extends into the preset depth of the inner cavity of the subcutaneous wound, and the conveying pump conveys the cleaning liquid to the first conduit, so that the cleaning liquid can be conveyed 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 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 comprises a negative pressure source and a second catheter, wherein the second catheter is partially inserted into the inner cavity of the subcutaneous wound by a preset depth, and the negative pressure source is communicated with the second catheter to generate negative pressure to force the inner cavity of the subcutaneous wound to be in the closed state in the healing process and drain the effusion in the inner cavity of the subcutaneous wound, 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 second catheter is the medical drainage tube described in the embodiment of the first aspect of the present application, but since the second catheter already includes a flushing device in this embodiment, and the flushing device includes a delivery pump and a first catheter, the first catheter can deliver a cleaning solution to the subcutaneous wound cavity while cleaning the subcutaneous wound cavity, and therefore the function of the first catheter in this embodiment is the same as that of the cleaning tube in the embodiment of the first aspect of the present application. Therefore, to avoid conflict, the medical drain tube used in this embodiment does not include the irrigation tube portion of the embodiment of the first aspect of the present application.

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 drainage and cleaning system for the suture-free closed skin wound can maintain the stability of the tissue positions of the skin wound and the peripheral area thereof through the negative pressure generated by the negative pressure device, thereby being beneficial to tissue healing. The negative pressure drainage and the cleaning system of this application no suture closed skin wound's second aspect 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 colonization 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 negative pressure drainage and cleaning system for the sutureless closed skin wound 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 negative influence on the patient is avoided and the vacuum degree of the inner cavity of the subcutaneous wound is maintained. In addition, the negative pressure drainage and cleaning system for the skin wound closed without the suture can assist in realizing the suture-free 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 on the surface of the skin caused by suture compression/cutting, 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 will be appreciated that in embodiments according to the third aspect of the present application, the skin wound comprises a break formed by a continuous interruption of a skin or other tissue site, 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. 26, fig. 26 is a schematic view of an embodiment of the vacuum drainage and cleansing system for a skin wound closed by a suture, as shown, the vacuum drainage and cleansing system for a skin wound closed by a suture, comprising: a flushing device 9, a negative pressure device 3 and a control device 10.

In an exemplary embodiment, please refer to fig. 27, which is a schematic diagram of an embodiment of the present application of the negative pressure drainage and cleansing system for suture-free closed skin wounds. As shown, the flushing device 9 comprises a delivery pump 903 and a second conduit 102 partially extending into the subcutaneous wound cavity 7 to a predetermined depth, and is used for delivering the cleaning solution to the subcutaneous wound cavity 7 to the predetermined depth through the second conduit 102.

It should be understood that the subcutaneous wound lumen 7 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 7, 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 subcutaneous wound lumen 7, such as antibiotics in the cleaning fluid when there is a bacterial infection in the wound, liquid medicaments with anti-inflammatory components in 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 7.

In an exemplary embodiment, referring to fig. 31, which is a schematic view of an embodiment of an irrigation device in the negative pressure drainage and cleansing system for closing skin wounds without sutures according to the present application, as shown in the figure, the irrigation device 9 further comprises: a cleaning liquid container 901, a second pressure sensor 904 and a second vacuum sensor 902.

Wherein the cleaning liquid container 901 stores the cleaning liquid for flushing the subcutaneous wound cavity 7, and the delivery pump 903 is communicated with the second conduit 102. The second conduit 102 is used to deliver a cleansing fluid to a predetermined depth of the subcutaneous wound lumen 7 to facilitate healing of the subcutaneous wound lumen 7. In a mode of this embodiment, can adopt intermittent type nature mode to carry the washing liquid to subcutaneous wound inner chamber 7 through control washing unit 9, make blood clot, tissue liquid piece etc. of solidifying in subcutaneous wound inner chamber 7 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 7 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 liquid container 901 and the transfer pump 903 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 7 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. When the bacterial content in the tissue exceeds 105/g, bacterial colonization can occur 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 9 can deliver a cleaning fluid to the subcutaneous wound inner cavity 7 through the second conduit 102 for diluting bacterial infection which may be produced or has been produced in the subcutaneous wound inner cavity 7, so as to dilute the potential infection focus reaching the colonization concentration; meanwhile, the cleaning liquid conveyed by the flushing device 9 can also achieve the purpose of flushing the infected part in the inner cavity 7 of the subcutaneous wound, and after the flushing is finished, the cleaning liquid in the inner cavity 7 of the subcutaneous wound is sucked away through the drainage effect of the negative pressure device 3, so that bacteria are drained and removed, and the inner cavity 7 of the subcutaneous wound is kept in a clean state.

In actual clinical treatment, the amount of the washing liquid of the washing device 9, the time for diluting the bacteria-infected part, the washing frequency of the washing liquid, the operating frequency of the negative pressure device 3, and the like can be controlled according to the judged infection condition of the subcutaneous wound lumen 7 of the patient. For example, in an exemplary embodiment, the washing device 9 washes the cleaning solution in the subcutaneous wound cavity 7 for 2 to 3 days, for example. Since the cleaning liquid container 901 and the transfer pump 903 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 903 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 second pressure sensor 904 is configured to feed back the sensed pressure value of the fluid in the second conduit 102 between the delivery pump 903 and the subcutaneous wound lumen 7 to the control device 10, so as to adjust the rotation speed of the delivery pump 903 to control the output pressure of the cleansing liquid. In the process of cleaning the subcutaneous wound inner cavity 7 by the flushing device 9, 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 7 cannot be flushed completely, and the effusion still remains in the subcutaneous wound inner cavity 7, which is not beneficial to the healing of the wound. In order to avoid the above situation, a second pressure sensor 904 is arranged on the second conduit 102 between the delivery pump 903 and the subcutaneous wound cavity 7, the fluid pressure value sensed by the second pressure sensor 904 reflects the fluid pressure value at the output end of the second conduit 102, and the fluid pressure value sensed by the second pressure sensor 904 is fed back to the control device 10, so that the control device 10 adjusts the rotation speed of the delivery pump 903, 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 second pressure sensor 904 is provided to the control device 10, so that the control device 10 adjusts the rotation speed of the delivery pump 903 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 second pressure sensor 904 or the first pressure sensor 34 may be a pressure sensor including, but not limited to, model number MPXH 6300A.

In an exemplary embodiment, the second vacuum sensor 902 is used for sensing the vacuum degree of the second conduit 102 between the delivery pump 903 and the cleaning liquid container 901 to monitor the exhaustion state of the cleaning liquid in the cleaning liquid container 901. When the cleaning liquid in the cleaning liquid container 901 is used up, infusion needs to be stopped or the cleaning liquid needs to be supplemented in time, which may cause air to enter the subcutaneous wound cavity 7. Here, by providing the second vacuum sensor 902 in the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901, whether or not the cleaning liquid in the cleaning liquid container 901 is used up can be reflected by detecting the degree of vacuum of the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901.

In an exemplary embodiment, when the cleaning liquid in the cleaning liquid container 901 is detected to be used up or to be used up, the detection result is fed back to the control device 10, so that the control device 10 turns off the delivery pump 903, thereby avoiding the delivery pump 903 from continuing to work.

It should be understood that the second vacuum sensor 902 is located on the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901. The vacuum level detected by the second vacuum sensor 902 reflects the vacuum level of the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901. When the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901 is filled with liquid or a large amount of liquid passes through, the vacuum degree in the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901 is zero or close to zero, but when no liquid or very little liquid passes through the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901, it indicates that the cleaning liquid in the cleaning liquid container 901 is used up or nearly used up, and at this time, the vacuum degree in the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901 will rise obviously. Therefore, after the second vacuum sensor 902 is disposed on the second conduit 102 between the conveying pump 903 and the cleaning liquid container 901, whether the cleaning liquid in the cleaning liquid container 901 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 901 can be judged according to the vacuum degree value detected by the second vacuum sensor 902.

In an exemplary embodiment, referring to fig. 28, fig. 28 is a schematic view 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 9 further comprises an alarm device 14 for outputting an alarm signal when the second vacuum sensor 902 detects the exhaustion of the cleaning liquid in the cleaning liquid container 901. Here, when the second vacuum sensor 902 provided on the second conduit between the transfer pump 903 and the cleaning liquid container 901 detects that the cleaning liquid in the cleaning liquid container 901 is used up or is about to be used up, an alarm may be given by the alarm device 14 to prompt replenishment of the cleaning liquid or stop of the operation of the flushing device 9.

It should be understood that the alarm device 14 is a device capable of receiving the control signal of the control device 10 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 9 comprises a delivery pump 903, a second conduit 102, a cleaning liquid container 901, a second pressure sensor 904, a second vacuum sensor 902. The cleaning liquid container 901 is internally provided with a cleaning liquid for washing the inner cavity 7 of the subcutaneous wound. The delivery pump 903 is used for delivering the cleaning liquid in the cleaning liquid container 901 and controlling parameters such as flow rate, force and the like of the liquid. One end of the second conduit 102 is connected with the cleaning liquid container 901, and the other end of the second conduit 102 extends into the subcutaneous wound cavity 7 by a preset depth, so that the cleaning liquid in the cleaning liquid container 901 is delivered to the subcutaneous wound cavity 7. The second pressure sensor 904 is arranged on the second conduit 102 between the delivery pump 903 and the subcutaneous wound lumen 7, thereby feeding back a fluid pressure value to the control device 10, so that the control device 10 adjusts the rotation speed of the delivery pump 903, thereby controlling the output pressure of the washing liquid. The second vacuum sensor 902 is disposed in the second conduit 102 between the transfer pump 903 and the cleaning liquid container 901, so that whether the cleaning liquid in the cleaning liquid container 901 is used up or is about to be used up is determined by the vacuum degree value detected by the second vacuum sensor 902. When it is detected that the cleaning liquid in the cleaning liquid container 901 is used up or is about to be used up, the alarm device 14 can be triggered by the control device 10 to alarm or the delivery pump 903 can be turned off by the control device 10.

In an exemplary embodiment, the negative pressure device 3 includes a negative pressure source 6 and a first catheter 101 partially extending into the subcutaneous wound lumen 7 to a predetermined depth, and the negative pressure device 3 is used for generating negative pressure to force the subcutaneous wound lumen 7 to be in a closed state during healing and draining effusion of the subcutaneous wound lumen 7 through the first catheter 101. The first conduit 101 is used for generating negative pressure to force the inner cavity 7 of the subcutaneous wound to be in a closed state in the healing process, maintaining the detached tissues to be in a joint state, maintaining the blood seepage and the liquid seepage in the wound cavity to be cleared in time through continuous negative pressure suction, in the practical implementation process, the first conduit 101 of the negative pressure device 3 is inserted into the inner cavity 7 of the subcutaneous wound, the tissues on two sides of the inner cavity 7 of the subcutaneous wound are forced to be in opposite directions (directions shown by arrows on two sides of the scalp lower wound in fig. 27) to be jointed through the generated negative pressure to eliminate the inner cavity 7 of the subcutaneous wound, and the closing of the inner cavity 7 of the subcutaneous wound is beneficial to the healing of the wound. It will be appreciated that during this process, the portion of the first catheter 101 within the subcutaneous wound lumen 7 does not affect the growth of tissue on either side of the subcutaneous wound lumen 7.

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 7 of the subcutaneous wound is discharged through negative pressure, so that the adverse conditions of wound infection, inflammation, suppuration and the like can be avoided, and the healing of the wound is facilitated.

In an exemplary embodiment, referring to fig. 32, which is a schematic view of an embodiment of a negative pressure device in the negative pressure drainage and cleansing system for closing skin wounds without sutures according to the present application, as shown in the figure, the negative pressure device 3 further includes: a collection vessel 35, a first pressure sensor 34 and a first vacuum sensor 33.

Wherein the collection container 35 is used for collecting the effusion drained from the subcutaneous wound cavity 7 by the first catheter. The collection container 35 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 first catheter collects the effusion fluid drained from the subcutaneous wound lumen 7 in the collection container 35. When the collection container 35 is full, the collection container 35 may be replaced or the collection container 35 may be purged of liquid.

To ensure that the cleaning liquid container 901 and the collection container 35 are maintained in a sterile working environment, in an exemplary embodiment, the control portion of the control device 10 is integrated with the cleaning liquid container 901 and the collection container 35 in different equipment housings, for example, the control portion (including control device, delivery pump, negative pressure source) of the control device 10 is configured in a first housing, the cleaning liquid container 901 and the collection container 35 are configured in a second housing, the cleaning liquid container 901 and the collection container 35 are physically isolated in the second housing, each container has an independent and non-communicated space, the second housing is provided with a conduit interface for connecting the cleaning liquid container 901 and the collection container 35, respectively, for communicating with the respective conduits, that is, the collection container 35 communicates with the first conduit 101, the cleaning liquid container 901 communicates with the second conduit 102. In an embodiment, the cleaning solution container 901 and the collection container 35 are detachably connected to the housing, so as to facilitate replacement or maintenance.

In another exemplary embodiment, in a clinical setting, the washing liquid container 101 and the collection container 35 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 10 is disposed in a first housing, the washing liquid container 901 is disposed in a second housing, and the collection container 35 is disposed in a third housing. In an exemplary embodiment, the first pressure sensor 34 is used to monitor the full state of the collection container 35 by sensing the fluid resistance of the first conduit 101 between the negative pressure source 6 and the collection container 35. With continued reference to fig. 26, a first pressure sensor 34 is shown disposed on the first conduit 101 between the negative pressure source 6 and the collection container 35. When the liquid in the collection container 35 is full or about to be full, the fluid resistance in the first conduit 101 between the negative pressure source 6 and the collection container 35 is significantly increased, and the first pressure sensor 34 can detect the fluid resistance in the first conduit 101 between the negative pressure source 6 and the collection container 35 to determine whether the collection container 35 is full or about to be full, so as to determine the full state of the collection container 35.

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 35 is full of liquid, the fluid in the first conduit 101 is prevented from flowing into the collection container 35 by the resistance from the liquid in the collection container 35.

In an exemplary embodiment, the negative pressure device 3 further comprises an alarm device for outputting an alarm signal when the first pressure sensor 34 detects that the liquid loading in the collection container 35 is full or is about to be full. Here, when the first pressure sensor 34 disposed on the first conduit 101 between the negative pressure source 6 and the collection container 35 detects that the liquid loading in the collection container 35 is full or is about to be full, an alarm can be given by the alarm device to prompt replacement and cleaning of the collection container 35. In other cases, when the first pressure sensor 34 disposed on the first conduit 101 between the negative pressure source 6 and the collection container 35 detects that the liquid loading in the collection container 35 is full or is about to be full, the first pressure sensor 34 can also feed back this information to the control device 10, so that the control device 10 sends a signal to the negative pressure device 3 to stop working to turn off the negative pressure device 3.

In an exemplary embodiment, the first vacuum sensor 33 is used to feed back the sensed vacuum level of the first conduit 101 between the negative pressure source 6 and the subcutaneous wound lumen 7 to the control device 10 to adjust the power of the negative pressure source 6 to control the generated negative pressure. Referring to fig. 26, as shown in the figure, a first vacuum sensor 33 is disposed on the first catheter 101 between the negative pressure source 6 and the inner cavity 7 of the subcutaneous wound, and since the first catheter 101 partially protrudes into the inner cavity 7 of the subcutaneous wound by a preset depth, when the negative pressure in the first catheter 101 is too high, a secondary injury may be caused to the inner cavity 7 of the subcutaneous wound; when the negative pressure in the first catheter 101 is too small, the effects of closing the subcutaneous wound inner cavity 7 and draining the effusion in the subcutaneous wound inner cavity 7 cannot be achieved. Therefore, it is necessary to maintain the negative pressure in the first conduit 101 within a suitable range of values. Meanwhile, when the subcutaneous wound inner cavity 7 is in a closed state or close to the closed state, the vacuum degree in the first conduit 101 between the negative pressure source 6 and the subcutaneous wound inner cavity 7 is zero or close to zero, so that the first vacuum sensor 33 is arranged on the first conduit 101 between the negative pressure source 6 and the subcutaneous wound inner cavity 7, so that the vacuum degree in the first conduit 101 between the negative pressure source 6 and the subcutaneous wound inner cavity 7 can be reflected by the first vacuum sensor 33, and whether the negative pressure applied to the subcutaneous wound inner cavity 7 is in an ideal range or not can be further reflected. Further, the first vacuum sensor 33 feeds back the acquired vacuum degree of the first conduit 101 between the negative pressure source 6 and the subcutaneous wound inner cavity 7 to the control device 10, and the control device 10 adjusts the output power of the negative pressure source 6 according to the data fed back by the first vacuum sensor 33, so as to control the negative pressure generated by the negative pressure source 6, 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 6 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 13 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 6 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 6 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 10 is electrically connected to the irrigation device 9 and the negative pressure device 3, and is configured to control the output pressure or flow of the irrigation device 9 and the negative pressure device 3 according to the received feedback to maintain the vacuum level of the subcutaneous wound lumen 7.

It should be understood that the flushing device 9 outputs the cleaning liquid by means of the delivery pump 903, and that the pressure of the output cleaning liquid and the flow rate of the output cleaning liquid can be adjusted by means of the delivery pump 903. When the output pressure is too low, the subcutaneous wound inner cavity 7 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 7 of the subcutaneous wound, and when the output flow is too large, the output pressure can be increased, so that 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 9 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 7, for example: when the vacuum degree is higher, the two sections reflecting the inner cavity 7 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 7 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 7 of the subcutaneous wound have no gap or small gaps, which means that the negative pressure is probably in an ideal range or 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, the vacuum degree of the subcutaneous wound inner cavity 7 is maintained in an ideal range, so that the subcutaneous wound inner cavity 7 can be closed, secondary damage or pain feeling of a patient to the subcutaneous wound can be avoided, and the subcutaneous wound can be better recovered. In embodiments of the third aspect of 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 control device 10 can control the output pressure and the output flow of the flushing device 9 through a signal fed back by the induction flushing device 9 on the one hand, ensure that the output pressure of the flushing device 9 can remove accumulated liquid, impurities and the like in the inner cavity 7 of the subcutaneous wound while the subcutaneous wound is not damaged, and control the negative pressure strength of the negative pressure device 3 through a signal fed back by the induction negative pressure device 3 on the other hand, thereby ensuring that the accumulated liquid in the inner cavity 7 of the subcutaneous wound is drained while the subcutaneous wound is not damaged, closing the inner cavity 7 of the subcutaneous wound and maintaining the vacuum degree of the inner cavity 7 of the subcutaneous wound within an ideal range.

In an exemplary embodiment, the negative pressure device 3 may generate a vacuum of 70% to 80%, such as 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, so as to maintain the vacuum of the subcutaneous wound lumen 7 within a desired range.

In an exemplary embodiment, continuing to refer to fig. 28, the negative pressure device 3 includes a collection container 35, a first pressure sensor 34, a negative pressure source 6, a first vacuum sensor 33, and a first conduit. One end part of the first catheter is inserted into the subcutaneous wound inner cavity 7 to a preset depth, the other end of the first catheter is connected with a collecting container 35 through a negative pressure source 6, and a first pressure sensor 34 is arranged on the first catheter between the negative pressure source 6 and the collecting container 35 and used for judging whether the collecting container 35 is full or not by detecting the resistance. A first vacuum sensor 33 is arranged on a first conduit between the negative pressure source 6 and the inner cavity 7 of the subcutaneous wound, and is used for judging the negative pressure of the inner cavity 7 of the subcutaneous wound by detecting the vacuum degree of the inner cavity 7 of the subcutaneous wound. The control device 10 is respectively connected with a first pressure sensor 34 and the first vacuum sensor 33 through an a/D module, i.e. a digital-to-analog signal conversion module, and the first pressure sensor 34 feeds back sensed resistance information to the control device 10 so that the control device 10 can adjust the on-off of the negative pressure source 6 or control the alarm device 14 to give an alarm. Meanwhile, the first vacuum sensor 33 feeds back the sensed vacuum degree information to the control device 10 so that the control device 10 adjusts the rotation speed and the flow rate of the negative pressure source 6 through the duty ratio. The rinsing device 9 comprises a cleaning liquid container 901, a second conduit 102, a second vacuum sensor 902, a transfer pump 903 and a second pressure sensor 904. One end of the second conduit 102 extends into the subcutaneous wound inner cavity 7 by a preset depth, the other end of the second conduit 102 is connected with a cleaning liquid container 901 through a delivery pump 903, and a second pressure sensor 904 is arranged on the second conduit 102 between the delivery pump 903 and the subcutaneous wound inner cavity 7 and used for detecting the output pressure of the delivery pump 903. A second vacuum sensor 902 is disposed on the second conduit 102 between the delivery pump 903 and the cleaning liquid container 901, and is configured to detect a vacuum degree to determine an exhaustion of the cleaning liquid in the cleaning liquid container 901. The control device 10 is connected to the second vacuum sensor 902 and the second pressure sensor 904 through an a/D module, i.e., a digital-to-analog signal conversion module, the second vacuum sensor 902 feeds back the sensed vacuum degree to the control device 10, so that the control device 10 controls the alarm device 14 to alarm or control the on/off of the delivery pump 903, and the second pressure sensor 904 feeds back the sensed pressure to the control device 10, so that the control device 10 controls the output pressure of the delivery pump 903 through a duty ratio.

In an exemplary embodiment, the wound closure device 2 described in embodiments of the second aspect of the present application may be used to assist the negative pressure device 3 in closing the subcutaneous wound lumen 7. The wound closing device 2 can extrude the skin edge to enable the two exposed ends of the skin wound to be attached tightly, the subcutaneous wound inner cavity 7 is kept in a closed state in the healing and rehabilitation process under the force and assistance of the negative pressure device 3, the accumulated liquid in the subcutaneous wound inner cavity 7 can be sucked, meanwhile, the flushing device 9 can be used for flushing and conveying liquid medicine to the subcutaneous wound inner cavity 7, and then the infection focus which potentially reaches the colonization concentration in the subcutaneous wound inner cavity 7 is diluted and cleaned.

The structure of the wound closure device 2 is described in the embodiments of the second aspect of the application, and therefore will not be described in detail here.

In an exemplary embodiment, the first and/or second catheter is partially advanced to a predetermined depth of the subcutaneous wound lumen 7 via a predetermined location of the skin wound; or the first and/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 subcutaneous wound lumen 7.

In an exemplary embodiment, please refer to fig. 29, which is a schematic diagram illustrating an embodiment of the first catheter and the second catheter of the present negative pressure drainage and cleansing system for suture-free closed skin wound partially penetrating from a predetermined position of the skin wound to a predetermined depth of the lumen of the subcutaneous wound. As shown in the figure, the first catheter and the second catheter partially extend into the preset depth of the inner cavity 7 of the subcutaneous wound through a preset position of the skin wound, so that negative pressure can be generated, the inner cavity 7 of the subcutaneous wound is ensured to be in a closed state in the healing process, and meanwhile, effusion of the inner cavity 7 of the subcutaneous wound is drained, so that the detached tissues are maintained to be in a joint 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 7 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, with continued reference to fig. 27, the first and second catheters are passed through the skin and subcutaneous tissue via a predetermined location away from the skin wound to partially reach a predetermined depth of the subcutaneous wound lumen 7, thereby generating a negative pressure to ensure that the subcutaneous wound lumen 7 is closed during the healing process and simultaneously to suck the effusion from the subcutaneous wound lumen 7, so that the living space or environment of bacteria is eliminated due to the timely removal of the effusion from the subcutaneous wound lumen 7. In this embodiment, please refer to fig. 30, which is a schematic diagram illustrating an embodiment of the present application of the negative pressure drainage and cleansing system for suture-free closure of a skin wound, in which the first catheter and the second catheter pass through the skin and the subcutaneous tissue via a predetermined position 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 E in figure 30) to partially reach a predetermined depth within the subcutaneous incision lumen 7. The distal position is a predetermined position away from the skin incision (e.g. position shown in fig. 30), and the first and second catheters are not inserted into the subcutaneous incision lumen 7 through the skin incision in order to facilitate the closing and surface treatment of the skin incision, but are inserted partially into the subcutaneous incision lumen 7 through the skin and subcutaneous tissue from another position, i.e. a predetermined position away from the skin incision, and this embodiment is particularly suitable for the long and narrow incision shown in fig. 30.

In an exemplary embodiment, the second conduit and the first conduit are integrally formed, thereby reducing the number of pipe laying, and the integrally formed conduit includes two conduits isolated from each other and not communicated with each other, wherein the first conduit forms the second conduit and the second conduit forms the first conduit.

In another exemplary embodiment, the first conduit may be further sleeved inside the second conduit. In this embodiment, the second conduit and the first conduit are integrally formed, so that the number of buried pipes can be reduced, the integrally formed conduit is formed by two pipes which are not communicated with each other, the first conduit is sleeved in the second conduit, and the diameter of the second conduit is larger than that of the first conduit.

In an exemplary embodiment, a plurality of through holes are formed on the wall of the portion of the second catheter which extends to a predetermined depth into the skin wound. The second catheter is connected with the cleaning solution container, so that the cleaning solution in the cleaning solution container is conveyed to the preset depth of the inner cavity 7 of the subcutaneous wound by the second catheter, and simultaneously flows out of each part of the subcutaneous wound through the through hole in the second catheter, and more parts of the subcutaneous wound are cleaned or medicines are conveyed. In an exemplary embodiment, the plurality of through holes are uniformly distributed on the wall of the portion of the second catheter which extends into the skin wound to a predetermined depth at intervals, and particularly for a long and narrow wound, the wound cavity formed below the long and narrow wound is usually 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 pipeline at each position; in another exemplary embodiment, the plurality of through holes on the second catheter may also be designed in a non-equidistant manner (i.e., the plurality of through holes are unevenly distributed at intervals on the wall of the portion of the second catheter that protrudes to a predetermined depth into the skin wound) for different types of skin wounds or different purposes of surgery.

In an exemplary embodiment, a plurality of through holes are formed in the wall of the part of the first conduit which extends into the skin wound by a preset depth, the first conduit is connected with a negative pressure source so as to generate negative pressure, and the plurality of through holes in the first conduit can help to suck gas and liquid in the inner cavity of the subcutaneous wound, so that the sucking area and the sucking position are increased, and the subcutaneous wound is better healed. In an exemplary embodiment, the plurality of through holes are uniformly distributed at intervals on the wall of the portion of the first catheter which protrudes into the skin wound to a predetermined depth, particularly for a narrow wound, the wound cavity formed below the narrow wound is usually also an elongated cavity or gap, in order to ensure that the effusion or residual medical liquid secreted from each position of the elongated cavity or gap is sucked by the first catheter; in another exemplary embodiment, the plurality of through holes on the first catheter may also be designed in a non-equidistant manner (i.e., the plurality of through holes are unevenly distributed at intervals on the wall of the portion of the first catheter that protrudes to a predetermined depth into the skin wound) for different types of skin wounds or different purposes of surgery.

In yet another exemplary embodiment, the shape and structure of the second catheter and the first catheter extending into the skin wound at the predetermined depth may also be designed according to actual requirements, such as different depths or different tissue structures of the skin wound according to the expectation, different thicknesses or different flexibility of the second catheter and the first catheter, for example, 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 is further used for maintaining the tissue position of the skin wound surface and the peripheral area thereof stable by the generated negative pressure, thereby facilitating wound healing.

In an exemplary embodiment, the negative pressure device includes: 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 this embodiment, the negative pressure passage communicates with the negative pressure source through the first conduit, and communicates the negative pressure passage with the sealed space, thereby forming the sealed space.

In this embodiment, the negative pressure generated by the negative pressure device compresses the sealed space, thereby maintaining the local tissue toward the wound site. Meanwhile, the negative pressure generated by the negative pressure device also generates acting force on deep tissues under the wound, so that potential dead spaces are closed, and the wound healing is promoted. In this embodiment, the pressure value of the sealed space formed by the sealing film 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 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 condition 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. 33, which is a schematic view illustrating a sealing and force-applying structure of a negative pressure device in the present application of the negative pressure drainage and cleansing system for seamlessly closing a skin wound, as shown in the figure, the sealing film 30 is adhered to the skin and covers the surface of the skin wound, thereby forming a sealed space 32, after being pumped by the negative pressure device 3, the sealed space 32 inside the sealing film 30 is inwardly applied with a force, as shown by the arrow in fig. 33, to apply pressure to deep tissue while maintaining the local tissue position fixed, thereby closing a potential dead space. In this embodiment the sealing membrane 30 forms a sealing zone around the skin wound and such that the sealing zone forms a sealed space 32, in this embodiment the sealing membrane 30 is bonded to the surface of the skin by its adhesive layer to the skin surface, for example a flexible impermeable material comprising polyurethane coated with an acrylic adhesive.

In an exemplary embodiment, the sealing film 30 is provided with a viewing window of a light transmissive material. Here, the sealing film 30 may be made of a transparent material. Sealing membrane 30, which is a transparent material, may facilitate the clinician in visualizing the healing of the skin wound for timely intervention.

Referring to fig. 35, which shows a schematic view of an application example of the negative pressure drainage and cleansing system for closing skin wounds without sutures, as shown in the figure, an operator embeds the second catheter 102 of the irrigation device and the first catheter 101 of the negative pressure device 3 into the subcutaneous tissue of the skin, and extends the second catheter 102 and the first catheter 101 into the subcutaneous wound inner cavity 7. The negative pressure device 3 can drain effusion secreted by the subcutaneous wound inner cavity 7 through the first catheter 101, and meanwhile, the wound inner cavity is forced to be folded/combined due to the negative pressure effect, so that tissues on two sides are combined oppositely. In addition, the flushing device 9 can also deliver a cleaning solution and a liquid medicine to the subcutaneous wound inner cavity 7 through the second catheter 102 to facilitate healing, which is the first aspect; in the second aspect, the closing part 21 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 21 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 3 can assist in closing the inner cavity 7 of the subcutaneous wound. The operator continues to place the microporous covering 20 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 30 outside the micropore accessory to wrap the whole wound and the micropore covering piece 20 on the wound; in the third aspect, the sealing membrane 30 is pumped and pressed through the negative pressure channel of the negative pressure device 3, 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 3 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 for suturing 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 3 includes a humidity detection component (not shown) for providing the detected humidity information in the sealed space 32 to the negative pressure source so as to facilitate the negative pressure source to regulate the negative pressure output. The sensor of the humidity detection component is arranged in the sealed space 32 formed by the sealing film 30, and the information output port of the humidity detection component is connected with the control device 10, so that the detected humidity information is provided for the control pressure device to control the negative pressure device 3 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. 34, which is a schematic view of a first catheter in the negative pressure drainage and cleansing system for closing skin wounds without sutures according to the present application, as shown in the figure, the first catheter 101 includes a subcutaneous drainage hole 1010 and a subcutaneous negative pressure hole 60, the subcutaneous drainage hole 1010 is a plurality of through holes disposed on the wall of the first catheter 101 at the portion protruding into the skin wound by a predetermined depth; the sub-dermal pressure port 60 communicates with the sealed space 32 to apply a negative pressure to the sealed space 32. The first conduit 101 is connected with a negative pressure source 6, and the negative pressure source 6 provides negative pressure for the first conduit 101. The subcutaneous drainage hole 1010 of the first catheter 101 is positioned on the wall of the part of the first catheter 101, which extends into the skin wound by a preset depth, so that the subcutaneous wound inner cavity 7 is forced to be in a closed state in the healing process by the negative pressure generated by the negative pressure source 6, and the effusion of the subcutaneous wound inner cavity 7 is drained through the first catheter 101. The subcutaneous negative pressure hole 60 of the first catheter 101 is located in the sealed space 32 of the subcutaneous part and is used for communicating with the sealed space 32 to apply negative pressure to the sealed space 32, thereby maintaining the tissue position of the skin wound surface and the peripheral area thereof stable.

In an exemplary embodiment, with continued reference to fig. 26, the negative pressure drainage and cleansing system for sutureless closed skin wounds further comprises a computer 13, wherein the computer 13 is connected to the control device 10 in a communication manner including, but not limited to, a USB interface connection or a bluetooth or wireless network connection. The user can set a program on the computer 13 to set the working time, working mode, etc. of the flushing device 9 and the negative pressure device 3. For example, the drive parameters of the irrigation device 9 and the negative pressure device 3 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. 26, the negative pressure drainage and cleansing system for a sutureless closed skin wound further includes an interactive device 12, wherein the interactive device 12 includes, but is not limited to, a touch screen, a display screen, and an operation keyboard. 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 3 and the flushing device 9 are controlled, and the working state, the working time, the working mode and the like of the negative pressure device 3 and the flushing device 9 are known in real time through information fed back on the display screen.

In an exemplary embodiment, with continued reference to fig. 26, the negative pressure drainage and cleansing system for a sutureless closed skin wound further comprises a memory module 11, wherein the memory module 11 includes, but is not limited to, a memory chip such as an SD card or cloud storage. The storage module 11 can store operation information set by a user and an operation program downloaded from the computer 13, and data and the like during actual use.

In summary, the negative pressure drainage and cleaning system for the suture-free closed skin wound of the application makes the inner cavity 7 of the subcutaneous wound keep a closed state in the healing and rehabilitation process under the force of the negative pressure device 3, 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 7 of the subcutaneous wound, so that the blood clots coagulated in the inner cavity 7 of the subcutaneous wound are moistened to be removed conveniently, and the potential bacterial communities reaching the colonization concentration are diluted and removed along with the drainage of the cleaning solution, and the cleaning state in the wound cavity is maintained. Meanwhile, medicines can be added or replaced in the cleaning solution, so that the cleaning solution is conveyed to the subcutaneous wound inner cavity 7 to help the subcutaneous wound to heal; in the third aspect, the control device 10 can control the negative pressure of the negative pressure device 3 and the flushing pressure and flow of the flushing device 9 in real time through the feedback control of the negative pressure device 3, the flushing device 9 and the control device 10, so that the negative pressure of the negative pressure device 3 can play a good role in closing and draining, and the flushing device 9 can play a good role in flushing without generating negative influence on subcutaneous wounds. And in the use process, the control device 10 can trigger the alarm device 14 to alarm based on the feedback information of the vacuum sensor and the pressure sensor so as to remind an operator of replenishing the cleaning liquid or replacing the collecting container 35 in time. The negative pressure generated by the negative pressure device 3 can also maintain the stable tissue position of the skin wound and the peripheral area thereof, thereby being beneficial to healing of the tissue. In addition, the negative pressure drainage and cleaning system for closing the skin wound by the aid of the seamless lines can realize seamless line closing of all-layer tissues above deep fascia of the skin, avoids transverse scars (commonly called as centipede feet) caused by suture compression/cutting on the surface of the skin, and has no residual suture knots in the superficial fascia, so that important factors causing bacterial colonization and main causes of incision infection recurrence are eliminated.

Therefore, the negative pressure drainage and cleaning system for closing the skin wound without the suture can keep the inner cavity 7 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 the skin without using a needle, and not using medical tools such as a suture needle, a suture line and the like, 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 line or the leading-out wire head and the operation process, further eliminating the key links and important inducements of bacteria colonization, ensuring that the wound after healing can not leave the suture traces such as 'centipede feet' 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 traces, 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.

Soft tissue tension has been an important factor affecting healing in the treatment of wounds in the extremities. Local tissue inflammatory reaction is caused by trauma, so that vascular permeability is increased, and tissue edema is caused; the accumulation of a large amount of liquid in the tissue can increase the local tissue tension, cause hypoxia, form a vicious circle and cause extensive tissue necrosis. This inflammation-induced tissue edema can cause an increase in the inter-fascial pressure of the deep tissue, leading to inter-fascial compartment syndrome, resulting in limb necrosis. In the soft tissue layer of the skin, severe tissue swelling also causes blood circulation disorder of the soft tissue of the skin, which causes skin nonunion, skin margin necrosis, extensive ischemic necrosis of the skin and the like. The necrosis of the soft tissue of the skin can cause the exposure of bones, tendons or internal fixing steel plates, and the like, and can cause serious problems of secondary chronic infection (osteomyelitis), fracture nonunion and the like, so that the treatment cost is obviously increased, and the treatment period is obviously prolonged. The skin incision after closing limb trauma, which is effective in resisting tissue edema, protecting the soft skin group, safe and beautiful, has become a technical problem expected to be solved by the people in the field.

In addition, in soft tissues of four limbs, if edema is generated under deep fascia, inflammation is more likely to be caused, namely, tissue ischemia is caused due to the fact that the edema extrudes blood vessels to circulate, so that the tissue is necrotized and further hypoxia is caused, and a vicious circle (vicious circle) is formed; furthermore, in the treatment of common limb fracture patients, limb parts such as crus parts are often required to be cut open to fix the fracture part, and then the cut is closed, and because the soft tissue volume of limbs of a human body is limited, the anti-swelling capacity of the parts is weak, and swelling can cause more serious problems.

In view of this, the embodiment of the fourth aspect of the present invention provides a surgical auxiliary device for closing a skin wound in the deep fascia of a limb without suture, so as to replace the traditional needle and thread sewing manner for the soft tissue of the skin and achieve the purposes of closing the skin wound and draining the effusion in the soft tissue of the skin. In the examples provided below, the surgical aid for the sutureless closure of skin wounds in the deep fascia of the extremities of the present application comprises: subcutaneous negative pressure drainage device, wound closing device, negative pressure device and many drainage needles on the skin for carry out the drainage with the hydrops in the dark muscle membrane of subcutaneous soft tissue by hollow structure and drainage hole through many drainage needles, thereby keep the hydrops in the dark muscle membrane of subcutaneous soft tissue to discharge in time, the environment that maintains in the subcutaneous soft tissue is in healthy state. Simultaneously, the surgery auxiliary assembly of the dark intraductal no suture closed skin wound of four limbs of this application still extrudees the skin reason through wound closing device to under the forcing of subcutaneous negative pressure drainage device, make subcutaneous wound inner chamber keep the closure state at the recovered in-process of healing, subcutaneous negative pressure drainage device still can carry liquid medicine to subcutaneous wound inner chamber when the hydrops of drainage subcutaneous wound inner chamber, ensures that the environment of subcutaneous wound inner chamber keeps doing benefit to the state that the wound resumes. In addition, the skin negative pressure device can generate acting force through the negative pressure effect, so that the skin wound and the tissue position of the peripheral area of the skin wound are kept in a stable state, and the aim of closing the skin wound without a suture is fulfilled.

According to the surgical auxiliary equipment for closing the skin wound without the suture line in the deep fascia of the limbs, on the first hand, the two exposed ends of the skin wound are tightly attached through the wound closing device, and the wound closing device can play a role in extruding the skin margin while closing the wound, so that the bleeding of a blood vessel network under the skin dermis can be reduced; the second aspect is that under the force of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound is kept in a closed state in the healing and rehabilitation process, the detached tissue is kept in a joint state, and the blood seepage and the seepage in the wound cavity are kept to be removed in time through continuous negative pressure suction; on the basis, the liquid medicine is intermittently conveyed to the inner cavity of the subcutaneous wound, so that blood clots coagulated in the inner cavity of the subcutaneous wound are wetted to be removed conveniently, and potential bacterial communities reaching the colonization concentration are diluted and removed along with drainage of flushing fluid, so that the cleaning state in the wound cavity is maintained; in a third aspect, negative pressure may be generated by a negative pressure device on the skin to maintain the tissue position of the skin wound and its peripheral region stable, thereby facilitating tissue healing. According to the fourth aspect, the accumulated liquid in the deep fascia of the subcutaneous soft tissue can be drained through the drainage needles, subcutaneous accumulated blood and other tissue liquid are eliminated, and under the combined action of the drainage needles, the auxiliary wound closing device and the subcutaneous negative pressure drainage device are facilitated to apply acting force which is folded towards the wound direction to the skin tissue, so that the recovery of the skin wound is facilitated. In addition, through the surgical auxiliary equipment of this application can realize the seamless line closure of skin deep fascia above the full layer tissue, avoided the skin surface because of the horizontal scar that suture oppression/cutting arouses to no remains the suture knot in shallow fascia, thereby eliminated the main cause that causes the important factor of bacterial colonization and incision infection relapse.

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.

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 term "suture-free" as used herein refers to a therapeutic means for suturing the superficial fascia of the skin without using a needle thread in the treatment of closing the skin wound or in the healing process of the skin wound or in other treatments such as washing, disinfecting, dressing, etc. of the skin wound after the operation, and thus, there is no procedure for removing the wound or foreign materials in the wound surface of the superficial fascia of the skin, such as the step and operation of removing or removing a suture or a thread head, after the skin wound is healed.

It should be understood that in some cases, the deep fascia, also referred to as the resident fascia, is composed of dense connective tissue, located at the deep face of the superficial fascia, which coats the body wall, muscle and vascular nerves of the extremities, and the like. The deep fascia is very closely related to the muscle, and is layered with the muscle. Extending between muscle groups of the four limbs and deep fascia, and attaching to bones to form muscle intervals; forming a fascia sheath with the deep fascia surrounding the muscle group; the deep fascia also surrounds blood vessels and nerves to form a blood vessel nerve sheath; muscle attachment or as a starting point for the muscle may also be provided.

The deep fascia also refers to all dense fiber layers in ordered arrangement that interact with muscle; the deep fascia connects the various skeletal muscular system components and transmits muscle contraction forces distally. In the matrix, wavy collagen fibers coexist with a few elastin fibers. In the deep fascia, there are 3 different orientations of collagen fibers in the matrix: oblique direction, longitudinal direction, and transverse direction. In fascia, there is the most extensive continuity, with strong elasticity. The tight coating is on the surface of the muscle, and the excessive expansion of the muscle abdomen caused by the contraction of the muscle is prevented. When the muscles contract, the utility model plays a role of sliding assistance in order to avoid the friction force between the adjacent muscles. The deep fascia sometimes separates the muscle from the other structures that are wrapped and then bonds to another membrane. Thus, some fascia are connected to other fascia. There is a site where the insertion of the muscle fibers forms the attachment portion. And the continuity of periosteum and perichondrium, ligament and the like is assisted. Support blood vessels, nerves and lymphatic vessels, and have a mechanical function of allowing them to pass through them.

In an exemplary embodiment, referring to fig. 36, which is a schematic view of an embodiment of the surgical aid for sutureless closure of skin wounds in the deep fascia of an extremity of the present application, there is shown a surgical aid for sutureless closure of skin wounds in the deep fascia of an extremity of the present application comprising: the device comprises a subcutaneous negative pressure drainage device 1, a wound closing device 2, an epithelial negative pressure device 3 and a plurality of drainage needles 4.

In the embodiment shown in fig. 36, a plurality of drainage needles 4 of the surgical aid for closing skin wounds without sutures in the deep fascia of extremity are used for penetrating into the deep fascia of subcutaneous soft tissue from the peripheral side of the skin wound to drain effusion in the deep fascia of the subcutaneous soft tissue, the drainage needles 4 comprise drainage parts 41 formed on needle bodies thereof, and when the drainage needles 4 penetrate into the deep fascia of the subcutaneous soft tissue, a part of the drainage parts 41 is positioned outside the skin surface; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 3 is applied to the plurality of drainage needles 4 through the drainage part 41, when the drainage needles 4 absorb the effusion around the deep fascia of the subcutaneous soft tissue through the drainage part 41, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to tend to be attached in opposite directions under the influence of the negative pressure acting on the subcutaneous negative pressure device 3, and under the combined action of the plurality of drainage needles, the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 are facilitated to apply the acting force which is folded in the wound direction to the skin tissues, so that the effect of assisting in closing the wound is achieved.

It is understood that subcutaneous soft tissue refers to soft tissue located beneath the skin of the human body, including muscles, tendons, ligaments, joint capsules, synovial capsules, nerves, blood vessels, and the like. After the subcutaneous soft tissue is subjected to uncontrollable injury, the conditions such as subcutaneous hematocele and the like can be caused, swelling in the subcutaneous soft tissue is caused, and if the swelling is not timely removed, tissue necrosis can be caused, so that the recovery of a patient is seriously influenced.

In this embodiment, the drainage needle 4 is disposed on the periphery of the skin wound to drain the effusion in the deep fascia of the subcutaneous soft tissue. In other embodiments, the injury to the human body does not leave a wound on the skin surface, such as a case of subcutaneous soft tissue injury, such as a fracture, and drainage of effusion in the deep fascia of the subcutaneous soft tissue is also required to eliminate edema and avoid further necrosis of the tissue. In this case, the drainage needle 4 may be disposed at a position corresponding to the deep fascia of the injured subcutaneous soft tissue, or disposed near the deep fascia of the injured subcutaneous soft tissue or at another position requiring drainage, etc., according to actual needs. Therefore, the drainage needle 4 in the surgical auxiliary equipment for closing the skin wound without the suture in the deep fascia of the limbs is particularly suitable for the injury of the deep fascia of the subcutaneous soft tissue of the limbs or the fracture of the human body.

It should be understood that the drainage needle 4 is a component for draining the effusion in the deep fascia of the subcutaneous soft tissue to the outside of the human body, and in order to enable the drainage needle 4 to drain the effusion in the deep fascia of the subcutaneous soft tissue out of the human body, the drainage part of the drainage needle 4 is exposed out of the surface of the skin. The drainage needle 4 is provided with a drainage part 41, and the drainage part 41 is a part which is arranged on the needle body of the drainage needle 4 and is used for draining subcutaneous effusion.

It should be understood that the drainage needle 4 can be cylindrical or other special-shaped structures, and any shape that can pierce the skin and can provide the drainage portion 41 on the body of the drainage needle 4 to perform drainage can be used in the present invention.

It will be appreciated that during this procedure of draining the deep fascia of the subcutaneous soft tissue by penetrating a plurality of drainage needles 4, the subcutaneous portion of the drainage needles 4 does not affect the growth of tissue on either side of the subcutaneous wound lumen 7. And after the wound is healed, the needle hole left on the skin and the subcutaneous soft tissue after the drainage needle 4 is removed can be healed by self.

In an exemplary embodiment, the body of the drainage needle 4 is a hollow structure, the drainage part 41 is at least one drainage hole formed on the hollow structure, and the hollow structure and the drainage part 41 cooperate with each other to drain effusion in the deep fascia of subcutaneous soft tissue.

It should be understood that the drainage needle 4 is a component for draining the effusion in the deep fascia of the subcutaneous soft tissue to the outside of the human body, and in order to enable the drainage needle 4 to drain the effusion in the deep fascia of the subcutaneous soft tissue out of the human body, the drainage part of the drainage needle 4 is exposed out of the surface of the skin. The drainage needle 4 is provided with a drainage part 41, and the drainage part 41 is a part which is arranged on the needle body of the drainage needle 4 and is used for draining subcutaneous effusion.

It should be understood that the drainage needle 4 may be cylindrical or other shaped structures, and any shape that can pierce the skin and provide the drainage portion 41 on the body of the drainage needle 4 for drainage can be used in the present application.

It will be appreciated that during this procedure of draining the deep fascia of the subcutaneous soft tissue by penetrating a plurality of drainage needles 4, the subcutaneous portion of the drainage needles 4 does not affect the growth of tissue on either side of the subcutaneous wound lumen 7. And after the wound is healed, the needle hole left on the skin and the subcutaneous soft tissue after the drainage needle 4 is removed can be healed by self.

In an exemplary embodiment, the body of the drainage needle 4 is a hollow structure, the drainage part 41 is at least one drainage hole formed on the hollow structure, and the hollow structure and the drainage part 41 cooperate with each other to drain effusion in the deep fascia of subcutaneous soft tissue.

In an exemplary embodiment, please refer to fig. 44 to 45, which are schematic structural views of a drainage needle in the surgical auxiliary device for closing a skin wound without sutures in deep fascia of limbs of the present application in one embodiment, as shown in the figure, a needle body of the drainage needle 4 is a hollow structure, 4 drainage holes are uniformly distributed on the needle body of the drainage needle 4 to form a drainage portion 41, the drainage holes are respectively located on a front side, a left side, a right side and a rear side of the needle body, and a cavity 42 of the hollow structure is communicated with the drainage holes. After the drainage needle 4 is punctured into the skin to the deep fascia of the subcutaneous soft tissue, the drainage needle is mutually matched with the drainage part 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 1 is applied to the plurality of drainage needles 4 through the drainage parts 41 of the drainage needles, when the drainage needles 4 absorb effusion around the deep fascia of subcutaneous soft tissues through the drainage parts 41 of the drainage needles, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to tend to be attached in opposite directions under the influence of the negative pressure acting on the subcutaneous negative pressure device, and under the combined action of the drainage needles, the skin tissue is applied with the acting force folded in the wound direction by the auxiliary wound closing device and the subcutaneous negative pressure drainage device, so that the effect of assisting the wound closing is achieved.

In another exemplary embodiment, please refer to fig. 46 to 47, which are schematic structural views of a drainage needle in the surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs of the present application in another embodiment, as shown in the figure, a needle body of the drainage needle 4 is a hollow structure, a drainage portion 41 is formed on the needle body of the drainage needle 4, and a cavity 42 of the hollow structure is communicated with the drainage hole. After the drainage needle 4 is punctured into the skin to the deep fascia of the subcutaneous soft tissue, the drainage needle is mutually matched with the drainage part 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 1 is applied to the plurality of drainage needles 4 through the drainage parts 41 of the drainage needles, when the drainage needles 4 absorb the effusion around the deep fascia of the subcutaneous soft tissue through the drainage parts 41 of the drainage needles, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to be attached oppositely under the influence of the negative pressure of the subcutaneous negative pressure device 3, and under the combined action of the plurality of drainage needles, the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 are facilitated to apply the acting force which is folded towards the wound direction to the skin tissues, so that the effect of auxiliary wound closing is achieved.

In another exemplary embodiment, please refer to fig. 48 to fig. 49, which are schematic structural views illustrating a drainage needle in the surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs according to the present application in another embodiment, as shown in the figure, a needle body of the drainage needle 4 is a hollow structure, 3 drainage holes are uniformly distributed on the needle body of the drainage needle 4 to form a drainage portion 41, and a cavity 42 of the hollow structure is communicated with the drainage holes. After the drainage needle 4 is punctured into the skin to the deep fascia of the subcutaneous soft tissue, the drainage needle is mutually matched with the drainage part 41 through the hollow structure to drain the effusion in the deep fascia of the subcutaneous soft tissue; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 1 is applied to the plurality of drainage needles 4 through the drainage parts 41 of the drainage needles, when the drainage needles 4 absorb the effusion around the deep fascia of the subcutaneous soft tissue through the drainage parts 41 of the drainage needles, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to be attached oppositely under the influence of the negative pressure of the subcutaneous negative pressure device 3, and under the combined action of the plurality of drainage needles, the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 are facilitated to apply the acting force which is folded towards the wound direction to the skin tissues, so that the effect of auxiliary wound closing is achieved.

It should be understood that the number of drainage apertures may be 1, 2, 3, 4 or more. The arrangement form of the drainage holes can be a single-row regular arrangement form as shown in fig. 44 to 49, and can also be other arrangement forms, such as multi-row arrangement, irregular arrangement and the like. The shape of the drainage hole is not limited to the elongated shape shown in fig. 44 to 49, and may be circular, square, or the like.

In an exemplary embodiment, referring to fig. 42, which is a schematic view illustrating an application of the drainage needle in the surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs of the present application in an embodiment, as shown in the figure, the drainage needle 4 includes a needle head portion 44, a hollow needle body, and a needle tip portion 43, the at least one drainage hole is formed on the hollow needle body, the needle head portion has a through hole communicated with the hollow needle body, or/and the needle tip portion 43 has a through hole communicated with the hollow needle body. Here, one end of the drainage needle 4 penetrating into the skin is defined as a needle tip portion 43, and the other end is defined as a needle tip portion 44.

In an exemplary embodiment, please refer to fig. 42 again, the needle body of the drainage needle is a hollow structure, the needle head 44 has a through hole communicating with the hollow needle body, the needle body of the drainage needle 4 is provided with two drainage holes, the drainage holes and the through hole of the needle head 44 together form a drainage part for drainage, after the drainage needle 4 is inserted into the deep fascia of the subcutaneous soft tissue through the needle tip 43, the two drainage holes are located subcutaneously, and the needle head is located on the skin, so that the effusion in the deep fascia of the subcutaneous soft tissue is drawn to the cavity 42 of the hollow structure through the drainage holes on the hollow needle body and is discharged from the through hole of the needle head 44; the through hole of the needle head 44 is located in a sealed space formed by the sealing film adhered to the skin and covering the wound closure device, thereby enabling the force (negative pressure) of the vacuum device 1 on the skin to be applied to the drainage needle 4 through the drainage portion 41.

In another exemplary embodiment, please refer to fig. 43, which is a schematic view illustrating an application of the drainage needle in the surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs of the present application in another embodiment, as shown in the figure, the needle body of the drainage needle 4 is a hollow structure, the needle tip portion 43 has a through hole communicated with the hollow needle body, the needle body of the drainage needle 4 is provided with a drainage hole, the drainage hole and the through hole of the needle tip portion 43 together form a drainage portion for drainage, and a cavity of the hollow needle body is communicated with the drainage hole. After the drainage needle 4 penetrates the skin 50 to the deep fascia of the subcutaneous soft tissue, the middle lower part of the needle body of the drainage needle 4 and the middle lower part of the drainage hole are both positioned below the skin, and the needle head part 44 and the upper part of the drainage hole are positioned outside the surface of the skin, so that effusion in the deep fascia of the subcutaneous soft tissue can be drawn to the cavity through the through hole of the needle tip part 43 on the first hand, effusion in the deep fascia of the subcutaneous soft tissue is drawn to the cavity through the drainage hole positioned at the lower part of the skin on the other hand, and the effusion in the cavity is discharged through the upper part of the drainage hole; the upper part of the drainage hole is positioned in a sealed space formed by the sealing film adhered to the skin and covering the wound closure device, thereby enabling the acting force (negative pressure) of the subcutaneous negative pressure device 1 to be applied to the drainage needle 4 through the drainage part 41.

In yet another exemplary embodiment, the needle tip portion 43 and the needle head portion 44 each have a through hole communicating with the hollow needle body, when the drainage needle 4 penetrates the skin 50 to the deep fascia of the subcutaneous soft tissue through the needle tip portion 43, the drainage holes on the needle body are located under the skin, and the needle head portion is located on the skin, the through hole of the needle head portion 44, the through hole of the needle tip portion 43 and the drainage holes together form a drainage portion for drainage, so that the effusion in the deep fascia of the subcutaneous soft tissue is drawn to the cavity through the through hole of the needle tip portion 43 on the first hand, and the effusion in the deep fascia of the subcutaneous soft tissue is drawn to the cavity through the drainage holes on the needle body on the other hand, and the effusion in the cavity is discharged from the through hole of the needle head portion 44; the needle head 44 is located in a sealed space formed by the sealing film adhered to the skin and covering the wound closure device, whereby the force (negative pressure) of the vacuum device 1 on the skin can be applied to the drainage needle 4 through the drainage portion 41.

In an exemplary embodiment, please refer to fig. 37, which is a schematic structural diagram illustrating an application structure of a drainage needle in a surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs according to the present application in yet another embodiment, as shown in the figure, a needle body of the drainage needle 4 is a solid structure, and the drainage portion 41 is a drainage groove formed on the needle body. The drainage part 41 is designed as a drainage groove formed on the needle body, the solid structure means that the drainage needle 4 is designed as a solid structure without a cavity, and drainage is realized only through the drainage groove arranged on the needle body of the drainage needle 4; the drainage groove is positioned in a sealed space formed by adhering a sealing film on the skin and covering the wound closing device, so that the acting force (negative pressure) of the subcutaneous negative pressure device 1 can be exerted on the drainage needle 4 through the drainage part 41.

In this embodiment, two drainage holes are formed on the needle body of the drainage needle 4 to form a drainage portion 41, and after the drainage needle 4 is inserted into the deep fascia of the subcutaneous soft tissue through the needle tip portion 43, the effusion in the deep fascia of the subcutaneous soft tissue is drawn to the cavity 42 through the drainage holes located at the lower portion of the skin and is discharged through the upper portion of the drainage groove.

It should be understood that the number of drainage slots can be 1, 2, 3, 4 or more. The arrangement form of the drainage grooves can be a symmetrical arrangement form shown in fig. 37, and can also be other arrangement forms, such as irregular arrangement and the like. The shape of the drainage groove is not limited to the elongated shape shown in fig. 44 to 49, and may be circular, square, or the like.

In an exemplary embodiment, the drainage needles 4 are arranged on a flexible substrate, and the drainage needles 4 on the flexible substrate penetrate into the deep fascia of the subcutaneous soft tissue to provide a contraction force to press the skin edges so as to keep the skin wound closed during the healing process, and the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 apply a force which is folded towards the wound direction to the skin tissue, thereby playing a role in assisting the wound closure.

In this embodiment, please refer to fig. 38, which shows a schematic view of an application example of a plurality of drainage needles in the surgical auxiliary device for closing skin wounds without sutures in deep fascia of limbs of the present application, as shown in the figure, a plurality of drainage needles 4 are arranged on the flexible substrate 8. The drainage needles 4 on the flexible substrate 8 are inserted into the subcutaneous soft tissue deep fascia, and the drainage needles 4 can help drain effusion in the subcutaneous soft tissue deep fascia on the first aspect, so that hematoma and edema are reduced, the tension of the skin is reduced, and the recovery of the soft tissue is facilitated; on the other hand, the skin edge is pressed by the contractile force, so that the skin wound is kept in a closed state in the healing process.

It should be understood that the arrangement of the drainage needles 4 on the flexible substrate 8 may be set according to actual needs, and includes but is not limited to the multiple rows and multiple columns shown in fig. 38, the multiple rows and multiple columns, or the irregular arrangement, and the arrangement of the drainage needles 4 on the flexible substrate may be selected according to the specific situation of the portion to be drained.

It should be understood that the flexible substrate 8 is a component for disposing the drainage needles 4 thereon, and in order to ensure the adhesion between the flexible substrate 8 and the skin, the flexible substrate is made of a flexible material, such as a resin material or a silicone material.

In the embodiment shown in fig. 36, the subcutaneous negative pressure drainage device 1 comprises a catheter 100 partially inserted into the subcutaneous wound lumen 7 by a predetermined depth, and the catheter 100 is used for generating negative pressure to force the subcutaneous wound lumen 7 to be in a closed state during the healing process. Wherein the catheter is a drainage tube as described in embodiments of the first aspect of the present application. The catheter 100 is used for generating negative pressure to force the inner cavity 7 of the subcutaneous wound to be in a closed state in the healing process, maintaining the detached tissues to be in a joint state, maintaining the blood seepage and the liquid seepage in the wound cavity to be cleared in time through continuous negative pressure suction, in the actual implementation process, the catheter 100 of the subcutaneous negative pressure drainage device 1 is inserted into the inner cavity 7 of the subcutaneous wound, the tissues on two sides of the inner cavity 7 of the subcutaneous wound are forced to be in opposite joint through the generated negative pressure to eliminate the inner cavity 7 of the subcutaneous wound, and the closure of the inner cavity 7 of the subcutaneous wound is favorable for the healing of the wound. It will be appreciated that the portion of the catheter 100 in the subcutaneous wound lumen 7 does not affect the growth of tissue on either side of the subcutaneous wound lumen 7 during this process.

In another exemplary embodiment, the catheter 100 partially protrudes into the preset depth of the inner cavity 7 of the subcutaneous wound through a preset position of the skin wound, so as to generate negative pressure, ensure that the inner cavity 7 of the subcutaneous wound is in a closed state during healing, and simultaneously drain effusion of the inner cavity 7 of the subcutaneous wound, so as to maintain the detached tissue in a joint state, and maintain the blood seepage and the effusion in the wound in a timely manner through continuous negative pressure suction, so that the living space or environment of bacteria can be eliminated due to timely elimination of effusion such as blood seepage and/or effusion in the inner cavity 7 of the subcutaneous wound. 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, the catheter 100 penetrates the skin and the subcutaneous tissue through a preset position far away from the skin wound to partially penetrate into the preset depth of the subcutaneous wound inner cavity 7, so that negative pressure can be generated to ensure that the subcutaneous wound inner cavity 7 is in a closed state during the healing process and simultaneously suck the effusion in the subcutaneous wound inner cavity 7, and therefore, the effusion in the subcutaneous wound inner cavity 7 can be timely removed, and the living space or environment of bacteria is eliminated. In the present embodiment, the remote position refers to a predetermined position away from the skin wound, and in order to facilitate the closing treatment and surface treatment of the skin wound, the catheter 100 is not inserted into the subcutaneous wound inner cavity 7 through the skin wound, but is inserted from another position, i.e. a predetermined position away from the skin wound, through the skin and the subcutaneous tissue to be partially inserted into the subcutaneous wound inner cavity 7, and the present embodiment is particularly suitable for a long and narrow (long and narrow) wound.

In the embodiment shown in fig. 36, the surgical auxiliary equipment presses the skin edge through the wound closing device 2 to make the two exposed ends of the skin wound tightly contact with each other, and the subcutaneous wound inner cavity 7 is kept in a closed state in the healing and rehabilitation process under the force and the assistance of the subcutaneous negative pressure drainage device 1, and liquid medicine can be conveyed to the subcutaneous wound inner cavity 7 while the effusion in the subcutaneous wound inner cavity 7 is sucked, so that the infection focus which potentially reaches the colonization concentration in the subcutaneous wound inner cavity 7 is diluted and cleaned; meanwhile, the skin negative pressure device 3 can maintain the tissue position of the skin wound and the peripheral area thereof to be stable through the generated negative pressure, thereby being beneficial to wound recovery. In addition, a plurality of drainage needles 4 penetrate into the deep fascia of the subcutaneous soft tissue from the periphery of the skin wound so as to drain the effusion in the deep fascia of the subcutaneous soft tissue, and the negative pressure generated by the subcutaneous negative pressure device 3 can also help the drainage needles 4 drain the effusion in the deep fascia of the subcutaneous soft tissue; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 1 is applied to the plurality of drainage needles 4 through the drainage parts 41 of the drainage needles, when the drainage needles 4 absorb the effusion around the deep fascia of the subcutaneous soft tissue through the drainage parts 41 of the drainage needles, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to be attached oppositely under the influence of the negative pressure of the subcutaneous negative pressure device 3, and under the combined action of the plurality of drainage needles, the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 are facilitated to apply the acting force which is folded towards the wound direction to the skin tissues, so that the effect of auxiliary wound closing is achieved.

It should be understood that the subcutaneous wound lumen 7 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 7, 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.

In some embodiments, the tube wall of the portion of the catheter extending into the skin wound by the predetermined depth is provided with a plurality of through holes to help form a suction for the gas and liquid in the lumen of the subcutaneous wound, and in an exemplary embodiment, the plurality of through holes are uniformly distributed on the tube wall of the portion of the catheter extending into the skin wound by the predetermined depth, especially for a long wound, the wound lumen formed under the long wound is also generally an elongated cavity or gap, in order to ensure that the effusion or residual liquid medicine secreted from each position of the elongated cavity or gap is sucked by the catheter; in another exemplary embodiment, the plurality of through holes on the catheter may also be designed in a non-equidistant manner (i.e., the plurality of through holes are unevenly spaced on the wall of the portion of the catheter that extends to a predetermined depth into the skin lesion) for different types of skin lesions or for different purposes of surgery.

In yet another exemplary embodiment, the shape and structure of the catheter extending into the skin wound at a predetermined depth may also be designed according to actual requirements, such as different depths or different tissue structures of the skin wound according to the expected penetration, different thicknesses or different flexibility of the catheter, for example, 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 some embodiments, the predetermined depth of the catheter portion into the lumen of the subcutaneous wound is: the depth of the region from the superficial fascia layer to the deep fascia layer of the skin 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 subcutaneous negative pressure drainage device further comprises a negative pressure device, the negative pressure device is used for generating and controlling negative pressure, the negative pressure device is communicated with the catheter, so that effusion in the cavity of the subcutaneous wound can be drained through the generated negative pressure, and the negative pressure in the catheter is adjusted by the negative pressure device, so that the situation that the effusion cannot be completely drained due to the damage to the wound caused by the excessive negative pressure or the insufficient negative pressure is avoided.

In this embodiment, a one-way valve is disposed on the conduit communicated with the negative pressure device to prevent the gas or effusion sucked into the conduit from flowing back into the inner cavity of the subcutaneous wound to be harmful to the healing of the skin wound. In the embodiment, the check valve is a rubber member such as a duckbill valve or a cone valve, but is not limited thereto, and a valve assembly using mechanical or electrical control is also applicable to the present application.

In this embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, may be an air reservoir at negative pressure, or may be a manually or electrically driven 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 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).

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. When the bacterial content in the tissue exceeds 105/g, bacterial colonization can occur 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.

To this end, in an exemplary embodiment of the present application, the surgical aid for sutureless closure of a skin wound in the deep fascia of an extremity of the present application further includes a drug delivery device for delivering a liquid drug to a predetermined depth of the lumen of the subcutaneous wound through the catheter to facilitate healing of the lumen of the subcutaneous wound, and in a specific implementation state, the drug delivery device is, for example, a drug delivery device or a drug delivery machine including a micro pump or a syringe. In a mode of this embodiment, can be through the liquid medicine of control device through intermittent type nature transport to subcutaneous wound inner chamber, make the blood clot of solidifying in the subcutaneous wound inner chamber obtain moist in order to do benefit to removing to make the bacterial community that potentially reaches colonizing concentration obtain diluting, clear away along with the flush fluid drainage, thereby maintain subcutaneous wound inner chamber 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.

During the healing process, the drug delivery device can deliver liquid drugs to the inner cavity of the subcutaneous wound through the communicated catheter to dilute bacterial infection which may be generated or is generated in the inner cavity of the subcutaneous wound, so that potential infection focus reaching the colonization concentration is diluted; meanwhile, the liquid medicine delivered by the administration device can also achieve the purpose of flushing the infected part in the inner cavity of the subcutaneous wound, and after the flushing is finished, the liquid medicine in the inner cavity of the subcutaneous wound is sucked away through the drainage effect of the catheter of the subcutaneous negative pressure drainage device, so that bacteria are drained and removed, and the clean state of the inner cavity of the subcutaneous wound is kept.

In actual clinical treatment, the dosage of the administration device, the time for diluting the bacterial infection part, the flushing frequency of the liquid medicine, the working frequency of the subcutaneous negative pressure drainage device and the like can be controlled according to the judged infection condition of the inner cavity of the subcutaneous wound of the patient. For example, in an exemplary embodiment, the time period for the administration device to flush the liquid drug into the subcutaneous wound cavity is, for example, 2-3 days, and the administration device may be controlled by an integrated machine (e.g., an administration machine).

In an embodiment, the liquid medicine includes, but is not limited to, hydrogen peroxide, physiological saline, and the like.

The catheter can be a catheter integrated by two catheters or two catheters independent from each other, for example, in an exemplary embodiment, the catheter comprises a first catheter and a second catheter isolated from the first catheter, and the first catheter is communicated with the negative pressure device and is used for sucking effusion from the inner cavity of the subcutaneous wound; the second catheter is communicated with a drug delivery device and is used for delivering liquid drugs to the preset depth of the inner cavity of the subcutaneous wound.

In an exemplary embodiment, the first conduit and the second conduit are integrally formed, so that the number of buried pipes can be reduced, the integrally formed conduit comprises two conduits which are isolated from each other and not communicated with each other, wherein the first conduit forms the first conduit, the second conduit forms the second conduit, the first conduit is provided with a plurality of through holes, the first conduit is used for connecting a negative pressure device, and the second conduit is used for connecting a drug delivery device.

In an exemplary embodiment, the first conduit and the second conduit are integrally formed, so that the number of buried pipes can be reduced, the integrally formed first conduit and the second conduit are two pipes which are not communicated with each other, the second conduit is sleeved in the first conduit, the diameter of the whole conduit can not be increased without increasing the number of the conduits due to the fact that the thin conduit is sleeved in the thick conduit, the thick conduit is provided with a plurality of through holes and is used for connecting a negative pressure device, and the thin conduit is connected with a drug delivery device.

In the embodiment provided by the application, the wound closing device is used for extruding the skin margin to enable the skin wound to be in a closed state in the healing process, and meanwhile, the skin margin is extruded to reduce bleeding of a blood vessel network under skin dermis, so that the wound is recovered. The wound closure device is disposed on, and in some embodiments adhesively disposed on, a peripheral side of the skin wound. In some embodiments, the wound closure device comprises at least two closure members, the at least two closure members are respectively arranged at two side edges of the skin wound, and in the implementation process, the skin edges are pressed through the combination of the two closure members so as to keep the skin wound in a closed state in the healing process. In practice, the number of closure members may be determined by the length of the wound and the particular form of closure member.

In some embodiments, the wound closure device further comprises a microporous cover covering the closure element, the microporous cover being coupled to the closure element to conform to the contour of the closure element to form an integral part with the closure element to facilitate the absorption or wicking of secreted fluids exuded from the skin wound and retained on the closure element or drug fluids retained on the closure element. In one exemplary embodiment, the microporous cover and closure are of unitary construction. In another exemplary embodiment, the microporous cover is bonded to the closure element, such as by bonding or the like, to conform the microporous cover to the closure element.

In certain embodiments, the closure comprises a flexible body, meaning that a material having an elastic/flexible body 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 elastic/flexible body materials 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, silicones, and the like.

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

In an exemplary embodiment, the material of the microporous cover is medical cotton, absorbent cotton (degreasingcotton), foam, mesh, gauze, sponge, or porous biocompatible material, and the microporous cover has air permeability and moisture adsorption properties for adsorbing effusion possibly secreted by the skin wound during the healing process or moisture remaining in the drug residue not absorbed by the tissue of the skin wound.

In this embodiment, the closure member comprises: flexible body and rigid curved needle.

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

The rigid curved needle comprises a root part and a curved needle part, the root part of the rigid curved needle is embedded in the flexible body and is firmly arranged on the flexible body, and the curved needle part of the rigid curved needle is exposed out of the flexible body. In an exemplary embodiment, the root of the rigid curved needle is securely arranged in the flexible body by a deformed structural design, such as a hook-like structure or a T-shaped structure, etc.

In an exemplary embodiment, the curved needle portion of the rigid curved needle exposed out of the flexible body is partially inserted into one side of the skin wound to press the skin edge to keep the skin wound in a closed state during the healing process, and in a specific implementation process, a doctor needs to perform a wound-to-skin (aligning the skin edge of the skin, and preventing the skin edge from turning inwards to avoid poor skin healing) operation, and then insert the curved needle portion of the rigid curved needle into one side of the skin wound, so that the rigid curved needle of the closure members on two sides of the skin wound is inserted into the healthy tissue on the side edge of the wound to press the skin edge to reduce the bleeding of the blood vessel network under the dermis, thereby facilitating the wound healing and further enabling the skin wound to be in a closed state.

In another exemplary embodiment, the curved needle portion of the rigid curved needle exposed outside the flexible body 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 two sides of the skin wound are combined in an opposite manner, and healthy tissues on 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 exposed out of the flexible body penetrates into the flexible body disposed at the other side of the skin wound, so that the flexible bodies 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 to close the skin wound.

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. The depth of the stitching in this example is in the superficial fascia layer. The problem of concern in this application is the seamless manipulation of the superficial fascia portion of the skin (i.e., the epidermis, dermis and subcutaneous adipose tissue portions) to which the curved needle portions exposed outside the flexible body penetrate to a depth including the epidermis, dermis and subcutaneous adipose tissue portions of the superficial fascia portion of the skin.

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

In an exemplary embodiment, the closure member further comprises a clamping member for clamping the flexible bodies of the closure member adhered to both sides of the skin wound, the flexible bodies providing opposing forces to squeeze the skin edges under the action of the clamping member to ensure that the skin wound is in a closed state during the healing process. In a specific implementation, the clamping piece is a medical clamp or the like.

In the embodiments described above that employ a closure comprising a flexible body and a rigid curved needle, it may also be helpful to employ some auxiliary means for assisting adhesion between the closure and the skin surface and providing a constricting force to the closure that closes the skin wound.

In another exemplary embodiment, in the present embodiment, the closure member includes: the flexible body comprises a first flexible body and a second flexible body.

The first flexible body is adhered to the skin surface of the skin wound periphery, the first flexible body having a first bonding portion; the second flexible body is adhered to the skin surface of the skin wound periphery and is provided with a second combining part correspondingly combined with the first combining part. The combination of the first and second junctions provides opposing forces to the flexible bodies applied to both sides of the skin wound, thereby squeezing the edges to maintain the skin wound in a closed state during healing. In this embodiment, the first and second flexible bodies are made of a silicone material, a resin material, or a silicone resin material. The first and second flexible bodies are adhered to the skin surface on opposite sides of the skin wound by an adhesive, such as in some embodiments a medical adhesive, such as a quick adhesive including 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 and the second flexible body can achieve the purpose of the present embodiment, such as combination of the groove or the hole and the protrusion structure.

In some embodiments, the wound closure device further comprises an adjunct for assisting adhesion between the closure element and the skin surface and providing a contractile force to the closure element for closing the skin wound, in an exemplary embodiment, if the skin wound is an incision in a first direction, the adjunct adheres to a peripheral side of the skin wound and applies a force to the closure element in a second direction perpendicular to the first direction, which force is referred to in this embodiment as a contractile force, and the adjunct closure element provides for closing the skin wound. In this embodiment, the auxiliary element is adhered 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, which is the adhesive, may be designed as a strip-like structure extending from the center to opposite sides, which may be separate or integrated, which is adapted to be stretched manually for increased patient/patient comfort.

In the embodiment shown in fig. 36, the subcutaneous suction device 3 comprises a sealing membrane 30 and a suction channel 31. Referring to fig. 39, which is a schematic view of a sealing and force-applying structure of the skin negative pressure device of the present application in a surgical auxiliary device for closing a skin wound without sutures in the deep fascia of a limb, as shown in the figure, the sealing membrane is adhered to the skin and covers the wound closing device 2, thereby forming a sealed space 32, after being pumped by the negative pressure device, the sealed space inside the sealing membrane forms an inward acting force, and the force is applied in the direction of the arrow shown in fig. 39, so as to maintain the position of local tissues and apply pressure to deep tissues at the same time, thereby closing potential dead spaces; meanwhile, the acting force (negative pressure) of the subcutaneous negative pressure device 1 is applied to the plurality of drainage needles 4 through the drainage parts 41 of the drainage needles, when the drainage needles 4 absorb the effusion around the deep fascia of the subcutaneous soft tissue through the drainage parts 41 of the drainage needles, the tissues on the peripheral sides of the inserted parts of the drainage needles 4 can be forced to be attached oppositely under the influence of the negative pressure of the subcutaneous negative pressure device 3, and under the combined action of the plurality of drainage needles, the auxiliary wound closing device 2 and the subcutaneous negative pressure drainage device 1 are facilitated to apply the acting force which is folded towards the wound direction to the skin tissues, so that the effect of auxiliary wound closing is achieved.

In this embodiment the sealing membrane 30 forms a sealing zone around the skin wound and the wound closure device 2 placed over the skin wound, and such that the sealing zone forms a sealed space 32, in this embodiment the sealing membrane 30 is adhered to the surface of the skin by its adhesive layer to the skin surface, for example a flexible impermeable material comprising polyurethane coated with an acrylic adhesive.

In an exemplary embodiment, the sealing film 30 may be made of a transparent material. Sealing membrane 30, which is a transparent material, may facilitate the clinician in visualizing the healing of the skin wound for timely intervention.

In an exemplary embodiment, the sealing film 30 is provided with an observation window made of a transparent material so as to facilitate a clinician to observe the healing condition of the skin wound for taking corresponding medical measures.

Referring to fig. 36, as shown in the figure, the operator embeds the catheter 100 of the subcutaneous negative pressure drainage device into the subcutaneous tissue of the skin and extends the catheter 100 into the subcutaneous wound cavity 7. The subcutaneous negative pressure flow guide device can guide effusion secreted by the subcutaneous wound inner cavity 7 through the catheter 100, meanwhile, the wound inner cavity tends to be folded/combined due to the negative pressure effect, so that tissues on two sides are combined oppositely, and in addition, liquid medicine can be conveyed to the subcutaneous wound inner cavity 7 through the catheter to be beneficial to healing; in the second aspect, the skin on the two sides of the wound is folded inwards through the closing part 21, so that the skin wound is kept in a closed state in the healing process, the closing part 21 can reduce the bleeding of a hypodermic blood vessel network of the skin under the extrusion action of the skin margin, and the negative pressure of the subcutaneous negative pressure flow guide device can assist in closing the inner cavity 7 of the subcutaneous wound; in the third aspect, the accumulated fluid in the deep fascia of the subcutaneous soft tissue is drained after the plurality of drainage needles 4 are inserted into the deep fascia of the subcutaneous soft tissue, so that the subcutaneous accumulated blood and other accumulated fluids can be eliminated, the edema is relieved, the skin tension is reduced, the infection is avoided, the circulation is improved, and the recovery of the wound is facilitated. The operator continues to cover the microporous covering member 20 on the surface of the wound, so as to ensure that the secretion on the surface of the wound and the effusion drained by the drainage needle 4 can be absorbed in time in the healing process. Then covering a sealing film 30 outside the micropore accessory to wrap the whole wound and the micropore covering piece 20 on the wound; in the fourth aspect, the sealing membrane 30 is pumped through the negative pressure channel 31 of the vacuum device 3, so that the skin wound and the tissue in the peripheral region thereof are tightened, and the negative pressure generated by the vacuum device can apply a certain degree of pressure to the subcutaneous deep tissue to close the potential dead space, thereby accelerating the healing speed of the skin wound, and further, the treatment means for suturing (suture) the superficial fascia part of the skin without using a needle or a suture thread is adopted, and other medical tools are not used. Meanwhile, the negative pressure generated by the subcutaneous negative pressure device can also provide negative pressure for the drainage needle 4 to help the subcutaneous soft tissue deep fascia drainage.

It will be appreciated that closure of the skin wound, whether by conventional suturing or by the closure member of the present application, places additional tension on the skin surrounding the suture, thereby causing tension ischemia. Also, compressive ischemia may be caused to the subcutaneous portion of the suture. The surgical auxiliary equipment for closing the skin wound without the suture line in the deep fascia of the limbs enables the skin wound and the tissues of the peripheral area of the skin wound to be tightened up by the skin negative pressure device, and meanwhile, the plurality of drainage needles 4 and the flexible substrate exert contraction force (shown by arrows in figure 39) towards the wound direction and cannot cause extra pressure to the edges, so that tension ischemia and compression ischemia are avoided.

In this embodiment, the negative pressure channel 31 is communicated with a negative pressure device through a conduit, and the negative pressure channel 31 is communicated with the sealed space, so that a negative pressure source is provided to form the sealed space.

In this embodiment, the negative pressure generated by the negative pressure device compresses the sealed space, thereby maintaining the local tissue toward the wound site. Meanwhile, the negative pressure generated by the negative pressure device also generates acting force on deep tissues under the wound, so that the potential dead space is closed, and the wound closing device 2 is assisted to close the skin wound so as to promote the wound healing. In the present embodiment, the pressure value of the sealed space formed by the sealing film 30 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 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 condition 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 this embodiment, the conduit of the negative pressure channel 31 communicating with a negative pressure device is provided with a one-way valve to prevent the gas or effusion sucked into the conduit from flowing back into the sealed space and further being unfavorable for healing of the skin wound.

In this embodiment, the negative pressure supply of the negative pressure device, such as a negative pressure source, may be an air reservoir at negative pressure, or may be a manually or electrically driven 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 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.

In an exemplary embodiment, referring to fig. 40, which is a schematic view of the surgical aid for sutureless closure of skin wounds in the deep fascia of the limbs of the present application in another embodiment, as shown in fig. 40, the subcutaneous negative pressure drainage device and the subcutaneous negative pressure device can share a negative pressure source 6, and the negative pressure source is connected to the same negative pressure source through two different catheters, i.e., the catheter communicating with the sealed space 32 on the skin and the catheter communicating with the inner cavity 7 of the subcutaneous wound are two different catheters.

Referring to fig. 41, which is a schematic view of a surgical auxiliary apparatus for closing a skin wound without sutures in deep fascia of limbs according to the present application in yet another embodiment, as shown in the figure, in this embodiment, the subcutaneous negative pressure device and the subcutaneous negative pressure drainage device 1 can share a negative pressure source, and the subcutaneous wound inner chamber 7 and the subcutaneous sealed space 32 are respectively communicated through a catheter, wherein the catheter 100 includes a subcutaneous drainage hole 1010 and an intradermal negative pressure hole 60, and the subcutaneous drainage hole is a plurality of through holes 1010 formed in a tube wall of a portion of the catheter extending 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.

In an exemplary embodiment, the vacuum skin device further comprises a humidity detection component (not shown), wherein a sensor of the humidity detection component is disposed in the sealed space formed by the sealing film 30, and an information output port of the humidity detection component is connected to the vacuum device, so that the detected humidity information is provided to the vacuum device to control the vacuum device to regulate the output negative pressure. In this embodiment, the humidity detection component is, for example, a humidity sensor.

In summary, the surgical auxiliary equipment for closing the skin wound without the suture in the deep fascia of the limbs can realize safe closing in the deep fascia of the limbs to a certain extent; and the surgery auxiliary assembly of the closed skin wound of no suture in the deep fascia of four limbs of this application adopts the mode of initiative drainage and then having improved passive drainage among the prior art, can in time handle the effusion (for example oozing blood, sepage etc.) of subcutaneous tissue especially deep fascia, and then does benefit to the recovery of wound. Since the surgical aid of the present application closes the skin wound in a seamless manner.

In the first aspect, the exposed two ends of the skin wound are tightly attached through the wound closing device, and the wound closing device can play a role in squeezing the skin margin while closing the wound, so that the bleeding of the blood vessel network under the skin dermis can be reduced.

The second aspect is that under the force of the subcutaneous negative pressure drainage device, the inner cavity of the subcutaneous wound is kept in a closed state in the healing and rehabilitation process, the detached tissue is kept in a joint state, and the blood seepage and the seepage in the wound cavity are kept to be removed in time through continuous negative pressure suction; on the basis, the liquid medicine is intermittently conveyed to the inner cavity of the subcutaneous wound, so that the blood clots coagulated in the inner cavity of the subcutaneous wound are moistened to be beneficial to removal, and the potential bacterial community reaching the colonization concentration is diluted and eliminated along with drainage of flushing liquid, thereby maintaining the cleaning state in the wound cavity.

In a third aspect, negative pressure may be generated by a negative pressure device on the skin to maintain the tissue position of the skin wound and its peripheral region stable, thereby facilitating tissue healing.

The acting force (negative pressure) of the on-skin negative pressure device is further applied to the plurality of drainage needles through the drainage parts, when the drainage needles absorb effusion around the deep fascia of subcutaneous soft tissue through the drainage parts, tissues on the peripheral sides of the puncture parts of the drainage needles tend to be attached oppositely under the influence of the negative pressure of the on-skin negative pressure device, and under the combined action of the drainage needles, the auxiliary wound closing device and the subcutaneous negative pressure drainage device are helped to apply the acting force which is folded towards the wound direction to the skin tissues, so that the effect of assisting the wound closing is achieved.

In the fifth aspect, the accumulated liquid in the deep fascia of the subcutaneous soft tissue can be drained through a plurality of drainage needles, so that infection is avoided, edema is relieved, and skin tension is reduced. Meanwhile, pressure can be applied to the skin after the plurality of drainage needles penetrate the skin, and the skin edge is squeezed by the contractile force, so that the recovery of a patient is facilitated. In addition, the negative pressure generated by the skin negative pressure device can help the drainage needle to achieve better drainage effect by the negative pressure. In addition, the surgical auxiliary equipment of the fourth aspect of the application can realize the seamless closure of the whole layer of tissue above the deep fascia of the skin, avoid the transverse scar (commonly called 'centipede feet') on the surface of the skin caused by suture compression/cutting, and has no remained suture knot in the shallow fascia, thereby eliminating the important factors causing bacterial colonization and the main inducement of the recurrence of incision infection. Moreover, the surgical auxiliary equipment can drain effusion in the deep fascia of subcutaneous soft tissues, and is suitable for wound closure of limbs or fracture parts.

Therefore, the surgical auxiliary equipment for closing the skin wound without the suture in the deep fascia of the four limbs can enable the inner cavity of the subcutaneous wound to be always kept in a closed state in the healing and rehabilitation process under the condition of not using suture, and continuously drain the deep fascia of the subcutaneous soft tissue. Therefore, the healing speed of the skin wound is accelerated, a treatment means for suturing the skin without using a needle is adopted, medical tools such as a suture needle and a suture line are not used, so that after the skin wound is healed, a treatment process for removing a wound or foreign matters in a wound surface, such as a step and an operation process for removing or detaching a suture line or a line outlet head, is not required, a key link and an important cause of bacteria colonization are eliminated, a suture trace such as 'centipede feet' is ensured not to be left on the surface of the skin of the wound after healing, the attractiveness of an operation incision part is ensured, and the problems that the incision is easy to leave a trace after the operation and effusion is difficult to discharge in the prior art are solved.

Simultaneously, the problem of swelling and infection that the closed skin wound of no suture in the dark fascia of four limbs of this application caused because dark fascia hydrops of subcutaneous soft tissue has also been solved to the surgical auxiliary equipment of this application. The surgical auxiliary equipment for closing the skin wound without the suture in the deep fascia of the limbs is also 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 (23)

1. A medical drain, comprising:

the hose body is used for draining effusion at the periphery or the inner cavity of the wound through the generated negative pressure; and

the first supporting part is arranged in the hose body or formed on the hose body and used for supporting the hose body.

2. The medical drainage tube of claim 1, wherein the first support is a continuous support of a preset length.

3. The medical drainage tube of claim 1, wherein the first support is a spacer support of a preset length.

4. The medical drainage tube according to claim 1, wherein the first supporting portion is a filler filled in the hose body, the filler includes a plurality of micro-particles, and gaps for circulating the effusion are formed among the micro-particles.

5. The medical drain according to claim 4, wherein the outer surface of the microparticles has at least one curved or folded surface.

6. The medical drain according to claim 4, wherein the microparticles are a hard material.

7. The medical drainage tube according to claim 4 or 6, wherein the micro-particles are made of polymer plastic.

8. Medical drain according to claim 4, wherein the hose body is provided with a fixation structure for fixing the filling.

9. The medical drain of claim 8, wherein the fixing structure is integrally formed on an inner wall of the hose body.

10. The medical drain according to claim 8, wherein the fixing structure is engaged with an inner wall of the hose body.

11. The medical drainage tube according to claim 1, wherein the first support part is a steel wire provided on an inner wall of the hose body and disposed in conformity with a length direction of the hose body.

12. The medical drain according to claim 11, wherein the steel wires are arranged in a circumferential direction of a cross section of the hose body and have at least 3 in number.

13. The medical drainage tube of claim 1, wherein the first support is a threaded tube.

14. The medical drainage tube according to claim 1, wherein the hose body includes two end coupling portions and a middle portion between the two end coupling portions, and the first supporting portion is located at least one predetermined position of the middle portion.

15. The medical drainage tube according to claim 1, wherein a second support part is provided in a tube of the coupling part of at least one end of the hose body.

16. The medical drain of claim 15 wherein the second support portion is a spring.

17. The medical drainage tube of claim 15, wherein the tube body is further provided with a negative pressure hole adjacent to the second support portion for maintaining the tissue position of the wound and the peripheral region thereof stable by the generated negative pressure.

18. The medical drain according to claim 1, further comprising a position limiting structure for fixing said medical drain.

19. The medical drain of claim 1 further comprising an irrigation tube for delivering the liquid medicament to a predetermined depth around the wound periphery or lumen.

20. The medical drain of claim 19, wherein the irrigation tube is integrally formed with the hose body or the irrigation tube is nested within the hose body.

21. A surgical aid for use in the sutureless closure of a skin wound in the superficial fascia of the skin, comprising:

the subcutaneous negative pressure drainage device comprises a catheter, a drainage tube and a drainage tube, wherein part of the catheter extends into the inner cavity of a subcutaneous wound by a preset depth and is used for generating negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process; the catheter is a medical drain according to any one of claims 1-20;

the wound closing device is arranged on the peripheral side of the skin wound and used for pressing the skin edges to keep the skin wound in a closed state in the healing process;

the skin negative pressure device is arranged at the periphery of the skin wound and used for generating negative pressure to maintain the stable tissue position of the skin wound and the peripheral area thereof.

22. A negative pressure drainage and cleaning system for closing a skin wound with a suture, 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;

a negative pressure device comprising a negative pressure source and a second catheter partially extending into the inner cavity of the subcutaneous wound to a predetermined depth for generating negative pressure to force the inner cavity of the subcutaneous wound to be in a closed state during healing and draining the effusion in the inner cavity of the subcutaneous wound through the second catheter, wherein the second catheter is the medical drainage tube according to any one of claims 1 to 18;

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.

23. A surgical aid for sutureless closure of skin wounds in the deep fascia of a limb, comprising:

the subcutaneous negative pressure drainage device comprises a catheter, a drainage tube and a drainage tube, wherein part of the catheter extends into the inner cavity of a subcutaneous wound by a preset depth and is used for generating negative pressure so as to force the inner cavity of the subcutaneous wound to be in a closed state in a healing process; the catheter is a medical drain according to any one of claims 1-20;

The wound closing device is arranged on the peripheral side of the skin wound and used for pressing the skin edges to keep the skin wound in a closed state in the healing process;

the skin negative pressure device is arranged at the periphery of the skin wound and is used for generating negative pressure to maintain the stable tissue position of the skin wound and the peripheral area of the skin wound;

the drainage needles are used for penetrating into the deep fascia of the subcutaneous soft tissue from the peripheral sides of the skin wound so as to drain the effusion in the deep fascia of the subcutaneous soft tissue, each drainage needle comprises a drainage part formed on a needle body of the drainage needle, and one part of the drainage part is positioned outside the surface of the skin when the drainage needle penetrates into the subcutaneous soft tissue.

Images