Skin and soft tissue stretch and closure device

Abstract

The present disclosure discloses a skin and soft tissue stretching and closing device, which includes: a decompression device, which is fixed to the edge skin of a first side of a wound surface via a flexible line and is in an elongated shape, the flexible line being arranged in a U-shape, and the bottom of the U-shape resting against the side wall of the decompression device; and a bite device, which is fixed to the edge skin of a second side of the wound surface opposite to the first side via the flexible line and is connected to the decompression device via the flexible line, the bite device including a first clamping member and a second clamping member pivotable relative to each other around a pivot axis, the first clamping member and the second clamping member clamping a length of the two protruding sections of the U-shape of the flexible line to control the length of the flexible line between the decompression device and the bite device. The skin and soft tissue stretching and closing device disclosed in the present disclosure is easy to use and can be applied to a wide range of areas.

Description

Technical Field

[0001] The present disclosure generally relates to the fields of wound repair and tissue reconstruction. More specifically, the present disclosure relates to a skin and soft tissue stretching and closure device. Background Art

[0002] With the rapid development of medical technology in recent years, various sutures, medical glues, skin staplers, skin transplants, and flap transplants have been successfully used for wound closure. However, there is no ideal solution for wounds with large areas of skin and soft tissue defects. Currently, skin transplants or flap transplants are routinely used in clinical practice. Not only are the operations complex and require high operating techniques, but they also require obtaining tissue from the donor area, which can cause secondary trauma. In addition, the newly transplanted skin or transferred flaps often feel poor and can only meet basic wound closure requirements, but cannot achieve functional repair needs. Therefore, finding and exploring more ideal wound repair methods is a difficult problem that needs to be urgently solved in clinical practice.

[0003] It was discovered from the process of a woman's abdomen swelling during pregnancy and childbirth that the skin, subcutaneous soft tissue, fascia and muscles can expand and regenerate under conditions of continuous tension. Subsequent studies have found that soft tissues such as skin have unique viscoelastic properties and can expand and stretch under conditions of continuous tension and stress. Based on this, various skin expanders and skin stretching technologies have been used for skin expansion and regeneration. Compared with traditional skin transplantation and flap transplantation, they have certain advantages. However, in vivo skin expanders require surgical implantation of the expander first, and then 1-2 months of water injection to complete the slow expansion of the skin. This is not only time-consuming, but also has the risk of implant infection, and is not suitable for repairing closed wounds. Skin stretching technology has become a research hotspot in recent years because of its simple operation and convenience. Currently, commercial products for clinical application mainly come from European and American countries. It is mainly composed of three parts: skin attachment system, traction power system and tension maintenance system. The equipment structure is relatively complex and the cost is relatively expensive. Moreover, the skin attachment system is mostly implemented with metal equipment such as Kirschner wires, staplers or skin hooks. Not only does it cause serious damage to the skin, but its attachment system is mainly fixed and riveted to the dermis of the skin. In clinical applications, it can only complete the traction and expansion of a single tissue structure of the skin, and cannot achieve the synchronous expansion of the subcutaneous superficial fascia, deep fascia and muscle tissue. When it is used to close wounds with deeper soft tissue defects, there is a risk of incomplete closure and remaining subcutaneous cavities. In addition, due to its complex structure and large spatial volume, it is limited to the actual use site in actual clinical applications. Therefore, the current clinically used products have many defects in wound repair and reconstruction, and cannot achieve full-dimensional reconstruction of the ideal soft tissue structure.

[0004] The skin and soft tissue stretching and closure device designed in this invention avoids the various risks and complications associated with implanted expanders while simultaneously combining the advantages of skin stretching technology. Its main body is constructed of soft materials and cleverly incorporates needle and thread suturing techniques, integrating the three components of traditional stretching products (skin attachment system, stretching power system, and tension maintenance system) into one, achieving a systemic integration of skin fixation, stretching, and tension maintenance. This not only simplifies the structure, facilitates surgical operation, and significantly reduces damage to skin tissue, but also achieves simultaneous expansion and regeneration of subcutaneous fascia, muscle tissue, and skin, achieving functional reconstruction while fulfilling the basic requirements of wound closure. Furthermore, the device incorporates a pressure-sensing chip that displays the amount of pressure exerted on the skin under stretching tension, providing an alarm for high-tension conditions and preventing potential skin pressure damage. This invention provides a simple, flexible, and convenient wound repair and reconstruction device that addresses the key difficulties of current skin expander implantation and skin stretching technologies. It can be used to repair skin and soft tissue defects caused by various causes, including trauma, burns, bedsores, diabetic foot, scar excision, and surface tumor resection. Summary of the Invention

[0005] One of the purposes of the present disclosure is to provide a skin soft tissue stretching and closure device that can overcome at least one of the drawbacks of the prior art.

[0006] One aspect of the present disclosure relates to a skin and soft tissue stretching and closure device, which is used for repairing wounds or reconstructing tissues, wherein the skin and soft tissue stretching and closure device comprises:

[0007] a pressure relief device, the pressure relief device being fixed to the skin edge of a first side of the wound surface by a flexible line and being elongated, the flexible line being arranged in a U-shape, and the bottom of the U-shape being against the side wall of the pressure relief device; and

[0008] A bite device, which is fixed to the edge skin of the wound on the second side opposite to the first side through the flexible line and is connected to the decompression device through the flexible line, and the bite device includes a first clamping member and a second clamping member that can pivot relative to each other around a pivot axis, and the first clamping member and the second clamping member clamp a length of the two protruding sections of the U-shape of the flexible line to control the length of the flexible line between the decompression device and the bite device.

[0009] In some embodiments, the pressure relief device is hollow and has an inner sidewall and includes two opposing open ends along the elongated direction.

[0010] In some embodiments, the bottom of the U-shape of the flexible wire rests against the inner side wall of the pressure relief device, and the two protruding sections of the U-shape of the flexible wire leave the two opposite open ends of the pressure relief device and extend toward the bite device.

[0011] In some embodiments, the outer cross-section of the pressure relief device is generally circular or oval.

[0012] In some embodiments, the pressure relief device is made of a compliant material.

[0013] In some embodiments, the pressure relief device is solid and includes a plurality of through holes therethrough transverse to the direction of elongation.

[0014] In some embodiments, the bottom of the U-shape of the flexible wire abuts against the outer side wall of the pressure relief device, and the two protruding sections of the U-shape of the flexible wire pass through two through holes of the plurality of through holes of the pressure relief device and extend toward the engaging device.

[0015] In some embodiments, adjacent through-holes in the plurality of through-holes are evenly spaced apart from each other, or are unevenly spaced apart from each other.

[0016] In some embodiments, the pressure reducing device has a plurality of micro-holes having a diameter smaller than that of the through-hole.

[0017] In some embodiments, the pressure relief device is generally spindle-shaped, capsule-shaped, or cylindrical.

[0018] In some embodiments, the pressure relief device is made of a compliant material.

[0019] In some embodiments, the snapping device is generally clip-shaped.

[0020] In some embodiments, the first clamping member and the second clamping member are substantially plate-shaped and have a substantially rectangular or trapezoidal outer contour.

[0021] In some embodiments, the first clamping member and the second clamping member respectively include a first wire clamping portion and a second wire clamping portion, which are configured to clamp and fix a length of the two protruding segments of the U-shape of the flexible wire and are respectively arranged on the relative inner surfaces of the first clamping member and the second clamping member facing each other.

[0022] In some embodiments, the first wire clamping portion and the second wire clamping portion are disposed on a pivot axis of the snapping device and / or are disposed offset from the pivot axis toward a central portion of the snapping device.

[0023] In some embodiments, the first clamping portion includes at least one first protrusion protruding from the inner surface of the first clamping member toward the second clamping member and / or at least one first recessed portion recessed from the inner surface of the first clamping member, and the second clamping portion includes at least one second protrusion protruding from the inner surface of the second clamping member toward the first clamping member and / or at least one second recessed portion recessed from the inner surface of the second clamping member, and the at least one second protrusion and / or the at least one second recessed portion correspond to the at least one first protrusion and / or the at least one first recessed portion in shape, number and position.

[0024] In some embodiments, the first protrusion and / or the first recess are symmetrically distributed in position and quantity about the central axis of the bite device perpendicular to the pivot axis, and the second protrusion and / or the second recess are symmetrically distributed in position and quantity about the central axis of the bite device perpendicular to the pivot axis.

[0025] In some embodiments, the cross-sections of the first protrusion and / or the first recess, and the second protrusion and / or the second recess are substantially rectangular, truncated cone, or arc-shaped.

[0026] In some embodiments, the surface of the first protrusion and / or the first recessed portion is provided with serrations or wavy portions, and / or the surface of the second protrusion and / or the second recessed portion is provided with serrations or wavy portions.

[0027] In some embodiments, the first protrusion and / or the first recess, and the second protrusion and / or the second recess are arranged outside the pivot and pivot hole structures of the first clamp and the second clamp in the direction of the pivot axis.

[0028] In some embodiments, the first clamping member and the second clamping member respectively include a first angle fixing portion and a second angle fixing portion, which are configured to fix the first clamping member and the second clamping member at a certain angle and are respectively arranged at the free ends of the first clamping member and the second clamping member away from the pivot axis.

[0029] In some embodiments, the first angle fixing portion and the second angle fixing portion fix the first clamping member and the second clamping member at a certain angle by engaging with each other or engaging with each other.

[0030] In some embodiments, the first angle fixing portion extends from an inner surface of the first clamping member toward the second clamping member, and the first angle fixing portion is provided with at least one barb on a surface thereof facing the pivot axis.

[0031] In some embodiments, the second angle fixing portion is provided with at least one barb or hook hole on its surface facing away from the pivot axis, and one or more of the at least one barb of the first angle fixing portion can be engaged with one or more of the at least one barb or hook hole of the second angle fixing portion.

[0032] In some embodiments, the at least one barb of the first angle fixing portion includes one or more rows and / or one or more lines of barbs, and the at least one barb or hook hole of the second angle fixing portion includes one or more rows and / or one or more lines of barbs or hook holes.

[0033] In some embodiments, a fixing band is provided on the outer periphery of the free end portion of the second clamping member, and the fixing band is configured to prevent the first angle fixing portion from being separated from the second angle fixing portion when the first angle fixing portion and the second angle fixing portion are engaged.

[0034] In some embodiments, the second clamping member is provided with a boss-shaped finger support portion on an outer surface close to the second angle fixing portion.

[0035] In some embodiments, the second angle fixing portion includes a recessed portion that is recessed from an inner surface of the free end portion of the second clamping member, and a side surface thereof includes at least one barb or hook hole.

[0036] In some embodiments, the first angle fixing portion is disposed in a through cavity, which is disposed on the free end of the first clamping member and has a position on the first clamping member corresponding to a position of the recess on the second clamping member.

[0037] In some embodiments, the first angle fixing portion includes a spring supporting portion, and a connected barb portion and a handle portion, and the spring is disposed between the spring supporting portion and the barb portion.

[0038] In some embodiments, the spring support portion protrudes from a side surface of the through cavity toward the interior of the through cavity and is configured to support the spring.

[0039] In some embodiments, the barb portion is elongated and extends from the through cavity toward the recess.

[0040] In some embodiments, the barb portion is provided with a groove on a first side thereof for receiving an end portion of the spring support portion, and the spring is sandwiched between the groove of the barb portion and the end portion of the spring support portion.

[0041] In some embodiments, the barb portion is provided with at least one barb on a second side opposite to the first side, and one or more of the at least one barb engages one or more of the at least one barb or hook hole of the second angle fixing portion under the biasing force of the spring.

[0042] In some embodiments, the at least one barb of the first clamp comprises one or more rows and / or one or more lines of barbs, and the at least one barb or hook eye of the second clamp comprises one or more rows and / or one or more lines of barbs or hook eyes.

[0043] In some embodiments, the handle portion is connected to the barb portion through a through hole in the through cavity.

[0044] In some embodiments, the pressure display module is disposed on the bite device and is electrically connected to the pressure and / or tension sensor of the decompression device and / or the pressure and / or tension sensor of the bite device in a wired or wireless manner.

[0045] Other features and advantages of the subject technology of the present disclosure will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by practicing the subject technology of the present disclosure. The advantages of the subject technology of the present disclosure will be realized and obtained through the structure particularly pointed out in the written description and claims thereof as well as the accompanying drawings.

[0046] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology of the present disclosure as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Aspects of the present disclosure will be better understood after reading the following detailed description in conjunction with the accompanying drawings, in which:

[0048] Figure 1 A schematic diagram showing a use state of the skin soft tissue stretching and closing device according to the present disclosure;

[0049] Figure 2 Show Figure 1 A perspective view of the decompression device of the skin and soft tissue stretch closure device is shown;

[0050] 3A-3D illustrate perspective views of other examples of pressure relief devices;

[0051] Figures 4A-4B Shows a perspective view and a side view of an articulating device according to a first embodiment;

[0052] Figures 5A-5B A perspective view and a side view showing another example of the bite device shown in FIG. 4 ; and

[0053] Figures 6A-6D A perspective view, a front view, a side view, and an upper cross-sectional view of a bite device according to a second embodiment are shown. DETAILED DESCRIPTION

[0054] The present disclosure will be described below with reference to the accompanying drawings, which illustrate several embodiments of the present disclosure. However, it should be understood that the present disclosure can be presented in many different ways and is not limited to the embodiments described below; in fact, the embodiments described below are intended to make the present disclosure more complete and fully illustrate the scope of protection of the present disclosure to those skilled in the art. It should also be understood that the embodiments disclosed herein can be combined in various ways to provide many additional embodiments.

[0055] It should be understood that like reference numerals refer to like elements throughout the drawings. In the drawings, the dimensions of some features may be distorted for clarity.

[0056] It should be understood that the terms used in this specification are intended only to describe specific embodiments and are not intended to limit the present disclosure. Unless otherwise defined, all terms (including technical and scientific terms) used in this specification have the meanings commonly understood by those skilled in the art. For the sake of brevity and / or clarity, well-known functions or structures may not be described in detail.

[0057] The singular forms "a", "an", "the" and "the" used in this specification include the plural forms unless otherwise expressly stated. The terms "include", "comprise" and "contain" used in this specification indicate the presence of the claimed features, but do not exclude the presence of one or more other features. The term "and / or" used in this specification includes any and all combinations of one or more of the relevant listed items. The terms "between X and Y" and "between approximately X and Y" used in this specification should be interpreted as including X and Y. The term "between approximately X and Y" used in this specification means "between approximately X and approximately Y", and the term "from about X to Y" used in this specification means "from about X to about Y".

[0058] In the specification, when an element is referred to as being "on," "attached," "connected," "coupled," or "in contact with" another element, the element may be directly on, attached, connected, coupled to, or in contact with another element, or there may be intervening elements. In contrast, when an element is referred to as being "directly" "on," "directly attached," "directly connected," "directly coupled," or "in direct contact with" another element, there may be no intervening elements. In the specification, when a feature is arranged "adjacent" to another feature, it may mean that a feature has a portion that overlaps with an adjacent feature or a portion that is above or below an adjacent feature.

[0059] In the specification, spatial terms such as "upper," "lower," "left," "right," "front," "back," "higher," and "lower" may be used to describe the relationship of one feature to another feature in the accompanying drawings. It should be understood that these spatial terms encompass not only the orientation shown in the accompanying drawings, but also different orientations of the device during use or operation. For example, if the device in the accompanying drawings is turned over, a feature previously described as "below" another feature might now be described as "above" the other feature. The device may also be otherwise oriented (rotated 90 degrees or in other orientations), and relative spatial relationships will be interpreted accordingly.

[0060] Figure 1 A schematic diagram of the use state of the skin and soft tissue stretching and closure device according to the present disclosure is shown. As shown in the figure, the skin and soft tissue stretching and closure device includes a decompression device 2 and a bite device 3 connected by a flexible line 1. The decompression device 2 and the bite device 3 are removably fixed to the edge skin on opposite sides of the wound surface through the flexible line 1, and together with the flexible line 1, pull the edge skin on both sides toward each other. The decompression device 2 is used to reduce the pressure on the skin caused by the pulling of the flexible line 1. The bite device 3 is used to reduce the pressure on the skin caused by the pulling of the flexible line 1 on the one hand, and on the other hand, it is used to control the total length of the flexible line 1 extending between the decompression device 2 and the bite device 3, thereby controlling the relative distance between the skin on both sides. The flexible line 1 can be a continuous line, and for example, a surgical suture, a steel wire, a nylon line, etc.

[0061] like Figure 2 As shown, the pressure relief device 2 includes an elongated hollow body 21, which has two opposing open ends 22 and 23 along its length for the flexible cord 1 to pass through. The outer wall of the body 21 rests against the skin at the edge of the wound. The flexible cord 1, which originates from the engaging device 3, passes through the skin at the edge of the wound, enters the body 21 from one open end 22, traverses the entire interior of the body 21, exits the body 21 from the other open end 23, again passes through the skin at the edge of the wound, and ultimately reaches the engaging device 3. In other words, the flexible cord 1 is configured in a U-shape, with the bottom of the U resting against the inner wall of the body 21, while the two protruding sections of the U exit from the open ends 22 and 23 of the body 21, pass through the skin at the edge of one wound, span the entire wound, pass through the skin at the opposite edge of the wound, and ultimately reach the engaging device 3. The outer wall of the body 21 increases the contact area between the flexible cord 1 and the skin, mitigating the significant pressure exerted on the skin by the pulling of the flexible cord 1, thereby preventing potential skin damage caused by the flexible cord 1. In some embodiments, a pressure and / or tension sensor (not shown) may be provided on the main body 21 to measure the pressure and / or tension applied by the decompression device 2 to the skin.

[0062] The outer cross-section of the main body 21 can be substantially circular, oval, or any other suitable shape. The main body 21 can be made of a flexible material, such as a silicone material, a resin material, a rubber material, and the like.

[0063] In an alternative embodiment, as shown in Figures 3A-3D, the pressure-relief device 2 may include an elongated solid body 24, with the body 24 including a plurality of through-holes 25 extending transversely to the direction of elongation, for passage of the flexible wire 1. The outer sidewall of the body 24 rests against the skin at the edge of the wound bed. The flexible wire 1, originating from the engaging device 3, passes through the skin at the edge of the wound bed, passes through one of the through-holes 25 away from the skin, travels along the outer sidewall of the body 24, passes through another through-hole 25 toward the skin, again passes through the skin at the edge of the wound bed, and ultimately reaches the engaging device 3. In other words, the flexible wire 1 is configured in a U-shape, with the bottom of the U resting against the outer sidewall of the body 24, while the two protruding sections of the U pass through the two through-holes 25 of the body 24, penetrate the skin at the edge of one side of the wound bed, span the entire wound bed, pass through the skin at the edge of the opposite side of the wound bed, and ultimately reach the engaging device 3. The outer sidewall of the main body 24 increases the contact area between the flexible wire 1 and the skin, reducing the significant pressure exerted on the skin by the pulling of the flexible wire 1, thereby preventing potential damage to the skin caused by the flexible wire 1. In some embodiments, a pressure and / or tension sensor (not shown) may be provided on the main body 24 to measure the pressure and / or tension exerted on the skin by the pressure-reducing device 2.

[0064] As shown in Figures 3A-3D, the plurality of through holes 25 can be two through holes, four through holes, or any other number of through holes. Adjacent through holes 25 can be evenly or unevenly spaced. Two suitable through holes can be selected for the flexible thread 1 to pass through based on the desired width between the two extended sections of the flexible thread 1. In some embodiments, in addition to the through holes 25, the main body 24 also has a plurality of micropores 26 having a smaller diameter than the through holes 25. The plurality of micropores 26 extends through the main body 24. The hollowed-out arrangement of the multiple micropores can reduce localized pressure on the skin and facilitate skin ventilation.

[0065] The main body 24 can be roughly spindle-shaped, capsule-shaped, cylindrical, or any other suitable shape. The main body 24 can be made of a flexible material, such as a silicone material, a resin material, a rubber material, etc.

[0066] Figure 4A and 4BThe figures show a perspective view and a side view of an engaging device 3 according to a first embodiment of the present disclosure. As shown, the engaging device 3 is generally clip-shaped and includes a clamping member 4 and a clamping member 6 that are pivotable relative to each other. The clamping members 4 and 6 can clamp any length of the two extended sections of the flexible cable 1 as needed, thereby controlling the length of the flexible cable 1 extending between the pressure-reducing device 2 and the engaging device 3.

[0067] The clamping member 4 includes a main body 41, a wire clamping portion 42, and an angle fixing portion 43 disposed on the main body 41. Similarly, the clamping member 6 includes a main body 61, a wire clamping portion 62, and an angle fixing portion 63 disposed on the main body 61. One of the main bodies 41 and 61 is provided with a pivot shaft, while the other is provided with a pivot hole. The pivot shaft can pivot in the pivot hole, thereby allowing the main bodies 41 and 61 to pivot relative to each other about a pivot axis O. The main bodies 41 and 61 can be generally plate-shaped and have outer contours that are generally rectangular, trapezoidal, other polygonal, or any other suitable shape.

[0068] The wire clamping portion 42 and the wire clamping portion 62 are used to clamp and secure a length of the two extended sections of the flexible wire 1. The wire clamping portion 42 and the wire clamping portion 62 are respectively disposed on opposing inner surfaces of the main body 41 and the main body 61, and are offset from the pivot axis O of the main body 41 and the main body 61 toward the center of the main body. The wire clamping portion 42 includes two protrusions that project from the inner surface of the main body 41 toward the main body 61, and the two protrusions may be symmetrical about the central axis of the engaging device 3, which is perpendicular to the pivot axis O. Correspondingly, the wire clamping portion 62 includes two recesses that are recessed from the inner surface of the main body 61, and the two recesses may be symmetrical about the central axis. The position and shape of the protrusions on the main body 41 correspond to the position and shape of the recesses on the main body 61. During use, the length of the two extended sections of the flexible wire 1 can be clamped and secured between the two protrusions and two recesses, respectively, thereby locking the length of the flexible wire 1 between the pressure-reducing device 2 and the engaging device 3.

[0069] In alternative embodiments, the wire clamp 42 may include a single protrusion (instead of two protrusions) extending across the central axis, while the wire clamp 62 may include a single recess (instead of two recesses) extending across the central axis. In some embodiments, the wire clamp 42 may include a recess (instead of a protrusion), while the wire clamp 62 may include a protrusion (instead of a recess). In some embodiments, the wire clamp 42 may include a recess and a protrusion located on either side of the central axis, while the wire clamp 62 may include a single protrusion and a recess located on either side of the central axis. In some embodiments, the wire clamp 42 may include a combination of at least one protrusion and at least one recess on each side of the central axis, with the number and position of the protrusions and recesses being symmetrical about the central axis, while the wire clamp 62 may include a combination of at least one recess and at least one protrusion on each side of the central axis, with the number and position of the protrusions and recesses being symmetrical about the central axis. Correspondingly, the wire clamp 62 may include a combination of at least one recess and at least one protrusion on each side of the central axis, with the number and position of the protrusions and recesses being symmetrical about the central axis. The cross-sections of the raised and recessed portions may be generally rectangular, frusto-conical, arcuate, or any other suitable shape.

[0070] The wire clamping portion 42 and the wire clamping portion 62 can be positioned relatively close to the pivot axis O of the main body (e.g., between the pivot axis O and the center of the main body), thereby applying a greater clamping force to the flexible wire 1. Furthermore, the raised and / or recessed portions of the wire clamping portion 42 and the wire clamping portion 62 can be positioned outside the pivot and pivot hole structures of the main body 41 and the main body 61 in the direction of the pivot axis O, thereby facilitating the insertion of the flexible wire 1 between the raised and recessed portions from outside the main body 41 and the main body 61. In some embodiments, the raised and / or recessed portions can be provided with serrations or wavy features on their surfaces to better clamp the flexible wire.

[0071] The angle-fixing portion 43 and the angle-fixing portion 63 are used to secure the clamping members 4 and 6 at a predetermined angle, thereby maintaining the clamping force exerted by the two wire clamping members 42 and 62 on the flexible wire 1. The angle-fixing portion 43 and the angle-fixing portion 63 are respectively disposed at the free ends of the main body 41 and the main body 61, distal from the pivot axis O. The angle-fixing portion 43 extends from the inner surface of the main body 41 toward the main body 61 and is provided with at least one barb 44 on its surface facing the pivot axis O. Correspondingly, the angle-fixing portion 63 is provided with at least one barb or hook hole 64 (shown as a barb) on its surface facing away from the pivot axis O. One or more of the barbs 44 on the angle-fixing portion 43 can engage with one or more of the barbs or hook holes 64 on the angle-fixing portion 63, thereby securing the clamping members 4 and 6 at a predetermined angle. In some embodiments, the at least one barb 44 may include one or more rows and / or one or more lines of barbs, and the at least one barb or hook hole 64 may include one or more rows and / or one or more lines of barbs or hook holes. In some embodiments, the structures of the angle fixing portion 43 and the angle fixing portion 63 may be interchanged.

[0072] In some embodiments, a fixing band 65 may be provided on the outer periphery of the free end portion of the main body 61. Figures 5A-5B The two ends of the fixing belt 65 are fixed to the outer periphery of the main body 61 and prevent the angle fixing portion 43 from being separated from the angle fixing portion 63 when the angle fixing portions 43 and 63 are engaged, thereby strengthening the engagement between the angle fixing portion 43 and the angle fixing portion 63.

[0073] In some embodiments, the main body 61 is provided with a boss-shaped finger support portion 66 on the outer surface near the angle fixing portion 63 for fingers to pinch the biting device 3.

[0074] In some embodiments, a pressure and / or tension sensor (not shown) may be provided on the bite device 3 to measure the pressure and / or tension applied to the skin by the bite device 3. In some embodiments, a pressure display module may be provided on the outer wall of the bite device 3 and electrically connected to the pressure and / or tension sensor of the decompression device 2 and / or the bite device 3 via a wired or wireless manner to display the pressure and / or tension values ​​measured by the pressure and / or tension sensor.

[0075] Refer to the following Figure 1The following describes the method for operating the skin and soft tissue stretching and closure device according to the present disclosure. First, the flexible wire 1 is passed through the interior of the hollow body 21 of the pressure relief device 2 via its two open ends 22 and 23, or through two spaced-apart through-holes 25 in the solid body 24 of the pressure relief device 2. Next, the two extended segments of the flexible wire 1 are inserted into the skin edge on one side of the wound using a needle, spanning the entire wound surface and exiting through the skin edge on the other side. The flexible wire 1 is tensioned between the pressure relief device 2 and the bite device 3, and a length of the two extended segments of the flexible wire 1 is placed between the protrusion and recess of the clamping members 4 and 6 of the bite device 3. The clamping members 4 and 6 are pivoted toward each other, so that the protrusion enters the recess and the flexible wire 1 is clamped between the protrusion and recess. The barbs 44 and 64 of the angle fixing members 43 and 63 are engaged together, thereby securing the flexible wire 1 in the bite device 1.

[0076] To adjust (e.g., decrease or increase) the relative distance between the skin edges on either side of the wound, the barbs 44, 64 of the angle fixing portions 43 and 63 are disengaged from each other, and the clamps 4 and 6 are pivoted away from each other, so that the protrusions move away from the recesses. The position of the flexible cord 1 between the protrusions and recesses of the clamps 4 and 6 is adjusted. Thereafter, the clamps 4 and 6 are pivoted toward each other, so that the protrusions enter the recesses, thereby once again clamping the flexible cord 1 between the protrusions and recesses. The barbs 44, 64 of the angle fixing portions 43 and 63 are engaged together, thereby completing the adjustment of the relative distance between the skin edges on either side of the wound.

[0077] Figures 6A-6D A schematic diagram of a second embodiment of the present disclosure is provided for describing a snapping device 103, wherein the snapping device 103 will be represented by the same or similar structure as the reference numeral in the snapping device 3 plus 100. The snapping device 103 can be Figure 2 Used with any of the pressure reducing devices 2 shown in 3A-3D.

[0078] As shown in the figure, the engaging device 103 is in the shape of a clip and includes a clamping member 104 and a clamping member 106 that are pivotable relative to each other. The clamping member 104 and the clamping member 106 can clamp any length of the two extended sections of the flexible wire 1 as needed, thereby controlling the length of the flexible wire 1 extending between the pressure reducing device 2 and the engaging device 103.

[0079] The clamp 104 includes a main body 141, a wire clamping portion 142, and an angle fixing portion 143 disposed on the main body 141. Similarly, the clamp 106 includes a main body 161, a wire clamping portion 162, and an angle fixing portion 163 disposed on the main body 161. One of the main bodies 141 and 161 is provided with a pivot shaft, while the other is provided with a pivot hole. The pivot shaft can pivot in the pivot hole, thereby allowing the main bodies 141 and 161 to pivot relative to each other about a pivot axis O. The main bodies 141 and 161 can be generally plate-shaped and have outer contours that are generally rectangular, trapezoidal, other polygonal, or any other suitable shape.

[0080] The wire clamping portion 142 and the wire clamping portion 162 are used to clamp and secure a length of the two extended sections of the flexible wire 1. The wire clamping portion 142 and the wire clamping portion 162 are respectively disposed on the opposing inner surfaces of the main body 141 and the main body 161, and are located on the pivot axis O of the main body 141 and the main body 161, and outside the pivot and pivot hole structure. The wire clamping portion 142 includes two arcuate protrusions that protrude from the inner surface of the main body 141 toward the main body 161, and the two arcuate protrusions can be symmetrical with respect to the central axis of the engaging device 3 perpendicular to the pivot axis O. Correspondingly, the wire clamping portion 162 includes two arcuate recesses that are recessed from the inner surface of the main body 161, and the two arcuate recesses can be symmetrical with respect to the central axis. The position and shape of the arcuate protrusions on the clamping member 104 correspond to the position and shape of the arcuate recesses on the clamping member 106. During use, a length of the two extended sections of the flexible wire 1 can be clamped and fixed between the two arc-shaped protrusions and the two arc-shaped recesses, respectively, thereby locking the length of the flexible wire 1 between the decompression device 2 and the engaging device 3. In some embodiments, the surface of the arc-shaped protrusions and / or the arc-shaped recesses can be configured with a serrated or wavy shape to better fix the flexible wire.

[0081] In alternative embodiments, the wire clamping portion 142 may be configured to include two arcuate recesses (rather than arcuate protrusions) symmetrically relative to the central axis, while the wire clamping portion 162 may include two arcuate protrusions (rather than arcuate recesses) symmetrically relative to the central axis. In some embodiments, the wire clamping portion 142 may include one arcuate recess and one arcuate protrusion located on either side of the central axis, while the wire clamping portion 162 may include one arcuate protrusion and one arcuate recess located on either side of the central axis. In some embodiments, the wire clamping portion 142 may include a combination of at least one protrusion and at least one recess on each side of the central axis, and this combination is symmetrical about the central axis in terms of the number and position of the protrusions and recesses, while the wire clamping portion 162 may correspondingly include a combination of at least one recess and at least one protrusion on each side of the central axis, and this combination is symmetrical about the central axis in terms of the number and position of the protrusions and recesses.

[0082] In some embodiments, the structure of the wire clamping portions 142 and 162 can also be applied to the bite device 3 of the first embodiment, and replace the wire clamping portions 42 and 62, or be used in combination with the wire clamping portions 42 and 62; or, the structure of the wire clamping portions 42 and 62 can also be applied to the bite device 103 of the second embodiment, and replace the wire clamping portions 142 and 162, or be used in combination with the wire clamping portions 142 and 162.

[0083] The angle-fixing portion 143 and the angle-fixing portion 163 are used to secure the clamping members 104 and 106 at a predetermined angle, maintaining the clamping force exerted by the two wire clamping members 142 and 162 on the flexible wire 1. The angle-fixing portion 143 and the angle-fixing portion 163 are respectively disposed at the free ends of the main bodies 141 and 161, distal from the pivot axis O. The angle-fixing portion 163 includes a recess 169. The recess 169 is recessed from the inner surface of the free end of the main body 161 and has a first side surface 169L and a second side surface 169R perpendicular to the pivot axis O. A plate 167 is secured to the first side surface 169L and includes at least one barb or hook hole 164 (shown as a hook hole). The hook hole 164 can receive the barb 144 of the angle-fixing portion 143 (described in detail below), thereby securing the clamping members 104 and 106 at a predetermined angle.

[0084] The through-cavity 145 is disposed at the free end of the main body 141 and has a first side surface 145L and a second side surface 145R perpendicular to the pivot axis O. The position of the through-cavity 145 on the main body 141 corresponds to the position of the recess 169 on the main body 161. The angle fixing portion 143 is disposed in the through-cavity 145 and includes a spring support portion 146, a connected barb portion 147, and a handle portion 148. The spring support portion 146 extends from the second side surface 145R of the through-cavity 145 toward the interior of the through-cavity 145 in the direction of the pivot axis O. The coil spring 149 is supported on the spring support portion 146 and extends beyond the free end of the spring support portion 146. The barb portion 147 is elongated and extends from the through-cavity 145 toward the recess 169. Barb portion 147 has a groove 150 at its upper portion, facing second side surface 145R, for receiving the end of spring support portion 146. A coil spring 149 is sandwiched between groove 150 of barb portion 147 and the end of spring support portion 146, biasing barb portion 147 toward first side surface 145L. Barb portion 147 has at least one barb 144 at its lower center portion, facing first side surface 145L, for insertion into hook hole 164 of angle fixing portion 163 under the bias of coil spring 149. Handle portion 148 extends through hole 151 in first side surface 145L through cavity 145 and connects to the upper portion of barb portion 147 above barb 144. The operator can push the handle portion 148 toward the second side surface 145R against the biasing force of the coil spring 149 to disengage the barbs 144 of the barb portion 147 from the hook holes 164 of the angle fixing portion 163. In some embodiments, the at least one barb 144 may include one or more rows and / or one or more lines of barbs, and the at least one hook hole 164 may include one or more rows and / or one or more lines of hook holes.

[0085] In some embodiments, the structures of angle fixing portion 143 and angle fixing portion 163 can be interchanged. In some embodiments, the structures of angle fixing portion 143 and angle fixing portion 163 can also be applied to the engaging device 3 of the first embodiment, replacing angle fixing portion 43 and angle fixing portion 63; alternatively, the structures of angle fixing portion 43 and angle fixing portion 63 can also be applied to the engaging device 103 of the second embodiment, replacing angle fixing portion 143 and angle fixing portion 163.

[0086] The operation of the skin and soft tissue stretching and closure device including the bite mechanism 103 is substantially similar to that of the skin and soft tissue stretching and closure device including the bite mechanism 3, differing in the method for fixing the angle between the two angle fixing portions. In the skin and soft tissue stretching and closure device including the bite mechanism 103, the engagement between the barb 144 and the hook hole 164 is automatically achieved by the biasing force of the coil spring 149, while the disengagement between the barb 144 and the hook hole 164 is achieved by pushing the handle 148.

[0087] The pull cord of the skin and soft tissue stretching and closure device disclosed herein is arranged in a U-shaped pattern, with the bottom section of the U connected to the pressure relief device, and the two protruding sections of the U connected to the engaging device. The two protruding sections of the U are roughly parallel, thereby generating a relatively balanced pulling force on the skin and soft tissue.

[0088] The pull line of the skin soft tissue stretching and closing device according to the present invention plays a dual role, namely, not only for fixing the decompression device and the bite device on the edge skin on both sides of the wound surface, but also for pulling the decompression device and the bite device toward each other.

[0089] The skin soft tissue stretching and closure device disclosed herein uses a decompression device and a bite device to contact the skin on both sides of the wound. The decompression device and the bite device have a large contact area with the skin, thereby alleviating the huge pressure on the skin caused by the pulling of the flexible thread.

[0090] The skin soft tissue stretching and closing device disclosed herein uses a simple biting operation to adjust the distance between the skin on both sides of the wound surface. The operation steps are simple, which reduces the time and labor costs required for the adjustment.

[0091] The skin and soft tissue stretching and closure device disclosed herein is relatively small in size and can be widely used on wounds in various locations, such as under the arms.

[0092] The skin soft tissue stretching and closing device according to the present disclosure has a simple structure and a small number of components, thereby greatly reducing manufacturing costs.

[0093] Although exemplary embodiments of the present disclosure have been described, it will be understood by those skilled in the art that various changes and modifications may be made to the exemplary embodiments of the present disclosure without departing substantially from the spirit and scope of the present disclosure. Therefore, all such changes and modifications are intended to be within the scope of protection of the present disclosure as defined by the appended claims. The present disclosure is defined by the appended claims, and equivalents of these claims are intended to be included therein.

Claims

1. A skin and soft tissue stretching and closing device, which is used for wound repair or tissue reconstruction, and is characterized by: The skin and soft tissue stretching and closing device comprises: a pressure relief device, the pressure relief device being fixed to the skin edge of a first side of the wound surface by a flexible line and being elongated, the flexible line being arranged in a U-shape, and the bottom of the U-shape being against the side wall of the pressure relief device; and a bite device, the bite device being fixed to the skin at the edge of the wound surface on a second side opposite to the first side via the flexible wire and being connected to the decompression device via the flexible wire, the bite device comprising a first clamping member and a second clamping member pivotable relative to each other about a pivot axis, the first clamping member and the second clamping member clamping a length of the two protruding sections of the U-shaped flexible wire to control the length of the flexible wire between the decompression device and the bite device; In which, the first clamping member and the second clamping member respectively include a first angle fixing portion and a second angle fixing portion configured to fix the first clamping member and the second clamping member at a certain angle, the second angle fixing portion includes a recess, the first angle fixing portion is arranged in the through cavity of the first clamping member, and includes a spring support portion extending from the side surface of the through cavity toward the inside of the through cavity, a barb portion located in the through cavity, and a handle portion connected to the barb portion through a through hole on the through cavity, a spring is arranged between the spring support portion and the barb portion, the barb portion is configured to complete the engagement with the recess by the biasing force of the spring, and the handle portion is configured to complete the disengagement between the recess and the barb portion by a pushing movement.

2. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The pressure relief device is hollow and has an inner side wall, and includes two opposite open ends along the elongated direction.

3. The skin and soft tissue stretching and closing device according to claim 2, characterized in that: The bottom of the U-shape of the flexible wire abuts against the inner side wall of the pressure relief device, while the two protruding sections of the U-shape of the flexible wire leave the two opposite open ends of the pressure relief device and extend toward the bite device.

4. The skin and soft tissue stretching and closing device according to claim 2 or 3, characterized in that: The outer cross-section of the pressure reducing device is substantially circular or elliptical.

5. The skin and soft tissue stretching and closing device according to claim 2 or 3, characterized in that: The pressure relief device is made of a compliant material.

6. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The pressure relief device is solid and includes a plurality of through holes therethrough transverse to the direction of elongation.

7. The skin and soft tissue stretching and closing device according to claim 6, characterized in that: The bottom of the U-shape of the flexible wire abuts against the outer side wall of the decompression device, and the two protruding sections of the U-shape of the flexible wire pass through two through holes of the plurality of through holes of the decompression device and extend toward the bite device.

8. The skin and soft tissue stretching and closing device according to claim 6 or 7, characterized in that: Adjacent through-holes among the plurality of through-holes are evenly spaced apart from each other, or are unevenly spaced apart from each other.

9. The skin and soft tissue stretching and closing device according to claim 6 or 7, characterized in that: The pressure reducing device has a plurality of micro holes with diameters smaller than that of the through holes.

10. The skin and soft tissue stretching and closing device according to claim 6 or 7, characterized in that: The pressure reducing device is generally in the shape of a spindle, a capsule or a cylinder.

11. The skin and soft tissue stretching and closing device according to claim 6 or 7, characterized in that: The pressure relief device is made of a compliant material.

12. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The bite device is generally in the shape of a clip.

13. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The first clamping member and the second clamping member are substantially plate-shaped and have a substantially rectangular or trapezoidal outer contour.

14. The skin and soft tissue stretching and closing device according to any one of claims 1, 12 and 13, characterized in that: The first clamping member and the second clamping member respectively include a first wire clamping portion and a second wire clamping portion, which are configured to clamp and fix a length of the two protruding sections of the U-shape of the flexible wire and are respectively arranged on the opposite inner surfaces of the first clamping member and the second clamping member facing each other.

15. The skin and soft tissue stretching and closing device according to claim 14, characterized in that: The first wire clamping portion and the second wire clamping portion are arranged on the pivot axis of the snapping device and / or are arranged to be offset from the pivot axis towards a central portion of the snapping device.

16. The skin and soft tissue stretching and closing device according to claim 14, characterized in that: The first clamping portion includes at least one first protrusion protruding from the inner surface of the first clamping member toward the second clamping member and / or at least one first recessed portion recessed from the inner surface of the first clamping member, and the second clamping portion includes at least one second protrusion protruding from the inner surface of the second clamping member toward the first clamping member and / or at least one second recessed portion recessed from the inner surface of the second clamping member, and the at least one second protrusion and / or the at least one second recessed portion correspond to the at least one first protrusion and / or the at least one first recessed portion in shape, number and position.

17. The skin and soft tissue stretching and closing device according to claim 16, characterized in that: The first protrusion and / or the first recess are symmetrically distributed in position and number about the central axis of the bite device perpendicular to the pivot axis, and the second protrusion and / or the second recess are symmetrically distributed in position and number about the central axis of the bite device perpendicular to the pivot axis.

18. The skin and soft tissue stretching and closing device according to claim 16, characterized in that: The cross sections of the first protrusion and / or the first recess, and the second protrusion and / or the second recess are substantially rectangular, truncated cone, or arc-shaped.

19. The skin and soft tissue stretching and closing device according to claim 16, characterized in that: The surface of the first protrusion and / or the first recessed portion is provided with serrations or wavy portions, and / or the surface of the second protrusion and / or the second recessed portion is provided with serrations or wavy portions.

20. The skin and soft tissue stretching and closing device according to claim 16, characterized in that: The first protrusion and / or the first recess, and the second protrusion and / or the second recess are arranged outside the pivot and pivot hole structures of the first clamping member and the second clamping member in the direction of the pivot axis.

21. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The first angle fixing portion and the second angle fixing portion are respectively arranged at free ends of the first clamping member and the second clamping member away from the pivot axis.

22. The skin and soft tissue stretching and closing device according to claim 21, characterized in that: The first angle fixing portion and the second angle fixing portion fix the first clamping member and the second clamping member at a certain angle through engagement between the barbs or engagement between the barbs and the hook holes.

23. The skin and soft tissue stretching and closing device according to claim 21 or 22, characterized in that: The first angle fixing portion extends from an inner surface of the first clamping member toward the second clamping member, and the first angle fixing portion is provided with at least one barb on a surface thereof facing the pivot axis.

24. The skin and soft tissue stretching and closing device according to claim 23, characterized in that: The second angle fixing portion is provided with at least one barb or hook hole on its surface facing away from the pivot axis, and one or more of the at least one barb of the first angle fixing portion can be engaged with one or more of the at least one barb or hook hole of the second angle fixing portion.

25. The skin and soft tissue stretching and closing device according to claim 24, characterized in that: The at least one barb of the first angle fixing portion includes one or more rows and / or one or more lines of barbs, and the at least one barb or hook hole of the second angle fixing portion includes one or more rows and / or one or more lines of barbs or hook holes.

26. The skin and soft tissue stretching and closing device according to claim 23, characterized in that: A fixing band is provided on the outer periphery of the free end portion of the second clamping member, and the fixing band is configured to prevent the first angle fixing portion from being separated from the second angle fixing portion when the first angle fixing portion and the second angle fixing portion are engaged.

27. The skin and soft tissue stretching and closing device according to claim 23, characterized in that: The second clamping member is provided with a boss-shaped finger support portion on the outer surface close to the second angle fixing portion.

28. The skin and soft tissue stretching and closing device according to claim 21 or 22, characterized in that: The recess is recessed from the inner surface of the free end portion of the second clamping piece, and a side surface thereof includes at least one barb or hook hole.

29. The skin and soft tissue stretching and closing device according to claim 28, characterized in that: The through cavity is provided on the free end portion of the first clamping member, and the position of the through cavity on the first clamping member corresponds to the position of the recess on the second clamping member.

30. The skin and soft tissue stretching and closing device according to claim 29, characterized in that: The spring support portion is configured to support the spring.

31. The skin and soft tissue stretching and closing device according to claim 29, characterized in that: The barb portion is elongated and extends from the through cavity toward the recess.

32. The skin and soft tissue stretching and closing device according to claim 29, characterized in that: The barb portion is provided with a groove on a first side thereof for receiving the end of the spring support portion, and the spring is sandwiched between the groove of the barb portion and the end of the spring support portion.

33. The skin and soft tissue stretching and closing device according to claim 32, characterized in that: The barb portion is provided with at least one barb on a second side opposite to the first side, and one or more of the at least one barb engages one or more of the at least one barb or hook hole of the second angle fixing portion under the biasing force of the spring.

34. The skin and soft tissue stretching and closing device according to claim 33, characterized in that: The at least one barb of the first clamping member comprises one or more rows and / or one or more lines of barbs, and the at least one barb or hook hole of the second clamping member comprises one or more rows and / or one or more lines of barbs or hook holes.

35. The skin and soft tissue stretching and closing device according to claim 1, characterized in that: The pressure display module is provided on the bite device and is electrically connected to the pressure and / or tension sensor of the decompression device and / or the pressure and / or tension sensor of the bite device in a wired or wireless manner.

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