Skin soft tissue augmentation device with gradient pressure control

Abstract

The present disclosure discloses a skin soft tissue rapid expansion device with gradient pressure control, comprising two skin attachment devices, the two skin attachment devices being configured to be fixed to the skin on both sides of a wound edge, each skin attachment device comprising an attachment plate placed on the skin, and a plurality of piercing members pivotally connected to the attachment plate and capable of piercing the skin, wherein the plurality of piercing members are distributed on the attachment plate in a direction away from the wound edge, and the pivotable angle relative to the attachment plate gradually becomes smaller; and a pulling member removably connected to the two skin attachment devices. The skin soft tissue rapid expansion device according to the present disclosure performs gradient stretching and expansion on the skin at different distances on both sides of the wound edge, thereby avoiding excessive pressure on the skin at a single site.

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 soft tissue rapid expansion device with gradient pressure control. Background Art

[0002] How to quickly repair skin and soft tissue injuries and close skin and soft tissue defect wounds has always been the focus of clinical research. With the rapid development of medical technology in recent years, various sutures, medical glues, skin staplers, skin transplants, flap transplants, etc. have been used for wound closure. However, there is currently no ideal solution for wounds with larger areas of skin and soft tissue defects. The skin transplantation or flap transplantation methods used in clinical practice are not only complicated and require high operating skills, but also require obtaining tissue from the donor area, causing secondary trauma. In addition, the newly transplanted skin or flap has poor sensation and cannot meet the needs of functional repair. Therefore, finding and exploring more ideal wound repair methods is a difficult problem that needs to be urgently solved in clinical practice.

[0003] Based on the viscoelastic properties of skin soft tissue, various skin expanders and skin stretching technologies are used for skin expansion and regeneration, which have certain advantages over traditional skin transplantation and flap transplantation. However, in vivo skin expanders are time-consuming and have the risk of implant infection, and are not suitable for rapid repair and closure of wounds. The skin stretching devices currently used in clinical practice are mainly composed of three parts: a skin attachment system, a traction power system, and a tension maintenance system. They have the disadvantages of complex structure, large trauma, and high cost. In addition, the skin stretching device mainly exerts its stretching effect by anchoring the skin near the wound edge, and can only achieve stretching of the skin at a single site, which easily causes the skin near the wound edge to become the point of maximum stretching force, which not only easily causes skin compression injuries, but also fails to fully expand the distal skin on both sides of the wound. Therefore, the products currently used in clinical practice have limited capabilities in wound repair and reconstruction, and cannot achieve sufficient and rapid expansion of skin soft tissue. Summary of the Invention

[0004] One of the purposes of the present disclosure is to provide a skin soft tissue rapid expansion device with gradient pressure control that can overcome at least one defect in the prior art.

[0005] The present disclosure relates to a skin soft tissue augmentation device with gradient voltage control, wherein the skin soft tissue augmentation device comprises:

[0006] Two skin attachment devices configured to be fixed to the skin on either side of a wound edge, each skin attachment device comprising an attachment plate placed on the skin, and a plurality of piercing members pivotally connected to the attachment plate and capable of piercing the skin, wherein the plurality of piercing members are distributed on the attachment plate in a direction away from the wound edge and have gradually decreasing pivotable angles relative to the attachment plate; and

[0007] A pull member is removably connected to the two skin attachment devices.

[0008] In some embodiments, each piercing member includes a pivot block and one or more needles extending from the pivot block, the pivot block includes a pivot hole for pivoting the piercing member, and a limiting groove that is generally arc-shaped with the center of the pivot hole as the center of the circle, wherein the curvature of the limiting grooves of the multiple piercing members gradually increases along the direction away from the wound edge.

[0009] In some embodiments, the one or more needles extend downwardly from a lower surface of the pivot block and are configured to penetrate the skin as the attachment plate is placed on the skin on either side of the wound margin.

[0010] In some embodiments, the one or more needles are configured to bend slightly forward and have a generally hook shape.

[0011] In some embodiments, the attachment plate includes a plate body and a plurality of pivot assemblies arranged on the plate body, each pivot assembly includes a pivot shaft received in a pivot hole, and a limiting column movable in the limiting groove along the length direction of the limiting groove.

[0012] In some embodiments, the arc between the front end and the rear end of the limiting groove defines an angular range within which the pivot block can pivot.

[0013] In some embodiments, in an initial state, the limiting post is positioned at a position of the limiting groove close to the wound edge.

[0014] In some embodiments, the pivot shaft and the limiting post of each pivot assembly both extend outward from the left side surface of the plate body, or both extend outward from the right side surface of the plate body.

[0015] In some embodiments, the pivot axis of each pivot assembly is disposed near the top of the corresponding limiting post, or near the bottom of the corresponding limiting post.

[0016] In some embodiments, the pivot shaft and the limiting post of each pivot assembly are fixed to the plate body by being directly inserted into the plate body or inserted into a protruding block on the plate body.

[0017] In some embodiments, the plurality of pivoting components are symmetrically or asymmetrically distributed relative to the central axis of the plate.

[0018] In some embodiments, the plurality of pivot assemblies are evenly spaced apart from each other or unevenly spaced apart from each other along a direction away from the wound edge.

[0019] In some embodiments, the plate body is provided with a plurality of through holes that are evenly or unevenly distributed to allow the skin below the attachment plate to breathe.

[0020] In some embodiments, the plate is made of a soft material to adapt to the curve of the skin surface.

[0021] In some embodiments, the attachment plate further comprises a pulling block fixed on the plate body, wherein the pulling block is configured to cooperate with the pulling member to adjust the relative distance between the two attachment plates.

[0022] In some embodiments, the pulling block is provided with a through hole extending from front to back, and the elastic arm is accommodated in the through hole.

[0023] In some embodiments, the elastic arm is configured to have a generally upwardly convex arc shape.

[0024] In some embodiments, the front end of the elastic arm is fixed at the bottom of the front part of the through hole, extending backward and upward, and the rear end is fixed at approximately the middle height of the rear part of the through hole through rod-shaped flanges extending on the left and right sides.

[0025] In some embodiments, the pulling member passes through the through hole of the pulling block above the elastic arm.

[0026] In some embodiments, the pulling member is in a substantially elongated plate shape, and a plurality of teeth arranged in a front-to-back direction are provided on a lower surface thereof.

[0027] In some embodiments, the elastic arm is provided on its upper surface with a plurality of teeth arranged in the front-to-back direction and capable of engaging with the teeth of the pulling member.

[0028] In some embodiments, the resilient arm is configured to deform under a compressive force to disengage the teeth of the puller member from the teeth of the resilient arm.

[0029] 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.

[0030] 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

[0031] Aspects of the present disclosure will be better understood after reading the following detailed description in conjunction with the accompanying drawings, in which:

[0032] Figure 1 is a perspective view of a skin soft tissue augmentation device according to an embodiment of the present disclosure;

[0033] Figure 2 and3 yes Figure 1 The skin attachment device of the skin soft tissue augmentation device is shown in an assembled perspective view and an exploded perspective view;

[0034] Figure 4 yes Figure 1 A cross-sectional view of the skin attachment device of the skin soft tissue augmentation device is shown. DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] It should be understood that the terms used in the specification are only used 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 the 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.

[0038] The singular forms "a", "an", "the" and "the" used in the specification include the plural forms unless otherwise expressly stated. The terms "include", "comprise" and "contain" used in the 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 the 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 the 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".

[0039] 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 the feature has a portion that overlaps with the adjacent feature or a portion that is located above or below the adjacent feature.

[0040] 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 may now be described as "above" the other feature. The device may also be oriented in other ways (rotated 90 degrees or in other orientations), and the relative spatial relationships will be interpreted accordingly.

[0041] Figure 1 A skin soft tissue augmentation device 1 with gradient pressure control according to an embodiment of the present disclosure is shown. The skin soft tissue augmentation device 1 achieves expansion and proliferation of the skin, subcutaneous fascia tissue, and muscle tissue in a manner that gradient forces the skin at different distances on both sides of the wound edge. The skin soft tissue augmentation device 1 includes two skin attachment devices 2 fixed to both sides of the wound edge, and a pulling member 3 removably connected to the two skin attachment devices 2. The skin attachment devices 2 are fixed on the skin surface on both sides of the wound edge, and are capable of achieving gradient forces on the skin at different distances on both sides of the wound edge. The pulling member 3 is used to adjust the relative distance between the two skin attachment devices 2 to adjust the relative distance between the two sides of the wound edge.

[0042] like Figure 2 and 3As shown, the skin attachment device 2 includes an attachment plate 21 and a plurality of piercing members 22 pivotally connected to the attachment plate 21. The attachment plate 21 is placed on the skin surface on both sides of the wound edge. The attachment plate 21 includes a substantially flat plate body 211. The outer contour of the plate body 211 is roughly rectangular, and has a front end close to the wound edge and a rear end away from the wound edge. In other embodiments, the plate body 211 may also use other suitable outer contour shapes, including but not limited to polygons other than rectangles, circles, ellipses, etc. In some embodiments, the plate body 211 is provided with a plurality of through holes that are evenly distributed or unevenly distributed to allow the skin under the attachment plate 21 to breathe. In some embodiments, the plate body 211 is made of a soft material to adapt to the curve of the skin surface.

[0043] The pulling block 212 is fixed to the front end of the plate body 211 and is used in conjunction with the pulling member 3 to adjust the relative distance between the two attachment plates 21. The pulling block 212 has a generally triangular cross-section along the front-to-back direction, but other suitable cross-sectional shapes may be used, including but not limited to trapezoidal, rectangular, semicircular, etc.

[0044] The pulling block 212 is provided with a through hole 213 extending from front to back in the middle, and the elastic arm 214 is accommodated in the through hole 213. Figure 4 As shown, the elastic arm 214 is in a generally convex arc shape. The front end of the elastic arm 214 is fixed at the bottom of the front portion of the through hole 213, extending obliquely backward and upward, and the rear end is fixed at approximately the middle height of the rear portion of the through hole 213 via rod-shaped flanges 215 extending on both sides. The elastic arm 214 is provided with a plurality of teeth arranged in the front-to-back direction on its upper surface. Accordingly, as shown in FIG. Figure 1 As shown, the pulling member 3 is in the shape of a generally elongated plate, and has a plurality of teeth arranged opposite each other in the front-to-back direction on its lower surface. The pulling member 3 can pass through the through-hole 213 above the elastic arm 214, and one or more teeth on the pulling member 3 can engage with one or more teeth on the elastic arm 214 to connect the pulling member 3 to the pulling block 212, thereby locking the relative distance between the two skin attachment devices 2. The elastic arm 214 and its rod-shaped flange 215 have a certain degree of elasticity. By pressing downward on the elastic arm 214 near the rod-shaped flange 215, the elastic arm 214 and the rod-shaped flange 215 can deform, causing the teeth of the pulling member 3 to disengage from the teeth of the elastic arm 214. As a result, the pulling member 3 can slide relative to the pulling block 212 through the through-hole 213 to adjust the relative distance between the two skin attachment devices 2.

[0045] return Figure 2 and 3Multiple pivot assemblies 216 are disposed on the plate body 211 and located between the pulling block 212 and the rear end of the plate body 211. These assemblies are used to mount corresponding insertion members 22 and enable the insertion members 22 to pivot within a limited angular range. Each pivot assembly 216 includes a pivot shaft 217 and a limiting post 218. The pivot shaft 217 provides a pivot axis for the insertion member 22, while the limiting post 218 limits the angular range of the insertion member 22. The pivot shaft 217 and limiting post 218 of each pivot assembly 216 extend outward from the left side surface of the plate body 211, or extend outward from the right side surface of the plate body 211. The pivot shaft 217 can be disposed near (e.g., directly above) the limiting post 218, but in other embodiments, it can also be disposed near (e.g., directly below) the limiting post 218. The pivot shaft 217 and the limiting post 218 can be fixed to the plate body 211 by being directly inserted into the plate body 211 or inserted into the protruding block 219 on the plate body 211. The plurality of pivot assemblies 216 can be symmetrically distributed relative to the central axis of the plate body 211 and can be evenly spaced apart from each other along the front-to-back direction of the plate body 211. In other embodiments, the plurality of pivot assemblies 216 can also be asymmetrically distributed relative to the central axis of the plate body 211, or the plurality of pivot assemblies 216 can also be unevenly spaced apart from each other along the front-to-back direction of the plate body 211.

[0046] Multiple piercing members 22 are pivotally mounted on corresponding pivot assemblies 216. Each piercing member 22 includes a pivot block 221 and one or more needles 222 extending downwardly from the pivot block 221. The pivot block 221 includes a pivot hole 223 and a limiting groove 224. The pivot hole 223 is used to receive the pivot shaft 217, so that the pivot shaft 217 can rotate within the pivot hole 223. The limiting groove 224 is generally arc-shaped with the center of the pivot hole 223 as the center, and the limiting post 218 can move within the limiting groove 224 along the length of the limiting groove 224. The curvature between the front and rear ends of the limiting groove 224 defines the angular range within which the pivot block 221 can pivot. In the initial state, the limiting post 218 is positioned near the wound edge of the limiting groove 224. The needle 222 extends downward from the surface (e.g., the lower surface) of the pivot block 221 to penetrate the skin as the attachment plate 21 is placed on the skin on both sides of the wound edge, thereby fixing the skin attachment device 2 on the skin surface. In some embodiments, the needle 222 is slightly bent forward and is generally hook-shaped to better fix it in the skin.

[0047] As described above, the plurality of pivot assemblies 216 are spaced apart from one another along the front-to-back direction of the plate body 211. Accordingly, the plurality of piercing members 22 mounted on the plurality of pivot assemblies 216 are spaced apart from one another along the front-to-back direction of the plate body 211. The limiting grooves 224 of the pivot blocks 221 of the piercing members 22 are configured such that the arc increases toward the front end of the plate body 211 (i.e., closer to the wound edge) and decreases toward the rear end of the plate body 211 (i.e., farther from the wound edge). Therefore, the pivotable angle of the pivot block 221 gradually decreases as it moves from the front to the back of the plate body 221 (i.e., away from the wound edge).

[0048] After the operator inserts needle 222 into the skin on both sides of the wound edge, the relative distance between the two skin attachment devices 2 needs to be reduced. During this period of distance reduction, needle 222 will exert a gripping force on the skin. The closer the needle is to the rear end of plate 211 (i.e., farther from the wound edge), the smaller the curvature of the limiting groove 224 of pivot block 221, the smaller the range over which needle 222 can pivot backward, and thus the greater the gripping force exerted by needle 222 on the skin. Conversely, the closer the needle is to the front end of plate 211 (i.e., closer to the wound edge), the larger the curvature of the limiting groove 224 of pivot block 221, the greater the range over which needle 222 can pivot backward, and thus the less gripping force exerted by needle 222 on the skin. In other words, the gripping force exerted by needle 222 on the skin gradually increases as the needle moves from front to back along plate 221 (i.e., away from the wound edge). This arrangement results in less stretched skin near the wound edge, while more stretched skin away from the wound edge, achieving a gradient of gripping force. This not only fully utilizes the distal skin on both sides of the wound edge but also improves the overall force distribution in the skin near the wound edge.

[0049] In other embodiments, the distribution of the gripping force applied by the needle 222 to the skin along the front-to-back direction of the plate body 211 can be changed by adjusting the relative size of the curvature of the limiting grooves 224 of the plurality of pivot blocks 221 along the front-to-back direction of the plate body 211 and / or adjusting the relative distance between the plurality of pivot blocks 221.

[0050] According to the embodiment of the present disclosure, the skin soft tissue rapid expansion device with gradient pressure control is constructed with a soft material as the main body, cleverly combines needle and thread suturing technology, and arranges movable curved needles at different positions on both sides of the device to achieve gradient force on the skin at different distances on both sides of the wound edge during skin stretching and expansion.

[0051] The skin soft tissue rapid expansion device with gradient pressure control, according to the disclosed embodiment, performs gradient stretch expansion on skin at varying distances on either side of the wound edge, avoiding excessive pressure on a single skin location. This not only fully expands the skin at varying distances on either side of the wound edge, significantly reducing damage to a single skin tissue, but also achieves the simultaneous expansion and proliferation of subcutaneous fascia, muscle tissue, and skin, achieving functional reconstruction of wound repair while fulfilling the basic requirement of wound closure.

[0052] The embodiments of the present disclosure provide a simple, easy-to-use, flexible and convenient wound repair and reconstruction device, which can quickly achieve the closure of skin and soft tissue defects, solving the key pain points of current skin stretching technology. It can be used to close skin and soft tissue defects caused by various reasons such as trauma, burns, bedsores, diabetic foot, scar resection, and surface tumor resection.

[0053] 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 soft tissue amplification device with gradient pressure control, characterized in that: The skin soft tissue augmentation device comprises: Two skin attachment devices configured to be fixed to the skin on either side of a wound edge, each skin attachment device comprising an attachment plate placed on the skin, and a plurality of piercing members pivotally connected to the attachment plate and capable of piercing the skin, wherein the plurality of piercing members are distributed on the attachment plate in a direction away from the wound edge and have gradually decreasing pivotable angles relative to the attachment plate; and a pull member removably connected to the two skin attachment devices; Each piercing member includes a pivot block and one or more needles extending from the pivot block. The pivot block includes a pivot hole for the piercing member to pivot, and a limiting groove that is generally arc-shaped with the center of the pivot hole as the center of the circle. The curvature of the limiting grooves of the multiple piercing members gradually increases along the direction away from the wound edge.

2. The skin soft tissue augmentation device according to claim 1, characterized in that: The one or more needles extend downwardly from a lower surface of the pivot block and are configured to penetrate the skin as the attachment plate is placed on the skin on either side of the wound margin.

3. The skin soft tissue augmentation device according to claim 1, characterized in that: The one or more needles are configured to be slightly bent forward and to have a generally hook shape.

4. The skin soft tissue augmentation device according to any one of claims 1 to 3, characterized in that: The attachment plate includes a plate body and a plurality of pivot assemblies arranged on the plate body, each pivot assembly includes a pivot shaft received in a pivot hole, and a limiting column movable in a limiting groove along a length direction of the limiting groove.

5. The skin soft tissue augmentation device according to claim 4, characterized in that: The arc between the front end and the rear end of the limiting groove defines the angular range within which the pivot block can pivot.

6. The skin soft tissue augmentation device according to claim 5, characterized in that: In an initial state, the limiting post is positioned at a position of the limiting groove close to the wound edge.

7. The skin soft tissue augmentation device according to claim 4, characterized in that: The pivot shaft and the limiting column of each pivot assembly both extend outward from the left side surface of the plate body, or both extend outward from the right side surface of the plate body.

8. The skin soft tissue augmentation device according to claim 4, characterized in that: The pivot of each pivot assembly is arranged near the top of the corresponding limiting column, or near the bottom of the corresponding limiting column.

9. The skin soft tissue augmentation device according to claim 4, characterized in that: The pivot and the limiting column of each pivot assembly are fixed to the plate body by being directly inserted into the plate body or inserted into the protruding blocks on the plate body.

10. The skin soft tissue augmentation device according to claim 4, characterized in that: The plurality of pivoting components are distributed symmetrically or asymmetrically relative to the central axis of the plate body.

11. The skin soft tissue augmentation device according to claim 4, characterized in that: The plurality of pivot assemblies are evenly spaced apart from each other or unevenly spaced apart from each other along a direction away from the wound edge.

12. The skin soft tissue augmentation device according to claim 4, characterized in that: The plate body is provided with a plurality of through holes which are evenly or unevenly distributed so as to allow the skin below the attached plate to breathe.

13. The skin soft tissue augmentation device according to claim 4, characterized in that: The plate is made of soft material to adapt to the curve of the skin surface.

14. The skin soft tissue augmentation device according to claim 4, characterized in that: The attachment plate further comprises a pulling block fixed on the plate body, wherein the pulling block is configured to cooperate with the pulling member to adjust the relative distance between the two attachment plates.

15. The skin soft tissue augmentation device according to claim 14, characterized in that: The pulling block is provided with a through hole which passes through from front to back, and the elastic arm is accommodated in the through hole.

16. The skin soft tissue augmentation device according to claim 15, characterized in that: The elastic arm is configured to be in a generally upwardly convex arc shape.

17. The skin soft tissue augmentation device according to claim 15, characterized in that: The front end of the elastic arm is fixed to the bottom of the front part of the through hole and extends obliquely backward and upward, and the rear end is fixed to the approximately middle height of the rear part of the through hole through rod-shaped flanges extending on both sides.

18. The skin soft tissue augmentation device according to claim 15, characterized in that: The pulling member passes through the through hole of the pulling block above the elastic arm.

19. The skin soft tissue augmentation device according to claim 18, characterized in that: The pulling member is in a substantially elongated plate shape, and a plurality of teeth arranged in the front-rear direction are provided on the lower surface thereof.

20. The skin soft tissue augmentation device according to claim 19, characterized in that: The elastic arm is provided with a plurality of teeth on its upper surface, which are arranged in the front-to-back direction and can mesh with the teeth of the pulling member.

21. The skin soft tissue augmentation device according to claim 20, characterized in that: The elastic arm is configured to be deformable under a compressive force to disengage the teeth of the pulling member and the teeth of the elastic arm.

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