Skin and Soft Tissue External Expansion Device

Abstract

The present disclosure discloses a skin and soft tissue external expansion device, comprising: a decompression device which is fixed on the skin at the edge of the first side of the wound surface by a single continuous flexible wire and is in an elongated shape, the flexible wire is arranged in a U shape, and the bottom of the U shape abuts against the side wall of the decompression device; and a wire winding device which is fixed on the skin at the edge of the second side of the wound surface opposite to the first side by the flexible wire and is connected to the decompression device through the flexible wire, the wire winding device includes a wire winder sleeve placed on the edge skin and a wire winder received in the wire winder sleeve, the wire winder includes a wire head fixing part and a wire winding part connected to each other, the wire head fixing part is configured to fix the two protruding segments of the U shape of the flexible wire, and the wire winding part is configured to wind the flexible wire between the decompression device and the wire head fixing part to control the length of the flexible wire between the decompression device and the wire winding device. The skin and soft tissue external expansion device of the present disclosure is easy to use and has a wide range of applicable parts.

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 external expansion device. Background Art

[0002] Skin and soft tissue injuries may be the most common traumas in a person's life. From various injuries during hunting in the wild in ancient times, to various factory accidents and traffic traumas under the rapid development of modern society, and then to chronic wounds (such as diabetic foot, vascular ulcers, pressure sores, etc.) caused by various chronic diseases affecting the skin in modern society, the repair of skin and soft tissue injuries has always been the focus of clinical research. Wound debridement and suture is the earliest surgical treatment technique invented and applied clinically. With the rapid development of medical technology in recent years, various sutures, medical glues, skin staplers, skin grafts, flap grafts, etc. have been successfully used for wound closure. However, there is still no ideal solution for wounds with large-area skin and soft tissue defects. Currently, skin grafting or flap grafting is commonly used clinically. It is not only complex in operation and requires high operating skills, but also requires obtaining tissues from the donor site, which will cause secondary trauma. In addition, the newly transplanted skin or the transferred flap often has poor sensation, and can only meet the basic requirements of wound closure, and cannot meet the needs of functional repair. Therefore, finding and exploring a more ideal wound repair method is an urgent problem that needs to be solved clinically.

[0003] It has been found that during the process of a woman's pregnancy and childbirth when the abdomen bulges and enlarges, the skin, subcutaneous soft tissue, fascia, and muscles can all expand and regenerate under the condition of continuous tension. Subsequently, studies have found that soft tissues such as the skin possess unique viscoelastic properties and can expand and extend under continuous tension and stress conditions. Based on this, various skin expanders and skin stretching techniques have been applied to the expansion and regeneration of the skin. Compared with traditional skin grafting and skin flap transplantation, they have certain advantages. However, for in-vivo skin expanders, the expander needs to be surgically implanted first, and then the skin can be slowly expanded through 1-2 months of water injection. This not only takes a long time but also has the risk of implant infection and is not suitable for repairing closed wounds; the skin stretching technique has become a research hotspot in recent years because of its simple operation and convenience. Currently, commercially available products for clinical application mainly come from European and American countries. It mainly consists of three parts: a skin attachment system, a pulling power system, and a tension maintenance system. The device structure is relatively complex and the cost is relatively high. Moreover, the skin attachment system mostly uses metal devices such as Kirschner wires, skin staples, or skin hooks. This not only causes relatively serious damage to the skin but also its attachment system is mainly fixed and riveted to the dermis layer of the skin. In clinical applications, it can only complete the pulling expansion of a single skin tissue structure and cannot achieve synchronous expansion of the subcutaneous superficial fascia, deep fascia, and muscle tissues. There is a risk of incomplete closure and subcutaneous cavity retention when it is applied to the closure of wounds with deeper soft tissue defects. In addition, due to its complex structure and large spatial volume, it is limited in actual clinical applications by the actual use site. Therefore, the currently clinically applied products have many defects in wound repair and reconstruction and cannot achieve the full-dimensional reconstruction of the ideal soft tissue structure.

[0004] The skin and soft tissue external expander designed in this disclosure avoids various risks and complications brought by in-vivo implanting expanders and at the same time combines the advantages of the skin stretching technique. Its main body is constructed with soft materials and cleverly combines the suture technique to integrate the three parts (skin attachment system, pulling power system, and tension maintenance system) in traditional stretching products, achieving the system integration of skin fixation, stretching, and tension maintenance. This not only simplifies the structure, facilitates surgical operation, significantly reduces the damage to skin tissue, but also can achieve synchronous expansion and regeneration of the subcutaneous fascia tissue, muscle tissue, and skin. While meeting the basic requirements of wound closure, it realizes the functional reconstruction of wound repair. In addition, this design embeds a pressure sensing chip, which can display the magnitude of the pressure generated on the skin under pulling tension and achieve an alarm reminder under high pulling tension conditions to avoid possible skin pressure damage. The technology of this invention provides a simple, convenient, flexible, and easy-to-use wound repair and reconstruction device, solving the key difficulties existing in the current skin expander implantation technology and skin stretching technology. It can be used for the repair of skin and soft tissue defects caused by various reasons such as trauma, burns, pressure sores, diabetic foot, scar resection, and resection of body surface tumors. Summary of the Invention

[0005] One object of the present disclosure is to provide a skin and soft tissue external expansion device that can overcome at least one defect in the prior art.

[0006] One aspect of the present disclosure relates to a skin and soft tissue external expansion device for wound repair or tissue reconstruction. The skin and soft tissue external expansion device includes:

[0007] A decompression device fixed to the marginal skin on the first side of the wound through a flexible wire and in an elongated shape. The flexible wire is arranged in a U shape, and the bottom of the U shape abuts against the side wall of the decompression device; and

[0008] A wire winding device fixed to the marginal skin on the second side opposite to the first side of the wound through the flexible wire and connected to the decompression device through the flexible wire. The wire winding device includes a wire winder sleeve placed on the marginal skin and a wire winder received in the wire winder sleeve. The wire winder includes a wire end fixing part and a wire winding part connected to each other. The wire end fixing part is configured to fix a length on two extending segments of the U shape of the flexible wire, and the wire winding part is configured to wind the flexible wire between the decompression device and the wire end fixing part to control the length of the flexible wire between the decompression device and the wire winding device.

[0009] In some embodiments, the decompression device is hollow and has an inner side wall, and includes two opposite open ends along the elongation direction.

[0010] In some embodiments, the bottom of the U shape of the flexible wire abuts against the inner side wall of the decompression device, while the two extending segments of the U shape of the flexible wire leave the two opposite open ends of the decompression device and extend towards the wire winding device.

[0011] In some embodiments, the outer cross-section of the decompression device is generally circular or elliptical.

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

[0013] In some embodiments, the decompression device is solid and includes a plurality of through holes passing through it transversely to the elongation direction.

[0014] In some embodiments, the bottom of the U shape of the flexible wire abuts against the outer side wall of the decompression device, while the two extending segments of the U shape of the flexible wire pass through two of the plurality of through holes of the decompression device and extend towards the wire winding device.

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

[0016] In some embodiments, the decompression device has a plurality of micropores with diameters smaller than the through-hole.

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

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

[0019] In some embodiments, the thread fixing portion is elongated and has slots at both of its opposite ends, and the slots are configured to receive and fix a length on two protruding segments of the U-shape of the flexible thread.

[0020] In some embodiments, the slots are configured to be recessed inwardly from the outer surface of the thread fixing portion.

[0021] In some embodiments, the distance between two opposite surfaces of each slot remains substantially constant and is smaller than the diameter of the flexible thread.

[0022] In some embodiments, the distance between two opposite surfaces of each slot gradually decreases from the outer edge to the center, and the minimum distance between the two opposite surfaces is smaller than the diameter of the flexible thread.

[0023] In some embodiments, there are pin holes between two opposite surfaces of the slot, and the size of the pin holes is larger than the maximum distance between two opposite surfaces of the slot.

[0024] In some embodiments, the pin holes are configured to removably receive pins, and the pins can block the flexible thread clamped in the slot from disengaging from the slot along a direction parallel to the opposite surfaces of the slot.

[0025] In some embodiments, the thread fixing portion is generally cylindrical or capsule-shaped.

[0026] In some embodiments, the winding portion includes a winding post, one end of the winding post is connected to the thread fixing portion, and a flange protruding transversely to the winding post is provided at the opposite end.

[0027] In some embodiments, the take-up device further includes a take-up handle separate from the take-up reel, and the take-up handle is configured to operate the take-up reel to rotate so as to wind the flexible thread around the winding portion.

[0028] In some embodiments, the take-up handle includes an operating rod, an insertion rod, and a connecting post connecting the operating rod and the insertion rod.

[0029] In some embodiments, the thread fixing portion is provided with a through-hole for inserting the insertion rod.

[0030] In some embodiments, the winding portion and the thread fixing portion are integrally formed.

[0031] In some embodiments, the winding portion and the wire head fixing portion are formed separately and then connected and fixed together.

[0032] In some embodiments, the wire winder further includes a handle portion connected to the wire head fixing portion.

[0033] In some embodiments, the handle portion includes an operating rod and a connecting column, and one end of the connecting column is fixed to the operating rod while the opposite end is fixed to the wire head fixing portion.

[0034] In some embodiments, the wire head fixing portion, the winding portion, and the handle portion are integrally formed.

[0035] In some embodiments, the wire head fixing portion, the winding portion, and the handle portion are formed separately and then connected and fixed together.

[0036] In some embodiments, the wire winder sleeve includes a hollow cylinder, and the cylinder includes two opposite open ends and an opening on the outer sidewall of the cylinder.

[0037] In some embodiments, the wire winder is placed inside the cylinder through the opening, and the two protruding U-shaped segments of the flexible wire pass through the two opposite open ends of the cylinder and are fixed to the wire head fixing portion of the wire winder.

[0038] In some embodiments, the pressure display module is provided on the outer sidewall of the cylinder and is electrically connected to the pressure and / or tension sensor of the pressure reducing device, and / or the pressure and / or tension sensor of the wire winding device and / or the cylinder, by wired or wireless means.

[0039] In some embodiments, the outer cross-section of the cylinder is generally circular or elliptical.

[0040] In some embodiments, the cylinder is made of a compliant material.

[0041] In some embodiments, the wire winder sleeve further includes a wire winder belt configured to cover and fix the wire winder from above the opening.

[0042] In some embodiments, the wire winder belt is integrally formed with the cylinder, one end of the wire winder belt is integrally connected to the edge of the opening, and the other end is removably fixed to the outer sidewall of the cylinder.

[0043] In some embodiments, the wire winder belt is formed separately from the cylinder, and its opposite ends are removably fixed to the outer sidewall of the cylinder.

[0044] Other features and advantages of the subject technology of the present disclosure will be set forth in the following description, and in part will be obvious from the description, or may be learned by practice of the subject technology of the present disclosure. The advantages of the subject technology of the present disclosure will be realized and obtained by the structures particularly pointed out in the written description, claims, and drawings.

[0045] It should be understood that the foregoing general description and the following detailed description are both exemplary and explanatory, and are intended to provide further explanation of the claimed subject technology of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] After reading the following detailed description in conjunction with the accompanying drawings, various aspects of the present disclosure will be better understood. In the drawings:

[0047] Figure 1 A schematic diagram showing the usage state of a skin and soft tissue external expansion device according to the present disclosure;

[0048] Figure 2 Show Figure 1 A perspective view of the decompression device of the skin and soft tissue external expansion device shown;

[0049] Figures 3A - 3D show perspective views of other examples of the decompression device;

[0050] Figure 4 Show Figure 1 A perspective view of the wire winding device of the skin and soft tissue external expansion device shown;

[0051] Figures 5A - 5B Show Figure 4 A perspective view and a side view of the wire winder of the wire winding device shown;

[0052] Figure 6 Show Figure 4 A perspective view of the wire winder sleeve of the wire winding device shown;

[0053] Figure 7 Show Figure 4 A perspective view of the wire winder handle of the wire winding device shown;

[0054] Figures 8A - 8E Show Figure 1 The operation method of the skin and soft tissue external expansion device shown;

[0055] Figures 9A - 9B A perspective view and a side view of another example of the wire winder; and

[0056] Figure 10 A perspective view of yet another example of the wire winder. DETAILED DESCRIPTION

[0057] 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 disclosure of the present disclosure more complete and to fully explain 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 more additional embodiments.

[0058] It should be understood that in all the drawings, the same reference numerals represent the same elements. In the drawings, for clarity, the dimensions of some features may be distorted.

[0059] It should be understood that the terminology used in the specification is only for describing specific embodiments and is not intended to limit the present disclosure. All terms used in the specification (including technical terms and scientific terms) have the meanings commonly understood by those skilled in the art unless otherwise defined. For the sake of brevity and / or clarity, well-known functions or structures may not be described in detail.

[0060] The singular forms "a", "the", and "said" used in the specification include the plural forms unless clearly specified. The terms "comprising", "including", and "containing" 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 related listed items. The phrases "between X and Y" and "between about X and Y" used in the specification should be interpreted to include X and Y. The phrase "between about X and Y" used in this specification means "between about X and about Y", and the phrase "from about X to Y" used in this specification means "from about X to about Y".

[0061] In the specification, when an element is said to be "on", "attached" to, "connected" to, "coupled" to, or "in contact" with another element, etc., the element can be directly on, attached to, connected to, coupled to, or in contact with the other element, or there may be an intermediate element. In contrast, when an element is said to be "directly" on, "directly attached" to, "directly connected" to, "directly coupled" to, or "directly in contact" with another element, there will be no intermediate element. In the specification, a feature being arranged "adjacent" to another feature may mean that the feature has a part overlapping with the adjacent feature or a part located above or below the adjacent feature.

[0062] In the specification, spatial relationship terms such as "upper", "lower", "left", "right", "front", "rear", "high", "low", etc. may describe the relationship between one feature and another feature in the drawings. It should be understood that spatial relationship terms include not only the orientations shown in the drawings but also different orientations during the use or operation of the device. For example, when the device in the drawing is inverted, a feature originally described as "below" other features may then be described as "above" the other features. The device can also be oriented in other ways (rotated 90 degrees or in other orientations), and the relative spatial relationships will be correspondingly interpreted at that time.

[0063] Figure 1 The schematic diagram of the usage state of the skin and soft tissue external expansion device according to the present disclosure is shown. As shown in the figure, the skin and soft tissue external expansion device includes a decompression device 2 and a wire winding device 3 connected by a flexible wire 1. The decompression device 2 and the wire winding device 3 are removably fixed to the marginal skin on opposite sides of the wound surface through the flexible wire 1, and together with the flexible wire 1, pull the marginal skin on both sides towards each other. The decompression device 2 is used to slow down the pressure generated on the skin by the pulling of the flexible wire 1. The wire winding device 3 is used on the one hand to slow down the pressure generated on the skin by the pulling of the flexible wire 1, and on the other hand to control the total length of the flexible wire 1 extending between the decompression device 2 and the wire winding device 3, thereby controlling the relative distance between the two sides of the skin. The flexible wire 1 can be a continuous wire, and for example, it can be a surgical suture, a steel wire, a nylon wire, etc.

[0064] As Figure 2 shown, the decompression device 2 includes an elongated hollow body 21, and the body 21 includes two opposite open ends 22 and 23 along the elongated direction for the flexible wire 1 to pass through. The outer side wall of the body 21 abuts against the marginal skin of the wound surface. The flexible wire 1 from the wire winding device 3 passes through the marginal skin of the wound surface, enters the body 21 from one of the open ends 22, traverses the entire interior of the body 21, leaves the body 21 from the other open end 23, penetrates into the marginal skin of the wound surface again, and finally reaches the wire winding device 3. In other words, the flexible wire 1 is arranged in a U-shaped configuration, and the bottom of the U abuts against the inner side wall of the body 21, while the two protruding segments of the U leave the open ends 22 and 23 of the body 21, penetrate into the marginal skin on one side of the wound surface, span the entire wound surface, penetrate into the marginal skin on the opposite side of the wound surface, and finally reach the wire winding device 3. The outer side wall of the body 21 increases the contact area between the flexible wire 1 and the skin, slows down the huge pressure generated on the skin by the pulling of the flexible wire 1, thereby avoiding 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 body 21 to measure the pressure and / or tension applied by the decompression device 2 to the skin.

[0065] The outer cross-section of the main body 21 can be generally circular, oval, or any other suitable shape. The main body 21 can be made of a compliant material, such as a silicone material, a resin material, a rubber material, etc.

[0066] In an alternative embodiment, as shown in FIGS. 3A-3D, the decompression device 2 can include an elongated solid main body 24, and the main body 24 includes a plurality of through holes 25 that pass through the main body 24 transversely to the elongation direction for the flexible wire 1 to pass through. The outer sidewall of the main body 24 abuts against the skin at the wound edge. The flexible wire 1 from the wire take-up device 3 passes through the skin at the wound edge, passes through one of the through holes 25 in a direction away from the skin, travels along the outer sidewall of the main body 24, passes through another through hole 25 in a direction towards the skin, penetrates into the skin at the wound edge again, and finally reaches the wire take-up device 3. In other words, the flexible wire 1 is arranged in a U-shaped configuration, and the bottom of the U abuts against the outer sidewall of the main body 24, while the two protruding segments of the U pass through the two through holes 25 of the main body 24, penetrate into the edge skin on one side of the wound, span the entire wound, penetrate out of the edge on the opposite side of the wound, and finally reach the wire take-up device 3. The outer sidewall of the main body 24 increases the contact area between the flexible wire 1 and the skin, reducing the huge pressure exerted on the skin by the pulling of the flexible wire 1, thereby avoiding potential damage to the skin caused by the flexible wire 1. In some embodiments, a pressure and / or tension sensor (not shown) can be provided on the main body 24 to measure the pressure and / or tension exerted by the decompression device 2 on the skin.

[0067] As shown in FIGS. 3A-3D, the plurality of through holes 25 can be two through holes, four through holes, or any other number of through holes. The adjacent through holes 25 can be evenly spaced or unevenly spaced. Two suitable through holes can be selected according to the required width between the two protruding segments of the flexible wire 1 for the flexible wire 1 to pass through. In some embodiments, in addition to having the through holes 25, the main body 24 further has a plurality of micro holes 26 with a diameter smaller than that of the through holes 25. The plurality of micro holes 26 penetrate through the main body 24, and the hollowed-out arrangement of the plurality of micro holes can relieve local skin pressure and facilitate skin ventilation.

[0068] The main body 24 can be generally spindle-shaped, capsule-shaped, cylindrical-shaped, or any other suitable shape. The main body 24 can be made of a compliant material, such as a silicone material, a resin material, a rubber material, etc.

[0069] Figure 4 A perspective view of the wire take-up device 3 is shown. As shown, the wire take-up device 3 includes a wire take-up reel 4 and a wire take-up reel sleeve 5, and the wire take-up reel 4 is accommodated in the wire take-up reel sleeve 5. The wire take-up reel 4 is used to control the total length of the flexible wire 1 extending between the decompression device 2 and the wire take-up device 3, and the wire take-up reel sleeve 5 is used to reduce the pressure exerted on the skin by the pulling of the flexible wire 1 and the compression of the wire take-up reel 4.

[0070] As Figure 5A and 5B shown, the wire winder 4 includes a wire end fixing part 41 and a winding part 42 connected to each other. The wire end fixing part 41 is used to fix a length on two extended segments of the flexible wire 1, and the winding part 41 is used to wind the flexible wire 1, so as to control the length of the flexible wire extending between the decompression device 2 and the wire end fixing part 41. The wire end fixing part 41 includes an elongated main body 43. The main body 43 is provided with a through hole 44 transversely passing through the middle thereof for removably receiving the wire winder handle 6 (to be described in detail below). The main body 43 is provided with slots 45 at its opposite ends. The two slots 45 are recessed inward from the outer surface of the main body 43 for receiving and fixing a length on two extended segments of the flexible wire 1. The distance between two opposite surfaces of each slot 45 can be kept substantially constant, or can gradually become smaller from the outer edge to the center (for example, see Figure 5B ), and the minimum distance between the two opposite surfaces is less than the diameter of the flexible wire 1. The flexible wire 1 can elastically enter the minimum distance between the two opposite surfaces of the slot 45 and be clamped at the minimum distance. The main body 43 can be generally cylindrical, capsule-shaped, or any other suitable shape. In some embodiments, a reinforcing member 48 can be provided at a portion of the main body 43 near the through hole 44 to increase the strength of the main body 43.

[0071] The winding part 42 includes a winding post 46 for winding the flexible wire 1. One end of the winding post 46 is connected to the main body 43 of the wire end fixing part 41, and the opposite end is provided with a flange 47 extending transversely to the winding post 46 to prevent the wound flexible wire 1 from slipping off the winding post 46. The winding part 42 can be integrally formed with the wire end fixing part 41, or can be separately formed and connected and fixed together by any known method (such as welding, threaded connection, snap connection, bonding, etc.).

[0072] As Figure 6As shown, the thread take-up sleeve 5 includes a hollow cylinder 51, and the cylinder 51 includes two opposite open ends 52 and 53, and an opening 54 leading to the interior on the outer sidewall of the cylinder 51. The outer sidewall of the cylinder 51 abuts against the skin at the wound edge, and the thread take-up device 4 is placed inside the cylinder 51 through the opening 54. Two extending segments of the flexible wire 1 enter the interior of the cylinder 51 through the open ends 52 and 53, and are fixed into the slot 45 of the thread take-up device 4. The outer sidewall of the cylinder 51 increases the contact area between the thread take-up device 4 and the skin, reducing the huge pressure on the skin caused by the pulling of the flexible wire 1 and the compression of the thread take-up device 4, thereby avoiding potential damage to the skin caused by the flexible wire 1 and the thread take-up device 4. In some embodiments, a pressure and / or tension sensor (not shown) may be provided on the cylinder 51 to measure the pressure and / or tension applied by the thread take-up device 3 to the skin. In some embodiments, a pressure display module 56 may be provided on the outer sidewall of the cylinder 51 and electrically connected to the pressure and / or tension sensor of the pressure relief device 2 and / or the thread take-up device 3 in a wired or wireless manner to display the pressure and / or tension value measured by the pressure / tension sensor.

[0073] The outer cross-section of the cylinder 51 may be generally circular, elliptical, or any other suitable shape. The cylinder 51 may be made of a compliant material, such as a silicone material, a resin material, a rubber material, etc.

[0074] The thread take-up sleeve 5 may further include a thread take-up band 55. The thread take-up band 55 is used to cover and fix the thread take-up device 4 from above the opening 54 to prevent the thread take-up device 4 from rotating and / or disengaging from the interior of the cylinder 51 due to the pulling of the wound flexible wire 1. The thread take-up band 55 may be integrally formed with the cylinder 51, and one end thereof is integrally connected to the edge of the opening 54, while the other end may be removably fixed to the outer sidewall of the cylinder 51 by any known method (such as bonding, snap-fastening, etc.). In other embodiments, the thread take-up band 55 may be separately formed from the cylinder 51, and its opposite ends are removably fixed to the outer sidewall of the cylinder 51 by any known method (such as bonding, snap-fastening, etc.).

[0075] As Figure 7 shown, the thread take-up device 3 may further include a thread take-up handle 6 separate from the thread take-up device 4. The thread take-up handle 6 is used to operate the thread take-up device 4 to rotate so as to wind the flexible wire 1 around the winding portion 42. As shown in the figure, the thread take-up handle 6 includes an operating rod 61, a connecting column 62, and an insertion rod 63. The operating rod 61 is for the operator's hand to hold. The connecting column 62 extends transversely to the operating rod 61, and one end thereof is fixed to the operating rod 61 (such as the middle part), while the opposite end is fixed to the end of the insertion rod 63. The insertion rod 63 is used to insert into the through-hole 44 of the thread take-up device 4 to drive the thread take-up device 4 to rotate, thereby winding the flexible wire 1 around the winding column 46 of the thread take-up device 4.

[0076] Refer to the following Figures 8A - 8E The method of operating the skin soft tissue expansion device according to the present disclosure is described. Figure 8A As shown, first, the flexible wire 1 is passed through the two open ends 22 and 23 to cross the interior of the hollow body 21 of the decompression device 2, or the flexible wire 1 is passed through the two spaced through holes 25 of the solid body 24 of the decompression device 2. Afterwards, the two extended sections of the flexible wire 1 are respectively penetrated into the edge skin on one side of the wound surface by a needle, spanning the entire wound surface, and passing out from the edge skin on the other side of the wound surface. The two extended sections of the flexible wire 1 are passed through the two open ends 52 and 53 of the cylinder 51 of the take-up sleeve 5, and pass out from the opening 54 of the cylinder 51. The take-up sleeve 4 is placed into the interior of the cylinder 51 through the opening 54, and the two extended sections of the flexible wire 1 are clamped into the two opposite narrow slots 45 of the take-up sleeve 4 in a relatively tight manner. Thus, the decompression device 2 and the take-up sleeve 3 are fixed on the edge skin on both sides of the wound surface through the flexible wire 1.

[0077] like Figures 8B - 8D As shown, the insertion rod 63 of the wire take-up handle 6 is inserted into the through hole 44 of the wire take-up 4, and the wire take-up 4 is slightly lifted out of the cylinder 51 of the wire take-up sleeve 5 and rotated, so that the flexible wire 1 is wound around the winding post 46 of the wire take-up 4 to reduce the length of the flexible wire 1 between the decompression device 2 and the wire take-up device 3, thereby reducing the relative distance between the skin on both sides. After winding, the wire take-up 4 is put back into the cylinder 51 through the opening 54, and the insertion rod 63 of the wire take-up handle 6 is removed from the through hole 44 of the wire take-up 4. The wire take-up belt 55 is used to cover and fix the wire take-up 4 from above the opening 54, and the free end of the wire take-up belt 55 is removably fixed to the outer wall of the cylinder 51. The initial placement of the skin soft tissue external expansion device is thus completed.

[0078] Later, when it is necessary to adjust (e.g., reduce or increase) the relative distance between the edge skins on both sides of the wound surface, the wire take-up belt 55 is removed from above the opening 54. The insertion rod 63 of the wire take-up handle 6 is inserted into the through hole 44 of the wire take-up 4, and the wire take-up 4 is slightly lifted out of the cylinder 51 of the wire take-up sleeve 5 and rotated, so that the flexible wire 1 is wound around the winding post 46 of the wire take-up 4 or unwound from the winding post 46 of the wire take-up 4. Afterwards, the wire take-up 4 is put back into the cylinder 51 through the opening 54, and the insertion rod 63 of the wire take-up handle 6 is removed from the through hole 44 of the wire take-up 4. The wire take-up belt 55 is used to cover and fix the wire take-up 4 from above the opening 54, and the free end of the wire take-up belt 55 is removably fixed to the outer side wall of the cylinder 51. In this way, the relative distance between the edge skins on both sides of the wound surface is adjusted.

[0079] Figure 9A and 9BSchematic diagram of the take-up device 104 according to another embodiment of the present disclosure, wherein the take-up device 104 will be represented by adding 100 to the reference numerals in the drawings of the take-up device 4 for the same or similar structures. The take-up device 104 can be used together with Figure 6 the take-up sleeve 5 shown, and Figure 2 any one of the decompression devices 2 shown in FIGS. 3A - 3D. The take-up device 104 is accommodated in the take-up sleeve 5. The take-up device 104 is used to control the total length of the flexible wire 1 extending between the decompression device 2 and the take-up device 3, and the take-up sleeve 5 is used to reduce the pressure on the skin caused by the pulling of the flexible wire 1 and the pressing of the take-up device 104.

[0080] As shown in the figure, the take-up device 104 includes a wire head fixing part 141, a winding part 142, and a handle part 148 that are connected to each other. The wire head fixing part 141 is used to fix a length of one of the two protruding segments of the flexible wire 1; the winding part 142 is used to wind the flexible wire 1, thereby controlling the length of the flexible wire extending between the decompression device 2 and the wire head fixing part 141; and the handle part 148 is used to operate the take-up device 104 to rotate so as to wind the flexible wire 1 around the winding part 142.

[0081] The wire head fixing part 141 includes an elongated body 143. The body 143 is provided with slots 145 at its opposite ends. The two slots 145 are recessed inward from the outer surface of the body 143 for fixing the two protruding segments of the flexible wire 1. The distance between the two opposite surfaces of the slot 145 can be kept substantially constant, or can gradually decrease from the outer edge to the center (for example, see Figure 9B ), and the minimum distance between the two opposite surfaces is less than the diameter of the flexible wire 1. The flexible wire 1 can elastically enter the minimum distance between the two opposite surfaces of the slot 145 and be clamped at this minimum distance. The body 143 can be generally cylindrical, capsule-shaped, or any other suitable shape. In some embodiments, see Figure 10 , a pin hole 149 is provided between the two opposite surfaces of the slot 145, and the size of the pin hole 149 can be larger than the maximum distance between the two opposite surfaces of the slot 145. The pin hole 149 can removably receive a pin (not shown), and the pin can block the flexible wire 1 clamped in the slot 145 from detaching from the slot 145 along the direction parallel to the opposite surfaces of the slot 145. The pin hole 149 can also be applicable to the structure of the slot 45.

[0082] The winding part 142 includes a winding column 146 for winding the flexible wire 1. One end of the winding column 146 is connected to the lower part of the body 143 of the wire head fixing part 141, and the opposite end is provided with a flange 147 protruding transversely to the winding column 146 to prevent the wound flexible wire 1 from slipping out of the winding column 146.

[0083] The handle portion 148 includes an operating rod 161 and a connecting column 162. The operating rod 161 is for an operator's hand to hold. The connecting column 162 extends transversely to the operating rod 161, and one end is fixed to the operating rod 161 (such as its middle part), while the opposite end is fixed to the upper part of the main body 143 of the wire head fixing portion 141.

[0084] The wire head fixing portion 141, the wire winding portion 142, and the handle portion 148 can be integrally formed, or can be separately formed and fixed together by any known method (such as welding, threaded connection, snap connection, bonding, etc.).

[0085] The operation method of the skin soft tissue external expansion device including the wire take-up device 104 is basically similar to that of the skin soft tissue external expansion device including the wire take-up device 4, but the steps of inserting the insertion rod 63 of the wire take-up handle 6 into the through hole 44 of the wire take-up device 4 and removing it from the through hole 44 of the wire take-up device 4 are omitted.

[0086] The pulling wire of the skin soft tissue external expansion device according to the present disclosure adopts a U-shaped wiring method, and the bottom section of the U shape is connected to the decompression device, while the two protruding sections of the U shape are connected to the wire take-up device. The two protruding sections of the U shape are substantially parallel, so as to be able to generate a relatively balanced pulling force on the skin.

[0087] The pulling wire of the skin soft tissue external expansion device according to the present disclosure plays a dual role, that is, it is not only used to fix the decompression device and the wire take-up device on the edge skin on both sides of the wound surface, but also used to pull the decompression device and the wire take-up device towards each other.

[0088] The skin soft tissue external expansion device according to the present disclosure uses the decompression device and the wire take-up sleeve to contact the skin on both sides of the wound surface. The contact area between the decompression device and the wire take-up sleeve and the skin is large, thus alleviating the huge pressure generated by the pulling of the flexible wire on the skin.

[0089] The skin soft tissue external expansion device according to the present disclosure uses a simple rotation operation to adjust the distance between the skins on both sides of the wound surface. The operation steps are simple, reducing the time and labor costs required for adjustment.

[0090] The skin soft tissue external expansion device according to the present disclosure is small in volume and can be widely applied to wound surfaces in various parts, such as under the arm, etc.

[0091] The skin soft tissue external expansion device according to the present disclosure has a simple structure and a small number of components, thus greatly reducing the manufacturing cost.

[0092] While exemplary embodiments of the present disclosure have been described, those skilled in the art will appreciate that various changes and modifications can be made to the exemplary embodiments of the present disclosure without departing from the spirit and scope of the present disclosure in essence. Accordingly, all such changes and modifications are included 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 also included.

Claims

1. A skin and soft tissue external expansion device, which is used for repairing wounds or tissue reconstruction, characterized in that, The skin and soft tissue external expansion device includes: A decompression device, which is fixed to the skin at the edge of the first side of the wound surface by a flexible wire and is elongated. The flexible wire is arranged in a U shape, and the bottom of the U shape abuts against the side wall of the decompression device; and A wire winding device, which is fixed to the skin at the edge of the second side of the wound surface opposite to the first side by the flexible wire and is connected to the decompression device through the flexible wire. The wire winding device includes a wire winder sleeve placed on the edge skin and a wire winder received in the wire winder sleeve. The wire winder includes a wire head fixing part and a wire winding part connected to each other. The wire head fixing part is provided with a slot configured to receive and fix a length of one of the two protruding segments of the U shape of the flexible wire. The wire winding part includes a wire winding column configured to wind the flexible wire between the decompression device and the wire head fixing part to control the length of the flexible wire between the decompression device and the wire winding device.

2. The skin and soft tissue external expansion device according to claim 1, wherein The decompression 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 external expansion device according to claim 2, wherein, The bottom of the U shape of the flexible wire abuts against the inner side wall of the decompression device, while the two protruding segments of the U shape of the flexible wire leave the two opposite open ends of the decompression device and extend towards the wire winding device.

4. The skin and soft tissue external expansion device according to claim 2 or 3, characterized in that The outer cross-section of the decompression device is generally circular or elliptical.

5. The skin and soft tissue external expansion device according to claim 2 or 3, characterized in that, The decompression device is made of a compliant material.

6. The skin and soft tissue external expansion device according to claim 1, wherein The decompression device is solid and includes a plurality of through holes passing through it transversely to the elongated direction.

7. The skin and soft tissue external expansion device according to claim 6, wherein, The bottom of the U shape of the flexible wire abuts against the outer side wall of the decompression device, while the two protruding segments of the U shape of the flexible wire pass through two of the plurality of through holes of the decompression device and extend towards the wire winding device.

8. The skin and soft tissue external expansion device according to claim 6 or 7, characterized in that, The adjacent through holes among the plurality of through holes are evenly spaced from each other or unevenly spaced from each other.

9. The skin and soft tissue external expansion device according to claim 6 or 7, characterized in that, The decompression device has a plurality of micropores with a diameter smaller than the through holes.

10. The skin and soft tissue external expansion device according to claim 6 or 7, characterized in that, The decompression device is generally spindle-shaped, capsule-shaped or cylindrical.

11. The skin and soft tissue external expansion device according to claim 6 or 7, characterized in that, The decompression device is made of a compliant material.

12. The skin and soft tissue external expansion device according to claim 1, wherein The wire head fixing part is elongated and is provided with the slot at both of its opposite ends.

13. The skin and soft tissue external expansion device according to claim 12, wherein The slot is configured to be recessed inward from the outer surface of the wire head fixing part.

14. The skin and soft tissue external expansion device according to claim 12, characterized in that, The distance between the two opposite surfaces of each slot remains generally constant and is smaller than the diameter of the flexible wire.

15. The skin and soft tissue external expansion device according to claim 12, characterized in that, The distance between the two opposite surfaces of each slot gradually decreases from the outer edge to the center, and the minimum distance between the two opposite surfaces is smaller than the diameter of the flexible wire.

16. The skin and soft tissue external expansion device according to claim 12, characterized in that, A pin hole is provided between the two opposite surfaces of the slot, and the size of the pin hole is larger than the maximum distance between the two opposite surfaces of the slot.

17. The skin and soft tissue external expansion device according to claim 16, wherein The pin hole is configured to removably receive a pin, and the pin can block the flexible wire clamped in the slot from disengaging from the slot along the direction parallel to the opposite surfaces of the slot.

18. The skin and soft tissue external expansion device according to claim 12, wherein The wire head fixing part is generally cylindrical or capsule-shaped.

19. The skin and soft tissue external expansion device according to claim 12, wherein One end of the wire winding column is connected to the wire head fixing part, and the opposite end is provided with a flange protruding transversely to the wire winding column.

20. The skin and soft tissue external expansion device according to any one of claims 12-19, characterized in that, The wire winding device further includes a wire winder handle separate from the wire winder, and the wire winder handle is configured to operate the wire winder to rotate to wind the flexible wire on the wire winding part.

21. The skin and soft tissue external expansion device according to claim 20, characterized in that, The wire winder handle includes an operating rod, an insertion rod, and a connecting column connecting the operating rod and the insertion rod.

22. The skin and soft tissue external expansion device according to claim 21, wherein, The wire head fixing part is provided with a through hole for the insertion rod to be inserted.

23. The skin and soft tissue external expansion device according to claim 20, wherein The winding part and the lead wire fixing part are integrally formed.

24. The skin and soft tissue external expansion device according to claim 20, wherein, The winding part and the lead wire fixing part are separately formed and then connected and fixed together.

25. The skin and soft tissue external expansion device according to any one of claims 12-19, characterized in that, The wire rewinder further includes a handle part connected to the lead wire fixing part.

26. The skin and soft tissue external expansion device according to claim 25, wherein The handle part includes an operating rod and a connecting column, and one end of the connecting column is fixed to the operating rod while the opposite end is fixed to the lead wire fixing part.

27. The skin and soft tissue external expansion device according to claim 25, wherein The lead wire fixing part, the winding part and the handle part are integrally formed.

28. The skin and soft tissue external expansion device according to claim 25, characterized in that, The lead wire fixing part, the winding part and the handle part are separately formed and then connected and fixed together.

29. The skin and soft tissue external expansion device according to claim 1, characterized in that, The wire rewinder sleeve includes a hollow cylindrical body, and the cylindrical body includes two opposite open ends and an opening on the outer side wall of the cylindrical body.

30. The skin and soft tissue external expansion device according to claim 29, characterized in that, The wire rewinder is placed inside the cylindrical body through the opening, and the two protruding sections of the U-shaped flexible wire pass through the two opposite open ends of the cylindrical body and are fixed to the lead wire fixing part of the wire rewinder.

31. The skin and soft tissue external expansion device according to claim 29 or 30, characterized in that, The pressure display module is arranged on the outer side wall of the cylindrical body and is electrically connected to the pressure and / or tension sensor of the pressure reducing device, and / or the pressure and / or tension sensor of the wire rewinding device and / or the cylindrical body in a wired or wireless manner.

32. The skin and soft tissue external expansion device according to claim 29 or 30, characterized in that, The outer cross-section of the cylindrical body is generally circular or oval.

33. The skin and soft tissue external expansion device according to claim 29 or 30, characterized in that, The cylindrical body is made of a compliant material.

34. The skin and soft tissue external expansion device according to claim 29 or 30, characterized in that The wire rewinder sleeve further includes a wire rewinder belt, and the wire rewinder belt is configured to cover and fix the wire rewinder from above the opening.

35. The skin and soft tissue external expansion device according to claim 34, wherein, The wire rewinder belt is integrally formed with the cylindrical body. One end of the wire rewinder belt is integrally connected to the edge of the opening, and the other end is removably fixed to the outer side wall of the cylindrical body.

36. The skin and soft tissue external expansion device according to claim 34, wherein, The wire rewinder belt is separately formed from the cylindrical body, and its opposite ends are removably fixed to the outer side wall of the cylindrical body.

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