Device and method for harvesting discarded limbs and creating soft tissue stumps during amputation.

Abstract

This invention discloses a device and method for harvesting and preparing soft tissue from discarded limbs during amputation, belonging to the field of medical device technology. This invention aims to solve the problems of existing autologous fascia lata harvesting methods, which rely on surgeon experience, lack standardized instruments, and struggle to simultaneously control the size, curvature, and moisture state of the excised fascia sheet, resulting in wasted fascia lata resources from discarded limbs. This invention includes a fascia lata dissector, a multi-stage cutting template, a pre-formed tray, and elastic clamps; the dissector has a detachable longitudinal cutter, the pre-formed tray has a shallow concave curved area and a saline moisturizing groove, and the elastic clamps circumferentially hold the tissue in place. The procedure is performed concurrently with the main surgery under the assistance of a second assistant, resulting in a short procedure time. This invention can standardize the preparation of autologous fascia lata sleeve semi-finished products, eliminating the need for exogenous materials, improving the quality of soft tissue shaping at the stump, and enhancing prosthesis fit.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a device and method for collecting and preparing soft tissue from discarded limbs during amputation. Background Technology

[0002] Amputation is a crucial clinical treatment for severe limb trauma, malignant tumors, and irreversible ischemic necrosis of the limb. The long-term functional recovery of the stump and the comfort of the prosthesis directly depend on the quality of the stump soft tissue shaping. The surface of the stump soft tissue not only needs to cover the deep bony structures and muscle ends but also needs to withstand repeated pressure, shear forces, and relative displacement during long-term use of the prosthesis socket. If the stump soft tissue has an irregular contour, uneven local thickness, or lacks a stable support interface between the deep fascia and subcutaneous tissue, it can lead to poor fit between the prosthesis socket and the stump, sudden changes in local pressure, and consequently, a series of complications such as muscle retraction, subcutaneous tissue slippage, tenderness and ulceration of the skin in bony prominence areas, and potential dead space formation, severely impacting the patient's quality of life.

[0003] Currently, clinical methods for improving the quality of soft tissue reshaping of stumps mainly include myoplasty, muscle fixation, and reinforcement with autologous fascia or artificial patches. However, these methods still face many engineering and technical challenges in clinical application. Firstly, the intraoperative harvesting of autologous fascia is highly dependent on the surgeon's personal experience and lacks standardized instrument control methods. When the surgeon manually dissects the fascia, it is difficult to accurately control the dissection depth, resulting in uneven thickness, irregular edges, and insufficient area of ​​the obtained fascia sheets. The quality of fascia sheets varies significantly between different surgeons and between different surgeries performed by the same surgeon, making it impossible to achieve repeatable shaping results.

[0004] Secondly, the completely severed limb segments (especially the thigh segments) from amputations contain autologous fascia lata tissue that is anatomically continuous, large in area, and possesses excellent mechanical properties. This tissue originates from the same patient and the same surgical procedure, offering natural advantages such as no immune rejection, no need for additional donor sites, and immediate availability, making it an ideal material for covering the soft tissue surface of the limb stump. However, current clinical procedures only focus on the proximal end of the stump, lacking a standardized system for identifying, harvesting, cutting, and preforming fascia lata resources from the severed limb segments. This results in a large amount of high-quality autologous tissue being discarded along with the limb, leading to a waste of medical resources.

[0005] Third, ex vivo fascia lata sheets possess natural curling, resilience, and edge drift characteristics. Simply relying on the surgeon's freehand cutting and temporary fixation cannot simultaneously meet the comprehensive requirements of the soft tissue flap at the stump for thickness, size, curvature, and wettability. The lack of specialized preforming and shaping instruments makes it difficult to prepare a shallow curvature fascia sheet matching the stump diameter within the limited intraoperative time window.

[0006] Fourth, while using artificial patches or exogenous scaffold materials to reinforce the stumps can improve the soft tissue shaping effect to some extent, it can also introduce problems such as immune rejection, long-term degradation byproducts, and increased risk of infection. In addition, it can significantly increase the patient's medical expenses and is limited by the stability of the material supply chain.

[0007] Therefore, there is an urgent clinical need for a standardized instrument kit and corresponding ex vivo preparation method specifically for the reuse of autologous fascia lata of discarded limbs in amputation. This kit should be able to quickly and efficiently prepare semi-finished autologous fascia lata soft tissue surface coverings with precise dimensions, matching curvature, stable shape, and good moisture condition without affecting the main surgical procedure. Summary of the Invention

[0008] This invention provides an apparatus and method for harvesting and creating stump soft tissue in amputation surgery, which addresses the problems in the above-mentioned background art, such as the lack of standardized instruments for harvesting autologous fascia lata in surgery, the difficulty in simultaneously controlling the size, curvature and moisture status of the ex vivo fascia sheet, reliance on the surgeon's experience and difficulty in reproducibility.

[0009] To achieve the above objectives, in a first aspect, the present invention provides the following technical solution: an apparatus for harvesting and preparing stump soft tissue from discarded limbs during amputation, comprising a fascia lata dissector, a multi-stage cutting template, and at least one pre-forming tray. The pre-forming tray has a shallow concave curved surface area and an outwardly extending supporting edge portion surrounding the shallow concave curved surface area. The outwardly extending supporting edge portion has multiple through-grooves surrounding the shallow concave curved surface area, and elastic claws pass through these grooves. The openings of the claws face the shallow concave curved surface area for fixing a fascia lata sheet onto the shallow concave curved surface area. The multi-stage cutting template has multiple cutting through-grooves around its center, through which the fascia lata sheet is... The combination of a fascia dissector, multi-level cutting template, pre-formed tray, and elastic clamps constitutes a complete integrated instrument system, realizing the standardization and mechanization of the entire process of reusing discarded fascia lata, and changing the traditional non-standard operation mode that relies on the surgeon's experience. The shallow concave curved area of ​​the pre-formed tray can provide a standardized shallow curvature forming benchmark for the fascia sheet, so that the fascia sheet is pre-formed into an arc that matches the outer periphery of the stump, solving the problem that the naturally curled detached fascia sheet is difficult to fit the stump. The outwardly expanded support edge provides a stable installation base for the elastic clamps, while avoiding interference with the forming effect of the shallow concave curved area when the clamps are holding it.

[0010] Preferably, the bottom of the shallow concave curved area is provided with multiple saline moisturizing grooves. The saline moisturizing grooves can store sterile physiological saline and continuously provide a moist environment for the isolated fascia lata sheet through capillary action, preventing the fascia sheet from drying out, shrinking, and hardening due to water evaporation, and maintaining its good elasticity and mechanical properties.

[0011] Preferably, the saline moisturizing groove is a long, shallow groove, and the arrangement of the long, shallow groove can be any combination of concentric circles, radial lines, or grids. The long, shallow structure can increase the storage capacity of saline and the contact area with the fascia sheet, thereby improving the continuity and uniformity of the moisturizing effect. The shallow groove design will not disrupt the smooth transition of the shallow concave curved surface area and avoid leaving indentations on the fascia sheet. The combination of various forms can further optimize the moisturizing performance and meet different clinical needs.

[0012] Preferably, the planar projection shape of the outer support edge is square or polygonal. Square or polygonal outer support edges have good stability and are not easy to roll or tip over when placed on the operating table.

[0013] Preferably, the preformed tray comes in three types, with the diameter of the limb stump corresponding to the curvature of its shallow concave curved area being Φ60mm, Φ80mm, and Φ100mm, covering the diameter range of most adult amputation stumps in clinical practice, and providing a precisely matched shallow curvature preformed reference for patients of different body types.

[0014] Preferably, the preformed tray has a base at its bottom, and the lower end surface of the base is flat. The flat base can significantly improve the stability of the preformed tray when placed on the operating table, prevent it from tipping over or sliding during operation, and ensure the accuracy of the preforming and shaping process.

[0015] Preferably, the fascia lata dissector includes a horizontal section and a handle section connected to one end of the horizontal section. The other end of the horizontal section is provided with a horizontal blade section. A detachable longitudinal cutter is installed on the horizontal section near the horizontal blade section. The longitudinal cutter passes through the horizontal section from top to bottom. The horizontal blade section is used to perform horizontal dissection along the direction of the fascia lata fibers, which can obtain a large area of ​​fascia sheet with uniform thickness and avoid damage to deep tissues. The longitudinal cutter longitudinally cuts the edge of the fascia sheet, which facilitates the complete separation of the fascia sheet from the abandoned limb and improves the dissection efficiency. When using it, the outline of the fascia sheet can be cut out with the longitudinal cutter first, and then the longitudinal cutter can be removed. The horizontal blade section can be inserted horizontally under the skin to remove the fascia sheet.

[0016] Preferably, the longitudinal cutter includes a horizontal mounting part and a vertical cutting edge part. The horizontal mounting part is embedded in a groove on the horizontal part and locked in place by screws. The vertical cutting edge part passes through the horizontal part, which can effectively prevent the longitudinal cutter from loosening or shifting during the peeling process and ensure cutting accuracy. Disassembly is convenient; the longitudinal cutter can be removed for cleaning or replacement simply by loosening the screws.

[0017] Preferably, the preformed tray has a first center positioning mark at its center, and the multi-stage cutting template has a center positioning hole or a second center positioning mark at its center. The center positioning mark helps the surgeon to quickly and accurately align the center of the fascia sheet with the center of the cutting template and the preformed tray, ensuring that the cut fascia sheet is accurate in size and symmetrical at the edges, and that the force is evenly distributed during the preforming process, avoiding skewing or wrinkles. Furthermore, the second center positioning mark is used to align the center of the original fascia sheet during the cutting stage, and the first center positioning mark is used to align the center of the cut fascia sheet during the preforming stage, achieving consistent center positioning throughout the entire process.

[0018] In a second aspect, the present invention also provides a method for using the device described in the first aspect for harvesting and creating stump soft tissue in amputation surgery, the method being performed only on a discarded thigh segment that has been completely severed from the patient's body, comprising the following steps: S1. Debridement of the original fascia lata sheet: Select a longitudinal cutter of the corresponding size according to the actual measured diameter of the patient's stump and install it on the fascia lata dissector. Fix the discarded thigh segment on the operating table and use the fascia lata dissector to peel out the original fascia sheet of uniform thickness along the direction of the fascia lata fibers. S2. Standardized template cutting: Lay the peeled fascia lata sheet flat on a sterile operating table. Select the corresponding size cutting groove on the multi-level cutting template according to the diameter of the residual end, so that the center of the cutting groove is aligned with the center of the fascia lata sheet, and cut out a square fascia lata sheet along the edge of the cutting groove. S3. Shallow curvature preforming: Select the preforming tray with the corresponding curvature setting according to the diameter of the residual end. Align the center of the cut square ribbed diaphragm A with the first center positioning mark on the preforming tray and lay it flat on the shallow concave curved surface area. Insert multiple elastic claws into the grooves of the outwardly expanding support edge in sequence, so that the opening of the elastic claws faces the shallow concave curved surface area and clamps the edge of the square ribbed diaphragm A, so that the square ribbed diaphragm A completely fits the shallow concave curved surface area and forms a shallow curvature shape that matches the diameter of the residual end. S4. Moisturizing and Preservation and Finished Product Acquisition: Sterile physiological saline is injected into the saline moisturizing groove at the bottom of the shallow concave curved area of ​​the pre-formed tray to maintain the moist state of the square fascia lata sheet, thus obtaining the semi-finished product of the ex vivo autologous fascia lata soft tissue surface cover.

[0019] All procedures are performed on the severed, unusable limbs, causing no additional trauma to the patient and not affecting the surgeon's handling of the patient's stump, resulting in a high level of surgical safety.

[0020] Compared with the prior art, the beneficial effects of the present invention are: The multi-level square outer contour cutting templates standardize the size range of the finished sheet material; the fascia lata peeler is easy to operate and can completely peel off the fascia lata sheet. By combining the curvature grading of the shallow concave curved surface area with the outer support edge, the square fascia lata sheet can be pre-shaped with shallow curvature under in vitro conditions, so that the central area forms a shallow arc shape corresponding to the diameter grading of the residual end; the saline moisturizing groove keeps the in vitro fascia lata sheet moist during the preparation process; the interval distribution of the rounded non-puncture elastic claws on the outer support edge can maintain the unfolded shape of the square sheet during the shaping stage and reduce the shape drift caused by in vitro curling; the device can be used in parallel by the surgical assistant under the operating table, and the entire in vitro preparation process can be completed within 20 to 30 minutes, thereby reducing the time occupied by the main surgeon; autologous fascia lata does not introduce exogenous scaffolds or patch materials, avoiding the immunological and cost issues associated with exogenous materials. The apparatus and method of this invention, by forming a semi-finished autologous fascia lata shallow curvature sleeve corresponding to the diameter grade of the stump, can provide a standardized and repeatable morphological basis for the reconstruction of the soft tissue surface of the stump, making the soft tissue contour of the stump more continuous and reducing local morphological irregularities caused by sheet curling, inconsistent size or insufficient molding, thereby providing favorable structural conditions for subsequent fitting of the prosthesis cavity and long-term load-bearing stability of the stump. Attached Figure Description

[0021] Figure 1 This is a flowchart of the present invention; Figure 2 This is a three-dimensional structural diagram of the fascia lata peeler of the present invention; Figure 3 This is a front view structural diagram of the fascia lata peeler of the present invention; Figure 4 This is a partial cross-sectional view of the fascia lata peeler of the present invention; Figure 5 This is a schematic diagram of the multi-level cutting template of the present invention; Figure 6 This is a three-dimensional structural diagram of the preformed tray of the present invention; Figure 7 This is a front sectional view of the preformed tray of the present invention; Figure 8 This is a schematic diagram showing the installation state of the elastic claws of the preformed tray of the present invention.

[0022] Figure label: 1. Fascia lata peeler; 2. Multi-stage cutting template; 3. Outwardly expanding support edge; 4. Elastic claw; 5. Pre-formed tray; 6. Base; 7. Through slot; 8. Salt water moisturizing groove; 9. First center positioning mark; 10. Shallow concave curved surface area; 11. Longitudinal cutter; 12. Handle; 13. Horizontal part; 15. Screw; 16. Horizontal blade part; 22. Cutting through slot; 23. Second center positioning mark; 24. Connecting part; 41. Rounded clamping end; 42. Claw body; 111. Vertical blade part; 112. Horizontal mounting part; A. Fascia lata sheet. Detailed Implementation The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0023] like Figure 1-8 As shown, this invention addresses the problems in existing technologies, such as the lack of standardized instruments for autologous fascia lata harvesting, the difficulty in simultaneously controlling the size, curvature, and moisture state of ex vivo fascia sheets, reliance on surgeon experience, and difficulty in reproducibility. To achieve the above objectives, in a first aspect, this invention provides the following technical solution: a device for harvesting discarded limbs and creating stump soft tissue during amputation, comprising a fascia lata dissector 1, a multi-stage cutting template 2, and at least one pre-forming tray 5. The pre-forming tray 5 has a shallow concave curved area 10 and an outwardly extending supporting edge 3 surrounding the shallow concave curved area 10. Multiple slots 7 are provided on the outwardly extending supporting edge 3 around the shallow concave curved area 10. Elastic claws 4 pass through the slots 7, and the openings of the claws 4 face the shallow concave curved area. The surface area 10 is used to fix the fascia lata sheet A on the shallow concave curved surface area 10. The multi-level cutting template 2 is provided with multiple cutting through slots 22 around the center. Through the combination of the fascia lata peeler 1, the multi-level cutting template 2, the pre-forming tray 5 and the elastic claw, a complete integrated instrument system is constructed, realizing the standardization and mechanization of the entire process of reusing discarded fascia lata, changing the traditional non-standard operation mode that relies on the surgeon's experience. The shallow concave curved surface area 10 of the pre-forming tray 5 can provide a standardized shallow curvature forming benchmark for the fascia sheet, so that the fascia sheet is pre-formed into an arc that matches the outer periphery of the stump, solving the problem that the detached fascia sheet is difficult to fit the stump due to natural curling. The outwardly expanded supporting edge 3 provides a stable installation base for the elastic claw 4, while avoiding interference with the forming effect of the shallow concave curved surface area when the claw is clamped.

[0024] In this embodiment, the bottom of the shallow concave curved area 10 is provided with multiple saline moisturizing grooves 8. These grooves 8 can store sterile physiological saline, continuously providing a moist environment for the isolated fascia lata sheet through capillary action. This prevents the fascia sheet from drying out, shrinking, and hardening due to moisture evaporation, maintaining its good elasticity and mechanical properties. The saline moisturizing grooves 8 are elongated shallow grooves, arranged in any combination of concentric circles, radial lines, or a grid pattern. The elongated structure increases the amount of saline stored and the contact area with the fascia sheet, improving the continuity and uniformity of the moisturizing effect. The shallow groove design does not disrupt the smooth transition of the shallow concave curved area, avoiding indentations on the fascia sheet. Combinations of various shapes can further optimize moisturizing performance and meet different clinical needs.

[0025] In this embodiment, the planar projection shape of the outwardly expanding support edge 3 is square or polygonal. Square or polygonal outwardly expanding support edges have good stability and are not easily rolled or tipped over when placed on the operating table. In this embodiment, the pre-formed tray 5 comes in three types, with the diameters of the limb stumps corresponding to the curvature of its shallow concave curved surface area 10 being Φ60mm, Φ80mm, and Φ100mm. This covers the diameter range of most adult amputation stumps in clinical practice, providing a precisely matched shallow curvature pre-forming reference for patients of different body types. Specifically, the radius of curvature of the shallow concave curved surface area 10 of the pre-formed tray corresponding to a stump diameter of Φ60mm is 30mm, and the maximum concavity depth is 8mm; the radius of curvature of the shallow concave curved surface area 10 of the pre-formed tray corresponding to a stump diameter of Φ80mm is 40mm, and the maximum concavity depth is 11mm; the radius of curvature of the shallow concave curved surface area 10 of the pre-formed tray corresponding to a stump diameter of Φ100mm is 50mm, and the maximum concavity depth is 15mm.

[0026] In this embodiment, the bottom of the preformed tray 5 is provided with a base 6. The lower end surface of the base 6 is flat. The flat base can significantly improve the stability of the preformed tray placed on the operating table, prevent it from tipping over or sliding during operation, and ensure the accuracy of the preforming and shaping process. Specifically, the base 6 is a cylindrical structure with a diameter of 50mm and a height of 10mm. It is integrally formed with the preformed tray 5 body, and the lower end surface is polished.

[0027] In this embodiment, the fascia lata dissector 1 includes a horizontal part 13 and a handle part 12 connected to one end of the horizontal part 13. The other end of the horizontal part 13 is provided with a horizontal blade part 16. A detachable longitudinal cutter 11 is installed on the horizontal part 13 near the horizontal blade part 16. The longitudinal cutter 11 passes through the horizontal part 13 from top to bottom. The horizontal blade part 16 is used to perform horizontal dissection along the direction of the fascia lata fibers, which can obtain a large area of ​​fascia sheet with uniform thickness and avoid damage to deep tissues. The longitudinal cutter makes longitudinal cuts on the edge of the fascia sheet, which facilitates the complete separation of the fascia sheet from the abandoned limb and improves the dissection efficiency. When using it, the outline of the fascia sheet can be cut out with the longitudinal cutter 11 first, and then the longitudinal cutter can be removed. The horizontal blade part 16 can be inserted horizontally under the skin to remove the fascia sheet.

[0028] The longitudinal cutter 11 includes a horizontal mounting part 112 and a vertical cutting edge part 111. The horizontal mounting part 112 is embedded in a groove on the horizontal part 13 and is locked in place by a screw 15. The vertical cutting edge part 111 passes through the horizontal part 13, which can effectively prevent the longitudinal cutter from loosening or shifting during the peeling process and ensure cutting accuracy. It is easy to disassemble; the longitudinal cutter can be removed for cleaning or replacement simply by loosening the screw.

[0029] In this embodiment, the center of the preformed tray 5 is provided with a first center positioning mark 9, and the center of the multi-stage cutting template 2 is provided with a center positioning hole or a second center positioning mark 23. The center positioning mark can help the surgeon quickly and accurately align the center of the fascia sheet with the center of the cutting template and the preformed tray, ensuring that the cut fascia sheet is accurate in size and symmetrical at the edges, and that the force is evenly distributed during the preforming process, avoiding skewing or wrinkles; and the second center positioning mark 23 is used to align the center of the original fascia sheet during the cutting stage, and the first center positioning mark 9 is used to align the center of the cut fascia sheet during the preforming stage, achieving consistent center positioning throughout the entire process.

[0030] As a specific embodiment of this embodiment, such as Figure 2-8As shown, the fascia lata peeler 1 includes a handle portion 12 and a horizontal portion 13. Both the handle portion 12 and the horizontal portion 13 are made of 316L stainless steel and are at an obtuse angle for easy operation. A horizontal blade portion 16 is provided at the front end of the horizontal portion 13. The blade is hardened to a hardness of HRC45-50, making it sharp and durable. A rectangular groove is formed on the horizontal portion 13 near the horizontal blade portion 16, and a detachable longitudinal cutter 11 is installed within the groove. The longitudinal cutter 11 includes a horizontal mounting portion 112 and a vertical blade portion 111. The horizontal mounting portion 112 is embedded in the groove and secured by an M2×3mm screw 15. The vertical blade portion 111 extends downward through a through hole in the horizontal portion 13 and protrudes from the lower surface of the horizontal portion 13.

[0031] The multi-level cutting template 2 is a 120mm × 120mm × 1.5mm medical-grade PEEK plate with a smooth and transparent surface, facilitating observation of the underlying fascia sheet. Five square cutting slots 22, measuring 6×6cm, 7×7cm, 8×8cm, 9×9cm, and 10×10cm, are sequentially arranged around the center of the template. The edges of each slot are chamfered to facilitate the sliding cutting of the scalpel along the slot walls. A cross-shaped second center positioning mark 23 is engraved in the very center of the template, and a 2mm diameter center positioning hole is provided. To prevent the portion enclosed by the square cutting slots 22 from detaching from the multi-level cutting template 2, the square cutting slots 22 are not closed, forming a connecting portion 24. After cutting the fascia sheet, it is separately cut at the connecting portion 24.

[0032] like Figure 3 As shown, the pre-formed tray 5 is precision cast from medical-grade 316L stainless steel, and is square in shape with a side length of 120mm. The central area of ​​the tray is a shallow concave curved area 10. The bottom of the shallow concave curved area 10 is provided with saline moisturizing grooves 8, which adopt a combination of concentric circles and radial lines, including 3 concentric circular grooves and 8 radial grooves. The groove depth is 0.5mm and the width is 1mm. A cross-shaped first center positioning mark 9 is engraved in the center of the shallow concave curved area 10. An outwardly extended support edge 3 is formed around the shallow concave curved area 10, with a width of 15mm. Ten through slots 7 are evenly opened on the outwardly extended support edge 3. The through slots 7 are 3mm × 12mm in size and are used to install elastic claws 4. The bottom of the pre-formed tray 5 is integrally formed with a cylindrical base 6, with a diameter of 50mm and a height of 10mm. The lower end surface is precision polished, with high flatness and stable placement.

[0033] The elastic jaw 4 is made of 0.3mm thick 316L stainless steel sheet, stamped into an "Ω" shape, including the jaw body 42 and a rounded clamping end 41. The contact surface width of the rounded clamping end 41 is 2.5mm, and it is polished to avoid damaging the fascia tissue. The natural opening angle of the jaw is 30°, and the clamping force of a single jaw is approximately 0.5N, which can stably clamp its edge without damaging the fascia.

[0034] This embodiment also provides a method of using the device described above for harvesting and creating stump soft tissue from discarded limbs during amputation. The method is performed only on discarded thigh segments that have been completely severed from the patient's body, and includes the following steps: S1. Debridement of the original fascia lata sheet: Select the corresponding size of the longitudinal cutter 11 according to the actual measured diameter of the patient's stump and install it on the fascia lata peeler 1. Fix the discarded thigh segment on the operating table and use the fascia lata peeler 1 to peel out the original fascia lata sheet of uniform thickness along the direction of the fascia lata fibers. S2, Standardized template cutting: Lay the peeled fascia lata sheet flat on a sterile operating table, select the corresponding size cutting groove 22 on the multi-level cutting template 2 according to the diameter of the residual end, align the center of the cutting groove 22 with the center of the fascia lata sheet, and cut out a square fascia lata sheet A along the edge of the cutting groove 22. S3. Shallow curvature preforming: Select the preforming tray 5 with the corresponding curvature level according to the diameter of the residual end. Align the center of the cut square ribbed diaphragm A with the first center positioning mark 9 on the preforming tray 5 and lay it flat on the shallow concave curved surface area 10. Insert multiple elastic claws 4 into the through grooves 7 of the outwardly expanding support edge 3 in sequence, so that the opening of the elastic claws 4 faces the shallow concave curved surface area 10 and clamps the edge of the square ribbed diaphragm A, so that the square ribbed diaphragm A completely fits the shallow concave curved surface area 10 and forms a shallow curvature shape that matches the diameter of the residual end. S4. Moisturizing and Preservation and Finished Product Acquisition: Sterile physiological saline is injected into the saline moisturizing groove 8 at the bottom of the shallow concave curved area 10 of the pre-formed tray 5 to maintain the moist state of the square fascia lata sheet A, thus obtaining the semi-finished product of the ex vivo autologous fascia lata soft tissue surface cover.

[0035] All procedures are performed on the severed, unusable limbs, causing no additional trauma to the patient and not affecting the surgeon's handling of the patient's stump, resulting in a high level of surgical safety.

[0036] As a specific embodiment of this usage method: Example 1: An adult female patient underwent a mid-to-lower thigh amputation due to severe trauma to her left lower limb. Preoperative imaging measurements showed the stump diameter to be approximately 58-62 mm. The aim was to prepare a semi-finished autologous fascia lata soft tissue cover to fit the stump.

[0037] 1. Dissection of the original fascia lata flap: After the primary surgeon completes the thigh amputation and hands the discarded limb segment to the second assistant's operating table, the second assistant immediately fixes the discarded thigh segment on a sterile operating frame, performs routine disinfection and draping, and exposes the fascia lata region on the lateral side of the thigh. Holding the fascia lata dissector 1 with the longitudinal cutter 11 attached, the lower surface of the horizontal part is pressed tightly against the surface of the fascia lata. Centered on the predetermined center point, a square closed contour of approximately 7×7cm is drawn with the longitudinal cutter, cutting to the depth reaching the gap between the deep fascia and the vastus lateralis muscle, ensuring that the four sides of the contour are completely connected. Loosen the screw 15, remove the longitudinal cutter 11, and insert the horizontal blade 16 horizontally into the subfascial layer from any side of the square contour incision, ensuring that the thickness limiting sheet is always attached to the epithelial surface of the fascia lata. Advance the dissector slowly and evenly along the direction of the fascia lata fibers, maintaining uniform force and avoiding blade tilting, until a fascia lata flap of approximately 7×7cm with uniform thickness is completely dissected, and covered with sterile saline gauze for later use.

[0038] 2. Standardized template cutting: Lay the original fascia lata sheet obtained from the peeling process with the epithelial side facing up on a sterile treatment towel. Gently pull the four corners with hemostatic forceps to flatten it and avoid wrinkles. Cover the original sheet with the multi-level cutting template 2, so that the cross-shaped second center positioning mark in the center of the template is precisely aligned with the center point of the original sheet. Use a sterile scalpel to slowly cut along the inner edge of the 6×6cm cutting groove. When cutting, the blade should be close to the groove wall to ensure that the cut is straight, and a standard square fascia lata sheet A with a size of 6×6cm is obtained. 3. Shallow Curvature Preforming and Edge Shaping: Take out the preforming tray 5 with a Φ60mm setting and place it on a sterile operating table, ensuring the tray base is stable and does not wobble; use sterile forceps to pick up the cut square fascia sheet A and transfer it to the preforming tray 5, making sure the center of the fascia sheet completely coincides with the first center positioning mark of the shallow concave curved surface area 10. Insert the elastic claws 4 sequentially into the eight through-slots 7 along the outer supporting edge 3, so that the rounded clamping end 41 of the elastic claws 4 presses about 2mm inside the edge of the square fascia sheet A, and naturally springs back to clamp; adjust the clamping position of each claw to ensure that the force on the fascia sheet is uniform around the perimeter, completely conforms to the shallow concave curved surface, and there are no wrinkles or edge curling; 4. Moisturizing and Preservation and Finished Product Acquisition: Use a 1ml sterile syringe to draw sterile saline and slowly inject it into the saline moisturizing groove 8 at the bottom of the shallow concave curved area 10 until the groove is full and no liquid overflows; the saline diffuses to the entire fascia sheet under the fascia sheet through capillary action, maintaining its moist state, thus obtaining the semi-finished product of the ex vivo autologous fascia lata soft tissue surface cover that is adapted to the Φ60mm residual end.

[0039] Example 2: An adult male patient underwent mid-thigh amputation due to irreversible necrosis caused by atherosclerotic obliterans of the right lower extremity. The preoperative measurement of the stump diameter was approximately 78-82 mm. It is planned to prepare a semi-finished autologous fascia lata sleeve of the corresponding size.

[0040] 1. Dissection of the original fascia lata flap: After the surgeon removes the discarded thigh segment, the second assistant fixes it to the operating table, exposing the fascia lata area and performing routine disinfection. A longitudinal incision 11 is installed, and a 9×9cm square closed contour is drawn with the predetermined center point, extending to the subfascial layer. The longitudinal incision 11 is removed, and the horizontal blade 16 is inserted through the incision at the edge of the contour, dissecting horizontally from proximal to distal along the fiber direction. During the process, the fascia surface is continuously moistened with saline to prevent drying. The complete 9×9cm original fascia flap is dissected and covered with moist gauze for protection.

[0041] 2. Standardized template cutting: Lay the original sheet flat, cover it with multiple cutting templates, align the center positioning mark, and cut along the edge of the 8×8cm cutting groove to obtain a standard square fascia broadleaf sheet A. Use sterile forceps to trim the rough edges. 3. Shallow Curvature Preforming and Edge Shaping: Place the Φ80mm preforming tray and align the center of the fascia sheet with the center positioning mark of the tray; gently press the central area to initially fit the fascia sheet against the shallow concave curved surface 10, and insert 10 elastic claws 4 in sequence to evenly clamp the edges of the four sides and four corners of the square wide fascia sheet A; check the fit of the fascia sheet, and gently adjust any slight wrinkles with tweezers to ensure that the entire curved surface is free of air bubbles and protrusions. 4. Moisturizing and Preservation and Finished Product Acquisition: Sterile physiological saline is injected into the saline moisturizing groove 8 to maintain the fascia sheet in a moist state, thereby obtaining a semi-finished cover that fits the Φ80mm residual end.

[0042] As a verification embodiment of the present invention: The feasibility of using SD rats for surface capping of soft tissue stumps was observed, and the evaluation indicators were limited to capping coverage, shape maintenance, adhesion, and edge stability.

[0043] Experimental methods: Using the device according to the present invention, the fascia lata from the hind limb segment of a discarded SD rat was collected in vitro, cut, pre-shaped with shallow curvature and shaped with a claw to obtain a semi-finished product of the ex vivo fascia lata soft tissue surface cover; the semi-finished product was attached to the soft tissue surface of the hind limb stump of the SD rat, and only attachment and suturing were performed. On the 7th day after the operation, samples were taken for gross and histological observation.

[0044] The experimental results are shown in Table 1 below: Table 1. Feasibility observation of surface sealing of soft tissue stumps in SD rats (n=4) Observations on stump soft tissue reconstruction and socket fitting: In an SD rat hind limb stump model, an ex vivo soft tissue surface cover was prepared using autologous fascia lata taken from a discarded limb segment according to the method described in this invention. This cover was then placed between or on the surface of the muscle fascia layer and subcutaneous tissue layer of the stump. The improvement effect of this invention on the quality of stump soft tissue shaping and the basis for subsequent prosthetic socket fitting was evaluated based on the regularity of the stump surface contour, the uniformity of soft tissue thickness, the relative slippage between the deep fascia layer and the subcutaneous tissue layer, the potential dead space / fluid gap, the interface stability under simulated socket compression and cyclic shear load, and the integrity of the epidermis in the bony prominence area.

[0045] Table 2. Observations on soft tissue formation and socket adaptation in SD rat stumps The above results show that, compared with the model control group, the application group of this invention shows an improved trend in terms of the regularity of the surface contour of the stump, the uniformity of soft tissue thickness, the relative slippage between the deep fascia layer and the subcutaneous tissue layer, the potential dead space / fluid gap, the interface stability under pressure and cyclic shear load, and the integrity of the epidermis in the bony prominence area. This indicates that the semi-finished product of the surface soft tissue cap of the stump prepared by autologous fascia lata of the discarded limb segment according to the method described in this invention can provide a relatively continuous soft tissue constraint and buffer interface between or on the surface of the muscle fascia layer and the subcutaneous tissue layer of the stump. This is beneficial to improving the quality of the soft tissue shaping of the stump, reducing local load-bearing abrupt changes, reducing shear concentration in the bony prominence area, and providing a morphological basis for subsequent prosthesis socket fitting and local load-bearing continuity.

[0046] It should be noted that all directional indicators (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicator will also change accordingly.

[0047] Furthermore, in this invention, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly and specifically defined.

[0048] In this invention, unless otherwise explicitly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0049] Furthermore, the technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are feasible for those skilled in the art. If the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

Claims

1. A device for collecting discarded limbs and creating stump soft tissue during amputation, characterized in that, The device includes a fascia lata peeler (1), a multi-stage cutting template (2), and at least one preformed tray (5). The preformed tray (5) has a shallow concave curved area (10) and an outwardly extended support edge (3) extending outward around the shallow concave curved area (10). The outwardly extended support edge (3) has multiple through slots (7) around the shallow concave curved area (10). An elastic claw (4) passes through the through slot (7). The opening of the claw (4) faces the shallow concave curved area (10) and is used to fix the fascia lata sheet (A) on the shallow concave curved area (10). The multi-stage cutting template (2) has multiple cutting through slots (22) around the center.

2. The device for collecting discarded limbs and creating stump soft tissue during amputation according to claim 1, characterized in that: The bottom of the shallow concave curved surface area (10) is provided with multiple salt water moisturizing grooves (8).

3. The device for collecting discarded limbs and creating stump soft tissue during amputation according to claim 2, characterized in that: The salt water moisturizing groove (8) is a long, shallow groove, and the arrangement of the long, shallow groove is any one or a combination of concentric circles, radial lines or grids.

4. The device for collecting discarded limbs and creating stump soft tissue during amputation according to claim 3, characterized in that: The planar projection shape of the outer support edge (3) is square or polygonal.

5. The apparatus for collecting discarded limbs and creating stump soft tissue during amputation according to claim 4, characterized in that: The preformed tray (5) has three types, and the diameter of the limb stump corresponding to the curvature of its shallow concave curved area (10) is divided into Φ60mm, Φ80mm and Φ100mm.

6. The apparatus for collecting discarded limbs and creating stump soft tissue during amputation according to claim 5, characterized in that: The bottom of the preformed tray (5) is provided with a base (6), and the lower end surface of the base (6) is a plane.

7. The apparatus for collecting discarded limbs and creating stump soft tissue during amputation according to claim 1, characterized in that: The fascia lata peeler (1) includes a horizontal part (13) and a handle part (12) connected to one end of the horizontal part (13). A horizontal blade part (16) is provided at the other end of the horizontal part (13). A detachable longitudinal cutter (11) is installed on the horizontal part (13) near the horizontal blade part (16). The longitudinal cutter (11) passes through the horizontal part (13) from top to bottom.

8. The apparatus for collecting discarded limbs and creating stump soft tissue during amputation according to claim 7, characterized in that: The longitudinal cutter (11) includes a horizontal mounting part (112) and a vertical cutting edge part (111). The horizontal mounting part (112) is embedded in a groove on the horizontal part (13) and locked by a screw (15). The vertical cutting edge part (111) passes through the horizontal part (13).

9. The apparatus for collecting discarded limbs and creating stump soft tissue during amputation according to claim 8, characterized in that: The preformed tray (5) is provided with a first center positioning mark (9) at its center, and the multi-stage cutting template (2) is provided with a center positioning hole or a second center positioning mark (23) at its center.

10. A method of using the apparatus for harvesting and preparing stump soft tissue from discarded limbs during amputation, based on any one of claims 1-9, characterized in that, The method is performed only on discarded thigh segments that have been completely severed from the patient's body, and includes the following steps: S1. Peeling of the original fascia lata sheet: Select a longitudinal cutter (11) of the corresponding size according to the actual measured diameter of the patient's stump and install it on the fascia lata peeler (1). Fix the discarded thigh segment on the operating table and use the fascia lata peeler (1) to peel off the original fascia sheet of uniform thickness along the direction of the fascia lata fibers. S2, Standardized template cutting: Lay the peeled fascia lata sheet flat on a sterile operating table, select the corresponding size cutting groove (22) on the multi-level cutting template (2) according to the diameter of the residual end, align the center of the cutting groove (22) with the center of the fascia lata sheet, and cut out a square fascia lata sheet (A) along the edge of the cutting groove (22). S3. Shallow curvature preforming: Select the preforming tray (5) with the corresponding curvature level according to the diameter of the residual end, align the center of the cut square rib diaphragm (A) with the first center positioning mark (9) on the preforming tray (5), lay it flat on the shallow concave curved area (10), insert multiple elastic claws (4) into the through groove (7) of the outwardly expanding support edge (3) in sequence, so that the opening of the elastic claws (4) faces the shallow concave curved area (10) and clamps the edge of the square rib diaphragm (A), so that the square rib diaphragm (A) completely fits the shallow concave curved area (10) to form a shallow curvature shape that matches the diameter of the residual end; S4. Moisturizing and Preservation and Finished Product Acquisition: Sterile physiological saline is injected into the saline moisturizing groove (8) at the bottom of the shallow concave curved area (10) of the preformed tray (5) to maintain the moist state of the square fascia lata sheet (A), thus obtaining the semi-finished product of the ex vivo autologous fascia lata soft tissue surface cover.

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