Special wound constraining clothes used after breast resection
By adopting the synergistic effect of multi-layer optical structure and pH-responsive microcapsules in the post-mastectomy bonding clothing, combining the gradient wetting structure and the composite regulation mechanism of elastomer and memory foam, the shortcomings of traditional bonding clothing in infection monitoring, exudate management and pressure regulation are solved, and early infection identification, construction of dry wound environments and dynamic pressure adaptation are achieved, which significantly improves wound healing efficiency and patient comfort.
Patent Information
- Application Number
- CN202510285472.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-11
- Publication Date
- 2025-05-23
AI Technical Summary
The cloaking after traditional mastectomy has problems with poor wound healing and high incidence of complications caused by lag in infection monitoring, risk of secondary infection caused by the accumulation of seepage, and the inability to adapt to the fixed pressure mode to dynamic recovery requirements.
A special wound binding clothing after mastectomy was designed, using the synergistic effect of multi-layer optical structure and pH-responsive microcapsules to achieve an intuitive chromogenic reaction when the wound exudate environment is abnormal; combining the gradient wetting structure and the composite regulation mechanism of elastomer and memory foam, a dynamic pressure system is constructed, and a modular underarm pressurization design is adopted, allowing patients to independently adjust pressure according to the postoperative exudate condition and wound healing progress.
Through chromogenic reactions, we can realize early identification and early warning of infection, actively build a dry microenvironment of the wound, prevent bacteria from growing, and the dynamic pressure system adapts to different recovery stages, reduces the risk of complications, and improves wound healing efficiency and patient comfort.
Smart Images

Figure CN120022139A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medical devices, in particular to a special wound restraint garment for mastectomy surgery. Background Art
[0002] Mastectomy is a common surgical method for tumor treatment. Effective management of postoperative wounds directly affects the patient's recovery process. Clinical studies have shown that standardized postoperative pressure therapy can significantly reduce the incidence of complications such as hematoma and seroma, and promote wound closure. For this reason, medical restraints are widely used in postoperative care, which stabilize the wound surface and limit abnormal swelling by applying moderate circumferential pressure.
[0003] However, the post-mastectomy restraints currently on the market generally have functional limitations and clinical adaptation defects: First, traditional restraints are made of pure cotton or elastic knitted fabrics and are simply stitched together. Although they have the ability to apply basic pressure, they lack an infection risk warning mechanism. The medical team needs to frequently disassemble the device to observe the characteristics of wound exudate, which not only increases the risk of nosocomial infection, but may also delay the early detection window period for the invasion of pathogenic bacteria such as Staphylococcus aureus. Secondly, the exudate management module of existing products is extensively designed, relying mostly on passive adsorption of multiple layers of gauze, resulting in the accumulation of exudate at the wound edge to form a moist environment, which in turn accelerates bacterial growth (clinical data show that the infection rate increases by 23%), and repeated changes of dressings are prone to cause secondary damage. More importantly, the traditional straitjacket has a single pressure control method, using standard sizes with Velcro mechanical adjustment, which is difficult to adapt to different recovery stages after surgery (high pressure hemostasis is required in the acute stage, and moderate decompression is required in the rehabilitation stage to promote healing) and dynamic chest circumference changes caused by the patient's breathing movement, which often leads to uneven pressure distribution: the actual contact pressure fluctuation in the wound area exceeds 40%, which can neither effectively compress hemostasis nor cause skin ischemia and necrosis due to local pressure overload. These problems seriously restrict the quality of postoperative care, and the present invention provides a special wound straitjacket for mastectomy. Summary of the invention
[0004] In view of the deficiencies in the prior art, the present invention provides a special wound restraint garment for post-mastectomy surgery, which solves the problems of delayed post-operative infection monitoring, risk of secondary infection caused by exudate accumulation, and poor wound healing and high incidence of complications caused by the inability of the fixed pressure mode to adapt to dynamic recovery needs in traditional post-mastectomy restraint garments.
[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: a special wound restraint garment for mastectomy, comprising a restraint garment body, a color sensitive area is arranged at the bottom of the restraint garment body, two replacement areas are arranged on the front side of the restraint garment body, and a booster component is arranged on the outside of the restraint garment body, which is used to ensure that the wound suture site after surgery receives effective pressure, prevent postoperative complications, and accelerate wound healing. A sub-patch and a mother patch are respectively arranged on both sides of the color sensitive area.
[0006] Preferably, the straitjacket body is composed of an outer protective layer, a breathable layer, a support layer and a contact layer in sequence from the outside to the inside, and the boundaries of each layer are sealed by ultrasonic welding.
[0007] Preferably, the outer protective layer is made of anti-ultraviolet polyester fiber, and the breathable layer is made of 3D mesh fabric blended with nylon and spandex, with a pore density of 50-80 holes / cm 2 The supporting layer is made of density gradient memory foam covered with high-elastic Lycra, and the contact layer is made of a composite functional substrate, anionic blended cotton and a unidirectional moisture-conducting structure.
[0008] Preferably, the composite functional substrate is a bidirectional woven fabric blended with copper-ammonia yarn and cotton, and its longitudinal air permeability is 1800-2000 ml / (cm 2 ·s), transverse air permeability is 800-1000ml / (cm 2 ·s), the unidirectional moisture-conducting structure consists of an inner hydrophobic layer and an outer hydrophilic layer, the inner hydrophobic layer has a contact angle of 152°-158° and is made of a nano-silicon dioxide hydrophobic coating, and the outer hydrophilic layer has a contact angle of 22°-28° and is made of hydroxyethyl cellulose modified cotton fiber.
[0009] Preferably, the color-developing sensitive area is composed of an outer protective layer 2, a breathable layer 2, a support layer 2 and a contact layer 2 from the outside to the inside.
[0010] Preferably, the outer protective layer 2 is provided with an array of transparent windows, the diameter of the transparent windows is 5-8mm, the interval between the transparent windows is 10-15mm, the air permeable layer 2 forms an unobstructed light channel corresponding to the transparent window area, the support layer 2 is made of foamed silicone material, the Shore hardness is 15A-20A, the transmittance is ≥60%, and the opening rate is 80-85%. The contact layer 2 is embedded with color-changing fibers containing acid-base responsive microcapsules, and the particle size of the microcapsules is 2-5μm. The color-changing fibers of the contact layer 2 change from white to purple when the pH value of the exudate is greater than 7.4, and the color difference ΔE is ≥40. The color-changing fibers of the contact layer 2 are fixed to the surface of the support layer 2 by hot melt adhesive dot matrix bonding, and the bonding point density is 4-6 / cm 2 .
[0011] Preferably, the boosting assembly comprises a pressure enhancing belt, which is arranged in front of the two replacement areas, and the two sides of the pressure enhancing belt are respectively connected to the second sub-strip and the second mother-strip.
[0012] Preferably, the pressure enhancement belt is made of TPE elastomer.
[0013] Preferably, both sides of the top of the restraint garment body at the armpit position are connected to pressure supports through connecting parts, and the pressure supports are provided with fixing belts for fixing the pressure supports at the armpit position of the human body.
[0014] The present invention provides a special wound restraint garment for mastectomy. It has the following beneficial effects: 1. The present invention can trigger an intuitive color reaction when the wound exudate environment is abnormal through the synergistic effect of the multi-layer optical structure and the pH-responsive microcapsules. The embedded microcapsule rapid response mechanism can achieve intuitive early warning through color changes at the early stage of infection, and form a visual monitoring window with the light-transmitting design. Compared with traditional laboratory detection methods, it significantly shortens the infection identification cycle and strives for a critical time window for clinical intervention.
[0015] 2. The contact layer of the present invention adopts a gradient wetting structure design, and through the interfacial synergistic effect of the hydrophobic barrier layer and the hydrophilic moisture conductive layer, it realizes the rapid and directional discharge of the exudate. Combined with the multi-directional breathable characteristics of the fabric, it actively constructs a dry microenvironment on the wound surface, effectively preventing the bacterial growth caused by liquid retention, and avoiding the risk of secondary contamination caused by passive liquid absorption of traditional dressings.
[0016] 3. The present invention is based on the composite regulation mechanism of elastomer and memory foam to construct a dynamic pressure system that can evolve autonomously with the postoperative recovery stage. In the acute phase, stable supporting pressure is formed to prevent complications. In the recovery phase, the elasticity of the material is intelligently adapted to the respiratory movement. The unique pressure buffering characteristics of the system not only improve the effectiveness of treatment, but also eliminate the hidden dangers of skin damage caused by traditional rigid pressurization, providing continuous comfortable protection for patients.
[0017] 4. The present invention adopts a modular underarm pressure design, which combines the pressure support component with an ergonomic fixing belt to accurately fit the underarm curve, ensuring stable pressure while avoiding the problems of traditional restraints or bandages slipping and uneven pressure. Its design allows patients or medical staff to adjust the pressure independently according to the postoperative exudate situation and wound healing progress, avoiding discomfort or secondary injury caused by the fixed pressure mode. The modular detachable design enables patients to flexibly adjust the wearing method according to the postoperative recovery stage, which can provide continuous pressure in the early stage when there is more exudate, and reduce pressure in the later stage, thereby improving comfort and promoting recovery. Compared with commercially available products, the present invention has significantly improved the flexibility, comfort and postoperative care effect of underarm pressure. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Figure 1 It is a schematic plan view of the restraint garment of the present invention; Figure 2 It is a schematic diagram of the hierarchical structure of the straitjacket body of the present invention; Figure 3 Schematic diagram of the hierarchical structure of the color sensitive area of the present invention.
[0019] Among them, 1. the body of the straitjacket; 101. the contact layer one; 102. the support layer one; 103. the breathable layer one; 104. the outer protective layer one; 2. the color sensitive area; 201. the contact layer two; 202. the support layer two; 203. the breathable layer two; 204. the outer protective layer two; 3. the replacement area; 4. the sub-patch one; 5. the mother patch one; 6. the pressure enhancement belt; 7. the sub-patch two; 8. the mother patch two; 9. the connection part; 10. the pressure support; 11. the fixing belt. DETAILED DESCRIPTION
[0020] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0021] Please refer to the attached Figure 1 The embodiment of the present invention provides a special wound restraint garment for mastectomy, comprising a restraint garment body 1, a color sensitive area 2 is arranged at the bottom of the restraint garment body 1, two replacement areas 3 are arranged on the front side of the restraint garment body 1, and a booster component is arranged on the outside of the restraint garment body 1, which is used to ensure that the wound suture site after surgery receives effective pressure, prevent postoperative complications, and accelerate wound healing. A sub-patch 4 and a mother patch 5 are respectively arranged on both sides of the color sensitive area 2.
[0022] Specifically, when the patient wears the garment, the color sensitive area 2 at the bottom of the restraint garment body 1 is first aligned with the inframammary fold, and the color sensitive area 2 is adjusted to cover the surgical suture, and then the sub-sticker 4 and the mother-sticker 5 on both sides are used to fix and form initial pressure. At this time, the outer protective layer 104 (polyester fiber) blocks external pollutants and ultraviolet rays, the breathable layer 103 (3D mesh fabric) actively dissipates heat through pores, and the contact layer 101 (copper ammonia silk / cotton two-way moisture-conducting substrate) quickly guides the exudate to the edge evaporation area through the hydrophobic-hydrophilic interface gradient.
[0023] After fixation, operate the front booster assembly, and use the pressure enhancement belt 6 made of TPE elastomer to wrap from the front chest to the back. According to the recovery stage, stretch the elastic belt to 150% (acute stage) or 100% (rehabilitation stage), and then cross-bond the mother-and-child stickers to the back, and cooperate with the gradient memory foam layer inside the restraint body 1 (the low-density area disperses 80% of the pressure to healthy tissues, and the high-density area maintains rigid support) to form a uniform 15-25mmHg circumferential pressure. The wearer can insert two fingers to test the pressure adaptability. At this time, the three-dimensional pore structure of the breathable layer 103 opens and closes dynamically with breathing, optimizing air circulation and reducing local temperature rise.
[0024] The color sensitive area 2 serves as a dynamic monitoring window, allowing cold light to penetrate the inner pH sensitive fiber through the light-transmitting silicone layer: when the pH of the exudate is normal (<7.4), it appears white; if the infection causes the pH to rise (>7.4), the microcapsule ruptures and releases the indicator to make the color sensitive area appear purple locally. At this time, the magnetic suction slot in the replacement area can quickly connect the negative pressure drainage module to remove the exudate, or switch to the infrared therapy module to promote healing. The entire system forms a closed-loop management through the elastic regulation of the pressure enhancement belt 6, the directional extraction of the exudate from the contact layer 201, and the real-time feedback of the color sensitive area, which minimizes the risk of hematoma, infection and mechanical injury.
[0025] Please see attached Figure 2 The restraint garment body 1 is composed of an outer protective layer 104, a breathable layer 103, a support layer 102 and a contact layer 101 from the outside to the inside, and the boundaries of each layer are sealed by ultrasonic welding.
[0026] The outer protective layer 104 is made of UV-resistant polyester fiber, and the breathable layer 103 is made of 3D mesh fabric blended with nylon and spandex, with a pore density of 50-80 holes / cm 2 The supporting layer 102 is made of density gradient memory foam covered with high elastic Lycra, and the contact layer 101 is made of composite functional substrate, anionic blended cotton and unidirectional moisture conduction structure.
[0027] The composite functional base material is a two-way woven fabric blended with copper-ammonia silk and cotton, and its longitudinal air permeability is 1800-2000ml / (cm 2 ·s), transverse air permeability is 800-1000ml / (cm 2 ·s), the unidirectional moisture-conducting structure consists of an inner hydrophobic layer and an outer hydrophilic layer. The inner hydrophobic layer has a contact angle of 152°-158° and is made of a nano-silicon dioxide hydrophobic coating. The outer hydrophilic layer has a contact angle of 22°-28° and is made of hydroxyethyl cellulose modified cotton fiber.
[0028] Specifically, the four-layer structure of the straitjacket body 1 from the outside to the inside adopts ultrasonic welding technology to form a fully closed boundary, and the tensile strength of the weld reaches 3.2N / mm, avoiding the friction stimulation of the traditional sewing process on the sensitive skin after surgery.
[0029] The outer protective layer 104 is woven with polyester fibers with a warp density of ≥120 strands / inch. Through the synergistic effect of the nano zinc oxide coating and benzotriazole ultraviolet absorbers, the ultraviolet radiation blocking rate in the 280-400nm band is increased to 99.6% (ASTMD6603 standard). At the same time, its plain weave structure is combined with a hydrophobic finishing process (contact angle 135°) to achieve splash-proof function (AATCC22 standard ≥4 level), effectively resisting the penetration of external pollutants such as droplets and dust. This layer forms a functional coupling with the underlying breathable layer 103 - the pore density of the nylon / spandex blended 3D mesh fabric (50-80 holes / cm 2 ) Through computer simulation optimization, a micropore array with a diameter of 0.5-0.8mm is set in the central part of the corresponding surgical suture area to achieve an air vortex effect (Reynolds number Re=1200-1500), and 1.2-1.5mm large holes are distributed in the edge area to form turbulence and accelerate heat dissipation (local wind speed increased by 60%). The overall air permeability efficiency is increased by 3.2 times compared with conventional stretch fabrics.
[0030] The support layer 102 adopts a composite design of density gradient memory foam and high elastic Lycra to achieve intelligent mechanical response: the skin contact side is a low-density area (50kg / m 3 / Shore hardness 10A), its open-cell foam structure absorbs more than 60% of the peak pressure through 35%-40% compression deformation; the outer high-density area (100kg / m 3 / Shore hardness 25A) adopts a closed-cell structure and an outer-covering Lycra fabric (elongation 500%-800%) to form a dynamic pressure compensation system - when the patient takes a deep breath and the chest circumference expands by 5%-8%, the elastic modulus of the Lycra fiber changes (0.5→0.2GPa) to instantly release the tension, while the stress relaxation characteristics of the memory foam (τ=8-10s) slowly restore the basic pressure during the exhalation phase, so that the interface pressure fluctuation amplitude is controlled within 12% (traditional restraint clothing>40%).
[0031] Contact layer 101 realizes active regulation of wound microenvironment through material functional bionic design: heterosexual weaving process of copper-ammonia silk / cotton blended bidirectional woven substrate (longitudinal 1800-2000ml / (cm 2 ·s) / horizontally 800-1000ml / (cm 2·s) forms moisture permeability anisotropy - ultra-high permeability along the body axis accelerates the longitudinal dissipation of water vapor, while the transverse restricted permeability prevents airflow from blowing directly on the wound surface and causing low temperature stimulation. The unidirectional moisture-conducting structure of the bottom layer generates a capillary driving force of 3.5kPa through a wetting gradient difference of 132° (inner hydrophobic layer 152°-158° / outer hydrophilic layer 22°-28°), so that the exudate is directionally pumped to the edge evaporation zone at a rate of 1.8μL / (s·cm), combined with the antibacterial function (Staphylococcus aureus killing rate>99.5% / 24h) achieved by the quaternary ammonium salt groups (loading amount 2.1mmol / g) grafted on the surface of anionic blended cotton fibers, forming a synergistic protective closed loop of antibacterial-moisture-conducting-breathable. The composite system can stabilize the humidity of the wound contact area at 50±5%RH (traditional dressings>70%RH), and the temperature fluctuation is less than 1.5℃, which optimizes the healing microenvironment to the greatest extent.
[0032] Please see attached Figure 3 The color sensitive area 2 is composed of an outer protective layer 204, a breathable layer 203, a support layer 202 and a contact layer 201 from the outside to the inside.
[0033] The outer protective layer 204 is provided with an array of transparent windows, the diameter of the transparent windows is 5-8mm, the interval between the transparent windows is 10-15mm, the air permeable layer 203 forms an unobstructed light channel corresponding to the transparent window area, the support layer 202 is made of foamed silicone material, the Shore hardness is 15A-20A, the transmittance is ≥60%, the opening rate is 80-85%, the contact layer 201 is embedded with color-changing fibers containing acid-base responsive microcapsules, the particle size of the microcapsules is 2-5μm, the color-changing fibers of the contact layer 201 change from white to purple when the pH value of the exudate is greater than 7.4, and the color difference ΔE is ≥40, and the color-changing fibers of the contact layer 201 are fixed to the surface of the support layer 202 by hot melt adhesive dot matrix bonding, and the bonding point density is 4-6 / cm 2 .
[0034] Specifically, the multi-layer composite design of the color-sensitive area achieves in-situ visual monitoring of the pH of postoperative wound exudate through the synergistic effect of directional light transmission and biomolecular response. The surface of the outer protective layer 204 is laser-etched to form a circular hole array window with a diameter of 5-8mm and an interval of 10-15mm. Its hexagonal arrangement pattern (porosity of approximately 42%) allows more than 90% of visible light to pass through while maintaining mechanical strength (tensile modulus ≥1.5MPa). The grid density of the corresponding window area of the lower breathable layer 203 is reduced to 30 holes / cm 2 , forming a branchless straight-through optical path (light scattering angle < 8°) to avoid stray light interference.
[0035] The foamed silicone of the second support layer 202 adopts an open-cell-closed-cell composite structure design: the 80%-85% high open-cell area allows the exudate to quickly infiltrate the inner fiber through the channel with a pore size of 100-200μm, while the locally distributed closed-cell units (diameter 50-80μm) serve as light transmission media to increase the overall light transmittance to 66%-70% (ISO13468 standard). Combined with the hardness range of 15A-20A, it achieves wound pressure buffering (pressure dispersion rate ≥55%) and compatibility with optical detection.
[0036] The acid-base response color changing system of contact layer 201 achieves accurate early warning through triple matching optimization: Microcapsule coating technology: gelatin-gum arabic is used as the wall material to encapsulate the cresol violet indicator (inner diameter 2-5μm), and the amphiphilic modification of the shell (contact angle reduced from 78° to 32°) is used to ensure that the exudate penetrates within 10 seconds to trigger the color reaction; Color enhancement mechanism: The surface of the microcapsules is modified with nano-titanium dioxide (particle size 10-15nm), which amplifies the color difference to ΔE=42-48 (CIELAB standard) through Mie scattering, making purple patches with a diameter of more than 3mm visible to the naked eye; Adhesive process adaptability: hot melt adhesive dot matrix (4-6 dots / cm 2 ) uses modified EVA material (melt index 25g / 10min) and forms bonding points with a diameter of 0.2-0.3mm by pulse hot pressing at 85-90℃ to ensure fiber fit (peel strength ≥1.8N / cm) and open more than 80% of the effective color development area.
[0037] When the pH value of wound exudate exceeds 7.4, the ester bond of the microcapsule wall material undergoes alkaline hydrolysis and ruptures, and the released indicator reacts with hydroxyl radicals, completing the color transition from white (L*=92) to purple (L*=58, a*=18, b*=-36) within 30 seconds. At this time, the light-transmitting properties of the silicone support layer allow medical staff to conduct non-destructive observation through an external cold light flashlight (illuminance 500-800lux), and its open-pore structure simultaneously guides the unreacted exudate to the edge adsorption layer to avoid liquid retention affecting color interpretation (contrast loss rate <5%).
[0038] Please see attached Figure 1 The pressurizing component includes a pressure enhancement belt 6, which is arranged in front of the two replacement areas 3. The two sides of the pressure enhancement belt 6 are respectively connected to a sub-strip 7 and a mother-strip 8.
[0039] The pressure enhancement belt 6 is made of TPE elastomer.
[0040] Specifically, operate the booster assembly on the front side, wrap the pressure enhancement belt 6 made of TPE elastomer from the front to the back of the chest, cross-bond the sub-sticker 2 7 and the mother sticker 2 8 connected at both ends to the corresponding position of the back, and the patient can take a deep breath to test after wearing it. The pressure is moderate if two fingers can be inserted into the gap between the corset and the chest wall. Adjust the stretching rate according to the acute phase or rehabilitation phase of the postoperative recovery stage. In the early postoperative period, stretch the elastic band to 150%, and adjust it to 100% in the late recovery period. Cross-bond the sub-sticker 2 7 and the mother sticker 2 8 connected at both ends to the corresponding position of the back to form a uniform annular pressure distribution.
[0041] Please see attached Figure 1 The top two sides of the restraint garment body 1 are connected to the pressure stays 10 at the armpits through the connecting parts 9, and the pressure stays 10 are provided with fixing belts 11 for fixing the pressure stays 10 at the armpits of the human body.
[0042] Specifically, according to the condition, for patients with simple mastectomy, no additional pressure bandage is required for the armpits. For patients with mastectomy + axillary lymph node dissection, the breast surgery area + axillary dissection area needs to be pressure bandaged after surgery to reduce subcutaneous exudate and promote wound healing. At this time, the pressure support 10 can be worn under the patient's armpit through the fixing belt 11. The pressure support 10 fits the human body's axillary structure, and the pressure support 10 is consistent with the main structure of the restraint garment body 1. In order to ensure the patient's comfort when wearing, gauze can be stuffed between the pressure support 10 and the armpit.
[0043] Working principle: When using, the patient first flattens the body of the straitjacket so that the color-sensitive area 2 at the bottom is located at the position of the inframammary fold, and then puts on the body of the straitjacket 1. After putting it on, it is fixed with the sub-patch 1 4 and the mother patch 1 5 on both sides. Then, operate the booster component on the front side, and wrap the pressure-enhanced belt 6 made of TPE elastomer around the chest from the front to the back, and cross-bond the sub-patch 2 7 and the mother patch 2 8 connected at both ends to the corresponding position of the back. After putting it on, the patient can take a deep breath to test, and the pressure is moderate if two fingers can be inserted into the gap between the straitjacket and the chest wall. Adjust the stretching rate according to the acute phase or rehabilitation phase of the postoperative recovery stage. In the early postoperative period, stretch the elastic band to 150%, and adjust it to 100% in the late recovery period. Cross-bond the sub-patch 2 7 and the mother patch 2 8 connected at both ends to the corresponding position of the back to form a uniform circumferential pressure distribution. After putting it on, within 30 minutes, use a medical cold light flashlight to illuminate the transparent window of the color-sensitive area 2 to confirm that the following are met: Unobstructed light channel: The wound covering layer (contact layer 201) can be seen below the transparent window and is uniformly white; Abnormal detection: If purple patches appear locally (pH>7.4 triggers discoloration), the device must be disassembled and inspected immediately.
[0044] During the entire use process, it is necessary to ensure that the light-transmitting area of the foamed silicone support layer is accurately aligned with the wound to ensure uninterrupted observation of the color development signal.
[0045] During use, the multi-layer composite structure of the straitjacket body 1 works in coordination: The UV-resistant polyester fiber of the outer protective layer 104 is densely woven to resist external pollution and UV radiation, while allowing air to circulate through the 3D mesh breathable layer 103 below it, with 50-80 holes / cm 2 The pore density ensures the longitudinal air permeability ≥1800ml / (cm 2 ·s) to avoid local overheating during wearing; The middle support layer 102 is composed of density gradient memory foam covered with high elastic Lycra. Its dynamic buffering ability enables the straitjacket to produce adaptive deformation when it is first fixed - the low-density sponge area (hardness 10A) fits the skin's undulations, while the high-density area (hardness 25A) balances the initial preload through the nonlinear elasticity of the Lycra material to prevent skin indentations caused by tight edges; The skin-contacting layer 101 is based on a cuprammonium silk / cotton blended bidirectional fabric, using a longitudinal 1800-2000ml / (cm 2 ·s) to quickly remove hot and humid gases. The one-way moisture conduction function integrated in this layer drives the directional migration of exudate through the wetting gradient difference between the inner hydrophobic layer and the outer hydrophilic layer, ensuring that wound exudate is removed to the hydrophilic fiber evaporation area within 30 seconds.
[0046] According to the condition, for patients with simple mastectomy, no additional pressure bandage is required for the armpit. For patients with mastectomy + axillary lymph node dissection, the breast surgery area + axillary dissection area needs to be pressure bandaged after surgery to reduce subcutaneous exudate and promote wound healing. At this time, the pressure support 10 can be worn at the patient's armpit through the fixing belt 11.
[0047] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A wound restraint garment for use after mastectomy, comprising a restraint garment body (1), characterized in that: The bottom of the straitjacket body (1) is provided with a color sensitive area (2), the front side of the straitjacket body (1) is provided with two replacement areas (3), the outside of the straitjacket body (1) is provided with a pressurizing component, which is used to ensure that the wound suture site after surgery is effectively pressurized, prevent postoperative complications, and accelerate wound healing, and a sub-strip (4) and a main strip (5) are respectively provided on both sides of the color sensitive area (2).
2. The wound restraint garment for post-mastectomy surgery according to claim 1, characterized in that: The straitjacket body (1) is composed of an outer protective layer (104), a breathable layer (103), a support layer (102) and a contact layer (101) in sequence from the outside to the inside, and the boundaries of each layer are sealed by ultrasonic welding.
3. The wound restraint garment for post-mastectomy surgery according to claim 2, characterized in that: The outer protective layer 1 (104) is made of UV-resistant polyester fiber, and the breathable layer 1 (103) is made of a 3D mesh fabric blended with nylon and spandex, with a pore density of 50-80 holes / cm 2 The support layer 1 (102) is made of density gradient memory foam coated with high elastic Lycra, and the contact layer 1 (101) is made of a composite functional substrate, anionic blended cotton and a unidirectional moisture conduction structure.
4. The wound restraint garment for post-mastectomy surgery according to claim 3, characterized in that: The composite functional substrate is a bidirectional woven fabric blended with copper-ammonia silk and cotton, and its longitudinal air permeability is 1800-2000 ml / (cm 2 ·s), transverse air permeability is 800-1000ml / (cm 2 ·s), the unidirectional moisture-conducting structure consists of an inner hydrophobic layer and an outer hydrophilic layer, the inner hydrophobic layer has a contact angle of 152°-158° and is made of a nano-silicon dioxide hydrophobic coating, and the outer hydrophilic layer has a contact angle of 22°-28° and is made of hydroxyethyl cellulose modified cotton fiber.
5. The wound restraint garment for post-mastectomy surgery according to claim 1, characterized in that: The color development sensitive area (2) is composed of an outer protective layer 2 (204), a breathable layer 2 (203), a support layer 2 (202) and a contact layer 2 (201) from the outside to the inside.
6. The wound restraint garment for post-mastectomy surgery according to claim 5, characterized in that: The outer protective layer 2 (204) is provided with an array of transparent windows, the diameter of the transparent windows is 5-8mm, the interval between the transparent windows is 10-15mm, the air permeable layer 2 (203) forms an unobstructed light channel corresponding to the transparent window area, the support layer 2 (202) is made of foamed silicone material, the Shore hardness is 15A-20A, the transmittance is ≥60%, and the opening rate is 80-85%, the contact layer 2 (201) is embedded with color-changing fibers containing acid-base responsive microcapsules, the particle size of the microcapsules is 2-5μm, the color-changing fibers of the contact layer 2 (201) change from white to purple when the pH value of the exudate is greater than 7.4, and the color difference ΔE is ≥40, and the color-changing fibers of the contact layer 2 (201) are fixed to the surface of the support layer 2 (202) by hot melt adhesive dot matrix bonding, and the bonding point density is 4-6 / cm 2 .
7. The wound restraint garment for post-mastectomy surgery according to claim 1, characterized in that: The pressurizing assembly comprises a pressure enhancing belt (6), the pressure enhancing belt (6) being arranged in front of the two replacement areas (3), and the two sides of the pressure enhancing belt (6) being respectively connected to a second sub-strip (7) and a second mother-strip (8).
8. The wound restraint garment for post-mastectomy surgery according to claim 7, characterized in that: The pressure enhancement belt (6) is made of TPE elastomer.
9. The wound restraint garment for post-mastectomy surgery according to claim 1, characterized in that: Both sides of the top of the restraint garment body (1) are located at the armpits and are connected to pressure supports (10) via connecting parts (9). The pressure supports (10) are provided with fixing belts (11) for fixing the pressure supports (10) at the armpits of the human body.