Timing pressurizing device for nipple protection after breast surgery

Abstract

The utility model relates to a timed pressurizing device for nipple protection after a breast surgery, which comprises a double-layer main body protection cover consisting of a hard shell on the outer layer and a silica gel lining on the inner layer, and a transparent visual window is arranged at the top of the double-layer main body protection cover; the timed pressurization air bag backing ring is located at the bottom of the double-layer main body protection cover, comprises an air pump device and a control module and supports setting of an automatic inflation and deflation time interval; and the three fixing belts comprise two transverse fixing belts and one longitudinal fixing belt. The breast pad is simple in structure, soft in inner side and high in supporting performance, can be pressed and relaxed regularly, and can effectively protect fragile nipple areola tissues after a breast surgery; according to the nipple and areola complex compression device, regular compression and relaxation of a nipple and areola complex can be achieved, nipples can be protected against compression deformation of foreign objects, the blood supply condition of the nipple and areola complex can be observed in real time through the visual window, avascular necrosis caused by long-time compression of the nipple and areola complex is effectively avoided, and the prognosis condition of a patient is improved.

Description

Technical Field

[0001] This utility model relates to a medical device, specifically a protective stent for nipple compression deformation and ischemia after surgeries such as mastectomy and nipple correction that preserve the nipple-areola complex, which can be directly applied in clinical practice. The stent has adjustable pressure application time. Background Technology

[0002] Breast cancer is one of the most common malignant tumors in women, and its high incidence and mortality rates have made it a "pink killer" threatening women's health. With continuous advancements in medical screening technology, increased health awareness, and women's growing pursuit of physical beauty, the proportion of early-stage breast cancer is increasing. Surgical treatment for early-stage breast cancer is also constantly innovating and progressing, from the previous total mastectomy to the current nipple-areola complex-preserving mastectomy. Extensive research and clinical practice have proven that nipple-areola complex-preserving radical mastectomy has no significant difference in local recurrence risk and long-term survival rate compared to traditional modified radical mastectomy. However, the psychological impact of mastectomy on women is undoubtedly enormous, causing varying degrees of psychological trauma and even depression in many women. While nipple-areola complex-preserving mastectomy is unanimously recognized by breast surgeons for its treatment effectiveness, the survival of the preserved nipple during the surgery is crucial to the success of the surgical aesthetics, as the nipple accounts for 50% of the aesthetic appearance of the breast. Postoperative blood supply problems in the nipple-areola complex are the most common cause of partial or complete necrosis of the nipple and areola, with an ischemic necrosis rate of approximately 3%-37%. In addition, postoperative breast blood supply impairment and surgical trauma can make the nipple vulnerable to pathogen invasion and infection, as well as easily deformed by external pressure.

[0003] Following breast cancer surgery, pressure bandages are commonly used in clinical practice to apply pressure to the chest to prevent postoperative bleeding. However, nipple and areola ischemia and necrosis are closely related to the pressure and duration of these compression bandages. To reduce nipple ischemia caused by bandaging, gauze is often modified in clinical practice by creating openings in the center to provide simple nipple protection. However, these gauze loops are difficult to secure, have poor stability and support, offer inadequate nipple protection, and make it difficult to observe nipple blood supply.

[0004] The risk of local ischemia increases significantly when pressure is applied for more than one hour. Currently, existing nipple protection devices after breast cancer surgery suffer from problems such as a single pressure point, prolonged pressure duration, inability to periodically depress and relax the pressure, and difficulty in observing the blood supply to the nipple-areola complex. For example, a breast postoperative protection device disclosed in patent publication number CN107928872A includes a rigid protective cover and an elastic fixation strap. The protective cover has an observation window at the top and a ring-shaped airbag at the bottom. The airbag's pressure is adjusted manually via an inflation valve, but it lacks a timed inflation and deflation function, making it difficult to routinely implement in clinical practice. Furthermore, the fixation strap is only secured with Velcro, resulting in poor stability. Therefore, there is an urgent need for a novel postoperative nipple protection bracket that can achieve timed pressure application and relaxation after breast cancer surgery, protecting the nipple from external pressure and facilitating observation of the blood supply to the nipple-areola complex. Summary of the Invention

[0005] The purpose of this invention is to address the issue of nipple protection after breast surgery by proposing a timed pressure device for nipple protection after breast surgery. This nipple protection bracket can protect the nipple from ischemia and necrosis or deformation caused by prolonged pressure from gauze or protective brackets, and also facilitates doctors to observe the blood supply of the nipple-areola complex.

[0006] To achieve the above objectives, the technical solution of this utility model is: a timed pressure device for nipple protection after breast surgery, comprising:

[0007] The double-layered protective cover consists of an outer rigid shell and an inner silicone liner, with a transparent viewing window on the top.

[0008] The timed pressurization airbag cushion ring is located at the bottom of the double-layer main body protective cover and includes an air pump device and control module, which supports setting the automatic inflation and deflation time interval;

[0009] There are three fixing straps, including two horizontal fixing straps and one vertical fixing strap. The horizontal fixing straps are located on the left and right sides of the double-layer main body protective cover, and the vertical fixing strap goes around the shoulders and connects to the back fixing strap.

[0010] Furthermore, the rigid outer shell is made of resin material, and the silicone liner is made of silica gel material, both of which are made by thermosetting and bonding a TPU film.

[0011] Furthermore, the diameter of the transparent viewing window is 5-7cm, the rigid outer shell side of the transparent viewing window is covered with transparent plastic, and the silicone inner liner side forms a nipple accommodating space.

[0012] Furthermore, the control module includes a touch screen interface that supports user-defined inflation cycles, with the default setting being inflation every 1 hour and deflation every 15 minutes.

[0013] Furthermore, the longitudinal fixing strap has a detachable ring buckle at the near end and a double row of buckles at the far end.

[0014] Furthermore, the outer rigid shell is made of 3D printed resin material, the inner silicone liner is medical-grade silica gel, and the surface has a wavy structure to disperse pressure.

[0015] Furthermore, the rigid outer shell of the transparent viewing window is made of polycarbonate material, while the silicone inner liner side retains an opening to ensure that the nipple and areola are exposed within the visible range.

[0016] Furthermore, the air pump device integrates a micro motor with a noise level below 30 decibels; the control module has a built-in touch screen that supports setting the inflation / deflation time, such as 1 hour of pressurization / 15 minutes of deflation, and also has an emergency manual button.

[0017] Furthermore, the horizontal fixing strap is made of elastic nylon with a width of 2-4cm, and the vertical fixing strap is an adjustable webbing with double-row hook and loop fasteners at the ends covering the Velcro area to ensure a secure back fixation.

[0018] Furthermore, the device is adaptable to different breast sizes, and the left and right protective covers are connected by detachable ring buckles.

[0019] The beneficial effects of this utility model are:

[0020] This invention relates to a timed pressure device for nipple protection after breast surgery. The device features a simple structure, a soft inner surface, and strong support. It allows for timed compression and relaxation, effectively protecting the fragile blood supply to the nipple and areola tissue after breast surgery. Its design enables timed compression and relaxation of the nipple-areola complex, protecting the nipple from deformation due to external pressure. A viewing window allows for real-time observation of the blood supply to the nipple-areola complex, effectively preventing ischemia and necrosis caused by prolonged pressure and improving patient prognosis.

[0021] The timed pressurization device for nipple protection after breast surgery of this utility model has the following innovative features:

[0022] 1. Timed intelligent pressurization: Solves the ischemia problem caused by continuous compression in existing technologies;

[0023] 2. Dual-layer protection design: Hard outer shell protects against external impacts, while silicone inner lining disperses pressure;

[0024] 3. Viewing window design: The transparent viewing window allows doctors to observe the blood supply to the nipple-areola complex at any time;

[0025] 4. Multi-dimensional fixation: The horizontal and vertical fixation straps work together to adapt to different body types. Attached Figure Description

[0026] Figure 1 This is a front structural diagram of the timing pressurization device;

[0027] Figure 2 This is a schematic diagram of the fixing belt in this timed pressurization device;

[0028] In the diagram: 1. Main protective cover; 2. Timed pressurization airbag cushion ring; 3. Fixing strap; 101. Rigid outer shell; 102. Silicone inner liner; 103. Transparent viewing window; 301. Horizontal fixing strap; 302. Vertical fixing strap; 303. Double row buckle; 304. Detachable ring buckle. Detailed Implementation

[0029] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0030] like Figure 1 As shown in Figure 2, this embodiment of the present invention provides a timed pressure device for nipple protection after breast surgery, with an overall hemispherical structure. It includes a double-layer main protective cover 1, a timed pressure airbag ring 2, and three fixing straps 3. The double-layer main protective cover 1 includes an outer rigid shell 101 and an inner silicone liner 102, as well as a transparent viewing window 103 located at the top of the hemispherical shape.

[0031] The timed pressurization airbag cushion ring 2 is located at the bottom of the protective cover. Three fixing straps 3 include two horizontal fixing straps 301 and one vertical fixing strap 302. The horizontal fixing straps 301 are located on the left and right sides of the main protective cover, and the vertical fixing strap (302) wraps around the shoulders and connects to the back fixing strap. The near end of each fixing strap is equipped with a detachable ring buckle 303, which can be connected to the protective bracket on the other side. The far end of each fixing strap is equipped with a double-row buckle 304 for back fixation.

[0032] The rigid outer shell 101 of this utility model is made of resin material, and the inner silicone liner 102 is made of silica gel material. It is non-toxic and odorless, has strong chemical stability and good biocompatibility. It is often used in fields such as female nipple protection or breast reconstruction. It can also be made by thermosetting silicone and then combining it with TPU film.

[0033] The transparent viewing window 103 at the top of the double-layer main protective cover of this utility model has a diameter of about 6cm. The hard outer shell side is covered with transparent plastic to serve as a viewing window, while the silicone inner lining side is left untreated and serves as a space for nipple protection.

[0034] The timed-pressure airbag cushion ring 2 of this utility model includes an air pump device and a control module. The control module issues commands, and the air pump device inflates the airbag cushion ring after receiving the commands. This timed-pressure airbag cushion ring 2 supports automatic inflation and deflation, and has timed pressure and relaxation functions, effectively avoiding ischemic necrosis of the nipple-areola complex and pressure sores on the breast skin caused by prolonged pressure.

[0035] The fixing strap 3 of this utility model includes two transverse fixing straps 301 and one longitudinal fixing strap 302. The transverse fixing straps 301 are located on the left and right sides of the main protective cover, and the longitudinal fixing strap 302 passes around the shoulder and connects to the back fixing strap. The near end of the fixing strap is equipped with a detachable ring buckle 303, which can be connected to the protective bracket on the other side, and the far end of the fixing strap is equipped with a double row of buckles 304 for fixation.

[0036] Preferably, the outer rigid shell 101 is made of 3D printed resin material with a thickness of 2mm, providing rigid support.

[0037] Preferably, the inner silicone liner 102 is made of medical-grade silica gel with a thickness of 5 mm and a wavy surface to disperse pressure;

[0038] Preferably, the rigid outer shell side of the transparent viewing window 103 is made of polycarbonate material, while the silicone inner liner side retains an opening to ensure that the nipple and areola are exposed within the visible range.

[0039] Preferably, the air pump device 201 integrates a micro motor with a noise level below 30 decibels;

[0040] Preferably, the control module 202 has a built-in touch screen that supports setting the inflation / deflation time, such as 1 hour of pressurization / 15 minutes of deflation, and has an emergency manual button.

[0041] Preferably, the transverse fixing strap 301 is made of elastic nylon and is 3cm wide, and is connected to the opposite device by a detachable ring buckle 303.

[0042] Preferably, the longitudinal fixing strap 302 is an adjustable webbing, and the double-row buckles 304 at the end cover the Velcro area to ensure a secure back fixation.

[0043] Preferably, silicone anti-slip strips are added to the inside of all fixing straps to prevent displacement.

[0044] The protective bracket of this utility model only covers part of the breast, is suitable for different breast sizes, and can distinguish between the left and right sides.

[0045] This utility model discloses a timed pressure device for nipple protection after breast surgery. In use: the hemispherical main protective cover, with its open end facing downwards, is placed over the breast to be protected. The nipple to be protected is positioned within a transparent viewing window, and the timed pressure airbag rings are evenly distributed on the outer skin of the areola. It is then secured with a fixing strap. The condition of the nipple and areola can be observed through the transparent viewing window. After the timed pressure device for nipple protection after breast surgery is in place, the automatic inflation and deflation interval of the airbag is set according to the patient's specific condition; it is recommended to release the airbag for 15 minutes every hour.

[0046] The specific usage procedure of the timed pressure device for nipple protection after breast surgery according to this utility model is as follows:

[0047] (1) Align the open end of the main protective cover 1 with the postoperative breast, so that the nipple is located in the center of the transparent viewing window 103;

[0048] (2) Adjust the horizontal fixing strap 301 and the vertical fixing strap 302, and fix them to the back with double-row buckles 304;

[0049] (3) Set the inflation and deflation cycle in the control module 202. After starting, the airbag cushion ring 2 will automatically pressurize and depressurize at the set interval;

[0050] (4) Observe the nipple blood supply in real time through the transparent viewing window 103, and manually adjust the pressure or stop the operation if necessary.

Claims

1. A timed pressure device for nipple protection after breast surgery, characterized in that, include: The double-layer main protective cover (1) consists of an outer hard shell (101) and an inner silicone liner (102), with a transparent viewing window (103) on the top. The timed pressurized airbag cushion ring (2) is located at the bottom of the double-layer main body protective cover (1), and includes an air pump device (201) and a control module (202), which supports setting the automatic inflation and deflation time interval; Three fixing straps (3) include two horizontal fixing straps (301) and one vertical fixing strap (302). The horizontal fixing straps (301) are located on the left and right sides of the double-layer main body protective cover (1), and the vertical fixing strap (302) goes around the shoulders and connects to the back fixing strap.

2. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The rigid outer shell (101) is made of resin material, and the silicone liner (102) is made of silica gel material. The two are made by thermosetting and bonding a TPU film.

3. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The diameter of the transparent viewing window (103) is 5-7cm. The rigid outer shell of the transparent viewing window (103) is covered with transparent plastic, and the silicone inner liner forms a nipple accommodating space.

4. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The control module (202) includes a touch screen interface that supports user-defined inflation cycles. The default setting is to inflate and pressurize every 1 hour and deflate and relax every 15 minutes.

5. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The longitudinal fixing strap (302) has a detachable ring buckle (303) at the near end and a double row of buckles (304) at the far end.

6. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The outer hard shell (101) is made of 3D printed resin material, and the inner silicone liner (102) is made of medical grade silica gel with a wavy surface to disperse pressure.

7. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The rigid outer shell of the transparent viewing window (103) is made of polycarbonate material, while the silicone inner liner has an opening to ensure that the nipple and areola are exposed within the visible range.

8. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The air pump device (201) integrates a micro motor with a noise level below 30 decibels; the control module (202) has a built-in touch screen that supports setting the inflation and deflation time, such as 1 hour of pressurization / 15 minutes of deflation, and has an emergency manual button.

9. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The transverse fixing strap (301) is made of elastic nylon and is 2-4cm wide. The longitudinal fixing strap (302) is an adjustable webbing with double-row hook and loop fasteners (304) at the end covering the Velcro area to ensure a secure back fixation.

10. The timed pressurization device for nipple protection after breast surgery according to claim 1, characterized in that: The device is adapted to different breast sizes, and the left and right protective covers are connected by a detachable ring buckle (303).

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