Pressure-sensing volume-variable breast prosthesis

Abstract

The invention discloses a pressure-sensing volume-variable breast prosthesis which comprises an elastic flexible shell, and a cavity used for containing filler is formed in the flexible shell; an injection valve is further arranged on the flexible shell; a sheet-shaped accommodating space is arranged in a contact area of the outer surface of the flexible shell and the inner surface of the flap; a pressure measuring unit is arranged in the sheet-shaped accommodating space, and the pressure measuring unit comprises a flexible pressure sensing array and a wireless transmitting module; wherein the pressure measuring unit is used for measuring the pressure between the side flexible shell and the skin flap; the sheet-shaped containing space is arranged in the contact area of the flexible shell and the inner surface of the skin flap, the pressure measuring unit is arranged in the containing space, the pressure between the flexible shell and the skin flap can be monitored in real time, the pressure of the breast prosthesis on the skin flap is judged through the pressure, excessive stretching of the skin flap is avoided, and therefore the probability of skin flap necrosis is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of breast prostheses, and in particular relates to a pressure-sensitive volume-variable breast prosthesis. Background Art

[0002] Breast cancer is the most common malignant tumor in women. With the advancement of systemic treatment, the survival rate of breast cancer patients has been improved, and patients have higher and higher requirements for quality of life. Traditional mastectomy brings great physical and psychological pain to patients. In order to alleviate this pain, surgeons have developed many breast reconstruction procedures in the past few decades, which can be roughly divided into breast reconstruction based on prosthesis implantation and autologous tissue flap breast reconstruction. Recent trends show that prosthesis-based breast reconstruction has become the most popular reconstruction method after mastectomy.

[0003] The most serious surgical complication of prosthesis-based breast reconstruction is prosthesis removal. Past studies have found that the main factor leading to prosthesis removal is flap necrosis. One of the reasons for flap necrosis is improper selection of prosthesis volume, which results in excessive flap pressure, leading to ischemia and subsequent necrosis. Summary of the invention

[0004] The purpose of the present invention is to provide a pressure-sensitive volume-variable breast prosthesis to reduce the probability of skin flap necrosis during breast reconstruction.

[0005] The present invention adopts the following technical solution: a pressure-sensitive variable-volume breast prosthesis, comprising an elastic flexible shell, wherein the flexible shell has a cavity for accommodating a filler;

[0006] An injection valve is also provided on the flexible shell;

[0007] A sheet-shaped accommodation space is provided in the contact area between the outer surface of the flexible shell and the inner surface of the flap;

[0008] A pressure measuring unit is arranged in the sheet-shaped accommodation space, and the pressure measuring unit includes a flexible pressure sensing array and a wireless transmission module;

[0009] The pressure measuring unit is used to measure the pressure between the side flexible shell and the skin flap.

[0010] Further, the sheet-shaped accommodation space has an opening.

[0011] Furthermore, an adhesive layer (20) is provided on the outer surface of the flexible shell, and a sheet-shaped accommodation space is provided between the adhesive layer (20) and the outer surface of the flexible shell.

[0012] Furthermore, the number of the sheet-shaped accommodating space is at least one.

[0013] Furthermore, the flexible pressure sensing array and the wireless transmission module are both in sheet form.

[0014] Further, the injection valve is flush with the outer surface of the flexible housing.

[0015] Furthermore, a flexible temperature sensor array is also arranged in the sheet-shaped accommodation space.

[0016] Furthermore, the area of ​​the flexible shell facing the skin flap is a rough surface.

[0017] Another technical solution of the present invention: a pressure-sensitive variable-volume breast prosthesis, comprising the above-mentioned pressure-sensitive variable-volume breast prosthesis;

[0018] Wherein, the cavity of the flexible shell is filled with fillers.

[0019] Another technical solution of the present invention: a pressure-sensitive variable-volume breast prosthesis assembly, comprising the above-mentioned pressure-sensitive variable-volume breast prosthesis;

[0020] It also includes a wireless receiving module and a display module, and the display module is used to display the pressure data measured by the pressure measuring unit.

[0021] The beneficial effects of the present invention are as follows: by providing a sheet-shaped accommodation space in the contact area between the flexible shell and the inner surface of the skin flap, and providing a pressure measuring unit in the accommodation space, the present invention can monitor the pressure between the flexible shell and the skin flap in real time, judge the pressure of the breast prosthesis on the skin flap by the pressure, avoid excessive stretching of the skin flap, and thus reduce the chance of skin flap necrosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic structural diagram of a pressure-sensitive volume-variable breast prosthesis according to an embodiment of the present invention;

[0023] Figure 2 This is a schematic diagram of the surface structure of a pressure-sensitive and volume-variable breast prosthesis according to an embodiment of the present invention;

[0024] Figure 3 This is a schematic diagram of an application scenario of a pressure-sensitive volume-variable breast prosthesis according to an embodiment of the present invention.

[0025] Wherein: 10. flexible shell; 20. adhesive layer; 30. injection valve; 40. pressure measuring unit; 50. syringe; 60. display unit; 70. wireless transmission path. DETAILED DESCRIPTION

[0026] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0027] Breast reconstruction based on breast prosthesis can be divided into immediate breast reconstruction (i.e., stage I breast reconstruction) and delayed breast reconstruction (i.e., stage II breast reconstruction). Currently, stage I breast reconstruction has higher complications than stage II breast reconstruction, and stage II breast reconstruction requires a second operation, which causes secondary damage to the patient's physical, psychological and economic conditions and limits its use.

[0028] When the size of the breast implant is too large, the skin flap will be subjected to mechanical pressure, causing the skin flap to be overstretched, which can easily lead to ischemic necrosis. At the same time, when the breast implant is too large, it will compress the surrounding blood vessels, resulting in insufficient blood supply to the tissue, which can also cause necrosis.

[0029] The present invention discloses a pressure-sensitive volume-variable breast prosthesis, comprising an elastic flexible shell 10, wherein the flexible shell 10 has a cavity for accommodating a filler; an injection valve 30 is also provided on the flexible shell 10; a sheet-shaped accommodating space is provided in the contact area between the outer surface of the flexible shell 10 and the inner surface of the skin flap; a pressure measuring unit 40 is provided in the sheet-shaped accommodating space, and the pressure measuring unit 40 includes a flexible pressure sensing array and a wireless transmission module; wherein the pressure measuring unit 40 is used to measure the pressure between the side flexible shell 10 and the skin flap.

[0030] The present invention provides a sheet-shaped accommodation space in the contact area between the flexible shell 10 and the inner surface of the skin flap, and provides a pressure measuring unit 40 in the accommodation space, so as to monitor the pressure between the flexible shell 10 and the skin flap in real time, judge the pressure of the breast prosthesis on the skin flap by the pressure, avoid excessive stretching of the skin flap, and thus reduce the chance of skin flap necrosis.

[0031] When the flexible pressure sensing array shows that the pressure is too high, the pressure on the skin flap can be reduced by reducing the volume of the flexible shell 10, thereby preventing the occurrence of skin flap necrosis. Specifically, it is usually necessary to determine the pressure threshold according to the individual situation of the operator, and finally adjust it according to the threshold, or the pressure detected when less saline is injected into the flexible shell 10 at the beginning. Later, when the skin expands, the pressure can be reduced, and monitoring can be performed based on the previous pressure value to prevent the skin flap from being necrosis due to excessive pressure.

[0032] When the pressure is appropriate, the volume of the flexible shell 10 can be gradually increased to achieve expansion of the tissue, thereby protecting the skin and reducing complications of reconstruction.

[0033] In the present invention, the skin flap refers to the breast epidermis that is not removed after mastectomy. The skin flap has a large number of blood vessels. If the breast prosthesis compresses these blood vessels, it will cause vascular necrosis, thereby causing ischemic necrosis of the skin flap. If the compression pressure is controlled within a certain range, these blood vessels will regenerate by themselves to ensure that the skin flap recovers slowly.

[0034] The flexible shell 10 is made of flexible material, so that its shape can be changed. It can be placed in the breast after surgery to inhibit the contraction of the skin flap. Preferably, the flexible shell 10 can be made of silicone material, and the safety of silicone prosthesis implantation has been verified in past studies.

[0035] In the present invention, the sheet-shaped receiving space may or may not have an opening.

[0036] When an opening is provided, the pressure measuring unit 40 can be easily removed later. However, due to the contact with the skin flap, some body fluids or blood may seep into the sheet-shaped cavity, increasing the risk of tissue infection. Therefore, when an opening is provided, the pressure measuring unit 40 can be coated with a waterproof layer on the outside and then placed in the sheet-shaped accommodation space.

[0037] When no opening is provided, body fluid or blood will not penetrate into the sheet-shaped cavity. After the hydrogel is injected into the flexible housing 10, an opening needs to be cut out of the sheet-shaped accommodation space, and then the pressure measurement unit 40 is taken out.

[0038] The sheet-shaped accommodation space refers to a space with a small thickness. In one case, since the flexible shell 10 has a thickness, a biased accommodation space can be dug out on the surface of the flexible shell 10, and then the pressure measuring unit 40, which is also a sheet, is inserted therein. Since the pressure measuring unit 40 is thin, the surface does not change significantly after insertion, and the normal use of the breast prosthesis will not be affected.

[0039] For example, Figure 1 and Figure 2 As shown, an adhesive layer 20 is provided on the outer surface of the flexible shell 10, and a sheet-shaped accommodation space is provided between the adhesive layer 20 and the outer surface of the flexible shell 10. Compared with the above-mentioned method of opening a hole on the surface of the flexible shell 10, this method can avoid damaging the overall structure of the flexible shell 10 and improve the service life of the prosthesis. Specifically, the adhesive layer 20 can be made of the same material as the flexible shell 10, and the two can even be integrally formed. The shape of the adhesive layer 20 can be designed according to the size of the pressure measuring unit 40, such as rectangular, elliptical, semicircular, etc.

[0040] The number of the sheet-shaped accommodation space is at least one. Since the pressure between the flexible housing 10 and the flap needs to be measured, and there is a certain contact area between the two, the number of the sheet-shaped accommodation space can be increased as needed to increase the measurement accuracy.

[0041] The thickness of each position of the adhesive layer 20 corresponding to the sheet-shaped accommodating space is equal, and matches the surface of the flexible shell 10, so that the breast shape will not be changed, so that the flexible shell 10 will not protrude due to the existence of the pressure measuring unit 40, thereby losing the shape of the prosthesis itself, and the outer surface of the prosthesis or the circular surface is curved. The adhesive layer 20 in the present invention matches the surface of the flexible shell 10, that is, the sheet-shaped cavity is set to adapt to the curvature of the flexible shell 10 itself, so as not to affect the shape of the flexible shell 10.

[0042] The flexible shell 10 used in the present invention is configured in a teardrop shape or a disc shape to meet the needs of different breast reconstructions. The pressure measurement unit 40 is placed at the most protruding part of the flexible shell 10 (e.g., the disc-shaped flexible shell 10 refers to the highest point of the disc, and the teardrop-shaped flexible shell 10 refers to the lower protruding part of the teardrop).

[0043] In addition, in order to increase the accuracy of measurement and the aesthetics of the breast prosthesis, the flexible pressure sensing array and the wireless transmission module are both in sheet form, so that when the measuring unit 40 is placed in the sheet-shaped accommodating space, the shape of the breast prosthesis does not change significantly, but the position corresponding to the sheet-shaped accommodating space will be slightly protruding, but this will not affect the overall effect.

[0044] The material of the flexible shell 10 used in the present invention is silica gel, which can completely wrap the flexible pressure sensor array. On the one hand, it can fix the flexible pressure sensor to prevent displacement, and on the other hand, it can isolate the contact between the pressure sensor and the autologous tissue, thereby reducing the occurrence of allergic reactions. The sensor unit size of the flexible pressure sensor array selected by the present invention can be designed to be 0.5×0.5mm, so that the shape of the breast prosthesis can be maintained.

[0045] In the present invention, in order to further enhance the aesthetics, the injection valve 30 is flush with the outer surface of the flexible housing 10. The injection valve 30 used in the present invention is preferably a self-sealing injection port, similar to the insertion port of an infusion port, which can be used for repeated punctures without leakage.

[0046] In addition, a flexible temperature sensing array is also provided in the sheet-shaped accommodation space. Specifically, the flexible temperature sensing array and the flexible pressure measuring unit can be installed in the same sheet-shaped accommodation space, or they can be installed in different sheet-shaped accommodation spaces. It should be noted that when the two are installed in different sheet-shaped accommodation spaces, a wireless transmission module needs to be installed for the flexible temperature sensing array.

[0047] When blood circulation disorders occur in a certain area, such as thrombosis, the skin temperature of the area may decrease because the blood flow is blocked, resulting in insufficient heat supply. On the contrary, if the blood flow in a certain area increases, such as due to inflammation or infection, the skin temperature may increase. Therefore, changes in skin temperature can reflect the status of local blood circulation, and have important application value in diagnosing blood circulation disorders, monitoring the risk of pressure injuries, and evaluating the effect of regional blockade.

[0048] Therefore, the temperature of the skin is closely related to the blood flow of the skin. This embodiment can detect both temperature and pressure receptors to better prevent skin flap ischemia. At the same time, when inflammation occurs, the temperature will rise, which can also better guide doctors to use anti-inflammatory drugs in a timely manner.

[0049] The area of ​​the flexible shell 10 facing the skin flap is a rough surface. In other words, the surface of the flexible shell 10 used in the present invention is designed to have a rough surface structure, so that it is easy to merge with the tissue to form a fiber capsule and promote rapid shaping.

[0050] The breast prosthesis of the present invention can be applied to patients receiving radiotherapy. Radiotherapy is an important factor leading to skin flap necrosis. During radiotherapy, the volume of the flexible shell 10 can be reduced (ie, the amount of liquid injected therein is reduced) to reduce the occurrence of skin flap necrosis.

[0051] After the flexible shell 10 of the present invention is gradually expanded to reach the required capacity, the flexible pressure sensing microarray can be removed after the postoperative pressure remains stable and the patient recovers well.

[0052] The pressure-sensitive volume-variable breast prosthesis of the present invention can inject physiological saline into the flexible shell in the initial stage, and when the flexible shell reaches the expected volume, the filled physiological saline is replaced with hydrogel using a high-pressure syringe.

[0053] During use of the pressure-sensitive variable-volume breast prosthesis of the present invention, physiological saline is first injected into the flexible housing 10 through the injection valve before the breast prosthesis is implanted, so that the breast prosthesis has a certain volume before implantation. Then, the breast prosthesis is implanted into the patient's body, and the pressure is observed after implantation. According to the pressure, liquid is extracted or injected from the injection valve to adjust the volume of the prosthesis.

[0054] After surgery, the volume of the breast prosthesis is adjusted in real time by real-time monitoring of pressure, injecting or extracting saline from the skin puncture to the injection valve, until the breast volume gradually expands to the required capacity. After the patient's breast expands to the required volume, the saline is replaced with hydrogel. After the replacement is completed and the wound heals well, the pressure detection unit 40 can be removed or retained.

[0055] The present invention also discloses a pressure-sensitive variable-volume breast prosthesis, which includes the pressure-sensitive variable-volume breast prosthesis described above, wherein the cavity of the flexible shell 10 is filled with a filler, which may be saline or hydrogel.

[0056] The present invention also discloses a pressure-sensitive volume-variable breast prosthesis assembly, such as Figure 3 As shown, it includes the above-mentioned pressure-sensing variable-volume breast prosthesis; it also includes a wireless receiving module and a display module 60 connected by signals, the wireless receiving module is used to receive the pressure data sent by the wireless sending module, and the display module 60 is used to display the pressure data measured by the pressure measuring unit 40. The wireless sending module and the wireless receiving module transmit signals through a wireless transmission path 70.

[0057] In addition, a syringe 50 may be included, through which physiological saline may be injected into or extracted from the flexible shell 10 , and physiological saline may be extracted and injected into the hydrogel.

Claims

1. A pressure-sensitive variable volume breast prosthesis, characterized in that: It comprises an elastic and flexible shell (10), wherein the flexible shell (10) has a cavity inside for accommodating a filler; The flexible housing (10) is also provided with an injection valve (30); A sheet-shaped accommodation space is provided in the contact area between the outer surface of the flexible shell (10) and the inner surface of the skin flap; A pressure measuring unit (40) is arranged in the sheet-shaped accommodation space, and the pressure measuring unit (40) comprises a flexible pressure sensing array and a wireless transmission module; Wherein, the pressure measuring unit (40) is used to measure the pressure between the flexible shell (10) and the skin flap.

2. A pressure-sensitive variable volume breast prosthesis as claimed in claim 1, characterized in that: The sheet-shaped accommodation space has an opening.

3. A pressure-sensitive variable volume breast prosthesis as claimed in claim 2, characterized in that: The outer surface of the flexible shell (10) is provided with an adhesive layer (20), and the sheet-shaped accommodation space is between the adhesive layer (20) and the outer surface of the flexible shell (10).

4. A pressure-sensitive variable volume breast prosthesis as claimed in claim 3, characterized in that: The number of the sheet-shaped accommodating space is at least one.

5. A pressure-sensitive variable volume breast prosthesis according to any one of claims 2 to 4, characterized in that: The flexible pressure sensing array and the wireless transmission module are both in sheet shape.

6. A pressure-sensitive variable volume breast prosthesis according to any one of claims 2 to 4, characterized in that: The injection valve (30) is flush with the outer surface of the flexible shell (10).

7. The pressure-sensitive variable volume breast prosthesis according to claim 4, characterized in that: A flexible temperature sensor array is also arranged in the sheet-shaped accommodation space.

8. A pressure-sensitive variable volume breast prosthesis as claimed in claim 2 or 3, characterized in that: The area of ​​the flexible shell (10) facing the skin flap is a rough surface.

9. A pressure-sensitive variable volume breast prosthesis, characterized in that: A pressure-sensitive variable-volume breast prosthesis comprising any one of claims 1 to 8; Wherein, the cavity of the flexible shell (10) is filled with a filler.

10. A pressure-sensitive variable volume breast prosthesis assembly, characterized in that: A pressure-sensitive variable-volume breast prosthesis comprising any one of claims 1 to 8; It also comprises a wireless receiving module and a display module (60), wherein the display module (60) is used to display the pressure data measured by the pressure measuring unit (40).

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