Patent Application
20240000655
The present invention relates to a device for softening post-operative scar tissue and a method for stretching such scar tissue.
In France, it is estimated that between 49,000 and 58,000 breast cancers are diagnosed every year and that the number is increasing by an average of 1.1% per year. In about 30 to 40% of cases, women (or other people with breast cancer) have a mastectomy, i.e. the total or partial removal of one or more breasts. This is a major surgical procedure that can be both physically and psychologically painful.
After a mastectomy, breast reconstruction is available. Breast reconstruction is usually an integral part of breast cancer management, particularly after non-conservative breast surgery such as mastectomy. Breast reconstruction can be immediate, i.e. performed at the same time as the mastectomy, or delayed, i.e. performed again some time later.
As is well known from the state of the art, breast reconstruction takes place in three stages: reconstruction of the breast volume, harmonisation of the two breasts, and creation of the areola and nipple area. There are currently three different forms of breast reconstruction:
Implant reconstruction presents significant risks of post-operative complications, such as implant rejection, peri-prosthetic shell phenomenon or various retractions. These complications cause a lot of pain and in some cases can be infectious in themselves. In very rare cases, patients with major post-operative complications may even develop cancer of the lymphatic system (Large Cell Anaplastic Lymphoma associated with the breast implant or LAGC-AIM).
Flap reconstruction, on the other hand, requires seven to eight hours of surgery under general anaesthesia, performed in microsurgery by highly specialised surgeons. In addition to the risks associated with a general anaesthetic, the waiting time for such an operation is therefore long. In addition, this type of reconstruction has a risk of failure ranging from 2 to 4%, i.e. the vessels have a significant risk of becoming blocked and leading to necrosis of the grafted flesh.
Reconstruction with injections has a low risk of post-operative complications as it is a relatively non-invasive surgical procedure, quite similar to non-invasive cosmetic treatments. However, the mastectomy leaves scar tissue with a high degree of rigidity. This scar tissue does not stretch well and it can therefore be difficult to inject fatty tissue under the rigid (and therefore very unstretchable) skin of this traumatised area. This rigidity can even prevent reconstruction by injection, even though this presents the least risk of post-operative complications and is very non-invasive.
In view of all the risks, disadvantages and limitations outlined above, only two out of ten women have breast reconstruction.
One of the objectives of the present invention is to enable any woman (or other person) who so desires to have breast reconstruction following a mastectomy.
The present invention thus offers a solution to combat the scar rigidity induced by mastectomy, thereby increasing the possibilities of using injection breast reconstruction, which is less invasive and less dangerous than other currently proposed methods.
This is achieved in accordance with the invention by a skin massage device configured to be positioned in contact with a person's skin, the device comprising:
The invention is characterised in that the device forms a decompression cone which, when switched on, simultaneously generates a suction and a series of vibrations in the action area.
This solution achieves the above-mentioned objective. In particular, the suction of the skin allows it to be stretched outwards, creating a pocket that can accommodate fatty tissues. The combination of suction with vibrations allows an improvement of the blood circulation and thus restores flexibility and elasticity to the traumatised skin in addition to creating the pocket.
The skin massage device according to the invention may comprise one or more of the following features, taken alone from each other or in combination with each other:
The invention has also for object a skin stretching method, using the device as described here-above, characterised in that it comprises, in the following order, the following steps:
The invention will be better understood, and other purposes, details, features and advantages thereof will become clearer on reading the following detailed explanatory description of embodiments of the invention given by way of purely illustrative and non-limiting examples, with reference to the attached drawings:
In the first part, the parts making up the skin massage device 10 will be described. Its operation will be detailed in a second part.
The positioning membrane 12, the main suction device 14 and the vibrator ring 16 are each rotationally symmetrical with regards to the axis A, and when these three elements are fitted together along the axis A, the vibrator ring 16 is attached in a detachable and sealed way between the positioning membrane 12 and the main suction device 14. Thus, once assembled, the device 10 presents a general rotational symmetry around the axis A. In the embodiment illustrated in
The advantages of having a device 10 with several parts to be assembled allow the materials in which these parts are made to be alternated. This also makes it possible to change one of the parts without changing the others if they are still functional. Furthermore, as each woman (and even each person in general) has different and personal morphologies, the fact that it is the result of an assembly of several parts allows the device 10 to be modular and adaptable to each of these morphologies. The different parts thus present a variety of dimensions based on the usual dimensions of the cup sizes of lingerie articles. More particularly, the membrane 12 is thus detachable from the main suction device 14, which makes it possible to change it regularly, for example between two users or between two uses by the same user, allowing good disinfection.
The sealing between the different elements to be fitted together is ensured, for example as illustrated in
The ring seal 15 also serves to dampen the vibrations of the vibrator ring 16 around the suction device 14. The annular seal 15 also serves to dampen the noise of the vibrator ring 16.
The device 10 can be operated by means of either:
The rechargeable battery B1 (shown in
The positioning membrane 12 is configured to
It is important to be able to precisely delimit an action area 18 of the device 10 on the skin of a user because the action of the device 10 must be targeted. Indeed, if the action of the device 10 is not targeted, the effect would be less and above all, in the idea of reconstructing a breast, it is very important that this is reconstructed in a place precisely decided and chosen by the user. The precision of the action of the device 10 is therefore essential to the success of the breast reconstruction made possible by the device 10. This is all the more important as the device 10 is intended to be used several times on the same action area 18, so it is essential that this action area 18 can be targeted as many times as necessary with precision and reliability by any user.
It is also essential, for the proper functioning of the device 10, to ensure a complete seal both between the interlocking parts as seen above, and between the device 10 and the user's skin.
In the embodiment illustrated in
The main suction device 14 is made of a rigid material to ensure a good grip and to optimise suction. The main suction device 14 is configured to draw in ambient air. It is hollow, as seen in
In the embodiment illustrated in
Regardless of the number of suction devices 14, 22, each suction device 14, 22 has three different suction forces:
At the beginning of the treatment, when the device 10 is used for the first time, when the skin (scar tissue) of the action area 18 is still very rigid and fragile, the use of a low suction force allows the user's skin to be spared. As the health of the skin (scar tissue) in the action area 18 improves, the skin has a near-normal elasticity and the suction force can be increased without causing damage.
Each suction generates a vacuum in the decompression chamber 20.
Each suction device 14, 22 may be operated in continuous functioning (operation) or, depending on the embodiment, in discontinuous functioning (operation). In this case, each suction device 14, 22 produces a series of 40 to 60 suctions per minute, each time generating a vacuum in the decompression chamber 20. Between two vacuums, the pressure in the decompression chamber 20 rises. This rise is either active i.e., each suction device 14, 22 can also inject air into the decompression chamber 20, or passive i.e., the pressure in the decompression chamber 20 returns to ambient pressure simply by means of a release valve 26.
In some embodiments, this release valve 26 may also serve to connect the auxiliary suction device 22 to the main suction device 14. In this case, the auxiliary suction device 22 itself has an auxiliary release valve 27 which serves the same purpose.
The vibrator ring 16 is configured to produce a series of vibrations in accordance with a predetermined pattern.
The vibrator ring 16 may be configured to receive a motherboard for recording the pre-set pattern of vibrations. In the embodiment shown in
Due to its annular shape and the tight fit of the various parts of the device 10 along the axis A, the vibrator ring 16 extends the decompression chamber 20 defined by the main suction device 14. It thus makes it possible to propagate the negative pressure generated by the main suction device 14 (or the auxiliary suction device 22, if necessary) to the positioning membrane 12 (or directly to the action area 18 if the membrane 12 is annular). The device 10 thus generates a series of suctions on the action area 18, i.e. on the user's skin.
It can be seen from
The suction device 14, each vibration spot 28 of the vibrator ring 16 and the release valves 26, 27 are controlled by an operating element 30. In the embodiment illustrated in
In alternative embodiments, the operating element 30 may be integrated with the vibrator ring 16. In another embodiment, the operating element 30 may also take the form of a remote-control operating, for example, via Bluetooth. In some embodiments, the operating element 30 may comprise the battery B1.
The operating element 30 implements each pre-set vibration pattern. Thus, as seen in
The operating element 30 has a series of control buttons 31 for:
The operating element 30 may also, as seen in
In an embodiment not shown, the operating element 30 is an application directly installed on the user's mobile phone. The device 10 can thus be conveniently controlled by the mobile phone, making its use easier, more domestic and more familiar.
It should be kept in mind that the skin of the action area 18 is often very damaged, not only by the mastectomy but also by repeated chemotherapy or radiotherapy. Thus, to further promote healing and regeneration of the skin of the action area 18, it can be seen in
It is well known that light therapy uses the light spectrum to stimulate and rebalance the body's cells. To do this, it uses different colours which will intervene according to the problems to be treated. In particular, red light therapy has regenerative and healing properties. It is therefore commonly used to repair tissues and help healing. In addition, several studies have shown the ability of red light to relieve pain and reduce oxidative stress. Indeed, red light stimulates the mitochondria of cells to function more efficiently, accelerating their ability to produce healing anti-inflammatories and protective antioxidants. In addition, red light appears to have properties that stimulate the skin's natural collagen production, which would tend to increase its elasticity.
Thus, the device 10 has a regenerative action on the skin (by the double action of light therapy and vibrations) as well as a preparatory action for a breast reconstruction (by aspiration).
The operation of the device 10 will now be described.
The implementation (or operation) of the device 10 takes place, in the following order stated, according to the following steps:
Each suction of either of the suction devices 14, 22, thus generates a suction movement from the action area 18 towards the interior of the device 10 in order to stretch it. This suction movement may be applied through the positioning membrane 12 if the positioning membrane 12 is disc-shaped or applied directly to the action area 18 if the positioning membrane 12 is annular. Each vibration further generates the propagation of movement waves in the skin of the action area 18, so as to metabolically stimulate it, as described above.
One use cycle can last up to 4 hours.
After several uses of the device 10, the user thus observes:
This enlargement of the skin surface of the action area 18 creates a space which, in time, allows a fatty tissue graft to be received. The process can be repeated until a reconstructed breast of the desired size is obtained. No rejection is possible since the fat graft is derived from the user's own fat tissue.
The present invention thus offers a simple, durable and non-invasive breast reconstruction. Due to its small size and the presence of a rechargeable battery, the device 10 can be used anywhere, at any time, without major inconvenience.
| Number | Date | Country | Kind |
|---|---|---|---|
| FR2011624 | Nov 2020 | FR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/FR2021/051999 | 11/10/2021 | WO |
