EA013782B1 - Soft tissue support - Google Patents

Abstract

The invention comprises a soft tissue support (1) in the form of a biocompatible resilient layer with a predetermined shape and means to secure the support subcutaneously. The support may be a generally L-shaped or U-shaped and be manufactured from a biocompatible resilient mesh.

Description

Technical field

The present invention relates to soft tissue support, including, but not limited to, human mammary gland support.

BACKGROUND OF THE INVENTION

Soft tissues, such as human breasts, tend to sag with age. This is caused by the weakening of the supporting tissue structures in question. In the case of human breasts, the supporting structure includes ligaments and breast skin.

The skin surrounding each breast supports the chest, hanging from the area around the clavicle above the chest. With age, the skin loses its elasticity and stretches. The ligaments that support the breast tissue from the inside also lose some of their elasticity due to aging. The combination of loss of elasticity of ligaments and loss of elasticity and distensibility of the skin of the chest causes a deterioration in the structure of support for the breast. This leads to a change in the shape of the breast, which is called drooping breasts. In fact, the weight of the breast tissue deforms the shape of the breast.

There are many procedures and prostheses that deal with breast prolapse. Some include breast lifting by skin removal. A significant problem for such procedures is scarring, which may include scars around or below the nipple. Such procedures also do not solve the initial problem of deterioration of the supporting structure of the breast.

Several breast prostheses have been developed to address the aesthetic problems associated with aging breasts. They include enlarging implants of normal breasts, which are not aimed at the problem of lowering the breast, but simply increase the volume of the breast. In some cases, this may have a beneficial effect. However, a breast-enhancing implant does not lift the breast, but rather feeds it forward. If the patient already has a prolapse of the chest, the enlarging implant simply moves the sagging breast outward, rather than lifting it.

Some prostheses for lifting the breast have been developed.

Some of them have been described in patent applications, including the following: РЯ 2682284 (Эе ^ еП); RY 2746298 (Be11yu); υδ 4840629 (81Shem. 8Shopope E. Ιηδΐτ. MeFS); \ ¥ About 9704722 (P1dpa1ato) and υδ 5217494 (Roddick e! A1.).

A common problem for these prostheses is the complexity of the operation required to implant them. For some of these previously known prostheses, such as those described in \ PO 9704722 and υδ 5217494, the prosthesis must be attached to the patient’s bone, namely to the ribs or clavicle. The screws used and the technique required to fit the prosthesis in this way increase the cost and make the procedure lengthy, and the risks associated with the procedure increase.

For some other prostheses, such as those described in υδ 4840629, OW 2746298 and OW 2682284, a significant number of incisions are required in order to prepare the patient for surgery. Usually, the skin of the breast is separated from the breast tissue and raised above it, leaving only the areola (the pigmented area around the nipple) to bind the skin and breast tissue. The prosthesis is then inserted between the skin and the breast tissue and attached to the breast tissue through sutures. The skin is then attached with sutures that leave a significant amount of visible sutures on the skin of the chest.

A common problem for previously developed prostheses is that the prosthesis is implanted in a way that secures the prosthesis between the skin and breast tissue, which makes inspection very difficult. Complicating this problem is the fact that most of these prostheses must be implanted using a relatively invasive procedure, which makes examination using an existing prosthesis very difficult.

If the patient experiences further breast prolapse, the only practical possibility is to repeat the operation, which includes removing the existing prosthesis and implanting a new prosthesis.

The next problem is that in some cases it is very difficult for the surgeon to control the shape of the breast after the prosthesis is installed. It is also very difficult for the surgeon to control the change in the positions in which the prosthesis is fixed. This could be used to modify the shape of the breast, which means that the surgeon does not have significant freedom to modify the shape of the breast.

With some of the previously known prostheses, the surgeon simply applies the prosthesis to their various points of accession, and then the shape of the breast is then determined by factors outside the control of the surgeon. This often leads to less than satisfactory results. For some prostheses, it is possible to correct the position of the prosthesis by shifting the attachment site, but this shift is limited. It also prevents the surgeon from significantly affecting the shape of the breast. This can be very important in some cases, such as cases where the patient has breasts that are uneven and the patient wants it to be fixed.

The next very real problem with previously known breast prostheses is that they do nothing with the breast shape as such except maintaining it instead of the pectoral muscle. Previously known prostheses can at best be likened to a very tight sports shirt that presses the breasts and thereby prevents their movement, preventing the breasts from taking a natural, natural shape.

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Although these problems have been described using breast prolapse as an example, similar problems exist for other types of soft tissue. These include buttocks, abdomen, facial skin, etc.

In addition, the problems described above are mainly aesthetic in nature, and procedures that take action on them are optional. In many cases, corrective cosmetic surgery is required by the patient in order to minimize the visible effects of the surgery to treat diseases such as breast cancer.

Object of the invention

The objective of the invention is to provide soft tissue support, which, at least in part, overcomes the disadvantages of the aforementioned prostheses.

SUMMARY OF THE INVENTION

In accordance with this invention, the proposed support soft tissue of mammals, including a biocompatible elastic layer with a predetermined shape, including devices for subcutaneous fixation of the support.

It is further provided that the layer includes means so that the support is effectively attached to the sternum or to the second chondrodrug joint of the recipient.

It is further provided that the layer includes a grid of elastically elongating elements, preferably a grid of filaments of circular cross section, preferably polypropylene filament.

It is further provided that the means for attaching the support to the recipient include a ligature, preferably an insoluble ligature, passing through the fascia at the level of the second intercostal space to which the support is attached, and at least around one mesh thread.

It is further provided that the mesh is usually L-shaped, alternatively L-shaped and includes a working lateral branch and a working medial branch, and it is further preferred that the lateral branch is wider than the medial branch.

It is further provided that the support includes at least one mark on the support, which indicates a cut line in order to quickly change the shape of the support.

It is further provided that the elevation should be substantially parallel to the edge of the support in order to define a reformed support having a predetermined size smaller than that of the support.

It is further envisaged that the support includes a plurality of predetermined marks, with each mark indicating a non-repeatable cut line.

It is further envisaged that the mark must be heat sealed in order to effectively create an edge after the cut through which the support will be attached subcutaneously.

According to a further characteristic feature of the invention, there is provided a soft tissue support system including a soft tissue support as defined above with an additional template attached, the template being practically impervious to body fluids.

Brief Description of the Drawings

The implementation of the invention is described below by way of example only and with reference to the accompanying drawings, in which:

FIG. 1 shows a plan view of a female breast support according to the invention;

FIG. 2 shows the female breast after an areola incision has been made in it in order to enable implantation of the prosthesis of FIG. one;

FIG. 3 shows the chest of FIG. 2 with skin surrounding the areola, drawn in order to allow access to the chest tissue, and with a prosthesis template placed in position on the chest tissue;

FIG. 4 shows the prosthesis after it has been placed on the template and attached to the fascia of the second intercostal space and breast tissue;

FIG. 5 shows a template removed from under the prosthesis;

FIG. 6 shows the prosthesis after the template has been removed from under it;

FIG. 7 shows a section through the skin of a recipient of a prosthesis and breast tissue;

FIG. 8 shows incisions for an alternative prosthesis implantation technique, and FIG. 9 shows incisions for another alternative prosthesis implantation technique.

DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of a soft tissue support according to the invention is shown in the drawings. In this embodiment, the support (1) is shaped and configured to effectively support the human female breast.

The support (1), as shown in FIG. 1, usually includes an L-shaped layer of a biocompatible elastic network (2); The L-shaped support (1) includes the lateral branch (3) and the medial branch (4), of which the lateral branch (3) is slightly wider than the medial branch (4). Mesh (2) includes thermally welded periphery (5). The mesh (2) is a synthetic mesh in this embodiment made of polypropylene. The mesh (2) includes a diamond-shaped openwork structure (6), and each thread (7) of the mesh (2) is made of polypropylene.

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The support (1) is effectively positioned so that the long size of each of the rhombuses in the openwork structure (6) is oriented mainly from top to bottom relative to the body of the recipient, and the short size of each rhombus of the openwork structure (6) is oriented mainly across the grid (2 ), in other words, almost horizontally.

The orientation of the threads (7) in the diamond-shaped openwork structure (6) allows the support (1) to provide more support in the vertical direction than in the horizontal direction. The long size of the diamond-shaped openwork structure (6) resists deformation more than the deformation resistance in a short dimension. This makes it possible for support (1) to resist the force of gravity, which is usually responsible for sagging breasts, but also allows the breast to expand naturally, as it should, for example, during swelling of the breast due to the female menstrual cycle.

To implant the support (1), the surgeon must expose the breast tissue. The type of procedure used depends on the size of the patient’s chest and the amount of drooping or sagging chest present.

Patients with a breast cup of size between size B and size C, who have a relatively small prolapse of the chest, may have a support (1) implanted through a periareol access point, i.e. an incision (8) that is made around the areola (9), as shown in FIG. 2. This leaves the structure of the nipple completely intact and leaves a scar that is easily hidden by the outline of the areola (9). As shown in FIG. 3, the skin (10) is pulled back to allow access to underlying breast tissue.

An alternative to this is to make a semicircular incision (12) above the areola (13) and another incision (14) in the pectoral fold (15), as shown in FIG. 8. This operation makes it possible to access the chest tissue from two access points. The tissue above the nipple is accessible through a semicircular incision (13), and the area above the breast fold to the nipple is accessible from the incision of the breast fold (14).

Patients with a bowl of sizes C and above and those who experience significant prolapse usually need breast reduction in combination with support implantation (1). For such patients, the surgeon usually needs more access than the one given by the procedure mentioned above. In such cases, a periareol incision is made (16) followed by an incision (17) down to the breast fold and a cut (18) in the breast fold, as shown in FIG. 9. This allows the skin to be turned away in order to provide the required access to the breast tissue for reduction and subsequent implantation of the support (1).

The implantation procedure of the support (1) will be described as an example with respect to the incision (8) shown in FIG. 2, but any of the other surgical procedures mentioned may also be used. These procedures with regard to exposure of breast tissue are not unique and are used in conventional breast surgery, which includes breast reduction, breast lift and implantation of conventional gel or brine-filled breast prostheses.

With respect to FIG. 2 procedure begins, making a periareol incision (8). The overall structure of the tissue that forms the female breast is shown schematically in FIG. 7. It can be seen that under the skin (19) there is a layer of fat (20), then the mammary gland (21) and, finally, the pectoral muscle (22).

The purpose of the procedure is to implant the support (1) into the fat layer (20). The support (1) cannot be implanted directly under the skin (19), as this will create a risk that some of the threads (7) of the mesh can be extruded through the skin (19). The support (1) is also not implanted directly on the mammary gland (21), since its implantation at this level means that the surgeon must cut off the adipose tissue (20) from the gland, which should be avoided if possible. Therefore, adipose tissue (20) is dissected into two layers: the first (20A), which is left attached to the skin (19), and the second (20B), which is left to cover the mammary gland (21). After the support (1) is implanted in the layer of fat (20), adipose tissue grows inside the mesh (2) to introduce it into the breast tissue.

A layer of fat (20) is dissected to the medial side of the chest to a height of approximately the second intercostal space (23) and around the chest (24). This exposes a layer of fat covering the mammary gland to which the support (1) should be attached.

The support (1) forms part of the system that the surgeon uses to implant it. The system includes a support (1) and optionally a template (25), which is made of a sterilized layer of plastic material. The template (25) exactly matches the shape of the support (1), allowing the edges of the support (1) to be stretched to the edges of the template (25) when the support (1) is placed on the template (25). The template (25) is used by the surgeon to determine the most suitable position for the support (1) on the chest tissue.

This is necessary because it is easier to rotate the template (25) on the layer of fat (20B) on the breast (21) than the support (1). The template (25) is made of an elastic plastic material that is not exposed when in contact with body fluids. As shown in FIG. 3, the template (25) is used to capture the breast tissue after it has been exposed. The end (29) of the medial branch (26) of the template (25) is placed in a position in which the support (1) should be fixed, i.e. usually above the second intercostal space (23).

The base (27) of the L-shaped template (25) is then stretched below the breast tissue to capture it, and the end (30) of the lateral branch (28) is placed on top of the end (29) of the medial branch (26) of the template (25). The lateral branch (28) is wider than the medial branch (26), which allows it to support breast tissue, which can stretch to the patient's armpit.

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The end (30) of the lateral branch (28) can be extended over the end (29) of the medial branch (26), which allows the surgeon to shape the chest (24). The support (1) forms what can be compared with a hammock in which chest tissue is supported (11). The distance by which the end (30) of the lateral branch (28) is pulled over the end (29) of the medial branch (26) determines the length of the support (1), which actively supports the breast tissue. Using the hammock analogy, the distance the end (30) of the lateral branch (28) extends over the end (29) of the medial branch (26) determines the length of the hammock.

The surgeon can also adjust the angle at which the end (30) of the lateral branch (28) extends over the end (29) of the medial branch (26). The normal orientation should be such that the ends (29, 30) are at an angle of about 65 ° to each other, where an angle of 0 ° means that the ends (29, 30) lie exactly aligned and elongated in the same direction. However, the surgeon can change the angle so that it is approximately between 45 and 90 °. This allows the surgeon to shape the breast (24) and shift the position of the nipple relative to the chest of the patient (24).

As shown in FIG. 4, after the ideal position of the end (30) of the lateral branch (28) relative to the end (29) of the medial branch (26) is reached, the support (1) is placed on the template (25), which at this time is held in place and in the desired position simply sticking to body fluid from adipose tissue (20B) underneath. Then the support (1) is attached to the selected intercostal space (23) with a ligature (32), which passes through the end (35) of the medial branch (36) of the support (1) and the fascia of the intercostal space (23). Then, the support body (1) is attached to the breast tissue under the template with surgical clips (33) through the edge (34) of the support (1) inside the adipose tissue (20B) under it. The end (37) of the lateral branch (38) of the support (1) is finally attached to the selected intercostal space (23) and to the end (35) of the medial branch (36) below it.

Thus, the support (1) is fixed in the patient’s chest, not allowing it to come into full contact with the patient’s body fluids until it is fixed in place. The template (25) also helps implantation, providing the surgeon with a device to determine the size of the support (1) that is needed. The surgeon can also cut the template (25) to the exact size to determine the most suitable before implanting the support (1). After the exact size is determined, the support (1) can be cut to the same size as the template before the implantation of the support (1).

After the support (1) is attached to the chest along its outer edge and at both ends, the template (25) is removed from under the support (1). This is done by pulling the template (25) through the hole left along the inner edge of the support (1) around the areola (19), as shown in FIG. 5.

This completes the implantation of the support (1), and the incision (8) can be closed using conventional surgical methods.

It should be clear that the above embodiments are provided by way of example only and are not intended to limit the scope of the invention. It is possible, for example, to slightly change the support without going beyond the scope of the invention.

It is possible to change the orientation of the support from a support that lies from a point above the chest to below the chest with two ends overlapping above the chest to a support that has two or more ends that overlap below the chest. With this support, one end should be attached above the chest and, for example, the two ends should extend around the nipple to connect below the chest. In principle, the chest is still supported as a hammock, and the difference lies in the points of attachment to the chest and the net itself.

Claims (20)

CLAIM 1. The support is a soft tissue of mammals, including a biocompatible resilient layer with a predetermined shape, including a base from which two branches extend, essentially at a right angle to each other, and devices for subcutaneous fastening of the support. 2. The support according to claim 1, which includes a working medial branch and a working lateral branch and in which the lateral branch is wider than the medial branch. 3. The support according to claim 1 or 2, in which the layer is substantially b-shaped. 4. The support according to claim 1 or 2, in which the layer is essentially I-shaped. 5. Support according to any one of claims 1 to 4, in which the layer includes a grid of elastic elongated elements. 6. Support according to claim 5, in which the layer includes a grid of filaments of circular cross-section. 7. Support according to claim 5 or 6, in which the elastic elongated elements include polypropylene filaments. 8. A support according to any one of the preceding claims, wherein the means for subcutaneous fastening of the support includes an edge of the end of the medial branch of the support and the end of the medial branch of the support operatively attached to the fascia surrounding any one of the first three intercostal spaces, through a ligature passing through the end of the medial branch and fascia. 9. Support of claim 8, in which the means for subcutaneous fastening support includes the edge of the end of the lateral branch of the support and the end of the lateral branch of the support, operatively attached to the fascia surrounding any one of the first three intercostal spaces, through a ligature passing through the end of the lateral branch, the fascia and the end of the medial branch of the support. - 4 013782 10. The support of claim 8 or 9, in which the means for subcutaneous fastening of the support includes an edge around the periphery of the support and an edge operatively attached to the underlying breast tissue by means of a ligature or clips passing through the edge inside the underlying breast tissue. 11. A support according to any one of claims 8 to 10, in which the edge of the layer is heat sealing. 12. Bearing according to any one of claims 8-11, in which the edge of the layer is creased. 13. Support according to any one of claims 1 to 12, which includes at least one mark on the support, which indicates the incision line in order to promptly change the shape of the support. 14. Bearing on item 13, in which the mark is located essentially parallel to the edge of the support, to determine the reformed support, having a predetermined size smaller than the support. 15. A support according to claim 14, which includes a plurality of predetermined marks, each mark indicating a non-repeatable cut line. 16. Bearing according to any one of claims 13 to 15, in which the mark is heat sealed in order to effectively create an edge after the cut through which the support will be fixed subcutaneously. 17. The supporting system of the soft tissue of a mammal, comprising a support according to any one of claims 1 to 16, and a pattern having a shape complementary to the support. 18. The system of claim 17, wherein the template has dimensions complementary to the dimensions of the support. 19. The system of claim 18, wherein the pattern has the same dimensions as the dimensions of the support. 20. A system according to any one of claims 17-19, in which the template is made of an elastic sterilizable plastic material.