BRPI0610761A2 - mammal soft tissue support and system - Google Patents

Abstract

FAMILY MOLE FABRIC SUPPORT AND ITS SYSTEM. The invention comprises a soft tissue support (1) in the form of a biocompatible resilient layer of a predetermined shape and means for securing support subcutaneously. The support may generally be confirmed in L or U to be manufactured from a biocompatible elastic mesh.

Description

"Mammal Soft Tissue Support Respective System"

Descriptive Report

Field of the Invention

This invention relates to a soft tissue support including, but not limited to, a human breast support.

Background of the Invention

Soft tissue, like the human breast, is prone to deformation with age. This is caused by a weakening of the relevant soft tissue support structures. In the case of human breasts, the supporting structure includes ligaments and sinus skin.

The skin that encapsulates each breast supports the breast by suspending it from the area around the collarbone above the breast. With aging, the skin loses its elasticity and exhausts. Ligaments that support the breast tissue inwardly also lose some of their resilience due to aging. The combination of ligament-de-resilience loss and loss of elasticity and stretching of the sinus skin causes the breast support structure to be compromised. This leads to deformation of the sinus conformation, which is called sinus ptosis. In fact, the weight of the breast tissue deforms the shape of the breast.

Many procedures and prostheses that treat breast ptosis are available. Some include lifting the breast by removing the skin. A significant problem with these procedures are scarring, which may include scarring around or below the nipple. These procedures also do not solve the original problem of a compromised breast support structure.

Some breast implants have been developed to treat aesthetic problems associated with breast aging. These include normal breast augmentation implants that do not resolve the breast ptosis problem but merely add volume to the breast. In some cases this may have beneficial effects. However, a breast augmentation implant does not lift the breast, but rather pushes it forward. If the patient already has sinus ptosis, an implant augmentingly pushes the fallen sinus out and does not lift it.

Some breast lift prostheses have been developed. Some of these have been described in patent applications including the following: FR 2682284 (Dessart); FR 2746298 (Bellity); US 4840629 (Silimed Silicone and Medical lnstr); WO09704722 (Pignataro); and US 5217494 (Coggins et al.).

A common problem with these prostheses is the complexity of the procedure required to implant them. With some of these prior art prostheses, such as those described in WO09704722 and US 5217494, the prosthesis needs to be attached to the patient's bone, specifically the ribs or clavicle. The screws used and the technique required to adjust the prosthesis in this way increase the cost and make the procedure long, which increases the risks associated with the procedure.

With some of the other prostheses, such as those described in US 4840629, FR 2746298 and FR 2682284, a significant amount of cuts is required to prepare the patient for the procedure. Generally, the sinus skin is separated from and raised from the breast tissue, leaving only the areola to connect the breast skin and the breast tissue. The prosthesis is then slid between the skin and the breast tissue and attached to the breast. sinus by means of points. The skin is then closed by stitches, which leaves a significant amount of visible scars on the skin dose.

A common problem with prior art prostheses is that the prosthesis is implanted in a manner that holds the prosthesis between the skin and the breast tissue in a way that makes revision very difficult. Compounding this problem is the fact that most These prostheses must be implanted by relatively invasive procedures, which makes revision using the existing prosthesis very difficult.

If the patient experiences more sinus ptosis, the only practical option is to repeat the procedure, including removal of the existing prosthesis and implantation of a new prosthesis.

An additional problem is that in some cases it is very difficult for the surgeon to manipulate the shape of a sinus after the prosthesis has been implanted. It is also very difficult for the surgeon to vary and manipulate the places where the prosthesis is fixed. This could have been helpful in modifying the shape of the breast, meaning that the surgeon does not have a significant scope to modify the shape of the breast.

With some of the prior art prostheses, the surgeon simply attaches the prosthesis to its various fixation locations and the shape of the sinus is then determined by factors beyond the surgeon's control. This often results in less than satisfactory results. With some prostheses it is possible to adjust the position of the prosthesis by shifting the fixation site, but this movement is limited. Nor does it allow the surgeon to significantly manipulate the formed sinus. This can be very important in some cases such as those where the patient has breasts that are not similarly shaped and the patient wishes to have this corrected.

An additional very practical problem with the technique of the prostate sinus is that they do nothing to conform the breast themselves, but hold it against the sinus muscle. The state-of-the-art prostheses can at best be compared to a very tight sports bra that squeezes the breasts and thus prevents movement without allowing the breasts to assume an ideal natural shape.

While these problems have been described using breast aptitude as examples, similar problems exist for other soft tissue types. These include buttocks, bellies, facial skin and so on. In addition, the problems described above are generally aesthetic in nature and the procedures for treating them are elective. In many cases, the patient requires corrective plastic surgery to minimize surgery of visible effects to treat diseases such as breast cancer.

Purpose of the Invention

It is an object of this invention to provide a soft held support that overcomes at least in part the aforementioned problems.

Summary of the Invention

According to this invention, there is provided a mammalian soft-held support comprising a biocompatible resilient layer of a predetermined shape including means for securing the support subcutaneously.

It is further provided that the layer includes means for the support to be operably attachable to the breast bone or the second chondernal joint of the container.

It is further provided that the layer comprises a mesh of resilient elongate members, preferably a mesh of circular straight section filaments, preferably preferably a polypropylene filament.

It is further provided that the medium holds the support in the container so as to comprise the suture, preferably non-dissolvable suture, extended through the fascia at the level of the second intercostal space to which the support is attached and around at least one filament of the mesh. .

It is further provided that the mesh is generally L-shaped, alternatively U-shaped, and includes a lateral operative leg and a middle operative leg, and preferably that the lateral leg is wider than the mediate leg.

It is further provided that the support includes at least one support marker indicating a cut line for operatively reconfiguring the support.

It is further provided that the mark is located substantially parallel to the end of the support to define a conforming support having a predetermined size smaller than the support.

It is further provided that support includes a plurality of predefined marks with each mark indicating a single cut line.

It is further provided that the mark is heat sealed to operably provide an end after cutting through which the support is subcutaneously fixable.

According to a further feature of the invention there is provided a soft tissue support system comprising a soft tissue support as defined above with an associated complementary model so that the model is substantially impermeable to body fluids.

Brief Description of the Drawings

An embodiment of the invention is described below by way of example only and with reference to the accompanying drawings in which:

Figure 1 shows a plan view of a breast support according to the invention;

Figure 2 shows a woman's breast after a periareolar incision is made into her to enable implantation of the prosthesis of Figure 1;

Figure 3 shows the breast of Figure 2 with the skin surrounding the stretched areola to allow access to the breast tissue and common prosthetic model placed in position in the breast tissue;

Figure 4 shows the prosthesis after it has been placed in the model and has been attached to the fascia of the second intercostal rib and to the dose tissue, Figure 5 shows the model being removed from below the prosthesis;

Figure 6 shows the prosthesis after the model has been removed from under it;

Figure 7 shows a section through a recipient of the prosthetic skin and breast tissue;

Figure 8 shows the incisions for an alternative prosthetic implant procedure; and

Figure 9 shows the incisions for another alternative prosthetic implant procedure.

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 formed and configured to operably support a human breast.

The support (1) as shown in Figure 1 comprises a generally L-shaped layer of biocompatible resilient mesh (2). The L-shaped support (1) includes a lateral leg (3) and a mediate leg (4), whose lateral leg (3) is slightly wider than the mediate leg (4).

The mesh (2) includes a heat sealed periphery (5). Mesh (2) is a synthetic mesh in this embodiment made from polypropylene. The mesh (2) includes a diamond-shaped hollow structure (6) and each filament (7) of the mesh (2) is made of polypropylene.

The support (1) is operatively arranged such that the elongated size of each of the diamonds in the shaped casting structure (6) is substantially oriented from top to bottom with respect to the container body and the smaller size of each casting diamond (6) is substantially oriented through the mesh (2), in other words, operatively horizontally.

The orientation of the filaments (7) in the diamond-shaped cast structure (6) allows the support (1) to provide more support in the vertical direction than in the horizontal direction. The larger dimension of the diamond-shaped cast structure (6) resists deformation more than the deformation is resisted in the smaller dimension. This enables support (1) to resist gravity, which normally contributes to breast deformation, but still allows the breast to expand naturally, as would be the case, for example, with swollen dosing due to the female menstrual cycle.

To implant the support (1), the surgeon needs to expose the breast tissue. The type of procedure used depends on the size of the patient's bones and the amount of ptosis or deformation that they present.

Patients with a sinus cup size between size B and size C and having relatively small ptosis may have the support (1) implanted through a peroperaolar access point, ie an incision (8) that is made around the areola (9), as shown in Figure 2. This leaves the nipple structure completely intact and leaves a scar that is easily hidden by the areola outline (9). As shown in Figure 3, the skin (10) is stretched open to allow access to the underlying breast tissue (11).

An alternative to this is to make a semicircular incision (12) above the areola (13) and another incision (14) in the infra-mammary fold (15), as shown in Figure 8. This procedure allows access to the breast tissue from of two access points. The tissue above the mammary gland is accessed through the semicircular incision (13) and the area above the mammary fold to the nipple is accessed from the infra-mammary fold incision (14).

Patients with cup sizes of C and above who experience large amounts of ptosis usually need to have a sinus reduction in conjunction with the support implant (1). For these patients, the surgeon usually needs greater access than the previously mentioned procedures allow. In these cases, a periareolar incision (16) is made, followed by an incision (17) down the infra-mammary fold and an incision (18) in the infra-mammary fold, as shown in Figure 9. This allows the skin to be torn stay open to allow adequate access to the tissue of the tooth for reduction and then the implantation of the support (1).

The implant implantation procedure (1) will be described by way of example with reference to the incision (8) shown in Figure 2, but any of the other surgical procedures mentioned may also be used. These procedures, as they expose the sinus tissue, are not unique and are used for conventional sinus surgery, which includes breast reductions, breast lift and the implantation of conventional gel or saline-filled breast prosthesis.

Referring to Figure 2, the procedure is started by making the periareolar incision (8). The general construction of the tissue that forms the breast is schematically shown in Figure 7. It can be seen that under the skin (19) there is a layer of fat (20), then the sinus agglomerate (21) and finally the muscle. of the breast (22).

The purpose of the procedure is to implant the support (1) in the fat layer (20). The support (1) cannot be implanted directly under the skin (19), as this will create the risk that some of the mesh filaments (7) will be extruded through the skin (19). The support (1) is also not implanted directly over the dose gland (21), since implanting it at this level means that the surgeon has to dissect the fatty tissue (20) of the gland, which should be avoided if possible. The fatty tissue (20) is therefore dissected into two layers, a first (20A) that is left attached to the skin (19) and a second (20B) that is allowed to cover the sinus gland (21). After the support (1) has been implanted in the fat layer (20), the fat tissue grows into the mesh (2) to incorporate it into the dose tissue.

The fat layer (20) is dissected to the medial dose at about the second intercostal space (23) and around the dose (24). This exposes a layer of fat that covers the dose gland to which the support (1) must be fixed.

The bracket (1) is part of a system that is used by the surgeon to deploy it. The system includes the support (1) and a complementary model (25), which is manufactured from a sterile plastic material layer. The template (25) precisely matches the shape of the holder (1), allowing the ends of the holder (1) to extend marginally above the ends of the template (25) when the holder (1) is placed over the template ( 25). Model (25) is used by the surgeon to determine the most appropriate position for support (1) over breast tissue.

This is necessary since it is easier to move the template (25) around the fat layer (20B) over the sinus gland (21) than the support (1). Model 25 is made from resilient plastic material that is unaffected by contact with body fluids. As shown in Figure 3, model 25 is used to capture breast tissue after it has been exposed. The end (29) of the mediaper (26) of the model (25) is placed in a position where the support (1) will be fixed, that is, typically over the second intercostal space (23).

The base (27) of the L-shaped model (25) is then extended under the breast tissue to capture it and the end (30) of the side leg (28) is placed over the end (29) of the middle leg. (26) of the model (25). The lateral leg 28 is wider than the leg 26, which allows it to support the sinus tissue that may extend under the patient's armpit.

The end (30) of the side leg (28) may be extended over the end (29) of the middle leg (26), which allows the surgeon to form the breast (24). The support (1) forms what can be compared to a mesh within which the breast tissue (11) is supported. The extent to which the end (30) of the side leg (28) is displaced over the end (29) of the middle leg (26) determines the length of the support (1) that actively supports the breast tissue. Using the net analogy, the amount by which the end (30) of the pernalateral (28) extends above the end (29) of the middle leg (26) determines the length of the net.

It is also possible for the surgeon to adjust the angle at which the end (30) of the side leg (28) extends above the end (29) of the middle leg (26). The normal orientation would be for the ends (29, 30) to be at an angle of about 65 ° to each other, where an angle of 0 ° would mean that the ends (29, 30) are perfectly aligned, extending in the same direction.

However, it is possible for the surgeon to change the angle to be anywhere from about 45 ° to about 90 °. This allows the surgeon to conform to the breast (24) and shift the domamil position relative to the patient's chest (31).

As shown in Figure 4, once the ideal orientation of the end (30) of the lateral leg (28) has been achieved with respect to the end (29) of the middle leg (26), the support (1) is placed over the model (25). which is held in place and in the desired orientation at the same time merely by sticking to the body fluid of the fatty tissue (20B) underneath it. The support (1) is then fixed to the selected intercostal space (23) by suture (32) which is extended through the end (35) of the bracket (36) of the support (1) and the fascia of the intercostal space ( 23). The support body (1) is then affixed to the breast tissue under the template by surgical sections (33) through the end (34) of the support (1) within the fat tissue (20B) underneath it. The end (37) of the lateral leg (38) of the support (1) is finally sutured into the selected inter-costal space (23) and the end (35) of the lower middle leg (36).

In this way, the support (1) is fixed within the patient without always allowing full contact with the patient's body fluid until it has been fixed in place. Model (25) also assists the implant by providing the surgeon with a device for determining the size of support (1) that is required. It is possible for the surgeon to cut the model (25) to the correct size to determine the best fit before the support (1) is implanted. Once the correct size has been determined, the bracket (1) can be cut to the same size as the template before deploying the bracket (1).

Once the bracket (1) has been fixed inwards along its outer end and at both ends, the template (25) is removed from under the bracket (1). This is done by pulling the template (25) through the opening left along the inner end of the bracket (1) around the areola (9) as shown in Figure 5.

This completes the implant of the support (1) and the incision (8) can be closed using conventional surgical techniques.

It will be appreciated that the embodiments described above are given by way of example only and are not intended to limit the scope of the invention. For example, it is possible to slightly change the change of the supports without departing from the scope of the invention.

It is possible to change the orientation of the support from a support extending from a point above the under-dose breast with both ends overlapping above the breast to a support having two or more overlapping ends below the dose. With this support, a single end will be fixed above the dose and, for example, two ends will reach around the nipple to join below the breast. In principle, the breast is still sustained in the mode of a net, with the difference being the attachment points to the breast and the mesh itself.

Claims (21)

"Mammal Soft Tissue Support Respective System" 1. Mammalian Soft Tissue Support, characterized in that it comprises a biocompatible resilient layer of a predetermined shape including means for securing the support subcutaneously. Mammalian Soft Tissue Holder according to Claim 1, characterized in that it includes a base from which two legs extend at a substantially right angle to one another. Mammalian Soft Tissue Holder according to Claim 2, characterized in that it includes a median operating leg and a lateral operating leg and wherein the lateral leg is wider than the midline. Mammalian Soft Tissue Holder according to any one of Claims 1 to 3, characterized in that the layer is generally L-shaped. Mammalian Soft Tissue Holder according to any one of Claims 1 to 3, characterized in that the layer is generally U-shaped. Mammalian Soft Tissue Holder according to any one of Claims 1 to 5, characterized in that the layer comprises a mesh of resilient elongate members. Mammalian Soft Tissue Holder according to Claim 6, characterized in that the layer comprises a mesh of straight circular section defilements. Mammalian Soft Tissue Holder according to Claim 6 or 7, characterized in that the resilient elongate members comprise polypropylene filaments. Mammalian Soft Tissue Holder according to any one of the preceding claims, characterized in that the means for subcutaneously screwing the holder comprises a dofinal end of the median leg of the holder and that the end of the median leg is operably attachable to the surrounding fascia of any one. one of the first to the third intercostal spaces by means of suture that extends to the end of the median leg and the fascia. Mammalian Soft Tissue Holder according to Claim 9, characterized in that the means for securing the subcutaneously support includes an end of the lateral leg end of the support and that the end of the lateral leg is operably attachable. to the fascia surrounding any of the first to the third intercostal spaces by suture extending to the end of the lateral leg, the fascia and the end of the median leg of the support. Mammalian Soft Tissue Holder according to Claim 9 or 10, characterized in that the means for subtly attaching the holder includes an end around the periphery of the holder and the end is operably attachable to the fabric. underlying breast by suture or staples that extend across the end and into the underlying chest tissue. Mammalian Soft Tissue Holder according to any one of Claims 9 to 11, characterized in that the end of the layer is hermetically sealed. Mammalian Soft Tissue Holder according to any one of Claims 9 to 12, characterized in that the end of the layer is folded upwards. Mammalian Soft Tissue Holder according to any one of Claims 1 to 13, characterized in that it includes at least one marking on the holder indicating a cut line for operatively shaping the holder. Mammalian Soft Tissue Holder according to Claim 14, characterized in that the marking is located substantially parallel to the end of the holder so as to define a shaped supporter having a predetermined size smaller than the holder. . Mammalian Soft Tissue Holder according to Claim 15, characterized in that it includes a plurality of predefined markings with each marking indicating a single cut line. Mammalian Soft Tissue Holder according to any one of Claims 14 to 16, characterized in that the marking is heat sealed so as to operably provide an end after cutting through which the holder is provided. attachable subcutaneously. A mammalian soft tissue support system, characterized in that it comprises a support as claimed in any one of Claims 1 to 17 and a model having a complementary shape for the support. 19. Mammalian Soft Tissue Support System according to Claim 18, characterized in that the model has dimensions complementary to those of the support. 20. Mammalian Soft Tissue Support System according to Claim 19, characterized in that the model has the same dimensions as those of the support. Mammalian Soft Tissue Support System according to any one of Claims 18 to 20, characterized in that the model is made from a resilient sterilizable plastic material.