KR20080007485A - Soft tissue support - Google Patents

Abstract

The present invention comprises means for securing the support subcutaneously and includes a soft tissue support 1 in the form of a biocompatible elastic layer having a predetermined shape. The support of the present invention may be L-shaped or U-shaped as a whole, and may be made of a biocompatible elastic net structure.

Description

Soft Tissue Support {SOFT TISSUE SUPPORT}

TECHNICAL FIELD This invention relates to soft tissue support containing the support used for a human breast (but not limited to this).

Soft tissues, such as the human breast, are areas that tend to sag as they age. As soft tissue ages, sagging occurs as the support structure of the associated soft tissue weakens. In the case of human breasts, the support structure comprises ligaments and breast skin.

The skin that surrounds the breast supports the breast by hanging on the periphery of the collarbone above the breast. As the skin ages, it loses its elasticity and elasticity. Ligaments that support breast tissue internally also lose some elasticity as they age. As the ligaments lose elasticity and the skin surrounding the breast loses elasticity and elasticity, the breast support structure may be compromised. Due to this phenomenon, deformation can occur in the shape of the breast, which is called breast ptosis. Indeed, the shape of the breast can be changed by the weight of the breast tissue.

To address this breast sewage, many procedures and prosthesis can be used. Among these are the methods of removing the skin to lift the breasts. An important problem with these methods is that scarring remains, which can result in scarring around or under the nipple. Thus, these methods do not solve the inherent problems with the damaged support structure of the breast.

Some breast implants have been developed to address the aesthetic problems of the breast as they age. Among these, there is a typical breast enlargement insert that does not solve the problem of breast sewage but only increases the volume of the breast. Such typical breast augmentation inserts may have a positive effect in some cases, but do not lift the breast, but rather allow them to protrude forward. If the patient already has a breast sewer, this augmentation technique only protrudes the sagging breast forward and does not lift it up.

Implants have also been developed to lift the breasts. Some of these are described in FR2682284 (Dessart); FR2746298 from Bellity; US 4,840,629 (Silimed Silicone E Instr Medic); WO97 / 04722 (Pignataro); And US Pat. No. 5,217,494 to Coggins et al.

A common problem with these implants is that the procedures required to insert the implants are complex. In the case of these conventional implants such as those disclosed in WO97 / 04722 and US Pat. No. 5,217,494, it is necessary to fix them to the bones of the patient, in particular the ribs or clavicle. Screws are used, and the technique for fixing the implant in this way is expensive and lengthy, thus increasing the risks associated with the procedure.

For implants such as those disclosed in US Pat. No. 4,840,629, FR2746298, and FR2682284, a significant amount of incision must be made to perform the procedure on the patient. In general, breast skin is separated from breast tissue and lifted up, so only breastplates (areolas) are connecting breast skin and breast tissue. The implant is inserted between the breast skin and the breast tissue and the implant is secured to the breast tissue using a stitch, which is sutured by the suture, leaving a significant amount of visible scar on the breast skin.

A common problem with conventional implants is that they are inserted in such a way as to fix the implant between the skin and breast tissue in a way that makes the revision very difficult. Further exacerbating this problem is that most of these implants must be inserted by a relatively invasive procedure which makes it very difficult to correct using existing implants.

If the patient experiences breast sewage again, the only option that can actually be selected is to repeat the procedure, which involves removing the existing implant and inserting a new implant.

Another problem is that in some cases, after inserting the implant, it is very difficult for the surgeon to manipulate the shape of the breast. In addition, there is a problem that it is very difficult to change the position where the doctor fixed the implant. If the doctor could change the position of the implant, it would have been useful to change the shape of the breast, but it would mean that the doctor would not have a significant opportunity to change the shape of the breast.

In conventional implants, the surgeon simply attaches the implant to a variety of different attachment locations, and the shape of the breast is determined by external factors beyond the control of the surgeon. This often does not produce satisfactory results. In some implants, the position of the implant can be adjusted by moving the attachment point, but this movement is limited. In addition, the doctor cannot manipulate the shape of the breast to a satisfactory level. This can be very important in some situations, i.e. if the shape of both breasts of the patient is not similar and the patient wishes to correct this.

Another practical problem with conventional breast implants is that the implant does nothing but essentially shape the breast other than supporting the breast against the breast muscle. With conventional implants, these implants are at most similar to very tight sports tops that tighten the chest to prevent movement, and do not make the breasts in their ideal shape.

Although these problems have been described using breast sewage as an example, similar problems exist for other types of soft tissue. These other types of soft tissues include buttocks, tummies, facial skins, and the like.

In addition, the problems described above are generally for aesthetic features, and the procedure for solving the problems is optional. In many cases, patients require corrective cosmetic surgery to remove visible surgical traces of treating diseases such as breast cancer.

The present invention aims to provide soft tissue support that at least partially solves the aforementioned problems.

The present invention provides a mammalian soft tissue support comprising a biocompatible resilient layer comprising a means for securing the support subcutaneous and having a predetermined form. to provide.

In addition, the biocompatible elastic layer is intended to allow the support to be operably secured to a second chondro-sternal junction or breast bone at the recipient site. It is intended to include means.

In addition, the biocompatible elastic layer has a net structure consisting of an elastic elongated member, preferably a net structure consisting of strands having a circular cross section, and more preferably a net made of strands made of polypropylene. Include structure.

In addition, the means for securing the support to the insertion site includes sutures, preferably fusions, extending through the fascia at a level of second intercostal space where the support is secured around the strands of the one or more mesh structures. It includes non-dissolvable sutures.

The net structure is also entirely L-shaped and generally U-shaped, and includes an operable side leg and an operable middle leg. In addition, the side legs are preferably wider than the middle legs.

The support also includes one or more markings on the support to indicate a cut line for operatively reshaping the form of the support.

In addition, the marker is positioned substantially parallel to the edge of the support to form a reshaped support having a size smaller by a predetermined size than the support.

The support also includes a plurality of predefined indicia, each representing a unique cut line.

In addition, the label is heat sealed to provide an operable edge to allow the support to be subcutaneously fixable after incision.

According to another aspect of the present invention, there is provided a support system comprising soft tissue support as defined above and a template complementary thereto. The template is substantially impermeable to body fluids.

1 is a plan view showing a female breast support according to the present invention.

FIG. 2 shows a female breast after incision around the areola to insert the implant of FIG. 1. FIG.

FIG. 3 shows the breast of FIG. 2 with the breast skin around the arena being pulled to access breast tissue and a template of the implant placed on the breast tissue.

4 shows the implant after being placed on the template and secured to the fascia and breast tissue of the second intercostal rib.

5 shows the template pulled from below the implant.

6 shows the implant after the template has been removed from the bottom.

7 shows a cross section through the insertion site of the implant skin and breast tissue.

8 shows an incision for another procedure for inserting the implant.

9 shows an incision for another procedure for inserting the implant.

Best Mode for Carrying Out the Invention Embodiments of the present invention will be described below with reference to the accompanying drawings.

A preferred embodiment of the soft tissue support according to the invention is shown in the drawings. In this embodiment, a support 1 for operably supporting a breast of a human female is provided.

As shown in FIG. 1, the support 1 consists of a layer of a biocompatible resilient mesh 2 which is approximately L-shaped and biocompatible. This L-shaped support 1 includes a side leg portion 3 and an intermediate leg portion 4, and the side leg portion 3 is slightly wider than the middle leg portion 4.

The elastic net 2 comprises a heat sealed periphery 5. This elastic net 2 was made of polypropylene in this embodiment. The elastic net 2 has a diamond-shaped openwork structure 6, and each strand 7 of the elastic net 2 is made of polypropylene.

The support 1 is such that the longer side of each diamond shape in the formed hollow structure 6 faces substantially from top to bottom with respect to the portion to which the support is to be inserted, and among the diamond shapes in the hollow structure 6 It is configured to be operable such that the shorter side substantially crosses the elastic net 2, that is, in the horizontal direction.

The direction of the strands 7 in the diamond shaped hollow structure 6 causes the support 1 to have more supportive action in the vertical direction than in the horizontal direction. In the hollow structure 6 in diamond form, the longer dimension suppresses the deformation more than the shorter dimension. According to this configuration, the support 1 generally withstands gravity, which causes the breast to sag, while allowing the breast to naturally inflate, such as when the breast swells, for example, by a woman's menstrual cycle.

In order to insert the support 1, the surgeon needs to expose the breast tissue. The type of procedure used may vary depending on the size of the patient's breast and the amount of sewage or sagging of the breast.

Patients with a chest size between a size B cup and a size C cup, and with relatively low ptosis, may have a peri areola access point, i.e., the circumference of the areola 9, as shown in FIG. The support 1 can be inserted by an incision 8 made in. According to this, the nipple structure remains intact at all, and the scar is easily hidden by the contour of the areola 9. As shown in FIG. 3, the breast skin 10 is opened in a pulled state to allow access to the underlying breast tissue 11.

Alternatively, as shown in FIG. 8, an incision 14 is made in a semi-circular incision 12 and infra-mammary crease 15 over the areola 13. This procedure allows access to breast tissue from two access points. The tissue above the teat is accessed through a semi-circular incision 13, and the site up to the teat up the breast folds can be accessed by the breast pleat incision 14.

Patients with a chest size of a size C cup and a large amount of sewage usually need to undergo breast reduction with the insertion of the support 1. For these patients, doctors typically need more access than the procedure described above allows. In this case, as shown in Fig. 9, after the incision 16 around the areola is made, an incision 17 is performed downward to the lower breast pleat, and an incision 18 is performed in the lower breast pleat. This allows the skin flap of the breast skin to be flipped open, allowing for proper access to breast tissue for later implanting and reduction of the support 1.

The procedure for inserting the support 1 is described with reference to the incision 8 shown in FIG. 2, but other surgical procedures other than those mentioned above are also possible. Such procedures for exposing breast tissue are not the only ones and are also used in conventional breast surgery, including shrinking the breasts, lifting the breasts, and inserting breast implants filled with conventional gels or saline.

With reference to FIG. 2, the procedure is initiated by performing a perimeter ring dissection 8. The general configuration of the tissue forming the breast of a woman is schematically shown in FIG. Below the breast skin 19, it can be seen that there is a fat layer 20, a breast gland 21 and a breast muscle 22.

The purpose of this procedure is to insert the support 1 into the fat layer 20. The support 1 cannot be inserted directly underneath the breast skin 19 because there may be a risk that some of the strands 7 of the elastic net may be pushed out through the breast skin 19. The support 1 is also not directly inserted into the mammary gland 21, which means that inserting the support at that level means that the physician will bisect the adipose tissue 20 from the mammary gland, which should be avoided if possible. Thus, the fat layer 20 is divided into two layers. The first layer 20A is attached to the breast skin 19 and the second layer 20B is left to cover the mammary gland 21. After inserting the support 1 into the fat layer 20, the adipose tissue grows into the elastic net 2 and is bonded to the breast tissue.

The fat layer 20 is bisected along the medial side of the breast to approximately the height of the periphery of the second intercostal space 23 and the periphery of the breast 24. Thereby, the fat layer which covers the streamline to which the support 1 is fixed is exposed.

The support 1 forms part of the system used by the surgeon for insertion. The system comprises a support 1 and a complementary template 25, which is composed of a layer of sterile plastic material. The template 25 is precisely matched to the shape of the support 1 so that when the support 1 is placed on top of the template 25, the edge of the support 1 extends beyond the edge of the template 25 to the end. (marginally) can be extended. The template 25 is used by the doctor to determine the most appropriate position of the support 1 in the breast tissue.

This is necessary because moving the template 25 around the fat layer 20B on the streamline 21 is easier than moving the support 1. The template 25 is made of an elastic plastic material that is not affected by contact with body fluids. As shown in FIG. 3, template 25 is used to hold the exposed breast tissue after the breast tissue is exposed. The end 29 of the intermediate leg 26 of the template 25 is arranged at the position where the support 1 is to be fixed, ie typically above the second intercostal space 23.

The template 25 is L-shaped, the base 27 of the template 25 extends down the breast tissue to catch the breast tissue, and the end 30 of the side leg 28 is in the middle of the template 25. It is disposed above the end 29 of the leg 26. By making the side leg 28 wider than the middle leg 26, it is possible to support breast tissue that may extend down the armpit of the patient.

The end 30 of the side leg 28 can be extended above the end 29 of the middle leg 26, thereby enabling the surgeon to shape the breast 24. The support 1 forms something like a hammock in which the breast tissue 11 is supported therein. By the extent that the end 30 of the lateral leg 28 can move above the end 29 of the intermediate leg 26, the length of the support 1 for actively supporting breast tissue is defined. All. By having a hammock-like function, the length of the hammock is determined by the extent to which the end 30 of the side leg 28 extends above the end 29 of the middle leg 26.

The surgeon can also adjust the angle at which the end 30 of the side leg 28 extends above the end 29 of the middle leg 26. Normal orientiation should be that the end 29 and the end 30 are at an angle of approximately 65 ° relative to each other, and when the angle is 0 °, the ends 29, 30 are completely straight and the same It means extending in the direction. However, the surgeon can change the angle at any angle between about 45 ° and about 90 °. According to this, the doctor can grasp the shape of the breast 24 and can move the position of the nipple with respect to the chest 31 of the patient.

As shown in FIG. 4, when the ideal orientation of the end 30 of the side leg 28 with respect to the end 29 of the middle leg 26 is achieved, the support 1 is placed on top of the template 25. The support, which is simply sticking to the body fluid from the adipose tissue 20B under the support, is held in the desired position and has the desired orientation. The support 1 is then interposed between the intercostal space 23 and the intercostal space 23 selected by a suture 32 extending through the end 35 of the intermediate leg 36 of the support 1. Fixed to the fascia. Subsequently, the body of the support 1 is, by surgical staples 33, the breast tissue under the template inward of the fat layer 20B via the edge 34 of the support 1. Is fixed to. Finally, the end 37 of the side leg 38 of the support 1 is sealed to the selected intercostal space 23 and the end 35 of the intermediate leg 36 beneath it.

In this way, the support 1 is secured to the patient's breast without making full contact with the patient's liquor until secured in place. The template 25 aids in insertion by providing a device for the physician to size the support 1 required. The surgeon can cut the template 25 to the correct size to determine the optimum fit before inserting the support 1. Once the correct size is determined, the support 1 can be cut out to the same size as the template before insertion.

When the support 1 is secured to the breast with two ends along the outer end, the template 25 is removed from underneath the support 1. This is accomplished by pulling the template 25 through a hole left along the inner edge of the support 1 around the raceway 9, as shown in FIG. 5.

By this, insertion of the support 1 is completed and the incision 8 can be closed by conventional surgical techniques.

It will be appreciated that the embodiments disclosed above are exemplary only and are not intended to limit the scope of the present invention. For example, it is possible to change or modify the support without departing from the scope of the present invention.

It is possible to change the orientation of the support from a support extending from a point above the chest below the chest, with two ends overlapping above the chest, to a support having at least two ends overlapping the bottom of the chest. According to this support, a single end will be fixed above the chest, for example the two ends will reach the circumference of the teat which is connected under the chest. In principle, the chest is supported on the same principle as the hammock, the difference being the point of attachment to the chest and the net itself.

Claims (21)

As a mammalian soft tissue support, And means for securing the support subcutaneous and comprising a biocompatible resilient layer having a predetermined form. The method of claim 1, The mammalian soft tissue support includes a base, From the base, the two legs extend substantially perpendicular to each other, Maternal soft tissue support. The method of claim 2, Including an operable intermediate leg and an operable side leg, Wherein said lateral leg is wider than said middle leg. The method according to any one of claims 1 to 3, Wherein said biocompatible elastic layer is L-shaped as a whole. The method according to any one of claims 1 to 3, The biocompatible elastic layer is mammalian soft tissue support, which is generally U-shaped. The method according to any one of claims 1 to 5, And the biocompatible elastic layer comprises a mesh of resilient elongate members. The method of claim 6, The biocompatible elastic layer comprises mammalian soft tissue support comprising a network structure of strands having a circular cross section. The method according to claim 6 or 7, The elastic elongated member comprises a strand made of polypropylene. The method according to any one of claims 1 to 8, Means for securing the support subcutaneously includes an edge of an end of the intermediate leg of the support, The end portion of the middle leg is suture extending through the end portion and the fascia of the fascia surrounding one of a first intercostal space and a third intercostal space. Mammalian soft tissue support, which can be operably fixed. The method of claim 9, Means for securing the support subcutaneously includes an edge of an end of the side leg portion of the support, The end portion of the side leg portion has a fascia surrounding one of the first intercostal space and the third intercostal space, and a suture line extending through the end portion of the side leg portion, the fascia, and the end portion of the intermediate leg portion of the support. Mammalian soft tissue support, which can be operatively fixed. The method of claim 9 or 10, Means for securing the support subcutaneously includes an edge around a periphery of the support, And the edge can be operatively secured to a lower breast tissue by sutures or staples extending through the edge to the lower breast tissue. The method according to any one of claims 9 to 11, And said end of said biocompatible elastic layer is heat sealed. The method according to any one of claims 9 to 12, And said end of said biocompatible elastic layer is folded over. The method according to any one of claims 1 to 13, And one or more markings on the support, the one or more markings representing a cut line for operatively reshaping the support. The method of claim 14, And the marker is positioned substantially parallel to an edge of the support to define a reshaped support having a size smaller than the support by a predetermined size. The method of claim 15, Including a plurality of predefined indicia, Wherein each marker exhibits a unique cut line. The method according to any one of claims 14 to 16, After incision, the marker is heat sealed to operatively provide an edge that enables the support to be fixed subcutaneously. The support claimed in any one of claims 1 to 17, And a template having a form complementary to said support. The method of claim 18, And the template has dimensions complementary to the dimensions of the support. The method of claim 19, And the template has dimensions equal to the dimensions of the support. The method according to any one of claims 18 to 20, The template is made from a sterilizable elastic plastic material.

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