WO2004096098A1

WO2004096098A1 - Prothesis for soft tissue support

Info

Publication number: WO2004096098A1
Application number: PCT/IB2004/001311
Authority: WO
Inventors: Jonathan Hamilton; Gary Pierre Lauryssen
Original assignee: Formhold Medical Investment Holdings
Priority date: 2003-04-29
Filing date: 2004-04-29
Publication date: 2004-11-11

Abstract

A mammalian soft tissue support comprising a biocompatible resilient layer and means to secure the layer subcutaneously to a mammal is disclosed. The layer is also formed to adopt a predetermined shape in use. Also disclosed is that the invention may be used on humans and animals, and more specifically female humans. The predetermined shape is either a breast or a buttock or an udder.

Description

PROSTHESIS FOR SOFT TISSUE SUPPORT

FIELD OF THE INVENTION

This invention relates to a supporting device for soft tissue, specifically human soft tissue.

BACKGROUND TO THE INVENTION

Human soft tissue is prone to sagging with age. This is in part due to weakening of supporting tissue, such as ligaments and skin with age. This is an important issue for females since their breast form an important part of their images. A factor that also causes sagging of female breasts is breast-feeding.

There have been various attempts to modify the appearance of breasts, which include the wearing of garments, such as corsets and brassieres, and surgical procedures.

The wearing of garments may produce acceptable results, but it is obviously of no use when not worn. Surgical procedures include the so-called breast lift procedure, which involves removal of part of the skin of the breast and repositioning the nipple in an attempt to reshape the breasts. This has the disadvantage that it involves scarring of the breast skin, which may remain visible for a long time. It also does not solve the problem of stretching of the supporting tissue, such as skin and ligaments, which will cause the breasts to again sag over time.

Another surgical procedure is so-called breast augmentation. This involves implanting a liquid filled bladder in the breasts. The liquid is typically either a saline solution or a silicone solution. The main aim of this procedure is to augment the size of the breasts, but this procedure is also used to reshape the breasts. An implant is inserted either between the breast tissue and the pectoral muscle, or inside the pectoral muscle.

A problem with breast augmentation is that some of the implants contain silica- compounds, which are difficult to seal inside an implant. There have been incidents where implants have leaked, causing the shape and size of the affected breast to change and causing serious concern about the effect of leaked silica-compound on the patient.

To overcome this problem the polymer from which the bladder is manufactured is made slightly toxic to the human body. This causes the tissue surrounding the bladder to react to the bladder and encapsulate it, thereby sealing the bladder and any liquid that might leak from it. This is obviously not an ideal solution.

Another problem with implants is that an implant alone do not necessarily modify the shape of the patient's breasts to a desired shape, but rather just increase the size. The natural and commonly accepted ideal female breast shape includes a slightly inward curve of the tissue above the nipple, a nipple that points slightly upwards, and the skin supporting the breast under the nipple stretching from the nipple to the ribcage with a slight downward curve without substantial contact between the breast skin and the ribcage skin.

With an augmentation implant it is difficult to achieve this shape since the breast tissue is generally pushed forward, which results in at least the curve above the nipple being pushed outward rather than inward. The result is a breast that appears to protrude from the female's chest.

In addition, since the implant is inserted between the breast tissue and the pectoral muscle, or splits the pectoral muscle, it is still possible for the breast tissue to sag with age and in effect slide over the implant.

Another area where men and woman have resorted to implants is in their buttocks. The soft tissue of the buttocks is also prone to sagging with age and people have used implants to counter the effect of this. This has also not been entirely successful.

OBJECT OF THE INVENTION

It is an object of this invention to provide a support for human soft tissue to alleviate at least some of the abovementioned problems.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a mammalian soft tissue support comprising a biocompatible resilient layer and means to secure the layer subcutaneously to a mamma, the layer formed to adopt a predetermined shaped in use. There is further provided for the layer to be made from a synthetic material, and for the layer to be perforated; alternatively for the layer to be made from one of a webbed material, woven material or pressed material.

There is further provided for the layer to be manufactured from an expanded polytetrafluoroethylene (ePTFE), in particular from an ePTFE material with the trade name Gore-Tex®.

There is further provided for the soft tissue to be a breast, and for the layer to be formed into a predetermined breast shape.

There is further provided for the mammal to be a human, for the support to include an upper section and a lower section, and for the upper section to be securable to the skeletal structure of the human above the breast.

There is further provided for the lower section to be securable to tissue proximate the lower section, and for the tissue to include breast support tissue, specifically ligaments.

There is also provided for the support to include a nipple aperture and a slit from an edge of the layer to the aperture.

A further feature of the invention provides for the soft tissue to be a buttock and for the layer to be formed into a predetermined buttock shape.

There is still further provided for the human to be a female.

BRIEF DESCRIPTION OF THE DRAWINGS

An embodiment of the invention will be described below by way of example only and with reference to the accompanying drawings in which: Figures 1 A is an elevation of a support according to the invention;

Figure 1B is an elevation of the support of Figure 1A with a nipple aperture and slit.

Figure 2 is a part sectional view of a human female breast with an implanted support according to the invention;

Figure 3A is a part sectional view of a human female breast with an augmentation implant between the breast tissue and the pectoral muscle;

Figure 3B is a part sectional view of a human female breast with an augmentation implant in the pectoral muscle;

Figure 4 is a side view of a human female breast before sagging; and

Figure 5 is a side view of a human female breast after sagging;

Figure 6 is a part sectional view of a human female breast with an implanted support according to the invention and an augmentation implant between the breast tissue and the pectoral muscle;

DETAILED DESCRIPTION OF THE DRAWINGS

A preferred embodiment of a soft tissue support (1) according to the invention is shown in Figure 1A. It comprises a biocompatible resilient layer (2) that is formed to the shape of human female breast. The support includes means to secure it subcutaneously to a female, which in this embodiment is a tab (3) formed at the upper section (4) of the support (1). The layer is formed of a moulded ePTFE material with the trade name Gore- Tex®. The material is chosen to allow the support (1) to be made to adopt a predetermined shape, in this instance that of a female breast, in use.

Figure 1B shows the support of Figure 1A with a nipple aperture (40) and a slit (41) from the edge of the layer (2) to the aperture (40) which allows for implanting the layer (2) subcutaneously without separating the nipple from the breast tissue.

As shown in more detail in Figure 2 the support (1) is secured subcutaneously in the patient's, a human female, breast (9). It (1) is inserted between the skin (7) and the soft breast tissue (8) through an incision in the armpit of the patient. The upper section (4) is secured (10) to the collarbone (11) of the female by stitching the tab (3) around the collarbone (11). The lower section (5) of the support (1 ) is secured to the supporting ligaments (not shown) of the breast (9) through the incision in the armpit and an incision underneath the nipple of the particular breast. The last incision is made along the border of the areola to minimize visibility of the incision.

This leaves the support (1) located between the skin (7) and the breast tissue (8), and secured at the upper section (4) and the lower section (5).

Since the support (1) is made to adopt a predetermined ideal breast shape in use it will support the breast tissue (8) into this ideal natural shape. The support (1) is resilient which allows normal movement of the supported breast (8), yet still retains the predetermined shape.

As shown in Figures 3A and 3B conventional augmentation implants allows an implant (14) to be located between the breast tissue (15) and the pectoral muscle (16), or an implant (17) to be located inside the pectoral muscle (19) and for the interface between the pectoral muscle (19) and the breast tissue (18) to be retained.

It is not entirely possible for such an implant to provide a breast with an ideal shape. The reason is simply that the skin between a nipple and respective collarbone naturally supports a breast, and that weakening of this portion of skin causes sagging of the breast. The same applies to ligaments that support the breast.

The natural sagging of breast is shown in Figures 4 and 5. Figure 4 shows a breast (20) of a young female that has not yet sagged. The breast (20) is supported by the skin (21) between the nipple (22) and the area (23) around the collarbone (not shown). The breast (20) has a typical ideal shape, which includes a slight inward curve of the upper portion (24) of the breast (20). The lower portion (25) of the breast (20) extends upwards from the ribcage (26) without the lower portion skin (27) resting on the rib cage (26).

Figure 5 shows a breast (30) of a female that has started to sag. The breast (30) is still supported by the skin (31) between the nipple (32) and the area (33) around the collarbone (not shown). The breast (30) has a typical sagged shape, which includes a pronounced inward curve of the upper portion (34) of the breast (30). The lower portion (35) of the breast (30) does not extend upward from the ribcage (36), and the lower portion skin (37) rests on the ribcage (36).

From Figures 4 and 5 it is clear that implanting an augmentation implant into the breast (30) shown in Figure 5 will not give this breast (30) the ideal shape shown in Figure 4. It will provide the breast (30) will more volume, which will not lift the lower portion (35) of the breast (30). It is possible that the pronounced inward curve of the upper section (34) will be corrected, but this will not lift the lower portion skin (37) from the ribcage (36). It is also possible that the result of an augmentation implant will be to reverse the inward curve to an outward curve (not shown), which also departs from the ideal breast shape.

Therefore, although the volume of the breast will be increased, the shape of the sagged breast (30) will not be corrected by an augmentation implant.

The invention allows for the shape of a sagged breast to be corrected, as shown in Figure 2, since the support (1) positively shapes the breast (9) to the ideal shape. It lifts the lower section of the breast, which pushes the breast upward. This is done without any substantial increase in the volume of the breast, apart from the slight increase gained from the actual volume of the support.

It is also possible to use the support (1) with an augmentation implant (12), as is shown in Figure 6. In this instance the augmentation implant (12), in the form a liquid filled bladder, is located between the breast tissue (8) and the pectoral muscle (13). This allows for increasing the size of the breast (9A), and at the same time ensures that the enlarged breast (9A) is maintained to the ideal shape.

From the above it is clear that the support functions like a subcutaneous brassiere. It has the advantage that it provides permanent support and shapes the breast to the ideal shape.

It will be understood that this is only one embodiment of the invention. It is possible to alter some aspects of the embodiment without departing from the scope of the invention. It is for instance possible to use a support in the shape of a lower section support for a female breast. In this instance the support will be in the shape of a breast cup and will be secured to the breast support tissue around the lower section of the breast. Such a support will function very much like a strapless brassiere. It is also possible to make a support that will function for other body parts, such as buttocks, arms or the like.

It is further possible to make a support that could find application in animals, specifically animals that are milked such as cows or goats. With these animals, especially cows, the amount of milk produced per day determines the value of the animal. The cows are therefore bred to attain udders that are as large as possible since this increase the daily milk production. However, if an udder gets too big it may drag on the ground, or tear loose from the supporting tissue. In some instances it then becomes necessary to put the animal down.

It is also possible to use different techniques to secure the support subcutaneously, which are not described here but falls within the scope of the invention.

Claims

1. A mammalian soft tissue support comprising a biocompatible resilient layer and means to secure the layer subcutaneously to a mammal, and the layer formed to adopt a predetermined shape in use.

2. A support as claimed in claim 1 in which the layer is inert.

3. A support as claimed in claim 1 or 2 in which the soft tissue is a breast and the predetermined shape is a breast shape.

4. A support as claimed in claim 3 in which the mammal is a human, the support includes an upper and a lower section, the upper section is securable to human tissue above the breast, and the lower section is securable to tissue proximate the lower section.

5. A support as claimed in claim 4 in which the upper section is securable to the skeletal structure of the human.

6. A support as claimed in claim 4 or 5 in which the lower section is securable to breast support tissue.

7. A support as claimed in claim 6 in which the lower section is securable to ligaments.

8. A support as claimed in claim 1 to 7 in which the support includes a nipple aperture.

9. A support as claimed in claim 8 in which the support includes a slit from an edge of the layer to the nipple aperture.

10. A support as claimed in claim 1 or 2 in which the in which the soft tissue is a human buttock and the layer is formed to, in use, adopt a predetermined buttock shape.

11. A support as claimed in claim 4 to 10 in which the human is a female.

12. A support as claimed in claim 1 or 2 in which the mammal is an animal and the soft tissue is an udder.

13. A support as claimed in claim 12 in which the animal includes a cow and a goat.

14. A support as claimed in any one of claims 1 to 13 in which the layer is made from a synthetic material.

15. A support as claimed in claim 14 in which the layer is perforated.

16. A support as claimed in claim 14 or 15 in which the layer is made from a webbed material, woven material or pressed material.

17. A support as claimed in claim 14 to 16 in which the layer is manufactured from an expanded polytetrafluoroethylene (ePTFE).

18. A support as claimed in claim 17 in which the layer is manufactured from an expanded polytetrafluoroethylene (ePTFE) with the trade name Gore-

Tex®.

19. A support substantially as herein described with reference to Figures 1, 2 and 6.