AU2006242962B2

AU2006242962B2 - Soft tissue support

Info

Publication number: AU2006242962B2
Application number: AU2006242962A
Authority: AU
Inventors: Jonathan Hamilton; Gary Pierre Lauryssen
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-04-29
Filing date: 2006-04-28
Publication date: 2013-02-07
Anticipated expiration: 2026-04-28
Also published as: JP4782824B2; AU2006242962A1; EA200702373A1; WO2006117622A1; EA013782B1; EP1898838A1; NO20076154L; ZA200711206B; CA2606969A1; IL186995A0; MX2007013295A; CA2606969C; NZ563828A; BRPI0610761A2; KR20080007485A; JP2008538964A

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

WO 2006/117622 PCT/IB2006/001056 1 5 SOFT TISSUE SUPPORT 10 FIELD OF THE INVENTION This invention relates to a soft tissue support, including but not limited to a human mammary support. 15 BACKGROUND TO THE INVENTION Soft tissue, such as human breasts, is prone to sagging with age. This is caused 20 by a weakening of the support structures of the relevant soft tissue. In the case of human breasts, the support structure includes ligaments and the breast skin. The skin encapsulating each breast supports the breast by suspending it from the area around the collarbone above the breast. With ageing, the skin looses its 25 elasticity and stretches. Ligaments that support the breast tissue internally also loose some of its resilience because of ageing. The combination of loss of resilience of the ligaments and loss of elasticity and stretching of the breast skin causes the breast support structure to be compromised. This leads to WO 2006/117622 PCT/IB2006/001056 2 deformation of the shape of the breast, which is referred to as breast ptosis. In effect the weight of the breast tissue deforms the shape of the breast. Many procedures and prosthesis are available which deal with breast ptosis. 5 Some include lifting the breast through the removal of skin. A significant problem with such procedures is scarring, which may include scars around or below the nipple. Such procedures also do not solve the original problem of a compromised support structure of the breast. 10 Some breast prostheses have been developed to treat aesthetic problems associated with ageing breasts. These include normal breast augmentation implants which do not address the problem of breast ptosis but merely add volume to the breast. In some instances this may have beneficial effects. However a breast augmentation implant does not lift a breast, but rather pushes 15 it forward. If the patient already has breast ptosis, an augmentation implant merely pushes the sagged breast outward and does not lift it. Some prostheses have been developed to lift a breast. Some of these have been described in patent applications including the following: FR2682284 (Dessart); 20 FR2746298 (Bellity); US4840629 (Silimed Silicone E Instr Medic); W09704722 (Pignataro); and US5217494 (Coggins et al). A common problem with these prostheses is the complexity of the procedure needed to implant them. With some of these prior art prostheses, such as those 25 described in W09704722 and US5217494, the prosthesis needs to be secured to bone of the patient, specifically ribs or the collarbone. The screws used and the technique that is required to fit the prosthesis in this manner increases the cost WO 2006/117622 PCT/IB2006/001056 3 and makes the procedure lengthy, which increases risks associated with the procedure. With some of the other prostheses, such as those described in US4840629, 5 FR2746298, and FR2682284, a substantial amount of cutting is required to prepare a patient for the procedure. Generally, the breast skin is separated from the breast tissue and lifted from it, leaving only the areola to connect the breast skin and breast tissue. The prosthesis is then slid in between the skin and breast tissue and secured to the breast tissue by means of stitches. The skin is then 10 closed up by stitches, which leaves a significant amount of visible scarring on the breast skin. A common problem with the prior art prostheses is that the prosthesis is implanted in a manner which secures the prosthesis between the skin and breast 15 tissue in a manner which makes revision very difficult. Compounding this problem is the fact that most of these prostheses have to be implanted by means of relatively invasive procedures, which makes revision using the existing prosthesis very difficult. 20 If a patient experiences further breast ptosis the only practical option is to repeat the procedure, which includes removal of the existing prosthesis and implanting a new prosthesis. A further problem is that it is in some instances very difficult for a surgeon to 25 manipulate the shape of a breast after the prosthesis has been implanted. It is also very difficult for the surgeon to vary manipulate the locations at which the prosthesis is secured. This could have been useful to modify the shape of the WO 2006/117622 PCT/IB2006/001056 4 breast, which means that a 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 5 to its various attachment locations and the shape of the breast is then determined by factors outside the control of the surgeon. This often results in less than satisfactory results. With some prostheses it is possible to adjust the position of the prosthesis by moving the attachment location, but this movement is limited. It also does not allow the surgeon to manipulate the shape of the breast 10 significantly. This may be very important in some cases such as where a patient has breasts that are not similarly shaped and the patient wishes to have this corrected. A further very practical problem of the prior art breast prostheses is that these do 15 nothing to shape the breast per se other than supporting it against the breast muscle. The prior art prostheses can at best be likened to a very tight sports top which squashes the breasts and thereby prevents movement without allowing the breasts to take on a natural ideal shape. 20 Although these problems have been described using breast ptosis as an example, similar problems exist for other types of soft tissue. These include buttocks, tummies, facial skin and so forth. In addition, the problems described above are generally of an aesthetic nature 25 and the procedures to address them are elective. In many instances a patient requires corrective cosmetic surgery to minimise the visible effects surgery to treat illnesses such as breast cancer.

5 It is a desirable outcome of certain embodiments of this invention to provide a soft tissue support that at least partly overcomes the mentioned problems. 5 Reference to any prior art in the specification is not, and should not be taken as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge in Australia or any other jurisdiction or that this prior art could reasonably be expected to be ascertained, understood and regarded as 10 relevant by a person skilled in the art. SUMMARY OF THE INVENTION As used herein, except where the context requires otherwise, the term 15 "comprise" and variations of the term, such as "comprising", "comprises" and "comprised", are not intended to exclude further additives, components, integers or steps. In accordance with this invention there is provided a mammalian soft tissue 20 support comprising a biocompatible resilient layer with a predetermined shape including a base from which a lateral and a medial leg extend at substantially a right angle to each other and means to secure the support subcutaneously, and wherein the lateral leg is wider than the medial leg, 25 There is further provided for the layer to include means for the support to be operatively securable to the breast bone or second chondro-sternal junction of the recipient.

5A There is further provided for the layer to comprise a mesh of resilient elongate members, preferably a mesh of circular cross section strand, further preferably a polypropylene strand. 5 There is further provided for the means to secure the support to the recipient to comprise suture, preferably non-dissolvable suture, extended through the fascia at the level of the second intercostal space, to which the support is secured and around at least one strand of mesh. 10 There is still further provided for the mesh to be generally L-shaped, alternatively U-shaped.

WO 2006/117622 PCT/IB2006/001056 6 There is further provided for the support to include at least one marking on the support which indicates a cut line to reshape the support operatively. 5 There is further provided for the marking to be located substantially parallel to the edge of the support to define a reshaped support having a predetermined size smaller than the support. There is still further provided for the support to include a plurality of predefined 10 markings with each marking indicating a unique cut line. There is also provided for the marking to be heat sealed to provide, operatively, an edge after cutting through which the support is securable subcutaneously. 15 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 complimentary template, for the template to be substantially impermeable to body fluids. 20 BRIEF DESCRIPTION OF THE DRAWINGS An embodiment of the invention is described below by way of example only and 25 with reference to the accompanying drawings in which: Figure 1 shows a plan view of a female breast support according to the invention; WO 2006/117622 PCT/IB2006/001056 7 Figure 2 shows a female breast after a peri areola incision has been made into it to enable implanting of the prosthesis of Figure 1; Figure 3 shows the breast of Figure 2 with the skin surrounding the areola stretched to allow access to the breast tissue and with a template of 5 the prosthesis placed in position on the breast tissue; Figure 4 shows the prosthesis after it has been placed on the template and has been secured to the fascia of the second intercostal rib and the breast tissue; Figure 5 shows the template being withdrawn from underneath the 10 prosthesis; Figure 6 shows the prosthesis after the template has been removed from underneath it; Figure 7 shows a section through a recipient of the prosthesis skin and breast tissue; 15 Figure 8 shows the incisions for an alternative procedure to implant the prosthesis; and Figure 9 shows the incisions for another alternative procedure to implant the prosthesis. 20 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 25 configured to support, operatively, a human female 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 8 (4) and medial leg (3), of which the lateral leg (4) is slightly wider than the medial leg (3). The mesh (2) includes heat sealed periphery (5). The mesh (2) is a synthetic 5 mesh, in this embodiment manufactured from polypropylene. The mesh (2) includes a diamond shaped openwork structure (6) and each strand (7) of the mesh (2) is manufactured of polypropylene. The support (1) is operatively arranged such that the long dimension of each of 10 the diamonds in the shaped openwork structure (6) is orientated substantially from top to bottom relatively to the recipient's body, and the short dimension of each diamond of the openwork structure (6) is orientated substantially across the mesh (2), in other words operatively horizontally. 15 The orientation of the strands (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 dimension of the diamond shaped openwork structure (6) resists deformation more than deformation is resisted in the short dimension. This enables the support (1) to resist gravity which normally 20 contributes to sagging of a breast, but still allows the breast to expand naturally as would be the case during, for example, breast swelling because of the female menstrual cycle. To implant the support (1) the surgeon needs to expose the breast tissue. The 25 type of procedure used depends of the size of the patient's breasts and the amount of ptosis or sagging of the breasts present.

WO 2006/117622 PCT/IB2006/001056 9 Patients with a breast cup size of between a size B and a size C and which have relatively little ptosis can have the support (1) implanted through a peri areola access point, i.e. an incision (8) which is made around the areola (9) as is shown in Figure 2. This leaves the nipple structure completely intact and leaves a scar 5 that is easily hidden by the outline of the areola (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 semi-circular incision (12) above the areola (13) and another incision (14) in the infra-mammary crease (15), as is shown in 10 Figure 8. This procedure allows access to the breast tissue from two access points. The tissue above the nipple is accessed through the semi-circular incision (13) and the area above the infra-mammary crease up to the nipple is accessed from the infra-mammary crease incision (14). 15 Patents with cup sizes of C and above and which experience large amounts of ptosis normally need to have a breast reduction in conjunction with the implanting of the support (1). For such patients a surgeon normally needs greater access than what the previously mentioned procedures allow. In such cases, a peri areola incision (16) is made, followed by an incision (17) downwards to the infra 20 mammary crease and an incision (18) in the infra-mammary crease, as is shown in Figure 9. This allows the skin to be flapped open to allow adequate access to the breast tissue for the reduction and the implanting of the support (1) afterwards. 25 The procedure to implant the support (1) will be described by way of example with reference to the incision (8) shown in Figure 2, but it any of the other surgical procedures mentioned can also be used. These procedures as far as exposing the breast tissue is not unique and are used for conventional breast surgery WO 2006/117622 PCT/IB2006/001056 10 which includes breast reductions, breast lifts, and the implanting of conventional gel or saline filled breast prosthesis. With reference to Figure 2, the procedure is started by making the peri areola 5 incision (8). The general construction of the tissue which forms the female breast is shown schematically in Figure 7. It can be seen that underneath the skin (19) there is a layer of fat (20), then the breast gland (21) and finally the breast muscle (22). 10 The aim of the procedure is to implant the support (1) in the layer of fat (20). The support (1) cannot be implanted directly underneath the skin (19) since that will create the risk that the some of the strands (7) of the mesh may be extruded through the skin (19). The support (1) is also not implanted directly onto the breast gland (21) since implanting it at that level means the surgeon has to 15 dissect the fatty tissue (20) from the gland, which is to be avoided if possible. The fatty tissue (20) is therefore dissected into two layers, a first (20A) which is left attached to the skin (19) and a second (20B) which is left to cover the breast gland (21). After the support (1) has been implanted into the layer of fat (20), the fatty tissue grows into the mesh (2) to incorporate it into the breast tissue. 20 The layer of fat (20) is dissected up to the medial side of the breast to the height of about the second intercostal space (23) and around the breast (24). This exposes a layer of fat covering the breast gland over which the support (1) is to be secured. 25 The support (1) forms part of a system which is used by a surgeon to implant it. The system includes the support (1) and a complimentary template (25), which is manufactured from a sterilised layer of plastics material. The template (25) 11 matches the shape of the support (1) precisely, allowing the edges of the support (1) to be extend marginally over the edges of the template (25) when the support (1) is placed onto the template (25). The template (25) is used by a surgeon to determine the most appropriate position for the support (1) on the breast tissue. 5 This is necessary since it is easier to move the template (25) around- over the layer of fat (20B) on the breast gland (21) than the support (1). The template (25) is manufactured from a resilient plastics material which is not affected by contact with body fluids. As shown in Figure 3, the template (25) is used to capture the 10 breast tissue after it has been exposed. The end (29) of the lateral leg (26) of the template (25) is placed in position where the support (1) will be secured, i.e. typically over the second intercostal space (23). The base (27) of the L-shaped template (25) is then extended below the breast 15 tissue to capture it and the end (30) of the medial leg (28) is placed over the end (29) of the lateral leg (26) of the template (25). The lateral leg (26) is wider than the medial leg (28) which allows it to support breast tissue which may extend to underneath the armpit of the patient. 20 The end (30) of the medial. leg (28) may be extended over the end (29) of the lateral leg (26), which allows the surgeon to shape the breast (24). The support (1) forms what may be equated with a hammock within which the breast tissue (11) is supported. The extent to which the end (30) of the medial leg (28) is moved over the end (29) of the lateral leg (26) determines the length of the 25 support (1) which actively supports the breast tissue. Using the analogy of the hammock, the amount by which the end (30) of the medial leg (28) extends over the end (29) of the lateral leg (26) determines the length of the hammock, 12 It is also possible for the surgeon to adjust the angle at which the end (30) of the medial leg (28) extends over the end (29) of the lateral 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 00 would mean the ends (29, 30) lie perfectly aligned 5 and extending in the same direction. However, it is possible for the surgeon to change the angle to be anything between about 450 and about 90* This allows the surgeon to shape the breast (24) and move the position of the nipple relatively to the patient's thorax (31). 10 As shown in Figure 4, once the ideal orientation of the end (30) of the medial leg (28) relative to the end (29) of the lateral leg (26) has been attained, the support (1) is placed over the template (25), which is held in place and at the desired orientation at the same time merely by sticking to the body fluid from the fatty tissue (20B) underneath it. The support (1) is then secured to the selected 15 intercostal space (23) by suture (32) which is extended through the end (35) of the lateral leg (36) of the support (1) and the fascia of the intercostal space (23). The body of the support (1) is then secured to the breast tissue underneath the template by surgical staples (33) through the edge (34) of the support (1) into the fatty tissue (20B) underneath it. The end (37) of the medial leg (38) of the 20 support (1) is finally sutured to the selected intercostal space (23) and the end (35) of the lateral leg (36) underneath it. In this manner, the support (1) is secured in the patient's breast without allowing it to come in complete contact with body fluid of the patient until it has been 25 secured in place. The template (25) also aids the implanting by providing the surgeon with a device to determine the size of the support (1) that is needed. It is possible for the surgeon to cut the template (25) to the correct size to determine the best fit before the support (1) is implanted. Once the correct size WO 2006/117622 PCT/IB2006/001056 13 has been determined, the support (1) may be cut to the same size as the template before implanting the support (1). Once the support (1) has been secured to the breast along its outer edge and at 5 the two ends, the template (25) is removed from underneath the support (1). This is done by pulling the template (25) through the opening left along the inside edge of the support (1) around the areola (9), as is shown in Figure 5. This completes the implanting of the support (1) and the incision (8) can be 10 closed up 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. It is for example possible to alter the change of the support somewhat without departing 15 from the scope of the invention. It is possible to change the orientation of the support from a support which extends from a point above the breast underneath the breast with the two ends overlapping above the breast, to a support which has two or more ends which 20 overlap below the breast. With such a support, a single end will be secured above the breast and, for example, two ends will reach around the nipple to be joined below the breast. In principle the breast is still supported in the fashion of a hammock, with the difference being the attachment points to the breast and of the mesh to itself. 25

Claims

1. A mammalian soft tissue support comprising a biocompatible resilient layer with a predetermined shape including a base from which a lateral 5 and a medial leg extend at substantially a right angle to each other and means to secure the support subcutaneously, and wherein the lateral leg is wider than the medial leg. 10

2. A support as claimed in claim 1 in which the layer is generally L-shaped.

3 A support as claimed in claims 1 in which the layer is generally U shaped. 15

4. A support as claimed in any one of claims 1 to 3 in which the layer comprises a mesh of resilient elongate members.

5. A support as claimed in claim 4 in which the layer comprises a mesh of circular cross section strands. 20

6. A support as claimed in claim 4 or 5 in which the resilient elongate members comprise polypropylene strands,

7. A support as claimed in any one of the preceding claims in which the 25 means to secure the support subcutaneously comprise an edge of the end of the medial leg of the support, and for the end of the medial leg to be operatively securable to fascia surrounding any one of the first to the 15 third intercostal spaces by means of suture extending through the end of the medial leg and the fascia,

8. A support as claimed in claim 7 in which the means to secure the support 5 subcutaneously includes an edge of the end of the lateral leg of the support, and for the end of the lateral leg to be operatively securable to fascia surrounding any one of the first to the third intercostal spaces by means of suture extending through the end of the lateral leg, the fascia, and the end of the medial leg of the support. 10

9. A support as claimed in claim 7 or 8 in which the means to secure the support subcutaneously includes an edge around the periphery of the support and for the edge to be operatively securable to underlying breast tissue by means of suture or staples extending through edge and into the 15 underlying breast tissue.

10. A support as claimed in any one claims 7 to 9 in which the edge of the layer is heat sealed. 20

11. A support as claimed in any one claims 7 to 10 in which the edge of the layer is folded over.

12. A support as claimed in any one of claims I to 11 which includes at least one marking on the support which indicates a cut line to reshape the 25 support operatively. 16

13. A support as claimed in claim 12 in which the marking is located substantially parallel to the edge of the support to define a reshaped support having a predetermined si e smaller than the support. 5

14. A support as claimed in claim 13 Nhich includes a plurality of predefined markings with each marking indica ing a unique cut line.

15. A support as claimed in any one o claims 12 to 14 in which the marking is heat sealed to provide, operativel , an edge after cutting through which 10 the support is securable subcutan ously,

16. A mammalian soft tissue support system comprising a support as claimed in any one of claims I to 15 an a template having a complimentary shape to the support, 15

17. A system as claimed in claim 16 in which the template has dimensions complimentary to that of the suppoi

18, A system as claimed in claim 17 in which the template has the same 20 dimensions as that of the support.

19. A system as claimed in any one o claims 16 to 18 in which the template is manufactured from a resilient st rilisable plastics material,