WO2022187907A1

WO2022187907A1 - A breast prosthesis and a method of forming a breast prosthesis

Info

Publication number: WO2022187907A1
Application number: PCT/AU2022/050207
Authority: WO
Inventors: Stephanie WEISS; Surithi YOGALINGAM
Original assignee: Arula Technologies Pty Ltd
Priority date: 2021-03-12
Filing date: 2022-03-11
Publication date: 2022-09-15
Also published as: AU2022232651A1

Abstract

There is disclosed herein a method of forming a breast prosthesis, the method comprising the steps of: (a) obtaining a three-dimensional image of a patient's breast; (b) converting the three-dimensional image of the patient's breast to a three-dimensional model; (c) constructing, using a three-dimensional printer, a mould having a mould cavity that corresponds to the three-dimensional model; and (d) at least partially filling the mould cavity with one or more materials to form a breast prosthesis.

Description

A BREAST PROSTHESIS AND A METHOD OF FORMING A BREAST PROSTHESIS

FIELD

[0001] The present invention relates to a prosthesis to simulate the presence of surgically removed tissue. In particular, the present invention relates to a breast prosthesis and a method of forming a breast prosthesis.

[0002] The invention has been developed primarily for use in applications involving a breast prosthesis and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use.

BACKGROUND

[0003] Following a mastectomy or a lumpectomy surgery to either wholly or partially remove a patient’s breast tissue to treat or prevent breast cancer, the patient may have various options to restore the shape, feel, and weight of the removed breast tissue. One option is to undergo a breast reconstruction, which a complex surgical procedure to reshape a patient’s breast tissue with the use of breast implants made from silicone, for example.

[0004] Another option is to wear a breast prosthesis. A permanent breast prosthesis is typically formed with silicone in an attempt to replicate the shape, feel, and weight of a patient’s original breast tissue. The breast prosthesis may be made to fit into the patient’s bra, or otherwise attached directly to the patient’s skin.

[0005] One disadvantage of conventional breast prosthesis products on the market is a lack of size differentiation. Whilst such products may be provided in different sizes, for example, they are typically ‘off the shelf products which do not adequately account for the numerous different shapes, weight and sizes of breast tissue, which naturally varies from one patient to another. Accordingly, such products lack personalisation and customisation to suit the requirements of different patients. [0006] A further disadvantage of conventional breast prosthesis products on the market is that they are typically quite heavy, with most products being formed of silicone weighing about 750 grams on average. For many patients, such conventional products are too heavy and painful to wear throughout the day. An unsuitable or uneven weight distribution from such products may lead to balance and spine alignment issues for the patient, depending on their particular body type and biomechanics.

[0007] Some manufacturers have attempted to resolve the weight and discomfort issues by utilising air pockets in the breast prosthesis. However, such air-filled breast prosthesis products typically feel unrealistic and may therefore also lead to comfort issues in the long term.

SUMMARY

[0008] It is an object of the present invention to substantially overcome, or at least ameliorate, one or more of the disadvantages of existing arrangements, or at least provide a useful alternative to existing arrangements.

[0009] There is disclosed herein a method of forming a breast prosthesis, the method comprising the steps of:

(a) obtaining a three-dimensional image of a patient’s breast;

(b) converting the three-dimensional image of the patient’ s breast to a three- dimensional model;

(c) constructing, using a three-dimensional printer, a mould having a mould cavity that corresponds to the three-dimensional model; and

(d) at least partially filling the mould cavity with one or more materials to form a breast prosthesis.

[0010] Preferably, step (d) comprises the steps of: at least partially filling the mould cavity with a first material to form a first outer layer of the breast prosthesis; and filling the remainder of the mould cavity with a second material to form an inner core of the breast prosthesis. [0011] Preferably, the first material is a layer of silicone, and the second material is a mixture of silicone and aerogel.

[0012] Alternatively, the first material may be a layer of silicone, and the second material is a mixture of gel wax and aerogel.

[0013] Alternatively, step (d) may comprise the steps of: at least partially filling the mould cavity with a first material to form a first outer layer of the breast prosthesis; at least partially filling the mould cavity with a third material to form a third outer layer of the breast prosthesis; and filling the remainder of the mould cavity with a second material to form an inner core of the breast prosthesis.

[0014] Preferably, the first material is a layer of silicone, the second material is a polyurethane foam, and the third material is gel wax

[0015] Preferably, the method further comprises the steps of:

(e) removing the breast prosthesis from the mould cavity; and

(f) applying a film of material to the breast prosthesis to form a second outer layer of the breast prosthesis.

[0016] Preferably, the film material is polyurethane, and step (f) comprises the step of encasing the inner core and the first and/or third outer layer with the polyurethane film to increase the durability of the breast prosthesis.

[0017] Preferably, the method further comprises the step of:

(g) applying a support layer to the breast prosthesis.

[0018] Preferably, the support layer is a gel memory foam layer, and step (g) comprises attaching the gel memory foam layer to a rear portion of the inner core or the third outer layer. [0019] Preferably, the method further comprises the step of:

(h) applying an additional material to a front portion of the breast prosthesis to form a nipple.

[0020] Preferably, the method further comprises the step of:

(i) applying a sling to the breast prosthesis, the sling being adapted to support the breast prosthesis on the body of the patient.

[0021] There is also disclosed herein a breast prosthesis comprising: a first outer layer formed of a first material; an inner core formed of a second material and attached to the first outer layer; and a second outer layer that encases the first outer layer and the inner core, the second outer layer being formed of a third material.

[0022] Preferably, the first material of the first outer layer is silicone.

[0023] Preferably, the silicone outer layer has a thickness of between 1 to 6 mm.

[0024] Preferably, the thickness of the silicone outer layer is 3 mm.

[0025] Preferably, the second material of the inner core is a mixture of silicone and aerogel.

[0026] Preferably, the mixture comprises between 50 to 80 % of silicone and between 20 to 50 % of aerogel.

[0027] Preferably, the mixture comprises 60 % of silicone and 50 % of aerogel.

[0028] Alternatively, the second material of the inner core may be a polyurethane foam.

[0029] Alternatively, the second material of the inner core may be a mixture of polyurethane foam and another type of foam.

[0030] Alternatively, the second material of the inner core is a mixture of gel wax and aerogel. [0031] Preferably, the mixture comprises between 50 to 80 % of gel wax and between 20 to 50 % of aerogel.

[0032] Preferably, the mixture comprises 60 % of gel wax and 50 % of aerogel.

[0033] Preferably, the second outer layer is a film of the third material, with the third material being polyurethane or plastic.

[0034] Preferably, the polyurethane film has a thickness of between 0.01 to 0.08 mm.

[0035] Preferably, the polyurethane film has a thickness of 0.03 mm.

[0036] Preferably, the breast prosthesis further comprises a support layer attached adjacent to a rear portion of the inner core.

[0037] Preferably, the support layer is a gel memory foam layer.

[0038] Preferably, the breast prosthesis further comprises an additional material attached to a front portion of the breast prosthesis, the additional material having the form of a nipple.

[0039] Preferably, the breast prosthesis further comprises a sling to house the breast prosthesis and to provide support for the breast prosthesis on the body of a patient.

[0040] There is also disclosed herein a breast prosthesis comprising: a first outer layer formed of a first material; and an inner core formed of a second material and attached to the first outer layer.

[0041] Alternatively, the first material of the first outer layer may be silicone, and the second material of the inner core is a polyurethane foam.

[0042] Alternatively, the first material of the first outer layer may be silicone, the second material of the inner core is a mixture of polyurethane foam and another type of foam. [0043] Preferably, the first material of the first outer layer is silicone, and the second material of the inner core is a mixture of gel wax and aerogel.

[0044] Preferably, the breast prosthesis further comprises a second outer layer that encases the first outer layer and the inner core, the second outer layer being formed of a third material.

[0045] Preferably, the second outer layer is a film of the third material, with the third material being polyurethane.

[0046] Preferably, the breast prosthesis further comprises a third layer that at least partially surrounds the inner core, the third layer being formed of a fourth material.

[0047] Preferably, the fourth material of the third layer is a gel wax.

[0048] There is also disclosed herein method of forming a breast prosthesis mould, the method comprising the steps of:

(a) obtaining a three-dimensional image of a patient’s breast;

(b) converting the three-dimensional image of the patient’ s breast to a three- dimensional model; and

(c) constructing, using a three-dimensional printer, a breast prosthesis mould having a mould cavity that corresponds to the three-dimensional model.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Preferred embodiments of the present invention will be described by way of example only, with reference to the accompanying drawings, in which:

[0050] Figure l is a schematic side sectional view of one embodiment of a breast prosthesis;

[0051] Figure 2 is a schematic front view of the breast prosthesis shown in Figure 1;

[0052] Figure 3 is a schematic front view of the breast prosthesis shown in Figure 1 supported by a half torso sling; [0053] Figure 4 is a schematic front view of the breast prosthesis shown in Figure 1 supported by a full torso sling;

[0054] Figure 5 is a schematic side sectional view of another embodiment of a breast prosthesis;

[0055] Figure 6 is a schematic front view of the breast prosthesis shown in Figure 5;

[0056] Figure 7 is a schematic side sectional view of another embodiment of a breast prosthesis;

[0057] Figure 8 is a schematic isometric view of one embodiment of a breast prosthesis mould;

[0058] Figure 9 is schematic isometric view of a further embodiment of a breast prosthesis;

[0059] Figure 10 is schematic isometric view of a further embodiment of a breast prosthesis;

[0060] Figure 11 is schematic isometric view of a further embodiment of a breast prosthesis;

[0061] Figure 12 is schematic isometric view of a further embodiment of a breast prosthesis mould;

[0062] Figure 13 is schematic isometric view of a further embodiment of a breast prosthesis mould;

[0063] Figure 14 is schematic isometric view of a further embodiment of a breast prosthesis mould;

[0064] Figure 15 is a schematic isometric view of a further embodiment of a breast prosthesis mould and accompanying lid component;

[0065] Figure 16 is a schematic isometric view of a further embodiment of a breast prosthesis mould and accompanying lid component

[0066] Figure 17 is a further schematic isometric view of the breast prosthesis mould and accompanying lid component shown in Figure 16 [0067] Figure 18 is a schematic isometric view of a further embodiment of a breast prosthesis mould shown in a left and right side pair;

[0068] Figure 19 is a further schematic isometric view of the breast prosthesis moulds shown in Figure 18; and

[0069] Figure 20 is a schematic front view of the breast prosthesis moulds shown in Figure 18.

DETAILED DESCRIPTION

[0070] In Figures 1 to 4 of the accompanying drawings, there is schematically depicted an embodiment of a breast prosthesis 10 that is adapted to replicate or at least simulate the size, shape, feel, and/or weight of a patient’s original breast tissue. The breast prosthesis 10 includes a first outer layer 15, an inner core 20, and a second outer layer 25. The first outer layer 15 is formed from a suitably lightweight, soft and flexible first material such as silicone. A deadener may be added to soften the silicone. Other suitable materials that may be used to form the first outer layer 15 include polyurethane foam, polyurethane gel elastomers, or the like. The first outer layer 15 has a thickness of between 5 to 15 mm, and in a preferred form, the first outer layer 15 has a thickness of approximately 7 mm. In other embodiments, the first outer layer 15 has a thickness of between 1 to 6 mm, and in a preferred form, the first outer layer 15 has a thickness of approximately 3 mm.

[0071] The inner core 20 is attached to the first outer layer 15 and is also formed from a suitably lightweight, soft and flexible second material. In embodiments, the second material of the inner core 20 is a mixture of two materials, being silicone and aerogel. The mixture may be between 50 to 80 % of silicone and between 20 to 50 % of aerogel, for example. In a preferred form, the mixture is approximately 60 % of silicone and approximately 40 % of aerogel. It will be understood that in other forms, the second material of the inner core 20 may be a single material formed of either one of silicone (with or without a deadener), gel wax, or aerogel, or any one of other suitable materials including polyurethane foam, polyurethane gel elastomers, memory foam, and/or other silicone-based materials that may have expanding properties. In other embodiments, the second material of the inner core 20 is a mixture of gel wax and aerogel. The mixture may be between 50 to 80 % of gel wax and between 20 to 50 % of aerogel, for example. In a preferred form, the mixture is approximately 60 % of gel wax and approximately 40 % of aerogel. The total volume of the inner core 20 may be between 250 to 600 mL, and in a preferred form, the total volume of the inner core is approximately 450 mL. Accordingly, it will be understood that the combined weight of the inner core 20 and the first outer layer 15, depending on the composition of the inner core 20 material mixture, may range from between 150 to 360 g, and in a preferred form, the combined weight is approximately 270 g.

[0072] The second outer layer 25 at least partially encases the first outer layer 15 and the inner core 20. In the depicted embodiment, the second outer layer 25 wholly encases the first outer layer 15 and the inner core 20. The second outer layer 25 is formed from a suitably durable material such as polyurethane film or sheeting, polyurethane gel, or polyethylene sheeting. In a preferred form, the second outer layer 15 is a thin film of polyurethane having a thickness of between 1 to 3 mm, and preferably having a thickness of approximately 1 mm. In other embodiments, the second outer layer 15 has a thickness of between 0.01 and 0.08 mm, and preferably a thickness of approximately 0.03 mm. It will be appreciated that the second outer layer 25 encases the first outer layer 15 and the inner core 20 so as to hold the first outer layer 15 and the inner core 20 together, and to increase the durability of the breast prosthesis 10. It will be understood that the second outer layer 25 would be suitably thin and lightweight such that the second outer layer 25 would not meaningfully or substantially increase the combined weight of the inner core 20 and the first outer layer 15 as discussed above.

[0073] In the depicted embodiment, the breast prosthesis 10 further includes a support layer 30 that is attached adjacent to a rear portion 35 of the inner core 20. In the depicted embodiment, the support layer 30 is attached to a rear portion 38 of the second outer layer 25 which extends over the rear portion 35 of the inner core 20. The support layer 30 is formed from a suitably lightweight, soft and flexible material such as gel memory foam, which may also provide a natural feel to the patient and create a comfortable connection between the breast prosthesis and the patient’s bra or body. Other suitable materials that may be used to form the support layer 30 include memory foam, silicone (with or without a deadener) and/or polyurethane elastomers.

The support layer 30 has a thickness of between 5 to 20 mm, and in a preferred form, the support layer 30 has a thickness of approximately 10 mm. The support layer 30 may have a weight of between 20 to 80 grams, and in a preferred form, the support layer 30 has a weight of approximately 35 grams. It will be understood that in other embodiments (not shown), the support layer 30 may not necessarily need to be included as part of the breast prosthesis 10, as the final composition or arrangement may depend on the specific requirements of the patient. [0074] In the embodiment depicted in Figure 1, the breast prosthesis 10 further includes an optional hydrogel patch 39 attached to and at least partially extending over the support layer 30 to provide an additional level of comfort for the connection between the breast prosthesis 10 and the patient’s bra or body.

[0075] It will be appreciated from the above that the various components of the breast prosthesis 10 may be altered or adjusted to be any weight, shape, size, or material suitable for a particular patient, and therefore allow the breast prosthesis 10 to closely match the patient’s original breast tissue. In a partial mastectomy, for example, in which only one breast is removed from the patient, the weight of the breast prosthesis 10 may be adjusted to closely match the remaining breast to ensure that the balance of the patient’s body and alignment of the patient’s spine may be maintained. The breast prosthesis 10 may also be adjusted to be as lightweight as possible to increase comfort for the patient. The breast prosthesis 10 may also be adjusted to be as soft as possible and have a skin-like texture to at least provide a more seamless and natural transition between the breast prosthesis 10 and the patient’s body.

[0076] In the embodiment depicted in Figure 2, the breast prosthesis 10 further includes an optional additional material attached to a front portion 40 of the breast prosthesis 10, with the additional material having the form of a nipple 45 and areola 47 to better replicate the patient’s original breast tissue. The nipple 45 and areola 47, and any other optional additional materials that may be added to the breast prosthesis 10, are envisaged to be formed from silicone or the like. In the depicted embodiment, the breast prosthesis 10 is also shown as having an optional edge (overhang) portion 50 that provides a smooth, tapered connection between the surface of the breast prosthesis and the surface of the patient’s skin. This arrangement may at least allow for a more subtle and natural transition between the breast prosthesis 10 and the patient’s skin so that the presence of the breast prosthesis 10 is less visually apparent when worn by the patient.

[0077] In the embodiments depicted in Figures 3 and 4, the breast prosthesis 10 is provided with an optional sling 55 to house the breast prosthesis 10 and to provide support for the breast prosthesis 10 on the body 58 of the patient. The sling 55 may be a half torso sling as shown in Figure 3, or a full torso sling as shown in Figure 4. The sling 55 includes a compartment 60, as shown in Figure 3, or a pair of compartments 60, as shown in Figure 4, into which the breast prosthesis 10 is inserted. The sling 55 also includes a strap 65 (or a pair of straps 65) that is adjustable to suit the patient’s requirements for the position of the breast prosthesis 10 on their body. In the embodiment of Figure 3, the sling 55 includes a lattice portion 70 to increase flexibility and comfort for the patient. The sling 55 also includes a fastening portion 75 that may be in the form of a clasp, for example, to allow the breast prosthesis 10 to be secured to the sling 55. The various components of the sling 55 may be formed from silicone or other suitable material, such as thermoplastic elastomers, polyvinyl acetate. It is envisaged that the bottom portion of the sling 55 may be thicker so as to better hold the weight of the breast prosthesis 10. It will be appreciated that the sling 55 may allow the weight of the breast prosthesis 10 to be carried or distributed to the back of the patient, as opposed to the patient having to carry all weight on their chest area. The sling 55 is also envisaged to be formed from a clear material (such as clear silicone), or skin-coloured, so as to be sufficiently discreet that a bra and/or other clothing may be worn over the sling 55. The sling 55 is also envisaged to have little to no seams or other obvious protruding features that are obviously visible or may be felt by the patient, or that may cause chafing when worn by the patient. It will be appreciated that the sling 55 may provide a more comfortable and practical way for the patient to wear the breast prosthesis 10, as it may be easily put on and taken off in a similar way to any other item of clothing, without the need to use adhesives or other means to attach the breast prosthesis 10 to the body.

[0078] In Figures 5 and 6 of the accompanying drawings, there is schematically depicted another embodiment of a breast prothesis 100, which functions in a generally similar manner as the breast prothesis 10 described above, with like reference numerals being used to indicate like features. In this embodiment, the first outer layer 15 is formed from silicone, and the inner core 20 is formed from a mixture of two materials as described above in relation to the embodiment breast prosthesis 10. It will be appreciated that silicone may at least simulate skin, which is relatively lightweight in comparison with the surrounding tissue. In a preferred form, the inner core 20 of this embodiment is formed from a mixture of gel wax and aerogel to simulate deep tissue. It will be appreciated that gel wax may simulate muscle tissue, for example, which is denser and heavier than surrounding tissue. Further, aerogel may be used to at least expand the inner core 20 (or any other layer). In this embodiment of the breast prosthesis 100, a third layer 105 that at least partially surrounds the inner core 20 is also provided, and this third layer 105 is preferably formed from gel wax to simulate tissue. The various layers may be glued to one another or otherwise attached using any other suitable joining means. This embodiment of the breast prosthesis 100 may also include the support layer 30 that is formed from memory foam. It is envisaged that the third layer 105 may be added to the embodiment of the breast prosthesis 10 described above in any suitable combination with the other layers and/or other components.

[0079] In Figure 6, the breast prosthesis 100 is also shown as having a wider edge (overhang) portion 50 that provides a smooth, tapered connection between the surface of the breast prosthesis and the surface of the patient’s skin. The edge portion 50 is similar to the edge portion 50 as shown in Figure 2, although it is not of a completely perfect teardrop shape as it smoothens and tapers towards the patient’s skin.

[0080] In Figure 7 of the accompanying drawings, there is schematically depicted yet another embodiment of a breast prosthesis 1000, which again functions in a generally similar manner as the breast protheses 10 and 100 described above, with like reference numerals being used to indicate like features. In this embodiment, the first outer layer 15 is made from silicone having a thickness of up to 8mm in a preferred form. The inner core 20 may be formed from mixture of materials as described above, and include between 30 to 60% of the weight/volume of the overall breast prosthesis 1000. In a preferred form, the inner core 20 of this embodiment is formed from a combination of polyurethane foam and/or another type of foam. In another preferred form, the inner core 20 of this embodiment is formed from a combination of gel wax and aerogel being silicone and aerogel. The third layer 105 may be formed from gel wax, and include between 50 to 70% of the weight/volume of the overall breast prosthesis 1000. The support layer 30 may be included and may be formed from memory foam. Finally, a thin layer of material (not shown) similar to the second outer layer 25 of the breast prosthesis 10 described above may be included and may be formed from polyurethane or other type of preferably flexible plastic wrapping. This thin layer of material may encase the first outer layer 15 and the inner core 20 so as to hold the first outer layer 15 and the inner core 20 together, and to increase the durability of the breast prosthesis 1000. In some embodiments, the thin layer of material may encase the first outer layer 15, the inner core 20, and the support layer 30. As discussed above in relation to the second outer layer, it will be understood that this thin layer of material would be suitably thin and lightweight such that it would not meaningfully or substantially increase the combined weight of the inner core 20 and the first outer layer 15 as discussed above.

[0081] In the Figure 8 of the accompanying drawings, there is schematically depicted a breast prosthesis mould 200 that is formed using a three-dimensional (3D) printing process, as will be described in further detail below. The breast prosthesis mould 200 is formed as a block 205 of selected material, such as Polylactic Acid (PLA), Acrylonitrile Butadiene Styrene (ABS), Stereolithography (SLA) (Resin 3D printing). Other suitable materials commonly used in the 3D printing space include plastics, resin, and, composites. This may at least save on the amount of material needed to produce the breast prosthesis mould 200. The breast prosthesis mould 200 has a mould cavity 210 which corresponds to the size and shape of the breast of the breast prosthesis 10, 100, or 1000 to be formed. The block 205 and the associated mould cavity 210 may be of any suitable size and shape, depending on the size and shape requirements of the breast prosthesis 10, 100, or 1000 to be formed. It will be understood that the breast prosthesis mould 200 does not necessarily need to be printed as a block, and may alternatively be printed as a shell corresponding to the shape of the breast prosthesis 10, 100, or 1000 (see the examples of Figures 12 to 14 as will be described below), or any other suitable shape that can be printed.

[0082] Figures 9 to 11 of the accompanying drawings depict various examples of three- dimensional models 250 that may be used to create the breast prosthesis 10, 100, or 1000 described above. In the example of Figure 9, the three-dimensional model 250 includes a protruding end portion 255 so as to facilitate support and insertion of the corresponding breast prosthesis. In the example of Figure 10, the three-dimensional model 250 includes a tapered end portion 257, and in the example of Figure 11, the three-dimensional model 250 includes a rounded end portion 259. Figures 12 to 14 of the accompanying drawings additionally depict various examples of three-dimensional models 260 that may be used to create the breast prosthesis moulds described above and their associated mould cavity shapes. In the examples of Figures 12 and 14, mould cavities 265 are visible on the three-dimensional model 260, and the breast prosthesis mould is provided as a shell that defines the shape of the mould cavities 265. Additionally, in the examples of Figures 12 and 13, the three-dimensional models 260 include a tab, flange or gripping portion 267 that is connected to the shell of the mould, which allows the user to better grip and manipulate the mould, for example, during filling of the mould with the materials used to form the breast prosthesis. It should be understood that the three-dimensional models as depicted are examples only, and are not intended to limit the scope, applicability, or configuration of the breast prosthesis 10, 100, or 1000 or breast prosthesis mould 200 in any way.

[0083] Figures 15 to 17 of the accompanying drawings depict various further examples of three- dimensional models 280 that may be used to create the breast prosthesis 10, 100, or 1000 described above. In these examples, the three-dimensional models 280 each include an accompanying removable lid component 285 that is adapted to be mounted on the model 280 and over the mould cavity 265. It will be appreciated that this lid component 285 may allow for the material within the mould cavity 265 to take on a flat outer shape or profile. The removable lid component 285 may have an inner flange 287 to facilitate the mounting of the lid component 285 on the rim of the model 280. In the examples of Figures 16 and 17, the lid component 285 is envisaged to include a curved part 289 to allow for the material within the mould cavity 265 to take on a curved outer shape or profile. It will also be appreciated that the three-dimensional models 280 described above may be printed at a smaller size, for example at 50% of the size of the overall breast prosthesis 10, 100, or 1000, to accommodate a smaller mould cavity 265 within which the inner core 20 may be formed.

[0084] Figure 18 to 20 of the accompanying drawings depict various further examples of three- dimensional models 290a, 290b that may be used to create the breast prosthesis 10, 100, or 1000 described above. In these examples, the three-dimensional models 290a, 290b have been designed to include mould cavities 295a, 295b that take on different shapes suitable for the left or right breast, respectively. It will be appreciated that this may at least allow the outer side of the mould cavities 295a, 295b to follow the curvature of bra underwires so as to provide a more natural look and feel.

[0085] A method of forming the breast prosthesis mould 200 and the corresponding breast prosthesis 10, 100, or 1000 will now be described.

[0086] A first step of the method involves obtaining a three-dimensional image of a patient’s breast. The three-dimensional image may be obtained by way of a three-dimensional photogrammetry application and an image capture device, such as a smartphone application and smartphone camera.

[0087] A second step of the method involves converting the three-dimensional image of the patient’s breast (obtained via the first step above) to a three-dimensional (digital) model. The three-dimensional image may be converted to the three-dimensional (digital) model using suitable image processing software. Alternatively, the three-dimensional (digital) model may be created using one or more parameters based on data/measurements obtained from existing users. For example, the three-dimensional (digital) model may be created from an inventory of lengths, widths, thicknesses, and/or curvature from previously-created prostheses. The particular parameters from the inventory for the three-dimensional (digital) model may be selected based on a closest match to a patient’s body type or requirements.

[0088] After the three-dimensional model has been obtained by way of the conversion described in the second step above, a third step of the method involves constructing, using a three- dimensional printer, a breast prosthesis mould 200 having a mould cavity 210 that corresponds to the three-dimensional model described above. The breast prosthesis mould 200 may be formed using any suitable three-dimensional printing materials such as plastics, resins, or composites. This third step of the method may involve constructing multiple breast prosthesis moulds corresponding to the various layers of the breast prosthesis 10, 100, or 1000 as described above. For example, this third step of the method may involve constructing a first breast prosthesis mould having a mould cavity that corresponds to the inner core 20 as described above, a second breast prosthesis mould having a mould cavity that corresponds to the second outer layer 105 as described above, and a third breast prosthesis mould 200 having a mould cavity 210 as described above. It is envisaged that this step of the method may involve the construction of any suitable number and combination of the different layers/components of the breast prosthesis 10, 100, or 1000 as described above.

[0089] After the breast prosthesis mould 200 has been constructed by way of the three- dimensional printing third step described above, a fourth step of the method involves at least partially filling the mould cavity 210 with one or more materials to form a breast prosthesis 10 or 100. In this fourth step, the mould cavity 210 may be filled with a single material, and is preferably filled with a first material and a second material. In a preferred form, this fourth step involves at least partially filling the mould cavity 210 with a first material (such as silicone) to form a first outer layer 15 of the breast prosthesis 10 or 100, and subsequently filling the remainder of the mould cavity 210 with a second material (such as a silicone and aerogel mixture, or a gel wax and aerogel mixture) to form an inner core 20 of the breast prosthesis 10 or 100. Alternatively, the mould cavities of the first/ second/third moulds may be filled with the respective first/ second/third materials corresponding to the various layers of the breast prosthesis 10, 100, or 1000. For example, the mould cavity of a first mould (corresponding to the inner core 20) may be filled with polyurethane foam liquid, and left to expand for a suitable amount of time to create a polyurethane foam inner core. The mould cavity of a second mould (corresponding to the third outer layer 105) may then be partially filled with gel wax. The polyurethane foam inner core may then be placed into the gel wax whilst it is curing, ensuring that at least half of the polyurethane foam inner core is submerged in the gel wax. The remaining mould cavity of a second mould may then be filled with gel wax to create a combined polyurethane foam inner core and gel wax first outer layer. The mould cavity of a third mould may then be coated in silicone, and the combined polyurethane foam inner core and gel wax first outer layer may then be placed into this mould cavity of the third mould to form the breast prosthesis. It will also be appreciated that prior to filling the mould cavities, the moulds may be covered or wrapped in a thin layer of material (such as cling film) to prevent the materials from sticking to the moulds. It is envisaged that this step of the method may involve the filling of the mould cavities in any sutiable order and combination, depending on the design requirements of the breast prosthesis 10, 100, or 1000 as described above.

[0090] A fifth step of the method involves removing the breast prosthesis 10, 100, or 1000 (formed by way of the fourth step described above) from the mould cavity 210, and a sixth step may involve subsequently applying a film of material to the breast prosthesis 10, 100, or 1000 to form a second outer layer 25 of the breast prosthesis 10, 100, or 1000. In a preferred form, the film material is polyurethane or plastic, and this fifth step may involve at least partially encasing the breast prosthesis 10, 100, or 1000 in the polyurethane or plastic film to increase the durability of the breast prosthesis. Other materials may be added to coat the breast prosthesis to ensure a smooth coating/fmishing, and residual or excess material may also be trimmed from the final breast prosthesis.

[0091] A seventh step of the method may involve applying a support layer 30 to the breast prosthesis 10, 100, or 1000. In a preferred form, the support layer 30 is a gel memory foam layer, and this seventh step involves attaching the gel memory foam layer to a rear portion of the inner core 20. As described above, the support layer 30 may provide a more natural feel to the patient and create a comfortable connection between the breast prosthesis 10, 100, or 1000 and the patient’s bra or body.

[0092] An eighth step of the method may involve applying an additional material to a front portion 40 of the breast prosthesis 10, 100, or 1000 to form a nipple 45, and ninth step of the method may involve applying a sling 55 to the breast prosthesis 10, 100, or 1000. As described earlier, the sling 55 may be adapted to support the breast prosthesis 10, 100, or 1000 on the body of the patient and to provide a comfortable and practical way for the patient to wear the breast prosthesis 10, 100, or 1000.

[0093] Various forms of the breast prosthesis, breast prosthesis moulds, processes and methods described above may have one or more of the following advantages. The materials used to form the breast prosthesis and various components thereof are carefully selected to allow for a significant lighter breast prosthesis, and to also provide a more comfortable way for patients to wear their prostheses. The breast prosthesis is designed with comfort in mind and to be worn by a patient every day, but still allow the breast prosthesis to feel as natural and connected to their bodies as possible. The breast prosthesis is customisable (bespoke) to provide any size, shape, weight and feel that is suitable for the patient, thus allowing the patient to have complete control over the breast prosthesis that meets their personal requirements.

[0094] It will be appreciated that the breast prosthesis is able to be customised to accommodate any type of breast conserving surgeries, so that the patient may have a breast prosthesis that is unique to their body type and biomechanics. The breast prosthesis is constructed using the methods described above to fit the patient’s body as an alternative to surgery and conventional prostheses products. The breast prosthesis may at least allow patients to have the shape of their breast(s) pre-surgery, which may provide some confidence in that they do not have to change their clothing or appearance following what is often a traumatic event. As the breast prosthesis is customisable is size, shape, weight and feel, is may also readily fit into existing mastectomy bras already on the market. Alternatively, the breast prosthesis may be customised to fit into the sling described above so that patients will be able to wear their existing (pre-mastectomy) clothing and undergarments. The materials used to form the breast prosthesis as described above also provide a breast prosthesis that is soft to touch in order to be as close as possible to human skin, so that patients do not feel ashamed of wearing the prostheses.

[0095] As discussed earlier, the various forms of the breast prosthesis, breast prosthesis moulds, processes and methods described above may be useful in applications for patients that have had a mastectomy or any type of breast removal surgery. Possible alternative commercial applications may include applications for transgender and drag queen community, the entertainment or costume-making industry, women with uneven breast sizes, and for plastic surgeons to show patients how their bodies will look post-surgery. [0096] Although specific embodiments of the invention are illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternative and/or equivalent implementations exist. It should be appreciated that the exemplary embodiment or exemplary embodiments are examples only and are not intended to limit the scope, applicability, or configuration in any way. Rather, the foregoing summary and detailed description will provide those skilled in the art with a convenient road map for implementing at least one exemplary embodiment, it being understood that various changes may be made in the function and arrangement of elements described in an exemplary embodiment without departing from the scope as set forth in the appended claims and their legal equivalents. Generally, this application is intended to cover any adaptations or variations of the specific embodiments discussed herein.

[0097] It will also be appreciated that in this document the terms "comprise", "comprising", "include", "including", "contain", "containing", "have", "having", and any variations thereof, are intended to be understood in an inclusive (i.e. non-exclusive) sense, such that the process, method, device, apparatus or system described herein is not limited to those features or parts or elements or steps recited but may include other elements, features, parts or steps not expressly listed or inherent to such process, method, article, or apparatus. Furthermore, the terms "a" and "an" used herein are intended to be understood as meaning one or more unless explicitly stated otherwise. Moreover, the terms "first", "second", etc. are used merely as labels, and are not intended to impose numerical requirements on or to establish a certain ranking of importance of their objects.

Claims

1. A method of forming a breast prosthesis, the method comprising the steps of:

(a) obtaining a three-dimensional image of a patient’s breast;

(b) converting the three-dimensional image of the patient’s breast to a three- dimensional model;

2. The method of claim 1, wherein step (d) comprises the steps of: at least partially filling the mould cavity with a first material to form a first outer layer of the breast prosthesis; and filling the remainder of the mould cavity with a second material to form an inner core of the breast prosthesis.

3. The method of claim 2, wherein the first material is a layer of silicone, and the second material is a mixture of silicone and aerogel.

4. The method of claim 2, wherein the first material is a layer of silicone, and the second material is a mixture of gel wax and aerogel.

5. The method of claim 1, wherein step (d) comprises the steps of: at least partially filling the mould cavity with a first material to form a first outer layer of the breast prosthesis; at least partially filling the mould cavity with a third material to form a third outer layer of the breast prosthesis; and filling the remainder of the mould cavity with a second material to form an inner core of the breast prosthesis.

6. The method of claim 5, wherein the first material is a layer of silicone, the second material is a polyurethane foam, and the third material is gel wax.

7. The method of any one of claims 2 to 6, further comprising the steps of: (e) removing the breast prosthesis from the mould cavity; and

8. The method of claim 6, wherein the film material is polyurethane, and step (f) comprises the step of encasing the inner core and the first and/or third outer layer with the polyurethane film to increase the durability of the breast prosthesis.

9. The method of any one of claims 5 to 8, further comprising the step of:

(g) applying a support layer to the breast prosthesis.

10. The method of claim 9, wherein the support layer is a gel memory foam layer, and step (g) comprises attaching the gel memory foam layer to a rear portion of the inner core or the third outer layer.

11. The method of any one of claims 1 to 10, further comprising the step of:

12. The method of any one of claims 1 to 11, further comprising the step of:

13. A breast prosthesis comprising: a first outer layer formed of a first material; an inner core formed of a second material and attached to the first outer layer; and a second outer layer that encases the first outer layer and the inner core, the second outer layer being formed of a third material.

14. The breast prosthesis of claim 13, wherein the first material of the first outer layer is silicone.

15. The breast prosthesis of claim 14, wherein the silicone outer layer has a thickness of between 0 to 8 mm.

16. The breast prosthesis of claim 15, wherein the thickness of the silicone outer layer is 3 mm.

17. The breast prosthesis of any one of claims 13 to 16, wherein the second material of the inner core is a mixture of silicone and aerogel.

18. The breast prosthesis of claim 17, wherein the mixture comprises between 50 to 80 % of silicone and between 20 to 50 % of aerogel.

19. The breast prosthesis of claim 18, wherein the mixture comprises 60 % of silicone and 50 % of aerogel.

20. The breast prosthesis of any one of claims 13 to 16, wherein the second material of the inner core is a polyurethane foam.

21. The breast prosthesis of any one of claims 13 to 16, wherein the second material of the inner core is a mixture of polyurethane foam and another type of foam.

22. The breast prosthesis of any one of claims 13 to 16, wherein the second material of the inner core is a mixture of gel wax and aerogel.

23. The breast prosthesis of claim 22, wherein the mixture comprises between 50 to 80 % of gel wax and between 20 to 50 % of aerogel.

24. The breast prosthesis of claim 23, wherein the mixture comprises 60 % of gel wax and 50 % of aerogel.

25. The breast prosthesis of any one of claims 13 to 24, wherein the second outer layer is a film of the third material, with the third material being polyurethane or plastic.

26. The breast prosthesis of claim 25, wherein the film has a thickness of between 0.01 to 0.08 mm.

27. The breast prosthesis of claim 26, wherein the film has a thickness of 0.03 mm.

28. The breast prosthesis of any one of claims 13 to 27, further comprising a support layer attached adjacent to a rear portion of the inner core.

29. The breast prosthesis of claim 28, wherein the support layer is a gel memory foam layer.

30. The breast prosthesis of any one of claims 13 to 29, further comprising an additional material attached to a front portion of the breast prosthesis, the additional material having the form of a nipple.

31. The breast prosthesis of any one of claims 13 to 30, further comprising a sling to house the breast prosthesis and to provide support for the breast prosthesis on the body of a patient.

32. A breast prosthesis comprising: a first outer layer formed of a first material; and an inner core formed of a second material and attached to the first outer layer.

33. The breast prosthesis of claim 2, wherein the first material of the first outer layer is silicone, and the second material of the inner core is a mixture of gel wax and aerogel.

34. The breast prosthesis of claim 32, wherein the first material of the first outer layer is silicone, and the second material of the inner core is a polyurethane foam.

35. The breast prosthesis of claim 32 wherein the first material of the first outer layer is silicone, the second material of the inner core is a mixture of polyurethane foam and another type of foam.

36. The breast prosthesis of any one of claims 32 to 35, further comprising a second outer layer that encases the first outer layer and the inner core, the second outer layer being formed of a third material.

37. The breast prosthesis of claim 36, wherein the second outer layer is a film of the third material, with the third material being polyurethane or plastic.

38. The breast prosthesis of any one of claims 32 to 37, further comprising a third layer that at least partially surrounds the inner core, the third layer being formed of a fourth material.

39. The breast prosthesis of claim 38, wherein the fourth material of the third layer is a gel wax.

40. A method of forming a breast prosthesis mould, the method comprising the steps of:

(a) obtaining a three-dimensional image of a patient’s breast;

(b) converting the three-dimensional image of the patient’s breast to a three- dimensional model; and