Patent Application
20230039216
The invention in general pertains to a method of manufacturing an external breast prosthesis, the method comprising the steps of providing a 3D image of the breast prosthesis allowing a unique individualisation of the prosthesis, forming the breast prosthesis from a polymer using an additive manufacturing process, in which additive manufacturing process the breast prosthesis is made by forming a structure of the polymer (i.e. incorporating this polymer when building the structure), the structure corresponding to the 3D image of the breast prosthesis. The invention also pertains to a breast prosthesis that can be made with this method. The method and prosthesis according to the invention allow an accommodation for an anomalous breast shape of a person due to surgery or other event inducing a shape differentiation, or a naturally existing shape differentiation.
A shape differentiation in breast typically occurs after surgery for breast cancer. During such surgery typically a certain amount of breast tissue is be removed from a patient. Even a small amount of tissue removed creates a deficit that can't be overlooked, and causes anxiety. For example, it may become difficult to obtain satisfactory undergarments that will compensate for the deficit. In addition, existing brassieres may create pressure from the brassiere structure, especially the chest/back band. This pressure is often a source of pain at the breast surgery site in many users, which may become very fatiguing and taxing as a day wears on. Straps and bands, while managing weight, volume and position, cause significant discomfort and often, pain, especially in post-surgical situations. In practice, the deficit is often balance using an external breast prosthesis, the use of which might also decrease discomfort at the surgery site. The prosthesis typically is a structure of a material that resembles the look and/or feel of an intact natural breast, which structure may be combined with other materials such as a liner.
There are various types of traditional external post-mastectomy and lumpectomy prostheses, also called breast forms. The type of prosthesis required is determined by the amount of breast tissue that is removed. A prosthesis can be worn against the skin, inside the pocket of a mastectomy bra, or attached to the chest wall. Prosthetic devices are designed to look feminine while ensuring comfort.
The most common type of external prosthesis is the silicone breast prosthesis, such as for example known from WO2013/091720. An external silicone breast prosthesis is a weighted prosthesis, typically made of silicone polymer, which is designed to simulate natural breast tissue. The idea is that since this type of breast prosthesis is weighted, it may help the patient's posture, prevent shoulder drop, and problems with balance. However, many patients find these prostheses uncomfortable, cumbersome and impractical. Silicone prostheses are often described as heavy, hot and irritating the skin. An alternative type of prosthesis is a non-silicone light-weight breast form made of foam or fiberfill. Non-silicone breast prostheses may be worn during exercise, swimming, and hot weather. However, the feel of such a light weight prosthesis is very unnatural. Another type of prosthesis is a self-adhesive breast form that attaches securely to the chest wall with adhesive strips. Self-adhesive prostheses however require regular cleaning. Yet another type of prosthesis is a soft form worn in a camisole, thus providing a light-weight, removable breast form that fits into a camisole garment (a soft, stretchy garment with lace elastic straps that can be pulled up over the hips if raising the arms is difficult). Post-surgical camisole is often worn immediately following a mastectomy, lumpectomy, radiation therapy, or during reconstruction breast surgery. However, a camisole is less suitable for every day long term use.
A novel technology for manufacturing breast prostheses is based on so called additive manufacturing technologies. US 2017/0281367 describes a prosthesis that is made to perfectly fit an individual. For this a 3D image is made of the breast prothesis, based on 3D scans of the patient in various positions, taking before and/or after the surgery. Based on the image, a unique breast prosthesis is made using selective laser sintering. The prosthesis is built up out of multiple separate parts that allow a variability enhanced over common single-piece (unitary) manufacturing techniques. This leads to a prosthesis that comprises an inner wall mesh having a first density (the inner wall mesh being configured to coincide with a chest wall of the patient), and which inner wall mesh typically has fixed intersections. The breast prosthesis further comprises a distinct outer wall mesh having a second density. The outer wall mesh is configured to have an ideal shape for the patient. The outer wall mesh typically has moveable intersections to provide additional movement and flexibility. The prosthesis further comprises a band mesh having a density greater or equal to the first or second density of the inner wall mesh and outer wall mash, respectively. Lastly, the breast prosthesis comprises a central portion disposed in between the inner and outer wall meshes. The central portion may be filled with foam, batting, gel, or another suitable material. This technology wherein the prosthesis is composed out of multiple separate parts instead of using a single-piece structure, allows for the manufacture of an individualized external breast prosthesis that is comfortable to wear. However, this is at the cost of a very complicated manufacturing process.
It is an object of the invention to devise a method to manufacture an external breast prosthesis, which method is relatively simple to perform and allows the production of a prosthesis that is comfortable to wear for the patient and at the same time has mechanical properties that resemble natural breast tissue.
In order to meet the object of the invention a method as described in the General Field of the Invention section supra has been devised, wherein the polymer used for making the structure is a thermoplastic elastomer, and at the same time, forming the structure as a reticulated solid foam. Preferably the structure is formed by having at least 50% of the weight formed by the polymer, more preferably at least 55, 60, 65, 70, 75, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or even 100%.
Applicant has found that a relatively simple single piece manufacturing technique can be used, i.e. a technique wherein the basic structure of the prosthesis may be formed as a single piece of material (not excluding the use of an additional material for example as a liner, a shield, protector, a dispersed filler etc, and wherein the additional material amounts to no more than 40% of the volume and/or weight of the ultimate configuration (including the actual prosthesis, plus garment or brassiere, lining, padding , strapping etc.), preferably 35% or less, such as 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1% or even less), and still the prosthesis may be individualized, comfortable to wear and resembling the bulk mechanical properties of natural breast tissue very adequately. This means that the core of the prosthesis, i.e. the internal filling structure, is formed as the reticulated solid foam. This core corresponds to the above at least 60% of the volume and/or weight of the ultimate configuration. This core determines the physico-mechanical properties of the prosthesis and hence the look and feel and comfort. Essential for this is that the polymer used for making the structure is a so called thermoplastic elastomer, and at the same time the structure is formed as a reticulated solid foam. This way the breast prosthesis can be formed as a unitary structure of a reticulated solid foam, instead of a multi-piece prosthesis as known form the art.
It was found that the combination of providing the structure as a reticulated solid foam and at the same time making sure the polymer is a thermoplastic elastomer, the mechanical properties of a natural breast tissue can be resembled adequately, while at the same time having a density less than common silicon polymer filled external prostheses. This means that the prosthesis may not feel "heavy" despite having adequate mechanical properties. For example, by varying the porosity (i.e. the volumetric void fraction) in various areas of the structure, the mechanical properties of varies areas in a natural breast can be mimicked very adequately. Next to this, the reticulated solid foam structure allows for any surrounding air to be able and freely penetrate completely through the prosthesis. This way, heat can be effectively transported away from the chest surface, even though the polymer itself may be an insulating material and thus typically a bad conductor of heat. At the same time, moist can be also be transported relatively easily from an inner surface of the prosthesis to an outer surface through the open and continuous pores, which in addition may contribute significantly to a comfortable wearing experience.
The method according to the invention allows the provision of an easy to manufacture external breast prosthesis, comfortable to wear and having a very good look and feel, the prosthesis comprising as a basic structure (i.e. more than 60% of the volume and/or weight of the ultimate configuration to wear, in particular at least 65%, 70, 75, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or even higher) a reticulated solid foam made of a thermoplastic elastomer. This way the breast prosthesis may be a unitary structure of a reticulated solid foam, instead of a multi-piece prosthesis as known form the art.
It is noted that that the prosthesis may be manufactured by including various items into the prosthesis which can be used either cosmetically, for comfort, or even medically. Such items may be for example additional fillers to obtain particular (local) densities to perfectly match a natural breast in its mechanical properties, or to increase comfort, and it may even comprise sensors to sense all kinds of body parameters, or medicaments for gradual transdermal release into the body of the wearer. The latter also includes hormones that are typically used during treatment against cancer. It is also foreseen to incorporate actuators for local stimulation of body tissue of the wearer. In any case, any kind of item or compound can be incorporated into the prosthesis of the invention.
It is noted that from CN 109172044 a biodegradable implant is known for use as a breast prosthesis. This implant is a core-shell structure of which the shell is formed as a reticulated structure of a polymer. However, it is not disclosed that this shell is formed using an elastomer. Indeed, this is not necessary for this known implant, and would even be disadvantageous, since the shell structure is needed for stably determining its surface properties (for interaction with living breast tissue), not the volume properties (i.a. the basic look and feel) of the prosthesis. This is not an issue at all for the known prosthesis since after implant this prosthesis is replaced by natural tissue in due course, by growth of the natural breast tissue into the stable prosthesis and at the same time gradual degradation of the artificial bio-degradable prosthesis. Only thereafter the breast obtains its natural look and feel. The materials mentioned, like PVA, PLA PBS, etc. indeed are commonly known as biodegradable polymers for constituting rigid structures.
An external breast prosthesis is an artificial breast that is worn under clothing to imitate the shape of the breast. There are a wide variety of external breast prostheses available. Some are held within specially designed bras, while others are attached to the skin with a sticky backing.
The inner surface of an external breast prosthesis is the surface of the prosthesis that is designed for coinciding (adjoining.abutting) with an outer chest surface of a person wearing the breast prosthesis, notwithstanding that in between the chest surface and the inner surface of the prosthesis itself there is a liner, like a piece of cloth or otherwise. The inner surface of the prosthesis is opposed by an outer surface that provides the outer visible shape of the breast prosthesis.
A 3D image of a structure is a data set representing an actual three dimensional structure.
Reticulated means resembling a net or network, typically having veins, fibers, or lines that cross.
A polymer is a substance (a material) that has a molecular structure consisting substantially of macromolecules that consists of a large number of similar units bonded together, e.g., many synthetic organic materials used as plastics and resins. Small compounds are often present in the substance to enhance its properties (e.g. preservatives, UV-stabilisers, viscosity modifiers, flame retardants etc), but the amount of macromolecules is such that the overall physical properties determine that the substance has the physical properties of a polymer (also called a plastic) including its toughness, viscoelasticity, and a tendency to form glasses and semicrystalline structures rather than crystals.
A thermoplastic elastomer (TPE) is an elastomer comprising a thermoreversible network. A TPE belongs to a class of copolymers and/or a physical mix of polymers (usually a plastic and a rubber) that consist of materials that provide the TPE with both thermoplastic and elastomeric properties. A TPE typically has the ability to be stretched to moderate elongations and, upon the removal of stress, return to something close to its original shape, is processable as a melt at elevated temperature, and shows no significant creep. There are six generic classes of commercial TPEs: styrenic block copolymers (TPS or TPE-s), thermoplastic polyolefinelastomers (TPO or TPE-o), thermoplastic vulcanizates (TPV or TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC or TPE-E), thermoplastic polyamides (TPA orTPE-A).
Next to this there is class of non-classified thermoplastic elastomers called TPZ. Examples of TPE materials that come from block copolymers group are amongst others CAWITON, THERMOLAST K, THERMOLAST M, Arnitel, Hytrel, Dryflex, Mediprene, Kraton, Pibiflex, Sofprene, and Laprene. Out of these styrenic block copolymers (TPE-s) are CAWITON, THERMOLAST K, THERMOLAST M, Sofprene, Dryflex and Laprene. Desmopan or Elastollan are examples of thermoplastic polyurethanes (TPU). Santoprene, Termoton, Solprene, THERMOLAST V, Vegaprene, or Forprene are examples of TPV materials. Examples of thermoplastic olefin elastomers (TPO) compound are For-Tec E or Engage.
Additive manufacturing (official industry standard term according to ASTM F2792) or simply "AM", is defined as the process of joining materials to make objects from a 3D image, usually layer upon layer, as opposed to subtractive manufacturing methodologies in which material is removed by machining. Common to additive manufacturing (AM) is the use of a computer, 3D modeling software (Computer Aided Design or CAD), machine equipment and layering material. Once a CAD sketch, i.e. the 3D image, is produced, the AM equipment reads in the 3D image and lays downs or adds successive parts of liquid, powder, sheet material or other, usually in a layer-upon-layer fashion to manufacture a 3D structure. The term additive manufacturing encompasses many technologies including subsets like 3D Printing, Rapid Prototyping (RP), Direct Digital Manufacturing (DDM), layered manufacturing and additive fabrication.
Solid foams are a class of lightweight cellular materials. These foams are typically classified into two types based on their pore structure: open-cell-structured foams (also known as reticulated foams) and closed-cell foams. At high enough cell resolutions, any type can be treated as continuous or "continuum" materials and are referred to as cellular solids, with predictable mechanical properties. Open-cell-structured foams contain pores that are connected to each other and form an interconnected network. Open-cell foams fill with whatever gas surrounds them. In a reticulated foam the pores are continuous, form inner wall to outer wall, as opposed to local pores. Local pores may only permit local air flow through the structure whereas continuous pores permit air flow through the complete structure, hence enabling the transport of heat and moisture throughout the entire structure.
In a further embodiment of the method according to the invention the porosity of the reticulated solid foam, i.e. the volumetric void fraction in the solid foam, is between 50 and 95%, such as for example 50, 55, 60, 65, 70, 75, 70, 85, 90 or 95%. It was found that when using a TPE as polymer, at such a void fraction, adequate physical properties of the prosthesis for all various essential aspects (mechanical feel, heat transport, moist transport, density) can be provided in one and the same structure. Most advantageously, the porosity of the reticulated solid foam is between 60 and 85%, e.g. 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72,73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84 or 85%. The porosity need not be the same throughout the volume of the prosthesis, but may locally vary to meet locally desired properties.
In a further embodiment of the method according to the invention the thermoplastic elastomer is a non-biodegradable polymer. In yet a further embodiment of the method according to the invention the thermoplastic elastomer is a styrene block copolymer. This particular copolymer was found to be very suitable for making a breast prosthesis with the method of the current invention. A particular suitable copolymer was found to be a styrene-ethylene-butylene-styrene copolymer. The type of polymer allows manufacturing of very comfortable prostheses, while at the same time being safe upon prolonged skin contact.
In an embodiment, the additive manufacturing is performed using a 3D printing technology, for example an inkjet deposition technology (regarding the latter, although the polymer might not be coloured and thus as such, might not be regarded as an "ink", due to resemblance with drop-on-demand inkjet technology, this term is also used for this type of AM technologies). This technology was found to be particularly suitable for use in the present method. Advantageously, in the manufacturing process the thermoplastic elastomer is deposited to become part of the structure in the form of multiple separate droplets that fuse together after being deposited. So instead of using a technique wherein in a continuous layer of a particular material certain parts are fused to become solid, separate drops of elastomer are deposited on demand on the growing structure (corresponding to the 3D image of the structure to be formed) and fuse with the previously deposited droplets right after their deposition. This drop-on-demand inkjet technology has shown to be particularly advantageous for manufacturing a reticulated solid foam of a thermoplastic elastomer.
In yet another embodiment the reticulated solid foam structure comprises multiple elongated thermal conductors. It was found that for some patients the demand for transport of heat is so high, either throughout the entire prosthesis or locally due to local uneven heat production, that the open cell structure as such cannot guarantee (local) uncomfortable temperature rise. It may be that the needed void fraction is so high, that the resulting mechanical properties are found to be below a desired level. In such a case the transport of heat can be improved by incorporating in the prosthesis one or more elongated thermal conductors that are able to conduct heat away from the chest. For example, each of the multiple elongated thermal conductors extends from a position adjacent an inner surface of the breast prosthesis to a position adjacent to an outer surface of the breast prosthesis. This way, heat can be effectively transferred to an outer surface of the breast prosthesis, mimicking transport of heat to the outer surface of the natural breast via transport of blood through veins.
In a further embodiment the elongated thermal conductors are polymer fibres, preferably of an oriented strand polymer. Polymer conductors have found to be suitable for use in an external breast prosthesis. Although inherently being worse thermal conductors than for example (most) metal or carbon fibres, the heat conductivity of polymers may suffice for the current application, in particular when using an oriented strand polymer like DYNEEMA (DSM, Heerlen, The Netherlands). Such polymers have a very high heat conductivity and still have the mechanical properties (in particular the flexibility and density) of a polymer making them ideally suitable for incorporation as thermal conductors in a polymeric breast prosthesis.
With regard to the breast prosthesis according to the invention, this is further embodied in any prosthesis made using any of the further embodiments of the method according to the invention. In particular, such a further embodiment of the breast prosthesis has a porosity (of the reticulated solid foam) between 50 and 95% as described here above. Next to this, the thermoplastic elastomer in an embodiment is a styrene block copolymer as described here above. Also, the breast prosthesis in an embodiment comprises multiple elongated thermal conductors as described here above.
The invention will now be further illustrated using the following particular examples.
Example 1 describes a method of manufacturing a breast prosthesis.
Example 2 describes various tests of breast prostheses.
In Step 2 a 3D scan is made of the site of operation, thus providing an image of the chest of the patient and remaining breast tissue (if any), on to which the external prosthesis has to be placed in order to arrive at the desired shape for the operated breast.
In Step 3 a 3D image of the prosthesis is generated using the 3D scan of the residual breast (mirror imaged) and the 3D scan of the site of operation. The part of the image that misses in the latter scan when compared to the former corresponds to the external breast prosthesis.
In Step 4 this 3D image of the external breast prosthesis is send to the additive manufacturing machine, for example an inkjet deposition printer wherein a molten polymer is deposited in the form of multiple separate droplets that fuse together after being deposited to become part of the printed structure.
In Step 5 This machine manufactures a structure that corresponds to the 3D image of the breast prosthesis. This way, a unitary structure is made that can be used as an external breast prosthesis (for example in a brassiere), to arrive at the desired shape when positioned on the site of the operated breast.
The method can be adapted to meet any individual desire for shape, feel, heat and moist conducting properties etc. depending on how the unitary structure is configured and depending on the use of any additional materials in the manufacturing process. For example, a structure according to the invention is a reticulated solid foam, of which foam the porosity can be varied significantly, typically from 5 to 95%. This has a significant influence on the ultimate physical properties of the prosthesis. Also, the droplet size can be varied, as well as the polymer material used. Next to this, various additional materials can be added after or during the manufacture of the basic unitary structure. For example, thermal conductors can be dispersed in the structure during (or after) the printing process. Also, padding can be added if desired. This way, the prosthesis can be completely individualized and even adapted to the occasion. For example, it is envisioned that for different levels of physical exercise, different prostheses are made for the same patient. Also, different prostheses may be made to fit different garments of the same patient.
In
In
This example describes a method of manufacturing a breast prosthesis according to the invention (see
The same way, various variants were made of the breast prosthesis, all reticulated solid foams of the same material, but differing in porosity from very high (95%) to low (25%). Table 1 gives an overview of the various structures.
This example describes various test performed on prostheses A through E as described in Example 1. The first two tests pertain to the resilience after compression, and the third test pertains to the property to transport heat through the prosthesis.
In this test the resilience after repeated compression and decompression is measured. For this a sample of each prosthesis A though E, having a thickness of about 19-20 mm, was subjected to 15 compression cycles (same force for every sample, leading to nearly full compression, i.e. 80-40% compression depending on porosity). After this, the sample height for each type of prosthesis was remeasured. As a positive control the height for a commercial silicon breast prosthesis sample was measured, which appeared to be 19.5 ± 0.4 mm. So any change at this level was found acceptable. The results are indicated in Table 2.
It can be seen that all types of prosthesis have an acceptable resiliency, albeit that at a porosity of 50% or lower there seems to be a tendency of less resilience (however still acceptable).
In this test the resilience after long term compression (1 cycle) is measured. Given the fact that all types of prosthesis appear to have almost the same resilience against repeated compression, the resilience against long term compression was only measured for prosthesis type C, having a porosity of 75%. The compression used was of the same level as that used in Test 1, but it was maintained for 24 hours. After this, the recovery was measured by measuring the sample height as a percentage of the original sample height before compression. A recovery to at least 90% in 3 hours was set as a threshold for adequate recovery after long term compression for an external breast prosthesis. The results are indicated in Table 3.
It appeared that the recovery was acceptable, being already over 90% after 1 hour and 13 minutes recovery time.
The third test pertains to the property to transport heat through the prosthesis, based on mere unforced conduction through the bulk of the prosthesis. For this samples of a common commercially available silicon breast prosthesis and prosthesis of type C (having the same dimensions) were heated one sided with a common air flow heat gun. After heating up the one side to a temperature 16° C. above the opposing side, the samples were left and the difference in temperature of the two opposing sides was monitored for half an hour (1800 seconds). The results are indicated below in Table 4.
It appeared that the novel prosthesis material has a significantly increased capability of heat regulation. This contributes significantly to mitigation of the problem of an external breast prosthesis getting uncomfortable by heat build up at the surface where the chest and prosthesis coincide. It is expected that by applying thermal conductors in the prostheses as tested (cf.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2024687 | Jan 2020 | NL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/050652 | 1/14/2021 | WO |
