Patent Description:
Breast implants are typically used to increase the size of the breast or to replace a removed breast or part of breast. Some known breast implants are designed to be progressively absorbed by the body while being replaced by body tissues. Document <CIT> describes tissue engineering devices and methods employing scaffolds made of absorbable material for use in the human body for tissue genesis and regenerative and cellular medicine including breast reconstruction.

With gravity, a breast tends to fall, sometimes giving rise to a breast ptosis, where the areola is too low and the gland goes below the level of the submammary fold. A breast ptosis may happen in a breast without implant but also with a breast including an implant, especially when the implant is absorbed by the body.

An object of the invention is to provide a breast implant decreasing the risk of breast ptosis.

According to this first aspect, the invention provides a breast implant comprising:.

wherein the first part is more rigid than the second part, and wherein the first part is less absorbable than the second part such that a longer time is required to dissolve the first part in a mammal body than to dissolve the second part in same mammal body.

The flexibility of the second part is advantageous during the positioning of the implant, while the rigidity of the first part decreases the risk of breast ptosis.

Since the first and the second scaffolds are absorbable, they progressively dissolve in the body. They can be said bio-absorbable. With the implant according to the invention, the first part, i.e., the axial part, remains longer than the second part, which further decreases the long term risk of breast ptosis.

The higher rigidity and the lower absorbability of the first part with respect to the second part may be due to several characteristics of the first part and the second part, especially of the first scaffold and the second scaffold.

The higher rigidity of the first part with respect to the second part comes, at least in part, from the difference in shape between the first and the second patterns. Indeed, the geometry of the pattern influences the bending of the scaffold. The lower absorbability of the first part with respect to the second part may also come, at least in part, from the difference in shape between the first and the second patterns. For example, both patterns may comprise polygons, the second pattern polygons having fewer sides than the first pattern polygons.

The first part is preferably extending further along the axis than in any direction perpendicular.

In average, the first part is denser than the second part. The second part surrounds the first part at <NUM>°.

The first part is more rigid than the second part at least in the radial directions: a higher force is required to bend a portion of the first part than to bend an equivalent portion of the second part.

The first part is less absorbable than the second part: a longer time is required to dissolve the first part in a mammal body than to dissolve the second part in same body. In an embodiment, the first part is configured for taking <NUM> month, preferably <NUM> months, more preferably <NUM> months longer than the second part to dissolve in a mammal body. In the present application, the mammal body is preferably a human body such as a female human body.

The basis is preferably planar. After implantation, the basis is expected to be vertical or approximately vertical when the patient is standing.

The external surface of the breast implant comprises, preferably consists in, the basis and a curved external surface. The basis and the curved external surface are porous.

The implant comprises a top, located on the curved external surface. The top is the point of the curved external surface that is the furthest from the base. The top preferably corresponds to the areola of the breast.

In the frame of the present document, an axial direction is a direction parallel to the axis and a radial direction is perpendicular to the axis.

The implant is elastically deformable in a direction perpendicular to the axis.

The first and the second scaffolds are suitable for colonization by the vascular network with fat cells (differentiated cells) and their precursors (undifferentiated cells).

The first and the second scaffolds are three-dimensional structures. The first and the second scaffolds are preferably homogeneous. They may be anisotropic. The first and the second patterns are preferably three-dimensional structures.

The first scaffold is preferably a repetition of the first patterns, preferably in the three dimensions. The second scaffold is preferably a repetition of the second patterns, preferably in the three dimensions.

In an embodiment, the first and/or second pattern can be a square, a rectangle, a triangle, a polygon, a cube, a tetrahedron.

A pattern is preferably a mesh. The first (respectively second) pattern may be considered, in an embodiment of the invention, as the smallest building unit that repeats, possibly with a rotation, in three dimensions to form the first (respectively second) scaffold. A scaffold is preferably a three-dimensional meshing. A scaffold is porous.

The first scaffold is more rigid and less absorbable than the second scaffold.

If the first part comprises two or more scaffolds and/or the second part comprises two or more scaffolds, at least one of the scaffold(s) of the first part is more rigid and less absorbable than at least one of the scaffold(s) of the second part.

In an embodiment wherein the first part comprises two or more scaffolds and/or the second part comprises two or more scaffolds, it is possible that any of the scaffold(s) of the first part is more rigid and less absorbable than any of the scaffold(s) of the second part. All scaffolds are absorbable.

The first scaffold comprises a plurality of first bars and/or first plates and the second scaffold comprises a plurality of second bars. Preferably, the first scaffold consists in a plurality of first bars and/or first plates, and/or the second scaffold consists in a plurality of second bars. The first bars and/or first plates preferably form the first patterns. The second bars preferably form the second patterns. The bars are preferably straight. The plates are preferably planar. Some or all of the plates may be parallel to the axis. Some or all of the plates may be perpendicular to the axis.

The first bars and/or first plates are preferably distributed in at least three directions in order to form a three-dimensional grid. The second bars are preferably distributed in at least three directions in order to form a three-dimensional grid. In an embodiment of the invention, the second bars are distributed in only three directions. The bars and/or plates contact each other at crossings where they stick to each other.

The first and the second scaffolds are in polymer. The Young modulus of the material(s) of the first scaffold is preferably between <NUM> and <NUM> MPa, preferably between <NUM> and <NUM> MPa. The Young modulus of the material(s) of the second scaffold is preferably between <NUM> and <NUM> MPa, preferably between <NUM> and <NUM> MPa.

The axis is preferably the anteroposterior axis. The axis is preferably perpendicular to the basis. The axis extends between the basis and the curved external surface. The axis preferably extends between the basis and the top. The axis is not necessarily a symmetry axis of the breast implant.

The first end of the first part is preferably located on the basis. It preferably includes the center of the basis. The second end of the first part is preferably on the curved external surface. The second end of the first part preferably extends to the top.

The limit between the first part and the second part is a transition interface.

In an embodiment, the second scaffold comprises a plurality of second bars and.

In other words, the first scaffold is distributed in more directions than the second scaffold. This increases the rigidity of the first scaffold with respect to the second scaffold. For example, the first patterns may comprise hexagonal sides (with bars in three directions) or plates parallel to the axis, while the second patterns may comprise rhombic sides (with bars in two directions).

In an embodiment, the first scaffold comprises a plurality of first bars and/or first plates and the second scaffold comprises a plurality of second bars, a thickness of the plurality of first bars and/or the thickness of the plurality of first plates being at least <NUM>,<NUM> times a thickness of the second bars.

The first bars and/or first plates are preferably at least twice thicker than the second bars i.e., the thickness of the first bars and/or first plates are preferably at least <NUM> times the thickness of the second bars. This increases the absorbability of the second scaffold with respect to the first scaffold.

In an embodiment, the first part comprises a plurality of scaffolds, said plurality of scaffolds comprising at least once the first scaffold.

The first scaffold, with its first patterns of the first shape, may be repeated several times within the first part, the different instances of the first scaffold being spaced from each other. A volume of an instance of the first scaffold may be defined as the zone of space occupied by i.e., filled by the different instances of the first scaffold. For example, the sum of the volumes of all the instances of the first scaffold is at least <NUM>% of a volume of the first part.

In an embodiment, a volume of the first scaffold, or a sum of volumes of a plurality of scaffolds comprising at least once the first scaffold, occupies at least <NUM>% of a volume of the first part. Preferably, the volume of the first scaffold, or the sum of the volumes of the plurality of scaffolds comprising at least once the first scaffold, occupies <NUM>% of the volume of the first part. This means that at least <NUM>%, and preferably <NUM>%, of the volume of the first part is occupied by the first scaffold or by the plurality of scaffolds comprising at least once the first scaffold. Preferably, said plurality of scaffolds comprising at least once the first scaffold are all based on patterns of the first shape.

In the present document, the volume of the first part includes the material within the first part and the empty space within the first part. Similarly, the volume of the first scaffold includes the material within the first scaffold and the empty space within the first scaffold. Similarly, the volume of the first pattern includes the material within the first pattern and the empty space within the first pattern.

In the present document, the volume of the second part includes the material within the second part and the empty space within the second part. Similarly, the volume of the second scaffold includes the material within the second scaffold and the empty space within the second scaffold. Similarly, the volume of the second pattern or any other element includes the material within the second pattern or any other element, respectively and the empty space within the second pattern or any other element, respectively.

Before implanting the breast implant, the volume of an instance of the first scaffold thus comprises absorbable material of the scaffold and empty space filled for instance by air. For example, a volume filling rate of the volume of the instance of the first scaffold by the absorbable material is preferably comprised between <NUM>% and <NUM>%, typically between <NUM>% and <NUM>%.

In an embodiment, a volume of the second scaffold, or a sum of volumes of a plurality of scaffolds comprising at least once the second scaffold, occupies at least <NUM>% of a volume of the second part. Preferably, the volume of the second scaffold, or the sum of the volumes of the plurality of scaffolds comprising at least once the second scaffold, occupies <NUM>% of the volume of the second part. This means that at least <NUM>%, and preferably <NUM>%, of the volume of the second part is occupied by the volume of the second scaffold or by the sum of the volumes of the plurality of scaffolds comprising at least once the second scaffold.

In an embodiment, the first part has a horizontal radial extension that is between <NUM>% and <NUM>% of the horizontal extension of the basis. The radial extensions are measured along the basis.

In an embodiment, the second part has a lower density than the first part. In other words, the ratio between the mass and the occupied volume is higher for the first part than for the second part. This helps in decreasing the absorbability of the first part with respect to the second part.

In an embodiment, the volume of the first part is comprised between <NUM><NUM> and <NUM><NUM>, preferably between <NUM><NUM> and <NUM><NUM>. In an embodiment, the volume of the second part is comprised between <NUM><NUM> and <NUM><NUM>, preferably between <NUM><NUM> and <NUM><NUM>.

In an embodiment, a ratio of the volume of the first part to the volume of the second part is comprised between <NUM> % and <NUM> %, preferably between <NUM> % and <NUM> %.

Preferably, the second scaffold has a lower density than the first scaffold.

In an embodiment, first patterns have a lower volume than second patterns. Preferably, each of the first patterns have a lower volume than each of the second patterns. Smaller patterns help in increasing the rigidity and decreasing the absorbability.

In an embodiment, the first pattern has openings and the second pattern has openings such that the openings of the first pattern are smaller than the openings of the second pattern. The openings may for example be in a vertical plan parallel to the basis.

In an embodiment, the first patterns have a dimension between <NUM> et <NUM>. A dimension of the first patterns, which is preferably the distance between two adjacent parallel first bars and/or first plates, is preferably between <NUM> and <NUM>. Said dimension is preferably measured vertically.

In an embodiment, the second patterns have a dimension between <NUM> and <NUM>. A dimension of the second patterns, which is preferably the distance between two adjacent parallel second bars, is preferably between <NUM> and <NUM>. Said dimension is preferably measured vertically.

The dimension of the first pattern is preferably lower than the dimension of the second pattern.

In an embodiment, the first part is removable with respect to the second part. In another embodiment of the invention, the first part is not removable with respect to the second part.

In an embodiment, the breast implant is an assembly of the first part and the second part. This means that the breast implant is obtained by assembling the first part and the second part after producing them separately.

The disclosure relates also to a process to produce a breast implant using additive manufacturing to produce the first scaffold and the second scaffold. The first and the second scaffold may be printed as separated pieces, or, preferably, may be printed as a single piece. The breast implant is preferably printed as a single piece.

In an example, the additive manufacturing involves a deposition of a fused filament.

For a better understanding of the present invention, reference will now be made, by way of example, to the accompanying drawings. In the description of the drawing, the implant is supposed to be within a standing patient, as illustrated on <FIG>.

The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto. The described functions are not limited by the described structures.

The term "comprising", used in the claims, should not be interpreted as being restricted to the elements or steps listed thereafter; it does not exclude other elements or steps. It needs to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression "a device comprising A and B" should not be limited to devices consisting only of components A and B, rather with respect to the present invention, the only enumerated components of the device are A and B, and further the claim should be interpreted as including equivalents of those components.

On the figures, identical or analogous elements may be referred by a same number.

<FIG> illustrates a breast implant <NUM> according to an embodiment of the invention. The breast implant <NUM> has a basis <NUM> and an external curved surface <NUM>, with a top <NUM> opposed to the basis <NUM>. The breast implant <NUM> comprises a first part <NUM> extending along an axis <NUM>, and a second part <NUM> located around the first part <NUM>. The basis <NUM> is partially included in the first part <NUM> and partially included in the second part <NUM>. The first part <NUM> and the second part <NUM> extend from the basis <NUM> towards the external curved surface <NUM>.

The basis <NUM> is expected to be placed to be vertical on a standing patient (as illustrated on <FIG>). The axis <NUM> is preferably expected to be horizontal towards the front, i.e. perpendicular to the basis.

The curved external surface <NUM> may be a hemispheric dome (first embodiment of the invention) or an asymmetric dome (second embodiment of the invention), with the top <NUM> shifted down (corresponding to the shape of a breast hanging down). Other shapes are possible without departing from the frame of the invention.

In the first embodiment of the invention, the basis <NUM> is preferably circular or have the shape of a polygon with at least <NUM> sides. In the second embodiment of the invention, the basis <NUM> is preferably an oval.

All combination of features hereby described as being part of the first or the second embodiments of the invention are possible within the frame of the present invention.

The curved external surface <NUM> is preferably a meshing, preferably with holes <NUM> opening in all directions forward. The holes <NUM> preferably have an opening of at least <NUM> by <NUM>, preferably of at least <NUM> by <NUM>, in the first part <NUM> and in the second part <NUM>. Such a minimum dimension is preferred in order to make possible an injection from all direction forward.

The first part <NUM> is more rigid and less absorbable than the second part <NUM>. Preferably, the second part <NUM> has a lower density than the first part <NUM>.

<FIG> illustrates a possible variation of the basis <NUM> in the first embodiment of the invention. <FIG> illustrates a possible variation of the basis <NUM> in the second embodiment of the invention.

The first part <NUM> comprises a first scaffold <NUM>, which is preferably located directly around the axis <NUM>. The first scaffold <NUM> is made of first patterns <NUM>. The first part <NUM> may comprise other elements than the first scaffold <NUM>, for example it may comprise other scaffolds or absorbable non-porous parts. At least, preferably <NUM>% of the volume of the first part <NUM> is taken by the first scaffold <NUM> or a plurality of scaffolds comprising at least once the first scaffold <NUM>.

The second part <NUM> comprises a second scaffold <NUM>, which preferably radially surrounds the first part <NUM>. The second scaffold <NUM> is made of second patterns <NUM>. The second part <NUM> may comprise other elements than the second scaffold <NUM>, for example it may comprise other scaffolds or absorbable non-porous parts. At least, preferably <NUM>% of the volume of the second part <NUM> is taken by the second scaffold <NUM> or a plurality of scaffolds comprising at least once the second scaffold <NUM>.

The first scaffold <NUM> preferably comprises a plurality of first bars <NUM> and/or first plates <NUM> (visible at <FIG>) and the second scaffold <NUM> comprises a plurality of second bars <NUM>. The first bars <NUM> and/or first plates <NUM> preferably have a thickness <NUM> (illustrated at <FIG> ) that is at least <NUM>,<NUM> times the thickness of the second bars <NUM>. The first bars <NUM> and/or first plates <NUM> more preferably have a thickness <NUM> (illustrated at <FIG> ) that is at least between <NUM>,<NUM> and <NUM>,<NUM> times the thickness of the second bars <NUM>.

The first bars <NUM> and/or first plates <NUM> may have a thickness <NUM> (illustrated at <FIG>) between <NUM>,<NUM> and <NUM>,<NUM>, preferably between <NUM>,<NUM> and <NUM>,<NUM>. The first scaffold <NUM> may comprise first bars <NUM> of several thicknesses <NUM>. Two first bars <NUM> may be next to each other to form a thicker first bar.

The second bars <NUM> may have a thickness between <NUM>,<NUM> and <NUM>,<NUM>, preferably between <NUM>,<NUM> and <NUM>,<NUM>. The second scaffold <NUM> may comprise second bars <NUM> of several thicknesses, for example <NUM>,<NUM> and <NUM>,<NUM>. Two second bars <NUM> of <NUM>,<NUM> may be next to each other to form a second bar <NUM> of <NUM>,<NUM> by <NUM>,<NUM>.

The first patterns <NUM> have a first shape and the second patterns <NUM> have a second shape, which is different from the first shape. The second patterns <NUM> are not the same as the first patterns with a different size or with a different size of the bars <NUM>, <NUM>: the second shape in itself is different than the first shape. For example, as illustrated in <FIG>, the number of directions of the first bars <NUM> within the first pattern <NUM> may be higher than the number of directions of the second bars <NUM> within the second pattern <NUM>.

The implant <NUM> has a higher tip <NUM>, located at the higher junction between the basis <NUM> and the curved external surface <NUM>. The implant <NUM> has a lower tip <NUM>, located at the lower junction between the basis <NUM> and the curved external surface <NUM>. The higher tip <NUM> and the lower tip <NUM> are preferably vertically aligned. The vertical extension of the basis <NUM>, between the lower tip <NUM> and the higher tip <NUM>, may be lower, equal or higher than the horizontal extension of the basis <NUM>, perpendicular to the vertical extension <NUM>. The vertical extension of the first part <NUM>, measured along the basis <NUM>, may be lower, equal or higher than the horizontal extension of the first part <NUM>, measured along the basis <NUM> and perpendicular to the vertical extension <NUM>. The horizontal extension of the basis <NUM> is preferably <NUM>,<NUM> to <NUM>,<NUM> times the horizontal extension of the first part <NUM>.

The vertical extension of the basis <NUM> is preferably in the range between <NUM> and <NUM>. The horizontal extension of the basis <NUM> is preferably in the range between <NUM> and <NUM>.

The interface between the first part <NUM> and the second part <NUM> is a transition interface <NUM>. The transition interface <NUM> is preferably a cylinder, for example a cylinder with a square basis, a rectangular basis or a circular basis. However, the transition interface <NUM> may have another shape, for example a conical shape, without departing from the scope of the present invention. The first part <NUM> may be, or not, removable with respect to the second part <NUM>. The first part <NUM> may be engaged in a hole of the second part <NUM>. For example, the breast implant may be an assembly of the first and second parts. In this case, the first part <NUM> and the second part <NUM> may be produced separately and assembled afterwards.

<FIG> illustrates a possible variation of the curved external surface <NUM> in the first embodiment of the invention. <FIG> illustrates a possible variation of the curved external surface <NUM> in the second embodiment of the invention.

<FIG> illustrates a possible variation of the implant <NUM> in the first embodiment of the invention. <FIG> illustrates a possible variation of the implant <NUM> in the second embodiment of the invention. These figures illustrate in particular crossings <NUM> between first bars <NUM> and crossings <NUM> between second bars <NUM>. In the invention, it is preferred that the first bars <NUM> stick to each other at the crossings <NUM>, and the second bars <NUM> stick to each other at the crossings <NUM>.

The distance between the basis <NUM> and the top <NUM> is preferably in the range between <NUM> and <NUM>. The arc distance <NUM> (<FIG>) in the second embodiment is preferably in the range between <NUM> and <NUM>.

<FIG> illustrate two exemplary embodiments of the first pattern <NUM>. <FIG> illustrate two exemplary embodiments of the second pattern <NUM>. Arrow <NUM> indicates a direction parallel to the axis <NUM>. In <FIG>, <FIG>, the bars <NUM>, <NUM> are illustrated as lines for the sake of illustration, but they have a thickness of course. The thickness <NUM> of a first bar <NUM> is illustrated at <FIG>. The first plates <NUM>, which are preferably perforated with holes <NUM>, are also illustrated at <FIG>.

The first pattern <NUM> may have different shapes. It may include a hexagon (<FIG>) or a star (<FIG>), preferably in a plan perpendicular to the axis <NUM>. The second pattern <NUM> may have different shapes. It may include a rhombus (<FIG>) or a hexagon (<FIG>), preferably in a plan perpendicular to the axis <NUM>.

The first pattern <NUM> has a dimension <NUM>, which is the distance between two parallel bars, for example taken vertically, that is preferably between <NUM> and <NUM>. The second pattern <NUM> has a dimension <NUM>, which is the distance between two parallel bars, for example taken vertically, that is preferably between <NUM> and <NUM>.

The first pattern <NUM> has preferably a lower volume than the second pattern <NUM>.

The first pattern <NUM> has preferably an opening <NUM> in a plan perpendicular to the axis <NUM>. The second pattern <NUM> has preferably an opening <NUM> in a plan perpendicular to the axis <NUM>. The area of the opening <NUM> of the first pattern <NUM> is preferably lower than the area of the opening <NUM> of the second pattern <NUM>.

Since the shape of the first <NUM> and second <NUM> patterns are different, the first pattern <NUM> of <FIG> may combine with the second pattern <NUM> of <FIG>, but not with the second pattern of <FIG>. The first pattern <NUM> of <FIG> may combine with the second pattern <NUM> of <FIG>.

<FIG> illustrates a possible variation of an implant <NUM> according to the invention. The first part <NUM> comprises a plurality of scaffolds. The plurality of scaffolds comprises several times the first scaffold <NUM> and several times a third scaffold <NUM>. The third scaffold <NUM> may be identical to the second scaffold <NUM>.

<FIG> illustrates the position of the breast implant <NUM> within a patient body.

The first and the second parts may be in the same material or in different materials. The first and/or second scaffold may be for example in any or in several of the following materials: Polydioxanone; Poly(caprolactone) and Poly(L-lactide-co-glycolide); Poly(L-lactide); Poly(L-lactide-co-D, L-Lactide); Poly(D,L-lactide); Poly(L-lactide-co-ε-caprolactone) in various ratios (for example <NUM> :<NUM>); PEG with Poly(L-lactide) or Poly(L-lactide-co-D, L-lactide ; Poly(glycolide-co-trimethylene carbonate); Poly(glycolide); Poly(glycolide-co-L-lactide).

The implant <NUM>, or at least one of the first <NUM> and second <NUM> scaffolds, is preferably produced by additive manufacturing, for example by a process of deposition of a fused filament.

In other words, the disclosure relates to a breast implant <NUM> and to a process to produce at least part of it by additive manufacturing. The breast implant <NUM> includes a first part <NUM>, more rigid, along an axis <NUM>, and a second part <NUM>, more resorbable, around the first part <NUM>. The implant <NUM> is bio-absorbable and elastically deformable in a direction perpendicular to the axis <NUM>. The implant <NUM> is suitable for colonization by the vascular network with fat cells (differentiated cells) and their precursors (undifferentiated cells).

Although the present invention has been described above with respect to particular embodiments, it will readily be appreciated that other embodiments are also possible. In particular, examples are not limiting and that equivalents could be envisaged without departing from the essence of the invention. The functions are not limited by the structures provided in the present document.

Claim 1:
Breast implant (<NUM>) comprising:
∘ a first part (<NUM>) extending, from a basis (<NUM>), along an axis (<NUM>) and comprising a first scaffold (<NUM>), the first scaffold (<NUM>) being absorbable and being made of first patterns (<NUM>) of a first shape,
∘ a second part (<NUM>) radially surrounding the first part (<NUM>) and comprising a second scaffold (<NUM>), the second scaffold (<NUM>) being absorbable and being made of second patterns (<NUM>) of a second shape, the second shape being different from the first shape,
wherein the first part (<NUM>) is more rigid than the second part (<NUM>), and characterized in that the first part (<NUM>) is less absorbable than the second part (<NUM>) such that a longer time is required to dissolve the first part (<NUM>) in a mammal body than to dissolve the second part (<NUM>) in same mammal body.