FIELD OF THE INVENTION

The present invention concerns improvements made to stem cell activators advantageously, but not exclusively, of the portable type.

BACKGROUND OF THE INVENTION

Stem cell activators that are suitable to treat adipose tissue in order to release the stem cells contained therein are known.

In recent years, in fact, it has been discovered that adipose tissue, especially the abdominal one, but not only, is much richer in stem cells than bone marrow; furthermore, the removal of stem cells from adipose tissue is much simpler and less invasive than other methods used.

However, once the adipose tissue is recovered, it has to be treated appropriately in order to release the stem ceils that are trapped inside the fat.

In this regard, activator devices are known that, through a specific washing operation, remove additional components such as oils or blood incorporated in the fat, allowing the stem cells to be recovered.

The present invention concerns improvements to the activator devices with which a bag cooperates, which has suitable inlets and outlets, inside which there is disposed a temporary container of the agglomerated material to be treated.

The support structure, according to a variant, can also be box-shaped and have a window that, during use, is positioned aligned with the temporary container, or with a part of it.

According to some variants, machines can also be provided that work simultaneously on two or more bags in which homogeneous or differentiated materials to be treated are present.

Said temporary container, present in the bag, has at least part of the walls equipped with apertures, or calibrated holes, consistent with the selective needs that the material to be treated presents.

The apertures, or calibrated holes, are such as to allow the escape of oils, blood or other substances that can be incorporated into the adipose tissue and at the same time retain the adipose cells and stem cells. In the bags there are currently suitable conduits that allow to introduce a diluting liquid and discharge it together with the impurities obtained from washing the adipose cells. In addition, other conduits directly connected to the temporary filtering container allow, respectively, to feed an agglomerated assembly of fat and stem cells and remove the fat and stem cells in fluidized form.

The fat and stem cells in fluidized form can be re-emitted into the human body from which they were taken.

The selection of the adipose cells and stem cells occurs by mechanical action. A suitable manual, or mechanized, spatula is made to slide on the bag, exerting an alternating and/or variable pressure on the temporary filtering container, said action decomposes the fat agglomerates contained therein, so as to make them fluid, thus releasing the stem cells.

However, this method has limitations in terms of at least time, and sometimes quality of results, because not all available adipose tissues have the same characteristics, and in particular not all allow to easily release the stem cells with the desired characteristics.

The present invention therefore concerns methods that provide a support structure that can at least partly contain and advantageously presents means for positioning the bag that, in turn, contains and positions, possibly entirely internally, a temporary container containing the agglomerate of fat and stem cells.

The support structure is advantageously equipped with means to at least position, or possibly house, the usual inlet channels of the agglomerated material and the diluting liquid, as well as channels for removing the stem cells and the diluting liquid used.

The temporary container of the fat agglomerate normally provides an inlet channel through which the agglomerate is introduced into the chamber itself, at least one inlet channel of the diluting liquid, and at least one outlet channel for removing the stem cells when the cycle/process is finished.

As mentioned, this temporary container has at least part of the walls with suitable holes having a caliber defined on each occasion. The temporary container is at least partly inserted in the bag which defines a watertight chamber, which is provided with a discharge conduit through which the diluting liquid used, together with the fat cells, is discharged. To facilitate the dissolution, or the crushing, of the fat, spatula means are used, manual or mechanized, which exert the desired pressure on at least one of the walls of the bag, or of the chamber containing the fat agglomerate, facilitating the crushing and therefore the escape of the stem cells.

The present invention therefore aims to improve the mechanical action of the spatula, or of an equivalent mean thereof, or of what is employed to act mechanically on the fat.

In the state of the art, the chamber in which the fat agglomerate containing the stem cells is present, during the spatulating action, rests on a flat wall.

This flat wall is provided in the support structure that temporarily positions and retains the bag.

In the state of the art, this operation is long because the fat is normally compact, and it is not easy to crush and/or dissolve it to the level where the stem cells are free.

The present invention therefore aims to improve the process of crushing and fluidization of the fat by speeding up the operation.

One purpose of the present invention is to develop an improved selector device that allows to crush and fluidize the fat in a more effective and efficient manner compared to traditional solutions.

Another purpose of the invention is to provide a versatile selector device, which can be adapted and modified easily and quickly in relation to specific requirements, possibly also in relation to the type of fat to be treated.

Another purpose of the invention is also to provide a selector device that allows to perform different types of crushing and fluidization actions.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims. The dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

In accordance with the above purposes, in a new and original way, also achieving considerable advantages compared to the state of the prior art, there is provided an activator device for an agglomerated material according to the present invention, in particular an agglomerated material formed by fat and stem cells.

The present description focuses on the manual use of these tools; however, it is within the spirit of the invention to extend to mechanized systems in which the bags, even with different contents, are worked in battery although, possibly, in a customized manner in order to achieve specific required results.

The activator device according to the invention comprises a support structure suitable to support and position a bag which in turn contains a filtering container inside which the agglomerated material to be separated is present. The bag comprises a lower wall and respective inlets and outlets of the bag and the filtering container, and the filtering container, at least in the step of treating the agglomerated material, cooperates with spatula means or similar.

Preferably, but not necessarily, the activator device is of the portable type and has reduced sizes in terms of width, length and thickness, such that it can advantageously be used by one user.

According to some variants, machines can also be provided that work simultaneously on two or more bags in which there are homogeneous or differentiated materials to be treated.

It is in the spirit of the invention for it to be applied to mechanized systems suitable to simultaneously treat two or more bags, the bags containing homogeneous adipose material, or of two or more different origins, obtaining dimensionally homogeneous stem cells or ones of variable sizes.

If the invention is used for battery systems, each battery will be equipped to receive its own bag and to operate on it.

Furthermore, in the case of battery use, the adjustments will be consistent with the needs of the material present in the specific bag.

The filtering container is provided with at least one wall which acts as a filter and which has apertures ranging from 30 to 500 micrometers, generally around 40- 60 micrometers, such as to allow oils, blood or other substances which may be trapped in the fat cell agglomerates to pass through them, and at the same time retain the fat cells and stem cells which are larger in size.

In accordance with one aspect of the invention, the support structure, whether it is mobile or fixed, of the activator device comprises a contrast surface provided with superficial deformations and disposed at least temporarily to cooperate with an extended wall of the filtering container opposite the wall on which the spatula means operate.

Preferably, the bag and the filtering container have a plan extension greater than their thickness, and comprise respective extended opposing walls directly or indirectly connected to each other in correspondence with the respective edges not affected by the inlets and outlets.

The support structure can comprise a lower wall which, during use, is positioned underneath the bag.

According to possible embodiments, the support structure also comprises an opposite upper wall, which is provided with a window through which it is possible to exert an action on the filtering container by means of a spatula, or whatever is used for this purpose, in order to crush the fat to the desired value.

The Applicant has verified that, if the contrast surface on which the filtering container containing the agglomerated material to be separated rests presents deformations, or surface variations, the working times are reduced, and the qualitative results improved.

The deformations, or surface variations, can have a height compatible with 0.2 up to around 2 mm.

According to the invention, if, at least temporarily during the action of breaking the fat containing the stem cells, the contrast surface on which the filtering container rests presents surface deformations, in particular one or more even random series of extensions or depressions which operate in contrast to the action of the spatula, the result of the crushing and fluidization is obtained in a shorter time and normally with better results.

Moreover, this mode of crushing the agglomerated material allows to crush the fat without ruining or damaging the stem cells present therein.

The fluidized material resulting from this operation contains fat cells and stem cells substantially in the same percentages as the starting agglomerated material; however, since it is in fluid form, it can be injected into the body of a patient even in areas different from those in which it was taken, since it is possible to use very thin needles.

The deformations, whether extensions or depressions, can all have the same characteristics of shapes or sizes, or be different in height, extension and/or shape.

The deformations, whether vertical and/or depressions, create temporary actions of constriction and/or compression and/or deformation which facilitate, improve and anticipate the action of disintegrating the fat, facilitating both its dilution and also the exit of the stem cells.

In addition, the spatula can present at least the surface which cooperates with the part of the bag, according to the action desired and/or type of fat, which can be at least partly elastic, either in a direction that is orthogonal to the axis or, or also, perpendicular, that is, it can present a zone elasticity.

The conformation of the contrast surface, being also in relation to the spatula and/or the characteristics of the fat, can present surface deformations according to a continuity, or a random distribution or in zones.

The deformations can be totally or partly bubble-shaped, recessed-shaped, and/or with a conformation that is linear, curved, cylindrical, oval, etc. There may be specific deformations depending on the type and origin of the fat containing the stem cells (human, horse, dog, etc.).

The deformations can be fixed below the filtering container inside which the fat agglomerate is present, or temporally positionable or positioned below the filtering container.

Moreover, the deformations can be positioned in specific zones below the filtering container, or be distributed in such a way as to operate on the entire surface of the filtering container.

They can also be characteristic for a specific type of fat (human, male and/or female, animal, class of animal, etc.).

According to a variant, instead of the extensions, holes can be provided, variously positioned and with any preferred shapes, with orthogonal edges, or connected, flared, etc.

According to the invention, the spatula can be moved by hand, or mechanically, for example in the case of batteries of selectors.

In the case of mechanized drive, different drive regimes can be provided.

According to the invention, the filtering container has at least one wall provided with calibrated apertures or holes, with sizes comprised between 30 and 500 micrometers, preferably between 30 and 150 micrometers, and the deformations are disposed at least below the zone occupied by the perforated wall.

According to the invention, the contrast surface, that is, the contrast surface provided with extensions and/or deformations, can be part of a sliding and/or replaceable wall.

According to some variants, the contrast surface, in its various and possible forms in relation to the type of fat (human, male and/or female, animal, etc.) can be connected for example with a mobile wall, preferably of the sliding type, or of the applicable and/or replaceable type, or with other equipment, or with a flat surface.

The present invention also concerns a method for the selection of an agglomerated material comprising:

- positioning a bag, in which, advantageously although not necessarily, the agglomerated material comprising an indistinct assembly of fat and stem cells has already been fed, on a support structure;

- feeding a diluting fluid at least into the filtering container;

- exerting a desired pressure on the bag and in particular on the filtering container by means of spatula means, the aim of this action being to press the agglomerated material so that it cooperates with deformations of a contrast surface, the aim of this action being to crush and fluidize the agglomerated material in order to release the stem cells;

- recovering the material containing the stem cells through a first outlet connected to the filtering container;

- recovering the diluting liquid through a second outlet.

DESCRIPTION OF THE DRAWINGS

These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 is a three-dimensional view of a single selector device according to the present invention in a condition of use;

- fig. 2 is an exploded view of the components of the selector device of fig. 1 and a chamber containing a fat-stem cell assembly;

- fig. 3 is a top view of the selector device of fig. 1 in which the upper covering element has been removed to make the interior visible; - fig. 4 is a section view of the selector device of fig. 1 taken along the plane n of fig. i;

- fig. 5 is a section view of a selector device according to the invention in accordance with a variant;

- the pairs of figs. 6a/6b-9a/9b shown some examples of a contrast surface of a selector device according to the invention in top and lateral views, respectively.

We must clarify that the phraseology and terminology used in the present description, as well as the figures in the attached drawings also in relation as to how described, have the sole function of better illustrating and explaining the present invention, their purpose being to provide a non-limiting example of the invention itself, since the scope of protection is defined by the claims.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can be conveniently combined or incorporated into other embodiments without further clarifications. DESCRIPTION OF SOME EMBODIMENTS OF THE PRESENT INVENTION

With reference to fig. 1, a single selector device 10 according to the present invention is described, which can be used to operate on a bag 11 for containing an agglomerated material M to be separated, in order to subject this material to crushing and fluidization.

It is in the spirit of the invention to provide the mechanization of the single selector device 10, or the creation of batteries of said selectors 10. According to the invention, in the case of batteries of selectors 11 , the individual batteries can be made to operate with the same parameters, that is, customized according to the type of fat to be treated and the result desired.

In particular, the selector device 10 according to the invention is suitable to be used to crush adipose cells, for example of human or animal fat, in order to release the stem cells incorporated therein, obtaining a fluidized material, and allow their recovery.

The selector device 10 is in particular suitable to be used in combination with a bag 11 delimiting a chamber 14 containing inside it a filtering container 12, inside which the agglomerated material M is present, in particular an assembly of fat and stem cells. The filtering container 12 is at least partly made as a filter 13 whose sizes and characteristics are such as to retain the stem cells inside it, while simultaneously allowing the outward passage of fat or other substances.

By way of example, the filter 13 has holes with sizes comprised between 30 and 500 micrometers, preferably between 30 and 150 micrometers.

The bag 11 comprises a first inlet 15 for the material to be treated and a second inlet 16 for a diluting fluid, suitable to facilitate the separation between fat and stem cells. Both inlets communicate with the interior of the filtering container 12.

The bag 11 also comprises a first outlet 17 for the fluidized material containing the stem cells, communicating with the filtering container 12, and a second outlet 18 communicating with the chamber 14 outside the filtering container 12, through which the diluting liquid can be discharged together with oils, blood or other substances derived from washing the fat.

In correspondence with the inlets 15, 16 and the outlets 17, 18, respective connector elements 20 can be provided to which respective feed conduits 21 , 22 can be connected in order to respectively feed the assembly of fat and stem cells and the diluting liquid, and evacuation conduits 23, 24 of the fluidized material containing the adipose cells and stem cells, and of the diluting liquid itself.

The selector device 10 comprises a support structure 25 suitable to position the bag 11 in order to keep it stable during the operations of separating the agglomerated material.

The bag 11 comprises a lower wall I la which, during use, comes into contact with a contrast surface 33, as will be better explained below.

According to a first embodiment described with reference to figs. 1-5, the support structure 25 comprises a lower wall 26 which, during use, is positioned below the bag 11.

According to a first embodiment described with reference to figs. 1-4, the support structure 25 also comprises an upper wall 27, opposite the lower wall 26, which is provided with a window 28 made through.

According to a variant shown with reference to fig. 5, the support structure 25 comprises only the lower wall 26.

The support structure 25 also comprises a lateral wall 26a for containing the bag 11. According to some embodiments, the support structure 25 can be provided, in addition or alternatively to the lateral wall 26a, with first coupling members 19a configured to cooperate with mating second coupling members 19b provided on the bag 11 , in order to obtain a stable connection between the two components, for example by same-shape coupling. The first coupling members 19a are preferably provided on the lower wall 26.

During use, either directly or through the window 28, a user can exert an action that squeezes the bag by means of a suitable spatula 29, or other suitable instrument.

Preferably, the spatula 29 has a gripping portion 31 which can have a rectangular shape, or preferably shaped to facilitate the grip by a user’s hand 30, and an operating potion 32 connected to the gripping portion 31 and able to act on the bag 1 1.

According to some embodiments, the operating portion 32 can have a substantially rectilinear and thin end, suitable to exert a punctual action on the bag 11 increasing the efficiency of crushing the assembly of fat and stem cells.

The spatula 29 can have a surface that, according to the desired action, can be at least partly elastic, that is, it can present a zone elasticity.

Preferably, the longitudinal extension of the end of the operating portion 32 can be substantially equal to the width of the window 28, if present, whereby the edges of the latter can act as guide elements.

According to one aspect of the invention, the selector device 10 comprises a contrast surface 33 provided with deformations 34, or surface variations, and able to cooperate at least temporarily with a lower surface of the bag 11 in correspondence with the area affected by the filtering container 12.

According to some embodiments, the deformations 34 occupy the entire contrast surface 33, or specific zones of the contrast structure 33 where the filtering container 12 is positioned, during use.

According to some embodiments, in plan view the contrast surface 33 has an extension substantially corresponding to the extension of the filtering container 12.

In accordance with one aspect of the present invention, during use the contrast surface 33 is positioned in contact with the lower wall I la of the bag 1 1 in correspondence with the extended wall of the filtering container 12 opposite the wall on which the spatula 29 operates.

In this way, when the spatula 29 is pressed on the bag 11 and on the filtering container 12 so as to crush the adipose substances, thus releasing the stem cells enclosed therein, the pressure on the particles is increased in correspondence with the deformations 34, and therefore the effectiveness of the treatment also consequently increases.

According to a first embodiment, for example described with reference to figs. 1-5, the contrast surface 33 is made on a mobile wall 35 that can be inserted inside the support structure 25 when necessary, and subsequently removed.

For example, the support structure 25 can be sized in such a way as to allow the positioning of the mobile wall 35 and the bag 11 inside it.

The mobile wall 35 can, for example, be positioned in contact with the lower wall 26 and subsequently the bag 11 can be placed resting on the mobile wall 35.

According to other variants, the mobile wall 35 itself can act as a support structure for the bag 1 1.

Advantageously, according to the embodiment of figs. 1-4, a slit 37 can be provided on a lateral wall 36 of the support structure 25, and the mobile wall 35 can be inserted and extracted from the support structure 25 like a drawer.

In this case, the mobile wall 35 can be provided with a gripping element 38 which, during use, remains external to the support structure 25 in such a way as to allow a user to easily grasp it to extract it.

According to this embodiment, alignment members 39 configured to cooperate with the mobile wall 35 in order to guarantee a correct alignment and positioning thereof can be provided on the lower wall 26.

According to some variants, the mobile wall 35 with the contrast surface 33 can be positioned in the support structure 25 with an insertion/extraction movement in a vertical direction.

According to another variant, not shown, the contrast surface 33 can be directly made on the lower wall 26.

Advantageously, the support structure 25 has respective through apertures 40, 41, 42, 43 which, during use, align with the inlets 15, 16 and the outlets 17, 18 of the bag 11, allowing the passage of the feed and evacuation conduits 21, 22, 23, 24. According to the embodiment shown in fig. 5, the support structure 25 can consist only of a lower half-shell 45.

According to the embodiments shown in figs. 1-4, the support structure 25 can be formed by a lower half-shell 45 and by an upper half-shell 46, which are configured to be coupled and connected to each other by means of respective coupling members 47, 48, preferably of the interlocking type.

In this case, the slit 37 and/or the through apertures 40-43 can be completely made on only one of the two half-shells, for example on the lower half-shell 45, or partly on each of the half-shells 45, 46.

According to some embodiments, the filtering container 12 is offset laterally with respect to a longitudinal axis X of the bag 11 and of the support structure 25, consequently the apertures 40-43 on the latter are also offset laterally.

In the case of the mobile wall 36, the deformations 34 can be provided on its entire extension, preferably only on the contrast surface 33 that is positioned in the area affected by the filtering container 12.

According to some embodiments, the deformations 34 can be made as extensions, that is, protruding with respect to a base surface 49, or as depressions, that is, recessed in the base surface 49. The deformations 34 in the form of extensions are however preferred, because they allow to progressively reduce the space between the edge of the operating portion 32 of the spatula 29 and the top of the deformations 34.

According to some embodiments, the surface deformations 34 can have a height, or depth, comprised between 0.2 and 2 mm.

The deformations 34, whether extensions or depressions, can all have the same characteristics of shapes or sizes, or differ in height, extension and/or shape.

According to some embodiments, it can also be provided that the contrast surface 33 has zones with deformations 34 that differ from each other in height, extension, shape, or even number density.

The conformation of the contrast surface 33 can present the surface deformations 34 according to a continuity, or according to a distribution in zones, also in relation to the spatula 29 that is used and/or to the characteristics of the adipose tissue to be treated, for example its human or animal origin, or the type of tissue itself, for example abdominal or other. The deformations 34 can have a totally or partly bubble-shaped conformation, as for example shown in figs, from 1 to 6, or even different, for example linear, curved, cylindrical, oval, etc.

There can also be provided deformations 34 with a specific conformation in relation to the type and origin of the adipose tissue containing the stem cells (human, horse, dog, etc.).

Figs. 6a, b - 9a, b show some examples of distribution and conformation of the deformations, respectively in a top view and in section.

Figs. 6a, b and 7a, b show deformations 34 with a bubble-shaped conformation, protruding with respect to the base surface 49, respectively ordered according to a matrix pattern and aligned on lines that are inclined with respect to the direction D of feed of the agglomerated material M.

Figs. 8a, b show deformations 34 with a polygonal conformation, in particular made as elongated elements with a trapezoidal geometric section, protruding with respect to the base surface 49.

Figs. 9a, b show deformations 34 with a polygonal conformation, in particular made as pointed elements having a substantially rectangular extension, with a trapezoidal section.

According to some embodiments, the deformations 34 can be disposed in a coordinated manner according to a predefined pattern ordered in a uniform manner.

According to other variants, the deformations 34 have a non-uniform distribution.

According to other variants, the deformations 34 have homogeneous shapes with respect to each other.

According to other variants, the deformations 34 have coordinated shapes, for example round, oval, polygonal.

According to other variants, the deformations 34 have different shapes associated in a random manner. In other words, combinations of lines, points or other types of deformations 34 can be provided, possibly distributed homogeneously or even non-homogeneously, so as to give differentiated contrast actions on the material to be treated.

According to other variants, the deformations 34 have random and different shapes from each other, according to a non-uniform distribution. It is clear, however, that deformations 34 with a different shape can also be provided. Moreover, it can also be provided that the deformations 34 on a same contrast surface 33 may vary in shape, height or density.

This can allow to define two or more different operating zones, possibly both accessible from the window 28, if present, for example suitable to perform respectively a coarse first treatment step and a finer second treatment step.

According to a variant, not shown, instead of the deformations 34, holes can be provided, variously positioned and with preferred shapes, with orthogonal, that is, connected edges. If the holes are provided, at the end of the first breaking step, or at the end of the fat disposal step, these can be closed for possible final passes of the spatula, or the contrast surface 33, if mobile, can be removed.

The present invention also concerns a selection kit 50 comprising a selector device 10 having at least one bag 11 containing the agglomerated material M to be treated, insertable or inserted in the support structure 25, and at least one spatula 29 or other similar instrument.

According to some embodiments, the selection kit 50 can comprise a plurality of mobile walls 36, each provided with its own contrast surface 33, wherein the deformations 34 on the respective contrast surfaces 33 differ according to at least one of either shape, size or density.

The operation of the support device 10 described heretofore, which corresponds to a selection method according to the present invention, comprises:

- positioning a bag 11 in the support structure 25 with the filtering container 12 positioned above the contrast surface 33;

- feeding the agglomerated material M comprising an assembly of fat and stem cells and a diluting fluid into the filtering container 12 through respective inlets 15, 16;

- exerting a pressure on the bag 1 1, and in particular on the filtering container 12, by means of a spatula 29 disposed made through, through the window, in order to press the agglomerated material M against the deformations 34 of the contrast surface 33 and crush the aforementioned agglomerated material, separating fat and stem cells from each other;

- recovering the crushed and fluidized material containing the stem cells through a first outlet 17; - recovering the diluting liquid through a second outlet.

According to some embodiments, the method can also provide to introduce the agglomerated material and/or the diluting fluid into the bag 11, or into the filtering container 12, before inserting the bag 11 into the support structure 25.

In particular, the method provides to exert a pressure by pressing the operating portion 32 of the spatula 29 on the bag 11, while at the same time making it slide in a direction parallel to the direction of feed of the agglomerated material M.

According to other embodiments, the method can also provide to carry out a first treatment step using a first contrast surface 33 provided with its own deformations 34, and subsequently remove the first contrast surface 33 to carry out a second treatment step.

In particular, the second treatment step can be carried out by operating directly on the lower wall 26 or on a second contrast surface 33 provided with deformations 34 that differ according to at least one of either shape, size or density with respect to the first contrast surface 33.

It is clear that modifications and/or additions of parts may be made to the selector device 10, to the selection kit 50 and method as described heretofore, without departing from the field and scope of the present invention, as defined by the claims.

It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art will be able to achieve other equivalent forms of selector device 10, selection kit 50 and method, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

In the following claims, the sole purpose of the references in brackets is to facilitate their reading and they must not be considered as restrictive factors with regard to the field of protection defined by the claims.