transplantation from a lobular fat extracted by liposuction

专利摘要:
TRANSPLANTATION FROM LOBULAR FAT EXTRACTED BY LIPOSUCTION. Device and method for preparing an adipose tissue for transplantation from lobular fat extracted, for example, by suction, such fat consisting of a fluid component comprising an oily component, a blood component and or sterile solutions and a solid component comprising fragments cells, cells and one or more macro-agglomerated cells of heterogeneous size, where such a device consists of at least one separation and washing container (1) having a washing chamber (101) to wash the liposugated material to enter the washing chamber ( 101) through an outlet (103), such a washing chamber (101) including means for forming an emulsion of fluid components. A method of treating the volume of bodily and facial deficiencies, improving skin trophism and / or for biological simulation by the adipose tissue obtained through such a device and method, whose tissue is compatible for use as a source of cells such as chondrocytes, osteocytes , adipocytes.
公开号:BR112012029376B1
申请号:R112012029376-1
申请日:2011-05-20
公开日:2020-10-27
发明作者:Carlo Tremolada
申请人:Lipogems International S.P.A.；
IPC主号:

专利说明:

The present invention relates to a device and a method for preparing a tissue, particularly an adipose tissue, for transplantation, from a lobular fat tissue extracted by liposuction. The invention also relates to a method for treating body and skin volume deficiencies, improving skin trophism and / or for biological stimulation by adipose tissue obtained through such a device and method. The present invention also relates to an assembly for carrying out such a method.
According to the prior art, the preparation required to reuse the liposugated material involves the separation of the vital cellular component to be reinjected from waste material composed of anesthetic liquid or biological fluids (serum or blood) and debris from cells and resulting oil rupture of sucked adipocytes.
Such separation can occur inside the syringe that is used to remove, or in special containers, essentially in three ways: by resolution: materials separated by differences in density under gravity, by centrifugation: materials separated by differences in density under force effects centrifuging, by washing: the liposuction is placed in a fine mesh sieve and washed, usually with a saline solution, which can be progressively replaced or not.
According to the best known technique (Coleman lipoestructure), syringes containing the liposuction are closed at the bottom by a luer closure plug, and are placed in a centrifuge to separate the liquid phase from a solid biological material.
Before using the biological material then obtained, the anesthetic and biological liquids left in the bottom of the syringe after centrifugation must be manually drained, removing the luer closure plug from the syringe and causing them to flow out by gravity, while cell fragments and the oil resulting from the breakdown of adipocyte cell walls rest in the cell material to be transplanted and are removed in an incomplete and rudimentary way, using gauzes that partially absorb the excess oil and generally render the last part of the sucked material unusable .
The techniques described above suffer from certain drawbacks.
First, the centrifugation suction and separation step causes a considerable amount of adipocytes to break down and release a lot of oil, which cannot be completely removed with the Coleman technique, and makes a significant part of the liposugate unusable, that is, the part of cellular material which, after centrifugation, is located at the top of the syringe barrel, in contact with the oil, and is therefore contaminated by such oil.
This is because the presence of oil in the biological filler to be injected increases the risk of infection and rejection and makes inflammation high.
In addition, the process described above involves multiple contacts of the liposugated material with surfaces of various types of instruments, as well as prolonged contact with air in a potentially non-sterile environment, where use of it in an operating room is recommended.
A technique is also known, but rarely used, which involves mechanical fragmentation of the cells sucked together using a blender, whose cutting blades separate the fat lobes and provide an injectable cell suspension.
This fragmentation technique has many drawbacks.
First, the fragmentation step, which is followed by centrifugation, causes a considerable amount of adipocytes to break, which makes more than half of the liposugated material useless for future aesthetic treatment. As a direct result, a high amount of liposuction sections are required to compensate for this loss of material that occurred during the preparation of the material to be transplanted, with greater discomfort for the patient.
In addition, the amount of useful cell suspension that can be obtained using the procedure described above and the devices largely depends on the skills of the healthcare team in setting the speed and parameters of the blender and centrifuge operating time and the conditions of the instruments: an excessive rotation speed of the blades or the use, for example, of a blender with weak cutting blades, does not separate the fat lobes, but the mechanical breaking of the cell walls of a large amount of adipocytes, which involves the formation of oil and renders the cell suspension useless, in addition to requiring precise separation of cell fragments and oil from the suspension. This is because the presence of oil in the biological filler to be injected increases the risk of infections and rejections.
Furthermore, the process described above involves multiple contacts of the liposugated material with the surfaces of various types of instruments, as well as some contact with air in an environment that is not perfectly sterile, as is the case in the doctor's office. Since the material is biological in nature, extended contact with air or with multiple instruments, which may not be perfectly sterile, increases the risk of contamination by bacteria or viruses, and can impair the results of treatment. The technique that involves washing through a sieve also has certain drawbacks.
Particularly, the sieve net can easily become clogged with the liposugated material, which requires a manual action to remove the grease from the meshes, thus slowing down the preparation process and especially increasing the risk of contamination of the material to be injected.
The use of a simple sieve does not allow the liposugated material to be kept constantly in a perfectly sterile environment during the preparation process, that is, from the liposuction stage to the injection stage.
Patent documents are known for the disclosure of cell isolation devices.
International Application WO 2009/073724 discloses a method and apparatus for isolating cells from liposuction.
In particular, it discloses a method for separating the adipocyte and the oil fraction from a non-fat cell fraction in a liposuction.
In order to obtain lipids and adipocytes that float in the cell solution of interest and other smaller cells within a container defined as a “separation chamber”, the adipose tissue is placed in a digestion chamber, and forced through a filter and through a head having pores in such a "chamber".
The steps of washing the tissue, removing excess fluids, enzymatic digestion, the addition of antibiotics and cell selection can take place in a container defined as a “digestion chamber”. The digestion chamber may contain a filter that retains tissue, but allows dissociated cells and fluids to pass through. An aqueous emulsion containing adipocyte lipids is formed in this chamber.
The material dissociated in the digestion chamber can pass through a dispersion filter with pores smaller than the pores in the head of the dispersion contained in the first "separation chamber." This filter 115 is used to prevent clogging of the dispersion head pores.
In the “separation chamber”, lipids and adipocytes are separated from the cell population.
The device provides a cell population from a tissue without using the centrifuge, but forcing the solution through filters with pores of varying sizes.
Such a device is particularly complex in terms of construction, as shown in the figures.
In addition, the many passages of organic material through chambers and filters extends the duration of the method, and exposes the organic material to risks of contamination.
Also, the complexity of the method and the device makes it incompatible for use, for example, environments outside the patient, which require a quick preparation of the injectable material from the liposuction and a fast performance of the correction of defects in the face and body without the assistance of particularly specialized personnel.
Furthermore, in this method, emulsions are formed using chemicals and not just through the use of mechanical means and forces.
US Application 2007/0274960 discloses a method for preparing a composition containing a stem cell. In order to prepare the stem cell population, in certain modalities the fat-absorbed adipose tissue is physically treated, that is, cut or chopped into small pieces, and subjected to an enzymatic treatment, which facilitates the release of the cells of interest from components of other fabrics.
Therefore US 2007/0274960 allows adipose tissue to be divided into small pieces by forcing it through a series of screens, to obtain small parts of uniform sizes, which can be subjected to an enzymatic treatment in a more uniform manner, thus providing a faster release of stem cells and reducing the contact time between released cells and the enzyme solution.
According to this patent, an emulsion of adipose tissue can be prepared using a perfluorocarbon solution, whose emulsion is separable from the stem cells of interest.
The patent does not include the preparation of the liquid emulsion which can be mechanically separated from the lipid cells or small cell clusters.
The container containing the cutting means cannot also be used for the injection of fatty tissue into a patient. US Patent 6,02,196 discloses a method for collecting microvascular endothelial cells.
The patent describes a method of treating sucked adipose tissue, whose adipose tissue, sucked by a syringe with a barrel having openings of such a size to minimize stress on cellular components and to obtain homogeneous adipose tissue, is forced from a syringe to another through a filter (74) located between the suction ports of the two syringes.
By pulling the syringe pistols, the fatty tissue sucked is homogenized and forced through filters from one syringe to another.
A low viscosity of the sucked material leads to easier removal of contaminants and improves the digestion of the sample, by obtaining endothelial cells.
The method as disclosed in this patent suffers from certain drawbacks that make it incompatible for use in the preparation of an injectable fat, because: the filter can become blocked by the adipose tissue: the device holding the filter forms a restriction in the flow line of an syringe for another; the clogged filter blocks the passage of adipose tissue from one syringe to another and requires disconnecting the syringe and replacing the filter to continue washing the adipose tissue; due to these steps, the preparation of an emulsion of solid and liquid components becomes difficult and time consuming and the organic material is exposed to contamination; the passage through the filter meshes for the disintegration of the connected tissues also leads to a breakdown of the adipocytes, with the formation of excess oil and the need for a precise separation later of the intact fat cells from the oil.
US 6,020,196 provides a homogenate from which endothelial cells can be extracted with the addition of collagenase and centrifugation, therefore through the combination of chemical and physical actions. The patent does not involve the formation of an emulsion of liquid components on which lipid cells or small clumps of lipid cells obtained from a liposugated adipose tissue can float, whose cells are directly injectable, after an appropriate treatment, in a patient, without requiring particularly sterile environment conditions, for example, without requiring a perfectly sterile operating room.
US 6,020,196 does not involve the possibility of providing a single device that, through a few simple treatment steps, allows the preparation of liposugated material and the collection and temporary storage of fat, until rejection.
US patent application 2003/0100105 discloses an apparatus for extracting cells from organs. The apparatus includes a digestion chamber containing the organ and the protease, and means of agitation, such as balls having at least one cavity, whose balls only act on the organ.
Therefore, like the previous patents, this patent involves chemically aggressive treatment of organic materials.
As described in column 3, paragraph 0026, the agitation means 14 are moved with the digestion chamber 12 to agitate the organ and facilitate the release of the cells.
The patent does not involve the possibility of transplanting a lobular fat, particularly the patent involves the use of balls to shake the organ and facilitate the release of cells from such an organ.
The object of the present invention is to provide a simple and inexpensive device, capable of obviating the above disadvantages, for preparing the tissue, particularly the adipose tissue for the transplantation of a lobular fat, that is, fat composed of macro agglomerated cells, cells and fragments of cells, the fat of which is obtained by means of liposuction.
The object of the present invention is to provide a tissue for transplantation without using chemicals for the preparation, that is, without any chemical aggression or any other chemical treatment of the liposuction. This provides a user-friendly and simple device, which only uses manually applied mechanical forces, the device of which may not require screening for medical use, or only requires simple screening. The device of the present invention can also be used in medical environments outside the patient, without requiring particularly sterile conditions, such as those required in an operating room.
Another object of the present invention is a method that involves the use of such a device to prepare a tissue, particularly the adipose tissue for transplantation, such a method and device allows the biological material to be kept in a completely closed system, that is, a system that prevents any contact of the sucked patient material with the external environment.
Another object is also a method of treating deficiencies in body and face volume, improving skin trophism and / or for biological stimulation by adipose tissue obtained through such a device and method.
In particular, the device of the present invention allows for the preparation of cellular agglomerates, particularly adipocyte agglomerates, using few simple instruments and few processing steps, without using chemical or physical-chemical treatments, but only mechanical agitation, while eliminating most oily components and avoiding the handling of biological materials in an environment that is not perfectly sterile.
Thus, also due to the use of especially fine needles, transplantation of adipose tissue will be less invasive, less traumatic and more effective. In addition, the cell agglomerate transmitted by the device of the present invention is prepared with minimized contact or without contact with the external environment and using available instruments that reduce the risks of contamination of biological material, the risks of instrument deterioration and inconveniences associated with the washing and re-sterilization.
The biological material then obtained can be injected into any tissue or organ.
The aforementioned objects are filled by a device composed of at least one washing and separating container having a washing chamber to wash the liposugated material, the chamber of which has an inlet and an outlet for the liposugated material to enter the washing chamber through from the inlet and at least part of the material, particularly the fluid component, to exit such a chamber through the outlet, such a wash chamber includes means for mechanically forming an emulsion of fluid components, in which the cellular components designed to be used for a future transplant will fluctuate, separate from the liquid component.
Preferably, the tissue then prepared is used for self-transplantation, although the device can also be used for preparing the tissue for allotransplantation.
The device and method of the present invention can provide not only adipose tissue for use as a biological filler, that is, for the correction of volume deficiencies in the face and body, but also macro-agglomerate adipose tissues with stem cells on their surfaces, whose arrangement in contact with the tissue of the injection area, allows a quick regeneration of the treated tissues.
These means for mechanically forming the emulsion are able to obtain an emulsion of blood fluids, blood residues, oils and 5 other solutions (such as washing saline solutions), contained in the liposugated material, by a simple mechanical action, allowing such fluids remain separate from the solid cellular material, that is, lipid cells, stem cells.
The separation of the liquid phase to be eliminated from the solid phase 10 to be transplanted is only achieved by a mechanical (and not chemical) action.
In the preferred mode, this action is performed by means of agitation, which can be of any type, particularly the active or passive type.
Passive means are motorized agitation means, driven by a motor or a motive force to provide the agitation movement.
Passive means are means that exert their action on the agitation of the container, and that is why it operates, for example, by inertia.
The stirring means form an emulsion of liquids to be eliminated, and particularly fatty liquids, in a solvent such as a physiological washing fluid. Especially in the mode with passive stirring, the device has a simple and effective construction.
With this device, the mechanical action of the container, in combination with the passive stirring means will not be of such force as to require the use of the mechanical means. Manual agitation is sufficient in the present device.
Preferably, the mechanical stirring action consists of a rotation of the container on an axis, for example, a longitudinal axis, perpendicular to the ends of the container surfaces, and both outside and inside the container. Other types of agitation can also be provided, such as agitation or the like.
These means for forming an emulsion by simple or possibly mechanical manual agitation of the washing and separation container, without using chemicals or enzymes that can lead to the disintegration of the cellular material, provide for the separation of the solid component from the liquid component in the washing chamber, and it particularly allows the solid component, consisting of cellular fragments, cells and cellular aggregates, to float in an emulsion of liquid substances, such as blood, sterile solutions and oils transmitted from the broken fat cells. In a preferred embodiment, the solid component is washed in the washing chamber: a sterile washing solution, for example, a sterile saline, is injected once or several times into the washing and separation container through the inlet. With agitation of the container, this solution allows the cellular material for transplantation to be cleaned of any residual liquid, such as blood and oil.
The sucked fat is made up of a mixture of fluid materials and cell fragments, cells and one or more macro-agglomerates of heterogeneous sizes.
The emulsion formed on agitation, due to the presence of mechanical emulsification means in the washing chamber, is taken out of the outlet and collected in a sealed container, to prevent contamination of the external environment as well as to obtain cellular material (fragments of cells, cells, cell clusters) for transplantation, stored in the wash chamber under perfectly sterile conditions.
Then, such cellular material is taken out of the washing and separation chamber, and is injected or divided and stored, for future transplantation, in one or more sterile containers, such as syringes or similar.
Therefore, an emulsion of residual liquids is simply formed, in which cell fragments, lipid cells, micro-agglomerated lipids and stem cells float, whose fragments or cells will be ready for use without any additional treatment, particularly without any chemical treatment.
The washing and separation container will be filled with liposuction up to about 1/3 of its volume, the rest of the volume being filled with washing liquid.
There is no air in the container during material treatment.
The fat and / or the washing of the fat or treatment liquids are forced through the device of the present invention by applying pressure or suction to the contents of such washing and separation containers and / or reducing the size, that is, in the material for be treated, through the use of compression means such as syringes connected to such containers, pistols that cooperate with the openings of such containers or the like.
Therefore, the device allows the washing of the liposuction and the separation of the cell mass from the emulsion of fluid materials, such as washing solution, saline solution, anesthetic solution, blood and oil, so that a minimized amount of unwanted impurities is collected at the end of the procedure with the aggregated cells or cells, particularly adipocytes.
With the device of the present invention, the emulsion is formed by mechanical means and particularly washing, with the emulsion elimination of liquid components through a density gradient.
The device can be used to wash liposuction divided into small cells and / or agglomerates.
The techniques are known for dividing the liposugated material, for example, using a blender.
In a preferred embodiment, the liposugated material, particularly the macro-agglomerated cells are reduced to smaller sizes for easier transplantation.
According to the invention, in the washing and separating container or in another container, known as a size reduction container, which is adapted to be tightly connected to flow into such a washing and separation container, size reduction means are provided for reduce the size of the solid component of the liposuction, particularly macro-agglomerated cells, to proportionally equal smaller cell clusters, having a size equal to or less than the given value, which means to consist of at least a series of intersecting or parallel sheets or strands cutting, to form at least one size reduction network, through which the liposugated material is passed.
In a preferred embodiment, the homologation and / or reduction of the size of the liposuction takes place before washing, by means of a first size reduction network, through which the liposugated material is forced before entering the washing chamber of the container. washing and separation, and a second homologation / reduction of size occurs through a size reduction network, whose size reduction is carried out after at least one step of washing cellular material in the washing and separation container.
The second homologation / reduction in size can occur at the end of the washing steps, before the material leaves for the transplantation of the washing and separation container.
Preferably, the second size reduction network has a narrower mesh than the first size reduction network.
Obviously, the material for transplantation can be made to pass through multiple nets or downsizing means, particularly through two or more nets or downsizing means, such downsizing means possibly being provided in a single container. or in two or more connectable washing and separating containers.
The first reduction facilitates washing as it fragments or stops the fibrous component of the fat lobes and approves the size of the liposuctioned mass by the reduction in smaller agglomerates, separated from each other by the liposuctioners themselves. The second reduction provides a washed cellular material ready for transplantation, the size of which allows injection by any type of needle, even of very small sizes.
The presence of at least two means of reduction, having meshes or openings of different sizes, particularly wider meshes or openings in the network located at the liposuctioned entrance and smaller nets in the network located at the exit for material ready for transplantation, and the provision of a given distance between such two means, that is, on the final sides of the washing chamber, prevents such size reduction means from being obstructed with cellular materials, while the size reduction occurs gradually.
In addition, such a gradual reduction in the size of the liposuction allows larger needles to possibly be used during the removal of tissue from the donor areas, thus speeding up the process of collecting the material. Therefore, even when the liposugated material is composed of larger agglomerates, it still does not obstruct the openings or means of reducing the size of the device, since it is progressively reduced in smaller agglomerates, not passing through single size reduction meshes, nets or leaves , but passing sequentially through two or more size reduction means with meshes or size openings decreasing in the direction of the flow of the material to be treated.
Preferably, the cellular material is reduced to a size that allows it to be transplanted through very fine needles after the end of the washing step (s).
The use of transplantation tubes of smaller sizes particularly reduces the trauma caused by the transplantation procedure, and allows the latter to be performed under local anesthesia with no suture or particular medication and with rapid healing results.
Considering that the liposugated material also contains stem cells, the reduction in fat size provides clusters of smaller cells, particularly micro-clusters or fat cells or individual cells, with stem cells adhered to their surface. The reduction of the lipoaspirated mass in many agglomerates provides a large amount of stem cells potentially contacting the tissue to be treated by injection of material prepared by the method and the device of the present invention, while the action of reducing the size, in addition to reducing the sucked mass in many agglomerates small in size, it also causes an increase in the surface area potentially contacting the tissue to be treated, thus increasing the area exposed with the stem cells there.
The transformation of lobules of adipose tissue transmitted by liposuction into a biological filler, that is, a cell or mass suspension or an agglomerated fluid or semifluid containing adipocytes, other types of cells, such as stem or mesenchymal cells, and possible cellular fragments and residues of connective materials, whose suspension, at the end of the transformation procedure of the present application, has a solid phase composed of cells and / or aggregated cells of small, proportionally homogenized sizes, adapted to be injected in larger or smaller quantities, allows the fat prepared to be used not only for an intra or submuscular injection, but also for subcutaneous injections, without irregularities, side effects, calcifications and total reabsorption of the injected fat.
Even so, the fat material can be injected into any tissue or organ.
In addition, the separation of the fat lobules into small cells or cell clumps facilitates the graft, that is, integration of the cell mass in the tissues in which they are injected.
The division of the lobules of fat into the aggregated cells also provides an increase in the surface of the injected cell mass that contacts the tissues undergoing transplantation, thus promoting a biological stimulation of treated tissues and thus the integration of the injected cell material.
The use of a simple device, composed of few sterile components, which isolate the biological material extracted from the external environment generally during the preparation procedure, considerably reduces the risk of contamination of biological material, personnel and the environment, and thus the risk of infections or rejections during future use of cellular material.
Therefore, the device of the present invention also allows the treatment of biological material outside the operating rooms, in outpatient configurations.
The simple construction of the device and the lack of any chemical and / or enzyme treatment of the liposuction, except the washing solutions leading to the formation of emulsions, can facilitate production and sales, and can avoid, facilitate or reduce the research steps. long and costly steps taken to collect safe and effective data on new drugs or new devices to obtain authorizations for its use.
Thus, the device and method of the present invention provide a simple and quick procedure, for example, requiring a single outpatient section, for suction of fat from the patient's body, treatment of such fat, without a chemical / enzyme emulsion liposuction, and storage and / or rejection in the patient.
With the device of the present invention, having means there, particularly balls, to form an emulsion of liquids, a very short time is required to obtain the emulsion of liquids and the separation of the solid cellular material floating in such an emulsion, by manual mechanical stirring. .
The time required for the treatment of liposuction and making it compatible for use is proportionally 10 to 20 minutes; in any case, the time required to obtain the transplantable material is shorter than that required with other prior art devices or methods.
The device for storage and treatment of liposuction can also be used for the future stage of transplantation.
Otherwise, preferably, the treated material can be divided and transferred to other containers, for example, one or more 10 cc syringes, whose containers can be subjected to fixation and / or centrifugation, to separate the residual liquid / oily component from the component solid, which will then be ready for transplantation, by a subsequent transfer in one or more smaller capacity syringes.
Therefore, the device of the present invention quickly provides for the reduction of the size of the adipose tissue clusters, allowing them to be injected through very small needles, leaving no visible scar on the patient (the prepared tissue can be used for face transplantation, where none visible or large hole would be aesthetically acceptable), and separate the cell / emulsion phases, to obtain injectable cells or cell clusters having larger surfaces for the stem cells contained in the liposuction, in contact with the tissues to be treated.
The reduction in small clusters allows the activation of peripheral stem cells resting on the external surface of such clusters. The more clusters, the greater the exposed cell surface and the more peripheral stem cells potentially interacting with the treated tissues.
The method, device and assembly as described in more detail below can be used to treat not only the lipid material, but also any type of aggregate cell requiring a reduction in size and / or washing and separation of the liquid phase from the solid cell, simply by mechanical agitation.
These and other characteristics and advantages of the present invention will appear more clearly from the following descriptions of some modalities, illustrated in the attached drawings, in which: Figure 1 is a view and perspective of a washing and separation container according to an embodiment, Figure 2 is a view and perspective of a washing and sorting container according to a different embodiment. Figure 3 is a side view of the washing and sorting container. Figure 4 is a longitudinal section view of the washing and sorting container. separation, with a filter located close to the outlet, Figure 5 is a longitudinal sectional view of the washing and separation container, having: a cell reduction size network located near the entrance of the washing chamber, a second reduction network in size located near the outlet, and stirring elements in the washing chamber, Figure 6 is a perspective view of the size reduction container, Figure 7 is a longitudinally sectional view of the size reduction container having a size reduction net near the entrance and a collection chamber for the reduced size fat. Figures 8a-8d show the liposuction treatment steps taking place in the washing container and separation, Figure 9 is a longitudinal sectional view of the washing and separation container with a solid component of floating in the emulsion of the liquid components to exit through the exit of the washing chamber. Figure 10 shows the device of the present invention in the foreground, connected surgical and / or outpatient equipment. Figures 11a, 11b, 11c show a modality of a size reduction net, with an enlarged detail, Figures 13a, 13b, 13c show a mode of the washing and separation container and the closing terminal, Figure 14 shows a needle adapted for use in combination with the device, for transplanting the prepared material.
The device of the present invention provides a suspension of adipose tissue cells to be used with a biological filler, that is, a filler of natural and autologous or heterologous origin, during the face and body volume correction procedures and / or during the biological stimulation of any tissue or organ injected with such adipose material treated alone or with any other natural or synthetic filler.
Lobular fat material, that is, the macro cluster of cells, particularly adipocytes, which are treated by the device of the present invention, can be obtained by means of a liposuction procedure that involves extraction of adipose tissue from any donor area of the patient, example , subcutaneous hip, abdominal or knee areas, under local anesthesia or generally in patient definitions.
Once such adipose tissue has been treated with the device of the present invention, it can be used for self-transplantation, that is, injection into specific areas of the patient's body from which the tissue has been removed, to fill areas that, due to age, diseases, treatments, for example, radiation therapy, or past surgeries, exhibit volume deficiencies or subcutaneous fat reabsorption, with the relevant part of the body being submerged, with protruding bones and sagging skin.
The tissue treated with the device and the method of the present invention can be arranged for use in recipient patients other than the donor patient.
An exemplary liposuction procedure will now be described.
The liposuction procedure includes the preparation of anesthetic liquids, properly diluted and possibly added with vasoconstrictive adrenaline, in sterile syringes, preferably having a needle or a connecting pipe known as a leur connector, with the volume bar compatible for the surface area. of the body to be anesthetized, for example syringes of 10 to 60 cc.
Once the areas for the removal of adipose tissue have been marked and compatible disinfected, the local anesthetic liquid is injected through tubes with blunt ends available about 1 mm in diameter, preferably having a leur connector.
The patient's skin is sterilized with conventional techniques and anesthetized by a wheal. Anesthesia is obtained by introducing the anesthetic solution by gradually introducing the sterile blunt-ended disposable tube through the skin into the subcutaneous tissue to impregnate the total area with the anesthetic.
For anesthetic injection and future insertion of the needle or tube for the removal of adipose tissue, the skin can be punctured by a sterile tip needle or a sterile lanceolate blade of sufficient diameter to allow a future introduction of the withdrawal tube.
If necessary, the patient can be sedated.
Liposuction, that is, the removal of adipose tissue is performed, preferably having multiple holes with a diameter in the range of 1.2 to 3 mm. Pipes up to 6 mm in diameter can also be used.
With the device of the present invention, large diameter pipes (preferably 3 mm multiple-hole pipes) can be used for removal, allowing a rapid extraction of a large amount of adipose tissue, because the macroclusters of cells then extracted will be subjected to a reduction in size before use, as described in more detail below. In one embodiment, such a syringe, having at least a 10 cc volume, has a luer connector for connection to the available sterile pipes, whose pipes have one or more holes on their surfaces for the suction of the tissue.
Obviously, the volume of the suction syringe and the suction pipe depends on the amount of adipose tissue to be sucked, which in part depends on the volume of treated adipose tissue that is considered to be required for future filling and / or correction procedure.
The fat removal tube is preferably introduced through holes formed in the skin prior to anesthesia.
10 cc syringes are preferentially used for liposuction, as they exert adequate pressure on the tissues and allow easy handling.
There are preferably the known leur closure cap syringes 7, which are connected to a suction pipe having a corresponding leur connector, directly or with the interposition of two-way valves between the pipe and the syringe, whose valves, as those shown schematically in figure 10, they are connected by a tube or conduit 8 at the entrance 102 of the device, preferably equipped to be transferred directly through one or more steps, from the patient to the device of the invention.
Such transfer can occur in a closed system, in which the biological material never comes into contact with the external environment.
The device and method as described in the claim below uses sucked lobular fat to obtain a cell suspension with a solid phase consisting of cells, agglomerated cells having small and proportionately constant sizes, and a liquid phase free of any impurities such as blood, oil , cellular debris and anesthetic fluid.
As shown in figures 1 and 2, the device of the present invention is composed of a washing and separating container 1 having a washing chamber 101 for washing the liposugated material, whose container 1 has an inlet 102 and an outlet 103 for the material liposugated to enter the washing chamber 101 through inlet 102 and for at least part of such material, particularly for the purpose of time, first the fluid component and then the solid component, to leave such chamber 101 through outlet 103, such a washing chamber 101 including means for mechanically forming an emulsion of fluid components, particularly oil obtained from broken adipocytes, blood and / or other sterile liquid solutions.
Such emulsion forming means consist of at least one stirring element 104, such as balls or the like of different or equal sizes, to increase the emulsion of liquid components when the washing and separating container 1 is subjected to agitation. In the device of the present invention, a simple manual stirring of the device can provide for the separation of the liquid phase composed of a solid phase fluid emulsion composed of cells, cell fragments, aggregated cells.
Mechanical agitation can also obviously be provided, to stimulate at least the force exerted manually.
These stirring elements 104 can be relatively small in size compared to the washing chamber 101, because if they are too large they may not move freely in chamber 101 and may damage the cellular material contained in that chamber 101. The weight of such members stirring should also be sufficient to form a liquid emulsion without causing the cell wall to break.
These stirring members 104 can be of substantially spherical bodies, that is, having continuous rounded outer surfaces, and be hollow or solid, and can rotate and move within the chamber 10 to assist gently mixing the liquid components.
The stirring members 104 are preferably made of a sterile material contained in the washing chamber or with the injected solutions for washing the cellular material: for example, they can be made of metal, which is easy to sterilize, even at high temperatures, and prevents the brake shaking members from being deformed after a collision with each other or with the inside walls of the washing chamber 101.
The rounded surfaces of the stirring members 104 can also facilitate sterilization, as they prevent the creation of areas of debris formation or areas of bacterial proliferation in such members 104, which could prevent cleaning and maintenance of sterile conditions. Preferably, the stirring members 104 consist of balls having a given weight and size, to facilitate the mutual emulsion of liquids without causing mechanical breakage of the cell walls during manual or mechanical agitation.
The liquid emulsion is obtained due to the presence of stirring means 104 that elevate the mixing action, while gently shaking the container to obtain an emulsion of liquids, and preventing abrupt movements that can lead to cell breakage, such agitation does not involve disintegration of the alloys between the liquid components.
Stirring members 104 of any shape and material, such as glass, can obviously be used.
The washing and separating container 1 preferably has a cylindrical shape, but it can be formed in any shape and size that both can contain a given amount of fat-saturated fat and ensure optimum handling.
In a preferred embodiment, the liposuction in the washing chamber does not exceed 1/3 of the total capacity of the chamber. The remaining volume is filled with liquids.
For example, a container 1 having a volume of 10 to 3000 cc can be provided.
The preferred size is a 300 to 600 cc container, with about 100 to 250 cc of liposuction being treated there.
As shown in the figures, the washing and separating container 1 is composed of a central tubular part 111 with the washing chamber 101 formed there, and two closing terminals 112, 113 at the ends of such tubular part 111 such as plugs 112,113 or similar, the inlet 102 and the outlet 103 of the washing chamber 101 of the washing and separation container 1 consisting of a hole formed in each plug 112, 113, communicating with a connection terminal 1021, 1031 and / or shut-off valves .
Obviously, such terminals 1021, 1031 and / or such at least one inlet 102 and one outlet 103 can be designed to be closed with sterile plugs and / or to be equipped with backflow prevention means, such as one-way valves, during the injection stage and pressing the fat inside such a container 1.
For example, such input 102 and / or output 103 and / or such connection terminals 1021, 1032 can be connected to three-way valves 9 like those schematically shown in figure 10.
The fat material is injected into a washing chamber 101 of the container 1 through the opening 102 which is equipped, for example, with a leur connector 1021 and / or a three-way valve 9.
Neutral leur connectors, male and female are known, and allow the tight connection of fluid between two devices having such connectors. Leur connectors are sold, for example, by GVS, on its website WWW.avs.com. Examples of syringes with two-way valves are shown at WWW.internationalDbi.it.
At least one filter 4 can be provided in the washing chamber 101 of the washing and separating container 1 near outlet 103 which allows the fluid component and / or the solid fat component to pass through and retains the stirring elements 104 in the cleaning chamber. wash 101.
In a variant embodiment of the present invention, such filter 4 may consist of a selectively permeable membrane that allows at least part of the liquid phase to pass through, consisting of an oily component, a blood component, sterile solutions such as anesthetic liquid and / or saline and retains the solid phase, consisting of cell fragments, all cells and cell clusters, thus allowing the separation of the liquid phase from the emulsion from the solid phase.
Such a permeable membrane can selectively consist of a network of fine meshes, which is smooth, that is, without projected or irregular parts or sharp surfaces that can damage cell walls, whose meshes or through interstices are smaller than the cell clusters contained in the washing chamber 101 of the washing and separation container 1.
The mesh of the network that forms the permeable membrane selectively can have a range of 1000 to 50 pm.
Such filter 4 is used to retain the stirring members 104 in the washing chamber 101 and prevent it from blocking the outlet 103 during washing and separation of the solid cellular component from the emulsion.
In a preferred embodiment, as best described above, such filter 4 is replaced by a fine mesh cutting network that provides a means to reduce the size of the solid components of the liposuction that come out of the washing chamber 101.
In one embodiment, at the opposite end, i.e., inlet 102, the size reduction means can be provided for reducing the size of the solid component of the fat-liposate 3, particularly the macro-agglomerated cells, to the smallest agglomerated cells, i.e. , which means to consist of at least a series of parallel or intersecting sheets or cutting threads made of sterile material, example metal, to form at least one size reduction network, through which the liposugated material is passed before entering the washing chamber 101 of the washing and separation container 1.
The container can be made of sterile plastic or glass, or in any case a translucent material, preferably resistant to high temperatures and a treatable autoclave, for the injection of fat-saturated fat there.
As shown in figures 4 and 5, such a size reduction network for cell agglomerates 3 is subtended in the washing chamber 102 near the entrance 103 of the washing and separation container 1 in a position substantially perpendicular to the direction of the fat flow entering the washing chamber 101 of such washing and separation container 1.
In a preferred embodiment of the present invention, the sizes of the liposuction are progressively reduced.
Such a progressive reduction is obtained by forcing the liposuctioned at least once through the meshes or openings of two or more size reduction nets at a given distance from each other.
In addition to the network near entry 102, the wash and sort container 1 has a second size 6 cut-off net, subtended in the wash chamber 101 near outlet 103 of the wash and sort container 1 in a substantially position perpendicular to the direction of the fat flow out of the washing chamber 101 of such washing and separation container 1, so that the liposuction that enters the washing and separation chamber 101, before leaving such chamber 101, can flow through two networks with progressively thinner meshes, the thick meshes being provided in a network located near entrance 102.
Therefore, the two networks are located at a given distance from each other: in particular, they are located at the side ends of the washing and separating container 101 containing the stirring means 104 as well as sufficient space to form an emulsion.
Considering the direction of the liposuction flow, the first network 3, that is, the one located near the entrance 102, for the fibrous components of the fat lobes and performs a first small reduction, for example, it provides a cell agglomerate of a relatively large homogenate maximum, that is, having a diameter of 0.5 to 2 mm, while the second net 6, located next to the outlet 103, performs another reduction of the agglomerates, which have previously been washed. For example, pellets and / or cells exiting the washing and separating container 1 can have a diameter of up to 10 pm.
The second net 6, as a replacement for the filter 4, can be used to hold the agitated members in the washing and separation chamber.
Such a progressive reduction through the cutting meshes of the multiple nets provides a solid component to be injected which is composed of agglomerates of various small diameters and, if necessary, of individual cells. The device of the present invention allows the liposuction to be reduced to a transplantable material of any size.
As the cellular material passes through the second network 6 located near the outlet 103, after the washing step it performs in the washing and separation chamber 103, such network having small mesh or openings, can lead to the formation of oil, due to breakage adipocytes.
This oil can be removed by transferring the cellular material to another container 1 having a washing and separating chamber 101, with or without the size reduction means.
As an alternative to or in combination with such a transfer to a second washing and separating container, any residual liquid / oil can be removed by fixing and / or centrifuging the treated material that leaves the washing and separating chamber one or one and is placed in special containers.
These containers can be one or more syringes held in a syringe holder.
As shown in figures 12a and 12b, the localized nets, with known techniques and means, close to the entrance and exit of the washing and separation chamber 101, may have honeycomb-shaped cutting meshes.
In one embodiment, the area of each mesh of the network near entrance 102, is about 4 mm2, while the area of each mesh of the network near exit 103 is about 1 mm2.
The reduction and homologation of the size of the cellular agglomerate are provided by the sheets or the mesh of the net or preferably the two cut nets located in the container 1.
Each net has equal meshes or through interstices, having a diameter that is in the range of 2000 pm to 50 pm, preferably from 1500 pm to 100 pm.
Since the meshes of the network 3 located near the entrance 102 are larger than the meshes of the second network 6 located near the exit 103, a first homologation of size and / or reduction of liposuctioned agglomerates is obtained by passing through the meshes of the first net 3, and the second high reduction is obtained when the material is taken out of the container 1, being passed through the meshes of the second net 6.
In one embodiment, the interstices (meshes, openings) of the size reduction means for cell agglomerates, particularly in network 6 located near exit 103, have a diameter in the range of 750 to 50 pm and in any case sufficient to allow the passage of cellular material, even individual cells.
Obviously, the size reduction of the liposuction and / or washing may also not occur using a single washing and separation container 1, with the means of reducing size there, that is, one, two or more nets, but using a succession of two or more containers 1, adapted to be connected together. The mesh / s 3, 6 of each container 1 can have different sizes from the mesh / s of mesh located in another container 1 and / or the mesh of nets or networks of a container can be different sizes from each other.
Therefore, for a progressive size reduction of the liposuctioned agglomerates, the material can be forced from a device to a device with a washing and separation chamber 1 and size reduction means having smaller meshes then the net or the nets located in the previously used device.
As shown in figures 6 and 7, at least one size reduction network for cell clusters 3 is subtended between an inlet 202 and an outlet 203 in a reduction chamber 201 of a size 2 reduction container, close to such an entrance 202 of the size reduction container 2 to receive the fat entering such reduction chamber 202, such container 2 also having an outlet 203, for the fat-fat to be injected through the entrance 202, passed through the size reduction net 3 in a reduction chamber 201 of the second container 2 and allowed to exit from such reduction chamber 201 through outlet 203, such outlet 203 being designated to be connected to an inlet 102 of the collection and separation container 1 to provide communication between the size reduction chamber (201 of the size reduction container (2) and size reduction chamber 101 of the washing and separation container 1.
Alternatively and preferably, the multi-step reduction can occur by collecting the cellular material in syringes, for example, 10 cc syringes, and using the latter to introduce the material into a second complete device having progressively thinner meshes.
As shown in figures 6 and 7, the size reduction container 2 can be composed of two parts and two shell halves connected together, at least one of such two parts, preferably the part with outlet 203, having an inlet chamber 201 for the collection of small size fat.
In one embodiment, such a collection container 2 can be designed to consist of two elements similar to the washing chamber closure terminals as described here.
The two terminals can be connected to each other in a fixed or removable manner, to form a size 2 reduction container with a reduced size chamber 201.
Like the washing and separation chamber 1, the collection container is preferably of the disposable type or can be removed for sterilization of internal elements and reused.
Obviously, the size reduction chamber 201 may be allowed to have varying sizes, to collect various amounts of reduced size cellular material, passing through at least one size reduction network.
Near the outlet 203 another agglomerate size reduction network can be provided.
In particular, two lipoaspirated size reduction nets can be provided in the size reduction container 2, one near inlet 202 and the other near outlet 203, such two nets having meshes of different sizes: particularly, the net close to inlet 202 has larger meshes than the net near outlet 203. According to a variant, the device of the present invention is composed of at least one size 2 reduction container and at least one washing and separation container to separate the component fluid from the solid component, such a size 2 reduction container having a size 201 reduction chamber with an inlet 202 and an outlet 203 and a size 3 reduction net between them, the outlet 203 having tightened fluid connection means 2021 , 2031 for connection with coupled connection means 102 located at the entrance 102 of the washing chamber 101 of the washing and separation container 1.
As shown in figure 7, the size 2 reduction container has an inlet 202 and an outlet 203 and a size 3 reduction net for the cell clusters that form the solid component of the fat, located in an intermediate position between the entry 202 and the outlet 203 or moved towards the entrance 203, and the lower compartment, in relation to the direction of the fat injection, acts as a collection chamber for the reduced size material 202, such compartment having a predetermined volume.
The inlets 102, 202 and the outlets 103, 203 of the size reduction container 2 and / or the washing and separating container 2 and / or the washing and separating container 1 having tight fluid connection means, such as connectors luer or similar, for connection to medical devices, such as syringes, bags or the like, having removable tight fluid connection means compatible with the means located in the openings 102, 202, 103, 203.
Obviously, inlets 202 and outlets 203 of the size 2 reduction container can be designed to be closed with sterile plugs and / or to be equipped with backflow prevention means, such as one-way valves, during size reduction .
In order to allow liposugated fat to flow into and out of the size reduction chamber 201 of the size reduction container and / or the wash chamber 101 of the wash and separation container 1 and to allow removal of the fluid, i.e., the emulsion obtained by the mechanical stirring of the washing chamber 101, the means are provided for compressing or aspirating the fluid component and / or the solid fat component, such as syringes or the like, whose means can be connected removably and tightly fluid form with the coupling means 1021, 1031, 2021, 2031 located at the inlets 102, 202 and the exits 103, 203 of the size reduction chamber 201 and / or the washing and separation chamber 101.
Obviously, the flow of fat material through the mesh size reduction mesh 3, 4 can be facilitated by mixing such fat material with liquids, particularly a saline.
The size reduction net / s 3, 6 in the wash and separation container 1 and / or the size net / s 3 in the size 2 reduction container can each be designed to have different sized interstices or meshes, so that the networks in one container have meshes of different sizes from each other and / or the meshes of the network / s in another container, so that the reduction in size of the desired cell agglomerate in obtaining the cell agglomerates equal to or less than the given value , occurs in multiple stages through the networks in such containers 1 and / or 2.
Therefore, the purpose of this part of the device of the invention is to reduce the size of the lobes of adipose tissue by forcing them through a special cutting net or parallel cutting sheets, preferably through two networks, and to form a cell suspension with cells and / or cell clusters, particularly adipocytes, having reduced and proportionally uniform sizes, or in any case clusters having sizes equal to or less than a predetermined value, the cell suspension salt being adapted for use in a next transplantation step using particularly needles or fine tubes , while avoiding its obstruction.
The purpose of the size reduction network / s is also to increase the amount of peripheral stem cells that can contact the tissue to be treated after the injection, whose stem cells adhere to the external surfaces of the cell clusters obtained by reducing the liposuctioned mass.
With the above devices, the sizes of the cell clusters, after passing through the size reduction means, are substantially identical and in the range from 2000 pm to 50 pm, preferably from 1500 pm to 100 pm.
As shown in the figures, the washing and separating container 1 is composed of a central tubular body 111 and two closing terminals 112, 113 or plugs, which are or can be attached to the ends of the central body 111.
Such a central part 111 is shown to be cylindrical in shape, but can be of any shape and size.
The washing container 101 has a size so that it can be handled by one hand.
In a variant, as shown in figures 2, 3, 4 and 5, an enlarged cup-shaped section 115 is provided at one end of the central tubular part 111, the section of which is an enlarged axial end of such tubular part, whose diameter internal is larger than the central part 111.
A closing terminal 112 has an opening adapted to fit with the end of the central part, while the second closing terminal 113 has a cylindrical axial extension 116 for fitting the cup-shaped accent 115 of the central part 111, leaning against the external annular radial shoulder shoulder 117.
On the contact surfaces of the axial extension 116 of the closing terminal 113 and the enlarged cup-shaped part 115 at one end of the wire part 111, and between the outer surface of the lateral end of the central part and the inner surfaces of the opening of the second closing terminal 112 in contact with it, means for the tight connection of fluid, such as O-rings or the like can be provided, which form, in combination with the above-mentioned components, i.e., the closing terminals 112, 113 and with the central part 111, a completely sterile washing chamber 101, isolated from the external environment. Indents and splines can also be provided on these contact surfaces, to ensure the attachment of these terminals 112, 113 on the tubular body 111.
Such closure terminals 112, 113 can be designed to be removably attached to the central tubular body 111, but such a wash and separation container 1 can also be designed to be removable to allow separation of one or both terminals of the tubular part 111. Therefore, this will provide a disposable washing and separation container 1, which is adapted to be sterilized also in its internal washing chamber 101, and thus be reusable.
As shown in figures 13a, 13b, 13c, the closing terminals 112, 113 and the central tubular part can have very simple constructions: the two closing terminals can be in the form of plugs fixedly or removably mounted on the ends of the tubular body 111.
These terminals can have shoulders on the side facing towards the washing chamber, to prevent deformation of the nets, which can be thin and delicate.
These closing terminals 112, 113 have openings, such as through holes, formed in the central longitudinal axis of the tubular part, whose openings have closing valves and / or tight fluid connection means 1021,1031 such as luer connectors, or adjustment of fitting or screw connectors or the like, or multipath valves, providing connections from the wash chamber 101 with one or more of the medical devices, possibly at the same time, such as syringes, bags or the like, or with the reduction chamber on the side 201 of the size reduction container, through respective entrances 202 and / or exits 203 having coupling connection means 2021, 2031.
As shown in the figures, filter 4 is provided at outlet 103, at the connection between the closing terminal 113 and the lateral end of the central tubular part, inside the washing chamber, substantially perpendicular to the longitudinal axis of the central tubular part 111, whose filter maintains the stirring members 104 within the washing chamber 101, to prevent it from obstructing any opening, particularly the outlet 133, when the washing and separating container 2 is vertically oriented relative to the floor for the removal of the liquid emulsion. As mentioned above, the washing and separating container 1 can also be designed to be provided, at port 102, with size reduction means 3 for reducing the size of the lobular fat transmitted by liposuction, to cells and cell clusters , particularly adipocytes and stem cells, of smaller and identical or similar sizes.
As mentioned above, instead of or in addition to filter 4, the size reduction means for the liposuctioned material can be provided, such as a liposuctioned size reduction network, whose liposuction is further divided into smaller agglomerates before leaving the washing and separation chamber 101.
Therefore, at the connection between the closing terminal 112 and the lateral end of the central tubular part, a size reduction network is provided in the washing chamber next to the entrance 102, substantially perpendicular to the longitudinal axis of the central tubular part 111, whose network reduces the size of the macro clusters at a predetermined value, the macro clusters of which are injected or pushed into the washing and separation chamber through the inlet 102.
Another size reduction network can be provided at the connection between the closing terminal 113 and the lateral end of the central tubular part, in the washing chamber 101 next to the outlet 103, substantially perpendicular to the longitudinal axis of the central tubular part 111.
In this preferred embodiment, the passage between the first size reduction network, near entrance 102, fragments the pieces of the connective tissues of the liposuction and / or provides a first thick reduction in the size of the agglomerated liposuction, while the passage through the second network of size reduction located near exit 103 provides cell clusters whose size is equal to or less than the given value, such networks having meshes of different sizes, particularly the first network, in relation to the direction of the flow of fat in the washing container and separation 1, having larger meshes than the second net.
The mass of adipose tissue prepared by the device described above, that is, the adipose tissue that has undergone a reduction in size through the size reduction network and / or washing and separation of such solid component from the solid component, is mainly composed of adipocytes, but also other types of viable and perfectly healthy cells that can be found in a liposuction, and can be used for transplantation in face and / or body remodeling procedures.
The present invention deals with a method of treating or preventing injuries or illnesses in a patient, particularly a method of treating volume deficiencies in the body and face, improving skin trophism and / or biological stimulation, the methods of which include: at least one step of extracting biological material from donor areas of the patient, particularly the fatty tissue extracted by liposuction, at least one step of treating such material, at least one step of injecting the treated material into a patient.
Before the injection stage, the biological material collection and storage stage can obviously be provided.
The treatment step includes at least one size reduction step to reduce the size of the extracted material and / or at least one washing step and separation of the liquid phase from the solid cell phase, such treatment step being carried out using the device and the method of the present invention.
In the present method, the donor patient is also the receiving patient in which the injection step is performed.
However, the donor and recipient may also be different people.
Obviously, the device and method for treating the tissue and the method for treating the patient may involve the use of tissue other than adipose tissue.
An exemplary procedure for transplanting the biological material prepared by the above device will now be described.
The material prepared using the device described above can be stored in one or more sterile containers, for example, syringes, and allowed to fix and possibly centrifuged to separate the solid component from any residual oil or solutions.
Cellular material prepared using the device and method of the present invention can be injected into any type of tissue and with any compatible procedure.
Once the receiving areas have been precisely designated and disinfected, the needle or microcane of the syringe containing the prepared cell suspension is introduced into the subcutaneous or muscle tissue, thus creating a three-dimensional network of tunnels for the injection of very small amounts of cell clusters.
This step is preferably carried out using a disposable sterile blunt-ended pipe with a luer connector, having a very small diameter.
The small size of the tunnels formed in the treated tissues facilitates the integration of the cells, and the cell clusters in the interstitial spaces of the subcutaneous tissue or in the muscle tissue, thus reducing surgical trauma and facilitating a quick return to the normal consistency of the tissues submitted to augmentation treatments. volume and remodeling.
Therefore, the formation of very small diameter tunnels in the tissues optimizes the reconstruction of the tissue volume and / or the results of biological stimulation. The reduction of the size of the fat lobules by dividing these lobes into cell clusters provides a greater contact surface between the injected mass and the tissues being treated, thus facilitating the biological stimulation of the relevant areas and the integration of the transplanted adipose tissues.
The use of these particularly thin tubes, possibly less than 1 mm, is permitted by the reduction in the size of the liposugated lobular fat, which occurs in at least one size 2 reduction container and / or in at least one washing and separation container 1 having size reduction means consisting of at least one series of parallel sheets and / or at least one network of threads or thin sheets, preferably at least two networks, at least one of such two networks having meshes of very small sizes, which they allow cell clusters to pass through or even individual cells having micron order sizes.
No reduction in fat size should occur, the pipes that are used in transplant procedures would become clogged.
As an alternative to sterile pipes with a blunt end, spiral or helical pipes 5 having a pointed or blunt end like the one shown in figure 12 can be used for transplantation of fat cells.
The helical tube 5 is particularly useful for injection into organs in which few stages of penetration of the transplant needle are required: the corkscrew needle provides a maximized density of cellular material deposited along a single pathway.
This type of tube allows the transplantation of adipose tissue agglomerates even in high-consistency or particularly delicate tissues, such as scar tissue, bone, cartilage, myocardium or other organs, through a single injection point that allows the treatment of a certain volume of tissue. The barrel is introduced with a rotating motion to allow the helix to enter the tissue, so the barrel is extracted in the same way while injecting the cell clumps or clusters of adipose tissues. This will considerably increase the amount of adipose tissue transplanted per unit volume, when compared to the individual injection by a straight needle, and therefore the volume treated without reducing the contact surface between the injected adipose tissue and the tissue received thereby increasing the potential of vascularization of the injected cells, as the adipose tissue is released as very fine strips or granules of cells, due to the small diameter of the pipe, and in a spiral path.
The use of these tubes, which allow the prepared adipose tissue, containing, in addition to adipocytes, other types of cells including stem cells, to be released in a spiral path within the tissue to be treated, is particularly compatible when there is no way to Coleman filling, that is, to form a network of tunnels in the tissue to be treated due, for example, to an excessive consistency of tissue to be treated, or when the trauma of the tissue is unwanted, such as in the treatment of the myocardium . The present invention also relates to a tissue for transplantation, for example, for autotransplantation or heterotransplantation, the tissue of which is composed of cells, possibly cellular fragments and / or cell clusters, and is obtained using the above described device and / or method.
The tissue is composed of cellular material of uniform size, with proportional diameters in the range of 10 pm to 2 mm.
Preferably 0.05 to 1.5 mm, especially about 0.75-0.5 mm or less (up to 10 pm).
If necessary, the present device can also provide tissue composed of individual cells.
In a preferred embodiment, the tissue is an adipose tissue composed primarily of adipocytes and stem cells.
Such stem cells are adapted to be used to create any type of cell, such as chondrocytes, osteocytes, adipocytes, nerve cells.
After preparation, this adipose tissue has a small liquid fraction, free of any impurity, which is mixed with the cell clusters and is sufficient to facilitate the introduction of cells into the tissues to be treated.
Such a liquid fraction can be about 50% by weight of adipose tissue prepared for transplantation.
The present invention also obviously refers to a tissue having one or more of the above characteristics, but other than adipose tissue.
The present invention relates to a preferably sterile and disposable set, adapted for use both in outpatients and surgical configurations.
The device or assembly of the present invention has two- or three-way connectors, with or without valves, connection tubes and syringes, and several containers (eg, a bag for washing with saline and a bag for collecting washing residue ).
The set can be used to treat cellular material of any kind, preferably fat for self or heterotransplantation 1 and comprises at least one container 1 to wash the solid fat component and separate such solid component from the fluid component, such washing container and separation 1 being formed as described above.
This set, which is composed of at least one washing and separation container having a size reduction means in the washing chamber 101, is particularly advantageous when used in the field of cosmetic treatment, for example, in outpatient settings, as it provides a perfectly simple sterile device , to be used to quickly treat the material extracted from the patient, with no risk of contamination of the cellular material due to contact with the external environment.
The set allows the treatment of biological material, from the first stage of tissue suction to the last stage of injection, in a completely closed system, which allows the material to be treated without causing it to contact the external environment and / or without using means that could contaminate it.
This is permitted through the use of one or more tubes, syringes, bags, multipath valves, luer connectors and obviously one or more wash and separate containers 1 (and possibly one or more size 2 reduction containers), which are sterile and connected or connectable together in a tight fluid way.
Therefore, the system that provides the removal of biological material, treatment of material, storage, injection of biological material is a system that is completely isolated from the external environment at all stages, from the removal of the patient to the injection in the recipient patient.
One or more system components can be mechanized by connecting special equipment, so that one or more stages of the process including suction and / or treatment of biological material and / or injection can be performed without requiring any action by an operator .
This set is particularly compatible for the minority of cosmetic surgery procedures. In a preferred embodiment, the assembly comprises one or more containers 1 having at least one size reduction network, preferably two size reduction networks, as described above. Each container 1 in the set can be designed to have networks with meshes of different sizes from those of the other containers 1 so that, by forcing the material through the meshes of the multiple container networks, cell agglomerations are progressively reduced in size to the desired value allowing transplantation.
Such a progressive reduction avoids the risk of obstruction of the meshes of the nets and prevents the treatment process from being slowed down.
As an alternative, an assembly may be provided in which it comprises: at least one container 1 for washing the solid fat component and separating such solid component from the fluid component, possibly having at least one size reduction network or sheets 3, at least at least one size reduction container 2 formed as described above and adapted to be connected to such container 1.
In one embodiment, the set has two or more size 2 reduction containers, which are adapted to be alternatively connected via its 203 or inlet 202 inputs to the 102 or the 103 wash and separation container 1 outlet, a predetermined quantity of reduced size fat being stored and preserved in sterile conditions in the reduction chamber 201 of each size 2 reduction container.
A set having a series of size 2 reduction containers can also be provided, which is composed of at least two size 2 reduction containers having different sizes in terms of size 3 mesh netting and / or the volume of reduced size fat contained in the reduction chamber 201.
For example, the assembly can be designed to contain two or more size reduction containers 2 having size reduction means 3 through which the cellular material can be forced, each having a network 3 with different sized mats.
The provision of two or more size 2 reduction containers allows the treatment of a large amount of fat without the risk of obstructing the meshes of the size reduction net and therefore slowing down the material treatment process.
Washing and sorting containers 1 and / or size reduction containers 2 may be of the disposable type or may be formed in such a way as to allow complete sterilization and future reuse thereof.
The set of the present invention may also include, alternatively or in combination: one or more sterile syringes with different volumes, one or more sterile pointed needles or lanceolated blades of particularly different sizes to allow transcutaneous introduction of the tube for anesthesia, removal and transplantation, one or more sterile disposable pipes having a pointed or blunt end, at least one of which has a very small diameter, on the order of 1 mm, one or more of one or multiple-way valves, with or without check valves, for example, three-way valves to be connected to inlets 102, 202 and / or outlets 103, 203 of containers 1 and / or 2, one or more sterile tubes with luer connectors, allowing the passage of biological material from one component of the set to another (example, from the syringe to the washing and separation chamber 1 or from the saline bag to the washing and separation chamber). means or containers, such as syringes, to allow fixation and / or possible centrifugation of the fat material prepared using the device described above, the fat material of which can be distributed in one or more sterile containers, to provide additional component separation solid, which floats after fixation in the residual liquid / oily component to be removed before transplantation, means for preserving the biological material then prepared and ready for transplantation, example, means for cryopreserving it in a closed environment simulating a clean room , that is, a container having controlled conditions, for example, in terms of particular population, pressure and temperature.
As shown schematically in figure 10, the assembly may comprise one or more devices such as one or more size 1 washing and separating and reducing containers, syringes 8 for sucking patient material, syringes 12 for collecting / injecting treated biological material , bags of washed liquid 10 (example, a bag containing saline), bags 11 for the collection of residual material, which are or can be connected together by sterile tubes, multipath valves, luer connectors.
Instead of or in addition to such a smaller diameter pipe, the assembly may include at least one helical or spiral shaped pipe 5 with a pointed or blunt end allowing, as described above, the transplantation of the cell mass of adipose tissue into particularly delicate tissues or high consistency increasing the volume of the treated tissue with a single injection point.
The set may also include an instrument to close syringes during suction to temporarily prevent the plunger from returning, for example, during liposuction, and to allow less traumatic suction of adipose tissue.
The assembly may also comprise a biased spring mechanism to transmit a reciprocal movement to the syringe piston, whose mechanism is connected to the two-way valve and provides a quick removal of the adipose tissue, whose adipose tissue is transmitted to the washing and separation 101 without contacting the external environment, through a tube with luer connectors at its ends.
The provision of a three-way valve at inlet 102 of the chamber still allows the injection of a washing solution into such a chamber without disconnecting the withdrawal syringe.
The syringes in the set can be made of plastic, preferably with a luer connector, or similar, and have several volumes.
The following can be used, as an example: 10 to 60 cc syringes for injection of local anesthesia, 5 cc syringes with needle to create an anesthetic papule, 10 cc syringes or larger volumes, connected to a sterile 1 cannula , 5 to 3 mm in diameter for removal of adipose tissue from donor areas, syringes of 1 to 5 cc for tissue transplantation,
Therefore, the treatment method that can be performed with the device of the present invention allows the preparation of an adipose extract, for example; obtained by liposuction, in which it is a mixture of fluid materials and cell fragments and one or more cell agglomerates of heterogeneous sizes, in a cell suspension containing cell clusters, particularly adipocyte clusters, with smaller and identical or similar sizes, in any case, less than a given value, to allow the transplant in areas of the patient's face or body, requiring a filling procedure with minor trauma, and accompanied by biological simulation of the tissues involved in the procedure.
The method can be carried out in a closed system to avoid contamination of the cellular material before its administration to a patient.
Obviously, the adipose tissue to be transplanted can be obtained not only by liposuction, but also using other known techniques.
As described above, agglomerates can be obtained with an average size of 500 pm, or smaller, for example: approximately 100-10 pm, depending on the mesh sizes or openings of the size reducers means that it has been used for material size reduction liposuctioned.
For that reason, the preparation of fat material involves dividing said fat material into cell fragments, cells or cell clusters that are smaller than the aspirated macro-clusters.
Such division, as mentioned above, increases the activity of stem cells, as this creates a favorable microenvironment facilitating the contact of stem cells with the tissue in which transplants occur.
In the present invention, for cell clusters to be divided into sizes equal to or less than a given value, progressive reduction in the size of liposuction is preferred, which means that fat is forced at least once through at least one cutting net. of intersecting or parallel wires and sheets, preferably through two networks located at a given distance from each other, said that the networks have different size meshes.
Before and / or after the size reduction, the fat can obviously be washed once or multiple times with a sterile washing solution.
The cell clusters thus obtained undergo an additional treatment, which involves washing with sterile solutions and separating the cellular component from the liquid phases, example: blood, oil resulting from the breakdown of adipocytes, any anesthetic solutions in use, and the solution in each such agglomerates were mixed, for example: a saline solution.
Washing and separation are permitted by the use of a container 1 with a washing chamber containing mixing members 104 such as balls or the like which, when moving container 1, can form an emulsion of the liquid components contained in said washing chamber.
The washing of cell pellets in one or more washing and separation containers can continue until the phase of liquid waste leaving the outlet 103 is perfectly clear.
Advantageously, from the progressive reduction of the size of the liposuction, it is obtained by forcing it through at least two nets located at a given distance between each other in a washing and separation container, for example: at the end of the central tubular portion, agglomerates of cells are washed a first time after a first step of separating lobes of adipose tissue or macro-agglomerates and reducing / homologating the sizes of said agglomerates below a predetermined value, from the passage through the adipose tissue the reduction in size means 3, which is obtained by applying pressure to said adipose tissue, can cause adipocyte cell walls to break, with the formation of oil that has to be removed from the cell suspension containing cell clusters, to ensure a successful transplant of said tissue.
One or more subsequent washing steps will be performed after the second or subsequent size reduction steps, to obtain a solid component of suitable size for transplantation.
Washing and separation of the cell component from the liquid phase of the fat extracted in container 1, described above, can also occur before the steps of reducing the size of the aggregate cell.
The method of the present invention includes, instead of or in addition to the division step, at least one step of washing cellular aggregates, which are carried out at the same time as a step of separating the fluid component, in the form of emulsion, at from the solid component. Figures 8A-8d and 10 schematically illustrate the method.
In a first step, the washing and separation container area 1 is released, and the entire internal volume is filled with a liquid.
For example, the air to be released before using the device can be removed by aspirating saline solution with syringe 7, causing it to enter bag 10 by gravity and causing air to escape from syringe 12 (after removing the syringe lid) and / or container 11 (which may be equipped with an openable escape valve).
The washing and separating container 1 is oriented vertically with the outlet 103 open and facing upwards: the liquid is introduced into the container 1 and the air is exhausted there through the inlet 102.
The liquid can be a saline solution contained in a bag 10 connected by an tube to the opening of the chamber, which has a three-way valve.
Then, liposuction is injected into the washing and separation chamber 101.
Liposuction can be injected directly from the suction syringe of container 1 or through a completely closed system as shown in figure 10.
Syringes of any volume can be used. 10 cc syringes are preferable.
The fat material is injected into chamber 101 through a suction syringe used for removal, for example: a two-way syringe equipped with a valve directly or through a tube connected to a syringe and the opening of a container and material of fat is pushed into said chamber by the pressure exerted by the syringe piston.
In this step, the container is preferably held in an upright position with the outlet 103 facing downwards towards the floor.
The presence of size reduction means near entrance 102 provides a first reduction / approval of the size of the liposuction.
A hydraulic force can be applied to the fat material through a pressure washing fluid, which is injected into the separation and washing chamber 101 and forces the fat material into and out of the washing chamber 101.
The adipose agglomerate injected into the washing and separation container 1 through the inlet 102, can be repeatedly by pressure injection of liquid materials such as sterile saline solutions into said interior of the washing chamber 101 to obtain a cell agglomerate of high purity, free of any oil, blood and any solution used during withdrawal.
The washing and separation step in which said fluid materials are separated from said agglomerates occurs through: at least one injection of a sterile washing solution, example: saline solution, inside the washing chamber 101 containing the fat material, of a separation and washing container 1, which the washing chamber 101 contains at least one movement element 104.
In this step, the container is held in an upright position with the outlet 103 facing and parallel to the floor. manual or mechanical movement, manual movement being sufficient, of said washing and separation container 1 to facilitate the emulsion of fluid components, particularly the oily and blood component with sterile fluid substances; the emulsion being formed when orienting the separation and washing container in a horizontal position, example: approximately parallel to the floor (Figure 8b), arrangement of the separation and washing container 1 in a vertical position relative to the floor, with the exit 103 facing towards low, to obtain a stratification of the solid components in the liquid emulsion in which it constitutes the fat contained in the washing chamber 101, particularly to obtain a solid component composed of cellular fragments, cells and one or more floating cell agglomerates in an emulsion of fluid components in the smallest portion of the washing chamber 101 in contact with the outlet 103 of the separation and washing container 1, discharging the emulsion of fluid components (example: oils / liquids) from the washing chamber 101 through the outlet 103 of the separation container and wash 1 (Figure 8c). The emulsion is forced out by the injection of washing fluid through the opening 102, with a given pressure.
Since the container has a cylindrical shape, its horizontal position means that its largest axis passes through the end faces parallel to the ground, while its vertical position means that the cylinder is oriented with its largest axis perpendicular to the ground.
The emulsion is collected in another container 11 which is hermetically connected fluid by means suitable for said opening 103, to prevent contamination of both, the external environment and the cellular material contained in the chamber 101.
Therefore, in the washing step, the separation and washing container 1 containing fat mixed with sterile solution, for example: either saline solution injected with a syringe through inlet 102 or saline solution removed from a bag, is shaken with a force that does not cause the cell walls to break but is sufficient to form an emulsion. Example: the dispersion of tiny drops of oil into the washing fluid, due to balls 104.
The container is agitated to form the emulsion with container 1 horizontally oriented.
Obviously in this step the entries, for example: at least one entry 102 and / or exit 103 of container 1 are closed to prevent any material leakage.
At the end of the container movement stage, the container is moved to an upright position and the different densities of materials that form the liposuction create a solid layer of cells and cellular fragments in the washing chamber 101, such a layer floats in the liquid emulsion.
The washing step is repeated by injecting sterile washing solutions into the chamber, with subsequent formation of emulsion (by shaking the container with the inlet and outlet closed) and unloading of the emulsion (through the injection of clean washing solution), until the outflow of liquid-oil-blood emulsion appears to be free of any impurities such as blood and oil.
Therefore, the discharge of fluid component emulsions can be repeated.
Such emulsion discharge is obtained through the flow of a physiological liquid caused by gravity, which allows the removal of liquid components (oil / liquid) through a density gradient, at least for a given interval time, example: until there is an emulsion between tiny drops of oil and liquid, which is sufficient each time, for example: for each washing cycle, to remove a considerable amount of liquid waste (particularly oil).
The water / oil emulsion is eliminated from the container through a density gradient, following the fluid leaving the liquids (the inlet flow 102 to the outlet 103) obviously as long as the said washing flow is sufficient.
As shown in Figure 9, the oil / liquid emulsion is discharged.
Oil can be discharged as long as it is part of an emulsion.
What is discharged is an emulsion of minuscule tastes of oil and washing liquid.
The cell mass floats in said emulsion.
Therefore, the emulsion is required to allow the elimination of impurities, such as oil, in liposuction.
At the end of the washing step, the solid component floats in the clean washing solution.
Therefore, at the end of the separation and washing step, the material in the container chamber 101 can be used for transplants.
Washing adipose tissue is an important step, since it allows the removal of oil resulting from the breakdown of the adipocyte cell wall during mechanical removal of adipose tissue, using cannulas or needles, from donor areas and during the passage of fat , under pressure, by reducing the size to Network 3.
The solid component is discharged from the separation and washing container by vertically orienting said container with outlet 103, with a reduction in size of Net 6 preferably supplied in the same proximity, facing upwards, so that the solid component floats in the solution of washing (figure 8d).
Therefore, the solid component to be discharged is located near outlet 103.
The solid component is pushed out through a second mesh 6, by injecting the washing solution through the inlet 102.
It was found that an aqueous solution with little cellular material is discharged first, then a solution rich in cellular material and finally a solution with little cellular material.
One or more containers can be connected to outlet 103, one after the other, for example, syringes 12, to collect the prepared biological material mixed with liquid.
Such material was subjected to further reduction / approval through Network 6.
Containers 12 are allowed to settle to achieve separation of the solid component from the liquid residual component.
Instead of, or in addition to, the above, separation can occur by centrifugation.
The so prepared biological material is preserved or preferably cryopreserved in a closed environment, simulating a clean room.
Obviously, the material stored in container 12 can be designated to be treated again in a separation and washing container 1 and / or a size reduction container 2, before finally being preserved and / or reinjected.
The material system of the entire treatment is closed, from the patient's withdrawal for reinjection. This characteristic is particularly important for banks and biological tissues, for example: preservation of this in biological banks.
Therefore, the biological material transmitted into the container 12 had to always be in a closed sterile system, never in contact with the air.
Thus, said material can be directly cryopreserved with no further changes requiring the use of a clean chamber.
As described above, multiple mutually connected wash separation containers can be provided, for progressive reduction and / or for liposuction washing.
The device of the present invention allows simple, fast and inexpensive treatment of cellular extracts in the form of cellular macro agglomerates agitated with the liquid phase, which provides cellular aggregates of substantially identical whole and viable cells of predetermined size, in any way less than the predetermined value , in which agglomerates are separated from the liquid component, in the form of an emulsion, containing liquid waste. These clusters can be used for transplants.
Obviously, the material produced from the treatment of fatty lobes can contain not only cell aggregates but also individual cells and cell fragments to be used as biological fillers.
In addition, the liposuction material contains not only adipocytes, but also other types of cells, such as stem cells.
The treatment method implemented by the device does not involve the use of enzymes or other components that may have a chemical action on the liposuctioned material, or a biological action on composer cell clusters, but uses the possibility of changing the size of the cell clusters, to obtain greater exposure to the cell surface, which can contact the tissues treated during transplantation. Particularly, solid material for injection is provided, which also forms an ideal micro-environment in vivo for the action of stem cells in the areas in which said treated material is reinjected, which stem cells are contained in the aspirated material.
Therefore, the method of the present invention simply and economically provides biologically active injectable biological material from the material extracted from the patient, also due to the presence of stem cells, and requires neither the use of chemicals such as emulsifiers or enzymes, nor in vitro culture steps. Therefore, these clusters of very small cells can be transplanted using a very thin cannula, which reduces surgical trauma and optimizes tissue integration.
Also, the use of a device of the present invention provides a closed system that isolates biological material from the external environment and allows it to be prepared for use in a very short time, thereby reducing possible risks of contamination.
The device, kit and method disclosed above, which form the object of the present invention, can obviously be used not only to prepare adipose tissue for transplantation, but also to prepare any type of cell agglomerate that is required to have a high level of purity for use.

权利要求:
Claims (27)
[0001]
1. Device for the preparation of adipose tissue for transplantation of lobular fat extracted, for example, by liposuction, such fat consisting of a fluid component comprising an oily component, a blood component and / or sterile solutions and a solid component comprising cell fragments, cells and one or more heterogeneous size cellular macro-agglomerates, comprising one or more washing and separating container (1) having a washing chamber (101) for washing the liposuction material, whose container (1) has an inlet (102) and a outlet (103) for the lipoaspirated material to enter the washing chamber (101) through the inlet (102) and for a part of such material, particularly the fluid component, to exit the said chamber (101) through the outlet (103), such a washing chamber (101) including means (104) for forming an emulsion of fluid components, by mechanical stirring, characterized in that said emulsion forming means (104) are passive means which act by inertia after shaking the container (1) and comprise a plurality of stirring elements (104) each having a relatively small size when compared to the washing chamber (101) in order to move freely in the chamber (101) without damaging the cellular material contained in that chamber (101).
[0002]
Device according to claim 1, characterized in that said emulsion forming means comprise a plurality of stirring elements (104) having continuous rounded outer surfaces for rotating and moving within the chamber (101) to assist mixing liquid components.
[0003]
Device according to claim 1, characterized in that the size reduction means (3) are provided to reduce the size of the solid component of the lipoaspirated fat (3), particularly the cellular macro-agglomerates, for smaller cell agglomerates, that is, having a size equal to or less than a given value, the means of which consist of a series of parallel or intersecting sheets or cutting threads, to form a size reduction network, through which the lipoaspirated material is passed before entering in the washing chamber (101) of the washing and separating container (1).
[0004]
Device according to claim 3, characterized in that said size reduction network for cell agglomerates (3) is located in the washing chamber (101) next to the entrance (102) of the washing and separation container (1) in a position perpendicular to the direction of the flow of fat entering the washing and separating chamber (101) of said washing and separating container (1).
[0005]
Device according to claim 3, characterized in that a second size reduction network for cell agglomerates (6) is located in the washing chamber (101), spaced from the first network (3) which is located close to the entrance ( 102).
[0006]
Device according to claim 5, characterized in that said second size reduction network for cell agglomerates (6) is located in the washing chamber (101) next to the outlet (103) of the washing and separation container (1) in a position perpendicular to the direction of the flow of fat entering the washing chamber (101) of said washing and separating container (1), so that the washing and separating chamber (101) is interposed between said two networks ( 3, 6).
[0007]
Device according to claim 3, characterized in that said size reduction networks for cellular agglomerates (3, 6) have different meshes or openings, from one network (3) to the other (6), and close to the entrance (102), the net (3) has meshes or openings that are larger than the meshes or openings of the reduction net (6), located near the outlet (103).
[0008]
Device according to claim 3, characterized in that such size reduction networks for cellular agglomerates (3, 6) have meshes or openings with a diameter in the range of 2000 pm to 50 pm.
[0009]
Device according to claim 3, characterized in that the size reduction network for cell agglomerates (3) is located between the inlet (202) and the outlet (204) in a reduction chamber (201) of a container of size reduction of fat (2), close to said inlet (202) of the size reduction container (2), to receive the fat entering said reduction chamber (201), said container (2) also having a outlet (203), for the lipoaspirated fat to be injected through the inlet (202), passed through the size reduction net (3) to the reduction chamber (201) of the second container (2) and allowed to leave said reduction chamber (201) through the outlet (203), said outlet (203) being designed to be connected to the inlet (102) of the washing and separating container (1) in order to provide communication between the reduction chamber (201) of the container size reduction (2) and the washing chamber (101) of the washing and separating container (1).
[0010]
Device according to claim 1, characterized in that it includes a size reduction container (2) and a washing and separation container for separating the fluid component from the solid component, such size reduction container (2) having a reduction chamber (201) with an inlet (202) and an outlet (203) and a size reduction net (3) between them, the outlet (203) having removable and fluid impermeable connection devices (2021, 2031) for connection with coupling connection devices (1021) located at the entrance (102) of the washing chamber (101) of the washing and separation container (1).
[0011]
Device according to claim 1, characterized in that one or more filters (4) are provided in the washing chamber (101) of the washing and separating container (1) near the outlet (103), which allows passage of the fluid component and retains the stirring elements (104) in the washing chamber (101).
[0012]
Device according to claim 1, characterized in that it comprises a filter consisting of a selectively permeable membrane that allows the passage of part of the liquid phase, consisting of an oily component, a blood component, sterile solutions, such as anesthetic liquid and / or saline, and retains the solid cell phase, which consists of cell fragments, whole cells and cell clusters, thus allowing the separation between the liquid phase of the emulsion and the solid phase.
[0013]
Device according to claim 1, characterized by the inlets (102, 202) and outlets (103, 203) of the size reduction container (2) and / or by the washing and separation container (1) having devices removable and fluid impermeable connection points (1021, 1031, 2021, 2031), such as luer connectors, two or more valves or similar, sterile containers or tubes, for connection with one or more medical devices, such as syringes, bags or similar, having removable and fluid-impermeable connection devices compatible with the devices located in the openings (102, 202, 103, 203).
[0014]
Device according to claim 1, characterized in that the devices are provided for compressing or aspirating the fluid component and / or the solid fat component to or from the washing chamber (101) of the washing and separation container (1 ) and / or the reduction chamber (201) of the size reduction container (2).
[0015]
Device according to claim 1, characterized in that the washing and separating container (1) consists of a central tubular part (111) with the washing chamber (101) formed there, and two closing terminals (112, 113) at the ends of said tubular part (111), such as caps (112, 113) or the like, the inlet (102) and the outlet (103) of the washing chamber (101) of the washing and separating container (1) consisting of a hole formed in each cover (112, 113), communicating with a connection terminal (1021, 1031) and / or valves.
[0016]
Device according to claim 1, characterized in that the size reduction container (2) has an inlet (202) and an outlet (203) and a size reduction network (3) for cellular agglomerates that form the component fat solid, located in an intermediate position between the inlet (202) and the outlet (203) or displaced towards the inlet (202), and through the downstream compartment, in relation to the fat injection direction, to act as a chamber of collection for the reduced material (201), said compartment having a predetermined volume.
[0017]
17. Method for preparing adipose tissue for transplantation, from lobular fat extracted, for example, by liposuction, said fat consisting of a fluid component comprising an oily component, a blood component and / or sterile solutions and a solid component comprising cell fragments, cells and one or more cellular macro-agglomerates of heterogeneous sizes, characterized in that it includes the step of separating the fluid component, in the form of an emulsion, from the solid component; said washing and separation step occurring by: - at least one injection of a sterile washing solution into a washing chamber (101) containing the greasy material, from a washing and separation container (1), in which the chamber wash (101) contains at least one stirring element (104); - manual or mechanical agitation of said washing and separation container (1) to obtain an emulsion of the fluid components, such as blood fluids, blood residues, oils and other solutions contained in the liposuction material, allowing said fluids to remain separate from the material solid cell without the use of enzymes or chemicals; - arrangement of the washing and separating container (1) in a vertical position in relation to the floor, with an outlet (103) facing downwards, to obtain a stratification of the solid components in the liquid emulsion that constitutes the fat contained in the washing chamber ( 101), to obtain a solid component composed of cell fragments, cells and one or more cell clusters floating in an emulsion of the fluid components at the bottom of the washing chamber (101) in contact with said outlet (103) of the washing container and separation (1); - discharge the emulsion of fluid components from the washing chamber (101) through the outlet (103) of the washing and separating container (1); - positioning the solid component near the outlet (103) and unloading the solid component from the outlet (103); wherein said method is carried out without using either chemicals, such as emulsifiers or enzymes, or in vitro culture steps.
[0018]
Method according to claim 17, characterized in that the solid component is discharged by: - positioning the washing and separating container (1) in such a way that the solid component is located close to the outlet (103); - discharge the solid component of the washing and separation container from the outlet (103).
[0019]
19. Method according to claim 17, characterized in that, during the injection of said sterile washing solution, the container (1) is kept in a vertical position with its outlet (103) facing and parallel to the ground.
[0020]
20. Method according to claim 17, characterized in that it comprises a step of dividing said fat into cell clusters smaller than said macro clusters, so that said cell clusters are as large as or smaller than a pre-size determined, and so that they are, on average, the same size, in which the size reduction step is performed making the said lobular fat extracted pass through the size reduction devices (3) at least once, consisting of at least one series of parallel or intersecting sheets or threads that form at least one size reduction net located in a washing and separation container (1) and / or a size reduction container (2).
[0021]
21. Method according to claim 20, characterized in that the step of dividing or reducing or homogenizing the sizes of fats is carried out in a progressive manner, passing the fat through two or more size reduction nets (3, 6), having meshes or openings of different diameters, particularly nets having meshes or openings of decreasing diameter, in the direction of the fat flow.
[0022]
22. Method according to claim 17, characterized in that said arrangements and discharge steps for solid components are carried out by vertically orienting said container with the outlet (103) facing upwards, so that the solid component floats in the solution of washing.
[0023]
23. Method according to claim 17, characterized in that the stirring element (104) is a passive device that exerts its action after stirring the container (1) and operates by inertia.
[0024]
24. Method according to claim 17, characterized in that said step of washing and separating said fluid substances from said agglomerates is repeated several times until the fluid output components are free of any impurity, such as oil and / or blood.
[0025]
25. Disposable set for preparing tissue for transplantation from lobular fat extracted by liposuction characterized by comprising: - one or more devices as defined in any one of claims 1 to 16; - one or more syringes; - one or more grants; - one or more multipath valves; and - one or more luer connectors, which are all sterile and connectable together, in an airtight manner.
[0026]
26. Set according to claim 25, characterized in that it comprises: - one or more sterile disposable syringes with different volumes; - one or more sterile disposable cannulas having a blunt or pointed end, at least one of which having a diameter of the order of 1 mm; - one or more two or more way valves; - devices for storage of biological material prepared, under controlled conditions, for transplantation; - devices for preserving and administering washing solutions, such as bags or the like, - devices for collecting residual liquid components, - tubes, conduits and luer locking connectors to create a closed system in which the treated material never comes into contact with the external environment.
[0027]
27. Assembly according to claim 26, characterized in that a spiral or helical cannula (5), with a blunt or pointed tip, is provided instead of or in addition to small diameter cannulas.

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法律状态:
2017-12-12| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2017-12-12| B07D| Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]|Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |

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2018-05-02| B07G| Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]|

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2018-06-12| B25D| Requested change of name of applicant approved|Owner name: LIPOGEMS INTERNATIONAL S.P.A. (IT) |

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2018-09-25| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2019-10-01| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2020-04-07| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-10-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/05/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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ITGE2010A000057|2010-05-20|

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ITGE2010A000057A|IT1400069B1|2010-05-20|2010-05-20|DEVICE AND METHOD FOR THE PREPARATION OF FABRIC, IN PARTICULAR ADIPOUS FABRIC FOR TRANSPLANTATION OBTAINED FROM ADIPOUS LOBULAR MATERIAL EXTRACTED THROUGH LIPOSUCTION|

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PCT/IB2011/052204|WO2011145075A2|2010-05-20|2011-05-20|Device and method for preparing tissue, particularly adipose tissue, for transplantation from lobular fat extracted by liposuction|

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