Device for purifying and isolating adipose tissue components

Abstract

Based on the structure of a conventional or purpose-built centrifuge, the device of the invention includes a tank (1) for receiving adipose tissue to be purified, which has a frustoconical tubular configuration, there being defined in the upper base a port or inlet (2) with universal coupling to a vacuum cannula of a liposuction device, and a second port or outlet (3) that connects to an air suction system. A drain outlet (4) with a three-way stopcock (5) is provided at the base of the tank, on the external lateral edge of same, and a counterweight (6) is provided opposite the drain outlet. The device allows the separation of viable adipose cells extracted by means of a liposuction process and is capable of handling large volumes of adipose tissue quickly and simply.

Description

[0001] DEVICE FOR PURIFICATION AND ISOLATION OF ADIPOSE TISSUE COMPONENTS

[0002] DESCRIPTION

[0003] TECHNICAL SECTOR

[0004] The present invention relates to a device for purifying and isolating components of adipose tissue, which falls within the field of medical-surgical equipment.

[0005] The object of the invention is to provide a device that allows the rapid and simple separation of viable fat cells extracted after a liposuction process, which can be used in cosmetic, plastic and reconstructive surgery procedures, to restore or increase the volume of certain areas of the body.

[0006] These areas may become deficient as a result of certain surgical, pharmacological, or radiotherapeutic procedures, the passage of time, or lack of development, whether physiological or due to congenital abnormalities.

[0007] BACKGROUND OF THE INVENTION

[0008] Liposuction is a medical procedure aimed at removing excessive or localized adipose tissue. It is typically performed with hollow cannulas connected to a vacuum inlet, commonly found in all operating rooms. An oscillating motion is exerted on the cannula, either manually or assisted by mechanical vibrating devices, following a surface plane where the subcutaneous fat is located. The cannula, with small holes at the tip, breaks up the adipose tissue and partially disaggregates it into small lobes, allowing the fat to exit through the proximal orifice of the cannula, which is in turn connected to a suction system via hollow, flexible tubes. Until the late 1990s, this fat was discarded. The idea of ​​using this tissue as a filler, however, has always been there. Adipose tissue is an ideal candidate for filling soft tissue.The problem consistently described when using fat as a filler has been the partial resorption of this grafted tissue, often unpredictably. The systematization of this tissue processing by Dr. Coleman in the late 1990s greatly improved this behavior, making the outcome of adipose tissue filling predictable. This led to the widespread use of this procedure and its application in multiple fields of cosmetic and reconstructive surgery.

[0009] This prestigious surgeon described a protocol that basically consisted of centrifuging the effluent obtained from liposuction at low speeds in conventional laboratory centrifuges (hereafter centrifuges). This technique remains widely accepted among surgeons in the field of aesthetic, plastic, and reconstructive surgery to purify and separate the different components of adipose tissue.

[0010] The fluid obtained after liposuction has three fundamental components in its composition, which are evident after centrifuging the sample, from top to bottom, according to its density (low in the upper layers and high in the lower ones):

[0011] 1- Fragmented adipose cells (what we will call “oil”).

[0012] 2- Viable adipose tissue.

[0013] 3- Serohematic fluid.

[0014] Although not generally visible, given that it is a very small fraction of adipose tissue, when mature adipocytes break down, the so-called stromal cells, better known by their acronym SVF (stromal vascular fraction hereafter), are released. These cells are located between layers 2 and 3. There are numerous devices on the market whose main purpose is precisely to release this SVF from mature adipose cells, since different pluhpotent cell lines can be characterized with great interest in regenerative medicine. Globally, these immature cells are usually referred to as adipose-derived stem cells, ASCs hereafter. These three components have different physical characteristics and can be separated by other methods, such as filtration, which some commercial devices employ for this purpose.The separation of these components is intended to select only viable cells, which can be used in cosmetic, plastic, and reconstructive surgery procedures for the aforementioned indications.

[0015] Processing adipose tissue by centrifugation with the current state of the art is slow and tedious, mainly for two reasons:

[0016] First, the centrifugation devices used are the same as those used in other laboratory settings, for example, clinical analysis. These commercially available devices are designed to process small individual samples and therefore have small wells in which the sample containers are placed. For this general use, the wells can accommodate, at most, 10 to 50 cc syringes, and most models allow processing of 8 to 10 small syringes, or 4 larger ones, per centrifugation round. It should be noted at this point that the volume of fat processed in many reconstructive and cosmetic surgery procedures can exceed 1000 cc, and therefore, it is understandable that, in small syringes, it is extremely long and tedious to process the entire required sample volume.

[0017] Secondly, the steps in Dr. Coleman's centrifugation processing protocol include, but are not limited to, the following:

[0018] Once liposuction is performed, the raw adipose tissue is transferred to syringes. A cap is placed on the end of the Luer Lock (universal) syringe, and the plunger is carefully removed, holding it vertically. Each syringe body thus prepared is placed in the sample well of the centrifuge. The rotor of said machine must be sterilized after each use to prevent contamination of the syringes, which can then be maintained asepsis and safely returned to the surgical field. After centrifugation for 3 minutes at a speed of 2000 to 3000 rpm, equivalent to 1500 g, the operating room assistant must individually collect each syringe, open the cap, and allow the layer closest to the syringe outlet (serum) to freely flow out.The oil is then discarded from each syringe by tilting it towards the plunger inlet area and finally, the plunger is replaced leaving the viable adipose tissue layer ready for infiltration. It should be noted at this point that during centrifugation, the centrifuged syringe bodies do not have a plunger, as it would collide with the centrifuge lid. This means that the adipose tissue is in direct contact with the ambient air for several minutes. For this reason, the centrifugation system is classified as “non-closed” and is therefore more susceptible to contamination by viruses, fungi or bacteria present in the ambient air, as opposed to commercial systems in which the fat is never exposed to the outside environment and which are considered “closed”, thus helping to reduce the risk of contamination / infection.

[0019] Due to its complexity and lack of automation, this protocol also requires one or more highly qualified individuals specifically dedicated to the task of fat processing—usually the scrub nurse or an assistant surgeon—and external personnel to open and close the centrifuge with each centrifugation cycle, as well as start it up (the centrifuge housing, lid, etc., are not sterile, only the rotor), with the associated cost and time. The surgeon, remember, will be performing the liposuction procedure to provide the tissue for processing, so his or her attention cannot / should not be focused on these important processing steps.

[0020] More recently, closed adipose tissue filtration and washing systems, such as Puregraft R and Revolve R, have gained popularity. It is important to note that, as they are based on a filter of a specific pore size, these systems also allow small adipose globules to pass through, thereby generating significant waste of otherwise perfectly viable adipose tissue.

[0021] Centrifugation also allows for maximum physical concentration of adipose tissue, modifying its theological characteristics. Thus, the grafted product is much denser than that obtained by filtration or decantation. This characteristic is very advantageous, since the cohesiveness of the tissue processed by centrifugation prevents it from diffusing into surrounding tissues or undesired areas.

[0022] Once the fat has been processed, by whatever method, the standard technique for any fat graft consists of transferring it into syringes, which are attached to small-caliber cannulas, and the fat is distributed evenly throughout the area to be treated. This final aspect of the technique is identical whether it is decanted, filtered, or centrifuged, and is not affected by our invention. DESCRIPTION OF THE INVENTION

[0023] The proposed device for purifying and isolating adipose tissue components fully satisfactorily resolves the aforementioned problem, based on a highly effective solution.

[0024] To this end, the device of the invention is replaceable and single-use, allowing the processing of a volume of between 700 and 1200 cc of adipose tissue per round of centrifugation.

[0025] It is therefore a compact, lightweight, sterile, closed device that is very easy to use and can be reused on the same patient, allowing it to process the entire volume required to meet the needs of the particular case.

[0026] More specifically, the device, intended to collect adipose tissue directly obtained by liposuction, has a tubular configuration in the form of a truncated cone, and is limited on its internal face by a wall parallel to the external one, delimiting a hollow space, or deposit, for the reception of fat, whose profile view consists of a rhomboid parallelogram, with a narrow base and high height (8). This arrangement is identical to that of a syringe or laboratory sample inserted into the processing well of any laboratory centrifuge, and is the characteristic that will allow the stratification of the different components of the adipose tissue into different layers or strata, according to their density.

[0027] At the upper base of the truncated cone two ports are established:

[0028] An input port or socket (2) to the deposit (of adipose tissue), intended to be connected by plug to the tubing that conducts the suction force towards the cannula of the liposuction equipment.

[0029] Diametrically opposed to said inlet, a second port (3) or outlet (air) is established, which is connected, also by plug, to the air suction system available in any operating room, or to a specific vacuum machine for liposuction, the latter case with the advantage of being able to select the suction power. In correspondence with the bottom of the tank, a third hole (4) is established, assisted by a plug or three-way valve (5), which will allow the tank to be emptied once the centrifugation process has finished.

[0030] This unilateral element will have a minimum weight, so that it affects the balance of the tank as little as possible in its centrifugation process, having foreseen that in diametrical opposition said tank can include a counterweight (6) that balances the whole.

[0031] The device thus described will be fitted by means of a plug onto the metal axis of rotation (9) of a centrifuge, which constitutes a universal element of all of them. For this purpose, there is obviously a hole (7) in the centre of rotation of the truncated cone, which passes through the device in its entirety, and has the appropriate diameter for its plug adjusted to the axis of rotation of the centrifuge (9).

[0032] A screw (13) or other tongue and groove system will allow stable fixing of this device to the centrifuge rotor shaft.

[0033] The objective of the invention is to achieve the stratification of the liposuction effluent (17) into its different components in horizontal strata, which will be arranged exactly the same as the adipose tissue processed following the Coleman method, that is, oil, viable fat and serum at the bottom. The advantage of our device lies in the fact that said biological material will be contained in a single cavity, of estimated volumes between 700 and 1200 cc (limited only by the size of the centrifuge bowl), allowing the simultaneous processing of a large volume of biological material, thus greatly accelerating the processing with respect to the current state of the art. Furthermore, it can be appreciated that it is a closed system, the adipose tissue follows a closed circuit from the liposuction cannula, during centrifugation, and until its final transfer to syringes.

[0034] The invention therefore consists of replacing the standard centrifuge rotor, which invariably has a plurality of wells for locating the sample containers, with a single hollow tank. It is its rhomboid configuration in the sectional view (8, 20) that causes the lower strata of the fluid housed inside to be subjected to g forces much greater than the surface strata, since, following the formula for the g force in a centrifugal machine, namely: g = rpm 2 x 1.118 x 10 -5 x r, we see that the relative difference will be directly proportional to the difference in the radius of the upper sections of a truncated cone with respect to the lower ones. For example, if we take a device size with an average upper radius of 6 cm and an average lower radius of 11 cm, the g force in the upper strata will be, rotating at 3500 rpm, for example, 822 g, and in the lower ones, 1507 g.This gradient enables our device to separate liquid / semi-solid biological tissues with components of different relative densities. Although we refer throughout to adipose tissue and the stromal vascular fraction, this device can certainly be used in other laboratory settings, such as medical or veterinary research, or perhaps in the food industry. We focus on adipose tissue processing and SVF extraction because that is our area of ​​professional expertise.

[0035] As for the ratio between the radius of the upper base of the truncated cone and the lower base, we estimate a difference of between 40 and 100 % between these dimensions to be optimal. In other words, the angle of inclination of the rhomboid (20) should be between 20 and 45 0 with respect to the vertical axis, to achieve optimal separation of components of the fluid to be separated in the vertical direction.

[0036] In a preferred embodiment, the geometric figure in the coronal section of the tank may not be a rhomboid, but a trapezoid (21), defined by:

[0037] A lower side that is longer than the upper side, these two sides being parallel to each other.

[0038] An outer side with a greater angle relative to the device's axis of rotation than the inner side. This maximizes the ability to separate, at lower levels of the tank, not only horizontal strata with different compositions, but also heavier elements of a given stratum, located in the peripheral rings of that stratum. This is because, with this design, there will be a maximum differential in g-force between the upper and inner regions of the tank and the lower and outer regions.

[0039] The upper and lower sides of this geometric figure in the coronal section of the tank may not be parallel to each other, and may not be horizontal, with a variable slope outwards, with respect to the horizontal (22). They may also be, one or both, arcs of a circle (23, 24). Finally, all sides of the rhomboid of the original design may be arcs of circles with equal or different radii (25). Thus, the equipment will have centrifuges already existing on the market.

[0040] As previously mentioned, the tanks will be single-use and can be made of biocompatible plastic, such as polyethylene or polycarbonate. They have the advantage of being translucent or transparent, allowing for evaluation of the different cellular layers while they are being extracted. Regarding the manufacturing method, additive manufacturing using 3D printing may initially be used, although in the mass production phase, plastic injection molding or extrusion may be the ideal manufacturing method due to its low cost. They could also be made of metal suitable for surgical use, such as stainless steel or titanium.

[0041] In a preferred embodiment, to preserve the sterility of the tank and allow its safe return to the surgical field, a sterile cover (26) can be manufactured very simply with a shape adapted to the core of the centrifuge being used, which has a hole (27) in its base, suitable for the passage of the centrifuge rotor shaft (9).

[0042] According to a second embodiment of the invention, one or more sieves (14) may be included between the inner and outer walls of the tank, preferably in a radial arrangement, to break up the larger particles of adipose or fibrous tissue. The purpose of this screen is twofold:

[0043] On the one hand, to prevent the syringes used for adipose tissue drainage or the outlet opening from becoming blocked by fibrous tissue accumulations. This is a common problem with many adipose tissue processing systems. On the other hand, by agitating and fragmenting the adipose tissue, stromal cells are released, allowing, with the appropriate rotation speed and time, a large proportion of mature adipose cells to be disrupted. The device serves, in this case, to select the SVF. To achieve this objective, the holes in the mesh or sieve are not intended to be a very small filter, unlike filtration systems, which do separate serum from adipose tissue thanks to the small hole size of their filter.

[0044] In our device, this stratification of the effluent into its components is achieved exclusively by centrifugal force, and not by any filter. In fact, and as a guide, the hole sizes can range from 2 mm to 10 mm. The primary purpose of this sieve is, therefore, to break up large globules of adipose and fibrous tissue.

[0045] In this regard, it should be noted that, at the beginning of centrifugation, and until the programmed spin speed is reached, the adipose tissue does not rotate in unison with the tank, just as a teaspoon rotates faster than the coffee in a cup until their speeds equalize. It is the friction of the fluid with the tank walls that ultimately causes the fluid to rotate at the same speed as the tank. During these first spins, this sieve can perform the aforementioned function.

[0046] The description of this sieve (14) is merely exemplary, and not limiting in terms of the number of sieves within the tank, orientation with respect to the rotor axis, arrangement of the holes, size or position of the same, etc.

[0047] Also optionally, near the base of the reservoir a horizontal membrane (16) could be implanted that physically separates the reservoir outlet from the fluid layer immediately above it. The relevance of this separating partition consists in that, as we have said, the interest of the device lies in being able to separate the different layers of different components in a very precise manner. When the fluid level is close to the interface between any 2 layers, this separating membrane (14) moves the aspiration vortex of the syringe away from its immediately higher level, avoiding the inadvertent mixing of viable adipose tissue with the oil, or of serum with the adipose tissue.

[0048] Also optionally, in the opposite positions 90° to the outlet hole (tentative location, although this configuration allows easy balancing of the assembly), two or more small sub-reservoirs (18) are arranged threaded into the base of the reservoir, and with direct access to it through small holes in the base of the reservoir. The purpose of these small receptacles, located in the most distal and external portion thereof, is to collect the densest portion of tissue after evacuation of the serosanthematic fluid, that is, the one corresponding to the SVF. This portion of the liposuctioned tissue contains a large population of cells with a regenerative role widely studied in the scientific literature. These small reservoirs collect these cells based on the fact that their specific density is greater with respect to oil, and to purified adipose tissue, but lower than the serosanthematic fluid.The entrance opening of each of these sub-deposits will therefore be located in the lower and lateral portion of the depot. It is envisaged that these depots may be attached to the main depot by means of a screw or other system that allows for easy release and simultaneously preserves the tightness of the assembly. In this way, the SVF can be isolated from the rest of the adipose tissue using the mechanism discussed below. They may also remain permanently attached to the main depot. Separation of the SVF from mature adipocytes can be achieved, as described in the literature, by using higher spin rates and centrifugation times of the centrifuge. In this way, a significant proportion of the mature adipocytes, or even all of them, will be inevitably fragmented, and the SVF will remain as the cellular layer immediately below the unfragmented adipose tissue.In this scenario, it is easy to deduce that these cells, heavier than unfragmented mature adipose tissue, preferentially lodge in the sub-deposits, as their entrance is located in the most lateral and inferior portion of the main depot. This can also be achieved by making the lower base of the truncated cone elliptical, rather than circular. The entrance to the sub-deposits will be located, in this case, at the end most distal to the central axis, following the major axis of the ellipse.

[0049] Based on this structure, the operation would be as follows:

[0050] After removing the device from its sterile packaging, it is placed horizontally in the surgical field, the upper inlet and outlet ports (2, 3) are connected to the connection tubes to the aspiration cannula, on the one hand, and to the connection tubes to the vacuum, on the other, and the lower drain valve (4) is grounded, so that once this is done, the surgeon can begin liposuction, continuing until the fluid obtained (17) reaches the maximum suction level. It is very important to keep the tank in a horizontal position, to avoid the accidental exit of the adipose tissue through the upper hole that is connected to the suction (3).

[0051] Once the tank is full, the pipes are disconnected and the upper plugs designed for this purpose (28) are screwed on. In this way, the entire contents of the tank can be centrifuged simultaneously, without needing to extract it using syringes or undergo any additional manipulation. The tank, thus closed, is placed by plugging onto the rotor shaft (9) of the centrifuge (12). A screw (13) with a wide head (10) for this purpose fixes the tank to said shaft (many commercially available centrifuges have metal shafts that, as standard, have a thread inside, precisely because it is essential to stabilize the rotors of the centrifuges by means of some simple fixing system).

[0052] Once the adipose tissue has been centrifuged for the time contemplated in the Coleman protocol, or another different time and spin protocol, the centrifuge lid (15) is opened, the fixing screw (13) is released, the device is carefully removed from the centrifuge, and placed in a horizontal position or slightly inclined towards the lower outlet port (4).

[0053] The 3-way valve (5) or plug at the bottom of the tank is opened to drain the serum, by gravity or with syringes. Once the level of purified fat is reached (19), it is transferred to the desired size syringes for infiltration. The process concludes when the oil level is reached, which is discarded. Finally, the SVF, which we remember is deposited in the sub-tanks (18) for this purpose, can either be removed by unscrewing them, for individual use of the SVF in regenerative indications, or incorporated into the fat once the serum has been drained. The tank, once empty, can be returned to the surgical field, and liposuction and the collection of more additional fat can be restarted.

[0054] This creates easy-to-use, simple equipment capable of processing larger volumes of tissue in less time and in a completely closed and sterile manner.

[0055] BRIEF DESCRIPTION OF THE DRAWINGS

[0056] To complement the description that follows and in order to help better understand the characteristics of the invention, in accordance with a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description, in which the following has been represented for illustrative and non-limiting purposes:

[0057] Figure 1.- Shows a perspective view of the device for purifying and isolating components of adipose tissue made in accordance with the object of the present invention.

[0058] Figure 2.- Shows a diametrical section view in a vertical plane of the assembly in Figure 1.

[0059] Figure 3.- Shows the different tank design variations, shown in a diametrical section view in a vertical plane of the device, showing possible designs of said tank as a rhomboid (20), trapezoid with upper and lower bases parallel to the horizontal plane (21)1, trapezoid with upper and lower bases inclined towards the external slope of the tank (22), figures in which one or several sides of the original rhomboid have been replaced by circular arcs (23, 24 and 25).

[0060] Figure 4 shows a view similar to that of Figure 1, but corresponding to a vahante embodiment in which the tank includes a sieve (14) arranged radially between its internal and external side walls.

[0061] Figure 5.- Shows a perspective view of the placement of the tank (1) in the centrifuge (12) by plugging it into the centrifuge's rotation axis (9), and the possible stabilization of the assembly by means of a fixing screw (13).

[0062] Figures 6 and 7 show diametrical section views of the tank filled with adipose tissue to be treated, before and after the centrifugation process.

[0063] Figure 8.- Shows a view similar to that of Figure 1, but corresponding to a variant of an embodiment in which the tank includes a horizontal separating membrane at the level of its lower base.

[0064] Figure 9.- Shows a bottom perspective view of a variant of the device in Figure 1, which includes basal deposits for collecting the SVF (18).

[0065] Figure 10.- Shows a sectional view of a vahante embodiment of the device of the invention showing the location of the sub-tanks along the major axis of a lower base of the elliptical truncated cone, as well as the closing plugs of the upper inlets of the device.

[0066] Figures 11 to 13 show three other variants of the configuration that the device of the invention could adopt. PREFERRED EMBODIMENT OF THE INVENTION

[0067] In view of the figures outlined, and especially Figure 5, it can be observed how the device of the invention uses the conventional structure of a sample centrifuge equipment (12), whether existing or designed for this purpose, in which a casing open at the top participates, assisted by a closing cover (15), inside which an electric motor is established, with a vertical axis of rotation (9), defining a receptacle for the introduction of the samples to be centrifuged.

[0068] In any case, and in accordance with the invention, it has been provided that the vertical axis of rotation (9) of the centrifuge is connected by plug, tongue and groove, screwing, or other fixing means, to a device (1) for receiving the adipose tissue to be purified.

[0069] The equipment could include a sterile bottom cover (26) of the centrifuge bowl, with a hole (27) through which the vertical axis of rotation (9) emerges, so that the accidental spillage of the contents of the tank, or the accidental contact of the instrumental nurse with the edge of the centrifuge bowl does not compromise the sterility of the procedure.

[0070] As can be seen in Figure 1, the device (1) has a tubular configuration in the form of a truncated cone, at the upper base of which there is an input port or socket (2), for universal coupling to a vacuum system, intended to be connected to the cannula tubing of the liposuction equipment, while in diametrical opposition to said input socket there is a second output port or socket (3) that is connected to any air aspiration system.

[0071] In correspondence with the bottom of the tank and on the external side edge of the same, a third intake is established, for emptying in this case, (4) assisted by a three-step valve (5), or another plug for this purpose.

[0072] To compensate for the imbalance that said drain outlet (4) with its key may generate in the centrifugation process, the tank includes a counterweight (6) in diametric opposition.

[0073] The configuration of the device in the form of a truncated conical tubular element will be suitable so that the diameter of the upper base is smaller than the diameter of the lower base, and is limited on its internal face by a wall parallel to the external one, delimiting a hollow space, or deposit, for the reception of the grease, which, in a vertical section view, consists of a rhomboid parallelogram, with a narrow base and high height (8).

[0074] As for the ratio between the radius of the upper base of the truncated cone and the lower base, we estimate a difference of between 40 and 100% between these dimensions to be optimal. In other words, the angle of inclination of the rhomboid should be between 20 and 45 0 with respect to the vertical axis, to achieve optimal separation of the fluid components in the vertical direction. This inclination is the same one used in the design of the laboratory centrifuge rotor, which our device replaces.

[0075] In a preferred embodiment, the geometric figure in the coronal section of the tank may not be a rhomboid, but a trapezoid (21), defined by:

[0076] A lower side that is longer than the upper side, these two sides being parallel to each other.

[0077] An outer side with a greater angle relative to the tank's axis of rotation than the inner side. This maximizes the ability to separate, at lower levels of the tank, not only horizontal strata with different compositions, but also heavier elements of a given stratum, located in the peripheral rings of that stratum. This is because, with this design, there will be a maximum differential in g-force between the upper, inner regions of the tank and the lower, outer regions.

[0078] The upper and lower sides of this geometric figure in the coronal section of the device may, in other design variations, not be parallel to each other, and may also not be horizontal, with a variable slope with respect to the horizontal (22). They may also be, one or both, arcs of a circle (23, 24). Finally, all sides of the rhomboid of the original design may be arcs of circles of equal or different radii (25.

[0079] This tank, as well as the entire device itself, can obviously be manufactured in different sizes, with the preferred embodiment having a volume, merely as an example, between 700 and 1200 cc.

[0080] According to the embodiment shown in figure 4, between the internal and external wall of the tank (1), preferably in a radial arrangement, a chba (14) may be included that collects the larger particles of adipose or fibrous tissue, which allow said particles to be broken, so that the device serves in this case to select the SVF.

[0081] As shown in Figure 8, in a second embodiment of the invention, it has been provided that near the lower base of the tank (1) a horizontal membrane (16) is arranged that partially affects said base and physically separates the tank's drain inlet hole (4) from the fluid immediately above it.

[0082] The importance of this separating membrane is that, when the syringe filling process with purified adipose tissue is nearing completion, the reservoir outlet will be very close to the oil layer, which includes fragmented and therefore non-viable adipose cells. The separating membrane directs the syringe's aspiration vortex away from its immediately superior level, preventing the inadvertent mixing of viable adipose tissue with the oil from fragmented cells.

[0083] According to figures 9 and 10, the presence of at least 2 small sub-tanks (18) located at the lower base of the tank, diametrically opposed and on the axis at 90° of the outlet port of the tank has been provided. In this way, the 4 components of the liposuction fluid can be sequentially drained. For better operation of this solution, optionally the base of the device could not be circular, but in the shape of an ellipse, so that the inlet to the sub-tanks will be located, in this case, at the most distal end to the central axis following the major axis of said ellipse.

[0084] Based on the presence of these sub-deposits, aimed at the selection of the SVF, the operating procedure of the device would be as follows:

[0085] First, the serum comes out when the bottom cap is opened, or it is drained using syringes.

[0086] Secondly, the purified adipose tissue is collected.

[0087] Thirdly, the oil can be drained, which in practice will be the last syringe aspirated before the reservoir is completely emptied, which is then discarded, as it contains non-viable fat cells.

[0088] Finally, the SVF can be selected by unscrewing the small reservoirs at the base of the reservoir. If SVF-enriched adipose tissue is desired, the de-oiled adipose tissue can be added back to the reservoir through either the top or bottom fill ports. By shaking or inverting it, the adipose tissue easily mixes with the SVF, ultimately obtaining SVF-enriched adipose tissue.

[0089] It is relevant to point out that, although the truncated cone is the geometric shape with the greatest structural rigidity and economy of materials (best surface / volume ratio), the present invention also covers any proposal for manufacturing a device with similar geometries that allow the physical principle of centrifugal separation of fluids with different components, that is, tanks with the shape of a truncated pyramid, a base with an ellipsoid shape (elliptical cone) or any combinations of said geometries, such as those shown in figures 11 to 13.The most relevant criterion for achieving centrifugation, obviously, is that the radius of revolution of the reservoir at the top of the device must be smaller than the radius of revolution of the reservoir at the bottom of the device (thus, greater centrifugal force at the bottom of the reservoir, and therefore, light components will be collected in the upper layer, and heavy components of the sample, in the lower layer).

[0090] Similarly, and as shown in Figure 13, the invention also provides for the pairing of more than one tank in an equiangularly distributed manner around a common centrifugation axis, where the tanks have a width of their lower base greater than that of their upper base.

[0091] According to figure 14, in a preferred embodiment, to preserve the sterility of the tank and allow its safe return to the surgical field, a sterile cover (26) can be manufactured very simply as a tray, with a shape adapted to the core of the centrifuge being used, which has a hole (27) in its base, suitable for the passage of the rotor shaft of the centrifuge (9).

Claims

1. Device for purifying and isolating components of adipose tissue, being of the type that uses centrifuge equipment, in which a housing (7) with upper access participates, inside which an electric motor is established, with a vertical axis of rotation (9), defining a receptacle or bucket for the introduction of the samples to be centrifuged, characterized in that the vertical axis of rotation (9) is linked to a device^ ) for receiving the adipose tissue to be purified, which has a tubular configuration in the form of a truncated cone, in whose upper base an inlet port or socket (2) is established, of universal coupling to the vacuum cannula of the liposuction equipment, including a second port or outlet (3) that is connected to an air aspiration system, which leads to a circumferential tank that, in its section view, has the shape of a rhomboid geometric figure (8),It has been foreseen that in correspondence with the bottom of the tank and on the external lateral edge of the same a drain inlet (4) is established assisted by a three-way valve (5), in opposition to which the tank includes on its opposite edge a counterweight (6).

2. Device for purifying and isolating components of adipose tissue, according to claim 1, according to a sectional view of the device, wherein the geometric shape of the tank (8) mentioned in claim 1 can be seen, which enables the device to allow the separation of a fluid with components of different densities, which will be organized in horizontal strata when the device rotates with the assistance of a centrifuge device, the axis of which will be housed in the central hollow space for this purpose (7).

3. Device for purifying and isolating components of adipose tissue, according to a sectional view of alternative designs of the reservoir defined according to claims 1 and 2.

4. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein between the internal and external wall of the tank (1), preferably in a radial arrangement, a sieve (14) is included for fragmenting the larger particles of adipose or fibrous tissue.

5. Device for the purification and isolation of components of adipose tissue, according to claim 1, where the presence of selective closing plugs of ports 2 and 3 (28) can be seen, which, once sealed by said plugs, allow the connection by means of a plug of said device (1) to the rotor shaft of a centrifuge (9), and its stabilization by means of a fixing screw (13) whose stem passes through the hole of the device for this purpose (7), screwing directly to the axis of the centrifuge (9) and fixing the device to the centrifuge by having a screw head (10) wider than the central hole (7) of the device.

6. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the unpurified adipose tissue fills the reservoir completely (17) 7. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the reservoir, once centrifuged, (1) can be emptied by syringes or other drainage means through the outlet port (4) 8. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein a horizontal membrane (16) is arranged near the lower base of the tank (1) which partially affects said base and physically separates the drain inlet hole (4) from the tank from the fluid immediately above it.

9. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the tank (1) includes at least 2 small sub-tanks (18) located at the lower base of the tank, diametrically opposed, determining the means of drainage in sequence of the four components of the liposuction fluid.

10. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the sub-tanks have their inlet and connection to the main tank at the end most distal to the axis of rotation of the device, the lower base of which is elliptical in shape and said inlets are located on the major axis of said ellipse.

11. Device for purification and isolation of components of adipose tissue, according to claim 1, wherein the tank (1) is capable of adopting a configuration in the form of a truncated pyramid.

12. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the reservoir (1) is capable of adopting a configuration in the form of an elliptical truncated cone.

13. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the device (1) is made up of more than one tank equiangularly distributed around a common centrifugation axis, wherein the tanks have a width of their lower base greater than that of their upper base.

14. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the device includes a sterile bottom cover of the container (26), with an orifice (27) through which the vertical axis of rotation (9) emerges.

15. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein in a preferred embodiment, and like claim 14, referring to the means for preserving the sterility of the device, and thus allowing the reuse of the deposit recommended according to claim 1, a sterilizable adapter base (29) can be manufactured, which connects by plug, on one side with the axis of the centrifuge (9) by means of a hole (30) and on the external face it will be designed as a truncated cone in such a way that it fits with the internal face of the deposit for collecting adipose tissue.

16. Device for purifying and isolating components of adipose tissue, being of the type that incorporates centrifuge equipment, in which a housing (7) with upper access participates, inside which an electric motor (8) is established, with a vertical axis of rotation (9), defining a receptacle or bucket for introducing the samples to be centrifuged, characterized in that the vertical axis of rotation (9) is linked to a base (11) of adaptation for a tank (1) for receiving the adipose tissue to be purified, tank (1) that has a tubular configuration in the form of an inverted truncated cone, in whose upper base an inlet port or socket (2) is established, of universal coupling to the vacuum cannula of the liposuction equipment, including a second port or outlet (3) that is connected to an air aspiration system, having been provided that in correspondence with the bottom of the tank and on the external side edge of the same, a drain outlet (4) is established assisted by a three-step valve (5), in opposition to which the tank includes a counterweight (6) on its opposite edge.

17. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the base (11) has a discoidal configuration, with a central upper truncated-conical appendage in accordance with the configuration of the internal face of the tank (1), base that includes a tongue and groove coupling to the vertical axis of rotation (9), as well as an upper hole for the passage of a screw for stabilizing the assembly, threadable on the vertical axis of rotation (9) and finished in an upper cover for retaining the tank (1).

18. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein between the internal and external wall of the tank (1), preferably in a radial arrangement, a filter (14) is included for collecting the larger particles of adipose or fibrous tissue.

19. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein a horizontal membrane (16) is arranged near the lower base of the tank (1) which partially affects said base and physically separates the drain inlet orifice (4) from the tank from the fluid immediately above it.

20. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) has a single-use character.

21. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the input (2) and output (3) ports include selective use plugs.

22. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) has a volume of between 1200 and 1400cc.

23. Device for purification and isolation of components of adipose tissue, according to claim 16, wherein the control electronics of the device are powered by a rechargeable battery system.

24. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the device includes a sterile bottom cover of the container, with a hole through which the vertical axis of rotation (9) emerges.

25. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the tank (1) ends in an upper base from which a hollow central neck or axis emerges internally with means for connecting directly to the rotor axis of the centrifuge machine.

26. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) includes at least 2 small sub-reservoirs (18) located at the lower base of the reservoir, diametrically opposed, determining means for sequential drainage of the four components of the liposuction fluid.

27. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the base of the tank (1) is elliptical, so that the entrance to the sub-tanks (18) is located at the ends of the major axis of said ellipse.

28. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) is capable of adopting a configuration in the form of a truncated pyramid.

29. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) is capable of adopting a truncated cone-shaped configuration.

30. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the reservoir (1) is capable of adopting a configuration in the form of a truncated elliptical cone.

31. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the tank (1) is made up of more than one tank equiangularly distributed around a common centrifugation axis, wherein the tanks have a width of their lower base greater than that of their upper base.

32. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the device is complemented with a sterile cover (19) in the form of a tray with a shape adapted to the bottom of the centrifuge, which has a hole (20) in its base, suitable for the passage of the rotor shaft of said centrifuge.

33. Device for purifying and isolating components of adipose tissue, according to claim 16, wherein the tank (1) includes plugs (26) corresponding to the inlet (2) and outlet (3) ports.

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