ES3023107A1 - Device for purification and isolation of adipose tissue components (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Device for purifying and isolating components of adipose tissue. Based on the structuring of a conventional centrifuge or one designed for this purpose, the device of the invention includes a tank (1) for receiving the adipose tissue to be purified, and which has a tubular configuration in the form of a truncated cone, at the upper base of which there is an inlet port or socket (2), for universal coupling to the vacuum cannula of the liposuction equipment, and a second port or outlet (3) that is connected to an air aspiration system. In correspondence with the bottom of the tank and on the external lateral edge thereof, there is a drain socket (4) assisted by a three-way valve (5) and opposite it a counterweight (6). The device allows the separation of viable adipose cells extracted after a liposuction process, being capable of treating large volumes of adipose tissue quickly and easily. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

Device for purification and isolation of adipose tissue components

TECHNICAL SECTOR

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

The object of the invention is to provide a device, lightweight and easily sterilizable 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 body areas that are deficient as a result of certain surgical, pharmacological or radiotherapeutic procedures, the passage of time or lack of development due to congenital anomalies.

BACKGROUND OF THE INVENTION

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, which is universally found in all operating rooms. If this inlet is unavailable, vacuum machines are occasionally connected independently of the operating room's general suction inlet. A manual oscillating motion is exerted over the cannula following a surface plane where the subcutaneous fat is located. The cannula, with small holes at the tip, breaks up the adipose tissue and "breaks" it up, allowing the fat to exit through the cannula connected to a suction system. This fat, until the late 1990s, was discarded.

The idea of using that fabric as a filling material, however, has always been there.

Prostheses, although made with biocompatible materials, are not without risks, and artificial fillers also present multiple disadvantages. Adipose tissue was, therefore, an ideal candidate for these goals of filling soft tissue. The problem described has always been the partial resorption of this grafted tissue, often unpredictably. The systematization of the processing of this tissue by Dr. Coleman in the late 1990s led to the widespread use of this procedure, which basically involved centrifuging it at low speeds. 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.

In this regard, the most recently published scientific article investigating this topic is from March 2023. Vizcay M, Saha S, Mohammad A, Pu LLQ, Yoshimura K, Magalon G, Khouri R, Coleman S, Rigotti G, DeFazio S. Current Fat Grafting Practices and Preferences: A Survey from Members of ISPRES. Plast Reconstr Surg Glob Open. 2023 Mar 29;11(3):e4849. doi: 10.1097/GOX.0000000000004849. PMID: 37006989; PMCID: PMC10060090.

Among the authors is Dr. Coleman, the "inventor" of adipose tissue purification techniques as we know them today, and this work confirms that centrifugation remains the preferred method for processing adipose tissue.

The fluid obtained after liposuction is composed of three fundamental components: viable adipose tissue, fragmented adipose cells (what we refer to as "oil"), and blood serum. Each of these three components has distinct physical characteristics and can be separated by various methods, the most commonly used being filtration and centrifugation.

The separation of these components aims to exclusively select viable adipose cells, which can be used in cosmetic, plastic, and reconstructive surgery procedures to restore or increase the volume of certain body areas that are deficient as a result of certain surgical, pharmacological, or radiotherapeutic procedures, the passage of time, or lack of development due to congenital abnormalities.

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

First, the centrifugation devices used are the same as those used in other laboratory settings, for example, clinical analysis. Commercially available devices are heavy, large, and the entire external chassis is either not sterilizable or impractical to sterilize, given their weight and size. Therefore, they cannot be used within the surgical field itself.

Although home-made devices for fat processing are known, the sterility of the centrifugation system is important, and this is difficult to achieve with standard centrifuges.

On the other hand, all centrifuges on the market are designed to process small, individual samples and therefore have 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 can process 8 to 10 small syringes or 4 larger ones per centrifugation round.

Once centrifugation is complete, which must be done with extreme care to avoid contaminating the samples, the operating room assistant must individually collect each syringe, manually separate the serum, which remains at the bottom of the syringe, and recover the already isolated adipose tissue from the serum. Carefully replace the plunger on the syringe, leaving it ready for injection. In the best-case scenario, the traditional centrifugation technique allows for the processing of 120-200 cc of unpurified adipose tissue in each round (the sample must spin for 2 to 3 minutes at speeds of 2000-3000 rpm). Once centrifuged, this process becomes 50-70 cc of adipose tissue ready for infiltration into the desired area. Completing each round, in expert hands, takes 5 to 7 minutes and requires a dedicated person and external personnel to open, close, and start the centrifuge, at the expense of time and expense involved.

Since many cosmetic and reconstructive surgery procedures require processing 800–1600 cc of adipose tissue, the traditional technique can take up to 90–120 minutes to process the tissue alone. More importantly, a dedicated operating room assistant/scrub technician is dedicated exclusively to processing the adipose tissue, with the associated operating room costs. This has led many surgeons to resort to simple adipose tissue decanting techniques.

It seems obvious that, although decantation is not a bad system, it is not feasible to achieve the concentration/compaction of adipose tissue that is achieved by centrifugation, and the proof of this is that, even in those surgeons who systematically use decantation, when a small volume is required and its location is very precise, they (almost) always centrifuge their fat sample to obtain the graft of the highest quality and density possible.

More recently, closed adipose tissue filtration and washing systems, such as Puregraft R, have gained popularity, primarily because they are closed, sterile systems that are faster than traditional centrifugation for medium volumes and achieve similar adipose tissue quality in terms of cell viability.

Its cost, however, is quite high, especially for processing large volumes.

It's important to emphasize that decantation or filtration lacks one unsurpassed advantage of centrifugation: the latter allows for maximum concentration of adipose tissue, and the graft product is much denser than that obtained by filtration or decantation. This characteristic is very advantageous, since the density of the processed tissue prevents it from diffusing into surrounding tissues or undesired areas, or from spontaneously escaping through the adipose tissue entry ports.

Once the fat has been processed, by whatever method, the standard technique 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.

EXPLANATION OF THE INVENTION

The proposed device for purifying and isolating adipose tissue components fully addresses the aforementioned problem, providing a highly effective solution.

To this end, the device of the invention is constituted from a piece of equipment that includes a replaceable, single-use tank, which allows the processing of an estimated volume of between 1200 and 1400 cc of adipose tissue per round of centrifugation.

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.

More specifically, the reservoir, intended to be filled with adipose tissue directly obtained by liposuction, has a tubular configuration in the form of an inverted truncated cone, at the upper base of which there is a port or inlet, with universal coupling to a vacuum system, intended to be connected to the tubing of the cannula of the liposuction equipment, in which the surgeon introduces the end of said cannula into the subcutaneous plane of the patient, and by means of oscillating movements, fragments the adipose tissue and aspirates it by suction.

Diametrically opposed to said inlet, a second port or outlet is established that connects 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.

Corresponding to the bottom of the tank, there is a third universal inlet, assisted by a three-way valve, also universal, which will allow the tank to be emptied once the centrifugation process is complete.

This element will have a minimum volume so that it affects the balance of the tank as little as possible during its centrifugation process. It has been planned that in diametrical opposition, said tank will include a counterweight that balances the whole.

The tank thus described will be placed by plugging onto a rotating base that will have a configuration in which a discoidal base is defined, with a central truncated-conical appendage of dimensions in accordance with the internal dimensions of the tank that fits onto this base, an assembly that will be stabilized by means of an upper cover with a fixing screw that threads onto the centrifugation axis itself associated with said coupling base of the tank.

Thus, the equipment will include a housing with a motor that drives a vertical centrifuge shaft to which the aforementioned tank base is connected, making it possible to utilize the structure of some centrifuges already on the market.

As previously stated, the tanks will be single-use.

According to a second variant embodiment of the invention, between the internal and external wall of the tank, preferably in a radial arrangement, a filter may be included that collects the larger particles of adipose or fibrous tissue.

In this sense, at the beginning of centrifugation, the adipose tissue does not rotate in unison with the tank until friction causes the fluid inside the tank to rotate at the same speed. During these first spins, this filter can collect large particles, which could block the tank's outlet and make adipose tissue extraction difficult.

Also optionally, a horizontal membrane could be implanted near the base of the reservoir, physically separating the reservoir's outlet from the fluid immediately above it. The importance of this separating partition is that, when the syringes are nearly filled with purified adipose tissue, the reservoir's outlet will be very close to the oil layer, which includes fragmented adipose cells and is therefore unsuitable for use as an adipose tissue graft.

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

After removing the reservoir from its sterile packaging, it is placed horizontally, the suction and vacuum ports are connected, and the lower drain valve is closed. Once this is done, the surgeon can begin liposuction, continuing until the fluid obtained reaches the maximum suction level. It is very important to keep the reservoir horizontal to prevent accidental leakage of adipose tissue through the upper hole connected to the suction port.

Once the tank is full, the entire contents of the tank can be centrifuged simultaneously, remaining fixed to the rotor shaft of the centrifugal machine.

When the centrifuge is in operation, the centrifuge/tank adapter transmits the rotational motion to the tank, so that they rotate together.

Before starting the centrifugation, the upper ports of the tank must be covered with plugs for this purpose, with two objectives: to minimize contact between the inside of the tank and the outside, and to prevent the contents of the tank from escaping through them during centrifugation.

Once the adipose tissue has been centrifuged, the tank is carefully removed from the centrifuge and placed on the base to drain the adipose tissue.

This is a base that provides stability to the tank and tilts it slightly, allowing the maximum amount of purified fat to drain without mixing with whey or oil. A whey system is connected to the three-way valve, and the valve is opened to drain the whey by gravity or with high-volume syringes.

Once the purified fat level is reached, it is transferred to syringes of the desired size for injection. The process concludes when the oil level is reached, and the oil is discarded. The reservoir can be returned to the surgical field, and liposuction can continue.

This creates easy-to-use, simple equipment capable of treating larger volumes of tissue in less time and in a completely sterilized manner.

BRIEF DESCRIPTION OF THE DRAWINGS

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 its practical embodiment, 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:

Figure 1 shows a perspective view of the reservoir that participates in a device for purifying and isolating components of adipose tissue made in accordance with the object of the present invention.

Figure 2 shows a diametrical section view in a vertical plane of the assembly of Figure 1.

Figure 3 shows a view similar to that of Figure 1, but corresponding to a variant embodiment in which the tank includes a filter arranged radially between its internal and external side walls.

Figure 4 shows an exploded view of the device of the invention.

Figures 5 and 6 show diametrical section views of the tank filled with the adipose tissue to be treated, before and after the centrifugation process.

Figure 7 finally shows a view similar to that of Figure 1, but corresponding to a variant embodiment in which the tank includes a horizontal separating membrane at the level of its lower base.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the figures shown, and especially of figure 4, it can be observed how the device of the invention is based on the conventional structure of a sample centrifuge equipment, whether existing or designed for this purpose, in which a casing (7) is involved, open at the top, assisted by a closing cover (15), inside which an electric motor (8) is established, with a vertical axis of rotation (9), defining a receptacle for the introduction of the samples to be centrifuged.

The device's control electronics can be powered by a rechargeable battery system, giving the device an independent character, although it could also be powered through a mains connection socket.

In any case, and in accordance with the invention, it has been provided that the vertical axis of rotation (9) of the equipment is linked to an adaptation base (11) for a deposit (1) for receiving the adipose tissue to be purified.

Said base (11) has a discoidal configuration, with a central appendage of truncated conical configuration, including a vertical tongue and groove hole, complementary to a tongue and groove (10) provided in the vertical axis of rotation (9), including an upper hole (12) for the passage of a screw (13) associated with the corresponding upper stabilization cover of the tank (1) by screwing it to the vertical axis of rotation (9).

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

As can be seen in figure 1, the tank (1) has a tubular configuration in the form of an inverted truncated cone, at the upper base of which there is an inlet 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 inlet socket a second port or outlet socket (3) is established which is connected to any air aspiration system.

In correspondence with the bottom of the tank and on the external side edge of the same, a third universal intake, or drain intake (4) is established, assisted by a three-step valve (5), also universal.

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.

The configuration in the form of a truncated-conical tubular element will be suitable for the internal face of the tank to adapt tightly to the surface of the appendix provided in the base (11) for adapting the tank to the centrifugal machine, stabilising the assembly, as previously stated, through a screw (13) finished in an upper cover that prevents the vertical movement of the tank.

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 1200 and 1400 cc.

According to the variant embodiment shown in figure 3, between the internal and external wall of the tank (1), preferably in a radial arrangement, a filter (14) may be included that collects the larger particles of adipose or fibrous tissue.

Finally, as shown in Figure 7, in a second variant embodiment of the invention, 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. The importance of this separating partition consists in that, when the process of filling the syringes with purified adipose tissue is about to end, the outlet orifice of the tank will be very close to the oil layer, which includes fragmented adipose cells and is therefore not useful for use as an adipose tissue graft.

Claims (9)

1. 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 an adaptation base (11) 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 lateral edge of the same a drain socket (4) is established assisted by a three-way valve (5), as opposed to which the tank includes a counterweight (6) on its opposite edge. 2. Device for purifying and isolating components of adipose tissue, according to claim 1, 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). 3. 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 filter (14) is included for collecting the larger particles of adipose or fibrous tissue. 4. 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 orifice (4) from the tank from the fluid immediately above it. 5. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the reservoir (1) has a single-use character. 6. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the input (2) and output (3) ports include selective-use plugs. 7. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the reservoir (1) has a volume of between 1200 and 1400cc. 8. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the control electronics of the device are powered by a rechargeable battery system. 9. Device for purifying and isolating components of adipose tissue, according to claim 1, wherein the device is a sterile bottom cover of the container, with a hole through which the vertical axis of rotation (9) emerges.