Method for purifying adipose tissue and associated purified adipose tissue
Patent Information
- Application Number
- FR2021013138
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-12-08
- Publication Date
- 2025-08-22
- Estimated Expiration
- 2041-12-08
Smart Images

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Abstract
Description
Title of the invention: Method for purifying adipose tissue and associated purified adipose tissue Technical field
[0001] The present invention relates to a method for purifying adipose tissue and an associated purified adipose tissue suitable for reintroduction into the body of a patient. The invention finds application in particular for autologous adipose tissue grafting operations (referred to as "lipofilling" in English) for aesthetic and reconstructive purposes. The invention finds use, in particular, for breast surgery operations, the implementation of the invention however not being limited to this application. Prior art
[0002] Autologous adipose tissue grafting operations are used in surgery, particularly in breast surgery, to shape the breast to give it a more natural appearance after a Deep Inferior Epigastric Perforator (DIEP), a latissimus dorsi flap reconstruction, or after the placement of a breast implant. These operations consist of taking fat from a patient in a donor area and then reintroducing it into the area of interest of the patient's body. These operations do not currently have a reproducible result and may require several interventions due to the resorption of the introduced material (loss of volume encountered after the operation).Furthermore, the preparation of the fat for reintroduction is carried out by an operator, surgeon or surgeon's assistant, which results in a relatively high cost of implementing the operation and a risk of error or loss of reproducibility. It is therefore desirable to propose a technique that simplifies and makes existing operations more reliable.
[0003] Document US 2020 / 0054824 sought to propose an improvement by implementing a closed-loop system in which the fat is recovered to be prepared for reintroduction by being mixed with a washing liquid in a gravity filtration device marketed under the commercial reference Revolve®, and then reintroduced into the patient's body using a centrifugal pump. It is however possible to improve the quality of the reintroduced fat. Disclosure of the invention
[0004] The present invention aims to overcome the drawbacks of the prior art and relates to a method for purifying adipose tissue, comprising at least: - the addition of a washing liquid to an adipose tissue to be purified comprising materials pollutants and present in a treatment volume delimited by means of retention of adipose tissue and filtration of polluting materials, - filtration of a fraction of the polluting materials from the adipose tissue, contained in the washing liquid, by centrifugation of the contents of the treatment volume by rotating the retention and filtration means, and - an evacuation of the washing liquid containing the fraction of filtered polluting materials.
[0005] Characteristically, the invention implements a purification of the adipose tissue by filtration of the polluting materials through the retention and filtration means due to the rotation of the latter. This advantageously makes it possible to optimize the quality of the purified adipose tissue by reducing the presence of interstitial liquid and by eliminating the presence of a mixing or kneading member which could affect the integrity of the adipose cells as in the case of the device marketed under the commercial reference Revolve® implemented in US 2020 / 0054824. The adipose tissue thus purified has in particular a resorption rate much lower than that obtained with the purification solutions of the prior art. The polluting materials may include at least one of oil, blood or water.The addition of the washing liquid makes it possible to recover a fraction of the polluting materials from the adipose tissue, which fraction is then eliminated by filtration due to the centrifugation of the contents of the treatment volume. As will be recalled below, if a purer adipose tissue is desired, it is possible to complete this sequence of adding washing liquid, filtration and evacuation by other treatments making it possible to eliminate an additional fraction of the polluting materials. The invention uses centrifugation-assisted filtration in which the separation between the adipose tissue and the polluting materials is facilitated by the rotation of the retention and filtration means. The adipose tissue is subjected to centrifugal accelerations against the internal wall of the retention and filtration means, making it possible to drain the polluting materials through the pores of these means while the adipose tissue is retained in the treatment volume.The solution according to the invention also differs from centrifuge centrifugation techniques where the adipose tissue and pollutants are present in a completely closed container and which implement very high accelerations, generally greater than 400 G, to obtain phase separation and can lead to damage to the adipose tissue. In addition, compared to these techniques, the purification according to the invention makes it possible to eliminate the oil present, the reintroduction of which into the patient's body must be avoided because it can form oily cysts.
[0006] In an exemplary embodiment, the filtration of the fraction of polluting materials contained in the washing liquid comprises a succession of phases of rotation of the retention and filtration means separated by one or more phases of interruption of this rotation.
[0007] Such a characteristic advantageously contributes to further improving the quality of the purified adipose tissue obtained insofar as intermittent rotation of the retention and filtration means further reduces the risk of damaging the adipose tissue compared to continuous rotation.
[0008] In an exemplary embodiment, the filtration of the fraction of polluting materials contained in the washing liquid is carried out while the washing liquid is added to the treatment volume.
[0009] Centrifugation while the washing liquid is introduced into the treatment volume makes it possible to mix all the materials present in this volume and avoid any risk of clogging of the filtration and retention means by adipose tissue.
[0010] In an exemplary embodiment, the method further comprises, after evacuation of the washing liquid, filtration of an additional fraction of the polluting materials from the adipose tissue by centrifugation of the contents of the treatment volume by rotating the retention and filtration means.
[0011] Such a characteristic advantageously contributes to further improving the quality of the purified adipose tissue obtained.
[0012] In particular, after the washing liquid has been evacuated: - an additional addition of the washing liquid to the adipose tissue, - the filtration of the additional fraction of polluting materials, contained in the washing liquid thus added, by centrifugation of the contents of the treatment volume by rotating the retention and filtration means, and - an evacuation of the washing liquid thus added containing the additional fraction of filtered polluting materials.
[0013] Such a characteristic advantageously contributes to further improving the quality of the purified adipose tissue obtained by allowing the elimination of an additional fraction of the polluting materials. Of course, and if desired, the addition of the washing liquid, the filtration and the evacuation of the washing liquid can be repeated in order to eliminate an additional fraction of the polluting materials.
[0014] In an exemplary embodiment, before adding the washing liquid, the adipose tissue to be purified is introduced into the treatment volume and a preliminary filtration of a fraction of the polluting materials present in an interstitial liquid of this introduced adipose tissue is carried out by centrifugation of the contents of the treatment volume by rotating the retention and filtration means.
[0015] Such a characteristic advantageously contributes to further improving the quality of the purified adipose tissue obtained, in particular by making it possible to further reduce the quantity of polluting materials.
[0016] Preliminary filtration can be carried out while the adipose tissue to be purified is introduced into the treatment volume.
[0017] Such a characteristic advantageously makes it possible to accommodate a larger volume of adipose tissue in the treatment volume due to the elimination of water as the adipose tissue is introduced.
[0018] In particular, the preliminary filtration may comprise a succession of phases of rotation of the retention and filtration means separated by one or more phases of interruption of this rotation.
[0019] Such a characteristic advantageously contributes to further reducing the quantity of polluting materials in the purified adipose tissue obtained while further reducing the risk of damaging the adipose tissue compared to continuous rotation.
[0020] In an exemplary embodiment, an acceleration of between 5 G and 40 G is imposed on the polluting materials when the retention and filtration means are rotated. These acceleration values may be imposed on the polluting materials contained in the washing liquid and / or on the polluting materials contained in the interstitial liquid during the preliminary filtration which may be carried out before the addition of the washing liquid.
[0021] Such a characteristic advantageously contributes to optimizing the elimination of liquids present in the adipose tissue and in particular interstitial water and to further improving the quality of the purified adipose tissue. Furthermore, limiting the acceleration to values well below those used in conventional centrifugation also contributes to obtaining adipose tissue of optimal quality and with a slight quantity of residual interstitial liquid allowing it to be easily injected into the patient's body.
[0022] In particular, an acceleration imposed on the polluting materials during the preliminary filtration is greater than an acceleration imposed on the polluting materials during the filtration of the polluting materials contained in the washing liquid.
[0023] Such a characteristic advantageously contributes to further reducing the level of interstitial water in the purified adipose tissue obtained as well as further reducing the quantity of polluting materials.
[0024] The invention also relates to a purified adipose tissue comprising adipose cells and having a total liquid content of between 0.05 grams per milliliter of adipose tissue and 0.15 grams per milliliter of adipose tissue with an oil content of less than or equal to 0.075 grams per milliliter of tissue.
[0025] Such adipose tissue differs from adipose tissue directly taken from the patient in its composition and can be obtained by the purification process described above. It In particular, it has a limited resorption rate when reinjected into the patient's body, while being easily injectable. Limiting the amount of oil in the tissue helps avoid the creation of oil cysts after injection into the patient, which can be one of the most undesirable side effects of autologous adipose tissue transplantation operations.
[0026] According to one example, the total liquid content is between 0.07 grams per milliliter of adipose tissue and 0.12 grams per milliliter of adipose tissue.
[0027] According to one example, the oil content in the purified adipose tissue is less than or equal to 0.05 grams per milliliter of adipose tissue, for example less than or equal to 0.03 grams per milliliter of adipose tissue. This content may, for example, be between 0.005 grams per milliliter of adipose tissue and 0.05 grams per milliliter of adipose tissue, for example between 0.005 grams per milliliter of adipose tissue and 0.03 grams per milliliter of adipose tissue.
[0028] The invention also relates to a surgical device comprising at least one reservoir containing the purified adipose tissue as described above in communication with an introduction element capable of introducing the purified adipose tissue from the reservoir into the body of a patient.
[0029] Such a surgical device may correspond to a device marketed under the reference LipoGrafter® by the company MTFBiologics incorporating the adipose tissue purified by the method according to the invention and connected to a cannula capable of injecting this adipose tissue into the patient's body. Those skilled in the art will recognize that other surgical devices can be used for reintroduction into the patient's body. Brief description of the drawings
[0030] [Fig-1] [Fig.l] is a flowchart showing different steps of an example of method according to the invention.
[0031] [Fig.2] [Fig.2] is an exploded schematic view of an exemplary pu device verification usable within the framework of the invention.
[0032] [Fig.3] [Fig.3] is a schematic sectional view of the purification device of [Fig.2] when assembled.
[0033] [Fig.4] [Fig.4] is a schematic sectional view showing the puri device fication of [Fig.3] after moving the bottom.
[0034] [Fig.5] [Fig.5] schematically represents a possible evolution of the rotation speed of the retention and filtration means usable within the framework of the invention for the stages of filtration of polluting materials.
[0035] [Fig.6] [Fig.6] represents, in a schematic and partial manner, a device chi surgical procedure comprising purified adipose tissue according to the invention and capable of allowing its reintroduction into the patient's body. Description of the embodiments
[0036] The following describes an example of a method for purifying adipose tissue removed from a patient's body for reintroduction into the patient's body for an autologous adipose tissue transplant operation, for example for breast surgery or in other parts of the body.
[0037] The adipose tissue is removed from the patient's body by suction using a suction cannula. The suction cannula is connected to a purification device, an example of the structure of which will be described below, which is capable of purifying the removed adipose tissue by filtration of pollutants assisted by centrifugation. The purification device comprises in particular means for retaining the adipose tissue and for filtering the pollutants, for example in the form of a filtering side wall, as well as a rotational drive means capable of rotating these means. These means have pores having a size configured to allow the pollutants to pass through, for example in the form of a liquid medium, and to retain the adipose tissue.During sampling, the adipose tissue is introduced into the purification device and, more particularly, into a treatment volume delimited by the retention and filtration means (step E10).
[0038] The following describes, in connection with Figures 2 to 4, an example of a purification device 100 that can be implemented within the framework of the invention. This type of device can be implemented for all of the steps of filtration of the polluting materials carried out during the purification process. The device 100 is described for illustrative and non-limiting purposes.
[0039] The purification device 100 comprises a sealed enclosure 110 formed here by a cover 111, a side wall 112 and a bottom 113. These elements are fixed together in a sealed manner. The means 102 for retaining the adipose tissue and for filtering the polluting materials are present in the sealed enclosure 110. The means 102 delimit a centrifugation chamber 160 (visible in [Fig. 3] and which defines the treatment volume V intended to accommodate the adipose tissue removed). In the example described here, the means 102 have a cylindrical shape but those skilled in the art will recognize that the means 102 may have other shapes suitable for centrifugation. The means 102 have a pore size configured to allow a liquid medium to pass through and retain adipose tissue. The pore size is chosen specifically to allow the passage of liquids such as oil, blood or physiological solution while retaining fatty tissue.Generally, the pore size of the means 102 may be less than or equal to 1.5 mm, for example less than or equal to 0.5 mm. This size may be between 0.05 mm and 1.5 mm, for example between 0.2 mm and 0.5 mm. The means 102 may be made of polymeric material, for example. example polyester or polypropylene but those skilled in the art will recognize that other materials can be used.
[0040] In the example described here, a stiffening element 130 is present between the wall 112 of the sealed enclosure 110 and the means 102. Its function is in particular to ensure the structural strength of the means 102 during centrifugation. The stiffening element 130 is for example made of metallic or plastic material and has an openwork structure defining a plurality of openings 1300 in order to allow the evacuation of the liquid medium drained by the means 102.
[0041] The stiffening element 130 is associated with a rotary plate 131. More precisely, the stiffening element 130 comprises at its lower end teeth 1301 which cooperate with grooves 1310 present in the vicinity of the external periphery of the rotary plate 131. Those skilled in the art will recognize that the element 130 can be connected to the plate 131 in different ways. The rotary plate 131 is connected to a rotational drive means which can be manual or motorized. In the example described here, the rotary plate is connected to an electric motor 1000, such as a stepper motor or a brushless direct current motor, via a bidirectional clutch 2000 configured to ensure the rotational drive of the rotary plate 131 in a first direction of rotation RI ([Fig. 3]).
[0042] Seals 114 and 115 are placed respectively below and above the rotary plate 131 in order to ensure sealing in the lower part of the purification device.
[0043] The centrifugation is carried out by rotating the means 102. More precisely, the electric motor 1000 is controlled in the first direction of rotation RI to drive the rotary plate 131 and the stiffening element 130 in engagement with the plate 131. The rotation of the plate 131 and the stiffening element 130 causes the rotation of the means 102 which are integral with the stiffening element 130, for example by being glued or clipped to the latter. The speed of the electric motor 1000 is controlled so as to apply a centrifugal force to the material in the volume V. Thus, an adipose tissue present in the volume V will be subjected to a centrifugal force against the internal wall of the means 102, which makes it possible to effectively drain the polluting materials from the adipose tissue, contained in the washing liquid or the interstitial liquid depending on the stage of purification, without damaging the adipose tissue.
[0044] During centrifugation, these polluting materials passing through the means 102 and the stiffening element 130 are collected in a volume 170 delimited between the stiffening element 130 and the wall 112 of the enclosure 110. The washing liquid or the interstitial liquid containing the polluting materials can then be evacuated via an evacuation port 1131 present on the bottom 113 of the enclosure 110. In the example described here, the cover 111 comprises three ports 1110, 1111 and 1112 intended to be connected respectively to an adipose tissue suction device (vacuum pump allowing sampling), to a conduit for introducing the adipose tissue taken into the volume V and to a device for delivering the washing liquid. The purification device comprises a cover 101 having openings 1010, 1011 and 1012 which cooperate with the ports 1110, 1111 and 1112 of the cover 111. The vacuum pump connected to the purification device 100 which allows the sampling of adipose tissue and its introduction into the volume V can also be connected to the evacuation port 1131. The adipose tissue taken is retained in the device 100 by the means 102. The vacuum pump also serves to evacuate the polluting materials, contained in the washing liquid or the interstitial liquid, from the interior of the device 100 by suction. The vacuumed materials are collected in a bin connected to the vacuum pump and port 1131.
[0045] The purification device may further comprise a bottom 104 of the volume V, for example in the form of a movable collection tray. As illustrated in the example of FIGS. 2 and 3, the collection tray 104 is movable in translation in a direction DT along the axis X of the means 102. More precisely, the purification device 100 comprises a threaded rod 141 which extends vertically inside the centrifugation chamber 160 along the axis X of the means 102. The lower end 1412 of the threaded rod is connected to the electric motor 1000 via a guide 150 and the bidirectional clutch 2000. The guide 150 comprises a housing 1500 in which the lower end 1412 is fixed.A lower portion 1501 of the guide 150 is connected to a part of the bidirectional clutch 2000 which is engaged with the electric motor 1000 only when the latter transmits a rotational movement in a second direction of rotation R2 opposite to the first direction of rotation RI used for centrifugation. When the electric motor 10 rotates in the first direction of rotation RI, no rotational movement is transmitted by the bidirectional clutch 2000 to the guide 150 to which the threaded rod 141 is connected and the means 102 are rotated due to the rotation of the rotary plate 131. This results in the filtration of the polluting materials contained in the washing liquid or the interstitial liquid through the means 102. When the motor 1000 rotates in the second direction of rotation R2, no rotational movement is transmitted by the bidirectional clutch 2000 to the rotary plate 131 and, consequently, to the means 102.The collection tray 104 has on its upper face a central opening 1400 extended by a neck 1401 which extends from the lower face of the tray 104. The neck 1401 comprises a portion 1402 comprising a tapping 1403 which cooperates with a thread 1411 of the threaded rod 141. Thus, when the threaded rod is rotated in the second direction of rotation R2, the collection tray 104 rises in the centrifugation chamber 160 in the direction DT.
[0046] The peripheral edge 1404 of the collection tray 104 is opposite the internal wall of the means 102. Thus, when the collection tray 104 is moved in vertical translation along the direction DT, it acts as a piston which makes it possible to scrape the internal wall of the filter so as to collect more adipose tissue and facilitate the evacuation of the purified adipose tissue at the top of the device for introduction into the patient's body via a reintroduction device which will be described below in connection with [Fig.6].
[0047] According to a particular aspect, the threaded rod 141 can be housed in a protective sheath 142. The protective sheath 142 which extends between an upper end 1421 and a lower end 1422 makes it possible to prevent the threaded rod 141 from coming into contact with the adipose tissue which, by accumulating at the level of the tapping 1403 of the collection plate 104, can block the movement of the latter.
[0048] [Fig.4] shows the purification device 100 after actuation of the electric motor 1000 in the second direction of rotation R2 allowing the threaded rod 141 to be driven in rotation. The rotation of the threaded rod 141 causes the vertical translation of the collection tray 104 in the direction DT.
[0049] The lower end 1422 of the protective sheath is fixed in the opening 1400 of the collection tray 104. In order to allow the movement of the protective sheath 142 during the movement of the tray 104, the cover 111 and the lid 101 respectively comprise an opening 1113 and an opening 1013 through which the sheath 142 slides. A seal 115 is present around the opening 1113 in order to preserve the seal at the top of the centrifugation chamber.
[0050] In another embodiment, the means 102 are made of a self-supporting rigid material such as, for example, a metallic material. In this case, the stiffening element 130 is no longer necessary and it is the self-supporting means 102 which are directly engaged with the rotary plate 131.
[0051] The following describes details on the step of filtration of a fraction of the polluting materials which are valid whatever the filtration step considered, in particular for the preliminary filtration (step E20), as well as for the filtrations of steps E40, E60 and E90 which will be described below.
[0052] The filtration of a fraction of the polluting materials, contained in the washing liquid or in the interstitial liquid, is carried out by centrifugation of the contents of the volume V by rotating the means 102. The means 102 are rotated on themselves. The means 102 are rotated around the axis X. The axis X can correspond to the axis of the height of the means 102, and for example to an axis of symmetry or revolution of these means 102. When the means 102 are rotated, the adipose tissue and the polluting materials can undergo an acceleration greater than or equal to 8 G, for example greater than or equal to 10 G or greater than or equal at 12G. This acceleration measured in G corresponds to the ratio between the acceleration undergone by the material and the acceleration of Earth's gravity, which is approximately 9.81 m2 / s. The acceleration undergone by the material corresponds to the ratio of the centrifugal force applied and the mass of the material considered. The centrifugal force applied is equal to m*co2 * R where m is the mass of the object considered, co is the angular velocity of the means 102 expressed in rad / s and R the distance from the X axis of rotation to the center of gravity of the object considered. During the rotation of the means 102, the adipose tissue and the polluting materials may undergo an acceleration less than or equal to 40 G, for example less than or equal to 30 G, or even less than or equal to 25 G or less than or equal to 20 G. This acceleration may be between 8 G and 40 G or between 8 G and 30 G or between 8 G and 25 G or between 8 G and 20 G.This acceleration may be between 10 G and 40 G or between 10 G and 30 G or between 10 G and 25 G or between 10 G and 20 G. This acceleration may be between 12 G and 40 G or between 12 G and 30 G or between 12 G and 25 G or between 12 G and 20 G. The duration of a filtration step may typically be greater than or equal to 5 seconds. This duration may be less than or equal to 60 seconds. This duration may, for example, be between 5 seconds and 60 seconds, for example between 15 seconds and 45 seconds. Whatever the filtration step considered, the means 102 can be rotated intermittently, that is to say by successively imposing at least a first phase RO of rotating the means 102, a phase AR of interrupting this rotation where the means 102 are immobilized, and a second phase RO of rotating the means 102, as illustrated in [Fig.5].The acceleration imposed on the polluting materials during the first rotation phase RO may be identical or different from that imposed during the second rotation phase RO. These accelerations may have the values in G described above. The rotation phases RO of the means 102 may, according to one example, have a duration T1 greater than or equal to 5 seconds, for example between 5 seconds and 15 seconds and the stopping phases AR may, according to one example, have a duration T2 greater than or equal to 2 seconds, for example between 2 seconds and 10 seconds. [Fig. 5] shows rotation phases RO which have identical durations T1, as well as stopping phases AR which also have the same duration T2 but it is not outside the scope of the invention when this is not the case.It is not outside the scope of the invention if more phases RO of rotation are carried out, thus it is possible to carry out a second phase AR of interruption of the rotation where the means 102 are immobilized after the second phase RO of rotation, then a third phase of rotation of the means 102 and so on. It is thus possible to carry out an alternation of phases of rotation of the means 102 and phases of interruption of this rotation during a step of filtration of a fraction of the polluting materials. It will be noted that . the use of intermittent rotation is advantageous in particular for the preliminary filtration (step E20) and the filtration of the fraction(s) of polluting materials present in the washing liquid (step E60) but it does not go beyond the scope of the invention if all or part of the filtration steps are carried out by implementing a single phase of rotating the means 102 applied continuously.
[0053] Step E20 of [Fig. 1] concerns the carrying out of a preliminary filtration of a fraction of the polluting materials contained in the interstitial liquid of the adipose tissue being introduced into the treatment volume V. An intermittent rotation of the means 102 as described above may be imposed during this step. The preliminary filtration makes it possible to eliminate polluting materials in liquid form present in the introduced adipose tissue, such as blood, water or oil. During this phase, there is no introduction of a washing liquid into the volume V, only the removed adipose tissue is introduced into the volume V.Thus, the removal of the adipose tissue can be initiated (step E10) and then, when a first predetermined volume has been introduced into the volume V, a first phase RO of rotating the means 102 can be carried out while the removal of the adipose tissue continues, resulting in the introduction of more adipose tissue into the volume V. According to one example, the first phase RO of rotating the means 102 can be initiated when a volume of between 50 cm3 and 250 cm3 of adipose tissue has been introduced into the volume V. The means 102 are then stopped (phase AR) while the removal of adipose tissue continues during this phase AR of interruption after the first phase of rotating.When a second predetermined volume of adipose tissue has been introduced into the volume V, the second predetermined volume being greater than the first predetermined volume, the second phase RO of rotating the means 102 can be initiated, and so on if it is desired to continue the preliminary filtration. The example of [Fig.l] concerns the case where the preliminary filtration (step E20) is carried out while the adipose tissue is introduced into the volume V but it is not outside the scope of the invention when the preliminary filtration is initiated only after completion of the removal of the adipose tissue.
[0054] Once the desired quantity of adipose tissue has been introduced into the volume V, the sampling is stopped (step E30, stopping the introduction of adipose tissue into the volume V). The means 102 can then be rotated again so as to filter a fraction of the polluting materials contained in the interstitial liquid (step E40, optional), before the addition of the washing liquid (step E50) and while adipose tissue is no longer introduced into the volume V. A single continuous rotation of the means 102 can be carried out during step E40, but it would be possible, as a variant, to apply intermittent rotation, as described above.
[0055] The vacuum pump used for sampling is then activated so as to evacuate by suction of the interstitial liquid containing the filtered pollutants. The duration of the evacuation can be greater than or equal to 5 seconds, for example between 5 seconds and 60 seconds.
[0056] The washing liquid is then introduced into the volume V (step E50). The washing liquid mixes with the removed adipose tissue in order to recover a fraction of the polluting materials from this tissue. The washing liquid can thus recover blood, water and oil present in the adipose tissue. The washing liquid can be a physiological solution. The washing liquid is introduced through the port 1112 in the example of device 100 described above. It will be noted that the washing liquid can be added while the means 102 are rotated as described above and in particular with intermittent rotation. The phases of rotation and interruption(s) of the rotation can be carried out during the introduction of the washing liquid (while it continues to be introduced into the volume V).The addition of the washing liquid can be carried out simultaneously with the filtration of the fraction of polluting materials contained in the washing liquid (step E60). During this step E60, the washing liquid containing the fraction of polluting materials passes through the pores of the means 102 to exit the volume V in which the adipose tissue is retained. The polluting materials are recovered in the volume 170 in the illustrated example of device 100. This produces a separation of the adipose tissue and the washing liquid containing the fraction of polluting materials. It will be noted that it is not outside the scope of the invention if the addition of the washing liquid and the filtration (step E60) are carried out sequentially, the filtration (step E60) being initiated once the addition of the washing liquid is complete (step E70).
[0057] Once the introduction of the washing liquid is complete (step E70), suction is carried out by the vacuum pump through the port 1131 in order to evacuate the washing liquid containing the fraction of polluting materials filtered from the device 100 and recover it in a bin (step E80). This suction can for example be carried out using the vacuum pump used to sample the adipose tissue. The evacuation can be carried out for a duration greater than or equal to 5 seconds, for example between 5 seconds and 60 seconds. If desired, it is then possible to continue to eliminate the remaining washing liquid containing polluting materials by rotating the means 102 followed by suction in a manner similar to that described above (optional step E90) without adding washing liquid during this step.It is then possible, if desired, to repeat the steps of adding washing liquid (step E50), filtering a fraction of the polluting materials present in the washing liquid (step E60) and evacuating the washing liquid (step E80), as shown by arrow E100 (optional).
[0058] The purification can also be completed after the sequences described above. by compacting the adipose tissue in which the bottom 104 can be raised, like a piston (see position of the bottom 104 in [Fig.4]), and suction can be carried out on the compacted adipose tissue to evacuate the air and any polluting materials that may still be present.
[0059] The inventors carried out tests to measure the reduction in the amount of oil and liquids in the purified adipose tissue compared to the adipose tissue directly taken from the patient's body. The results obtained over five series of tests are shown in Tables 1 to 5 below.
[0060] [Tables 1] nT Tissue initiai 50ml test series. Quantity Quantity Oil fe) Quantity % Oil % Total Liquid (ml) Liquid |g) IeZibU igâW Tube NT 50 5.33 7 11% 14% Tube NT 50: 5 / 4 7.5 n% 15% Tube NT 50 5.1 7 10% 14% Average initial sample so 5.29 7.17 11% 14% Suri fied tissue 50mL Total quantity (mt] Quantity Quantity % Oil % Liquid isMl Hyne Liquœç Igî Tube NT 50' i 5.5 ■ 2% 11% Tube NT 50 0 5 0% 10%- Tube NT 50 1.1 3' 2% 6% Tube N°4 50' 0 4.2 0% 8% Tube N*5 50 Oi 3 0% 7% Average sample treated 50 0.42 4.14 1% 8%
[0061] [Tables2] Test Series No. 2 Initial tissue 50mL Total quantity (mL) Quantity Oil Quantity Liquid % Oil % Liquid. Tube Ml 50 6.1 10 12% 20%: Tube N°2 50' 5 11 12% 22% Tube N'3 50' 5.9 10 12% 20% Average initial sample 50 S 10.33 12% 21% Purified tissue 50mL Total quantity (mL) Quantity Oil Quantity Liquid (gL) % Oil % Liquid (gL) Tube N'I 50 2.4 7.5 5% 15%: Tube M"2 '50 2 7.5 4%' 15% Tube M°3 50 2.5 7.5 5¾} 15% Tube N°4 50' 2 5 4% Ï0%: Tube M°5 50 2 5 4% 10% Average sample treated 50 2.1S 6.5 4% 13%
[0062] [Tables3] Test Series No. 3 Initial tissue bûmL Total quantity (mL| Quantity Oil such Quantity- Liquid % Oil WmQ- % Liquid teZmO Tube MQ 50 4 19 8% 38%: Tube N°2 50' 4.1 20 3% 40%: Tube N'3 50' 4 20 8% 40% Tube M'4 50: 5 20 10% 40%. average initial sample 50 4 19.67 834 39% i purified from 50ml Total quantity (mL| Quantity Oil such Quantity Liquid such Oil % Liquid Wml) Tube M'i 50 1 7 <2% 14%. Tube «”2 50: 1.2 7 2% 14% Tube N°3 50' 0.9: 7.2 2% 14% TubeM'4 50 O- 5 0% 10%: Tube M°5 50' 0 5 0% 10% Mayenne sample treated 50 0.62 6.24 1% 12%:
[0063] [Tables4] Test series n°4 Tissue ùtitiai 50mL Quantity. Total (mlj Quantity Huüejgl Quantity Liquid fe) % Oil àùnü % Liquid Tube N'i 50 0: 19 0# 38% Tube N°2 50 0 20 0% 40%: Tube NQ3 50' 0 20 0¾ 40% Tube 50: CL 20 0% 40% Average initial sample 50 0 19.67 0% 39% Purified tissue 50ml Total quantity (mil Quantity Oil fal Quantity Liquid %Huüe ig / mL) %Li§ulde iâswi Tube hfl 50 0 7 0¾ 14% Tube N°2 50- 0' 7 0% 14%: Tube N'3 50' 0 7.2 O%- 14% Tube TL# 50 o' 5 0% 10%. Tube No. 5 50' 0 5 0% 10% Average sample treated sa 0 6.24 0% 12%
[0064] [Tables5] Test series h “S Quantity. Initial tissue 50mL total (mt) Quantity Oil se fe) Quantity Liquid {g} % Oil % Liquid £g / mLl isÉoU Tube Ml 50' 1 12.5 „2% 25%- Tube NQ 50 2 10 4% 20% Tube N°3 50 -L 10 2% 20%. average initial sample 50 1.3 10.83 3% 22% Quantity Guntiê Tissue 50 m L total (mL| Quantity Oil such Liquid Quantity % Oil % Liquid lâMi Tube N'1 50: g: 5 ■0% 10% Tube M°2 50' Q 3.,1 0% 6% Tube N'3 50 0 3 0% 6% Tube N°4 50 Q: 3.4 0% 7% Average sample treated 50 0 3.025 0% 7%
[0065] The averages over the five series of tests carried out are provided in Table 6 below.
[0066] [Tableauxô] Initial tissue 50mL Total quantity (ml) Quantity Oil fel Quantity Liquid Qj % Oil feÔnL) % Liquid Wmü 17 tubes 50 5.23 14.23 6.47% 28.59% Purified tissue 50mL Quantity Quantity Quantity % Oil % Total liquid (mt) Oil fej Liquid (g} 24 tubes 80 0.67 5.42 1.34% 10.84%
[0067] The measurement method used to quantify the quantities of liquid and oil are provided below.
[0068] 3 to 5 x 50mL of adipose tissue are centrifuged at 1600 G (3000 rpm) in 50mL graduated tubes for 3 minutes. At the exit, the tubes present 3 phases (from bottom to top): - the liquid phase (blood and infiltration fluid or lavage fluid), - the adipose tissue phase, and - the oil phase.
[0069] For each tube, the oil is gently aspirated with a micropipette and a 1000L cone. The oil is placed in a plastic cup to be weighed on a precision balance (0.001g). For each tube, a 10mL pipette connected to an electric pipettor is gently pushed into the bottom of each tube. All the liquid is aspirated, leaving only the adipose tissue phase in the tube. For each tube, the liquid is transferred into a receptacle and then weighed on a precision balance (0.001g).
[0070] Once the purification is complete, the surgeon reintroduces this tissue into the patient's body. In the exemplary device 100 illustrated in FIGS. 2 to 4, the purified adipose tissue can be compacted against the cover 111 in the configuration of the device in [Fig. 4] and introduced into a surgical device, for example such as a device marketed under the reference LipoGrafter® by the company MTF-Biologics, in order to carry out the reintroduction into the patient's body. The introduction device can for example be connected to the port 1112 of the exemplary device 100 described above and the compaction pressure applied by the bottom 104 to the purified adipose tissue can be sufficient to allow the transfer of the tissue to the reintroduction device. Alternatively, a pump can be placed between the treatment volume V and the reintroduction device in order to cause this transfer. [Fig.6] schematically and partially an example of a device 250 capable of allowing the reintroduction of purified adipose tissue TAP into the patient's body. The device 250 comprises a body 252 provided with a first port 252a connected to the device. 100 (connection not shown), a second port 252b connected to a syringe 254 and a third port 252c connected to an injection cannula 256. The purified adipose tissue is introduced from the treatment volume V into the syringe 254 through the first port 252a. The first port 252a is provided with a non-return valve so as to allow the injection of the purified adipose tissue TAP into the patient through the cannula 256 by pressing the plunger of the syringe 254. The surgeon can act directly on the syringe 254 in order to cause the introduction of material into the patient's body, or alternatively this action can be automated.
[0071] The expression “between ... and ...” must be understood as including the limits.
Claims
Claims
1. A method for purifying adipose tissue, comprising at least: - adding a washing liquid (E50) to an adipose tissue to be purified comprising polluting materials and present in a treatment volume (V) delimited by means (102) for retaining the adipose tissue and filtering the polluting materials, - filtering (E60) a fraction of the polluting materials of the adipose tissue, contained in the washing liquid, by centrifuging the contents of the treatment volume by rotating the retention and filtration means, and - removing (E80) the washing liquid containing the filtered fraction of polluting materials, in which, before adding the washing liquid, a preliminary filtration (E20) of a fraction of the polluting materials, present in an interstitial liquid of the adipose tissue to be purified in the treatment volume, is carried out,by centrifugation of the contents of the treatment volume by rotating the retention and filtration means.,
2. Method according to claim 1, in which the filtration (E60) of the fraction of polluting materials, contained in the washing liquid, comprises a succession of phases of rotation of the retention and filtration means (102) separated by one or more phases of interruption of this rotation.
3. Method according to any one of claims 1 or 2, in which the filtration (E60) of the fraction of polluting materials, contained in the washing liquid, is carried out while the washing liquid is added (E50) into the treatment volume (V).
4. Method according to any one of claims 1 to 3, in which the method further comprises, after the evacuation (E80) of the washing liquid, a filtration (E90; E100) of an additional fraction of the polluting materials of the adipose tissue by centrifugation of the contents of the treatment volume by rotating the retention and filtration means (102).
5. Method according to claim 4, in which the following are carried out after the evacuation (E80) of the washing liquid: - an additional addition (E100+E50) of the washing liquid to the adipose tissue, - the filtration (E100+E60) of the additional fraction of polluting materials, contained in the washing liquid thus added, by centrifugation fugation of the contents of the treatment volume by rotating the retention and filtration means (102), and - evacuation (E100+E80) of the washing liquid thus added containing the additional fraction of filtered polluting materials.
6. Method according to any one of claims 1 to 5, in which the preliminary filtration (E20) comprises a succession of phases of rotating the retention and filtration means (102) separated by one or more phases of interrupting this rotation.
7. Method according to any one of claims 1 to 6, in which the polluting materials are subjected to an acceleration of between 5 G and 40 G when the retention and filtration means (102) are rotated.
8. A method according to any one of claims 1 to 7, wherein an acceleration imposed on the polluting materials during the preliminary filtration (E20) is greater than an acceleration imposed on the polluting materials during the filtration (E60) of the polluting materials contained in the washing liquid.