Adipose tissue purification device

Abstract

Adipose tissue purification device The present invention relates to a device (1), comprising: - an enclosure (3), - a flexible filter (5) capable of retaining adipose tissue, the filter extending along a main axis (X) between a lower end (5b) and an upper end (5a), - a lower attachment element (9) secured to the lower end and an upper attachment element (731) secured to the upper end, - an evacuation conduit (11) extending between a lower portion and an upper portion in communication with the exterior of the device, and - a drive system (100) capable of assuming a purification configuration in which the lower and upper attachment elements are set in joint rotation, and an evacuation configuration in which one of the attachment elements (9) is set in relative movement relative to the other attachment element (731) so as to roll the filter on itself.Figure for abstract: Fig. 3.

Description

Title of the invention: Device for purifying adipose tissue Technical field

[0001] The present invention relates to a device for purifying adipose tissue and an associated purification method. 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 relatively simple technique which 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 invention relates to a device for the purification of adipose tissue and the removal of purified adipose tissue, comprising: - an enclosure, - a flexible filter delimiting a treatment volume and being capable of retaining adipose tissue and filtering a liquid medium, the filter being present in the enclosure and extending along a main axis between a lower end and an upper end, - a lower attachment element secured to the lower end of the filter and an upper attachment element secured to the upper end of the filter, - an exhaust duct extending into the treatment volume between a lower portion provided with an inlet orifice and an upper portion in communication with the exterior of the device, and - a drive system capable of taking a purification configuration in which the lower and upper attachment elements are rotated jointly around the main axis, and capable of taking a discharge configuration in which one of the attachment elements is rotated around the main axis and in relative movement with respect to the other attachment element so as to roll the filter on itself.

[0005] The invention provides a device of relatively simple design for purifying adipose tissue and removing this purified adipose tissue for reintroduction into the patient's body. The device removes polluting materials from the adipose tissue, which may include at least one of oil, blood, or water. A washing liquid may be added to the adipose tissue in the treatment volume so as to recover a fraction of the polluting materials, which fraction is then removed by filtration due to the centrifugation of the contents of the treatment volume. The device according to the invention is based on connecting ends of the filter to separate attachment elements, the movement of which is controlled differently by the drive system depending on whether the aim is to purify the adipose tissue or to carry out removal.Thus, in the purification configuration, the lower and upper ends of the filter rotate together, which leads to centrifugation of the adipose tissue against the inner wall of the filter, and in particular to evacuation of the washing liquid containing the polluting materials, allowing the purification of the adipose tissue. The liquid medium present in and around the adipose tissue is then effectively drained through the filter while the adipose tissue is retained in the treatment volume. A significant quantity of liquid is thus eliminated, allowing the provision of purified adipose tissue which, once reimplanted, has a resorption rate much lower than that obtained with the solutions of the prior art.On the other hand, when the drive system is put into the discharge configuration, one of the ends of the filter is rotated with a relative movement with respect to the other end, which can in particular be fixed by no longer being engaged with the drive system. This causes the filter to roll up on itself from its upper end (zone of least stress with no or . less fatty tissue than in the lower end) towards its lower end. This coil applies evacuation pressure which pushes the purified fatty tissue into the evacuation conduit to allow its transfer outside the device for reintroduction into the patient's body.

[0006] In an exemplary embodiment, the device further comprises a rigid filter retention cage, surrounding the filter and located between the latter and the enclosure, which is capable of being crossed by the liquid medium.

[0007] The retention cage makes it possible to retain the filter deformed under the effect of centrifugal force during purification in order to avoid any risk of it coming into contact with the enclosure and the drainage of the liquid medium being disturbed. This advantageously makes it possible to make the device more compact without hindering the quality of the purification.

[0008] In particular, the rigid retention cage may define the upper attachment member and may be configured to be rotated into the purification configuration.

[0009] Such a feature allows the design of the device to be further simplified by reducing the number of elements required due to a combination of the filter retention function and the filter attachment.

[0010] In an exemplary embodiment, said other attachment element is fixed in the evacuation configuration.

[0011] In other words, in this case, in the discharge configuration, the upper attachment element is fixed while the lower attachment element rotates, or conversely the lower attachment element is fixed while the upper attachment element is rotatable. Such a characteristic makes it possible to obtain rapid winding of the filter on itself with a relatively simple drive system.

[0012] In an exemplary embodiment, the device further comprises a foldable evacuation assistance element located around the inlet orifice of the evacuation conduit, said foldable element being configured to pass from a deployed configuration in the purification configuration to a folded configuration under the effect of the winding of the filter in the evacuation configuration.

[0013] Such a feature makes it easier to push the purified adipose tissue into the discharge conduit in order to maximize the efficiency of the operation.

[0014] The invention also relates to an assembly for the purification of adipose tissue and the introduction of the purified adipose tissue into the body of a patient, comprising a device as described above, a discharge segment in communication with the upper portion of the discharge conduit and a surgical device comprising (i) a reservoir intended to receive the purified adipose tissue and in communication with the discharge segment, and (ii) an introduction element in communication with the reservoir and capable of introducing purified adipose tissue from the reservoir into a patient's body.

[0015] The invention also relates to a method for purifying adipose tissue using a device as described above containing adipose tissue to be purified in the treatment volume, comprising: - centrifugation of adipose tissue by putting the drive system in the purification configuration, and - the evacuation of the purified adipose tissue, obtained after centrifugation, by putting the drive system in the evacuation configuration so as to roll the filter on itself and thus apply an evacuation pressure on the purified adipose tissue allowing its transfer to the outside of the device through the evacuation conduit.

[0016] The invention also relates to an element for filtering an adipose tissue intended to be integrated into a device as described above, comprising: - the flexible filter delimiting the treatment volume and being capable of retaining the adipose tissue and filtering a liquid medium, the filter extending along the main axis between the lower end and the upper end,

[0017] - the lower attachment element secured to the lower end of the filter, comprising a means of cooperation with the drive system to achieve rotation around the main axis, and

[0018] - the exhaust duct extending into the treatment volume between the portion lower portion provided with the inlet orifice and the upper portion in communication with the exterior of the treatment volume.

[0019] Such an object is intended to be mounted to the other constituent elements of the device before carrying out the treatment of the adipose tissue. It corresponds to the consumable which can be removed from the rest of the device and replaced after the evacuation of the purified adipose tissue. This filtration element is in a sterile state.

[0020] In an exemplary embodiment, the filtration element further comprises the foldable evacuation aid element located around the inlet orifice of the evacuation conduit, said foldable element being configured to pass from the deployed configuration in the purification configuration to the folded configuration under the effect of the winding of the filter in the evacuation configuration. Brief description of the drawings

[0021] [Fig-1] [Fig.l] represents, in a schematic and partial manner, an example of purification device according to the invention.

[0022] [Fig.2] [Fig.2] represents, in a schematic and partial manner, the device of the [Fig.l] during the purification of adipose tissue.

[0023] [Fig.3] [Fig.3] schematically and partially represents the device of [Fig.l] during the evacuation of purified adipose tissue.

[0024] [Fig.4] [Fig.4] represents, in a schematic and partial manner, a device surgical procedure capable of allowing the reintroduction of purified adipose tissue into the patient's body which can be used within the framework of the invention.

[0025] [Fig.5] [Fig.5] schematically and partially represents a variant of a filtration element equipped with a folding evacuation aid element in the deployed configuration.

[0026] [Fig.6] [Fig.6] schematically and partially represents the filtration element of [Fig.5] with the folding element in the process of changing to the folded configuration under the effect of the winding of the filter.

[0027] [Fig.7] [Fig.7] represents, in a schematic and partial manner, the element of filtration of [Fig.5] with the folding element in the folded configuration. Description of the embodiments

[0028] [Fig.l] shows a device 1 for the purification of adipose tissue T taken from the body of a patient. The device 1 comprises an enclosure 3 defining the outer surface of the device 1. The enclosure 3 may be formed of a material transparent to visible light, such as plexiglass, so that the contents thereof can be viewed by the surgeon during the procedure. The enclosure 3 comprises a cover 33 in communication with an inlet port 2 through which the adipose tissue T is introduced into the device 1. The port 2 may be located above the enclosure, as illustrated. The enclosure 3 may also comprise a suction port 32, the function of which will be detailed below.The port 2 can be connected to a suction cannula (not shown) for removing the adipose tissue T from the patient's body, and the introduction of the removed adipose tissue T into the device 1 can be assisted by suction through the port 32 using a pumping device (not shown). [Fig. 1] shows the device 1 being filled with the adipose tissue T. In the example considered, the adipose tissue T successively passes through the port 2, a first opening 33a of the cover 33 then a second opening 73a defined by a rigid retention cage 7 to be collected in a treatment volume V. The volume V is defined by a filter 5 which is present in the enclosure 3 and located inside the cage 7. Various solutions are possible for holding the cage 7 in place in the enclosure 3, for example by using rods (not shown) extending between the cover 33 and the lower edge 35 of the enclosure 3.The filter 5 here forms a pocket receiving the adipose tissue T for the purpose of purifying it. The filter 5 is capable of retaining the adipose tissue T but allows a liquid medium containing polluting materials to be eliminated to pass through. The filter 5 may have a plurality of pores of . size adapted to this function. The pore size is chosen in particular to allow the passage of liquids such as oil, blood or a physiological solution while retaining the adipose tissue T. Generally, the pore size of the filter 5 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 filter 5 may be made of polymeric material, for example polyester or polypropylene, but those skilled in the art will recognize that other materials may be used. The filter 5 is made of flexible material, that is to say a material capable of twisting to carry out the evacuation of the purified adipose tissue outside the device 1, as will be described below in connection with [Fig. 3].

[0029] The cage 7 surrounds the filter 5 and prevents it from coming into contact with the enclosure 3, in particular with its side wall 31, during centrifugation. The presence of the cage 7 remains optional, in particular for devices having an enclosure of larger transverse dimension and sufficient to guarantee a spacing between the filter and the enclosure during centrifugation. The cage 7 is rigid, so it does not deform under the effect of centrifugal force during purification so as to retain the filter 5. The cage 7 can be made of metallic or plastic material. The cage 7 comprises a lateral portion 71 having a plurality of orifices through which the polluting materials to be evacuated can pass. The cage 7 is spaced from the enclosure 3 by a non-zero distance dl so as to define a space 4 for concentrating the centrifuged polluting materials with a view to their subsequent evacuation by suction through the port 32.The lateral portion 71 is located between an upper edge 73, defining the opening 73a mentioned above, and a lower edge 75 defining an opening 75a. The cage 7 extends along a main axis X corresponding to the axis of the height of the device. The cage 7 may or may not have a shape of revolution around the axis X, for example having a substantially cylindrical shape. In the example illustrated, an upper attachment element 731 secured to an upper end 5a of the filter 5 is defined by the upper edge 73 of the cage 7. The element 731 may form, as illustrated, a fixing neck which is surrounded by the lateral portion 71 and connected to the end 5a. The element 731 is here crossed by the introduced adipose tissue T and opens into the treatment volume V. .

[0030] The filter 5 extends along the X axis between the upper end 5a and a lower end 5b. As indicated above, the upper end 5a is here connected to the cage 7, and more particularly to the fixing neck 731 which forms the upper attachment element. Various solutions can be used to connect the end 5a to the element 731 such as gluing, clamping or clipping. The lower end 5b is integral with a lower attachment element 9, here in the form of a support transverse to the X axis, which is distinct from the cage 7. The element 9 is here located inside of the cage 7 while being surrounded by the lateral portion 71. The element 9 can be distant from the cage 7 while being spaced from its lower edge 75 by a non-zero distance d2. The element 9 can delimit the bottom of the treatment volume V and of the filter 5. Various solutions can be used to connect the end 5b to the element 9 such as gluing, clamping or clipping.

[0031] The element 9 is connected to a drive system 100 by means of an axis 91 capable of cooperating with this system 100. The element 9 comprises a means of cooperation with the axis 91. The axis 91 extends along the axis X and passes through the opening 75a to the outside of the enclosure 3 by passing through the opening 35a defined by the lower edge 35 of the enclosure 3. The axis 91 cooperating with the system 100 and the element 9 makes it possible to set the element 9 in rotation on itself around the axis X. The cage 7 is also connected to the system 100 by means of its lower edge 75 which defines one or more drive portions 751 extending outside the enclosure 3. The drive portions 751 are capable of cooperating with the system 100 so as to rotate the cage 7 on itself around the X axis, and in particular to rotate the element 731.

[0032] The system 100 has a first configuration, called the purification configuration, in which it cooperates with the element 9 and the element 731 so as to drive them in joint rotation on themselves around the axis X. Thus, the ends 5a and 5b of the filter rotate jointly which allows the centrifugation of the adipose tissue T as illustrated in [Fig.2]. The same rotation speed can be imposed on the elements 9 and 731 in the purification configuration. When the purification is finished, the system 100 can be put into a second configuration, called the evacuation configuration, in which there is a relative movement of one element 9 with respect to the other 731 which will produce a winding of the filter 5 on itself. In the example illustrated, the element 9 cooperates with the system 100 but not the element 731 in the evacuation configuration.Thus, the element 9 is rotated around the axis X while the element 731 remains fixed, which leads to a winding of the filter 5 as illustrated in [Fig. 3] resulting in the evacuation of the purified adipose tissue TP through an evacuation conduit 11. The evacuation conduit 11 extends inside the filter 5 along the main axis X between a lower portion 11b, which is here connected to the lower attachment element 9, and an upper portion 11a in communication with the outside of the device 1. The portion 11a opens above the cover 33 into an evacuation segment 12 connected to the cover 33 and intended to transfer the purified adipose tissue to a surgical device capable of carrying out the reintroduction into the patient's body, possibly with the assistance of a pump to aid this transfer. Various solutions can be used to connect the lower portion 11b to the element 9 such as gluing, clamping or clipping. The portion 11b is . provided with one or more inlet orifices 110 connecting the volume V with the interior 112 of the conduit 11 so as to evacuate the purified adipose tissue outside the device 1 due to the pressure applied by the filter 5 during its winding. The orifice(s) 110 may be in the vicinity of the element 9, for example at a distance d3, measured along the axis X, less than or equal to 50 mm from the latter. The distance d3 may be substantially equal to 10 mm or less than 10 mm. A winding of the filter for the evacuation of the purified adipose tissue TP obtained by rotation of the element 9 while keeping the element 731 stationary has been described, but it will be recognized that it is not outside the scope of the invention if the reverse is carried out with a fixed element 9 and an element 731 rotated, or by rotating the lower 5b and upper 5a ends with non-zero and different rotation speeds, or even rotation movements in the opposite direction.The system 100 may for example comprise a bidirectional clutch system known per se, capable of driving the elements 9 and 731 jointly in a first direction of rotation S1 in the purification configuration, and of driving only one of the elements 9 or 731 in a second direction of rotation S2 in the evacuation configuration. The system 100 is here connected to an electric motor M which may be an integral part of the device or be present in a plate separate from the device on which the device 1 is intended to be positioned. Alternatively, a manually driven device 1 could be used.

[0033] Various details of the structure and operation of an example of device 1 according to the invention have just been described. The following describes in more detail the various operating steps: filling of volume V with the adipose tissue T to be purified, purification of this adipose tissue and evacuation of the adipose tissue thus purified with a view to reintroduction into the patient's body.

[0034] The device 1 is, of course, in a sterile state before use. As illustrated in [Fig.l], the adipose tissue T falls by gravity from the port 2 into the volume V. The flexible filter 5 deforms as it is filled with the adipose tissue T so as to form a zone 52 of greater transverse dimension DT and may define a neck at the upper end 5a of the filter 5. The transverse dimension DT of the filter 5 containing the adipose tissue T, taken perpendicular to the main axis X, may be strictly decreasing from the zone 52 towards the end 5a. [Fig.2] illustrates the purification of the adipose tissue T by centrifugation in which the system 100 drives the cage 7 and the element 9 in joint rotation, as indicated above. The liquid medium is evacuated through the filter 5 by application of centrifugal force (arrows EML) and the adipose tissue retained in the volume V.There is no winding of the filter 5 in the purification configuration. As shown in [Fig.2], the flexible filter 5 deforms during centrifugation, the cage 7 . does not deform and retains the filter 5 to avoid contact with the enclosure 3, in this case with its side wall 31. When the filter 5 is rotated in the purification configuration, 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 to 12 G. 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 filter 5 expressed in rad / s and R the distance from the axis X of rotation to the center of gravity of the object considered.When the filter 5 rotates in the purification configuration, 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. It will be noted that it is possible to rotate the filter 5 intermittently during the purification, that is to say by successively imposing at least a first phase of rotation of the filter 5, a phase of interruption of this rotation where the filter 5 is immobilized, and a second phase of rotation of the filter 5.It is thus possible to alternate phases of rotation of the filter 5 and phases of interruption of this rotation during purification.

[0035] The purification can be carried out with or without the addition of a washing liquid, for example in the form of a physiological solution. It will be noted that the purification can be carried out while the adipose tissue T is being introduced into the volume V, and possibly continued once this introduction is complete. The polluting materials are sucked through the port 32 to be evacuated outside the device 1.

[0036] Once the purification is complete, the system 100 is put into the evacuation configuration so as to transfer the purified adipose tissue TP out of the device for reintroduction into the patient. As indicated above and shown diagrammatically in [Fig. 3], the evacuation configuration results in the filter 5 being wound on itself which produces a pressure pushing the purified adipose tissue TP through the orifice 110 and the interior 112 of the conduit 11 to reach the evacuation segment 12. The purified adipose tissue TP is then transferred into a surgical device 250 capable of allowing reintroduction into the patient (shown in [Fig. 4]) for example such as a device marketed under the reference LipoGrafter® by the company MTFBiologics. The torque given to the motor makes it possible to adapt the pressure exerted during winding and therefore to calibrate the desired flow rate. As indicated above, a pump may or may not be arranged between the volume V and the reintroduction device 250 in order to assist this transfer. [Fig. 4] shows a schematic and partial example of a device 250 capable of allowing the reintroduction of purified adipose tissue TP into the patient's body. The device 250 comprises a body 252 provided with a first port 252a connected to the evacuation segment 12 (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 TP into the patient through the cannula 256 by pressure of 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 (arrow FT), or alternatively this action can be automated.

[0037] In connection with Figures 5 to 7, a variant is shown in which the device further comprises a foldable evacuation aid element 54 located around the inlet orifice 110 of the evacuation conduit 11, said foldable element being configured to pass from a deployed configuration in the purification configuration to a folded configuration under the effect of the winding of the filter in the evacuation configuration. [Fig. 5] shows the foldable element 54 in the deployed configuration, [Fig. 6] the passage to the folded configuration under the effect of the winding of the filter 5 and [Fig. 7] the foldable element 54 in the folded configuration. The foldable element is located in the treatment volume V and is integral with the filter 5. It can for example be glued to the filter.

[0038] The expression “between ... and ...” must be understood as including the limits.

Claims

Claims

1. Device (1) for the purification of adipose tissue (T) and the evacuation of purified adipose tissue (TP), comprising: - an enclosure (3), - a flexible filter (5) delimiting a treatment volume (V) and being capable of retaining the adipose tissue and filtering a liquid medium, the filter being present in the enclosure and extending along a main axis (X) between a lower end (5b) and an upper end (5a), - a lower attachment element (9) integral with the lower end of the filter and an upper attachment element (731) integral with the upper end of the filter, - an evacuation conduit (11) extending in the treatment volume between a lower portion (11b) provided with an inlet orifice (110) and an upper portion (11a) in communication with the outside of the device,and - a drive system (100) capable of taking a purification configuration in which the lower and upper attachment elements are put into joint rotation (SI) around the main axis, and capable of taking an evacuation configuration in which one of the attachment elements (9) is put into rotation (S2) around the main axis and into relative movement with respect to the other attachment element (731) so as to roll the filter up on itself.,

2. Device (1) according to claim 1, in which the device further comprises a rigid cage (7) for retaining the filter, surrounding the filter (5) and located between the latter and the enclosure (3), which is capable of being crossed by the liquid medium.

3. Device (1) according to claim 2, wherein the rigid retention cage (7) defines the upper attachment element (731) and is configured to be rotated in the purification configuration.

4. Device (1) according to any one of claims 1 to 3, wherein said further attachment element (731) is fixed in the evacuation configuration.

5. A device (1) according to any one of claims 1 to 4, wherein the device further comprises a collapsible evacuation aid member (54) located around the inlet orifice (110). of the exhaust duct, said foldable element being configured to pass from a deployed configuration in the purification configuration to a folded configuration under the effect of the winding of the filter (5) in the exhaust configuration.

6. An assembly for purifying adipose tissue (T) and introducing the purified adipose tissue (TP) into the body of a patient, comprising a device (1) according to any one of claims 1 to 5, a discharge segment (12) in communication with the upper portion (11a) of the discharge conduit (11) and a surgical device (250) comprising (i) a reservoir (254) intended to receive the purified adipose tissue and in communication with the discharge segment, and (ii) an introduction element (256) in communication with the reservoir and capable of introducing the purified adipose tissue from the reservoir into the body of a patient.

7. Adipose tissue filtration element intended to be integrated into a device according to any one of claims 1 to 5, comprising: - the flexible filter (5) delimiting the treatment volume (V) and being capable of retaining the adipose tissue and filtering a liquid medium, the filter extending along the main axis (X) between the lower end (5b) and the upper end (5a), - the lower attachment element (9) integral with the lower end of the filter, comprising means for cooperating with the drive system to rotate it around the main axis, and - the discharge conduit (11) extending into the treatment volume between the lower portion (11b) provided with the inlet orifice (110) and the upper portion (11a) in communication with the outside of the treatment volume.

8. The filter element of claim 7, further comprising the collapsible discharge aid member (54) located around the inlet port (110) of the discharge conduit, said collapsible member being configured to move from the deployed configuration in the purification configuration to the collapsed configuration under the effect of the winding of the filter (5) in the discharge configuration.

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