Device and method for preparing adipose tissue for transplantation

Abstract

A device for preparing adipose tissue for transplantation, from lobular fat extracted, for instance, by liposuction. The device comprises at least one washing and separating container (1) having a washing chamber (11) for washing the liposuctioned material, which washing and separating container (1) has at least one inlet (12) and at least one outlet (13) for the liposuctioned material to enter the washing chamber (11) through the inlet (12) and for at least part of said material, the fluid component, to exit said chamber 11 through the outlet 13. The washing and separating container (1) is coupled to stirring means via coupling means (2) for releasably coupling said washing and separating container (1) to said stirring means, drive means being provided for driving said stirring means. The stirring means comprising a stirring member (31) supported by a support structure (32), said washing and separating container (1) being releasably coupled to said stirring member (31) via said coupling means, and said stirring member (31) being driven by said drive means, emulsion generating means (14) being provided in said washing chamber (11), for generating an emulsion of the fluid components by mechanical stirring.

Claims

1. A device for preparing adipose tissue for transplantation from lobular fat material extracted by liposuction, said fat material comprising (a) a solid component composed of adipocytes arranged in cell agglomerates of heterogeneous sizes, and (b) a fluid component comprising one or more of an oily component derived from lysis of adipocytes, blood residues, and medicated saline solutions containing anesthetics, as used during the liposuction procedure, said device comprising at least one washing and separating container (1) having a washing chamber (11) for washing the liposuctioned material, said washing and separating container (1) having at least one inlet (12) and at least one outlet (13) for the liposuctioned material to enter the washing chamber (11) through the inlet (12) and for at least part of said material, separated from the fluid component, to exit said chamber (11) through the outlet (13), wherein said washing and separating container (1) is coupled to stirring means via coupling means (2) for releasably coupling said washing and separating container (1) to said stirring means, said stirring means provides drive means for driving said stirring means, said stirring means comprises a stirring member (31) supported by a support structure (32), said washing and separating container (1) being releasably coupled to said stirring member (31) via said coupling means, and said stirring member (31) being driven by said drive means, said washing chamber (11) provides emulsion generating means (14) for generating an emulsion of the fluid components by mechanical stirring, and said washing and separating container (1) comprises a tubular element, the stirring member (31) supporting said washing and separating container (1) such that it can rotate about at least one axis of rotation incident on the longitudinal axis of the washing and separating container and such that it can be cyclically translated in at least one or more predetermined directions.

2. A device as claimed in claim 1, wherein said washing and separating container (1) is connected at said inlet (12), via a two-way connection (121), to a saline vessel (42) and a liposuctioned material vessel (52) respectively, and said outlet (13) is connected, via a two-way connection (131), to a waste product vessel (53) and a collection vessel (54), respectively.

3. A device as claimed in claim 2, wherein said two-way connections (121, 131) have self-closing valves.

4. A device as claimed in claim 2, wherein said washing and separating container (1) is connected to said saline container (42) through pumping means (6).

5. A device as claimed in claim 2, wherein said washing and separating container (1) is connected to said collection vessel (54) through a solenoid-operated pinch valve (55).

6. A device as claimed in claim 1, wherein said coupling means (2) are made of one piece with said washing and separating container (1).

7. A device as claimed in claim 1, further comprising at least one electronic control unit, said electronic control unit having at least one input/output interface unit (321), at least one display unit (321), and at least one processing unit containing processor means for executing a logic program.

8. A device as claimed in claim 1, further comprising at least one sensor for detecting identification parameters concerning the movement of said washing and separating container and/or concerning the solution contained in said container.

9. A device as claimed in claim 1, wherein the stirring member (31) simultaneously rotates the washing and separating container (1) such that the container periodically moves to the left and right, and cyclically translates the washing and separating container (1) such that the container periodically moves up and down.

10. A device for preparing adipose tissue for transplantation from lobular fat material extracted by liposuction, said fat material comprising (a) a solid component composed of adipocytes arranged in cell agglomerates of heterogeneous sizes, and (b) a fluid component comprising one or more of an oily component derived from lysis of adipocytes, blood residues, and medicated saline solutions containing anesthetics, as used during the liposuction procedure, said device comprising a washing and separating container (1) having a washing chamber (11) for washing the liposuctioned material, said washing and separating container (1) having at least one inlet (12) and at least one outlet (13) for the liposuctioned material to enter the washing chamber (11) through the inlet (12) and for at least part of said fluid component to exit said chamber (11) through the outlet (13), wherein said washing and separating container (1) has coupling members (2) made of one piece with said container (1), for coupling said container (1) to at least one support structure.

11. A device as claimed in claim 10, wherein said washing and separating container (1) is connected at said inlet (12), via a two-way connection (121), to a saline vessel (42) and a liposuctioned material vessel (52), respectively, said outlet (13) is connected via a two-way connection (131) to a waste product vessel and a collection vessel (53), respectively, and said two-way connections (121, 131) are complemented by self-closing valves.

12. A device as claimed in claim 10, wherein said washing and separating container comprises a cylindrical body having two corresponding closing heads at its end sides, said closing heads being fixed at said at least one inlet and said at least one outlet, and said two-way connections are made of one piece with said closing heads.

13. A method of preparing adipose tissue for transplantation, from lobular fat material extracted by liposuction, said fat material comprising (a) a fluid component comprising one or more of an oily component, a blood component, and/or sterile solutions, and (b) a solid component comprising cell fragments, cells, and one or more cell macroagglomerates of heterogeneous size, said method comprising the steps of: a) flushing a washing and separating container having a chamber for washing the liposuctioned material, an inlet and an outlet, by introducing a saline into said washing chamber through said inlet, b) introducing the liposuctioned material into said washing chamber through said inlet, c) stirring said washing and separating container to facilitate emulsion of the fluid components with the sterile fluid substances, by emulsifying means, d) placing the washing and separating container in such a position as to obtain a stratification of the solid components on the liquid emulsion, which constitutes the fat contained in the washing chamber, to obtain a solid component composed of cell fragments, cells, and one or more cell agglomerates floating on an emulsion of the fluid components in the lower portion of the washing chamber and in contact with the outlet of the washing and separating container, and e) injecting a saline through said inlet and discharging the emulsion of fluid components from the washing chamber through the outlet of the washing and separating container, with density gradient removal of the emulsion of fluid components, wherein at least step c) is carried out in automated fashion, said washing and separating container being coupled to stirring means via coupling means for releasably coupling said washing and separating container to said stirring means, and said stirring means provides drive means for driving said stirring means.

14. A method as claimed in claim 13, wherein steps a), c), d) and e) are automated.

15. A method as claimed in claim 13, further comprising an additional flushing step by introducing a saline into said washing chamber through said inlet, at the same time as step b).

16. A method as claimed in claim 13, wherein step c) is obtained by a combination of a rotation or oscillation about an axis of rotation perpendicular to the longitudinal axis of said washing and separating container and a translation in at least one predetermined direction.

17. A method as claimed in claim 16, wherein stirring of said washing and separating container is carried out according to certain rotation and/or translation identification parameters.

18. A method as claimed in claim 17, further comprising a step in which said identification parameters are entered.

19. A method as claimed in claim 13, further comprising a step in which controls for operation of said steps a) to e) are entered.

20. A method as claimed in claim 13, wherein step a) is followed by a sub-step a1) in which said washing and separating container is stirred.

Description

(1) These and other features and advantages of the present invention will appear more clearly from the following description of a few embodiments, illustrated in the annexed drawings, in which:

(2) FIGS. 1a and 1b show two perspective views of the device of the present invention;

(3) FIGS. 2a to 2d show details of the device of the present invention;

(4) FIGS. 3a to 3d show the steps of the method of the present invention;

(5) FIGS. 4a to 4h show different screens of the user interface as displayed by the device of the present invention;

(6) FIG. 5 shows a possible embodiment of the washing and separating container provided in the device of the present invention;

(7) FIGS. 6a and 6b show two views of the washing and separating container according to a possible embodiment.

(8) It should be understood that the figures annexed hereto only concern a possible embodiment of the device and method of the present invention and shall be intended without limitation, as having the purpose of merely explaining the inventive principle of the present invention, i.e. the provision of a device and a method that can standardize the process for preparing adipose tissue for transplantation from lobular fat.

(9) Particularly referring to the figures, FIGS. 1a and 1b show a device for preparing adipose tissue for transplantation from a solid component composed of adipocytes arranged in cell agglomerates of heterogeneous sizes, a fluid component comprising an oily component derived from lysis of adipocytes, blood residues and other liquid components, such as medicated saline solutions containing anesthetics, as used during the liposuction procedure.

(10) The device comprises at least one washing and separating container 1 having a washing chamber 11 for washing the liposuctioned material, which washing and separating container 1 has at least one inlet 12 and at least one outlet 13 for the liposuctioned material to enter the washing chamber 11 through the inlet 12 and for at least part of said material, particularly the fluid component, to exit said chamber 11 through the outlet 13.

(11) The washing and separating container 1 is coupled to stirring means via coupling means 2 for releasably coupling the washing and separating container 1 to the stirring means.

(12) Drive means are also provided, for driving the stirring means, such stirring means comprising a stirring member 31 supported by a support structure 32.

(13) The washing and separating container 1 is releasably coupled to the stirring member 31 via the coupling means 2, and the stirring member 31 is driven by said drive means.

(14) Emulsion generating means 14 are also provided in the washing chamber 11, for generating an emulsion of the fluid components by mechanical stirring.

(15) It shall be noted that the washing and separating container may comprise all the features as disclosed in the International Patent Application WO2011/145075.

(16) FIGS. 1 and 1b do not show the coupling between the stirring member 31 and the drive means that drive it, but such coupling may be provided with any known method that can ensure transmission between a motion generating member, one or more mechanisms that perform the required movements, and the functional actuator members.

(17) The coupling means 2 for coupling the container to the stirring member 31 may consist of any element that can rigidly join the container 1 to the stirring member 31.

(18) In the particular case of FIGS. 1b and 2a, the coupling means 2 consist of an elastic element 2 that is rigidly joined to the stirring member 31 and surrounds the outer surface of the container 1.

(19) Other clamp or jaw elements may be also used.

(20) In a possible embodiment as shown in FIG. 5, the washing and separating container 1 has coupling means formed of one piece with the walls of the tubular body of the container 1.

(21) These coupling means consist of members 21 that cooperate with a corresponding engagement seat integrally formed on the stirring member 31.

(22) Particularly the members 21 may engage with the stirring member 31 by means of a sliding or bayonet connector equipped with a lock device.

(23) This will avoid the need of forming the coupling means as shown in FIG. 2a.

(24) As shown in the figures, the container 1 consists of a tubular element.

(25) The stirring member 31 supports the washing and separating container 1 such that it can rotate or oscillate about an axis of rotation incident on the longitudinal axis of the washing and separating container 1 and such that it can be translated in at least one predetermined direction.

(26) Arrows A and B of FIG. 1b show the possible movements of the stirring member 31, and hence the container 1.

(27) The rotation and translation occur simultaneously and periodically, i.e. the drive means move the stirring member 31 such that the container periodically moves up and down, as shown by arrow B, while periodically rotating to the right and left, as shown by arrow A.

(28) This will not simply provide a mechanical transmission system, but a system in which constraints are not fixed, but set by user controls, as more clearly explained below.

(29) FIGS. 3a and 3b show a possible configuration of the washing and separating container 1, in which the container 1 is connected at the inlet 12, via a two-way connection 121, to a saline vessel 42 and a liposuctioned material vessel 52 respectively.

(30) The outlet 13 is connected via a two-way connection 131 to a waste product vessel 53 and a collection vessel 54 respectively.

(31) Preferably the connections 121 and 131 are equipped with self-closing valves.

(32) Particularly the cylindrical body of the container 1 has the inlet 12 and the outlet 13 consisting of two closing heads 122 and 132 which may be formed of one piece with the two-way connections 121 and 131.

(33) Each two-way connection has at least one self-closing valve.

(34) As explained below, for example, when the syringe 52 is connected to the valve 121, see FIG. 3b, the self-closing valve allows the liposuctioned material to be introduced into the container 1, but as soon as the syringe is disconnected, the self-closing valve closes to prevent exit of the material and to isolate the inner environment.

(35) As clearly shown in FIGS. 3a to 3d, the system composed of the container 1 and the various parts connected thereto is a closed system, with the connecting tubes integrated in said system, which may be mounted to the structure 32 of FIGS. 1a and 1b.

(36) Both the closing heads 122, 132 of the container 1 and the connections 121 and 131 with their self-closing valves may be connected by screw, interlocking, welding or chemical bonding arrangements, or by complex connections, as needed, provided that they can withstand with appropriate safety margins the mechanical and pressure stresses exerted thereon during treatment and extraction of the material being processed.

(37) The two-way connections 121 and 131 allow two different inlet or outlet ports to be integrated into a single connection.

(38) FIGS. 6a and 6b show a possible embodiment of the two-way connections.

(39) Particularly, the washing and separating container qq is composed of a cylindrical body having two corresponding closing heads 112 and 113 at its end sides, such heads being fixed at the inlet 12 and at the outlet 13.

(40) Preferably, the closing heads 112 and 113 are formed integrally, i.e. of one piece, with the two-way connections 121 and 131.

(41) Furthermore, the washing and separating container 1 is connected to the saline container 42 through pumping means 6, e.g. a peristaltic pump or the like.

(42) In a possible embodiment, the device of the present invention may include a safety door 7, which causes the process to stop as soon as it is opened.

(43) FIGS. 2a to 2d further show the particular arrangements that can be envisaged both for the connecting tubes and for the pumping means 6 attached to the support structure 32.

(44) Particularly, FIG. 2c shows a possible component of the system, i.e. a solenoid-operated pinch valve 8 which connects the washing and separating container 1 to the collection vessel 53 of FIG. 3b, in which the solenoid-operated pinch valve 8 is schematically represented by knot that closes the tube 81.

(45) Thus, the solenoid-operated pinch valve 8, which is preferably controlled by the electronic unit, allows the tube 81 to automatically closed and opened in synchronism with the process, and when the tube 81 is required to be closed, the solenoid-operated valve closes and the area defined by the container 1 is isolated from the discharge bag 53.

(46) Particularly referring to FIGS. 1a and 1b, the device of the present invention includes at least one electronic control unit, which electronic control unit has at least one input/output interface unit, at least one display unit, at least one processing unit containing processor means for executing a logic program.

(47) The electronic control unit is contained in the support structure 32 and the display unit and the input/output interface unit are preferably integrated in a screen 321, such as a touchscreen or the like.

(48) The input/output interface 321 may be used to enter the controls to set the operation of the logic program.

(49) Then, the logic program generates controls to regulate the movements of the stirring member 31 and carry out the method of the present invention, as initially shown in FIGS. 3a to 3d.

(50) The method of the present invention is a method of preparing adipose tissue for transplantation, from lobular fat extracted, for instance, by liposuction, the fat consisting of a fluid component composed of an oily component, a blood component and/or sterile solutions and a solid component composed of cell fragments, cells and one or more cell macroagglomerates of heterogeneous size.

(51) The method of the present invention includes the steps of:

(52) a) filling the washing and separating container 1, as shown in FIG. 3a.

(53) The pumping means 6 pump the saline contained in the vessel 42 into the washing chamber 11.

(54) The saline fills the entire washing chamber 11, thereby completely removing air through the inlet 12 and the two-way connection 121.

(55) b) introducing the liposuctioned material into the washing chamber 11, as shown in FIG. 3b.

(56) A syringe 52 is introduced into one of the two ports of the two-way connection 121 and the liposuctioned material is pushed into the washing chamber 11 through the inlet 12.

(57) Any amount of liposuctioned material may be injected using a plurality of syringes.

(58) The provision of a solenoid-operated pinch valve 8 allow regulation of the waste fluid that flows from the outlet 13 and is collected in the vessel 53.

(59) c) stirring the washing and separating container 1, as shown in FIG. 3c, to facilitate emulsion of fluid components, particularly the oily component with the sterile fluid substances, by the provision of emulsifying means 14 for generating an emulsion of the fluid components.

(60) d) placing the washing and separating container 1, as shown in FIG. 3d, in such a position as to obtain a stratification of the solid components 111 on the liquid emulsion 112.

(61) Particularly, the container 1 is in such a position that the container 1 has its longitudinal axis parallel to a vertical axis, whereby from FIG. 3a to FIG. 3D the container 1 is rotated by 180.

(62) Thus, the material in the washing chamber 11 has a solid component 111 composed of cell fragments, cells and one or more cell agglomerates floating on an emulsion of the fluid components 112 in the lower portion of the washing chamber 11 in contact with the outlet 13 of the washing and separating container 1.

(63) e) injecting saline and withdrawing the solid component 111 for use in the transplantation.

(64) The syringe 54 is connected to the two-way connection 131 associated with the outlet 13 of the container 1.

(65) The pumping means 6 pump the saline from the vessel 42 into the washing chamber 11 through the inlet 12.

(66) Pressure in the washing chamber 11 increases until the processed material is ejected from the outlet connected to the collecting syringe.

(67) Step c) is carried out in automated fashion, the washing and separating container 1 being coupled to stirring means, as described above.

(68) As better explained below, steps a), c), d) and e) are preferably also automated.

(69) In step b), as shown in FIG. 3b, the saline may be simultaneously introduced into the container 1 from the vessel 42.

(70) As shown in FIG. 3c, step c), in which the container 1 is stirred, is obtained by a combination of a rotation or oscillation, as shown by arrow A, about an axis of rotation perpendicular to the longitudinal axis of the washing and separating container 1 and a translation, as shown by arrow B, in at least one predetermined direction.

(71) Preferably, the oscillation has an amplitude of about 70 mm and a frequency not exceeding 6.5 Hz.

(72) Advantageously, step a) is followed by a sub-step a1) in which the washing and separating container 1 is stirred.

(73) In a possible embodiment, stirring of said washing and separating container 1 is carried out according to certain rotation and/or translation identification parameters.

(74) These identification parameters may be selected and set by a user.

(75) A user may also select and set a sequence of variation of such parameters, e.g. frequency and amplitude of oscillation and tilt, orientation of movement axes, time-dependent washing flow, from predetermined sequences, treatment programs and profiles, or according to physical and chemical detections by sensors that may be provided on the apparatus.

(76) Particularly, the identification parameters or the sequences or logics of variation of such parameters during treatment, may be entered through the logic program executed by the above described processing unit.

(77) Likewise, like the identification parameters, operating controls for carrying out said steps from a) to e) may be entered.

(78) FIGS. 4a to 4h show different screens of the user interface as displayed by the touchscreen 321.

(79) Once the container 1 is mounted to the stirring member 31, the program is started and a start screen is displayed, as shown in FIG. 4a, whereby the user may start the treatment by pressing the start button 61.

(80) Each screen may have a button 62 for stopping the process.

(81) As soon as the process starts, the user may select the type of final product to be obtained, as shown in FIG. 4b: the user selects one of the buttons 63, 64, 65, 66 to chose a product type, having differentiated chemical and physical properties.

(82) The program provides a series of preset types, although the characteristics of the product may be set manually.

(83) Obviously, each type will be associated with different identification parameters.

(84) According to the selected type, the program may set, for example, the amount of liposuctioned material and the flow of saline to be introduced into the washing chamber 11, the washing time, the speed, orientation, frequency and amplitude of the movements and the duration thereof.

(85) The products may be also differentiated according to the type of container 1 to be used in the process, both in terms of size and parts thereof, e.g. the nets used therein, as described in greater detail in WO2011/145075.

(86) The inlet and outlet 12 and 13 are connected to the vessels as described above and the button 67 is selected to start the pumping means 6 and fill the container with saline.

(87) Thus, the filling step starts, and the container 1 is placed with its longitudinal axis in a vertical position, with the inlet 12 at a lower position than the outlet 13.

(88) Each screen may include a button 68 for the user to change the process settings.

(89) Furthermore, one or more monitoring screens may be provided, for checking whether the container 1 is properly connected.

(90) Then the filling step starts, as shown in FIG. 4d, and the program displays a screen that shows the amount and volume of saline that is being introduced, and allows the process may be paused, by button 69 or stopped, by button 70.

(91) The filling step may automatically stop as soon as the preset volume is reached.

(92) FIG. 4e shows the next screen, through which loading of the liposuctioned material or processing may be started, by buttons 70 or 71 respectively.

(93) The user starts loading the liposuctioned material, and the screen of FIG. 4f shows the loaded amount and more lipoisuctioned material may be added, by button 72, or loading may be stopped, by button 73.

(94) When pressing the button 73, the program displays the screen of FIG. 4g through which stirring of the container 1 may be started/paused by button 74 or stopped, by button 75.

(95) Furthermore, the overall stirring time and the washing volume may be monitored.

(96) Once the stirring process has ended, the screen 4h will be displayed, through which the process may be terminated, by button 76, or new liposuctioned material may be loaded, by button 77, to repeat the stirring step.

(97) When the button 76 is selected, the program will prompt for the insertion of a syringe to collect the product so formed in the washing chamber, as described with respect to FIG. 3d.

(98) Now the user may decide whether to repeat the process to increase the amount of generated product, or end the process if an adequate amount of product has been obtained thereby.