ADIPOSE TISSUE PARTICLE PROCESSING, TRANSFER AND STORAGE SYSTEM
20220390333 · 2022-12-08
Inventors
Cpc classification
C12M45/02
CHEMISTRY; METALLURGY
C12M21/08
CHEMISTRY; METALLURGY
G01N1/4077
PHYSICS
International classification
Abstract
A method and system for processing an adipose tissue material sample to create and collect fat aspirate particles having particle diameters less than or equal to a selected size are disclosed. A filter screen assembly having an interface part, a closed end opposite to the interface part, and a screen portion therebetween is inserted through a first port in a lid of a container, with the interface part providing access to an interior of the container for insertion of a transfer cannula connected to a syringe filled with the adipose tissue material. The screen portion includes a plurality of apertures having diameters of the selected size. Adipose tissue material is expelled from the transfer cannula through the apertures of the filter screen assembly into the container to create and collect the fat aspirate particles having particle diameters less than or equal to the selected size.
Claims
1. A method of processing adipose tissue material to create and collect fat aspirate particles in a container, the fat aspirate particles having particle diameters less than or equal to a selected size, the method comprising: (a) inserting a filter screen assembly into an interior of the container, the filter screen assembly comprising: an interface part configured with an opening to provide access to the interior of the container through a first port in a container lid; a closed end opposite to the interface part; and a screen portion between the interface part and the closed end, the screen portion including a plurality of apertures having diameters of the selected size, the screen portion being supported in the interior of the container via insertion of the filter screen assembly; (b) providing a volume of the adipose tissue material in a syringe, with a transfer cannula having its proximal end connected to the syringe; (c) inserting the transfer cannula into the opening in the interface part of the filter screen assembly, and positioning the transfer cannula within the filter screen assembly so that a distal end of the transfer cannula is inside the screen portion of the filter screen assembly; (d) depressing a plunger of the syringe to expel the adipose tissue material from the distal end of the transfer cannula and through the apertures of the screen portion of the filter screen assembly into the container, thereby processing the adipose tissue material into processed adipose tissue material having the fat aspirate particles with particle diameters less than or equal to the selected size; (e) providing an additional volume of the adipose tissue material in the syringe; (f) evaluating whether the apertures of the screen portion of the filter screen assembly are clogged with debris from the adipose tissue material, and in response to determining clogging, replacing the filter screen assembly with a replacement filter screen assembly; and (g) repeating steps (c)-(f) until a desired amount of processed fat aspirate particles having particle diameters less than or equal to the selected size are collected in the container.
2. The method of claim 1, wherein the interface part of the filter screen assembly comprises a female luer, and inserting the transfer cannula into the opening in the interface part of the filter screen assembly comprises inserting the transfer cannula into the female luer of the interface part.
3. The method of claim 1, further comprising: (h) extracting the processed adipose tissue material from the canister through a second port located near a bottom of the canister.
4. The method of claim 1, wherein the closed end of the filter screen assembly comprises a threaded cap that is threadedly attached to the screen portion.
5. The method of claim 1, wherein the plurality of apertures in the screen portion have diameters of 1500 microns, and the adipose tissue material is processed via the screen portion of the filter screen assembly so that the fat aspirate particles in the processed adipose tissue material have diameters of less than 1500 microns.
6. The method of claim 1, wherein the plurality of apertures in the screen portion have diameters of 1200 microns, and the adipose tissue material is processed via the screen portion of the filter screen assembly so that the fat aspirate particles in the processed adipose tissue material have diameters of less than 1200 microns.
7. The method of claim 1, wherein the screen potion of the filter screen assembly has a length of at least 127 millimeters.
8. The method of claim 1, wherein the canister has a volume of at least 1000 milliliters.
9. The method of claim 1, wherein the step of inserting the transfer cannula into the opening in the interface part of the filter screen assembly, and positioning the transfer cannula within the filter screen assembly so that a distal end of the transfer cannula is inside the screen portion of the filter screen assembly, comprises: positioning the transfer cannula within the filter screen assembly to an extent that leaves selected apertures of the screen portion of the filter screen assembly that are unclogged by sinuate debris unobstructed by the transfer cannula.
10. An adipose tissue processing system for processing adipose tissue material to create and collect fat aspirate particles in a container, the fat aspirate particles having particle diameters less than or equal to a selected size, the system comprising: a filter screen assembly that is insertable into an interior of the container, the filter screen assembly comprising: an interface part configured with an opening to provide access to the interior of the container through a first port in a container lid; a closed end opposite to the interface part; and a screen portion between the interface part and the closed end, the screen portion including a plurality of apertures having diameters of the selected size, the screen portion being configured to be supported in the interior of the container via insertion of the filter screen assembly into the container; and a syringe configured to be fillable with a volume of the adipose tissue material, and a transfer cannula having a proximal end connected to the syringe, the syringe and transfer cannula being configured to be inserted into the opening in the interface part of the filter screen assembly, to allow positioning of the transfer cannula within the filter screen assembly so that a distal end of the transfer cannula is inside the screen portion of the filter screen assembly, such that expelling the adipose tissue material from the syringe through the transfer cannula will cause the adipose tissue material to pass through the apertures of the screen portion of the filter screen assembly into the container, thereby processing the adipose tissue material into processed adipose tissue material having the fat aspirate particles with particle diameters less than or equal to the selected size.
11. The adipose tissue processing system of claim 10, wherein the interface part of the filter screen assembly comprises a female luer configured to receive the transfer cannula into the opening in the interface part of the filter screen.
12. The adipose tissue processing system of claim 10, wherein the canister comprises a second port located near a bottom thereof.
13. The adipose tissue processing system of claim 10, wherein the closed end of the filter screen assembly comprises a threaded cap that is threadedly attached to the screen portion.
14. The adipose tissue processing system of claim 10, wherein the plurality of apertures in the screen portion have diameters of 1500 microns.
15. The adipose tissue processing system of claim 10, wherein the plurality of apertures in the screen portion have diameters of 1200 microns.
16. The adipose tissue processing system of claim 10, wherein the screen potion of the filter screen assembly has a length of at least 127 millimeters.
17. The adipose tissue processing system of claim 10, wherein the canister has a volume of at least 1000 milliliters.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The drawings are intended to illustrate embodiments of, but not to limit, the present invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.
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DETAILED DESCRIPTION
[0019] The present disclosure provides an adipose tissue particle processing system that allows a physician to process (precision size by micro-fragmentation, and filter and remove debris and strands) adipose tissue into controlled fat aspirate particle sizes for use in autologous fat transfer and/or autologous regenerative treatments containing the autologous fat aspirate particles.
[0020]
[0021] Also, in the embodiment shown (see
[0022] In the embodiment shown, centrifuge tube 14 is made of clear plastic, and has a tapered configuration from its top (where cap/bushing 16 is provided) to its bottom (where a conical tapered end is provided). This is a common configuration for a plastic centrifuge tube, which is readily manufactured by injection molding, for example. In an alternative embodiment, a zero-draft, cylindrical plastic centrifuge tube may be constructed and used, which has no taper from the top to the bottom of the tube, and which has a flat bottom surface rather than a conical tapered end. With such a construction, the cylindrical plastic centrifuge tube could be used with the system described in U.S. patent application Ser. No. 16/295,695 entitled “Aspirating Separated Liquid Components From A Vessel” filed on Mar. 7, 2019, which is incorporated by reference herein in its entirety. In the system described in U.S. patent application Ser. No. 16/295,695, a diaphragm is slidably coupleable to the hollow inner portion of the centrifuge tube, and allows liquid contained in the centrifuge tube to be selectively and controllably aspirated out of the centrifuge tube through the diaphragm.
[0023] Centrifuge tube 14 shown in
[0024] In the embodiment shown (see
[0025] Exemplary dimensions for the various features of cap/bushing 16 are shown in
[0026] Apertures 18 in screen portion 17 of filter screen assembly 12 may be formed in by laser drilling in some embodiments. Example sizes/diameters of apertures 18 may be as large as 4.0 millimeters, as small as 0.2 millimeters, any size/diameter in between, or sizes/diameters larger than 4.0 millimeters or smaller than 0.2 millimeters, depending on the application in which the adipose tissue particle processing system 10 is used.
[0027] In one example, screen portion 17 of filter screen assembly 12 may have an outer diameter of about 0.259 inches (about 6.58 millimeters). In other examples, screen portion 17 of filter screen assembly 12 may have larger or smaller radial dimensions. In some embodiments, filter screen assembly 12 is composed of stainless steel.
[0028] In various embodiments, some of the components of adipose tissue particle sizing system 10 are designed to be reusable components (typically made of stainless steel), while other components are designed to be single-use, disposable components (typically made of plastic). In this context, components described as reusable are capable of being cleaned and sterilized multiple times, such as be a sterilizing autoclave, by enzyme treatment, or by other methods, while single-use, disposable components are provided in sterile packaging for a single use.
[0029] In operation, as shown in
[0030] Once the micro-fragmented “sized” fat aspirate particles are transferred through screen portion 17 of filter screen assembly 12 into centrifuge tube 14, then centrifuge tube 14 may be prepared for centrifugation, by removing components of adipose tissue particle processing system 10, and replacing cap/bushing 16 with a conventional threaded lid. After the micro-fragmented fat aspirate particles are separated by either gravity decantation, or by centrifugation in a centrifuge system, various separated components may be aspirated from centrifuge tube 14. In some embodiments, aspiration may be performed by inserting a transfer cannula into the interior of centrifuge tube 14 and aspirating material through the transfer cannula with a syringe coupled to the transfer cannula (as illustrated in
[0031] Filter screen assembly 12 may be cleaned after use by removing male luer cap 20 from the distal end, and inserting a cannula cleaner that is configured with projecting surfaces such as convex fins into the interior of filter screen assembly 12. Cleaning is performed by scraping, dislodging, and removing debris and contaminants when making direct physical contact with the interior of a cannula device when moved back-and-forth following use of the cannula device, to be moved back and forth to cause frictional engagement with filter screen assembly 12 for cleaning. The cannula cleaner may be made of medical-grade nylon in some embodiments. In some embodiments, the cannula cleaner may be configured as shown and described in U.S. Provisional Application No. 62/855,167 entitled “Method and Apparatus for Cleaning the Interior Cannula of Suction Lipoplasty Cannula Devices and Adipose Tissue and/or Fluid Particle Sizing Devices,” filed on May 31, 2019, which is hereby incorporated by reference.
[0032]
[0033] As an initial step, a collected sample of adipose tissue particles is provided in one or more syringes, and a transfer cannula is attached to the output of a syringe, so that the adipose tissue sample in the syringe can be output through the transfer cannula.
[0034] In order for adipose tissue particles to be able to pass through the apertures of filter screen assembly 12, transfer cannula 60 is positioned by a clinician so that the distal end or transfer cannula is located just above the first unclogged apertures 18 of filter screen assembly 12 (step 41,
[0035] While adipose tissue particles are being transferred into container 14 through filter screen assembly 12, the clinician monitors the process to determine whether the container 14 is full (step 44). When container 14 is full, the particle transfer process is paused. The clinician then removes transfer cannula 60 from filter screen assembly 12 and removes filter screen assembly 12 from container 14 (step 45), and determines whether there are additional containers that need to be filled (step 46). If no further containers need to be filled, the process is over. If there are additional containers to be filled, filter screen assembly 12 is inserted into the next container 14 (step 47), and the process returns to step 40, in which the clinician inserts transfer cannula 60 attached to syringe 30 into the interior of filter screen assembly 12.
[0036] Also, while adipose tissue particles are being transferred into container 14 through filter screen assembly 12, the clinician monitors the process to determine whether syringe 30 is empty (step 48). If syringe 30 is empty, the clinician removes transfer cannula 60 from filter screen assembly 12 and disconnects transfer cannula 60 from (empty) syringe 30 (step 49). The clinician then determines whether there are additional syringes containing adipose tissue that needs to be sized (step 50). If there are no further adipose tissue samples that need to be sized, the process is over. If there are additional syringes containing adipose tissue to be sized, the clinician attaches transfer cannula 60 to the next syringe 30 (step 52), and the process returns to step 40, in which the clinician inserts transfer cannula 60 attached to syringe 30 into the interior of filter screen assembly 12.
[0037] If syringe 30 is not empty, the clinician continues to monitor the process to determine whether apertures 18 of filter screen assembly 12 adjacent to the distal end of transfer cannula 60 are clogged (step 54). Depending on the nature of the adipose tissue being processed, the volume of syringe 30, the volume of container 14, and the total amount of samples of adipose tissue particles to be sized, apertures 18 in filter screen assembly 12 may begin to become clogged with sinuate or other material that is filtered by filter screen assembly 12 during the adipose tissue sizing process. If the monitoring clinician determines that apertures 18 are not clogged, then the clinician continues to depress the plunger of syringe 30 to expel adipose tissue through filter screen assembly 12, illustrated by the process looping back to step 42 and continuing to be monitored by decision steps 44, 48 and 54. If apertures 18 are clogged, the clinician repositions transfer cannula 60 within filter screen assembly 12 so that the distal end of transfer cannula 60 is located just above higher, unlogged apertures 18 of filter screen assembly (step 41). This concept is illustrated in
[0038] If all of the apertures 18 of filter screen assembly 12 are clogged (that is, the top/proximal-most apertures 18 are clogged), then it is necessary to replace filter screen assembly 12 with a new filter screen assembly 12 in order to continue the process. That is, the process is stopped in order to insert a new filter screen assembly 12 into container 14, and the process then begins again by inserting transfer cannula 60 through the opening of female luer fitting 28 at the proximal end of filter screen assembly 12, to extend into the interior of filter screen assembly 12 (step 40,
[0039] The process shown in
[0040] Several examples of the successive/repeated process illustrated in
[0041] In order to transfer intermediate “sized” adipose tissue particles from a centrifuge tube into a syringe for further sizing, in some embodiments, a clinician may insert a clean filter screen assembly 12, having apertures 18 with the same diameter as was just used to size the adipose tissue particles, into container 14, with luer cap 20 removed (leaving an open distal end). Then, the clinician takes an empty syringe 30 having transfer cannula 60 attached, and inserts transfer cannula 60 through filter screen assembly 12 to a position at or near the bottom of container 14. In other embodiments, the clinician may simply insert transfer cannula 60 attached to an empty syringe 30 through the opening of cap/bushing 16 into the interior of container 14, without using filter screen assembly 12. In either case, next, the clinician pulls up the plunger of syringe 30, while slightly repositioning transfer cannula 60 within container 14 as needed, to draw the adipose tissue particles up into syringe 30. This allows the clinician to fill one or more syringes with the intermediate “sized” adipose tissue particles for further sizing (particle size reduction) in subsequent processes as shown in
[0042]
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[0044] In operation, syringe 230 (which may be a 30 ml syringe in one exemplary embodiment) is filled with adipose tissue to be filtered/sized, such as by drawing adipose tissue through a suction port from a separate container (not shown) through transfer cannula 232. The adipose tissue to be filtered/sized may consist of particles that have a larger size than would be desirable for autologous fat transfer, so that filtering/sizing is needed to reduce the particle size of the adipose tissue and remove sinuate from the tissue—in one example embodiment, the initial size of the particles of the adipose tissue to be filtered/sized that is contained in syringe 230 is about 2-3 mm. Once syringe 230 is filled with adipose tissue to be filtered/sized, transfer cannula 232 may be inserted through the central opening of mating plug 216 into the interior of screen portion 217 of filter screen assembly 212. With the transfer cannula 232 held in position inside filter screen assembly 212, the plunger of syringe 230 may be depressed, to push the adipose tissue to be filtered/sized out of transfer cannula 232, where the adipose tissue will then pass through the apertures 218 of screen portion 217 of filter screen assembly 212 and be filtered and resized to a smaller particle size, into the interior of canister 215. This process can be repeated multiple times through the same filter screen assembly 212, with the transfer cannula 232 successively positioned adjacent to apertures 218 of screen portion 217 that remain unclogged, in the general manner shown in
[0045] This filtering/sizing operation is similar to that described above with respect to adipose tissue processing system 10, and allows a large volume of adipose tissue to be filtered/sized and collected in canister 215, using multiple filter screen assemblies 212 as each individual filter screen assembly becomes clogged with sinuate debris. For example, canister 215 may have a volume of 1000 mL in some embodiments. This may be particularly advantageous for larger volume autologous fat transfer applications, such as breast or buttock augmentation. For example, the filtering/sizing operation may involve adipose tissue filled in syringe 230 with a particle size of about 2-3 mm, and apertures 218 in screen portion 217 of filter screen assembly 212 may have a diameter of 1500 microns, so that adipose tissue particles are precision sized to 1500 microns with sinuate connective material removed, suitable for use in a breast or buttock augmentation procedure. In other examples, different sized apertures may be used, such as 1200 microns or other sizes. It is also possible to repeat the entire process to further reduce the size of the adipose tissue by successively using a filter screen assembly 212 with smaller apertures, if desired, as described above in relation to
[0046] Canister 215 may include a port near its bottom for removal of fat from canister 215 after adipose tissue has been filtered/sized. Also, port 213 may be equipped with or receive a seal in order to seal lid 214 of canister 215 after filter screen assembly 212 is removed. Once the desired amount of filtered/sized adipose tissue is obtained inside canister 215, a tube may be coupled to the port near the bottom of canister 215 (preferably with port 213 sealed) in order to decant the liquid (typically a small amount of excess water that was harvested as part of the adipose tissue filtering/sizing operation) contained in canister 215.
[0047] In some embodiments, filter screen assembly 212 shown in
[0048] Adipose tissue particle processing systems 10 and 210 described herein allow adipose tissue material to be micro-fragmented (“sized”) to a controllable fat aspirate particle size, with easy connections of components. In various embodiments, the systems minimize contamination, spillage, and infection issues, while maintaining an essentially closed system during the processing of tissue and/or fluid, and/or provide a fast and convenient way to transfer adipose tissue to be filtered/sized into a vessel or container for additional sizing and/or for use in an autologous fat transfer procedure.
[0049] While various components of adipose tissue particle processing systems 10 and 210 are shown and/or described in the exemplary embodiments herein as integrated, connected, or separate components, it should be understood that in alternative embodiments, components may be integrally formed, connected, and/or separated in different ways than are shown and described herein, all within the scope and spirit of the present invention. Similarly, the sizes and dimensions of components, both in terms of absolute sizes and relative sizes with respect to other components, may be varied from what is shown and described herein, all within the scope of the present invention.
[0050] While certain example embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.