CHAMBER FOR THE COLLECTION OF LIPOASPIRATE

20180207331 ยท 2018-07-26

    Inventors

    Cpc classification

    International classification

    Abstract

    Embodiments of the present invention disclose a device for collection and purification of adipose tissue and methods of making and using the same.

    Claims

    1. A device for adipose tissue collection and purification, comprising: a) an adipose tissue collection and filtration component on the inside; b) a rigid container (canister) on the outside that allows for a vacuum collection of lipoaspirate; and c) a lid on the rigid container comprising a fluid logic, wherein the fluid logic is controlled by a pinch cam which selectively pinches off tubing connections depending on the desired fluid configuration, and wherein the fluid logic comprises a configuration such that when there is a need to open the canister, the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere.

    2. The device of claim 1, wherein the entire assembly is pre-assembled and disposable.

    3. The device of claim 1, wherein the entire assembly is made entirely of plastic.

    4. The device of claim 1, wherein the fluid connections/logic is controlled by the product itself as opposed to humans needing to make and adjust connections.

    5. The device of claim 1, wherein the lid comprises a knob, wherein the pinch cam comprises pitch valves, and wherein turning of the knob causes the pinch valves to open and/or close in accordance with the fluid logic diagram.

    6. The device of claim 1, wherein the fluid logic comprises a plurality of ports and positions related to each other in a way to effect adipose tissue collection and purification.

    7. The device of claim 6, wherein the position comprises a harvest position, a wash position, and an off position, wherein: in the harvest position, the fluid logic would be such that a vacuum source via a vacuum port would be pulling tissue from a patient port and into the adipose tissue collection and filtration component, in the meanwhile pulling fluid out of a drain port; in the wash position, the drain would be closed off so the adipose tissue collection and filtration component is filled with fluid; and in the off position, all of the pinch valves are closed and an eccentric cam is used to eject the lid off to open it and gain easy access to the adipose tissue collection and filtration component inside in the event that some of the tissue is stuck in the adipose tissue collection and filtration component to squeeze out the stuck tissue.

    8. The device according to claim 7, wherein the adipose tissue collection and filtration component is a Puregraft bag.

    9. A method of adipose tissue collection and purification, comprising: providing a device comprising a) an adipose tissue collection and filtration component on the inside; b) a rigid container (canister) on the outside that allows for a vacuum collection of lipoaspirate; and c) a lid on the rigid container comprising a fluid logic, wherein the fluid logic is controlled by a pinch cam which selectively pinches off tubing connections depending on the desired fluid configuration, and wherein the fluid logic comprises a configuration such that when there is a need to open the canister, the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere, and performing adipose tissue collection and purification using the device so as to harvest and purify an amount of adipose tissue in a manner that the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere.

    10. The method of claim 9, wherein the entire assembly of the device is pre-assembled and disposable.

    11. The method of claim 9, wherein the entire assembly of the device is made entirely of plastic.

    12. The method of claim 9, wherein the fluid connections/logic is controlled by the product itself as opposed to humans needing to make and adjust connections.

    13. The method of claim 9, wherein the lid comprises a knob, wherein the pinch cam comprises pitch valves, and wherein turning of the knob causes the pinch valves to open and/or close in accordance with the fluid logic diagram.

    14. The method of claim 9, wherein the fluid logic comprises a plurality of ports and positions related to each other in a way to effect adipose tissue collection and purification.

    15. The method of claim 14, wherein the position comprises a harvest position, a wash position, and an off position, wherein: in the harvest position, the fluid logic would be such that a vacuum source via a vacuum port would be pulling tissue from a patient port and into the adipose tissue collection and filtration component, in the meanwhile pulling fluid out of a drain port; in the wash position, the drain would be closed off so the adipose tissue collection and filtration component is filled with fluid; and in the off position, all of the pinch valves are closed and an eccentric cam is used to eject the lid off to open it and gain easy access to the adipose tissue collection and filtration component inside in the event that some of the tissue is stuck in the adipose tissue collection and filtration component to squeeze out the stuck tissue.

    16. The method of claim 9, wherein the adipose tissue collection and filtration component is a Puregraft bag.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0049] FIG. 1 illustrates an embodiment of the invention device.

    [0050] FIG. 2 is a photographic image of a 3D-printed/machined prototype of lid 300 with the liquid logic diagram 310.

    [0051] FIG. 3 shows an invention device 100 being tested along with a pump 410 (left) and catch canister 420 (center).

    DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

    Definitions

    [0052] As used herein, the term adipose tissue is used interchangeably with the term fat, the meaning of which is well known to a person of ordinary skill in the art.

    [0053] As used herein, the term adipose tissue removal or tissue removal or harvesting or liposuction are used interchangeably to mean remove an amount of adipose tissue from a live subject such as a male or female patient.

    [0054] As used herein, the term Puregraft bag refers to an adipose tissue collection and purification bag marketed by Puregraft LLC. Examples of Puregraft bag are described in U.S. Pat. No. 9,133,431 B2, teaching of which is incorporated herein by reference. In some embodiments, Puregraft bag is used interchangeably with the term PG bag.

    [0055] As used herein, the term filter, if applicable, refers to a porous material having a size or size distribution useful for adipose tissue filtration. Some examples of filter useful for the present invention are described in U.S. patent application Ser. No. 12/771,985, issued as U.S. Pat. No. 9,133,431, the teachings of which is incorporated herein by reference in its entirety.

    Adipose Tissue Collection and Purification

    [0056] In one aspect of the present invention, it is provided a device for adipose tissue collection and purification, comprising:

    a) an adipose tissue collection and filtration component on the inside;
    b) a rigid container (canister) on the outside that allows for a vacuum collection of lipoaspirate; and
    c) a lid on the rigid container comprising a fluid logic,

    [0057] wherein the fluid logic is controlled by a pinch cam which selectively pinches off tubing connections depending on the desired fluid configuration, and

    [0058] wherein the fluid logic comprises a configuration such that when there is a need to open the canister, the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere.

    [0059] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the entire assembly is pre-assembled and disposable.

    [0060] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the entire assembly is made entirely of plastic.

    [0061] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the fluid connections/logic is controlled by the product itself as opposed to humans needing to make and adjust connections.

    [0062] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the lid comprises a knob,

    [0063] wherein the pinch cam comprises pitch valves, and

    [0064] wherein turning of the knob causes the pinch valves to open and/or close in accordance with the fluid logic diagram.

    [0065] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the fluid logic comprises a plurality of ports and positions related to each other in a way to effect adipose tissue collection and purification.

    [0066] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the position comprises a harvest position, a wash position, and an off position, wherein:

    [0067] in the harvest position, the fluid logic would be such that a vacuum source via a vacuum port would be pulling tissue from a patient port and into the adipose tissue collection and filtration component, in the meanwhile pulling fluid out of a drain port;

    [0068] in the wash position, the drain would be closed off so the adipose tissue collection and filtration component is filled with fluid; and

    [0069] in the off position, all of the pinch valves are closed and an eccentric cam is used to eject the lid off to open it and gain easy access to the adipose tissue collection and filtration component inside in the event that some of the tissue is stuck in the adipose tissue collection and filtration component to squeeze out the stuck tissue.

    [0070] In some embodiments of the invention device, optionally in combination with one or more embodiments of invention disclosed herein, the adipose tissue collection and filtration component is a Puregraft bag.

    [0071] Exemplary embodiments of the invention are shown in FIGS. 1-3. Based on the current Puregraft Vacuum lid we were able to conceive and reduce to practice a device that wouldn't suffer from any of the above issues. The device would use Puregraft filtration on the inside, and would have a rigid container on the outside that would allow for a vacuum collection of lipoaspirate, and the entire assembly would be pre-assembled, disposable, and made entirely of plastic. The fluid connections/logic would be controlled by the product itself as opposed to humans needing to make and adjust connections.

    [0072] In the current embodiment that has been prototyped, this fluid logic is controlled by a pinch cam which selectively pinches off tubing connections depending on the desired fluid configuration. Please see FIG. 1 for the fluid logic diagram, which is a core part of the invention. In this concept, the user would turn a knob, which opens and closes the pinch valves in accordance with the fluid logic diagram. As used herein, a pinch cam is meant to be a way to valve the fluid logic. Generically, any valves would work (i.e. ball valve, pinch valve, etc.)

    [0073] For example, in the harvest position, the fluid logic would be such that the vacuum source (via the vacuum port) would be pulling tissue from the patient port and into the PG bag, while also pulling fluid out of the drain port. But in the wash position, the drain would be closed off so the bag could be filled with fluid. All of these connections and settings are subject to change, but the general idea of using a simple knob to control such complex fluid connections may be novel in this application.

    [0074] In the off position, all of the valves would be closed and an eccentric cam would help to eject the lid off to open it and gain easy access to the bag inside in the event that some of the tissue was stuck in the bag and needed to be squeezed out, like other Puregraft bags, which has been effective. Note that even if the canister were to be opened in this manner, the PG bag and lid would still be in connection and closed to the atmosphere from a sterility point of view.

    Adipose Tissue Harvesting, Collection and Purification, and Application

    [0075] In another aspect of the present invention, it is provided a method of adipose tissue collection and purification, comprising:

    [0076] providing a device comprising [0077] a) an adipose tissue collection and filtration component on the inside; [0078] b) a rigid container (canister) on the outside that allows for a vacuum collection of lipoaspirate; and [0079] c) a lid on the rigid container comprising a fluid logic, wherein the fluid logic is controlled by a pinch cam which selectively pinches off tubing connections depending on the desired fluid configuration, and wherein the fluid logic comprises a configuration such that when there is a need to open the canister, the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere, and

    [0080] performing adipose tissue collection and purification using the device so as to harvest and purify an amount of adipose tissue in a manner that the adipose tissue collection and filtration component and lid remain in connection and closed to the atmosphere.

    [0081] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the entire assembly of the device is pre-assembled and disposable.

    [0082] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the entire assembly of the device is made entirely of plastic.

    [0083] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the fluid connections/logic is controlled by the product itself as opposed to humans needing to make and adjust connections.

    [0084] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the lid comprises a knob,

    [0085] wherein the pinch cam comprises pitch valves, and

    [0086] wherein turning of the knob causes the pinch valves to open and/or close in accordance with the fluid logic diagram.

    [0087] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the fluid logic comprises a plurality of ports and positions related to each other in a way to effect adipose tissue collection and purification.

    [0088] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the position comprises a harvest position, a wash position, and an off position, wherein:

    [0089] in the harvest position, the fluid logic would be such that a vacuum source via a vacuum port would be pulling tissue from a patient port and into the adipose tissue collection and filtration component, in the meanwhile pulling fluid out of a drain port;

    [0090] in the wash position, the drain would be closed off so the adipose tissue collection and filtration component is filled with fluid; and

    [0091] in the off position, all of the pinch valves are closed and an eccentric cam is used to eject the lid off to open it and gain easy access to the adipose tissue collection and filtration component inside in the event that some of the tissue is stuck in the adipose tissue collection and filtration component to squeeze out the stuck tissue.

    [0092] In some embodiments of the invention method, optionally in combination with one or more embodiments of invention disclosed herein, the adipose tissue collection and filtration component is a Puregraft bag.

    [0093] A brief description of the invention device as shown in FIGS. 1-3 is provided below. [0094] a. Open box that contains PG canister+Lid+bag assembly and set onto mayo stand (sterile field) [0095] b. Connect Vacuum port to preferred vacuum source an Patient port to preferred lipo cannula. Loop both tubes through the base clips (not pictured) to prevent tipping. Optional: clamp canister base to mayo stand. [0096] c. With device in Harvest position, perform liposuction (extra fluid will drain during). [0097] d. Adjust to Wash position and dip cannula into clean saline and suck in 1:1 ratio of saline to fat. [0098] e. Adjust to dry to stop harvesting and suck out all of the waste fluid. Repeat 4 and 5 if desired. [0099] f. Turn off lipo machine, and adjust device to removal position and extract fat via a catheter syringe out of the catheter tip port. [0100] g. If all tissue cannot be removed, adjust to off position to lift lid. Remove PG bag. [0101] h. Use traditional PG methods (hang and squeegee) to get all remaining tissue out of syringe port. [0102] i. Dispose of entire PG system when finished.

    Method of Use

    [0103] In a further aspect of the present invention, it is provided a method of using the device of invention, the adipose tissue collection and purification device of invention and/or the system of invention. In some embodiments, the use includes biomedical and cosmetic applications on a subject. Cosmetic applications can be, for example, organ reshaping or augmentation. Biomedical applications can be, for example, tissue grafting, and cell therapy or tissue regenerative therapies.

    EXAMPLES

    Example 1. Adipose Tissue Collection and Purification

    [0104] FIGS. 1-3 describe embodiments of invention device and use of the invention device to collect and purified a volume of adipose tissue.

    [0105] In FIG. 1, an invention device 100 includes a canister 200 having a lid 300. Lid 300 includes a liquid logic diagram 310 connected to a Puregraft bag 400. The liquid logic diagram includes cam positions marked from top down as 1) Harvest, 2) Wash, 3) Dry, 4) Removal, and O) Off; on the lid sideleft to right, Vacuum (two ports joined as Y), 0.2 m/ATM Can(1)canister 1, and Patient; and on the bag sideleft to right, which corresponds one-by-one with the lid side markings, Drain, Canister (2) joining the middle port as Y, Vent, and on the far right, Tissue. The Tissue tubing connects with PG Bag 400, which allows adipose tissue from patient to enter the bag and washed and the resultant waste liquid to drain from the bag with the assistance vacuum. As used herein, the label ATM refers to atmospheric pressure, and the other label 0.2 um refers to a 0.2 micrometer pore size vent filter, common in blood processing. This port allows atmospheric pressure to enter the canister to allow one to squeeze the bag dry, meanwhile the contents of the bag remain closed to the environment.

    [0106] FIG. 2 is a photographic image of a 3D-printed/machined prototype of lid 300 with the liquid logic diagram 310.

    [0107] FIG. 3 shows an invention device 100 being tested along with a pump 410 (left) and catch canister 420 (center).

    [0108] While various embodiments of the present invention have been shown and described herein, it will be obvious that such embodiments are provided by way of example only. Numerous variations, changes and substitutions may be made without departing from the invention herein. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

    [0109] The teachings of the references, including patents and patent related documents, cited herein are incorporated herein in their entirety to the extent not inconsistent with the teachings herein.