Liposuction tissue processing
Patent Information
- Application Number
- JP2022554466
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-05-28
- Filing Date
- 2021-03-08
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2041-03-08
Smart Images

Figure 0007645898000001 
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Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority from U.S. provisional patent application US62 / 986,806, filed March 9, 2020, and UK patent application GB2008023.0, filed May 28, 2020, both of which are incorporated by reference as if fully set forth herein.
[0002] The present invention, in some embodiments, relates to the cosmetic and / or medical fields, and more particularly, but not exclusively, to methods and apparatus for treating liposuction tissue. [Background technology]
[0003] Liposuction is a well-known method for aesthetic body shaping in which a portion of subcutaneous adipose tissue is harvested from a part of a patient's body as lipoaspirate tissue by suction through a cannula. Typically, the aspiration is accompanied by simultaneous irrigation with an aqueous tumescent solution. The harvested liposuction tissue contains adipose tissue along with waste fluid including blood and tumescent solution.
[0004] [Autologous fat grafting (AFT)] Harvested lipoaspirate tissue is often used for autologous fat transfer (AFT). In AFT, waste fluid is removed from the harvested lipoaspirate tissue and the remaining lipoaspirate tissue is washed one or more times with an aqueous wash, leaving clean lipoaspirate tissue consisting mainly of adipose tissue fragments. This clean lipoaspirate tissue is then injected into a body part, sometimes as is, and sometimes after a homogenization step performed by moving the clean lipoaspirate tissue back and forth between two connected syringes to reduce the size of the adipose tissue fragments.
[0005] [Stroma vascular cell group (SVF)] It has become accepted that at least a portion of the harvested lipoaspirate tissue can be processed to produce stromal vascular fraction (SVF) containing adipose-derived stromal cells (ASCs) useful for various purposes, such as regenerative medicine, wound healing (e.g., wound healing after radiation therapy), treatment of osteoarthritis, and treatment of autoimmune diseases (e.g., scleroderma, lichen sclerosis). For this purpose, a certain amount of lipoaspirate tissue (usually clean lipoaspirate tissue) is treated (enzymatically and / or mechanically) to disrupt the adipose tissue and release the ASCs and other entities present within the tissue. The degraded adipose tissue is centrifuged to separate the light fat debris from the intact ASCs, which sink to the bottom of the centrifuge vessel as the SVF pellet. The SVF pellet is suspended in an aqueous solution to separate the ASCs from the contaminants and centrifuged again to obtain a purified SVF pellet. The purified SVF pellet is suspended in an aqueous solution and can be used therapeutically as is. Preferably, the purified SVF pellet is cultured in a medium that allows the ASCs to survive while excluding non-ASCs. After a sufficient culture time (usually several days), the ASCs purified in this manner can be used therapeutically.
[0006] [Concentrated Lipoaspirate Tissue for Improvement of AFT] One of the challenges of AFT as described above is that a significant portion of the transplanted adipose tissue is resorbed, leading to poor aesthetic outcomes and often necessitating multiple repeat AFT procedures to achieve the desired aesthetic effect.
[0007] It has been found that better AFT can be performed by using lipoaspirate tissue that has been enriched by adding SVF or ASCs before injection into the body. When this superior lipoaspirate tissue is transplanted into the body using the conventional method, fat absorption is suppressed and the retention of the transplanted fat is improved.
[0008] In a typical modified AFT procedure, a relatively large amount of lipoaspirate tissue is harvested by liposuction (~1000ml) for body shaping. A small amount of the harvested lipoaspirate tissue (typically ~100ml) is processed to obtain an SVF pellet, typically ~1% w / w of the processed lipoaspirate tissue. The SVF, or ASCs isolated therefrom, is added to a volume of unprocessed cleaned lipoaspirate tissue (typically 100ml, optionally homogenized as described above), providing the concentrated lipoaspirate tissue that is then used in modified AFT. As a result of the concentration, modified AFT is more successful and provides better results than AFT using non-concentrated lipoaspirate tissue. It would be useful to find a simple method of processing lipoaspirate tissue that can be used for AFT that has one or more advantages over known methods of processing lipoaspirate tissue. Summary of the Invention
[0009] Some embodiments of the invention herein relate to methods and devices for processing lipoaspirate tissue, in some embodiments, suitable for AFT, and in some embodiments, to create SVF. According to an aspect of some embodiments of the present invention, there is provided a method of processing lipoaspirate tissue, comprising the steps of: a. receiving lipoaspirate tissue harvested from a patient into a lipoaspirate filter canister; b. following "a", mechanically processing (in some embodiments, vortex mixing) the lipoaspirate tissue in the lipoaspirate filter canister to mix the lipoaspirate tissue, said mechanical processing reducing the average size of the fat cell fragments in the lipoaspirate tissue without substantially rupturing them therein; c. following "b", draining fluid released from the lipoaspirate tissue by said mechanical treatment from the lipoaspirate filter canister; Thereby providing processed lipoaspirate tissue contained in a liposuction filter canister.
[0010] As used herein, "mechanical processing" means that the lipoaspirate tissue is moved relative to the filter liner of the lipoaspirate filter canister, an action sufficient to break down the adipose tissue particles in the lipoaspirate tissue such that the average size of the adipose tissue particles in the lipoaspirate tissue is reduced. In some embodiments, the average size of the adipose tissue particles is reduced to 50%, to 25%, or even to 10% of the original.
[0011] As used herein, "without substantially rupturing the fat cells therein" means that at least 90%, at least 95%, or even at least 98% of the fat cells in the lipoaspirate tissue are not ruptured as a result of the mechanical treatment.
[0012] In some embodiments, "b" begins only when "a" is completed, i.e., all of the desired harvested lipoaspirate tissue is received ("a") before mechanical processing ("b") begins. Alternatively, in some embodiments, mechanical processing ("b") begins when at least some of the harvested lipoaspirate tissue is received ("a"). As a result, in such alternative embodiments, mechanical processing is performed simultaneously with receipt of some of the harvested lipoaspirate tissue.
[0013] Any suitable mode of mechanical treatment that reduces the average size of the adipose tissue fragments but is gentle enough to avoid substantial rupture of the adipocytes may be used in carrying out the teachings herein. In some embodiments, the mechanical treatment is selected from the group consisting of vortex mixing the liposorbent in the canister; vibrating the liposorbent in the canister; and mechanically mixing the liposorbent in the canister. Particularly preferred is vortex mixing, which has been experimentally shown to provide high quality processed liposorbate tissue, is currently believed to be more easily kept sterile, and is easy to perform.
[0014] Thus, according to an aspect of some embodiments of the present invention there is also provided a method of processing lipoaspirate tissue, comprising: a. receiving lipoaspirate tissue harvested from the patient in a lipoaspirate filter canister; b. following "a", vortexing the lipoaspirate tissue in the lipoaspirate filter canister to mix the lipoaspirate tissue; and c. following "b", draining the fluid released from the lipoaspirate tissue by vortex mixing from the lipoaspirate filter canister; thereby providing processed lipoaspirate tissue contained in a liposuction filter canister.
[0015] Thus, according to an aspect of some embodiments of the present invention there is also provided a method of processing lipoaspirate tissue comprising: a. receiving lipoaspirate tissue harvested from a patient into a lipoaspirate filter canister; b. following "a", vibrating the lipoaspirate tissue within the lipoaspirate filter canister to mix the lipoaspirate tissue; and c. following "b", draining fluid released from the liposuction tissue by the vibration from the liposuction filter canister; thereby providing processed lipoaspirate tissue contained in a liposuction filter canister.
[0016] Thus, according to an aspect of some embodiments of the present invention there is also provided a method of processing lipoaspirate tissue comprising: a. receiving lipoaspirate tissue harvested from a patient into a lipoaspirate filter canister; b. following "a", mechanically mixing the lipoaspirate tissue in a lipoaspirate filter canister to mix the lipoaspirate tissue; and c. Following "b", draining fluid released from the lipoaspirate tissue by mechanical mixing from the lipoaspirate filter canister: thereby providing processed lipoaspirate tissue contained in a liposuction filter canister.
[0017] In some embodiments, mechanical treatment, such as vortex mixing, is applied within 60 minutes of harvesting the lipoaspirate tissue.
[0018] In some embodiments, a volume of an aqueous solution is added to the liposuction filter canister before and / or during mechanical treatment, such as vortex mixing.
[0019] In some embodiments, the mechanical treatment is vortex mixing performed at 3000 rpm or less, or even 1000 rpm or less. In some embodiments, the mechanical treatment is vortex mixing for 30 minutes or less. In some embodiments, the mechanical treatment is vortex mixing for 60 seconds or more.
[0020] In some embodiments, the liposuction filter canister remains functionally associated with the fluid evacuation module during mechanical processing, i.e., there is no need to disconnect an already connected fluid evacuation module in order to perform mechanical processing. In some embodiments, the fluid evacuation module is a component of a liposuction vacuum module.
[0021] In some embodiments, the method of processing lipoaspirate tissue further comprises, following effluent processing step "c", transferring the lipoaspirate tissue to an autologous fat transfer (AFT) device. In some embodiments, the method of processing lipoaspirate tissue further comprises implanting the transferred lipoaspirate tissue into a patient using the AFT device. Alternatively, in some embodiments, the step of implanting the transferred lipoaspirate tissue is a method of surgical treatment and is outside the scope of the claims.
[0022] In some embodiments, the lipoaspirate tissue in the liposuction filter canister is not washed following mechanical processing "b", such as vortex mixing, and prior to transfer of the lipoaspirate tissue to the AFT device.
[0023] In some embodiments, the lipoaspirate tissue in the liposuction filter canister is not centrifuged following mechanical processing "b", such as vortex mixing, and prior to transfer of the lipoaspirate tissue to the AFT device. In some embodiments, the liposuction canister filter has a volume of equal to or greater than 50 ml and equal to or less than 10,000 ml. In some embodiments, the amount of harvested lipoaspirate tissue received in the liposuction filter canister is between 50 ml and 10,000 ml.
[0024] In some embodiments, the lipoaspirated tissue was harvested from the patient using a method selected from the group consisting of laser assisted liposuction, ultrasound assisted liposuction, and RF assisted liposuction.
[0025] In some embodiments, laser assisted liposuction is performed using a laser wavelength in the range of 800-1600 nm, and in some embodiments, in the range of 1400-1500 nm. In some embodiments, laser-assisted liposuction was performed using radially irradiating optical fibers.
[0026] Any suitable cannula having any suitable size may be used in practicing the teachings herein, and in some embodiments, lipoaspirate tissue was harvested using a cannula having an inner diameter of at least 2 mm and no more than 5 mm.
[0027] Any suitable suction pressure may be used to harvest the lipoaspirate tissue. In some embodiments, the lipoaspirate tissue was harvested using a suction pressure of at least 20 kP and no more than 98 kP.
[0028] In some embodiments, the method further comprises, following d. "c", applying additional mechanical processing (such as vortex mixing or other options described above) to the lipoaspirate tissue contained in the liposuction filter canister to mix the lipoaspirate tissue, the additional mechanical processing further comprising reducing the average size of the adipocyte fragments in the lipoaspirate tissue without substantially rupturing the lipid cells therein.
[0029] In some embodiments, the method further comprises, following the additional mechanical processing "d", transferring the lipoaspirate tissue to an autologous fat transfer (AFT) device. In some embodiments, the method further comprises using the AFT device to implant the implanted lipoaspirate tissue into the patient. Alternatively, in some embodiments, the step of implanting the transferred lipoaspirate tissue is a method of surgical treatment and is outside the scope of the claims. In some embodiments, the method further comprises, following e. "d", isolating fluid released from the lipoaspirate tissue as a result of the additional mechanical processing as SVF fluid.
[0030] The method embodiments may be practiced using any suitable device or combination of devices, hi some preferred embodiments, the method is practiced using a liposuction device in accordance with the teachings herein.
[0031] In accordance with an aspect of some embodiments of the present invention there is also provided, in some embodiments, a liposuction apparatus that is particularly suitable for carrying out method embodiments in accordance with the teachings herein.
[0032] Thus, according to an aspect of some embodiments of the present invention there is provided a liposuction apparatus configured for performing liposuction by harvesting adipose tissue from a body as lipoaspirate tissue via a cannula and transferring (also referred to as "transporting" in the priority document) at least a portion of the harvested adipose tissue to a liposuction filter canister operatively associated with the liposuction apparatus, the apparatus comprising: a liposuction processing unit;
[0033] The liposuction processing unit is configured, when activated, to mechanically process the lipoaspirate tissue contained within a lipoaspirate filter canister operatively associated with the liposuction apparatus, the mechanical processing reducing the average size of the adipose tissue fragments without substantially rupturing the adipocytes therein. Without wishing to be bound by any one theory, it is presently believed that such gentle mechanical processing produces a relatively homogenous processed lipoaspirate tissue containing various non-factors (e.g., SVF) in a form accessible for use when transplanted.
[0034] In some embodiments, the liposuction apparatus further comprises a liposuction vacuum module attachable to a liposuction filter canister operatively associated with the liposuction apparatus via its vacuum port, the liposuction vacuum module being configured, when attached to the liposuction filter canister and activated, to perform liposuction via the liposuction filter canister and via a liposuction probe operatively associated therewith, thereby allowing harvested adipose tissue (i.e., adipose tissue harvested as a result of liposuction) to be captured within a filter liner of the attached filter canister. In some embodiments, the liposuction apparatus is configured to allow activation of a liposuction processing unit to mechanically process the contents of the liposuction filter canister operatively associated with the liposuction apparatus while the liposuction filter canister is attached to the liposuction vacuum module.
[0035] In some embodiments, the liposuction apparatus comprises a fluid evacuation module distinct from the liposuction vacuum module, the fluid evacuation module being attachable via its evacuation port to a liposuction filter canister operatively associated with the liposuction apparatus, the fluid evacuation module being configured to remove liquid from a container of the attached liposuction filter canister when attached to such liposuction filter canister and activated. In some embodiments, the liposuction apparatus operates the liposuction processing unit to mechanically process the contents of the liposuction filter canister operatively associated with the liposuction apparatus while the liposuction filter canister is attached to said fluid evacuation module.
[0036] In some embodiments, the liposuction apparatus further comprises a liposuction probe having a distal end attachable to a liposuction cannula and a proximal end attachable through a suction inlet thereof to a liposuction filter canister operatively associated with the liposuction apparatus, said liposuction probe configured to direct lipoaspirate collected via the attached liposuction cannula from the distal end of the probe through the proximal end of the probe to a receptacle of the attached liposuction filter canister. In some embodiments, the liposuction apparatus is configured to operate the liposuction processing unit to mechanically process contents of the liposuction filter canister operatively associated with the liposuction apparatus while the liposuction filter canister is attached to the liposuction probe.
[0037] In some embodiments, the liposuction apparatus further comprises a cleaning module attachable to a liposuction filter canister operatively associated with the liposuction apparatus via the access port thereof, the cleaning module configured to add a quantity of liquid (e.g., cleaning fluid), preferably a metered amount of liquid, to a container of the attached liposuction filter canister. In some embodiments, the liposuction apparatus is configured to operate the liposuction processing unit to mechanically process the contents of the liposuction filter canister operatively associated with the liposuction apparatus while the liposuction filter canister is attached to the cleaning module.
[0038] In some embodiments, the liposuction device further comprises a controller configured to automatically process the liposuction tissue contained in a liposuction filter canister operatively associated with the liposuction device, the automatic processing including activating the liposuction tissue processing unit, the liquid evacuation module, and / or the irrigation module in a desired sequence and for a desired duration. In some embodiments, the controller is configured to operate only one of the three units / modules. In some embodiments, the controller is configured to operate only two of the three units / modules. In some embodiments, the controller is configured to operate all three units / modules.
[0039] In some embodiments, the liposuction device further comprises a liposuction filter canister operatively associated with the liposuction device, the liposuction filter canister comprising a container; a longitudinal axis, a canister vacuum port (preferably attached to the liposuction vacuum module); a cap for sealing the container; a canister suction port (preferably attached to the proximal end of the liposuction probe); an access port (preferably attached to the irrigation module); and a filter liner defining an internal volume within the container, the filter canister being configured to be attached to the liposuction probe via the canister suction inlet and to be attached to the liposuction vacuum module via the vacuum port such that activation of the liposuction vacuum module can perform liposuction via the liposuction probe and capture harvested adipose tissue within the filter liner (i.e., within the internal volume defined by the filter liner). In some embodiments, the liposuction filter canister further comprises an exhaust port attachable (preferably attached to) to the liquid exhaust module, the exhaust port allowing removal of liquid retained in the container outside the filter liner. In some embodiments, the exhaust port is a canister vacuum port. Alternatively, in some embodiments, the exhaust port is a separate component from the canister vacuum port.The filter canister may be of any suitable size, for example, as described below.
[0040] [Vortex mixing unit] In some preferred embodiments, the lipoaspirate tissue processing unit comprises a vortex mixing unit configured, when activated, to generate and impart a vortex-inducing motion to a lipoaspirate filter canister operatively associated with the lipoaspirate apparatus, the vortex-inducing motion being effective to mechanically process the lipoaspirate tissue contained in the interior volume of the filter canister.
[0041] In some embodiments, the vortex mixing unit includes an engagement member that transfers at least a portion of the vortex-inducing motion generated by the vortex mixing unit to a liposuction filter canister operatively associated with the liposuction apparatus when the vortex mixing unit is activated.
[0042] In some embodiments, the vortex mixing unit is configured such that the bottom of a filter canister operatively associated with the liposuction apparatus rests on the vortex mixing unit, such an embodiment is shown in Figures 2A, 2B, and 2C.
[0043] In some such embodiments, the vortex mixing unit includes a flat upper surface upon which rests the flat bottom of a filter canister operatively associated with the liposuction apparatus. Such embodiments are shown in Figures 2A and 2B. In some such embodiments, the flat upper surface is defined by an upper surface of a mating component of the vortex mixing unit. Such an embodiment is shown in Figure 2A.
[0044] In some such embodiments, the mating piece at least partially surrounds a bottom of the filter canister that rests on the flat upper surface. Such an embodiment is shown in FIG. 2B.
[0045] In some such embodiments, the vortex mixing unit includes a non-planar upper surface on which rests a non-planar bottom of a liposuction filter canister operatively associated with the liposuction apparatus, the non-planar upper surface surrounding at least a portion of the bottom of the filter canister. Such an embodiment is shown in FIG. 2C.
[0046] In some embodiments, the vortex mixing unit is configured, when activated, to vortex mix the contents of the liposuction filter canister operatively associated with the liposuction apparatus at no more than 3000 rpm, no more than 2000 rpm, no more than 1000 rpm, and in some embodiments even no more than 700 rpm. In some embodiments, the vortex mixing unit is configured, when activated, to vortex mix the contents of the liposuction filter canister operatively associated with the liposuction apparatus at no less than 60 rpm, and in some embodiments no less than 100 rpm.
[0047] In some embodiments, the vortex mixing unit and / or the controller of the liposuction apparatus are configured to enable vortex mixing of the contents of a liposuction filter canister operatively associated with the liposuction apparatus for a period of 30 minutes or less, 20 minutes or less, 10 minutes or less, or even 7 minutes or less.
[0048] In some embodiments, the vortex mixing unit and / or controller is configured to enable vortex mixing of the contents of a liposuction filter canister operatively associated with the liposuction apparatus for a period of 30 seconds or more, or even 60 seconds or more.
[0049] [Vibration unit] In some embodiments, the lipoaspirate tissue processing unit comprises a vibration unit which, when activated, is configured to generate and apply vibrations to the lipoaspirate tissue contained in an interior volume of a lipoaspirate filter canister operatively associated with the lipoaspirate apparatus, the vibrations being effective to mechanically process the lipoaspirate tissue.
[0050] In some embodiments, the vibration unit comprises at least one sonicator probe configured to be disposed within an interior volume defined by a filter liner of a liposuction filter canister operatively associated with the liposuction apparatus. In such embodiments, during use, the probe is at least partially immersed in the liposuction tissue. Such an embodiment is illustrated in Figures 3A and 3B.
[0051] In some embodiments, the vibration unit comprises an acoustic generator configured to be physically associated with a filter liner of a liposuction filter canister operatively associated with the liposuction device such that, when activated, the acoustic generator vibrates the filter liner with which it is physically associated. The vibrating filter liner transmits vibrations from the acoustic generator to the liposuction tissue held therein. Such an embodiment is shown in FIG. 3C.
[0052] It is important to note that in some such embodiments, the ultrasonic generator is a component of the liposuction filter canister, and the liposuction device includes, for example, an electrical connector and is configured to enable operation of the ultrasonic generator of the liposuction canister in accordance with the teachings herein.
[0053] [Mechanical mixing] In some embodiments, the liposuction processing unit comprises: a mechanical mixing component configured to be disposed within an interior volume defined by a filter liner of a liposuction filter canister operatively associated with a liposuction device;
[0054] a mixing motor effective for mechanically manipulating the lipoaspirate tissue to move a mechanical mixing component relative to the lipoaspirate tissue contained within the volume, thereby mechanically mixing the lipoaspirate tissue; Equipped with.
[0055] In some embodiments, the mixing motor is configured such that the relative motion of the mechanical mixing component with respect to the liposuction filter canister consists of or consists of movement parallel to the longitudinal axis of the liposuction filter canister. Such embodiments are shown in Figures 4A, 4B, and 4C. In some such embodiments, the filter canister is moved parallel to the longitudinal axis (Figure 4B). Additionally or alternatively, in some such embodiments, the mechanical mixing component is moved parallel to the longitudinal axis (Figure 4C). In some such embodiments, the mechanical mixing component consists of or is a flow-restricting barrier, such as a permeable plunger (Figure 4A). In some such embodiments, the mechanical mixing component, such as a flow-restricting barrier, is a component of the filter canister. In some such embodiments, the mechanical mixing component, such as a flow-restricting barrier, is not a component of the filter canister.
[0056] Alternatively or additionally, in some embodiments, the mixing motor is configured to rotate the filter liner relative to the receptacle of the liposuction filter canister about an axis parallel to the longitudinal axis of the liposuction canister. Such an embodiment is shown in Figures 4D and 4E. In some such embodiments, the mechanical mixing component comprises mixing elements affixed to the inner surface of the filter liner and projecting into the interior volume that rotate with the filter liner (Figures 4D and 4E). Additionally or alternatively, in some embodiments, the mechanical mixing component comprises mixing elements that do not rotate with the filter liner (Figure 4E).
[0057] Alternatively or additionally, in some embodiments, the mixing motor is configured to rotate a mechanical mixing component separate from the filter liner located within the interior volume. Such embodiments are shown in Figures 4F, 4G, and 4H. Any suitable type or combination of types of mechanical mixing components, such as one or more components selected from the group consisting of an impeller (Figure 4F), a propeller (Figure 4G), and a paddle (Figure 4H). In some such embodiments, the mechanical mixing component is a component of the filter canister. In some such embodiments, the mechanical mixing component is not a component of the filter canister.
[0058] In some embodiments, the liposuction device is selected from the group consisting of: a laser assisted liposuction device; an ultrasound assisted liposuction device; and an RF assisted liposuction device.
[0059] In some embodiments, the liposuction device is a laser assisted liposuction device configured to irradiate adipose tissue with laser light having a wavelength in the range of 800 nm and 1600 nm during liposuction. In some embodiments, the laser wavelength is in the range of 1400 nm to 1500 nm, 1450 to 1490 nm, or even 1460 to 1480 nm, such as a 1470 nm laser wavelength as used in some commercially available laser assisted liposuction devices. In some embodiments, the liposuction device is a laser-assisted liposuction device configured to perform liposuction using radially illuminating optical fibers.
[0060] In some embodiments, the liposuction apparatus is configured to harvest lipoaspirate tissue through a cannula having an inner diameter of at least 2 mm and no more than 5 mm. In some embodiments, the liposuction apparatus is configured to apply a suction pressure of at least 20 kP and no more than 98 kP.
[0061] Liposuction Filter Canister of the Teachings Herein In some embodiments, the teachings herein are practiced using a liposuction filter canister in accordance with the teachings herein.
[0062] In accordance with one aspect of some embodiments of the teachings herein, there is provided a liposuction filter canister operatively associated with a liposuction apparatus, the liposuction filter canister comprising a container having a longitudinal axis; a canister vacuum port operatively associated with a liposuction vacuum module of the liposuction apparatus; a cap for sealingly closing the container; a canister suction inlet attachable to a proximal end of a liposuction probe; and a filter liner defining an internal volume within the container, the filter canister being configured such that when attached to the liposuction probe through the canister suction inlet and to the liposuction vacuum module through the vacuum port, activation of the attached liposuction vacuum module can effect liposuction through the liposuction probe and capture harvested adipose tissue in the internal volume defined by the filter liner.
[0063] The liposuction filter canister further includes at least one of the following: i. an acoustic transmitter probe located within the internal volume, the probe configured to vibrate at an acoustic frequency of 10 kHz or less when activated, such that the activation leads to mechanical manipulation of lipoaspirate tissue retained within the internal volume; ii. a sheath projecting into the internal volume, the sheath configured to receive an acoustic transmitter probe such that when the probe is activated to vibrate, vibrations pass through the sheath and lead to mechanical processing of lipoaspirate tissue held within the internal volume; iii. An acoustic wave generator physically associated with the filter liner, the acoustic wave generator configured, when activated, to vibrate the filter liner at an acoustic frequency of 10 kHz or less, such that activation leads to mechanical manipulation of the lipoaspirate tissue retained within the internal volume. iv. A mechanical mixing component located within the internal volume, the mechanical mixing component operatively associated with the mixing motor and configured to move relative to the fat adsorbing liquid contained in the internal volume when the mixing motor is actuated, such that such relative movement results in mechanical processing of the fat adsorbing liquid held in the volume.
[0064] In some embodiments, the mechanical mixing component is configured to move with a motion vector that is or includes a component parallel to the longitudinal axis (e.g., the mechanical mixing component is or consists of a flow-restricting barrier, such as a partially permeable plunger).
[0065] In some embodiments, the mechanical mixing component is configured to rotate relative to the vessel (eg, the mechanical mixing component is a propeller, impeller, or paddle, or the filter liner is configured to rotate). [Brief description of the drawings]
[0066] Some embodiments of the present invention are described herein with reference to the accompanying drawings. By describing together with the drawings, it will become apparent to a person skilled in the art how some embodiments of the present invention can be implemented. The drawings are for illustrative purposes and no attempt is made to show structural details of the embodiments in more detail than is necessary for a fundamental understanding of the present invention. For clarity, some objects shown in the drawings are not drawn to scale. [Figure 1] FIG. 1 is a schematic diagram of one embodiment of a liposuction filter canister useful in practicing the teachings herein. [Figure 2A] FIG. 1 is a schematic diagram of an embodiment of an apparatus useful for practicing an embodiment of a method according to the teachings herein, the apparatus including a laser-assisted liposuction unit and a vortex mixing unit. [Figure 2B] FIG. 1 is a schematic diagram of an embodiment of an apparatus useful for practicing an embodiment of a method according to the teachings herein, the apparatus including a laser-assisted liposuction unit and a vortex mixing unit. [Figure 2C] FIG. 1 is a schematic diagram of an embodiment of an apparatus useful for practicing an embodiment of a method according to the teachings herein, the apparatus including a laser-assisted liposuction unit and a vortex mixing unit. [Figure 2D] FIG. 1 is a schematic diagram of an embodiment of an apparatus useful for practicing an embodiment of a method according to the teachings herein, the apparatus including a laser-assisted liposuction unit and a vortex mixing unit. [Figure 3A] 1 is a schematic diagram of components of an embodiment of an apparatus useful for practicing embodiments of the methods according to the teachings herein, the apparatus including a vibration unit. [Figure 3B] 1 is a schematic diagram of components of an embodiment of an apparatus useful for practicing embodiments of the methods according to the teachings herein, the apparatus including a vibration unit. [Figure 3C] 1 is a schematic diagram of components of an embodiment of an apparatus useful for practicing embodiments of the methods according to the teachings herein, the apparatus including a vibration unit. [Figure 4A] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4B] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4C] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4D] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4E] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4F]FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4G] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. [Figure 4H] FIG. 1 is a schematic diagram of components of an embodiment of an apparatus useful for carrying out embodiments of the methods according to the teachings herein, the apparatus being configured for mechanical mixing. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0067] Some embodiments of the invention herein relate to methods and devices for processing lipoaspirate tissue, in some embodiments to make it suitable for AFT (autologous fat transfer), and in some embodiments to produce SVF (stromal vascular factor).
[0068] The principles, applications and implementations of the teachings of the present invention may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures presented herein, one skilled in the art will be able to practice the teachings of the present invention without undue effort or experimentation. In the figures, like reference numerals refer to like parts throughout.
[0069] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details and arrangements of construction and / or methodology described herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[0070] As is known in the art, tissue, including the adipose tissue that constitutes the lipoaspirate tissue, can be mechanically processed in a number of ways, for example, using a meat grinder (US 5,731,199), a perforated rasp (WO 2016 / 097960), forcibly processing the fat by perforation (WO 2017 / 180076, WO 2019 / 125324), or using high-speed rotating blades as a "food processor" (WO 2016 / 199149).
[0071] The inventors have studied the art and conducted experimentation which has led them to conclude that mechanical processing of lipoaspirate tissue can be considered to have a combination of three distinct effects.
[0072] The first of the three effects is homogenization of the lipoaspirate tissue, reducing the size of the adipose tissue fragments to produce a more fluid lipoaspirate tissue containing viable fat cells that can be more easily and precisely injected during the AFT procedure, providing improved cosmetic results.
[0073] The second of the three effects is to damage adipose tissue and rupture fat cells in the liposuction tissue, resulting in the production and / or release of harmful factors such as cell / tissue debris and pro-inflammatory and toxic substances, including hormones and other factors. The inventors believe that such harmful factors contribute significantly to the challenges and complications of known AFT treatments, including inflammation and post-transplant resorption of transplanted fat.
[0074] The third of the three effects is the release of beneficial factors from the adipose tissue, including the stem cells that compose the SVF, which are well known for their therapeutic effects. As mentioned in the introduction, after mechanical or enzymatic treatment, the beneficial factors can be isolated for direct therapeutic use or to perform improved AFT. In the art, the three effects are considered separately, each for a particular application.
[0075] For AFT, moderate homogenization of the lipoaspirate tissue is performed to generate more fluid lipoaspirate tissue that can be more precisely transferred to the patient using small needles during AFT. Also, the lipoaspirate tissue used for AFT, whether homogenized or not, is rigorously and repeatedly washed with irrigation fluid to remove harmful factors.
[0076] If it is desired to provide SVF or isolated ASCs from harvested lipoaspirate tissue, the lipoaspirate tissue is vigorously processed to completely destroy adipose tissue and adipocytes to ensure that the maximum amount of ASCs is released from the tissue, and then undergoes extensive purification (including centrifugation, washing with lavage fluid, and culture) to remove deleterious factors and generate therapeutically useful SVF or ASCs. As mentioned above, one application of such purified SVF / ASCs is to enrich lipoaspirate tissue to improve AFT.
[0077] The inventors have discovered and now disclose a method of processing lipoaspirate tissue that balances these three effects and results in a clearly enriched lipoaspirate tissue. Specifically, the inventors have discovered that harvested lipoaspirate tissue can be gently mechanically processed to produce lipoaspirate tissue that is clearly enriched in beneficial factors but has few, if any, harmful factors. In some embodiments, the method results in a processed lipoaspirate tissue that increases the success of AFT performed using the processed lipoaspirate tissue, for example, by reducing the amount of inflammation after AFT and / or reducing the resorption of transplanted fat. The method is particularly suitable for use with lipoaspirate tissue harvested using gentle liposuction techniques, such as laser-assisted liposuction. Furthermore, the inventors have discovered that some embodiments of the method allow AFT to be prepared aseptically in a clinical environment with little human intervention.
[0078] In some embodiments, the present methods are faster than some known methods, allowing for harvesting, processing and subsequent improved AFT of lipoaspirate tissue in a relatively short time suitable for one session in a cosmetic or therapeutic clinic. In some embodiments, it is believed that the short time between harvesting and AFT reduces stress on the transplanted tissue which may further enhance the success of AFT.
[0079] In some embodiments, the method is performed in a manner that more easily prevents contamination, allowing for safer AFT with reduced chance of inflammation and even sepsis, resulting in increased customer satisfaction and reduced liability for clinics performing the method.
[0080] In some embodiments, the method can be easily performed by individuals who are pressed for time or who are not specialized laboratory technicians, such as nurses or clinic assistants who practice the method.
[0081] In some embodiments, the methods are amenable to at least partial automation, reducing the workload required of personnel and, in some embodiments, improving the reproducibility and consistency of results, even when performed by persons who are not specialized laboratory technicians.
[0082] [Method of processing liposuction tissue] According to aspects of some embodiments of the teachings herein, there is provided a method of processing lipoaspirate tissue, comprising: a. receiving lipoaspirate tissue from a patient contained in a liposuction filter canister; b. following "a", mechanically processing (in some embodiments, vortex mixing) the lipoaspirate tissue in the lipoaspirate filter canister to mix the lipoaspirate tissue, said mechanical processing reducing the average size of the adipose tissue fragments in the lipoaspirate tissue without substantially rupturing the adipocytes therein; and c. following "b", draining fluid released from the lipoaspirate tissue by mechanical processing from the lipoaspirate filter canister; Thereby providing processed lipoaspirate tissue contained in a liposuction filter canister.
[0083] Receiving liposuction tissue into the liposuction filter canister At "a", liposuction tissue harvested from the patient is received in a liposuction filter canister. Preferably, the liposuction filter canister is a disposable, sterile liposuction filter canister. Any suitable liposuction filter canister can be used, including commercially available liposuction filter canisters such as the Contour™ canister from Bemis® Health Care™, Sheboygan Falls, WI, USA, or the Tissue-Trans® Filtron Unit from Tulip® Medical Instruments, San Diego, CA, USA. In some embodiments, the liposuction filter canister is a liposuction filter canister according to the teachings herein.
[0084] An exemplary liposuction filter canister 10 is shown diagrammatically in cross section in FIG. 1. Liposuction filter canister 10 includes a container 12, a longitudinal axis 13, a canister vacuum port 14, and a cap 16 that hermetically closes container 12. Extending through cap 16 is a canister suction port 18 and a sealable access port 20. Retained within container 12 is a filter liner 22 that defines an interior volume 23 (with filter holes, typically between 100 micrometers and 1000 micrometers). Sealable access port 20 is an opening that can be optionally closed to prevent contamination and air from entering container 12, but reversibly opened to allow the addition of material (e.g., a washing solution) or the removal of material (e.g., a sample of lipoaspirate tissue retained in filter liner 22).
[0085] For use (see Figures 2A-2D), the canister 10 is operatively associated with a liposuction apparatus 24 by holding the canister 10 in a filter canister holder 25, connecting the canister vacuum port 14 to a liposuction vacuum module 26 of the liposuction apparatus 24, and connecting the canister suction port 18 to a liposuction probe 28 having a liposuction cannula 30 at its distal end.
[0086] The vacuum module 26 is activated to generate suction at the liposuction inlet of the cannula 30. When the cannula 30 contacts adipose tissue within the body, the adipose tissue is drawn from the body into the cannula 30 and transferred to the canister 10 as lipoaspirate tissue. The adipose tissue is captured in the interior volume 23 of the filter liner 22 while liquid waste such as blood and swelling fluid is removed through the filter pores of the filter liner 22 to the vacuum module 26 and typically discarded. As a result, the lipoaspirate tissue received in a liposuction filter canister such as 10 consists essentially of adipose tissue and is relatively free of liquid waste such as blood and / or tumescent solution.
[0087] Mechanical processing of lipoaspirate tissue As described above, at "b", the lipoaspirate tissue in the liposuction filter canister is mechanically treated (in some embodiments, vortex mixed) to mix the lipoaspirate tissue. The mechanical treatment reduces the average size of the adipose tissue fragments in the lipoaspirate tissue without substantially rupturing the fat cells therein. As described above, any suitable method of mechanical treatment sufficient to break down the adipose tissue fragments, but gentle enough to avoid substantial rupture of the fat cells, may be used in practicing the teachings herein. In some embodiments, the mechanical mixing is selected from the group consisting of vortex mixing the liposorbent in the canister; vibrating the liposorbent in the canister; and mechanically mixing the liposorbent in the canister.
[0088] For the sake of brevity and clarity, the following description will be directed to an embodiment in which the mechanical treatment is vortex mixing, and this description applies mutatis mutandis to other methods of mechanical treatment. At "b", vortex mixing is applied to the lipoaspirate tissue held within the liposuction filter canister, thereby vortex mixing the lipoaspirate tissue. Any suitable method and / or device may be used to vortex mix the lipoaspirate tissue.
[0089] In some embodiments, the vortex mixing is by a vortex mixing unit that the bottom of the filter canister container rests on. Figures 2A, 2B and 2C show an embodiment having a vortex mixing unit 32 that the bottom of the filter canister 10 container rests on.
[0090] Alternatively or additionally, in some embodiments, the vortex mixing is by a vortex mixing unit that at least partially surrounds at least a portion of the filter canister's container. Figures 2B, 2C, and 2D show an embodiment having a vortex mixing unit 32 that at least partially surrounds at least a portion of the filter canister 10. It is important to note that Figures 2, 3, and 4B-4H are shown as having a gap between the bottom of the canister 10 and the depicted piece of equipment, e.g., mixing unit 32. This gap is shown for clarity and in reality, the canister is in physical contact with the piece.
[0091] As known to those skilled in the art, a vortex mixing unit is a unit that generates and applies motion to a container in which a fluid is held (e.g., a filter canister in which liposuction tissue is held), where the applied motion induces the formation of vortices in the fluid, which vortices are effective to mix the fluid. In some embodiments, a vortex mixing unit used to practice the teachings herein includes an engagement member that transfers at least a portion of the vortex-inducing motion generated by the vortex mixing unit to a filter canister held by a filter canister holder when the vortex mixing unit is activated.
[0092] In Figure 2A, the flat bottom 34 of the filter canister 10 is shown resting on the flat top surface 36 of the vortex mixing unit 32. In Figure 2A, the flat top surface 36 of the vortex mixing unit 32 is defined by the top surface of its mating part, a rubber mat 38. When the vortex mixing unit 32 is activated, the vortex-inducing motion is transferred to the filter canister 10 through the mating part, the rubber mat 38. In some similar embodiments, the mating part is made of a material other than rubber, such as plastic or silicone.
[0093] In FIG. 2B, the flat bottom 34 of the filter canister 10 is shown resting on the flat top surface 36 of the vortex mixing unit 32, with a rubber ring 40, which is an engagement part of the vortex mixing unit 32, surrounding the bottom of the filter canister 10. When the vortex mixing unit 32 is activated, the vortex-inducing motion is transferred to the filter canister 10, particularly by the rubber ring 40. In FIG. 2B, the rubber ring 40 completely surrounds the entire bottom of the filter canister 10. In some similar embodiments, the engagement part surrounds only a portion of the bottom of the filter canister, e.g., an incomplete ring. In some similar embodiments, the engagement part is made of a material other than rubber, e.g., plastic, silicon, or metal.
[0094] In Fig. 2C, the non-flat (conical) bottom 42 of the filter canister 10 is shown resting on the non-flat top surface 44 of the vortex mixing unit 32. The non-flat top surface 44 of the vortex mixing unit 32 on which the filter canister 10 rests and which surrounds the bottom of the filter canister 10 constitutes an engagement part of the vortex mixing unit 32. When the vortex mixing unit 32 of the device shown in Fig. 2C is activated, the vortex stirring-inducing motion is transferred to the filter canister 10, in particular, via the non-flat top surface 44 which is an engagement part. In such an embodiment having a non-flat bottom as an engagement part, an additional engagement part is also provided, for example a rubber ring 40 as an additional engagement part in the embodiment shown in Fig. 2C. Some embodiments similar to the one shown in Fig. 2C have a non-flat bottom as an exclusive engagement component.
[0095] In FIG. 2D, the flat bottom 34 of the filter canister 10 is shown resting on the smooth surface of the flat support shelf 46. The mating part of the vortex mixing unit 32 shown in FIG. 2D is a rubber-lined ring 48 that surrounds the side of the filter canister 10. When the vortex mixing unit 32 is activated, the vortex-inducing motion is transferred to the filter canister 10 through its side by the mating rubber-lined ring 48. In FIG. 2D, the mating rubber-lined ring 18 completely surrounds the side of the filter canister 10. In some similar embodiments, the mating part surrounds only a portion of the filter canister, e.g., an incomplete ring. In some similar embodiments, the mating part is made of a different material than the rubber-lined ring, e.g., a plastic, silicone or metal-lined ring or an unlined ring made of plastic, rubber, silicone or metal.
[0096] Since mechanical processing, such as vortex mixing, is performed within the liposuction filter canister, there is no need to transfer the liposuction tissue from the filter canister for processing, and in some embodiments, processing of the liposuction tissue can be performed in a sterile manner simultaneously with the actual collection and / or immediately after the actual collection is completed. Without wishing to be bound by any theory, it is believed to be advantageous to mechanically process the liposuction tissue simultaneously with and / or immediately after collection. It is currently hypothesized that rapid processing leads to less stress on the harvested adipose tissue. Thus, in some embodiments, mechanical processing is initiated within 60 minutes of collection of the liposuction tissue. In some embodiments, mechanical processing is performed within 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute, 30 seconds, 5 seconds, or even simultaneously with the collection of the liposuction tissue.
[0097] In some embodiments, mechanical treatment, such as vortex mixing, is applied to the lipoaspirate tissue without adding additional materials in the lipoaspirate filter canister. In some alternative embodiments, a volume of aqueous solution is added to the lipoaspirate filter canister (e.g., via the access port 20 or other suitable components) before and / or during application of the mechanical treatment. In some embodiments (such as some embodiments of vortex mixing), the addition of the aqueous solution has been found to increase the effectiveness of the mechanical treatment and improve its results. In such embodiments, the aqueous solution is preferably sterile. In some such embodiments, the aqueous solution is isotonic. Examples of suitable aqueous solutions include PBS (phosphate buffered saline), saline, and Ringer's solution. If added, the amount of aqueous solution is any suitable amount, and in some embodiments, is 100% or less, 80% or less, 60% or less, or even 50% or less of the volume of the lipoaspirate tissue contained in the filter canister. In some embodiments, the amount of aqueous solution added depends at least in part on the characteristics of the filter canister container, and the amount of aqueous solution added is such that about 30% or more, about 50% or more, or even about 65% or less of the lipoaspirate tissue is at or below the level of the aqueous solution added to the filter canister. In preferred such embodiments, during drainage "c", the added aqueous solution is also discharged from the lipoaspirate filter canister.
[0098] Mechanical Processing Parameters The parameters of the mechanical treatment may be any suitable parameters that achieve the desired effect. It is desirable that the mechanical treatment is sufficient to disrupt the lipid debris in the lipoaspirate tissue and release a significant amount of beneficial factors from the tissue, but not so intensive that a significant amount of harmful factors are released and / or a significant number of adipocytes are damaged.
[0099] In some embodiments, the vortex mixing is performed at 3000 rpm or less. In some embodiments, the vortex mixing is performed at 1000 rpm or less, 800 rpm or less, or even 700 rpm or less. Thus, in some embodiments, the vortex mixing is performed at 60 rpm or more, or even 100 rpm or less.
[0100] Generally, the duration of vortex mixing is preferably as short as possible to save time, thereby efficiently using the device used to process liposuction tissue, but long enough to release a significant amount of beneficial factors from tissue.In some embodiments, vortex mixing is performed for a time of 30 minutes or less, 20 minutes or less, 10 minutes or less, or even 7 minutes or less.In some embodiments, vortex mixing is performed for a time of 30 seconds or more, or even 60 seconds or less.
[0101] Discharge of released fluids At "c", following mechanical processing, fluid released from the lipoaspirate tissue as a result of the mechanical processing is removed from the lipoaspirate filter canister. The released fluid includes the harmful factors released from the lipoaspirate tissue by the mechanical processing, as well as blood and / or tumescent solution debris, and aqueous solutions added to aid in the mechanical processing, if present. Importantly, what remains trapped in the filter liner (22 in FIG. 1) is clean adipose tissue suitable for AFT that is somewhat enriched in beneficial factors. It is currently hypothesized that mechanical processing, such as vortex mixing, gently breaks down the adipose tissue debris retained in the filter canister and releases the beneficial factors that are typically considered components of SVF. Furthermore, it appears that mechanical processing, such as vortex mixing, is sufficiently gentle to result in the generation and / or release of fewer harmful factors than are released during known methods of processing lipoaspirate tissue. Mechanical processing, such as vortex mixing, is also effective in removing at least a portion of the harmful factors that passed through the filter liner (whether previously present or released as a result of the mechanical processing).
[0102] In some embodiments, to drain the released fluids, the filter canister is removed from the liposuction vacuum module (22 in FIG. 2A) of the liposuction apparatus, and the filter canister containing the lipoaspirate tissue is moved to another location for mechanical processing and / or draining the released fluids. For example, in some embodiments, the filter canister is removed from the liposuction vacuum module of the liposuction apparatus and moved to a desired mechanical processing device for mechanical processing, e.g., a vortex mixer for vortex mixing. In such embodiments, any suitable device and mechanism may be used to mechanically process the lipoaspirate tissue in the filter canister, and in some embodiments, devices and / or mechanisms similar to those shown in FIGS. 2A-2D, 3A-3C, and 4A-4H may be used.
[0103] In some such embodiments, during mechanical processing such as vortex mixing, the filter canister is not attached (i.e., "attached" is an adjective) to a fluid ejection mechanism, such as a liposuction vacuum module of a liposuction apparatus. In such embodiments, following mechanical processing, the filter canister containing the liposuction tissue is reattached to the fluid ejection mechanism, e.g., reattached to a liposuction vacuum module of a liposuction apparatus, to eject fluids released from the liposuction tissue.
[0104] In preferred embodiments, the liposuction filter canister is attached (i.e., "attached" is an adjective) to a fluid evacuation mechanism during mechanical processing. In some such embodiments, the filter canister is attached to a fluid evacuation mechanism that is not the liposuction vacuum module of the liposuction apparatus during mechanical processing. In preferred embodiments, the filter canister remains connected to the liposuction vacuum module of the liposuction apparatus to function as a fluid evacuation mechanism. In such embodiments, evacuation of fluids released from the liposuction tissue as a result of mechanical processing is preferably performed by activating the liposuction vacuum module.
[0105] AFT using mechanically treated adipose tissue In some embodiments, the method further includes transferring the lipoaspirate tissue from the filter canister to an autologous fat transfer (AFT) device following the discharge "c". The AFT device is any device or component of a device used to transfer fat to a living patient, including, for example, a syringe or syringe barrel. In some embodiments, the lipoaspirate tissue is transferred directly, i.e., from the filter canister to the AFT device. In some embodiments, the lipoaspirate tissue is transferred indirectly, for example, from the filter canister to a container and from the container to the AFT device. For example, in some embodiments, a syringe 56 (as an AFT device, such as a fat transfer device or a container) is inserted through the open access port 20 to remove the vortex mixed adipose tissue.
[0106] In some embodiments, the method further comprises using the AFT device to transplant the lipoaspirated tissue into a living patient, preferably into the same patient from which the adipose tissue was harvested (autologous). In some embodiments, transplanting the lipoaspirated tissue into a living patient is not part of the claimed invention.
[0107] Washing of mechanically processed adipose tissue As described above, as a result of the mechanical processing, fluid is released from the lipoaspirate tissue, passes through the filter liner (22, FIG. 1) and collects in the reservoir (12, FIG. 1) of the filter canister 10. The released fluid contains harmful substances released from the lipoaspirate tissue as a result of the mechanical processing, as well as remnants of blood and / or tumescent solution.
[0108] In some embodiments, following mechanical processing of the lipoaspirate tissue "b", and preferably also following fluid evacuation "c" (if performed), but prior to transferring the vortex-mixed lipoaspirate tissue to the AFT device, the method further comprises adding a washing solution (e.g., saline, Ringer's solution, PBS) to the filter canister and draining it from the container in a conventional manner, for example, by activating a fluid drainage mechanism, such as the lipoaspirate vacuum module or, in some embodiments, a separate drainage module. Such washing serves to remove at least a portion of harmful substances from the lipoaspirate tissue. Such washing solutions are preferably sterile and / or isotonic.
[0109] In some preferred embodiments, following mechanical processing of the lipoaspirate tissue [b], preferably following also the drainage of fluids "c" (if performed), but before transferring the mechanically processed lipoaspirate tissue to the AFT device, the mechanically processed lipoaspirate tissue in the lipoaspirate filter canister is not washed. Additionally or alternatively, in some preferred embodiments, following mechanical processing of the lipoaspirate tissue "b", preferably following also the drainage of fluids "c" (if performed), but before transferring the mechanically processed lipoaspirate tissue to the AFT device, the mechanically processed lipoaspirate tissue in the lipoaspirate filter canister is not centrifuged. Not having a washing and / or centrifugation step has numerous advantages, including, among others, saving time and costs by simplifying the equipment used to process the lipoaspirate tissue, eliminating the need to provide a washing solution, and reducing the amount of biological waste that needs to be disposed of. Surprisingly, embodiments of AFT performed with non-washed / non-centrifuged lipoaspirate tissue that has been mechanically processed according to the teachings herein have been very successful. This success indicates that the mechanical processing releases sufficient beneficial material that remains in the lipoaspirate tissue, concentrating the lipoaspirate tissue. In parallel, sufficient harmful materials are removed from the lipoaspirate tissue through the filter of the lipoaspirate filter canister so as not to substantially reduce the quality of the lipoaspirate tissue for AFT.
[0110] Filter canister volume and amount of lipoaspirate tissue processed Those of ordinary skill in the art recognize that in accepted prior art methods of processing lipoaspirate tissue, the improved AFT is necessarily performed only on low volumes of concentrated adipose tissue, around 100 ml. This is a result of the complexity of the preparation of SVF for concentrating adipose tissue, which involves vigorously mechanically and / or enzymatically treating a portion of the lipoaspirate tissue, followed by centrifugation to produce a 1 gram SVF pellet. The produced SVF pellet is then washed and subsequently added to the relatively small amount of adipose tissue (typically about 100 ml) that is thereby concentrated and used for the improved AFT.
[0111] In accordance with the teachings herein, any desired amount of lipoaspirate tissue contained within a liposuction filter canister can be processed by application of mechanical processes such as vortex mixing to produce concentrated lipoaspirate tissue, limited only by the volume of the liposuction filter canister and the amount of adipose tissue harvested from the patient.
[0112] Thus, in some embodiments, the liposuction filter canister containing the liposuction tissue has a volume of 50 ml to 10 liters, or even 5 liters or less. In some embodiments, the liposuction filter canister is selected from the group consisting of a small size having a volume of 50 ml to 100 ml, a medium size having a volume of 100 ml to 500 ml, a large size having a volume of 500 ml to 1 liter, and an extra large size having a volume of 1 liter or less.
[0113] In some embodiments, the amount of harvested lipoaspirate tissue received in the liposuction filter canister is between 50 ml and 10 liters. In some embodiments, the amount of harvested lipoaspirate tissue received in the liposuction filter canister is selected from the group consisting of between 50 ml and 100 ml, between 100 ml and 500 ml, between 500 ml and 1 liter, or even greater than 1 liter.
[0114] Enzyme treatment As mentioned in the introduction, it is known to process lipoaspirate tissue by the addition of exogenous enzymes to release stem cells and the like from the adipose tissue. In preferred embodiments of the teachings herein, no exogenous enzymes are added to the lipoaspirate tissue from the time of collection until drainage of fluids released from the lipoaspirate tissue "c" and, if applicable, transfer of the lipoaspirate tissue to the AFT device. In some such preferred embodiments, the lipoaspirate tissue is not in contact with any exogenous enzymes from before "a" to immediately after "b" and before "c". In some such preferred embodiments, the lipoaspirate tissue is not in contact with any exogenous enzymes from before "a" to immediately after "c". In some such preferred embodiments, the lipoaspirate tissue is not in contact with any exogenous enzymes as long as the lipoaspirate tissue is contained in the lipoaspirate filter canister.
[0115] liposuction The method teachings herein are based on the discovery that gentle mechanical processing of the harvested lipoaspirate tissue enables the harvested lipoaspirate tissue to be processed in a liposuction filter canister to obtain concentrated lipoaspirate tissue for improved AFT.
[0116] It is currently believed that the processing method according to the teachings herein is particularly suitable for use with high quality lipoaspirate tissue, i.e., lipoaspirate tissue harvested gently with relatively little trauma, resulting in less waste such as blood, less dead or damaged fat cells (also called adipocytes), and less traumatized fat cells. Without being bound by any theory, it is believed that such gently harvested lipoaspirate tissue contains fewer harmful factors. Thus, in some embodiments, the received lipoaspirate tissue is lipoaspirate tissue harvested using a gentle lipoaspirate method and / or device. In some embodiments, the gentle liposuction method is ultrasound assisted liposuction, and the liposuction is performed using an ultrasound assisted liposuction device. In some embodiments, the gentle liposuction method is radio frequency (RF) assisted liposuction, and the liposuction is performed using an RF assisted liposuction device. In some embodiments, the lipoaspirate tissue is harvested using a cannula having an inner diameter of at least 2 mm and no more than 5 mm. In some embodiments, the lipoaspirate tissue was harvested using an aspiration pressure of at least 20 kP and no more than 98 kP.
[0117] In some embodiments of the method, the received lipoaspirate tissue is harvested from the patient using a laser-assisted liposuction device, as shown in Figures 2A-2D. In some such embodiments, the laser-assisted liposuction is performed using a laser wavelength in the range of 800-1600 nm, 1400-1500 nm, 1450-1490 nm, or even 1460-1480 nm, such as the 1470 nm laser wavelength used in some commercially available laser-assisted liposuction devices, such as the LipoLife® by Alma Lasers (Caesarea, Israel). In some such embodiments, the laser-assisted liposuction is performed using a radially irradiated optical fiber, such as that used in some commercially available laser-assisted liposuction devices, such as the LipoLife® by Alma Lasers.
[0118] Without wishing to be bound by any theory, it is currently believed that laser-assisted liposuction, particularly using the above wavelengths and / or radially emitting optical fibers, is much gentler and causes fewer adverse effects than other liposuction methods.
[0119] Further processing of lipoaspirate tissue Following mechanical processing "b" or evacuation of released fluids "c" as described above, the processed lipoaspirate tissue in the liposuction filter canister is typically ready for use in the AFT, with or without a subsequent washing step.
[0120] However, in some instances, the "c" indicates that the processed lipoaspirate tissue is not sufficiently fluid for some types of AFT, and that the processed lipoaspirate tissue typically contains a relatively large proportion of relatively large adipose tissue fragments. Further, in some embodiments, it may be desirable to additionally or alternatively produce SVF for use in enriching lipoaspirate tissue for AFT or for other therapeutic purposes.
[0121] The inventors have found that the lipoaspirate tissue contained in the liposuction filter canister following discharge "c" can be further processed to provide a more fluid lipoaspirate tissue suitable for AFT and / or SVF. Thus, in some embodiments, the method includes: d. further comprising, following "c", applying an additional mechanical treatment, such as vortex mixing, to the lipoaspirate tissue contained in the liposuction filter canister to mix the lipoaspirate tissue, the additional mechanical treatment reducing the average size of the fat cell fragments in the lipoaspirate tissue without significantly rupturing the fat cells therein.
[0122] The parameters of the additional mechanical treatment (including the time following collection, the addition or absence of additional material to the liposuction filter canister, the intensity at which the mechanical treatment is performed, and the duration for which the mechanical treatment is performed) are as described above for vortex mixing in "b" (and for other mechanical treatment methods herein) and will not be described again for reasons of brevity.
[0123] In some embodiments, an additional mechanical treatment "d" is performed following "c" on the entire contents of the liposuction filter canister. In some alternative embodiments, following "c", a portion of the lipoaspirate tissue is removed from the lipoaspirate filter canister and the additional mechanical treatment is performed only on the lipoaspirate tissue remaining in the lipoaspirate filter canister. In some embodiments, the type of mechanical treatment in "b" is different from the type of mechanical treatment in "d". For simplicity, in preferred embodiments, the type of mechanical treatment in "b" is the same as the type of mechanical treatment in "d".
[0124] fluid liposuction tissue Following "d", it has been found that additional mechanical processing of lipoaspirate tissue makes it more fluid and therefore suitable for finer definition of AFT or body in finer areas of the body in some embodiments.It is currently believed that additional mechanical processing reduces the average size of the adipose tissue fragments that make up lipoaspirate tissue.It is also believed that lipoaspirate tissue is enriched for use in improved AFT, since a relatively small number of harmful factors are released, while additional beneficial factors are released.
[0125] Thus, in some embodiments, the method further comprises transferring the lipoaspirate tissue to an autologous fat transfer (AFT) device following the additional mechanical processing "d". In some embodiments, the lipoaspirate tissue is transferred directly, i.e., from the filter canister to the AFT device. In some embodiments, the lipoaspirate tissue is transferred indirectly, e.g., from the filter canister to the container and from the container to the AFT device. In some embodiments, the method further comprises using the AFT device to transplant the lipoaspirate tissue into a living patient, preferably the same patient from which the adipose tissue was harvested (i.e., autologous).
[0126] interstitial vascular factor Similar to the first mechanical treatment "b," the additional mechanical treatment "d" releases fluid that passes through the filter liner of the liposuction filter canister and is found to be enriched in beneficial factors, such as stem cells, which can be collected and concentrated in conventional manner to create an SVF pellet.
[0127] Thus, in some embodiments, the method further comprises: e. Following the additional mechanical treatment "d", separating the fluid released from the lipoaspirate tissue due to the additional mechanical treatment as SVF fluid.
[0128] In some embodiments, the SVF fluid is processed to make an SVF pellet. In some such embodiments, such processing includes placing the SVF fluid in a centrifuge container and centrifuging the SVF fluid in the centrifuge container to produce an SVF pellet at the bottom of the centrifuge container. The SVF pellet can be used in a conventional manner, for example, suspended in a fluid as an injectable therapeutic agent, or added to adipose tissue / lipoaspirate tissue to concentrate adipose tissue for AFT, including lipoaspirate tissue processed according to the teachings herein.
[0129] Apparatus for carrying out the method The embodiments of the method according to the teachings herein may be implemented using any suitable device or combination of devices as discussed herein. Some embodiments are preferably implemented using a liposuction device according to the teachings herein, such as the device 24 described with reference to Figures 2A-2D above, or the device shown in Figures 3A-3C or 4A-4H. In some embodiments, such a liposuction device is substantially a liposuction device 24 configured for performing liposuction, which includes a vortex mixing unit (e.g., 32 shown in Figures 2A-2D) as a liposuction tissue processing unit, which, when activated, is configured to generate and apply a vortex-inducing motion with a certain intensity and duration to a liposuction filter canister operatively associated with the liposuction device to implement one or more embodiments of the method according to the teachings herein. Such a vortex-inducing motion induces the formation of vortices in the contents of the liposuction filter canister, thereby vortex-mixing the contents of the liposuction filter canister.
[0130] As mentioned above, an embodiment of such an apparatus includes: a liposuction vacuum module, as known in the art for performing liposuction, which in some embodiments may function as a liquid evacuation module for removing liquid from the liposuction filter canister, such as liquid released from the liposuction tissue as a result of vortex mixing; a liquid evacuation module distinct from the liposuction vacuum module for removing liquid from the liposuction filter canister, such as liquid released from the liposuction tissue as a result of vortex mixing; a liposuction probe having a distal end attachable to a liposuction cannula and a proximal end attachable via a suction inlet thereof to a liposuction filter canister operatively associated with a liposuction device, the liposuction probe being configured to direct liposuction tissue collected via the liposuction cannula from said distal end through said proximal end into a receptacle of the associated liposuction filter canister; a cleaning module attachable to a liposuction filter canister operatively associated with the liposuction apparatus via its access port, the cleaning module configured to deposit a quantity of liquid (e.g., cleaning fluid) into a reservoir of the attached liposuction filter canister (preferably a measured quantity of liquid); a controller configured to automatically process (preferably according to an embodiment of a method according to the teachings herein) lipoaspirate tissue contained in a lipoaspirate filter canister operatively associated with the lipoaspirate device, the automatic processing including activating a vortex mixing unit, a fluid evacuation module (in some embodiments where the fluid evacuation module is the same as the lipoaspirate vacuum module, and in other embodiments where the fluid evacuation module is different from the lipoaspirate vacuum module) and a cleaning module in a desired order, preferably according to an embodiment of the teachings herein; The controller may include one or more of the following: A person having ordinary skill in the art can implement the controller without inventive efforts by reading this specification. Typically, the controller is implemented as a series of commands to modules (implemented in software, hardware and / or firmware) on a computer (custom or general-purpose, for example, a computer that also functions as a controller for operating a liposuction device to perform liposuction), communication devices and protocols to various control modules, and in some embodiments, electrical and / or electromechanical components such as switches, solenoids and robotic arms.
[0131] The liposuction apparatus 24 shown in FIG. 2A includes a controller 50 and an irrigation module 52. The liposuction vacuum module 26 is configured to also function as a fluid evacuation module.
[0132] Mechanical treatment by vibration As mentioned above, in some embodiments, the method is carried out where the mechanical treatment is vibration. Similarly, in some embodiments, the lipoaspirate tissue processing unit of the apparatus teachings herein comprises a vibration unit (instead of or in addition to a vortex mixing unit) that, when activated, is configured to generate and apply vibrations to the lipoaspirate tissue contained within a lipoaspirate filter canister operatively associated with the lipoaspirate apparatus, the vibrations being effective to mechanically process the lipoaspirate tissue.
[0133] The vibrations applied are of any suitable frequency and intensity to achieve the desired balance of mechanical treatment without substantially rupturing the fat cells. One of ordinary skill in the art can determine the appropriate frequency and intensity to achieve the desired effect without undue experimentation.
[0134] Those skilled in the art are aware that vibrations with ultrasonic frequencies higher than 20kHz can cause extracellular cell lysis.Thus, in some embodiments, the applied vibrations have frequencies less than 20kHz, less than 10kHz, or even less than 5kHz.Suitable devices for generating suitable frequencies include commercially available low-frequency sonic transducers, for example, available from Sensor Technology Ltd. (Collingwood, Ontario, Canada).
[0135] In some embodiments, the vibration unit and / or controller of the liposuction apparatus is configured to enable vibration of the contents of a liposuction filter canister operatively associated with the liposuction apparatus for a period of 30 minutes or less, 20 minutes or less, 10 minutes or less, or even 7 minutes or less.
[0136] In some embodiments, the vibration unit and / or controller is configured to enable vibration of the contents of a liposuction filter canister operatively associated with the liposuction apparatus for a period of 30 seconds or more, or even 60 seconds or less.
[0137] 3A-3C show schematic components of an embodiment of an apparatus useful for carrying out an embodiment of a method according to the teachings herein in which the mechanical treatment is vibration, and in which a liposuction apparatus 58 includes a vibration unit 60 as a liposuction tissue treatment unit. [Sound transmitter probe]
[0138] In some embodiments, the vibration unit includes at least one sonic transmitter probe configured to be placed inside a volume enclosed by a filter liner of a liposuction filter canister operatively associated with the liposuction device. As known in the art of sonic therapy, a sonic transmitter probe is a device that generates vibrations and transmits the vibrations to a medium, for example, liposuction tissue according to the teachings herein. In such embodiments, during use, the probe is at least partially immersed in the liposuction tissue.
[0139] In some embodiments, the vibration unit includes a single sonicator probe. The advantage of a single sonicator probe is simplicity. In FIG. 3A, a filter canister 10 is shown in cross section in functional association with the device 58. An elongated sonicator probe 62 located within the internal volume 23 of the canister 10 is arranged such that when the volume 23 contains a fluid such as lipoaspirate tissue, the probe 62 is immersed therein. The sonicator probe 62 is functionally associated with a controller (not shown) of the device 58 via a cable 64. When required, the controller provides the necessary power for the required duration so that the probe 62 generates vibrations for treating the lipoaspirate tissue contained in the volume 23 in accordance with the teachings herein.
[0140] In some embodiments, the vibration comprises at least two, at least three, or even at least four sonic probes. The advantage of two or more sonic probes is that the mechanical processing caused by the vibration of the probes is more effectively distributed throughout the volume of liposuction tissue. In some embodiments, one or more of the sonic probes are elongated. In Fig. 3B, a filter canister 10 is shown in functional association with the device 58. The device 58 shown in Fig. 3B is the same as that shown in Fig. 3A, but includes two elongated sonic probes 62a and 62b.
[0141] In some such embodiments, some or all of the sonicator probe is a component of the liposuction filter canister and the liposuction device includes, for example, an electrical connector and is configured to enable operation of the sonicator probe of the liposuction canister in accordance with the teachings herein. Alternatively or additionally, in some embodiments, some or all of the sonicator probe is a component of the liposuction device.
[0142] In some embodiments, the probe is covered with a sheath-like covering for use in preventing non-sterile contact between the probe and liposuction tissue, hi some embodiments, at least the outer portion of the probe is discarded after use.
[0143] [Vibration filter liner] In some embodiments, the vibration unit comprises an acoustic transmitter configured to be physically associated with a filter liner of a liposuction filter canister functionally associated with a liposuction device such that, when activated, said acoustic transmitter vibrates the physically associated filter liner. In such embodiments, the vibrating filter liner transmits vibrations from the acoustic transmitter to the liposuction tissue held therein. In such embodiments, at least a portion of the filter liner is made of a material that transmits acoustic vibrations, such as medical grade metal or medical grade plastic, such as polyester. In some such embodiments, the acoustic transmitter is a component of the liposuction filter canister, and the liposuction device includes, for example, an electrical connector, and is configured to enable operation of the acoustic transmitter of the liposuction canister in accordance with the teachings herein. Alternatively, in some such embodiments, the acoustic transmitter is a component of the device and the liposuction filter canister is a separate component, both configured to enable reversible acoustic mating of the transmitter with the filter liner.
[0144] In Figure 3C, there is shown a filter canister 10 operatively associated with an apparatus 58. An acoustic transmitter 66 operatively associated with the filter liner 22 of the canister 10 is operatively associated with a controller (not shown) of the apparatus 58 via a cable 64. When required, the controller provides the necessary power for the required duration such that the transmitter 66 generates vibrations that are transmitted by the filter liner 22 to the lipoaspirate tissue contained in the volume 23 to treat the lipoaspirate tissue. In some embodiments, the sonicator 66 is a component of the device 58 that is reversibly coupled to the filter liner 22 via a connector 68 .
[0145] In some alternative embodiments, the sonic generator 66 is a component of the canister 10 that is reversibly coupled to the device 58 via a cable 64 through a connector 70 .
[0146] mechanical mixing As mentioned above, in some embodiments, the method is carried out where the mechanical treatment is mechanical mixing. Similarly, in some embodiments, the liposuction tissue processing unit of the apparatus according to the teachings herein comprises: a mechanical mixing component configured to be positioned within a volume enclosed by a filter liner of a liposuction filter canister operatively associated with the liposuction device; a mixing motor configured to move the lipoaspirate tissue contained within the container relative to a mechanical mixing component to mechanically mix the lipoaspirate tissue, the mechanical mixing being effective to mechanically process the lipoaspirate tissue; Equipped with.
[0147] 4A-4H are schematic diagrams of components of an embodiment of an apparatus useful for practicing an embodiment of a method according to the teachings herein, the apparatus being configured for mechanical mixing. [Translational mixed components]
[0148] In some embodiments, the mixing motor is configured such that relative motion of the mechanical mixing component with respect to the liposuction filter canister translates parallel to a longitudinal axis of the liposuction filter canister. In some embodiments, the filter canister moves parallel to the longitudinal axis. Additionally or alternatively, in some embodiments, the mechanical mixing component moves parallel to the longitudinal axis.
[0149] In some such embodiments, the mixing component is a flow-restricting barrier, i.e., the mixing component constitutes a partial barrier to the flow of lipoaspirate tissue therethrough. As a result of translation of the canister relative to the mixing component, the lipoaspirate tissue contained in the interior volume of the filter liner passes through and / or alongside (between the mixing component and the filter liner) the mixing component at a restricted and increased pressure, a flow that results in mechanical mixing of the lipoaspirate tissue that is effective to mechanically process the lipoaspirate tissue.
[0150] In some such embodiments, the flow-restricting barrier comprises or is a partially permeable plunger. As used herein, a partially permeable plunger is a flow-restricting barrier that has a small dimension parallel to the longitudinal axis and a large dimension perpendicular to the longitudinal axis and is configured to be partially permeable, i.e., to allow lipoaspirate tissue contained in the interior volume of the filter liner to pass through or alongside the plunger (between the plunger and the filter liner itself). A partially permeable plunger is contrasted with an impermeable plunger, i.e., a component of a prior art syringe that does not allow fluid to pass through or alongside it.
[0151] In some embodiments, the outer shape of the partially transparent plunger in the dimension perpendicular to the longitudinal axis 13 is round, e.g., the plunger 66a in cross section from above in FIG. 4A-1 is a solid thin plate having a diameter smaller than the inner diameter of the liner 22 so that during translation, the lipoaspirate tissue passes through the space between the edge of the plunger 66a and the inner wall of the liner 22.
[0152] In some embodiments, the plunger profile in the dimension perpendicular to the longitudinal axis 13 is jagged, e.g., the flower-shaped plunger 66b in cross section from above in FIG. 4A-2, a flower-shaped plate with perforations such that the lipoaspirate tissue passes through the spaces between the depressions during translation.
[0153] In some embodiments, the outline of the plunger in the dimension perpendicular to the longitudinal axis 13 is the same as the outline of the inner wall of the liner, such as plunger 66a in FIG. 4A-1.
[0154] In some embodiments, the outer diameter of the plunger in the dimension perpendicular to the longitudinal axis 13 differs from the outer profile of the inner wall of the liner, such as plunger 66b in FIG. 4A-1 or plunger 66c in cross section from above in FIG. 4A-3.
[0155] In some embodiments, the plunger lacks a gap to allow passage of lipoaspirate tissue therethrough, such as plunger 66a of FIG. 4A-1 or plunger 66c of FIG. 4A-3.
[0156] In some embodiments, the plunger is perforated, such as perforated plunger 66b in FIG. 4A-2 or mesh plunger 66d in FIG. 4A-4, allowing lipoaspirate tissue to pass through mesh 67 that forms part of plunger 66d in a manner similar to a French press.
[0157] The speed of the relative translational movement is any suitable speed, typically depending on the properties of the mixed components, e.g., more restrictive barriers are moved slower and less restrictive barriers are moved faster. In some preferred embodiments, the speed is between 1 mm / sec and 10 cm / sec. In some embodiments, the device (e.g., controller) is configured such that the movement is performed only once in one direction (e.g., from top to bottom or from bottom to top). In some alternative embodiments, the movement is performed at least twice (e.g., from top to bottom and back to top, or from bottom to top and back to bottom).
[0158] 4B, a liposuction device 68 is shown operatively associated with the filter canister 10. Disposed within the interior volume 23 defined by the filter liner 22 is a mechanical mixing component including a permeable plunger 66 and a rigid linear support bar 70 fixed to the device 68 parallel to the longitudinal axis 13. A mixing motor 72 is configured to move the filter canister 10 parallel to the axis 13 while the partially permeable plunger 66 and bar 70 are stationary such that lipoaspirate tissue within the volume 23 is forced past and / or through the plunger 66 to be mixed and thereby mechanically processed.
[0159] 4C shows a liposuction apparatus 74 similar to apparatus 68. In apparatus 74, filter canister 10 is fixed in position relative to apparatus 74 and mix motor 72 is configured to move partially transmissive plunger 66 and rigid linear support bar 70 parallel to longitudinal axis 13.
[0160] [Rotating filter liner mixing element] Alternatively or in addition to translational mixing, in some embodiments, the mixing motor is configured to rotate the filter liner relative to the liposuction filter canister vessel about an axis parallel to the longitudinal axis of the liposuction filter canister. In some such embodiments, the mechanical mixing component comprises a mixing element that protrudes from an inner surface of the filter liner into the interior volume, and the mixing element rotates with the filter liner. Additionally or alternatively, in some embodiments, the mechanical mixing component comprises a mixing element that does not rotate with the filter liner.
[0161] In FIG. 4D, a liposuction apparatus 76 is shown operatively associated with filter canister 10, which is shown in schematic cross-section. Electric mixing motor 72 is configured to rotate filter liner 22 via gear 78 that engages matching gear teeth 80 on the upper inner edge of filter liner 22 when activated. Protruding from the inner surface of filter liner 22 into interior volume 23 is mixing element 82, a 3 mm thick rigid polyethylene paddle. When mixing motor 72 is activated, filter liner 22 and mixing element 82 rotate together about axis 13, mixing and thereby mechanically processing liposuction tissue contained within volume 23.
[0162] 4E shows a liposuction device 84, similar to device 76. Fixedly attached to the cap of filter canister 10 within interior volume 23 is a stator paddle 86 (of 3 mm thick polyethylene). Operation of mixer motor 72 in device 84 is similar to that of device 76, however, the presence of stator paddle 86 improves the efficiency of mechanical processing of the liposuction tissue.
[0163] Rotational Mixed Components Alternatively or in addition to a translational mixing and / or rotating filter liner, in some embodiments the mixing motor is configured to rotate a mechanical mixing component separate from the filter liner located within the interior volume of the filter liner, typically but not necessarily in a plane perpendicular to the longitudinal axis of the liposuction filter canister. Any suitable type or combination of types of mechanical mixing components apart from the filter liner may be used.
[0164] In some embodiments, the mechanical mixing component comprises an impeller. In some embodiments, the impeller is a radial flow impeller. Alternatively, in some embodiments, the impeller is an axial flow impeller. In FIG. 4F, a liposuction apparatus 88 is shown operatively associated with a filter canister 10, which is shown in schematic side cross section. The electric mixing motor 72, when activated, is configured to rotate the impeller 90 via the shaft 92 to mix and thereby mechanically process the liposuction tissue contained in the volume 23.
[0165] Alternatively or additionally, in some embodiments, the mechanical mixing component comprises a propeller that is a mechanical mixing component that axially drives fluid, such as lipoaspirate tissue, contained within the internal volume 23. In Fig. 4G, a liposuction apparatus 94 is shown operatively associated with a filter canister 10, which is shown in schematic side cross section. When activated, the electric mixing motor 72 is configured to rotate the propeller 96 via the shaft 92 to mix and thereby mechanically process the lipoaspirate tissue contained within the volume 23.
[0166] Alternatively or additionally, in some embodiments, the mechanical mixing component is a mechanical mixing component comprising a paddle and having a flat surface for driving fluid, such as lipoaspirate tissue contained in the internal volume 23, in a direction tangential to the axis of rotation. In Fig. 4H, a liposuction device 98 is shown operatively associated with a filter canister 10, which is shown in schematic side cross section. The electric mixing motor 72, when activated, is configured to rotate a paddle 100 (of 3 mm thick polyethylene) via shaft 92 to mix and thereby mechanically process the lipoaspirate tissue contained in the volume 23.
[0167] In embodiments having a mechanical mixing component (e.g., a rotating filter liner and / or a rotating mixing component separate from the filter liner), the speed and duration at which the mechanical mixing component is rotated may be any suitable value. In some embodiments, the mechanical mixing unit and / or controller is configured to mechanically mix the contents of the liposuction filter canister operatively associated with the liposuction apparatus for a period of 10 minutes or less, 5 minutes or less, 1 minute or less, or even 1 minute or less. Moreover, in some embodiments, the mechanical mixing unit and / or controller is configured to allow mechanical mixing of the contents of the liposuction filter canister operatively associated with the liposuction apparatus for a period of 10 seconds or more, or even 15 seconds or more. In some preferred embodiments, the rotational speed of the mechanical mixing member is less than 960 rpm, less than 480 rpm, less than 240 rpm, or even less than 120 rpm.
[0168] In some such embodiments, the mixing motor and the entire mechanical mixing component (eg, plunger and handle) are components of the liposuction device.
[0169] In some such embodiments, the mixing motor and a portion of the mechanical mixing component (eg, the handle) are components of the liposuction device, and a portion of the mechanical mixing component (eg, the plunger) is part of the filter canister.
[0170] In some such embodiments, the mixing motor is a component of the liposuction device, and the entire mechanical mixing component (eg, plunger and handle) is a component of the filter canister.
[0171] In some such embodiments, the mixing motor and the entire mechanical mixing component (e.g., plunger and handle) are components of the filter canister. In some such embodiments, the liposuction device provides the power (e.g., electricity) to operate the mixing motor. Alternatively, in some such embodiments, the power to operate the electric motor is provided from a source separate from the liposuction device. In some embodiments, the liposuction apparatus includes two or more types of mixing components.
[0172] The teachings herein may be advantageously practiced with any type of liposuction and liposuction equipment, but are advantageously practiced with gentler liposuction equipment. For example, in some embodiments, liposuction device 24 shown in FIG. 2A is an ultrasonically assisted liposuction device and component 54 is an ultrasonic module that includes some of the components necessary to apply ultrasonic energy to the adipose tissue being liposuctioned.
[0173] For example, in some embodiments, liposuction device 24 shown in FIG. 2A is an RF-assisted liposuction device and component 54 is an RF module that includes some of the components necessary to apply radio frequency energy to the adipose tissue undergoing liposuction.
[0174] 2A is a laser assisted liposuction device and component 54 is a laser module that includes some of the components necessary to apply laser energy to the adipose tissue undergoing liposuction. For example, in some embodiments, the liposuction device is a modified LipoLife® Laser Assisted Liposuction Device by Alma Lasers.
[0175] Similarly, in some embodiments, any one of liposuction apparatus 58 (FIGS. 3A-3C), apparatus 68 shown in FIG. 4B, apparatus 74 shown in FIG. 4C, apparatus 76 shown in FIG. 4D, apparatus 84 shown in FIG. 4E, apparatus 88 (FIG. 4F), apparatus 94 (FIG. 4G) or apparatus 98 (FIG. 4H) is any one of an ultrasonically assisted liposuction apparatus, an RF assisted liposuction apparatus or a laser assisted liposuction apparatus.
[0176] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.
[0177] As used herein, the terms "comprise," "include," "have," and grammatical variations thereof are deemed to specify stated features, integers, steps or components, but do not exclude the addition of one or more additional features, integers, steps, components or groups thereof.
[0178] As used herein, the indefinite articles "a" and "an" have the meaning "at least one" or "one or more" unless the context clearly dictates otherwise. As used herein, when a numerical value is preceded by the term "about," the term "about" is intended to indicate ±10%.
[0179] As used herein, a phrase of the form "A and / or B" means a selection from the group consisting of (A), (B) or (A and B). As used herein, a phrase of the form "at least one of A, B and C" means a selection from the group consisting of (A), (B), (C), (A and B), (A and C), (B and C) or (A and B and C).
[0180] It will be understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperable without those elements.
[0181] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the appended claims.
[0182] Citation or identification of any document in this application shall not be construed as an admission that such document is available as prior art to the present invention. Section headings are used herein to facilitate comprehension of the specification and should not be construed as necessarily limiting.
Claims
1. 1. A liposuction device configured to harvest endogenous adipose tissue from a body through a cannula as lipoaspirate tissue and perform liposuction by transferring at least a portion of the harvested adipose tissue to a liposuction filter canister in operative association with the liposuction device, a liposuction processing unit configured, upon activation, to mechanically process liposuction tissue contained within a liposuction filter canister operatively associated with said liposuction apparatus; the liposuction processing unit comprises a vortex mixing unit configured, when activated, to generate and impart a vortex-inducing motion to a liposuction filter canister operatively associated with the liposuction apparatus, the vortex-inducing motion being effective to mechanically process the liposuction tissue; A liposuction apparatus in which the mechanical treatment reduces the average size of the adipose tissue fragments without substantially rupturing the fat cells in the aspirated tissue.
2. a liposuction vacuum module attachable via its vacuum port to a liposuction filter canister operatively associated with said liposuction apparatus; 2. The liposuction device of claim 1, wherein the liposuction vacuum module, when attached to a liposuction filter canister and activated, is configured to perform liposuction through the liposuction filter canister and a liposuction probe operatively associated therewith, thereby enabling harvested adipose tissue to be captured within a filter liner of the attached filter canister.
3. 3. The liposuction apparatus of claim 2, configured to enable activation of the liposuction processing unit to mechanically process the contents of a liposuction filter canister operatively associated with the suction apparatus while the liposuction filter canister is attached to the liposuction vacuum module.
4. 4. The liposuction apparatus of claim 2, wherein the liposuction vacuum module is further configured to function as a liquid evacuation module for removing liquid from a container of a liposuction filter canister operatively associated with the liposuction apparatus.
5. 4. The liposuction apparatus of claim 2 or 3, further comprising a fluid exhaust module distinct from said liposuction vacuum module, said fluid exhaust module being attachable via an exhaust port thereof to a liposuction filter canister operatively associated with said liposuction apparatus, said fluid exhaust module being configured, when attached to such liposuction filter canister, to remove liquid from a container of said attached liposuction filter canister.
6. 6. The liposuction apparatus of claim 1, further comprising a liposuction probe having a distal end attachable to a liposuction cannula and a proximal end attachable through its suction inlet to a liposuction filter canister operatively associated with said liposuction apparatus, said liposuction probe configured to direct lipoaspirate collected through the attached liposuction cannula into a receptacle of the attached liposuction filter canister.
7. 7. The liposuction apparatus of claim 1, further comprising a cleaning module attachable to a liposuction filter canister operatively associated with the liposuction apparatus via its access port and configured to add an amount of liquid to a reservoir of the attached liposuction filter canister.
8. 8. The liposuction device of claim 7, further comprising a controller configured to automatically process liposuction tissue contained in a liposuction filter canister operatively associated with the liposuction device, the automatic processing including activating the liposuction processing unit, a liquid drainage module for removing liquid from a container of the liposuction filter canister, and the cleaning module in a desired order and for a desired time.
9. 9. The liposuction apparatus of claim 8, wherein the vortex mixing unit includes an engagement member that transfers at least a portion of the vortex-inducing motion generated by the vortex mixing unit to a liposuction filter canister operatively associated with the liposuction apparatus when the vortex mixing unit is activated.
10. 10. The liposuction apparatus of claim 1, wherein the vortex mixing unit includes an engagement member configured to at least partially surround at least a portion of a liposuction filter canister operatively associated with the liposuction apparatus.
11. 11. The liposuction apparatus of claim 1, wherein the vortex mixing unit is configured, when activated, to vortex mix the contents of a liposuction filter canister operatively associated with the liposuction apparatus at up to 1000 rpm.
12. 12. The liposuction device of claim 1, wherein the liposuction processing unit comprises a vibration unit configured, when activated, to generate and apply vibrations to the liposuction tissue contained within a liposuction filter canister functionally associated with the liposuction device, the vibrations being effective to mechanically process the liposuction tissue.
13. The liposuction apparatus of claim 12, wherein the vibration has a frequency of less than 20 kHz.
14. 14. The liposuction apparatus of claim 12, wherein the vibration unit includes at least one ultrasonic transmitting probe configured to be positioned within a volume enclosed by a filter liner of a liposuction filter canister operatively associated with the liposuction apparatus.
15. 14. The liposuction device of claim 12, wherein the vibration unit comprises an ultrasonic generator configured to be physically associated with a filter liner of a liposuction filter canister functionally associated with the liposuction device, and when activated, the ultrasonic generator vibrates the filter liner with which it is physically associated.
16. The liposuction processing unit includes: a mechanical mixing component configured to be disposed within a volume enclosed by a filter liner of a liposuction filter canister operatively associated with the liposuction apparatus; a mixing motor configured to move lipoaspirate tissue contained within the volume relative to the mechanical mixing component to mechanically mix the lipoaspirate tissue and provide mechanical mixing effective to mechanically treat the lipoaspirate tissue; 16. A liposuction apparatus according to any one of claims 1 to 15, comprising:
17. 17. The liposuction apparatus of claim 16, wherein the mixing motor is configured such that relative movement of the mechanical mixing component with respect to the liposuction filter canister moves parallel to a longitudinal axis of the liposuction filter canister.
18. 17. The liposuction apparatus of claim 16, wherein the mixer motor is configured to rotate the filter liner relative to a receptacle of the liposuction filter canister about an axis parallel to a longitudinal axis of the liposuction filter canister.
19. 17. The liposuction apparatus of claim 16, wherein the mixing motor is configured to rotate a mechanical mixing component separate from the filter liner, the mechanical mixing component being disposed within the interior volume.
20. 20. The liposuction device of any one of claims 1 to 19, selected from the group consisting of a laser assisted liposuction device, an ultrasound assisted liposuction device, and an RF assisted liposuction device.
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