WO2015143165A1 - Dispositif de traitement de tissu adipeux et concentrateur de cellules manuels - Google Patents

Dispositif de traitement de tissu adipeux et concentrateur de cellules manuels Download PDF

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Publication number
WO2015143165A1
WO2015143165A1 PCT/US2015/021481 US2015021481W WO2015143165A1 WO 2015143165 A1 WO2015143165 A1 WO 2015143165A1 US 2015021481 W US2015021481 W US 2015021481W WO 2015143165 A1 WO2015143165 A1 WO 2015143165A1
Authority
WO
WIPO (PCT)
Prior art keywords
processing chamber
adipose tissue
cannula
hand
held
Prior art date
Application number
PCT/US2015/021481
Other languages
English (en)
Inventor
Rolf Wolters
Anthony Yang
Josh NELSON
Stuart K. Williams
Original Assignee
Tissue Genesis, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/221,272 external-priority patent/US20140207103A1/en
Application filed by Tissue Genesis, Inc. filed Critical Tissue Genesis, Inc.
Publication of WO2015143165A1 publication Critical patent/WO2015143165A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0652—Cells of skeletal and connective tissues; Mesenchyme
    • C12N5/0653—Adipocytes; Adipose tissue
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M45/00—Means for pre-treatment of biological substances
    • C12M45/09—Means for pre-treatment of biological substances by enzymatic treatment

Definitions

  • This disclosure relates to the processing of adipose tissue, the purification, and the subsequent concentration of product resulting from said processing in an integrated system.
  • Adipose tissue has numerous uses. When such tissue is digested, the freed cells are capable of a multitude of uses, including tissue engineering, tissue repair, release of therapeutic factors by the cell, including factors released as a result of genetic engineering of the cells.
  • a problem with existing methods of extracting and isolating adipose cells is that existing equipment, such as liposuction cannulas and pumps and digestion devices, is not expected to be very portable. Furthermore, the liposuction, digestion, and cell concentration are often carried out in separate devices, and there are consequent issues in maintaining sterility as tissue and cells are transferred between devices. Consequently, it would be advantageous to have a portable, sterile device which was capable of carrying out the functions of extracting tissue, digesting the tissue, and concentrating the cells.
  • a hand-held device for processing and concentrating a SVF and cell product.
  • This device may comprise: a processing chamber comprising a digestion area; a filter within the processing chamber, which may be configured to allow SVF and liquids to pass from the processing chamber through the filter, while not allowing larger solid materials to pass through the filter; a wash chamber in which the SVF and cell product may be contained by a porous barrier that enables active fluid transfer; and a SVF and cell product concentrator.
  • a method for processing and concentrating a SVF and cell product may comprise: providing a hand-held device comprising: a processing chamber comprising a digestion area; a cannula with one end connected to the processing chamber in an airtight manner, and the other end open to the atmosphere; and a vacuum source connected to the processing chamber such that when the cannula is inserted into adipose tissue and the vacuum source is activated, the adipose tissue can be aspirated through the cannula into the processing chamber; inserting a tip of the cannula into adipose tissue within a patient; opening the valve to induce a vacuum within the chamber, which may cause a portion of the adipose tissue to move through the cannula into the processing chamber; situating the adipose tissue within the digestion area; digesting the portion of the adipose tissue in the chamber by incubation in the presence of a digesting enzyme, while maintaining
  • FIG. 1 is an illustration of a hand-held cartridge hybrid system.
  • FIG. 2 is an illustration of an alternate embodiment of a hand-held cartridge system.
  • FIG. 3 is an illustration of a hand-held cartridge system with a pre-processor.
  • FIG. 4 is an illustration of an all-in-one hand-held device for lipoaspiration and processing.
  • FIG. 5 is a flow chart illustrating an example of liposuction and fully automatic processing.
  • FIG. 6 is a flow chart illustrating an example of pre-processing and fully automatic processing.
  • Described herein are examples of a set of related compact devices that isolate cells from adipose tissue, such as stromal vascular fraction (SVF), and including stem cells.
  • adipose tissue such as stromal vascular fraction (SVF)
  • SVF stromal vascular fraction
  • One embodiment is a device that may process, purify, and concentrate cell product.
  • Adipose tissue may, in one example, be processed in one continuous cycle.
  • One embodiment is an integrated system that is miniaturized and may be hand-held.
  • Use of the term hand-held herein means a portable device that is capable of being held in one hand.
  • a possible volume of adipose tissue harvested may be less than approximately 20 ml. Larger sizes of adipose tissue (e.g., 30 ml, 40 ml, 100 ml, etc.) may be also be accommodated by scaling the device.
  • the device may accept aspirated adipose tissue into a cassette style configuration that comprises a series of connected syringe bodies. Each syringe body may contribute a step to an overall process of digestion and processing, which may collectively enable the process in a continuous and closed cycle.
  • FIG. 1 illustrates one embodiment of such a device in the form of a hand-held cartridge hybrid.
  • a cannula 104 may be used for liposuction to extract adipose tissue from a patient.
  • a vacuum may be supplied, for example, by an external vacuum pump or by a vacuum aspiration chamber 103.
  • a backup vacuum chamber 109 may be connected as an extra vacuum source. For example, this backup chamber may be used if the vacuum in the primary chamber is lost during use.
  • Vacuum chambers 103, 109 may be recharged through a vacuum recharge access 110. Such recharging may, for example, take place during the liposuction procedure if for some reason the vacuum is lost.
  • the vacuum may be used to create adequate negative pressure through the cannula 104 such that adipose tissue with which the cannula comes in contact may be forcibly removed from a host and collected by the device.
  • Solid tissue may be collected in a chamber 101, which may also serve as a digestion chamber.
  • Aspirant from the liposuction procedure may be collected into the vacuum aspiration chamber 103.
  • Fluidics control valves are shown as 102.
  • the vessel(s) should be of sufficient volume to provide necessary suction for liposuction.
  • a vacuum pump may be attached to the device during operation.
  • a vacuum pump in a base unit may serve to evacuate one or more vessels in the device while it is cradled in the base.
  • the hand-held device may be pumped down so that the device can operate independently of the base, providing vacuum for the lipoaspiration procedure.
  • a vacuum may be engaged by a push of a button on the handle by the operator, and the vacuum may be disengaged upon the release of said button.
  • a pressure pump or vessel able to provide a supply gas, for example compressed air, oxygen or nitrogen, and a vacuum pump able to provide negative pressure.
  • This positive or negative pressure may be used to move fluids throughout the system.
  • An alternate embodiment produces positive pressure through the use of an incorporated micro-pump or series of micro-pumps.
  • a pump in a base may pressurize a vessel in the hand-held while it is cradled in a base, so that the hand-held may operate independent of the base.
  • a pump in the base may supply positive pressure and negative pressure for the hand-held only while it is cradled, thereby only moving fluids by pressure during the cradled phase. Fluid flow may be managed by the cycling of valves, including check valves, electrically actuated valves, and other valves.
  • FIG. 1 also shows an example hand-held cartridge unit (right) associated with the device shown on the left. It may contain a port for an enzyme vial 105, a trituration syringe or digestate syringe 108, a filter or series of filters 106, and wash media syringes 107.
  • a cartridge/base station configuration may permit a cartridge containing adipose cells from liposuction to slide into the receiver-slot of the small sized base station.
  • An alternate embodiment may involve a
  • An alternate embodiment is a single-piece hand-held unit and a base.
  • An alternate embodiment may involve multiple handheld units in a carousel-style base, thereby giving an operator the option to harvest and process incremental volumes of fat, depending on their intended use.
  • the carousel base may double as a centrifuge.
  • FIG. 2 illustrates a related configuration.
  • the enzyme vial 205 filter or series of filters 206, wash media syringes 207, and trituration syringe/digestate syringe 208, there is a port for attachment of a digestion chamber 201 and adipose syringe 202.
  • FIG. 3 also shows enzyme vial 305, filter or series of filters 306, wash media syringes 307, and trituration syringe/digestate syringe 308, and digestion chamber 301, but also illustrates an adipose mincer/preprocessor 303.
  • Appropriate sterile, physical connections including pumps and/or valves may be routed between the various cartridges, so that, for example, wash from wash media syringes 207 may flow to digestion chamber 201.
  • tissue may be processed by enzymatic digestion under the appropriate conditions.
  • the tissue may be digested with collagenase at a physiological temperature, for an amount of time sufficient to break down the interstitial matrix of the tissue.
  • Other means of digesting adipose tissue are known in the art.
  • the suspension may be purified and concentrated, leaving behind concentrated cells, as described below.
  • processing of the collected adipose tissue may involve mechanically mincing the tissue in a mincer 303, thereby preparing the tissue to undergo further processing via enzymatic digestion. The tissue may then be washed and concentrated by removing fluid and waste.
  • Enzymes may be supplied in specified aseptic vials 105, 205, 305 (supply vials). These vials may in one embodiment be introduced into the device by "snapping-in" the vial in a specified location, during which an incorporated vial access spike punctures the seal. This vial may then remain within the device for the duration of the process.
  • FIG. 4 illustrates a configuration in which all steps are integrated into a single assembly.
  • a cannula 404 may be used for liposuction to extract adipose tissue from a patient.
  • a vacuum may be supplied by a vacuum aspiration chamber 403, with a secondary reserve vacuum chamber 409.
  • the device may comprise durable components and disposable components.
  • any component that comes in contact with fluid may be disposable.
  • the entire hand-held may be a disposable, into which all fluid-contacting components necessary for the process may be incorporated.
  • the handle of the hand-held device may also include a connector onto which a cannula may be mounted.
  • Valves that may control fluid path flow may be coupled to and actuated by the base
  • the base may contain the heater, pressure and vacuum pumps, and a physical coupling with the cartridge which may be inserted in the base. Adipose tissue may then be introduced into the cartridge for processing.
  • the use of the device may in one embodiment involve three steps: aspiration, processing, and use of product.
  • Aspiration is envisaged to be minimally invasive due to the nature of small volume "micro-liposuction.”
  • the hand-held design may be intended to be small and easy to handle during the aspiration step.
  • the hand-held may in one embodiment be inserted into the base.
  • the base may provide heat to the processor region of the hand-held to optimize the digestive process for a specified amount of time.
  • An alternate embodiment includes an inductive charger to recharge a battery in the hand-held, so that the battery may provide electricity for a heater.
  • the base may contain a heater, wash media, pressure and vacuum pumps, or any combination thereof, coupling with the hand-held when it is cradled in the base.
  • a device may use a combination of flow-through filters and containment filters. Larger pore size filters to trap large materials and pass the desired product via positive pressure may be employed, while subsequent filters that prevents product from escaping via containment follow sequentially.
  • digestate may be washed via a dynamic processes in which it is introduced into a submersed containment area, flushed with wash media, and retrieved for further processing.
  • the containment area may comprise a tubular filter with pore sizes small enough to prevent stem cells from passing, but large enough to let non-nucleated cells (red blood cells) and cell fragments to pass.
  • An alternate containment area may be a porous substrate that prevents stem cells from passing, but allows residual enzyme and endotoxins to wash away.
  • Cells may in one example be concentrated and purified using a hollow- fiber bioreactor or porous substrate tube. As the medium passes through the tubes, fluid and enzymes may diffuse out of the fiber for disposal, while cells and stromal and vascular fractions may pass through as retentate. This process may be repeated until the desired concentration of cells is achieved. Additional wash can be added to arrive at a preset dilution.
  • product cells may be extracted via syringe, ready for use.
  • the cell product may be delivered by the device through a dedicated needle, at a specified delivery pressure and concentration.
  • the cell product may be extracted from the hand-held after processing via a syringe that contains an intermediate filter assembly. The negative pressure from withdrawing the syringe-plunger may pull the cells through the filter assembly before entering the syringe.
  • a device may use positive flow-through filters and negative containment filters. Such a device may use a dynamic wash process to purify the product. Such a device may also use a hollow-fiber filter, a porous substrate or a porous tube to concentrate the product. Advantages of the above inventions include the speed by which the device
  • fat-harvesting may occur from multiple areas on the body of the patient (using multiple devices), or allowing for periodic harvest over time, always being able to access virgin fat. Furthermore, dialing in the amount of fat needed and processed depending on stem cell application is appealing (take only what you need).
  • FIG. 5 is a flow chart showing an example of the steps one might take in using liposuction in accordance with the devices described herein, followed by a fully-automatic processing.
  • a hand-held device with a vacuum, may be used to aspirate adipose tissue during a liposuction procedure.
  • fat may be mixed with wash media and enzyme fluid.
  • the solution is incubated and mixed, then the mixing may be stopped while gravity is allowed to decant the fluid, separating oils from the cell containing suspension.
  • the material passes through a pre-filter, and then is subject to a dynamic wash, after which may pass through a filter, such as a membrane based tangential flow filtration (TFF). At this point, the cells may be ready for use.
  • a filter such as a membrane based tangential flow filtration (TFF).
  • FIG. 6 describes a related process, except that a pre-processing step is added, and the liposuction step is not shown.
  • adipose tissue may be loaded into the device and passed through a mincer and then pre-processed.
  • Step 1 15 cc's of decanted aspirated fat is injected into device.
  • Step 2 Device pre-processes fat to mince connective tissue.
  • Step 3 Device automatically initiates the digestion process.
  • Step 4 Temperature is raised to around 37 C for digestion.
  • Step 5 Digestate is washed to arrest digestion and to remove red blood cells
  • Step 6 Cells are automatically concentrated via filtration.
  • Step 7 The doctor attaches a syringe to the product access point to retrieve final product.
  • the doctor retrieves a separate product reservoir from the device to access the final product.

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Abstract

L'invention concerne des dispositifs et des procédés de traitement de tissu adipeux avec un dispositif manuel. Ce dispositif peut comprendre une chambre de traitement, une canule, une source de vide, une zone de digestion, et une chambre de concentration des cellules produites. Diverses inventions sont décrites ici, dont des exemples particuliers sont résumés ici. Dans un mode de réalisation, l'invention concerne un dispositif manuel pour le traitement et la concentration d'un produit de SVF et de cellules.
PCT/US2015/021481 2014-03-20 2015-03-19 Dispositif de traitement de tissu adipeux et concentrateur de cellules manuels WO2015143165A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/221,272 2014-03-20
US14/221,272 US20140207103A1 (en) 2012-09-20 2014-03-20 Hand-held adipose processor and cell concentrator

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WO2015143165A1 true WO2015143165A1 (fr) 2015-09-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994016099A1 (fr) * 1993-01-15 1994-07-21 Baxter International Inc. Milieux pour l'isolation et la stabilisation de cellules
US20050025755A1 (en) * 2001-12-07 2005-02-03 Hedrick Marc H. Methods of using adipose tissue-derived cells in augmenting autologous fat transfer
US20060051865A1 (en) * 2004-08-31 2006-03-09 Higgins Joel C Systems and methods for isolating stromal cells from adipose tissue and uses thereof
US20120172834A1 (en) * 2009-08-05 2012-07-05 Cucin Robert L Tissue sampling, processing and collection device and method of using same
US20120276628A1 (en) * 2011-04-29 2012-11-01 General Electric Company Automated systems and methods for isolating regenerative cells from adipose tissue
US20130164731A1 (en) * 2010-07-09 2013-06-27 The Gid Group, Inc. Apparatus and methods relating to collecting and processing human biological material containing adipose
US20140081237A1 (en) * 2012-09-20 2014-03-20 Tissue Genesis, Inc. Hand-held micro-liposuction adipose harvester, processor, and cell concentrator

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994016099A1 (fr) * 1993-01-15 1994-07-21 Baxter International Inc. Milieux pour l'isolation et la stabilisation de cellules
US20050025755A1 (en) * 2001-12-07 2005-02-03 Hedrick Marc H. Methods of using adipose tissue-derived cells in augmenting autologous fat transfer
US20060051865A1 (en) * 2004-08-31 2006-03-09 Higgins Joel C Systems and methods for isolating stromal cells from adipose tissue and uses thereof
US20120172834A1 (en) * 2009-08-05 2012-07-05 Cucin Robert L Tissue sampling, processing and collection device and method of using same
US20130164731A1 (en) * 2010-07-09 2013-06-27 The Gid Group, Inc. Apparatus and methods relating to collecting and processing human biological material containing adipose
US20120276628A1 (en) * 2011-04-29 2012-11-01 General Electric Company Automated systems and methods for isolating regenerative cells from adipose tissue
US20140081237A1 (en) * 2012-09-20 2014-03-20 Tissue Genesis, Inc. Hand-held micro-liposuction adipose harvester, processor, and cell concentrator

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