US20160192640A1 - System and method to divide liposuction fat into aliquots to be use and cryopreserved - Google Patents

System and method to divide liposuction fat into aliquots to be use and cryopreserved Download PDF

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Publication number
US20160192640A1
US20160192640A1 US14/909,467 US201414909467A US2016192640A1 US 20160192640 A1 US20160192640 A1 US 20160192640A1 US 201414909467 A US201414909467 A US 201414909467A US 2016192640 A1 US2016192640 A1 US 2016192640A1
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Prior art keywords
fat
container
cryopreservation
sealed
circuit
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Abandoned
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US14/909,467
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English (en)
Inventor
Marco Bertoni
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BIOMED DEVICE Srl
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BIOMED DEVICE Srl
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Assigned to BIOMED DEVICE S.R.L. reassignment BIOMED DEVICE S.R.L. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BERTONI, MARCO
Publication of US20160192640A1 publication Critical patent/US20160192640A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/89Suction aspects of liposuction
    • A61M1/892Suction aspects of liposuction with treatment of the collected fat
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0236Mechanical aspects
    • A01N1/0242Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
    • A01N1/0252Temperature controlling refrigerating apparatus, i.e. devices used to actively control the temperature of a designated internal volume, e.g. refrigerators, freeze-drying apparatus or liquid nitrogen baths
    • A01N1/0257Stationary or portable vessels generating cryogenic temperatures
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0278Physical preservation processes
    • A01N1/0284Temperature processes, i.e. using a designated change in temperature over time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/89Suction aspects of liposuction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/89Suction aspects of liposuction
    • A61M1/892Suction aspects of liposuction with treatment of the collected fat
    • A61M1/893Suction aspects of liposuction with treatment of the collected fat with extraction of specific components, e.g. of stem cells
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • C12N5/0602Vertebrate cells
    • C12N5/0652Cells of skeletal and connective tissues; Mesenchyme
    • C12N5/0653Adipocytes; Adipose tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A61M1/3695Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging with sedimentation by gravity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/08Lipoids
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • C12N5/0602Vertebrate cells
    • C12N5/0652Cells of skeletal and connective tissues; Mesenchyme
    • C12N5/0662Stem cells

Definitions

  • the present invention relates to a system and a method to divide liposuction fat into aliquots for use and cryopreservation purposes.
  • the fat removed by means of liposuction is known to be used in the ambit of surgical operations, e.g. for aesthetic and/or regenerative purposes.
  • the fat is used as soon as removed through the liposuction operation, because there is no way of effectively storing the fat in order to use it when needed, in subsequent times.
  • the main aim of the present invention is to provide a system and a method that enable to divide liposuction fat into aliquots, so it can be cryopreserved in order to use it over time for operations of aesthetic and regenerative type.
  • one object of the invention is to provide a system and a method to divide liposuction fat into aliquots, which process the fat in a bacteriologically isolated manner.
  • Another object of the present invention is to provide a system and a method to divide liposuction fat into aliquots which allow to overcome the mentioned drawbacks of the prior art in the ambit of a simple, rational, easy and effective to use as well as affordable solution.
  • FIG. 1 is a schematic representation of the system according to the invention.
  • reference numeral 1 is the system of the invention.
  • the adipose material containing subcutaneous fat, which remains at the end of an operation of liposuction, is made available in suitable containers, which will hereinafter be referred to as taking containers 12 .
  • such material also comprises an aqueous fluid which is substantially formed by the water used in this method, in the form of a pressurized jet, to detach the fat from the surrounding tissues, preparing it for aspiration.
  • the proposed system 1 comprises at least a transfer circuit 4 , 10 , 11 able to transfer sealed the adipose material, and also comprises syringe pumping means 2 , 3 , connected to said transfer circuit 4 , 10 , 11 , and able to alternately take and contain sealed said adipose material from the taking container 12 and to transfer sealed said fat or said aqueous fluid within said circuit 4 , 10 , 11 .
  • the pumping means 2 , 3 are available so as to separate by gravity, the fat from the aqueous fluids composing the adipose material contained in them.
  • the system 1 also provides one or more rejection receptacles 5 connected sealed to the circuit 4 , 10 , 11 , downstream of the pumping means 2 , 3 , and able to receive the aqueous fluid, which is a waste for the purposes of the present system 1 (as it will be better clarified hereinafter, when explaining its operation).
  • the invention provides at least a cryopreservation container 6 (but preferably a plurality) to receive the fat in a sealing manner, which cryopreservation container 6 is connected to the circuit 4 , 10 , 11 of the proposed system 1 , downstream of the pumping means 2 , 3 .
  • This cryopreservation container 6 can be made of a material resistant to a cryoprotective substance (such as in particular dimethyl sulfoxide), for reasons that will be explained hereinafter.
  • a cryoprotective substance such as in particular dimethyl sulfoxide
  • connection between the cryopreservation container 6 and the circuit is of the releasable type.
  • the circuit also comprises first valve means 4 for allowing alternately the communication between the pumping means 2 , 3 and the rejection receptacle 5 or between the pumping means and the cryopreservation container 6 (or containers).
  • the proposed system 1 may further comprise at least one access 7 , 8 for the injection of the cryoprotective substance, which access is able to be put in communication with the inside of the cryopreservation container 6 .
  • the system 1 described above is bacteriologically isolated, since it is able to preserve and process the adipose material (or its components), without this coming into contact with the external environment, thus ensuring the highest level of sterility in particular to the fat that has to be used again for the aforementioned aesthetic and/or reconstructive operations.
  • the aforementioned pumping means preferably comprise: a pumping syringe 2 and second valve means 3 (e.g. comprising one or more two- or three-way cocks) able to put in sealed communication, alternately, the syringe 2 with the taking container 12 or the syringe 2 with the first valve means 4 .
  • second valve means 3 e.g. comprising one or more two- or three-way cocks
  • the second valve means 3 may be connected sealed to an inlet channel 9 having, at the free end thereof, a needle for the introduction of said adipose material.
  • the adipose material is made available in the taking containers and is preferably “enriched” with mesenchymal cells, especially if the aliquots of fat obtained with the proposed system 1 are to be used in operations of the regenerative type.
  • the presence of mesenchymal cells is the reason why the invention may provide for the use of the cryoprotective substance and, consequently, of components made of a material resistant to this substance.
  • cryoprotective substance is used to prevent, when the aliquots of fat undergo a significant lowering of temperature, the mesenchymal cells from being damaged by the formation of crystals within the fat itself.
  • the second valve means 3 are operated so as to be arranged in the configuration wherein they enable the communication between the syringe 2 and the container of adipose material (with the possible interposition of the inlet channel 9 ).
  • the syringe 2 is operated to aspirate inside the adipose material.
  • the adipose material is left within the syringe 2 , which is preferably arranged vertical so that, by virtue of the difference in specific weight between fat and water, the latter deposits at the bottom of its containment barrel, at the so-called “beak”.
  • This operation to be completed can take from fifteen to thirty minutes.
  • the above mentioned first valve means 4 preferably comprise a ramp of three-way cocks, each individually connected either to the rejection receptacle 5 or to at least a respective cryopreservation container 6 (in the example shown the cocks are five in number).
  • first and second valve means 3 , 4 are arranged in a respective configuration wherein they only allow communication between the syringe 2 and the rejection receptacle 5 , where the water separated from the fat is transferred, as a result of the suitable operation of the syringe 2 itself.
  • rejection receptacle 5 can be connected sealed to the second valve means through a rejection channel 11 , included in the circuit.
  • the rejection receptacle 5 which can also be a common drip bag, is removed and replaced.
  • the second valve means 3 change again their configuration to enable the communication between the syringe 2 and the ramp 4 of three-way cocks, the latter being in turn in a configuration that allows the communication between the cock of the second valve means 3 and the cryopreservation containers 6 , while it prevents communication with the rejection receptacle 5 .
  • the fat contained in the syringe 2 , and separated from water, is transferred within the cryopreservation containers 6 , to define as many aliquots of fat, usable for the already mentioned operations.
  • the mentioned access for the injection of the cryoprotective substance can be obtained at the outer periphery of each cryopreservation container 6 , in which case it is substantially an inlet 8 which can be perforated by the needle of a syringe for injecting the cryoprotective substance, which preferably comprises, or consists of, dimethyl sulfoxide (DMSO).
  • DMSO dimethyl sulfoxide
  • cryopreservation container the container in its entirety, and not only the walls that define the inner containment volume (and therefore are included access tangs, ports, etc . . . ).
  • an inlet 7 which may be perforated for the injection of dimethyl sulfoxide (or other substance) can be arranged at a further free end of said inlet channel 9 , which therefore has a forked configuration as in the representation of FIG. 1 , and in practice the second valve means 3 are connected to an access 7 (which may or may not be single) and are configured so as to also allow the sealed communication between the access 7 and the first valve means 4 .
  • the channel 9 not only the channel 9 , but also the entire circuit 4 , 10 , 11 and the pumping means 2 , 3 are made of a dimethyl sulfoxide-resistant material.
  • each container 6 is made of a DMSO-resistant material.
  • each cryopreservation container 6 has internally, completely protected, an aliquot of fat which can be stored in the refrigerator, to define a sort of liposuction fat bank, from which each aliquot can be taken and used when needed, thus overcoming all the drawbacks of prior art.
  • each of these containers 6 is connected to the respective cock of the ramp 4 through a relative outlet channel 10 , included in the circuit of the invention.
  • this outlet channel 10 is sealed by the user at a given point of its length and then cut according to procedures widely known to the skilled person.
  • each container 6 is made individually and can be put into the refrigerator.
  • each cryopreservation container 6 has, at one of its peripheral walls, a breakable port, in communication with its interior, which can be substantially a closed tang that, following its breaking, allows the outflow of the aliquot of fat for the execution of the operation.
  • the container 6 may be the type of a syringe device connected in a releasable manner to the first valve means 4 and able, alternately, to contain sealed or to inject fat for the infiltrations.
  • this syringe device comprises a receptacle (such as a drip bag) connected in a sealing manner with an infiltration syringe (e.g. through a channel and a single-acting valve incorporated to the syringe itself), to define, as a result of their filling with fat, a portable unit to contain (in isolation), and to inject an aliquot of fat.
  • the taking container 12 After the taking container 12 has been emptied, it is separated from the aforementioned inlet channel 9 , at the branch of the aforementioned bifurcation, e.g. through the common practice of sealing and cutting off.
  • the proposed system 1 is devised to implement the method of the invention, which comprises the stages listed below:
  • a taking container 12 that contains adipose material removed by means of liposuction (and to which a predefined quantity of mesenchymal cells is preferably added); taking a quantity of material from the container, keeping such material isolated from the external environment; separating the fat from the aqueous fluids (which as said are substantially made of water) composing the adipose material of the taken quantity; and transferring in a sealing manner the separated fat into one or more cryopreservation containers 6 , to define as many isolated aliquots of fat.
  • the method includes the stage of adding a cryoprotective substance to each aliquot of fat, especially in the event of mesenchymal cells being added to the adipose material, for the reasons already explained when describing the system 1 .
  • cryopreservation containers 6 are made of a material resistant to a cryoprotective substance (preferably the aforementioned DMSO).
  • each of said cryopreservation containers 6 which substantially identify respective aliquots of portable fat, is placed in a refrigerator, where the fat is also kept for years without any deterioration.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
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  • Veterinary Medicine (AREA)
  • Zoology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Dentistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Environmental Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Developmental Biology & Embryology (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
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  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
US14/909,467 2013-08-02 2014-08-01 System and method to divide liposuction fat into aliquots to be use and cryopreserved Abandoned US20160192640A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT000228A ITMO20130228A1 (it) 2013-08-02 2013-08-02 Sistema e metodo per aliquotare grasso da liposuzione ai fini dell'uso e della crioconservazione
ITMO2013A000228 2013-08-02
PCT/IB2014/063632 WO2015015470A2 (en) 2013-08-02 2014-08-01 System and method to divide liposuction fat into aliquots to be use and cryopreserved

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/063632 A-371-Of-International WO2015015470A2 (en) 2013-08-02 2014-08-01 System and method to divide liposuction fat into aliquots to be use and cryopreserved

Related Child Applications (1)

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US16/286,633 Continuation US11273248B2 (en) 2013-08-02 2019-02-27 Method to divide liposuction fat into aliquots to be used and cryopreserved

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US20160192640A1 true US20160192640A1 (en) 2016-07-07

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US14/909,467 Abandoned US20160192640A1 (en) 2013-08-02 2014-08-01 System and method to divide liposuction fat into aliquots to be use and cryopreserved
US16/286,633 Active 2035-11-23 US11273248B2 (en) 2013-08-02 2019-02-27 Method to divide liposuction fat into aliquots to be used and cryopreserved

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US16/286,633 Active 2035-11-23 US11273248B2 (en) 2013-08-02 2019-02-27 Method to divide liposuction fat into aliquots to be used and cryopreserved

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US (2) US20160192640A1 (pl)
EP (1) EP3027238B1 (pl)
JP (1) JP6473954B2 (pl)
DK (1) DK3027238T3 (pl)
ES (1) ES2817005T3 (pl)
HU (1) HUE050860T2 (pl)
IT (1) ITMO20130228A1 (pl)
PL (1) PL3027238T3 (pl)
WO (1) WO2015015470A2 (pl)

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US10092600B2 (en) 2013-07-30 2018-10-09 Musculoskeletal Transplant Foundation Method of preparing an adipose tissue derived matrix
US10912864B2 (en) 2015-07-24 2021-02-09 Musculoskeletal Transplant Foundation Acellular soft tissue-derived matrices and methods for preparing same
US11052175B2 (en) 2015-08-19 2021-07-06 Musculoskeletal Transplant Foundation Cartilage-derived implants and methods of making and using same

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ITMO20130228A1 (it) 2013-08-02 2015-02-03 Biomed Device Srl Sistema e metodo per aliquotare grasso da liposuzione ai fini dell'uso e della crioconservazione
ITUB20151961A1 (it) * 2015-07-06 2017-01-06 Mario Goisis Kit per procedure chirurgiche di liposuzione e lipofilling

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EP1930033A2 (de) * 2006-12-05 2008-06-11 Franz Dr. Beer System für die Kryokonservierung von Körperflüssigkeiten und Verfahren zur Verwendung eines derartigen Systems
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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10092600B2 (en) 2013-07-30 2018-10-09 Musculoskeletal Transplant Foundation Method of preparing an adipose tissue derived matrix
US10596201B2 (en) 2013-07-30 2020-03-24 Musculoskeletal Transplant Foundation Delipidated, decellularized adipose tissue matrix
US11191788B2 (en) 2013-07-30 2021-12-07 Musculoskeletal Transplant Foundation Acellular soft tissue-derived matrices and methods for preparing same
US11779610B2 (en) 2013-07-30 2023-10-10 Musculoskeletal Transplant Foundation Acellular soft tissue-derived matrices and methods for using same
US10912864B2 (en) 2015-07-24 2021-02-09 Musculoskeletal Transplant Foundation Acellular soft tissue-derived matrices and methods for preparing same
US11524093B2 (en) 2015-07-24 2022-12-13 Musculoskeletal Transplant Foundation Acellular soft tissue-derived matrices and methods for preparing same
US11052175B2 (en) 2015-08-19 2021-07-06 Musculoskeletal Transplant Foundation Cartilage-derived implants and methods of making and using same
US11806443B2 (en) 2015-08-19 2023-11-07 Musculoskeletal Transplant Foundation Cartilage-derived implants and methods of making and using same
US11938245B2 (en) 2015-08-19 2024-03-26 Musculoskeletal Transplant Foundation Cartilage-derived implants and methods of making and using same

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Publication number Publication date
JP6473954B2 (ja) 2019-02-27
US11273248B2 (en) 2022-03-15
EP3027238A2 (en) 2016-06-08
PL3027238T3 (pl) 2020-11-30
WO2015015470A2 (en) 2015-02-05
JP2016527026A (ja) 2016-09-08
HUE050860T2 (hu) 2021-01-28
ES2817005T3 (es) 2021-04-06
DK3027238T3 (da) 2020-08-31
US20190183113A1 (en) 2019-06-20
EP3027238B1 (en) 2020-06-24
ITMO20130228A1 (it) 2015-02-03
WO2015015470A3 (en) 2015-07-23

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