EP2566426A1 - Kit pour obtenir et traiter une matière dérivée d'un tissu physiologique - Google Patents

Kit pour obtenir et traiter une matière dérivée d'un tissu physiologique

Info

Publication number
EP2566426A1
EP2566426A1 EP10736804A EP10736804A EP2566426A1 EP 2566426 A1 EP2566426 A1 EP 2566426A1 EP 10736804 A EP10736804 A EP 10736804A EP 10736804 A EP10736804 A EP 10736804A EP 2566426 A1 EP2566426 A1 EP 2566426A1
Authority
EP
European Patent Office
Prior art keywords
rotor
kit according
clot
kit
membrane
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP10736804A
Other languages
German (de)
English (en)
Inventor
Tiziano Batani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Silfradent Srl
Original Assignee
Silfradent Srl
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
Application filed by Silfradent Srl filed Critical Silfradent Srl
Publication of EP2566426A1 publication Critical patent/EP2566426A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/10—Apparatus for enzymology or microbiology rotatably mounted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3616—Blood, e.g. platelet-rich plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • 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
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/12—Apparatus for enzymology or microbiology with sterilisation, filtration or dialysis means
    • C12M1/121—Apparatus for enzymology or microbiology with sterilisation, filtration or dialysis means with sterilisation means
    • 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
    • C12M45/05—Means for pre-treatment of biological substances by centrifugation

Definitions

  • the present invention relates to the recovering, treatment and processing of physiological tissues, and particularly it relates to a kit for the recovering and processing of physiological tissues as well as to a method of recovering, treatment and processing of physiological tissues.
  • Fibrin Glue (Tissucol Baxter), Platelet Concentrate cPRP (Marx 1998), Platelet-Rich Plasma (PRP), Plasma-Rich Growth Factors (PRGFs, E.Anitua), Fibrin-Rich Plasma (2001 J.Choukroun).
  • a method of obtaining a material based on the use of growth factors has been designed.
  • Growth factors can be naturally occurring, and therefore they can be extracted from tissues or cells and processed: Pituitary Hormones, Platelet Derived Growth Factors (PDGFs), Calcitonin, Insulin-Like Growth Factors (IGFs), Fibroblast Growth Factors (FGFs), cytokines, especially IL-1 and TNF-a, osteoprotegerin (OPG), insulin-like GFs (IGF-I and IGF-II), etc.; otherwise they can be synthetic, and therefore they can be completely synthesized: GF, ALP, BMP, etc.
  • the search according to the present invention led to the isolation of a material derived from physiological tissues which can be used directly to reconstruct tissues and which is easy to be tained. Such a material will be hereinafter referred to with the acronym C.G.F. (concentrated growth factor).
  • C.G.F. is a wound-healing biomaterial having absolutely special features and characteristics with respect to comparable platelet concentrates.
  • the process of preparation thereof, its biochemical aspects, its structure, the composition of the clot, the structure of fibrin, the role of platelet cytokines, the leukocyte activation, the potential interaction between C.G.F. and bone cells, its potential use with soft tissues and bone regeneration all make it a biomaterial easy to be produced and used in several clinical applications with very surprising results.
  • C.G.F induces both an improved wound-healing of tissues due to the development of an effective neo-vascularization, and a surgical wound healing associated to a fast remodelling of scar tissues with almost no infectious sequelae.
  • PRP the technique of extraction thereof doesn't require any other components added besides of blood (in the case of PRP, thrombin and calcium chloride are added).
  • periodontology is useful in stabilizing the marginal periodontium as well as in obtaining optimal aesthetic results for the restorations. It allows the initial bone volume to be maintained or reconstructed by promoting the alignment of tooth necks and the presence of papillae, resulting in an improved profile of emergence for the prosthetic restorations.
  • C.G.F. facilitates the operatory management of surgical sites and enhances the incorporation and remodelling of grafted biomaterials.
  • C.G.F. consists of an autologous fibrin matrix inherently having a high amount of plasma cytokines and leukocyte-derived cytokines incorporated therein; it can be said that this immune platelet concentrate is characterized by f ou r key-featu res : ibrin clot plays a very important mechanical role due to its stiffness, and when its particles are mixed with graft material, they form a biological cross- linker.
  • the immune aspect is very important due to the existence of leucocytes in the clot to incorporate inflammatory and anti-inflammatory cytokines.
  • the progressive regulation of these molecules appears to play a self-regulating role for inflammatory and infectious phenomena at the graft site.
  • fibrin alone can induce angiogenesis. This extremely important property can be explained by both the three-dimensional structure of fibrin gel and the combined action of cytokines trapped in its meshes.
  • Fibrin- and fibrinogen-degradation products stimulate the migration of neutrophils and increase the ability of the CD11/CD18 receptors on the surface thereof, which receptors allow the neutrophils not only to adhere to the endothelium and transmigrate, but also to adhere to fibrinogen at the same time. Furthermore, these components modulate phagocytosis and enzymatic degradation processes.
  • the fibrin matrix carries out the coverage healing of the damaged sites by acting on epithelial cells and fibroblasts. All these elements of meditation allow us to identify C.G.F. as a fibrin clot able to develop a micro- vascularization while having the ability of driving the migration of epithelial cells to its surface.
  • the object of the present invention is a kit for obtaining and processing a material derived from a physiological tissue and particularly from human blood, comprising separating means for removing a fraction of the physiological tissue; mixing means for conditioning said previously removed fraction; injecting means for injecting the clot, membrane-forming means for producing a membrane from the clot, and positioning means for positioning the resulting membrane.
  • Said separating means includes a centrifuge properly designed to separate the fibrin and clot from the blood, which centrifuge can operate at a given speed and with a suitable configuration of the rotor; furthermore, said centrifuge is provided with means for sterilizing the processed tissues.
  • said sterilizing means includes an ultraviolet ray lamp.
  • the mixing means for conditioning the removed fraction includes a rotary mixer which allows the physiological tissue to be mixed with optional charges which can include other biological tissues such as bone tissues, or other biocompatible materials.
  • Figure 1 A is an elevation view with parts broken-away and sectioned of a first component of the kit according to the present invention
  • Figure 1 B is a side elevation view of the component of Figure 1A;
  • Figure 2 is a plan view with sectioned parts of a second component of the kit according to the present invention.
  • Figure 3 is a plan view of a third component of the kit according to the present invention.
  • Figure 4 is a broken-away and enlarged detail of Figure 3;
  • Figure 5 is the same detail as of Figure 4 in a side elevation; and Figures 6 and 7 are both views of a fourth component of the kit according to the present invention.
  • FIG 1A there is shown a first component of the kit according to the present invention
  • reference numeral 1 designates the body of the centrifuge provided with a lid 101 enclosing the chamber 201 in which the rotor 301 is located, the rotor being provided with housings 311 intended for accommodating the test tubes 401.
  • the centrifuge 1 internally has a germicidal lamp 501 facing toward the chamber 201.
  • the centrifuge which is designed to process freshly withdrawn blood, has certain features: firstly, a one-piece rotor 301 with a properly sized tilt angle of the test tube, particularly with a tilt angle within the range of 30° to 50° with respect to the revolution axis of the rotor.
  • a UV germicidal lamp 501 is fitted within the chamber 201 to optimize the security of processing operations in terms of sepsis.
  • Acceleration and braking are controlled to avoid troubles while separating the material being subjected to the action of the centrifuge. Cooling of the rotor is also controlled to achieve an increased level of performance. Test tube-holders can be conveniently sterilized using an autoclave. Finally, the centrifuge provides for the automatic opening of the lid when a cycle has finished.
  • FIG. 2 there is shown a second component of the kit according to the present invention; reference numeral 2 designates the fibrin injector.
  • Such an injector includes a first cylinder 102 to which a piston is slidably fitted, the piston sliding within the chamber 112 formed in the cylinder 102.
  • the cylinder 102 is provided with grasping means in the form of rings 142, and similarly, the ring 222 provides grasping means for the piston 202.
  • a flexible stem 212 is fitted within the piston, and it is extended through the restriction 122 of the chamber 112 and the conduit 302 fitted within the axial cavity 132 in communication with said restriction 122.
  • the other end of the conduit is fitted to the end of the second cylinder 402 at 412, and the piston 2 driven by the flexible stem 212 connected thereto slides within the chamber 422 of the second cylinder 402.
  • the end 442 of the second cylinder 402 is fitted to the axial cavity 612 in communication with the chamber 642 of the third cylinder 602.
  • the piston 622 provided with sealing means 632 slides within the third cylinder 602.
  • the cylinder has a radial flange 652 protruding outwardly as a handle.
  • FIG. 3 there is shown a third component of the kit according to the present invention
  • reference numeral 3 designates the membrane-forming tool which produces a membrane by processing the biological tissue according to the present invention.
  • the membrane-forming tool 3 is a nipper with two arms 103 provided with grasping rings 113 at one end thereof, which arms are pivoted at 203 and provided at the opposite end with extensions 303 to which two disks 403 are respectively attached.
  • Figure 4 there is shown a detail of Figure 3 with sectioned parts; like reference numerals refer to like parts.
  • Figure 5 further elucidates the location of the extension 303, plate 313 and attaching means 323.
  • FIGs 6 and 7 there is shown a fourth component of the kit according to the present invention
  • reference numeral 4 designates the applicator tool, comprising a stylus 104 to whose ends there are connected two bushes 114 carrying a paddle-like member 124 respectively; as it can be noted from Figure 7, both the paddles 124 are oriented at 180° to each other. The curvature shape of each paddle is also characteristic.
  • the operation of the kit according to the present invention will become apparent from the following.
  • the whole blood tissue is taken from the same patient to whom the scar reconstruction has to be applied.
  • Blood is treated with the centrifuge as designed for the kit according to the invention, and ee phases are separated: plasma, fibrin component and red-cell component with platelets.
  • the fibrin concentrate is then mixed with the blot and optional charges in the rotary mixer, and it can be subsequently subjected to further processing steps.
  • the resulting tissue is characterized by the formation of an elastic multi-molecular web with a high potential of configuration; therefore, it is possible to produce membranous structures which can be easily applied to the area intended to be treated.
  • the obtained material could be injected by extrusion by means of the injector; the material is introduced in the third cylinder of the injector, that is to say the one having the greater section, and then it is charged in the portion of the device which is able to feed it in the cavity that has to be subjected to the treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Botany (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un kit pour obtenir et traiter une matière dérivée d'un tissu physiologique, et en particulier du sang humain, comprenant des moyens de séparation pour prélever une fraction du tissu physiologique; des moyens de mélange pour conditionner ladite fraction préalablement prélevée; des moyens d'injection pour injecter le caillot, des moyens de formation de membrane pour produire une membrane à partir du caillot, et des moyens de positionnement pour positionner la membrane formée.
EP10736804A 2010-05-06 2010-05-06 Kit pour obtenir et traiter une matière dérivée d'un tissu physiologique Withdrawn EP2566426A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2010/000200 WO2011138803A1 (fr) 2010-05-06 2010-05-06 Kit pour obtenir et traiter une matière dérivée d'un tissu physiologique

Publications (1)

Publication Number Publication Date
EP2566426A1 true EP2566426A1 (fr) 2013-03-13

Family

ID=44140797

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10736804A Withdrawn EP2566426A1 (fr) 2010-05-06 2010-05-06 Kit pour obtenir et traiter une matière dérivée d'un tissu physiologique

Country Status (4)

Country Link
EP (1) EP2566426A1 (fr)
KR (1) KR20130107197A (fr)
CN (1) CN102869328A (fr)
WO (1) WO2011138803A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106890732A (zh) * 2017-04-07 2017-06-27 长沙湘智离心机仪器有限公司 一种美容离心机及其操作方法
US11191698B2 (en) * 2017-11-03 2021-12-07 Enso Discoveries, Llc Apparatus and method for processing platelet rich fibrin
EP3650531A1 (fr) * 2018-11-09 2020-05-13 DSM IP Assets B.V. Dispositif de traitement de l'adipose

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1230059B (it) * 1989-04-17 1991-09-27 Dorin Olimpiu Petrescu Procedimento per la preparazione in vitro di membrane emostatiche artificiali.
US7608258B2 (en) * 2002-04-13 2009-10-27 Allan Mishra Method for treatment of tendinosis using platelet rich plasma
ITMI20022501A1 (it) * 2002-11-26 2004-05-27 Dorin Olimpiu Petrescu Medicazione organica cicatrizzante ed emostatica.
WO2007005820A1 (fr) * 2005-06-30 2007-01-11 Cytomedix, Inc. Procédé de traitement de blessures avec agent de cicatrisation enrichi en plaquettes

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011138803A1 *

Also Published As

Publication number Publication date
KR20130107197A (ko) 2013-10-01
CN102869328A (zh) 2013-01-09
WO2011138803A1 (fr) 2011-11-10

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