System of multiple bags and method for the preparation of hemocomponents
AssigneesFondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Meditalia Srl
InventorsGiovanni MAZZARO, Paolo REBULLA, Eugenio PARATI
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Abstract
The present invention relates to a biomedical device for the production, storage, traceability and administration of blood components.
Claims41
A multiple bag system (1) for the preparation and storage of blood components comprising a bag (6) for the adhesion of said blood component product to a biocompatible scaffold (or substrate) (100).
The multiple bag system (1) according to the preceding claim, further comprising:
- a bag (3) for the separation of red blood cells from the platelet-rich plasma;
- a bag (4) for the separation of a platelet sediment and a supernatant of platelet-poor plasma, connected to said first bag (3) for the separation of red blood cells from the platelet-rich plasma and to said bag (6) for the adhesion of the blood component product and optionally further comprising one or more of:
- a bag (5) for the separation of said platelet-poor plasma, connected to said bag (4) for the separation of a platelet sediment and a supernatant of platelet-poor plasma and possibly to a plurality of further bags (5′) for the separation of aliquots of platelet-poor plasma;
- and
- a bag (2) for collecting an isolated whole blood sample from a subject.
The multiple bag system (1) according to the preceding claim, wherein said biocompatible material of the scaffold (or substrate) 100 is selected from the group comprising:
- material of proteic origin, which may include:
- fibroin, collagen, gelatin, retronectin and other similar materials;
- non proteic polisaccharides, which may include:
- chitosan, hyaluronic acid, alginates, ulvan and other similar materials;
- non degradable synthetic polymers, which may include:
- polyester, hydrogels and other similar materials;
- degradable polymers, which may include:
- polylactic acid, polyglycolic acid, polycaprolactone and other similar materials;
- other materials that may include:
- ceramic (hydroxyapatite).
The multiple bag system (1) according to the preceding claim, wherein the inner surface of said bags (2,3,4,5,5′,6) is modified by means of anti-fouling and/or anti-adhesion and/or antithrombotic treatments.
The multiple bag system (1) according to the preceding claim, wherein said traceability system is represented by a microchip, a smart-code, a radio-frequency micro-transponder.
The multiple bag system (1) according to the preceding claim, wherein said facilitated breakage portion (34,134) comprises a plurality of partial engraving (35,36,35′,36′) of the thickness of said sheet (31,131,32,132).
A kit for the preparation and storage of blood components from umbilical cord blood, comprising:
- a set of bags comprising a bag (3) for the separation of red blood cells from the platelet-rich plasma, a bag (4) for the separation of a platelet sediment and a supernatant of platelet-poor plasma, connected to said bag (3) for the separation of red blood cells from the platelet-rich plasma and a bag (5) for the separation of said platelet-poor plasma, connected to said bag (4), said bag (5) possibly being also connected to a plurality of bags (5′) for the separation of aliquots of platelet-poor plasma;
- and separately
- a bag (6) for the adhesion of said blood component product to a biocompatible scaffold (or substrate) 100.
A kit according to the preceding claim, further comprising a bag (2) for the collection of an isolated blood sample, said bag (2) being connectable to said bag (3) for the separation of red blood cells from the platelet-rich plasma.
A method according to the preceding claim, wherein said step a) is carried out at a speed of about 220 rpm for a period of about 10 minutes.
A method according to the preceding claim, wherein said platelet-rich plasma adheres to a scaffold (or substrate) (100) contained into said bag (6,6′,6″,30,130).
A method according to the preceding claim, wherein said anticoagulant preparation comprises
- Amount (g per 100 mL of
- Component
- anticoagulant solution)
- Sodium citrate dihydrate
- 2.63
- Sodium citrate hydrate
- 0.327
- Monosodium phosphate dihydrate
- 0.251
- Dextrose monohydrate
- 2.55
- Injectable water
- as needed to 100 mL
A method according to the preceding claim, wherein said anticoagulant preparation is included in an amount of about 10-60% (volume/volume of whole blood or blood component).
A method according to the preceding claim, wherein said three-dimensional scaffold (or substrate) (100) is obtained by means of 3D printing techniques.
A method for the culture of cells comprising the step of culturing said cells in the biomedical device according to the preceding claim.
The method for the culture of cells according to the preceding claim, wherein said cells and stem cells.
The method according to the preceding claim, wherein said corneal diseases are selected from the group comprising:
- dry eye syndrome, graft-versus-host disease (GVHD), injuries caused by chemical burns, neurotrophic keratitis, Sjogren's syndrome, systemic sclerosis, rheumatoid arthritis and autoimmunity, corneal ulcers, keratoconjunctivitis.
Dependencies are inferred from the claim text.