WO2008035240A2 - Système de congélation de plaquettes - Google Patents

Système de congélation de plaquettes Download PDF

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Publication number
WO2008035240A2
WO2008035240A2 PCT/IB2007/052856 IB2007052856W WO2008035240A2 WO 2008035240 A2 WO2008035240 A2 WO 2008035240A2 IB 2007052856 W IB2007052856 W IB 2007052856W WO 2008035240 A2 WO2008035240 A2 WO 2008035240A2
Authority
WO
WIPO (PCT)
Prior art keywords
platelet
freezing
concentrate
preparation
containing means
Prior art date
Application number
PCT/IB2007/052856
Other languages
English (en)
Other versions
WO2008035240A3 (fr
Inventor
Pietro Giuseppe Argento
Original Assignee
Medical Mediterranea S.R.L.
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 Medical Mediterranea S.R.L. filed Critical Medical Mediterranea S.R.L.
Publication of WO2008035240A2 publication Critical patent/WO2008035240A2/fr
Publication of WO2008035240A3 publication Critical patent/WO2008035240A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0236—Multiple bag systems for separating or storing blood components with sampling means, e.g. sample bag or sampling port
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0272—Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging

Definitions

  • the present invention is referred to a Platelet freezing system, and to a feasible platelet freezing method with such system.
  • the field of application of the invention pertains to the area of the treatment of extra-bodily biological fluid and the preservation of its components.
  • the system according to the invention was developed with special care to the cryo- preservation of a platelet concentrate, or of a therapeutic unit of platelet, to a temperature, preferably, of about - 8O 0 C.
  • the platelet of the concentrate are usually obtained by an apheresis procedure and/or from a platelet aggregate, a so-called platelet "pool”, that usually includes a platelet concentrate obtained from a so-called "buffy coat”.
  • Purpose of the present invention is that of resolving the problems of the known technique, supplying a platelet freezing system of simple and economical accomplishment, that guarantees the sterility of the final product. It is also purpose of the present invention to supply a flexible system, that allows a simple and swift freezing and thawing of the therapeutic platelet units in it contained. Another purpose is that of allowing a simple separation of the platelet concentrate from the freezing solutions used for its freezing. A further purpose is that of realizing a system that allows a simple division in containers of the platelet contents of the therapeutic unit, realizing at the same time a sampling of the portions distributed.
  • the invention has for object a platelet freezing system and a method of platelet freezing as reported in the claims that follow.
  • One of the advantages of the present invention is that of allowing the cryo-preservation of a platelet concentrate, realizing a sterile connection and preserving therefore the concentrate from the risk of pathogen pollution.
  • the system according to the present invention allows besides the defrosting and the centrifugation of the platelet concentrate, the procedures necessary to separate the freezing solution and the added physiological solution to the platelet contents.
  • the system according to the invention allows an operator to add a freezing solution in a percentage, between those more in use, variable, permitting so to add precisely the quantity wanted.
  • a platelet freezing system comprises containing means for the accommodation and the sterile containment of a platelet preparation.
  • the containing means are of the type suitable for freezing a extra-bodily biological fluid and in particular a platelet preparation.
  • the containing means comprise at least a container for the platelet concentrate collection prepared to be frozen, preferably a couple of main bags 1 in plastic material, for example, but not limited to PVC, sterile, non-pyrogenic and dry.
  • Each main bag 1 includes at least an access opening 16 for the withdrawal of the relevant content.
  • the main bags 1 are sterile connected to connecting means comprising, for example, connecting tubes and one or more "Y" type connection elements.
  • connecting means comprising, for example, connecting tubes and one or more "Y" type connection elements.
  • Two first connecting tubes 2 connect the main bags 1 to a second connection tube 5 through a "Y" connection element 4.
  • Flow controlling means for example clamps and/or so-called "break-away” devices 3, are disposed on the pair of the connecting tubes 2.
  • the flow controlling means 3 permit to divide or to direct, in the use, the prepared platelet concentrate coming from the connecting tube 5 in one or in both the main bags 1, at discretion of the operator carrying out the control .
  • the container device and/or dispenser of the platelet concentrate includes for example a bag containing the platelet concentrate sterile connected to the connection tube 5.
  • the feeding means include for example, but not limited to, a syringe 8, or a bag, containing a certain quantity of freezing solution, and can naturally be connected, according to the various requirements, also to an other connection tube, for example but do not limited to, to the tube 2, without for this go out from the scope of the present invention.
  • the feeding means also include flow controlling means, for example clamps 7, to moderate, in the use, the influx of the freezing solution in the inside of the connection tube 5.
  • flow controlling means for example clamps 7, to moderate, in the use, the influx of the freezing solution in the inside of the connection tube 5.
  • the syringe 8 is of known type and capable of containing at least a quantitative of about 30 ml of freezing solution, sufficient for the cryopreservation of a therapeutic unit of platelets.
  • the system of the present invention includes futher containing means, for example mini-bags 9 of smaller dimensions in respect to the main bags.
  • Each of these mini- bags comprise sterile connecting means for the connection to the main bags 1 and, preferably, but not limited to, a vacuum-packed sampling system 15, and further flow controlling means, for example, but do not limited to, clamps and/or "break-away" devices 10, for controlling the platelet preparation flowing between the main bag 1 and the mini-bag 9.
  • Such disposition of elements is able to realize closed circuit bacteriological controls on the platelet preparation present in every main bag 1.
  • the system of the present invention includes a further mini- bag 11, of smaller dimensions with respect to the main bags.
  • This mini-bag 11 is connected to one of the two main bags 1, in particular to the bag on the left according to the system represented in figure 1, by means of a sterile connection, and includes, preferably, but not limited to, a vacuum-packed sampling system 15, and further flow controlling means, for example, but not limited to, clamps and/or "break-away" devices 12.
  • Such disposition of elements is able to carry out the operation of platelet count.
  • the mini-bag 11 for platelet count is connected, by means of another "Y" connection also to a third connection tube, including a "luer-lock” type terminal 13 and further flow controlling means, for example a clamp 14 for controlling the flow, preferably but not limited to, of a solution towards the bag 1.
  • the platelet freezing system according to the present invention can naturally be connected to an independent refrigeration system for freezing or defrosting of prepared platelets.
  • the refrigeration system not illustrated for simplicity of illustration, can be of known type without for this change the advantages and the results obtained from the present invention.
  • a platelet concentrate freezing procedure comprises a first phase of providing the above listed closed circuit means for the accommodation and the sterile containment of a platelet concentrate, a second phase of sterile connection of the connection tube 5 to the container device and/or dispenser of the platelet concentrate to freeze, and a third phase of dispensing of the platelet content to the inside of the connection tube 5. Therefore, in the following phases a certain quantity of freezing solution is added to the inside of the connection tube 5 through the syringe 8, for example about 30 ml for a therapeutic unit of platelets.
  • the platelet preparation so made is directed to the main bags 1, where it is collected after that the first flow controlling means have determined the division and the direction of the preparation in the precise quantity requested by the operator.
  • the preparation is immediately ready for the elimination of the freezing solution from the platelet present in the inside of the main bags 1.
  • Such main bags can be simply withdrawn from the system and put, sterile and sealed, inside means of element separators, for example, but not limited to, centrifugation accelerators, to carry out the separation and to obtain again only the platelet concentrate.
  • the system just described includes a closed circuit, sterile that has no need to operate in neighboring sterile environment or to use a special device for such purpose.
  • the system also allows an operator to be able to decide if and when to freeze the platelet concentrate, without the need to acquire all the components singularly. In this manner the operator, without the need of further products or of supplementary procedures, acquires an absolute freedom of making in the process of freezing and thawing of the platelet concentrates, succeeding therefore in satisfying the need of the center and/or of the hospital where he/she works .

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Ropes Or Cables (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne un système de congélation de plaquettes comportant un moyen (1) pour contenir une préparation de plaquettes et un moyen de connexion (2, 5) qui peut être connecté de façon stérile, lors de l'utilisation, à un dispositif de contenant et/ou un distributeur d'un concentré de plaquettes. Le système comporte également un moyen (8) d'introduction d'une solution de congélation connecté audit moyen de connexion (2, 5). Le moyen (1) pour contenir la préparation de plaquettes, le moyen de connexion (2, 5) et le moyen d'introduction (8) sont connectés entre eux pour créer un circuit fermé.
PCT/IB2007/052856 2006-07-19 2007-07-18 Système de congélation de plaquettes WO2008035240A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO2006A000539 2006-07-19
IT000539A ITBO20060539A1 (it) 2006-07-19 2006-07-19 Sistema di congelamento piastrinico

Publications (2)

Publication Number Publication Date
WO2008035240A2 true WO2008035240A2 (fr) 2008-03-27
WO2008035240A3 WO2008035240A3 (fr) 2008-09-12

Family

ID=39200917

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/052856 WO2008035240A2 (fr) 2006-07-19 2007-07-18 Système de congélation de plaquettes

Country Status (2)

Country Link
IT (1) ITBO20060539A1 (fr)
WO (1) WO2008035240A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018119377A1 (fr) * 2016-12-22 2018-06-28 Regenerative Sciences, Llc Dispositif et procédés de lyse ou d'activation plaquettaire
EP3669904A1 (fr) * 2018-12-21 2020-06-24 Fenwal, Inc. Procédés et systèmes pour cryoconservation de plaquettes
US10905721B2 (en) 2013-01-28 2021-02-02 Regenexx, Llc. Device and methods for platelet lysis or activation
US11541155B2 (en) 2018-05-31 2023-01-03 Vitalant Closed and sterile container devices for cryopreservation and resuspension of body fluids

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993025176A1 (fr) * 1992-06-15 1993-12-23 The Secretary Of State For Defence In Her Britannic Majesty's Government Of The United Kingdom Of Great Britain And Northern Ireland Poches de congelation
WO1999036109A1 (fr) * 1998-01-20 1999-07-22 Baxter International Inc. Procedes et systemes de traitement et de stockage du sang placentaire ou ombilical
US20030191005A1 (en) * 2002-04-08 2003-10-09 Coelho Philip H. Blood component separation method and apparatus
WO2004096319A1 (fr) * 2003-04-30 2004-11-11 Crb Nederland B.V. Procede et appareil de fractionnement sanguin
US20050084838A1 (en) * 2001-10-22 2005-04-21 Lampeter Eberhard F. Sterile system and methods for collecting, transporting, storing and cyropreserving body fluids

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993025176A1 (fr) * 1992-06-15 1993-12-23 The Secretary Of State For Defence In Her Britannic Majesty's Government Of The United Kingdom Of Great Britain And Northern Ireland Poches de congelation
WO1999036109A1 (fr) * 1998-01-20 1999-07-22 Baxter International Inc. Procedes et systemes de traitement et de stockage du sang placentaire ou ombilical
US20050084838A1 (en) * 2001-10-22 2005-04-21 Lampeter Eberhard F. Sterile system and methods for collecting, transporting, storing and cyropreserving body fluids
US20030191005A1 (en) * 2002-04-08 2003-10-09 Coelho Philip H. Blood component separation method and apparatus
WO2004096319A1 (fr) * 2003-04-30 2004-11-11 Crb Nederland B.V. Procede et appareil de fractionnement sanguin

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10905721B2 (en) 2013-01-28 2021-02-02 Regenexx, Llc. Device and methods for platelet lysis or activation
US11903970B2 (en) 2013-01-28 2024-02-20 Regenexx, LLC Device and methods for platelet lysis or activation
WO2018119377A1 (fr) * 2016-12-22 2018-06-28 Regenerative Sciences, Llc Dispositif et procédés de lyse ou d'activation plaquettaire
US11541155B2 (en) 2018-05-31 2023-01-03 Vitalant Closed and sterile container devices for cryopreservation and resuspension of body fluids
EP3669904A1 (fr) * 2018-12-21 2020-06-24 Fenwal, Inc. Procédés et systèmes pour cryoconservation de plaquettes

Also Published As

Publication number Publication date
ITBO20060539A1 (it) 2008-01-20
WO2008035240A3 (fr) 2008-09-12

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