EP0335882A1 - Separation cryogenique amelioree de globuline - Google Patents

Separation cryogenique amelioree de globuline

Info

Publication number
EP0335882A1
EP0335882A1 EP87907885A EP87907885A EP0335882A1 EP 0335882 A1 EP0335882 A1 EP 0335882A1 EP 87907885 A EP87907885 A EP 87907885A EP 87907885 A EP87907885 A EP 87907885A EP 0335882 A1 EP0335882 A1 EP 0335882A1
Authority
EP
European Patent Office
Prior art keywords
vessel
plasma
nipple
cryoprecipitate
body portion
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Withdrawn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
EP87907885A
Other languages
German (de)
English (en)
Other versions
EP0335882A4 (en
Inventor
David M. Dillon
Stephen H. Franks
Read S. Mccarty
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.)
Baxter International Inc
Original Assignee
Baxter International Inc
North American Biologicals 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 US06/925,318 external-priority patent/US4917804A/en
Priority claimed from US07/081,484 external-priority patent/US4915847A/en
Application filed by Baxter International Inc, North American Biologicals Inc filed Critical Baxter International Inc
Publication of EP0335882A1 publication Critical patent/EP0335882A1/fr
Publication of EP0335882A4 publication Critical patent/EP0335882A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0407—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles
    • B04B5/0428—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles with flexible receptacles
    • 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
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • 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
    • A61M1/0231—Multiple bag systems for separating or storing blood components with gas separating means, e.g. air outlet through microporous membrane or gas bag
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other 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

Definitions

  • cryoprecipitate having a hollow cylindrical vessel with a first closed end, a second end and a longitudinal axis, the first end having a port with a sterile docking connector for transferring plasma between the vessel and a plasma bag, and the second end having a generally contoured face with a nipple extending from and closing the second end.
  • the nipple has a generally cylindrical shape and encloses a volume of approximately 2 to 5 percent of the volume of the vessel.
  • Figure 4 shows a section of another embodiment of the invention
  • Figure 7 shows a detail of a radial section of the vessel of Figure 6;
  • Figure 8 shows a longitudinal cross-section of another separation vessel
  • FIG. 1 shows a schematic illustration of a set 1 according to a basic embodiment of the invention.
  • Set 1 includes a plurality of vessels 10 each having an inlet end 12 with a port 14.
  • a branch tube 16 runs from each port 14 to a common tube 17 which connects to a plasma bag 18.
  • the plasma bag 18 may be the plasma receiving bag of a conventional phlebotomy set, and tube 17 may connect in a conventional manner to such bag so as to form a sterile system.
  • the entire set including bag 18 tubes 17, 16 and vessels 10 may be formed as a sterile sealed unit.
  • tube 17 connects to plasma bag 18 via a spike or other fitting 20, which is preferably a sterile docking fitting.
  • the plasma is frozen and then thawed to precipitate out the cryoprecipitate.
  • a good yield is obtained by completely freezing to minus thirty degrees C, thawing in a refrigerator at two to six degrees C and centrifuging at two to five thousand g (RCF) for ten to thirty minutes.
  • Vessels 10 and the empty plasma bag 18 are then placed in the fixture 30 described above and centrifuged at a speed and for a time sufficient to separate out the cryoprecipitate as a viscous mass in the nipple 22.
  • the centrifuge is then stopped, the vessels 10 and bag 18 removed therefrom, and the cryo-poor plasma faction is decanted from each vessel back into the plasma bag 18, whence it may be returned to the donor or otherwise used.
  • Each vessel 10 then contains one aliquot of cryoprecipitate from its corresponding volume of plasma.
  • FIG. 3 shows a partial view and section of a preferred embodiment of a three vessel sterile docking set for the isolation of cryoprecipitate according to the invention.
  • a capped bag spike 20 connects to tube 17 which communicates via a trifurcated adaptor manifold 19 to three tubes 16, which extend to respective collection vessels 40.
  • a suitable adaptor manifold 19 is a Medex part no. B-1450-09.
  • Each vessel 40 has a generally cylindrical body 45 with a cap 42 at one end and a nipple portion 50 at the other end.
  • Body 45 is preferably formed of a semi-rigid material such as a thick walled polyvinyl chloride plastic, and has an interior volume in the range of 60 to 80 milliliters.
  • End cap 42 is formed with an inlet port 44 and also a vent 46 which permits the displacement of air when plasma is transferred from a plasma bag to the vessel or vice versa.
  • Vent 46 includes a hydrophobic microporous filter 48 having a pore size in the range of .45 microns for preventing the influx of contaminants while permitting gas to vent therethrough.
  • a suitable filter is a membrane-type filter sold by the Burron Medical Products company of Pennsylvania as their filter membrane, part no. A-700 4020.
  • Cap 42 is cemented or otherwise bonded to body 45 for sealing the end thereof.
  • Vessel 60 is formed of a semi-rigid but sufficiently flexible material, such as a .030 to .040 inch thick flexible PVC, so that with the inlet tube 16 sealed closed, the vessel 60 may be squeezed by hand to extrude the precipitate from the end 72 of the vessel.
  • the conical end has a taper of approximately fifteen degrees, terminating in a tip having an inner spherical radius in the range of (.05) to (0.10) inches, thus providing both a high degree of operator visibility, and a fine extrusion filament of precipitate when so squeezed.
  • FIG. 5 shows yet another embodiment of a vessel 80 according to the invention having a body 85 and a nipple portion 90.
  • nipple 90 has an open tip with an inner surface 91 and an outer surface 92 configured for twist lockable connection to a mating Luer fitting.
  • a cap 93 closes the end.
  • the body of vessel 80 is formed of a substantially rigid material such as a polycarbonate plastic, and has an end cap 82 which includes, in addition to a vent 86 and an inlet port 84, a hermetically mounted piston structure 83.
  • Piston structure 83 includes a soft rubber or similar piston 87a having a shank 87b which extends through the cap 82 and is hermetically sealed by a removable lock cap 84. Piston structure 83 is centered over the cylindrical nipple 90. A separate plunger 88 is provided, and after separation of the cryoprecipitate, the supply tube 16 may be severed and sealed so that the vessel 80, containing a sterile aliquot of cryoprecipitate, may be stored and used directly as a surgical applicator.
  • sump 105 has a diameter of approximately .8 inches, and the tapered wall portion 104b assures that the interface, after centrifuging, between the separated cryoprecipitate and the plasma has a relatively small area. This helps prevent remixing during post processing operations such as decanting the plasma.
  • Vessel 100 is equipped with three ports.
  • a first port 108 is located at the tip of the nose portion, and is used in operation for access for the separated cryoglobulin after processing has been completed. This port may have a Luer fitting or other connector as described in relation to the previously described vessel embodiments.
  • a second port 110 enters the vessel in the tapered wall portion 104b just above the receiving sump.
  • a third port 112 is centrally located in the cap 102, and may serve as a vent during the filling and unfilling of the vessel. Port 112 contains a bacterial hydrophobic filter, and may be capped during centrifuging, as required.
  • It serves as a drainage channel through which, when the vessel is slightly tilted toward port 110, the separated plasma near the sump interface can flow without introducing turbulence and remixing at the separation line. This permits the plasma to be substantially completely decanted after processing, resulting in a clear separation of product.
  • FIG 8 shows a cross-sectional view, similar to that of Figure 7, of yet a further embodiment of a separation vessel 120 according to the invention.
  • Parts of vessel 120 are numbered identically to corresponding parts of vessel 100.
  • Vessel 120 contains, in addition, a hollow interior column 122 communicating with an outlet port 124 and preferably also a vent 126, with elements 122, 124 and 126 all mounted on the cap portion 102.
  • Hollow column 122 has a plurality of apertures 130 at its lower end, and is filled with packing material 132 which provides a filtration matrix for fluids passing therethrough.
  • vessel 120 One specific application of vessel 120 which applicant envisages is that platelet rich blood products may be placed in column 122 and thus may be subjected to the freezing and thawing protocols described above for the isolation of cryoprecipitate. Such freezing is expected to rupture the platelet membranes so that upon subsequent centrifuging, cellular products contained within the platelets will pass through the filtration matrix 132 into the cryoprecipitate, while the cellular membrane material will be effectively filtered out and retained within the column by the filter. Thus, vessel 120 may be used to prepare cryoprecipitate enriched with platelet growth factor, to promote enhanced recovery in topical surgical applications of cryo-glue or the cryoprecipitate as described above.
  • FIG. 9 shows a further embodiment of a separation vessel 140 which is similar in some respects to vessel 100 of Figure 6.
  • Vessel 140 differs in being formed as a flat bag, rather than a rigid or semi-rigid container. Vessel 140 requires no hydrophobic filters or other provision for accommodating changes of volume.
  • components corresponding to elements of vessel 100 are identically numbered.
  • the harvesting outlet port 108 is shown in some detail, and includes an exit tube 141 adapted to connection with a applicator or transfer device, a membrane 142 sealing the exit port during processing, and a break-away cover 143 which maintains the exit tube sterile prior to use.
  • Bag 140 is formed with RF welded seams 145 of sufficient strength and has apertures 146 at the top for hanging in a centrifuge bucket.
  • one or more auxiliary bags are preferably attached to one or more of the ports 110, 112, 148 for the initial drawing of blood and separation of plasma therefrom for provision to the vessel, and for drawing off the cryoprecipitate-depleted plasma from the vessel following the above described processing.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

Un assemblage (1) d'isolation d'un cryoprécipité comprend un récipient creux (10) ayant une première extrémité fermée (12), une deuxième extrémité et un axe longitudinal. Un embout (22) allongé ferme la deuxième extrémité et renferme environ 2 à 5 % du volume du récipient creux.
EP19870907885 1986-10-31 1987-10-30 Improved cryoglobulin separation Withdrawn EP0335882A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US06/925,318 US4917804A (en) 1986-10-31 1986-10-31 Method and vessel for separation of cryoglobin
US925318 1986-10-31
US07/081,484 US4915847A (en) 1987-08-04 1987-08-04 Cryoglobulin separation
US81484 1987-08-04

Publications (2)

Publication Number Publication Date
EP0335882A1 true EP0335882A1 (fr) 1989-10-11
EP0335882A4 EP0335882A4 (en) 1990-09-26

Family

ID=26765623

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19870907885 Withdrawn EP0335882A4 (en) 1986-10-31 1987-10-30 Improved cryoglobulin separation

Country Status (3)

Country Link
EP (1) EP0335882A4 (fr)
JP (1) JPH02501356A (fr)
WO (1) WO1988003045A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5030215A (en) * 1990-01-03 1991-07-09 Cryolife, Inc. Preparation of fibrinogen/factor XIII precipitate
US5092996A (en) * 1991-02-19 1992-03-03 Miles Inc. Blood filtering system
US5891327A (en) * 1996-07-10 1999-04-06 Axygen, Inc. Centrifuge tube with rotational position index
DE10134913C2 (de) * 2001-07-18 2003-06-26 Hiberna Ag Vorrichtung und Verfahren zur Blutpräparation
JP4983204B2 (ja) * 2006-10-27 2012-07-25 ニプロ株式会社 遠心分離容器及び遠心分離方法
US8419705B2 (en) * 2007-07-30 2013-04-16 Jms Co., Ltd. Apparatus for separating and storing blood components
KR101265243B1 (ko) 2009-02-04 2013-05-16 가부시끼가이샤 제이엠에스 액성 성분 채취장치
JP5322790B2 (ja) * 2009-06-15 2013-10-23 川澄化学工業株式会社 血液成分のサンプリングシステム及び血液成分のサンプリング方法並びに採血管
JP5955353B2 (ja) * 2014-07-23 2016-07-20 みゆき 山川 体液収容器
US10080981B2 (en) * 2016-03-02 2018-09-25 The Boeing Company In-line centrifugal sealant debubbler

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1171178B (de) * 1960-02-06 1964-05-27 Martin Christ Fa Zentrifugenzelle
US4066414A (en) * 1977-02-15 1978-01-03 Donald Selby One piece tube and microscope slide manipulative laboratory device
WO1986001814A1 (fr) * 1984-09-07 1986-03-27 The Trustees Of Columbia University In The City Of Concentre d'un adhesif de fibrine prepare a partir du plasma frais congele d'un seul donneur

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL252802A (fr) * 1959-11-20
US3897902A (en) * 1974-02-01 1975-08-05 Sindco Corp Phase separating tube
US3986506A (en) * 1974-09-03 1976-10-19 Baxter Travenol Laboratories, Inc. Apparatus for separation of cryoprecipitate from blood plasma and method
US4364903A (en) * 1981-04-02 1982-12-21 Becton, Dickinson And Company Contamination-free separation device
US4483825A (en) * 1982-07-09 1984-11-20 Fatches Keith R Pipette and filter combination
DE3238471C1 (de) * 1982-10-16 1983-10-20 Holger A.G. Dr.med. 7300 Esslingen Müller Küvette für Kapillarblut
US4698311A (en) * 1985-10-30 1987-10-06 Ortho Diagnostic Systems Inc. Particle washing and separation method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1171178B (de) * 1960-02-06 1964-05-27 Martin Christ Fa Zentrifugenzelle
US4066414A (en) * 1977-02-15 1978-01-03 Donald Selby One piece tube and microscope slide manipulative laboratory device
WO1986001814A1 (fr) * 1984-09-07 1986-03-27 The Trustees Of Columbia University In The City Of Concentre d'un adhesif de fibrine prepare a partir du plasma frais congele d'un seul donneur

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
IBM TECHNICAL DISCLOSURE BULLETIN, vol. 25, no. 11B, April 1983, New York, US; P.C. ALTER: "Centrifuge tube", pages 6032-6033 *
See also references of WO8803045A1 *

Also Published As

Publication number Publication date
EP0335882A4 (en) 1990-09-26
JPH02501356A (ja) 1990-05-17
WO1988003045A1 (fr) 1988-05-05

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