|Publication number||US3654925 A|
|Publication date||11 Apr 1972|
|Filing date||23 Sep 1969|
|Priority date||23 Sep 1969|
|Publication number||US 3654925 A, US 3654925A, US-A-3654925, US3654925 A, US3654925A|
|Inventors||Holderith William J|
|Original Assignee||Becton Dickinson Co|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (10), Referenced by (63), Classifications (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent [151 3,654,925 51 Apr. 11,1972
Holderith  PLASMA SEPARATOR SYSTEM  Inventor: William J. Holderith, Wyckoff, NJ.
 Assignee: Becton, Dickinson and Company, East Rutherford, NJ.
 Filed: Sept. 23, 1969  Appl. No; 860,191
 US. Cl ..128/272, 128/318 M  Int. Cl. ..A61j 01/00  Field ofSearch ..l28/2,2l8 M,218D, 272
 References Cited UNITED STATES PATENTS 1,614,067 1/1927 Heublein ..128/272 1,928,998 10/1933 Kovacs ..128/272 2,342,214 2/1944 Perelson... ..128/272 UX 2,655,919 10/1953 Goodstein et a1. ..128/218 M 2,734,649 2/1956 Callahan et al. ....128/272 X 2,908,274 10/1959 Bujan ....128/272 3,200,813 8/1965 Christakis. ..128/2 3,221,741 12/1965 LeVeen ....128/272 3,490,437 l/1970 Bakondy et a1. ..128/272 X Primary Examiner-Joseph S. Reich Attorney-Kane, Dalsimer, Kane, Sullivan and Smith [5 7] ABSTRACT A blood-collecting tube of the evacuated type containing an anticoagulant receives through normal techniques whole blood to be tested. Thereafter, a cell-collecting tube is interconnected with the blood-collecting tube through the intermediary of a double-ended needle assembly including an external discoidal hub intermediate the ends thereof, such that the interior of both tubes communicate with one another. The tubes with the interconnecting needle assembly are then subjected to centrifugation with the cell-collecting tube being spaced radially outwardly relative to the blood-collecting tube and the axis of rotation. Upon generation of sufficient centrifugal forces, the plasma separates from the heavier constituents with the latter and particularly the blood cells being forced out into the cell-collecting tube and packed therein. The relative capacities of the tubes are such that in the bloodcollecting tube only plasma will remain following completion of centrifugation. The needle assembly is then removed from the blood-collecting tube to effectively separate and remove plasma from the remaining constituents of the blood.
1 Claims, 3 Drawing Figures PLASMA SEPARATOR SYSTEM BACKGROUND OF THE INVENTION In the testing of blood, it is often desired to obtain a sample of blood plasma, the clear, straw-colored liquid left when all formed elements in uncoagulated blood have been removed. To obtain plasma, it is common practice to draw blood into a tube containing an anticoagulant, centrifuge this sample, and remove the supernatant plasma either by decanting (pouring it off) or removing it with an aspirating device such as a pipette or syringe. These removal methods are not entirely satisfactory in that both require the tube to be opened and exposed to the air, thereby risking contamination. The decanting method also risks mixing of the formed elements with the plasma, rendering the plasma unusable. The transfer method is also unsatisfactory in that the sample may be contaminated by the transfer device, and the cost of the transfer device adds extra expense to the determination and analysis.
SUMMARY OF THE INVENTION It is, therefore, an object of this invention to provide a more effective system and procedure for removing plasma from whole blood after the sample has been centrifuged.
Another object is to provide a device and system of this type which permits the removal of the plasma portion without disturbing the packed red cells thus allowing the use of pure plasma in many tests wherein the presence of formed elements might render the test invalid.
A further object is to provide a system of this type which is essentially closed" in that neither portion of the original sample is exposed to the atmosphere.
BRIEF DESCRIPTION OF THE DRAWING FIG. 3 is a similar longitudinal sectional view showing theblood-collecting tube associated with the cell-collecting tube through the intermediary of the double-ended needle.
DESCRIPTION OF THE PREFERRED EMBODIMENTS The illustrated blood plasma collecting system includes a blood-collecting tube such as is described in US. Pat. No. 2,460,641 titled Blood Collecting Apparatus, granted Feb. 21, 1949 a cell-collecting tube 12, and an intermediate needle assembly 14 which may be either affixed to the stopper of the cell-collecting tube 12 or be constructed as a separate unattached assembly. Referring initially to the tube 10, it will be noted that a tubular body 16 of essentially cylindrical configuration includes a closed end 18 and an open end 20. Sealing the open end 20 is a penetrable self-sealable stopper 22. In accordance with conventional practice, the stopper 22 cooperates in maintaining a vacuum within the tube 10 which also conveniently receives an anticoagulant for whole blood. The stopper 22 includes an interiorly disposed plug portion 24 and an exterior radially extending flange portion 26 disposed against the open end 20. An exterior conical recess 28 facilitates penetration of the stopper 22 by a pointed needle. The interior of the plug portion 24 includes an inner end 30 forming the base of a truncated conical recess, the conical walls of which serve a funneling function in facilitating the complete removal of the solid constituents of whole blood during centrifugation in a manner to be described in detail below.
The cell-collecting tube 12, on the other hand, includes a tubular body portion 32 having a closed end 34 and an open end 36 across which a stopper 38 extends in sealing relationship. In this connection, the capacity of tube 10 relative to tube 12 should be such that all of the heavier constituents of the separated blood are accommodated and only a minimum amount of plasma will be present. The stopper 38 includes the usual plug portion 40 and flange portion 42. This stopper is also adapted to be penetrated and self-scalable. For purposes of this invention, the tube 12 need not be evacuated and may possess essentially the same capacity as tube 10, but is preferably smaller in volume.
The needle assembly 14 is provided with a double-ended cannula 44 having bevel pointed ends 46 and 48. A hub 50 is affixed to a cannula 44 intermediate its ends. The needle assembly 14 may conveniently form a part of the tube 12 as shown in FIG. 2 or be an independent assembly but necessary component or part of the plasma-collecting system of this invention.
In use, the blood-collecting tube 10 is employed together with a double-ended hypodermic needle (not shown) to collect a sample of venous or arterial blood in a manner similar to that disclosed in US. Pat. No. 2,460,641. As soon as convenient thereafter, the cell-collecting tube 12 is attached to tube 10 by inserting the bevel end 46 of cannula 44 through stopper 22, such that the parts assume the position illustrated in FIG. 3. The assembly is then placed in a centrifuge (not shown) and held therein in such a manner that centrifugal forces will act along the common axis of the assembly from the blood-collecting tube 10 towards the cell-collecting tube 12. The centrifuge is run for a sufficient period of time to enable the generated centrifugal forces to force the liquid in the tube 10 to displace the air in tube 12 and eventually urge the solid constituents of the blood and particularly the cells thereof to be packed within the tubular body 32 of cell-collecting tube 12 as shown in FIG. 3. The plasma passes through the cannula 44 into the tube 10 with a minor portion of the plasma remaining in tube 12. When centrifugation is complete the assembly is removed and the tube 10 separated from the needle assembly l4, and consequently the tube 12. Remixing of plasma and the fomied elements or solid constituents of the blood is prevented by removal of the connecting cannula, while the assembly is held vertically and contamination is prevented by maintaining a closed system which can be made entirely sterile if desired.
As stated in the foregoing, the conical recess 30 of stopper 22 avoids entrapment of red cells or other solid constituents in the upper tube 10 during centrifugation. It is also preferred that the bevel end 46 of cannula 44 not protrude into the conical recess 30 for this same reason but be disposed in the cylindrical extension 32 of this recess. By the same token, the bevel end 48 of cannula 44 should be disposed within the tube 12 and related to its internal capacity such that this bevel end be disposed in the plasma portion and not protrude into the packed cell portion following centrifugation.
In an alternate embodiment of the plasma separator system, tubes 10 and 12 may be of substantially equal size and capacity. With this in mind both tubes may be utilized to collect blood. However, the needle assembly 14 does not form part of tube 12 and is a separate unit which is thereafter employed to join the tubes together. This assembly is then centrifuged and the blood separated. The plasma and cells are then isolated one from the other and collected for the intended purposes.
Thus, the aforenoted objects and advantages are most effectively obtained. Although several preferred embodiments of the invention have been disclosed and described in detail herein, it should be understood that this invention is in no sense limited thereby and its scope is to be determined by that of his appended claims.
l. A plasma separating system comprising in combination a blood-collecting tube comprising a tubular body having a closed end and an open end fitted with a needle penetrable stopper; said stopper extending across and covering the open end thereof; said blood-collecting tube having whole blood disposed therein; a cell-collecting tube comprising a tubular body having a closed end and an open end fitted with a stopper; said stopper extending across and closing the open end thereof; said cell-collecting tube having a volume such that the cells obtained from separating whole blood disposed in the blood-collecting tube would fill a major portion of the cell-collecting tube; a double-ended needle assembly mounted on the blood-collecting and cell-collecting tubes; said doubleended needle assembly having cannula and a hub disposed between the ends thereof, each end of the cannula having a beveled pointed end so as to penetrate through the stopper of the blood-collecting tube and the stopper of the cell-collecting tube so that the interior of each of said tubes is in fluid communication with each other whereby the cells contained in the whole blood are adapted to be separated by external forces on said system and when separated will substantially till a major portion of the cell-collecting tube by passing through the cannula of the double needle assembly and, at the same time, the liquid plasma portion of the whole blood will fill at least a portion of the blood-collecting tube, and said hub being adapted to engage with an exterior surface of said stopper on said cellcollecting tube such that the pointed end of the needle associated with the cell-collecting tube is disposed interiorly thereof and short of the cells of the blood collected therein following said separation.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US1614067 *||12 Mar 1925||11 Jan 1927||Oskar Heublein Wilhelm||Ampulla for injection liquids comprising separated compartments|
|US1928998 *||28 Jan 1931||3 Oct 1933||Nikolaus Kovacs||Double ampule for sterile solutions|
|US2342214 *||23 Sep 1942||22 Feb 1944||Fuel Refining Corp||By-product coke oven plant|
|US2655919 *||17 Apr 1951||20 Oct 1953||Charles B Goodstein||Hypodermic syringe and cartridge therefor|
|US2734649 *||5 Apr 1952||14 Feb 1956||Moistureproof vial closure|
|US2908274 *||29 Jun 1953||13 Oct 1959||Abbott Lab||Closure|
|US3200813 *||24 Dec 1962||17 Aug 1965||Christakis George J||Aspirating syringes|
|US3221741 *||18 Jun 1962||7 Dec 1965||Veen Harry H Le||Container for collecting and storing blood having anticoagulant means therein|
|US3490437 *||17 Oct 1966||20 Jan 1970||Osten Taylor A||Embryonic organ cells in a state of preservation and methods for preserving the same|
|FR1227395A *||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3866608 *||23 Oct 1973||18 Feb 1975||Sorenson Research Co||Aseptic suction collection system and method|
|US3939822 *||14 Aug 1974||24 Feb 1976||Jack Markowitz||Disposable blood collection and filtering device|
|US4230584 *||8 Feb 1979||28 Oct 1980||Terumo Corporation||Liquid separating composition and apparatus for applying said composition|
|US4811866 *||2 Jan 1987||14 Mar 1989||Helena Laboratories Corporation||Method and apparatus for dispensing liquids|
|US4818386 *||8 Oct 1987||4 Apr 1989||Becton, Dickinson And Company||Device for separating the components of a liquid sample having higher and lower specific gravities|
|US4824560 *||4 Apr 1986||25 Apr 1989||Assaf Pharmaceutical Industries Ltd.||Separation of materials from a liquid dispersion by sedimentation|
|US5555920 *||3 Sep 1993||17 Sep 1996||Automed Corporation||Method and apparatus for aliquotting blood serum or blood plasma|
|US5968018 *||30 Oct 1996||19 Oct 1999||Cohesion Corporation||Cell separation device and in-line orifice mixer system|
|US5997811 *||2 Jul 1997||7 Dec 1999||Cohesion Technologies, Inc.||Method for sterile syringe packaging and handling|
|US6132353 *||21 Jul 1997||17 Oct 2000||Winkelman; James W.||Apparatus and method for separating plasma or serum from the red cells of a blood sample|
|US6398705 *||13 Sep 2000||4 Jun 2002||Manfred Grumberg||Apparatus for separating plasma or serum from the red cells with a blood sample|
|US6979307 *||15 Jan 2002||27 Dec 2005||Cascade Medical Enterprises Llc||Systems and methods for preparing autologous fibrin glue|
|US7745106||26 Jun 2003||29 Jun 2010||Cascade Medical Enterprises, Llc||Methods and devices for separating liquid components|
|US7766900||8 Sep 2005||3 Aug 2010||Biomet Manufacturing Corp.||Method and apparatus for application of a fluid|
|US8182769||4 Apr 2008||22 May 2012||Biomet Biologics, Llc||Clean transportation system|
|US8313954||3 Apr 2009||20 Nov 2012||Biomet Biologics, Llc||All-in-one means of separating blood components|
|US8328024||4 Aug 2011||11 Dec 2012||Hanuman, Llc||Buoy suspension fractionation system|
|US8337711||27 Feb 2009||25 Dec 2012||Biomet Biologics, Llc||System and process for separating a material|
|US8444620||8 Jul 2010||21 May 2013||Biomet Biologics, Llc||Method and apparatus for application of a fluid|
|US8491564 *||15 Apr 2009||23 Jul 2013||Cascade Medical Enterprises, Llc||Systems and methods for preparing autologous fibrin glue|
|US8518272||4 Apr 2008||27 Aug 2013||Biomet Biologics, Llc||Sterile blood separating system|
|US8567609||19 Apr 2011||29 Oct 2013||Biomet Biologics, Llc||Apparatus and method for separating and concentrating fluids containing multiple components|
|US8591391||12 Apr 2010||26 Nov 2013||Biomet Biologics, Llc||Method and apparatus for separating a material|
|US8596470||20 Feb 2012||3 Dec 2013||Hanuman, Llc||Buoy fractionation system|
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|US8783470||25 May 2012||22 Jul 2014||Biomet Biologics, Llc||Method and apparatus for producing autologous thrombin|
|US8794452||1 Aug 2013||5 Aug 2014||Becton, Dickinson And Company||Density phase separation device|
|US8801586 *||20 Dec 2012||12 Aug 2014||Biomet Biologics, Llc||System and process for separating a material|
|US8802362||18 May 2010||12 Aug 2014||Cascade Medical Enterprises, Llc||Methods and devices for separating liquid components|
|US8808551||15 Nov 2010||19 Aug 2014||Biomet Biologics, Llc||Apparatus and method for separating and concentrating fluids containing multiple components|
|US8950586||1 Jul 2013||10 Feb 2015||Hanuman Llc||Methods and apparatus for isolating platelets from blood|
|US8992862||15 Nov 2012||31 Mar 2015||Biomet Biologics, Llc||All-in-one means of separating blood components|
|US8998000||14 May 2010||7 Apr 2015||Becton, Dickinson And Company||Density phase separation device|
|US9011800||16 Jul 2009||21 Apr 2015||Biomet Biologics, Llc||Method and apparatus for separating biological materials|
|US9028457||21 May 2013||12 May 2015||Biomet Biologics, Llc||Method and apparatus for application of a fluid|
|US9079123||6 Aug 2013||14 Jul 2015||Becton, Dickinson And Company||Density phase separation device|
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|US9239276||28 Oct 2013||19 Jan 2016||Biomet Biologics, Llc||Apparatus and method for separating and concentrating fluids containing multiple components|
|US9339741||2 May 2014||17 May 2016||Becton, Dickinson And Company||Density phase separation device|
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|US9682373||15 Apr 2013||20 Jun 2017||Becton, Dickinson And Company||Device for separating components of a fluid sample|
|US9694359||24 Feb 2015||4 Jul 2017||Becton, Dickinson And Company||Mechanical separator for a biological fluid|
|US9701728||24 Jul 2015||11 Jul 2017||Biomet Biologics, Llc||Methods and compositions for delivering interleukin-1 receptor antagonist|
|US20020169408 *||15 Jan 2002||14 Nov 2002||Roberto Beretta||Systems and methods for preparing autologous fibrin glue|
|US20040071786 *||26 Jun 2003||15 Apr 2004||Grippi Nicholas A.||Methods and devices for separating liquid components|
|US20060074394 *||22 Nov 2005||6 Apr 2006||Cascade Medical Enterprises, Llc||Systems and methods for preparing autologous fibrin glue|
|US20060196885 *||8 Sep 2005||7 Sep 2006||Biomet Manufacturing Corp.||Method and apparatus for application of a fluid|
|US20080190857 *||22 Mar 2006||14 Aug 2008||Cascade Medical Entrprises, Llc||System and Methods of Producing Membranes|
|US20090203613 *||15 Apr 2009||13 Aug 2009||Cascade Medical Enterprises, Llc||Systems and methods for preparing autologous fibrin glue|
|US20090250413 *||4 Apr 2008||8 Oct 2009||Biomet Biologics, Llc||Sterile Blood Separating System|
|US20090258056 *||14 Apr 2009||15 Oct 2009||Cascade Medical Enterprises, Llc||Systems and methods for preparing autologous fibrin glue|
|US20100274206 *||8 Jul 2010||28 Oct 2010||Biomet Manufacturing Corp.||Method and Apparatus for Application of a Fluid|
|US20100288694 *||14 May 2010||18 Nov 2010||Becton, Dickinson And Company||Density Phase Separation Device|
|US20110020196 *||18 May 2010||27 Jan 2011||Grippi Nicholas A||Methods and devices for separating liquid components|
|US20130196425 *||20 Dec 2012||1 Aug 2013||Biomet Biologics, Llc||System and Process for Separating a Material|
|WO2007021344A1 *||16 May 2006||22 Feb 2007||Cascade Medical Enterprises, Llc||Systems and methods for preparing autologous fibrin glue|
|WO2014019255A1 *||10 Aug 2012||6 Feb 2014||Shanghai Kehua Diagnostic Medical Products Co., Ltd.||Vacuum blood collection pipe capable of directly separating serum and method thereof|
|U.S. Classification||604/413, 210/789|
|Cooperative Classification||A61B5/150755, A61J1/05, G01N33/49|