CA2130893A1 - Method and system for collecting, processing and storing blood components - Google Patents
Method and system for collecting, processing and storing blood componentsInfo
- Publication number
- CA2130893A1 CA2130893A1 CA002130893A CA2130893A CA2130893A1 CA 2130893 A1 CA2130893 A1 CA 2130893A1 CA 002130893 A CA002130893 A CA 002130893A CA 2130893 A CA2130893 A CA 2130893A CA 2130893 A1 CA2130893 A1 CA 2130893A1
- Authority
- CA
- Canada
- Prior art keywords
- bag
- plasma
- eva
- storage bag
- vinyl acetate
- 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.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- 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
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/24—Medical-surgical bags
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/27—Cryogenic
Abstract
Method and System for Collecting, Processing, and Storing Blood Components ABSTRACT
Apparatus and method for collecting, processing, and storing blood components, such as plasma. The method involves collecting the blood component in a flexible storage bag manufactured from ethylene vinyl acetate EVA, having a composition of between about 9% and about 18% vinyl acetate by weight of total EVA co-polymer. The EVA
bag is sealed, and the sample is from in the bag at a temperature of at least as low as -30°C to form a substantially solid pellet contained in the storage bag. The bag then is fractured and the pellet is removed in its intact, frozen form. The co-polymer bag may have an inner surface with an etched or embossed pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the storage bag.
Apparatus and method for collecting, processing, and storing blood components, such as plasma. The method involves collecting the blood component in a flexible storage bag manufactured from ethylene vinyl acetate EVA, having a composition of between about 9% and about 18% vinyl acetate by weight of total EVA co-polymer. The EVA
bag is sealed, and the sample is from in the bag at a temperature of at least as low as -30°C to form a substantially solid pellet contained in the storage bag. The bag then is fractured and the pellet is removed in its intact, frozen form. The co-polymer bag may have an inner surface with an etched or embossed pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the storage bag.
Description
2~ 3~3 Metbod arld System for Collecting, Processin~, and StoriDg Blood Compon~nts ~EII~ .
~h~
The present invention relates to plastic bags used for the collection, 10 p}ocessing, and storage of blood products, such as plasma Specifically, the invention relates to an ethylene vinyl acetaoe bag used in the collection of human plasma,freezing the plasma after collection, storing the frozen plasma, and subsequent processing.
4~ A~
Current conta~ners used for plasma storage and processing are of t~vo principle ~s: ( 1) a polyvinyl chloride (PVC~ fle sible bag, or (2) a rigid or ser2i-rigid blow molded olefin bottle or bag.
PVC bags have bcen used for decades for freeze stonng plasma, and have the advantages of efficient manufacturability, low contai~er cost, and good blood compatibility. However, signific~nt disadvantages also exist with this type of -container. The most significant disadvantage is the fragility of the container when ~rozen. The glass transition temperatulc (Tg~, or temperature at which the film changes from flexible to brittle, is higher than the freezing temperatu~es commonly usedforplasma. ;
2S This mean~ that thç bag is flexible and reladvely strong at room tempe}ature, but becomes e~cessively brittle or glass-like when frozen. This fragility leads to some percentage of the bags breaklng duling storage and handling. Bag breakage is undesirable since it allows for potendal contam~nation (bacterial, particulate, and the lilce) ~hat can adversely iaffect the purity of productsi subseiquently made from this plasma Bacterii31 contaminadoa, ia piarticular, can adversely i~ffest protein yields and S
quiality during dle fractionadon process due to the releasie of proteolytic enzyrnes and pyrogens.
The PVC film used in the rnanUIaCtUre of the plasma bags presently on the market has routinely been manufac~ured using the plasticizer di-2-ethyl-hexyl phthalate (DEHP). Considerable arno2n~s ~f ~ 3re leach~d from the walls of the blood bags by the plasma during storage. Recently, concern has been raised over the potentially han~ful effects of DEHP in blood products chronically transfused to patients.
A comrnon method for removing plasma in a frozen state &om PVC sto~age bags is fracturing the bags at cryogenic temperarures, followed by shucking the bag from the frozen plasrna. That process involves dipping the entire bag and contents into liquid nitrogen. The frozen bag then is shattered, for example by dropping ths frozen bag onto a surf~e from a distance. I he frozen plasma or blood component then is removed, using a process known as "shucking", from the shattered bag fragments.
During the shusking step, when the bag fragments are removed from the plæma "pellet", often some plasma sample is lost due to ~dherence to the inside of the bag. The bag, thus, should not adsorb any of the plasma, but should perrnit the total release of all plasma from the bag walls.
By contrast, olefin bottles and bags typically are break resistant while frozcn,but are otherwise difficult to opell. Olefin bags do not readily shat~t using the liquid nitrogen ptocess desctibcd above. The p~cess required to remove plasma from frozen olefin bags and bottles involves the time consurning and cumbersome thawing, or "skin thawing", process. This process involves pattially thawing the frozen bag and plasma until the bag lifts away from the plasma surfæe. This process potentially degrades the desired prote~ns coD~aincd ill the Ifrozen plasrna Further, s~nce the olef~
bottles are not fle~uble ~hey requue subs~antial storage space due to bullc of the containers.
Medical solution bags are available on Ihe market that arc marlufactured from high concentrations of ethylene tinyl a~etate. For e~ample, one such bag contains appro~ely 18% viDyl a etate per total poiymer content. However, such bags are not useful for the fracturing process outlined above, sinc plasma adheres to the walls of the bags. Th~s, it is dif~lCUIt to get a coalplete extraction of plasma from bags having a high vinyl ace~ate content, i.e., a content above 18% vinyl æetate per total polymer content, resulti~g in sigDificant loss of product due to losses of plasma adhering to discarded film fragments.
Ethylene vinyl acetate films with vinyl acetate contents below 9% have sl~itable plasma release characteristics ds~ring the cryogenie fracturing process.
However, these films do not readily fo~m into plasma bags since they do not fonn ~-2 ~ 3 ~ 3 good radio frequency seals due to the lack of sufficient polarity in the polymerstructure. This lack of suf~lcient molecular polarity is due to the low level of the vinyl acetate component in the film structure. Radio frequency (RF) sealing is the pre~ered method of bag manufactur~ due to its known efficiency and ability to prodlJce water-5 tight, high-pressure seals.
Thus, there remains a need ~or a sa~e, effective method and bag for collecting, processing, and storing plasma and other blood protein components that permits complete recovery of the plasma sample from within the bag during a cryogenic fracnlring process.
~u~lAAy~l~QN
The present invention involves a flexible, cryogenically openable ethylene vinyl acetate (EVA) bag where the vinyl acetate component comprises between 9 and 18% of the total EVA co-polyrner. The bag may haYe an elmbossed inner s~lrfa~
to facilitate removal of the cryogenically preserved sample, Ot pellet, from the bag, as 15 described in funther detail below.
The inventive method in~volves collecting plasrna or another blood component in a flexible bag manufactwed from ethyleno vinyl acetate EVA wherein the vinyl acetate is present in an amount of between about 9% and about 189'o by weight of total ~-EVA co-polymer. Thc EVA bag is sealed, znd the plasma is frozen in the bag at a 20 temperature of appro~mately -30C to ~orm a substantially solid protein or plasrna pellet contained in the bag. l he bag then may be stored for a des~red period of timc at a sufficient temperature to rnaintain the pellot in a frozen state. The method then involves a cryogen~c fractunng process, followed by a shuckirlg process, to remove the pellet in its intact, ~zen form from the bag. The intact, frozen pellet then may be 25 fu~her prwessed for separation of biological products.
:
The freeze fracturing process ~volvos e~posing the bag, together with its contents, to a tem~ra~ of appro~mately -180C. The bag is fractured using one ofa var~ety of methods Icnown in the art to loosen the bag from the pellet. The intact, ~rozen pellet then may be removed from the bag firagmellts. The ethylene vinyl 30 acetate (EVA) material breaks into lasge, reladvely i~tact sections, with little debris.
The invendon further includes a plasma s~orage bag, having at le~t one port in communicatdon with a plasma source, for introducing plasma into the s~orage bag.The inner surface of the storage bag may include a pattern, such as an etched orembossed pattern, of sufficient dimensions so as to enhance the removai of the plasma 2~3~
c3 . ~ in a cryogenic state from the storage bag. The pattern preferably is a plurality of shapes, which may include an embossed portion thal may be either a raised shape or raised cross-hatches.
The port may be manufactured by co-extruding ethylene vinyl acetate (EVA) S with polyvinyl chloride (PVC), to form a port having an outer surface of EVA and an inner surface of PVC. The port thus rnay be integrated with an EVA bag body of the type described abo~ e and may be capable of receiving staadard PVC tubing.
Preferably, the port has a cross-sectional composition of at least about 60% total EVA
co-polymer.
The present inYention also is a plasmapheresis system havin~ a blood processing system, including a blood collection system and a separation system for separating the plasma f~om the cells in the collected sarnple. The invention includcs a plasma storage bag, in cornmlmication with the separation system, for receiving the plasma and manufactnred from ethylene vinyl ~cetate (EYA). The pheresis system may include at least one port, in co~unication with ~he separation system and the plasma storage bag9 for introducing fhe plasma from the separation system into the plasma storage bag. The port prefe~ably is co extnJded with EVA and PVC, such thal the outer I~VA layer is 60% of the tbic~ness of the port.
FIGURE I is a flow chart illustrating the invelltive method.
E:IGURE 2 is a ~ont elevation view of an e~emplary ~VA plasma bag ~hat may be used in practici~g the prosent invention.
FIGURES 3A-3B show e~emplary patterns of an embodiment of ?he present invendon.
FI~?URE 4 is an e~lemplasy plasimaphe~esis system embodying the p~esent invendon.
The present invention involves a method of collecting, processing, imd storing bl~od components, sucb as plas na, in an ethyleine ~inyl iacetate (EVA) bag, and :
specific co-polymer bags th~t may bc used in conjuncdon wi?^h the inventive method.
The invention also involvcs a~ improYed pliasmapheresis sys?~em ~ncluding a plasma 2 L ~ O ~ ~ ~
bag compnsing 9% - 18% vinyl acetate by weight of total EVA co-polymer, and having a patterned inner surface.
There are certain advantages to using EYA co-polymer material for such storage bags over using conventional PVC co-polymer rnaterial. One sueh advaotage 5 is that there is no apparent leæhing of plasticizer from the EVA bag into the blood component contents. As described above, a recently-discovered problem with the PVC bags is leæhing of DEHP into the bag contents. Furthermore, EVA has a low adsorption of protein components so tha~ recovery of pro~in components from an EVA bag is higher than with PVC bags.
For purposes of the following discussion, plasma is cited as the preferred blood component. However, other blood components, sush as platelets, may be suitable for use in COnjUnCtiOD with the method and system described herein.
ElGURE 1 is a floYv chart illustrating the method of the present inventioo. The method generally involves the steps of collecting 1~) the blood component into aflexible bag maDufactured from ~VA, then sealing 102 the bag to secure the bloodcomponent in the bag. The bag, ~vith its conlents, ne~t are frozen 104 by exposing the bag to a temperature at least as low as -30C to form a substantially solid pellet within the bag. L~ one embodiment, the pellet is stored at a sufficient temperature to maintain the pellet in a frozen state. The pellet may be removed from the bag h a substantially solid, frozen form by f~st fracturing 106 and then shucking 108 the bag.
The bag may be shipped after the ~eezing step 104 and prior to the fracturing step 106.
A prefes~ed ~orm of the storago bag 200 is shown in FIGURE 2. The bag 200 may be substantially any shapo, pre~erably having a shape that op~imizes the surface asea of the con~ents for ~eze storage.
In the illustrated embodiment, the corners 201 of the bag 200 are rounded to miaim~ze the frach~re of the &ozen pellet 210 dur~ng transport, storage, and handling to avoid brea~ing ~he bag. Sharp corners on bags tend to cause damage to the bag200, particularly during shipping and handlin~, since broken pellet fragments a~sharp if fractured and may pierce the bag. In a preferred form of the bag 200. at least one port 202 is included to coMect the bag 200 to a fill source (not shown) of blood component. One port 202 may be connected to a flexible tubing 2W that enables distal connection of other bags, fill sources, and the like.
r..... ~ x `.ii.. i;,.. ,.s.. ,.. , . .," ..... .. ..
213~3 The storage bag 200 preferably is flexible to facilitate storage, both in the empty and filled states. By minimizing the arnount of spæe the bag 200 occupies during storage, shipping, and the like, the cost of collecting, processing, and storing blood protein components may be reduced.
A preferred polymer bag 200 used in practicing the inventive method is manufactured using an ethylene vinyl acetate ~EVA) co-polymer. A preferred rangeof the vinyi acetate content is about 9% to about 18% by weight of totai EVA co-polymer, most preferably a vinyl acetate content of approximately 12 percent by weight of total EVA co-polymer. Other than having an EVA composition, the bags 200 are manufactured in the sarne n~nner as nther polymer and co-polymer bags. Por example, the bag may be manufactured from a smgle sheet of materiai, from two seaied sheets of material, from a coliapsed blown bubble of matenal, and the like.
The matonal preferably is e~uded, but may be fon~ed by other appropriate meth~s known in the art.
As mendoned above, co-polymer bags manufactured wi~h a vinyl acetate ~ ;
content of over 18% by weight of total EVA c~polymer are less desirable because plasma adheres to the bag surface. In such bags, reco~ery of proteins, such as plasm~.
is reduced since some of the plasrna remains attached to the bag. On the othor ha~d, if a co-polymer bag is manufactu~ed with a vinyl acctate content of less than ~% byweighL of total EVA c~polyrner, ~hero may be a problem with manufacturing the bag using radio frequency (RF~ signals. That is, thc resultLng RP seals may not remain wa~er-dght. Although other methods of manufacturing a sealed plastic bag, specifically a plasma bag, are available, the use of RF sealing is the proferred form in thc industry. An RF seal is clea~, efficieot, and strong. However, absent a suf~lciellt molecular polaliey as provided by the vinyl a~eta~e, R F sig~als may be reladvely L~effective.
In a pre~erred form of the presellt inYoDtion, and as shows~ in E;IGURES 3A-3B, the co~polymer bag 20() includes a psede~ermined pattern etched or embossed on the inner surface 300 of one or both sides of the bag. In the illustrated embodimen~
the patterns include raised cross-hatchings 302 or raised areas 304'. The pattern may have several fonns, such as a diamond, rectangular, square, or other polygonal shapes ~ormed by the cross-hatchings. A surprising discovery is that if the lines 302, 302' of the pattern are too close together, the plastic bag 200 does sot leadily and completely peel away from the pellet 210 dun~g the shuc~ing step 108. However, if the patte~n lines 302, 302' are too far apart, a sir~ilar di~lculty during shucking lû8 arises.
'"~ ' ''' ''.'.'.' ''' '''~ '' ` ', 2 ~ 3 In a preferred ~orrn of the invenlion, the raised portion 304' of the pattern covers at least one quarter of the raised surface area of the inner surface of each bag side. In the embodiment having a diarnond or rectangular shaped pattern, the raised portions 304' preferably are approximately 0~35 mm x 0.6 rnrn in dimension. Other S patterns and specific dimensions may be appropriate and may depend on the specific composidon of the bag 200, the manufacluring capabilities, design considerations, and the like.
Embossing or etching a pattern on the inner surface of the bag 200 has ~ :~
surprisingly been found to improve the amount of plasma recovered during the 10 shuc~ing step 108, as described above. Although shucking non-embossed bags does resul~ in the collection of plasmal often the recovery is less than for embossed bags.
1;- addition, the patterned surface, particularly the embossed portion, reduces adherence of the inner bag walls to each other during fabrication, stora~e, and shipping of the bags, prior to intsoducdon of plasma and minihnizes the amount of 15 prossure requ~red to open the bag 200 in use.
The ports 202, 202' of the illustrated embodiment of the present invendon pre~erably are co~truded with EVA and PVC. Tho ports 202, 202' include an out~r s~face material of EVA arld an ismer surfacc rna~erial of PVC. Using ports 202, 202' of this particular EVA/PVC composition, it is possible to co-mingle, RF weld~ or20 otberwise integrally form the port 202 with the EVA bag body. In a preferred embodiment, the por~s have an EVA content of about 60% of the radial thickness of the port. The ir~er PVC surface enables formadon of a solvent bond, or other type of bonding, with an external PVC tube (o.g., tubing 204 of FIWR~ 2). The use of at least one port 202 having such a composidorl optimizes the attaching of th~ bag 200 to 25 external sou~es, improvulg the ability to maintain a closed system. It may also be possible to remove the tubin~ 204 and seal the post 202~ after filli~g the bag, resulting in an EVA bag having a mi~limal amou~t of PVC and thus is "cold frieadly", maintaining its p~ope~ties when exposed to temperatures of less than about -30C for e~tended periods of time.
After collecting 10() the protein in the bag 200, the bag 201) may be sealed l02using any method ~nown to those skilled in the art. For e~ample, as discussed a~ove, the bag closu~e may be a~ RF seal. The bag 200 ne~t is exposed to a temperature suf~lcient to freeze 104 the plasma to a substan~ially solid fo~n. Preferably, the temperature at the ~eezi~g step 104 is at least as low as -30C. This ~eezing step 104 may be accomplished by placing the bag 200 into any freezer environrnent or in any o~her manner known to those skilled in the art.
: `
Once the bag and its contents are frozen, the entire assembly may be stored for subsequent use. The bags 200 may be maintained in an environment that sustains an~inimum temperature sufficient to maintain the pellet 210 in a fro~en state in the bag 200. ~.e length of storage depends on end-user requirements.
S There are several methods available for removillg the frozen pellet 210 from the EVA bag 200. The preferred method is a cryogenic fracturi~g process that involves dipping the enure bag 200, including the froæn pellet 210, into a container of liquid nitrogen for se~/eral seconds .The bag 200 next is mechanically fractured 106, or otherwise disrupted, for exaraple by impact with a solid surface. Upon impact, the bag cracks, allowing shucking 108 of the intact, solid frozen pellet. Other exemplary methods of frachlring 106 the bag include using ~aYity to crack and pull the bag 200 away from the pellet, chopping, peeling, or cutthlg the bag 200 away from the frozen pellet. In one embodiment, following the freezing step 104, the bag 200 may ~e sent to a fractionator prior to shucking 108.
In another embodiment of the invention, thc EVA bags ars used in conjuncdon with a plasmapheresis system 400, as shown in FIGURE 4. In that embodiment, a unit of blood is collectcd into a blood collcction system 402 and a separa~or system 404. In the illustrated embodiment, the blood collection system 402 includes a needle assembly 403 and an anticûagulaut assembly 405, co~nected by tubing 410. The system 401) may also include a ret~ filter 412, to remove a~y clots, and a pressure monitoring bag 414. Blood is drawn from a blood source (not shown), usmg the ~ -collecdon systern 402, and then passed through the separator system 404 to sçparate the plasrna componeD~ from thc cell component of the collected blood. In a preferred embodiment, the plasma component is collected into the plasma collecdon bag 200 of the ~e described above. The separator system 4W may include a cen~ifuge bowl (as illustrated i~ URE 4) or a~y ~rpei of f~lter system presently commercially a~railable.
The invendon is further desl~ribed by the following noQ-limiting e~ample. ~ -Plasma is collected into E~VA plasma collection bags haYin~ approxima~ely 12 percent vinyl acetate by weight total EYA co-polymer. After tho plasma collection, the bags are sealed off, frozeD at about -30C, and packaged for shipping or storage.
The bags then are removed from around the froæn plasma pellet. Removal occurs by immersing the froæn bags in a cryogenic substance, such as liquid nitrogen, 2 ~ 3 ~
for nominally 10 seconds. followed by quick manual separation of the frozen plasrna unit from the fractured bag. The EVA bag tends to remain together when fr~ctured, thus minimizing small pieces of plastic in the pool. The bag tends to fracture in the center, with the top and bottom remai~ng intact. The me hanics of the shucking S tends to be peeling the tOp nd bottom of the bag aw:ly from and o ff of the plasma pellet. ~ `
Although the discussion above indicates plasma as the preferred blood component, it should be understood that other blood components, proteins, solutions.
liquids, and the like may be suitable for use in conjunction with the present method 10 and system. The bag also may be used for coUect~ng, processing, or storing such other products. Other variations will be apparent to one skilled in the relevant art. : ~;
In prariticing the present inventive method. the plasma may be collected i~ any method known to ~hose skilled in the art. For exasnple, the EVA bags may be used in conjunctlon with a plasma coUection system generaUy known and available to those ~-15 skilled in the art. FssentiaUy ceU-free plasrna preferably is used in the present system, however, other blood components may be used in conjunction with the inventive bag and method. Any component or product of which it is desirable to store &ozen forsubsequent removal may benefit from thc pre~nt invention, particularly those components which would otheswise adsorb/adhere to plastic bags of a standard .20 composition or are of high mone~ary value and would benefit from storage in a tough, break-resistan~ bag.
Although the foregoing invention bas been descnbed in some detail by way of illustration and example for purposes of clari~y of understanding, it will be obvious that certain changes and modifications may bl~ practiced withm the scope of the 25 invention claimed herein.
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, " , . ., ,.,, : ~ . . ~, . .
~ ., :'"`.,.,,,. j,'.' '
~h~
The present invention relates to plastic bags used for the collection, 10 p}ocessing, and storage of blood products, such as plasma Specifically, the invention relates to an ethylene vinyl acetaoe bag used in the collection of human plasma,freezing the plasma after collection, storing the frozen plasma, and subsequent processing.
4~ A~
Current conta~ners used for plasma storage and processing are of t~vo principle ~s: ( 1) a polyvinyl chloride (PVC~ fle sible bag, or (2) a rigid or ser2i-rigid blow molded olefin bottle or bag.
PVC bags have bcen used for decades for freeze stonng plasma, and have the advantages of efficient manufacturability, low contai~er cost, and good blood compatibility. However, signific~nt disadvantages also exist with this type of -container. The most significant disadvantage is the fragility of the container when ~rozen. The glass transition temperatulc (Tg~, or temperature at which the film changes from flexible to brittle, is higher than the freezing temperatu~es commonly usedforplasma. ;
2S This mean~ that thç bag is flexible and reladvely strong at room tempe}ature, but becomes e~cessively brittle or glass-like when frozen. This fragility leads to some percentage of the bags breaklng duling storage and handling. Bag breakage is undesirable since it allows for potendal contam~nation (bacterial, particulate, and the lilce) ~hat can adversely iaffect the purity of productsi subseiquently made from this plasma Bacterii31 contaminadoa, ia piarticular, can adversely i~ffest protein yields and S
quiality during dle fractionadon process due to the releasie of proteolytic enzyrnes and pyrogens.
The PVC film used in the rnanUIaCtUre of the plasma bags presently on the market has routinely been manufac~ured using the plasticizer di-2-ethyl-hexyl phthalate (DEHP). Considerable arno2n~s ~f ~ 3re leach~d from the walls of the blood bags by the plasma during storage. Recently, concern has been raised over the potentially han~ful effects of DEHP in blood products chronically transfused to patients.
A comrnon method for removing plasma in a frozen state &om PVC sto~age bags is fracturing the bags at cryogenic temperarures, followed by shucking the bag from the frozen plasrna. That process involves dipping the entire bag and contents into liquid nitrogen. The frozen bag then is shattered, for example by dropping ths frozen bag onto a surf~e from a distance. I he frozen plasma or blood component then is removed, using a process known as "shucking", from the shattered bag fragments.
During the shusking step, when the bag fragments are removed from the plæma "pellet", often some plasma sample is lost due to ~dherence to the inside of the bag. The bag, thus, should not adsorb any of the plasma, but should perrnit the total release of all plasma from the bag walls.
By contrast, olefin bottles and bags typically are break resistant while frozcn,but are otherwise difficult to opell. Olefin bags do not readily shat~t using the liquid nitrogen ptocess desctibcd above. The p~cess required to remove plasma from frozen olefin bags and bottles involves the time consurning and cumbersome thawing, or "skin thawing", process. This process involves pattially thawing the frozen bag and plasma until the bag lifts away from the plasma surfæe. This process potentially degrades the desired prote~ns coD~aincd ill the Ifrozen plasrna Further, s~nce the olef~
bottles are not fle~uble ~hey requue subs~antial storage space due to bullc of the containers.
Medical solution bags are available on Ihe market that arc marlufactured from high concentrations of ethylene tinyl a~etate. For e~ample, one such bag contains appro~ely 18% viDyl a etate per total poiymer content. However, such bags are not useful for the fracturing process outlined above, sinc plasma adheres to the walls of the bags. Th~s, it is dif~lCUIt to get a coalplete extraction of plasma from bags having a high vinyl ace~ate content, i.e., a content above 18% vinyl æetate per total polymer content, resulti~g in sigDificant loss of product due to losses of plasma adhering to discarded film fragments.
Ethylene vinyl acetate films with vinyl acetate contents below 9% have sl~itable plasma release characteristics ds~ring the cryogenie fracturing process.
However, these films do not readily fo~m into plasma bags since they do not fonn ~-2 ~ 3 ~ 3 good radio frequency seals due to the lack of sufficient polarity in the polymerstructure. This lack of suf~lcient molecular polarity is due to the low level of the vinyl acetate component in the film structure. Radio frequency (RF) sealing is the pre~ered method of bag manufactur~ due to its known efficiency and ability to prodlJce water-5 tight, high-pressure seals.
Thus, there remains a need ~or a sa~e, effective method and bag for collecting, processing, and storing plasma and other blood protein components that permits complete recovery of the plasma sample from within the bag during a cryogenic fracnlring process.
~u~lAAy~l~QN
The present invention involves a flexible, cryogenically openable ethylene vinyl acetate (EVA) bag where the vinyl acetate component comprises between 9 and 18% of the total EVA co-polyrner. The bag may haYe an elmbossed inner s~lrfa~
to facilitate removal of the cryogenically preserved sample, Ot pellet, from the bag, as 15 described in funther detail below.
The inventive method in~volves collecting plasrna or another blood component in a flexible bag manufactwed from ethyleno vinyl acetate EVA wherein the vinyl acetate is present in an amount of between about 9% and about 189'o by weight of total ~-EVA co-polymer. Thc EVA bag is sealed, znd the plasma is frozen in the bag at a 20 temperature of appro~mately -30C to ~orm a substantially solid protein or plasrna pellet contained in the bag. l he bag then may be stored for a des~red period of timc at a sufficient temperature to rnaintain the pellot in a frozen state. The method then involves a cryogen~c fractunng process, followed by a shuckirlg process, to remove the pellet in its intact, ~zen form from the bag. The intact, frozen pellet then may be 25 fu~her prwessed for separation of biological products.
:
The freeze fracturing process ~volvos e~posing the bag, together with its contents, to a tem~ra~ of appro~mately -180C. The bag is fractured using one ofa var~ety of methods Icnown in the art to loosen the bag from the pellet. The intact, ~rozen pellet then may be removed from the bag firagmellts. The ethylene vinyl 30 acetate (EVA) material breaks into lasge, reladvely i~tact sections, with little debris.
The invendon further includes a plasma s~orage bag, having at le~t one port in communicatdon with a plasma source, for introducing plasma into the s~orage bag.The inner surface of the storage bag may include a pattern, such as an etched orembossed pattern, of sufficient dimensions so as to enhance the removai of the plasma 2~3~
c3 . ~ in a cryogenic state from the storage bag. The pattern preferably is a plurality of shapes, which may include an embossed portion thal may be either a raised shape or raised cross-hatches.
The port may be manufactured by co-extruding ethylene vinyl acetate (EVA) S with polyvinyl chloride (PVC), to form a port having an outer surface of EVA and an inner surface of PVC. The port thus rnay be integrated with an EVA bag body of the type described abo~ e and may be capable of receiving staadard PVC tubing.
Preferably, the port has a cross-sectional composition of at least about 60% total EVA
co-polymer.
The present inYention also is a plasmapheresis system havin~ a blood processing system, including a blood collection system and a separation system for separating the plasma f~om the cells in the collected sarnple. The invention includcs a plasma storage bag, in cornmlmication with the separation system, for receiving the plasma and manufactnred from ethylene vinyl ~cetate (EYA). The pheresis system may include at least one port, in co~unication with ~he separation system and the plasma storage bag9 for introducing fhe plasma from the separation system into the plasma storage bag. The port prefe~ably is co extnJded with EVA and PVC, such thal the outer I~VA layer is 60% of the tbic~ness of the port.
FIGURE I is a flow chart illustrating the invelltive method.
E:IGURE 2 is a ~ont elevation view of an e~emplary ~VA plasma bag ~hat may be used in practici~g the prosent invention.
FIGURES 3A-3B show e~emplary patterns of an embodiment of ?he present invendon.
FI~?URE 4 is an e~lemplasy plasimaphe~esis system embodying the p~esent invendon.
The present invention involves a method of collecting, processing, imd storing bl~od components, sucb as plas na, in an ethyleine ~inyl iacetate (EVA) bag, and :
specific co-polymer bags th~t may bc used in conjuncdon wi?^h the inventive method.
The invention also involvcs a~ improYed pliasmapheresis sys?~em ~ncluding a plasma 2 L ~ O ~ ~ ~
bag compnsing 9% - 18% vinyl acetate by weight of total EVA co-polymer, and having a patterned inner surface.
There are certain advantages to using EYA co-polymer material for such storage bags over using conventional PVC co-polymer rnaterial. One sueh advaotage 5 is that there is no apparent leæhing of plasticizer from the EVA bag into the blood component contents. As described above, a recently-discovered problem with the PVC bags is leæhing of DEHP into the bag contents. Furthermore, EVA has a low adsorption of protein components so tha~ recovery of pro~in components from an EVA bag is higher than with PVC bags.
For purposes of the following discussion, plasma is cited as the preferred blood component. However, other blood components, sush as platelets, may be suitable for use in COnjUnCtiOD with the method and system described herein.
ElGURE 1 is a floYv chart illustrating the method of the present inventioo. The method generally involves the steps of collecting 1~) the blood component into aflexible bag maDufactured from ~VA, then sealing 102 the bag to secure the bloodcomponent in the bag. The bag, ~vith its conlents, ne~t are frozen 104 by exposing the bag to a temperature at least as low as -30C to form a substantially solid pellet within the bag. L~ one embodiment, the pellet is stored at a sufficient temperature to maintain the pellet in a frozen state. The pellet may be removed from the bag h a substantially solid, frozen form by f~st fracturing 106 and then shucking 108 the bag.
The bag may be shipped after the ~eezing step 104 and prior to the fracturing step 106.
A prefes~ed ~orm of the storago bag 200 is shown in FIGURE 2. The bag 200 may be substantially any shapo, pre~erably having a shape that op~imizes the surface asea of the con~ents for ~eze storage.
In the illustrated embodiment, the corners 201 of the bag 200 are rounded to miaim~ze the frach~re of the &ozen pellet 210 dur~ng transport, storage, and handling to avoid brea~ing ~he bag. Sharp corners on bags tend to cause damage to the bag200, particularly during shipping and handlin~, since broken pellet fragments a~sharp if fractured and may pierce the bag. In a preferred form of the bag 200. at least one port 202 is included to coMect the bag 200 to a fill source (not shown) of blood component. One port 202 may be connected to a flexible tubing 2W that enables distal connection of other bags, fill sources, and the like.
r..... ~ x `.ii.. i;,.. ,.s.. ,.. , . .," ..... .. ..
213~3 The storage bag 200 preferably is flexible to facilitate storage, both in the empty and filled states. By minimizing the arnount of spæe the bag 200 occupies during storage, shipping, and the like, the cost of collecting, processing, and storing blood protein components may be reduced.
A preferred polymer bag 200 used in practicing the inventive method is manufactured using an ethylene vinyl acetate ~EVA) co-polymer. A preferred rangeof the vinyi acetate content is about 9% to about 18% by weight of totai EVA co-polymer, most preferably a vinyl acetate content of approximately 12 percent by weight of total EVA co-polymer. Other than having an EVA composition, the bags 200 are manufactured in the sarne n~nner as nther polymer and co-polymer bags. Por example, the bag may be manufactured from a smgle sheet of materiai, from two seaied sheets of material, from a coliapsed blown bubble of matenal, and the like.
The matonal preferably is e~uded, but may be fon~ed by other appropriate meth~s known in the art.
As mendoned above, co-polymer bags manufactured wi~h a vinyl acetate ~ ;
content of over 18% by weight of total EVA c~polymer are less desirable because plasma adheres to the bag surface. In such bags, reco~ery of proteins, such as plasm~.
is reduced since some of the plasrna remains attached to the bag. On the othor ha~d, if a co-polymer bag is manufactu~ed with a vinyl acctate content of less than ~% byweighL of total EVA c~polyrner, ~hero may be a problem with manufacturing the bag using radio frequency (RF~ signals. That is, thc resultLng RP seals may not remain wa~er-dght. Although other methods of manufacturing a sealed plastic bag, specifically a plasma bag, are available, the use of RF sealing is the proferred form in thc industry. An RF seal is clea~, efficieot, and strong. However, absent a suf~lciellt molecular polaliey as provided by the vinyl a~eta~e, R F sig~als may be reladvely L~effective.
In a pre~erred form of the presellt inYoDtion, and as shows~ in E;IGURES 3A-3B, the co~polymer bag 20() includes a psede~ermined pattern etched or embossed on the inner surface 300 of one or both sides of the bag. In the illustrated embodimen~
the patterns include raised cross-hatchings 302 or raised areas 304'. The pattern may have several fonns, such as a diamond, rectangular, square, or other polygonal shapes ~ormed by the cross-hatchings. A surprising discovery is that if the lines 302, 302' of the pattern are too close together, the plastic bag 200 does sot leadily and completely peel away from the pellet 210 dun~g the shuc~ing step 108. However, if the patte~n lines 302, 302' are too far apart, a sir~ilar di~lculty during shucking lû8 arises.
'"~ ' ''' ''.'.'.' ''' '''~ '' ` ', 2 ~ 3 In a preferred ~orrn of the invenlion, the raised portion 304' of the pattern covers at least one quarter of the raised surface area of the inner surface of each bag side. In the embodiment having a diarnond or rectangular shaped pattern, the raised portions 304' preferably are approximately 0~35 mm x 0.6 rnrn in dimension. Other S patterns and specific dimensions may be appropriate and may depend on the specific composidon of the bag 200, the manufacluring capabilities, design considerations, and the like.
Embossing or etching a pattern on the inner surface of the bag 200 has ~ :~
surprisingly been found to improve the amount of plasma recovered during the 10 shuc~ing step 108, as described above. Although shucking non-embossed bags does resul~ in the collection of plasmal often the recovery is less than for embossed bags.
1;- addition, the patterned surface, particularly the embossed portion, reduces adherence of the inner bag walls to each other during fabrication, stora~e, and shipping of the bags, prior to intsoducdon of plasma and minihnizes the amount of 15 prossure requ~red to open the bag 200 in use.
The ports 202, 202' of the illustrated embodiment of the present invendon pre~erably are co~truded with EVA and PVC. Tho ports 202, 202' include an out~r s~face material of EVA arld an ismer surfacc rna~erial of PVC. Using ports 202, 202' of this particular EVA/PVC composition, it is possible to co-mingle, RF weld~ or20 otberwise integrally form the port 202 with the EVA bag body. In a preferred embodiment, the por~s have an EVA content of about 60% of the radial thickness of the port. The ir~er PVC surface enables formadon of a solvent bond, or other type of bonding, with an external PVC tube (o.g., tubing 204 of FIWR~ 2). The use of at least one port 202 having such a composidorl optimizes the attaching of th~ bag 200 to 25 external sou~es, improvulg the ability to maintain a closed system. It may also be possible to remove the tubin~ 204 and seal the post 202~ after filli~g the bag, resulting in an EVA bag having a mi~limal amou~t of PVC and thus is "cold frieadly", maintaining its p~ope~ties when exposed to temperatures of less than about -30C for e~tended periods of time.
After collecting 10() the protein in the bag 200, the bag 201) may be sealed l02using any method ~nown to those skilled in the art. For e~ample, as discussed a~ove, the bag closu~e may be a~ RF seal. The bag 200 ne~t is exposed to a temperature suf~lcient to freeze 104 the plasma to a substan~ially solid fo~n. Preferably, the temperature at the ~eezi~g step 104 is at least as low as -30C. This ~eezing step 104 may be accomplished by placing the bag 200 into any freezer environrnent or in any o~her manner known to those skilled in the art.
: `
Once the bag and its contents are frozen, the entire assembly may be stored for subsequent use. The bags 200 may be maintained in an environment that sustains an~inimum temperature sufficient to maintain the pellet 210 in a fro~en state in the bag 200. ~.e length of storage depends on end-user requirements.
S There are several methods available for removillg the frozen pellet 210 from the EVA bag 200. The preferred method is a cryogenic fracturi~g process that involves dipping the enure bag 200, including the froæn pellet 210, into a container of liquid nitrogen for se~/eral seconds .The bag 200 next is mechanically fractured 106, or otherwise disrupted, for exaraple by impact with a solid surface. Upon impact, the bag cracks, allowing shucking 108 of the intact, solid frozen pellet. Other exemplary methods of frachlring 106 the bag include using ~aYity to crack and pull the bag 200 away from the pellet, chopping, peeling, or cutthlg the bag 200 away from the frozen pellet. In one embodiment, following the freezing step 104, the bag 200 may ~e sent to a fractionator prior to shucking 108.
In another embodiment of the invention, thc EVA bags ars used in conjuncdon with a plasmapheresis system 400, as shown in FIGURE 4. In that embodiment, a unit of blood is collectcd into a blood collcction system 402 and a separa~or system 404. In the illustrated embodiment, the blood collection system 402 includes a needle assembly 403 and an anticûagulaut assembly 405, co~nected by tubing 410. The system 401) may also include a ret~ filter 412, to remove a~y clots, and a pressure monitoring bag 414. Blood is drawn from a blood source (not shown), usmg the ~ -collecdon systern 402, and then passed through the separator system 404 to sçparate the plasrna componeD~ from thc cell component of the collected blood. In a preferred embodiment, the plasma component is collected into the plasma collecdon bag 200 of the ~e described above. The separator system 4W may include a cen~ifuge bowl (as illustrated i~ URE 4) or a~y ~rpei of f~lter system presently commercially a~railable.
The invendon is further desl~ribed by the following noQ-limiting e~ample. ~ -Plasma is collected into E~VA plasma collection bags haYin~ approxima~ely 12 percent vinyl acetate by weight total EYA co-polymer. After tho plasma collection, the bags are sealed off, frozeD at about -30C, and packaged for shipping or storage.
The bags then are removed from around the froæn plasma pellet. Removal occurs by immersing the froæn bags in a cryogenic substance, such as liquid nitrogen, 2 ~ 3 ~
for nominally 10 seconds. followed by quick manual separation of the frozen plasrna unit from the fractured bag. The EVA bag tends to remain together when fr~ctured, thus minimizing small pieces of plastic in the pool. The bag tends to fracture in the center, with the top and bottom remai~ng intact. The me hanics of the shucking S tends to be peeling the tOp nd bottom of the bag aw:ly from and o ff of the plasma pellet. ~ `
Although the discussion above indicates plasma as the preferred blood component, it should be understood that other blood components, proteins, solutions.
liquids, and the like may be suitable for use in conjunction with the present method 10 and system. The bag also may be used for coUect~ng, processing, or storing such other products. Other variations will be apparent to one skilled in the relevant art. : ~;
In prariticing the present inventive method. the plasma may be collected i~ any method known to ~hose skilled in the art. For exasnple, the EVA bags may be used in conjunctlon with a plasma coUection system generaUy known and available to those ~-15 skilled in the art. FssentiaUy ceU-free plasrna preferably is used in the present system, however, other blood components may be used in conjunction with the inventive bag and method. Any component or product of which it is desirable to store &ozen forsubsequent removal may benefit from thc pre~nt invention, particularly those components which would otheswise adsorb/adhere to plastic bags of a standard .20 composition or are of high mone~ary value and would benefit from storage in a tough, break-resistan~ bag.
Although the foregoing invention bas been descnbed in some detail by way of illustration and example for purposes of clari~y of understanding, it will be obvious that certain changes and modifications may bl~ practiced withm the scope of the 25 invention claimed herein.
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Claims (37)
1. Method of collecting, storing, and processing protein component from blood,comprising the steps of:
A. collecting the protein components in a flexible bag manufactured from ethylene vinyl acetate EVA, wherein vinyl acetate is present in an amount of between about 9 and about 18 percent by weight of total EVA;
B. sealing the bag;
C. exposing the bag to a temperature at least as low as about -30°C to form a substantially solid protein pellet therein; and D. removing the solid protein pellet from the bag in an intact, frozen form.
A. collecting the protein components in a flexible bag manufactured from ethylene vinyl acetate EVA, wherein vinyl acetate is present in an amount of between about 9 and about 18 percent by weight of total EVA;
B. sealing the bag;
C. exposing the bag to a temperature at least as low as about -30°C to form a substantially solid protein pellet therein; and D. removing the solid protein pellet from the bag in an intact, frozen form.
2. The method of claim 1, wherein Step D comprises exposing the bag to a mechanical impact sufficient to disengage the bag from the solid protein pellet.
3. The method of claim 1, wherein Step D comprises exposing the bag to a cryogenic substance prior to removing the solid protein pellet from the bag.
4. The method of claim 1, wherein the protein component is plasma, the method further comprising the step of, prior to Step A, separating the plasma from a collection of whole blood.
5. The method of claim 1, wherein the flexible bag further comprises at least one port, in communication with a blood source, the port comprising an outer port surface material including an ethylene vinyl acetate (EVA) and an inner surface materialincluding a polyvinyl chloride (PVC), the method comprising the further step of:
prior to Step A, attaching a tubing, including a polyvinyl chloride (PVC), to the port.
prior to Step A, attaching a tubing, including a polyvinyl chloride (PVC), to the port.
6. The method of claim 1,2,3,4 or 5, wherein Step B further comprises:
detaching the tubing from the port; and sealing the port.
detaching the tubing from the port; and sealing the port.
7. A flexible storage bag for collecting, processing, and storing plasma, the bag comprising:
A. a predetermined amount of ethylene vinyl acetate; and B. an inner bag surface, in communication with the plasma, including a pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the storage bag.
A. a predetermined amount of ethylene vinyl acetate; and B. an inner bag surface, in communication with the plasma, including a pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the storage bag.
8. The plasma storage bag of claim 7, wherein the pattern further comprises anembossed portion.
9. The storage bag of claim 8, wherein the embossed portion covers at least about one quarter of the inner bag surface.
10. The storage bag of claim 7, wherein vinyl acetate is present in an amount of between 9 and about 18 percent by weight of total EVA.
11. The storage bag of claim 7, further comprising at least one port, in communication with a plasma source, for introducing the plasma from the plasma source into the storage bag.
12. The plasma storage bag of claim 11, wherein the port comprises:
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
13. The plasma storage bag of claim 12, wherein the outer port surface materialcomprises at least about 60 percent EVA radial thickness.
14. In a plasmapheresis system. including a blood collection system and a separation system, the improvement comprising:
a plasma storage bag, in communication with the separation system, for containing an amount of plasma and manufactured from ethylene vinyl acetate EVA,wherein vinyl acetate is present in an amount of between about 9 and about 18 percent by weight of total EVA.
a plasma storage bag, in communication with the separation system, for containing an amount of plasma and manufactured from ethylene vinyl acetate EVA,wherein vinyl acetate is present in an amount of between about 9 and about 18 percent by weight of total EVA.
15. The system of claim 14, wherein the vinyl acetate is present in an amount of bout 12 percent by weight of total EVA.
16. The system of claim 14, wherein the plasma storage bag further comprises:
an inner surface of the plasma storage bag, in communication with the plasma, including a pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the plasma storage bag.
an inner surface of the plasma storage bag, in communication with the plasma, including a pattern of sufficient dimensions to permit removal of the plasma in a frozen state from the plasma storage bag.
17. The system of claim 16, wherein the pattern further comprises an embossed portion.
18. The system of claim 17, wherein the embossed position covers at least aboutone quarter of the inner surface.
19. The system of claim 14, further comprising:
at least one port, in communication with the blood collection system and the plasma storage bag, for introducing the plasma from the blood collection system into the plasma storage bag.
at least one port, in communication with the blood collection system and the plasma storage bag, for introducing the plasma from the blood collection system into the plasma storage bag.
20. The system of claim 19, wherein the port comprises:
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
21. The system of claim 20, wherein the outer port surface material comprises at least about 60 percent EVA radial thickness.
22. A copolymer bag comprising about 9 to about 18 percent vinyl acetate by weight of total polymer.
23. The bag of claim 22 comprising about 12 percent vinyl acetate by weight total polymer.
24. The bag of claim 22, further comprising a quantity of a blood product contained therewithin.
25. The bag of claim 24, wherein the blood product comprises plasma.
26. The bag of claim 25, wherein the plasma comprises frozen plasma.
27. The bag of claim 24, further comprising:
an inner surface of the bag, in communication with the blood product, including a pattern of predetermined dimensions.
an inner surface of the bag, in communication with the blood product, including a pattern of predetermined dimensions.
28. The bag of claim 249 further comprising:
at least one port for introducing the blood product into the bag.
at least one port for introducing the blood product into the bag.
29. The bag of claim 28, wherein the port comprises:
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
30. The bag of claim 29, wherein the outer port surface material comprises at least about 60 percent EVA radial thickness.
31. A blood product storage bag for collecting and storing a blood product sample, the bag comprising:
an inner bag surface, in communication with the blood product sample, including a pattern of sufficient dimensions to permit removal of the blood product sample in a frozen state from the storage bag.
an inner bag surface, in communication with the blood product sample, including a pattern of sufficient dimensions to permit removal of the blood product sample in a frozen state from the storage bag.
32. The storage bag of claim 31, wherein the pattern further comprises an embossed portion.
33. The storage bag of claim 32, wherein the embossed portion covers at least about one quarter of the inner bag surface.
34. The storage bag of claim 31, further comprising ethylene vinyl acetate EVA,wherein vinyl acetate is present in an amount of between about 9 and about 18 percent by weight of total polymer.
35. The storage bag of claim 31, further comprising:
at least one port, in communication with a blood product source, for introducing blood product sample from the blood product source into the storage bag.
at least one port, in communication with a blood product source, for introducing blood product sample from the blood product source into the storage bag.
36. The storage bag of claim 35, wherein the port comprises:
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
an outer port surface material including an ethylene vinyl acetate (EVA); and an inner port surface material including a polyvinyl chloride (PVC).
37. The storage bag of claim 36, wherein the outer port surface material comprises at least about 60 percent EVA radial thickness.
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| US12352193A | 1993-09-17 | 1993-09-17 | |
| US08/123,521 | 1993-09-17 |
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| CA002130893A Abandoned CA2130893A1 (en) | 1993-09-17 | 1994-08-25 | Method and system for collecting, processing and storing blood components |
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| CA2130893A1 (en) * | 1993-09-17 | 1995-03-18 | Bayer Corporation | Method and system for collecting, processing and storing blood components |
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| DE19534455C1 (en) * | 1995-09-16 | 1996-12-12 | Fresenius Ag | Multilayer plastics tube free from PVC, for medical purposes |
-
1994
- 1994-08-25 CA CA002130893A patent/CA2130893A1/en not_active Abandoned
- 1994-08-26 AU AU71502/94A patent/AU7150294A/en not_active Abandoned
- 1994-09-08 EP EP94114136A patent/EP0648507A1/en not_active Ceased
-
1995
- 1995-06-06 US US08/466,614 patent/US5578027A/en not_active Expired - Fee Related
- 1995-06-06 US US08/467,474 patent/US5578028A/en not_active Expired - Fee Related
- 1995-08-16 US US08/515,692 patent/US6045546A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP0648507A1 (en) | 1995-04-19 |
| AU7150294A (en) | 1995-03-30 |
| US5578027A (en) | 1996-11-26 |
| US5578028A (en) | 1996-11-26 |
| US6045546A (en) | 2000-04-04 |
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Legal Events
| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Dead |