EP0076062A2 - Behälter zur Speicherung von Blutkomponenten - Google Patents

Behälter zur Speicherung von Blutkomponenten Download PDF

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Publication number
EP0076062A2
EP0076062A2 EP82304876A EP82304876A EP0076062A2 EP 0076062 A2 EP0076062 A2 EP 0076062A2 EP 82304876 A EP82304876 A EP 82304876A EP 82304876 A EP82304876 A EP 82304876A EP 0076062 A2 EP0076062 A2 EP 0076062A2
Authority
EP
European Patent Office
Prior art keywords
apex
closure seam
container according
seam
seams
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.)
Granted
Application number
EP82304876A
Other languages
English (en)
French (fr)
Other versions
EP0076062B1 (de
EP0076062B2 (de
EP0076062A3 (en
Inventor
Richard M. Lueptow
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.)
Latham Labs Inc Te Braintree Massachusetts Ver
Original Assignee
Haemonetics Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23181023&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0076062(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Haemonetics Corp filed Critical Haemonetics Corp
Priority to AT82304876T priority Critical patent/ATE20821T1/de
Publication of EP0076062A2 publication Critical patent/EP0076062A2/de
Publication of EP0076062A3 publication Critical patent/EP0076062A3/en
Publication of EP0076062B1 publication Critical patent/EP0076062B1/de
Application granted granted Critical
Publication of EP0076062B2 publication Critical patent/EP0076062B2/de
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers

Definitions

  • This invention relates generally to the field of blood component therapy and more particularly relates to containers for apparatus for the collecting, storing and dispensing of blood plasma to be processed into blood components such as albumin, globulins and so on.
  • a relatively modern medical technology known as blood component therapy involves administering to a patient just that part of the blood that he actually needs. Rather than whole blood, the physician decides what portion or component of blood is necessary for the patient and administers only that component to him. He, thus, avoids many of the hazards which are inherent in whole blood usage. Not only is the practice better for the patient in that certain risks involving transfusing whole blood are reduced, but it permits one unit of donated blood to be used for more than one patient. For example, from one unit of whole blood, which subsequently is fractionated; there may be derived red blood cells, platelets, fresh plasma, frozen or stored plasma, albumin, globulins and so on.
  • cell separators permit the separation of blood into its components while the donor is in the process of making a donation.
  • a blood bank it is possible for a blood bank to take from the donor specific components which are needed by a patient while other components are returned simultaneously to the donor.
  • the plasma is separated from the cellular elements of the blood and the cells returned to the donor.
  • the plasma is then subsequently used for blood volume expansion or blood augmentation in the form of stored plasma or fresh frozen plasma.
  • the plasma can also be processed into a number of useful products such as albumin, globulins and antihemophiliac factor. It is to this purpose that the present invention is directed.
  • Plasma Blood is collected from the donor in a connected, sealed collection system and then centrifuged to separate the cells and the plasma.
  • the cells are returned to the donor and the plasma is subsequently frozen in the collection bag.
  • the plasma may be stored for a number of months before being removed for plasma component manufacturing. Subsequently, large quantities of plasma are batch processed, i.e., plasma from many donors.
  • Present practice involves receiving blood from the donor in a collection system and centrifuging it so that the plasma is collected in one of the bags of the system.
  • the plasma containing bag is then separated from the rest of the collection system and is stored after freezing its contents, all prior to processing weeks or months later. Subsequently, many bags are opened, and the plasma put in a container for batch processing.
  • the present invention is directed to an "easy-open" plasma bag which need not be cut to remove the plasma.
  • The"easy-open" bag which holds the plasma is a sealable container of flexible material. It comprises a body having frangible seams joined in an apex. A closure seam seals the body and intersects the apex transversely of the frangible seams.
  • the bag is so constructed as to direct a manually applied force to the apex whereby the closure seam ruptures at the apex and the body tears open along the frangible seams and is separated from the frozen plasma without any necessity for the bag being cut by a knife or any other instrument.
  • an "easy-open" container of flexible material for use in blood component storage characterised by a body having frangible seams therein meeting at an apex of the body, and a closure seam sealing the body and intersecting the apex, the container construction serving to direct an applied opening force to the apex whereby in use the closure seam may be ruptured at the apex and the body torn along the frangible seams to separate the body from its contents.
  • the invention also provides a container of flexible material for using in blood component storage, characterised by a body having frangible seams therein joined at an apex and a closure seam of V-shape configuration sealing the body and transversely intersecting the apex, the said closure seam defining a V-shape removable portion of body material on the side of the closure seam which is opposite the frangible seams whereby the closure seam may be ruptured at the apex and the body torn open along the frangible seams to separate it from its contents after the V-shape body material is removed.
  • the bag is provided with means which may be gripped by hand to facilitate the application of the rupturing force.
  • the bag is preferably formed of a material which is capable of remaining flexible at temperatures of -25 to -80°C, e.g. of polyolefinic type.
  • Fig. 1 shows a transfer bag embodying the present invention.
  • the bag was used as part of multiple bag collection system and is now in an inverted position and containing frozen plasma ready for opening.
  • the body 10 of the bag communicated with a donor bag (not shown) by means of a flexible tube 12, the tube now being closed by a conventional seal 14.
  • the bag includes hanger holes 16 which may be employed when the donor bag is being filled.
  • the bag comprises a sealable container of flexible plastics material such as polyolefin of 6 mils thickness (0.15 mm) which is capable of remaining flexible at temperatures from -25 to -80°C, i.e. the range of temperatures in which plasma is frozen and stored.
  • the body 10 of the container includes a pair of frangible seams 20 running from the top to the bottom of the body (as oriented in Fig. 1). The seams are joined at an apex 22.
  • the seams 20 will be seen to be located at opposite sides of the body 10 and in a plane bisecting the body.
  • a closure seam 24 Transversely intersecting the apex 22 of the frangible seams 20 is a closure seam 24 which is of greater width than the width of the frangible seams.
  • a pair of ears 26 lie laterally of the apex 22 to one side of (in this instance above) the closure seam 24, opposite the frangible seams 20.
  • the edges of the ears 26 are rounded and converge toward the apex 22.
  • the closure seam 24 is essentially along a straight line, sealing the top of the bag and separating the interior of the body from the ears 26.
  • ribs 28 are formed in the body and extend from the closure seam 24 in diverging directions away from the apex 22 to the edges of the body 10.
  • the ribs 28 define portions 30 of the body lying laterally of the apex which are sealed from the interior of the body and accordingly contain no plasma.
  • the ears 26 alone or together with the closure seam 24 and/or the portions 30 are gripped and pulled apart either as shown in Fig. 2 or in Fig. 3, thereby directing force to the apex 22.
  • the bag ruptures at the apex 22 permitting the body 10 to be torn apart along the frangible seams 20 whereby the flexible plastics film may be peeled away from the frozen plasma within the bag and the plasma allowed to fall into a collection container without being touched by a knife or other opening instrument, or by the hands.
  • the bag of course would be inverted from the positions shown in Figs. 1, 2 and 3 for releasing its contents. While Figs. 2 and 3 show the flexible container being torn apart by bare hands, some may prefer to wear gloves-as insulation from the cold contents.
  • opening required the bag to be cut open with a knife to expose the plasma as well as thawing of its contents slightly from the outside inwardly to release the frozen plasma from the inner surface of the bag. Because of the construction of the present invention, the bag need not be cut. Since the bag is essentially peeled back away from the frozen plasma, there is no skin thawing necessary preparatory to opening the bag.
  • Fig. 4 shows an alternative construction of the openable portion of the bag.
  • the closure seam 24, as in the Fig. 1 construction, is essentially a straight line running across top of the bag intersecting the apex 22 of the frangible seams 20.
  • the closure seam 24 has a notch 34 aligned with the apex 22 to concentrate rupturing force at the apex 22.
  • FIG. 5 Another alternative construction of the body is shown in Fig. 5.
  • the closure seam 24 is of V-shape configuration comprising portions 24a and 24b converging toward the apex 22.
  • Ribs 28 define areas 30 equivalent to the portions 30 in the Fig. 1 construction. Again, the ribs 28 and unfilled areas 30 are optional. However, since there are no ears, it would be the closure seam portions 24a and 24b (with the portions 30 if provided) that would be gripped and pulled apart.
  • the V-shape configuration of the seam 24 concentrates the applied force at the apex 22 to initiate tearing of the frangible seams 20.
  • Figs. 6 and 7 show another alternative construction.
  • the closure seam 24 as in the Fig. 5 construction is of V-shape configuration converging at the apex 22 of the frangible seams 20.
  • the ribs 28a and 28b also converge at the apex 22 and as described above define unfilled areas 30.
  • the ribs 28a and 28b converge at the apex 22.
  • the closure seam portions 24a and the rib 28a are aligned linear extensions of each other as are the seam portion 24b and the rib 28b.
  • the triangular portion 40 remains attached to the bag until it is ready to be opened. It will be noted in Fig. 6 that a line of serrations 46 extend along the closure seam portions 24a and 24b. The provision of the triangular portion 40 lends additional strength to the bag to guarantee against premature rupture at the apex 22.
  • the portion 40 is torn from the bag along the lines of serration 46 rendering the bag as it appears in Fig. 7. Thereafter, the portions 30 and/or the closure seam portions 24a and 24b may be gripped and pulled apart to develop and concentrate rupturing force at the apex 22 as in above described constructions.
  • the various constructions may be fabricated in various ways. They may be made by cutting off blanks from a continuous tube of polyolefin material and forming the frangible seams 20, the bottom 36, the closure seam 24, and the ribs 28 by heat sealing. Another method of fabrication would be to start with sheet material folded upon itself with the various ribs and seams also formed by heat sealing.
  • Another method would be by forming the entire bag by blow molding.
  • the various ribs and seams would be formed in the mold cavity and imparted to the bag in the blow molding process.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • External Artificial Organs (AREA)
  • Bag Frames (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP82304876A 1981-09-25 1982-09-16 Behälter zur Speicherung von Blutkomponenten Expired EP0076062B2 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT82304876T ATE20821T1 (de) 1981-09-25 1982-09-16 Behaelter zur speicherung von blutkomponenten.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30549081A 1981-09-25 1981-09-25
US305490 1981-09-25

Publications (4)

Publication Number Publication Date
EP0076062A2 true EP0076062A2 (de) 1983-04-06
EP0076062A3 EP0076062A3 (en) 1984-03-28
EP0076062B1 EP0076062B1 (de) 1986-07-23
EP0076062B2 EP0076062B2 (de) 1989-12-27

Family

ID=23181023

Family Applications (1)

Application Number Title Priority Date Filing Date
EP82304876A Expired EP0076062B2 (de) 1981-09-25 1982-09-16 Behälter zur Speicherung von Blutkomponenten

Country Status (7)

Country Link
EP (1) EP0076062B2 (de)
JP (1) JPS5864953A (de)
AT (1) ATE20821T1 (de)
AU (1) AU8756582A (de)
DE (1) DE3272155D1 (de)
DK (1) DK426382A (de)
ES (1) ES276158Y (de)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2133383A (en) * 1983-01-14 1984-07-25 Scottish Health Service Common Plasma bags
EP0159792A2 (de) * 1984-03-16 1985-10-30 Tuta Laboratories (Australia) Pty Ltd. Beutelreissmaschine
EP0167955A2 (de) * 1984-07-13 1986-01-15 Miles Inc. Plasmabeutel

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE533018A (de) *
US3051368A (en) * 1958-11-28 1962-08-28 Schneider Dispensing container
US3412918A (en) * 1966-10-31 1968-11-26 Phillips Petroleum Co Dispensing container
DE2023419A1 (de) * 1970-05-13 1971-11-25 Imbert, Daniel, Marseille; Chaput, Jean-Guy, Cannes; (Frankreich) Kapseln zur Verpackung von Zäpfchen
US3913789A (en) * 1974-02-13 1975-10-21 United States Banknote Corp Fluid container of the flexible wall capsule type
GB2044220A (en) * 1979-03-08 1980-10-15 Baxter Travenol Lab Multiple-bag blood collection system and a method of emptying separated plasma from bag of said system
FR2495583A1 (fr) * 1980-12-09 1982-06-11 Boncolac Sa Perfectionnement aux doses unitaires de creme glacee conditionnee pour une consommation individuelle

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4813052U (de) * 1971-06-25 1973-02-14
JPS55158844U (de) * 1979-05-02 1980-11-14
JPS5943225Y2 (ja) * 1980-11-10 1984-12-20 株式会社生産日本社 合成樹脂製袋

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE533018A (de) *
US3051368A (en) * 1958-11-28 1962-08-28 Schneider Dispensing container
US3412918A (en) * 1966-10-31 1968-11-26 Phillips Petroleum Co Dispensing container
DE2023419A1 (de) * 1970-05-13 1971-11-25 Imbert, Daniel, Marseille; Chaput, Jean-Guy, Cannes; (Frankreich) Kapseln zur Verpackung von Zäpfchen
US3913789A (en) * 1974-02-13 1975-10-21 United States Banknote Corp Fluid container of the flexible wall capsule type
GB2044220A (en) * 1979-03-08 1980-10-15 Baxter Travenol Lab Multiple-bag blood collection system and a method of emptying separated plasma from bag of said system
FR2495583A1 (fr) * 1980-12-09 1982-06-11 Boncolac Sa Perfectionnement aux doses unitaires de creme glacee conditionnee pour une consommation individuelle

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2133383A (en) * 1983-01-14 1984-07-25 Scottish Health Service Common Plasma bags
EP0159792A2 (de) * 1984-03-16 1985-10-30 Tuta Laboratories (Australia) Pty Ltd. Beutelreissmaschine
EP0159792A3 (de) * 1984-03-16 1986-11-20 Tuta Laboratories (Australia) Pty Ltd. Beutelreissmaschine
EP0167955A2 (de) * 1984-07-13 1986-01-15 Miles Inc. Plasmabeutel
GB2161453A (en) * 1984-07-13 1986-01-15 Tuta Lab Plasma bags
US4619650A (en) * 1984-07-13 1986-10-28 Miles Laboratories, Inc. Plasma bags
GB2161453B (en) * 1984-07-13 1989-05-17 Tuta Lab Plasma bags
EP0167955B1 (de) * 1984-07-13 1990-02-28 Miles Inc. Plasmabeutel

Also Published As

Publication number Publication date
ES276158Y (es) 1985-03-01
EP0076062B1 (de) 1986-07-23
DK426382A (da) 1983-03-26
AU8756582A (en) 1983-03-31
ATE20821T1 (de) 1986-08-15
DE3272155D1 (en) 1986-08-28
EP0076062B2 (de) 1989-12-27
JPH0563381B2 (de) 1993-09-10
ES276158U (es) 1984-08-01
EP0076062A3 (en) 1984-03-28
JPS5864953A (ja) 1983-04-18

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