EP0076062B1 - Behälter zur Speicherung von Blutkomponenten - Google Patents

Behälter zur Speicherung von Blutkomponenten Download PDF

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Publication number
EP0076062B1
EP0076062B1 EP82304876A EP82304876A EP0076062B1 EP 0076062 B1 EP0076062 B1 EP 0076062B1 EP 82304876 A EP82304876 A EP 82304876A EP 82304876 A EP82304876 A EP 82304876A EP 0076062 B1 EP0076062 B1 EP 0076062B1
Authority
EP
European Patent Office
Prior art keywords
juncture
closure seam
bag according
bag
weakenings
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.)
Expired
Application number
EP82304876A
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English (en)
French (fr)
Other versions
EP0076062A2 (de
EP0076062A3 (en
EP0076062B2 (de
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23181023&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0076062(B1) "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

    • 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

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.
  • 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 a 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.
  • the system just described is the subject of GB-A-2,044,220.
  • the blood product collection bag of that system is made of flexible material and has a body with front and rearfaces and there is a closure seam at or adjacent an end of the body. As noted above, this bag has to be cut open to free the frozen plasma, which is then ejected from the bag by squeezing the bag.
  • the 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 so constructed that a manually applied opening force exerted thereon causes the body to rupture at predetermined locations and to tear open along predetermined lines, thus affording separation of the body from the frozen plasma without any necessity for the bag being cut by a knife or any other instrument, or for the plasma to be contacted by the hands.
  • a blood product storage bag made of .flexible material and having a body with front and rear faces and a closure seam at or adjacent an end of the body, characterised by the body having an easy-open frangible construction provided by opposed weakenings, one in each of the said faces, which extend to the closure seam and are aligned with one another thereat, and stress-concentrating means which concentrate an applied opening force at the juncture of the seam and said weakenings for causing the body to rupture at the juncture and be torn open along the weakenings to separate the bag from its contents.
  • the closure seam can be of V-shape configuration, the point of which intersects the juncture, the said closure seam defining a V-shape removable portion of body material on the side of the closure seam which is opposite the weakenings whereby the closure seam may be ruptured at the juncture and the body torn open along the weakenings 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 of -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 weakening lines comprising frangible seams 20 or similar running from the.top to the bottom of the body (as oriented in Fig. 1).
  • the seams join one another at a juncture 22.
  • the lines 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 juncture 22 of the frangible lines 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 juncture 22 to one side of (in this instance above) the closure seam 24, opposite the frangible lines 20.
  • the edges of the ears 26 are rounded and converge toward the juncture 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 juncture 22 to the edges of the body 10.
  • the ribs 28 define portions 30 of the body lying laterally of the juncture 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 or concentrating force at the juncture 22.
  • the bag ruptures at the juncture 22 permitting the body 10 to be torn apart along the frangible lines 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 juncture with the frangible lines 20.
  • the closure seam 24 has a notch 34 aligned with the juncture 22 to concentrate rupturing force at the juncture 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 juncture 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 juncture 22 to initiate tearing of the frangible lines 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 juncture with the frangible seams 20.
  • the ribs 28a and 28b also converge at the juncture and as described above define unfilled areas 30.
  • the ribs 28a and 28b converge at the juncture.
  • 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 juncture 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 juncture 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 lines 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, seams and lines also formed by heat sealing.
  • Another method would be by forming the entire bag by blow molding.
  • the various ribs, seams and lines would be formed in the mold cavity and imparted to the bag in the blow molding process.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
  • Packages (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Bag Frames (AREA)

Claims (14)

1. Beutel zur Speicherung von Blutkomponenten aus flexiblem Material mit einem Aufnahmeteil (10) mit einer Vorder- und einer Rückseite sowie einer Verschlußnaht (24) am oder nahe dem Ende des Aufnahmeteils, dadurch gekennzeichnet, daß der Aufnahmeteil (10) eine leicht zu öffnende aufreißbare Konstruktion aufgrund von einander gegenüberliegenden Schwächungen (20) aufweist, von denen eine in jeder der Beutelseiten vorgesehen ist und die zur Verschlußnaht (24) hinlaufen und dort miteinander in Übereinstimmung gebracht sind, und daß Spannungskonzentrationsmittel (z.B. 34) vorgesehen sind, die eine aufgebrachte Öffnungskraft an der Verbindungsstelle (22) der Verschlußnaht (24) und der Schwächungen (20) für ein Aufreißen des Aufnahmeteils an der Verbindungsstelle (22) und ein Auftrennen entlang den Schwächungen (20) zur Trennung des Beutels von seinem Inhalt konzentrieren.
2. Beutel nach Anspruch 1, gekennzeichnet durch Bereiche (26; 30) des Aufnahmeteils (10), die seitlich der Verbindungsstelle (22) angeordnet sind und Handhabungsmittel zum Aufbringen der Öffnungskraft bilden, die an der Verbindungsstelle (22) konzentriert ist.
3. Beutel nach Anspruch 1 oder 2, gekennzeichnet durch Rippen (28), die von der Verschlußnaht (24) ausgehen, von der Verbindungsstelle (22) fort divergieren und unbefüllte Bereiche (30) des Aufnahmeteils (10) begrenzen, die ergriffen werden können, um die Öffnungskraft aufzubringen, die in der Verbindungsstelle (22) konzentriert ist.
4. Beutel nach Anspruch 3, dadurch gekennzeichnet, daß die Rippen (28a, 28b) fluchtende lineare Verlängerungen einer V-förmigen Verschlußnaht (24) sind.
5. Beutel nach Anspruch 1, 2, 3 oder 4, dadurch gekennzeichnet, daß seitlich der Verbindungsstelle (22) auf der Seite der Verschlußnaht (24) gegenüber den Schwächungen (20) Bereiche (26) des flexiblen Materials liegen und derart geformt sind, daß sich die Öffnungskraft an der Verbindungsstelle bei einem Auseinanderziehen der seitlichen Bereiche (26) konzentriert.
6. Beutel nach einem der Ansprüche 1 bis 3 oder 5, dadurch gekennzeichnet, daß die Verschlußnaht (24) im wesentlichen entlang einer geraden Linie verläuft.
7. Beutel nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die Verschlußnaht (24) eine V-Form besitzt, die an der Verbindungsstelle (22) zum Konzentrieren der Öffnungskraft an dieser Stelle zusammenläuft.
8. Beutel nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß die Verschlußnaht (24) zum Konzentrieren der Öffnungskraft an der Verbindungsstelle (22) eingekerbt ist (bei 34).
9. Beutel nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß der Aufnahmeteil (10) von Folie gebildet ist und die Schwächungen (20) und die Verschlußnaht (24) bildende Nähte durch Heißsiegeln gebildet sind.
10. Beutel nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß der Aufnahmeteil (10) durch Blasformen gebildet ist.
11. Beutel nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß er aus Kunststoffmaterial besteht, das bei einer Temperatur von -25°C bis -80°C flexibel bleibt.
12. Beutel nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, daß wegnehmbares Material (40,42) auf einer Seite der Verschlußnaht (24) gegenüber den Schwachungen (20) vorgesehen ist, um die Festigkeit des Behälters zu erhöhen und es unwahrscheinlich zu machen, daß die Verschlußnaht (24) vorzeitig aufgerissen wird.
13. Beutel nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, daß die Verschlußnaht (24) eine V-förmige Gestalt aufweist, die Spitze des V die Verbindungsstelle (22) schneidet und die Verschlußnaht einen V-förmigen wegnehmbaren Bereich (40) des Aufriahmeteilmaterials auf der Seite der Verschlußnaht begrenzt, die den Schwächungen (20) gegenüberliegt, wodurch die Verschlußnaht (24) an der Verbindungsstelle (22) aufgerissen und der Aufnahmeteil (10) entlang den Schwächungen (20) offengetrennt werden kann, um ihn von seinem Inhalt nach dem Entfernen des V-förmigen Aufnahmeteilmaterials zu trennen.
14. Beutel nach Anspruch 13, gekennzeichnet durch Schwächungslinien (46), die den wegnehmbaren Bereich (40) vom verbleibenden Bereich des Aufnahmeteils (10) trennen.
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 EP0076062A2 (de) 1983-04-06
EP0076062A3 EP0076062A3 (en) 1984-03-28
EP0076062B1 true 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)

Families Citing this family (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
EP0159792A3 (de) * 1984-03-16 1986-11-20 Tuta Laboratories (Australia) Pty Ltd. Beutelreissmaschine
GB2161453B (en) * 1984-07-13 1989-05-17 Tuta Lab Plasma bags

Family Cites Families (9)

* 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
JPS4813052U (de) * 1971-06-25 1973-02-14
US3913789A (en) * 1974-02-13 1975-10-21 United States Banknote Corp Fluid container of the flexible wall capsule type
US4253458A (en) * 1979-03-08 1981-03-03 Baxter Travenol Laboratories, Inc. Method and apparatus for collecting blood plasma
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
FR2495583A1 (fr) * 1980-12-09 1982-06-11 Boncolac Sa Perfectionnement aux doses unitaires de creme glacee conditionnee pour une consommation individuelle

Also Published As

Publication number Publication date
DE3272155D1 (en) 1986-08-28
EP0076062A2 (de) 1983-04-06
JPS5864953A (ja) 1983-04-18
JPH0563381B2 (de) 1993-09-10
EP0076062A3 (en) 1984-03-28
DK426382A (da) 1983-03-26
AU8756582A (en) 1983-03-31
ATE20821T1 (de) 1986-08-15
ES276158Y (es) 1985-03-01
EP0076062B2 (de) 1989-12-27
ES276158U (es) 1984-08-01

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