Stock material or miscellaneous articles – Hollow or container type article – Nonself-supporting tubular film or bag
Patent
1996-05-28
2000-01-25
Teskin, Fred
Stock material or miscellaneous articles
Hollow or container type article
Nonself-supporting tubular film or bag
428 352, 428 357, 428 366, 428 43, 428500, 428516, 604410, 604416, 206219, 206828, 383 38, 383200, 383207, 1563063, A61J 110, B32B 706
Patent
active
060175982
DESCRIPTION:
BRIEF SUMMARY
The invention concerns a multilayer polymer film for a multichamber medical bag for preparation of mixed medical solutions, which has at least two chambers which are separated from each other by a sealed separation zone to be opened and are sealed in the outer border zone, whereby in the seam of the outer border zone at least one tube is provided in at least one chamber.
Multichamber medical bags have been used for years for preparation of mixed solutions. The known multichamber bags have different systems as separation arrangements between the chambers.
One of these systems uses breakable separation parts made of rigid, breakable materials. These have the advantage of largely universal applicability, but have disadvantages to the extent that they only free a limited breaking or mixing opening and undesirable particle formation may occur upon breakage of the separation arrangement.
Such a system, which has a predetermined breaking point in the chamber separation zone, which can be broken, for example, by exerting pressure on one chamber, is disclosed in EP 0 378 183, whereby a peel strip is also advantageously included in the seal in the zone of the predetermined breaking point.
A second type of separation arrangement is designed as a squeezing system, which presses the films of the bag, for example, by means of external clamps for sealing and can be opened before use. The advantages of such squeezing systems lie in the possible large mixing opening which can as a rule be produced without any particles. However, such systems are disadvantageous to the extent that they are limited to film materials for the bags which must have high elasticity and temperature resistance in order to effect the desired separation. Often, such systems have leaks. In order to avoid these, it is necessary to precisely coordinate the tolerances of bag thickness and the squeezing system to each other.
In order not to be restricted in squeezing systems to certain types of films as materials for the multichamber bag and to improve the separation action, according to German patent DE 41 07 223, an elastic strip of film which serves as a seal during activation of the squeezing device is disposed is the region of the later mixing opening. Because of the squeezing arrangement and the strip of film, this system has the disadvantage that it is very expensive.
Consequently, the object of the invention is to make available another film for a multichamber medical bag which, upon sealing at a first low temperature, produces a peelable seam and, upon sealing at a second temperature, produces a durable seam.
This object is achieved according to the invention in that the layer of the multilayer film facing the chambers has essentially two components, i.e., a matrix polymer and a phase polymer. The surprising advantage of the multichamber bag made from the film according to the invention lies in the fact that it is possible, because of the polymer material facing the chambers, to form both inseparable seams in the outer border zone and subsequently separable seams in the chamber separation zone.
A seam in the chamber separation zone should be separable with a force in the range from 5 to 20 N. If the seam is separable with a force of less than 5 N, no reliable separation of the chambers is possible, since the bond can release by itself, for example, as a result of slight shocks during transport which exert pressure on one or a plurality of chambers. At a force of 20 N, the seam is can be separated only with great difficulty. There is the danger that instead of the seam, the film will tear and the bag will thus become leaky.
Moreover, the separation force of the seam must be high enough that the bag can withstand a drop from a two-meter height.
The above-described multichamber bag made of the film according to the invention permits a very simple design since neither breakable separation parts nor squeezing arrangements are required. Also, no additional sealing and film materials are needed in the chamber separation zone.
Nevertheless, a reliable se
REFERENCES:
patent: 4210686 (1980-07-01), Gajewski et al.
patent: 4496046 (1985-01-01), Stone et al.
patent: 4778697 (1988-10-01), Genske et al.
Heilmann Klaus
Kreischer Thomas
Nicola Thomas
Zimmermann Michael
Fresenius AG
Teskin Fred
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