Surgery – Container for blood or body treating material – or means used... – Bag type
Reexamination Certificate
1999-12-01
2003-12-09
Sykes, Angela D. (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Bag type
C604S410000, C604S411000, C604S416000, C604S903000, C220S277000, C383S202000
Reexamination Certificate
active
06659994
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a bag arrangement including a bag for accommodating a first substance to be inserted, in particular, into the human or animal body and having at least one jacket enclosed on all sides and a piercing device attached to the jacket or to be attached to it, with the piercing device having means for piercing the jacket.
2. Description of the Prior Art
SUMMARY OF THE INVENTION
This and other objects of the present invention, which will become apparent hereinafter, are achieved by providing a bag arrangement of the above describe type in which the a receptacle for accommodating a second substance is formed by the abutment of the piercing device, which is separated from the inner chamber of the bag with the first substance, with the mixing process being started between the first and second substances with or after the piercing device has been actuated.
A central idea of the present invention can be seen therein that a receptacle provided on the piercing device is made for accommodating a second substance which is separated vis-à-vis the bag interior or the first substance. The bag is made in such a way that, after the piercing device has been activated, a mixing process is initiated between the first and second substance.
The second substance can be present especially in a liquid, solid, powdery gaseous or gelatinous state. It should be especially noted that the first and second substance can, in principle, be the same, so that they can be refilled via the abutment by connection to a filling system or additional bag in the bag actually provided for draining. If a second bag is connected via the abutment and if the first and second substance are present in a liquid state with comparable viscosity, then, surprisingly, a mixing ratio of 50/50 results between the first and second substance in the bag actually tested. Second substances which can only be preserved for a short time in the first substance or which decompose relatively quickly in the first substance can be conveyed via the abutment to the first substance per bag puncture. Examples of secondary substances of this type are live microbiological cultures of sensitive substances such as glutamine or enzymes.
A further idea of the invention can be seen in the separating film inserted between the first and second substance, said separating film being perforated at the same time as the bag is punctured.
In another advantageous embodiment, the separating film is formed by the jacket of the bag itself, so that the manufacture and mounting of a separate separating film can be omitted.
In an actual preferred embodiment, the piercing device comprises a slide-mounted punch for puncturing the at least one jacket as well as an abutment into which the punch sinks when piercing the jacket.
Preferably, the receptacle for the second substance is formed by the abutment of the piercing device. Since the abutment is advantageous for mechanical reasons, the second substance to be inserted can be simultaneously accommodated therein. Actuating the piercing device and especially the sinking of the punch of the piercing. device accelerate the mixing process between the first and second substance.
In an alternative design, a draining connection is formed on the piercing device or a drain line can be attached thereto, whereby the receptacle is formed on the draining connection or in the drain line. In this embodiment, the mixing process takes place when the bag is being emptied whereas, in the alternatives described above, a first and second substance can also be mixed inside the bag prior to draining said bag.
In a possible embodiment, the abutment is only open toward the inside of the bag, however, it is covered with the separating film and otherwise sealed on all sides. In this embodiment, the second substance can already be inserted when manufacturing and assembling the bag or when attaching the piercing device to the jacket of the bag. This alternative design is suitable for second substances which can be preserved by themselves without contact with the first substance, whereby a mixing between first and second substance is desired prior to use of the bag.
Preferably, the receptacle is designed to accommodate a single pack containing the active substance provided with a perforable film. An especially cup-shaped abutment can, for example, form the receptacle for a tablet sealed with a film. When the perforable film is punctured, the first substance present in the bag can come into contact with the tablet, so that a desired effect is produced by mixing the first subtance and the second substance (here the tablet), or the second substance is dissolved.
Just when the first substance is present in liquid form, the piercing device can be provided with means that promote the flow of the liquid substance into the receptacle. This can, in particular, be attained thereby that the piercing device has a punch with cutting ribs, whereby the cutting ribs convey the liquid into the receptacle.
Alternatively to the design of the receptacle open to the bag interior, the receptacle can also have a further opening, preferably at its end facing away from the bag. This opening can be sealed by a protective cover or a protective film. When the protective cover is removed or the protective film perforated, a second or supplementary bag or a substance cartridge can be attached or the liquid drawn off. This design offers numerous additional application possibilities for the bag.
First, the connection of supplementary bags or bag systems or refilling devices will be considered. In this case, for example, the first substance in the bag to be drained could be diluted separately depending on the application. As already discussed above, a very constant mixing ratio of 50/50 results surprisingly in the configuration tested. This could be verified both via density measurements and via chloride ion determinations so as to be reproducible. To this end, 500 ml of a first substance in the bag were mixed with an additional 500 ml diluent as a second substance in the intermediate bag space.
In particular when administering nutrients from the bag, a complete diet can be put together with different substances by connecting supplementary bags, whereby these substances can be administered either simultaneously, staggered in time or in succession, without it being necessary to make any changes in the feeding devices between the first bag and the patient.
In an especially preferred embodiment, a substance cartridge can be attached to the receptacle. In this case also, we can keep the administration of nutrients in mind, whereby special active substances, additives, medicine or the like can be contained in the substance cartridge. With a bag of the proposed design, it is possible to add a suitable substance cartridge, or one prescribed by the doctor, to a first substance as basic substance depending on the individual patient's specific requirements. With respect to the possible designs for the substance cartridge which is attachable to the bag so as to be largely germ-free, reference is made to the actual embodiments described below.
Advantageously, for a largely germ-free attachment, the opening of the receptacle provided for the protective cartridge is covered with a protective film, whereby this protective film is cut through when the substance cartridge is inserted.
In an actual design, the substance cartridge can be either pushed onto the receptable or into the receptacle, whereby a seal between the substance cartridge and receptacle is ensured by at least one circumferential projection between substance cartridge and receptacle. The volume of the substance cartridge can be adapted to the volume of the receptacle. To increase the fill volume of the substance cartridge, however, an expansion outward is provided. In an actual design, this expansion is obtained at maximum in the form of a second bag that can be directly attached.
When both the substance cartridge and the receptacle have a circumferenti
Baumann Karlheinz
Fritzmeier Franz
Krause Michael
Mader Helmut
Schwietz Horst
Bianco Patricia
Nutrichem Diät + Pharma GmbH
Sidley Austin Brown & Wood LLP
Sykes Angela D.
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