Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
1998-10-23
2001-08-28
Seidel, Richard K. (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S408000, C604S905000
Reexamination Certificate
active
06280431
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a sterile formed, filled and sealed flexible solution container with an attached administration port system which is effectively sealed to the container and which accommodates complete draining of the solution.
BACKGROUND OF THE INVENTION
Various foodstuffs, liquids, and other degradable material can be sterilely packaged in pouch-type flexible containers made from webs of flexible film that are folded and sealed together along the peripheral side edges. This type of flexible packaging is commonly referred to as a form, fill, and seal package. There are a number of advantages to these pouch-type flexible containers, including low weight, durability, and low cost fabrication. Some medical solutions have also been sterilely packaged in pouch-type flexible containers of the form, fill, and seal type.
One disadvantage of these pouch-type flexible containers for medical solution use is that it is difficult to make a sterile connection to the flexible container for withdrawing the contents in a sterile manner. The wall material of the container is flexible and lacks rigidity. Thus it is difficult to obtain a liquid-tight and leakproof connection through the flexible wall using traditional medical connectors such as needles or piercing pins.
Traditionally, it has been necessary for flexible solution containers used for parenteral solutions to include administration ports to facilitate sterile and liquid-tight access to the solution. These pre-formed, administration ports are often molded from a suitable medical grade thermoplastic material. The usual considerations for the material employed in the administration ports are the ease of molding and the capability to be securely bonded to the flexible film walls of the container. For example, a “boat” administration port may be sealed (by known thermal bonding processes) between the two opposed sides or walls of the flexible film container so as to form a flexible solution container with an administration port. Ultrasonic welding or solvent bonding may also be used to seal the boat port to the container.
The majority of flexible films used for flexible solution containers are monolayer PVC films. Recently, some multiple-layer, extrusion-laminated or adhesive-laminated films have been used in form, fill, and seal packaging for fabricating flexible solution containers. The inner, solution-contacting film layer must be substantially inert to the solution. Also, the inner layer of the film must be readily bondable to itself when it folded over. Furthermore, the outer layer of the film must be bondably compatible with the plastic material used for the attachable administration port. The outer layer of the laminated film must be durable and also compatible with other materials that may contact, or be attached to, the outside surface. If neither the inner nor outer layer has the desired solution-maintaining characteristics and barrier characteristics, such as a low moisture and/or low oxygen permeability, then additional film layers may be required between the inner and outer layers.
A primary disadvantage of known flexible solution containers which include the above-described inserted port construction is that the port material typically has a higher oxygen permeability than the film material; that is, the port structure can be characterized as acting like a “hole” in the sealed bag material. The permeability characteristic of the port material is much greater than the permeability characteristic of the laminated film used to make the flexible container. Thus, the administration port of known flexible solution containers is often the weakest part of the barrier function of the container. This factor becomes extremely important for certain medical solutions which are sensitive (i.e., deleteriously affected by) oxygen or other penetrating gases, for example.
In the past, attempts to overcome the above-discussed deficiencies have been made by overwrapping the flexible solution container, and/or the administration ports, with a low permeability overwrap material. While this redundancy in packaging may provide the desired barrier characteristics, the overwrap material introduces two important disadvantages. First, there is the additional cost to fabricate, and later dispose of, the overwrap. Second, there is concern that extractables from the overwrap material may migrate into the contained solution during post-filling procedures, such as during a heat sterilization process or even during shelf life.
Pre-formed administration ports constitute potential places of leakage and are potential points of contaminant ingress in an otherwise sealed, durable, flexible container. Moreover, the ports make it more difficult to arrange an outer protective overwrap package around the flexible container. Also, the protective overwrap only initially prevents the packaged solution from losing its potency due to evaporation or diffusion. When the overwrap is removed or breached, the installed administration ports in the film essentially function as an undesirable breaches or “holes” in the barrier characteristics of the flexible container for certain sensitive drugs.
For example, due to the sensitivity of certain solutions to oxygen, such as amino acids, it is desirable to fabricate the flexible solution containers for the parenteral administration of these solutions from materials that minimize the permeation of oxygen. The gas permeation properties of the flexible container film can be easily controlled by the choice of film material(s) per se.
On the other hand, the oxygen permeation properties of materials conventionally used for the port structure per se typically do not have low oxygen permeation properties, and the gas permeation properties of such materials are not as easily controlled. Thus, it would be desirable to use the film, with its good gas barrier properties, to provide both the solution contacting surface and a pierceable diaphragm in the administration port system so that the poorer barrier properties of a conventional system material do not contribute to gas migration into or out of the flexible container. However, various known flexible containers having preformed, rigid port systems sealed between the film layers of the flexible container cannot function in such a manner.
Moreover, some known flexible container and administration port systems often include an entry port in addition to the administration port. The entry ports are likewise inserted between film layers at the container perimeter seal. Each port thus constitutes a breach or “hole” through an otherwise effective perimeter barrier.
A pierceable diaphragm can be provided in some administration ports to prevent an outflow of solution. During packaging, the flexible container may be filled through the entry port. After filling, the entry port is sealed, but the port, and specifically the exposed port material, is the potential weak point for compromising the barrier characteristics.
Flange ports are an alternative to inserted ports and may be advantageously sealed to a film surface. However, in many of flexible solution containers produced by known form, fill, and seal processes, the use of flange ports does not remove the barrier deficiency. Consider, for example, the flexible parenteral solution container that includes a flange-sealed port assembly as disclosed in U.S. Pat. No. 4,695,337 to Christine and in U.S. Pat. No. 4,779,397 to Christine et al. A major disadvantage of the disclosed flexible solution container is that the flexible film barrier of the flexible container is purposefully breached during the assembly steps to mount and seal the administration port or fitment to the inside surface of the flexible container, as seen, for example, in
FIGS. 4
a
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4
b
of the patents.
Thus, due to the inherent breaches or “holes” in the film barriers of various known form, filled, and sealed flexible solution containers in current use, parenteral solutions may be subjected to degradation during the shelf life of the product solution
Abrahamson Kent D.
Carveth Peter
Coules Ron
Domkowski John
Szempruch Walter T.
Abbott Laboratories
Maynard Jennifer
Seidel Richard K.
Vrioni Beth A.
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