The present invention relates generally to medical products and compositions for making same. More specifically, the present invention relates to non-PVC material and medical tubing made therefrom.
It is known to use closures for blood containers and IV containers that consist of membrane tubes. In this regard, once a drug container is filled through an open-ended filling port, a membrane tube closure is coated with a solvent, such as cyclohexanone, and inserted into a fill port tubing. During this process, a chemical bond is achieved between the fill port and the membrane tube closure. When it is desired to access the container, an end user pierces the membrane, in the tube, to allow drug administration or other access to the container.
Typically, such a medical membrane tubing is constructed from plasticized polyvinyl chloride (PVC). Usually, the PVC is plasticized with DEHP.
Recently, there has been concern with respect to the use of DEHP plasticized PVC. DEHP has been alleged to be a suspected carcinogen. However, the characteristics that are afforded by plasticized PVC are very desirable especially in the medical area and for uses such as in a membrane tube closure for a container.
In this regard, such medical tubings should exhibit certain characteristics. It is desirable that the tubing can be solvent bonded to a PVC container as well as containers constructed from other alloys. It is also desirable that the tubing is RF sealable to form membrane tube closures so as to be usable with current manufacturing equipment.
Additionally, the materials should be autoclavable without cross-linking at 121xc2x0 C. Further, it would be desirable if the tubing was compatible with currently used manufacturing machines. Moreover, the material should be sterilizable via either ETO or gamma sterilization processes. Likewise, in order to be a usable membrane tube closure, the material must be easy to pierce during drug administration and allow the spike to be removed after the drug is administered. Additionally, it is desirable that the scrap is recyclable for further use.
Although there are other components in the art from which, arguably, medical tubing could be created, each of these components suffers disadvantages. Most importantly, the resultant product does not have the same desirable characteristics as a plasticized PVC product.
For example, flexible polyester is not as RF responsive as is plasticized PVC. Aliphatic polyurethane is not autoclavable. Further, such tubings, due to their characteristics, cannot be used on currently available commercial machinery in, for example, a blood collection system.
U.S. patent application Ser. No. 07/270,006, filed Nov. 14, 1988, discloses a citrate ester and a non-PVC material. U.S. patent application Ser. No. 07/494,045, filed. May 15, 1990, is a divisional application to that patent application. Both of these applications are assigned to the assignee of the present invention.
U.S. patent application Ser. No. 07/636,337, filed Dec. 31, 1990, and assigned to the assignee of the present invention, relates to a medical grade tubing comprising a blend of polyurethane and polyester, and the resultant tubing being autoclavable and RF sealable. A continuation-in-part to that patent application, U.S. Ser. No. 07/828,436, now U.S. Pat. No. 5,533,992, is being filed on the same day as this patent application.
The present invention provides a non-PVC, non-DEHP material that can be used for medical grade tubing. Additionally, the present invention provides medical grade tubing made from such a material.
The resultant tubing of the present invention exhibits the characteristics that are desirable for medical grade tubing. These characteristics include being RF responsive to form membrane tube closures with present manufacturing equipment. The material is solvent bondable to itself, as well as plasticized PVC. The material can be autoclaved without cross-linking at 121xc2x0 C. The scrap is recyclable for future use.
The material can be sterilized via steam, gamma, E beam, or ETO sterilization processes. The material, when it forms a membrane, is easy to pierce during drug administration. Additionally, it is easy to remove a spike from the tubing after the drug is administered. Further, the tube is flexible and contact clear.
Additionally, an advantage of the material is that it is a multilayer coextruded tubing that does not contain PVC or plasticizer.
To this end, the present invention provides a medical grade tubing comprising a multilayer coextruded structure including: a layer comprising a blend of polyurethane and polyester; and at least a layer comprising a blend chosen from the group consisting of: polypropylene, ethylenevinyl acetate, and polyurethane; polypropylene and styrene-ethylene-butylene-styrene; polypropylene, styrene-ethylene-butylene-styrene, and ethylenevinyl acetate; polypropylene, ethylenevinyl acetate, styrene-ethylene-butylene-styrene, and thermoplastic polyester elastomer; polypropylene, ethylenevinyl acetate, styrene-ethylene-butylene-styrene, thermoplastic polyester elastomer, and polyurethane; polyester, thermoplastic polyester elastomer, and polyurethane; polyester and polyurethane; and polypropylene, styrene-ethylene-butylene-styrene, and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene, ethylenevinyl acetate, and polyurethane; and a second layer comprising a blend of polyurethane and polyester.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene and styrene-ethylene-butylene-styrene; a second layer comprising a blend of polyurethane and polyester; and a tie layer between the first and second layer.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene, styrene-ethylene-butylene-styrene, and ethylenevinyl acetate; a second layer comprising a blend of polyurethane and polyester; and a tie layer between the first and second layers.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene, ethylenevinyl acetate, and polyurethane; a second layer comprising a blend of polyurethane and polyester; and a tie layer between the first and second layers.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polyester and polyurethane; a second layer comprising a blend of polypropylene, ethylenevinyl acetate, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polyester, thermoplastic polyester elastomer, and polyurethane; a second layer comprising a blend of polypropylene, ethylenevinyl acetate, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising-a blend of polypropylene, ethylenevinyl acetate, styrene-ethylene-butylene-styrene, and thermoplastic polyester elastomer; a second layer comprising a blend of polypropylene, ethylenevinyl acetate, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polyester and polyurethane; a second layer comprising a blend of polypropylene, styrene-ethylene-butylene-styrene, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polyester, thermoplastic polyester elastomer, and polyurethane; a second layer comprising a blend of polypropylene, styrene-ethylene-butylene-styrene, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene, ethylenevinyl acetate, styrene-ethylene-butylene-styrene, and thermoplastic polyester elastomer; a second layer comprising a blend of polypropylene, styrene-ethylene-butylene-styrene, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
In an embodiment, the multilayer coextruded structure comprises: a first layer comprising a blend of polypropylene, ethylenevinyl acetate, styrene-ethylene-butylene-styrene, and thermoplastic polyester elastomer; a second layer comprising a blend of polypropylene, styrene-ethylene-butylene-styrene, and polyurethane; and a third layer comprising a blend of polyester and polyurethane.
Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments and from the drawings.