Abstract:
A sterile product and a method for sterilizing and assembling such a product are disclosed wherein the product has two or more portions, such as a medical fluid containing portion (12) and a flow control apparatus portion (14), which are mutually incompatible with regard to the method of sterilization. The sterile product is preferably produced by exposing one portion of the product, e.g., the flow control apparatus (14), to a first form of sterilization such as an electron beam, while shielding the other portion of the product, e.g., the medical fluid containing portion (12), from the first form of sterilization. The product may be integral, with the step of sterilizing the first portion occurring while the other product portion remains attached in close association therewith. The present invention has particular application in association with a product having first and second incompatible portions (12 and 14) which are joined by a flow path. In such a product, each product portion and its respective flow path portion may be sterilized in the appropriate manner. The flow path may then be isolated from the respective product portion and the flow paths joined together. Subsequent to joinder, the isolated portion of the flow path may be sterilized, as by electron beam, while any product portion incompatible with such form of sterilization is shielded from the effects of the sterilization.
Abstract:
A blood filtration device encapsulates a filter pad assembly Within a flexible housing. The filter pad assembly includes first and second filter media layers. A first heat and pressure sealed region integrally bonds the peripheries of the first and second media layers together. The flexible housing comprises a peripheral rim aligned with the first heat and pressure sealed region of the first media layer. A second heat and pressure sealed region, formed after the first heat and pressure sealed region, joins the rim of the flexible housing to the first heat and pressure sealed region, thereby forming a composite seal that encapsulates the filter pad assembly within the housing.
Abstract:
A container has first and second walls, each formed of a thermoplastic sheet having a peripheral edge. A peripheral seal joins the peripheral edges together to form an interior chamber enclosed by the first and second walls. A port communicates with the interior chamber. The port is spaced from and does not extend through the peripheral seal. The port comprises a hollow thermoplastic tube, which extends through a slit in one of the first and second sheets and is oriented tangentially thereto. The slit is fused by heat about the tube, forming a heat fused junction. A medical product or a blood filter material can be housed in the interior chamber.
Abstract:
A container has first and second walls, each formed of a thermoplastic sheet having a peripheral edge. A peripheral seal joins the peripheral edges together to form an interior chamber enclosed by the first and second walls. A port communicates with the interior chamber. The port is spaced from and does not extend through the peripheral seal. The port comprises a hollow thermoplastic tube, which extends through a slit in one of the first and second sheets and is oriented tangentially thereto. The slit is fused by heat about the tube, forming a heat fused junction. A medical product or a blood filter material can be housed in the interior chamber.
Abstract:
Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.
Abstract:
Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.
Abstract:
A sterile product and a method for sterilizing and assembling such a product are disclosed wherein the product has two or more portions, such as a medical fluid containing portion (12) and a flow control apparatus portion (14), which are mutually incompatible with regard to the method of sterilization . The sterile product is preferably produced by exposing one portion of the product, e.g., the flow control apparatus (14), to a first form of steriliza tion such as an electron beam, while shielding the other portion of the product, e.g., the medical fluid containing portion (12), from the first form of sterilization. The product may be integral, with the step of sterilizing the fir st portion occurring while the other product portion remains attached in close association therewith. The present invention has particular application in association with a product having first and second incompatible portions (12 and 14) which are joined by a flow path. In such a product, each product portion and its respective low path portion may be sterilized in the appropriate manner. The flow path may then be isolated from the respective product portion and the flow paths joined together. Subsequent to joinder, the isolated portion of the flow path may be sterilized, as by electron beam, while any product portion incompatible with such form of sterilization is shielded from the effects of the sterilization.
Abstract:
A container has first and second walls, each formed of a thermoplastic sheet having a peripheral edge. A peripheral seal joins the peripheral edges together to form an interior chamber enclosed by the first and second walls. A port communicates with the interior chamber. The port is spaced from and does not extend through the peripheral seal. The port comprises a hollow thermoplastic tube, which extends through a slit in one of the first and second sheets and is oriented tangentially thereto. The slit is fused by heat about the tube, forming a heat fused junction. A medical product or a blood filter material can be housed in the interior chamber.
Abstract:
A blood filtration device (16) encapsulates a filter pad assembly (20) within a flexible housing (18). The filter pad assembly (20) includes first and second filter media layers (44, 46). A first heat and pressure sealed region (28) integrally bonds the peripheries of the first and second media layers (44, 46) together. The flexible housing (18) comprises a peripheral rim (34) aligned with the first heat and pressure sealed region (28) of the first media layer (44). A second heat and pressure sealed region (32), formed after the first heat and pressure sealed region (28), joins the rim (34) of the flexible housing (18) to the first heat and pressure sealed region (28), thereby forming a composite seal that encapsulates the filter pad assembly (20) within the housing (18).