Patent classifications
A61J1/10
MEDICAL BAG
A medical bag comprising: a bag main body comprising a flexible sheet material having an interior portion partitioned via a partition part into a first space and a second space that is smaller than the first space, a first liquid housed in the first space, and a second liquid housed in the second space. When the volume of the first liquid is set as L1 and the volume of the second liquid is set as L2, L1/L2 is 2.0 to 6.0. The partition part has a breaking strength of 5 to 25 kPa.
Insulin premix formulation and product, methods of preparing same, and methods of using same
A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
Insulin premix formulation and product, methods of preparing same, and methods of using same
A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
Storage/containement unit for flexible pouch filled with biopharmaceutical fluid, and method of assembling a freeze/thaw containment system, using a protecting body of controlled deformation
A flexible pouch is placed in a stack provided with two plates forming a protecting body to sandwich and constrain the flexible pouch. At opposite margin portions, the protecting body has slots cooperating with positioning members of an outer shell device belonging to the stack. Between the shell parts, the plates can move during filling of the pouch and the margin portions shrink inwardly in a protecting body plane. Some of the positioning members act as stoppers, in order to have lower clearance range for shrink strokes of the protecting body in a middle part thereof, as compared to a higher clearance range at respective longitudinal end parts of the two opposite margin portions. A higher constraining effect can be obtained in a center of the pouch, to limit maximum thickness of its content, which is of interest for managing freeze/thaw operations of biopharmaceutical materials contained in the pouch.
Storage/containement unit for flexible pouch filled with biopharmaceutical fluid, and method of assembling a freeze/thaw containment system, using a protecting body of controlled deformation
A flexible pouch is placed in a stack provided with two plates forming a protecting body to sandwich and constrain the flexible pouch. At opposite margin portions, the protecting body has slots cooperating with positioning members of an outer shell device belonging to the stack. Between the shell parts, the plates can move during filling of the pouch and the margin portions shrink inwardly in a protecting body plane. Some of the positioning members act as stoppers, in order to have lower clearance range for shrink strokes of the protecting body in a middle part thereof, as compared to a higher clearance range at respective longitudinal end parts of the two opposite margin portions. A higher constraining effect can be obtained in a center of the pouch, to limit maximum thickness of its content, which is of interest for managing freeze/thaw operations of biopharmaceutical materials contained in the pouch.
Fluid Manifold Systems and Methods of Manufacture
A fluid manifold system includes a first manifold having portions of opposing flexible sheets welded together to form a fluid flow path therebetween, a fluid inlet communicating with the fluid flow path. The fluid flow path of the first manifold includes: a primary flow path communicating with the fluid inlet of the first manifold; and a plurality of spaced apart secondary flow paths that branch off of the primary flow path. Each secondary flow path has a first end communicating with the primary flow path and an opposing second end, each secondary flow path having a diameter that is smaller than a diameter of the primary flow path. The fluid manifold system also includes a plurality of tubular connectors with each tubular connector being secured to the first manifold at the second end of a corresponding one of the secondary flow paths.
INJECTION PREPARATION KIT AND INJECTION PREPARATION SYSTEM COMPRISING SAME
Disclosed is an intravenous drug dispensing kit including: a cylinder cartridge for introducing and discharging external fluids through changes in the volume of a cylinder occurring when a pair of first and second pistons disposed therein is fixed and rotates relatively to each other; a first tube connected to an outlet tube of the cylinder cartridge; a three-way valve having a first introducing flow path, a second introducing flow path, and a discharge flow path connected to any one of the first introducing flow path and the second introducing flow path; a second tube for connecting the discharge flow path of the three-way valve to an inlet tube of the cylinder cartridge; a third tube connected to the first introducing flow path of the three-way valve; and a fourth tube connected to the second introducing flow path of the three-way valve.
Storage bag
A method of making a storage bag comprising the following steps performed in any order: (a) forming a composite tube having an inner surface comprising a higher melting polymer, an outer surface comprising a lower melting polymer, two ends, and a diameter; (b) flattening the tube in a direction perpendicular to the diameter; (c) forming a joint at one of the ends at a temperature between respective melting points of the higher melting polymer and the lower melting polymer; (d) providing a composite sheet having a first side comprising a higher melting polymer and a second side comprising a lower melting polymer; and (e) disposing the composite sheet over the joint such that the first side comprising a lower melting polymer engages the joint and forming a lap seam over the joint at a temperature between respective melting points of the higher melting polymer and the lower melting polymer, and a storage bag made by such method.
Storage bag
A method of making a storage bag comprising the following steps performed in any order: (a) forming a composite tube having an inner surface comprising a higher melting polymer, an outer surface comprising a lower melting polymer, two ends, and a diameter; (b) flattening the tube in a direction perpendicular to the diameter; (c) forming a joint at one of the ends at a temperature between respective melting points of the higher melting polymer and the lower melting polymer; (d) providing a composite sheet having a first side comprising a higher melting polymer and a second side comprising a lower melting polymer; and (e) disposing the composite sheet over the joint such that the first side comprising a lower melting polymer engages the joint and forming a lap seam over the joint at a temperature between respective melting points of the higher melting polymer and the lower melting polymer, and a storage bag made by such method.
Sterile solutions product bag
A sterile solution product bag includes sterilization grade filter integrated directly into the product bag such that microbial and particulate matter filtration can be performed using the filter directly at the point of fill. The filter can include a hollow fiber filter membrane contained in a stem connected to a bladder of the product bag.