JP2009542367A5

JP2009542367A5 -

Info

Publication number: JP2009542367A5
Application number: JP2009518556A
Authority: JP
Filing date: 2007-06-28
Publication date: 2010-08-19

Claims

A fluid container having flexibility, the container was surrounded by the container wall, comprising a flexible container body having a fluid reservoir formed in the container body, the container body is at least look including a port, the at least one port, a proximal end, a distal end, and comprises an elongated injection tube having a fluid passage extending to the distal end from the proximal end, The distal end extends from the container body and the proximal end is attached to the container body such that the fluid passage is in fluid communication with the fluid reservoir and the infusion tube is a non-circular lower portion adjacent to the proximal end The non-circular lower portion defines an outer peripheral surface adjacent to the proximal end of the infusion tube;
The container wall has an opposing inner surface that is in surface contact with the outer surface of the non-circular lower portion and against the outer surface so as to form a liquid tight seal around the lower portion of the infusion tube. Directly sealed and
The fluid container comprises a port closure system for sealing at least one port ;
A fluid container wherein the infusion tube includes a generally cylindrical top, the top including an annular flange extending radially outwardly thereon and an outer surface disposed below the flange .

Injection tube has a longitudinal axis, the lower portion of the non-circular, oval, semi-oval, oval, semi-elliptical, selected from the group of shapes including diamonds and semi-rhomboidal, the major axis and the major axis has a cross-sectional shape having a minor axis transverse, both major and minor axes of a perpendicular to the longitudinal axis of the injection tube, the long axis is longer than the minor axis, the container according to claim 1 .

The outer surface has a pair of flat-bottom notches on both sides formed in the outer surface, the notches extending longitudinally along the infusion tube, and the notch on the top of the infusion tube is the infusion tube 3. A container according to claim 2, which defines a flat-bottom planar notch perpendicular to the lower major axis.

Major axis, with form a terminal at both ends defining the width of the lower portion of the injection tube, a minor axis, without the terminal at both ends defining the bottom of the depth of the fill tube, note the lower portion of the lower portion of the width of the entrance tube infusion tube The container of claim 2 , wherein the container is greater than the depth of.

5. A container according to claim 4 , wherein the lower portion of the injection tube has an outer radius formed at both ends of the major axis.

6. A container according to claim 5 , wherein the outer radius formed at both ends of the major axis is a 0.005-0.015 inch radius.

5. A container according to claim 4 , wherein the lower portion of the infusion tube has an outer radius formed at at least one of both ends of the major axis.

8. A container according to claim 7 , wherein the outer radius formed at at least one of the ends of the minor axis is a 0.125-0.250 inch radius.

The container wall has a rear portion and a front portion that is superimposed on the rear portion at a contact surface to define a fluid reservoir and is joined to the rear portion in a hermetic manner along an outer peripheral seam. The lower part of the injection tube is between the front part and the rear part of the container wall so that the lower major axis is in the contact surface and the front part and rear part of the container wall part are hermetically joined to the lower part of the injection tube. The container according to claim 2 , which is inserted into the container.

Rear and front are, a sheet of polyolefin film having respectively, a multilayer flexible chosen to containers having a low water vapor transmission rate than one day about 0.060 grams / 100 square inches, claim 9 Container as described in.

At least one port comprises a pair of ports each with an infusion tube and a port closure system, the infusion tube is independently movable and the user infuses to insert at least one finger between the infusion tubes 11. A container according to claim 10 , wherein the lower part of each infusion tube is attached to the container body so that the tubes are sufficiently spaced.

The multilayer flexible polyolefin film includes a barrier layer disposed between the inner layer and the outer layer, the inner tie layer is disposed between the barrier layer and the inner layer, and the outer tie layer is Disposed between the barrier layer and the outer layer, the barrier layer including one side attached to the inner layer by the inner tie layer and an opposite side attached to the outer layer by the outer tie layer. Item 10. The container according to Item 10 .

The container of claim 1 , wherein the infusion tube is about 1-2 inches long.

14. A container according to claim 13 , wherein the infusion tube is about 1.4-1.8 inches long.

The infusion tube is defined by the infusion tube wall and an 18 gauge needle is prevented from being pushed through the infusion tube wall in a direction perpendicular to the infusion tube wall when a force of up to 6 pounds is applied. , the infusion tube wall has a sufficient thickness and rigidity, the container according to claim 1.

Injection tube, an ethylene content of from about 2% to about 6%, and comprises a random copolymer polypropylene having a melting point of about 129 ° C. to about 145 ° C., the container according to claim 1 5 .

The container of claim 16 , wherein the injection tube wall has a substantially uniform thickness between about 0.9 and 1.5 mm.

The container of claim 1 , wherein the container body, infusion tube and port closure system do not comprise PVC and DEHP.

Comprising: providing a container with a multilayer polyolefin bag with one port even without low,
Attaching an infusion tube to at least one port;
Injecting a predetermined amount of medical fluid into the container;
Sealing the infusion tube with a port closure system;
Autoclaving the container without confining the container within the overlap, and a method for packaging and storing the medical fluid.

20. The method of claim 19 , further comprising placing the container in a shipping cardboard and allowing the infused container to be exposed to ambient air for a period of up to 36 months.

Injection already container is made possible to be exposed to a period outside air up to 24 months, The method of claim 2 0.

Surrounded by the volume container wall portion, having a fluid reservoir formed in the container body, a container body having flexibility, a container body including one port even without low,
An infusion tube that is sealingly attached to at least one port, a proximal end attached to the container body, a distal end extending from the container body, and a fluid extending from the distal end to the proximal end An infusion tube having a fluid passage in communication with the reservoir, the distal end of the infusion tube having a flange extending radially outward thereon;
A flexible fluid comprising: a port closure system for sealing at least one port, the port closure system including a port housing configured to fluidly seal a distal end of an infusion tube container.

The port housing has a base surface including an annular portion attached to the infusion tube, the base surface comprising an annular recess at the inner edge of the annular portion, a chamfered portion at the outer edge of the annular portion, and an infusion tube. and a contact ring disposed between the recess and the chamfer for contacting a container according to claim 2 2.

24. A container according to claim 23 , wherein the contact ring is a substantially horizontal plane.

24. A container according to claim 23 , wherein the contact ring is attached to a flange at the distal end of the infusion tube.

Surrounded by the volume container wall portion, having a fluid reservoir formed in the container body, a container body having flexibility, a container body comprising one fluid port even without low,
A port housing configured to seal the fluid port closed;
A cap assembly connected to the port housing, wherein the cap assembly is a unitary structure and has a crown that is connected to the cap removable by the frangible region;
An outer shell, a lower shell which are connected engages the port housing, said crown having a sealed opening extending between the outer shell and the lower shell,
A cover that is sealed over the opening sealed by the frangible region and the cover to allow the user to manually pull the tensioning element to cut the frangible region and separate the cover from the crown. A flexible container comprising a removable cap comprising a connected pulling element.

An infusion tube sealingly attached to at least one infusion port, the proximal end attached to the container body, the distal end extending from the container body, and extending from the distal end to the proximal end 27. The container of claim 26 , further comprising an infusion tube having a fluid passage in communication with the fluid reservoir, the distal end of the infusion tube having a flange extending radially outward thereon.

The port housing has a base surface including an annular portion attached to the infusion tube, the base surface comprising an annular recess at the inner edge of the annular portion, a chamfered portion at the outer edge of the annular portion, and an infusion tube. 28. A container according to claim 27 , comprising a contact ring disposed between the recess and the chamfer for contact.

29. A container according to claim 28 , wherein the contact ring comprises a substantially horizontal plane.

29. A container according to claim 28 , wherein the contact ring is attached to a flange at the distal end of the infusion tube.

The container body has a two fluid ports, each of the two fluid ports has an infusion tube, equipped with a port closure system A container according to claim 3 0.

The infusion tube has an upper portion adjacent the distal end and a lower portion adjacent the proximal end, and the infusion tube is sufficiently spaced for a user to insert at least one finger between the infusion tubes. as placed, the lower portion of the infusion tube is attached to the container body, the container of claim 3 1.

28. A container according to claim 27 , wherein the container wall comprises a multilayer flexible polyolefin film and the container body, infusion tube and port closure system do not comprise PVC and DEHP.

34. The container of claim 33 , wherein the multilayer flexible polyolefin film has an inner layer and an outer layer.

Surrounded by the container wall comprising a longitudinal side edge of the front portion and the rear portion and a pair of opposite sides, with a fluid reservoir formed in the container main body provided with an elongated container body having flexibility,
Front and rear portion, to define a fluid reservoir, sealed together along the outer peripheral seam adjacent to one long side direction side edge portion,
Outer peripheral seam, is bent inwardly with respect to and one longitudinal side edges Ri Tado a concave path with respect to the longitudinal axis of the container,
A flexible fluid container, wherein the concave path has a concave ratio in the range of about 35-70 .

One longitudinal side edges adjacent to the outer peripheral seam Ru straight der A container according to claim 35.

36. The container of claim 35, wherein the concave path followed by the peripheral seam has a concave ratio in the range of about 40-70.

38. A container according to claim 37, wherein the concave path followed by the perimeter seam has a concave ratio of 53.

A top edge and a bottom edge opposite the top edge, the top edge and the bottom edge extending across the central axis of the container body, the container body being a top for hanging the container 36. A container according to claim 35 , having a hole formed through the top edge adjacent to the edge and a pair of sealed ports at the bottom edge.

40. The container of claim 39 , wherein the front and back are formed from a single sheet of multilayer polyolefin film that does not contain PVC and DEHP, and the sealed port does not contain PVC and DEHP.

40. The container of claim 39 , wherein the container has a water vapor transmission rate of less than about 0.060 grams / 100 square inches per day.

A flexible elongate container body having a fluid reservoir formed in the container body surrounded by a container wall having a front and rear and a pair of longitudinal side edges on both sides;
The front and rear are sealed together along a pair of outer circumferential seams, each adjacent to a pair of longitudinal side edges to define a fluid reservoir,
Each of the circumferential seams follows a concave path with respect to the longitudinal axis of the container,
A flexible fluid container, wherein the concave path has a concave ratio in the range of about 35 to 70.