JP2009542367A - Medical fluid container - Google Patents

Abstract

  A flexible non-PVC, non-DEHP polyolefin container or bag for medical fluids has an elongated container body formed of a polyolefin film. The container has one or more ports with a polyolefin injection tube and a port closure assembly. The container includes a concave seam on at least one of its longitudinal sides.

Description

  The present invention relates to the field of containers for holding medical fluids for administration to a patient. As used herein, the term “medical fluid” includes medical, physiological, and veterinary fluids. Thus, a “patient” can be a human, fish, mammal, reptile, amphibian, avian, etc. More particularly, the present invention relates to flexible autoclavable drip (IV) fluid containers or bags and non-vinyl chloride (non-PVC) polyolefin films for their construction. The present invention has a low water vapor transmission rate and is finally sterilized using a high temperature treatment, i.e. sterilized after injection to neutralize microorganisms inside the container (e.g., autoclaving). A flexible IV fluid container with a long shelf life is provided.

  Over 30 years ago, the introduction of flexible IV containers caused problems with moisture loss and port closure system integrity testing. A flexible container material system and appropriate port closure needed to be designed. The most common design chosen was a type of PVC monolayer film container with a very low cost closure system. By placing another material with higher barrier properties as an overlap around the infused container, the problem of moisture loss during shelf life was solved. The complete system was then steam sterilized and delivered to the customer for use.

  Polyvinyl chloride (PVC) is often used for the administration of small volume parenteral (SVP), often referred to as mini-bags, and large volume parenteral (LVP), various enteral nutrition and liquid formulations. A standard, widely used plastic packaging material used to make flexible containers (bags and pouches). These containers are often employed for patient hydration and / or to supply pharmaceutical preparations, drugs, vitamins, nutritives and the like. . To date, PVC has proven advantageous because of its heat resistance that allows containers to be finally sterilized using high temperature processing.

  However, PVC also has its disadvantages. PVC films in the thickness range that need to be flexible enough for IV fluid containers do not provide a high water vapor barrier (MVB). The flexible PVC container has a high water vapor transmission rate (MVTR), and overlap is included within it by providing improved water vapor barrier (MVB) properties compared to the MVB properties of PVC alone. It is necessary to extend the storage life of the fluid. In other cases, the overlap includes any leaks, and a flexible container port system to survive autoclaving (ie high temperature processing) or shipping and damage handling. ) To help. In some cases, particularly with respect to SVP packages (or bags), multiple SVP packages are placed in one overlap package. Unfortunately, once an overlap package is opened, the poor MVB characteristics of PVC limit the shelf life of the individual SVP packages contained therein to about 30 days. So if the practitioner opens an overlap containing SVP but does not use all SVPs immediately, the SVP package needs to be discarded about 30 days after the overlap is opened . Similar shelf-life issues exist for containers for large capacity PVC containers (LVP) that are typically manufactured with individual overlaps on each container. In any case, the overlap represents added packaging costs and weight, contributes to environmental waste, and depletes oil and other resources.

  As time passes and new materials and technologies are provided to the pharmaceutical industry, a laminated or multi-layered material, typically comprising three or more layers, is a container with IV flexibility. With regard to its use, it has reached its forefront. These laminated materials incorporate an integral overlap-type film layer to provide water vapor protection similar to a separate overlap system to a flexible IV container.

  In order to perform well, an infusion medical fluid container is 1) preferably with a readable falling meniscus and flows uniformly 2) minimal air so that patient air embolism is not a problem 3) It is necessary to leave a minimal residual amount on spill so that the patient receives exactly the prescribed amount of drug or fluid. All of these objectives can be met at the same time only if the container is flexible. A flexible container, as the term is used herein, means a container that collapses upon outflow, such as a bag. Of course, the rigid container does not change shape substantially upon outflow. The semi-rigid container has substantially the same shape in the injection state and the outflow state. That is, they may deform somewhat during the outflow, but will not collapse permanently without applying external force during the outflow. Semi-rigid containers or plastic bottles also require a significant amount of contained air or venting in order to flow out properly. Anyone who is pouring milk from a semi-rigid plastic container or oil from a semi-rigid can tends to spill sporadically and often unexpectedly unless the semi-rigid container is properly vented Will be evaluated. Undesirable exchange of spillage and suction can occur in semi-rigid containers. To date, flexibility has been achieved by making the bag or container material or film very thin (ie, in the order of a few mils), using a material with a very small modulus of elasticity, or both. It has been pursued in infusion fluid containers. However, low modulus materials or thin films tend to melt at temperatures lower than typical US or European autoclave temperature requirements and are not as desirable as the overlap required for each container. Has a high water vapor transmission rate.

Non-PVC materials such as polyolefins (eg, polyethylene or polypropylene), nylon or composite materials, either laminated or co-extruded configurations (including single and multi-layer configurations), and the like , Proposed for SVP and / or LVP. One advantage is to reduce or eliminate the use of PVC due to environmental concerns. Another advantage of materials such as polypropylene or polyethylene is that they have better MVB properties than PVC. However, manufacturing and regulatory agencies may have the potential to damage and / or leak from the port closure system of a flexible and fluid medical container made of polyolefin and sterile. Some processing concerns have hesitated to remove the overlap. Reliable, economical, longer shelf life, lower water vapor permeability, flexible medical fluid containers are still selected and / or mixed with port closure defects Due to the large number of materials to be used, it needs to be realized, along with many often conflicting design constraints that must be met. These constraints include: low temperature impact strength for “drop test”, ability to withstand the high heat autoclave cycles required in the US and Europe, USP conditions, drug concentration and analytical conditions, permitted injection volume, injection equipment and Manufacturing process tolerances, aesthetic appearance (transparency, gloss, haze, wrinkles), printability, spillability, and acceptable extract types and levels.

  Another advantage of replacing PVC with materials such as polypropylene or polyethylene is that by-products from the PVC packaging material ooze out into the pure deionized (USP for injection) water and contaminate it. Products such as pure deionized water cannot be effectively packaged in PVC, while materials such as polyolefins are formulated to minimize by-products that have exuded into pure deionized water. It can be made into.

  Access ports are commonly used in infusion containers to administer solutions to patients or to add drugs or other solutions to the containers prior to administration. Current fluid containers typically include a dedicated outlet port for liquid administration to the patient and a dedicated inlet port to add diluent or other components to the container. .

  The exit port shall be connected to an administrative set and is therefore commonly referred to as an administrative port, whereas the inlet port is into a partially infused container. Designed to allow infusion of therapeutics and nutrients, sometimes identified as an additional port. Such containers may include a partial injection of a sterile solution such as saline or glucose to act as a diluent for the injected additive. Alternatively, the container may contain the drug and the diluent may be added by injection into the container through an additional port. The diluted drug or nutrient is then administered to the patient by a management port and a management set that can be connected directly or indirectly to the patient (ie, through another solution set). Strict regulations or tolerances are often imposed on the analytical result or concentration of the drug to be delivered. Satisfying these regulations, especially when the injected container is stored for an extended period, is difficult if the moisture barrier of the container is too high.

  There are other challenges in assembling flexible containers. A conventional flexible container or IV bag has a substantially straight longitudinal side. The container has a peripheral seam or weld that joins the front and rear of the container wall. The seam extends linearly along the substantially linear longitudinal side of the container and curves convexly at the corners of the bag. In addition, changes in the seam passage around the outside of the container at the corners can cause both material tacking and unwanted tacking or blocking inside the container at or near the corners. obtain.

  Accordingly, it is an object of the present invention to provide an improved medical fluid container.

  It is a further object of the present invention to provide a container with a port closure assembly that improves the safety and ease of processing when fluid is removed or introduced.

  Another object of the present invention is to provide a port injection tube structure that improves the sealing reliability of the container as well as ease and efficiency of manufacture.

  It is a further object of the present invention to provide a container with a container wall formed of a selected multi-layer polyolefin material to meet the requirements for final sterilized IV containers.

  A further object of the present invention is more ergonomic to meet the objectives and is flexible with longitudinal side seam structures that reduce tack and blocking of unwanted material and unwanted material. Is to provide a container.

  It is a further object of the present invention to provide an improved method for assembling and injecting medical fluid containers.

  It is a further object of the present invention to provide an improved method for packaging and storing medical fluid containers.

  A further object of the present invention is to provide a container that is lighter than PVC but exhibits better water vapor transmission.

  These and other objects will be apparent to those skilled in the art.

  A container for medical fluid has a container body made of a multi-layer polyolefin film with one or more fluid ports therein. The port may have an infusion tube and a port closure system for coupling with the infusion tube to seal the closed port. The container body, infusion tube, and port closure system do not include PVC and DEHP.

  A port closure system for use with a fluid container having a fluid port may have an administrative port closure assembly and an additional port closure assembly. The management port closure assembly includes a management housing that receives a piercing pin and seals one closed fluid port. A sleeve extends from the inner surface beyond the base surface in the management housing. The sleeve has upper and lower portions of different diameters. A cap assembly is coupled to the management housing, thereby sealing the internal surface of the management housing. A removable cap provides access to the inner surface.

  An additional port closure assembly includes a reseal housing that receives the needle and seals another closed fluid port. A cap assembly couples with the reseal housing, thereby sealing the interior surface of the reseal housing. Similar to the management port closure system, a removable cap provides access to the interior surface. A reseal element is mechanically retained, secured or captured between the reseal housing and the cap assembly.

  The port housing and infusion tube include various features that facilitate reliable container assembly and use.

  A multilayer polyolefin film is selected, among other things, in terms of its impact strength, low water vapor transmission rate, its ability to survive autoclaving and heat sealing, and its excellent compatibility with the material of the injection tube and port closure assembly .

  In another aspect of the invention, a fluid reservoir is formed therein and surrounded by a container wall having front and rear portions and one or more longitudinal side edges. The fluid container includes an elongated container body having a length. The front and rear are sealed to one another along an outer peripheral seam adjacent to at least one of the longitudinal side edges to define a fluid reservoir. The perimeter seam follows a concave passage with respect to the longitudinal axis of the container and can also be curved inward with respect to one or more side edges. The side edges can be straight or can be curved inward toward the central axis of the container. Containers with concavely curved side seams are easy to grip and handle, durable against internal and external folds, and durable against film tacking or blocking inside containers near corners There is sex.

1 is a partially exploded perspective view of a port closure system of the present invention for use with a fluid container. FIG. 1 is a partial perspective view of a port closure system of the present invention used with a fluid container, needle and piercing tweezers. FIG. 2 is a partial cross-sectional exploded view of the port closure system of the present invention used with a fluid container. FIG. 1 is a partial cross-sectional assembly view of a port closure system of the present invention for use with a fluid container. FIG. FIG. 6 is a cross-sectional view of an additional port closure assembly of the present invention. FIG. 4 is a cross-sectional view of an additional port closure assembly of the present invention for use with a needle. It is a side view of the cap assembly of this invention. It is a perspective view of the cap assembly of this invention. FIG. 6C is an enlarged partial cross-sectional view of the cut portion of the cap assembly along line 6C-6C in FIG. 6B. FIG. 3 is a cross-sectional view of the reseal element of the present invention. FIG. 3 is a perspective view of the reseal element of the present invention. FIG. 3 is a cross-sectional view of the management port closure assembly of the present invention used with piercing tweezers. 1 is a cross-sectional view of one embodiment of a management port closure assembly of the present invention. FIG. 6 is a cross-sectional view of an embodiment of an additional management port closure assembly. FIG. 6 is a cross-sectional view of an embodiment of an additional management port closure assembly. FIG. 6 is a cross-sectional view of an embodiment of an additional management port closure assembly. FIG. 6 is a cross-sectional view of an embodiment of an additional management port closure assembly. FIG. 6 is a cross-sectional view of an embodiment of an additional management port closure assembly. FIG. 6 is a perspective view of an embodiment of an additional port closure system. FIG. 6 is a perspective view of an embodiment of an additional port closure system. FIG. 5 is a cross-sectional view similar to FIG. 4 of an alternative embodiment of an additional port closure assembly. FIG. 19 is an enlarged partial cross-sectional view of a portion of the additional port closure assembly from FIG. 18 before the cap assembly is coupled to the reseal housing. FIG. 20 is an enlarged partial cross-sectional view of an additional port closure assembly, showing the region surrounded by line 20-20 in FIG. FIG. 20 is similar to FIG. 19 but shows the same area after the cap assembly is coupled to the reseal housing. FIG. 3 is a front view of an injection tube port according to an embodiment of the present invention. FIG. 22 is a cross-sectional view of the infusion tube taken along line 22-22 in FIG. 21, showing a non-circular cross-section at the bottom of the infusion tube. FIG. 22 is a side view of the injection tube of FIG. 21. It is a longitudinal cross-sectional view of the injection tube along line 22-22 in FIG. It is a top view of the container by one Embodiment of this invention. It is a top view of the container by other embodiment of this invention. It is a top view of the container by other embodiment of this invention. FIG. 22 is a series of cross-sectional views showing the mold, film, and lower portion of the injection tube of FIG. 21 before and during attachment of the container according to the present invention to the body. FIG. 22 is a series of cross-sectional views showing the mold, film, and lower portion of the injection tube of FIG. 21 before and during attachment of the container according to the present invention to the body. FIG. 22 is a series of cross-sectional views showing the mold, film, and lower portion of the injection tube of FIG. 21 before and during attachment of the container according to the present invention to the body. FIG. 27B is an enlarged cross-sectional view of the container of the present invention along line 27-27 in FIG. 25A. 1 is a simplified schematic diagram illustrating the configuration of one embodiment of a multilayer polyolefin film that can be used to form the front and back of a container wall. FIG.

  With reference to FIGS. 1-3B, 25A and 27, a flexible and long shelf life autoclavable fluid container 12 is formed and surrounded by a flexible container wall 3. A container body 1 having a fluid reservoir 2 is provided. The container wall 3 has a front part 3A and a rear part 3B. The container body has at least one port 14, 16 formed therein. In one embodiment, there are two ports 14, 16 located at the same end of a container 12 having an elongated container body 1, as shown in FIGS.

  With reference to FIGS. 1-3B and 25A, a port closure system 10 is shown for use with a fluid container 12 having a flexible container body 1 with at least one port 14,16 therein. . A pair of ports (ie, two ports) can be provided as first and second fluid ports 14 and 16 that are accessible to the needle 18 and piercing tweezer 20 respectively. The fluid ports 14, 16 each include an elongate infusion tube 13, 15 in one embodiment.

  Referring to FIGS. 21-24, the infusion tubes 13, 15 are substantially identical in one embodiment, from the distal end 17, the proximal end 19, and the proximal end 19, respectively. A fluid passage 21 extends to the distal end 17. The injection tubes 13 and 15 are attached to the container body 1 as described later so that the fluid passage 21 of the injection tubes 13 and 15 is in fluid communication with the fluid reservoir 2 inside the container body 1. Infusion tubes 13, 15 have a generally cylindrical upper portion 23 adjacent to distal end 17 and a lower portion 25 adjacent to proximal end 19. The top 23 of the infusion tubes 13, 15 has a generally cylindrical cavity 27 formed therein for receiving one of the port closure assemblies described in more detail herein. The top 23 of the injection tubes 13, 15 also includes an annular flange 29 that extends radially outward. Flange 29 helps protect the user's finger from unintentional contact with the needle, cannula or spike when accessing ports 14,16. The upper part 23 of the injection tubes 13, 15 has an outer surface 31 below the flange 29.

  The outer surface 31 has at least one notch 33 formed thereon. In one embodiment, the outer surface 31 has a plurality of notches 33 formed thereon and spaced circumferentially. In another embodiment, a pair of notches 33 are provided on both sides at equal intervals. The notch 33 can be used to direct the infusion tubes 13, 15 with respect to the attachment of the container body 1. The notch 33 can employ many possible configurations and shapes. In one embodiment, the notch 33 has a flat bottom and extends longitudinally along the outer surface 31 of the infusion tube 13, 15 and is useful for the user to grasp and hold the infusion tube 13, 15. I will provide a.

  As best seen in FIGS. 21-24, the lower portion 25 of the elongate infusion tube 13, 15 has a non-circular cross section for a substantial portion of its length. In one embodiment, the non-circular cross-section is a rhombus or a half rhombus. In another embodiment, the non-circular cross-section is selected from the group of shapes consisting of oval, semi-oval, oval, semi-elliptical, diamond and semi-diamond. The non-circular cross section is defined by a first axis and a second axis that intersects the first axis. The first axis terminates at both ends defining the width of the lower portion 25 of the injection tubes 13, 15. The second axis terminates at both ends defining the depth of the lower portion 25 of the injection tubes 13, 15. In one embodiment, the width of the lower portion 25 of the infusion tube is greater than the depth, so that the first axis is the major axis of the cross section of the lower portion 25 of the infusion tubes 13, 15 and the second axis is the minor axis. is there. One or more notches 33 in the upper portion 23 of the infusion tubes 13, 15 can be used by an automated device to simplify the infusion tubes 13, 15 for proper attachment to the container body 1, as described below. Can be perpendicular to the first or long axis of the lower portion 25.

  The lower part 25 of the injection tubes 13, 15 has an outer radius R1 formed at both ends of the major axis of the cross section. In one embodiment, radius R1 is about 0.005-0.015 inches. In other embodiments, the radius R1 is about 0.005-0.010 inches. In yet another embodiment, the radius R1 is about 0.008 inches. The radius R1 is recognized as contributing to the strength and reliability of the injection tube / container body joint or heat sealed weld. Improved material flow and fusion at the critical junction Y of the container rear, container front, and injection tube has been observed with the improved injection tube design.

  The lower part 25 of the injection tubes 13, 15 may have an outer radius R2 formed at at least one of the ends of the transverse minor axis. In the embodiment shown in FIG. 22, an outer radius R2 of about 1 / 8-1 / 4 inch is formed at both ends of the short axis. In other embodiments, radius R2 is about 0.150-0.200 inches. In another embodiment, radius R2 is about 0.178 inches. Radius R2 is a light seal, adhesive or other attachment means, and a mildness of the container body film on the lower portion 25 of the infusion tube 13, 15 without excessive stretching or thinning of the container body film material. Provides a large and smooth area for uniform wrinkle-free drawing.

  An infusion tube 13, 15 having a lower portion 25 with a width of about 1/2 inch and a depth of about 1/4 inch is recognized as exhibiting acceptable filling and draining characteristics. Yes. In one embodiment, infusion tubes 13, 15 are approximately 0.75-2.0 inches long. In other embodiments, the length of the infusion tubes 13, 15 is about 1.4-1.8 inches. In another embodiment, the infusion tubes 13, 15 are about 1.5 inches long. The length of the relatively long infusion tube is such that a standard 1 inch or 1 and 1/2 inch long needle, spike or cannula can be routed through the passage 21 of the infusion tube 13, 15 into the container 12 or the container wall 3 of the IV bag. This is useful for preventing accidental penetration.

The infusion tubes 13, 15 have an infusion tube wall 35, which wall 35 when an 18 gauge needle is applied with a force of 3-6 pounds. In order to prevent being pushed through the wall portion 35 in the passage P perpendicular to the wall P, it has sufficient thickness and rigidity. In one embodiment, the infusion tube wall 35 has a substantially uniform thickness between about 0.9 and 1.5 mm. In other embodiments, the wall 35 is about 1.2 mm. The rigidity of the wall 35 is obtained from its material which will be explained in more detail below. Table 1 below is a comparison of the force required to pierce the infusion tube wall with an 18 gauge needle perpendicular to the surface for the present invention, a commercial IV bag or a flexible container.

  Referring to FIGS. 1-3B, the ports 14,16 extend laterally and are flexible in top and bottom sheets of multilayer film that are sealed to each other and to the injection tubes 13,15 by thermal welding or other means. It is connected by the main body part 124 including a sexual web. With a flexible web 124, the injection tubes 13, 15 of the ports 14, 16 are individually moved or handled. The lower portion 25 of each infusion tube 13, 15 is attached to the container body 1, and the infusion tube 13, 15 allows the user to place at least one finger in between (the “finger” as used herein is the thumb Are sufficiently spaced to insert. For a width of about ½ inch with respect to the lower portion 25 of the infusion tubes 13, 15, the center line of the tubes 13, 15 of the ports 14, 16 is placed about 1.5 inches apart, so that the spread S is about 1 inch. Can be realized. The protrusion of the infusion tubes 13, 15 from the container body 1, the position of the flange 29, or the length of the top 23 of the infusion tubes 13, 15 will also provide adequate space for one of the user's fingers. Can be selected.

  2-5, the port closure system 10 has two port closure assemblies. The first port assembly is an additional port closure assembly 22 configured to provide aseptic access of the needle 18 to the first fluid port 14. The additional port closure assembly 22 is configured to be assembled and sterilized as a subassembly prior to connection and use with the fluid container 12.

  The additional port closure assembly 22 includes a port housing 24 (hereinafter “reseal housing 24”) configured to seal the first fluid port 14 upon attachment to the infusion tube 13. Reseal housing 24 includes a base surface 26 configured to be coupled to first fluid port 14 or infusion tube 13, and an inner surface 28 configured to face outwardly from first fluid port 14. Have An open cylinder 30 extends from the inner surface 26 to the base surface 28 and has an upper rim 32. A reseal diaphragm 34 is connected to the open cylinder 30 to seal the open cylinder 30 closed against fluid flow from the container 12. The reseal diaphragm 34 is opened to fluid flow once the hole is opened by the needle 18. The reseal flange 36 extends from the open cylinder 30 in a substantially radial direction. The reseal flange 36 protects the user from accidental stabs when the needle 18 is added to the additional port closure assembly 22.

  Reseal flange 36 and open cylinder 30 are also oriented and arranged to receive a commercially available needleless access system (not shown) that is integral with reseal housing 24. U.S. Pat. No. 5,924,584 describes one embodiment of a needleless access system suitable for the present invention, the description of which is expressly incorporated herein in its entirety.

  With reference to FIGS. 3A-6C, the cap assembly 38 of the additional port closure assembly 22 is connected to the reseal housing 24. Generally, the cap assembly 38 has a lower shell 40 that is shaped to mate with the inner surface 28 of the reseal housing 24. Once engaged, the cap assembly 38 seals the inner surface 28 from potential contamination. A sealed opening 42 is provided in the cap assembly 38 and a removable cap 44 provides access to the sealed opening 42 and the inner surface 28. Once the removable cap 44 is removed, the additional port closure assembly 22 does not need to be sterilized again because the cap assembly 38 acts as a sterilization barrier to protect the inner surface 28 from potential contamination. The removable cap 44 is immediately recognizable as tampered because it cannot be reconnected once it has been removed. Further, if the cap 44 is pierced with the cap 44 in place, it clearly indicates that the cap has been pierced (ie, tampered with).

  The cap assembly 38 is a single structure and includes a crown 46 connected to the removable cap 44 by an annular frangible area 48. The term “frangible region” as used herein refers to any weak region or any region with some form of weak seal.

  The crown 46 of the cap assembly 38 has an outer shell 50. A sealed opening 42 extends between the outer shell 50 and the lower shell 40 to provide access to the inner surface 28 when the removable cap 44 is removed. A retaining rim 54 extends from the lower shell 40 and around the sealed opening 42. A coronal flange 56 extends substantially radially from the sealed opening 42. The coronal flange 56 protects the user from accidental stabs when adding the needle 18 to the additional port closure assembly 22.

  A notch region 58 is formed on the cap assembly 38 and is operably coupled to the frangible region 48 to weaken the frangible region 48 near the notch region 58. One skilled in the art will appreciate that the cutout region 58 may be on the removable cap 44 or on the crown 46 without departing from the invention, as shown in FIG. 6C. The cutout region 58 may be formed in a shape that focuses various forces, including but not limited to a partial pyramid shape, a V-shape, or a partial cone shape.

  The cover 60 of the removable cap 44 is sealed over the sealed opening 42 by the frangible region 48. The cover 60 has a thickness sufficient to withstand manual drilling by the needle 18 or the drill pin 20. Depending on the melting temperature of the material of the cover 60 at 129-144 ° C. and the presence of an air chamber under the cover once assembled, the cover 60 is configured to shape changes during heat sterilization. This allows the user to identify the sterilized state of the additional port closure assembly 22 depending on the shape of the cover 60.

  A pull element 62 of the removable cap 44 is connected to the cover 60. Thereby, the user can manually pull the pulling element 62 to cut the frangible region 48 and separate the cover 60 from the crown 46. The tension element 62 includes a lever 64 connected to one side of the cover and adjacent to the crown 46. The lever 64 is disposed adjacent to the notch region 58 and focuses the user's pulling force on the pulling element 62 in the notch region 58. The lever 64 includes a narrowed cross-sectional area that defines a tensile force concentration portion. The tensile force concentration portion is adjacent to the frangible region 48 and in the vicinity of the notch region 58. Other shapes, orientations and positions will not depart from the present invention as long as the structure focuses or concentrates the user's pull force on the pull element in the notch region 58, but preferably the pull force concentrator is It is defined by a transverse groove 65 having a rounded side wall at the top of the lever 64.

  A tension tab 66 is connected to the lever 64 by a tension ring 68 and is disposed on the opposite side of the lever 64 in the tension ring 68. The pull tab 66 provides an area for the user to grasp and pull the pull element 62 by hand.

  At least one pivot element 70 is radially spaced from the frangible region 48 and circumferentially spaced from the lever 64 in the pull ring 68. More preferably, a pair of pivot elements are arranged such that each pivot is equally spaced about 90 ° from the lever 64. The pivot element 70 contacts the crown 46 and pivots to absorb any impact force on the tensioning element 62 to prevent unintentional damage to the frangible region 48. Additional pivot elements may be employed as needed.

  With reference to FIGS. 3A, 4, 5, and 7, the reseal element 72 of the removable cap 44 is disposed between the lower shell 40 of the crown 46 and the inner surface 28 of the reseal housing 24. The Reseal element 72 has an annular shoulder 74 that extends radially from central core 76. The annular shoulder 74 divides the central core 76 into an upper core 78 having a raised surface 80 and a lower core 82.

  The raised surface 80 extends beyond the sealed opening 42 in the cap assembly 38 when the removable cap 44 is removed. The exposed raised surface 80 provides a convenient swabbable area for sterilization during subsequent use.

  The lower core 82 is received in the open cylinder 30 of the reseal housing 24. The diameter of the lower core 82 is selected in relation to the diameter of the open cylinder 30 so that the open cylinder 30 provides a seal between them and again when the piercing element 72 itself is re-opened when drilling. In order to seal, the lower core 82 is pressed radially inward. In other words, the lower core 82 is frictionally fitted or forced into the open cylinder 30 of the reseal housing 24. This frictional fit provides one means of securing or holding the reseal element 72 within the reseal housing 24 for subsequent assembly operations.

  An annular lip element 84 is connected to the outer rim 86 of the annular shoulder 74. The joint of the rim 86 and lip element 84 has a fillet or inner radius range 85. The lip element 84 extends in two directions across the annular shoulder 74. The upper and lower inner edges of the lip element 84 have a chamfered inner radius range or fillet 87 thereon to assist in molding and guide the retaining rim 54 or rim 32 toward the annular shoulder 74. Have. The annular lip element 84 has an inner diameter that is larger than the outer diameter of the retaining rim 54 and an outer diameter that is smaller than the outer diameter of the coronal flange 56. Reseal element 72 is mechanically maintained, held, secured, or more specifically clamped in place by retaining rim 54 of crown 46 and upper rim 32 of open cylinder 30. The retaining rim 54 and upper rim 32 are received between the central core 76 and the lip element 84 to retain the annular shoulder 74 when the cap assembly 38 and the reseal housing 24 are connected to each other. The uncompressed height of the annular shoulder 74 is equal to or more preferably greater than the spacing between the retaining rim 54 and the rim 32 when the cap 44 and the reseal housing 24 are joined. Can be selected. By selecting an uncompressed height greater than the effective spacing, the desired clamping force or seal is provided on the elastic material of the reseal element 72 at the shoulder 74. Alternatively, a small gap may initially be provided between the retaining rim 54 and the upper side of the shoulder 74. The gap may remain as it is or may be removed if the cap 44 is deformed during the heat sterilization of the assembly 22. In the latter case, the rims 32, 54 are adjacent or in contact with the lower and upper sides of the annular shoulder 74, respectively. As a result, the crown 46 and the reseal housing 24 together with the annular shoulder 74 and the reseal element lip 84 cooperate to provide a substantially permanent second mechanical means for securing the reseal element 72. To do. That means can be independent of the fit between the reseal element 72 and the open cylinder 30, eliminating the need for separate fastening means, solvent bonding, or swaging the reseal element 72 in place. . In addition to securely holding the reseal element 72 in place, the cap assembly 38 provides a removable cap 44 that seals the reseal element 72 from contamination until use. Regardless of the fact that the reseal element 72 is neither solvent bonded nor swaged into place, its fixation depends on the size of the component, the needle specification, the insertion force at the needle 18, or the cap 44 Unaffected by removal. The reseal element 72 is automatically mechanically held in place and is first constrained for both axial and radial movement by the connection of the crown 46 and reseal housing 24.

  With reference to FIGS. 1-3B, 9 and 10, the management port closure assembly 88 is shown as the second port closure assembly of the port closure system 10. The management port closure assembly 88 is configured to provide sterile access of the piercing tweezer 20 to the second fluid port 16. The management port closure assembly 88 is also configured to be assembled and sterilized as a subassembly prior to connection and use with the fluid container 12.

  With reference to FIGS. 1, 9, and 10, the management port closure assembly 88 includes a second port housing 90 (hereinafter “the second fluid port 16”) configured to seal the second fluid port 16 by attachment to the infusion tube 15. A management housing 90 "). Base surface 92 is configured to couple with second fluid port 16 or infusion tube 15, and internal surface 94 is configured to face outward from second fluid port 16.

  A sealing ring 95 extends from the base surface 92 and is configured to be received sealingly within the second fluid port 16. Seal ring 95 has a rigid structure and a large diameter of about 5/8 inch to provide improved user handling of management port closure assembly 88. An optional stiffening rib or rib 97, more preferably a pair of spaced apart ribs 97, seals to harden the sealing ring and withstand deformation during heat sealing to the port 16 and subsequent autoclave heat sterilization. A ring 95 extends radially inward.

  A sleeve 96 extends from the inner surface 94 beyond the base surface 92 and into the sealing ring 95. The sleeve 96 rests below the sealed opening 42 of the second cap assembly 38 connected to the management housing 90. This recessed recess protects the sleeve from accidental contamination of the inner surface 94 when the management port closure assembly 88 is opened. The sleeve 96 has an upper part 98 and a lower part 100. The upper portion 98 is adjacent to the inner surface 94 and has an opening 104 with a smaller diameter than the lower portion 100. Due to the difference in diameter between the upper portion 98 and the lower portion 100, the sleeve 96 receives and seals the piercing tweezers 20 that are sized differently, and between the various piercing tweezers 20. It is possible to adapt to changes in diameter.

  In the embodiment disclosed in FIG. 10, the upper portion 98 has a substantially uniform wall thickness and is inwardly into a bullet nose structure having a convex outer surface and a concave inner surface. Tapered. The taper can be formed by any well-known manufacturing technique including, but not limited to, cutting, rolling (with or without heat) and swaging. The upper 98 taper is preferably curvilinear, although a linear taper can also be used. In use, if the user's finger is within ¼ inch of the sleeve 96, this allows the user to easily control the position of the sleeve 96 relative to the piercing tweezers 20.

  The sleeve 96 and the sealing ring 95 are connected at a flexible annular joint 102 in the sleeve base 114 to form a single body. The flexible joint 102 allows some small displacement of the sleeve 96 relative to the rigid sealing ring 95 during use.

  An inflated moat 106 is disposed on the base surface 92 between the sealing ring 95 and the sleeve 96. The trench 106 allows the sealing ring 95 to contract and expand as needed based on the internal pressure of the container 12 during the heat sterilization cycle. As a result, the moat 106 protects the sleeve 96 from substantial permanent deformation that can lead to leakage or unacceptable insertion or withdrawal force conditions. The connection between the sealing ring 95 and the sleeve 96 provides a clamping or sealing force to the piercing tweezer 20 (not shown) during pin insertion and withdrawal. In addition to being physically separated from the sealing ring 95 except at the base 114, the sleeve 96 is sealed so that the moat 106 relieves external pressure on the sleeve 96 during autoclaving. The ring 95 and moat 106 protects against possible distortion during autoclaving.

  The management diaphragm 110 is connected to the sleeve 96 to seal the sleeve 96 closed against fluid flow. The management diaphragm 110 is opened against the fluid flow once the hole is made by the tweezers 20.

  The management flange 112 extends substantially radially from the sealing ring 95 and thus from the sleeve 96. The management flange 112 around the sleeve 96 provides an effective target area where the user should add piercing tweezers 20 and protects the user from accidental stabs.

  The second cap assembly 38 is connected to the management housing 90 to form a management port closure assembly 88. The lower shell 40 is shaped to mate with the inner surface 94 of the management housing 90. Once engaged, the cap assembly 38 seals the inner surface 94 from potential contamination. The removable cap 44 provides access to the sealed opening 42 and thus the inner surface 94. Once the removable cap 44 is disconnected, the management port closure assembly 88 does not need to be sterilized again because the cap assembly 38 acts as a sterilization barrier to protect the inner surface 94 from potential contamination.

  Referring to FIG. 1, during manufacture of port system 10, port housing 24/90, cap assembly 38 and reseal element 72 are molded. The additional port closure assembly 22 is formed by placing a reseal element 72 between the cap assembly 38 and the port housing 24 and permanently connecting the cap assembly 38 to the port housing 24. Management port closure assembly 88 is formed by connecting cap assembly 38 to port housing 90. The port closure assemblies 22/88 are connected to each other by ultrasonic or radiant heat fusion welding of the cap assembly 38 to the port housing 24/90. The port closure assembly 22/88 is radiation sterilized. The port closure assembly 22/88 previously sterilized by irradiation forms a subassembly that is connected to or attached to the fluid container 12. The fluid container 12 is connected to the port closure assembly 22/88 irradiated by conventional means including, but not limited to, ultrasonic welding, radiant heat fusion welding or hot tong heat sealing. Sealed. The connected port closure assembly 22/88 and fluid container 12 are then eventually heat sterilized by autoclaving after injection.

  The port closure assembly 22/88 is formed of a polymer blend that does not deteriorate during irradiation, sterilization, irradiation heat melting and ultrasonic welding. The term “deterioration” as used herein refers to deterioration to the extent that the material is no longer appropriate for its intended purpose. The polymer blend also exhibits ultrasonic sealability, irradiation heat meltability, and prevents coring when the polymer is drilled. The term “coring” as used herein refers to the process by which the polymer breaks upon drilling and leads to the formation of loose polymer particulates. The ability of the polymer blend to be sealed by ultrasonic bonding and / or radiant heat melting eliminates the need for any solvent or swaging bonds, and additional friction force adaptation to hold the port closure system 10 together. There is no need to prepare elements. In addition, the polymer blend provides a balance between insertion and withdrawal forces for improved handling by the user.

  An example of such a polymer blend includes, but is not limited to, a mixture of 70% commercially available Atofina Z9470 (Atofina Z9470) and 30% commercially available Beisel KS359P (Basell KS359P). Other suitable polypropylene and polyethylene copolymer mixtures may also be used without departing from the invention.

  Materials for the IV fluid container 12, infusion tubes 13, 15, port housings 24, 90 and cap assembly 38, along with their design, are selected to provide the required container and port system functionality. While the differences in function between these parts require different physical properties that can be supplied by various materials, the materials need to be compatible at the molecular level so that they can be joined together without adhesive.

  The infusion tubes 13, 15 are formed of a material that can be sealed against the IV fluid container 12 and the inner sealing surfaces of the port housings 24, 90. It needs to be able to be autoclaved without deformation that significantly affects its appearance or function of providing a channel between the container 12 and the ports 14,16. For the sealing surface of the container 12 and the port housings 24, 90 containing polyolefin, such as polypropylene homopolymer, polypropylene copolymer or a mixture of polypropylene copolymer with a material exhibiting elastic properties, the injection tubes 13, 15 Preferably comprises a polypropylene homopolymer or copolymer. While the copolymer exhibits better compatibility with the IV container 12 having a copolymer sealing surface, the homopolymer exhibits better dimensional stability through autoclaving. For container sealing surfaces and port housings containing random polypropylene copolymers or mixtures of random polypropylene copolymers with materials exhibiting elastic properties, the injection tubes 13, 15 are preferably from about 2% Random polypropylene copolymers with an ethylene content up to about 6% and a melting point from about 129 ° C to about 145 ° C are included. In order to reduce deformation during autoclaving at 125 ° C, the random polypropylene copolymer more preferably has an ethylene content of about 2.4-3.5% and a melting point of about 145 ° C. Have. In particular, a random polypropylene copolymer, Total Petrochemicals 7825, together with a container 12 with a polypropylene copolymer sealing layer and a port housing 24, 90 containing a mixture of polypropylene copolymers, is about 125 ° C. It has been found to give the best results at autoclave temperatures up to.

  The management port housing 90 must be stable to 18-45 kGy, or at least 18-32 kGy of gamma radiation, and thermally stable to both the infusion tube 13 and the cap assembly 38. is there. The management port housing 90 should be autoclavable up to about 125 ° C. without deformation that greatly affects its ability to receive and hold the piercing pin 20 with an acceptable force. Preferably, the material selected for the management port housing 90 has a high melting temperature and good elastic properties. Material mixtures are suitable for providing properties that are not obtainable from individual materials. A polypropylene-based material is first preferred for its chemical compatibility with the polypropylene injection tube 13. The choice of further materials depends on the radiation stability, the autoclave temperature, and the diameter range of the piercing pins used. Generally, polypropylenes with higher melting points, such as homopolymers or copolymers with low ethylene content, such as Total Petrochemicals 7825 with an ethylene content of about 2.4-3.5%, Withstands autoclaving, with smaller deformations. However, they have a relatively high factor that increases the insertion force of the piercing pin and limits the diameter range of the piercing pin that can be used. They are also less stable to gamma radiation if not intentionally stabilized with adhesives. By mixing them with low modulus, radiation stable polyolefins, their performance can be improved while a random copolymer (about 6% or more) with a high ethylene content is used as the base material. It is preferable to use it. A high ethylene content improves radiation stability and reduces the coefficient while maintaining acceptable resistance to autoclave deformation. It also suppresses the required softening material concentration. Such softening materials often have lower melting points, are tacky, and are difficult to injection mold. Preferably, a random polypropylene copolymer with a high ethylene content, such as Total Petrochemicals Z9470, is used for the base material.

  Unmodified high ethylene content random polypropylene copolymer can provide acceptable performance at a single piercing pin diameter while increasing the piercing pin diameter range and radiation stability In order to improve the temperature, it is preferable to soften a material including a polypolyolefin copolymer such as thermoplastic polypolyolefin elastomer (TPE) or plastomers. Acceptable performance can also be obtained with a suitable selection of TPE / plastomer and mixture ratios due to the low copolymer content of polypropylene with a low ethylene content. Similar to polypropylene copolymers, softer TPEs and plastomers generally have lower melting points. The ethylene-hexene and ethylene-octene copolymer flexomers or plastomers have a very low modulus and melting point (72 ° C. and 55 ° C., respectively) substantially below the autoclave temperature of 125 ° C. However, when mixed with a random copolymer of low ethylene content in the proportion of 70% polypropylene copolymer and 30% flexomer or plastomer, they show adequate softening and autoclave dimensional stability. Ethylene-octene flexomers or plastomers such as Dow Affinity EG8100 can be used to suppress the insertion force of the piercing pins. Although random copolymers of polypropylene with ethylene-propylene rubber copolymerized in a copolymer matrix, such as Basell's Adflex materials, provide softening less than that of Fraxomer or Plastoma. Has a higher melting temperature (about 144 ° C.). They are extremely suitable for softening high ethylene content random polypropylene copolymer base materials such as Total Petrochemicals Z9470 to reduce stiffness without suppressing autoclave dimensional stability It is. Basel Adflex KS359P is one material that has been found to provide effective softening and radiation stability. Mixtures made from 40% Z9470 / 60% KS359P to 70% Z9470 / 30% KS359P can be used, but a mixture of about 70% Z9470 / 30% KS359P is more preferred .

  The port cap assembly 38 can be sealed to both the management port housing 90 and the additional port housing 24 and must be stable to 18-45 kGy or at least 18-32 kGy of gamma radiation. . It needs to be autoclavable up to about 125 ° C. without deformation that will maintain sterility and significantly affect its function of opening with an acceptable tensile force. A clue to acceptable opening performance is to create an appropriate combination of material stiffness and tear detail thickness. The pull ring 68 or pull element 62 can snap off before opening the cap 44 using an excessively hard material or thick tear detail. The pull ring 68 can extend without opening the cap 44, or the cap 44 can deform during autoclaving with too soft material. Materials that provide the required properties to a minimum are high ethylene content polypropylene copolymers such as Total Petrochemicals Z9470 and random heterophasics such as Borealis Bosssoft SD233CF (Borealis Bosssoft SD233CF). Polypropylene. However, it is preferred to reduce the opening force by using a TPE polymerization modifier. It is also preferred that the same material be used in the same or similar proportions used in the port housing 90 in order to maximize sealability for the management port housing 90. The Baysel Adflex KS359P is again very suitable in that it provides softening without loss of autoclave dimensional stability. A range of 100% Z9470 / 0% KS359P to 70% Z9470 / 30% KS359P is acceptable, but 70% Z9470 / 30% KS359P is more preferred.

  Similar to the management port housing 90, the additional port housing 24 is sealable against both the infusion tube 13 and the cap assembly 38 and is stable to 18-45 kGy or at least 18-32 kGy gamma radiation. Need to be. It needs to be autoclavable up to about 125 ° C. without deformation that significantly affects its ability to be pierced by the needle 18 without coring. In order to withstand coring, it is preferred that the selected material has elastic properties. A random copolymer of polypropylene with an ethylene-propylene rubber copolymer copolymerized with a copolymer matrix, such as a Basel Adflex materials, is elastomeric and has 70% Z9470 / Sealable against 30% KS359P port cap. Adflex KS359P is preferred among adflex materials in terms of coring performance because it is the most elastomeric in the current adflex product line. Use the same material at the same 70% / 30% mix ratio as the cap assembly 38 to improve hermetic strength by maximizing chemical compatibility and to improve injection during injection molding Is preferred. In order to maximize the coring performance of the subject port diaphragm 34 at 18 mil thickness, a range of 40% Z9470 / 60% KS359P to 0% Z9470 / 100% KS359P is preferred. In order to optimize the injection molding, sealing and coring performance, a mixture of 40% Z9470 / 60% KS359P is more preferred. The range is adjusted depending on the diaphragm thickness, the thicker the diaphragm, the higher the overall elastomer concentration required. The mixture of resins used for the various parts to be welded by sonic or heat should exhibit a melting point that is not a dissimilar melting point that impedes proper sealing safety or reliability.

  Referring to FIG. 11, yet another embodiment of the management port closure assembly 88 has many of the same features as the embodiment of FIG. 10, but instead of a tapered sleeve end, a piercing tweezer 20 (FIG. It further has a small wiper 116 adjacent to the opening 104 of the sleeve 96 for sealing against (not shown). Sealing wiper 116 against piercing tweezers 20 (not shown) reduces the possibility of fluid leaking during activation. It will be appreciated by those skilled in the art that various methods, including but not limited to, swaging at the opening 104 can be used to form the wiper 116. The wiper 116 may also be combined with the tapered sleeve end of FIG.

  Referring to FIG. 12, yet another embodiment of the management port closure assembly 88 includes some of the features of the embodiment of FIGS. 9-11, but includes a management rim 120 extending from the retaining rim 54 and the shoulder 102. Pre-drilled with a wiping diameter 119 that is maintained in place, secured, held between, or clamped (especially once heat sterilized). It further has a controlled sealing washer 118. Management sealing washer 118 seals against perforated tweezers 20 (not shown). The wiping diameter 119 can be centrally located to reduce or balance the force required to insert and pull out the tweezers 20 and can be pre-drilled. However, it can be gradually increased as the spacing from the wiping diameter increases.

  Referring to FIG. 13, yet another embodiment of the management port closure assembly 88 includes some of the features of the embodiment of FIG. 12, but between the retaining rim 54 and the management rim 120 extending from the shoulder 102. It has a management reseal 118A similar to the reseal element 72 of the additional port closure assembly 22 that is maintained in place, secured, held, or more specifically clamped. Similar to the reseal element in the additional port closure assembly 22, particularly once the assembly 88 is heat sterilized, the administrative reseal portion 118 A is clamped by the rims 54 and 120. The management reseal portion 118A seals against the perforated tweezers 20 (not shown). Diaphragm 110 can optionally be eliminated in this embodiment because management reseal 118A completely seals opening 104 of sleeve 96. The central diaphragm 121 of the reseal 118A is relatively thick (greater than 0.050 inches or 1.27 mm) in the embodiment of FIG. In yet another embodiment, the reseal element 118A is thinner (0.010) than the pre-drilled opening or wiping diameter 119 or thick central diaphragm 121 of at least 0.050 inches or 1.27 mm as shown in FIG. The features of FIGS. 12 and 13 can be combined to include a central diaphragm 121. -0.050 inch or 0.254-1.27 mm). This thin diaphragm configuration is advantageous in that it makes it easier to mold the reseal element and leaves no flash in undesired areas.

  Referring to FIG. 14, yet another embodiment of the management port closure assembly 88 includes some of the same features of the embodiment of FIG. 10, but sealed to the piercing tweezer 20 (not shown). It further includes an injection molded or extruded controlled sealing washer 118B with a diameter 119A. The sealing washer 118B is maintained in place between the holding rim 54 and the sleeve 96, secured, held, or more specifically (especially once the assembly is heat sterilized) and clamped. .

  Referring to FIG. 15, yet another embodiment of the management port closure assembly 88 includes a small wiper 116 similar to the embodiment of FIG. 11, but the wiper 116 and sleeve 96 are similar to the small wiper 116 and the sleeve 96. Form a single body that is molded by co-injection molding to have different polymer contents. The wiper 116 is formed of isoprene and will generate a holding force during activation using the piercing tweezers 20 (not shown).

  Referring to FIG. 16, another embodiment of the port closure system 10 replaces the cap assembly 38 with a cover foil 122. The cover foil 122 is made of a peelable film metal material. In this embodiment, the reseal element 72 is swaged into place. The main body 124 connects the management port assembly 88 and the additional port assembly 22 together.

  Referring to FIG. 17, another embodiment of the port closure system 10 includes the same features as the embodiment of FIG. 16, and further includes a handle element 126 that joins the port assemblies 22, 88 to the user of the handle portion 126. A space 127 between the handle portion 126 and the fluid container 12 is included to allow a finger to loop around. In addition, the additional port assembly 22 is sized smaller than the management port assembly 88, and the additional port assembly 22 is managed to further distinguish the additional port assembly 22 from the management port assembly 88. It is placed lower with respect to the port assembly 88.

  With reference to FIGS. 18-20, another embodiment of the additional port closure assembly 22 includes a reseal housing 24 and reseal element 72 as previously described. However, the lower shell 40A of the cap assembly 38 differs from the lower shell 40 described above in several respects. The lower shell 40 </ b> A of the crown 46 includes at least one sealing element 150 that engages the lip 84 of the reseal element 72. Preferably, the sealing element 150 engages the upper surface 89 of the lip 84.

  Those skilled in the art will appreciate from this disclosure that in the illustrated embodiment, the sealing element 150 may take a variety of forms and shapes, which may extend downward from the lower shell 40A, any of which It includes at least one protrusion 152 defining 154, 156 troughs on either side thereof. The protrusion 152 can be shaped substantially V-shaped in cross section and has angled sides 158, 160 that converge to form a non-pointed rounded tip 162. Preferably, the protrusions 152 extend around the lower shell 40A in a circular pattern. The circular pattern can be broken to form circumferentially spaced protrusions or can be unbroken to form a continuous annular protrusion. Alternatively, the sealing element 150 can include a plurality of coaxially disposed protrusions 152.

  As best seen in FIG. 20, the sealing element 150 has the lower shell 40A of the coronal portion 46 connected, attached, or spliced to the inner surface 28 of the reseal housing 24 as previously described. In some cases, a lip 84 is engaged between the lower shell 40A and the inner or inner surface 28. The protrusion 152 or the tip 162 of the sealing element 150 and the angled sides 158, 160 contact the upper surface 89 of the lip 84 and engage in a sealing manner. The reseal element 72 is elastically deformed around the protrusion 152. Engagement of the protrusion 152 with the resilient reseal element 72 provides a clamping force at the lip 84 so that it clamps between the protrusion 152 in the lower shell 40A and the inner surface 28 of the reseal housing 24. Is done. If the sealing element 150 includes one or more protrusions 152 configured in a well-closed annular pattern, this configuration may be a liquid, vapor and gas that may otherwise pass around the reseal element 72. Provides effective sealing against. The present invention helps to prevent contaminants from reaching the inner surface 28 when the user removes the removable cap 44. Undesirable ingress or egress of liquid, vapor or gas is prevented during sterilization of the port closure assembly 22 or the fluid container 12 to which the port closure assembly is attached. This embodiment of the present invention provides the additional advantage of further restraining the reseal element 72 against movement that may otherwise occur during insertion or withdrawal of the needle 18 or similar piercing member.

  Those skilled in the art will appreciate that the principles of FIGS. 18-20 can be applied alone or in combination with other features disclosed herein. For purposes of illustration and not limitation, the principles are applicable to management port closure assemblies that employ reseal elements, such as the embodiment of FIG.

  Referring to FIGS. 4 and 10, the mounting of the infusion tubes 13, 15 to the flange 29, in one embodiment, is hermetically attached to the cap assembly 38 and fluidly seals the ports 14, 16 respectively. , 90 can each have additional beneficial features. The port housings 24, 90 have undercuts or annular recesses 91 formed in the annular portion of the base surface 26 or base surface 92, respectively. The base surface 26 or the annular portion of the base surface 92 also has a chamfered outer edge 93 and a contact ring 99 disposed between the annular recess 91 and the chamfered outer edge 93. In one embodiment, the contact ring 99 is smooth, planar, and substantially horizontal. An indented and chamfered annular configuration is used to attach the port housings 24, 90 to the cap assembly 38 by ultrasonic welding, and thereafter at the flange 29 by hot tong welding or other means. A good contact surface at the ring 99 is provided for attaching the port closure system or assembly 22, 88 to the injection tube 13, 15. The annular recess 91 and the chamfered outer edge 93 also help to remove any flash from molding or hot tong welds of the port housings 24, 90 or to redirect it into a safe area.

  The construction and assembly of the flexible container 12 or bag of the present invention will be described in more detail. As initially described, the container 12 includes a container body 1. As best seen in FIG. 27, in one embodiment, the container body 1 is a separate two-layer flexible flexible polyolefin film that is sealed together by thermal sealing or other means along the peripheral seam 5. It has a front and a rear 3A, 3B which can be separate double wound sheets. In other embodiments, the front and back portions 3A, 3B can be formed by folding a single sheet of film over itself.

  In one embodiment, a conventional non-PVC polypolyolefin film commercially available from Sealed Air Corporation under the trade name CRYOVAC M312 is used in container 12 with the port closure system of the present invention. This material has been found to exhibit excellent compatibility with non-PVC materials suitable for injection tubes 13, 15 and port closure systems. As best seen in FIG. 28, each sheet of CRYOVAC M312 material that defines the front 3A and rear 3B has five layers. The first layer L1, also referred to herein as the sealing layer or inner layer, is heat sealed, welded, or using conventional attachment techniques including, but not limited to, heat welding, or A polypropylene layer configured to be fused to itself. The second layer L2, also referred to as the base outer or release layer, is a polyester layer configured to contact and be released from the heat sealing tool. A polyethylene intermediate barrier layer L3 is disposed between the inner layer L1 and the outer layer L2. An inner tying layer L4 is disposed between the intermediate layer L3 and the inner layer L1. An outer tying layer L5 is disposed between the intermediate layer L3 and the outer layer L2. The coupling layers L4 and L5 attach the first layer L1 and the second layer L2 to the third or intermediate layer L3, respectively.

A container 12 infused with about 500 milliliters or 1000 milliliters of medical fluid with a port closure system 10 as described herein and a container wall 3 of CRYOVAC M312 film having an overall thickness of about 8 mils. Has been shown to provide a shelf life of up to 24 months or more and a water vapor transmission rate of less than about 0.060 grams / 100 square inches per day. Current tests show that the shelf life can be extended to 36 months, depending on acceptable injection volume and product analysis. The 500 ml or larger container 12 made with this film and the port closure system disclosed herein does not require a supplemental moisture barrier or overlap in the individual containers to achieve these results. As shown in Table 2 below, these containers 12 are inferior in terms of MVTR compared to conventional containers composed of single layer PVC film.

  The polyolefin container 12 obtains a double wound film from either a blown film or cast film process and uses it as a continuous web bag fabricator. It can be processed by sending it in. Containers 12 or bags are usually made side by side in a web of film, with injection ports 13, 15 protruding from one edge of the web.

  The film first has a label copy applied to it by one or more conventional processes. Hot stamping, lithography, thermal transfer printing or combinations thereof can be employed to place any necessary label information on the container.

  Thereafter, the film is opened and the injection tubes 13, 15 are placed between two film sheets, the front 3A and the rear 3B, as shown in FIG. 26A. The injection tubes 13, 15 are then heat-sealed by the tool T to the two sheets of film, the front 3A and the rear 3B.

  The film is then passed through a perimeter sealed press that further seals the injection tubes 13, 15 between the sheets 3A, 3B, creates a perimeter or perimeter seal 5, and detaches the container.

  The individual bags are then rotated so that the infusion tubes 13, 15 extend vertically. Next, the fluid reservoir 2 of the container body 1 is injected with a predetermined amount of medical solution through one or more injection tubes 13 and 15. Of course, depending on the intended use, a single infusion tube may be sufficient.

  Thereafter, the top of the injection tube flange 29 is radiant heated to receive the port assemblies 22, 88. At the same time, the base surfaces or base surfaces 26, 92 of the port housings 24, 90 are radiantly heated. Subsequently, the heat source is removed and the port assemblies 22, 88 and injection tubes 13, 15 are pressed together under controlled pressure and time conditions.

  Another method of joining the port assemblies 22, 88 to the injection tubes 13, 15 is by ultrasonic welding. In this process, the port assemblies 22, 88 and the injection tubes 13, 15 are pressed together while ultrasonic energy is passed through them. Once the ultrasonic energy is applied, the parts remain tightly assembled until the material is rebound.

  The injected container 12 is placed in an autoclave for steam heat sterilization to ensure that the final product is sterile. The contents of the container are steam sterilized using a 121 + 4 / −0 ° C. cycle with a peak dwell of 15 minutes for the coldest container.

  Thereafter, a plurality of individual filled containers 12 are placed in shipping cardboard, stored, and ultimately shipped to the user.

  The flexible container or IV bag 12 of FIG. 25A has a substantially straight longitudinal side. The container has an outer peripheral seam 5 that joins the front part 3 </ b> A and the rear part 3 </ b> B of the container wall 3. The seam 5 can be formed by well known conventional processes including, but not limited to, thermal welding, ultrasonic welding, and the like. The seam 5 or welded portion extends straight along the substantially straight longitudinal side of the container body 1 and bends convexly at the corners of the bag 12. However, it has been discovered that changes in the path of the outer circumferential seam 5 of the container 12 near the corner can result in material kinking, wrinkling and undesired tacking inside the container near the corner when the bag 12 is injected. Has been. Tacking is particularly apparent after autoclaving, which impairs the transparency of the film, adversely affects drainage, and can be perceived by the user as a defect in the bag 12 or its contents.

  The present invention provides a solution to these problems by providing a flexible fluid container or bag 12, as illustrated in FIGS. 25B, 25C, and 27. FIG. The container or bag 12 has a flexible elongated container body 1. As seen in FIG. 27, the main body 1 has a fluid reservoir 2 formed therein. The fluid reservoir 2 is surrounded by a container wall 3 having a front part 3A and a rear part 3B.

  The container body 1 has a pair of longitudinal side edges 37 and 39 on both sides as a whole. Many symmetric and asymmetric shapes are possible without departing from the invention, but symmetric shapes are illustrated, so that the container body 1 has a central longitudinal axis 41. The container body 1 includes a top edge 43 and a bottom edge 45 on the opposite side of the top edge 43. The upper edge portion 43 and the bottom edge portion 45 extend across the central axis 41 of the container body 1. The container body 1 has a hole 47 formed adjacent to the upper edge 43 for suspending the container 12. The container body 1 also has a pair of sealed ports at the bottom edge 45, for example as described above, although other port structures and configurations will not compromise this aspect of the invention. The front part 3A and the rear part 3B of the container wall 3 form a reservoir 2 to contain fluid along the outer seam 5 by heat sealing, bonding, joining, welding or other conventional joining means. Sealed to each other. The outer circumferential seam 5 extends adjacent to at least one of the longitudinal side edges 37, 39 on both sides.

  In one embodiment, the seam 5 follows a concave path relative to the longitudinal axis of the container body 1, such as the central longitudinal axis 41, regardless of the path of the longitudinal side edges 37, 39 to which it is adjacent. In another embodiment, the seam 5 follows a concave path with respect to both the central longitudinal axis 41 and at least one of the side edges 37, 39 to which it is adjacent. In other words, at least one of the longitudinal side edges 37 and 39 is substantially linear, and the outer peripheral seam 5 is bent inward with respect to the side edge 37 or 39. The spacing between the longitudinal side edges 37, 39 of the container and seam 5 increases overall as the seam approaches the middle of the container and decreases as the seam 5 approaches the top and bottom ends of the container. . In another embodiment, as shown in FIG. 25B, both longitudinal edges 37, 39 on both sides are straight and the seam 5 is inward relative to both longitudinal edges 37, 39 on both sides. It is bent to. In yet another embodiment shown in FIG. 25C, the longitudinal side edges 37, 39 are also bent inward. The side edges 37, 39 can vary at a distance from the bent seam 5, or can be parallel to the seam 5. Embodiments that are parallel to the seam 5 can help to reduce the amount of material present in the finished container 1 without compromising the integrity and reliability of the welded seam 5.

  Other paths for the curved perimeter seam 5 are conceivable, but a sufficient (all or nearly all) radius range (along the entire inner edge of the seam 5 as shown in FIGS. 25B and 25C) radius) gives good results. In a bag 12 about 9.25 inches long and 4.0 inches wide, the concave to concave ratio over the bag length of about 53 (the actual or virtual straight seam or the inner edge of the seam to the outer edge of the bag) Maximum offset inward) gave good results. On the other hand, a concave ratio of about 29 in the 7.25 inch bag failed to suppress wrinkle and film blocking. Based on this, a concave ratio of at least about 35 is desirable, and a concave ratio in the range of about 40-70 significantly suppresses wrinkles and film blocking that may otherwise occur during autoclaving of the container 12. I am convinced that

  The front part 3A and the rear part 3B can be formed in different ways and from different materials. Without being limited thereto, without departing from the scope of this aspect of the present invention, the film is a multi-layer film that does not include the low MVTR polyolefin DEHP and PVC that are described earlier in this application. Including the case of obtaining. In one embodiment, the front 3A and back 3B can each be formed of a separate sheet of flexible film. The front 3A film may be the same in terms of material relative to the back 3B film, or different films and / or materials may be used. In other embodiments, the front 3A and rear 3B are formed from a single film sheet that is folded along the top, bottom, or sides to form the front 3A and rear 3B. This arrange | positions the inner side layer of 3 A of front parts in the relationship which opposes or overlaps with the inner side layer of the rear part 3B.

  The shape of the front portion 3A is also different from the shape of the rear portion 3B. The shapes of the front part 3A and the rear part 3B can be multifaceted. For purposes of illustration only and not limitation, the sheet of film that makes up the front 3A and the back 3B may be substantially rectangular.

  The container of the present invention with a bent side seam is easy to grip and handle, makes it difficult to wrinkle in and out, and is resistant to film tacking or blocking inside the container near the corners. Have.

  One skilled in the art will appreciate that the present invention may be applied to flexible containers for enteral nutrition or other medical fluids as well.

  From the foregoing, it can be seen that the present invention achieves at least all of the aforementioned objectives. The present invention provides a port closure system that reduces the possibility of contamination during storage and use, improves ease of handling when fluid is drawn or introduced, and improves manufacturing ease and efficiency. provide. The present invention provides a container that does not contain PVC and DEHP. The container has a low MVTR that allows greater manufacturing tolerances near the target injection volume.

Claims (64)

A flexible container body having a fluid reservoir formed therein and surrounded by a container wall, the container body including at least one port therein;
A flexible fluid container comprising a port closure system for sealing at least one port.   At least one port comprises an elongate infusion tube including a proximal end, a distal end, and a fluid passage extending from the proximal end to the distal end, the distal end extending from the container body. And the proximal end is attached to the container body such that the fluid passage is in communication with the fluid reservoir, and the infusion tube includes an upper portion adjacent to the distal end and a lower portion adjacent to the proximal end. The container according to claim 1.   The upper portion of the injection tube is generally cylindrical and includes an annular flange extending radially outwardly thereon and an outer surface disposed below the flange, the outer surface having a pair of cutouts on both sides. The container of Claim 2 containing a part.   4. A container according to claim 3, wherein the lower part of the injection tube has a non-circular cross section.   A non-circular cross-section is selected from the group of shapes including oval, semi-oval, oval, semi-elliptical, rhombus, and semi-rhombus, and has a first axis and a second axis that intersects the first axis. The container according to claim 4.   6. A container according to claim 5, wherein the cutout at the top of the injection tube is perpendicular to the first axis at the bottom of the injection tube.   The first axis terminates at both ends defining the lower width of the infusion tube, the second axis terminates at both ends defining the lower depth of the infusion tube, and the first axis is the end of the infusion tube. 7. A container according to claim 6, wherein the lower width of the infusion tube is greater than the lower depth of the infusion tube so that the lower major axis and the second axis are minor.   A container according to claim 2, wherein the lower part of the injection tube has a non-circular cross section.   The non-circular cross section is one of an oval, a semi-oval, an ellipse, a semi-ellipse, a rhombus, and a semi-rhombus, and has a first axis and a second axis that intersects the first axis; The container according to claim 8.   The first axis terminates at both ends defining the lower width of the infusion tube, the second axis terminates at both ends defining the lower depth of the infusion tube, and the first axis is the end of the infusion tube. 10. A container according to claim 9, wherein the width of the lower portion of the infusion tube is greater than the depth of the lower portion of the infusion tube so that the lower major axis and the second axis are the minor axis.   11. A container according to claim 10, wherein the lower part of the injection tube has an outer radius formed at both ends of the major axis.   12. A container according to claim 11, wherein the outer radius formed at both ends of the major axis is a 0.005-0.015 inch radius.   11. A container according to claim 10, wherein the lower portion of the infusion tube has an outer radius formed at at least one of both ends of the major axis.   14. A container according to claim 13, wherein the outer radius formed on at least one of the ends of the minor axis is a 0.125-0.250 inch radius.   The container of claim 2, wherein the infusion tube is approximately 1-2 inches long.   16. A container according to claim 15, 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 container according to claim 2, wherein the injection tube wall has sufficient thickness and rigidity.   The container of claim 17, wherein the injection tube comprises a random polypropylene copolymer with an ethylene content of about 2% to about 6% and a melting point of about 129 ° C to about 145 ° C.   19. A container according to claim 18, wherein the injection tube wall has a substantially uniform thickness between about 0.9 and 1.5 mm.   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 sealed to the lower part of the injection tube The container according to claim 10, which is inserted into the container.   21. The rear and the front are each a sheet of multilayer flexible polyolefin film selected such that the container has a water vapor transmission rate of less than about 0.060 grams / 100 square inches per day. 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 22. A container according to claim 21, wherein the bottom 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 22. The container according to Item 21.   24. The container of claim 23, wherein the multi-layer flexible polyolefin film is a CRYOVAC M312 film.   The container of claim 2, wherein the container body, infusion tube and port closure system do not comprise PVC and DEHP. Providing a container comprising a multilayer polyolefin bag having at least one port therein;
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.   27. The method of claim 26, 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.   28. The method of claim 27, wherein the infused container is allowed to be exposed to outside air for a period of up to 24 months. A flexible container body having a fluid reservoir formed therein and surrounded by a container wall, the container body including at least one port therein;
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 outwardly 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. 30. A container according to claim 29, comprising a contact ring disposed between the recess and the chamfer for contact.   31. A container according to claim 30, wherein the contact ring is a substantially horizontal plane.   31. A container according to claim 30, wherein the contact ring is attached to a flange at the distal end of the infusion tube. A flexible container body having a fluid reservoir formed therein and surrounded by a container wall, the container body including at least one fluid port therein;
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;
A crown having an outer shell, a lower shell that is mateably connected to the port housing, and a sealed opening extending between the outer shell and the lower shell;
A cover that is sealed over an opening sealed by the frangible region and a cover that allows 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 35. The container of claim 33, 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. 35. A container according to claim 34, comprising a contact ring disposed between the recess and the chamfer for contact.   36. A container according to claim 35, wherein the contact ring comprises a substantially horizontal plane.   36. A container according to claim 35, wherein the contact ring is attached to a flange at the distal end of the infusion tube.   38. A container according to claim 37, wherein the container body has two fluid ports therein, each of the two fluid ports having an infusion tube and equipped with a port closure system.   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. 40. The container of claim 38, wherein the lower portion of the infusion tube is attached to the container body for placement.   35. The container of claim 34, 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.   41. The container of claim 40, wherein the multilayer flexible polyolefin film has an inner layer and an outer layer. A flexible elongate container body having a fluid reservoir formed therein and surrounded by a container wall including a front portion and a rear portion and at least one longitudinal side edge;
For defining a fluid reservoir, comprising a front portion and a rear portion that are sealed together along a peripheral seam adjacent to at least one longitudinal side edge;
A flexible fluid container in which the peripheral seam follows a concave path relative to the longitudinal axis of the container.   43. A container according to claim 42, wherein the at least one longitudinal side edge is straight and the perimeter seam is bent inward relative to the at least one longitudinal side edge.   43. The at least one longitudinal side edge comprises a pair of opposite longitudinal side edges, and the circumferential seam extends along a concave path adjacent each of the opposite longitudinal side edges. Container as described in.   45. A container according to claim 44, wherein both longitudinal side edges on both sides are straight and the outer circumferential seam is bent inward relative to both longitudinal side edges on both sides.   43. A container according to claim 42, wherein the front portion and the rear portion are each formed of a sheet of flexible film.   49. A container according to claim 46, wherein the front and back are each formed of a separate sheet of film.   47. The container of claim 46, wherein the front film is the same as the rear film.   49. The container of claim 48, wherein the front and back are formed from a single sheet of film that is folded to form the front and back.   49. The container of claim 48, wherein the front is formed from a first sheet of multilayer film and the rear is formed from a second sheet of multilayer film.   51. The container of claim 50, wherein the first sheet and the second sheet are each an individual multi-faced sheet of multilayer film.   52. A container according to claim 51, wherein the multifaceted sheet is rectangular.   49. The container of claim 46, wherein the flexible film comprises a polyolefin and does not comprise DEHP and PVC.   54. The container of claim 53, wherein the film is a multilayer polyolefin film that exhibits a water vapor transmission rate of less than about 0.060 grams / 100 square inches per day.   43. The container of claim 42, wherein the concave path followed by the peripheral seam has a concave ratio of at least about 35.   56. The container of claim 55, wherein the concave path followed by the peripheral seam has a concave ratio in the range of about 40-70. A flexible elongate container body having a fluid reservoir formed therein and surrounded by a container wall having front and rear portions and a pair of longitudinal side edges on both sides;
In order to define a fluid reservoir, it comprises a front part and a rear part sealed together along an outer peripheral seam adjacent to one of the longitudinal side edges,
A flexible fluid container, wherein the outer circumferential seam follows a concave path with respect to the longitudinal axis of the container and is bent inward with respect to one longitudinal side edge.   58. A flexible fluid container according to claim 57, wherein one longitudinal side edge is straight. A flexible elongate container body having a fluid reservoir formed therein and surrounded by a container wall having a front and a rear and a pair of longitudinally extending side edges on both sides;
In order to define a fluid reservoir, it comprises a front portion and a rear portion that are sealed along an outer circumferential seam that extends adjacent to the straight side edges on both sides;
Flexible seams adjacent to the straight side edges on both sides follow a concave path with respect to the central longitudinal axis of the container body and bend inward with respect to each of the straight side edges on both sides Fluid container.   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 60. A container according to claim 59, having a hole formed through the top edge adjacent the edge and a pair of sealed ports at the bottom edge.   59. A container according to claim 58, wherein the front and back are formed from a single sheet of multilayer polyolefin film free of PVC and DEHP, and the sealed port is free of PVC and DEHP.   60. The container of claim 59, wherein the container has a water vapor transmission rate of less than about 0.060 grams / 100 square inches per day.   60. The container of claim 59, wherein the concave path followed by the peripheral seam has a concave ratio of at least about 35.   64. The container of claim 63, wherein the concave path followed by the perimeter seam has a concave ratio in the range of about 40 to 70.

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