Patent Application
20090270832
The field of the invention relates generally to systems and connectors for allowing selective fluid communication with fluid containers, such as medication or medical fluid containers. The invention relates particularly to connectors and ports that allow for a first, receiving port for receiving a medicant fluid for mixing with a liquid within the medical fluid container and a second, administration port for delivery of the combined medicant and liquid or to a port which provides reception and delivery of fluids.
Medical solutions are provided in containers of several different constructions. For many years and even today solutions were provided in rigid containers such as glass containers. Other containers are not rigid but exhibit varying degrees of flexibility. These containers include blow molded containers which may be constructed of plastics including high density polyethylene. Containers made out of films form another type of flexible or non-rigid containers. Such containers or bags are typically formed of two flexible sheets or films of material joined at their peripheral edges by well-known methods, such as ultrasonic, heat, radiofrequency (RF), or laser sealing.
Containers for medical solutions may contain one or more ports to allow the administration of a preferred solution to a patient. For example, the container may include a separate medication or injection and administration port. The medication port allows a fluid to be added to the contents of the container while maintaining the sterility of the container. The administration port allows connection of the container to an administration set so that the contents may be provided to a patient.
In flexible containers, the containers include separate fill and administration ports which extend through a wall or seam of the bag. More specifically, such ports typically include plastic tubular members bonded within the peripheral seal, which allow for communication between an interior of the bag and the exterior. The tubular members are temporarily sealed by any of a number of conventional sealing devices, such as a pierceable diaphragm, elastomeric septums or frangible cannula, which are also all well known to those skilled in the medical fluid container field.
As noted above it is often desired in infusion therapy to mix a medication with the contents of a medical fluid container to dilute a medicament for administration to a patient. These medications are frequently provided in a glass vial or prefilled syringes. From time to time herein, the terms “vial,” “vial connection port,” and other uses of the word “vial” will be used in reference to a medical container, but it should be understood that embodiments of the present invention are not limited to use with a glass vial, but can be applied to any medicant container which includes a connection system which allows access and withdrawal of the contents of the container for introduction to the flexible medical fluid container or for withdrawal from the flexible medical fluid container.
If the medicant in the vial is provided as a liquid it may be withdrawn from the vial and added directly to the solution in a flexible medical fluid container for subsequent administration to a patient. In other applications, the contents may be lyophilized and must be reconstituted before withdrawal from the vial. Syringes with either needles or vial-piercing cannulas are utilized to access and withdraw the contents of the container.
It is desirable to allow the addition and withdrawal offluids to a container, such as a flexible bag, without using a needle. Present day containers typically have a medication port with a solid rubber septum that is pierced by a needle to allow access to the content. Such needles can cause needle sticks to caregivers and medical professionals, and can also cause leaks in the ports. Withdrawal is generally accomplished with a spike which forms a component of an administration set. Thus, it would be desirable to penetrate a port without having to use a needle or a spike. Variations of the previous art are illustrated in U.S. Pat. No. 4,410,321; U.S. Pat. No. 4,411,662; U.S. Pat. No. 4,432,755; U.S. Pat. No. 4,583,971; U.S. Pat. No. 4,606,734; U.S. Pat. No. 4,936,841; U.S. Pat. No. 5,308,347; U.S. Pat. No. 5,352,191; U.S. Pat. No. 5,364,386; and U.S. Pat. No. 5,826,713; and U.S. Pat. Appl. Publ. 2007/0299419, each being hereby incorporated herein by reference.
As set forth in more detail below, the present invention provides an improved port system for medicant mixing or administration with several aspects that may be employed separately or together to address one or more of the above drawbacks of prior containers and systems.
There are many embodiments of the invention. A first embodiment is a needleless access port. The needleless access port includes a base with a tower and a sealing area for sealing to a flexible bag, a sealing membrane within the base, an access portion moveably assembled to the base, the access portion including at least one seat and a spike. The needleless access port also includes a seal between the spike and the tower, wherein the access portion is configured for mounting to the tower in a first inactivated configuration and in a second activated configuration, and wherein the seal between the tower and the spike is maintained in the first and second configurations and during a transition between the first and second transitions, and wherein the sealing membrane is configured for piercing by the spike when the access portion is moved to the second configuration, and a cap covering the access portion.
Another embodiment is a needleless access port. The needleless accesss port includes a base with a sealing area, a prominent tower integrally joined with the base, the tower further including a step, and a sealing membrane within the base, and a housing slidably and sealingly mounted to the base, the housing including an outer sleeve and further including two mounting seats and at least one inner tab for mounting to the tower in a first configuration and a second inner tab for mounting to the tower in a second configuration. The needleless access port also includes a spike on an inside of the housing, the spike configured to pierce the sealing membrane when the housing is moved to the second configuration.
Another embodiment is a needleless access port. The needleless access port includes a base housing having a generally cylindrical tower, an area for sealing to a container, and a sealing membrane isolating the tower from the area for sealing. The needleless access port also includes a top housing including an inner spike for slidably mounting to the cylindrical tower, the top housing also including an integrally mounted outer sleeve, at least one connector mounted to the top housing; and it also includes a cap mounted over the top housing, wherein the top housing is configured for mounting to the base housing in two configurations, a first inactivated configuration and a second activated configuration, and wherein a seal between the top housing and the base housing is maintained in the first and second configurations and during a transition between the first and second configurations.
Another embodiment is a needleless access port. The needleless access port includes a plunger with an inner spike, an outer sleeve, and a top mounting seat. The needleless access port also includes a cap mounted over the plunger, and a base for sealing to a container, the base including an area for sealing to the container, an inner sealing membrane, and an outer surface for sealing to the plunger or the cap, wherein the base includes a prominent generally cylindrical tower integrally mounted to the base for interfacing with the spike, and wherein the plunger is configured for mounting to the base in a first inactivated position and in a second activated position, and wherein a seal is maintained between the outer surface and the plunger or the cap in the first and second positions and during a transition between the first and second positions.
Another embodiment is a needleless access port. The needleless access port includes a plunger including a spike, an outer sleeve, and a mount for a valve, and a cap configured for mounting over the plunger. The needleless access port also includes a base including an area for sealing to a connector, a membrane seal, a first tower for accepting the spike, a second tower for mounting to the plunger, and an outer surface for sealing to the cap, wherein the plunger and the base are configured for assembly in a first inactive position and for use in a second activated position, wherein the spike is maintained with the first tower in the first and second positions, and wherein a seal is maintained between the cap and the outer surface for sealing to the cap in the first and second positions.
Additional features and advantages are described herein, and will be apparent from, the following Detailed Description and the figures.
Embodiments allow medical professionals and care givers to add medicine or other liquid or fluid to a container without using needles. These same embodiments also allow withdrawal of the liquid in the container without using needles. As described below, container embodiments may have one port or more than one port. Single port embodiments may have one needleless access valve or more than one. A wide variety of embodiments are possible, of which only a few are discussed herein.
In a first embodiment, disclosed in
In one manner of assembly, a lower housing portion 22 of the port 20 is inserted through an opening 18 in an edge 14 of container or bag 10, such that the opening 18 of the bag 10 overlies the lower housing portion 22 of the port structure 20. Port 20 is bonded to the opening 18 using known methods, such as heat sealing, radiofrequency, ultrasonic or laser welding. Plastic welding or solvent bonding may also be used. When the opening 18 is sealed to the port 20, an interior chamber 12 of the unitary container 10 is defined by the flexible bag portion 10 and port 20. The illustrated container has a single chamber 12 or compartment, but it is contemplated that embodiments may include containers having a plurality of interior chambers or compartments.
The needleless access port 20 includes a lower housing 22, as noted, intended for assembly to sealing area 18 of the container 10. A portion of lower housing 22 is in the general form of a three-dimensional ellipse. Other embodiments may have a circular cross-section or other desired shape. The port 20 includes a generally cylindrical upper housing 26 that also includes the circular areas or seats 28 for valves 40, with a luer valve cap 42, shown with protective caps 46. Upper housing 26 also includes a transverse top section 30 and a tamper-evident ring 24, the tamper-evident ring intended for breaking-off before use of the needleless access port 20.
A closer view of the components is seen in
Needleless access port 20 also includes the spike 32 that is integrally molded to the upper housing 26, e.g., by injection molding. Other embodiments may use a spike 32 that is assembled or attached to the upper housing 26. The spike 32 also has a cross section that is generally in the shape of a circle. The needleless access port 20 includes a seal or membrane 36 that isolates the tower 222 from the lower portion 228 of lower housing 22, i.e., the seal 36 seals the fluid in the container 10. Needleless access port 20 includes a sleeve 34, which acts as a sliding seal and a friction member, allowing sliding movement of spike 32, which is connected to the upper housing 26, with respect to tower 222, which is connected to lower housing 22. Sleeve 34, which may be an elastomer or a thermoplastic elastomer (TPE), also acts to somewhat impede or dampen movement of spike 32 and thus upper housing 26. Inner shroud 264 and tower 222 act as a catch and latch system 44, in which the upper housing 26 is caught and latched by features on its inner sleeve 264 interacting with features on the tower 222.
A closer look at the components of the needleless access port 20 is taken in
As best seen in the left portion of
In one embodiment, the catch and latch system 44 prevents removal of the inner shroud 264 and upper housing 26 from lower housing 22. In another embodiment, the transverse portion 224 and lower male snap fit 268 are gently angled so that lower snap fit 268 may be removed from transverse portion 224 by an upward movement, thus removing inner shroud 264 and upper housing 26 from lower housing 22. With the upper housing removed, the lower housing, with tower 222 and membrane 36 remain. In this embodiment, a standard IV spike head, as seen in U.S. Pat. Appl. Publ. 2007/0299419, may be used instead. With only lower housing 22, tower 222, and seal 36 remaining, only seal 36 prevents access to the medication. Thus, a standard IV spike head, or even a needle, may be used to piece seal 36 and access the contents within the container. The diameter of seal 36 may be sufficiently large, from 5.5 mm to about 25 mm, to allow penetration of a variety of standard IV spikes or even needles.
In this application, as noted, a user is typically not trying to move the upper housing upward against the snap fits 224, 268 to remove the upper housing 26 from the lower housing 22.
When a user wishes to access internal portion 12 with needleless access port 20, the user presses downward on any part or component of upper housing 26. As shown in the
Tamper-evident ring 24 is seen to be attached to the upper housing 26 with a plurality of thin frangible connections 242, in this instance four such connections at 90° around the periphery of the ring. Other embodiments may use a different configuration or a different number of such connections. Of course, the tamper-evident ring 24 or seal need not encompass the entire circumference of the upper housing 26, it needs only cover a portion sufficient to prevent usage of the access port 20 without removing the ring or seal. Thus, a partial ring or even several tabs attached in a frangible or breakable manner are sufficient to serve as a tamper-evident seal or barrier to use. Upper housing 26 is also made with two circular seats or areas 28 for attachment of connectors or valves after the upper housing itself has been manufactured.
The materials used for the needleless access port, and its components, are primarily plastics. The port should be sufficiently rigid for ease and surety of handling by medical professionals and caregivers. Some embodiments are made from high density polyethylene (HDPE), which is sterilizable and economical. Other embodiments may be made from other olefins, olefin blends such as polyoctene-ethylene, polycarbonate, cyclic-olefin-copolymers (COCs) and other medically-acceptable polymers. Plastics with a Young's modulus of at least 1000 MPa have worked well. Of course, the needleless access port should be sterilized such as with γ-ray sterilization or β ray sterilization before it is permanently assembled to the container. Other techniques may be used. Sleeve 34 may be made from a medically-acceptable elastomer or thermoplastic elastomer (TPE), to seal between the surfaces of the tower 222 and the spike 32. The membrane 36 may be made of a thin plastic, or may be made from an elastomer, such as silicone or other material that is penetrated by the spike 32 without leaving shards or particulates.
The tamper-evident ring is molded to the outer shroud, as noted, by one or more thin sections which are easily broken, i.e., frangible. This ring provides an additional reason for using reasonably rigid materials, since relatively rigid or brittle thin sections can be broken off with reasonably small amounts of force, rather than a plastic which is tougher or more extensible and does not break as easily. While four thin frangible sections at 90° are used in one embodiment, more segments or fewer may be used, e.g., two sections at 180° or 3 sections at 120°, or 6 or 8 sections with appropriate separation to ensure full coverage. The force required to break off the ring is adjusted by tailoring the cross-sectional area of each section and the number of sections. In the present design, the ring is not removed from the port once the frangible sections are broken, the ring remains since its outer diameter is less than that of the upper portion and the valves. In other designs, the ring itself has a perforated section along its height. The perforations may be broken and the ring then completely removed.
It will be recognized that the upper housing and lower housing of the needleless access port are not necessarily molded as single parts. For example, the membrane 36 of the lower housing in some embodiments is made from an elastomer, although in some embodiments a thin section of plastic may be used. The upper housing, however, is far too complicated for manufacture or molding as a single component with a single tool. Thus, the components of the upper housing, in one embodiment, are first molded and then assembled in an integral manner. An integral assembly is an assembly which cannot be reversed without destroying the molded or assembled object.
For example, the portion of the upper housing that includes valve seats 28, Y-section 38, and internal spike 32 may be molded or formed integrally as a single piece. The inner sleeve may be molded, extruded, or formed as one or more pieces. The outer shroud 262 and top portion 30 may be molded with the frangible ring. The several pieces may then be assembled to form an integral assembly, including the upper housing, the inner shroud or shrouds, and the spike. Assembly may be accomplished with any medically-acceptable assembly technique, such as heat sealing, radiofrequency, ultrasonic or laser welding. Plastic welding or solvent bonding may also be used. The valves themselves, or a single valve, may be sonic welded onto the plunger or other component to which one or more valves mount. Other techniques may also be used. In other embodiments, other techniques and other molding and assembly methods may be used. The assembly should insure that the assembled parts are strong, leak-free and sterilized or sterilizable.
Another embodiment demonstrates that two separate ports may be used with flexible containers. In the embodiment of
There are other embodiments of a needleless port for access and infusion. A second embodiment of a needleless port 50 is presented in
As better shown in the exploded view of
Plunger 58 mounts to the gondola or base 52 through a snap fit connection in the activated position. Plunger 58 includes an outer housing 584 with two matching male snap fit connections 586 on opposite sides of outer housing 584. The snap fit connection is formed by orifices 536 in two portions 534 of the outer ring 528 of base or gondola 52. Orifices 536a and 536b act as female snap fit connections. The plunger 58 also includes a spike 582 at its distal portion. The upper or proximal portion of plunger 58 includes a flange 588 with two orifices 540, an upper housing 592, and a seat or mount 594 for mounting a valve or other outlet for the port 50. One example is a luer valve 40 with a luer valve cap 42.
The needleless access port cap 56 mounts to the plunger 58. Cap 56 includes an upper portion 562 with longitudinal ribs 564 and tactile nubs 566. Cap 56 also includes a lower portion 568 with two male snap fit connections 570, the male snap fit connections 570 for mating with orifices 540 on flange 588 of plunger 58. The upper portion 562 and lower portion 568 are joined at a very thin, frangible area 572, so that when one desires to use the port 50, the upper portion 562 of the cap 56 can be removed. Orifices 540 in this embodiment are mating female snap-fit connections. Finally, a tamper-evident ring 54 is also mounted atop the base or gondola 52. Tamper-evident ring 54 is molded from two halves 542, 544, the halves connected by a plurality of thin, frangible sections 546. The halves 542, 544 each have an upper portion 548 that matches the outer periphery of flange 588 of plunger 58. Tamper-evident ring 54 is mounted between the base 50 and the flange 588 of plunger 58, such that the frangible sections 546 are mounted squarely between grasping fingers 524 of base 52. The tamper-evident ring 54 may be designed so that the plunger 58 completely splits the two halves 542, 544 apart, allowing them to fall off, or the ring 54 may be designed as shown in this embodiment, in which the plunger 58 does not go down sufficiently far to completely separate the halves 542, 544. The tamper-evident ring 54 halves 542, 544 simply remain in place, making it obvious that someone has at least once activated the plunger 58. It is obvious that the ring 54 has been used because at least at the lower frangible sections 546 are split and the ring 54 itself now is missing or hangs loosely about outer ring 528.
Prior to activation, the snap fit between snap fit connection 586 and orifice 536a provides resistance to inadvertent activation during normal shipping and handling.
When activated, the plunger 58 is depressed and spike 582 pierces membrane 538, allowing fluid communication between a container (not shown) and valve 40. The seal is maintained between inner tower 530 and its ribs 532 against the inside of plunger outer housing 584. When the plunger has been depressed sufficiently far, the male snap-fit connectors 586 engage the second set of female snap-fit connectors 536b in outer ring 528 sections 534. This locks the plunger 58 in place and allows a continued fluid connection between the container (not shown) and the valve 40. The snap fit between the snap fit connection 586 and the second set of snap fit connectors 536b continues to maintain the plunger 58 in the activated position during use, even though the container may be in an upside down position with a portion of the weight of an infusion set (not shown) connected to the luer valve cap 42 acting on the plunger 58.
At the end of the plunging motion, a user then twists off upper cap portion 562, allowing access to luer valve cap 42 and valve 40. If the snap fit connectors 586a and 586b, 536 are designed to be reversible, the plunger may subsequently be raised to break the fluid connection and the cap 42 replaced to maintain a seal. The seal is also maintained by needleless valve 40. Alternatively, the plunger 58 may be left in the lowered position and upper portion 562 of the cap placed atop valve 40 or luer valve cap 42.
During assembly, a sterile connection is achieved for a medication and its port by placing the needleless port on a filled container of medication, and then sterilizing the assembly, usually by autoclaving or by steam sterilization. In a further embodiment the needleless port assembly may be sterilized in preliminary step, but the completed assembly may still be sterilized as a unit. In use, and as depicted in the cross-sectional view of
To activate the port 50, a user pushes down on cap 56. This forces the halves 542, 544 of the tamper-evident ring 54 to move down and out, away from the cap 56 and plunger 58. Plunger 58 moves downward, and spike 582 penetrates membrane 538, allowing access to a medication within the container. The snap-fit connectors 586 of the plunger 58 latch into the second set of mating connectors 536 and hold the plunger 58 in place with the tamper-evident ring 54 out of the way. The user then twists off upper cap portion 562, breaking the thin frangible area 572. The user removes upper cap portion 562 and connects valve 40 with the desired connection (not shown) for the downstream application. Upper cap portion 562 may be retained for replacement over the luer valve cap 42.
It is desirable to maintain the sterility seals described above. It will be understood that O-rings may be used instead of ribs 532 between the inner tower 530 and the inside of plunger outer housing 584. In addition, cap 56 should fit snugly against luer valve cap 42 and cap lower portion 568 should fit snugly against plunger upper housing 592.
Cap 66 is mounted to tamper-evident ring 64 through a thin frangible section 666. Cap 66 also includes grips 664 for the fingers of a user. Tamper-evident ring 64 mounts to base 62 through two male snap-fit connectors 662, which engage female snap-fits 626 on flange 624 of base 62.
Plunger 68 includes a spike 682 at a lower end of the plunger 68, a lower housing 684 and upper housing 686. Lower housing 684 includes two male snap fit connectors 690 for latching to female snap-fit connectors 636 of the base 62, and also includes a keyway 692 for engaging a matching slot (639) on the inside of outer ring 632. Upper housing 686 has a somewhat larger diameter than the lower housing 684. The upper housing 686 also includes two lugs 688, which act as guides for threads 694 on the inside of cap 66. The upper housing 686 also has a seat or mount 696 on its upper portion for integrally mounting a valve or other fluid communication device. Plunger 68 mounts within cap 66 and hollow tower base 63.
During normal shipment and handling the plunger 68 is maintained in the non-activated position as shown in
In use, a user approaches the port 60, grasps the container 10 (not shown) and the cap 66, and twists the cap 360°. Twisting cap 66 breaks the frangible area 666 and disengages the snap fit connector 690 from the upper snap fit connector 63. Rotating the cap 66 causes the plunger 68 with lugs 688 to lower its position as cap internal threads 694 rotate about lugs 688, depressing lugs 688 and plunger 68 until spike 682 pierces membrane 668 of the base 62 and male snap fits 690 of the plunger engage the second set of female snap fits 636 of outer ring 632 portions 634. This retains the plunger in the activated position during normal use of the container. By turning, cap 66 is broken away from frangible area 666 and plunger 68 is in an engaged position, with fluid communication between a bag (not shown) connected to port 60 valve 40.
As better seen in
It will be recognized that O-rings could be used in place of the ribs 638, the O-rings contained within grooves of the mating surfaces. It is also desirable that ring 64 fits tightly over flange 624 and ribs 638, to insure sterility of the fit. It is also desirable that cap 66 fits tightly over the luer cap 42 and upper housing 686.
As noted, the needleless access port embodiments include one or two valve seats or features used for connections or assembly to valves or other access devices. In one embodiment, such as with needleless valves 40, 42, these valves are luer access valves (LAV), generally available from a variety of manufacturers, such as Halkey-Roberts Corporation of St. Petersburg, Fla., USA. These valves are very useful, because they incorporate a septum and housing which allows repeatable sealed communication with a male luer connector. When a matching connector, such as from a syringe or administration set, is mated with the valve, the septum is penetrated by the luer tip allowing for fluid communication between the syringe or administration set and the interior of the needleless access port. In other embodiments, other connectors or valves may be used. Other needleless valves, including luer access valves may include CLEARLINK® valves by Baxter Healthcare, SmartSite® valves by Cardinal Health, and Ultrasite® valves by B. Braun.
The valves or connectors intended for these application are themselves molded from plastic parts, and may themselves include internal components, such as springs, and so forth. The plastics may include olefins, such as polyethylene, cyclic olefin copolymers (COCs), or other medically-acceptable polymers, such as polyesters, PVC, and polycarbonate (e.g., Lexan®). The polymers and other materials used should be sterilizable, such as by gamma-irradiation or beta-irradiation. The valves or connectors are then assembled to the needleless access port by any of the techniques described above, or any other leak-free, medically-acceptable joining technique.
It has been found that a harder, stiffer material such as polycarbonate is desirable for use as the spike. In addition, other hard, medically-acceptable materials, such as polysulfone may used. The caps for the valve and for the access port may be made of polyethylene or other suitable material. The gondola or base for these embodiments may be made from high density polyethylene (HDPE), which may also be used for the caps and for the tamper-evident features described herein. Any of the materials and devices described herein may be made with an antimicrobial or antibacterial additive or coating, such as those described in U.S. Pat. Appl. Publ. 2007/0003603 and U.S. Pat. appl. Publ. 2008/0027410. These coatings and additives have been shown to reduce infections, particularly catheter related blood stream infections.
It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
