WO2025194164A1

WO2025194164A1 - Fluid control port assembly

Info

Publication number: WO2025194164A1
Application number: PCT/US2025/020225
Authority: WO
Inventors: Hari Prasad; Narendar V; Raghavendra HN
Original assignee: Baxter Healthcare SA; Baxter International Inc
Current assignee: Baxter Healthcare SA; Baxter International Inc
Priority date: 2024-03-15
Filing date: 2025-03-17
Publication date: 2025-09-18
Anticipated expiration: 2026-09-15

Abstract

A medical fluid control port assembly is disclosed. The medical fluid control port assembly eliminates contamination of a fluid path in peritoneal dialysis solution containers by incorporating ways to operate fluid flow without using a frangible. The disclosed fluid control port assembly is made up of an upper stem and a lower stem. The upper stem has a male threaded portion configured for mating to the lower stem having a female threaded portion. The upper stem has at least two snapfit ridges and the lower stem has at least one snapfit ridge. The snapfit ridges are provided to lock the fluid control port in a closed configuration to restrict fluid flow, or in an open configuration to initiate fluid flow. The control port is configured to allow a patient to use their fingers to rotate the upper stem and lower stem during dialysis therapy to easily control fluid flow.

Description

FLUID CONTROL PORT ASSEMBLY

TECHNICAL FIELD

[0001] 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.

BACKGROUND

[0002] Due to various causes, a person’s renal system can fail. Renal failure produces several physiological derangements. It is no longer possible to balance water and minerals or to excrete daily metabolic load. Toxic end products of metabolism, such as, urea, creatinine, uric acid, and others, may accumulate in a patient’s blood and tissue.

[0003] Reduced kidney function and, above all, kidney failure is treated with dialysis. Dialysis removes waste, toxins and excess water from the body that normal functioning kidneys would otherwise remove. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is lifesaving.

[0004] One type of kidney failure therapy is Hemodialysis (“HD”), which in general uses diffusion to remove waste products from a patient’s blood. A diffusive gradient occurs across the semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion.

[0005] Hemodiafiltration (“HDF”) is a treatment modality that combines convective and diffusive clearances. HDF uses dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance. In addition, substitution solution is provided directly to the extracorporeal circuit, providing convective clearance.

[0006] Most HD, HF, and HDF treatments occur in centers. A trend towards home hemodialysis (“HHD”) exists today in part because HHD can be performed daily, offering therapeutic benefits over in-center hemodialysis treatments, which occur typically bi- or triweekly. Studies have shown that more frequent treatments remove more toxins and waste products and render less interdialytic fluid overload than a patient receiving less frequent but perhaps longer treatments. A patient receiving more frequent treatments does not experience as much of a down cycle (swings in fluids and toxins) as does an in-center patient, who has built-up two or three days’ worth of toxins prior to a treatment. In certain areas, the closest dialysis center can be many miles from the patient’s home, causing door-to-door treatment time to consume a large portion of the day. Treatments in centers close to the patient’s home may also consume a large portion of the patient’s day. HHD can take place overnight or during the day while the patient relaxes, works or is otherwise productive.

[0007] Another type of kidney failure therapy is peritoneal dialysis (“PD”), which infuses a dialysis solution, also called dialysis fluid or PD fluid, into a patient’s peritoneal chamber via a catheter. The PD fluid comes into contact with the peritoneal membrane in the patient’s peritoneal chamber. Waste, toxins and excess water pass from the patient’s bloodstream, through the capillaries in the peritoneal membrane, and into the PD fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. An osmotic agent in the PD fluid provides the osmotic gradient. Used PD fluid is drained from the patient, removing waste, toxins and excess water from the patient. This cycle is repeated, e.g., multiple times.

[0008] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal flow dialysis and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow used PD fluid to drain from the patient’s peritoneal cavity. The patient then switches fluid communication so that the patient catheter communicates with a bag of fresh PD fluid to infuse the fresh PD fluid through the catheter and into the patient. The patient disconnects the catheter from the fresh PD fluid bag and allows the PD fluid to dwell within the patient’s peritoneal cavity, wherein the transfer of waste, toxins and excess water takes place. After a dwell period, the patient repeats the manual dialysis procedure, for example, four times per day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0009] APD is similar to CAPD in that the dialysis treatment includes drain, fill, and dwell cycles. APD machines, however, perform the cycles automatically, typically while the patient sleeps. APD machines free patients from having to manually perform the treatment cycles and from having to transport supplies during the day. APD machines connect fluidly to an implanted catheter, to a source or bag of fresh PD fluid and to a fluid drain. APD machines pump fresh PD fluid from a dialysis fluid source, through the catheter and into the patient’s peritoneal chamber. APD machines also allow for the PD fluid to dwell within the chamber and for the transfer of waste, toxins and excess water to take place. The source may include multiple liters of dialysis fluid, including several solution bags. [0010] APD machines pump used PD fluid from the patient’s peritoneal cavity, though the catheter, to drain. As with the manual process, several drain, fdl, and dwell cycles occur during dialysis. A “last fdl” may occur at the end of the APD treatment. The last fdl fluid may remain in the peritoneal chamber of the patient until the start of the next treatment, or may be manually emptied at some point during the day.

[0011] 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 from fdms form another type of flexible or non-rigid containers. Such containers or bags are typically formed of two flexible sheets or fdms of material joined at their peripheral edges by well-known methods, such as ultrasonic, heat, radiofrequency (RF), or laser sealing.

[0012] Any of the above treatment modalities may operate with premade, e.g., bagged, solutions. Bagged solutions are typical for any type of PD (CAPD or APD). A bagged solution may also be used for HD, especially HHD (see for example U.S. Patent No. 8,029,454 assigned to the assignee of the present application). Continuous renal replacement therapy (“CRRT”) is an acute form of HD, HF or HDF and typically uses bagged dialysis fluids.

[0013] Premade, e.g., bagged, solutions for any of the above modalities are typically sterilized after fdling and then capped to maintain the medical fluid in a sterilized condition until use. There are different ways to access the sterilized solutions at the time of use. One way is to spike the connector at the time of use, establishing medical fluid flow between the bag and a use point, such as a patient or disposable cassette. Another way, which is very common with PD is to use a breakable frangible. The patient or caregiver bends and snaps open the breakable frangible to thereafter allow fluid flow. A further way is to make a luer connection, which is a known connection that involves threading mating luer connectors together to form a liquid-tight seal between the connectors.

[0014] 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 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.

[0015] 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.

[0016] There are different ways access facilitate the flow of fluid at time of use. One way to begin the flow of fluid is to break the frangible that is inserted into the end of the tubing. To stop the flow of fluid, a secondary seal is provided adjacent to the port tube and act as the stopper while solution is mixed. The actuation of the secondary seal is crucial as it is activated after the application of the threshold force to the frangible. Present day containers typically have a port that is a single tubular tube and a separate frangible at the bottom of the container. The port tube is of a sufficient length where it is the interface between the primary bag and the solution line. The port is generally bonded to the bag using techniques like heat sealing, RF welding, and solvent bonding.

[0017] Immediately prior to patient therapy, a patient must apply sufficient force on the frangible to break the line to facilitate the fluid flow. Upon breaking the frangible, the fluid passes through the broken frangible and into the patient line. It has been found that due to material and processing related issues, the frangible may become ductile which causes the frangible to be difficult to break. It has further been found that the force required to break the frangible generates fine particles. This may occur when the frangible becomes brittle and creates particulates during the brittle failure. This is a problem because the frangible is located inside of the fluid path and may contaminate the patient’s fluid consumption. It is desirable to allow the regulation of fluid flow from a container to a person without using a frangible and without using a secondary seal.

[0018] It is desirable to allow the addition and withdrawal of fluids to a container, such as a flexible dialysis bag, without using a frangible. There is accordingly a need for an improved apparatus and associated methodology for the fluid control port of bagged dialysis treatment solutions. [0019] The present disclosure eliminates any contamination of fluid path in PD solution containers by incorporating innovative way to operate fluid flow without breaking frangible used in current method. It is desirable to allow the regulation of fluid flow from a container to a person without using a frangible and without using a secondary seal.

SUMMARY

[0020] The present disclosure involves the use of a fluid control port (“control port”) for use with a solution container or bag, e.g., a flexible bag, that is operable with any type of dialysis treatment including any time of peritoneal dialysis (“PD”) treatment, hemodialysis (“HD”) treatment, hemofiltration (“HF”) treatment, hemodiafiltration (“HDF”) treatment, or continuous renal replacement therapy (“CRRT”) treatment. It should be appreciated that the control port may be used in any type of medical treatment having a bagged or otherwise stored medical fluid, which needs to be opened aseptically for use.

[0021] The control port is, in one embodiment, configured to selectively facilitate complete flow administration or restriction upon rotation of the port. The control port includes an upper stem and a lower stem. The upper stem is bonded to a primary bag or fluid line and the lower stem is bonded to a fluid line. The upper stem is rotatably and removably mounted to the lower stem. The control port upper stem is configured to have modified male luer features, while the lower stem has modified female luer features. When the upper stem is configured as having external male threaded features, the upper stem includes a body having a tubular hollow profile and a semicircular bowl shape at the end of the male threads. Further, when the lower stem is configured as having female threaded features, the lower stem includes a body having a tubular hollow profile and a semicircular bowl shape at the end of the female threads.

[0022] The upper stem is, in one embodiment, inbuilt with radial and vertical sealing line contacts, e.g., injection molded into the upper stem. The radial and vertical sealing line contacts provide line contact sealing surfaces acting as positive sealing between the upper stem and lower stem. A chamfer, or fillet edge, is provided at the mating edge of the upper stem and at the mating edge of the lower stem. The chamfer edge on the upper stem and lower stem provide mating of joint and sealing between the respective stems. The bottom edge of the upper stem has two snapfit ridges and the top edge of the lower stem has one snapfit ridge. [0023] The female threads of the lower stem threadingly connect to the male threads of the upper stem to establish medical fluid flow when the upper stem is rotated into an open configuration, and to restrict medical fluid flow when in a closed configuration. Rotation of the upper stem by 180 degrees opens or closes the fluid flow. In one configuration, a rotation of the lower stem completely in a clockwise direction causes the snapfit ridge of the lower stem to meet one snapfit ridge of the upper stem. Further rotation causes the lower stem to forcefully override the upper stem snapfit ridge and places the control port in a locking stage position. In the locking stage position, the lower stem and upper stem are in a closed configuration to restrict all fluid flow. To initiate therapy, e.g., begin fluid flow through the control port, the lower stem is rotated in a counterclockwise direction until it reaches the last male thread of the upper stem. At the last male thread of the upper stem, the lower stem passes over one of the snapfit ridges of the upper stem and is available for further rotation. Upon further rotation, the lower stem is configured in an open configuration to allow fluid flow through both stems of the control port. The second snapfit ridge provided at the opposite end of the first snapfit ridge of the upper stem prevents the lower stem from over-rotation.

[0024] In an embodiment, the control port is manufactured in a closed configuration. The control port has a 360 degree ball sealing surface configured for tightly sealing against a tapering portion of the lower stem, e.g., the container connector. A plurality of ribs provide mechanical spring action configured for supporting the ball sealing surface to tightly seal against incoming pressure from solution present in the container. To initiate therapy, e.g., begin fluid flow through the control port, the threading connection between the container connector and the upper stem is disengaged by rotating the upper stem in a reverse direction while holding the lower stem stationary. The rotation causes the ball sealing surface to move backwards, e,g., away from the lower stem, and allows fluid flow through the control port.

[0025] The upper stem and lower stem portions of the control port is in one embodiment formed, e.g., injection molded, from a polymer, such as, polypropylene (“PP”), polyamides, PP/styrene-(ethylene-butylene)-styrene (“SEBS”) blend, polyvinyl chloride (“PVC”) materials, polycarbonate (“PC”), or polyether imide (“PEI”). The use of these materials are capable of withstanding sterilization conditions including the threaded design portion of the control port. The use of PVC may present problems in forming the male and female threading portions if in the presence of di-2-ethylhexyl phthalate (“DEHP”) used as a plasticizer during formation. The leveraging of n-PVC material can be used in place of PVC to mitigate DEHP risk.

[0026] The control port of any embodiment can withstand steam sterilization. The control port may also be used with sterile tapes made of vinyl and latex which can be autoclavable. The sterile tape is configured for protecting the control port system from external microbial ingress.

[0027] It is accordingly expressly contemplated to provide an improved assembly for a fluid control port for selective fluid communication from a container, such as PD fluid bags, to a patient fluid line, in which the fluid control port regulates the fluid by simple rotation of its upper and lower stems. It is further expressly contemplated to provide an improved fluid control port that does not require a frangible or a second seal, which results in material savings. In this manner, the functionality of the fluid control port and its use in patient therapy are improved.

[0028] In light of the disclosure set forth herein, and without limiting the disclosure in any way, in a first aspect, which may be combined with any other aspect described herein, or portion thereof, a fluid control port includes: an upper stem having a male threaded portion and a generally tubular form; a lower stem having a female threaded portion and a generally tubular form; a semicircular bowl line contact sealing, provided on both the upper stem and lower stem, that includes a chamfer configured for rotatably and sealingly mounting the lower stem to the upper stem; and the upper stem is rotatably and sealingly assembled to the lower stem in two configurations, (i) a closed configuration, and (ii) an open configuration, and wherein a plurality of snapfit ridges on the upper and lower stems are configured for locking the upper stem and lower stem in the closed configuration and the open configuration.

[0029] In a second aspect of the present disclosure, which may be combined with any other aspect listed herein, the upper stem portion comprised a radial sealing line contact and a vertical sealing line contact.

[0030] In a third aspect of the present disclosure, which may be combined with any other aspect listed herein, the upper stem comprises two snapfit ridges.

[0031] In a fourth aspect of the present disclosure, which may be combined with any other aspect listed herein, the lower stem comprises one snapfit ridge.

[0032] In a fifth aspect of the present disclosure, which may be combined with any other aspect listed herein, the lower stem is configured to rotate clockwise to enter a snapfit locking stage to restrict fluid flow. [0033] In a sixth aspect of the present disclosure, which may be combined with any other aspect listed herein, the lower stem is configured to rotate counterclockwise 180 degrees relative to the upper stem to initiate fluid flow.

[0034] In a seventh aspect of the present disclosure, which may be combined with any other aspect listed herein, the upper stem comprises an O-ring seal.

[0035] In an eighth aspect of the present disclosure, which may be combined with any other aspect listed herein, a flexible bag is permanently assembled to the upper stem.

[0036] In a ninth aspect of the present disclosure, which may be combined with any other aspect listed herein, a fluid line is removably attached to the lower stem.

[0037] In a tenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the upper stem is threadably joined to the lower stem for actuation by rotating the upper stem with respect to the lower stem.

[0038] In an eleventh aspect of the present disclosure, which may be combined with any other aspect listed herein, the male threaded portion of the upper stem and the female threaded portion of the lower stem are inbuilt and configured for sealing the upper stem to the lower stem.

[0039] In a twelfth aspect of the present disclosure, which may be combined with any other aspect listed herein, the fluid control port includes a sterile barrier tape.

[0040] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, a fluid control port, includes: an upper stem having a male threaded portion, a ball sealing surface, and a valve having a plurality of ribs; a lower stem having a female threaded portion and a container connecter having a tapered portion; the upper stem is configured for mounting to the lower stem in two configurations, a closed configuration and an open configuration. A threaded connection between the upper stem and lower stem is configured for engagement and disengagement. Additionally, the ball sealing surface is moveably assembled to the tapered portion of the container connecter in the closed configuration.

[0041] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the ball sealing surface is configured for 360 degree rotation.

[0042] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the lower stem comprises an extended stem configured for connection to a fluid line. [0043] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, a flexible bag is permanently assembled to the upper stem.

[0044] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, a fluid line is removably attached to the lower stem.

[0045] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the upper stem is threadably joined to the lower stem for actuation by rotating the upper stem with respect to the lower stem.

[0046] In a twentieth aspect of the present disclosure, which may be combined with any other aspect listed herein, the male threaded portion of the upper stem and the female threaded portion of the lower stem are inbuilt and configured for sealing the upper stem to the lower stem.

[0047] Considering the above aspects and the present disclosure set forth herein, it is accordingly an advantage of the present disclosure to provide a medical fluid control port that selectively controls fluid flow via a rotation mechanism.

[0048] It is another advantage of the present disclosure to provide a medical fluid control port that initiates fluid flow when the lower stem is rotated counterclockwise as related to the upper stem.

[0049] It is another advantage of the present disclosure to provide a medical fluid control port that restricts fluid flow when the lower stem is rotated clockwise as related to the upper stem.

[0050] It is yet another advantage of the present disclosure to provide a medical fluid control port that may be used with many different medical fluids.

[0051] Additional features and advantages are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Also, any embodiment does not have to have the advantages listed herein and it is expressly contemplated to claim individual advantageous embodiments separately. Moreover, it should be noted that the language used in the specification has been selected principally for readability and instructional purposes, and not to limit the scope of the inventive subject matter. BRIEF DESCRIPTION OF THE FIGURES

[0052] Fig. 1 is a perspective view of a flexible solution container and a first embodiment of the fluid control port assembly;

[0053] Fig. 2 is a perspective view of a flexible solution container and a second embodiment of the fluid control port;

[0054] Fig. 3 is a perspective view of one embodiment of the fluid control port in an assembled configuration;

[0055] Fig. 4 is a perspective view of one embodiment of the fluid control port in an closed configuration;

[0056] Fig. 5 is a perspective view of one embodiment of the fluid control port in an open configuration;

[0057] Fig. 6 is a cross-section view of the fluid control port of Fig. 4;

[0058] Fig. 7 is a partial cross-section view of the internal rotation mechanism of the fluid control port of Fig. 3;

[0059] Fig. 8 is a partial cross-section view of the fluid control port in a closed configuration;

[0060] Fig. 9 is a partial perspective view of the snapfit ridge on the lower stem of the fluid control port;

[0061] Fig. 10 is a sectioned perspective view of the fluid control port in a closed configuration;

[0062] Fig. 11 is a sectioned perspective view of the fluid control port in an open configuration;

[0063] Figs. 12A-12C are perspective views of the upper stem of the fluid control port;

[0064] Figs. 13A-13B are perspective views of the lower stem of the fluid control port;

[0065] Fig. 14 is a perspective view of one embodiment of the fluid control port including sterile barrier tape;

[0066] Fig. 15A is a cross-section view of a second embodiment of a fluid control port in a closed configuration;

[0067] Fig. 15B is a perspective view of the fluid control port of Fig. 15;

[0068] Fig. 15C is a cross-section view of the internal rotation mechanism of the fluid control port of Fig. 15B. DETAILED DESCRIPTION

[0069] Referring now to the drawings and in particular to Figs. 1 and 2, an embodiment of a medical fluid container tubing assembly 10 of the present disclosure is illustrated, and which includes a fluid control port 12 that is bonded directly to a solution bag 14 or to n-PVC tubing 16 using known methods such as heat sealing. The solution container or bag is operable with any type of dialysis treatment using bagged dialysis fluid, including any type of peritoneal dialysis (“PD”) treatment, hemodialysis (“HD”) treatment, hemofiltration (“HF”) treatment, hemodiafiltration (“HDF”) treatment or continuous renal replacement therapy (“CRRT”) treatment.

[0070] The fluid control port 12 is in one embodiment formed, e.g., injection molded, from a polymer, such as, polypropylene (“PP”), polyamides, PP/styrene-(ethylene-butylene)-styrene (“SEBS”) blend, polyvinyl chloride (“PVC”) materials, polycarbonate (“PC”), or polyether imide (“PEI”).

[0071] As shown in Fig. 1, the fluid control port 12 of the present disclosure is located on the tubing 16 at a distance closer to the solution bag 14 than the control port 12 is located relative to the patient line (not shown in figures). Contrastingly, as shown in Fig. 2, the control port 12 is located on the tubing 16 at a distance closer to the patient line (not shown) than the control port 12 is located relative to the solution bag 14. The fluid control port 12 is in the general form of a cylindrical tube, and is configured for assemble to a solution bag 14 and to fluid line tubing 16.

[0072] Fig. 3 illustrates the fluid control port 12 in an open configuration. The control port 12 includes an upper stem portion 18 and a lower stem portion 20. The upper half of the upper stem 18 has the same circumference as the lower stem 20, but the lower half of the upper stem 18 has a smaller diameter than the lower stem 20 to enable the upper stem 18 to be inserted into the lower stem 20. The upper stem 18 is configured to have external male threads 22, while the lower stem 20 has internal female threads 24. The male threads 22 of the upper stem 18 are configured to be rotatably and removably assembled to the female threads 24 of the lower stem 20. The upper stem 18 includes two snapfit ridges 26, 28 while the lower stem comprises one snapfit ridge (not shown) configured to lock the two stems from unwanted rotation. Further, the upper stem 18 includes a radial sealing line contact 30. It will be recognized that a seal between the upper stem 18 and the lower stem 20 may be accomplished in other or additional ways, e.g., an O-ring 32 in appropriate grooves on the outside of the upper stem 18 and on the inside of the lower stem 20. The lower portion of the upper stem 18 comprises a semicircular bowl line contact sealing 34, and the lower stem 18 similarly comprises a semicircular bowl line contact sealing 36.

[0073] Fig. 4 similarly illustrates the control port 12 in an open configuration. The upper stem’s 18 semicircular bowl line contact sealing 34, and the lower stem’s 18 semicircular bowl line contact sealing 36 are the primary sealing components of the control port 12. In a first open configuration, the bowl line contact sealing 34, 36 do not form a closed circle, but rather the lower stem 18 bowl line contact sealing 36 is rotated at least partially behind the upper stem bowl line contact sealing 34.

[0074] Fig. 5 illustrates the control port 12 in an assembled and open configuration with fluid flowing through the port. In a first open configuration, the upper stem 18 is configured to remain stationary, and the lower stem 20 is configured to be aligned with the upper stem 18 to mate at the first male thread 22 of the upper stem 18. In the open configuration, the lower stem 20 does not cover the upper half of the upper stem 18, e.g., the upper half of the upper stem is exposed. The control port 12 is configured to rotate 180 degrees to facilitate the administration of fluid (indicated by the orange arrows). Specifically, a user can use their fingers to simply rotate the lower stem 20 to initiate the flow of fluid.

[0075] A user can place the control port 12 of the present disclosure in an open configuration or a closed configuration after first placing the control port 12 in a snapfit locking position, which the upper stem 18 remains stationary and the user rotates the lower stem 20 clockwise to the upper stem 18 until the lower stem 20 reaches the upper stem’s 12 first snapfit ridge 26. Further rotation by the user will cause the lower stem 20 to forcefully override the first snapfit ridge 26 of the upper stem 18 to enter the locking stage position, which will prevent the flow of fluid through the control port 12. To initiate the administration of fluid flow, e.g., initiate therapy, the user will rotate the lower stem 20 in a counterclockwise direction relative to the upper stem 18, and the lower stem 20 snapfit ridge (shown in Fig. 9) is available for further rotation. Upon further rotation, the lower stem 20 will override the upper stem’s 12 snapfit ridge 26, which initiates fluid flow through the control port 12. The upper stem’s 12 second snapfit ridge 28 will prevent the lower stem 20 from rotating beyond the 180 degrees and prevent the control port 12 from loosening up beyond the effective amount, e.g., the amount of rotation needed to facilitate or restrict fluid flow. [0076] Fig. 6 illustrates the cross-section of the control port 12 in a closed configuration. In a closed configuration the upper stem 18 and the lower stem 20 are threadably and rotatably assembled to restrict fluid flow. The upper stem’s 18 semicircular bowl line contact sealing 34 has a thinner wall than the lower stem’s bowl line contact sealing 36. For example, the upper stem’s bowl line contact sealing 34 may be up to one-half of the thickness of the lower stem’s bowl line contact sealing 36. Additionally, in the closed configuration, the upper stem’s 18 bowl line contact sealing 34 and the lower stem’s bowl line contact sealing 36 form a complete seal. Where the upper stem 18 includes a radial sealing line contact 30 as illustrated in Figs. 3, 4, and 5, the upper stem 18 also includes a vertical sealing line contact 38. The vertical sealing line contact 38 is inbuilt, e.g., injection molded, in the upper stem. The vertical sealing line contact 38 is positioned perpendicular to the radial sealing line contact 30.

[0077] Figs. 7 and 8 illustrate the control port 12 in a closed configuration. Particularly, Fig. 7 depicts the rotational mechanisms of the apparatus. The upper stem 18 includes a chamfer 40, or fillet edge, provided at its mating edge configured for mating with the chamfer 42 provided at the lower stem’s mating edge 20. The chamfers 40, 42 are configured to facilitate quick and easy mating between the upper stem 18 and the lower stem 20. When a user rotates the upper stem 18 relative to the lower stem 20, the upper stem 18 is translated vertically up or down depending on the direction the user rotates the apparatus, i.e., whether the user rotates the lower stem 18 counterclockwise or clockwise. When the control port 12 is in the closed configuration, the vertical sealing line contact 38 is positioned parallel to the lower stem’s mating edge 20.

[0078] Fig. 9 is a partial perspective view of the lower stem 20 including a snapfit ridge 44 provided at the end of the female threaded portion 24 of the lower stem 20. As discussed above with regard to Fig. 5, the lower stem 20 snapfit ridge 44 will override the upper stem 12 snapfit ridge 26, which initiates fluid flow through the control port 12. The upper stem 12 second snapfit ridge 28 will prevent the lower stem 20 from rotating beyond 180 degrees and, therefore, prevent the control port 12 from loosening up beyond the effective amount, e.g., the amount of rotation needed to facilitate or restrict fluid flow.

[0079] Fig. 10 is bottom perspective view of the control port 12 in a closed configuration. The upper stem 18 is located partially inside of the lower stem 20, and the semicircular bowl sealing ends 34, 36 of the upper stem 18 and the lower stem 20 are sealed together to form a circle and block the flow of fluid. [0080] Fig. 11 is a bottom perspective view of the control port 12 in an open configuration. The upper stem 18 is located partially inside of the lower stem 20, and the semicircular bowl sealing ends 34, 36 of the upper stem 18 and the lower stem 20 are rotatably and separably assembled to allow fluid to flow through the control port 12.

[0081] Figs. 12A-12C illustrate various views of the upper stem 18 of the control port 12. As noted, the upper stem 18 includes male threaded features 22, radial line sealing contact 30, vertical line sealing contact 38, at least two snapfit ridges 26, 28, and is generally in the form of a tube, which includes a semicircular bowl sealing end 34. The semicircular bowl sealing end 34 of the upper stem 18 includes a chamfer at its mating edge (shown in Figs. 7 and 8). The upper stem 18 has a diameter that is less than the diameter of the lower stem 20. The radial sealing line contact 30 protrudes radially from the lower half of the upper stem 18 and the radial sealing line contact 30 extends along the entire circumference of the upper stem 18. The vertical sealing line contact 38 protrudes radially from around the semicircular bowl sealing end 34 of the upper stem 18. Additionally, both ends of the vertical sealing line contact 28 extend to touch the radial sealing line contact 30.

[0082] Figs. 13A-13C illustrate various views of the lower stem 20 of the control port 12. As noted, the lower stem includes female threaded features 24, a chamfer 40 at its mating edge (shown in Figs. 7 and 8), and one snapfit ridge (as shown in Fig. 9), and is generally in the form of a tube, which includes a semicircular bowl line contact sealing 36.

[0083] It will be recognized that the semicircular bowl sealing lines 34, 36 of the upper stem 18 and the lower stem 20 are not necessarily molded as semicircles having exactly a 90- degree profile. The upper stem’s bowl line contact sealing may be, for example, a bowl shape having an obtuse angle, which would correspond to the lower stem’s bowl line contact sealing having an acute angle.

[0084] Fig. 14 illustrates the control port 12 in a closed configuration having a sterile barrier tape 72 wrapped around the seam between the upper stem 18 and lower stem 20. The sterile barrier tape 72 may be made of vinyl and latex materials, which can be autoclavable. It should be recognized that the sterile barrier tape 72 and the control port 12 can be steam sterilized.

[0085] Figs. 15A illustrates an alternative embodiment of the present disclosure, which discloses an alternative profile for sealing. Before the administration of a fluid, the control port 42 is in a closed configuration, which includes the upper stem 44 tightly sealed against the lower stem 46. The upper stem 44 is partially covered by the lower stem 46.

[0086] Fig. 15B illustrates a cross-section view of the fluid control port of 15 A. In this alternative embodiment, the lower stem 46 includes a container connector 48, a tapered portion 50, female threaded portion (not shown), and an extended stem 52. The upper stem 44 of this alternative embodiment includes a valve 54, a 360 degree ball sealing surface 56, an O-ring 58, an extended stem 60, and a male threaded portion 62. The upper stem 44 is partially located inside of the lower stem 46. The inner portion of the upper stem 44 is tapered towards the ball sealing surface 56 and the upper stem 44 includes at least two, and preferably four narrow projections 64, 66, 68, 70 that connect the upper stem 44 to the ball sealing surface 56.

[0087] Here, where the lower stem 46 includes a tapered portion 50, the upper stem 44 is configured to rotatably connect to the lower stem 46, and which the upper stem 44 includes the 360 ball sealing surface 56 to tightly seal against the tapered portion 50. In the illustrated embodiment, additional ribs (not shown) provide a mechanical spring action for the ball sealing surface 56 to tightly seal against incoming pressure from solution present in the container. During the initiation of therapy, the user rotates the container connecter 48 in the opposite direction of the valve 54, e.g., the user disengages the upper stem 44 from the lower stem 46 by using fingers to rotate the components. The ball sealing surface 56 translates towards the valve 54 of the control port 42 to allow fluid to flow through the control port 42, as shown in Fig. 15C.

[0088] It should be recognized that the fluid control port of any embodiment can be steam sterilizable along with the solution container or bag. It should further be recognized that the internal male and external female threads of the fluid control port of the present disclosure can be molded into the respective parts during the molding operation, i.e., during the manufacture of the respective stems. The threads would provide a sealing mechanism to avoid any microbial ingress. It is recognized that various known molding tools can be used to manufacture the threaded features into the fluid control port of the present invention. Additionally, the control port tube wall thickness of any embodiments can be increased or decreased to provide more or less stability to the control port tube when the control port is heat sealed with the solution tubing and bag.

[0089] It should further be recognized that there are various potential n-PVC materials and properties that could be used to create the fluid control port of any embodiment, including leveraging n-PVC as shown in Table 1 below. Table 1

[0090] 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. It is therefore intended that any or all such changes and modifications may be covered by the appended claims.

Claims

CLAIMS The invention is claimed as follows:

1. A fluid control port, comprising: an upper stem having a male threaded portion and a generally tubular form; a lower stem having a female threaded portion and a generally tubular form; and a semicircular bowl line contact sealing, wherein the semicircular bowl line contact sealing comprises a chamfer, and wherein the upper stem and lower stem each comprises a line contact sealing having a chamfer configured for rotatably and sealingly mounting the lower stem to the upper stem, wherein the upper stem is rotatably and sealingly assembled to the lower stem in two configurations, a closed configuration and an open configuration, and wherein a plurality of snapfit ridges on the upper and lower stems are configured for locking the upper stem and lower stem in the closed configuration and the open configuration.

2. The fluid control port according to Claim 1, wherein the upper stem further comprises a radial sealing line contact and a vertical sealing line contact.

3. The fluid control port according to Claim 1, wherein the upper stem comprises two snapfit ridges.

4. The fluid control port according to Claim 1, wherein the lower stem comprises one snapfit ridge.

5. The fluid control port according to Claim 1, wherein the lower stem is configured to rotate clockwise to enter a snapfit locking stage to restrict fluid flow.

6. The fluid control port according to Claim 1, wherein the lower stem is configured to rotate counterclockwise 180 degrees relative to the upper stem to initiate fluid flow.

7. The fluid control port according to Claim 1 , wherein the upper stem further comprises an O-ring seal.

8. The fluid control port according to Claim 1, further comprising a flexible bag permanently assembled to the upper stem.

9. The fluid control port according to Claim 1, further comprising a fluid line removably attached to the lower stem.

10. The fluid control port according to Claim 1, wherein the upper stem is threadably j oined to the lower stem for actuation by rotating the upper stem with respect to the lower stem.

11. The fluid control port according to Claim 1, wherein the male threaded portion of the upper stem and the female threaded portion of the lower stem are inbuilt and configured for sealing the upper stem to the lower stem.

12. The fluid control port according to Claim 1, further comprising a sterile barrier tape.

13. A fluid control port comprising: an upper stem having a male threaded portion, a ball sealing surface, and a valve having a plurality of ribs; and a lower stem having a female threaded portion and a container connecter having a tapered portion; wherein the upper stem is configured for mounting to the lower stem in two configurations, a closed configuration and an open configuration, wherein a threaded connection between the upper stem and lower stem is configured for engagement and disengagement, and wherein the ball sealing surface is moveably assembled to the tapered portion of the container connecter in the closed configuration.

14. The fluid control port according to Claim 13, wherein the ball sealing surface is configured for 360 degree rotation.

15. The fluid control port according to Claim 13, wherein the lower stem further comprises an extended stem configured for connection to a fluid line.

16. The fluid control port according to Claim 13, further comprising a flexible bag permanently assembled to the upper stem.

17. The fluid control port according to Claim 13, wherein the upper stem further comprises an O-ring seal.

18. The fluid control port according to Claim 13, further comprising a fluid line removably attached to the lower stem.

19. The fluid control port according to Claim 13, wherein the upper stem is threadably joined to the lower stem for actuation by rotating the upper stem with respect to the lower stem.

20. The fluid control port according to Claim 13, wherein the male threaded portion of the upper stem and the female threaded portion of the lower stem are inbuilt and configured for sealing the upper stem to the lower stem.

21. The fluid control port according to Claim 13, further comprising a sterile barrier tape.