WO2025171111A1

WO2025171111A1 - Bag in a box therapy system

Info

Publication number: WO2025171111A1
Application number: PCT/US2025/014763
Authority: WO
Inventors: Eric Jacques HÉNAUT; Virgil Claudiu MANTA; Mihai Alexandru MAIER; Davide POZZONI
Original assignee: Baxter Healthcare SA; Baxter International Inc
Current assignee: Baxter Healthcare SA; Baxter International Inc
Priority date: 2024-02-06
Filing date: 2025-02-06
Publication date: 2025-08-14
Anticipated expiration: 2026-08-06

Abstract

A bag in a box therapy system may be provided by an item of manufacture, comprising: a box, containing: a first bag; a second bag; and a plurality of tubes and a tube connector; wherein the first bag comprises an internal reservoir and a first port, and contains a fluid disposed within the internal reservoir; and the plurality of tubes is configured provide one-way fluid communication from the internal reservoir to the tube connector via the first port, and configured provide one way fluid communication from the tube connector to the second bag.

Description

TITLE

BAG IN A BOX THERAPY SYSTEM

CROSS-REFERENCES TO RELATED DISCLOSURES

[0001] The present disclosure claims the benefit of and priority to U.S. Provisional Patent Application No.: 63/550,448 titled “BAG IN A BOX THERAPY SYSTEM” and filed on 2024- 02-06, which is incorporated herein it its entirety.

BACKGROUND

[0002] At home peritoneal dialysis therapy systems are difficult to produce, generate large amounts of waste product, and are often complicated to operate. Despite all of these challenges, the home treatments systems are often preferable to in-office therapy systems due to the flexibility and convenience offered to users and their caretakers, who can avoid trips to hospitals or physicians’ offices as a result.

SUMMARY

[0003] The present disclosure provides a bag in a box therapy system, in which the necessary components for at-home peritoneal dialysis treatment are pre-assembled and contained within a box that also serves as a containment apparatus for the source reservoir during the therapy process. [0004] The present disclosure provides in one embodiment an item of manufacture, comprising: a box, containing: a source reservoir; a destination reservoir; and a plurality of tubes and a tube connector; wherein: the source reservoir comprises a delivery port, and contains a fluid therein; and the plurality of tubes is configured to provide fluid communication from the source reservoir to the tube connector via the delivery port, and configured provide fluid communication from the tube connector to the destination reservoir.

[0005] In some such embodiments of the item of manufacture the box is constructed of a material chosen from the group consisting of: cardboard, fiberboard, paper, paperboard, polyethylene terephthalate, and high density polyethylene.

[0006] In some such embodiments of the item of manufacture the source reservoir further comprises a second port configured to receive an additive and introduce the additive into the fluid. [0007] In some such embodiments of the item of manufacture the box has access flaps, defined by lines of weakness in a material of the box, such that when the access flaps are torn along the lines of weakness, a resulting opening allows a user to access at least the delivery port.

[0008] In some such embodiments of the item of manufacture the delivery port comprises: a tube having a first end and a second end, opposite to the first end, between which a fluid pathway is defined when in an open configuration, wherein a welded seal is defined between the first end and the second end to place the tube in a closed configuration that blocks fluid communication between the first end and the second end, wherein the welded seal is configured to disengage and return the tube to the open configuration when a compressive force is applied to the welded seal in a direction perpendicular to a longitudinal axis of the tube.

[0009] In some such embodiments of the item of manufacture the delivery port comprises: a section of tube, connected to the source reservoir, defining a crimped portion which prevents the fluid from exiting the source reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the source reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

[0010] In some such embodiments of the item of manufacture the delivery port has a first configuration and a second configuration and comprises: a housing, defining an interior volume; a tube, a portion of which is disposed in the interior volume of the housing and defines a fluid outlet from the housing; a frangible membrane adhered to the housing and adhered to the tube; wherein: in the first configuration, the frangible membrane is a barrier to the fluid in the source reservoir from entering the housing, and the tube is in a first position; in the second configuration, the tube is translated relative to the housing into a second position and the frangible membrane is disengaged, such that a fluid pathway is defined from the source reservoir, to the housing, through the tube and out the fluid outlet.

[0011] In some such embodiments of the item of manufacture, the item of manufacture further comprises: a supply tube of the plurality of tubes; an exchange port, in fluid communication with the source reservoir via the supply tube; and wherein the destination reservoir is secured to the exchange port via a locking ring, wherein a wall of the destination reservoir is configured to expand in surface area responsive to an outward fluid pressure upon an interior surface of the destination reservoir to allow the destination reservoir to distend to accommodate fluid from the exchange port.

[0012] In some such embodiments of the item of manufacture the destination reservoir comprises: an envelope including a closed end portion, a port connection portion and a distendable wall extending between the closed end portion and the port connection portion; wherein: the envelope is watertight in a first configuration having a first thickness of the distendable wall and defining a first volume between the port connection portion and the closed end portion described by the distendable wall; the envelope is watertight in a second configuration having a second thickness of the distendable wall and defining a second volume between the port connection portion and the closed end portion described by the distendable wall; the first thickness is greater than the second thickness; and the first volume is less than the second volume.

[0013] In some such embodiments of the item of manufacture, the item of manufacture further comprises: a second source reservoir including a second delivery port and containing a second fluid therein different than the fluid contained in the source reservoir; and wherein the plurality of tubes is configured to provide fluid communication from the second source reservoir to the tube connector via the second delivery port.

[0014] The present disclosure provides in one embodiment, a method, comprising: receiving a box containing in a space defined interior to outer walls of the box: a first reservoir; a second reservoir; and a plurality of tubes and a tube connector, wherein: the first reservoir comprises a first delivery port and contains a fluid disposed therein; the plurality of tubes is configured provide one-way fluid communication from the first reservoir via the first delivery port to the tube connector, and configured provide one way fluid communication from the tube connector to the second reservoir; and the box includes access flaps, defined by lines of weakness in the outer walls of the box, such that when the access flaps are tom along the lines of weakness, a resulting opening allows a user to access at least the first delivery port and remove the second reservoir from the space; tearing the box along the lines of weakness to open the access flaps; removing the second reservoir, the plurality of tubes, and the tube connector; and activating the first delivery port such that fluid flows out of the first reservoir and through a tube of the plurality of tubes.

[0015] In some such embodiments of the method, the method further comprises: hanging the box containing the first reservoir prior to activating. [0016] In some such embodiments of the method, the method further comprises: orienting the first reservoir above the user, and the second reservoir below the user, such that a gravitational force aids the fluid flow.

[0017] In some such embodiments of the method, the method further comprises: disposing of the box, the first reservoir, the second reservoir, the plurality of tubes, and the tube connector.

[0018] The present disclosure provides in one embodiment, an item of manufacture, comprising: a container box, containing: a first source reservoir; a second source reservoir; a destination reservoir; a tube connector having a first configuration, a second configuration and a third configuration; and a plurality of tubes; wherein: the first source reservoir comprises a first delivery port, and contains a first fluid therein; the second source reservoir comprises a second delivery port and contains a second fluid therein; and the plurality of tubes is configured to: provide fluid communication from the first source reservoir to the tube connector via the first delivery port; provide fluid communication from the second source reservoir to the tube connector via the second delivery port; and provide fluid communication from the tube connector to the destination reservoir, such that the tube connector commutes fluid from the first source reservoir in the first configuration, commutes fluid from the second source reservoir in the second configuration, and commutes fluid from both the first source reservoir and the second source reservoir in the third configuration.

[0019] In some such embodiments of the item of manufacture, at least one of the first delivery port and the second delivery port comprises: a section of tube, connected to the first source reservoir, defining a crimped portion which prevents the fluid from exiting the first source reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the first source reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

[0020] In some such embodiments of the item of manufacture, at least one of the first delivery port and the second delivery port has a first configuration and a second configuration and comprises: a housing, defining an interior volume; a tube, a portion of which is disposed in the interior volume of the housing and defines a fluid outlet from the housing; a frangible membrane adhered to the housing and adhered to the tube; wherein: in the first configuration, the frangible membrane is a barrier to the fluid in the first source reservoir from entering the housing, and the tube is in a first position; in the second configuration, the tube is translated relative to the housing into a second position and the frangible membrane is disengaged, such that a fluid pathway is defined from the first source reservoir, to the housing, through the tube and out the fluid outlet.

[0021] In some such embodiments of the item of manufacture, the destination reservoir comprises: an envelope including a closed end portion, a port connection portion and a distendable wall extending between the closed end portion and the port connection portion; wherein: the envelope is watertight in a first configuration having a first thickness of the distendable wall and defining a first volume between the port connection portion and the closed end portion described by the distendable wall; the envelope is watertight in a second configuration having a second thickness of the distendable wall and defining a second volume between the port connection portion and the closed end portion described by the distendable wall; the first thickness is greater than the second thickness; and the first volume is less than the second volume.

[0022] In some such embodiments of the item of manufacture, the container box has access flaps, defined by lines of weakness in a material of the container box, such that when the access flaps are torn along the lines of weakness, a resulting opening allows a user to access at least the first delivery port.

[0023] In some such embodiments of the item of manufacture, at least one of the first source reservoir and the second source reservoir further comprises a second port configured to receive an additive and introduce the additive into the fluid.

[0024] Additional features and advantages of the disclosed bag in a box therapy system 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, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1A illustrates a bag in a box therapy system, according to embodiments of the present disclosure. [0026] Figure IB illustrates a bag in a box therapy system with dual source reservoirs, according to embodiments of the present disclosure.

[0027] Figure 1C illustrates a bag in a box therapy system with combinable source reservoirs, according to embodiments of the present disclosure.

[0028] Figure 2 illustrates a medical fluid bag, according to embodiments of the present disclosure.

[0029] Figure 3A illustrates a container box in a closed configuration, according to embodiments of the present disclosure.

[0030] Figure 3B illustrates a container box in an open configuration, according to embodiments of the present disclosure.

[0031] Figures 4A-4F illustrate a pop-up valve, according to embodiments of the present disclosure.

[0032] Figures 5A-5N illustrate a peelable port tube, according to embodiments of the present disclosure.

[0033] Figure 6A-6G illustrate a distendable drain bag, according to embodiments of the present disclosure.

[0034] Figure 7 illustrates a Peritoneal Dialysis Therapy Kit, according to embodiments of the present disclosure.

[0035] Figures 8A-8C illustrate an injection stretch blow molded peritoneal dialysis solution container system, according to embodiments of the present disclosure.

[0036] Figure 9 illustrates a method of use for the bag in a box system, according to embodiments of the present disclosure.

DETAILED DESCRIPTION

[0037] The present disclosure provides an improved bag in a box therapy system, such as for peritoneal dialysis therapy. As described herein, the therapy system is preassembled, arrives in a recyclable and compact container box, and allows for improved ease of use, improved ease of disposal, reduced usage footprints, improved transportability, and reduced material usage for construction, among other benefits over previous therapy systems. The container box features tearaway access ports so that necessary components may be removed, but the box remains an operable housing for the source reservoir during the course of the therapy. Further aspects of improvement include specially designed valves, the operation of which requires a single simple action in both illustrated embodiments. These improvements contribute to lowered, production costs, increased recyclability, and lessened waste footprint.

[0038] A bag in a box style therapy system may be provided by an item of manufacture, including: a box, containing: a first bag; a second bag; and a plurality of tubes and a tube connector; wherein the first bag comprises an internal reservoir and a first port, and contains a fluid disposed within the internal reservoir; and the plurality of tubes is configured provide one-way fluid communication from the internal reservoir to the tube connector via the first port, and configured provide one way fluid communication from the tube connector to the second bag.

[0039] Figures 1A-1C illustrate a “bag in a box” therapy system 100, according to embodiments of the present disclosure. The system 100 includes a source reservoir 110 (e.g., a solution bag), a box 120, a destination reservoir 130 (e.g., a drain bag), a patient tube connector 140, and tubing 142. Although primarily discussed herein as the system 100 containing the components used to perform a therapeutic treatment in a user’s home, without the need for travelling to a medical facility, the present disclosure contemplates that the system 100 may be used in a medical facility and for the delivery of other solutions for other purposes (e.g., intravenous drips, serum delivery, and blood transfusions,).

[0040] According to some embodiments the source reservoir 110 is a bladder constructed of a medical grade plastic, such as PVC, containing a medical solution 116, as described in greater detail in regard to figure 2. The source reservoir 110 is flexible and is hermetically sealed around the extremities for purposes of sterility and containing the medical solution. The source reservoir includes the sealed bladder, medical solution and a valve for transporting the solution out of the bag during use. In some embodiments, the source reservoir may contain one or multiple compartments containing one or more fluids. Such embodiments may further include mechanisms with which to internally combine the fluid contents of multiple compartments prior to use.

[0041] According to some embodiments, the destination reservoir 130 is a bladder constructed of a medical grade plastic, silicone, or latex. The bag has no contents prior to use, and comprises a distendable reservoir portion, sealed about the extremities, and an inlet having a connection compatible with the tubing 142. [0042] The box 120 defines openings configured to allow access and removal of certain components from within the box 120, without compromising the integrity of the box 120, which can provide additional structural support to the therapy system 100 during the course of use. The system 100 is configured such that the displacement of a first access flap 122 allows access to the inside of container box 120, and the resulting opening is of sufficient size to remove the destination reservoir 130, the patient tube connector 140, and the tubing 142, while preventing removal of the filled source reservoir 110. The displacement of a second access flap 124 allows access to an injection site 114 of the source reservoir 110 (e.g., for the injection of medical additives via syringe). The source reservoir 110 is configured in the box 120 such that when the first access flap 122 is opened, the source reservoir 110 does not have to be manipulated in order to directly access the delivery port 112. In some embodiments, the system 100 is used for at-home peritoneal dialysis treatments, and those skilled in the art will appreciate that the system 100 has many further applications and uses.

[0043] According to some embodiments, the contents of the system 100 are received by the user in an assembled state. In other embodiments, the components of the system 100 are configured to be assembled by the user. The source reservoir 110 is connected to a first section of tubing 142A via the delivery port 112, which is connected to the patient tube connector 140. The patient tube connector 140 is connected to a second section of tubing 142B, which is connected to the destination reservoir 130. Both the first section of tubing 142A and the second section of tubing 142B are fluidly connected to the patient tube connector 140, yet the first section of tubing 142 A and the second section of tubing 142B are not directly connected with one another. The patient tube connector 140 is configured to connect to an external fluid connection, such as a peritoneal catheter. In the process of therapy, a solution 116 exits the patient tube connector 140 via the external fluid connection, and drainage fluid enters the patient tube connector 140 via the external fluid connection, which is then transported to the destination reservoir 130 via the second section of tubing 142B.

[0044] Figure 1A illustrates a bag in a box therapy system 100, including a single source reservoir 110, according to embodiments of the present disclosure.

[0045] Figure IB illustrates an embodiment of the system 100, including two source reservoirs 110A and HOB (generally or collectively source reservoirs 110), according to embodiments of the present disclosure. Each source reservoir 110 includes a respective delivery port 112 and corresponding length of tubing 142A connectable thereto. The patient connector 140 may be operated to commute fluid from the first source reservoir 110A (in a first configuration), the second source reservoir HOB (in a second configuration), or both source reservoirs 110 simultaneously (in a third configuration).

[0046] According to some embodiments, the tubing 142 may include dual lumen tubes, which may be used advantageously with embodiments of the system 100 having multiple source reservoirs 110. The diameters of the lumens or extent that the individual valves of delivery ports 112 are permitted to open may be tuned to control a mixing rate between the fluids and may include a third shared valve (downstream of individual ports 112) to ensure that the fluids are delivered simultaneously, even if the delivery ports 112 are opened at different times.

[0047] Figure 1C illustrates an embodiment of the system 100, including two source reservoirs 110 which are combinable, according to embodiments of the present disclosure. The source reservoirs are separated by a seal 111, which, when disengaged allows the fluid contents of the source reservoirs 110 to combine. The means by which the seal 111 may be disengaged varies between embodiments.

[0048] In some examples, the seal I l l is attached to a portion of the box 120, such as an access flap 122, and the opening of the access flap 122 applies sufficient force to the seal 111 such that the seal 111 is disengaged and the fluids may combine. Accordingly, the respective fluids are separated by the seal during manufacturing and transport of the system 100 until the system 100 is ready to be used, thereby mixing the fluids when a user initiates a therapy session by opening the box 120.

[0049] In some examples, the fluid pressure from a fluid in the first source reservoir 110A may support the engagement of the seal 111, and the draining of the first source reservoir 110A removes said support, such that the seal 111 becomes overstressed and disengages respondent to the emptying of the first source reservoir 110A. Accordingly, the fluid held in the second source reservoir HOB is emptied into the first source reservoir 110A once the initial fluid in the first source reservoir reaches a predefined level to allow the seal 111 to disengage. Examples using a self-disengaging seal 111 as described in the present example allow for the timing the delivery of the second fluid (initially held in the second source reservoir HOB) during a therapy session based on the delivery of the first fluid (initially held in the first source reservoir 110A). [0050] Other embodiments may include a pull tab, or similar operator component that is employed to disengage the seal 111 and combine the fluids.

[0051] Although illustrated without access flaps 122, 124 and an injection site 114, this disclosure contemplates embodiments having the differentiating features of Figures IB and 1C and the aforementioned un-illustrated components.

[0052] Figure 2 illustrates the source reservoir 110, according to embodiments of the present disclosure. According to some embodiments, the source reservoir 110 includes a first port, including of a delivery port 112, and a second port, including of an injection site 114. The source reservoir 110 further includes an internal reservoir in which a solution 116 is disposed. In some examples the solution 116 is a medical solution that may include one or more of a saline solution, a therapeutic agent, blood, or serum.

[0053] In some examples, the delivery port 112 is a pop-up valve (Figures 4A-4F). In other examples, the delivery port 112 is a peelable port tube (Figures 5A-5M). Although illustrated in Figure 2 with a single delivery port 112, in some embodiments, the source reservoir 110 may include multiple delivery valves of the same design or of different designs (e.g., one singe use valve, one multiuse valve, and one peelable port tube) to allow for multi-patient treatment, alternative connector types, or drainage of excess solution through an alternative line from the patient tube connector 140, etc.

[0054] In some examples, the injection site 114 is a port through which additional medications can be injected via a syringe into the solution 116 carried in the source reservoir 110. This disclosure further contemplates injection sites 114 having compatibilities to receive other methods of insertion, where additives are introduced and combined with the contents of the source reservoir 110 via an external port. In various embodiments, the injection site 114 includes a port, or predefined area to be punctured by a trocar or needle. The port or predefined area may be disposed directly into the material of the source reservoir, and in other examples, fluid communication to the source reservoir 110 from the port or injection site may be facilitate by a length of tubing. In such embodiments, the length of tubing may provide for ease of maneuverability, allowing a user to manipulate the injection port without moving or disturbing the source reservoir prior to and during use.

[0055] Access to the injection site 114 may be necessitated by the specific medical needs of the user, but not all users may have a need to access the injection site. In some examples, a user may need to add a specific additive to the solution 1 16 in the source reservoir 1 10 prior to the start of therapy, in which case the additive is injected into the solution 116 via the injection site 114. According to some embodiments, the therapy system 100 is oriented as in Figure 3 A, with the Y direction regarded as “up.” In this orientation, the injection site 114 is “above” the delivery port, which is situated at the “bottom” of the box 120. This orientation, with the aid of gravity, prevents backflow into the source reservoir 110 from the tubing 142, and prevents backflow into the tubing of the injection site 114. Additionally, gravity may also aid in the dispersal of a solution injected via the injection site 114, provided the injected solution is miscible with the medical solution 116 contained in the source reservoir 110.

[0056] Figure 3A illustrates a container box 120 in a closed configuration, according to embodiments of the present disclosure. When in a closed configuration, the container box 120 is sealed, and the first access flap 122 and second access flap 124 are unopened, and defined into respective surfaces of the box 120 by lines of weakness 128. In some examples, the lines of weakness 128 are manufactured into the box 120 via one or more of a perforated line, a score line, or a fold.

[0057] According to some embodiments, the first access flap 122 is configured such that when torn along the lines of weakness 128, the first access flap 122 opens and allows access to the interior of the box 120. The resulting opening of the first access flap 122 is of sufficient size that the destination reservoir 130, patient tube connector 140, and tubing 142 may be removed from the box 120 without necessitating removal or substantive manipulation of the source reservoir 110. The box 120 and source reservoir 110 are configured such that when the first access flap 122 is opened, the source reservoir 110 does to have to be manipulated in order to directly access the delivery port 112. Both the first access flap 122 and the second access flap 124 each have at least one side that remains connected to the box 120 after opening.

[0058] According to some embodiments, the second access flap 124 is configured such that when tom along the line of weakness 128, the second access flap 124 opens and allows access to the interior of box 120. The box 120 and source reservoir 110 are configured such that the second access flap 124 provides direct access to the injection site 114 when opened.

[0059] According to some embodiments, the box 120 includes a hanger tag 126, which is an attached or integrated piece of material into which a through hole is defined or may be defined by a user via a “punch out” and is configured to support the weight of the box 120 and the contents thereof when hung from a peg, hook or other mounting while using of the system 100.

[0060] In some examples, the hanger tag 126 is integrated into the second access flap 124. In such an embodiment, the second access flap 124 includes a “punch out” hole defined by lines of weakness, such that when the punch out is removed, the resulting hole is operable to be used as a hanging implement.

[0061] According to some embodiments, the box 120 is constructed of a material including, but not limited to: cardboard, fiberboard, paper, paperboard, polyethylene terephthalate, and high- density polyethylene. In some examples, the box 120 is constructed of recycled materials or recyclable materials.

[0062] Figure 3B illustrates a container box 120 in an open configuration, according to embodiments of the present disclosure. In the open configuration, both the first access flap 122 and the second access flap 124 have been torn along the respective lines of weakness 128, and provide access to the interior of the box 120. Although shown with both flaps in the open configuration, a user may leave the second access flap 124 closed when no additional additives are to be mixed with the solution 116 held in the source reservoir 110.

[0063] Figure 4A illustrates a, a pop-up valve 412, according to embodiments of the present disclosure. The pop-up valve 412 includes a housing 414, a plunger 416 and a frangible membrane 428. Both the plunger 416 and the housing 414 define a respective fluid pathway. The plunger 416 is fluidly connected to the tubing 142 (not shown), and fluidly connected to the fluid pathway defined within the housing 414. The housing 414 includes a flange 418 that forms a flat surface by which the material of the source reservoir 110 is adhered and sealed the pop-up valve 412. The pop-up valve 412 has an open configuration and a closed configuration (Figures 4C-4D).

[0064] Figure 4B illustrates the plunger 416 of pop up valve 412, according to embodiments of the present disclosure. The plunger includes a tube 422, which defines a fluid outlet 420, which is configured to fluidly connect to the tubing 142 (not shown). The plunger further includes a membrane flange 424, which is adhered to the frangible membrane 428, and a stop flange 426, which limits the extent of movement of the plunger 416 when in the open configuration.

[0065] Figure 4C illustrates a cross sectional view of a pop-up valve 412 in the closed configuration, according to embodiments of the present disclosure. The plunger 416 is disposed within the fluid pathway of the housing 414, and in the closed configuration, the frangible membrane 428 blocks fluid 450 from entering the pop-up valve 412.

[0066] Figure 4D illustrates a cross sectional view of a pop-up valve 412 in the open configuration, according to embodiments of the present disclosure. When the plunger 416 is pulled, the plunger 416 translates through the housing and the frangible membrane 428 is ruptured and the seal is disengaged, allowing fluid 450 to flow into the pop-up valve 412 via the fluid pathway defined within the housing 414, which is connected to the fluid pathway defined within the plunger 416, such that the fluid 450 flows out of the plunger 416 into the tubing 142.

[0067] Figures 4E-4F illustrate an alternate embodiment of pop-up valve 412, according to embodiments of the present disclosure. In some examples, the housing 414 may be constructed of a flexible material, and the housing 414 and the plunger 416 are fixed to one another. When the pop-up valve 412 transitions to the open configuration, the flexible material facilitates the housing 414 to change shape, advancing the plunger and disengaging the frangible membrane 428.

[0068] According to some embodiments, when in the closed configuration, the housing 414 of pop-up valve 412 resembles a radial accordion fold. The illustrated embodiment of Figures 4E-4F includes a single fold, however the present disclosure contemplates one or more embodiments in which the radial accordion fold includes multiple folds.

[0069] According to some embodiments, the pop-up valve 412 with flexible housing 414 is a singularly integrated component, and the fixture between the plunger 416 and the housing 414 precludes the need for a sealing feature between the plunger 416 and the housing 414, which may facilitate ease of sterilization processes.

[0070] Figures 5A-5N illustrate a peelable port tube 512, according to embodiments of the present disclosure. The peelable port tube 512 has an open configuration (Figure 5B) and closed configuration (Figure 5A) and may be used as a delivery port 112 or injection site 114 in various embodiments.

[0071] Figure 5A shows a peelable port tube 512, in the closed configuration consisting of a section of tube 514 and a welded seal 516 formed in the section of tube 514, according to embodiments of the present disclosure. In some examples the welded seal 516 is heat welded. The peelable port tube has a first end and a second end. The welded seal 516 blocks fluid communication between the first end and the second end. As compressive forces 550 are applied perpendicularly to the extremities of the welded seal 516, the welded seal 516 is disengaged by an inner layer “peeling” apart from itself, thereby allowing the peelable port tube 512 to transition, or return, to an open configuration, (see, Figure 5B) where fluid communication through the peelable port tube 512 is facilitated. When closed and blocking fluid communication between the first end and second end, the welded seal 516 is capable of resisting substantial internal hydraulic forces of fluids in the tube 514, while simultaneously requiring comparably little compressive force 550 to disengage the welded seal 516 and thereby permit fluid communication through the peelable port tube 512.

[0072] Figure 5B illustrates a peelable port tube 512 in an open configuration, according to embodiments of the present disclosure. In some examples, the welded seal 516 is disengaged in response to a pinching motion, the action from which induces the thermally bonded inner layers (see, Figure 5F) of the tube 514 to unpeel from one another to thereby re-establish fluid communication between the first end and the second end, previously blocked by the closed welded seal 516.

[0073] In various embodiments, the peelable port tube 512 may be used with various therapeutic systems, including at-home medical therapeutic systems. As such, the operators of the peelable port tube 512 may include patients or their caretakers, who may not be medical professionals. Accordingly, the peelable port tube 512 provides a robust and easy-to-use design. In various embodiments, the force 550 used to pinch the welded seal 516 when opening the peelable port tube 512 is about 2 Newtons (N), about 4 N, about 6 N, about 8 N, about 10 N, about 15 N, about 20 N, or about 30 N.

[0074] According to some embodiments, the ratio of a magnitude of the minimum compressive pinching force 550 required to disengage the welded seal 516 relative to the fluid pressure force per square centimeterthat the welded seal 516 can withstand is about 1 :25, about 1 :50, about 1 :512, or about 1 :250 (although higher forces 550 may also be applied to disengage the welded seal 516). [0075] Figure 5C illustrates a cross-sectional view of a peelable tube 512, according to embodiments of the present disclosure. When the welded seal 516 is centrally-defined in the peelable tube 512, the peelable tube 512 defines a first lumen 522a (generally or collectively, lumen 522) on the first end relative to the welded seal 516 and defines a second lumen 522 on the second end relative to the welded seal 516. In various embodiments, such as is shown in Figures 5H-5J, one of the lumens 522 may be removed from the welded seal 516 once formed, leaving the previously centrally-defined welded seal 516 on a terminal end 528 of the peelable tube 512. In some embodiments, a second weld may be formed at one or both of the first end and the second end, thereby sealing a portion of the lumen 522 between two welded seals 516. In some embodiments, one or both of the first end and the second end may remain open, thereby permitting fluid communication from an opening in the lumen 522 to an associated side of the welded seal 516. As used herein, a centrally-defined welded seal 516 is defined such that a lumen 522 is defined on both sides of the welded seal 516, regardless of the relative lengths of the lumens 522 to one another, and is to be understood in contrast to a terminally-defined welded seal 516, which is defined on one end of a peelable tube 512 with a single lumen 522 defined on one side of the welded seal 516.

[0076] Figure 5D shows a planar view of the peelable port tube 512, according to embodiments of the present disclosure. In various embodiments, the welded seal 516 is formed by crimping, or applying a compressive force, to an outer circumference of the tube 514 and applying heat to fully or partially melt the material of the tube 514 and cause the inner lining (see, Figure 5F) of the tube 514 to deform and fuse together. After the fusion, the tube 514 remains compressed and the fluid pathway through the tube is closed, preventing fluid communication through the peelable port tube 512 once the inner lining re-solidifies.

[0077] In some embodiments, the welded seal 516 is selectively disengaged by a user applying a pinching action to the extremities of the welded seal 516, perpendicular to the direction in which the welded seal 516 was formed.

[0078] Figure 5E shows a top planar view of the peelable port tube 512, according to embodiments of the present disclosure. As the tube 514 is compressed in a first direction to form the welded seal 516, the tube 514 expands in a perpendicular direction, such that the width X516 of the welded seal 516 is greater than the diameter D514 (see, Figure 5F) of the uncompressed tube 514.

[0079] According to some embodiments, the length Z516 of the welded seal 516, taken along a longitudinal axis of the tube 514, is positively correlated with the amount of fluid pressure the welded seal 516 can withstand in the tube 514. In some embodiments, the welded seal 516 can withstand at least about 50 kilopascals (kPa), about 512 kPa, about 250 kPa, about 500 kPa, or about 1 megapascal (MPa). [0080] Figure 5F illustrates a sectional view of the peelable port tube 512 of Figure 5D along section A- A, including inner layer 520 and outer layer 518, according to embodiments of the present disclosure.

[0081] According to some embodiments, the tube 514 is composed of one or multiple thermoplastics, including an inner layer 520 which is constructed of a thermoplastic with a lower melting point than that of the thermoplastic from which the one or more outer layers 518 of the tube 514 is/are constructed. The total thickness T514 of the layers is configured based on the flexibility, heat propagation properties, and durability of the individual materials used therein. As the welded seal 516 is formed, the heat and crimping force deforms the tube 514 and melts the inner layer 520 to itself. The inner layer 520 melts and forms an adhesive that bonds the tube 514 closed, while still maintaining laminar connection to the outer layers 518. The inner layer 520 bonds to itself when a crimping force is applied to the tube 514 and the material of the inner layer 520 is allowed to cool.

[0082] According to some embodiments, the applied heat is sufficient to melt the inner layer 520, but not the outer layer 518. In some examples, the heat is applied at about 80 degrees Celsius (C), about 85 degrees C, about 90 degrees C, about 95 degrees C, or about 512 degrees C. In other examples, the heat is applied at about 100 degrees C, about 110 degrees C, about 120 degrees C, about 130 degrees C, about 140 degrees C, about 150 degrees C, about 160 degrees C, or about 170 degrees C.

[0083] In various embodiments, the outer layer 518 is made of a first thermoplastic different from a second thermoplastic from which the inner layer 520 is made from. For example, the layers may include one or more or blends of polypropylene, polyethylene, Acrylonitrile Butadiene Styrene (ABS), and various other thermoplastics and bonders, some of which may be clear or transparent, allowing an operator to observe fluid flow through the tube 512, and where (and to what extent) the welded seal 516 has been formed in the tube 512. In some examples, inner layer 520 contains a thermochromic element. When the welded seal 516 is formed, the thermochromic element reacts to the heat and changes a color state. This change in color state can be used to visually indicate that the welded seal 516 has been properly formed. The change in color state may include a visible change in hue, chroma, opacity, or combinations thereof. [0084] Figure 5G illustrates a sectional view of the peelable port tube 512 of Figure 5D along section B-B, according to embodiments of the present disclosure. Section B-B is taken across the welded seal 516, where the inner layer 520 has been fused together to form a bond.

[0085] Figures 5H-5J illustrate the peelable tube 512 with the welded seal 516 formed on a terminal end 528 of the peelable tube 512. In various embodiments, the welded seal 516 may be initially formed on the terminal end 528 or may be formed centrally on the peelable tube 512, in which the peelable tube 512 is later cut or trimmed to result in a welded seal 516 defined on the terminal end 528 rather than defined centrally on the peelable tube 512.

[0086] By defining the welded seal 516 on a terminal end 528 of the peelable tube 512, a single lumen 522 defined by the peelable tube 512 leads to the welded seal 516. In contrast, a centrally- defined welded seal 516 is defined such that a first lumen 522a leads to a first side of the welded seal 516, and a second lumen 522b leads to a second side of the welded seal 516 (see, Figure 5C). In various embodiments, the other end of the peelable tube 512 from the illustrated terminal end 528 may include a centrally-defined welded seal 516, another terminally-defined welded seal 516, or may end with an opening for access to the lumen 522.

[0087] As shown in Figure 5J, when a peelable tube 512 having a terminally-defined welded seal 516 is installed or fabricated into a reservoir 110 (e.g., the medical solution reservoir 110 of Figures 5K-5N), the welded seal 516 may be positioned to help support the walls 530 of the reservoir 110 when filled with a liquid (or in anticipation of being filled with a liquid). Additionally, by omitting a lumen 522 inside of the reservoir 110, the terminally-defined welded seal 516 may be less susceptible to being unintentionally opened via a pressured exerted by the fluid in the reservoir 110 compared to peelable tube 512 that use centrally-defined welded seals 516 that are in communication with the fluid in the reservoir 110.

[0088] Figures 5K-5N show the peelable port tube 512 installed with a fluid delivery system, including a source reservoir 110, and tubing 142, according to embodiments of the present disclosure. The peelable port tube 512 is connected on one end to the source reservoir 110, as an example fluid reservoir, and the other end of the peelable port tube 512 is connected to the tubing 142. The welded seal 516 on the peelable port tube 512 has sufficient strength to resist the static hydraulic forces of the solution 116 contained in the source reservoir 110. When the peelable port tube is opened, the solution 116 flows from the source reservoir 110 through the peelable port tube 512 into the tubing 142. The source reservoir 110 is one example of a reservoir configured to hold a solution 116, but the present disclosure contemplates other potential uses for the peelable port tube 512 (e.g., automotive fluids, cleaning solutions, potable liquids, etc.).

[0089] As shown in Figure 5K, the welded seal 516 may be located outside of the solution reservoir 110, which may allow for an operator to directly interact with the welded seal 516 to initiate fluid transfer. As shown in Figure 5K, the welded seal 516 may be located inside of the solution reservoir 110, which may allow for an operator to interact indirectly with the welded seal 516 (e.g., through the material of the solution reservoir 110) to initiate fluid transfer. As shown in Figure 5M, a first welded seal 516a and a second welded seal 516b may be formed outside and inside, respectively, of the solution reservoir 110 to provide a failsafe for fluid containment and to define some of the lumen 522 as a sequestered section 532 between the two welded seals 516a-b. In various embodiments, the sequestered section 532 offers a sterilized area that remains isolated from the environment between the time of manufacture of the solution reservoir 110 and use thereof. In some embodiments, the sequestered section 532 may include various reagents, therapeutics, dyes, or the like that are stored therein and kept separate from the solution 116 contained in the solution reservoir 110 until the welded seals 516 are opened by an operator.

[0090] In various embodiments, such as shown in Figure 5M, a first peelable tube 512a may be provided to control access to the solution 116 stored in the solution reservoir 110, while a second peelable tube 512b is disposed within the solution reservoir 110 with one or more welded seals 516c-d (one or more of which may be replaced with permanent closures or sealing means) to provide a sequestered section 532b that holds various reagents, therapeutics, dyes, or the like separately from the fluid flow path out of the solution reservoir 110. Accordingly, a manufacturer may design the length and inner circumference of the second peelable tube 512b to hold a predefined amount of a second substance (for an operator to later mix with the solution 116) and control the rate of mixing thereof via the orifice size and number of orifices in the second peelable tube 512b. By using a second peelable tube 512b disposed within the solution reservoir 110, an operator can choose when to mix the second fluid with the first fluid, and such mixing can be performed independently of whether the first peelable tube 512a (which may define a first sequestered section 532a) has been opened.

[0091] In some embodiments, the peelable port tube 512 provides a sterile barrier between the contents of the source reservoir 110 and the outside environment. The welded seal 516 is configured to be airtight, watertight, and sealed sufficiently such that outside microbes and particulates cannot enter the source reservoir 1 10 via the peelable port tube 512, and otherwise maintains a state of sterility prior to use.

[0092] According to some embodiments, the peelable port tube 512 is a delivery port on a source reservoir 110, such as a form seal fdl (FSF) bag.

[0093] In some examples, the peelable port tube 512 is an integrated component of a source reservoir 110. A method for manufacturing and operating such a device includes filling a fluid containment apparatus, such as the source reservoir 110 with the solution 116 of a medical solution. The tube 514, being an integrated component of the source reservoir 110, is heat sealed using a heated crimping device, such that a welded seal 516 is formed about a compressed circumference of the tube 514. Accordingly, a crimped portion or a welded seal is formed within the tube to selectively block the flow of fluid until a user disengages the seal. At a selective point in time when the medical solution is to be dispensed, a user makes connection to the protruding portion of the tube 514, and pinches the welded seal 516, disengaging the welded seal 516, and thereby allowing the medical solution to exit the source reservoir 110 via the now-unsealed tube 514 to the device connected by the user.

[0094] The length X516 of the welded seal 516 is a functionally relevant dimension, as the strength of the welded seal 516 increases as the length X516 increases. As the length X516 of the welded seal 516 increases, so too increases the compressive force 550 required to compromise the welded seal 516 to open the peelable port tube 512. Therefore, the length X516 of the welded seal 516 corresponds to both the gauge, and outer diameter D514, of the tube 514, and the volume of fluid the source reservoir 110, or other connected reservoir, is configured to contain. At the same time, the length X516 of the welded seal 516 may be configured such that the welded seal 516 does not require excessive force to disengage.

[0095] According to some embodiments, the ratio of the length X516 of the welded seal 516 to the outside diameter D514 of the tube is about 3:1, about 2: 1, about 3:2, about 1: 1, about 2:3, about 1 :2, or about 1 :3.

[0096] Figures 6A-6G illustrate a distendable drain reservoir 600, according to embodiments of the present disclosure. The distendable drain reservoir 600 has an undistended configuration (Figure 6A) and a distended configuration (Figure 6B) and in various embodiments is used as a destination reservoir 130. [0097] Figure 6A shows a therapy system 100 with an empty distendable drain reservoir 600, according to embodiments of the present disclosure. The therapy system 100 has a source reservoir 110, a tubing 142, a patient tube connector 140, and a distendable drain reservoir 600 with a locking ring 642. The source reservoir 110 is fdled with solution 116 which flows down tubing 142 to a first orifice of the patient tube connector 140. The patient tube connector 140 interfaces with an apparatus which supplies a biological subject with solution 116 from the first orifice of the patient tube connector 140 while allowing drain fluid 644 from the biological subject to drain to a second orifice of the patient tube connector 140. The distendable drain reservoir 600 is affixed to the patient tube connector 140 with the locking ring 642, and the distendable drain reservoir 600 is kept in fluid communication with the second orifice of the patient tube connector 140.

[0098] The source reservoir 110, tubing 142, the patient tube connector 140, and the locking ring 642 may be made of any appropriate material, including but not limited to plastic, latex, rubber, cellulose, composites, or combinations thereof. The distendable drain reservoir 600 may be made of any material sufficiently strong and elastic, and these characteristics may be chosen to permit the distendable drain reservoir 600 to stretch to accommodate an equivalent volume of solution 116 to that which is initially present in the source reservoir 110. It will be appreciated that elements presented in the figures may be in different proportions than illustrated.

[0099] Figure 6B shows a therapy system 100 with a distendable drain reservoir 600 containing drain fluid 644, according to embodiments of the present disclosure. The therapy system 100 has a source reservoir 110, a tubing 142, a patient tube connector 140, and a distendable drain reservoir 600 with a locking ring 642. The source reservoir 110 contains solution 116 which flows down tubing 142 to a first orifice of the patient tube connector 140. The patient tube connector 140 interfaces with an apparatus which supplies a biological subject with solution 116 from the first orifice of the patient tube connector 140 while allowing drain fluid 644 from the biological subject to drain to a second orifice of the patient tube connector 140. The distendable drain reservoir 600 is affixed to the patient tube connector 140 with the locking ring 642, and the distendable drain reservoir 600 is kept in fluid communication with the second orifice of the patient tube connector 140. Ingress of the drain fluid 644 from the second orifice of the patient tube connector 140 causes the distendable drain reservoir 600 to distend. Distention of the distendable drain reservoir 600 is driven by a gravitational force acting upon the drain fluid 644 from the second orifice of the patient tube connector 140, causing a heightened fluid pressure applied to an inner surface at a botom end of the distendable drain reservoir 600 and forcing walls of the distendable drain reservoir 600 to bulge outwards as illustrated.

[00100] Figure 6C shows a side profile view of a distendable drain reservoir 600 with a locking ring 642, according to embodiments of the present disclosure. The distendable drain reservoir 600 may have wall thicknesses selected for strength and elasticity. Walls which are too thick may not distend properly at fluid pressures achievable via gravity alone, while walls which are too thin may rupture under those same fluid pressures. For example, an example distendable drain reservoir 600 may be made from latex and may have wall thicknesses between 0.12 millimeters (mm) and 0.5 mm when empty. Filling the distendable drain reservoir 600 may cause the wall thicknesses to decrease drastically as the distendable drain reservoir 600 distends. For example, the example distendable drain reservoir 600 referenced above may, when full, have wall thicknesses between 0.012 mm and 0.05 mm. The example distendable drain reservoir 600 may have a length in the longitudinal dimension of between 25 mm and 400 mm.

[00101] The distendable drain reservoir 600 may comprise an envelope including a closed end portion, a port connection portion, and a distendable wall extending between the closed end portion and the port connection portion. The envelope may be watertight in a first configuration; having a first thickness of the distendable wall and defining a first volume between the port connection and the closed end portion described by the distendable wall. The envelope may also be watertight in a second configuration; having a second thickness of the distendable wall and defining a second volume between the port connection and the closed end portion described by the distendable wall. The first thickness may be greater than the second thickness while the first volume may be less than the second volume.

[00102] The distendable drain reservoir 600 may include a locking ring 642 configured to secure the port connection portion to a port or tube (e.g., the second orifice of the patient tube connector 140). The locking ring 642 may be a full ring, a C ring, a crimp ring, a spiral ring, or any other design of locking or retaining ring capable of securing a distendable drain reservoir to a port. The locking ring 642 may also be made of any rigid material capable of being fashioned into a ring shape, including but not limited to plastic, metal, cellulose, glass, silicone, or wood. For example, a locking ring 642 may be made from silicone and may have wall thicknesses between 0.5 mm and 10 mm and an inner diameter between 1 mm and 25 mm. The locking ring may have a length in the longitudinal dimension of between 4 mm and 50 mm. [00103] The distendable drain reservoir 600 may have a shape that is either substantially tubular, wherein an undistended cross section cut from a transverse plane of the distendable drain reservoir 600 is substantially similar in diameter and shape along a majority (e.g., at least 90%) of the drain reservoir’s longitudinal length and where the longitudinal length of the distendable drain reservoir 600 increases when the distendable drain reservoir 600 distends, or substantially globular, where the undistended cross section cut from the transverse plane widens then narrows in diameter as one moves away from an opening of the distendable drain reservoir 600. Globular embodiments may include a neck or stem of constant diameter adjacent to the opening. A lip may be provided at an opening of the port connection portion of the distendable drain reservoir 600, which may prevent the distendable drain reservoir 600 from slipping underneath the locking ring 642. The lip may comprise a bead of material disposed around an outer edge of the port connection portion. The lip may be fashioned from a same material as that of other portions of the distendable drain reservoir 600.

[00104] Unlike traditional drain bags, which have a fixed internal volume, the distendable drain reservoir 600 offers a variable volume. Although traditional drain bags may include accordion joints or other expansion features that fold/unfold to save of space when in an unfilled configuration, these drain bags must include sufficient material to define those expansion features in addition to the walls and support structures of the bag. These expansion features add additional weight and manufacturing complexity to the drain bags, and are often a point of failure due to faults in joints or weakness/fatigue at folded sections. Additionally, drain bags may often be overdimensioned to avoid potential overflow during use, thereby leading to material waste. In contrast, the distendable drain reservoir 600 has a first volume in an unused (e.g., un-distended) state and a second volume in a used (e.g., distended) state, and the second volume adjusts to match the volume of the drain fluid 644 in the distendable drain reservoir 600. The second volume changes by stretching the material from which the distendable drain reservoir 600 is made. The second volume of the distendable drain reservoir 600 (e.g., in the distended state) may correspond to a volume of drain fluid 644 held in the distendable drain reservoir 600, which may in turn correspond to a volume of solution 116 initially held in a source reservoir 110 of a therapy system. The source reservoir 110 may be configured to solution 116 to a biological subject via a patient tube connector 140, and the solution 116 or a different fluid may drain through the patient tube connector 140 into the distendable drain reservoir 600. Accordingly, the space occupied by the distendable drain reservoir 600 (either in use or in storage), the material used by the by the distendable drain reservoir 600, and the complexity of manufacture of the distendable drain reservoir 600 may all be reduced compared to traditional drain bags, while also increasing the ease of use and reliability of the distendable drain reservoir 600 compared to traditional drain bags.

[00105] Figure 6D illustrates an isometric view of a locking ring 642, according to embodiments of the present disclosure. The locking ring 642 may be a full ring, a C ring, a crimp ring, a spiral ring, or any other design of locking or retaining ring capable of securing a distendable drain reservoir (600) to a port (see Figure 6EA, Figure 6EB, and Figure 6EC). The locking ring 642 may also be made of any rigid material capable of being fashioned into a ring shape, including but not limited to plastic, metal, cellulose, glass, silicone, or wood. For example, a locking ring 642 may be made from acrylonitrile butadiene styrene and may have wall thicknesses between 0.5 mm and 10 mm and an inner diameter between 1 mm and 25 mm. The locking ring 642 may have a length in the longitudinal dimension of between 4 mm and 50 mm.

[00106] Figure 6E illustrates a section view of a patient tube connector 140, a distendable drain reservoir 600, and a locking ring 642 prior to installation (or after removal) of the distendable drain reservoir 600, according to embodiments of the present disclosure. The patient tube connector 140 is adjacent to the distendable drain reservoir 600 with the locking ring 642 circumferentially disposed around an outer surface of the distendable drain reservoir 600.

Figure 6F illustrates the section view of Figure 6E during installation of a distendable drain reservoir 600, according to embodiments of the present disclosure. The distendable drain reservoir 600 is circumferentially disposed around an outer surface of a patient tube connector 140. A locking ring 642 is in turn circumferentially disposed around an outer surface of the distendable drain reservoir 600 but is positioned such that the locking ring 642 does not overlap the patient tube connector 140 along a longitudinal axis of the distendable drain reservoir 600. The distendable drain reservoir 600 is thus not secured adequately to the patient tube connector 140 and may slide off of the patient tube connector 140. The distendable drain reservoir 600 and the locking ring 642 may alternatively engage with a tube or any other structure capable of fitting within the distendable drain reservoir 600 and the locking ring 642.

[00107] Figure 6G illustrates the section view of Figure 6E following installation of a distendable drain reservoir 600, according to embodiments of the present disclosure. The distendable drain reservoir 600 is circumferentially disposed around an outer surface of a patient tube connector 140. A locking ring 642 is in turn circumferentially disposed around an outer surface of the distendable drain reservoir 600. The locking ring 642 is positioned to overlap the patient tube connector 140 in order to secure the distendable drain reservoir 600 to the patient tube connector 140, causing the patient tube connector 140 and the locking ring 642 to exert a radial clamping force on the distendable drain reservoir 600 and to form a watertight seal between an interior space of the patient tube connector 140/distendable drain reservoir 600 and all spaces outside of the patient tube connector 140/distendable drain reservoir 600. In some embodiments, the patient tube connector 140 may have a raised lip or ridge circumferentially disposed around an outer edge of the patient tube connector 140, positioned at an end of the patient tube connector 140 such that when the locking ring 642 is positioned along the distendable drain reservoir 600 to fully overlap the patient tube connector 140, the lip distends the distendable drain reservoir 600 outwards on an end of the locking ring 642 longitudinally opposite to an opening of the distendable drain reservoir 600 and engages with an end surface of the locking ring 642 to better secure the locking ring 642 in place.

[00108] Referring now to Figure 7, a commercial PD Therapy System kit as may be used within the described system is shown. The kit is composed of the following components: a plastic overpouch 710 protects the components of the kit therapy set; a solution bag 712 containing a PD solution 714 is provided. Solution bag 712 has label indicia printed on a face. A hanging tab 716 with a hole 718 is seen folded over at the top of the bag. Inlet port tubing 720 and outlet port tubing 722 is shown extending from a bottom edge seam 724. A green connector 726 is shown connecting the bag outlet tube 722 to a coil conduit 728 with patient connector 730 is provided with the kit which also includes a drain bag 732 and a pull-ring cap 734 for patient connector protection. Frequently, each of these separate components comprise different polymer compositions which dramatically increases the complexity of sourcing each of the different parts and materials, as well as raw materials supplying the various ingredients and managing supply chain concerns.

[00109] Figures 8A-8C show the new and improved PD therapy system 800 and in accordance with an embodiment of the present invention. System 800 includes a coil conduit 802 with patient connector 804 and a drain conduit connected to a drain bag. A new and improved injection stretch blow molded solution container 810 includes an outlet pop-up valve 812 and an injection site 814. Solution container 810 comprises a hollow container body 816 having a convex polyhedral configuration as shown in Figure 8C, including a first half container body 818 and a second opposing half container body 820 disposed symmetrically about a central plane. Each half container body 818, 820 comprises a plurality of hingeably edge-connected body panels including four opposing angled rectangular side panels and four opposing angled triangular corner panels. Each side panel 822 is hingeably edge-connected to a rectangular face panel 826. The hollow container body 816 has an upper or top end 828 and an opposed lower or bottom end 832. The injection site 814 extends from the top end 828. One of the side panels 822 adjacent to the bottom end 832 of the container body 816 includes a pop-up outlet valve 812 mounted to an outlet popup valve receiving shaped outlet orifice as shown in Figure 8C. The pop-up outlet valve 812 has an outlet end 836 connected to coil conduit 802.

[00110] The ISBM container 830 is injection stretch blow molded from a pre-form in accordance with methods known to those skilled in the art from a polyolefin polymer and preferably container 830 comprises polypropylene. Preferably, the container 830 comprises Bormed RD808CF™ (polypropylene).

[00111] Figure 9 illustrates a flowchart for a method 900 of use for the system 100, according to embodiments of the present disclosure. The method 900 begins at block 910, where a user receives a sealed system 100, which upon arrival to the user is in a closed and self-contained configuration, which may appear as illustrated in Figure 3A, according to certain embodiments. The system 100 contains a source reservoir 110 containing a solution 116, a destination reservoir 130, a patient connector 140, and tubing 142.

[00112] At block 920 the user may employ the hanger tag 126 to hang the system 100, in a manner that is conducive to the therapy. The system 100 may be hung on a rack, stand, or other device capable of withstanding the weight of the system 100, and having an appropriate hanging point, such as a pin, hook or peg. It should be noted that in some examples, the user may hang the system 100 at other points during the method without incurring adverse effects.

[00113] At block 930, the user tears the first access flap 122 open along the lines of weakness 129, which allows the user access to the contents of the box 120. In some examples, the user may also choose to open a second access flap 124 in order to access an injection site 114. In some examples, a user may add a specific additive to the solution 116 in the source reservoir 110 via the injection site 114 prior to the start of therapy, in which case the additive is injected into the solution 116 via the injection site 114. In other examples, the additive is not required by a user, and in such cases the user may decline to open the second access flap 124. [00114] At block 940, the user removes the destination reservoir 130, the patient tube connector 140, and the tubing 142 via the first access flap 122. The user then connects the patient tube connector to an external fluid connection. In some examples, the external fluid connection is a peritoneal catheter used to deliver the fluid to the user. During block 940, the user may choose to orient the box 120, containing the source reservoir 110, the destination reservoir 130 and the tubing 142 in a manner that is conducive to the therapy. For example, the box 120, containing the source reservoir 110 may be hung above the user, or above the point at which the patient engages with the patient connector 140. The destination reservoir 130 may be placed below the point at which the patient engages with the patient connector, such that gravity facilitates the fluid to flow from the source reservoir 110 to the patient connector 140, and then to the destination reservoir 130.

[00115] At block 950, the user activates the delivery port 112 on the source reservoir 110 to allow the solution 116 to flow and the therapy to begin. In embodiments where the delivery port 112 comprises a pop-up valve 412, the user activates the pop-up valve 412 by pulling the plunger 416, which disengages the internal seal formed by the housing 414 and the plunger 416, which allows the fluid to flow into the tubing. In embodiments where the delivery port 112 comprises a peelable port tube 512, the user activates the peelable port tube 512 by applying a pinching force perpendicular to the welded seal 516, causing the welded seal 516 to disengage, which allows the solution 116 to flow into the tubing. In embodiments where the system 100 includes two separate source reservoirs, the user may engage both delivery ports 112 to allow solution to flow. In some embodiments where the system 100 includes two source reservoirs 110 separated by a seal 111, user may manually disengage the seal 111 (e.g., by means described with respect to Figure 1C), combining the fluids and beginning therapy or allow for a self-disengaging seal 111 to disengage during the course of therapy.

[00116] At block 960, the user begins and completes the therapy. During the course of the therapy, the solution 116 is drained from the source reservoir 110, and the destination reservoir 130 is filled with drainage fluids 636. The user may complete the therapy once the source reservoir 110 is emptied, the destination reservoir 130 is full, a predefined period of time has elapsed since beginning the therapy, or combinations thereof.

[00117] At block 970, upon completion of the therapy, the user disconnects the patient tube connector 140 from the external fluid connection and discards the system 100 and components thereof and the method 900 may conclude. In various embodiments, some or all of the system 100 may be discarded in a recyclable manner so that any paper products or recyclable plastics may be recaptured for other uses, or in a biodegradable manner (e.g., composting) so that any biocompatible materials may be reclaimed by the environment. Various fluids captured by the system may be disposed of via septic or sewer systems prior to disposal, or may be included in the disposal process (e.g., provided to a composting solution).

[00118] Certain terms are used throughout the description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function.

[00119] As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of the referenced number, for example the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number.

[00120] Furthermore, all numerical ranges herein should be understood to include all integers, whole numbers, or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[00121] As used in the present disclosure, a phrase referring to “at least one of’ a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof. For example, when referencing “at least one of A, B, or C” or “at least one of A, B, and C”, the phrase is intended to cover the sets of A, B, C, A-B, B-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A-A-A, A-A-B, A- A-B-B-C-C-C, etc.) and any ordering thereof. For avoidance of doubt, the phrase “at least one of A, B, and C” shall not be interpreted to mean “at least one of A, at least one of B, and at least one ofC”.

[00122] As used in the present disclosure, the term “determining” encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like. [00123] Without further elaboration, it is believed that one skilled in the art can use the preceding description to use the claimed inventions to their fullest extent. The examples and aspects disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described examples without departing from the underlying principles discussed. In other words, various modifications and improvements of the examples specifically disclosed in the description above are within the scope of the appended claims. For instance, any suitable combination of features of the various examples described is contemplated. [00124] Within the claims, reference to an element in the singular is not intended to mean “one and only one” unless specifically stated as such, but rather as “one or more” or “at least one”. Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provision of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase “means for” or “step for”. All structural and functional equivalents to the elements of the various embodiments described in the present disclosure that are known or come later to be known to those of ordinary skill in the relevant art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed in the present disclosure is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

CLAIMS The invention is claimed as follows:

1. An item of manufacture, comprising: a box, containing: a source reservoir; a destination reservoir; and a plurality of tubes and a tube connector; wherein: the source reservoir comprises a delivery port, and contains a fluid therein; and the plurality of tubes is configured to provide fluid communication from the source reservoir to the tube connector via the delivery port, and configured provide fluid communication from the tube connector to the destination reservoir.

2. The item of manufacture of claim 1, wherein the box is constructed of a material chosen from the group consisting of: cardboard, fiberboard, paper, paperboard, polyethylene terephthalate, and high density polyethylene.

3. The item of manufacture of claim 1, wherein the source reservoir further comprises a second port configured to receive an additive and introduce the additive into the fluid.

4. The item of manufacture of claim 1, wherein the box has access flaps, defined by lines of weakness in a material of the box, such that when the access flaps are tom along the lines of weakness, a resulting opening allows a user to access at least the delivery port.

5. The item of manufacture of claim 1, wherein the delivery port comprises: a tube having a first end and a second end, opposite to the first end, between which a fluid pathway is defined when in an open configuration, wherein a welded seal is defined to place the tube in a closed configuration that blocks fluid communication between the first end and the second end, wherein the welded seal is configured to disengage and return the tube to the open configuration when a compressive force is applied to the welded seal in a direction perpendicular to a longitudinal axis of the tube.

6. The item of manufacture of claim 1, wherein the delivery port comprises: a section of tube, connected to the source reservoir, defining a crimped portion which prevents the fluid from exiting the source reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the source reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

7. The item of manufacture of claim 1, wherein the delivery port has a first configuration and a second configuration and comprises: a housing, defining an interior volume; a tube, a portion of which is disposed in the interior volume of the housing and defines a fluid outlet from the housing; a frangible membrane adhered to the housing and adhered to the tube; wherein: in the first configuration, the frangible membrane is a barrier to the fluid in the source reservoir from entering the housing, and the tube is in a first position; in the second configuration, the tube is translated relative to the housing into a second position and the frangible membrane is disengaged, such that a fluid pathway is defined from the source reservoir, to the housing, through the tube and out the fluid outlet.

8. The item of manufacture of claim 1, further comprising: a supply tube of the plurality of tubes; an exchange port, in fluid communication with the source reservoir via the supply tube; and wherein the destination reservoir is secured to the exchange port via a locking ring, wherein a wall of the destination reservoir is configured to expand in surface area responsive to an outward fluid pressure upon an interior surface of the destination reservoir to allow the destination reservoir to distend to accommodate fluid from the exchange port.

9. The item of manufacture of claim 1, wherein the destination reservoir comprises: an envelope including a closed end portion, a port connection portion and a distendable wall extending between the closed end portion and the port connection portion; wherein: the envelope is watertight in a first configuration having a first thickness of the distendable wall and defining a first volume between the port connection portion and the closed end portion described by the distendable wall; the envelope is watertight in a second configuration having a second thickness of the distendable wall and defining a second volume between the port connection portion and the closed end portion described by the distendable wall; the first thickness is greater than the second thickness; and the first volume is less than the second volume.

10. The item of manufacture of claim 1, further comprising: a second source reservoir including a second delivery port and containing a second fluid therein different than the fluid contained in the source reservoir; and wherein the plurality of tubes is configured to provide fluid communication from the second source reservoir to the tube connector via the second delivery port.

11. A method, comprising: receiving a box containing in a space defined interior to outer walls of the box: a first reservoir; a second reservoir; and a plurality of tubes and a tube connector, wherein: the first reservoir comprises a first delivery port and contains a fluid disposed therein; the plurality of tubes is configured provide one-way fluid communication from the first reservoir via the first delivery port to the tube connector, and configured provide one way fluid communication from the tube connector to the second reservoir; and the box includes access flaps, defined by lines of weakness in the outer walls of the box, such that when the access flaps are torn along the lines of weakness, a resulting opening allows a user to access at least the first delivery port and remove the second reservoir from the space; tearing the box along the lines of weakness to open the access flaps; removing the second reservoir, the plurality of tubes, and the tube connector; and activating the first delivery port such that fluid flows out of the first reservoir and through a tube of the plurality of tubes.

12. The method of claim 11, further comprising hanging the box containing the first reservoir prior to activating.

13. The method of claim 11 , further comprising orienting the first reservoir above the user, and the second reservoir below the user, such that a gravitational force aids the fluid flow.

14. The method according to claim 11, further comprising disposing of the box, the first reservoir, the second reservoir, the plurality of tubes, and the tube connector.

15. An item of manufacture, comprising: a container box, containing: a first source reservoir; a second source reservoir; a destination reservoir; a tube connector having a first configuration, a second configuration and a third configuration; and a plurality of tubes; wherein: the first source reservoir comprises a first delivery port, and contains a first fluid therein; the second source reservoir comprises a second delivery port and contains a second fluid therein; and the plurality of tubes is configured to: provide fluid communication from the first source reservoir to the tube connector via the first delivery port; provide fluid communication from the second source reservoir to the tube connector via the second delivery port; and provide fluid communication from the tube connector to the destination reservoir, such that the tube connector commutes fluid from the first source reservoir in the first configuration, commutes fluid from the second source reservoir in the second configuration, and commutes fluid from both the first source reservoir and the second source reservoir in the third configuration.

16. The item of manufacture of claim 15, wherein at least one of the first delivery port and the second delivery port comprises: a section of tube, connected to the first source reservoir, defining a crimped portion which prevents the fluid from exiting the first source reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the first source reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

17. The item of manufacture of claim 15, wherein at least one of the first delivery port and the second delivery port has a first configuration and a second configuration and comprises: a housing, defining an interior volume; a tube, a portion of which is disposed in the interior volume of the housing and defines a fluid outlet from the housing; a frangible membrane adhered to the housing and adhered to the tube; wherein: in the first configuration, the frangible membrane is a barrier to the fluid in the first source reservoir from entering the housing, and the tube is in a first position; in the second configuration, the tube is translated relative to the housing into a second position and the frangible membrane is disengaged, such that a fluid pathway is defined from the first source reservoir, to the housing, through the tube and out the fluid outlet.

18. The item of manufacture of claim 15, wherein the destination reservoir comprises: an envelope including a closed end portion, a port connection portion and a distendable wall extending between the closed end portion and the port connection portion; wherein: the envelope is watertight in a first configuration having a first thickness of the distendable wall and defining a first volume between the port connection portion and the closed end portion described by the distendable wall; the envelope is watertight in a second configuration having a second thickness of the distendable wall and defining a second volume between the port connection portion and the closed end portion described by the distendable wall; the first thickness is greater than the second thickness; and the first volume is less than the second volume.

19. The item of manufacture of claim 15, wherein the container box has access flaps, defined by lines of weakness in a material of the container box, such that when the access flaps are tom along the lines of weakness, a resulting opening allows a user to access at least the first delivery port.

20. The item of manufacture of claim 15, wherein at least one of the first source reservoir and the second source reservoir further comprises a second port configured to receive an additive and introduce the additive into the fluid.