Peelable tube

Abstract

A peelable tube, as may be used as part of a port, may be provided by a tube having a first end and a second end, opposite to the first end, between which a fluid passage 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.

Description

PEELABLE TUBECROSS-REFERENCES TO RELATED DISCLOSURES

[0001] The present disclosure claims the benefit of and priority to U.S. Provisional Patent Application No.: 63 / 550,430 titled “PEELABLE TUBE” and filed on 2024-02-06, which is incorporated herein it its entirety.BACKGROUND

[0002] In-home medical fluid delivery systems often use ports containing frangible sealing mechanisms. Frangible caps generate unwanted waste material, require complex machinery to produce, and can present operational challenges to non-medical professionals.SUMMARY

[0003] The present disclosure provides a peelable tube. The peelable tube is suitable for use with medial fluid delivery systems, such as in-home peritoneal dialysis therapy systems, as part of a port. The peelable tube is a low cost, easily operable single use port including a tube having a first end and a second end, opposite to the first end, between which a fluid passage is defined when in an open configuration. 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, and 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.

[0004] Additional features and advantages of the disclosed method and apparatus 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

[0005] Figure 1A illustrates a peelable tube in a closed configuration, according to embodiments of the present disclosure.

[0006] Figure IB illustrates a peelable tube in an open configuration, according to embodiments of the present disclosure.

[0007] Figure 1C illustrates a peelable tube in a cross-sectional view, according to embodiments of the present disclosure.

[0008] Figure 2A illustrates a side profile view of a peelable tube, according to embodiments of the present disclosure.

[0009] Figure 2B illustrates a top profile view of a peelable tube, according to embodiments of the present disclosure.

[0010] Figure 2C illustrates section view A-A of Figure 2A, according to embodiments of the present disclosure.

[0011] Figure 2D illustrates section view B-B of Figure 2A, according to embodiments of the present disclosure.

[0012] Figures 3A-3B illustrate profile views of one end of a peelable tube, according to embodiments of the present disclosure.

[0013] Figures 4A-4D illustrate a medical bag with a peelable tube, according to embodiments of the present disclosure.

[0014] Figure 5 illustrates a flowchart of an example method for providing a peelable tube, according to embodiments of the present disclosure.

[0015] Although a user may orient the devices of the present disclosure in a multitude of manners, some of the Figures are illustrated with respect to a shared coordinate system, which are indicated by the accompanying X-Y-Z compasses. These directionalities are not intended to limit the scope of the subject matter of the present disclosure, and are provided solely to aid in understanding. Furthermore, it is understood that measurements in the X-direction may be referred to as a width, measurements in the Y-direction as a height, and measurements in the Z-direction as a depth. The term length is used contextually and without respect to a set direction.DETAILED DESCRIPTION

[0016] The present disclosure provides a peelable tube, in which a single use valve is provided. The peelable tube is a sterile, user friendly, single use valve that reduces material cost and environmental impact compared to frangible and peelable seal systems currently used with medical solution bags. The peelable tube described herein provides a user friendly advantage over previous systems, as operation simply requires a pinching action from a user to operate the valve. Production advantages are also provided by the peelable tube, such that production of the valve simply requires a section of compatible tubing and an apparatus with which to form the welded seal. Although he welded seal is primarily discussed herein as being formed via a heat weld, the present disclosure contemplates that other plastic welding techniques may be used to produce the welded seal described herein.

[0017] Figure 1 A shows a peelable tube 100, in the closed configuration consisting of a section of tube 110 and a welded seal 120 formed in the section of tube 110, according to embodiments of the present disclosure. The peelable tube 100 has a first end 102 and a second end 104. The welded seal 120 blocks fluid communication between the first end 102 and the second end 104. Although illustrated centrally along the longitudinal length of the peelable tube 100, the welded seal 120 can be placed anywhere along the length of the tube 100. As compressive forces 150 are applied perpendicularly to the extremities of the welded seal 120, the welded seal 120 is disengaged by an inner layer “peeling” apart from itself, thereby allowing the peelable tube 100 to transition to an open configuration, (see, Figure IB) where fluid communication through the peelable tube 100 is facilitated. When closed and blocking fluid communication between the first end 102 and second end 104, the welded seal 120 is capable of resisting substantial internal hydraulic forces of fluids in the tube 110, while simultaneously requiring comparably little compressive force 150 to disengage the heat seal 120 and thereby permit fluid communication through the peelable tube 100.

[0018] Figure IB illustrates a peelable tube 100 in an open configuration, according to embodiments of the present disclosure. In some examples, the welded seal 120 is disengaged in response to a pinching motion, the action from which induces the thermally bonded inner layers (see, Figure 2C) of the tube 110 to unpeel from one another to thereby re-establish fluid communication between the first end 102 and the second end 104, previously blocked by the closed welded seal 120.

[0019] In various embodiments, the peelable tube 100 may be used with various therapeutic systems, including at-home medical therapeutic systems. As such, the operators of the peelable tube 100 may include patients or their caretakers, who may not be medical professionals. Accordingly, the peelable tube 100 provides a robust and easy-to-use design. In various embodiments, the force 150 used to pinch the welded seal 120 when opening the peelable tube 100 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.

[0020] According to some embodiments, the ratio of a magnitude of the minimum compressive pinching force 150 required to disengage the welded seal 120 relative to the fluid pressure force per square centimeter that the welded seal 120 can withstand is about 1 :25, about 1 :50, about 1 :100, or about 1 :250 (although higher forces 150 may also be applied to disengage the welded seal 120).

[0021] Figure 1C illustrates a cross-sectional view of a peelable tube 100, according to embodiments of the present disclosure. When the weld 120 is centrally-defined in the tube 110, the tube 110 defines a first lumen 160a (generally or collectively, lumen 160) on the first side 102 relative to the weld 120 and defines a second lumen 160 on the second side 104 relative to the weld 120. In various embodiments, such as is shown in Figures 3A-3C, one of the lumens 160 may be removed from the weld 120 once formed, leaving the previously centrally-defined weld 120 on a terminal end of the tube 110. In some embodiments, a second weld may be formed at one or both of the first end 102 and the second end 104, thereby sealing a portion of the lumen 160 between two welds 120. In some embodiments, one or both of the first end 102 and the second end 104 may remain open, thereby permitting fluid communication from an opening in the lumen 160 to an associated side of the weld 120. As used herein, a centrally-defined weld 120 is defined such that a lumen 160 is defined on both sides of the weld 120, regardless of the relative lengths of the lumens 160 to one another, and is to be understood in contrast to a terminally-defined weld 120, which is defined on one end (102, 104) of a tube 110 with a single lumen 160 defined on one side of the weld 120.

[0022] Figure 2A shows a planar view of the peelable tube 100, according to embodiments of the present disclosure. In various embodiments, the welded seal 120 is formed by crimping, or applying a compressive force, to an outer circumference of the tube 110 and applying heat to fully or partially melt the material of the tube 110 and cause the inner lining (see, Figure 2C) of the tube 110 to deform and fuse together. In various embodiments, the welded seal 120 is formed viaultrasonic welding, vibration welding, microwave welding, infrared welding, laser welding, solvent welding, or any other plastic welding technique known to those skilled in the art. After the fusion, the tube 110 remains compressed and the fluid pathway through the tube is closed, preventing fluid communication through the peelable tube 100 once the inner lining re-solidifies.

[0023] In some embodiments, the welded seal 120 is selectively disengaged by a user applying a pinching action to the extremities of the welded seal 120, perpendicular to the direction in which the welded seal 120 was formed.

[0024] Figure 2B shows a top planar view of the peelable tube 100, according to embodiments of the present disclosure. As the tube 110 is compressed in a first direction to form the welded seal 120, the tube 110 expands in a perpendicular direction, such that the width Y120 of the welded seal 120 is greater than the diameter DI 10 (see, Figure 2C) of the tube 110.

[0025] According to some embodiments, the length XI 20 of the welded seal 120, taken along a longitudinal axis of the tube 110, is positively correlated with the amount of fluid pressure the welded seal 120 can withstand in the tube 110. In some embodiments, the welded seal 120 can withstand at least about 50 kilopascals (kPa), about 100 kPa, about 250 kPa, about 500 kPa, or about 1 megapascal (MPa).

[0026] Figure 2C illustrates a sectional view of the peelable tube 100 of Figure 2A along section A-A, including inner layer 114 and outer layer 112, according to embodiments of the present disclosure.

[0027] According to some embodiments, the tube 110 is composed of one or multiple thermoplastics, including an inner layer 114 which is constructed of a thermoplastic with a lower melting point than that of the thermoplastic from which the one or more outer layers 112 of the tube 110 is / are constructed. When using a heat seal for the welded seal 120, as the welded seal 120 is formed, the heat and crimping force deforms the tube 110 and melts the inner layer 114 to itself. The inner layer 114 melts and forms an adhesive that bonds the tube 110 closed, while still maintaining laminar connection to the outer layers 112. The inner layer 114 bonds to itself when a crimping force is applied to the tube 110 and the material of the inner layer 114 is allowed to cool.

[0028] According to some embodiments, the applied heat is sufficient to melt the inner layer 114, but not the outer layer 112. 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 100 degrees C. In otherexamples 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.

[0029] In various embodiments, the outer layer 112 is made of a first thermoplastic different from a second thermoplastic from which the inner layer 114 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 100, and where (and to what extent) the welded seal 120 has been formed in the tube 100. In some examples, inner layer 114 contains a thermochromic element. When the welded seal 120 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 120 has been properly formed. The change in color state may include a visible change in hue, chroma, opacity, or combinations thereof.

[0030] Figure 2D illustrates a sectional view of the peelable tube 100 of Figure 2A along section B-B, according to embodiments of the present disclosure. Section B-B is taken across the welded seal 120, where the inner layer 114 has been fused together to form a bond.

[0031] Figures 3A-3C illustrate the peelable tube 100 with the weld 120 formed on a terminal end 310 of the tube 110. In various embodiments, the weld 120 may be initially formed on the terminal end 310 or may be formed centrally on the tube 110, in which the tube 110 is later cut or trimmed to result in a weld 120 defined on the terminal end 310 rather than defined centrally on the tube 110.

[0032] By defining the weld 120 on a terminal end 310 of the tube 110, a single lumen 160 defined by the tube 110 leads to the weld 120. In contrast, a centrally-defined weld 120 is defined such that a first lumen 160a leads to a first side of the weld 120, and a second lumen 160b leads to a second side of the weld 120 (see, Figure 1C). In various embodiments, the other end of the tube 110 from the illustrated terminal end 310 may include a centrally-defined weld 120, another terminally-defined weld 120, or may end with an opening for access to the lumen 160.

[0033] As shown in Figure 1C, when a peelable tube 100 having a terminally-defined weld 120 is installed or fabricated into a bag 330 (e.g., the medical solution bag 400 of Figures 4A-4D), the weld 120 may be positioned to help support the walls 332 of the bag 330 when filled with a liquid (or in anticipation of being filled with a liquid). Additionally, by omitting a lumen 160 insideof the bag 330, the terminally-defined weld 120 may be less susceptible to being unintentionally opened via a pressured exerted by the fluid in the bag 330 compared to peelable tube 110 that use centrally-defined welds 120 that are in communication with the fluid in the bag 330.

[0034] Figures 4A-4D show the peelable tube 100 installed with a fluid delivery system, including a medical solution bag 400, and tubing 410, according to embodiments of the present disclosure. The peelable tube 100 is connected on one end to the medical solution bag 400, as an example fluid reservoir, and the other end of the peelable tube 100 is connected to the tubing 410. The welded seal 120 on the peelable tube 100 has sufficient strength to resist the static hydraulic forces of the fluid 420 contained in the medical solution bag 400. When the peelable tube 100 is opened, the fluid 420 flows from the bag 400 through the peelable tube 100 into the tubing 410. The medical solution bag 400 is one example of a reservoir configured to hold a fluid 420, but the present disclosure contemplates other potential uses for the peelable tube 100 (e.g., automotive fluids, cleaning solutions, potable liquids, etc.).

[0035] As shown in Figure 4A, the weld 120 may be located outside of the solution bag 400, which may allow for an operator to directly interact with the weld 120 to initiate fluid transfer. As shown in Figure 4B, the weld may be located inside of the solution bag 400, which may allow for an operator to interact indirectly with the weld 120 (e.g., through the material of the solution bag 400) to initiate fluid transfer. As shown in Figure 4C, a first weld 120a and a second weld 120b may be formed outside and inside, respectively, of the solution bag 400 to provide a failsafe for fluid containment and to define some of the lumen 160 as a sequestered section 430 between the two welds 120a-b. In various embodiments, the sequestered section 430 offers a sterilized area that remains isolated from the environment between the time of manufacture of the solution bag 400 and use thereof. In some embodiments, the sequestered section 430 may include various reagents, therapeutics, dyes, or the like that are stored therein and kept separate from the fluid 420 contained in the solution bag 400 until the welds 120 are opened by an operator.

[0036] In various embodiments, such as shown in Figure 4D, a first peelable tube 100a may be provided to control access to the fluid 420 stored in the solution bag 400, while a second peelable tube 100b is disposed within the solution bag 400 with one or more welds 120c-d (one or more of which may be replaced with permanent closures or sealing means) to provide a sequestered section 440 that holds various reagents, therapeutics, dyes, or the like separately from the fluid flow path out of the solution bag 400. Accordingly, a manufacturer may design the length andinner circumference of the second peelable tube 100b to hold a predefined amount of a second substance (for an operator to later mix with the fluid 420) and control the rate of mixing thereof via the orifice size and number of orifices in the second peelable tube 110b. By using a second peelable tube 110b disposed within the solution bag 400, 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 110a has been opened.

[0037] In some embodiments, the peelable tube 100 is used in disposable therapeutic solution delivery systems, such as those used outside of medical facilities. As an example, in-home peritoneal dialysis systems use a medical solution bag 400, and tubing 410, among other components. The peelable tube 100 can be used to seal the medical solution (as the fluid 420) inside the medical solution bag 400, where the peelable tube 100 provides sufficient security from spillage during packaging and transit until the medical solution bag 400 is delivered to the end user. The end user can prepare the system for use, and by simply pinching the welded seal 120, the medical solution flows into the system, and the treatment can begin. The peelable tube 100 is preferable to alternate forms of single use valves, such as frangible caps, which generate additional unwanted waste products, require greater amounts of coordination to operate, incur greater production costs, and other disadvantages.

[0038] In certain embodiments, the peelable tube 100 provides a sterile barrier between the contents of the medical solution bag 400 and the outside environment. The welded seal 120 is configured to be airtight, watertight, and sealed sufficiently such that outside microbes and particulates cannot enter the medical solution bag 400 via the peelable tube 100, and otherwise maintains a state of sterility prior to use.

[0039] According to some embodiments, the peelable tube 100 is a single use valve on a medical solution bag 400, such as a form seal fill (FSF) bag.

[0040] According to some embodiments, the fluid 420 contained in the medical solution bag 400 may be saline solution, a therapeutic agent, blood, or serum.

[0041] In some examples, the peelable tube 100 is an integrated component of a medical solution bag 400. A method for manufacturing and operating such a device includes: filling a fluid containment apparatus, such as the medical solution bag 400 with the fluid 420 of a medical solution. The tube 110, being an integrated component of the medical solution bag 400, is heat sealed using a heated crimping device, such that a heat seal 120 is formed about a compressedcircumference of the tube 110. 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 110, and pinches the welded seal 120, disengaging the welded seal 120, and thereby allowing the medical solution to exit the medical solution bag 400 via the now-unsealed tube 110 to the device connected by the user.

[0042] The length X120 of the welded seal 120 is a functionally relevant dimension, as the strength of the welded seal 120 increases as the length X120 increases. As the length X120 of the welded seal 120 increases, so too increases the compressive force 150 required to compromise the seal 120 to open the peelable tube 100. Therefore, the length XI 20 of the welded seal 120 corresponds to both the gauge, and outer diameter DI 10, of the tube 110, and the volume of fluid the medical solution bag 400, or other connected reservoir, is configured to contain. At the same time, the length XI 20 of the welded seal 120 may be configured such that the welded seal 120 does not require excessive force to disengage.

[0043] According to some embodiments, the ratio of the length XI 20 of the welded seal 120 to the outside diameter DUO 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.

[0044] Figure 5 illustrates a flowchart of an example method 500 for providing a peelable tube 100, according to embodiments of the present disclosure. Method 500 begins at block 510, where an operator installs a section of tube 110 to be in fluid communication with an internal reservoir of a bag 400 configured to contain a fluid 420.

[0045] At block 520, the operator applies a crimping force to a circumference of the section of tube 110, such that the tube 110 deforms and the inner layer 114 of the section of tube 100 is pressed together.

[0046] At block, 530 the operator applies heat to a crimped circumference of the section of tube 110, such that a material from which the tube 100 is made deforms, and heat welds the crimped circumference of the section of tube together, forming a welded seal 120 that closes fluid communication between a first end 102 of the tube 110 installed to the internal reservoir of the bag 300 and the second end 104, open to an environment.

[0047] In various embodiments, block 520 and block 530 are performed substantially simultaneously. In some embodiments, block 530 is performed during block 520, and a single heating and crimping device is used, but as the device applies the heat after crimping the tube 100,and is un-crimped after the tube 100 altering disengaging the heat and allowing the tube 100 time to cool while remaining in a crimped state, thereby allowing the inner layer 114 to re-solidify and form the welded seal 120.

[0048] In addition or alternatively to crimping and heating the tube 100 per block 520 and block 530, in various embodiments, other plastic welding techniques (e.g., ultrasonic welding, vibration welding, microwave welding, infrared welding, laser welding, solvent welding, etc.) may be employed. Additionally, various pre-weld treatments may be applied to the surfaces of the tube 100 prior to or after welding, as will be familiar to those skilled in the relevant art.

[0049] At block 540, the operator disengages the welded seal 120 to permit the fluid 420 to flow through the peelable tube 100 from the internal reservoir of the medical solution bag 400, and be used for varying purposes. As compressive forces 150 are applied perpendicularly to the extremities of the welded seal 120, the welded seal 120 is disengaged by an inner layer “peeling” apart from itself, thereby allowing the peelable tube 100 to transition to an open configuration, where fluid communication through the peelable tube 100 is facilitated. At a time when the fluid 420 has been exhausted from the medical solution bag 400, method 500 may then conclude, and the operator may dispose of the system (including the tube 110).

[0050] In addition to the embodiments described herein, many examples of specific combinations are within the scope of the disclosure, some of which are detailed below:

[0051] Clause 1 : A port, comprising: a tube having a first end and a second end, opposite to the first end, between which a fluid passage 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.

[0052] Clause 2: The port of any of clauses 1 and 3-7, wherein the welded seal is defined such that an inner layer of the tube is compressed together, and forms a thermal bond around an inner diameter of the tube.

[0053] Clause 3: The port of any of clauses 1-2 and 4-7, wherein the welded seal is configured to withstand at least about 100 kilopascals (kPa), at least 250 kPa, at least 500 kPa, or at least 1 megapascal (MPa) of fluid pressure within the tube.

[0054] Clause 4: The port of any of clauses 1-3 and 5-7, wherein a ratio of a magnitude of a minimum compressive force required to change the port to the open configuration to an internal fluid pressure rating per square centimeter of the welded seal is about 1 :25, about 1 :50, about 1 : 100, or about 1 :250.

[0055] Clause 5: The port of any of clauses 1-4 and 6-7, wherein the tube contains an inner lining configured to bond with heat, such that the welded seal is defined by a crimping action applied to the tube with heat.

[0056] Clause 6: The port of any of clauses 1-5 and 7, wherein the tube or the inner lining contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state.

[0057] Clause 7: The port of any of clauses 1-6, wherein a ratio of a length of the welded seal, along a longitudinal axis of the tube, to a length of an outer diameter of the tube is about 2:1, about 3:2, about 1 :1, about 2:3, or about 1 :2.

[0058] Clause 8: A method, comprising: installing a section of tube to be in fluid communication with an internal reservoir of a bag configured to contain a fluid; applying a crimping force to a circumference of the section of tube, such that an inner layer of the section of tube is pressed together; and applying heat to a crimped circumference of the section of tube, such that a material from which the tube is made deforms and welds the crimped circumference of the section of tube together, forming a welded seal that closes fluid communication between a first end of the section of tube installed to the internal reservoir and an opposing end of the section of tube, open to an environment.

[0059] Clause 9: The method of any of clauses 8 and 10-13, further comprising applying a pinching force to extremities of the heat weld, in a direction perpendicular to the direction in which the welded seal was made, thereby disengaging the welded seal, and reestablishing fluid communication between the first end of the section of tube and the opposing end of the section of tube.

[0060] Clause 10: The method of any of clauses 8-9 and 11-13, wherein a ratio of a magnitude of a minimum compressive force required to disengage the welded seal to an internal fluid pressure rating per square centimeter of the welded seal is about 1:25, about 1 :50, about 1 : 100, or about 1 :250.

[0061] Clause 11 : The method of any of clauses 8-10 and 12-13, wherein the welded seal is configured to withstand at least about 100 kilopascals (kPa), at least 250 kPa, at least 500 kPa, or at least 1 megapascal (MPa) of fluid pressure within the section of tube.

[0062] Clause 12: The method of any of clauses 8-11 and 13, wherein the section of tube contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state of the thermochromic element.

[0063] Clause 13: The method of any of clauses 8-12, wherein a ratio of a length of the welded seal, along a longitudinal axis of the section of tube, to a length of an outer diameter of the section of tube is about 2: 1, about 3:2, about 1 : 1, about 2:3, or about 1 :2.

[0064] Clause 14: A fluid containment apparatus, comprising: a reservoir containing a fluid; and a section of tube, connected to the reservoir, defining a crimped portion which prevents the fluid from exiting the reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

[0065] Clause 15: The apparatus of any of clauses 14 and 16-20, wherein the fluid is one of a saline solution, a therapeutic agent, blood, or a serum.

[0066] Clause 16: The apparatus of any of clauses 14-15 and 17-20, wherein the crimped portion comprises a welded seal.

[0067] Clause 17: The apparatus of any of clauses 14-16 and 18-20, wherein a length of the welded seal, along a longitudinal axis of the tube, positively corresponds to a volume of fluid that the reservoir is configured to hold.

[0068] Clause 18: The apparatus of any of clauses 14-17 and 19-20, wherein a length of the welded seal, along a longitudinal axis of the tube, positively corresponds to an outer diameter of the section of tube in which the welded seal is made.

[0069] Clause 19: The apparatus of any of clauses 14-18 and 20, wherein the welded seal is configured to be watertight, airtight, and maintain a state of sterility within the reservoir while the crimped portion is closed.

[0070] Clause 20: The apparatus of any of clauses 14-19, wherein the section of tube contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state of the thermochromic element.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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”.

[0075] 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.

[0076] 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 underlyingprinciples 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.

[0077] 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

CLAIMSThe invention is claimed as follows:

1. A port, comprising: a tube having a first end and a second end, opposite to the first end, between which a fluid passage 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.

2. The port of claim 1, wherein the welded seal is defined such that an inner layer of the tube is compressed together, and forms a thermal bond around an inner diameter of the tube.

3. The port of claim 1, wherein the welded seal is defined as a terminally-defined weld on a terminal end of the tube of one of the first end or the second end.

4. The port of claim 1, wherein the welded seal is defined between the first end and the second end as a centrally-defined weld on the tube.

5. The port of claim 1, wherein the tube contains an inner lining configured to bond with heat, such that the welded seal is defined by a crimping action applied to the tube with heat.

6. The port of claim 5, wherein the tube or inner lining contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state.

7. The port of claim 1, wherein a ratio of a length of the welded seal, along a longitudinal axis of the tube, to a length of an outer diameter of the tube is about 2: 1, about 3 :2, about 1 : 1, about 2:3, or about 1 :2.

8. A method, comprising: installing a section of tube to be in fluid communication with an internal reservoir of a bag configured to contain a fluid; applying a crimping force to a circumference of the section of tube, such that an inner layer of the section of tube is pressed together; and applying heat to a crimped circumference of the section of tube, such that a material from which the tube is made deforms and welds the crimped circumference of the section of tube together, forming a welded seal that closes fluid communication between a first end of the section of tube installed to the internal reservoir and an opposing end of the section of tube, open to an environment.

9. The method of claim 8, further comprising applying a pinching force to extremities of the heat weld, in a direction perpendicular to the direction in which the welded seal was made, thereby disengaging the welded seal, and reestablishing fluid communication between the first end of the section of tube and the opposing end of the section of tube.

10. The method of claim 9, wherein a ratio of a magnitude of a minimum compressive force required to disengage the welded seal to an internal fluid pressure rating per square centimeter of the welded seal is about 1:25, about 1 :50, about 1: 100, or about 1 :250.

11. The method of claim 8, wherein the welded seal is defined on a terminal end of the tube that is disposed within the internal reservoir.

12. The method of claim 8, wherein the section of tube contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state of the thermochromic element.

13. The method of claim 8, wherein a ratio of a length of the welded seal, along a longitudinal axis of the section of tube, to a length of an outer diameter of the section of tube is about 2: 1, about 3:2, about 1 : 1, about 2:3, or about 1 :2.

14. A fluid containment apparatus, comprising: a reservoir containing a fluid; and a section of tube, connected to the reservoir, defining a crimped portion which prevents the fluid from exiting the reservoir through the section of tube, wherein the crimped portion is configured to open and permit the fluid to exit the reservoir through the section of tube in response to receiving a compressive force in a direction perpendicular to a longitudinal axis of the tube.

15. The fluid containment apparatus of claim 14, wherein the fluid is one of a saline solution, a therapeutic agent, blood, or a serum.

16. The fluid containment apparatus of claim 14, wherein the crimped portion comprises a welded seal defined on a terminal end of the section of tube that is disposed within the reservoir.

17. The fluid containment apparatus of claim 16, wherein the section of tube contains a thermochromic element, such that when the welded seal is formed, the welded seal is indicated by a change in color state of the thermochromic element.

18. The fluid containment apparatus of claim 14, wherein the crimped portion comprises a welded seal centrally defined on the section of tube, and that is disposed outside of the reservoir.

19. The fluid containment apparatus of claim 14, wherein the crimped portion comprises a first welded seal on a terminal end of the section of tube that is disposed within the reservoir and a second welded seal centrally defined on the section of tube that is disposed outside of the reservoir, wherein a lumen of the tube disposed between the first welded seal and the second welded seal defines a sequestered section.

20. The fluid containment apparatus of claim 19, wherein the sequestered section contains a second fluid, different than the fluid contained in the reservoir.21 . The fluid containment apparatus of claim 14, further comprising: a second section of tube, disposed within the reservoir, including a welded seal on at least one end thereof and defining a sequestered section between ends of the second section of tube, the welded seal being configured to open and permit a second fluid contained in the sequestered section to mix with the fluid contained in the reservoir in response to receiving a second compressive force in a second direction perpendicular to a longitudinal axis of the second section of tube.

Images