Fluid line connector devices methods and systems

Information

  • Patent Grant
  • 11504517
  • Patent Number
    11,504,517
  • Date Filed
    Friday, December 9, 2016
    7 years ago
  • Date Issued
    Tuesday, November 22, 2022
    a year ago
  • Inventors
  • Original Assignees
  • Examiners
    • Eisenberg; Rebecca E
    • Goldberg-Richmeier; Anna E
    Agents
    • Potomac Law Group, PLLC
    • Dolina; George S.
Abstract
A frangible connector has a first side that forms a female luer when a second side is fractured at a predefined break line. The second side may be connected to a fluid circuit, for example, a source of medical treatment fluid such as dialysate.
Description
BACKGROUND

The present invention relates to medical to fluid management systems and in particular embodiments, to fluid supply for renal replacement therapy. Renal failure is attended by physiological problems including water balance, minerals and the excretion metabolic waste, and others. Toxins such as urea, creatinine, and uric acid may accumulate in the blood and tissue compartments of patients. Dialysis treatments, including hemodialysis and dialysis removed excess water and toxins so as to replace the function of the kidneys. Dialysis may require a large volume of dialysate, for example about 50-120 liters may be required and consumed during one treatment session.


Dialysis helps restore the composition of the body's fluid environment to a more normal configuration. Dialysate composition are thus set to approximate the normal values in the body such that diffusion along favorable concentration gradients causes the concentrations of solutes that are initially abnormal are corrected. Certain electrolytes can be set at a nonphysiologic levels to achieve a more rapid correction. The dialysate can be individually adjusted to meet the specific needs of patients.


Fluids are used for priming a blood circuit of an extracorporeal fluid circuit and for treatment, for example as dialysate is consumed in dialysis treatments. There is a need to make connections and interchange connections in extracorporeal blood systems while maintaining sterility.


SUMMARY

A frangible connector has a first side that forms a female luer when a second side is fractured at a predefined break line. The second side may be connected to a fluid circuit, for example, a source of medical treatment fluid such as dialysate. By fracturing the frangible connector, the first side can be connected immediately to a different fluid circuit without undoing a connector. Further, the second side is not usable as a connector thereby preventing reconnection to a previously used fluid circuit. In embodiments, the second side is connected to an element that seals the fluid circuit to which it is attached. In embodiments, this seal is provided by a non-reopenable tubing clamp. In other embodiments, it can be provided with a cap. In still further embodiments, a self-sealing device such as a check valve may be provided to provide the seal. The second element with the non-reopenable tubing clamp may be provided as part of a fluid circuit such as a fluid circuit of a dialysis treatment system.


Objects and advantages of embodiments of the disclosed subject matter will become apparent from the following description when considered in conjunction with the accompanying drawings.





BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will hereinafter be described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements. The accompanying drawings have not necessarily been drawn to scale. Where applicable, some features may not be illustrated to assist in the description of underlying features.



FIGS. 1A, 1B, and 1C show embodiments of a frangible connector with optional elements and showing the frangible connector prior to, and after, fracturing, according to embodiments of the disclosed subject matter.



FIGS. 2-6 show the connector of FIGS. 1A, 1B, and 1C in a blood treatment implementation while illustrating a method of use, according to embodiments of the disclosed subject matter.



FIGS. 7 and 8 are perspective views of connectors according to the embodiments showing specific features that may be used with any embodiment, including features that help users distinguish the connector parts after fracturing.



FIG. 9 shows a frangible connection with two sides in which both sides form independent connectors.



FIG. 10 shows an oblique view of a separated connector according to the embodiment of FIGS. 7 and 8.



FIGS. 11A and 11B show an embodiment to illustrate devices and methods of a frangible connector device that forms two connectors when fractured.



FIG. 12 shows how in the embodiment of FIGS. 11A and 11B and others, the tapered concave conical recess of the female luer can be formed with a single pin having to define a positive draft with another pin opposite, whereby the connector device can be molded in a single operation with two pins and two mold halves.





DETAILED DESCRIPTION

Referring to FIGS. 1A, 1B, and 1C, a frangible connector 100 has a first side 118 that forms a connector 116 when a frangible portion 105 is fractured separating the first side 118 from a second side 120 of the frangible connector 100. In the embodiment, the formed connector 116 is a female luer connector but could be any type of connector including a male luer connector. The frangible connector 100 second side 120 is left behind when the frangible portion 105 is fractured, thereby preventing further attachment to the second side 120. In embodiments, the second side 120 may form another connector of any type, for example a female luer formed by the second side 120 of the embodiment shown in FIG. 9. The frangible connector 100 may be connected at the first end to a tube 106, for example by solvent or thermal bonding to a recess 108 thereof. The tube 106 may be connected to a fluid circuit. The frangible connector 100 may be connected at the second end 120 to a further tube 110, for example by solvent or thermal bonding in a recess 112 thereof. The connector 116 may have external threads 104 which engage threads of a locking collar 135 of a complementary connector such as a male locking luer as shown at 131. The second side 120 of the frangible connector 100 can also be connected via tube 110 to a further connector 132 such as a female luer connector as shown at 132. The tube 106 may be permanently bonded to a fluid circuit 140 in further embodiments. For example, the assembly shown in FIG. 1B (before being fractured, as shown in FIGS. 1B and 1C) may be capped and sealed to protect the internal space of a fluid circuit.


The tube 110 may be further connected to a connector 132 such as a female luer connector. The connector 132 may be capped to seal the pre-connected fluid circuit 140 if present. The fluid circuit and frangible connector 100 components together with connector 132 and cap 148 may form a sealed deliverable element for a treatment system. A non-reopenable tubing clamp 130 may also be provided pre-attached to tube 110 to allow the frangible connector 100 second side 120 to be sealed and remain connected by the connector 132 to a further fluid handing device (not shown here) to seal the latter until the connector 132 is removed.


Referring now to FIG. 2, the frangible connector 100 is attached by a tube 138 (or other means) to form part of a sealed fluid circuit 80 assembly that includes a fluid circuit 140 such as a cartridge, a vessel, a network of tubing or other type of fluid management circuit for a treatment system, such as a dialysis system. The sealed fluid circuit assembly 80 has a connector 132 sealed by the cap 148 as described above. A main fluid source 137 may have a connector 139, in the embodiment, a male locking luer type connector. The latter is sealed by a cap 147. The main fluid source 137 may be an online or batch dialysate supply such as in a clinic or a home. The connector 139 may be configured to be connectable to connector 132 to supply fluid to the fluid circuit 140. In case of an interruption in the supply of fluid from the main fluid source 137, a backup fluid source 136 may also be provided. The backup fluid source 136 may have a connector 131 (a male locking luer type, for example) sealed by a cap 147. The sealed fluid circuit assembly 80 may also include a non-reopenable tubing clamp 130 as discussed above. The latter may be provided in an open position such that the tube 110 is open and uncompressed prior to use.



FIGS. 3-6 show stages of use of the components described with reference to the foregoing figures. In FIG. 3, connector 132 and connector 139 are interconnected after removing the respective sealing caps 148 and 147. The main fluid source 137 supplies fluid to the fluid circuit 140 to support a treatment. For example, the main fluid source 137 may flow dialysate continuously to the fluid circuit 140 to support a dialysis treatment. If, during a treatment, the main fluid source 137 become inoperative or otherwise unusable or disfavored as a source of fluid, in order to complete the treatment, an operator may desire to switch to the backup fluid source 136. To do so, in an embodiment, the operator may close the non-reopenable tubing clamp 130 thereby sealing the tube 110 as shown in FIG. 4. Next, as shown in FIG. 5, the frangible connector 100 is fractured at the frangible portion 105. And the connector 116 formed of first side 118 of frangible connector 100 is connected to the connector 131 of the backup fluid source 136 as shown in FIG. 6. The main fluid source 137 remains sealed until the frangible connector 100 second side 120 is removed by disconnecting the connector 139.


Referring to FIGS. 7 and 8, a frangible connector 100 has a first side 118 and second side 120 connected by a frangible portion 105. External threads 104 on the first side 118 form a female luer-type connector 116 when the first 118 and second 120 sides are broken apart at the frangible portion 105. In the present embodiment, distinctive features 125 and 160 help to ensure the connector (first part 118) resulting from separation is easily distinguished from the non-connector (second part 120). In the example shown, a scalloped surface cylindrical surface 125 is formed which can be identified by touch. Wings 160 protrude from the connector which aids in locking the external threads 104 in a locking collar 135 of a mating male luer connector 131. FIG. 10 shows the connector 116 formed from the first part 118 of the FIGS. 7 and 8 embodiments.


Referring to FIG. 9, as indicated above, a frangible connector 100′ can formed such that it splits into two independent connectors 116A and 116B formed by first part 118′ and second part 120′. As in the embodiment of FIG. 1A and elsewhere herein, the first and second parts 118′ and 120′ may be separated by breaking along a frangible portion 105. FIGS. 11A and 11B show an embodiment to illustrate devices and methods of a frangible connector device that forms two connectors when fractured. Referring to FIGS. 11A and 11B, a first fluid device 202 may be a container, a fluid source, a drain, or other supply, conveyance, processing, or consuming device of any type. A second fluid device 204 may be a container, a fluid source, a drain, or other supply, conveyance, processing, or consuming device of any type. A third fluid device 206 may be a container, a fluid source, a drain, or other supply, conveyance, processing, or consuming device of any type. A fourth fluid device 208 may be a container, a fluid source, a drain, or other supply, conveyance, processing, or consuming device of any type. The first fluid device 202 is connected to third fluid device 206 by fluid lines 210 and a frangible connector 221 that can be broken into independent connector 220A and independent connector 22B. The independent connector 220A and independent connector 22B are both illustrated as female connectors but may instead be a combination of male and female connectors. As in the disclosed embodiments, the independent connector 220A and independent connector 220B are joined by a frangible portion to form a continuous lumen in the frangible connector 221 until the frangible portion is broken. Any or all the lines 210 may carry reopenable or non-reopenable clamps 212. The first fluid device 202 may be disconnected from the third fluid device 206 be closing line clamps, breaking the frangible portion of the frangible connector 221. The first fluid device 202 may then be connected to the second fluid device 204 by connecting the independent connector 220A to a connector 222 of the second fluid device 2014 as shown in FIG. 11. In a similar fashion, the independent connector 220B may be connected to a connector 224 of the fourth fluid device 208. It will be observed that a variety of methods may be implemented by combining multiple instances frangible connectors according to the embodiments to make and break connections between fluid devices.



FIG. 12 shows how in the connector device 100 embodiment of FIGS. 11A and 11B and others, the tapered concave conical recess of the female luer can be formed with a single pin having to define a positive draft with another pin opposite, whereby the connector device can be molded in a single operation with two pins and two mold halves. The shaded volume occupies the second part 120 and a portion of the first part 118 that forms the connector 116. This allows a pin in the shaded volume to be released during molding because the entire shaded volume has a neutral or positive draft. Another pin can be used to fill the unshaded recess. This characteristic may apply to any of the embodiments. Alternatively the parts may be formed by 3D printing and have internal overhangs or other negative draft features.


In all the embodiments, frangible connectors are illustrated in which a continuous lumen allows fluid to flow between two attached connectors or a connector and a non-connector. A frangible portion is provided so that when it is broken the one or two connectors can be separated and attached to one or more other connectors. The frangible portion is formed so as to create a clean and predictable edge of the separated one or two connectors. The connectors and/or non-connectors can have distinctive feature that allow a user to tell them apart easily without looking at them or at least to confirm by touch. Clamps can be reopenable or non-reopenable to achieve release stasis of fluid in connected fluid circuits. Any of the embodiments may be sterile sealed fluid devices including connectors herein. Any of the embodiments may be used for medical fluid handling. Any of the embodiments may be delivered in a sterile package as part of a medical device.


According to first embodiments, the disclosed subject matter includes a connector device that includes an inline fluid channel element. The inline fluid channel element has first and second end portions adapted for bonding to tubing segments. The inline fluid channel element has a middle portion defining a connector attached to the second end portion through a frangible portion that, when fractured, renders the connector operable to connect with a predefined mating connector.


Variations of the first embodiments may be provided to form additional first embodiments in which the connector is of a female locking luer type. Variations of the first embodiments may be provided to form additional first embodiments in which the connector has thread portions. Variations of the first embodiments may be provided to form additional first embodiments in which the connector has an opening shaped to receive the mating connector, a mouth of the opening coinciding with a circular channel defining the frangible portion. Variations of the first embodiments may be provided to form additional first embodiments in which the inline fluid channel is generally cylindrical in shape. Variations of the first embodiments may be provided to form additional first embodiments in which the connector device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the first embodiments may be provided to form additional first embodiments in which the connector device further includes a releasably capped connector connected to the second end portion. Variations of the first embodiments may be provided to form additional first embodiments in which the releasably capped connector is of a locking luer type. Variations of the first embodiments may be provided to form additional first embodiments in which the second end portion is connected to a tubing segment and with a pre-installed non-reopenable clamp. Variations of the first embodiments may be provided to form additional first embodiments in which the connector device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the first embodiments may be provided to form additional first embodiments in which the connector device further includes a releasably capped connector connected to the second end portion. Variations of the first embodiments may be provided to form additional first embodiments in which the releasably capped connector is of a locking luer type.


According to second embodiments, the disclosed subject matter includes a method of supplying fluid for a renal replacement therapy. The method includes connecting fluid circuit of a renal replacement therapy device to a first source of fluid by a fluid channel element. The method includes supplying fluid from the source to begin a therapeutic treatment. The method includes halting the supply of fluid from the source prior to completing the treatment. The method includes fracturing the fluid channel element to form a connector. The method includes connecting the connector to a second source of fluid and continuing the treatment.


Variations of the second embodiments may be provided to form additional second embodiments in which the method includes, after halting said supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element. Variations of the second embodiments may be provided to form additional second embodiments in which the method includes, after halting said supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element using a non-reopenable clamp. Variations of the second embodiments may be provided to form additional second embodiments in which the method includes, after halting said supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element using a non-reopenable clamp and leaving a portion of the fluid channel element on a connector of the first fluid source to keep it sealed from the external environment. Variations of the second embodiments may be provided to form additional second embodiments in which the fracturing is effective to define and render accessible the mouth of an opening of the connector. Variations of the second embodiments may be provided to form additional second embodiments in which the connector is of female luer type connector. Variations of the second embodiments may be provided to form additional second embodiments in which the fluid channel element is a generally cylindrical plastic part. Variations of the second embodiments may be provided to form additional second embodiments in which the fracturing includes fracturing at a circular score line on the generally cylindrical plastic part.


According to third embodiments, the disclosed subject matter includes a connector device that includes an inline fluid channel element. The inline fluid channel element has first and second end portions adapted for bonding to tubing segments. The inline fluid channel element has a middle portion defining a connector attached to the second end portion through a frangible portion that, when fractured, renders the connector to remain attached to the first portion and operable to connect with a predefined mating connector and also renders the second portion unusable as a connector thereby preventing connection to an external fluid circuit.


Variations of the third embodiments may be provided to form additional third embodiments in which the connector is of a female locking luer type. Variations of the third embodiments may be provided to form additional third embodiments in which the connector has thread portions. Variations of the third embodiments may be provided to form additional third embodiments in which the connector has an opening shaped to receive the mating connector, a mouth of the opening coinciding with a circular channel defining the frangible portion. Variations of the third embodiments may be provided to form additional third embodiments in which the inline fluid channel is generally cylindrical in shape. Variations of the third embodiments may be provided to form additional third embodiments in which the connect device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the third embodiments may be provided to form additional third embodiments in which the connect device further includes a releasably capped connector connected to the second end portion. Variations of the third embodiments may be provided to form additional third embodiments in which the releasably capped connector is of a locking luer type. Variations of the third embodiments may be provided to form additional third embodiments in which the second end portion is connected to a tubing segment and with a pre-installed non-reopenable clamp. Variations of the third embodiments may be provided to form additional third embodiments in which the connect device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the third embodiments may be provided to form additional third embodiments in which the connect device further includes a releasably capped connector connected to the second end portion. Variations of the third embodiments may be provided to form additional third embodiments in which the releasably capped connector is of a locking luer type.


According to fourth embodiments, the disclosed subject matter includes a connector device that includes an inline fluid channel element. The inline fluid channel element has first and second end portions adapted for bonding to tubing segments. The inline fluid channel element has a middle portion defining a connector attached to the second end portion through a frangible portion that, when fractured, renders the connector operable to connect with a predefined mating connector. Variations of the third embodiments may be provided to form additional third embodiments in which the connector is of a female locking luer type.


Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector has thread portions. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector has an opening shaped to receive the mating connector, a mouth of the opening coinciding with a circular channel defining the frangible portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the inline fluid channel is generally cylindrical in shape. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector device further includes a releasably capped connector connected to the second end portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the releasably capped connector is of a locking luer type. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the second end portion is connected to a tubing segment with a flow sealing element that prevents flow through the second end portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector device further includes a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the connector device further includes a releasably capped connector connected to the second end portion. Variations of the fourth embodiments may be provided to form additional fourth embodiments in which the releasably capped connector is of a locking luer type.


According to fifth embodiments, the disclosed subject matter includes a method of supplying fluid for a renal replacement therapy. The method includes connecting fluid circuit of a renal replacement therapy device to a first source of fluid by a fluid channel element. The method includes supplying fluid from the source. The method includes halting the supply of fluid from the source after a predetermined time. The method includes fracturing the fluid channel element to form a connector. The method includes connecting the connector to a second source of fluid and continuing the supplying.


Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the method further includes, after halting said supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the method further includes, after halting said supply of fluid, sealing a tube that connects the first source of fluid to the fluid channel element to prevent flow therethrough. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the method further includes, after halting said supply of fluid, sealing off flow through a tube that connects the first source of fluid to the fluid channel element and leaving a portion of the fluid channel element on a connector of the first fluid source to keep it sealed from the external environment. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the fracturing is effective to define and render accessible the mouth of an opening of the connector. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the connector is of female luer type connector. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the fluid channel element is a generally cylindrical plastic part. Variations of the fifth embodiments may be provided to form additional fifth embodiments in which the fracturing includes fracturing at a circular score line on the generally cylindrical plastic part.


According to embodiments, the disclosed subject matter includes a connector device. An inline fluid channel element has first and second end portions adapted for bonding to tubing segments. The inline fluid channel element connector has a middle portion defining a connector attached to the second end portion through a frangible portion that when fractured renders the connector operable to connect with a predefined mating connector.


Variants of the foregoing may be such that the connector is of a female locking luer type. Variants of the foregoing may be such that the connector has thread portions. Variants of the foregoing may be such that the connector has an opening shaped to receive the mating connector, a mouth of the opening coinciding with a circular channel defining the frangible portion. Variants of the foregoing may be such that the inline fluid channel is generally cylindrical in shape. Variants of the foregoing may include a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variants of the foregoing may include a releasably capped connector connected to the second end portion. Variants of the foregoing may be such that the releasably capped connector is of a locking luer type. Variants of the foregoing may be such that the second end portion is connected to a tubing segment and with a pre-installed non-reopenable clamp. Variants of the foregoing may include a fluid circuit for a renal replacement therapy device permanently bonded to the first end portion. Variants of the foregoing may include a releasably capped connector connected to the second end portion. Variants of the foregoing may be such that the releasably capped connector is of a locking luer type.


According to embodiments, the disclosed subject matter includes a method of supplying fluid for a renal replacement therapy. The method includes connecting fluid circuit of a renal replacement therapy device to a first source of fluid by a fluid channel element. The method includes supplying fluid from the source to begin a therapeutic treatment. The method includes halting the supply of fluid from the source prior to completing the treatment. The method includes fracturing the fluid channel element to form a connector. The method includes connecting the connector to a second source of fluid and continuing the treatment.


Variants of the foregoing may include after halting the supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element. Variants of the foregoing may include, after halting the supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element using a non-reopenable clamp. Variants of the foregoing may include, after halting the supply of fluid, clamping a tube that connects the first source of fluid to the fluid channel element using a non-reopenable clamp and leaving a portion of the fluid channel element on a connector of the first fluid source to keep it sealed from the external environment. Variants of the foregoing may be such that the fracturing is effective to define and render accessible the mouth of an opening of the connector. Variants of the foregoing may be such that the connector is of female luer type connector. Variants of the foregoing may be such that the fluid channel element is a generally cylindrical plastic part. Variants of the foregoing may be such that the fracturing includes fracturing at a circular score line on the generally cylindrical plastic part.


According to sixth embodiments, the disclosed subject matter includes a connector device. A fluid channel element is connected at a first end to a first fluid device and at a second end to a second fluid device permitting fluid to flow between the first and second fluid devices. The first and second fluid devices each include any, or a combination of, a fluid circuit, a fluid cartridge, a fluid consumer, a fluid supply, a sterile sealed cap, a drain, a tubing extension, a fluid conveyance, or a fluid store. The fluid channel element is generally elongate and having first and second parts, each with one of the first and second ends, that are integral and joined by a frangible portion that forms a smooth edge when fractured to separate the first and second parts. At least one of the first and second parts is shaped such that it is rendered a connector connectable by sealing and locking to a predefined connector.


In variants thereof, the sixth embodiments include some in which the first and second ends are bonded, respectively, to the first and second fluid devices. In variants thereof, the sixth embodiments include some in which the at least one of the first and second parts is the first part. In variants thereof, the sixth embodiments include some in which the first part has extensions protruding therefrom and the second part does not. In variants thereof, the sixth embodiments include some in which the second part has a textured surface that is different from the surface of the first part. In variants thereof, the sixth embodiments include some in which the first and second parts have different surface textures so that they can be discriminated tactilely by a user. In variants thereof, the sixth embodiments include some in which the at least one of the first and second parts is both the first and second part.


According to the seventh embodiments, the disclosed subject matter includes a connector device with a fluid channel element that has an internal lumen to permit fluid to flow between first and second ends of the element. The fluid channel element is generally elongate and having first and second parts, each terminating at a respective one of first and second ends, the parts is integral and joined by a frangible portion that forms a smooth edge when fractured to separate the first and second parts. At least one of the first and second parts is shaped such that it is rendered a connector connectable by sealing and locking to a predefined connector.


In variants thereof, the seventh embodiments include some in which the first and second ends are bonded, respectively, to the first and second fluid devices. In variants thereof, the seventh embodiments include some in which the at least one of the first and second parts is the first part. In variants thereof, the seventh embodiments include some in which the first part has extensions protruding therefrom and the second part does not. In variants thereof, the seventh embodiments include some in which the second part has a textured surface that is different from the surface of the first part. In variants thereof, the seventh embodiments include some in which the first and second parts have different surface textures so that they can be discriminated tactilely by a user. In variants thereof, the seventh embodiments include some in which the at least one of the first and second parts is both the first and second part.


Features of the disclosed embodiments may be combined, rearranged, omitted, etc., within the scope of the invention to produce additional embodiments. Furthermore, certain features may sometimes be used to advantage without a corresponding use of other features.


It is, thus, apparent that there is provided, in accordance with the present disclosure, dialysate methods, devices, and systems. Many alternatives, modifications, and variations are enabled by the present disclosure. While specific embodiments have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles. Accordingly, Applicants intend to embrace all such alternatives, modifications, equivalents, and variations that are within the spirit and scope of the present invention.

Claims
  • 1. A method of supplying a fluid for a renal replacement therapy, comprising: providing a fluid circuit that is fluidly connected by a first tube to a fluid channel element that has a first end and an opposite second end, the first end connected to the first tube and the second end connected to a second tube that extends to a first connector closed with a cap;removing the cap from the first connector;connecting the first connector to a luer-type connector on a first source of the fluid to create a fluid connection from the first source through the fluid channel element to the fluid circuit;supplying the fluid from the first source of the fluid to begin a therapeutic treatment, the supplying including flowing the fluid through the fluid channel element in a flow direction from the second end to the first end;halting the supplying of the fluid from the first source prior to completing the therapeutic treatment;fracturing the fluid channel element between the first end and the second end to form a second connector attached to the first end of the fluid channel element and to physically separate the second end from the first end;connecting the second connector to a luer-type connector on a second source of the fluid;flowing the fluid from the second source through the second connector in said flow direction; andcontinuing the therapeutic treatment with the fluid from the second source, whereinthe first connector and the second connector are physically configured to mate with a same luer-type connector.
  • 2. The method of claim 1, further comprising, after halting said supplying of the fluid, clamping a tube that connects the first source of the fluid to the fluid channel element.
  • 3. The method of claim 1, further comprising, after halting said supplying of the fluid, clamping a tube that connects the first source of the fluid to the fluid channel element using a non-reopenable clamp.
  • 4. The method of claim 1, further comprising, after halting said supplying of the fluid, clamping a tube that connects the first source of the fluid to the fluid channel element using a non-reopenable clamp and leaving the second end of the fluid channel element connected by the first connector to the first source of the fluid to keep the first source sealed from an external environment.
  • 5. The method of claim 1, wherein the fracturing is effective to define and render accessible a mouth of an opening of the second connector.
  • 6. The method of claim 5, wherein the second connector is female luer type connector.
  • 7. The method of claim 1, wherein the fluid channel element is a generally cylindrical plastic part.
  • 8. The method of claim 7, wherein the fracturing includes fracturing at a circular score line on the generally cylindrical plastic part.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national stage filing under 35 U.S.C. § 371 of International Application No. PCT/US2016/065894 filed Dec. 9, 2016, which claims the benefit of U.S. Provisional Application No. 62/266,553 filed Dec. 11, 2015, all of which are hereby incorporated by reference in their entireties.

PCT Information
Filing Document Filing Date Country Kind
PCT/US2016/065894 12/9/2016 WO
Publishing Document Publishing Date Country Kind
WO2017/100621 6/15/2017 WO A
US Referenced Citations (225)
Number Name Date Kind
4121585 Becker Oct 1978 A
4230109 Geiss Oct 1980 A
4396382 Goldhaber Aug 1983 A
4439188 Dennehey et al. Mar 1984 A
4512764 Wunsch Apr 1985 A
4585435 Vaillancourt Apr 1986 A
4585436 Davis et al. Apr 1986 A
4617012 Vaillancourt Oct 1986 A
4617161 Rollins et al. Oct 1986 A
4639019 Mittleman Jan 1987 A
4724900 Baurmeister et al. Feb 1988 A
4745950 Mathieu May 1988 A
4826486 Palsrok et al. May 1989 A
4834706 Beck et al. May 1989 A
4950255 Brown et al. Aug 1990 A
4997577 Stewart Mar 1991 A
5004535 Bosko et al. Apr 1991 A
5061365 Utterberg Oct 1991 A
5139483 Ryan Aug 1992 A
5163922 McElveen et al. Nov 1992 A
5201725 Kling Apr 1993 A
5221267 Folden Jun 1993 A
5242425 White et al. Sep 1993 A
5259843 Watanabe Nov 1993 A
5275724 Bucchianeri et al. Jan 1994 A
5279605 Karrasch et al. Jan 1994 A
5292308 Ryan Mar 1994 A
5303751 Slater et al. Apr 1994 A
5336173 Folden Aug 1994 A
5350201 Bynum Sep 1994 A
5372392 Dunn et al. Dec 1994 A
5431496 Balteau et al. Jul 1995 A
5437624 Langley Aug 1995 A
5484397 Twardowski Jan 1996 A
5584813 Livingston et al. Dec 1996 A
5690614 Carr et al. Nov 1997 A
5762789 Reyes et al. Jun 1998 A
5783072 Kenley et al. Jul 1998 A
5792425 Clark et al. Aug 1998 A
5836933 Buttitta et al. Nov 1998 A
5843309 Mancil Dec 1998 A
5871500 Jepson et al. Feb 1999 A
5938622 Chen Aug 1999 A
5957894 Kerwin et al. Sep 1999 A
5965086 Rose et al. Oct 1999 A
5988700 Prichard Nov 1999 A
6003556 Brugger et al. Dec 1999 A
6004311 Heilmann et al. Dec 1999 A
6050285 Goncze et al. Apr 2000 A
6056015 Lewis May 2000 A
6068770 Niermeyer et al. May 2000 A
6120490 Neftel Sep 2000 A
6142938 Satherley Nov 2000 A
6146354 Beil Nov 2000 A
6171484 Schnell et al. Jan 2001 B1
6315707 Smith et al. Nov 2001 B1
6322551 Brugger Nov 2001 B1
6387069 Utterberg May 2002 B1
6485483 Fujii Nov 2002 B1
6488650 Epstein et al. Dec 2002 B1
6502604 Lewis Jan 2003 B1
6565806 Grimm May 2003 B1
6572155 Dehmer Jun 2003 B2
6585703 Kassel et al. Jul 2003 B1
6613016 Ku Sep 2003 B1
6623455 Small et al. Sep 2003 B2
6635179 Summerton et al. Oct 2003 B1
6685677 Green Feb 2004 B2
6696018 Buchanan Feb 2004 B2
6712963 Schick Mar 2004 B2
6719907 Collins et al. Apr 2004 B2
6843513 Guala Jan 2005 B2
6893056 Guala May 2005 B2
6911014 Wentling et al. Jun 2005 B2
6945969 Morris et al. Sep 2005 B1
7017948 Sunohara et al. Mar 2006 B2
7052606 Gibbs et al. May 2006 B2
7070589 Lolachi et al. Jul 2006 B2
7077284 Ritter Jul 2006 B2
7135008 O'Mahony et al. Nov 2006 B2
7138045 Sferrazza Nov 2006 B2
7141097 Leahey Nov 2006 B2
7147620 Kessler et al. Dec 2006 B2
7247153 Guala Jul 2007 B2
7252308 Thilly Aug 2007 B2
7316662 Delnevo et al. Jan 2008 B2
7351218 Bene Apr 2008 B2
7507226 Stanus et al. Mar 2009 B2
7588692 Antwiler et al. Sep 2009 B2
7635343 McIntosh et al. Dec 2009 B2
7641753 Gao et al. Jan 2010 B2
7648494 Kornerup et al. Jan 2010 B2
7686279 Nerbonne et al. Mar 2010 B2
7686779 Gibbs Mar 2010 B1
7758082 Weigel et al. Jul 2010 B2
7766394 Sage et al. Aug 2010 B2
7789245 Westberg et al. Sep 2010 B2
7806737 Mark et al. Oct 2010 B2
7857802 Brandenburger et al. Dec 2010 B2
7892428 Ardans et al. Feb 2011 B2
7935258 Rovatti et al. May 2011 B2
7951121 Weaver et al. May 2011 B2
8012126 Tipsmark et al. Sep 2011 B2
8021319 Delnevo et al. Sep 2011 B2
8021334 Shekalim Sep 2011 B2
8042838 Buckler et al. Oct 2011 B2
8074964 Mansour et al. Dec 2011 B2
8088099 McIntosh et al. Jan 2012 B2
8152116 Westberg Apr 2012 B2
8163064 Bredesen et al. Apr 2012 B2
8172823 Rondeau et al. May 2012 B2
8177771 Butts et al. May 2012 B2
8182686 Witthaus et al. May 2012 B2
8210049 Brugger Jul 2012 B2
8333724 Barrett et al. Dec 2012 B2
8431086 Lurvey et al. Apr 2013 B2
8454573 Wyatt et al. Jun 2013 B2
8469331 Burbank Jun 2013 B2
8469931 Tryggvason et al. Jun 2013 B2
8508368 Potyrailo et al. Aug 2013 B2
8511638 Mansour et al. Aug 2013 B2
8512553 Cicchello et al. Aug 2013 B2
8562908 Kenley Oct 2013 B2
8596326 Loy Dec 2013 B2
8622893 Mathieu Jan 2014 B2
8622986 Ramella et al. Jan 2014 B2
8647326 Solomon et al. Feb 2014 B2
8738151 Nelson May 2014 B2
8771513 Heinrich et al. Jul 2014 B2
8858485 Neri et al. Oct 2014 B2
8944082 Cairns Feb 2015 B2
8945036 Szamosfalvi et al. Feb 2015 B2
8968238 Page et al. Mar 2015 B2
9057469 Wei Jun 2015 B2
9089682 Yeh et al. Jul 2015 B2
9101473 Sweeney et al. Aug 2015 B2
9119947 Tsao Sep 2015 B2
9145995 Gastauer et al. Sep 2015 B2
9198581 Eberle et al. Dec 2015 B2
9211075 Quintanar et al. Dec 2015 B2
9283372 Bondhus et al. Mar 2016 B2
9339605 Wimpenny et al. May 2016 B2
9345828 Browne May 2016 B2
9364652 Griffith et al. Jun 2016 B2
9370651 Zollinger et al. Jun 2016 B2
9393398 Truitt et al. Jul 2016 B2
9408971 Carlyon Aug 2016 B2
9532742 Sim et al. Jan 2017 B2
9629950 Park et al. Apr 2017 B2
9629951 Delmage et al. Apr 2017 B2
9636493 Chung May 2017 B2
9669163 McNall et al. Jun 2017 B2
9687645 Wesseler Jun 2017 B2
9694139 Shaw et al. Jul 2017 B2
9772246 Hoffman et al. Sep 2017 B2
20020043051 Manica et al. Apr 2002 A1
20030010717 Brugger et al. Jan 2003 A1
20030074862 Lohmuller Apr 2003 A1
20030187420 Akerlund et al. Oct 2003 A1
20040009542 Dumont et al. Jan 2004 A1
20040045890 Herczeg Mar 2004 A1
20040067161 Axelsson Apr 2004 A1
20050082210 Favre Apr 2005 A1
20050085762 Vijay et al. Apr 2005 A1
20060035494 Sugaya et al. Feb 2006 A1
20060272997 Liu Dec 2006 A1
20070073237 Rodd Mar 2007 A1
20070073245 Shih Mar 2007 A1
20070131610 Peng et al. Jun 2007 A1
20070173758 Chen Jul 2007 A1
20070197922 Bradley et al. Aug 2007 A1
20070261214 Nerbonne et al. Nov 2007 A1
20080077050 Malmborg et al. Mar 2008 A1
20080103476 Schulte May 2008 A1
20080132876 Felt Jun 2008 A1
20080139909 Corl et al. Jun 2008 A1
20080147012 Rome Jun 2008 A1
20090198170 Childers Aug 2009 A1
20090204080 Balteau et al. Aug 2009 A1
20090306621 Thome et al. Dec 2009 A1
20100152640 Golding et al. Jun 2010 A1
20110060328 Skwarek et al. Mar 2011 A1
20110226256 Dubach Sep 2011 A1
20120029333 Dogwiler et al. Feb 2012 A1
20120047623 Oudenallen et al. Mar 2012 A1
20120116321 Brugger May 2012 A1
20120175806 Delano Jul 2012 A1
20130165851 Geiger et al. Jun 2013 A1
20130237830 Warren et al. Sep 2013 A1
20130264821 Duck et al. Oct 2013 A1
20140008366 Genosar Jan 2014 A1
20140076483 Pirie et al. Mar 2014 A1
20140144794 Eyrard et al. May 2014 A1
20140187892 Gupta et al. Jul 2014 A1
20140238909 Brugger et al. Aug 2014 A1
20140296745 Cash Oct 2014 A1
20140306447 Werth Oct 2014 A1
20140318995 Eilertsen Oct 2014 A1
20140350485 Sonderegger et al. Nov 2014 A1
20140350486 Cordes Nov 2014 A1
20140371598 Okubo et al. Dec 2014 A1
20150034194 Uber, III Feb 2015 A1
20150093450 Riser et al. Apr 2015 A1
20150165185 Cohen et al. Jun 2015 A1
20150223671 Sung et al. Aug 2015 A1
20150238746 Nisipeanu et al. Aug 2015 A1
20150250945 Kim Sep 2015 A1
20150306372 Brault-Guyon et al. Oct 2015 A1
20160008224 Rahimy et al. Jan 2016 A1
20160015961 Mansour et al. Jan 2016 A1
20160101276 Tekeste Apr 2016 A1
20160113813 Lim et al. Apr 2016 A1
20160143811 Poncon et al. May 2016 A1
20160144118 Solomon et al. May 2016 A1
20160151573 Binninger Jun 2016 A1
20160158523 Helm Jun 2016 A1
20160175201 Schuessler Jun 2016 A1
20160199568 McNall et al. Jul 2016 A1
20160206868 Guala Jul 2016 A1
20160213441 Connolly Jul 2016 A1
20160220806 Mansour et al. Aug 2016 A1
20160317120 Elbert Nov 2016 A1
20160354288 Uehara et al. Dec 2016 A1
20170000979 Blacker Jan 2017 A1
20170203014 Kenley Jul 2017 A1
Foreign Referenced Citations (14)
Number Date Country
201150709 Nov 2008 CN
60013965 Mar 2006 DE
2275165 Jan 2011 EP
2538795 Nov 2016 GB
2001002127 Jan 2001 JP
3455701 Oct 2003 JP
4362036 Nov 2009 JP
5304073 Oct 2013 JP
5363928 Dec 2013 JP
2271834 Mar 2006 RU
02053211 Jul 2002 WO
WO-02053211 Jul 2002 WO
2006083653 Aug 2006 WO
2014037110 Mar 2014 WO
Non-Patent Literature Citations (4)
Entry
NxStageCriticalCare, ChangingTherapyFluidBags.wmv, Nov. 2, 2010, Youtube, https://www.youtube.com/watch?v=Aho-0zc5sXE (Year: 2010).
International Preliminary Report on Patentability for International Application No. PCT/US2016/065894 dated Jun. 21, 2018.
International Search Report and Written Opinion for International Application No. PCT/US2016/065894 dated Apr. 6, 2017.
Extended European Search Report dated Jun. 11, 2019 for European Patent Application No. 16873947.2.
Related Publications (1)
Number Date Country
20190001113 A1 Jan 2019 US
Provisional Applications (1)
Number Date Country
62266553 Dec 2015 US