WO2015160823A1

WO2015160823A1 - Filter assemblies, intravenous therapy devices including at least one filter and related assemblies and methods

Info

Publication number: WO2015160823A1
Application number: PCT/US2015/025776
Authority: WO
Inventors: Li Min She; Zhao JIE; Joel K. Faulkner; Aaron Garcia Faulkner
Original assignee: Health Line International Corp.
Priority date: 2014-04-18
Filing date: 2015-04-14
Publication date: 2015-10-22
Also published as: CN104998318A; CN106377816A; CN104998318B; CN106377816B; CN204233524U; CN104127932B; CN108853638A; CN204233526U; CN104127932A; CN204246586U

Abstract

An intravenous therapy device includes a fluid reservoir containing a therapeutic fluid. A filter may be fluidly coupled to the fluid reservoir. The filter may be isolated from contact with the therapeutic fluid prior to use of the intravenous therapy device. The method of using an intravenous therapy device includes providing a fluid reservoir at least partially filled with a therapeutic fluid. A fluid filter for the fluid reservoir is initially sealed from contact with the therapeutic fluid.

Description

FILTER ASSEMBLIES, INTRAVENOUS THERAPY DEVICES INCLUDING AT LEAST ONE FILTER AND RELATED ASSEMBLIES AND

METHODS PRIORITY CLAIM

This application claims the benefit of the filing date of United States Provisional Patent Application Serial No. 61/981 ,401, filed April 18, 2014, for "INTRAVENOUS THERAPY DEVICES INCLUDING AT LEAST ONE FILTER AND RELATED ASSEMBLIES AND METHODS," the disclosure of which is hereby incorporated herein in its entirety by this reference.

TECHNICAL FIELD

The disclosure generally relates to intravenous therapy devices and related assemblies and methods. In particular, embodiments of the disclosure relate to intravenous therapy devices including at least one filter and methods of using such intravenous therapy devices.

BACKGROUND

In the medical field and, in particular, within the area of intravenous delivery of therapeutic fluids to a subject (e.g., patient), a need exists to ensure that the fluid delivered to the subject is free of particulate contaminants.

Traditionally, an intravenous therapy device may include a fluid reservoir filled with a therapeutic fluid, such as a saline solution that may or may not include a pharmacologically active substance. A peripheral intravenous line may be fluidly coupled to the intravenous therapy device. The peripheral intravenous line may lead to a subject injection site, such as a needle injection site including an intravenous needle entering the vein of a subject. Therapeutic fluid may flow from the fluid reservoir, through the peripheral intravenous line, and into the vein of the subject at the needle injection site.

Any pathogenic and/or particulate contaminants entrained within the flow of the therapeutic fluid may enter the subject's body at the needle injection site and potential ly cause physiological harm to the subject. DISCLOSURE

Described are intravenous therapy devices including at least one filter isolated from a therapeutic fluid prior to use of the intravenous therapy device, and related assemblies and methods.

Disclosed is filter assembly for use with an intravenous therapy device including an inlet end for fluid coupling to a fluid reservoir of an intravenous therapy device, an outlet end comprising a seal covering a fluid outlet of the filter assembly, and at least one filter disposed between the inlet end and the outlet end for filtering a fluid passed from the inlet end to the outlet end through the filter assembly.

Also disclosed is filter assembly for use with an intravenous therapy device including an inlet end for fluid coupling to a fluid reservoir of an intravenous therapy device, an outlet end, at least one filter disposed between the inlet end and the outlet end for filtering a fluid passed from the inlet end to the outlet end through the filter assembly, and a puncture element disposed at the inlet end for piercing a seal disposed between a fluid reservoir and the filter assembly.

Further disclosed is an intravenous therapy device comprising a fluid reservoir for containing a therapeutic fluid, and a filter assembly comprising an inlet end for fluid coupling to the fluid reservoir, and an outlet end comprising a seal covering the outlet end of the filter assembly.

Also disclosed is an intravenous therapy device comprising a fluid reservoir comprising a first portion configured to initially hold a therapeutic fluid and a second portion configured to be initially isolated from the therapeutic fluid, a removable barrier initially isolating the first portion from the second portion, and a filter disposed within the second portion, the filter fluidly coupled to a port extending through a wall of the fluid reservoir.

Further disclosed is an intravenous therapy device comprising a fluid reservoir for containing a therapeutic fluid, and a filter assembly comprising an inlet end for fluid coupling to the fluid reservoir, and a piercing point disposed at the inlet end for piercing a seal disposed between the fluid reservoir and the filter assembly.

Yet further disclosed is a method of using an intravenous therapy device, the method comprising providing a fluid reservoir at least partially filled with a therapeutic fluid, providing a fluid filter for fluid coupling to the fluid reservoir, the fluid filter initially sealed from contact with the therapeutic fluid, connecting a peripheral intravenous line to an outlet of the fluid filter, removing an initial seal isolating the fluid filter from contact with the therapeutic fluid, and introducing a flow of therapeutic fluid from the fluid reservoir to an inlet of the fluid filter.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of an intravenous therapy device described herein.

FIG. 2 illustrates an enlarged cross-sectional view of a portion of the intravenous therapy device shown in FIG. 1.

FIG. 3 illustrates a perspective view of an intravenous therapy device described herein.

FIG. 4 illustrates a side view of the intravenous therapy device of FIG. 3. FIG. 5 illustrates an enlarged side view of an intravenous therapy device described herein.

FIG. 6 illustrates a side view of an intravenous therapy device described herein.

FIG. 7 illustrates a cross-sectional side view of a portion of the intravenous therapy device of FIG. 6.

FIG. 8 illustrates a cross-sectional side view of an intravenous therapy device described herein.

FIG. 9 illustrates a cross-sectional side view of an intravenous therapy device described herein.

FIGS. 10 and 1 1 illustrate a cross-sectional side view of a filter for an intravenous therapy device described herein.

MODE(S) FOR CARRYING OUT THE INVENTION Generally, intravenous therapy devices as described herein are utilized to supply a flow of therapeutic fluid (e.g., a saline solution with or without a pharmacologically active substance) to a subject. Intravenous therapy devices as described herein include a filter assembly through which the liquid may pass before being introduced to the subject. Such a filter may partially or completely remove foreign matter (e.g., particulates) from the fluid flow.

In some embodiments, the intravenous therapy device includes a fluid reservoir at least partially filled with the therapeutic fluid. The intravenous therapy device may also include a filter assembly for fluid coupling to the fluid reservoir. The filter assembly may include a filter housing and a filter element disposed within the filter housing. The filter assembly may be initially sealed from contact with the therapeutic fluid. In other words, the therapeutic fluid may be prevented from contacting the filter assembly prior to use of the intravenous therapy device.

The intravenous therapy device may include one or more ports for delivering fluids to the subject and for accepting fluids to be added to the fluid reservoir. The filter assembly may be coupled to the intravenous therapy device at the one or more ports. In one embodiment, a central port includes an outlet tube into which an inlet tube of a filter housing of the filter assembly fits in a substantially fluid-tight manner. The inlet tube of the filter housing may include a portion configured to puncture a seal or membrane of the intravenous therapy device (e.g., a seal of the fluid reservoir and/or a seal of the filter housing). For example, the filter housing may include a substantially pointed portion, such as a puncture needle. In other embodiments, the puncture portion or needle is provided on another component of the intravenous therapy device to which the filter housing is connected on a downstream side of the component. A removable stop device (e.g., a collar) may be disposed on the inlet tube of the filter housing and may prevent the inlet tube from being fully inserted into the outlet tube of the central port.

A membrane seal may be disposed within the central port and may isolate the filter assembly from contact with the therapeutic fluid in the fluid reservoir. When a practitioner desires to use the intravenous therapy device, the practitioner may insert a peripheral intravenous line into an outlet of the assembly filter and remove the collar. The practitioner may fully insert the inlet tube of the filter housing within the outlet tube of the centra! port such that the puncture portion or needle pierces the membrane seal. Therapeutic fluid may then flow through the filter assembly, into the peripheral intravenous line, and through the peripheral intravenous line to an injection site (e.g., a needle injection site on a subject.) In some embodiments, the fluid filter includes a seal on one or more ends of the fluid filter (e.g., an outlet end) of the fluid filter. Such a seal may prevent fluid flow initially through the fluid filter and/or may prevent external contaminants (e.g., dust, airborne pathogens) from entering the filter prior to use. Such a seal may be broken (e.g., removed) at the time of use of the intravenous therapy device (e.g., by insertion of a portion of the peripheral intravenous line into the outlet of the fluid filter).

In other embodiments, the filter assembly is connected to the fluid reservoir by, e.g., a flexible tube. The filter assembly may be permanently connected to the flexible tube, e.g., by an adhesive, or may be removably connected to the flexible tube, e.g., by a connector such as a Luer taper connection. A removable clamp may be disposed on the flexible tube. The clamp may be configured to collapse the flexible tube such that an internal passageway of the flexible tube is closed and prevents the therapeutic fluid from contacting the filter assembly.

During use, a practitioner may insert a portion of a peripheral intravenous line into an outlet of the fluid filter. The practitioner may then remove the clamp from the flexible tube, thereby allowing the therapeutic fluid to flow through the filter assembly, into the peripheral intravenous line, and ultimately to an injection site (e.g., a needle injection site on a subject).

In some embodiments, the fluid reservoir may be initially divided into a fluid-filled portion containing therapeutic fluid and a dry portion. A filter assembly may be disposed within the dry portion of the fluid reservoir and be initially isolated from the therapeutic fluid. The filter assembly may be connected to a port extending through a wall of the fluid reservoir.

The fluid reservoir may be made from a flexible polymeric material. The fluid reservoir may be divided by a bar clamp extending across the fluid reservoir and clamping (e.g., pinching) walls of the fluid reservoir together to isolate the dry and fluid-filled portions of the fluid reservoir. In use, a practitioner or health care provider may connect (e.g., insert) a portion of a peripheral intravenous line within the port and remove the bar clamp, thus enabling the therapeutic fluid to fill both the initially fluid-filled portion as well as the initially dry portion. The therapeutic fluid may saturate and flow through the filter assembly to the peripheral intravenous line and ultimately to a needle injection site.

FIG. 1 illustrates a perspective view of an intravenous therapy device 100. The intravenous therapy device 100 may include a fluid reservoir 102 containing a therapeutic fluid (e.g., a saline solution). The fluid reservoir 102 may comprise a flexible, substantially non-porous polymeric material. As a non-limiting example, the fluid reservoir 102 may be formed from two sheets of flexible polymeric material sealed (e.g., bonded) together around an outer periphery. In other embodiments, the fluid reservoir is formed of a substantially rigid material, such as high-density polyethylene or another polymer material. Prior to use of the intravenous therapy device 100, a portion of the fluid reservoir 102 containing the therapeutic fluid may be substantially hermetically sealed to prevent intrusion of air or external contaminants and to prevent leakage of fluid from the fluid reservoir 102.

The intravenous therapy device 100 may include one or more ports formed in the fluid reservoir 102. For example, the intravenous therapy device 100 may include at least a central port 104 and one or more ancillary ports 106. In use, a flow of fluid may leave the fluid reservoir 102 through one or more of the central port 104 and the ancillary ports 106. In some embodiments, a substance (e.g., a pharmacologically active substance) may be introduced to the fluid reservoir 102 through at least one of the central port 104 and the ancillary ports 106. For example, one of the ancillary ports 1 06 may include a needle hub and/or a needleless connection hub (e.g., Luer connection 107), to which a practitioner may connect a syringe (not shown) filled with a substance. The practitioner may then inject the substance from the syringe into the fluid in the fluid reservoir 102 through the ancillary port 106.

The intravenous therapy device 100 includes one or more filter assemblies 108 for fluid coupling to the fluid reservoir 102. The filter assembly 108 may include a filter element 1 10 (FIG. 2) disposed within a filter housing 1 12. The filter element 1 10 may be formed from a filtration media such as, for example, woven or matted fibers or other porous materials. A pore size of the filtration media may be chosen to block (e.g., impede) passage of particulates of a given size as fluid flows from the fluid reservoir 102, through the filter element 1 10, and through a peripheral intravenous line (not shown) to an injection site (also not shown).

As depicted, the filter assembly 108 may be disposed outside the hermetic seal of the fluid reservoir 102 prior to use of the intravenous therapy device 100. In other words, the filter assembly 108 may be isolated from the fluid contained in the fluid reservoir 102 prior to use of the intravenous therapy device 100. In some embodiments, the filter assembly 108 includes a seal 120 on one or more ends of the filter assembly 108. Such a seal may prevent fluid flow initially through the filter assembly 108 and/or may isolate the filter assembly 108 from external contaminants prior to use of the intravenous therapy device 100. For example, as shown in FIG. I , a seal 120 may be disposed at an outlet end 1 15 of the filter housing 1 12. The seal 120 may be a thin, flexible material (e.g., a polymer film or metal foil) that may be broken by piercing with a puncture element or device, such as a puncture needle. In other embodiments, the seal 120 is a cover (e.g., cap) that may be removed from the outlet end 1 15 of the filter housing 1 12 at the time of use.

The filter assembly 108 may be connected to a connection portion of a port (e.g., the central port 104 or an ancillary port 106). As shown in FIG. 1 , a filter assembly 108 may be disposed proximate the central port 104 of the fluid reservoir 102. The central port 104 may include an outlet tube 1 14 connected to and extending from the fluid reservoir 102. An inlet end 1 13 of the filter housing 1 12 of the filter assembly 108 may include an inlet tube 1 16. The inlet tube 1 16 may be shaped and sized to fit within the outlet tube 1 14 of the central port 104. For example, the inlet tube 1 16 and the outlet tube 1 14 may be sized such that a substantially fluid-tight seal is created between the inlet tube 1 16 and the outlet tube 1 14 when the inlet tube 1 16 is inserted in the outlet tube 1 14. As a non-limiting example, as shown in FIG. 1 , the inlet tube 1 16 may comprise a substantially cylindrical shape, and the outlet tube 1 14 may define a substantially cylindrical bore into which the inlet tube 1 16 may be inserted.

In some embodiments, the inlet tube 1 16 may be prevented from being fully inserted into the outlet tube 1 14 prior to use of the intravenous therapy device 100. For example, in the embodiment of FIG. 1 , a removable collar 1 1 8 may be initially disposed on the inlet tube 1 16 such that the collar 1 1 8 abuts the outlet tube 1 1 4 and the filter housing 112 to allow only partial insertion of the inlet tube 1 16 within the outlet tube 1 14. The collar 118 may comprise a resilient (i.e., elastic) clip or band that surrounds a portion of the inlet tube 1 16. In some embodiments, the collar 118 may be formed integrally with and configured to be relatively easily broken off from the outlet tube 1 14 or the inlet tube 1 16.

FIG. 2 illustrates a cross-sectional view of the embodiment of the intravenous therapy device 100 shown in FIG. 1. As shown in FIG. 2, the inlet tube 1 16 of the housing 1 12 of the filter assembly 108 may terminate at a puncture element, e.g., a substantially pointed portion (e.g., a puncture needle 202). The central port 104 may include a sealing membrane 204 disposed between the fluid reservoir 102 and the outlet tube 1 14. When it is desired to use the intravenous therapy device 100, a practitioner may insert a device such as a drip chamber (e.g., drip chamber 400 (FIGS. 3 and 4)) connected to a peripheral intravenous line (not shown) in the outlet end 115 of the filter housing 1 12 to break the seal 120. The practitioner may remove the collar 1 18 (FIG. 1 ) and completely insert the filter assembly 108 such that the inlet tube 1 16 is fully inserted within the outlet tube 1 14. As the inlet tube 1 16 further enters the outlet tube 114, the puncture needle 202 may pierce the sealing membrane 204, enabling the fluid contained within the fluid reservoir 102 to flow through the inlet tube 1 16 and into the filter housing 1 12. The fluid may flow into an outside diameter 206 of the filter element 1 10, through the filter element 110, into an inside diameter 208 of the filter element 1 10, and from the outlet end 1 15 of the filter housing 1 12 into the peripheral intravenous line to a needle injection site on a subject. In other embodiments, the filter housing 1 12 is inserted into the fluid reservoir 102 before connecting a device such as the drip chamber to the filter housing 1 12.

FIG. 3 illustrates an embodiment of an intravenous therapy device 300. As depicted, the intravenous therapy device 300 includes a filter assembly 1 08 attached to an ancillary port 106 of the fluid reservoir 102. In the embodiment of FIG. 3, a connection portion of the ancillary port 106 may include a flexible tube 302 extending from the ancillary port 106 to the filter assembly 108. The filter assembly 108 may be connected to the flexible tube 302 with, for example, a detachable mechanical connection, e.g., a Luer connector. In other embodiments, the filter assembly 108 is permanently attached to the flexible tube 302 by a chemical bond, e.g. , an adhesive. The intravenous therapy device 300 may include a clamp 304 disposed on the flexible tube 302.

FIG. 4 illustrates an enlarged side view of the intravenous therapy device 300 of the embodiment of FIG. 3. The clamp 304 may include clamping members 306 configured to clamp {e.g. , pinch) the flexible tube 302 to close an internal passageway of the flexible tube 302 when the clamp 304 is in a closed position, thus preventing fluid flow through the flexible tube 302 and isolating the filter assembly 108 from a fluid within the fluid reservoir 102.

When it is desired to use the intravenous therapy device 300, a practitioner may remove {e.g. , pierce) the seal 120 from the outlet end 1 15 of the filter assembly 108 and attach a peripheral intravenous line as described above in connection with FIG. 2 {e.g., with a peripheral intravenous line coupled to a drip chamber 400 having a piercing point). The practitioner may then open the clamp 304 to allow fluid to flow from the fluid reservoir 102, through the flexible tube 302, into the filter assembly 108, into the peripheral intravenous line, and finally to an injection site {e.g. , a needle injection site on a subject).

FIG. 5 illustrates a side view of an intravenous therapy device 500. In this embodiment, a fluid reservoir 502 is initially divided into a substantially fluid-filled portion 504 and an empty, dry portion 506. A filter assembly 508 is disposed within the dry portion 506 of the fluid reservoir 502 and is initially isolated from contact with the fluid within the fluid-filled portion 504 of the fluid reservoir 502. In this embodiment, the fluid reservoir 502 may be made from a flexible, substantially non-porous material such as a polymer. As shown in FIG. 5, in this embodiment, the fluid reservoir 502 is divided into the fluid-filled portion 504 and the dry portion 506 by a removable barrier {e.g. , a bar clamp 510) extending across the fluid reservoir 502. The bar clamp 510 may clamp {e.g. , pinch) two flexible exterior walls of the fluid reservoir 502 together to prevent the fluid in the fluid-filled portion 504 from entering the dry portion 506, thus preventing the fluid from contacting the filter assembly 508 prior to use.

The filter assembly 508 may be attached to a tube 512 extending through an exterior wall of the fluid reservoir 502. An outlet 514 of the tube 512 may be protected by a seal (e.g., a membrane or a cap) as discussed above in connection with the outlet end 1 15 of the filter assembly 108, to prevent fluid flow initially through the fluid filter and/or to prevent external contaminants from entering the tube 512 and the filter assembly 508.

When it is desired to use the intravenous therapy device 500, a practitioner may remove the seal from the outlet 514, attach a peripheral intravenous line (not shown) between the outlet 514 and a subject injection site, and remove the barrier (e.g., the bar clamp 510) from the fluid reservoir, thus eliminating the division between the fluid-filled portion 504 and the dry portion 506 of the fluid reservoir. Fluid is thus allowed to enter the entire fluid reservoir, including the previously dry portion 506, and may saturate and flow through the filter assembly 508, through the outlet 514, and through the peripheral intravenous line to the subject injection site.

In other embodiments, the fluid reservoir 502 is initially divided into a fluid-filled portion 504 and a dry portion 506 by a frangible seal. For example, a frangible membrane disposed within the fluid reservoir 502 may separate the reservoir 502 into the fluid-filled portion 504 and the dry portion 506. The frangible membrane may be broken when desired by a practitioner by, e.g., squeezing the fluid reservoir 502. In some embodiments, the fluid reservoir is made from two flexible sheets polymeric material bonded together around a peripheral edge. A seal between the two flexible sheets may extend from the peripheral edge on one side of the fluid reservoir to the peripheral edge on another side of the fluid reservoir and may divide the reservoir into the fluid-filled portion 504 and the dry portion 506. The seal extending between peripheral edges may be configured to be easily broken (i. e., more easily broken than the bond around the peripheral edge) by a practitioner when desired by, e.g., squeezing the fluid-filled portion 504 of the fluid reservoir 502 or by pulling the two flexible sheets apart in the vicinity of the seal.

FIG. 6 illustrates a side view of an intravenous therapy device 600. In this embodiment, a fluid reservoir 602 includes a port 604 with a coupling sleeve 606. An inlet end 608 of a filter assembly 610 may be attached to a coupling collar 612 configured to mechanically couple with the coupling sleeve 606. The coupling collar 612 may also include one or more ancillary ports 609. FIG. 7 illustrates an enlarged cross-sectional view of the intravenous therapy device 600 of FIG. 6. The coupling sleeve 606 may include connection features, e.g., threads 614, configured to interact with connection features disposed on the coupling collar 612, e.g., threads 616. The inlet end 608 of the filter assembly 610 (FIG. 6) may also include one or more puncture elements (e.g., puncture needles 618) disposed at least partially within the coupling collar 612. One or more of the puncture needles 618 may be fluidly connected to the filter assembly 610 through, e.g., a tube 622. For example, one puncture needle 618 may be fluidly connected to the filter assembly 610 and another puncture needle 618 may be fluidly connected to the one or more ancillary ports 609.

The one or more puncture needles 618 may be disposed on or through a carrier 624. The coupling collar 612 may be free to rotate with respect to the carrier 624 and the puncture needles 618.

When a practitioner desires to use the intravenous therapy device 600, the practitioner may place the coupling collar 612 over the coupling sleeve 606, and rotate the coupling collar 612 relative to the coupling sleeve 606 to engage the threads 614 with threads 616. As threads 614 and 616 engage and draw the coupling collar 612 and the one or more puncture needles 618 toward the fluid reservoir 602, the one or more puncture needles 618 may pierce a seal 626 disposed over one or more connection portions of the port 604 (e.g., openings 628 in an end plate 630) and the one or more puncture needles 618 may enter the fluid reservoir 602, bringing the fluid reservoir 602 into fluid communication with the filter assembly 610 through the tube 622. One or more portions of the coupling sleeve 606 may be configured to form a fluid-tight seal against the puncture needles 618 to prevent leakage. For example, one or more of the end plate, the septum forming the openings 628 in the end plate 630, and the seal 626 (e.g., a membrane) may be configured to form a fluid-tight seal against the puncture needles 618 to prevent leakage. The practitioner may insert a portion of a peripheral intravenous line, e.g., a drip chamber 400 (FIG. 6), into an outlet end 632 of the filter assembly 610, as described above in connection with FIG. 2. The outlet end 632 of the filter assembly 610 may include a seal, substantially as described above in connection with FIG. 2. FIG. 8 illustrates an enlarged cross-sectional view of an embodiment of an intravenous therapy device 800. In the embodiment of FIG. 8, a coupling sleeve 806 includes a substantially annular retainer (e.g., a snap ring 802) disposed on an outer diameter 804 of the coupling sleeve 806. The snap ring 802 may be configured to interface with an annular protrusion (e.g., a lip 808) disposed on an inner diameter 810 of a coupling collar 812. For example, a practitioner may place the coupling collar 812 over the coupling sleeve 806 and press the two components together until the lip 808 moves past the snap ring 802, and mechanical interference between the lip 808 and the snap ring 802 retains the coupling collar 812 on the coupling sleeve 806. As the coupling collar 812 and the coupling sleeve 806 are pressed together, a puncture needle 628 connected to an inlet end 608 of a filter assembly 610 (FIG. 6) may pierce a seal 626 and enter the fluid reservoir 602.

FIG. 9 illustrates an enlarged cross-sectional view of an embodiment of an intravenous therapy device 900. In the embodiment of FIG. 9, a filter assembly 902 is disposed within a coupling collar 906. The coupling collar 906 may include one or more connection features, e.g., a lip 808 for engagement with a snap ring 802 on a coupling sleeve 912 or a threaded attachment as discussed above in relation to FIGS. 6 and 7.

The filter assembly 902 may include a filter housing 904 enclosing a filter element 908. The filter housing 904 may include an inlet portion 914 with a puncture element (e.g., puncture needle 910) extending therefrom. The coupling collar 906 may be coupled with the coupling sleeve 902. For example, as described above in connection with FIG. 8, the coupling collar 906 may be placed over the coupling sleeve 902 and the two components may be pressed together until the lip 808 engages the snap ring 802. As the components are brought together, the puncture needle 910 may pierce a seal 626 and enter the fluid reservoir 602, thereby allowing fluid to flow from the reservoir 602 into the filter assembly 902. The filter assembly 902 may include an outlet 914 covered by a seal 916. A portion of a peripheral intravenous line, such as a drip chamber 400 (FIG. 6) including a puncture needle, may pierce the seal 916 as it is inserted into the outlet 914 of the filter assembly 902. FIGS. 10 and 1 1 illustrate a cross-sectional view of a filter assembly 1000 for an intravenous therapy device (e.g., intravenous therapy device 100 with fluid reservoir 102 (FIG. 1 )). Filter assembly may be similar to and include the various components and functioning of the filter assemblies discussed above.

In some embodiments, the filter assembly 1000 is secured to (e.g., coupled to) a fluid reservoir (e.g., fluid reservoir 102 (FIG. 1)) proximate a port in the fluid reservoir (e.g., where such a port may merely comprise a portion of the fluid reservoir that is intended to be punctured in order to place the filter assembly 1000 in fluid communication with the fluid in the fluid reservoir). For example, the filter assembly 1000 may be adhered to the fluid reservoir 102 (e.g., via ultrasonic welding) at a first end of the filter assembly 1000 (e.g., an inlet end). In other embodiments, puncturing of the fluid reservoir 102 (e.g., with a puncture element, as discussed below) may be utilized to secure the filter assembly 1000 to the fluid reservoir 102.

Filter assembly 1000 is shown in FIG. 10 in an initial position and is shown in FIG. 1 1 in an actuated position. As shown in FIGS. 10 and 1 1 , the filter assembly 1000 includes an inner housing 1002 and an outer housing 1004, which receives at least a portion of the inner housing 1002. Inner housing 1002 incudes a puncture element 1006 that is disposed within the outer housing 1 004 in the initial position of the filter assembly 1000. In some embodiments, the puncture element 1006 is similar to in structure and functions as the puncture elements and needles discussed above.

In the initial positon, a membrane (e.g., seal or membrane 1008) of the outer housing 1 004 that may at least partially seal a portion of the inner housing 1002 (e.g., a portion of the puncture element 1006 of the inner housing 1 002) within the outer housing 1004. For example, one or more fluid openings 1010 (e.g., inlets) formed in the puncture element 1006 of the inner housing 1002 may be sealed (e.g., at one end) in the outer housing 1004 prior to use of the filter assembly 1000 by the membrane 1008. The portion of the puncture element 1006 having the fluid openings 1 01 0 formed therein may be received in an aperture 1 012 in the outer housing 1004. In such an embodiment, a first portion of the puncture element 1006 proximate a first side of the fluid openings 1 01 0 formed in the puncture element 1006 may be sealed within the aperture 1 012 by the membrane 1008 and a second portion of the puncture element 1006 proximate a second, opposing side of the fluid openings 1010 may be sealed within the aperture 1012 of the outer housing 1004 (e.g., by O-ring 1014).

The filter assembly 1000 includes filter 1016 within the inner housing 1002, which filter 1016 may be similar in structure and function to the filters discussed above.

A portion of the filter assembly 1000 (e.g., the inner housing 1002) may include a membrane 1018 (e.g., a seal) positioned proximate an outlet end of the filter assembly 100. For example, the membrane 1018 of the inner housing 1002 may be positioned on a side of the filter assembly 1000 opposing the membrane 1008 of the outer housing 1004. Membrane 1018 of the inner housing 1002 may at least partially form a seal on one side of the filter assembly (e.g., distal to the coupling between the filter assembly 1000 and the fluid reservoir 102 (FIG. 1 )).

As further shown in FIGS. 10 and 1 1 , the inner housing 1002 and outer housing 1004 are movable relative to each other to move the filter assembly 1000 from the initial position (e.g., a sealed position) as shown in FIG. 10 to an actuated position as shown in FIG. 1 1. For example, a connection feature 1020 (e.g., threads) between the inner housing 1002 and outer housing 1004 may act to secure the filter assembly 1000 in the initial position. Rotation of the inner housing 1002 and outer housing 1004 relative to each other acts to move at least a portion of the puncture element 1006 (e.g., the portion including fluid openings 1010) to a position external to the outer housing 1004 (e.g., by piercing membrane 1008) as shown in FIG. 1 1. Rotation of the inner housing 1002 relative to the outer housing 1 004 may position the exposed portion of the puncture element 1006 within the fluid reservoir 102 (FIG. 1 ) such that the fluid openings 101 are in communication with the fluid in the fluid reservoir 102. In other words, connection feature 1020 enables the inner housing 1002 to move axially relative to the outer housing 1004 to pierce the membrane 1008 with the puncture element 1006 in order to extend the fluid openings 1010 from within the outer housing 1004. In such an embodiment, the second side of the fluid openings 1 010 remains sealed in the sealed within the aperture 1012 of the outer housing 1004 by the O-ring 1014 (e.g., ensuring that fluid flows only through the inner housing 1002 of the filter assembly 1000).

Such positioning of the puncture element 1006 and fluid opening 1010 will enable fluid from the fluid reservoir 102 to travel into the inner housing 1002 of the filter assembly 1000 and through the filter 1016. Another coupling element (e.g., another picture element such as drip chamber 400 (FIGS. 3 and 4) may be used to pierce the membrane 1018 of the inner housing 1002 (e.g., to form an outlet of the filter assembly 1000) such that fluid can continue to flow through to a peripheral intravenous line that is ultimately is placed in communication with a subject at an injection site.

In other embodiments, the connection feature between the inner housing 1002 and the outer housing 1004 comprises any suitable structure configured to selectively permit movement of the inner housing 1002 relative to the outer housing 1004 (e.g., via mechanical interference). For example, the connection feature 1020 may comprise one or more protrusions positioned on opposing surfaces of the inner housing 1002 and the outer housing 1004 such that a user may axially force the protrusions axially past each other to push the inner housing 1002 into the outer housing 1004. In other embodiments, friction between the inner housing 1002 and the outer housing 1004 or the membrane 1008 may be used to temporarily secure the filter assembly 1 000 in the initial position until a user overcomes the friction between the inner housing 1002 and the outer housing 1004 or punctures the membrane 1008 to enable the inner housing 1002 to move axially relative to the outer housing 1004.

In some embodiments, the filter assembly 1000 includes a collar (e.g., tear- off strip 1 022) or other suitable structure that prevents movement of the inner housing 1002 relative to the outer housing 1004 until the tear-off strip 1 022 is removed by a practitioner or other user.

Once being apprised of the instant intravenous therapy devices, one of ordinary skill in the art wil l be readily able to make and assemble the devices.

Additional non-limiting example Embodiments are described below:

Embodiment 1 : An intravenous therapy device comprising: a fluid reservoir for containing a therapeutic fluid, the fluid reservoir comprising a port having a connection portion extending through a wall of the fluid reservoir for accessing the therapeutic fluid within the fluid reservoir; and a filter assembly, comprising: an inlet end for fluid coupling to the connection portion of the port of the fluid reservoir; and an outlet end comprising a seal covering a fluid outlet of the filter assembly.

Embodiment 2: The intravenous therapy device of Embodiment 1 , wherein the inlet end of the filter assembly further comprises an inlet tube extending from a housing of the filter assembly, wherein the connection portion of the port of the fluid reservoir comprises an outlet tube extending from the port, and wherein the inlet tube of the filter assembly is configured to fit within the outlet tube of the fluid reservoir.

Embodiment 3 : The intravenous therapy device of Embodiment 2, further comprising a membrane disposed proximate the connection portion of the port of the fluid reservoir, wherein the membrane is configured to isolate a filter element of the filter assembly from contact with the therapeutic fluid prior to use of the intravenous therapy device.

Embodiment 4: The intravenous therapy device of Embodiment 3, wherein the inlet tube of the filter housing comprises a puncture element for piercing the membrane when the inlet tube of the filter housing is inserted a selected depth into the outlet tube of the port of the fluid reservoir.

Embodiment 5: The intravenous therapy device of Embodiment 4, wherein a removable collar disposed on the inlet tube of the filter housing prevents the inlet tube from being inserted the selected depth into the outlet tube.

Embodiment 6: The intravenous therapy device of any one of Embodiments 1 through 5, wherein the connection portion comprises a flexible tube extending from and in fluid communication with the fluid reservoir.

Embodiment 7: The intravenous therapy device of Embodiment 6, wherein a removable clamp disposed over the flexible tube is configured to close an internal passageway through the flexible tube and seal the filter from contact with the therapeutic fluid.

Embodiment 8: The intravenous therapy device of any one of Embodiments 1 through 7, wherein the connection portion of the fluid reservoir comprises a coupling sleeve comprising a connection feature configured to engage a complementary connection feature of a coupling collar connected to the inlet end of the filter assembly.

Embodiment 9: The intravenous therapy device of Embodiment 8, wherein the filter assembly is at least partially disposed within the coupling collar.

Embodiment 10: The intravenous therapy device of Embodiment 8 or 9, wherein the puncture element is at least partially disposed within the coupling collar.

Embodiment 1 1 : An intravenous therapy device comprising: a fluid reservoir comprising a first portion configured to initially hold a therapeutic fluid and a second portion configured to be initially isolated from the therapeutic fluid; a removable barrier configured to initially isolate the first portion from the second portion; and a filter disposed within the second portion, the filter fluidly coupled to a port extending through a wall of the fluid reservoir.

Embodiment 12: An intravenous therapy device comprising: a fluid reservoir for containing a therapeutic fluid; and a filter assembly comprising: an inlet end for fluid coupling to a connection port of the fluid reservoir extending through a wall of the fluid reservoir; and a puncture element disposed at the inlet end for piercing a seal disposed between the fluid reservoir and the connection port.

Embodiment 13 : The intravenous therapy device of Embodiment 12, wherein the connection port of the fluid reservoir comprises a coupling sleeve comprising a connection feature configured to engage a complementary connection feature of a coupling collar connected to the inlet end of the filter assembly.

Embodiment 14: The intravenous therapy device of Embodiment 13, wherein the filter assembly is at least partially disposed within the coupling collar.

Embodiment 15: The intravenous therapy device of Embodiment 13 or 14, wherein the puncture element is at least partially disposed within the coupling collar.

Embodiment 16: A method of using an intravenous therapy device, the method comprising: providing a fluid reservoir at least partially filled with a therapeutic fluid; providing a fluid filter for fluid coupling to the fluid reservoir, the fluid filter initially sealed from contact with the therapeutic fluid; connecting a peripheral intravenous line to an outlet of the fluid filter; removing an initial seal isolating the fluid filter from contact with the therapeutic fluid; and introducing a flow of therapeutic fluid from the fluid reservoir to an inlet of the fluid filter.

Embodiment 17: The method of Embodiment 16, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises breaking a fluid seal disposed at an outlet port of the fluid reservoir.

Embodiment 18: The method of Embodiment 16 or 17, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises removing a clamp from a flexible tube in fluid communication with the reservoir and the inlet of the fluid filter.

Embodiment 19: The method of any one of Embodiments 16 through 18, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises removing a clamp from the fluid reservoir.

Embodiment 20: An intravenous therapy device comprising: a fluid reservoir for containing a therapeutic fluid, the fluid reservoir comprising: a port having a connection portion extending through a wall of the fluid reservoir for accessing the therapeutic fluid within the fluid reservoir, the connection portion comprising an outlet tube extending from the port; and a membrane disposed proximate the connection portion of the port, the membrane configured to selectively isolate the therapeutic fluid within the fluid reservoir of the intravenous therapy device; and a filter assembly comprising: an inlet end comprising an inlet tube extending from a housing of the filter assembly, the inlet tube sized to fit within the outlet tube extending from the port; a puncture element on the inlet tube for piercing the membrane of the fluid reservoir when the inlet tube of the filter housing is inserted a selected depth into the outlet tube of the port; a removable collar disposed on the inlet tube of the filter housing that prevents the inlet tube from being inserted into the outlet tube to the selected depth when the removable collar is in place; and an outlet end comprising a seal covering a fluid outlet of the filter assembly.

Claims

What is claimed is: 1. A filter assembly for use with an intravenous therapy device, the filter assembly comprising:

an inlet end for fluid coupling to a fluid reservoir of an intravenous therapy device; an outlet end comprising a seal covering a fluid outlet of the filter assembly; and at least one filter disposed between the inlet end and the outlet end for filtering a fluid passed from the inlet end to the outlet end through the filter assembly.

2. The filter assembly of claim 1 , wherein the inlet end comprises another seal covering a fluid inlet of the filter assembly.

3. The filter assembly of claim 1 or claim 2, further comprising:

an outer housing; and

an inner housing at least partially received within the outer housing, the inner housing including a puncture element for piercing at least one of a seal covering an fluid inlet of the filter assembly and a portion of a fluid reservoir of an intravenous therapy device.

4. The filter assembly of claim 3, further comprising a connection feature between the outer housing and the inner housing, the connection feature configured to enable movement of the inner housing relative to the outer housing in order to selectively extend the puncture element from a portion of the filter assembly and to pierce the at least one of the seal covering the fluid inlet of the filter assembly and the portion of the fluid reservoir of the intravenous therapy device.

5. The filter assembly of claim 4, wherein the connection feature comprises threads on an inner portion of the outer housing and on an outer portion of the inner housing.

6. A filter assembly for use with an intravenous therapy device, the filter assembly comprising:

an inlet end for fluid coupling to a fluid reservoir of an intravenous therapy device; an outlet end;

at least one filter disposed between the inlet end and the outlet end for filtering a fluid passed from the inlet end to the outlet end through the filter assembly; and

a puncture element disposed at the inlet end for piercing a seal disposed between a fluid reservoir and the filter assembly.

7. An intravenous therapy device comprising:

a fluid reservoir for containing a therapeutic fluid; and

a filter assembly comprising:

an inlet end for fluid coupling to the fluid reservoir; and

a puncture element disposed at the inlet end for piercing a seal disposed between the fluid reservoir and the filter assembly.

8. The intravenous therapy device of claim 7, wherein the filter assembly is coupled to the fluid reservoir proximate the inlet end of the filter assembly.

9. The intravenous therapy device of claim 7 or claim 8, wherein the filter assembly further comprises an outlet end comprising another seal covering a fluid outlet of the filter assembly.

10. The intravenous therapy device of claim 7 or claim 8, wherein the filter assembly is configured to move from an initial position to an actuated position, and wherein, in the actuated position, the puncture element extends from the filter assembly to pierce the seal disposed between the fluid reservoir and the filter assembly and to place the filter assembly in fluid communication with the fluid reservoir.

1 1. The intravenous therapy device of claim 7, wherein the fluid reservoir comprises a coupling sleeve comprising a connection feature configured to engage a complementary connection feature of a coupling collar connected to the inlet end of the filter assembly.

12. An intravenous therapy device comprising:

a fluid reservoir for containing a therapeutic fluid, the fluid reservoir comprising a port extending through a wall of the fluid reservoir for accessing the therapeutic fluid within the fluid reservoir; and

a filter assembly, comprising:

an inlet end for fluid coupling to the port of the fluid reservoir; and an outlet end comprising a seal covering a fluid outlet of the filter assembly.

13. The intravenous therapy device of claim 12, wherein the inlet end of the filter assembly further comprises an inlet tube extending from a housing of the filter assembly, wherein the port of the fluid reservoir comprises an outlet tube extending from the port, and wherein the inlet tube of the filter assembly is configured to fit within the outlet tube of the fluid reservoir.

14. The intravenous therapy device of claim 13, wherein the inlet tube of the filter housing comprises a puncture element for piercing the membrane when the inlet tube of the filter housing is inserted a selected depth into the outlet tube of the port of the fluid reservoir.

15. The intravenous therapy device of claim 12, further comprising a membrane disposed proximate the port of the fluid reservoir, wherein the membrane is configured to isolate a filter element of the filter assembly from contact with the therapeutic fluid prior to use of the intravenous therapy device.

16. An intravenous therapy device comprising:

a fluid reservoir comprising a first portion configured to initially hold a therapeutic fluid and a second portion configured to be initially isolated from the therapeutic fluid;

a removable barrier configured to initially isolate the first portion from the second portion; and

a filter disposed within the second portion, the filter fluidly coupled to a port extending through a wall of the fluid reservoir.

17. A method of using an intravenous therapy device, the method comprising:

providing a fluid reservoir at least partially filled with a therapeutic fluid;

providing a fluid filter for fluid coupling to the fluid reservoir, the fluid filter initially sealed from contact with the therapeutic fluid;

connecting a peripheral intravenous line to an outlet of the fluid filter;

removing an initial seal on at least one isolating the fluid filter from contact with the therapeutic fluid; and

introducing a flow of therapeutic fluid from the fluid reservoir to an inlet of the fluid filter.

18. The method of claim 17, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises breaking a fluid seal disposed at an outlet port of the fluid reservoir with a puncture element of the filter.

19. The method of claim 17 or claim 18, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises moving a filter assembly including the filter from an initial position to an actuated position to extend a puncture element from the filter assembly to pierce the fluid seal disposed at the outlet port of the fluid reservoir.

20. The method of claim 17 or claim 18, further comprising piercing a membrane at an output end of a filter assembly including the filter with a puncture element on the peripheral intravenous line.

21. The method of claim 17, wherein removing an initial seal isolating the fluid filter from contact with the therapeutic fluid comprises removing a clamp from the fluid reservoir.