WO2016065112A1

WO2016065112A1 - Anti-reflux valve assembly

Info

Publication number: WO2016065112A1
Application number: PCT/US2015/056851
Authority: WO
Inventors: John Hall; Jason Hatton; Andrew Smith; Gregory Olechowski
Original assignee: Aptargroup, Inc.
Priority date: 2014-10-23
Filing date: 2015-10-22
Publication date: 2016-04-28
Also published as: AR102367A1

Abstract

A valve assembly (10, 10") is provided for reverse-flow prevention, i.e, anti-reflux flow control for associated components, such as for nutritional administration to patients. The valve assembly includes a valve body (12) including a main body portion (14) and a connector portion (16, 16', 16"). A valve member (24) is positioned with the valve body (12), and can be operated between dosed and opened orientations. A reciprocable valve actuating member (46, 46', 46") is positioned within the valve body (12), and is engageable with the valve member (24) so that movement of the actuating member (46, 46', 46") between the first and second positions moves the valve member (24) between its closed and opened orientations.

Description

ANTI-REFLUX VALVE ASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable.

MICROFICHE/COPYRIGHT REFERENCE [0003] Not Applicable.

FIELD OF THE INVENTION

[0004] The present invention relates generally to a valve assembly which can be advantageously used for patient care and like medical applications, and more

particularly to an anti-reflux valve assembly which can be configured to provide flow- control characteristics consistent with specific medical applications, including anti-reflux flow control for patient care.

BACKGROUND OF THE INVENTION

[0005] Many medical applications require flow-controlling devices for controlling flow of products for enteral nutritional administration, intravenous administration, and like patient care. To promote efficient use for various medical applications, systems and devices for administering solutions and other compounds can be configured to facilitate use for certain applications. For example, certain medical applications require certain flow characteristics, including reverse-flow prevention.

[0006] Additionally, various types of tubing connectors and the like can be configured for enteral nutritional administration, while the same connectors cannot be properly used for other applications, such as intravenous administration.

[0007] The present invention contemplates a valve assembly which can be specifically configured for specific medical applications, and in particular can be configured to provide anti-reflux, flow-control characteristics as may be required by the specific patient care application.

SUMMARY OF THE INVENTION

[0008] In accordance with one feature of the invention, a valve assembly is provided for controlling flow of flowable substances, which assembly is particularly suitable for medical applications, and can be configured for enteral nutritional administration. In one feature, the valve assembly is configured to substantially prevent anti-reflux flow, that is, to substantially prevent reverse reflux flow from a patient, such as in connection with an enteral feeding application. The valve assembly includes in internal, reciprocable actuating member which controls flow through the assembly. The actuation member cooperates with an associated valve member to effect opening of the valve member. The valve member is preferably configured to substantially prevent reverse flow through the valve member and through the valve assembly.

[0009] In the presently preferred form, the valve assembly can be specifically configured for a selected type of medical application, with the valve assembly being configured for use for that specific application only. This desirably avoids inadvertent connection of components associated with one type of patient care, e.g. enteral nutritional administration, with another type of patient care, e.g. intravenous

administration. The flow-control characteristics of the valve assembly can be specifically configured for the desired application, including anti-reflux characteristics, and anti-backflow characteristics, as can be desirable for certain applications.

[0010] In one feature, a valve assembly comprises a valve body defining an internal flow passage. A valve member is positioned within the valve body to control the flow of liquid through said internal flow passage, with the valve member being positionable in: (1) a first, closed orientation for substantially preventing the flow of liquid through the internal flow passage; and (2) a second, opened orientation for permitting flow of liquid through the internal flow passage.

[0011] As one feature, a reciprocablevalve actuating member is positioned within the valve body for operative engagement with the valve member. The valve actuating member is moveable between: (1) a first position wherein the valve member is in the closed orientation; and (2) a second position wherein the valve actuating member engages the valve member and maintains the valve member in the opened orientation thereof. The valve actuating member thus effects opening of the valve member to allow liquid flow with minimal pressure loss during times of desired flow (i.e., when a connector is attached to the valve assembly.

[0012] In the preferred practice of the invention the valve member is configured to prevent reverse liquid flow through the valve assembly when the valve member is in its first, closed orientation.

[0013] As one feature, in accordance with the illustrated embodiment, the valve member comprises a resiliently deformable slit valve defining a plurality of deflectable valve petals, with the valve actuating member engaging and deflecting said valve petals by movement of said valve actuating member from the first position to the second position thereof.

[0014] According to one feature, the valve actuating member includes a distal portion engageable with the valve member, and a proximal portion engageable by an associated connector element configured for detachable connection to said valve body. [0015] In another feature, the valve body includes a main body portion, and a connector portion joined to the main body portion, with the valve member being positioned generally between the main body portion and the connector portion. In the illustrated embodiment, an annular valve retainer is joined to the connector portion of the valve body, with the valve member being positioned between the connector portion and the valve retainer for engagement by the distal portion of said valve actuating member.

[0016] According to one feature, the connector portion of the valve body includes a plurality of circumferentially spaced retention fingers for engaging the valve member, with the valve actuating member defining a plurality of openings within which the retention fingers are respectively positioned.

[0017] As one feature, the connector portion of the valve body can be configured for enteral nutritional administration in accordance with ISO 80369-3. For other applications, such as for intravenous or dialysis administration, the connection portion of the valve body can be varied, as may be required for that application.

[0018] As one feature, the connector portion of the valve body defines at least one opening within which the at least one proximal portion of the valve actuating member is positioned. In the illustrated embodiment, the valve actuating member includes three of the proximal portions, and the connector portion defines three of the openings within which the three proximal portions of the valve actuating member are respectively positioned. This arrangement provides for reciprocable movement of the valve actuating member, attendant to attachment of an associated connector element to the valve assembly, by engagement of the connector element with the proximal portions of the valve actuating member.

[0019] In another feature, a biasing element is positioned in the valve body for cooperation with the valve actuating member. When the valve actuating member is moved from the first position thereof to the second position thereof, the biasing elementbiases the valve actuating member from the second position thereof toward the first position thereof.

[0020] As another feature, the biasing element comprises an annular, elastomeric biasing element, and can be formed unitarily with valve member of the valve assembly.

[0021] In one feature, the configuration of the valve member can be varied, depending upon the specific application of the valve assembly. The valve member is typically a one-way valve, with the arrangement providing for controlled flow of liquids. For enteral nutritional administration, the valve member can be configured to provide anti-reflux or anti-backflow characteristics, such as for nutritional administration, prior to, or after infusion. When configured for anti-reflux use, the present valve assembly can be operatively connected with the gastrostomy or other feeding tube provided for a patient, thus acting to preclude undesired reflux from the patient, as can occur if the patient is moved, coughs, or the like.

[0022] A resiliently deformable valve member suitable for use in the present valve assembly can be configured in accordance with the teachings of U.S. Patent No.

5,839,614, hereby incorporated by reference. Other designs or types of valves (not illustrated) may be employed instead.

[0023] In another feature, in an alternate embodiment, a modified valve actuating member of the present valve assembly is provided with a configuration to abate potential leakage of liquid through the components of the valve assembly. To this end, the valve actuating member includes a sleeve-like, cylindrical inlet portion, with a modified connector portion of the valve assembly defining an annular recess within which the cylindrical inlet portion of the valve actuating member is reciprocably moveable.

[0024] It should be appreciated that the invention may include any or all of the above described features, include only one of the above features, more than one of the above features, and any combination of the above features. Furthermore, other objects, features, and advantages of the invention will become apparent from a review of the entire specification, including the drawings.

[0025] Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention, from the claims, and from the accompanying drawings.

BRIEF DECRIPTION OF THE DRAWINGS

[0026] In the accompanying drawings forming part of the specification, in which like numerals are employed to designate like parts throughout the same,

FIG. 1 is an isometric view taken from an exterior side of an anti-reflux valve assembly embodying the present invention, and FIG. 1 shows the valve assembly partly partially connected at its upper, inlet end to an associated connector element of a tubing set, such as for enteral nutritional administration, and shows the valve assembly connected at its lower, outlet end to outlet tubing for extending to, for example, a patient;

FIG. 2 is a top, plan view thereof;

FIG. 3 is a cross-sectional taken along the plane 3-3 in FIG. 2;

FIG. 4 is a cross-sectional view taken along the plane 4-4 in FIG. 2;

FIG. 5 is an exploded, isometric view of the valve assembly shown in FIG. 1 ;

FIGS. 6 and 7 are cross-sectional views similar to FIGS. 3 and 4, respectively, but FIGS. 6 and 7 show the connector element more fully connected with the valve assembly;

FIGS. 8 and 9 are cross-sectional views similar to FIGS. 6 and 7, respectively, but in FIGS. 8 and 9, a connector element has been rotated about 180 degrees to actuate a valve in the valve assembly to an open condition which permits liquid flow therethrough;

FIG. 10 is an exploded, isometric view of the components shown in FIG. 8;

FIG. 11 is a relatively enlarged isometric view from an exterior side of a connector portion of the present valve assembly;

FIG. 12 is a further relatively enlarged isometric view from an exterior side of the connector portion of the present valve assembly;

FIG. 13 is a top plan view of the connector portion shown in FIGS. 11 and 12;

FIG. 14 is a bottom plan view of the connector portion shown in FIGS. 11 and 12;

FIG. 15 is a cross-sectional view of the connector portion taken along the plane

15- 15 of FIG. 13;

FIG. 16 is a cross-sectional view of the connector portion taken along the plane

16- 16 of FIG. 13;

FIG. 17 is a relatively enlarged isometric view of a valve actuating member of the present valve assembly;

FIG. 18 is a further relatively enlarged isometric view of the valve actuating member of the present valve assembly;

FIG. 19 is a top plan view of the valve actuating member shown in FIGS. 17 and

18;

FIG. 20 is a cross-sectional view of the valve actuating member taken along plane 20-20 of FIG. 19;

FIG. 21 is a relatively enlarged isometric view of a valve member, illustrated as a resilient slit valve, of the present valve assembly;

FIG. 22 is a further isometric view of the valve member of the present valve assembly; FIG. 23 is a side elevational view of the valve member of the present valve assembly;

FIG. 24 is a top plan view of the valve member of the present valve assembly;

FIG. 25 is a cross-sectional view of the valve member of the present valve assembly taken along the plane 25-25 of FIG. 24;

FIG. 26 is a relatively enlarged isometric view of an annular valve retainer of the present valve assembly;

FIG. 27 is a further relatively enlarged isometric view of theannular valve retainer of the present valve assembly;

FIG. 28 is a top plan view of the annular valve retainer shown in FIGS. 26 and

27;

FIG. 29 is a cross-sectional view of the valve retainer taken along plane 29-29 of FIG. 28;

FIG. 30 is a relatively enlarged isometric view of an alternate embodiment of a valve actuating member of the present invention;

FIG. 31 is a further relatively enlarged isometric view of the alternate

embodiment of the valve actuating member shown in FIG. 30;

FIG. 32 is a cross-sectional view of alternate embodiment of a connector portion of the present valve assembly;

FIG. 33 is a bottom plan view of the alternate embodiment of the connector portion shown in FIG. 32;

FIG. 34 is a cross-sectional view of the valve actuating member and the connector portion shown in FIGS. 30-33 in an assembled in condition, illustrating connection to an associated connector element of a tubing set; FIG. 35 is a cross-sectional view similar to FIG. 34 further illustrating connection of the associated connector element of the tubing set, whereby the valve assembly is placed in an open condition for liquid flow;

FIG. 36 is an exploded, isometric view of some components of another alternate embodiment of a valve assembly embodying the present invention;

FIG. 37 is a side elevational view of the components shown in FIG. 36, but in FIG. 37 the components are shown assembled, and the associated connector element is shown at a first axial distance in relation to the valve assembly connector portion;

FIG. 38 is a top plan view of the components shown in FIG. 37;

FIG. 39 is a cross-sectional view of the components shown in FIG. 37 taken generally along the plane 39-39 of FIG. 38;

FIG. 40 is a cross-sectional view of the components shown in FIG. 37 taken generally along the plane 40-40 of FIG. 38;

FIG. 41 is a cross-sectional view of the components shown in FIG. 37 taken generally along the plane 41-41 of FIG. 38;

FIG. 42 is a side elevational view of the components shown in FIG. 36, but in FIG. 42 the components are shown assembled, and the associated connector element is shown at a second axial distance in relation to the valve assembly connector portion, wherein the connector element is positioned further within the connector element;

FIG. 43 is a top plan view of the components shown in FIG. 42;

FIG. 44 is a cross-sectional view of the components shown in FIG. 42 taken generally along the plane 44-44 of FIG. 43;

FIG. 45 is a cross-sectional view of the components shown in FIG. 42 taken generally along the plane 45-45 of FIG. 43; FIG. 46 is a cross-sectional view of the components shown in FIG. 42 taken along the plane 46-46 of FIG. 43;

FIG. 47 is a side elevational view of the components shown in FIG. 36, but in FIG. 47 the components are shown assembled, and the associated connector element is shown at a third axial distance in relation to the valve assembly connector portion, wherein the connector element is positioned yet further within the connector element to actuate a valve in the valve assembly to an open condition which permits liquid flow therethrough;

FIG. 48 is a top plan view of the components shown in FIG. 47;

FIG. 49 is a cross-sectional view of the components shown in FIG. 47 taken generally along the plane 49-49 of FIG. 48;

FIG. 50 is a cross-sectional view of the components shown in FIG. 47 taken generally along the plane 50-50 of FIG. 48;

FIG. 51 is a cross-sectional view of the components shown in FIG. 47 taken generally along the plane 51-51 of FIG. 48;

FIG. 52 is an enlarged, side elevational view of the valve actuating member shown in FIG. 36;

FIG. 53 is a top plan view of the valve actuating member shown in FIG. 52;

FIG. 54 is a cross-sectional the valve actuating member shown in FIG. 52 taken along the plane 54-54 of FIG. 53;

FIG. 55 is a bottom plan view of the valve actuating member shown in FIG. 52;

FIG. 56 is an enlarged, side elevational view of the connector member shown in FIG. 36;

FIG. 57 is a top plan view of the connector member shown in FIG. 56; FIG. 58 is a cross-sectional the connector member shown in FIG. 56 taken generally along the plane 58-58 of FIG. 57;

FIG. 59 is a cross-sectional the connector member shown in FIG. 56 taken generally along the plane 59-59 of FIG. 57;

FIG. 60 is a cross-sectional the connector member shown in FIG. 56 taken generally along the plane 60-60 of FIG. 57;

FIG. 61 is a bottom plan view of the connector member shown in FIG. 56; and

FIG. 62 is an isometric view of the connector member shown in FIG. 56, as viewed from below and looking up through the connector member.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0027] While this invention is susceptible of embodiments in many different forms, this specification and the accompanying drawings disclosed one specific form as an example of the invention. The invention is not intended to be limited to the embodiment so described, however. The scope of the invention is pointed out in the appended claims.

[0028] As discussed in detail hereinafter, many medical applications require flow- controlling devices for controlling flow of products for enteral nutritional administration, intravenous administration, and like patient care. To promote efficient use for various medical applications, systems and devices for administering solutions and other compounds can be configured to facilitate use for certain applications, while precluding use for other applications. For example, various types of tubing connectors and the like can be configured for enteral nutritional administration, while the same connectors cannot be properly used for other applications, such as intravenous administration.

[0029] Additionally, certain medical applications require certain flow

characteristics, such as reverse-flow prevention, including anti-reflux flow control.

When configured for anti-reflux use, the present valve assembly can be operatively connected with the gastrostomy or other feeding tube provided for a patient, thus acting to preclude undesired reflux from the patient, as can occur if the patient moves, coughs, or the like.

[0030] The present invention contemplates a valve assembly which can be specifically configured for specific medical applications, and can be configured to exhibit anti-reflux or anti-backflow characteristics as may be required for specific applications, such as enteral nutritional administration. To this end, in accordance with the illustrated embodiment, the present valve assembly has been particularly configured for enteral nutritional administration, and includes a connector portion configured in accordance with ISO 80369-3. For other applications, such as for intravenous or dialysis

administration, including parenteral nutritional administration, the configuration of the connector portion can be varied, as may be required for that application.

[0031] As will be further described in detail, the present valve assembly comprises a valve body which defines an internal flow passage, with the valve body including a connector portion at one end thereof. As noted, this connector portion can be configured in accordance with ISO 80369-3, to facilitate use of the valve assembly for enteral administration, while precluding use in other applications.

[0032] In order to control flow through the valve assembly, the assembly includes a resiliently deformable valve member positioned within the valve body. In order to control liquid flow through the valve assembly, the valve member is positionable in: (1) a first, closed orientation for substantially preventing the flow of liquid through the internal flow passage, and; (2) a second, opened orientation for permitting flow of liquid through the internal flow passage.

[0033] While the specific configuration of the valve member can be varied, depending upon the specific application of the valve assembly, in the illustrated embodiment the valve member is configured to provide anti-reflex or anti-backflow characteristics, such as during enteral nutritional administration, prior, during, or after infusion.

[0034] In accordance with the present invention, the valve assembly includes a reciprocable valve actuating member in operative engagement with the valve member. As will be further described, the valve actuating member is moveable between: (1) a first position wherein when the valve member is in the closed orientation; and (2) a second position wherein the valve actuating member engages the valve member and maintains the valve member in the second, opened orientation thereof. Actuation in this manner is effected in conjunction with attachment of an associated connector element, such a from a suitable nutritional administration tubing set, to the connector portion of the valve body. In the preferred form the valve member is configured to substantially prevent reverse liquid flow through the valve assembly when the valve member is in its first, closed orientation. It is presently preferred that the valve member itself act to prevent reverse liquid flow, without the need to engage the valve actuating member.

[0035] With reference now to drawings, therein is illustrated a preferred embodiment of the present valve assembly of the present invention, designated 10. While valve assembly 10 can be configured for a wide variety of applications where reverse flow prevention is desired, this embodiment of the valve assembly has been particularly configured for enteral nutritional administration with anti-reflux flow control. For this application, one or more components of the assembly can be specifically configured in accordance with ISO 80369-3. Configuring one or more components of the present valve assembly in accordance with this design specification permits efficient and convenient use of the valve assembly in enteral nutritional administration systems, while precluding inadvertent use of the valve assembly in other applications, such as for intravenous application.

[0036] In accordance with the illustrated embodiment, integrated valve assembly 10 comprises a generally tubular valve body 12, including a main body portion 14, and connector portion 16 joined to the main body portion 14. Together, these components of the valve assembly define an internal flow passage 18 through which liquid flows through the valve assembly. In the illustrated embodiment, the connection portion 16 has been configured as a male connector in accordance with ISO 80369-3, with connector portion 16 including a suitable internal thread formation 20 for this purpose. The valve assembly 10 is thus configured for detachable connection to an associated tubing set configured for enteral feeding, including an associated connector element C, and tubing T. In the illustrated embodiment, the valve body 12 includes an enlarged external side portion that could include a side access port or balloon inflation line that are typical in standard gastrostomy tubes. These details are not shown in the illustration but are well known in the art.

[0037] In accordance with the present invention, valve assembly 10 includes a valve member 24 positioned within the valve body 12 to control the follow of liquid through the internal passage 18. In the preferred form, the valve member 24 comprises a resiliently deformable slit valve such as formed in accordance with the teachings of U.S. Patent No. 5,839,614, the disclosure of which is hereby incorporated by reference. Other designs or types of valves (not illustrated) may be employed instead.

[0038] In the preferred embodiment, the valve member 24 is a self-closing, slit- type valve and can be seen in greater detail in FIGS. 21-25. The valve member 24 is preferably molded as a unitary structure from material which is flexible, pliable, elastic, and resilient. This can include elastomers, such as a synthetic, thermosetting polymer, including silicone rubber, such as the silicone rubber sold by Dow Corning Corp. in the United States of America under the trade designation C6-560. Another suitable silicone rubber material is sold in the United States of America under the designation Wacker 3003-60 by Wacker Silicone Company. Both of these materials have a hardness rating of 60 Shore A. Other hardness materials could also be used. The valve member 24 can also be molded from other thermosetting materials or from other elastomeric materials, or from thermoplastic polymers or thermoplastic elastomers, including those based upon materials such as thermoplastic propylene, ethylene, urethane and stryrene, including their halogenated counterparts.

[0039] The valve member 24 is illustrated in greater detail in FIGS. 21-25. The valve member comprises a deformable head portion 26 defining at least one slit 28, with two such intersecting slits 28 shown in the illustrated embodiment. The slits 28 define a plurality of deflectable valve petals. The valve member 24 further includes a peripheral attachment portion 30 for mounting the valve member in the valve body 12, with the valve member further including an annular sleeve portion 32 which extends between and joins head portion 26 with peripheral attachment portion 30.

[0040] Notably, in accordance with the preferred embodiment of the present invention, valve member 24, includes a biasing element 34 formed unitarily with the valve member.

[0041] As will be further described, the biasing element 34 cooperates with a reciprocably moveable actuating member of the valve assembly to ensure consistent operation. By virtue of the elastomeric material, typically silicone, from which the valve member 24 is formed, the biasing element 34 is provided in the form of an annular, elastomeric biasing element. While the biasing element 34 could be otherwise configured, such as by the provision of a separate elastomeric O-ring or the like, formation of the biasing element unitarily with the valve member 24 facilitates efficient and economical manufacture of the valve assembly 10.

[0042] As noted, the valve body 12 of the valve assembly includes a main body portion 14, and a connector portion 16 joined to the main body portion. As illustrated, the valve member 24 is positioned generally between the main body portion 14 and the connector portion 16. In accordance with the illustrated embodiment, the valve member 24 is held in position by the provision of an annular valve retainer 36 joined to the connection portion 16 of the valve body 12. The specific configuration of the valve retainer 36 is illustrated in FIGS. 26-29 with the valve retainer defining an annular groove 38 within which a portion of the peripheral attachment portion of valve member 24 is fitted. Valve member 24 is thus held in captive relationship between the valve retainer 36 and the connector portion 16 when the valve retainer is joined to the connector portion 16. To this end, the connector portion defines the annular pocket 40 for receiving the annular valve retainer 36, with the valve member 24 thus held in position within the valve body 12.

[0043] In order to control the flow of liquid through the valve assembly 10, the valve member 24 is positionable in: (1) a first, closed orientation for substantially preventing the flow of liquid through the internal flow passage 18; and (2) a second, opened orientation for permitting the flow of liquid through the internal flow passage 18 of the valve body 12. Notably, the valve member 24 is moved and deflected between these two positions by the provision of a reciprocable valve actuating member 46 positioned within the valve body 12 for operative engagement with the valve member 24.

[0044] The specific configuration of the valve actuating member 46 is illustrated FIGS. 17-20. While the specific configuration can be varied while keeping with the principles disclosed herein, the valve actuating member 46 is configured to function such that it is engageable by the associated connector element C of the tubing set when the connector element is received within the connector portion 16 of the valve assembly, thereby moving and displacing the valve actuating member 46 for engaging and deflecting the petals of the deformable head portion 42 of the valve member. To this end, the valve actuating member 46 includes a distal portion 48 engageable with the valve member 24, and at least one proximal portion 50 engageable by the associated connector element C. As illustrated, the distal portion 48 of the valve actuating member has a generally annular configuration, defining a central opening 52 through which liquid flows from the connector portion 16, through the valve member 24 in its opened orientation, through the internal flow passage 18, and out of the valve assembly. [0045] Disposition of the valve actuating member 46 within the valve assembly is accommodated by the provision of at least one opening 54 in the connector portion 16 of the valve body. In accordance with the illustrated embodiment, wherein three of the proximal portions 50 are provided on the valve actuating member 46, the connector portion 16 defines three of the openings 54 within which the three proximal portions 50 of the valve actuating member 46 are respectively positioned. In the current

embodiment, assembly is facilitated by permitting the three proximal portions 50 to flex and deflect slightly inwardly to permit insertion upwardly into the openings 54 defined by the connector portion 16. The three proximal portions can then move slightly outwardly to resume their initial orientation, with the ledge-like barbs provided at the outer edges of the proximal portions (see FIGS. 17 and 18) cooperating with the connector portion 16 to maintain the valve actuating member 46 generally in position within the connector portion 16.

[0046] Thus, the valve actuating member 46 is positioned within the valve body 12 for operative engagement with the valve member 24. By virtue of the reciprocable disposition of the valve actuating member 46 within the valve body, the valve actuating member is moveable between: (1) a first position when the valve member 24 is in its closed orientation; and (2) a second position, wherein the valve actuating member engages the valve member 24, and maintains the valve member 24 in its second, opened orientation.

[0047] As noted, detachable connection of the connector element C of the associated tubing set to the connector portion 16 of the valve assembly results in the connector element C engaging the valve actuating member 46, whereby the valve actuating member is moved from its first position to its second position, thereby engaging and deflecting the valve member 24 from its first, closed orientation, to its second, opened orientation for permitting flow through the valve assembly. In turn, removal of the connector element C from the valve assembly permits the valve actuating member 46 to return to its first position from its second position. Movement in this fashion takes place under the influence of the resiliently deformable valve member 24, as the valve member 24 moves from its second, open orientation back to its first, closed orientation by movement of the petals defined by the valve slits 28.

[0048] In order to ensure consistent operation of the valve assembly, given the friction that can exist between the distal portion 48 of the valve actuating member 46 and the deformable petals of the head portion 26 of the valve member 24, the valve actuating member 46 is engageable with the biasing element 34 when the valve actuating member is moved from its first position to its second position. The biasing element 34 thus cooperates with the valve actuating member for biasing the valve actuating member from its second position towards its first position. Again, the provision of the biasing element 34 unitarily with the valve member 24 provides the valve assembly 10 with a desirably compact and efficient configuration, while minimizing the individual components required for the valve assembly.

[0049] Additional features of the present valve assembly contribute to its compact and efficient configuration. As will be appreciated, the reciprocable valve actuating member 46 is carried generally within connector portion 16 of the valve body, and is held in position therein generally by the annular valve retainer 36 and valve member 24. In order to hold valve member 24 in position, while accommodating reciprocable movement of the valve actuating member 46, the interior surface of the connector portion 16 includes a plurality of circumferentially spaced valve retention fingers 56 which are positioned within respective openings 58 defined by the valve actuating member 46. This configuration of the valve assembly permits the desired reciprocable movement of the actuating member, while ensuring that the valve member 24 is held in position in the valve body. As will be appreciated, because the present valve assembly is particularly configured to prevent reverse flow through the valve assembly, the annular valve retainer 36 at the "downstream" side of the valve member provides a substantially continuous interface with the peripheral attachment portion 30 and annular sleeve portion 32, while the "upstream" of the valve member 24 need not have such a continuous engagement interface, and can thus be held in position by the plurality of spaced apart retention fingers 56.

[0050] From the foregoing description, operation of the present valve assembly 10 will be readily appreciated. Insertion of connector element C into the valve body 12 for attachment to connector portion 16 results in the connector element C moving into the valve body and engaging the proximal portions 50 of the reciprocable valve actuating member 46. Threaded engagement of the connector element C with the connector portion 16 displaces the valve actuating member 46 from its first position to its second position. Attendant to this movement, the distal portion 48 of the valve actuating member engages and deflects the petals of the head portion 26 of the resiliently deformable slit valve 24, thereby moving the valve member from its first, closed orientation to its second, opened orientation for permitting flow through the valve assembly. Attendant to this action, the valve actuating member 46 engages the annular biasing element 34, compressing the elastomeric biasing element as the actuating member moves from its first to its second position.

[0051] Upon disconnection of connector element C from the valve assembly, valve member 24 moves from its opened orientation to its closed orientation, by virtue of the resilience of the head portion 26. At the same time, the annular biasing element 34 urges the reciprocable valve actuating member 46 from its second position back to its first position, as the valve actuating member moves within the connector portion 16 of the valve body. With the valve member 24 in its closed orientation, and the valve actuating member 46 in its first position, reverse fluid flow through the valve assembly is substantially prevented.

[0052] In the preferred practice of the present invention, the resilience and configuration of valve member 24 acts to substantially prevent reverse liquid flow through the valve assembly 10 when the valve member is in its closed orientation. The anti-reflux properties are aided by the diametric interference on the valve head as described in U.S. Patent Publication No. 2014/0224356, hereby incorporated by reference. Thus, engagement of the valve member 24 with the valve actuating member 46 may augment anti-reflux performance, but such engagement is not required to achieve the desired anti-reflux performance. The valve actuating member 46 functions to open the valve member 24 and allow liquid flow with minimal pressure loss during times of desired flow (i.e., when a connector is attached to the valve assembly 10.) Preferably, the valve assembly 10 of the present invention can achieve anti-reflux performance up to and exceeding 100 kPa.

[0053] Because the valve actuating member 46 is held in generally captive relationship within the connector portion 16, further upward movement is substantially prevented. Thus, in the first position of the valve actuating member 46, the actuating member is engageable by the valve member 24 in its first, closed orientation, and the actuating member thus can act as a mechanical stop to the valve member, and thus additionally act to substantially prevent reverse flow of liquid through the valve member and the internal flow passage of the valve assembly.

[0054] Referring now to FIGS. 30-35, features of an alternate embodiment of the present valve assembly are illustrated. In most respects, this embodiment is like the previously described embodiment, but includes a modified valve actuating member 46' provided with a configuration to abate potential leakage of liquid through the

components of the valve assembly. To this end, the valve actuating member 46' includes a sleeve-like, cylindrical inlet portion 45 extending generally upwardly from distal portion 48. A modified connector portion 16' (FIGS. 32 and 33) of the valve assembly defines an annular recess 45' within which the cylindrical inlet portion 45 of the valve actuating member is reciprocably moveable. The annular recess 45' thus provides a counterbore for the sleeve-like inlet portion 45 of the actuating member 46' to provide a substantially continuous flow path through the valve assembly, with the arrangement desirably acting to reduce the likelihood of leakage through the

connection. [0055] FIGS. 34 and 35 illustrate the modified valve actuating member 46' and the modified connector portion 16' in an assembled condition, showing coaction with an associated connector element of a tubing set. FIG. 34 shows the actuating member 46' in its first position, and the associated valve member 24 in its first, closed orientation, while FIG. 35 shows the actuating member in its second position, and the valve member in its second, opened orientation for permitting flow of liquid through the valve

assembly.

[0056] A third embodiment of the present invention is illustrated in FIGS. 36-62. As seen in FIG. 36, the third embodiment of the valve assembly 10" includes a connector portion 16" having threads 20" for receiving a connector element C. As seen in FIG. 40, the connector portion 16", together with an annular valve retainer 36, retains a valve member 24 within the connector portion 16". A valve actuating member 46" is held in a generally reciprocating, captive relationship with respect to the connector portion 16". The valve actuating member 46" further has a distal portion 48" for contacting and deflecting the petals of the head portion 26 of the resiliently deformable slit valve member 24.

[0057] The third embodiment of the valve assembly is similar to the first embodiment of the valve assembly shown in FIGS. 1-29. The connector element C, valve member 24, and retainer 36 in the third embodiment are identical to the identically designated components of the first embodiment described above with reference to FIGS. 1-29. However, the third embodiment of the valve assembly 10" has a modified connector portion 16" receiving a modified valve actuating member 46", the latter of which functions as a "floating post" which engages or interfaces with the connector element C in a different manner than that of the valve actuating member 46 of the first embodiment, as will be discussed in detail hereinafter.

[0058] Referring to FIG. 54, the valve actuating member 46" is provided with a modified proximal portion 50" having the form of an elongate, generally cylindrical wall or post with an outer surface 62" and an internal surface 64" that defines an internal, through passage. The outer surface 62" is tapered for being received within the connector element C and mating with a corresponding tapered, interior surface 66" of the connector element C (FIG. 39), as will be discussed hereinafter. The proximal portion 50" terminates in a sloping surface or chamfer 68" that helps to center the proximal portion 50" within the connector element C when the user initially mates the valve actuating member 46" within the connector element C to begin connecting the connector element C to the connector portion 16".

[0059] Referring next to FIG. 55, the modified valve actuating member 46" is further provided with an annular projection or flange 70" having a plurality of notches or openings 74". Preferably, the flange 70" has three openings 74". The flange 70" functions to abut or otherwise contact an inwardly-extending, annular projection 76" of the connector portion 16" (FIGS. 39 and 60) to limit movement of the valve actuating member 46" in one axial direction. The openings 74" function to accommodate a plurality of circumferentially spaced valve retention fingers or ribs 56" (FIGS. 40, 59, and 62) to limit rotational movement of the valve actuating member 46" with respect to the connector portion 16", as will be discussed herein.

[0060] Operation of the third embodiment of the valve assembly will now be discussed. Generally, the valve actuating member 46" is positioned within the connector portion 16" for operative engagement with the valve member 24. By virtue of the reciprocating disposition of the valve actuating member 46" within the connector portion 16", the valve actuating member 46" is moveable between at least: (1) a first position (FIG. 39) when the valve member 24 is in its closed orientation (e.g., configuration, state, or condition); and (2) a second position (FIG. 49), wherein the valve actuating member 46" engages the valve member 24, and maintains the valve member 24 in a second, opened orientation. The unobstructed passage defined by surface 64" allows for unimpeded nutritional formula flow during feeding through the valve assembly. [0061] FIGS. 37-41 show the connector element C at a first axial location with respect to the connector portion 16". Referring to FIG. 39, insertion of connector element C axially toward connector portion 16" results in the connector element C engaging the proximal portion 50" of the reciprocable, valve actuating member 46". Specifically, the connector element C moves axially over the valve actuating member 46" until its tapered outer surface 62" contacts the tapered interior surface 66" of the connector element C.

[0062] FIGS. 42-46 show the connector element C at a second axial location with respect to the connector portion 16", wherein the connector element C has initially made contact with the threads 20" of the connector portion 16". Movement of the connector element C toward the connector portion 16" has caused the surfaces 62" and 66" to become frictionally engaged at a predetermined location such that any further movement of the connector element C axially into the connector portion 16" (caused by the threading (screwing) action between the connector element C and connector portion 16") forces the valve actuating member 46" to also move axially with connector portion 16" even though the valve actuating member 46" is prevented from rotating by the engagement of the connector portion ribs 56" (FIG. 45) within the openings 74" of the valve actuating member 46".

[0063] As can be seen by comparing FIG. 39 with FIG. 44, the valve actuating member 46" has been moved axially toward the valve member 24 and the flange 70" has moved away from the annular projection 76" of the connector portion 16". In the second axial location of the connector element C, illustrated in FIGS. 44-46, it can be seen that the distal portion 48" of the valve actuating member 46" has engaged the head portion 26 of the valve member 24, but not in a manner sufficient to open the valve petals.

[0064] FIGS. 47-51 show the connector element C at a third axial location with respect to the connector portion 16", wherein the connector element C has been threaded further within the connector portion 16". Threading engagement of the connector element C with the connector portion 16" has further displaced the valve actuating member 46" in an axial direction toward, and through, the valve member 24. Attendant to this movement, the distal portion 48" of the valve actuating member 46" engages and deflects the petals of the head portion 26 of the resiliently deformable slit valve member 24, thereby moving or changing the valve member 24 from its first, closed orientation to its second, opened orientation for permitting flow through the valve assembly. Attendant to this action, the valve actuating member 46" engages the annular elastomeric biasing element 34 (FIGS. 39, 44, and 49), compressing the biasing element 34 as the actuating member 46" moves in the axial direction in the same manner is with the first embodiment illustrated in FIGS. 1-29.

[0065] It will be appreciated that the valve actuating member 46" is rotationally constrained by the valve retention ribs 56" (FIG. 50) that extend through the openings 74" in the flange 70" (FIG. 53). Thus, as the connector element C is threaded or rotated with respect to the connector portion 16", the frictional!y engaged surfaces 62" and 66" must actually slip to accommodate rotation of the connector element C with respect to the connector portion 16". Preferably, the frictional engagement between the surfaces 62" and 66" (albeit "slipping" rotationally) maintains a fluid-tight seal even during the slipping motion of the valve actuating member 46" within the connector element C. Furthermore, it is preferable that the surfaces 62" and 66" slip with a negligible or acceptable amount of wear to either surface 62" or 66". Even as the interior tapered surface 66" of the connector element C slips rotationally around the mating tapered surface 62" of the valve actuating member 46", which is prevented from rotating, the valve actuating member 46" is urged axially toward and through the valve member 24 due to the axial force and axial movement of the connector element C.

[0066] Referring to FIG. 49, the actuating member flange 70" can be seen as axially spaced a further distance from the annular projection 76" of the connector portion 16" when the connector element C is in the illustrated third axial location. [0067] Upon disconnection of connector element C from the valve assembly, valve member 24 moves from its opened orientation to its closed orientation, by virtue of the resilience of the valve head portion 26. At the same time, the annular biasing element 34 urges the reciprocable valve actuating member 46" axially away from the valve 24, within the connector portion 16". When the valve member 24 has returned to its closed orientation, and the flange 70" of the valve actuating member 46" is returned to its location proximal to, or against, the annular projection 76", reverse fluid flow through the valve assembly is prevented, or at least substantially prevented or minimized.

[0068] In the preferred practice of the third embodiment of the present invention, the resilience and configuration of valve member 24 acts to substantially prevent reverse liquid flow through the valve assembly when the valve member 24 is in its closed orientation. The anti-reflux properties are aided by the diametric interference on the valve head 26, as previously discussed above. Thus, engagement of the valve member 24 with the valve actuating member 46" may augment anti-reflux performance, but such engagement is not required to achieve the desired anti-reflux performance. The valve actuating member 46" functions to open the valve member 24 and allow liquid flow, into and through the through passage defined by the interior surface 64", with minimal pressure loss during times of desired flow (i.e., when a connector element C is attached to the connector portion 16"). Preferably, the valve assembly of the present invention (e.g., shown as assembly 10 in FIG. 1 and assembly 10" in FIG. 36) can achieve anti-reflux performance up to and exceeding 100 kPa.

[0069] Because the valve actuating member 46" is held in generally captive relationship within the connector portion 16", further axially upward movement is substantially limited. In the closed orientation of the valve 24, the abutment of the flange 70" and the annular projection 76" can act as a mechanical stop to the valve member 24, and thus additionally act to substantially prevent reverse flow of liquid through the valve member 24 and the internal flow passage of the valve assembly. [0070] The inventors have found that embodiments of the valve assembly shown herein may allow the patient or caregiver to perform an enteral feeding operation without first having to separately open a clamp or other mechanical seal on the inlet supply tubing because the valve 24 opens mechanically as a result of connection of the connector C within the valve assembly. Furthermore the patient or caregiver need not remember to replace a cap or plug after enteral feeding because the valve assembly closes automatically when the associated connector C is removed from the valve assembly.

[0071] It will be readily observed from the foregoing detailed description of the invention and from the illustrations thereof that numerous other variations and modifications may be effected without departing from the true spirit and scope of the novel concepts or principles of this invention.

Claims

WHAT IS CLAIMED IS:

1. A valve assembly (10, 10"), comprising:

a valve body (12) defining an internal flow passage (18); a valve member (24) positioned within said valve body (12) to control the flow of liquid through said internal flow passage (18), said valve member (24) being positionable in: (1) a first, closed orientation for substantially preventing the flow of liquid through said internal flow passage (18); and (2) a second, opened orientation for permitting flow of liquid through said internal flow passage (18), and a valve actuating member (46, 46', 46") positioned within said valve body (12) for operative engagement with said valve member (24), said valve actuating member (46, 46', 46") being moveable between: (1) a first position when said valve member (24) is in said closed orientation; and (2) a second position, wherein said valve actuating member (46, 46', 46") engages said valve member (24) and maintains said valve member (24) in said second, opened orientation thereof.

2. A valve assembly (10, 10") in accordance with claim 1 , wherein

said valve actuating member (46, 46', 46") includes a distal portion (48, 48") engageable with said valve member (24), and at least one proximal portion (50, 50") engageable by an associated connector element C configured for detachable connection to said valve body (12).

3. A valve assembly (10") in accordance with claim 2, wherein

said at least one proximal portion (50") has a tapered, outer surface (62") frictionally engageable within an associated connector element C configured for detachable connection to said valve body (12). A valve assembly (10") in accordance with claim 2, wherein

said valve actuating member (46") is configured to define a sliding seal with an associated connector element C when said associated connector element C is connected to said valve body (12). 5. A valve assembly (10, 10") in accordance with claim 1 , wherein

said valve body (12) includes a main body portion (14), and an connector portion (16, 16', 16") joined to said main body portion (14), said valve member (24) being positioned generally between said main body portion (14) and said connector portion (16, 16', 16"). 6. A valve assembly (10, 10") in accordance with claim 5, including

an annular valve retainer (36) joined to said connector portion (16, 16', 16") of said valve body (12), said valve member (24) being positioned between said connector portion (16, 16', 16") and said valve retainer (24) for engagement by said distal portion (48, 48") of said valve actuating member (46, 46', 46"). 7. A valve assembly (10, 10") in accordance with claim 6, wherein

said connector portion (16, 16', 16") includes a plurality of circumferentially spaced retention fingers (56, 56") for engaging said valve member (24), said valve actuating member (46, 46', 46") defining a plurality of openings (58, 74") within which said retention fingers (56, 56") are respectively positioned.

8. A valve assembly (10) in accordance with claim 5, wherein

said connector portion (16, 16') defines at least one opening (54) within which said at least one proximal portion (50) of said valve actuating member (46, 46') is respectively positioned. 9. A valve assembly (10) in accordance with claim 8, wherein

said valve actuating member (46, 46') includes three of said proximal portions (50), and said connector portion (16, 16') defines three of said openings (54) within which said three proximal portions (50) of said valve actuating member (46, 46') are respectively positioned. 10. A valve assembly (10, 10") in accordance with claim 1 , further comprising:

a biasing element (34) positioned in said valve body (12) for cooperation with said valve actuating member (46, 46', 46") when said valve actuating member (46, 46', 46") is moved from said first position thereof to said second position thereof for biasing said valve actuating member (46, 46', 46") from said second position thereof toward said first position thereof. 11. A valve assembly (10, 10") in accordance with claim 10, wherein

said biasing element (34) comprises an annular, elastomeric biasing element. 12. A valve assembly (10, 10") in accordance with claim 11 , wherein

said biasing element (34) is formed unitarily with said valve member (24). 13. A valve assembly (10, 10") in accordance with claim 2, wherein

said valve member (24) comprises a resiliently deformable slit valve defining a plurality of deflectable valve petals, said valve actuating member (46, 46', 46") engaging and deflecting said valve petals by movement of said valve actuating member (46, 46', 46") from said first position to said second position thereof.

14. A valve assembly (10, 10") in accordance with claim 13, including

a biasing element (34) positioned in said valve body (12) for cooperation with said valve actuating member (46, 46', 46") when said valve actuating member (46, 46', 46") is moved from said first position thereof to said second position thereof for biasing said valve actuating member (46, 46', 46") from said second position thereof toward said first position thereof. 15. A valve assembly (10, 10") in accordance with claim 14, wherein

said biasing element (34) is formed unitarily with said valve member (24). 16. A valve assembly (10, 10"), comprising:

a valve body (12) defining an internal flow passage (18); a valve member (24) positioned within said valve body (12) to control the flow of liquid through said internal flow passage (18), said valve member (24) being positionable in: (1) a first, closed orientation for substantially preventing the flow of liquid through said internal flow passage (18); and (2) a second, opened orientation for permitting flow of liquid through said internal flow passage (18), and a valve actuating member (46, 46', 46") positioned within said valve body (12) for operative engagement with said valve member (24), said valve actuating member (46, 46', 46") being moveable between: (1) a first position when said valve member (24) is in said closed orientation; and (2) a second position, wherein said valve actuating member (46, 46', 46") engages said valve member (24) and maintains said valve member (24) in said second, opened orientation thereof. 17. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said valve actuating member (46, 46', 46") includes a distal portion (48, 48") engageable with said valve member (24), and at least one proximal portion (50, 50") engageable by an associated connector element C configured for detachable connection to said valve body (12). 18. A valve assembly (10") in accordance with any proceeding claim, wherein said at least one proximal portion (50") has a tapered, outer surface (62") frictionally engageable within an associated connector element C configured for detachable connection to said valve body (12). 19. A valve assembly (10") in accordance with any proceeding claim, wherein

said valve actuating member (46") is configured to define a sliding seal with an associated connector element C when said associated connector element C is connected to said valve body (12). 20. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said valve body (12) includes a main body portion (14), and an connector portion (16, 16', 16") joined to said main body portion (14), said valve member (24) being positioned generally between said main body portion (14) and said connector portion (16, 16', 16"). 21 . A valve assembly (10, 10") in accordance with any proceeding claim, including an annular valve retainer (36) joined to said connector portion (16, 16', 16") of said valve body (12), said valve member (24) being positioned between said connector portion (16, 16', 16") and said valve retainer (24) for engagement by said distal portion (48, 48") of said valve actuating member (46, 46', 46"). 22. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said connector portion (16, 16', 16") includes a plurality of circumferentially spaced retention fingers (56, 56") for engaging said valve member (24), said valve actuating member (46, 46', 46") defining a plurality of openings (58, 74") within which said retention fingers (56, 56") are respectively positioned. 23. A valve assembly (10) in accordance with any proceeding claim, wherein said connector portion (16, 16') defines at least one opening (54) within which said at least one proximal portion (50) of said valve actuating member (46, 46') is respectively positioned. 24. A valve assembly (10) in accordance with any proceeding claim, wherein

said valve actuating member (46, 46') includes three of said proximal portions (50), and said connector portion (16, 16') defines three of said openings (54) within which said three proximal portions (50) of said valve actuating member (46, 46') are respectively positioned. 25. A valve assembly (10, 10") in accordance with any proceeding claim, further comprising:

a biasing element (34) positioned in said valve body (12) for cooperation with said valve actuating member (46, 46', 46") when said valve actuating member (46, 46', 46") is moved from said first position thereof to said second position thereof for biasing said valve actuating member (46, 46', 46") from said second position thereof toward said first position thereof. 26. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said biasing element (34) comprises an annular, elastomeric biasing element. 27. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said biasing element (34) is formed unitarily with said valve member (24). 28. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said valve member (24) comprises a resiliently deformable slit valve defining a plurality of deflectable valve petals, said valve actuating member (46, 46', 46") engaging and deflecting said valve petals by movement of said valve actuating member (46, 46', 46") from said first position to said second position thereof. A valve assembly (10, 10") in accordance with any proceeding claim, including a biasing element (34) positioned in said valve body (12) for cooperation with said valve actuating member (46, 46', 46") when said valve actuating member (46, 46', 46") is moved from said first position thereof to said second position thereof for biasing said valve actuating member (46, 46', 46") from said second position thereof toward said first position thereof. 30. A valve assembly (10, 10") in accordance with any proceeding claim, wherein said biasing element (34) is formed unitarily with said valve member (24).