FIELD

[0001] The field relates generally to fluid vaive systems, and more particularly to fluid valve systems having septa or a septum for receiving a needle.

BACKGROUND

[0002] Many conventional valve systems for sealing a container, especially those used in a medical or therapeutic setting, include a septum designed to be pierced by a needle or cannula of a syringe. Fluid may be transferred through the needle from the container to the syringe or vice versa.

[0003] Conventional needles often have holes at or near the tip of the needle. Holes through the septum formed by the needle may have an undesirable coring effect on the septum in which the needle undesirably removes a piece of the septum and creates particulates, These particulates may clog the needle or tube and obstruct the flow path of the fluid, or be released into the flow path and possibly into the patient. The particulates may further contaminate any fluid flowing through the flow path. Some septa have a pre-formed slit designed to receive the needle, but the needle may pierce the septum anywhere the tip makes contact, and may not necessarily be inserted through the slit area.

[0004] Moreover, repeated piercings of a septum by either a needle or a cannula may cause deterioration of the septum. This deterioration may lead to leakage and contamination. Many conventional valve systems and septa are designed to be used once, and repeated insertions of a needle or cannula not only introduce particulates into the flow path, but also facilitate leakage through the septum from stretching and overuse. It is important that the septum reseai with enough force that fluids do not leak therefrom and that airborne particulate matter, bacterial or viral matter do not enter therethrough. A more satisfactory system is needed.

[0005] This Background section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art. SUMMARY

[0006] In one aspect, a valve system for receiving a needle comprises a housing defining at least a portion of a fluid flow channel. The housing includes a first end, a second end, and a receiving portion. A septum is mounted in the housing for sealing the first end of the housing. The septum includes a longitudinal axis and is formed from a resilient material, The septum also includes a head portion including a tapered opening configured to receive the needle, a sealing portion configured to create a seal around the needle, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end, at Ieast one relief channel, and apertures formed in the relief channel. The apertures facilitate fluid communication between the chamber and the receiving portion when the expansion portion is extended parallel to the longitudinal axis into the receiving portion in an open position. The apertures are also configured to prevent flow communication when the expansion portion is in a closed position.

[0007j in another aspect, a septum comprises a head portion including a tapered opening configured to receive a needle about a longitudinal axis, a sealing portion configured to create a seal about a needle, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end housed within the expansion portion, at Ieast one relief channel, and a plurality of apertures formed in the relief channel. The apertures facilitate flow communication through the expansion portion when the expansion portion is extended parallel to the longitudinal axis in an open position. The apertures also prevent flow communication when the expansion portion is in a closed position.

[0008] Various refinements exist of the features noted In relation to the above- mentioned aspects. Further features may also be incorporated in the above-mentioned aspects as well. These refinements and additional features may exist individually or in any combination, For instance, various features discussed below in relation to any of the illustrated embodiments may be incorporated into any of the above-described aspects, alone or in any combination.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Fig. 1 is an exploded perspective view of a valve system including a cap, a septum, and a housing of one embodiment;

[0010] Fig, 2A and Fig, 2B respectively show perspective and side views of the septum of Fig, 1 in a closed position; [0011] Fig. 3A and Fig. 3B respectively show perspective and side views of the septum of Fig. 1 in an intermediate position;

[0012] Fig, 4A and Fig. 4B respectively show perspective and side views of the septum of Fig. 1 in an open position;

[0013] Fig. 5 is a cross-section view of the valve system of Fig. 1 with the septum in a closed position;

[0014] Fig. 6 is a cross-section view of the vaive system of Fig. 1 with the septum in an intermediate position;

[0015] Fig. 7 is a cross-section view of the valve system of Fig. 1 with the septum in an open position;

DETAILED DESCRIPTION

[0016] Referring to Fig. 1 , a system generally designated 100 is for use with a medical device of a fluid delivery system. However, system 100 may be used with other devices without departing from the scope of this disclosure, in this embodiment, system 100 is configured to prevent coring of an expanding member, such as a septum 102, when a need!e (not shown in Fig. 1) is inserted therein, while maintaining a fluid flow channel (not shown in Fig. 1) therethrough. System 100 includes a cap 106 having a tapered opening 122 for receiving the needle, a housing 104 having a first end 108 for receiving cap 106, a receiving chamber 114 for receiving septum 102 that controls fluid flow through system 100, and a second end 110 to facilitate directing fluid between system 100 and a medical device. Housing 104, septum 102, and cap 106 are configured to be coaxially aligned along longitudinal centerline axis 101. In this embodiment, the fluid is in liquid form and passes through a centrally formed fluid flow channel as described in further detail below.

[0017] Many known medical devices are configured to facilitate the passage of fluids therethrough. The term "medical device" may be used to indicate such medical instruments as surgical tubing, syringes, iV sets, medical vaive connectors, and other such devices. Medica! devices may include, but are not limited to the above list. As described below, valve system 100 may be connected to a medical valve connector, such as a Luer connector. However, system 100 may be used to transfer a fluid between any two devices. For example, for transferring fluid between a needle or cannula and a vial, for use in a pumping system for filling or emptying a vial or tube, or for transferring fluid between a needle and an IV line, Furthermore, a conventional needle, such as a bevei-tipped needie may be used, or a blunt-tipped cannula including a side port. Alternatively, any needle or cannula may be used with system 100.

[0018] In this embodiment, septum 102 is mounted within housing 104 of system 100 for sealing housing first end 108 and is substantially secured within housing 104 by cap 106. Although system 100 is designed as a two-way fluid connector valve for flow of fluid between two medical devices, it is to be understood that the direction of fluid flow as well as the particular details, size and shape of system 100 and its components may vary, including providing for one-way fluid flow, if desired.

[0019] As shown in Fig. 1, cap 106 is configured to be coupled to first end 108 of housing 104. In this embodiment, cap 106 is coupled to housing 104 via a press-fit connection. Alternatively, cap 106 may be coupled to first end 108 of housing 104 by any connection means that allows for system 100 to function as described herein, such as threadably coupled, snap-fit, or permanently attached. Cap 106 includes a first end 119 and an opposing second end 121. Cap first end 119 includes conicaily-tapered opening 122 that narrows within cap 106 and is defined by an annular guiding surface 120. Guiding surface 120 extends into cap 106 such that opening 122 terminates between first end 119 and second end 121. Guiding surface 120 is configured to direct the needle through taped opening 122. Cap 106 is formed of a hard, durable material such that contact with the needle does not damage cap 106.

[0020] In this embodiment, septum 102 includes two adjacent elements or portions. In particular, septum 102 includes a head portion 124 and an expansion portion 128. A first end 123 of head portion 124 Includes a second tapered opening 136 configured to receive a needle and expansion portion 128 includes a chamber (not shown in Fig. 1) defined therein and a relief channel 126. Expansion portion 128 extends from a head portion second end 125 opposite tapered opening 136. A sealing portion (not shown in Fig. 1) is defined within septum 102 between tapered opening 136 and the chamber. The sealing portion is configured to create a seal about the needie. The chamber is configured to receive the needle such that a pushing force by the needie facilitates elongating expansion portion 128 along axis 101 as described in further detail below.

[0021] Housing 104 includes first end 108 and opposing second end 110. First end 108 is configured to accept cap 106 on an outer surface 109 and is further configured to receive septum 102 within receiving chamber 114 within first end 108. Second end 110 includes a fluid flow member 118 and a connector portion (not shown in Fig. 1) for connecting system 100 to a medical device, such as a Luer device. The connector portion may be threaded for ease of connection to the device. It is to be noted that any type of medical device may be connected to the connector portion of the second end 110. For ease of description, system 100 will be described with respect to the needle of a syringe being inserted into opening 122 and a Luer device being connected to the connector portion of the second end 110, where the Luer device is in communication with a fluid delivery system, such as an I.V. set. The Luer device and I.V. set are omitted from the drawings for brevity.

[0022] Figs. 2A, 3A, and 4A illustrate a cross-sectional perspective view of septum 102 in the closed position, intermediate position, and open position, respectively. Figs, 2B, 3B, and 4B show a perspective side view of septum 102 in the closed position, intermediate position, and open position, respectiveiy. Septum 102 is made of a single piece of a substantially resilient material, such as rubber, latex, or silicone. Alternatively, septum 102 may be formed of any resilient material that enables system 100 to function as described herein. As described above, septum 102 includes head portion 124 and expansion portion 128. Head portion 124 includes first end 123 and opposing second end 125. Tapered opening 136 extends from head portion first end 123 toward head portion second end 125. Opening 136 is shaped substantially similarly to opening 122 such that guide surface 120 is received into opening 136 so as to direct the needle simultaneously through opening 122 of cap 106 and opening 136 of septum 102, A sealing portion 132 is defined within head portion 124 of septum 102. Sealing portion 132 extends from head portion second end 125 toward head portion first end 123, Tapered opening 136 and sealing portion 132 are in flow communication such that a channel is defined through head portion 124 between first and second ends 123 and 125.

[0023] In this embodiment, expansion portion 128 extends from head portion second end 125 opposite sealing portion 132 and opening 136, Expansion portion 128 includes a chamber 130 defined therein. Chamber 130 extends within expansion portion 128 between sealing portion 132 and a closed end 134 of chamber 130. Septum 102 is configured such that opening 136, sealing portion 132, and chamber 130 are co-axial about centerline 101 and form a single-ended tunnel between head portion first end 123 and chamber closed end 134.

[0024] Expansion portion 128 further includes a relief channel 126 formed in an outer wall 127 of expansion portion 128 and has a depth of approximately half the thickness of outer wall 127. Alternatively, relief channel 126 may be of any depth that facilitates septum 102 to function as described herein, in this embodiment, relief channel 126 is a continuous!y-spiraled channel defined between head portion second end 125 and a distal tip of expansion portion 128. Relief channel 26 terminates with a complete circular cut about the base of extension portion 128 at the union of expansion portion 128 and head portion second end 125. Alternatively, relief channel 126 may be a plurality or series of individual channels formed in outer wall 127. [0025] Figs, 2A and 28 show septum 102 in the re!axed, or dosed, position, wherein expansion portion 128 is at rest and has a first length Li. In the closed position, relief channel 126 is closed and appears as a spiraled line about expansion portion 128. Figs. 3A and 3B show septum 102 in an intermediate position, wherein expansion portion 128 is at least partially expanded. In the intermediate position, expansion portion 128 has a second length b, which is greater than first length Furthermore, extension portion 128 is extended in a longitudinal direction along axis 101 such that relief channel 126 becomes more defined and begins to separate. Expansion portion 128 lengthens in the intermediate position such that the interior volume of chamber 130 is greater in the intermediate position than in the closed position. Figs. 4A and 4B show septum 102 in the fully open position, wherein expansion portion 128 has a third length L3 greater than first and second lengths, Li and L ₂ . In the open position, expansion portion 128 is fully expanded and the interior volume of chamber 130 is greater in the open position than in the intermediate and closed positions. In the open position, relief channel 126 is fully open and exposes a plurality of apertures 138 defined within relief channel 126. Apertures 138 facilitate flow communication through outer wall 127 of expansion portion 128 between chamber 130 and the atmosphere surrounding expansion portion 128. In this embodiment, apertures 138 facilitate fluid flow through expansion portion 128 between chamber 130 and receiving chamber 114 of housing 104 when expansion portion 128 is extended parallel to longitudinal axis 101 into receiving chamber 114 in the open position, as shown in Figs. 5-7.

[0026] Fig. 5 is a cross-section of system 100 with septum 102 in the closed position. Fig. 6 is a cross-section view of system 100 with septum 102 in the intermediate position. Fig. 7 is a cross-section view of system 100 with septum 102 in the open position, in this embodiment, septum 102 is configured to seal first end 108 of housing 104. Specificaily, septum 102 is mounted into receiving chamber 114 of housing 104. Septum 102 is contained within receiving chamber 114 by cap 106, which is coupled to first end 108 of housing 104. Specificaily, cap 106 is coupled to outer surface 109 of housing first end 108 via a press-fit. Alternatively, cap 106 may be removably coupled to housing first end via interlocking threads or any other removable coupling means. System 100 is configured such that guide surface 120 of cap 106 is adjacent to tapered opening 136 such that opening 122 of cap 106, tapered opening 136, and sealing portion 132 of septum head portion 124 are coaxial along center axis 101 to simultaneously receive a needle 150 inserted therethrough.

[0027] Expansion portion 128 extends a distance Li into receiving chamber 114 of housing 104 from head portion 124 of septum 102 when in the closed position (shown in Fig. 5). In the closed position, sealing portion 132 has a first diameter Di. System 100 further includes a nosecone 103 housed within closed end 134 of chamber 130 of septum 102. In this embodiment, nosecone 103 is formed of a metallic material, such as stainless sfeel, and is configured to prevent the piercing of septum 102 by needle 150 and to facilitate extension of expansion portion 128 during a transition from the closed position to the open position to establish a fluid flow channel as described in further detail below. Furthermore, nosecone 103 is configured to align expansion portion 128 with longitudinal axis 101.

[0028] System 100 further includes a biasing mechanism 105 to facilitate operation of system 100, and, more specifically, septum 102. In this embodiment, biasing mechanism 105 is a coil spring 107 positioned within receiving chamber 114 of housing 104 between fluid flow member 118 and a distal end of expansion portion 128. Alternatively, biasing mechanism 105 may be a spring that forms a portion of the resilient material comprising expansion portion 128 of septum 102, Biasing mechanism 105 is configured to facilitate closure of septum 102 when transitioning from the open position to the closed position as described in further detail below.

[0029] In this embodiment, housing second end 110 of system 100 includes fluid flow member 118 and connector portion 117 for coupling system 100 to a medical device (not shown). Fluid flow member 118 extends between housing second end 110 and receiving chamber 114 through connector portion 117, and is coaxial with receiving chamber 114, expansion portion 128, and openings 136 and 122 along center axis 101. Fluid flow member 118 is configured to facilitate the passage of fluid through system 100. An interior surface 115 of housing connector portion 117 is formed to include one or more threads or similar members 116 for connection of medical device, such as a Luer device, it is to be noted that any type of medical device may be connected to connector portion 117 of second end 110. For ease of description, system 100 will be described with respect to needle 150 of a syringe 160 being inserted into opening 122 and a Luer device being connected to connector portion 117 of the second end 110, where the Luer device is in communication with a fluid delivery system, such as an S.V. set. The Luer device and I.V. set are omitted from the drawings for simplicity,

[0030] In operation, the Luer device of this embodiment is threadabiy coupled to connector portion 117 of housing second end 110, Fig, 6 shows syringe 160 and needle 150, having a diameter Ds, being inserted into system 100 with septum 102 in the intermediate position. Needle 150 is directed by guide surface 120 into system 100 through cap opening 122 and septum opening 136. Guide surface 120 is configured to direct needle 150 through openings 122 and 136 and also to protect from a tip 154 of needle 150 damaging head portion 124 of septum 102. in this embodiment, diameter Di (shown in Fig. 5} of sealing portion 132 in the closed position is smaller than the diameter D2 of needle, such that as needle 150 penetrates opening 136, sealing portion 132 of septum 102 expands radially to accommodate the larger diameter needle 150, Accordingly, a seal is created about needle 150 at sealing portion 132 of septum 102 that excludes exterior gases, liquids, or airborne matter from housing 104,

[0031) As needle 150 is inserted through sealing portion, needle tip 154 advances through chamber 130 and impinges nosecone 103 at closed end 134 of chamber 130, In this embodiment, nosecone 103 prevents the piercing or coring of septum 102 by needle tip 154. By preventing such coring, system 100 eliminates the possibility of particulates from septum 102 clogging needle 150, contaminating the fluid transferred, or being introduced into the patient, During advancement of needle 150 into system 100, when septum 102 is in the intermediate position (shown in Fig. 6), insertion of needle 150 facilitates deformation of septum 102 by extending expansion portion 128 into receiving chamber a distance b, which is greater than distance Li. Relief channel 126 facilitates such expansion by allowing expansion portion 128 to extend into receiving chamber 114 along center axis 101. The extension of expansion portion 128 compresses biasing mechanism 105 and coil spring 107 within receiving chamber 114, Spring 107 provides resistance to and limits the extension of expansion portion 128 within receiving chamber 114 to avoid damage to septum 102 when septum 102 is in the open position (shown in Fig. 7).

[0032] in this embodiment, as needle 150 is advanced farther into system 100, expansion portion 128 transitions from the intermediate position to the open position. The continued force of needle tip 154 upon nosecone 103 extends expansion portion 128 parallel to axis 101 into receiving chamber 114 a distance L3, which is greater than both distances b and b, in the open position. Nosecone 103 also prevents obstruction of a needle side port 152 by an interior wall 142 of chamber 130 by acting as a spacer between side port 152 and interior wail 142, The extension of expansion portion 128 further compresses spring 107 such that spring 107 limits the extension of expansion portion 128 to prevent damaging septum 102. in this embodiment, expansion portion 128 is fuily extended In the open position such that relief channel 126 fully opens to expose a plurality of apertures 138 defined therein.

[0033] In the open position of Figure 7, fluid flow member 118, receiving chamber 114, and septum 102 form a fluid flow channel 112 through housing 104 of system 100 to facilitate the transfer of fluid between syringe 160 and the Luer device. Accordingly, when septum 102 is in the open position, fluid may flow through the following structures (in the noted order), which as a whole make up fluid flow channel 112: syringe 160; needle 150; chamber 130 (via needle side port 152); receiving chamber 114 (via apertures 138); fluid flow member 118; and the Luer device. [0034] The plurality of apertures 138 and extension of expansion portion 128 facilitate fluid communication between syringe 160 and the inside of system housing 104. Specifically, apertures 138 establish flow channel 112 between needle 150 and receiving chamber 114. Syringe 160 may then be activated to discharge fluid from syringe 160 through channel 112 into the Luer device or to withdraw fluid from the Luer device through channel 112 into syringe 160. Once operation of syringe 160 is complete, needle 150 may be withdrawn from system 100. Spring 107 facilitates closure of septum 102 upon removal of needle 150 from septum 102 and maintains closure when septum 102 is not in use. Expansion portion 128 is compressed along center axis 101 by spring 107 to close the plurality of apertures 138 and seal chamber 130 from receiving chamber 114, thus providing a positive seal to prevent fluid communication and reduce contamination when expansion portion 128 is in the closed position.

[0035] The valve system is configured to prevent the piercing or coring of an expanding member, or septum, when a needle is inserted for fluid transfer through the system. The system described herein includes a housing, the septum, and a cap to contain the septum within the housing. The septum is formed from a resilient material and includes an expansion portion that extends into a receiving chamber of the housing from a closed position to an open position. The expansion portion includes a relief channel that facilitates such expansion and includes a plurality of apertures formed in the relief channel that are exposed when the septum is fully extended. The plurality of apertures facilitates the establishment of a fluid flow channel through the system between the needle and a medical device coupled to the opposite end of the system housing. Although the system is described as being connected to a Luer connector, the septum may be used in transferring a fluid between other types of devices. For example, for transferring fluid between a needle or cannula and a vial, for use in a pumping system for filling or emptying a via! or tube, or for transferring fluid between a needle and an IV line, A conventional needle, such as a bevel-tipped needle may be used, or a blunt- tipped cannula including a side port. After the transfer of desired fluid, removal of the needle from the septum returns the septum to its closed position. Closing may be aided by the presence of a biasing mechanism within the housing for returning and maintaining the septum in a closed position, and sealing the septum from contaminates when not in use.

[0036] To facilitate expansion of the septum from the closed position to the open position, the tip of the needle contacts a nosecone housed within a chamber within the expansion portion. The force of the needle advancing into the septum causes the expansion of the expansion portion. The nosecone not only facilitates extending the expansion portion to expose the apertures that create the fluid flow path, but also prevents the needle from coring the septum and introducing any particulates into the path, Preventing puncture or coring of the septum is particularly advantageous when the septum is used repeatedly. Exemplary embodiments of a medical valve system with an expanding member are described above in detail. The system and its components are not limited to the specific embodiments described herein, but rather, components of the valve may be used independently and separately from other components described herein. For example, the expanding member may also be used in combination with other sealing systems and methods, and are not limited to practice with only the medical valve system as described herein.

[0037] When introducing elements of the present disclosure or the embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the eiements. The terms "comprising," "including," "containing" and "having" are intended to be inclusive and mean that there may be additional eiements other than the listed elements. The use of terms indicating a particular orientation (e.g., "top", "bottom", "side", etc.) is for convenience of description and does not require any particular orientation of the item described.

[0038] As various changes could be made in the above constructions and methods without departing from the scope of the disclosure, it is intended that ail matter contained in the above description and shown in the accompanying drawing(s) shall be interpreted as illustrative and not in a limiting sense.