CORING-FREE VALVE SYSTEM
A system for receiving a needle includes a valve that defines a fluid flow channel, and a housing having a first end, a second end, and a receiving portion. The system further includes a septum formed from a resilient material and mounted in the housing. The septum includes a head portion including a tapered opening, a sealing portion, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end, at least one relief channel, and a plurality of apertures formed in the relief channel. The plurality of apertures facilitates fluid communication between the chamber and the receiving portion when the expansion portion is in an open position.
The field relates generally to fluid valve systems, and more particularly to fluid valve systems having septa or a septum for receiving a needle.
BACKGROUNDMany 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.
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.
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 reseal 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.
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.
SUMMARYIn 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 least 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.
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 least 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.
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.
Referring to
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 valve connectors, and other such devices. Medical 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 bevel-tipped needle may be used, or a blunt-tipped cannula including a side port. Alternatively, any needle or cannula may be used with system 100.
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.
As shown in
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
Housing 104 includes first end 108 and opposing second and 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
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.
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 continuously-spiraled channel defined between head portion second end 125 and a distal tip of expansion portion 128. Relief channel 126 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.
Expansion portion 128 extends a distance L1 into receiving chamber 114 of housing 104 from head portion 124 of septum 102 when in the closed position (shown in
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.
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 I.V. set. The Luer device and I.V. set are omitted from the drawings for simplicity.
In operation, the Luer device of this embodiment is threadably coupled to connector portion 117 of housing second end 110.
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
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 L1 and L2, 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 wall 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 fully extended in the open position such that relief channel 126 fully opens to expose a plurality of apertures 138 defined therein.
In the open position of
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.
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 vial 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.
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.
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 elements. The terms “comprising,” “including,” “containing” and “having” are intended to be inclusive and mean that there may be additional elements 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.
As various changes could be made in the above constructions and methods without departing from the scope of the disclosure, it is intended that all matter contained in the above description and shown in the accompanying drawing(s) shall be interpreted as illustrative and not in a limiting sense.
Claims
1. A valve system for receiving a needle comprising:
- a housing defining a fluid flow channel therethrough, the housing having a first end, a second end, and a receiving portion;
- a septum having a longitudinal axis and including a resilient material, the septum mounted in the housing for sealing the first end of the housing, the septum comprising: a head portion including a tapered opening for receiving the needle; a sealing portion for creating a seal around the needle; an expansion portion extending from the head portion opposite the tapered opening, the expansion portion including a chamber having a closed end, the expansion portion further including a relief channel and apertures formed in the relief channel such that 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 and the apertures are configured to prevent fluid communication when the expansion portion is in a closed position.
2. The valve system of claim 1, wherein movement of the expansion portion between the open and closed positions is caused by advancing the needle through the sealing portion and into the chamber.
3. The valve system in accordance with claim 1, further comprising a housing cap on the first end of the housing.
4. The valve system in accordance with claim 3, wherein the housing cap includes a conically shaped opening for receiving the needle through the housing cap and into the head portion of the septum.
5. The valve system in accordance with claim 1, further comprising a spring for biasing the septum in the closed position when the septum is not in use and for returning the septum to the closed position from the open position upon removal of the needle from the septum.
6. The valve system in accordance with claim 5, wherein the spring forms a portion of the resilient material of the septum.
7. The valve system in accordance with claim 5, wherein the spring is a coil spring.
8. The valve system in accordance with claim 1 further comprising a nosecone within the closed end of the chamber, the nosecone adapted to prevent the needle from piercing the closed end and to align the expansion portion with the longitudinal axis.
9. The valve system in accordance with claim 8, wherein the nosecone includes a metallic material.
10. The valve system in accordance with claim 1, wherein the resilient material includes at least one of rubber, latex, or silicone.
11. The valve system in accordance with claim 1, wherein the relief channel is a spiral channel extending about the length of the expansion portion.
12. The valve system in accordance with claim 1, wherein the relief channel includes a plurality of individual channels formed in an outer wall of the expansion portion.
13. The valve system in accordance with claim 1, wherein the relief channel includes a full circular cut about a base of the extension portion.
14. The valve system in accordance with claim 1, wherein the housing includes a fluid flow member that extends between the second end and the receiving portion, the fluid flow member is configured to facilitate the passage of fluid through the valve.
15. The valve system in accordance with claim 1, wherein the housing includes a threaded portion at the second end, the threaded portion is configured to couple the valve to a medical device.
16. The valve system in accordance with claim 1, wherein the receiving portion is configured to receive the expansion portion when the expansion portion is in the open position.
17. The valve system in accordance with claim 1, wherein the sealing portion has a diameter smaller than a diameter of the needle such that a seal is formed about the needle.
18. A septum for receiving a needle comprising:
- a head portion including a tapered opening having a longitudinal axis and adapted to receive the needle;
- a sealing portion adapted to create a seal about the needle;
- an expansion portion extending from the head portion opposite the tapered opening, the expansion portion including a chamber having a closed end housed within the expansion portion, the expansion portion further including at least one relief channel and a plurality of apertures formed in the relief channel such that the apertures facilitate flow communication through the expansion portion when the expansion portion is extended parallel to the longitudinal axis in an open position and the plurality of apertures are configured to prevent fluid communication when the expansion portion is in a closed position.
19. The septum in accordance with claim 18, wherein movement of the expansion portion between the first and second positions is facilitated by advancing the needle through the sealing portion and into the chamber.
20. The septum in accordance with claim 18, wherein the relief channel is a spiral channel about the length of expansion portion.
21. The septum in accordance with claim 18, wherein the relief channel includes a plurality of individual channels formed in an outer wall of the expansion portion.
22. The septum in accordance with claim 18, wherein the relief channel includes a full circular cut about a base of the expansion portion.
23. The septum in accordance with claim 18, wherein the sealing portion has a diameter smaller than a diameter of the needle such that a seal is formed about the needle.
24. The septum in accordance with claim 18, wherein the chamber is configured to house a metallic nosecone at the closed end, the metallic nosecone is configured to prevent the needle from piercing the closed end and to align the expansion portion with the longitudinal axis.
25. The septum in accordance with claim 18, wherein the septum is comprised of a resilient material.
26. The septum in accordance with claim 25, wherein the resilient material is one of rubber, latex, or silicone.
Type: Application
Filed: Mar 14, 2013
Publication Date: Sep 18, 2014
Inventors: Salah Ghodbane (Olivette, MO), Gary Eugene Dawson (St. Peters, MO), Kimberly Ann Moos (Chesterfield, MO)
Application Number: 13/802,935
International Classification: B65D 51/00 (20060101);