US20040034325A1 - Medical valve with fluid escape space - Google Patents

Abstract

A medical valve has a body and a flexible element. The body includes a wall structure defining an internal cavity having an inside and an outside. The body also has a proximal end and a distal end. The proximal end has an opening sufficiently large to receive a tip of a delivery end of a medical implement which transfers fluid through the delivery end. The body has a fluid escape space in its wall structure. The flexible element is adapted to be moved into a compressed state upon insertion of the tip of the medical implement into the opening. The flexible element is sufficiently resilient to return to a decompressed state upon removal of the tip of the medical implement from the opening. The fluid escape space is in fluid communication with the outside of the cavity when the seal is in its compressed state.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 10/004,561, filed on Dec. 4, 2001, which was a continuation of U.S. application Ser. No. 09/495,559, filed on Feb. 1, 2000, now U.S. Pat. No. 6,325,782, which was a continuation of U.S. application Ser. No. 09/055,646, filed on Apr. 6, 1998, now U.S. Pat. No. 6,019,748, which was a continuation of U.S. application Ser. No. 08/572,934, filed on Dec. 15, 1995, now U.S. Pat. No. 5,738,663.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• This invention relates to a closed, patient access system which automatically reseals after administering medication using a standard medical implement that directly connects with the system without the need of any intermediary needles, caps or adaptors. A two-way valve eliminating dead space is used which includes a seal which, upon being compressed by the medical implement, is pierced to open the valve and reseals upon being decompressed, maintaining a fluid tight seal even at high pressures and after repeated uses.[0003]
• 2. Backgound Discussion[0004]
• The manipulation of fluids for parenteral administration in hospital and medical settings routinely involves the use of connectors and adaptors for facilitating the movement of fluids between two points. Most fluid connectors and adaptors employ needles to pierce a septum covering sterile tubing or to pierce the septum of a medicament container of fluid. Fluid then passes from the container or fluid filled tubing into a syringe or second set of tubing. These connectors and adaptors often have mechanical or moving parts. Since the ready passage of fluids through the connectors and adaptors is often critical to patient survival, it is imperative that the connectors and adaptors function reliably and repeatedly. Adaptors and connectors that malfunction during use may be life-threatening. The more mechanical or moving parts such as springs and diaphragms, the more likely that they will function improperly. Improper functioning can result in the introduction of air embolisms into a patient. Thus, the fewer the mechanical parts, the more these connectors can be relied on and the better they will be accepted by the medical community.[0005]
• Many connectors or valves, especially those employing several mechanical components, have a relatively high volume of fluid space within them. This “dead space” within the device prevents the accurate introduction of precise fluid volumes and provides an opportunity for contamination upon disconnection of the device. Connectors and adaptors often include valves that permit or interrupt the flow of fluid along the course of fluid travel. Several of those commonly in use employ metal needles to puncture sterile seals. Such connectors are generally designed to accommodate fluid flow in one direction. This means that the fluid line must have connectors and tube aligned in complementary directions. These connectors often require further manipulation if, for example, the valve is inadvertently assembled in a direction that will not facilitate fluid flow. These manipulations increase handling, thereby increasing both the risk of contamination and the amount of time required to establish the fluid connection.[0006]
• Metal needles employed as part of connector devices often have through-holes placed at the tip of the needle. Connection of the valve with a flow line involves piercing the needle through a sealed septum. Through-holes placed at the needle tip can core the septum and release free particulates into the flow line. Such an event can prove fatal to a patient. Such through-holes may also become clogged easily with material from the septum. Moreover, the use of a needle with a sharp point may also cause deterioration of the septum.[0007]
• Reusable connectors and adaptors are preferred for medical applications since components must often be added or removed from a fluid line connected to a patient. Reusable connectors, however, are difficult to keep sterile. Sometimes caps are employed to cover the connector to keep it sterile. Frequently, these caps are lost, or simply not used because they are not readily available when needed.[0008]
• A closed, patient access system that is easy to use and employs only a valve device in communication with the patient that need not be capped or interconnected with the medical implement through a needle or adaptor, is swabbable, is sufficiently durable to maintain its function after several manipulations, and maintains a fluid-tight seal at high pressures, would be of great benefit to the medical community.[0009]
SUMMARY OF THE INVENTION
• The valve of this invention has several features, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this invention as expressed by the claims which follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled, “Detailed Description of the Preferred Embodiments,” one will understand how the features of this invention provide its advantages, which include safety, reliable and repeatable performance, simplicity of manufacture and use, and provides long life without malfunction.[0010]
• A preferred embodiment of a seal used in the present invention comprises a series of O-ring elements stacked together and connected to form a unitary structure. The O-ring elements have increasing diameters, with the smallest diameter element being adjacent the proximal end of the cavity. The O-ring element closest to the proximal end of the seal contacts the wall of the spike proximal the through-holes when the seal is in a decompressed state, thereby preventing fluid from leaking from the interior of the spike through the proximal opening in the housing. It is desirable that at least the next immediate O-ring element also be in contact with the spike proximate the through-holes. Such a design prevents fluid from applying enough pressure on the slit to force the slit open while the seal is in the decompressed state. With the preferred embodiment fluid may reside in the spike and between the spike and the seal distal the through-holes without opening the slit in the seal cap. The seal is designed so that if this fluid pushes the seal upwards slightly, lifting the first and second O-ring elements upwards and off the spike, the O-ring elements immediately distal the first and second elements move up and contact the spike so as to ensure that fluid does not flow through the seal cap and out of the valve. Maintaining this contact around the spike avoids having fluid pressure on the slit force the slit open, permitting the valve to leak.[0011]
• In another feature of the present invention, the housing is provided with fluid escape space, such as a groove or channel, to permit fluid contained between the exterior of the seal and the housing to escape during compression of the seal. In one embodiment, the proximal end of the housing is provided with at least one groove extending from the proximal end of the housing to indentations contained within the housing. During the compression of the seal, fluid between the exterior of the seal and the housing travels in a proximal direction through the grooves and out of the valve through the proximal end of the housing. In another embodiment, a channel is provided as the fluid escape space through the side wall of the housing. As the seal is compressed, fluid between the exterior of the seal and the housing travels through the channel to the exterior of the valve. As discussed in greater detail below, providing a groove or channel to permit fluid between the exterior of the seal and the housing side wall to escape from the valve during compression of the seal, provides several advantages.[0012]
BRIEF DESCRIPTION OF THE DRAWING
• The preferred embodiments of this invention, illustrating all its features, will now be discussed in detail. These embodiments depict the novel and non-obvious methods and valves of this invention as well as the medical implement indicators and methods of use thereof, as shown in the accompanying drawing, which is for illustrative purposes only. This drawing includes the following Figures, with like numerals indicating like parts:[0013]
• FIG. 1 is a perspective view of the first embodiment of a valve useful in connection with this invention.[0014]
• FIG. 2 is an exploded perspective view of the valve shown in FIG. 1 illustrating spike, seal, and body or housing components of the invention.[0015]
• FIG. 3 is a longitudinal cross-sectional view of the assembled valve of FIG. 1.[0016]
• FIG. 4 is a schematic, longitudinal, cross-sectional view of the assembled valve of FIG. 1 before compressing the seal.[0017]
• FIG. 5 is a schematic, longitudinal, cross-sectional view similar to FIG. 4 showing the valve during compression of the seal.[0018]
• FIG. 6 is a perspective view of a second embodiment of a valve useful in connection with the present invention.[0019]
• FIG. 7 is a longitudinal cross-sectional view of the valve of FIG. 6.[0020]
• FIG. 8 is a schematic illustration of an ANSI delivery end of a medical implement compressing the seal of a valve.[0021]
• FIG. 9 is a side elevation view, partially in cross-section, of an embodiment of the seal.[0022]
• FIG. 10 is a longitudinal cross-sectional view of the assembled valve of FIG. 1 using the seal of FIG. 9.[0023]
• FIG. 11 is a longitudinal cross-sectional view of the assembled valve of FIG. 1 using another embodiment of the seal.[0024]
• FIG. 12 is a longitudinal cross-sectional view of the assembled valve of FIG. 1 using yet another embodiment of the seal.[0025]
• FIG. 13 is a longitudinal cross-sectional view of an additional embodiment of the seal.[0026]
• FIG. 14 is a longitudinal section of the seal shown in FIG. 13 used in connection with the spike device shown in FIG. 2.[0027]
• FIG. 15 is a longitudinal partial cross-sectional view of a still further embodiment of the seal of this invention.[0028]
• FIG. 16 is a longitudinal cross-sectional view, after assembly, of the valve shown utilizing the seal of FIG. 15.[0029]
• FIG. 17 is a longitudinal cross-sectional view, after assembly, of the valve shown utilizing still another embodiment of the seal.[0030]
• FIG. 18 is a longitudinal cross-sectional view, after assembly, of the valve utilizing yet one more embodiment of the seal.[0031]
• FIG. 19 is a side elevation view, after assembly, of the seal and spike shown in FIG. 14 connected to the body or housing shown in FIGS. 20 and 21.[0032]
• FIG. 20 is a cross-sectional view taken along line[0033]20-20 of FIG. 19.
• FIG. 21 is a perspective view of the housing shown in FIG. 19, with sections broken away to show the wall structure of the cavity containing the seal shown in FIGS. 13 and 14.[0034]
• FIG. 22 is a greatly enlarged, cross-sectional view taken along line[0035]22-22 of FIG. 14.
• FIG. 23 is a longitudinal cross-sectional view of another preferred embodiment of the seal.[0036]
• FIG. 24 is a partial cross-sectional view, after assembly, of the valve shown utilizing the seal of FIG. 23 and another preferred embodiment of the spike.[0037]
• FIG. 25 is a partial cross-sectional view of the valve of FIG. 24, illustrating grooves in the housing.[0038]
• FIG. 26[0039]ais a top view of the valve of FIG. 25, illustrating the grooves in the housing.
• FIG. 26[0040]bis a top view of another preferred embodiment of the valve with a channel shown in phantom through the side wall of the valve.
• FIG. 27 is a partial cross-sectional view of the valve of FIG. 26[0041]billustrating the channel.
• FIG. 28 is a perspective view of the housing, with sections broken away to show the wall structure of the cavity containing the seal, including the groove in the housing.[0042]
• FIG. 29 is an elevational view of a preferred embodiment of the housing with a channel through the housing wall shown in phantom.[0043]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The term “proximal” is used to denote the end of the valve and other components at or near the[0044]spike tip32 in FIGS. 2 through 5,10 through12,14,16,24,25 and27, and at or near thespike tip60 in FIG. 6, and at or near theseal cap92 in FIGS. 8, 9,13 through19,23,24,25 and27. The term “distal” is used to denote the opposite end of the valve, or spike tip, or seal. The term “medical implement” is used to denote any medical tool known to those of skill in the art that can facilitate the passage of fluids, particularly liquids, therethrough. Examples of medical implements that are contemplated include, but are not limited to, tubing, conduit, syringes, IV sets (both peripheral and central lines), piggyback lines, medical valves, and other components. Medical implements are commercially available in standard sizes. Thus, either or both ends of the valve can be provided with fittings to accommodate such standard size medical implements.
• The valve is a closed, patient access system which automatically reseals after administering medication using a medical implement that directly connects with the system without the need of any intermediate needles, caps or adaptors. A two-way valve is employed utilizing a reusable seal that may be repeatedly pierced by an enclosed, protected spike rather than an exposed metal needle. The valve facilitates fluid, particularly liquid, transfer while maintaining sterility. The valve is easy to use and is capable of locking in place. After use, the valve is swabbed in the conventional manner with a suitable substance to maintain sterility. The design of the valve avoids accidental needle sticks. As will be discussed in detail below, the valve is useful as a medical connector or adaptor to enable liquid flow from a sealed container.[0045]
• The first feature of the invention is that the valve has a body including a wall structure defining an internal cavity having a proximal end and a distal end. The cavity has an open space into which the seal is pushed, and preferably has a plurality of radial indentations in the wall structure that are adjacent the seal to accommodate the expansion of the seal upon compression. The proximal end has an opening sufficiently large to receive a delivery end of a medical implement which transfers fluid through the delivery end. In most applications, the delivery end of the implement is tapered inward so that the wall structure and the tapered delivery end fit snug against each other upon insertion of the delivery end into the opening. The proximal end of the cavity preferably is adapted to fit snug with an ANSI (American National Standards Institute, Washington, D.C.) standard end of the medical implement. Typically, the implement is a syringe, a connector or inlet/outlet of an IV set, or any one of a wide variety of conduits used in medical applications.[0046]
• The second feature is that the spike has a tip with at least one hole located at or near the tip, and a passageway in communication with the hole that allows fluid to flow through this hole. Preferably, the hole is in a side of the spike adjacent the tip and is elongated, having a size of 18 gauge or greater. More than one hole is desirable for many applications, and three, symmetrically located holes inward of the proximal end are preferred. The spike is seated inside the cavity and the tip is embedded in the seal cap located at the proximal end of the seal. The tip of the spike is blunt and rounded so as to avoid deterioration of the seal from repeated penetration by the spike. The spike may include at least one rib which allows air to enter a space between the seal and the spike, thereby facilitating the sealing of the opening when the implement is removed. The spike may have a substantially conical shape, and the seal has a complementarily, substantially conical shaped cavity within it conforming to the shape of the spike.[0047]
• The third feature is that the resilient seal is adapted to be moved into a compressed state upon insertion of the tip of the medical implement into the opening and returns to a decompressed state upon removal of the tip. The seal in the decompressed state has a section which fills essentially completely a portion of the cavity adjacent the opening. In the compressed state, the seal section is pushed by the delivery end of the medical implement away from the opening and into the cavity. This seal section, known as the seal cap, may have a precut slit in which the proximal end of the spike is embedded. The delivery end of the implement and the seal are adapted to engage so that when the tip of the spike pierces the seal there is essentially no dead space between said delivery end and the seal. Consequently, a predetermined dosage amount of medication is transferred in its entirety to the patient using this invention, with none of the prescribed amount being collected in dead space in the valve. The delivery of an exact amount of medication may be critical in some situations when chemotherapeutic agents are being administered or small children are being treated.[0048]
• As best shown in FIGS. 1 and 2, the first embodiment of[0049]valve10, includes a valve body orhousing12, aspike element24, and aseal36. Theseal36 is prepared from a resilient material that is flexible, inert, impermeable to fluid, and readily pierceable by thespike26. In the valve embodiment shown in FIG. 13 depicting an alternate shapedseal36d, thisseal36dhas a precut slit11 in its proximal end. This provides a tiny orifice through which thetip32 of thespike element24 may easily pass, yet still provides a fluid tight seal upon withdrawal of the spike element. These three components are assembled, as depicted in FIG. 3, with thespike element24 enclosed to prevent accidental sticks. FIG. 2 illustrates how thehousing12,seal36, and spikeelement24 are attached without the need to use any adhesive or other bonding agent or process. Mechanical connection which provides a fluid tight closure is attained as is discussed subsequently. As shown in FIGS. 4 and 5, theseal36 moves within thehousing12, being pierced by thespike element24 to expose thetip32 of thespike element24 to allow fluid to flow through thevalve10.
• Referring to FIG. 1, one preferred embodiment of the[0050]housing12 has a bell-shapedskirt16 and an upper, preferably cylindrical,conduit20. Theskirt16 is integral with, and connected by anannular ring14, to theupper conduit20. Theskirt16 creates a shield for aninner conduit18 of thespike element24. Thisinner conduit18 is preferably cylindrical in shape, and slightly tapered.Inner conduit18 andupper conduit20 comprise aligned hollow tubes so thatinner conduit18 andupper conduit20 are in fluid communication with one another when thespike element24 pierces theseal36. There is anannular lip25 surrounding acircular opening25ain the top of the conduit20 (see FIG. 2).
• In the first embodiment of the valve, the[0051]upper conduit20 is adapted to receive the tip ornose48 of an ANSI standard syringe46 (see FIGS. 4 and 5). It is, however, contemplated that the outer diameter of theupper conduit20 can be of any size to accommodate the attachment of other connector devices thereto. Advantageously, the proximal end of theupper conduit20 can be equipped with a locking mechanism to facilitate locking of thevalve10 to a variety of medical implements. For example, referring to FIG. 1, lockingears22 near theproximal lip25 ofhousing12 are preferably provided such that thehousing12 can be locked into any compatible Luer-Lock device known to those with skill in the art. For example, referring to FIG. 19, conventional Luer-Lock threads180 can be provided on the outer diameter ofupper conduit20.
• Referring to FIG. 2, the[0052]spike element24 has at its distal end theinner conduit18 and at its proximal end ahollow spike26 which is integral with the inner conduit. Theinner conduit18 and spike26 present a continuous passageway for fluid during use. Anannular cuff28 on an intermediate portion of thespike element24 is integral with, and interconnects, theinner conduit18 and thespike26. As illustrated in FIG. 3, the rim28aof thecuff28 abuts the underside of theinner ring14, and has anannular detent28bthat snaps into anannular groove14bin the underside of the ring. Thecuff28 serves two functions. First, it serves as an attachment device to the underside of theannular ring14. Second, it serves as a support and attachment device for theseal36.
• The[0053]hollow spike26 has a tapered conical shape, ending in a sharp, pointedtip32. Preferably, along the length of the spike are raised, protrudingridges30. These raisedridges30 extend from the surface of the spike preferably between 0.2-2.0 mm. Theridges30 are preferably aligned along the length of the spike as illustrated in FIG. 2. Theseridges30 serve to break any vacuum created when thespike26 is sealed as described hereinbelow. Modifications to the alignment and orientation of the ridges are discussed hereinbelow in association with their function. Distal thespike tip32, there is situated at least one longitudinal through-hole34 to permit fluid communication between theinner conduit18 and theupper conduit20. Preferably, there are three through-holes34 within about 10 mm and more preferably within about 5 mm from thespike tip32. These through-holes34 may be of any size, however, the larger the size of the through-holes the greater the fluid flow rate through thevalve10. In a preferred valve embodiment, the size of the through-holes34 are 18-gauge to provide a flow rate three times that of a standard 18-gauge needle.
• The[0054]seal36 preferably has aseal cap40 with a generally flattop surface40b, an outwardlytapered side wall38, and alower lip42. Its interior is hollow to provide the conically shaped cavity37 (FIG. 3). Thus, theseal36 slips easily over thespike element24 to fit snugly within thecavity37. Theseal lip42 is seated within theannular cuff28 and wedged between the cuff and the underside of thering14. There are longitudinal grooves43 (FIG. 2) along the length of theseal36 which provide air pockets that facilitate compression of theseal36 during use. Thegrooves43 may be of variable shape or size to facilitate seal compression. In the first valve embodiment, there is asingle groove43 which completely surrounds theseal36 between theseal cap40 and thelip42.
• The base of the[0055]seal36 has a width such that theseal lip42 fits snugly into theannular cuff28. The hollow interior or cavity37 (FIG. 3) of theseal36 is preferably tapered to conform internally to the shape of thespike24, having awall portion44 which contacts thespike24distal seal cap40. The exterior of theseal36 is sized and shaped to fit inside theupper conduit20 of thehousing12. Thecap40 reseals thevalve10 when thetop surface40bis proximal the through-holes34. Preferably, thecap40 substantially fills the opening25ain the top of theconduit20. Thus, after assembly, thetop surface40bof theseal cap40 is essentially flush with thelip25, so that thelip25 andseal cap40 can be swabbed with alcohol or other disinfectant without leakage of disinfectant into thevalve10. It is important that thesurface40bbe exposed so that it may be swabbed with a disinfectant.
• As best shown in FIG. 3, the[0056]spike24, with contiguousinner conduit18, is affixed to thehousing12 through the association of the external potion ofannular cuff28 and the internal portion ofannular ring14. Although not necessarily required, these two pieces may be affixed by any one of a variety of methods known to those of skill in the art including, but not limited to, heat sealing, glue, pressure lock, bonding or the like. Theseal36 fits into theannular cuff28 and is held in place by aninternal lip27 along the internal portion of theannular ring14 of thehousing12. The length of thespike24 is such that, after assembly, the tip of the spike rests below the plane defined by thelip25 of thehousing12. Preferably, thespike tip32 is approximately from 0.525″ to 0.1″ below thelip25 of thehousing12. Theseal36 fits snugly against thespike24 and is essentially flush with thelip25 of thehousing12. Thespike tip32 is thus embedded within theseal cap40 prior to use or may be approximately 0.025″ distal theseal cap40 when thevalve10 is in the closed position. Theinner conduit18 is partially shielded by the bell shapedskirt16 of the housing12 (see FIGS.1-3). The inner surface of the bell shapedskirt16 preferably has protrudingthreads44 as an optional locking mechanism for attaching a medical implement thereto. Further, other medical devices can be pressure fit over the outer portion ofinner conduit18 without direct association with the protrudingthreads44.
• During use, the valve is designed to be adapted as a two-way valve. The orientation of the valve is independent to fluid flow and dependent on the preferred orientation of the preexisting connections. Thus, the valve can be used as a valve connector for an intravenous central or peripheral piggyback connector in either orientation. Parenteral fluid is delivered to patients through tubing such that the liquid flows from a container through a piercing element into the patient. The containers are frequently changed or additional fluid bottles are added. The valve disclosed herein is designed to interconnect medical implements along the route of fluid delivery to the patient. However, the valve is also useful in any environment in which a resealable fluid valve is desired. During use, a connector of the appropriate size is fitted over the[0057]inner conduit18. Locking can be achieved by a Luer-Lock mechanism, a pressure fit or any other locking mechanisms known to those with skill in the art, as described above. Thus, in one example, fluid passes from theinner conduit18 into thespike26. However, fluid flow is locked in place by theseal36.
• FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the medical implement connecting to the proximal end of the[0058]valve10 is asyringe46. However, this connecting implement could be any number of medical implements known to those of skill in the art. Thenose48 of thesyringe46 is placed on theseal cap40 inside thelip25 of thehousing12. The application of pressure on thesyringe46 in the direction of the arrows, as illustrated in FIG. 4 creates pressure onseal cap40. The resulting downward pressure compresses theseal36. This pushes thetip32 of thespike26 through theseal cap40 to expose the through-holes34. Compression is facilitated by thegrooves38. Fluid is now able to flow into thesyringe46, or vice versa, depending on whether fluid is to be withdrawn from the patient or medication injected into the patient. FIG. 5 showsvalve10 opened by insertion of thenose48 of thesyringe46 into the opening25a. Asyringe plunger49 in thesyringe46 is retracted thereby creating a vacuum to draw fluid through thevalve10 into the syringe. For intravenous applications, thevalve10 can be orientated in the position diagramed in FIGS. 4 and 5, or it can be rotated1800 such that fluid flows in the opposite direction.
• Upon removal of the syringe from the[0059]spike26, as shown in FIG. 4, theseal36 is free to return to its original shape and cover the through-holes34. The ability of theseal36 to return to its original shape is determined by the resiliency of the material used to prepare theseal36. In addition, the ability of theseal36 to return to its original shape is facilitated by the protrudingridges30 formed on the external surface of the spike. During compression, a vacuum may form in the area between thespike26 and theseal36, thereby preventing theseal36 from returning to its original position. The protrudingridges30 permit air to pass along the spike/seal interface to prevent vacuum formation and allow free return of theseal36. The ability of theseal36 to deform reversibly and return to its original position is particularly useful because (1) it immediately stops fluid flow through thevalve 10, (2) it covers the recessedspike26 to maintain its sterility, and (3) it reduces the risk that the spike could inadvertently pierce another object or person. In addition, since thevalve10 lacks movable parts, except for the seal, it is unlikely that when theseal36 is pushed down, thevalve10 would fail to function.
• Advantageously, the through-[0060]holes34 are located relatively low on thespike26. Thus, the through-holes34 are sealed relatively early in the process as theseal36 returns to its original configuration when thevalve10 is closed. In one preferred embodiment of the valve, the through-holes34 are located 0.075″ below the spike tip32 (see FIG. 2). Additionally, the through-holes34 are sealed even if theseal36 does not fully return to its original configuration depicted in FIG. 4. Further, the ability of theseal36 to return reversibly to its original position permits the reuse of thevalve10. Following disconnection, and before reuse, the surface ofpierced seal cap40 is essentially flush with thehousing12. Thus, this flush surface can advantageously be sterilized with alcohol or other surface decontaminating substances. Theskirt16 andupper conduit20 advantageously shield both connections from the surrounding environment to protect the sterility of the connection. Further, both theskirt16 andupper conduit20 function as collection reservoirs to prevent fluid from dripping from thevalve10 during manipulation.
• A cover cap (not shown) can be supplied to fit over the[0061]upper conduit20 as further protection for the seal surface between use. Such a cover cap, however, is not needed to maintain sterility since theseal36 may be swabbed with a disinfectant after each use. The reversibility of theseal36 makes thevalve10 particularly attractive as a connector valve to provide fluid communication between two fluid lines. Therefore, the valve provides for placing a first fluid line in communication with a second fluid line using the valve disclosed herein. The reversibility of thevalve10 permits multiple fluid lines to be successively added, for example, to a fluid line in direct communication with a patient's vein. Since the valve is easily sterilizable and sealable, fluid lines can be added and removed without disconnecting venous contact.
• The[0062]valve10 is preferably prepared from a hard plastic, such as ABS plastic, but it is additionally contemplated that the valve could be prepared from other medically inert materials known to those in the art. Thespike element24 is preferably prepared from the same material as thehousing12. However, a stronger material, such as a poly-carbonate material, may be desirous for thespike element24 to enable it to pierce a variety of connecting septums and seals. One particular advantage of this valve is that it does not rely on the use of metal needles. This dramatically reduces the risk of skin puncture during use and manufacture. Further, theupper conduit20 serves as a shield to thespike26 such that skin contact with thespike26 is further reduced. Thespike26 need only be strong enough to penetrate theseal cap40, or if necessary, to pierce a connecting septum.
• In the embodiment of the valve illustrated in FIGS.[0063]2-4, the through-holes34 are placeddistal spike tip32. This placement provides two important advantages. First, the placement of the through-holes34 facilitates resealing of thevalve10 after use. Second, if the through-holes were placed at thespike tip32, theholes34 may core theseal cap40 thereby introducing seal particulate into the fluid flow and possibly plug theholes34. Thus, the longitudinal placement of the through-holes distal thespike tip32 prevents the introduction of particulates into the fluid path and/or plugging of the through-holes34. It is additionally contemplated that the number and diameter of the through-holes34 can be adjusted to accommodate different fluid velocities. In a preferred embodiment of the valve, the preferred velocity of fluid passing through the through-holes34 is equal to or greater than the flow rate through an 18-gauge needle. Through-holes larger than 18 gauge will, of course, facilitate greater fluid flow rates.
• An important advantage of the[0064]valve10 is that it has very little dead space, thus the volume of liquid entering into thevalve10 is substantially equivalent to the volume of fluid leaving thevalve10. Further, the total equivalent fluid volume of the valve is very small such that the volume of fluid flowing through the system in order to place thevalve10 in fluid communication with a medical implement such as asyringe46 is substantially zero.
• In another preferred embodiment of the valve, illustrated by FIGS. 6 and 7, a disposable[0065]sterile adaptor valve50 is provided to function as a resealable lid for a container (not shown) of fluid. The fluid can thus be removed from the fluid container or permitted to flow from the container into a medical implement adapted to house fluid in a sterile manner. As is the conventional practice, an open mouth of the container will ordinarily be sealed with a cover member (not shown).
• FIG. 6 shows an[0066]adaptor valve50 having a body including anadaptor skirt52. Theadaptor skirt52 will preferably fit snugly over the open mouth of the container. Theskirt52 may be of any size to accommodate a range of container sizes. Alengthwise slit54 is preferably provided in at least one location along the length of the skirt to ensure a snug fit between theskirt52 and the container. Achamber56, preferably tubular in configuration, extends upward from theskirt52 and is similar in construction and design to theupper conduit20 of the first preferred valve embodiment. Similar to the first valve embodiment, the proximal portion of the valve may contain alocking mechanism59 that preferably comprises a Luer-Lock device or other locking device known to those of skill in the art.
• As depicted in FIG. 7, a[0067]spike58 extends upward through atubular chamber56. Aspike tip60 is preferably recessed from aproximal lip62 of thetubular chamber56. In a closed position, thistip60 is covered by aseal64, which is essentially the same asseal36. Protrudingridges66 and sealgrooves68 facilitate seal compression and promote closure following use. Thus, in the closed position as illustrated in FIG. 7, theseal64 covers the through-holes70 to prevent fluid out-flow from the container. Theadaptor valve50 contains asecond spike72 which points in the opposite direction as thespike58. Thesespikes52 and72 are in fluid communication with each other. Thespike72 extends downward inside theadapter skirt52. The two spikes preferably form one component of thevalve50 while theskirt52 and upper chamber form a second component. These two components can be assembled in a manner like that of thevalve10. Thespike72, like thespike58, has longitudinal through-holes74 and atip76. The through-holes74 are located inward of thetip76. Theadaptor valve50 is thus useable with containers holding sterile medicament having a cover or septum seal at the open mouth of the container. Examples of containers with such seals contemplated for use with this valve include dosage bottles for intramuscular injector antibiotic containers or the like. However, it is also contemplated that thevalve50 can be adapted with its own seal and locking mechanism to permit the valve to be employed on a variety of containers for medicaments or other fluids. Medicaments in these types of containers are preferably maintained under sterile conditions and the volume and nature of the medicament is such that multiple aliquots are intermittently removed over time. If the medicament is reconstituted, then, during use, any covering over the opening on the container is removed to reveal the rubber septum. Theadaptor valve50 is placed over the septum and direct pressure is applied to piercedistal spike72 through the septum and into the container. A syringe or the like can then be applied, as depicted in FIG. 4, in association with the first preferred valve embodiment, to withdraw fluid from the container. The pressure of thenose48 over thespike58 pushes thespike tip60 through theseal64. At the same time, theseal64 is compressed. Compression is accommodated by theseal grooves68. Fluid is withdrawn from the container and the syringe is removed from thespike58. Release of the pressure applied to theseal64 permits theseal64 to return to its original configuration. Thespike ridges66 facilitate movement of theseal64.
• Often the ingredients housed in containers are those that can be lyophilized at purchase. Lyophilized ingredients require reconstitution before use. If the medicament requires reconstitution before use, then sterile water, saline, or other fluid can be introduced into the container before fluid is extracted. The two-way nature of the valve permits this without any special adaptation. After the syringe is removed, the[0068]adaptor valve50 automatically seals. Subsequently, aliquots can be removed from the container by syringe or the like. Alcohol or other compatible surface sterilizing agents can be used to wipe thelip62 andseal64 before each use. Similar to the first valve embodiment, it is additionally contemplated that a cap can be provided to fit over theupper chamber lip62 between uses.
• The[0069]adaptor valve50 can be adapted to function as a medicament adaptor for an intravenous container. In this case, theadaptor valve50 is placed on a medicament container for intravenous delivery and attached via tubing to an intravenous feed. Thus, theadaptor valve50 can be placed in fluid communication with a connector valve of FIG. 1 to facilitate the flow of medicament from intravenous drip bottles.
• An alternative embodiment of the seal, a[0070]seal36a, is shown in FIG. 9. Theseal36acomprises aseal cap92 at the proximal end thereof and aseal lip96 at the distal end thereof. A cup-likeannular flange95 is provided proximal theseal cap92. Theseal cap92 andseal lip96 are connected by a seal wall consisting of a plurality of ringedwall portions94 that expand and collapse in an accordion like fashion. During compression of theseal36a, the diameter of the ringedwall portions94 expand outward in the radial direction. There areair pockets13a(FIG. 10) betweenring portions94 and the housing andair pockets13bbetween thespike24 and seal36a. Theseal36acontains acavity98 distal theseal cap92 and adjacent the ringedwall portions94. Theseal36ainteracts with the spike26 (FIG. 2) and other components of the valve in a similar fashion to theseal36 of FIG. 2.
• Referring to FIG. 10, the cup-like[0071]annular flange95 can be stretched around theupper conduit20 and held in place by anannular ring97. This creates a trampoline-like effect that assists returning theseal36ato a decompressed state after withdrawal of a syringe (not shown). This embodiment has two advantages. First, the proximal end of thevalve10 can be swabbed with alcohol or other disinfectant without leakage of disinfectant into thevalve10. Second, by affixing the cup-likeannular flange95 to theupper conduit20 at the proximal end thereof with theannular ring97, the repeated deformation and reformation of theseal36ais assisted.
• In an alternative embodiment of the seal, the[0072]seal36bis shown in connection with thevalve10 in FIG. 11. Theseal36bis similar to theseal36ashown in FIGS. 9 and 10, as theseal36ais comprised of aseal cap92, a side wall consisting of ringedwall portions94 and aseal lip96. Theseal36aalso has an outwardly extendingring99 which is at a right angle with respect to the longitudinal axis of thevalve10. Thisring99 is used to attach theseal36bto theupper conduit20. Preferably, an upper conduitannular plug20′ is inserted within theupper conduit20 to create a tight fit between theperpendicular ring99, aledge101 in theupper conduit20, and theplug20′. Thering99 assists in the reformation of theseal36bto enclose thespike26 upon withdrawal of a syringe (not shown).
• As shown in FIG. 12, the cup-like[0073]annular flange95 andring99 may both be used in connection with thevalve10, to provide theseal36c. Thisseal36c, provides rapid reformation upon withdrawal of a syringe (not shown) and realizes the advantages of both theseals36aand36b.
• Another alternative embodiment of the seal, a[0074]seal36d, is shown in FIG. 13. In this embodiment, theseal36dis comprised of aseal cap92, aseal lip96, and aside wall150 comprised ofcircular tires100 stacked in series one on top of an adjacent larger diameter lower tire. Thecircular tires100 are preferably solid throughout the diameter of the cross-section thereof. Thesecircular tires100 will deform and reform upon, respectively, compression and decompression of theseal36d, thereby exposing or covering a spike (not shown) as the case may be.
• As mentioned above, preferably the[0075]seal36dhas a precut slit11 in thecap92 lying along the longitudinal axis of thevalve10. Theseal cap92 has a unique configuration that insures that theslit11 closes and is sealed upon withdrawal of a syringe (not shown) and reformation of theseal36d. It includes an enlarged, internal, pressureresponsive member200 which is integral with theseal cap92. Between the proximal end of theside wall150 and themember200 is anannular space102 which is filled with the fluid in thecavity98. This fluid is under pressure, for example at the blood pressure of the patient to which thevalve10 is attached. Referring to FIG. 14, fluid, for example the patient's blood, flows through theholes34 in thespike26, filling thecavity102. This fluid presses against the exterior of themember200, closing theslit11 when the seal is decompressed as shown in FIGS. 14 and 19. The pressure from this fluid creates a high pressure seal which prevents fluid from escapingvalve10 through theslit11. There is a semi-cylindrical annularflange tear ring104 on the end of themember200 which advantageously extends the useful life of theseal36d.
• Preferably, there is a[0076]tear ring104 integral with themember200 along the perimeter of the internal surface themember200, and a slight saucer-like depression204 in the external surface of the seal. The pressure responsive element in the decompressed state closes any orifice in theseal36dto provide an essentially fluid-tight seal while in the decompressed state. The pressureresponsive member200 enables the valve to maintain a fluid-tight seal even at very high pressures sometimes experienced in medical applications, particularly when thevalve10 is connected to a patient's artery. The center of themember200 and theannular space102 are coaxial with the entryway11ato theorifice11. The pressurized fluid fills theannular space102 to apply pressure that compresses themember200 to tightly close the entryway11ato theorifice11. In a preferred valve embodiment the distance from the entryway11ato the proximal end of theseal cap92 is from 0.500 to 0.075 inches and more preferably approximately 0.100 inch.
• As best illustrated in FIG. 22, the[0077]tip32 is designed to avoid tearing the seal. Thetip32 has threefacets210,212, and214 which are joined with each other along parting lines a, b, and c. This junction of thefacets210,212, and214 frequently is ragged and will tear theseal36d. This is prevented by the parting lines a, b, and c, or junctions, being disposed withinrecesses220,222, and224, respectively, to provide “buried parting lines.”
• Another alternative embodiment of the[0078]valve10 using theseal36dis shown in FIG. 8 and FIGS. 19 through 21. In this embodiment, theinner wall160 of the upper end of theconduit20 is provided with at least one, and preferably, a plurality ofradial indentations107. Theindentations107 are elongated and disposed generally parallel to the longitudinal axis of thevalve10 in a symmetrical, star-like configuration. Each indentation has opposedlateral edges162 which engage theseal36dupon compression of theseal36d. The indentations provide space into which theseal36dexpands upon compression.
• Another preferred embodiment of the[0079]seal36his shown in FIGS. 23 through 25 and27. In this embodiment, theseal36hcomprises aseal cap92 having a saucer-like depression204 (FIG. 23). Theseal36hcontains aslit11 having a proximal endadjacent depression204 and adistal end11aat the distal end ofseal cap92. Referring to FIG. 23,circular tires100 similar to those in FIG. 13 are provided. Theseal36hhas aninternal cavity98. Further, theseal36hpreferably has aseal lip96 as discussed in more detail above.
• As best shown in FIG. 8, the[0080]wall181 of the proximal end of theupper conduit20 is tapered inward at the same angle as thenose48 of thesyringe46. In accordance with ANSI standards, the taper is 0.006 inch per linear inch. Thewall182 of thesyringe nose48 bears against thewall181 as the nose slides into the opening25ato push theseal36dinward compressing it and forcing thetip32 of thespike36 to enter theslit11. Theseal36dexpands upon compression to fill essentially completely the upper portions of theindentations107. Some sections of theseal36dare wedged between theedges162 and other sections fill theindentations107. As the liquid flows through thenose48 throughholes34, air in thenose48 is forced out of thenose48 and expelled from thevalve10 between thewalls181 and182. Thus, essentially the entire prescribed dosage is delivered through thevalve10 to the patient. Fluid flows through the through-holes34, but does not leak between either theseal36dand thewall181 or between the abuttingwalls181 and182.
• FIGS. 15, 16,[0081]17, and18 depict embodiments of seals, namely, seal36e, seal36f, and seal36g, which are substantially the same as theseals36a(FIG. 10), seal36b(FIG. 11), and seal36c(FIG. 12), except theside wall150 employing thecircular tires100 is used in place of theaccordion wall portion94.
• Other components of the valve interact with the various embodiments of the seal in a similar fashion to their interaction with[0082]seal36 of FIG. 2. Prior to use of thevalve10, it is preferable that the seal caps40 or92 be pierced centrally by a steel needle in the axial direction, precutting the seal to provide theslit11 in order to allow for more rapid decompression and reformation of the seal upon piercing by thespike26. The seals are advantageously formed from a material which can repeatedly reseal and prevent fluid from flowing around the seal material. Theseal36 should also be capable of being forced down and then spring back into position to reseal the valve. Material that is too soft will not reseal effectively; however, will not be capable of springing back after opening of the valve. Material that is too hard will provide sufficient spring force; however, will not effectively seal. Thus, in a preferred embodiment, the seal is formed from a silicone having a hardness in the range from 30-70 Shore durometer units, and more preferably in the range 40-50 Shore durometer units. A cure silicone polymer in the preferred hardness range is available from Wacker Silicone Corp. of Adrian, Mich. In some valve embodiments, it is desirable to provide additional lubricity to theseal36 to allow it to spring back and reseal more effectively. Dow Chemical Co. produces a silicone formulation with silicone oil built in to provide this additional lubricity.
• In general, the closing of the[0083]valve10 is provided not by the side wall of theseal36 which immediately covers the through-holes34, but by theseal cap40, or sealcap92 filling the proximal end of thecavity98 and theopening25a. Thus, the seal caps40 and92 are sufficiently thick to reseal theopening25aeffectively after valve closure. However, the seal caps40 and92 should also be sufficiently thin to allow them to readily return to the closed position. Preferably the thickness of thecaps40 and92 ranges between 0.075 and 0.500 inch and more preferably may be approximately 0.100 inch.
• The valve can be provided in a sterile and disposable form such that after its use in a given installation is exhausted, the device is discarded. However, as described above, in any given installation, the valve can be reused multiple times. Since the valve does not employ needles, there is little chance that the device will inadvertently cause skin puncture. Therefore, the extra precautions required for handling and disposing of needles is obviated. It will be apparent from the detailed description provided herein that the valve can provide for the elimination of nearly all needles used in the medical environment. With the use of the valve described above, the need for all needles except those that are directly input into a patient is, advantageously, eliminated.[0084]
• The[0085]valve10 is used to provide a closed, patient access system for transferring a predetermined amount of medication from a remote source to the patient. Thevalve10 is connected by the distal end to the patient, for example, a vein or artery in fluid communication with the valve. Blood fills the valve, but theseal36d, for example, prevents any blood from leaking from the valve. The delivery end ornose48 of the medical implement is inserted into the valve as depicted in FIG. 8, pushing thenose48 against the seal to compress the seal sufficiently to allow thetip32 of thespike24 to pierce the seal and enter said delivery end. The predetermined amount of medication in its entirety may now be transferred through thenose48 into thevalve10 and into the patient. Since thenose48 and seal36dengage in a manner so that thetip32 of thespike element24, upon piercing the seal, meets the seal to avoid formation of any dead space at the interface betweennose48 and theseal surface40b. Transfer directly through thevalve10 of essentially the entire predetermined amount of medication from thesyringe46 to the patient, so that essentially none of said predetermined amount is collected in any dead space in the valve, is accomplished. Upon withdrawing thenose48 from thevalve10 theseal36dreturns to the decompressed state to close the valve and maintain while in said decompressed state a fluid tight seal even at high pressures and after repeated uses.
• Another alternative embodiment of the seal, a[0086]seal36h, is shown in FIG. 23. In this embodiment, theseal36his similar to seal36dand is comprised of aseal cap92,seal lip96, and aside wall150 comprised ofcircular tires100 stacked in series one on top of an adjacent larger diameter lower tire.Side wall150 definescavity98. The circular tires are preferably solid throughout the diameter of the cross-section thereof. These circular tires will deform and reform upon, respectively, compression and decompression of theseal36h, thereby exposing or covering a spike (not shown) as the case may be.
• [0087]Seal36halso has a precut slit11 inseal cap92 lying along the longitudinal axis of theseal36h.Slit11 remains sealed whenseal36his in a decompressed state. As explained earlier, precutting the seal to provideslit11 allows for more rapid decompression and reformation of the seal upon piercing by the spike. Unlikeseal36d, however, sealcap92 ofseal36his substantially solid without having any pressure responsive member as is employed inseal cap92 forseal36d.
• An alternative embodiment of the present[0088]invention using seal36his shown in FIG. 24. Spike26a, residing withincavity98 and having a proximal end with atip32 embedded inseal cap92, is shown to be more tubular, and less frustoconical than thespike26 illustrated in other embodiments. Furthermore, thetip32 of spike26ais a blunt, rounded end, unlike the pointed tip ofspike26. Because the end is rounded, the seal cap is not subjected to deterioration through tearing byspike tip32. Thus a tear ring for the seal, as shown in FIG. 14 for example, is not necessary for this embodiment.
• Another feature of this embodiment is the arrangement of the spike[0089]26awith theseal36hwhen theseal36his in a decompressed state. In this state, roundedtip32 ofspike36his positioned to be embedded in slit entryway11a, whileslit11 remains closed to any fluid flow. FIG. 24 shows the entirerounded tip32 in contact with the distal end ofseal cap92. Additionally, the side wall circular tire closest to the proximal end of the seal,tire100a, contacts the side wall of spike26a. It is desirable that at least the next immediate distal circular tire,tire100b, also be in contact with the spike26aproximate the through-hole34. Having a plurality of tires in contact with spike26aproximal through-hole34 prevents fluid from passing fromcavity98 through the proximal end of thevalve10. Without such a design, fluid would leak through through-hole34, thereby applying enough fluid pressure onslit11 to force slit11 open while the seal is still in a decompressed state. Through-hole34 should be distal thetires100a,100b, which contact spike26a, so that fluid passing through through-hole34 will not apply pressure to slit11, and instead will be blocked bycircular tires100aand100bcreating a seal between the spike26aandseal36h.
• During medical applications, for example when the[0090]valve10 is connected to a patient's artery, the patient's blood flows through theholes34 in spike26a, filling the area incavity98 distal thesecond tire100b. Since the fluid residing between the first two tires,100aand100b, and betweenseal cap92 andtire100aconstitutes a very small volume, the fluid cannot exert enough pressure against the seal cap to openslit11.Pre-cut seal cap92 is designed to remain closed up to fluid pressure of 20 psi. Therefore, blood pressure will not open thevalve10.
• Upon connection of the distal end of[0091]valve10 with a patient's artery, however, as the blood pushes up againstseal36h, the fluid may forceseal cap92 to move proximally, thereby also pushing thesidewall tires100 in the proximal direction. This pressure may permit blood to flowpast tires100aand100bto place pressure on theslit11. However, due to increased fluid pressure, the tires immediately distal first andsecond tires100aand100bmove proximally and contact the spike26ato take the original positions oftires100aand100bso as to ensure that a plurality of tires are always in contact with spike26a. Because thesidewall tires100 ofseal36hare designed to bow outward from the proximal to the distal end, the tires immediatelydistal tires100aand100bmay not be in contact with spike26awhen in their original position. However, as will be understood by those of skill in the art, if fluid flows through the spike26a, through-hole34 and intocavity98 ofseal36h, forcing theseal36hto move in a proximal direction, tires distal thefirst tire100aandsecond tire100bwill also move in a proximal direction and contact the spike26aproximally through-hole34 strengthening the seal between the spike26aand theseal36h. That is, when fluid is not contained within thecavity98 of thevalve10, only thefirst tire100aandsecond tire100bcontact the spike26a. However, once fluid is introduced into thecavity98 of thevalve10, theseal36hmay travel in a proximal direction. If this occurs, tires directly distalsecond tire100bcontact seal26ain addition to thefirst tire100aandsecond tire100bstrengthening the seal between theseal36hand spike26aand preventing fluid from traveling through spike26a, through the through-hole34 into thecavity98 and past thetires100 to exert pressure on theslit11 in theseal cap92 ofseal36h.
• An alternative embodiment of the housing,[0092]housing12a, is shown in FIG. 25. In this partial cross-sectional view,housing12ais similar tohousing12, except forgrooves303,304 that are provided along the longitudinal axis of the interior wall of theupper conduit20. Thegrooves303,304 are provided as fluid escape spaces to ensure that a perfect seal between theseal cap92 and theinner wall305 of theupper conduit20 is not provided. Thegrooves303,304 preferably run from the proximal end of theupper conduit20 distally past the portion of theupper conduit20 in contact with theseal cap92. As best seen in FIG. 28, thegroove303 preferably extends from the proximal end of theupper conduit20 of thehousing12adistally to the proximal end of theradial indentations107.
• Provision of the fluid escape spaces provides the advantage of allowing any fluid residing in the space between the[0093]seal36hand theupper conduit20 to exit the housing upon compression of theseal36h. Referring to FIG. 25, during routine use of thevalve10 in transferring fluid, fluid may seep into the section of thehousing12abetween theseal36hand thewalls305 of theupper conduit20. When this area is filled with fluid and theseal cap92 is compressed distally by a medical implement (not shown), the user may experience difficulty in forcing theseal cap92 distally past the through-hole34 of the spike26a, because thesidewall tires100 no longer have any room within theupper conduit20 to be compressed due to the presence of the fluid. It is undesirable to require the user to apply extra force to compress the seal because oftentimes the user may twist the medical implement down onto the seal, leading to deterioration of the seal and eventual tearing. In addition, fluid between theseal36hand theinner wall305 of theupper conduit20 of thehousing12amay prevent theseal36hfrom compressing distal the through-hole34 of the spike26a. As a result, thevalve10 would not function properly.
• By providing[0094]grooves303,304 as fluid escape spaces, fluid present between theseal36hand theinner wall305 of theupper conduit20 of thehousing12amay travel proximally through thegrooves303,304 upon compression of theseal36hby a medical implement (not shown). As the fluid is expelled from thevalve10 through thegrooves303,304 at the proximal end of thehousing12a, theseal36hmay compress normally without use of excessive force by a user of thevalve10.
• FIG. 26[0095]ais a top plan view of the valve shown in FIG. 25.Grooves303,304 are shown in theupper conduit20 of thehousing12aof thevalve10. Importantly, when theseal36his compressed distally by a medical implement (not shown), theseal36hdoes not expand into thegrooves303,304 thereby preventing fluid flow therethrough.
• Another alternative embodiment for the housing,[0096]housing12b, is shown in FIG. 29. Thehousing12bemploys achannel307 as a fluid escape space which is substantially perpendicular to the longitudinal axis of thevalve10. Achannel307 is a bore that runs transversely through the side of the wall of theupper conduit20, and is positioned distal to anyLuer Lock threads309 or other locking mechanism that may surround theupper conduit20 near its proximal end. Similar to thegrooves303,304, thechannel307 provides a passageway for fluid within the area between theseal36 and theinner wall305 of theupper conduit20 to exit when thesidewall tires100 are compressed and expand into theradial indentations107. Since an avenue exists for the fluid to exit this area, a user does not have to apply excessive force in pushing a medical implement (not shown) distally into thevalve10.
• FIG. 26[0097]bis a top plan view of thevalve10 shown in FIG. 29. Thechannel305 is shown in phantom and is preferably located in theupper conduit20 of thehousing12bof thevalve10. Upon compression of theseal36hby a medical implement (not shown), fluid between theupper conduit20 and theseal36his expelled from thevalve10 through thechannel307 and out the side wall of theupper conduit20. Thus, achannel307 can be distinguished from a groove by its expulsion of fluid through a side wall, rather than the proximal end of thehousing12a, as for agroove303.
• As will be easily understood by those of skill in the art, a channel and groove may be incorporated in combination to assist in expelling fluid from the valve upon compression of the seal by a medical implement. For example, upon compression of the seal, fluid could travel through a groove proximally and thereafter through a channel in communication with the groove. The channel could be located distally the proximal end of the valve. Moreover, a single groove or channel may be utilized or multiple grooves or channels may be incorporated into the valve of the present invention as will be easily understood by those of skill in the art.[0098]
• Lack of a channel or groove as discussed above, may result in deterioration of the[0099]seal36 and prevent theseal cap92 from being pushed completely below through-hole34. If the through-hole is not completely open, the patient will not be able to receive a constant flow rate of medication. In some situations, the delivery of an exact amount of medication at a predetermined rate may be critical for treatment, and, therefore, through-hole34 must be completely open for passage of medication from the medical implement. The groove and/or channel ensures that the seal cap may be pushed distally the through-hole and that the seal may be compressed without any excessive force which may cause damage to the seal.

Claims (23)

The following is claimed:

1. A medical valve for controlling the flow of fluid between a first medical implement and a second medical implement, said valve comprising:

a body comprising an opening adapted to receive the first medical implement, and a wall structure defining an internal cavity adapted for fluid communication with the second medical implement, said cavity comprising a neck portion in fluid communication with said opening and a main portion with a larger internal diameter than the neck portion;

a flexible element positioned in said cavity movable between an uncompressed position in which a portion of the flexible element bears against the wall structure near said opening and obstructs fluid flow through said valve and a compressed position in which fluid flow is permitted through said valve, said flexible element comprising a wall with an inner surface and an outer surface, the wall flexing to accommodate axial compression of said flexible element, said flexible element comprising an end fitting against a ring-shaped support to assist in securing said flexible element in said cavity, said flexible element in said uncompressed position comprising a first external diameter near said opening, a second external diameter in said neck portion and a third external diameter in said main portion, said second diameter being smaller than said first diameter and said third diameter, and at least a portion of the outer surface of the wall of the flexible element between the second diameter and the third diameter being tapered; and

a fluid escape space in the wall structure of the body for relieving fluid from a space between the flexible element and the body in the cavity.

2. The valve ofclaim 1, wherein the fluid escape space comprises at least one groove.

3. The valve ofclaim 2, wherein the fluid escape space terminates at an end of the body adapted to receive the first medical implement.

4. The valve ofclaim 2, wherein the fluid escape space terminates at a location on the outer surface of the body between an end adapted to receive the first medical implement and an opposite end adapted to receive the second medical implement.

5. The valve ofclaim 1, wherein an end of the flexible element near the opening of the body in its uncompressed position is substantially flat.

6. The valve ofclaim 1, wherein said flexible element in the uncompressed position has an end substantially flush with the opening of said cavity of said body.

7. The valve ofclaim 1, further comprising:

a rigid member positioned within the flexible element to assist in supporting the flexible element and to assist in maintaining the flexible element along an axial centerline of the cavity when the flexible element moves between the uncompressed position and the compressed position.

8. The valve ofclaim 1, wherein the flexible element substantially completely fills the opening in its uncompressed position.

9. A medical valve for controlling the flow of fluid between a first medical implement and a second medical implement, the valve comprising:

a body comprising an opening adapted to receive the first medical implement, and a wall structure defining an internal cavity adapted for fluid communication with the second medical implement, the cavity comprising a neck portion in fluid communication with the opening and a main portion with a larger internal diameter than the neck portion;

a flexible element positioned in the cavity movable between an uncompressed position in which a portion of the flexible element bears against the wall structure near the opening and obstructs fluid flow through the valve and a compressed position in which fluid flow is permitted through the valve, the flexible element comprising a wall with an inner surface and an outer surface, the wall flexing to accommodate axial compression of the flexible element, the flexible element in the uncompressed position comprising a first external diameter near the opening, a second external diameter in the neck portion and a third external diameter in the main portion, the second diameter being smaller than the first diameter and the third diameter, and at least a portion of the outer surface of the wall of the flexible element between the second diameter and the third diameter being tapered; and

a fluid escape space in the wall structure of the body for relieving fluid from a space between the flexible element and the body in the cavity.

10. The valve ofclaim 9, wherein the fluid escape space comprises at least one groove.

11. The valve ofclaim 9, wherein the fluid escape space terminates at an end of the body adapted to receive the first medical implement.

12. The valve ofclaim 9, wherein the fluid escape space terminates at a location on the outer surface of the body between an end adapted to receive the first medical implement and an opposite end adapted to receive the second medical implement.

13. The valve ofclaim 9, wherein an end of the flexible element near the opening of the body in its uncompressed position is substantially flat.

14. The valve ofclaim 9, wherein the flexible element in the uncompressed position has an end substantially flush with the opening of the cavity of the body.

15. The valve ofclaim 9, further comprising:

a rigid member positioned within the flexible element to assist in supporting the flexible element and to assist in maintaining the flexible element along an axial centerline of the cavity when the flexible element moves between the uncompressed position and the compressed position.

16. The valve ofclaim 9, wherein the flexible element substantially completely fills the opening in its uncompressed position.

17. A medical valve for controlling the flow of fluid between a first medical implement and a second medical implement, the valve comprising:

a body comprising an opening adapted to receive the first medical implement, and a wall structure defining an internal cavity adapted for fluid communication with the second medical implement, the cavity comprising a neck portion in fluid communication with the opening and a main portion with a larger internal diameter than the neck portion;

a flexible element positioned in the cavity movable between an uncompressed position in which a portion of the flexible element bears against the wall structure near the opening and obstructs fluid flow through the valve and a compressed position in which fluid flow is permitted through the valve, the flexible element comprising a wall with an inner surface and an outer surface, the wall flexing to accommodate axial compression of the flexible element, the flexible element in the uncompressed position comprising a first cross-section near the opening having a first internal diameter and a first external diameter, a second cross-section in the neck portion having a second internal diameter and a second external diameter and a third cross-section in the main portion having a third internal diameter and a third external diameter, the second external diameter being smaller than the first external diameter and the third external diameter, and the third internal diameter being greater than the second internal diameter and the second internal diameter being greater than the first internal diameter; and

a fluid escape space in the wall structure of the body for relieving fluid from a space between the flexible element and the body in the cavity.

18. The valve ofclaim 17, wherein the fluid escape space comprises at least one groove.

19. The valve ofclaim 17, wherein the fluid escape space terminates at an end of the body adapted to receive the first medical implement.

The valve ofclaim 17, wherein the fluid escape space terminates at a location on the outer surface of the body between an end adapted to receive the first medical implement and an opposite end adapted to receive the second medical implement.

20. The valve ofclaim 17, wherein the inner surface in the uncompressed position has a taper between the first cross-section and the second cross-section that is different than a taper between the second cross-section and the third cross-section.

21. The valve ofclaim 17, wherein an end of the flexible element near the opening of the body in its uncompressed position is substantially flat.

22. The valve ofclaim 17, wherein the flexible element in the uncompressed position has an end substantially flush with the opening of the cavity of the body.

23. The valve ofclaim 17, wherein the flexible element substantially completely fills the opening in its uncompressed position.

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