Patent Publication Number: US-7722576-B2

Title: Medical valve and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   This application is a continuation of U.S. application Ser. No. 10/630,131, filed Jul. 30, 2003, now abandoned, which is a continuation of U.S. application Ser. No. 10/163,403, filed Jun. 5, 2002, now U.S. Pat. No. 6,669,673 which was a continuation of U.S. application Ser. No. 09/569,712, filed May 9, 2000, now U.S. Pat. No. 6,572,592, which was a continuation of U.S. application Ser. No. 08/905,370, filed Aug. 4, 1997, now abandoned, which was a continuation of U.S. application Ser. No. 08/334,846, filed Nov. 4, 1994, now U.S. Pat. No. 5,685,866, which was a continuation of U.S. application Ser. No. 08/096,659, filed Jul. 23, 1993, now U.S. Pat. No. 5,695,466, which was a continuation-in-part of PCT Application No. PCT/US92/10367, filed Dec. 1, 1992, now abandoned, which was continuation-in-part of U.S. application Ser. No. 07/813,073, filed Dec. 18, 1991, now abandoned. This application incorporates by reference the above identified applications in their entireties. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   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. 
   2. Description of the Related Art 
   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 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. 
   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 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. 
   Metal needles employed as part of connector devices increase the risk of puncture wounds to the user. The needles used in these 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. 
   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. 
   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. 
   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, elimination of dead space, simplicity of manufacture and use, and employment of a valve that is swabbable after use to provide sterility and has a fluid-tight seal at high pressure. 
   This invention 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, non-metallic 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. 
   The first feature of this invention in that the valve has a body including 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, and the wall structure adjacent the opening 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. 
   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. The spike is seated inside the cavity such that the tip is inward of the proximal end and is enclosed within the cavity. Preferably, the hole is in a side of the spike adjacent the tip and is elongated, having a size of 18 gauge or greater. The tip may be sharp or slightly rounded. More than one hole is desirable for many applications, and three, symmetrically located holes inward of the proximal end are preferred. 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. The spike is disposed within this conical cavity and the seal covers the tip. The tip may be imbedded in the proximal end of the seal or withdrawn into the conical cavity. Preferably, the tip of the spike has a plurality of facets which meet within a recess. The preferred spike should be able to penetrate the seal repeatedly without tearing the seal. Rough edges at the tip may present a tear problem. During injection molding of the preferred plastic spike, facets of the tip will abut along a “parting line,” and could form a rough edge which may tear the seal. This problem is avoided where the parting line is buried in a recess. Any rough edge at this parting line is disposed within a recess, so the seal material moves over the recess and does not contact the rough edge. 
   The third feature is that the resilient seal is adapted to be moved into a compressed state upon insertion of the tip of the medial 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. The seal section bears against the wall structure near the opening to seal 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. A fluid tight seal is maintained between the seal section and the wall structure as the seal is moved into the compressed state. The seal section bears against the wall structure as the seal is moved inward into the cavity by the tip of the medical implement. And most importantly, the delivery end 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 to 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. 
   A fluid tight seal is maintained over repeated opening and closing of the valve, and the seal has on its external surface a recess which provides an air pocket to facilitate the movement of the seal. Preferably, the seal presents an essentially flush surface with the proximal end of the cavity. In one embodiment, the proximal end of the seal is substantially flat, the seal is made of a material having a hardness of from 30 to 70 Shore units such as, for example, a silicone polymer. The seal may include a cup-like flange adapted to engage the body near the proximal end of the cavity. A preferred embodiment of the seal comprises of 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 begin adjacent the proximal end of the cavity. The proximal end of the seal may be precut to form a tiny orifice therein that allows the tip of the spike to pass therethrough easily upon compression of the seal. Preferably, the proximal end of the seal has a truncated conical shaped segment disposed within the cavity. The seal may also have a centrally located, anti-vacuum, saucer like depression therein, which does not interfere with the ability of the exposed, proximal end of the seal being swabbed when desired. 
   The fourth feature is that the body and spike are two separate components of the valve that are securely attached to each other by assembly of, and interlocking, of the body and spike. The body has a first locking element near the distal end of the cavity, and the spike has a second locking element adapted to interlock with said first locking element upon assembly. The seal has a lip extending beyond the distal end and positioned between the first and second locking elements so that, upon assembly, the lip is compressed between the locking elements to provide an essentially fluid tight seal upon interlocking. 
   The fifth feature is that the medical valve includes a support member connected to the spike which seals off the distal end of the cavity. The support member may have a Luer-Lock type connector element that enables the valve to be removably attached to, for example, a fluid line connected to a patient. The support member may also be in the form of an adaptor that enables the valve to be removably attached to a fluid dispenser or container. When used to dispense fluids from a container, the spike has a pair of opposed tips, respectively at the distal and proximal ends of the spike. The tip at the distal end of the spike pierces a cover member which seals the container. A radial slit on the adaptor enables it to deform reversibly sufficiently to fit snugly onto said container. 
   The sixth feature is that the seal has a proximal end including a pressure responsive element disposed on an inner surface of the seal adjacent the opening. The pressure responsive element in the decompressed state closes any orifice in the seal at the proximal end of the seal to provide an essentially fluid-tight seal while in the decompressed state. The pressure responsive element enables the valve to maintain a fluid-tight seal even at very high pressures sometimes experienced in medical applications, particularly when the valve is connected to a patient&#39;s artery. The valve of this invention will remain closed even when the pressure inside the valve is above 6 pounds per square inch (psi), and it can withstand pressures above 30 psi. Typically, the pressure responsive element is a section of the seal having an entryway into a precut orifice. This section has a substantially cylindrical configuration and is surrounded by an annular space which is filled with pressurized fluid. The center of the member and the annular space are coaxial with the entryway to the orifice. The pressurized fluid fills the annular space to apply pressure that compresses the cylindrical section to tightly close the entryway to the orifice. Preferably, the pressure responsive element has an anti-tear element. 
   In accordance with this invention, a known, prescribed, predetermined amount or dosage of medication may be transferred from the remote source to the patient directly, so that essentially none of said predetermined amount is collected in dead space in the valve. In other words essentially all the prescribed dosage is received by the patient and not lost in the valve. Thus, this invention also includes a method of transferring fluid from a remote source to a patient. This invention also includes transfer of fluid from the patient to a remote source. This is possible because the valve of this invention provides two-way communication. The fluid is transferred to the patient by applying pressure to the fluid as it passes through the implement so that the pressure applied to the fluid is greater than the pressure of fluid in the patient, enabling transfer from the remote source to the patient. To achieve transfer of fluid from the patient to the remote source, the pressure of fluid in the patient is greater than the pressure at the remote source, causing fluid to flow from the patient to the remote source. This invention also includes a method of transferring fluid in a container having an open mouth covered by a cover member which seals the open mouth. The fluid is caused to flow from the container through the passageway by creating a differential in pressure. Preferably, the valve has an adaptor having a radial slit for allowing the adaptor to deform reversibly sufficiently to fit snugly onto said container. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The preferred embodiments of this invention, illustrating all its features, will now be discussed in detail. These embodiments depict the novel and non-obvious method and valve of this invention shown in the accompanying drawing, which is for illustrative purposes only. This drawing includes the following Figures, with like numerals indicating like parts: 
       FIG. 1  is a perspective view of the first embodiment of the valve of this invention. 
       FIG. 2  is an exploded perspective view of the valve shown in  FIG. 1  illustrating the spike, seal, and the body or housing components of the invention. 
       FIG. 3  is a longitudinal cross-sectional view of the assembled valve of  FIG. 1 . 
       FIG. 4  is a schematic, longitudinal, cross-sectional view of the assembled valve of  FIG. 1  before compressing that seal. 
       FIG. 5  is a schematic, longitudinal, cross-sectional view similar to  FIG. 4  showing the valve during compression of the seal. 
       FIG. 6  is a perspective view of a second embodiment of the invention. 
       FIG. 7  is a longitudinal cross-sectional view of the valve of  FIG. 6 . 
       FIG. 8  is a schematic illustration of an ANSI delivery end of a medical implement compressing the seal of the valve of this invention. 
       FIG. 9  is a side elevation view, partially in cross-section, of a third embodiment of the seal. 
       FIG. 10  is a longitudinal cross-sectional view of the assembled valve of  FIG. 1  using the seal of  FIG. 9 . 
       FIG. 11  is a longitudinal cross-sectional view of the assembled valve of  FIG. 1  using a fourth embodiment of the seal. 
       FIG. 12  is a longitudinal cross-sectional view of the assembled valve of  FIG. 1  using a fifth embodiment of the seal. 
       FIG. 13  is a longitudinal cross-sectional view of the sixth embodiment of the seal. 
       FIG. 14  is a longitudinal section of the seal shown in  FIG. 13  used in connection with the spike device shown in  FIG. 2 . 
       FIG. 15  is a longitudinal partial cross-sectional view of a seventh embodiment of the seal of this invention. 
       FIG. 16  is a longitudinal cross-sectional view, after assembly, of the embodiment of the valve shown utilizing the seal of  FIG. 15 . 
       FIG. 17  is a longitudinal cross-sectional view, after assembly, of the eighth embodiment of the valve of this invention. 
       FIG. 18  is a longitudinal cross-sectional view, after assembly, of the ninth embodiment of the valve of this invention. 
       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 . 
       FIG. 20  is a cross-sectional view taken along line  20 - 20  of  FIG. 19 . 
       FIG. 21  is a perspective view, with sections broken away to show the wall structure of the cavity containing the seal shown in  FIGS. 13 and 14 . 
       FIG. 22  is a greatly enlarged, cross-sectional view taken along line  22 - 22  of  FIG. 14 . 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
   The term “proximal” is used to denote the end of the valve and other components at or near the spike tip  32  in  FIGS. 2 through 5 ,  10  through  12 ,  14  and  16 , and at or near the spike tip  60  in  FIG. 6 , and at or near the seal cap  92  in  FIGS. 8 ,  9 ,  13  through  19 . 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 connect to the present invention and facilitate the passage of fluids, particularly liquids, through the instant invention. 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, and other components which can be used in connection with medical valve. Medical implements are commercially available in standard sizes. Thus, either or both ends of the valve of this invention can be provided with fittings to accommodate such standard size medical implements. 
   As best shown in  FIGS. 1 and 2 , the first embodiment of the invention, valve  10 , includes a valve body or housing  12 , a spike element  24 , and a seal  36 . The seal  36  is prepared from a resilient material that is flexible, inert, impermeable to fluid, and readily pierceable by the spike  26 . In the embodiment shown in  FIG. 13  depicting an alternate shaped seal  36   d , this seal  36   d  has a precut slit  11  in its proximal end. This provides a tiny orifice through which the tip  32  of the spike element  24  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 the spike element  24  enclosed to prevent accidental sticks.  FIG. 2  illustrates how the housing  12 , seal  36 , and spike element  24  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 , the seal  36  moves within the housing  12 , being pierced by the spike element  24  to expose the tip  32  of the spike element  24  to allow fluid to flow through the valve  10 . 
   Referring to  FIG. 1 , one preferred embodiment of housing  12  has a bell-shaped skirt  16  and an upper, preferably cylindrical, conduit  20 . The skirt  16  is integral with, and connected by an annular ring  14 , to the upper conduit  20 . The skirt  16  creates a shield for an inner conduit  18  of the spike element  24 . This inner conduit  18  is preferably cylindrical in shape, and slightly tapered. Inner conduit  18  and upper conduit  20  comprise aligned hollow tubes so that inner conduit  18  and upper conduit  20  are in fluid communication with one another when the spike element  24  pierces the seal  36 . there is an annual lip  25  surrounding a circular opening  25   a  in the top of the conduit  20  (see  FIG. 2 ). 
   In the first embodiment, the upper conduit  20  is adapted to receive the tip or nose  48  of an ANSI standard syringe  46  (see  FIGS. 4 and 5 ). It is, however, contemplated that the outer diameter of the upper conduit  20  can be of any size to accommodate the attachment of other connector devices thereto. Advantageously, the proximal end of the upper conduit  20  can be equipped with a locking mechanism to facilitate locking of the valve  10  to a variety of connector devices. For example, referring to  FIG. 1 , locking ears  22  near the proximal lip  25  of housing  12  are preferably provided such that the housing  12  can be locked into any compatible Luer-Lock device known to those with skill in the art. For example, referring the  FIG. 19 , conventional Luer-Lock threads  180  can be provided on the outer diameter of upper conduit  20 . 
   Referring to  FIG. 2 , the spike element  24  has at its distal end the inner conduit  18  and its proximal end a hollow spike  26  which is integral with the inner conduit. The inner conduit  18  and spike  26  present a continuous passageway for fluid during use. An annular cuff  28  on an intermediate portion of the spike element  24  is integral with, and interconnects, the inner conduit  18  and the spike  26 . As illustrated in  FIG. 3 , the rim  28   a  of the cuff  28  abuts the underside of the inner ring  14 , and has an annular detent  28   b  that snaps into an annular groove  14   b  in the underside of the ring. The cuff  28  services two functions. First, it serves as an attachment device to the underside of the annular ring  14 . Second, it serves as a support and attachment device for the seal  36 . 
   The hollow spike  26  has a tapered conical shape, ending in a sharp, pointed tip  32 . Preferably, along the length of the spike are raised, protruding ridges  30 . These raised ridges  30  extend from the surface of the spike preferably between 0.2-2.0 mm. The ridges  30  are preferably aligned along the length of the spike as illustrated in  FIG. 2 . These ridges  30  serve to break any vacuum created when the spike  26  is sealed as described hereinbelow. Modifications to the alignment and orientation of the ridges are discussed hereinbelow in association with their function. Just distal the spike tip  32 , there is situated at least one longitudinal through-hole  34  to permit fluid communication between the inner conduit  18  and the upper conduit  20 . Preferably, there are three through-holes  34  within about 0.200 inch from the spike tip  32 . These through-holes  34  may be of any size, however, the larger the size of the through-holes the greater the fluid flow rate through the valve  10 . In a preferred embodiment, the size of the through-holes  34  are 18-gauge to provide a flow rate three times that of a standard 18 gauge needle. 
   The seal  36  has a seal cap  40  with a generally flat top surface  40   b , an outwardly tapered sidewall  38 , and a lower lip  42 . Its interior is hollow to provide the conically shaped cavity  37  ( FIG. 3 ). Thus, the seal  36  slips easily over the spike element  24  to fit snugly within the cavity  37 . The seal lip  42  is seated within the annular cuff  28  and wedged between the cuff and the underside of the ring  14 . There are longitudinal grooves  43  ( FIG. 2 ) along the length of the seal  36  which provide air pockets that facilitate compression of the seal  36  during use. The grooves  43  may be of variable shape or size to facilitate seal compression. In the first embodiment, there is a single groove  43  which completely surrounds the seal  36  between the seal cap  40  and the lip  42 . 
   The base of the seal  36  has a width such that the seal lip  42  fits snugly into the annular cuff  28 . The hollow interior or cavity  37  ( FIG. 3 ) of the seal  36  is preferably tapered to conform internally to the shape of the spike  24 , having a wall portion  44  which contacts the spike  24  distal seal cap  40 . The exterior of the seal  36  is sized and shaped to fit inside the upper conduit  20  of the housing  12 . The cap  40  reseals the valve  10  when the top surface  40   b  is above the through-holes  34 . Preferably, the cap  40  substantially fills the opening  25   a  in the top of the conduit  20 . Thus, after assembly, the top surface  40   b  of the seal cap  40  is essentially flush with the lip  25 , so that the lip  25  and seal cap  40  can be swabbed with alcohol or other disinfectant without leakage of disinfectant into the valve  10 . It is important that the surface  40   b  be exposed so that it may be swabbed with a disinfectant. 
   As best shown in  FIG. 3 , the spike  24 , with contiguous inner conduit  18 , is affixed to the housing  12  through the association of the external portion of annular cuff  28  and the internal portion of annular ring  14 . 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. The seal  36  fits into the annular cuff  28  and is held in place by an internal lip  27  along the internal portion of the annular ring  14  of the housing  12 . The length of the spike  24  is such that, after assembly, the tip of the spike rests below the plane defined by the lip  25  of the housing  12 . Preferably, the spike tip  32  is approximately from 0.525″ to 0.1″ below the lip  25  of the housing  12 . The seal  36  fits snugly against the spike  24  and is essentially flush with the lip  25  of the housing  12 . The spike tip  32  is thus embedded within the seal cap  40  prior to use or may be approximately 0.025″ distal the seal cap  40  when the valve  10  is in the closed position. The inner conduit  18  is partially shielded by the bell shaped skirt  16  of the housing  12  (see  FIGS. 1-3 ). The inner surface of the bell shaped skirt  16  preferably has protruding threads  45  as an optional locking mechanism for attaching a medical implement thereto. Further, other medical devices can be pressure fit over the outer portion of inner conduit  18  without direct association with the protruding threads  45 . 
   During use, the invention is designed to 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 invention 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 needle into the patient. The containers are frequently changed or additional fluid bottles are added. The invention disclosed herein is designed to interconnect medical implements along the route of fluid delivery to the patient. However, the invention 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 inner conduit  18 . Locking can be achieved by a Luer-Lock mechanism, a pressure fit or any other locking mechanisms know to those with skill in the art, as described above. Thus, in one example, fluid passes from the inner conduit  18  into the spike  26 . However, fluid flow is locked in place by the seal  36 . 
     FIGS. 4 and 5  illustrate valve activation. In  FIG. 4 , the medical implement connecting to the proximal end of the valve  10  is a syringe  46 . However, this connecting implement could be any number of medial implements known to those of skill in the art. The nose  48  of the syringe  46  is placed on the seal cap  40  inside the lip  25  of the housing  12 . The application of pressure on the syringe  46  in the direction of the arrows, as illustrated in  FIG. 4  creates pressure on seal cap  40 . The resulting downward pressure compresses the seal  36 . This pushes the tip  32  of the spike  26  through the seal cap  40  to expose the through-holes  34 . Compression is facilitated by the grooves  38 . Fluid is now able to flow into the syringe  46 , or vice versa, depending on whether fluid is to be withdrawn from the patient or medication injected into the patient.  FIG. 5  shows valve  10  opened by insertion of the nose  48  of the syringe  46  into the opening  25   a . A syringe plunger  49  in the syringe  46  is retracted thereby creating a vacuum to draw fluid through the valve  10  into the syringe. For intravenous applications, the valve  10  can be orientated in the position diagramed in  FIGS. 4 and 5 , or it can be rotated 180° such that fluid flows in the opposite direction. 
   Upon removal of the syringe from spike  26 , as shown in  FIG. 4 , the seal  36  is free to return to its original shape and over through-holes  34 . The ability of the seal  36  to return to its original shape is determined by the resiliency of the material used to prepare the seal  36 . In addition, the ability of the seal  36  to return to its original shape is facilitated by the protruding ridges  30  formed on the external surface of the spike. During compression, a vacuum may form in the area between the spike  26  and the seal  36 , thereby preventing the seal  36  from returning to its original position. The protruding ridges permit air to pass along the spike/seal interface to prevent vacuum formation and allow free return of the seal. The ability of the seal  36  to deform reversibly and return to its original position is particularly useful because (1) it immediately stops fluid flow through the valve  10 , (2) it covers the recessed spike  26  to maintain its sterility, and (3) it reduces the risk that the spike could inadvertently pierce another object or person. In addition, since the valve  10  lacks movable parts, except for the seal, it is unlikely that when the seal  36  is pushed down, the valve  10  would fail to function. 
   Advantageously, the through-holes  34  are located relatively low on the spike  26 . Thus, the through-holes  34  are seated relatively early in the process as the seal  36  returns to its original configuration with the valve  10  is closed. In one preferred embodiment the through-holes  34  are located 0.075″ below the spike tip  32  (see  FIG. 2 ). Additionally, the through-holes  34  are sealed if the seal  36  does not fully return to its original configuration depicted in  FIG. 4 . Further, the ability of the seal  36  to return reversibly to its original position permits the reuse of the connector valve  10 . Following disconnection, and before reuse, the surface of pierced seal cap  40  is essentially flush with the housing  12 . Thus, this flush surface can, advantageously, be sterilized with alcohol or other surface decontaminating substances. The skirt  16  and upper conduit  20  advantageously shield both connections from the surrounding environment to protect the sterility of the connection. Further, both the skirt  16  and upper conduit  20  function as collection reservoirs to prevent fluid from dripping from the valve  10  during manipulation. 
   A cover cap (not shown) can be supplied to fit over the upper conduit  20  as further protection for the seal surface between use. Such a cover cap, however, is not needed to maintain sterility since the seal  36  may be swabbed with a disinfectant after each use. The reversibility of the seal  36  makes the valve  10  particularly attractive as a connector valve to provide fluid communication between two fluid lines. Therefore, the present invention provides for placing a first fluid line in communication with a second fluid line using the valve disclosed herein. The reversibility of the valve  10  permits multiple fluid lines to be successively added, for example, to a fluid line in direct communication with a patient&#39;s vein. Since the valve is easily sterilizable and sealable, fluid lines can be added and removed without disconnecting venous contact. 
   The valve  10  is preferably prepared from a hard plastic, but it is additionally contemplated that the valve could be prepared from other medically inert materials known to those in the art. the spike element  24  is preferably prepared from the same material as the housing  12 . One particular advantage of this invention 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, the upper conduit  20  serves as a shield to the spike  26  such that skin puncture is further reduced. The spike  26  need only be strong enough to penetrate the seal cap  40 , or if necessary, to pierce a connecting septum. 
   In the embodiment of the invention illustrated in  FIGS. 2-4 , the through-holes  34  are placed distal spike tip  32 . This placement provides two important advantages. First, the placement of the through-holes  34  facilitates resealing of the valve  10  after use. Second, if the through-holes were placed at the spike tip  32 , the holes  34  may core the seal cap  40  thereby introducing seal particulate into the fluid flow and possibly plugging the holes  34 . Thus, the longitudinal placement of the through-holes distal spike tip  32  prevents the introduction of particulates into the fluid path and/or plugging of the through-holes  34 . It is additionally contemplated that the number and diameter of the through-holes  34  can be adjusted to accommodate different fluid velocities. In a preferred embodiment, the preferred velocity of fluid passing through the through-holes  34  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 velocities. 
   An important advantage of the invention is that the valve  10  has very little dead space, thus the volume of liquid entering into the valve is substantially equivalent to the volume of fluid leaving the valve. 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 the valve in fluid communication with a medical implement such as a syringe  46  is substantially zero. 
   Alternate Embodiments 
   In another preferred embodiment of the invention, illustrated by  FIGS. 6 and 7 , a disposable sterile adaptor valve  50  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 adaptor valve  50  having a body including an adaptor skirt  52 . The adaptor skirt  52  will preferably fit snugly over the open mouth of the container. The skirt  52  may be of any size to accommodate a range of container sizes. A lengthwise slit  54  is preferably provided in at least one location along the length of the skirt to ensure a snug fit between the skirt  52  and the container. A chamber  56 , preferably tubular in configuration, extends upward from the skirt  52  and is similar in construction and design to the upper chamber  20  of the first preferred embodiment. Similar to the first embodiment, the proximal portion of the valve contains a locking mechanism  59  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 spike  58  extends upward through a tubular chamber  56 . A spike tip  60  is preferably recessed from a proximal lip  62  of the tubular chamber  56 . In a closed position, this tip  60  is covered by a seal  64 , which is essentially the same as seal  36 . Protruding ridges  66  and seal grooves  68  facilitate seal compression in the open position and promote closure following use. Thus, in the closed position as illustrated in  FIG. 7 , the seal  64  covers the through-holes  70  to prevent fluid out-flow from the container. The adaptor valve  50  contains a second spike  72  which points in the opposite direction as spike  58 . These spikes  52  and  72  are in fluid communication with each other. The spike  72  extends downward inside the adaptor skirt  52 . The two spikes preferably form one component of the valve  50  while the skirt  52  and upper chamber form a second component. These two components can be assembled in a manner like that of the valve  10 . The spike  72 , like the spike  58 , has longitudinal through-holes  74  and a tip  76 . The through-holes  74  are located inward of the tip  76 . The adaptor valve  50  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 invention include dosage bottles for intramuscular injector antibiotic containers or the like. However, it is also contemplated that the valve  50  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. The adaptor valve  50  is placed over the septum and direct pressure is applied to pierce distal spike  72  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 embodiment, to withdraw fluid from the container. The pressure of the nose  48  over the spike  58  pushes spike tip  60  through seal  64 . At the same time, seal  64  is pushed back and compresses. Compression is accommodated by seal grooves  68 . Fluid is withdrawn from the container and the syringe is removed from the spike  58 . Release of the pressure applied to seal  64  permits the seal to return to its original configuration. The spike ridges  66  facilitate seal reversibility. 
   Often the ingredients housed in containers are those that ca 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 adaptor valve  50  automatically seals. Subsequently, aliquots can be removed from the container by syringe or the like. Alcohol or other compatible surface sterilizing agent can be used to wipe the lip  62  and seal  64  before each use. Similar to the first embodiment, it is additionally contemplated that a cap can be provided to fit over upper chamber lip  62  between use. 
   The adaptor valve  50  can be adapted to function as a medicament adaptor for an intravenous container. In this case, the adaptor valve  50  is placed on a medicament container for intravenous delivery and attached via tubing to an intravenous feed. Thus, the adaptor valve  50  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 seal  36   a , is shown in  FIG. 9 . Seal  36   a  comprises a seal cap  92  at the proximal end thereof and a seal lip  96  at the distal end thereof. A cup-like annular flange  95  is provided proximal seal cap  92 . The seal cap  92  and seal lip  96  are connected by a seal wall consisting of a plurality of ringed wall portions  94  that expand and collapse in an accordion like fashion. During compression of the seal  36   a , the diameter of the ringed wall portions  94  expand outward in the radial direction. There are air pockets  13   a  ( FIG. 10 ) between ring portions  94  and the housing and air pockets  13   b  between spike  24  and seal  36   a . The seal  36   a  contains a cavity  98  distal seal cap  92  and adjacent the ringed wall portions  94 . The seal  36   a  interacts with spike  26  ( FIG. 2 ) and other components of the present invention in a similar fashion to seal  36  of  FIG. 2 . 
   Referring to  FIG. 10 , the cup-like annular flange  95  may be stretched around the upper conduit  20  and held in place by an annular ring  97 . This creates a trampoline like effect that assists returning the seal  36   a  to a decompressed state after withdrawal of a syringe (not shown). This embodiment has two advantages. First, the proximal end of the valve  10  can be swabbed with alcohol or other disinfectant without leakage of disinfectant into the valve  10 . Second, by affixing cup-like annular flange  95  to upper conduit  20  at the proximal end thereof with annular ring  97 , the repeated deformation and reformation of the seal  36   a  is assisted. 
   An alternative embodiment of the seal, a seal  36   b  is shown in connection with the valve  10  in  FIG. 11 . The seal  36   b  is similar to the seal  36   a  and is comprised of seal cap  92 , a side wall consisting of ringed wall portions  94  and a seal lip  96 . It also has an outwardly extending ring  99  which is at a right angle with respect to the longitudinal axis of the valve  10 . This ring  99  is used to attach the seal  36   b  to upper conduit  20 . Preferably, an upper conduit annular plug  20 ′ is inserted within upper conduit  20  to create a tight fit between perpendicular ring  99 , a ledge  101  in the upper conduit  20 , and the plug  20 ′. The ring  99  assists in the reformation of seal  36   b  to enclose spike  26  upon withdrawal of a syringe (not shown). 
   As shown in  FIG. 12 , the cup-like annular flange  95  and ring  99  may both be used in connection with the valve  10 , to provide the seal  36   c . This seal  36   c , provides rapid reformation upon withdrawal of a syringe (not shown) and realizes the advantages of both the seals  36   a  and  36   b.    
   Another alternative embodiment of the seal, a seal  36   d , is shown in  FIG. 13 . In this embodiment, the seal  36   d  is comprised of seal cap  92 , seal lip  96 , and a side wall  150  comprised of circular tires  100  stacked in series one on top of an adjacent larger diameter lower tire. The circular tires  100  are preferably solid throughout the diameter of the cross-section thereof. These circular tires  100  will deform and reform upon, respectively, compression and decompression of the seal  36   d , thereby exposing or covering a spike (not shown) as the case may be. 
   As mentioned above, preferably seal  36   d  has a precut slit  11  in the cap  92  lying along the longitudinal axis of the valve  10 . The seal cap  92  has a unique configuration that insures that the slit  11  closes and is sealed upon withdrawal of a syringe (not shown) and reformation of the seal  36   d . It includes an enlarged, internal, pressure responsive member  200  which is integral with the cap  92 . Between the proximal end of the side wall  150  and the member  200  is an annular space  102  which is filled with the fluid in the cavity  98 . This fluid is under pressure, for example at the blood pressure of the patient to which the valve  10  is attached. Referring to  FIG. 14 , fluid, for example the patient&#39;s blood, flows through the holes  34  in the spike  26 , filling the cavity  102 . This fluid presses against the exterior of the member  200 , closing the slit  11  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 escaping valve  10  through the slit  11 . There is a semi-cylindrical annular flange tear ring  104  on the end of the member  200  which advantageously extends the useful life of seal  36   d.    
   Preferably, there is a tear ring  104  integral with the member  200  along the perimeter of the internal surface the member  200 , and a slight saucer-like depression  204  in the external surface of the seal. The pressure responsive element in the decompressed state closes any orifice in the seal  36   d  to provide an essentially fluid-tight seal while in the decompressed state. The pressure responsive member  200  enables the valve to maintain a fluid-tight seal even at very high pressures sometimes experienced in medical applications, particularly when the valve  10  is connected to a patient&#39;s artery. The center of the member  200  and the annular space  102  are coaxial with the entryway  11   a  to the orifice  11 . The pressurized fluid fills the annular space  102  to apply pressure that compresses the member  200  to tightly close the entryway to the orifice. In a preferred embodiment the distance from the entryway  11   a  to the proximal end of seal cap  92  is from 0.500 to 0.075 inches and more preferably approximately 0.100 inch. 
   As best illustrated in  FIG. 22 , the tip  32  is designed to avoid tearing the seal. Tip  32  has three facets  210 ,  212 , and  214  which are joined with each other along parting lines a, b, and c. This junction of the facets  210 ,  212 , and  214  frequently is ragged and will tear the seal  36   d . This is prevented by the parting lines a, b, and c, or junctions, being disposed within recesses  220 ,  222 , and  224 , respectively, to provide “buried parting lines.” 
   Another alternative embodiment of the present invention using the seal  36   d  is shown in  FIG. 8  and  FIGS. 19 through 21 . In this embodiment, the inner wall  160  of the upper end of the conduit  20  is provided with at least one, and preferably, a plurality of radial indentations  107 . The indentations  107  are elongated disposed generally parallel to the longitudinal axis if the valve  10  in a symmetrical, star-like configuration. Each indentation has opposed lateral edges  162  which engage the seal  36   d  upon compression of the seal  36   d . The indentations provide space into which the seal  36   d  expands upon compression. In the illustrated embodiments, the housing includes a cavity having a neck portion adjacent the opening and a main portion distal the neck portion. 
   As best shown in  FIG. 8 , the wall  181  of the proximal end of the conduit  20  is tapered inward at the same angle as the nose  48  of the syringe  46 . In accordance with ANSI standards, the taper is 0.006 inch per linear inch. The wall  182  of the syringe nose  48  bears against the wall  181  as the nose slides into the opening  25   a  to push the seal  36   d  inward compressing it and forcing the tip  32  of the spike  36  to enter the slit  11 . The seal  36   d  expands upon compression to fill essentially completely the upper portions of the indentations  107 . Some sections of the seal  36   d  are wedged between the edges  162  and other sections fill the indentations  107 . As the liquid flows through the nose  48  through holes  34 , air in the nose  48  is forced out of the nose  48  and expelled from valve  10  between walls  181  and  182 . Thus, essentially the entire prescribed dosage is delivered through valve  10  to the patient. Fluid flows through the through-holes  34 , but does not leak between either the seal  36   d  and the wall  181  or between the abutting walls  181  and  182 . 
     FIGS. 15 ,  16 ,  17 , and  18  depict embodiments of seals, namely, seal  36   e , seal  36   f , and seal  36   g , which are substantially the same as the seals  36   a  ( FIG. 10 ), seal  36   b  ( FIG. 11 ), and seal  36   c  ( FIG. 12 ), except the side wall  150  employing the circular tires  100  is used in place of the accordion wall portion  94 . 
   Other components of the present invention interact with the various embodiments of the seal in a similar fashion to their interaction with seal  36  of  FIG. 2 . Prior to use of valve  10 , it is preferable that the seal caps  40  or  92  be pierced centrally by a steel needle in the axial direction, precutting the seal to provide the slit  11  in order to allow for more rapid decompression and reformation of the seal upon piercing by the spike  26 . The seals are advantageously formed from a material which can repeatedly reseal and prevent fluid from flowing around the seal material. The seal  36  should also be capable of being forced down and then spring back into position to reseal the valve. Material that is too soft will 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 embodiments of the invention, it is desirable to provide additional lubricity to the seal  36  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 valve  10  is provided not by the side wall of the seal  36  which immediately covers the through-holes  34 , but by the seal cap  40 , or seal cap  92  filling the proximal end of the cavity  98  and the opening  25   a . Thus, the seal caps  40  and  92  are sufficiently thick to reseal the opening  25   a  effectively after valve closure. However, the seal caps  40  and  92  should also be sufficiently thin to allow them to readily return to the closed position. Preferably the thickness of the caps  40  and  92  ranges between 0.075 and 0.500 inch and more preferably may be approximately 0.100 inch. 
   The valve disclosed in this invention 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 device can be reused multiple times. Since the device 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 present invention can provide for the elimination of nearly all needles used in the medical environment. With the use of the valve of the present invention, the need for all needles except those that are directly input into a patient is, advantageously, eliminated. 
   Operation 
   The valve  10  is used to provide a closed, patient access system for transferring a predetermined amount of medication from a remote source to the patient. The valve  10  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 the seal  36   d , for example, prevents any blood from leaking from the valve. The delivery end or nose  48  of the medical implement is inserted into the valve as depicted in  FIG. 8 , pushing the nose  48  against the seal to compress the seal sufficiently to allow the tip  32  of the spike  24  to pierce the seal and enter said delivery end. The predetermined amount of medication in its entirety may now be transferred through the nose  48  into the valve  10  and into the patient. Since the nose  48  and seal  36   d  engage in a manner so that the tip  32  of the spike element  24 , upon piercing the seal, meets the seal to avoid formation of any dead space at the interface between nose  48  and the seal surface  40   b . Transfer directly through the valve  10  of essentially the entire predetermined amount of medication from the syringe  46  to the patient, so that essentially none of said predetermined amount is collected in any dead space in the valve, is accomplished with this invention. Upon withdrawing the nose  48  from the valve  10  the seal  36   d  returns 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. 
   Scope of the Invention 
   The above presents a description of the best mode contemplated of carrying out the present invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and alternate constructions from that discussed above which are fully equivalent. Consequently, it is not the intention to limit this invention to the particular embodiments disclosed. On the contrary, the intention is to cover all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention.