AU2005205776B2 - Medical valve - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 DIVISIONAL APPLICATION NAME OF APPLICANT: ICU Medical, Inc.

ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Nicholson Street Melbourne, 3000.

INVENTION TITLE: "Medical valve" The following statement is a full description of this invention, including the best method of performing it known to us: P:\OPER\DH12658880 div.dc-01/09/05 -1- MEDICAL VALVE This invention relates to a medical valve and 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 preferably 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.

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.

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 P\OPERfl1265UWI) spI doc-2IA)5/I28 00 -2handling, thereby increasing both the risk of contamination and the amount of time required to establish the fluid connection.

c1 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 n 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.

The present invention seeks to provide at least one of the above advantages.

In accordance with the invention, there is provided a needleless valve comprising: a housing comprising a proximal end, a distal end, and an internal cavity with a first region positioned near the proximal end with a first horizontal cross-sectional width, a second region with a second horizontal cross-sectional width larger than the first horizontal cross-sectional width, the second region positioned in a distal direction from the first region, the proximal end configured to receive a delivery end of a medical implement for transferring fluid through the delivery end; a flexible element with a proximal end and a distal end, the flexible element positioned within the internal cavity of the housing for controlling a flow of fluid through a fluid pathway through the valve, the flexible element comprising a first height in a first position and a second height in a second position, the first height being greater than the second height, the proximal end of the flexible element configured to move in a distal direction from the first position to the second position upon insertion of the delivery end of P: OPER\DHI265818 8pl dc-21)V12M 8 00 -3- Sthe medical implement into the proximal end of the housing, the proximal end of the flexible element configured to move in a proximal direction in the cavity to the first position upon removal of the delivery end from the proximal end of the housing, the flexible element comprising an orifice at its proximal end to facilitate fluid flow therethrough, wherein the proximal end of the flexible element, when in the first position, is generally flush with the proximal end of the housing, has at least a portion that contacts Sthe housing in a region at or near the proximal end of the housing, and presents an Simpediment to entry of bacteria into the fluid pathway without requiring a covering for the housing; and a spike with a proximal end and a distal end, the distal end disposed at or near a distal end of the cavity in the housing, the spike having a hole at the proximal end thereof, wherein the distal end of the flexible element is positioned in close radial proximity with a distal section of the spike.

(THE NEXT PAGE IS PAGE PA\OPER\DH\12658880 divdoc-01/09/05 Preferably, said flexible element comprises 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.

This invention in one embodiment may be employed to provide 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. The seal is advantageously capable of reuse such that it may be repeatedly pierced by the enclosed, protected, spike, which is preferably non-metallic, rather than an exposed metal needle. The valve can facilitate fluid, particularly liquid, transfer while maintaining sterility. The valve is also easy to use and is capable of locking in place. After use, the valve can be swabbed in the conventional manner with a suitable substance to maintain sterility. The design of the valve further helps to avoid 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.

Preferably, 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, 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.

In relation to the spike, the hole is preferably 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 return of the seal from the compressed to the decompressed state when the implement is removed. The spike may have a substantially conical shape, and the seal has a complementarily, substantially conical P:\OPER)-I12658880 div.doc-)1/09/05 -6shaped 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 possible 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.

In relation to the sealing action, a fluid tight seal is maintained between the section that fills essentially completely the portion of the cavity adjacent the opening 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. The delivery end and the seal are preferably 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 the medication is preferably 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 can be maintained over repeated opening and closing of the valve, and the seal has may be provided on its external surface with 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 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 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- P:\OPER\DHI12658880 div.doc-01/D9/05 -7vacuum, saucer like depression therein, which does not interfere with the ability of the exposed, proximal end of the seal being swabbed when desired.

In relation to the construction of the valve, the body and spike are preferably formed as two separate components of the valve that are securely attached to each other by assembly of, and interlocking, of the body and spike. As such, the body is preferably provided with 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 may therefore have 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.

Preferably, the valve also 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 seal may have a proximal end that includes 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 can assist 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's artery. The valve may remain closed even when the pressure inside the valve is above 6 pounds per square inch (psi), and possibly 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.

P:\OPER\DH\I2658880 div.doc-01109/05 -8- As may be appreciated from the above, the valve can be of assistance in transferring a known, prescribed, predetermined amount or dosage of medication 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 can be received by the patient and not lost in the valve. Thus, the invention, as described above, has application to transferring fluid from a remote source to a patient and can also include transfer of fluid from the patient to a remote source. This is possible because the valve of this invention can provide two-way communication. The fluid is preferably 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, as also described above, can also include 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.

The invention is now described in more detail, by way of non-limiting example only, with reference to the drawings. The drawings include the following Figures, with like numerals indicating like parts: Figure 1 is a perspective view of the first example of a valve.

Figure 2 is an exploded perspective view of the valve shown in Figure 1 illustrating spike, seal, and body or housing components.

Figure 3 is a longitudinal cross-sectional view of the assembled valve of Figure 1.

Figure 4 is a schematic, longitudinal, cross-sectional view of the assembled valve of Figure 1 before compressing the seal.

Figure 5 is a schematic, longitudinal, cross-sectional view similar to Figure 4 showing the valve during compression of the seal.

Figure 6 is a perspective view of a second example of a valve.

Figure 7 is a longitudinal cross-sectional view of the valve of Figure 6.

Figure 8 is a schematic illustration of an ANSI delivery end of a medical implement compressing the seal of the valve.

P:\OPERMDHfI 2658880 div.do-0110905 -9- Figure 9 is a side elevation view, partially in cross-section, of a seal.

Figure 10 is a longitudinal cross-sectional view of the assembled valve of Figure 1 using the seal of Figure 9.

Figure 11 is a longitudinal cross-sectional view of the assembled valve of Figure 1 using another seal.

Figure 12 is a longitudinal cross-sectional view of the assembled valve of Figure 1 using yet another seal.

Figure 13 is a longitudinal cross-sectional view of a further example of a seal.

Figure 14 is a longitudinal section of the seal shown in Figure 13 used in connection with the spike device shown in Figure 2.

Figure 15 is a longitudinal partial cross-sectional view of yet a further seal.

Figure 16 is a longitudinal cross-sectional view, after assembly, of the valve shown utilizing the seal of Figure Figure 17 is a longitudinal cross-sectional view, after assembly, of yet another example of a valve.

Figure 18 is a longitudinal cross-sectional view, after assembly, of a further example of a valve.

Figure 19 is a side elevation view, after assembly, of the seal and spike shown in Figure 14 connected to the body or housing shown in Figures 20 and 21.

Figure 20 is a cross-sectional view taken along line 20-20 of Figure 19.

Figure 21 is a perspective view, with sections broken away to show the wall structure of the cavity containing the seal shown in Figures 13 and 14.

Figure 22 is a greatly enlarged, cross-sectional view taken along line 22-22 of Figure 14.

P %OPERMIA 1~2658880 dw~de-01/09M) F16URE 23 is a longitudinal cros3suctionel view of the body of a teth embodiment of the valve of this irnenion, which is suitable for use In a second assembly method.

FIGURE 24 is a longitudinal tross-sectional view of the body of an eleventh embodiment of the valve of this Invention, which Is also suitable for use I the second asselibt mothod.

FIGURE 25 is a longitudinal crosssectional view of the tenth uembodiment of the valve of the present invention, comprising the spike and seal components from FIGURE 3 and the bod component from FIGURE 23.

assembled by using the second assmbly method, or a $unctiona*l equivalent method.

FIGURE 28 is a perspective view of a gouging bit and a base which ain preferably used In the second assembly method.

FIGURE 27 hs a cross-sectional view of the bit of FIGURE 26 taken along lie 27.27 thereof.

FIGURE 20 is a longitudinal cro ssctional view of the components of the assemblid valve of FIGURE before assembly, inserted with the gouging bit and base of FIGURE 29.

FIGURE 29 is a longitudinal cross-soctionel view of the assembled valva of FUIM 25. along with the gouging bit and base of FIGURE 26.

FIGURE 30 is an enlarged view of the ae Inside line 30-30 of FIGU~t 29.

FIGURE 31 ilustrates a partial crosssectlonal view of e manually operated punch machine for wsing the gouging bit and base of FIGURE 28 to-perform the second assembly method an the valve components shown as illustrated in FIGURE 28L FIGURE 32 is an exploded perspectiva view of a preferred medication transfer device utilized with a medical valve and syringe.

FIGURE 33 is a partiall exploded sid. view of one embodiment of a drip bag adaptor made in accordance with the present invention, showing the relationship between the drip beg, adaptor, and removable valve.

FIGURE 34 is a side view of another embodiment of the drip bag adaptor, having an integral valve.

FIGURE 35 is a side view of a new Y-site or piggybsck y-corinector made in accerdance with the present invention.

FIGURE 38 is a partially exploded side view of a hook adaptor made in accordance with this invention.

FIGURE 37 is a plan view of the hook adaptor shown in FIGURE 36, as viewed from the bottom.

FIGURE 38 is a side view of another embodiment of the hook adaprtor, having an integral valve.

FIGURE 39 is a partially exploded side view of a sslapcn adaptor made in accordance with this Invention.

FIGURE 40 is a plan view of the snap-on adaptor shown in FIGURE 39, as viewed from the bottom.

FIGURE 41 is a side view of another embodiment of the snap-on adaptor, having an integral valve.

FIGURE 42 is a partially exploded side view of a test tube adaptor made in accordance with the present invention.

FIGURE 43 is a side view of another embodiment of the test tube adaptor, having an integral valve.

P:\OPER\DH\1265888 div.doc-01/09/05 11 FIGURE 44 is an exploded perspective view of a medication transfer device in a typical orientation for drawing medication from a sealed vial.

FIGURE 45 is an exploded perspective view of the system of FIGURE 44.

Detailed Description of the Preferred Embodiments Referring firstly to Figures 44 and 45, a piercing element 520 for use in a medication container access system is shown. The system includes a standard medical implement used to measure and deliver a dose of fluid medication, such as a syringe 522, and a bottle or vial 524 containing the medication. Preferably, a single-dose vial suitable for disposal after one use is used, whereby the piercing element 520 may be disposable. FIGURES 44 and 45 are exploded views of the system, with FIGURE 44 showing the typical orientation of the system when fluid is withdrawn from the vial 524. FIGURE 45 shows an inverted orientation in order to better illustrate some of the elements of the system.

Flid medication may be delivered to patients by drawing the medication from the vial 524 through the piercing element 520 into the syringe 522, and thereafter injectig the ftlld from the syringe 522 into an existing IV delivery system. This method will be discussed in more detda below.

Preferably, the piercing alement 520 has a proximal end 570 and a distal end 580. The proximal end 570 of the piercing element 520 preferably has a connecting portion which may be in the form of a tubular extension 526, adapted to receive the tip or nose 528 of an ANSI (American National Standards Institute, Washington, D.C.I standard syringe 522. It is, however, contemplated that the inner diameter of the tubul extension 526 can be of any size to accommodate the attachment of any of a number of medical implements. Once inserted into a bore 552 of the extension 528, the nose 528 of the syringe 522 forms a substantialy fluld-tight fit with the extension 526.

Preferably, bore 552 becomes slightly smaller in diameter from distal end 570 of extension 528 towards the proximal end 580 to accommodate a tapered nose 528 and form a tight seal The taper of the bore 552 is preferably at the same angle as the nose 528 of the syringe 522 and, more preferably, in accordance with ANSI standards, the taper is 0.006 inch per linear inch. Although a fluid-tight seal is achieaed, the tapered shape of these cooperating parts also aUows them to be easily disengaged with a minimal separation force.

12- The medication vial 524 generally comprises a container portion 538 having a narrow neck 539 on which a cap or lid 536 fits. A resilient septum 534 is placed over a circular opening 535 in the lid 536 to simultaneously provide a seal for the vial 524 and an access site for the piercing element 520. The septum is prepared from a resilient material that is flexible, inert, impermeable to fluid and readily pierceable by the piercing element 520.

Referring now to FIGURE 45, the piercing element 520 preferably has, at its distal end 580, a penetration portion 532. The penetration portion 532 preferably is sized so as to be able to pierce the septum 534 of the vial 524 and extend into contact with the medication within the container 538. A fluid flow conduit in the form of bore 552 runs from at least one hole 548 in the piercing element 520, through to the proximal end 570 of the side wall of the piercing element 520. In a preferred form, the penetration portion 532 of the piercing element 520 has a tapered conical tip 544. Preferably, the distal end of the tip 544 is shaped to allow the tip 544 to pierce the septum 534 of the vial 524 and, therefore, the penetration portion 532 is sharply pointed. However, the penetration portion 532 may be slightly round to prevent accidental sticks and yet still be able to penetrate the septum 534.

As described above, preferably at least one longitudinal through hole 548 is provided proximal the distal end 580 of the piercing element 520 to permit fluid to flow from the container 524 into the bore 552.

Advantageously, by placing the through hole 548 proximal the distal end 580 of the piercing element 520, the risk of coring the septum 534 with the piercing element 520 is eliminated. If the through hole 548 were to be located at the distal end 580 of the piercing element 520, the piercing element 520 may core the septum 534 introducing particulates into the fluid which may harm a patient. In a preferred embodiment, there are three through-holes 548 within about 0.200 inch from the distal end 580 of the piercing element 520. These through-holes 548 may be of any size; however, the larger the size of the through-hols, the greater the fluid flow rate through the bore 552 of the piercing element 520. In a preferred case, the size of the through-holes 548 are 18-gauge or equivalent to provide a flow rate three times that of a standard 18-gauge needle.

In a preferred example, a disk-shaped stop 530 centrally located on the piercing element 520 is integral with, and interconnects, the extension 526 and the penetrating portion 532 of the piercing element 520. A distal face 540 on the disk-shaped stop 530 may contact a top surface 537 of the cap 536 of the vial 524 to limit the distance the piercing element 520 may extend into the vial 524. The stop 530 may, of course, have a variety of shapes and configurations.

A locking structure 550 is preferably attached to or integral with the pierctp element 520. In one example, the locking structure 550 may comprise two barbs on diametrically opposed sides of the piercing element 520 near the distal end 580. The barbs are desirably angled in the proximal direction in order to more easily pass through the elastomeric septum 534 into the vial 524. The barbs prevent the removal of the penetration portion 544 of the piercing element 520 back through the septum 534. The locking structure 550 thus retains a portion of the piercing element 520 in the vial 524. In one embodiment, the piercing element 520 is approximately 0.125 inch in diameter and the locking structure 550 extends at a 450 angle towards the proximal end a distance of approximately 0.0625 inch.

13- It is possible for the locking structure 550 to be located other than at the distal end 580 of the piercing element. For example, the locking element may comprise a somewhat elongate barbed structure, which extends from the piercing element 520 some distance from the distal end 580. Alternatively, the locking structure 550 may extend from the stop 530 of the piercing element, depending on its location. For example, one or more barb-like structures may extend downwardly from the stop 530 along a side of the piercing element 520.

Method of Using the Vial Access Device The vial access device provides a closed system for transferring a predetermined amount of medication from a remote source to a patient. Referring to FIGURES 44 and 45, the delivery end or nose 528 of a medical implement such as a syringe is engaged with the piercing element 520. The nose 528 is pushed into the proximal end of bore 552 of the piercing element 520 until a substantially fluid-tight fit is achieved between the syringe 522 and the piercing element 520. The distal end 580 of the piercing element 520 is then inserted through the septum 534 of the medication vial 524. The vial 524 is generally held in an inverted position, as shown in FIGURE 1, such that the fluid in the vial abuts the septum 534. The penetrating portion 544 of the piercing element 520 and the locking structure 550 are pushed through the septum 534, thereby exposing the through-hole(s) 548 to the fluid inside the vial 524. A plunger 560 inside the syringe 522 is withdrawn, thereby creating a vacuum which draws fluid from the vial 524, through the through hole(s) 548, the bore 552, a conduit 556 in the syringe nose 528 and into a chamber 558 in the syringe 522. The desired amount of medication is thus transferred from the vial 524, through the piercing element 520 and into the syringe 522.

After the desired amount of fluid has been drawn into the syringe 522, the syringe 522 is pulled away from the vial 524. Upon retraction of the syringe 522 from the piercing element 520, the locking structure 550 catches on the inner side of the septum 534, preventing the piercing element 520 from disengaging the vial 524. Further refraction force causes the syringe nose 528 to disengage from the piercing element 520. The user then transfers the fluid within the syringe 522 to a delivery system which administers the medication to the patient.

Preferably, if fluid remains in the vial 524 after the desired volume of fluid is transferred to the syringe 522, the syringe 522 is withdrawn from the piercing element 520 as shown in FIGURE 2 so that the fluid contained in the vial 524 does not spill. The vacuum created in the syringe 522 prevents the fluid medication from exiting the syringe 522 through the conduit 556 in the syringe nose 528.

The piercing element 520 is partially trapped in the vial 524 by the locking structure 550. The single-dose medication vial 524 and piercing element 520 may then be discarded as a unit. Advanlgeously, by not removing the penetration portion 544 of the piercing element 520 from the vial, the risk of a healthcare worker injuring himself or herself on the penetration portion 544 or locking structure 550 of the piercing element is eliminated.

Alternatively, if the vial contains sufficient medication for more than a single dose, a new syringe can be attached to the piercing element 520 held within the medication vial 524 and additional fluid can be transferred from the vial 524, through the piercing element 520 and into the new syringe 522.

The piercing element 520 is preferably manufactured from a hard plastic. The piercing element 520 may also be manufactured from other medically inert materials known to those of skill in the art. One particular P:\OPERUDHNA26S8880 div.doc-Ol09/05 -14advantage of this invention is that it eliminates the use of metal needles. This dramatically reduces the risk of skin puncture during the administration of fluids contained in a vial to a patient. The piercing element 520 need only be strong enough to penetrate the septum 534 of a vial 524 or other similar seal.

Alternate embodiment In a second example as shown in FIGURE 32 and described in more detail below, the piercing element 520 is used in conjunction with a medical valve 10 or 11 described below in order to transfer fluid from a vial 524 to a syringe 522.

FIGURES 3-31 illustrate the medical valve 10 or 11 and methods of manufacturing the valve 10 or 11. In this description and in conjunction with the FIGURES, the term "proximal" is used to denote the end of the valve and other components at or near the spike tip 32 in Figures 2 through 5, 10 through 12, 14 and 16, and at or near the spike tip 60 in Figure 6, and at or near the seal cap 92 in Figures 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 a 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 Figures 1 and 2, the first embodiment of the invention, valve includes a valve body or housing 12, which defines an internal cavity for receipt of 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 Figure 13 depicting an alternate shaped seal 36d, this seal 36d 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 Figure 3, with the spike element 24 enclosed to prevent accidental sticks. Figure 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 P:\OPERXDH1 2658880 div.dc-01/09/05 subsequently. As shown in Figures 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 Referring to Figure 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 shied 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 annular lip 25 surrounding a circular opening 25a in the top of the conduit 20 (see Figure 2).

In the first example, the upper conduit 20 is adapted to receive the tip or nose 48 of an ANSI standard syringe 46 (see Figures and 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 Figure 1, locking ears 22 near the proximal lip 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 to Figure 19, conventional Luer-Lock threads 180 can be provided on the outer diameter of upper conduit Referring to Figure 2, the spike element 24 has at its distal end the inner conduit 18 and at 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 Figure 3, the rim 28a of the cuff 28 abuts the underside of the inner ring 14, and has an annular detent 28b that snaps into an annular groove 14b in the underside of the ring. The cuff28 serves 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, preferably 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 are P:\OPERDHR\2658880 div.docOI09/05 -16preferably aligned along the length of the spike as illustrated in Figure 2. These ridges 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. Preferably, 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 40b, an outwardly tapered sidewall 38, and a lower lip 42. Its interior is hollow to provide the conically shaped cavity 37 (Figure Thus, the seal 36 slips easily over the spike element 24 to filt snugly within the cavity 37. The seal lip 42 is seated within the annular cuff28 and wedged between the cuff and the underside of the ring 14. There are longitudinal grooves 43 (Figure 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, for example, a single groove 43 may be provided 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 (Figure 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 is above the through-holes 34. Preferably, the cap 40 substantially fills the proximal end of the internal cavity and opening 25a in the top of the conduit 20. Thus, after assembly, the top surface 40b of the seal cap 40 is essentially flush with the lip 25, so that the lip 25 and seal cap can be swabbed with alcohol or other disinfectant without leakage of disinfectant into the valve 10. The surface 40b is exposed so that it may be swabbed with a disinfectant.

As best shown in Figure 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 P:\OPER\DHIA12658880 div.doc-OI/09/05 -17not 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 .525" to below the lip 25 of the housing 12. The seal 36 preferably 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 .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 Figures the inner surface of the bell shaped skirt 16 preferably has protruding threads 44 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 44.

During use, the valve is designed to be adapted as a two-way valve. The orientation of the valve in 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 needle 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 inner conduit 18. 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 the inner conduit 18 into the spike 26. However, fluid flow is locked in place by the seal 36.

Figures 4 and 5 illustrate valve activation. In Figure 4, the medical imnplement connecting to the proximal end of the valve 10 is a syringe 46. However, this connecting implement could be any number of medical 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 figure 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.

P:\OPERDH\M12658880 div.dc.Ol/09/05 -18- 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. Figure 5 shows valve 10 opened by insertion of the nose 48 of the syringe 46 into the opening 25a. 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 diagrammed in Figures 4 and 5, or it can be rotated 1800 such that fluid flows in the opposite direction.

Upon removal of the syringe from the spike 26, as shown in Figure 4, the seal 36 is free to return to its original shape and cover 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 it immediately stops fluid flow through the valve 10, it covers the :recessed spike 26 to maintain its sterility, and 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 sealed relatively early in the process as the seal 36 returns to its original configuration with the valve 10 is closed. In one preferred instance the through-holes 34 are located .075" below the spike tip 32 (see Figure Additionally, the through-holes 34 are sealed even if the seal 36 does not fully return to its original configuration depicted in Figure 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 P:\OPER\DH\12658880 divdoc-/9/05 -19conduit 20 function as collection reservoirs to prevent fluid from dripping from the valve 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 valve 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 successfully 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 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 Figures 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 possibly core the seal cap 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 arrangement, 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.

P:\OPER\DHI2658880 An important advantage of the valve 10 is that very little dead space is provided, 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 Examples In Figures 6 and 7, a disposable sterile adaptor valve 50 is shown, which functions 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).

Figure 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. Similar to the first valve example, 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 Figure 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 Figure 7, the seal 64 covers the through-holes 70 to prevent fluid out-flow from the container. The adaptor valve 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

I

P:\OPERMIDI12658880 div.doc-Oa1/09/05 -21 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 Figure 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 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 adaptor valve 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 valve example, it is additionally contemplated that a cap an 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 Figure 1 to facilitate the flow of medicament from intravenous drip bottles.

An alternative example of the seal, a seal 36a, is shown in Figure 9. Seal 36a comprises a seal cap 92 at the proximal end thereof and a seal lip 96 at the distal end thereof.

P:\OPERDI-kD'2658880 div.docOW/9/05 -22- A cup-like annular flange 95 is provided a 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 36a, the diameter of the ringed wall portions 94 expand outward in the radial direction. There are air pockets 13a (Figure 10) between ring portions 94 and the housing and air pockets 13b between spike 24 and seal 36a. The seal 36a contains a cavity 98 distal seal cap 92 and adjacent the ringed wall portions 94. The seal 36a interacts with spike 26 (Figure 2) and other components in a similar fashion to seal 36 of Figure 2.

Referring to Figure 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 36a to a decompressed state after withdrawal of a syringe (not shown). This seal 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 36a is assisted.

An alternative seal 36b is shown in connection with the valve 10 in Figure 11. S The seal 36b is similar to the seal 36a and is comprised of seal cap 92, a side wall consisting of ringed wall portions 94 and seal lip 96. It also has an outwardly extending ring 99 which is at right angle with respect to the longitudinal axis of the valve 10. This ring 99 is used to attach the seal 36b 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 36b to enclose spike 26 upon withdrawal of a syringe (not shown).

As shown in Figure 12, the cup-like annular flange 95 and ring 99 may both be used in connection with the valve 10, to provide the seal 36c. This seal 36c, provides rapid reformation upon withdrawal of a syringe (not shown) and realizes the advantages of both the seals 36a and 36b.

Another alternative seal 36d, is shown in Figure 13. The seal 36d 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 36d, thereby exposing or covering a spike (not shown) as the case may be.

P:\OPERMFH 1265888) div.doc-0109/05 -23- As mentioned above, preferably seal 36d 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 36d. 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 Figure 14, fluid, for example the patient'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 Figures 14 and 19. The pressure from this fluid creates a high pressure seal which prevents fluid from escaping valve 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 36d.

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 an orifice in the seal 36d 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's artery. The center of the member 200 and the annular space 102 are coaxial with the entryway 1 la 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. Preferably, the distance from the entryway I Ia to the proximal end of seal cap 92 is from .500 to .075 inches and more preferably .100 inch.

As best illustrated in Figure 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 36d. This prevented by parting lines a, b, and c, or junctions, being disposed within recesses 220, 222, and 224, respectively, to provide "buried partying lines".

Another alternative, using the seal 36d is shown in Figure 8 and Figures 19 through 21.

In this case, 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 P:\OPER\DH\I12658880 div.doc0 1/09/05 -24configuration. Each indentation has opposed lateral edges 162 which engage the seal 36d upon compression of the seal 36d. The indentations provide space into which the seal 36d expands upon compression.

As best shown in Figure 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 25a to push the seal 36d inward compressing it and forcing the tip 32 of the spike 36 to enter the slit 11. The seal 36d expands upon compression to fill essentially completely the upper portions of the indentations 107.

Some sections of the seal 36d 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 36d and the wall 181 or between the abutting walls 181 and 182.

Figures 15, 16, 17, and 18 depict seals, namely, seal 36e, seal 36f, and seal 36g, which are substantially the same as the seals 36a (Figure 10), seal 36b (Figure 11), and seal 36c (Figure 12), except the side wall 150 employing the circular tires 100 is used in place of the accordion wall portion 94.

Other components interact with the various seals in a similar fashion to their interaction with seal 36 of Figure 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, the seal is preferably 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, Michigan. 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 P:\OPER\IDH\l12658880 divdoc-01/09/05 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 25a. Thus, the seal caps 40 and 92 are sufficiently thick to reseal the opening 25a 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 .100 inch.

The valve described above 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 valve can provide for the elimination of nearly all needles used in the medical environment. With the use of the valve, the need for all needles except those that are directly input into a patient is, advantageously, eliminated.

Operation The valve 10 can be used to provide a closed, patient access system for transferring a predetermined amount of medication from a remote source to the patient. For that purpose, 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 36d, 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 Figure 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 36d 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 40b. 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. Upon P %OPERUMN ~2658880 dwv 26 withdrawing the nose 48 from the valve 10 the seal 36d 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.

FIGURE 23 Olustratua a body or housing 12 of a tenth embodiment of tin present invention, while FIGURE 24 8tustrates a body or housing 12 of an eleventh embodimnent of the present internio The housing 12 of FIGURE 2.3 or FIGURE 24 is substantially ui~lat to housing 12 descried above in conjnction with FIGURE 7. Thus, the housing 12 has a bell-siaped skint 16. an inner surface 254. protruding threads 45, an inner surface 260, and further PAOPER\DH\2658880 div.doc-O09/05 -27includes a gouging surface 252a. In FIGURE 24 the gouging surface 2520 is illustrated as a ledge extending arcuately from the inner surface 250, while in FIGURE 23 the gouging urface 252a Is llustrated as a .edge extending at a slope from the inner surface 250. The housing 12 is specially designed for use with a second, and improved, method of assembly, described in more detail below. In particular, for the improved method of assembly described below, a portion of the gouging surface 252e preferably has a smaller diameter than the effective diameter of the protruding threads 45. As recognized by a person of skill in the art, other embodiments of the housing 12, with variations to the gouging surface 252a. can be used with the improved method of assembly, or a functionally equivalent method, to provide an improved medical valve 11, based on the folowing description of the improved valve and method, FIGURE 25 illustrates the improved medical valve 11 comprising the housing 12 of FIGURE 23 (although the valve 11 could be made with the housing 12 of FIGURE 24 equally wel), the spike element 24 of FIGURE 7, and the seal 38 of FIGURE 7. An improved medical valve 11 can also be created from the spike element 24 and seal 36 of any of the first nine embodiments. Thus, for example, an improved medical valve 11 can be assembled using the housing 12 of FIGURE 23, the spike element 24 of FIGURE 14, and the seal 36d of any of FIGURES 3-7, 7 and 9-19 to create a new, and preferred, embodiment. The improved medical valve 11 is essentially similar to medical valve 10, described above, with the addition of retaining tabs 252c for securing the spike element 24 and the seal 38 inside the housing 12. and a variation in the interference fit between the spike element 24 and the housing 12.

Stil referring to FIGURE 25, the improved medical valve 11 comprises a spike element 24 and a seal 36 mounted in the housing 12. The seal ip 42 of the seal 36 is secured between the internal lp 27 of the hoising 12 and the annular cuff 28 of the spike element 24 to secure the seal 38 inside the housing 12. The annular cuff 28 of the spike element 24 is secured against the underside of the seal ip 42 of the seal 38 by retaining tabs 252c to secure the spike element 24 and the seal 38 inside the housing 12. The retaining tabs 252c preferably consist of a portion of the material that, before assembly, constituted either the gouging surface 252a of FIGURES 23 or FIGURE 24. These tabs 252c constitute material from the gouging surface 252a which has been gouged away from its original position on the housing 12 and forced against the tower surfce of the annular cuff 28. The retaining tabs 252c are rigid enough to hold the spike element 24 and the seal 38 against the underside of the annular ring 14 of the housing 12 and prevent leakage from the improved medical valve 11. The spike element 24 Is further prevented from removal from housing 12 because of the annular detent 28b on the annur cuff 28, which detent 28b snaps into the annular groove 14b of the annular ring 14.

The securing force provided by the retaiing tabs 252c reduces the need for friction or interference fit between the external portion of annular cuff 28 and the inner surface 254 of annular ring 14, as described above with respect to the first method of assembly. Thus, the outside diameter of the annular cuff 28 can be reduced rotative to the inside diameter of the annular ring 14, without allowing leakage to occur within the medical valve 11. For example, it has been found that the outside diatator of the annular cuff 28 can be as title as about 0.00 larger than the inside diameter of the ring 14 and stil provide a proper seaL The abity to reduce the P:\OPER\DH\ 12658880 div.doc-01/09/05 -28diameter of cuff 28 (in relation to the diameter of the ring 14) reduces the possbrlity that the housing 12 will crack in response to hoop stress, even when the spike element 24 expands because of the conduction of lipids, or other fats. Further, the lessened importance of providing exact tolerances between the annular cuff 28 and the annular ring 14 allows for variations in the materials and the manufacturing process of these components, reducing manufacturing costs.

FIGURE 28 shows a gouging bit 262 and a base 269 that are preferably used in the improved method of assembling valve 11. The gouging bit 262 has a central bore 298 tharethrough, a gouging edge 268 thereon, several guiding surfaces 292, 294, and 296, and a number of ribs 297. The base 260 includes a hole 268. FIGURE 27 shows a cross-sectional view of the tip of the gouging bit 262. This FIGURE shows the several guiding surfaces 292. 294, and 296, the ribs 297, along with the bore 298 and a contact surface 276 to which the ribs 297 re connected.

FIGURES 28, 29, and 30 iflustrate the use of the gouging bit 262 and the base 260 to perform the improved method to assemble an improved valve 11 of the present invention. Referring to FIGURE 28, a seal 36 of FIGURE 7 is placed onto a spike element 24 of FIGURE 7. The inner conduit 18 of the spike element 24 is placed inside the bore 298 in the gouging bit 262. The spike element 24 can be retained inside the gouging bit 262 by friction between the outer surface of the inner conduit 18 of the spike element 24 and the inner surface of the bore 298 of the gouging bit 282, or by other appropriate means.

Preferably, the contact surface 278 of the gouging bit 262 contacts the upper surface of the annular cuff 28 of the spike element 24. It is noted that the gouging bit 262 is shed such that the gouging edge 266 exterds beyond the outside perimeter of the spike element 24, including the annular detent 28b.

The valve housing 12 is placed inside of the hole 268 located in the base 260, with the distal end of the housing 111 protruding from the base 260. Once the gouging bit 262 and the base 260 are positioned so that their centers are in direct vertical alignment, the base 280 is moved upwardly, toward the gouging bit 282 (although, as one skilled in the art will recognie, alternately, the bh 282 may be moved downwardly towards the base 260).

As the base 260 approaches the gouging bit 282. the base 260 forces the housing 12 around the outside of the spike element 24 and the seal 36, so that the spike element 24 and the seal 38 penetrate the housing 112.

Continued movement of the base 260 causes the housing 12 to be pushed up around the spike element 24 and the seal 36 until the distal portion of the annular ring 14 of the housing 12 makes contact with the annular cuff 28 of the spike element 24, as shown in FIGURE 29.

Referring again to FIGURE 28, the inside diameter of the housing 12 (including the threads 45) is sufficiently large enough that when the housing 12 is pressed around the outside of the spike element 24 and the seal 35, the annular detent 28b of the spike element 24 passes by the protruding threads 45 and the gouging surface 252a of the housing. Further, the inside diameter of the housing 12 is sized such that the gouging edge 266 of the gouging bit 262 also do not contact the threads However, the housing 12 and bit 262 are sized such that the gouging edge 266 of the gouging bit 262 does make contact with the housing 12 at the gouging surface 252a. In this manner, the gouging edge 266 of the P:\OPER\DH\I 2658880 div.doc-01/09/05 -29gouging bit 262 gouges a portion of the gouging surface 252a away from the inner surface of the housing 12. The portion of the gouging surface 252a that is partially separated from the housing 12 is folded or crushed in towards the center of the gouging bit 262 and down toward the annular cuff 28 of the spike element 24 between pairs of ribs 297 by the guiding surfaces 292. 294, 298 to form a number of retainhng tabs 252c. as shown in FIGURES 29 and 30. At this point, the housing 12, the spike element 24, and the seal 36 have been assembled to form an improved medical valve 11, with the retaining tabs 252c securing the spike element 24 and the seal 38 inside the housing 12. The gouging bit 262 can then be separated from the base 260, and the assembled medical vahe 11 can be removed.

The method described above is the preferred method of assembly for the improved medical valve 11 of the present invention. However, this improved method of assembly can be modified in numerous ways without departing from the essential teachings of the present invention.

Referring again to FIGURES 26 and 27, the tip of the gouging bit 282 comprises a number of surfaces 276, 266 and 292, 294, and 296 that combine to perform three basic functions. First, the contact surface 276, which is preferably an annular surface having a diameter of less than the outer diameter of the bit 262, presses against the annular cuff 28 of a spike element 24 to drive the spike element 24 into the housing 12. Second, the gouging surface 266 on the gouging bit 262 scrapes a portion of the gouging surface 252e of the housing 12 away from the remainder of the gouging surface. Specifically, uging surface 266 is created by the intersection of surfaces 292 and 294 of the gouging bit 262 with the outside surface 291 of the gouging bit 262 to form a relatively sharp edge at the perimeter of the gouging bit 262 Third, the gouging bit 262 folds the gouged material from the gouging surface toward the center of the gouging bit 262 along surfaces 292, 294, and 296. In order to perform this guiding function, surfaces 292, 294 and 296 al preferaly slops downwardly and inwardly towards the contact surface 276. Further, in order to create thick retaining tabs as opposed to a thinnar retaining ing, ribs 297 are used to guide and separate the gouged material Each rib 297 thus partialy extends from the gouging edge 266 to the guiding surface 276. As iustrated, 112 ribs 297 are advantageously used to create 112 tabs.

FIGURES 26 and 27 illustrate the presently preferred embodineot of the gouging bit 262. However, a person of skiD in the art can modify the design of the gouging bit 282 in numerous ways without departing from the teachings of the present invention.

Substantial force is required to drive the base 280 toward the gouging bit 262 with sufficient force to insert the spike element 24 into the housing 12 and to gouge the gouging surface 252a of ie housing 12 and create the retaiing tabs 252c. Preferably, therefore, this assembly s accomplished through use of a machine 286.

FIGURE 31 iustrates the manually operated punch machine 298 that is preferably utlized, along with the gouging bit 262 and the base 260, to perform the improved method of assembly. The punch machine 286 illustrated in FIGURE 31 is wel-known to a person of skil In the art, and merely incorporates the specific bit 262 and base 260 described above. When utifing this machine 286, the gouging bit 262 is positioned in the punch machine 288 so that it is in direct vertical aligment with the base 260. Again, the seal 36 is placed over the spike element 24, which is placed inside the gouging bit 262. The valve housing 12 is placed inside the base 280. The punch micdne P:\OPER\DH\12658880 div.doc-OI/09/5 288 is operated by manually pulling down on a handle 280 to create rotational motion in an axle 282, which in turn creates vertical motion n a piston 284. The vertical motion of the piston 284 is then communicated to the-base 260. Thus, by this machine 286, a downward motion in the handle 280 is translated into an upward motion in the base 260 with respect to a stationary bit 282.

Movement of the piston 284 pushes the base 260 in which the valve housing 12 is located upwardly until the annular cuff 28 of the spike element 24 contacts the annular ring 14 of the housing 12. During this procedure.

the gouging edge 266 of the gouging bit 262 gouges a portion of the gouging surface 252a away from the inner surface of the housing 12 to create the retaining tabs 252c. A mechanical stop (not shown) is preferably used to prevent the base 260 from being driven too far relative to the gouging bit 262.

After the components of the medical valve have been assembled, the handle 280 is released and returned to its normal position as shown in FIGURE 31. At this time, the base 260 also returns to its normal position, also known in FIGURE 31. The completed valve 11 is then removed from the machine 286.

Although FIGURE 31 illustrates a manually-operated punch machine, a parson of skill in the art wil recogrnze that a wide variety of machines could be designed to implement the improved method of assembly, including an automated version of the machine 286 described above.

The valve 10 or 11 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 or 11 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 36d, for example, prevents any blood from leaking from the valve. The delivery end or nose 28 of the mecal implement (such as syringe 221 is inserted into the valve as depicted in FIGURE 8, pushing the nose 28 against the seal to compress the seal sufficiently to alow the tip 32 of the spike 24 to pierce the seal and enter said delvery end. The predetermined amount of medication in its entirety may now be transferred through the nose 28 into the valve 10 or 11 and into the patient. Since the nose 28 and seal 36d engage in a manner so that the tip 32 of the spike element 24, upon piercing the sea, meets the seal to avoid formation of any dead space at the interface between nose 28 and the seal surface 40b. Transfer directly through the valve 10 or 11 of essentially the entire predetermined amount of medication from the syringe 22 to the patient so that essentialy none of said predetermined amount is collected in any dead space in the valve, is accomplished with this invention. Upon withdrawing the nose 28 from the valve 10 or 11 the seal 36d returns to the decompressed state to cose the viave and maintain whie in said decompressed state a fluid tight seal even at high pressures and after repeated uses.

FIGURE 32 illustrates the piercing element 520 used in conjunction with the above-described valve 10 or 11. It is recognized that the piercing element 520 may be used in conjunction with any of the embodiments of the valve 10 or 11 described above.

In particular, in the preferred embodiment, the proximal end 570 of the piercing element 520 has a number of threads 588 located on the outside surface thereof for engagement with the threads 45 inside of the housing 12 of valve 10 or 11. These threads 588 may comprise standard threads, or, as shown, short wings for engaging the P:%OPERkD~FA]2658880 divdoc-OIA)9flS -31 threads 45 of the housing 12. When the proximial end 570 of the piercing element 520 is threadingly engaged With the distal end of the valve 10 or 11. the valve 10 ar I1I and piercing element 520 form a fluid tight seal.

It Is also contemplated that the piercing element 520 and valve 10 or 11 may be made as a single eleiren, wherein the conduit 19 of the valve 10 or1 Ie nd the connection portion at the proxiael end 570 of the piercing element 520 comprise a continuous single conduit or element. In one version the piercing element 520 (without threads thereon) may be connected to the conduit 18 of the valve 10 or I1I and be pernnnently affixed thereto.

This may be done, for example, by fusing the conduit 18B into the conecting portion of the piercing element ow by any other means known to one skilled in the art. Alternatively, the spike 24 may be foamed a an extension of the proximal end 570 of the piercing elemnent 520.

Method of Uftn the Alternate Embodimnent In operation, the piercing element 520 is preferably threaded into engapemnent with the housing 12 of the valve 10 or 11. The penetrating portion 532 of the pircing element 520 is then inserted through the septumi S34 of the vWa 524. asty, as best lllstrated in FI&URES 8 arnd 7. the nose 20 of syrige 22 is engaged with the proximial end of the valve 10 or 11. Onre the syringe 22 is engaged, a fluid conduit exists from the vial 524 through the piercing element 520 and valve 10 or 11 to the syringe Z2,. whereby fluid may be withdrawn Into the syringe 22 from the via 524.

Advantageously, the syringe 22 may be disengaged f rom the valve 10 or I1I at any time. Once disengalled, the fluid conduit is automaticaly closed by the seal 35 in the valve 10 or 11. This system allows later withdrsiwal of fluid with another syringe 2Z without the fear of contamination of. the fluid in the vial between uses.

In another preferred embodiment of the Invention, illustrated by FIGURES 33 and 34. a sterile adaptor 311 is provided to function as a connector to'a conta~ner 315 Ishown in phantom) of likd. Fluid can thus be remived from or added to the flaid container.

The adaptor 3111 is preferably masde of toiy medicall htt Matal In a preferrWed emfbodirmt of the adaptor 311. and especially where disposabilfity Is desired, the adaptor 311 is constructed of ti~id Oitic. In cthef embodiments, however, and particulaity where remsbifity Is desired, te adaptor 311 may be made of stainless steal or any other mefcally inert substance, to allow sterlization in an hbM10 or cii dinfa FIGURE 33 shows an adaptor 311 having a generally cylindrical body 314 with a proximal end and a distal end and en adaptor spike 312 located at the proximal end. The adapto spike 312 will preferably panstratei the outer surface of a seal 316 located on the container 315. The spik 312 may be of, any sue and shapte, to eccornmodata a range of Weniner end MI fifts in a ptifaewd emboditent of the adaptor 311, shown In FIGURE 33, the spike 312 ia generally cylidrial having a sharpened anniular proxirnal end. and is approximately 1.375 inches liOil. Aternatively, the Spike 312 may be generally fwtusocefltil I Shape.

A longitudinal channel 313 leads trom the prozirnal and of the spike to the distal end of the adaptor 311.

providing a roote for fluid to flow through the adaptor 311. The channel 313 is typically cylindrical although It may also be slightly f rustoconical to accomnmodate the change in diameter from the tip of the spike 311 to the distil end P\OPER\DfH\2658880 div.doc-0109/05 -32of the adaptor 311. In the preferred embodiment of the adaptor 311, the channel 313 has a generally smooth interior surface, to facilitate the easy flow of fluid through the adaptor 311.

Near the distal end of the spike is preferably located a flange 317, of a size and shape to sealably conform to the surface of the seal 316. In this manner, the spike 312 and flange 317 serve to first penetrate the seal 316 and next mate with the seal 316, preventing leakage of fluid from the container 315 around the outside surfaco of the adaptor 311. In addition, the flange 317 prevents the adaptr 311 from entirely transversing the seal 316.

In one embodiment, shown in FIGURE 33, strengthening ribs 318 are provided between the distal endt of the adaptor 311 and the flange 317. These ribs 318 provide rigiity to the body 314 and prevent unwanted bending or twisting of the adaptor 311. In addition, the ribs 318 provide a gripping surface for the fingers or hand cf a user, faclitating easy insertion or removal of the adaptor 311 through the seal 31 In other embodiments, howeer.

strengthening ribs 318 may not be required. This is particularly so where the length of the body 314 is relatively smalL The body 314 may be of any length necessary to accommodate easy connection to the fluid container 315.

In particular, it is advantageous that the body 314 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of the adaptor 311. In a preferred embodiment of the adaptor 311, the body 314 is approximately 1.625 inches long.

In one preferred embodiment of the adaptor 311, shown in FIGURE 33, the distal end of the adaptor .11 is provided with a locking mechanism 319 that preferably comprises a Luer-Lock device or other locking device known to those of skil in the art The locking mechanism 319 is adapted to removably and seatably connect the distal trd of the adaptor 311 to a medical valve 10 or 11 as previously described.

Alternatively, as shown in FIGURE 34, the distal end of the adaptor 311 can be provided with an integlral medical valve 10 or 11.

The adaptor 311 is thus useable with containers having a seaL Examples of containrs with such stals contemplated for use with this invention include medicament drip bags, bottles for intravenous delivery of fluids,, or the ike.

In use, the adaptor 311 coupted with a valve 10 or 11 is typically inserted into a medicament drip bag or the ke. Thereafter, the tip or nose of an ANSI standard IV set, syringe, or other connector or medical implement.

is then pushed into the proximal end of the medical valve 10 or 11. Referring now to FIGURES 6 and 7, this action pushes the tip 32 of the spike 26 through the seal 36, exposing the through holes 34 and thus bringing the IV tubing or other medical implement into fluid communication with the fluid in the bag 315, The connection process is more extensively described above with reference to FIGURES 6 and 7.

Y-Connector with Integral Valve Another embodiment of the present invention is shown in FIGURE 35. A connector 331 is provided to function as a conduit between either two or three fluid sources or receptacles. The connector 331 has a tutbular body 332. having a proximal and a distal end, and a tubular branch 335 located between the proximal and distal ends. At the poxinal end of the body 332 is provided an integral spike element 24 as previously described.

P:XOPERDI ~2658880 diw.dc-0 1109/05 33 The connector 331 is preferably made of any medically inert material. Advantageously, the connector 331 may be mi of a transparent material, allowing a user to see whether fluid is flowing therethrough. lq one preferred embodiment of the connector 331, and especilly where disposability Is desired, the connectoir is constitted 61f t~id tiitffit plastic.

A longitudinal channel 334 runs through the body 332 from the proximal and to the distal and, providing coninuous fluid communication from the through holes 34 of the spike elernent 24 through the connector 331. The channel 334 is generally cylindrical i shape, although it may he slightly conical or have Internal step changes in diameter to accommodate the difference in diameter between the base of the spike element 24 and the distal end of the body 332. Furthennora. in the preferred embodinmnt of the connector 331 the channel 334 has a generally smooth interior surface, to facilitate the flow of fMid through thre connector 331.

Toward the proximal end of the body 33 is provided the tubular brach port 335, which has a longitudinal channel 336 located theretirrough. The channel 338 is in fluid communication with the channel 334 of the main body 332. and is, like the main channel 334. generally cylindrical in shape. In addition. the channel 338 preferably has a generally smooth Interior surface.

The spike element 24 is preferably formed hnqerely with the main body 332. To form a Plastic body ih a continuous through-channel (such as the body 332 of this connector 331), en effective method of manufacIreV is to use a bare pin to mnanufacture the connector 331, TUs coamitor 331 of the present invenion has the advantage of easy manufacture at low cost. In addition, the connector 331 will be loss bulky, and will have a lower weight.

than a connector in which thre spike element 24 6s fanned separately and thin meanically attached.

At a later time, before use, the seal 38 and housing 12 of the medical valva 10 or I1I of other preferred embodiments can be placed over the spike element 24 and attaced by such means as were described eerfe In the discussion of thos embodintsM.

In use, the distal end of the body 332 can be placed in fluid communication with flexible tng (not shown) or another flid transmitting device ar medical irplemnt. The and of tire branch port 335 can be. Ike the distal end ofthe body 33Z placed in fluid communication with a soocoffhftd o:other fkodtransmilhttndavt*or medical hnplenmot The connector 331 typically connects one or two fluid sources with a fluid receiv such as a patienlL A first fluid source or parenteral fluid is. in use, placed in fluid comunincatlon with the tubular branch port 335. The fluid receiver, such as a patient. is, in m.e placed in fluid comumnlution with tire distalled of the body 332. In this manner, the first fluid flows from its sourc through the branch port channel 336 into the main channel 334 and then to the fluid receiver or patient.

When a second fluid needs to be administered to a patient, the tip or non of en ANSI standard syringe or other medical implement is pushe ifitO the end of the Mi1diell Valve 1 lof 11. Rehfih now to FIBURES 6 and 7. this action pushes the tip 32 of the spike 26 through the seal 35. exposing the through holes 34 and thus bringing the syringe or other connector into fluid communication with the connecor 331. The connection prczass is more extensively described above with reference to FIGURES 6 and 7. Once the second fluid has been Introduced PAMMPE\DHA22658880 di,.dc-01dO9/05 34 the yrannectar (also known as a y~ste or piggyback connector) can be disconnected and the seal closes the vahre or It Htook Adantor for Y-Cnnectois FIGURES 38. 37, and 38 illustrate another embodiment of the present invention, A hook adaptor 351 is provided to function as a connector to a standard piggyback or y~site (not shown) lbse hook adaptor 351 attache~s ta the piggyback or y-site. providing a stable fluid Ink to the piggyback or y-slte that is not easily or accidentally disconnected.

The hook adaptor 351 is preferably made of any medically inert matial. In a preferred embodimfent cif the hook adaptor 351, and especially where disposability is desired, the hook adaptor 351 is constructed of rigid plstic. In other embodiment:, howevey, and particularly where reuably i desired, the hook adaptor 351 may be made of stainless steel or any lIke substance, to allow steriliration in an autoclave or similar device.

As shown in FIGURE 36, the hook adaptor 351 has a generally cylindrical tubular body 354 with a prozim;ml end and a distal end, with en adaptor housing 355 and spike 356 at or near the distal end. In additon, a hook 357 loads downward and away from the housing 355, to roterably and removably engage an arm of the y-site when the hook adaptor 351 is placed in fluid conmmunication with the y-site, thereby providing a stable end not easily disconnected Ink.

Referring to FIGURE 38, the housing 355 has a depth, defined by the distance from the diltal tod of the outside walg 358 of the houseing 355 to the base 359 of the housing 355, sufficient to envelop a substantial portion of the end of the branch pert of the piggyback or yuhie connector. In thu preferred embtodiment Of this adaptor 3511, the housing 355 is approximately 0.375* deep.

Ths housing 355 may furthermore have a section 352 removed from a portion of the dista end of tt~e housing wall 358, to accommnodate the arm of the piggyback connector when the adaptor 351 is In the connected and locked position (see discussion belw4 Centrally located within the housing 355 is a spike 358. The spike 358 is tubular, heving a narrow channel 353 runnin longitudinally therethrough, providing a route for fluid to flow throug the spike 356 and into the bd~y 354 of the adaptor 351. The spike 356 will preferably penietrate a septum located on the end of the branch port.

The spike 356 may be of any length and shape, to accommodate&a range of septum sues. Most advantageously.

the spike is aproimately as long is, or smaller than, the deph of the housing 355, so that the end of the Spike does not substantialy protrude beyond the distal end 358 of the housin 355. This prevents a user from accidentally stcking himel or herself wbt the spike 356. In a preerred emboiiwnt oqtth idaptor 351, shown in FIGURE 36. the spike 358 is generely cylindrical having a sharpened annular prioximal end, and is epproximatOl 0.37 iniches long. Alternatively, the spike 356 may be generally frustoconical in shape.

The spike 356 should furthermore be smooth surfacedl, and as thin as possible to avoid substantialy rupturing or coring of the septum of the branch porl of the piggyback connector during insertion andlor romovel, yet large enough to provide a sufficient channel 353 for fluids, especially liquids, to pass easily therethrough. In P %OPERXDHMI2658880 dv.do.-O 1/09/05 35 particular, it is contemplated that the adaptor 351 may be repeatedly connected to. and removed fromt the same connector.

The longitudinal channel 353 is typicll cylindrical although it may also be slightly frustoconicul to accommodate the change h diameter from the tip of the spike 356 to the base 359 of the housing 355. In the preferred embodiment of the adaptor 351, the channel 353 has a generally smooth interior surface, to facilitate the easy flow of f luid through the adaptor 351.

The body 354 may be of any length necessary to accommodate easy connection to the piggyback connector. Mn particular, it is advantageous that the body 354 be "on enough to provide the user an adeqwate griping surface, to facilitate installation and removal of the adaptor 351. In a preferred embodiment of the adaptor 351. the body 354 is approximately 0.41 inches long, measured from the base 359 of the housing 355 to the proximal end of the body 354.

In one preferred embodiment of the adaptor 351. shown In FIGURE 38. the proximal end of the adaptor 351 is provided with a locking mechanism 350 that preferably comprises a Luer-Lock device or other locking device known to those of skill in the art. The locking mechanism 350 is adapted to removably and sealably connect the proximnal end of the adaptor 351 to a medial valve 10 o11 I Cs previously describied.

Alternatively, as shown in FIGURE 38. the proximal end of the adaptor 351 could be provided with en integral medical valve 10 or 11, The hook 357 is of a size and shape to rotesably engage an erm of the yralte. The hook 357 preferably leads downward from the housing 355 at a alight angle, to accommnodate the angle at which the branch port departs from the main body or am of the y-ulte. In the preferred embodiment of the adaptor 351 shown in RGURES 38 and 38, the hook 357 dechias from the housin 355 at an angle of approximately 27*, and 1s; approximately incheslon. The interor bend of thehook 357should be of aradkus to secoanodete the amof the y-site. and is in the shown prefred emdbodinmt approximae 0. 11 inches In raiuts.

In use. the housing 355 of the adaptor 351 is plaed over the end of the branch port of the yalta. and then pressed down until the spike 356 penetrates the septum on the branch port. providing fluid communication between the adaptor 351 and the y-stte The adaptor 351 Is than rotated until the hock 357 engages the an of the y-t, f imly holding the adaptor 351 onto the yfalaend preveting accidental disconnection of the adaptor 35 1.

To remove the adaptor 351, a user merely rotates the hook 351 in the opposite direction, disengaging the hook 357 from the y-site.% If using an adapter 351 of the type shown in FIGURE 38. a medical valve 10 or" I1 of the first preforred embodiment can be attached to the proximal end of thre adaptor 351, usfng the locking muchankam 350.

The tip or nose of an ANSI standard IV set, syringe, or other connector or medical imiplement. Is then pushed Into the proximal eW of the medial valve 10 ori11. Referring now to FIGURES 8 and 7, this action pushes the tip 32 of the spike 28 thrugh the seat 35. expos~N the through holes 34 and thus bringig the syrige or other connector into fbuld commuinbcation with the adaptor 351. The connection process is more extensively described above with reference to FIRES 6 ad 7.

P:OPERDR-0I 2658880 divdo-0I /D9/05 36 SnimwOn Adapitor for Pinvbeck Conector Another embodiment of the present invention is shown in FIGURES 39, 40, and 41. A sniap-on adaptar:371 is provided to function as a connector to a standard medical y-site. The snan adaptor 371 attaches to the braitch port or another arm of the y-slte. providing a stable fluid link to the y-connector 381 that is niat easily or iccidentaly disconnected.

The snap~n adaptor 371 is preferably made of any sterile medically inert material. tn addition, the material shold be capable of slight elasti defarmation, to allw, the adaptor 371 to "snap" into position (see description of use, below). In the preferred emnbodiment of the snap-on adaptor 371, and especially where disposability is desired, the adaptor 371 is constructed of rigid plastic, I other embodiments, however, ;and particularly where reusibiffity is desid the adaptor 371 may be made of stainless steel ar any Rie substance, to allow sterilization in en autoclave or similar device.

As shown in FIGURE 39, the snap-on adaptor 371 has a generall cylindrical tubular body 374 with a proximal end and a distal end, and en adaptor housing 375 and spike 379 at the distal end.

The adaptor housing 375 is generally cylindrical and of a size and shape to closaly surround the end of the branch part or other arn of the standard y-sitL. The housing 375 wall has in opening 372. shaped to closely accommodate the branch port or arm of the piggyback connector when the adaptor 371 is connected to the y-sie.

The opening 372 6s preferably just wide enough to allow the branch port or ann of the y-site to pass ean Wi tharethrough. In addition, in the pref erred embodimn of the adaptor 371 as shown in FIGURE 39, the openin 372 hassa rounded proximal end, to accommodate the radius of the protulding brantch port or arm of the y-site when -the adaptor 371 Is connected to the y-site. In a preferred embodimeint of the adaptor 371. the open*n 372 is approximately 0.22 Inches wide, and rounded at one end with a 0. 11 inch radius.

Toward the distal end 378 of the housing 375, the opening 372 narrows sharply and then gradually widens, so that a pal, of opposing and spaced apart tabs 377s, 377b ae formed. Integral with the housing 375. The tabs 377%. 377b are spaced apaen a istance sufficient to prevent the passage of the branch Pont or arm of the y.:dta theretrough, unlass deliberate prawn; is appld, I the pretenrd embodiz=en of the adaptor 371, the tus 377s, 377b are spaced apart by approximately 0.09 inches.

The openting 372 gradually widens from the tabs 377a, 377b toward the disal end of the housing wiall 378, thus providling entrance bearin surfaces 373a, 373b which assist in guiding in arm of the y-sit Into 'the opening 372. In the preferred embodiment of the adaptor 371 shown In FIGURES 39 IV 1. the entrance bearin surf aces 373a, 373b decline trom the horizontal at in angle of approximately 400.

Centrally located within the housing 375 is the spike 376. The spike 379 is tubular, having a narrow channel 381 running longitudinally therethrough. providing a route for fluid to flow through the spike 376 and into the body 374 of the adaptor 371. The spike 376 will preferably penetrate a septum located on a branch posit of a y-31te. The spike 376 may be of any length and shape, to accommodate a range of seal sune. Most advantageously, the spike does not protrude past the distal end of the housing 375. This prevnts a user tram accidentally sticking himself or herself with the spike 376. In a preferred embodiment of the adaptor 371, shown P:\OPER\DH\I 2658880 divdoc-01/09/05 -37in FIGURE 39, the spike 376 is generally cylindrical having a sharpened annular proximal and, and is approximately Inches long. Alternatively, the spike 376 may be generally frustoconical in shape.

The spike 376 should furthermore be smooth surfaced, and as thin as possible to avoid substantially rupturing the septum on the branch port of the piggyback connector during insertion andlor removal yet large enough to provide a sufficient channel 381 for fluids, especially liquids, to pass eadsy therethrough. In particular, it is contemplated that the adaptor 371 may be repeatedly connected to, and removed from, the same y-site, potentially tearing smag pieces of the septum off in the process. This poses the danger of causing particles of the septum to enter the fluid stream of the y-site, contaminating the stream and possibly harming a patient. Therefore, in the preferred embodiment of the adaptor 371, the spike 376 is only about 0.05 inches in diameter.

The longitudinal channe 381 is typically cylindrial plthough it may also be slightly frstoconi l to accommodate the change in diameter from the tip of the spike 376 to the base 379 of the housing 375. In a preferred embodiment of the adaptor 371, the channel 381 has a generally smooth interior surface, to facilitate the easy flow of fluid through the adaptor 371.

The body 374 may be of any length necessary to accommodate easy connection to the y-site. In particular, it is advantageous that the body 374 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of the adaptor 371. In the preferred embodiment of the adaptor 371, the body 374 is approximately 0.3 inches long, measured from the base 379 of the housing 375 to the proximal end of the body 374.

In one preferred embodiment of the adaptor 371, shown in FIGURE 39, the proximal end of the adaptor 371 is provided with a locking mechanism 382 that preferably comprises a LuarLock device or other locking device known to those of skill in the art. The locking mechanism 382 is adapted to removably and sealably connect the proximal end of the adaptor 371 to a medical valve 10 or 11, as previously described.

Alternatively, as shown in FIGURE 41, the proximal end of the adaptor 371 could be provided with an integral medical valve 10 or 11.

in use, the housing 375 of the adaptor 371 is placed over the end of the branch port of the y-site, and then advanced so that the spike 376 pierces the septum on the branch port. A dliberate force must be applied so that the arm of the y-site passes through the tabs 377a, 377b and into the opening 372. Constant pressure on the adaptor 371 thus causes the arm of the y-site to snap into the opening, and contemporaneously the spike 376 penetrates the septum, providing fluid communication batween the y-site and adaptor 371.

To remove the adaptor 371, the user must deliberately pull the adaptor 371 t the y-site.

If using an adaptor 371 of the type shown in FOURE 39, a medical valve 10 or 11 of the first preferred embodiment may be attached to the proximal and of the adaptor 371, using the locking mechanism 382.

The tip or nose of an ANSI standard IV set, syringe, or other connector, is then pushed into the proximal end of the medical valve 10 or 11. Referring now to FIGURES 6 and 7, this action pushes the tip 32 of the spike 28 through the seal 36, exposing the through holes 34 and thus bringing the syringe or other connector into fluid communication with the adaptor 371. The connection process is more extensively described above with refenmce to FIGURES 6 and 7.

P:\OPER\DH\12658880 div.doc-01/0905 -38- Test Tbe Adantor FIGURES 42 and 43 illustrate yet another embodiment of the present invention. A test tube adaptor 191 is provided to function as a device for withdrawing fluid from, or depositing fluid into, a test tube or other narrowly necked container. The test tube adaptor 391 either attaches to a medical valve 10 or 11 as previously described, as shown in IGURE 42; or is a single piece having an integral medical valve 10 or 11, as shown in FIGURE 43.

The test tube adaptor 391 is preferably made of any medicaly inert material. In the preferred embodiment of the test tube adaptor 391, and especially where disposabibty is desired, the test tube adaptor 391 is constructed of plastic. In other embodiments, however, and particularly where reusability is desired, the test tube adaptor 391 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.

As shown in FIGURE 42, the test tube adaptor 391 has a generally cylindrical tubular body 394 with a proximal and a distal end, and an open-ended tube 395 at the distal end.

The tube 395 is preferably flexible, and transparent, so that a user can see whether fluid is flowing theruin.

In the preferred embodiment the tube 395 is constructed of flexible medical tubing. In addition, the tube 395 should be of a length sufficient to reach substantially into a test tuba or similar narrowly necked container, so that fluids can be withdrawn. In the preferred embodiment, the tube 395 is approximately 5.5 inches long. The tube 395 should also have an inner diameter sufficient to allow fluids, especially liquids, to pass easily tharethrough. In the preferred embodiment, the tube 395 has an inner diameter of approximately 0.03 inches.

The body 394 is generally cylindrical, although it may also be conical or have a neck to accommodate the change in diameter from its proximal end to the distal end where the tube 395 is attached.

In one preferred embodiment of the adaptor 391, shown in FIGURE 42, the proximal end of the adaptor 391 is provided with a locking mechanism 392 that preferably comprises a Luer-.Lck device or othar locking device known to those of skil in the art. The locking mechanism 392 Is adapted to removably and seatably connect the proximal end of the adaptor 391 to a medical valve 10 or 11, as previously described.

Aternatively, as shown in FIGURE 43, the proximal end of the adaptor 391 could be provided with an integral medical valve 10 or 11.

In use, the tube 395 of the adaptor 391 is placed into the test tube or other container. If using an adartor 391 of the type shown In FtGUR 42. a medical valve 10 or 11 of the first preferred embodiment must be attached to the proximal end of the adaptor 391, using the locking mechanism 392. The tip or nose of an ANSI standard syringe IV set. or other connector, is than pushed into the proximal end of the medical ve 10 or 11. Referring now to FIGURES 6 and 7, this action pushes the tip 32 of the spike 28 through the seal 36, exposing the through holes 34 and thus bringing the syringe into fluid communication with the adaptor 391 and the test tube. The valve connection process is more extensively described above with reference to FIGURES 6 and 7.

The foregoing provides 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, conise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the invention. Although certain embodiments have been described, it is intended that the scope of the invention not be imited to the specific embodiments described.

P:\OPER\DHI2658880 div.doc-01/09/05 -39- It will be appreciated that certain modification and variations may suggest themselves to those skilled in the art. The spirit and scope of the invention are limited solely by the following claims.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

Claims (33)

1. A needleless valve comprising: a housing comprising a proximal end, a distal end, and an internal cavity with a r 5 first region positioned near the proximal end with a first horizontal cross-sectional width, a V)second region with a second horizontal cross-sectional width larger than the first horizontal cross-sectional width, the second region positioned in a distal direction from the first 0 region, the proximal end configured to receive a delivery end of a medical implement for transferring fluid through the delivery end; a flexible element with a proximal end and a distal end, the flexible element positioned within the internal cavity of the housing for controlling a flow of fluid through a fluid pathway through the valve, the flexible element comprising a first height in a first position and a second height in a second position, the first height being greater than the second height, the proximal end of the flexible, element configured to move in a distal direction from the first position to the second position upon insertion of the delivery end of the medical implement into the proximal end of the housing, the proximal end of the flexible element configured to move in a proximal direction in the cavity to the first position upon removal of the delivery end from the proximal end of the housing, the flexible element comprising an orifice at its proximal end to facilitate fluid flow therethrough, wherein the proximal end of the flexible element, when in the first position, is generally flush with the proximal end of the housing, has at least a portion that contacts the housing in a region at or near the proximal end of the housing, and presents an impediment to entry of bacteria into the fluid pathway without requiring a covering for the housing; and a spike with a proximal end and a distal end, the distal end disposed at or near a distal end of the cavity in the housing, the spike having a hole at the proximal end thereof, wherein the distal end of the flexibleelement is positioned in close radial proximity with a distal section of the spike.

2. The valve of Claim 1, wherein the spike facilitates a flow of fluid in a distal direction from the inside of the flexible element to a region outside of the flexible element. P\ OPERODH 126 5888O s I doc-2IlA5/2(X8 00 -41- ct

3. The valve of Claim 1, wherein the spike assists in supporting the flexible element within the cavity of the housing.

4. The valve of Claim 1, wherein the spike assists in centering the flexible element t within the cavity of the housing.

The valve of Claim 1, wherein the proximal end of the spike has a pointed tip.

6. The valve of Claim 1, wherein the flexible element in its first position completely blocks the flow of fluid through the valve.

7. The valve of Claim 1, wherein the flexible element further comprises a cap portion.

8. The valve of Claim 7, wherein the orifice is positioned in the cap portion of the flexible element.

9. The valve of Claim 8, wherein the shape of the cap portion is adapted to facilitate closure of the orifice when the flexible element is in the first position.

The valve of Claim 8, wherein the cap portion has a generally circular cross-section when the flexible element is in the first position.

11. The valve of Claim 1, wherein the internal cavity of the housing further comprises a third region with a third horizontal cross-sectional width larger than the second horizontal cross-sectional width, the third region positioned in a distal direction from the second region.

12. The valve of Claim 11, wherein the first, second, and third cross-sectional widths are diameters spanning substantially circular cross-sections of the internal cavity.

13. The valve of Claim 12, wherein at least a portion of the housing in a region of the internal cavity between the first region and the third region has a tapered interior surface. P\OPERDH12 59RO spl do-21MJ5/'2 00 -42-

14. The valve of Claim 1, wherein the valve provides substantially linear fluid flow N, from the medical implement through the valve.

The valve of Claim 1, wherein the orifice is made before the flexible element is used to transfer fluid therethrough.

16. The valve of Claim 1, wherein at least a portion of the flexible element is Scorrugated.

17. The valve of Claim 1, wherein at least a portion of an outer surface of the flexible element is an imperforate bellows.

18. The valve of Claim 1, wherein the spike is formed of plastic.

19. The valve of Claim 18, wherein the distal end of the spike is unitary with the housing.

The valve of Claim 1, wherein the flexible element moves between the first and second positions in an accordion-like fashion.

21. The valve of Claim 1, wherein the proximal end of the spike is located within the cavity in a distal direction from the proximal end of the housing.

22. The valve of Claim 21, wherein the proximal end of the spike is positioned approximately 0.1" to 0.525" from the proximal end of the housing.

23. The valve of Claim 22, wherein the proximal end of the spike is positioned approximately 0.525" from the proximal end of the housing.

24. The valve of Claim 1, wherein a horizontal radius of the spike is greater at the distal end of the spike than at the proximal end of the spike. The valve of Claim 1, wherein the housing further comprises a fluid conduit extending distally from the internal cavity in the housing and a skirt surrounding the fluid conduit.

P 1OPERODMI{2658R890p I dom.2I/I05I2IE 00 -43-

26. The valve of Claim 25, wherein the skirt further comprises internal and external N, surfaces and at least one thread positioned on the internal surface for detachably connecting the valve to a second medical implement.

27. The valve of Claim 1, wherein the housing is comprised of multiple, separately Smolded plastic structures configured to be joined together to define the internal cavity of N, the housing.

28. The valve of Claim 1, wherein the flexible element is made of a compound comprising silicone rubber.

29. The valve of Claim 5, wherein the pointed tip of the spike penetrates the flexible element when the flexible element is in the second position.

30. The valve of Claim 1, wherein the spike penetrates the orifice when the flexible element is in the second position to allow the flow of fluid therethrough.

31. The valve of Claim 1, wherein the spike is tapered.

32. The valve of Claim 1, wherein the portion of the flexible element that contacts the housing in the region at or near the proximal end of the housing fills essentially completely an opening in the proximal end of the housing in a horizontal cross-sectional dimension.

33. A needleless valve, substantially as described with reference to the drawings and/or examples.