Free Complaint - District Court of Delaware - Delaware

Case 1:07-cv-00468-JJF

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llllllllll W Illll I11 IlllllIllIIII lll 1 l l
USOO5685866A

United States Patent
Lopez

[I91

[ill [MI

Patent Number: Date of Patent:
a1982 711982 10/1983 21984 21984 311984 711984 41985
Pfister . Bayard et al. . Pearson. Gross et al. . Oscarsson . Larkin . Bellotti et al. . Oreopoulos et al.

5,685,866
Nov. 11, 1997

[54] MEDICAL VALVE AND METHOD OF USE [75] Inventor: George A. Lopez, Corona del Mar, calif. p3] Assignee: ICU Medical, hc., San Clemente, Calif. [21] Appl. No.: 334,846 [22] Filed:

4,334,551 4,338,933 4,411,662 4,432,759 4,432,765 4;439;193 4,457,749 4,508,367

(List continued on next page.) FOREIGN PATENT DOCUMENTS
1 105 959

Nov. 4, 1994 Related U.S. Application Data

0 114 677 A2

Continuation of Ser. No. 96,659,Jul. 23, 1993,which is a continuation-in-part of P(;TKJS92/10367, Dec. 1, 1992, whichis acontinuation-in-partof Ser. No. 813,073, Dec. 18, 1991,abandoned.

t ~ [5 11 h. C L ......................................................A61M 5/00 1521 U.S. C1. ............................................. 6041249; 604D.56 [58] Field of Search ..................................... 604246, 249, 604/247,256,283
[561

711981 Canada. 811984 Eurouean Pat. off. ~ u r o b a n Off. . Pat. European Pat. Off. . European Pat. Off. . European Pat. Off. . Germany. WIPO . WPO . WPO .

References Cited
U.S. PAIZNT DOCUMENTS

Primary h m i n e r 4 o r r i n e M. McDermott Attomex Agent, or Finn-Knobbe, Martens, Olson & Bear, LLP

D.321,250 1011991 Jepson et al. . D. 321,251 1011991 Jepson et al. . 1,578,517 311926 Hein . 2,289,677 711942 Perelson . 2,847,995 811958 Adams . 3,134,380 511964 Armao . 3,354,881 1111967 Bloch .
3,648,684 311972 3,852,385 1211974 3,974,832 811976 3,976,063 811976 3,986,508 1011976 4,019,512 411977 4,076,285 211978 4,080,965 311978 4,121,585 1011978 4,128,098 1211978 4,161,949 711979 4,187,846 211980 4,219,912 911980 4,328,802 511982

l.571

ABSTRACT

A closed system, needleless valve device includes a gener-

Bamwell et al. . Huggins . Kruck . Hememan et al. Banington . Tenaar . Martinez. Phillips . Becker,Jr. . Bloom et al. . Thanawalla . Lolachi et al. . Adams . W e y et al. .

ally tubular body defining an internal cavity. On the proximal end of the body there is an opening which is preferably sufficiently large to receive an ANSI standard tip of a medical implement. The distal end of the body has a generally tubular skirt. The valve also includes a hollow spike having a closed tip. The spike includes at least one longitudinal 18-gauge hole located distal the tip. and is seated inside the cavity such that the tip is below the proximal end of the body. An annular support cuff is connected to the spike which seals off a portion of the cavity of the body such that an upper cavity containing the tip is defined. The valve also includes a plastic. resilient silicone seal which fills the upper cavity and opening and covers the tip of the spike so as to present a flush surface. An adaptor enables the valve to be attached to a resealable container.
17 Claims, 19 Drawing Sheets

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U.S. PATENT DOCUMENTS
4,511,359 4,512,766 4,592,356 4,610,469 4,617,012 4,645,494 4,673,400 4,706,487 4,725,267 4,752,292 4,775,369 4,781,702 4,810,241 4,846,809 4,874,377 4,950,260 4,964,855 4,969,883 411985 Vaillancourt . 411985 Vailancoutt . 611986 Gutierrez . 911986 WoH-Mooij 1011986 Vaillancourt . 211987 Lee et al. . 611987 Martin . 1111987 Bandou et al. . 211988 Vaillancourt . 611988 Lopez et al. . 1011988 S c h w a . 1111988 Hen5 . 311989 Rogers . 711989 Sims . 1011989 Newgard et al. . 811990 Bonaldo . 1011990 Todd et al. . 1111990 Gilbert et al. .

...........................285f260

4,981,469 4,998,713 4,998,921 4,998,927 5,069,225 5,100,394 5,122,123 5,134,489 5,154,703 5,158,554 5,167,642 5,167,648 5,171,234 5,188,620 5,273,533 5,290,254 5,344,414 5,401,245

111991 311991 311991 311991 1211991 311992 611992 711992 1011992 1011992 1211992 1211992 1211992 211993 1211993 311994 911994 311995

Whitehouse et al. Vdancourt . Gckroy et al. . Vaillancourt . Okamura . Dudar et al. . Vaillancourt. Jepson et al. . Bonaldo . Jepson et al. . Fowles . Jepson et al. . Jepson et al. . Jepson et al. . Bonaldo . Vaillancourt . Lopez . Haining .

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U.S.

FIG. 3

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FIG. 4

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FIG. 9

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9 2

FIG. 11

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FIG. / 5

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FIG. 17

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MEDICAL VALVE AND METHOD OF USE

2

can prove fatal to a patient. Such through-holes may also become clogged easily with material from the septum. This application is a continuation of U.S. application Ser. Reusable connectors and adaptors are preferred for mediNo. 081096,659, filed Jul. 23,1993, which is a continuationcal applications since components must often be added or in-part of International Application NO. PaUS92\10367, 5 removed from a fluid line connected to a patient. Reusable filed Dec. 1.1992, now abandoned, which is a continuationconnectors. however, are dif6icult to keep sterile. Sometimes in-part of U.S. application Ser. No. 071813,W3, filed Dec. caps are employed to cover the connector to keep it sterile. 18, 1991, now abandoned. Frequently, these caps are lost, or simply not used because they are not readily available when needed. BACKGROUND OF THE INVEMTON lo A closed, patient access system that is easy to use and 1. Field of the Invention employs only a valve device in communication with the patient that need not be capped or interconnected with the This invention relates to a closed, patient access system medical implement through a needle or adaptor, is which automatically reseals after administering medication swabbable. is sdciently durable to maintain its function using a standard medical implement that directly connects with the system without the need of any intermediary l5 after several manipulations, and maintains a fluid-tight seal at high pressures, would be of great benefit to the medical needles, caps or adaptors. A two-way valve eliminating dead space is used which includes a seal which, upon being community. compressed by the medical implement, is pierced to open the SUh4MARY OF THE INVENTION valve and reseals upon being decompressed, maintaining a fluid tight seal even at high pressures and after repeated uses. 20 ~ h , of this bvention has several valve features, no single 2. Background Discussion one of which is solely responsible for its desirable attributes. Without limiting the scope of this invention as expressed by The manipulation of fluids forparenteral administration in the claims which follow, its more prominent features will hospital and medical settings routinely involves the use of connectors and adaptors for facilitating the movement of 25 now be discussed briefly. After considering this discussion, fluids between two points. Most fluid connectors and adap and particularly after reading the section entitled, tors employ needles to pierce a septum covering sterile "DETAILED DESCRIPTION OF THE PREFERRED tubing or to pierce the septum of a medicament container of EMBODIMENTS," one will understand how the features of this invention provide its advantages, which include safety. fluid Huid then passes from the container or fluid filled tubing into a syringe or second set of tubing. These con- 30 reliable and repeatable performance, elimination of dead nectors and adaptors often have mechanical or moving parts. space, simplicity of manufacture and use, and employment Since the ready passage of fluids through the connectors and of a valve that is swabbable after use to provide sterility and adaptors is often critical to patient survival, it is imperative has a fluid-tight seal at high pressure. This invention is a closed, patient access system which that the connectors and adaptors function reliably and repeatedly. Adaptors and connectors that malfunction during 35 automatically reseals after administering medication using a medical implement that directly connects with the system use may be life-threatening. The more mchanical or moving parts such as springs and diaphra&ms, the more likely without the need of any intermediate needles, caps or that they will function iInpro~er1~. Improper functioning can adaptors. A two-way valve is employed utilizing a reusable seal that may be repeatedly pierced by an enclosed, result in the introduction of air embolisms into a patient. Thus. the fewer the mechanical parts, the more these conprotected, non-metallic spike rather than an exposed metal nectors can be relied on and the better they wiU be accepted needle. The valve facilitates fluid, particularly liquid, transby the medical community. fer while maintaining sterility. The valve is easy to use and Many connectors or valves, especially those employing is capable of locking in place. After use, the valve is several mechanical components, have a relatively high volswabbed in the conventional manner with a suitable subume of fluid space within them. This "dead space" within the 45 stance to maintain sterility. The design of the valve avoids &vice prevents accurate introduction of precise fluid volaccidentalneedle sticks. As wiU be discussed in detail below, umes and provides an opportunity for contamination upon the valve is useful as a medical connector or adaptor to disconnection of the device. Connectors and adaptors often enable liquid flow from a sealed container. include valves that p d t or inta~upt flow of fluid along the The first featme of this invention is that the valve has a the course of fluid travel. Several of those commonly in use 50 body including wall structure defining an internal cavity employ metal needles to puncture sterile seals. Such Conhaving a proximal end and a distal end. The cavity has an nectars are generally designed to accommodate fluid flow in open space into which the seal is pushed, and preferably has a plurality of radial indentations in the wall structure that are one direction. This means that the fluid line must have connectors and tube aligned in complementary directions. adjacent the seal to accommodate the expansion of the seal These connectors often require further manipulation if, for 55 upon compression. The proximal end has an opening sufEiexample, the valve is inadvertently assembled in a direction ciently large to receive a delivery end of a medical irqplethat will not facilitate fluid flow. These manipulations ment which .transfers fluid through the delivery end. In most applications, the delivery end of the implement is tapered, increase handling, thereby increasing both the risk of contamination and the amount of time required to establish the and the wall structure adjacent the opening is tapered inward fluid connection. 60 so that the wall structure and the tapered delivery end fit Metal needles employed as part of connector devices snug against each other upon insertion of the delivery end increase the risk of puncture wounds to the user. The needles into the opening. The proximal end of the cavity preferably used in these devices often have through-holes placed at the is adapted to fit snug with an ANSI (American National tip of the needle. Connection of the valve with a flow line Standards Institute, Washington, D. C.) standard end of the involves piercing the needle through a sealed septum. 65 medical implement. vpically, the implement is a syringe, a Through-holes placed at the needle tip can core the septum connector or inletfoutlet of an I set. or any one of a wide V andrelease free particulates into the flow line. Such an event variety of conduits used in medical applications.

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4
The second feature is that the spike has a tip with at least cent the proximal end of the cavity. The proximal end of the one hole located at or near the tip, and a passageway in seal may be precut to form a tiny orifice therein that allows communication with the hole that allows fluid to flow the tip of the spike to pass therethrough easily upon comthrough this hole. The spike is seated inside the cavity such pression of the seal. Preferably, the proximal end of the seal that the tip is inward of the proximal end and is enclosed 5 has a truncated conical shaped segment disposed within the cavity. The seal may also have a centrally located, antiwithin the cavity. Preferably, the hole is in a side of the spike vacuum, saucer like depression therein, which does not adjacent the tip and is elongated, having a size of 18 gauge interferewith the ability of the exposed, proximal end of the or greater. The tip may be sharp or slightly rounded. More seal being swabbed when desired. than one hole is desirable for many applications, and three, The fourth feature is that the body and spike are two symmetrically located holes inward of the proximal end are lo separate components of the valve that are securely attached preferred. The spike may include at least one rib which to each other by assembly of, and interlocking, of the body allows a r to enter a space between the seal and the spike, i and spike. The body has a first locking element near the thereby facilitating the sealing of the opening when the distal end of the cavity, and the spike has a second locking implement is removed. The spike may have a substantially conical shape, and the seal has a complementarily, substan- 15 element adapted to interlock with said first locking element tialIy conical shaped cavity within it conforming to the upon assembly. The seal has a lip extending beyond the shape of the spike. The spike is disposed within this conical distal end and positioned between the first and second cavity and the seal covers the tip. The tip may be imbedded locking elements so that, upon assembly, the lip is comin the proximal end of the seal or withdrawn into the conical pressed between the locking elements to provide an essencavity. Preferably, the tip of the spike has aplurality of facets 20 tially fluid tight seal upon interlocking. it which meet within a recess. The preferred spike should be The f f h feature is that the medical valve includes a able to penetrate the seal repeatedly without tearing the seal. support member connected to the spike which seals off the Rough edges at the tip may present a tear problem. During distal end of the cavity. The support member may have a injection molding of the preferred plastic spike, facets of the Luer-Lock type connector element that enables the valve to tip will abut along a "parting line," and could form a rough 25 be removably attached to, for example. a fluid line conedge which may tear the seal. This problem is avoided where nected to a patient. The support member may also be in the the parting line is buried in a recess. Any rough edge at this form of an adaptor that enables the valve to be removably parting line is disposed within a recess, so the seal material attached to a fluid dispenser or container. When used to moves over the recess and does not contact the rough edge. dispense fluids from a container, the spike has a pair of The third feature is that the resilient seal is adapted to be 30 opposed tips, respectively at the distal and proximal ends of moved into a compressed state upon insertion of the tip of the spike. The tip at the distal end of the spike pierces a cover the medical implement into the opening and returns to a member which seals the container. A radial slit on the decompressed state upon removal of the tip. The seal in the adaptor enables it to deform reversibly sufficiently to fit decompressed state has a section which fills essentially snugly onto said container. completely aportion of the cavity adjacent the opening. The 35 The sixth feature is that the seal has a proximal end seal section bears against the wall structure near the opening including a pressure responsive element disposed on an to seal the opening. In the compressed state, the seal section inner surface of the seal adjacent the opening. The pressure is pushed by the delivery end of the medical implement responsive element in the decompressed state closes any away from the opening and into the cavity. Afluid tight seal orifice in the seal at the proximal end of the seal to provide is maintained between the seal section and the wall structure 40 an essentially fluid-tight seal while in the decompressed as the seal is moved into the compressed state. The seal state. The pressure responsive element enables the valve to section bears against the wall structure as the seal is moved maintain a fluid-tight seal even at very high pressures inward into the cavity by the tip of the medical implement. sometimes experienced in medical applications,particularly And most importantly, the delivery end and the seal are when the valve is connected to a patient's artery. The valve adapted to engage so that when the tip of the spike pierces 45 of this invention will remain closed even when the pressure the seal there is essentially no dead space between said inside the valve is above 6 pounds per square inch (psi), and delivery end and the seal. Consequently, a predetermined it can withstand pressures above 30 psi. Typically, the dosage amount of medication is transferred in its entirety to pressure responsive element is a section of the seal having the patient using this invention, with none to the prescribed an entryway into a precut orifce. This section has a subamount being collected in dead space in the valve. The so stantially cylindrical configuration and is surrounded by an delivery of an exact amount of medication may be critical in annular space which is filled with pressurized fluid. The some situations when chemotherapeutic agents are being center of the member and the annular space are coaxial with administered or small children are being treated. the entryway to the orifice. The pressurized fluid fills the Afluid tight seal is maintained over repeated opening and annular space to apply pressure that compresses the cylinclosing of the valve, and the seal has on its external surface 55 drical section to tightly close the entryway to the orifice. Preferably, the pressure responsive element has an anti-tear a recess which provides an air pocket to facilitate the element. movement of the seal. Preferably, the seal presents an In accordance with this invention, a known, prescribed, essentially flush surface with the proximal end of the cavity. In one embodiment, the proximal end of the seal is substanpredetermined amount or dosage of medication may be tially flat, the seal is made of a material having a hardness 60 transferred from the remote source to the patient directly, so of from 30 to 70 Shore units such as, for example, a silicone that essentially none of said predetermined amount is colpolymer. The seal may include a cup-like flange adapted to lected in dead space in the valve. In other words essentially all the prescribed dosage is receive by the patient and not engage the body near the proximal end of the cavity. A lost in the valve. Thus, this invention also includes a method preferred embodiment of the seal comprises a series of O-ring elements stacked together and connected to form a 65 of transferring fluid from a remote source to a patient. This invention also includes transfer of fluid from the patient to unitary structure. The O-ring elements have increasing a remote source. This is possible because the valve of this diameters, with the smallest diameter element being adja-

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FIG. 17 is a longitudinal cross-sectional view, after invention provides two-way communication. The fluid is assembly, of the eighth embodiment of the valve of this transferred to the patient by applying pressure the fluid as it invention. passes through the implement so that the pressure applied to the fluid is greater than the pressure of fluid in the patient, FIG. 18 is a longitudinal cross-sectional view, after enabling transfer from the remote source to the patient. TO 5 assembly. of the ninth embodiment of the valve of this achieve transfer of fluid from the patient to the remote invention. source, the pressure of fluid in the patient is greater than the HG. 19is a side elevationview, after assembly, of the seal pressure at the remote source, causing fluid to flow from the and spike shown in FIG. 14 connected to the body or patient to the remote source. This invention also includes a housing shown in FIGS. 20 and 21. method of transferring fluid in a container having an open 10 mG. 20 is a cross-sectional view taken along line 20-20 mouth covered by a cover member which seals the open of FIG. 19. mouth. The fluid is caused to flow from the container FIG. 21 is a perspective view, with sections broken away through the passageway by creating a differential in prescontaining the seal to show the wall structure of the sure. Preferably, the valve has an adaptor having a radial slit shown in FIGS. 1 3 and 14. for allowing the adaptor to deform reversibly sufficiently to 15 FIG. 22 is a greatly enlarged, cross-sectional view taken fit snugly onto said container. along line 2 - 2 22 of FIG. 14. BRIEF D E S C m O N OF THE DRAWING DERAILED DESCRIFTION OF THE The preferred embodiments of this invention, illustrating PREFERRED EMBODIMENTS all its features, will now be discussed in detail. These 20 embodiments depict the novel and non-obvious method and The term ''proximal" is used to denote the end of the valve and other components at or near the spike tip 32 in FIGS. 2 valve of this invention shown in the accoqnnying &awing, which is for illustrative purposes ody. This &awing through 5.10 through 12.14, and 16, and at or near the spike includes the following ~ iwith like ~ ~ infiat~ ~tip 60 in FIG. 6, and at or near the seal cap 92 in FIGS. 8, , 25 9, 13 through 19. The t r "distal" is used to denote the em ing like parts: opposite end of the valve, or spike tip, or seal. The term of the FIG. is a perspective view of the first "medical implement" is used to denote any medical tool valve of this invention. known to those of skill in the art that can connect to the EIG. 2is an ex~loded~ers~edive of view shown present invention facilitate the passage of fluids, parin FIG. 1illustrating the spike, seal, and the body or housing 30 titularly liquids, through the instant invention. Examples of components of the invention. medical implements that are contemplated include, but are FIG. 3 is a longitudinal cross-sectional view of the not limited to, tubing, conduit, syringes, IV sets (both assembled valve of FIG. 1. peripheral and central lines), piggyback lines, and other FIG. 4 is a schematic, longitudinal. cross-sectional view components which can be usedin connection with a medical of the assembled valve of FIG. 1before compressing the 35 valve. Medical implements are commercially available in seal. standard sizes. Thus, either or both ends of the valve of this invention can be provided with fittings to accommodate such FIG. 5 is a schematic, longitudinal, cross-sectional view standard size medical implements. similar to FIG. 4 showing the valve during compression of the seal. As best shown in FIGS. 1and 2, the first embodiment of FIG. 6 is a perspective view of a second embodiment of 40 the invention, valve 10, includes a valve body or housing 12, a spike element 24, and a seal 36. The seal 36 is prepared the invention. from a resilient material that is flexible, inert, impermeable FIG. 7 is a longitudinal cross-sectionalview of the valve to fluid, and readily pierceable by the spike 26. In the of FIG. 6. embodiment shown in FIG. 13 depicting an alternate shaped F I ~8.is a illustration of an ANSI delivery end the seal of the valve of 45 seal 36d, this seal 36d has a precut slit 1 in its ~roximal 1 end. of a implement This provides a tiny orifice through which the tip 32 of the this invention. spike element 2 may easily Pass, Yet still provides a fluid 4 incross-section. FIG. 9 is a side elevation view, tight seal upon withdrawal of the spike element. These three of a third embodiment of the seal. components are assembled. as depicted in HG. 3, with the m' l0 is a of FIG. 1using the seal of FIG. 9. of the 50 spike element 24 enclosed to prevent accidental sticks. FIG. longitudinal cross-sectiona1 view assembled valve 2 illustrates how the housing 12, seal 36, and spike element FIG. l1 is a lonadinal cross-sectional view of the 24 are attached without the need to use any adhesive or other assembled valve of FIG. 1using a fourth embodiment of the bonding agent or process. Mechanical which seal. provides a fluid tight closure is attained as is discussed FIG. l2 is a longitudinal cross-sectional view of the 55 subsequently. As shown in FIGS. 4 and 5, the seal 36 moves valve FIG. using a fifth embodiment the within the housing 12, being pierced by the spike element 24 seal. to expose the tip 32 of the spike element 24 to allow fluid to FIG. 13 is a longitudinal cross-sectional view of a sixth flow through the valve 10. embodiment of the seal. Referring to FIG. 1, one preferred embodiment of housing FIG. 14 is a longitudinal section of the seal shown in FIG. 60 12 has a bell-shaped 16 and an uppa; preferably 13used in connection with the spike device shown in F G I. cylindrical, conduit 20. m e skirt 16 is integral with, and 2. connected by an annular ring 14, to the upper conduit 20. FIG. 15 is a longitudinal partial cross-sectional view of a The skirt 16 creates a shield for an inner conduit 18 of the seventh embodiment of the seal of this invention. spike element 24. This inner conduit 18 is preferably cylinFIG. 16 is a longitudinal cross-sectional view, after 65 drical in shape, and slightly tapered. Inner conduit 18 and upper conduit 20 comprise aligned hollow tubes so that assembly, of the embodiment of the valve shown utilizing inner conduit 18 and upper conduit 20 are in fluid commuthe seal of FIG. 15.

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nication 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 FIG. 2). In the first embodiment, the upper conduit 20 is adapted syringe 46 to receive tip or nose 48 of an ANSI the (see FIGS. 4 and 5). It is, however. contemplated that the Outer diameter of the upper conduit 20 can be of any size to accommodate the attachment of other connector devices thereto' the end of the conduit 20 can be equipped with a locking mechanism to facilitate locking of the valve 10 to a variety of connector devices. For example, referring to FIG. 1, locking ears 22 near the proximal lip 25 of housing 12 are preferably provided such that the housing 12 be locked into any compatible Luer-Lock device known to those with skill in the art. For example, referring to FIG. 19, conventional Luer-Lock threads 180 can be provided on the outer dimeter of upper conduit 20. Referring to FIG. 2. the 'pike 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 IS and 'pike 26 present a continuous passageway for fluid during use. An annular cuff 28 on an intermediate portion Of the 'pike is and interconnects, the inner conduit 18 and the spike 26. As illustrated in FIG. 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 cuff 28 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 h~llow spike 26 has a tapered conical shape. ending in a sharp, pointed tip 32. Preferably. along the length of the spike are raised, protruding ridges 30. These raised ridges 30 extend from the surface of the spike preferably between 0-2-2-0 mm. The ridges 30 are preferably aligned along the length of the spike as illustrated in FIG. 2. These ridges 30 serve 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 pennit fluid communication between the inner conduit 18 upper 20there are three through34 within about 0.200 inch from the spike tip 32These 34 be any sizethe larger the size of the through-holes the greater the fluid flow rate through the valve l o . In a pefenred 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 (FIG. 3). Thus. the seal 36 slips easily over the spike element 24 to fit snugly within the cavity 37. The seal lip 42 is seated within the annular cuff 28 and wedged between the cuff and the underside of the ring 14. There are longitudinal grooves 43 (FIG. 2) along the length of the seal 36 which provide air pockets that facilitate compression of the seal 36 during use. The grooves 43 may be of variable shape or size to facilitate seal compression. 1 . the first embodiment. there is a single groove 43 which completely su~ounds seal 36 between the seal cap 40 and the lip 42. the 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

8
or cavity 37 (FIG. 3 ) of the seal 36 is preferably tapered to conforminternally 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 5 the upper conduit 20 of the housing 12. The cap 40 reseals the valve 10 when the top surface 40b is above the throughholes 34. Preferably, the cap 40 substantially fills the opening 2sa in the top of the conduit 20. Thus, after assembly, the top surface 406 of the seal cap 40 is essentially flush with the lip 25, so that the lip 25 and seal cap 40 can be swabbed with alcohol or other disinfectant without leakage of disinfectant into fhe valve It is important that the surface 40b be exposed so that it may be swabbed with a disinfectant. As best shown in FIG. 3, the 'pike with contiguous 15 inner conduit 18, is & x e d to the housing 12 through the association of the external potion of annular cuff 28 and the internal portion of ring 14. not required, these two pieces may be affixed by any one of a variety of methods known to those of skill in the art 2o including, but not limited to, heat sealing, glue, pressure lock, bonding or the like. The seal 36 fits into the annular 28 and is held in place by an lip 27 along the internal podon of the annular ring 14 of the housing 12. The length of the spike is such that, after assembly, the tip of 25 the spike rests below the plane defined by the lip 25 of the housing 12. Preferably, the spike tip 32 is approximately from 0.525" to 0.111below the lip25 of the housing 12. The seal 36 fits snugly against the spike 24 and is essentially flush with the lip 25 of the housing 12. The spike tip 32 is 30 thus embedded within the seal cap 40 prior to use or may be

35

40

45

50

55

60

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0.025M distal the seal cap 40 when the valve is in the closed position^ The inner conduit 18 is partially shielded by the bell shaped skht 16 of the housing 12 (see FIGS. 1-3). The inner surface of the bell shaped shirt 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 invention is designed to be adapted as a two-way valve. ne orientation of the valve in independent to fluid flow and dependent on the orientation of the preexisting connections. hthe invention can be used ~ ~ ~ , a valve connector for an intravenous central or peripheral piggyback either orientation. parentad 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 added me invention disclosed herein is designed to interconnect medical implements along the route of fluid delivery to the patient. However, the invention is also useful in any environment in which a resealable fluid valve is desired. During use, a connector of the appropriate size is fitted over the inner conduit 18. Locking can be achieved by a Luer-Lock mechanism, a pressure fit or any other locldng mechanisms known to those with skill in the art, as described above. Thus, in one example. fluid passes fromthe inner conduit 18 into the spike 26. However, fluid flow is locked in place by the seal 36. FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the medical implement connecting to the proend of the valve 10 is a syringe 46. However, this connecting implement could be any n-ber of medical mlements hewn to those of skill in the art. The nose 48 of the syringe 46 is placed on the seal cap 40 inside the lip 25 of the housing 12. The application of pressure on the syringe 46 in the direction of the arrows, as illustrated in FIG. 4 createspressure on seal

,,

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cap 40. The resulting downward pressure compresses the and sealable, fluid lines can be added and removed without disconnecting venous contact. seal 36. This pushes the tip 32 of the spike 26 through the seal cap 40 to expose the through-holes 34. Compression is The valve 10 is preferably prepared from a hard plastic, facilitated by the grooves 38. Fluid is now able to flow into but it is additionally contemplated that the valve could be the syringe 46, or vice versa, depending on whether fluid is 5 prepared from other medically inert materials known to to be withdrawn from the patient or medication injected into those in the art. The spike element 24 is preferably prepared the patient. FIG. 5 shows valve 10 opened by insertion of the from the same m a t e d as the housing 12. One particular nose 48 of the syringe 46 into the opening 2 5 ~A syringe . advantage of this invention is that it does not rely on the use plunger 49 in the syringe 46 is retracted thereby creating a of metal needles. This dramatically reduces the risk of skin Vt~cuum draw fluid through the valve 10 into the syringe. 10 puncture during use and manufacture. Further, the upper to For intravenous applications, the valve 10 can be orientated conduit 20 serves as a shield to the spike 26 such that skin in the position diagramed in FIGS. 4 and 5, or it can be puncture is further reduced. The spike 26 need only be rotated 180' such that fluid flows in the opposite direction. strong enough to penetrate the seal cap 40, or if necessary, Upon removal of the syringe from spike 26, as shown in to pierce a connecting septum. FIG. 4, the seal 36 is free to return to its original shape and 15 In the embodiment of the invention flustrated in FIGS. cover through-holes 34. The ability of the seal 36 to return 2-4,the through-holes 34 are placed distal spike tip 32. This to its original shape is determined by the resiliency of the placement provides two important advantages. First. the material used to Prepare the seal 36. In addition. the ability placement of the through-holes 34 facilitates resealing of the of the seal 36 to return to its original shape is facilitated by valve 10 after use. Second, if the through-holes were placed the promding ridges 30 formed on the external surface of 20 at the spike tip 32, the holes 34 may core the seal cap 40 the spike. D ~ com~ression, vacuum may form in the g a thereby introducing seal particulate into the fluid flow and area between the spike 26 and the seal 36, thereby preventpossibly plugging the holes 34. Thus, the longitudinal placeing the seal 36 from returning to its original position. The ment of the through-holes distal spike tip 32 prevents the protruding ridges pennit air to Pass along the spikdseal introduction of particulates into the fluid path andfor pluginterface to Prevent vacuum fomtion and allow free return 25 ging of the through-holes 34. It is additionally contemplated of the seal. The ability of the seal 36 to deform reversibly that the number and diameter of the though-holes 34 can be and return to its original position is particularly useful adjusted to accommodate different fluid velocities. In a because (1) it immediately stops fluid flow though the valve preferred embodiment, the preferred velocity of fluid pass10, (2) it covers the recessed spike 26 to maintain its st&% ing through the through-holes 34 is equal to or greater than and (3)it r~duces risk that the spike could inadvertently 30 the flow rate through an 18 gauge needle. Through-holes the larger than 18 gauge m,of course, facilitate greater fluid pierce another object or person. h addition, since the valve 10 lacks movable parts. except for the seal, it is unlikely that velocities. when the seal 36 is pushed down, the valve 10 would fail to A, advantage of the invention is that the valve function. 10 has very little dead space, thus the volume of liquid Advantageously, the through-holes 34 are located rela- 35 entering into the valve is substantially equivalent to the tively low on the spike 2 .Thus, the through-holes 34 are 6 volume of fluid leaving the valve. Further, the total equivasealed relatively early in the process as the seal 36 returns to lent fluid volume of the valve is very small such that the its original configuration with the valve 10 is closed. In one volume of fluid flowing through the system in order to place preferred anbodiment the thr~gh-holes34 are located the valve in fluid communication with a medical implement 0.075" below the spike tip 32 (see FIG. 2). Additionally, the 40 such as a syringe 46 is substantially zero. through-holes 34 are sealed even if the seal 36 does not fully ALTERNAIX EMBODIMENTS return to its original configuration depicted in FIG. 4. In another preferred embodiment of the invention, illusFurther, the ability of the seal 36 to return reversibly to its trated by FIGS. 6 and 7, a disposable sterile adaptor valve 50 originalposition permits the reuse of the connector valve 10. Following disconnection, and before reuse, the surface of 45 is provided to function as a resealable lid for a container(not pierced seal cap 40 is essentially flush with the housing 12. shown) of fluid.The fluid can thus be removed fromthe fluid Thus, this flush surface can, advantageously be sterilized container or permitted to flow from the container into a with alcohol or other surface decontaminating substances. medical implement adapted to house fluid in a sterile manThe skirt 16 and upper conduit 20 advantageously shield ner. AS is the conventional practice, an open mouth of the both connections from the surrounding environment to pro- 50 container will ordinarily be sealed with a cover member (not tect the stedity of the connection. Further, both the skirt 16 shown). F G 6 shows an adaptor valve 50 having a body including I. and upper conduit 20 function as collection reservoirs to prevent fluid from dripping from the valve 10 during an adaptor skirt 52. The adaptor skirt 52 will preferably fit snugly over the open mouth of the container. The skirt 52 manipulation. A cover cap (not shown) can be supplied to fit over the 55 may be of any size to accommodate a range of container sizes. A lengthwise slit 54 is preferably provided in at least upper conduit 20 as further protection for the seal surface between use. Such a cover cap, however, is not needed to one location along the length of the skirt to ensure a snug fit maintain s t m t y since the seal 36 may be swabbed with a between the skirt 52 and the container. A chamber 56, disinfectant after each use. The reversibility of the seal 36 preferably tubular in configuration,extends upward from the makes the valve 10 particularly attractive as a connector 60 skirt 52'and is similar in construction and design to the upper chamber 20 of the first preferred embodiment. Similar to the valve to provide fluid communication between two fluid lines. Therefore, the present invention provides for placing first embodiment, the proximal portion of the valve contains a locking mechanism 59 that preferably comprises a Luera first fluid line in communication with a second fluid line using the valve disclosed herein. The reversibility of the Lock device or other locking device known to those of skill valve 10 p d t s multiple fluid lines to be successively 65 in the art. added, for example, to a fluid line in direct communication As depicted in FIG. 7 a spike 58 extends upward through with a patient's vein. Since the valve is easily stailizable a tubular chamber 56. A spike tip 60 is preferably recessed

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proximal end thereof and a seal lip 96 at the distal end 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 thereof. A cuplike annular flange 95 is provided proximal essentially the same as seal 36. Protrudingridges 66 and seal seal cap 92. The seal cap 92 and seal lip 96 are connected by grooves 68 facilitate seal compression in the open position a seal wall consisting of a plurality of ringed wall portions and promote closure following use. Thus, in the closed 5 94 that expand and collapse in an accordion like fashion. position as illustrated in FIG. 7 , the seal 64 covers the ~~~i~~ compression seal 3ha, the diameter of the of the through-holes 70 to prevent fluid out-flow from the conringed portions expand 94 in the radial tailla: The valve 50 a second 'pike 72 tion. There are air pockets (FIG. 10) between ring which points in the opposite direction as spike 58. These 94 and the housing and air pockets 13b between spikes 52 and 72 are in fluid communication with each other. lo spike 24 and seal 36a. The seal 36a a cavity 98 The spike 72 extends downward inside the adapter skirt 52. distal seal cap 92 and adjacent the ringed wall portions 94. The two spikes preferably f m one component of the valve The seal 36a interacts with spike 26 (F'IG. 2) and other 50 while the skirt 52 and upper chamber form a second components of the present invention in a similar fashion to component. These two components can be assembled in a seal 36 of FIG. 2. manner like that of the valve 10. The spike 72.like the spike Refemng to FIG. 10, the cup-like annular flange 95 may 58, has longitudinal through-holes 74 and a tip 76. The '5 be stretched around the upper conduit 20 and held in place through-holes 74 are located inward of the tip 76. The adaptor valve 50 is thus useable with containers holding by an annular ring 97. This creates a trampoline like effect sterile medicament having a cover or septum seal at the open that assists returning the seal 36a to a decompressed state mouth of the container. Examples of containers with such after withdrawal of a syringe (not shown). This embodiment seals contemplated for use with this invention include d 0 ~ -20 has two advantages. First, the p r o w end of the valve 10 age bottles for intramuscularinjector antibiotic containers or can be swabbed with alcohol or other disinfectant without the l k .However, it is also contemplated that the valve 50 ie leakage ofdisinfectant into the valve 10. second, by mg can be adapted with its own seal and locking mechanism to cuplike annular flange 95 to upper conduit 20 at the containers permit the valve to be On a proximal end thereof with annular ring 97. the repeated for medicaments or other fluids. Medicaments in these types 25 deformation and reformation of the seal is assisted. of containers are preferably maintained under sterile condiAn alternative embodiment of the seal, a seal 36b is tions and the volume and nature of the medicament is such that multiple aliquots are intennittenfly over +.he. shown in connection with the valve 10 in FIG. 11. S The seal 36b is similar to the seal 36a and is comprised of seal cap ~f the medicament is reconstituted, then, during use, any and a covering over the opening on the container is removed to 30 92) a side wall consisting ringed wall portions seal lip %. It also has an outwardly extending ring 99 which reveal the rubber septum. The adaptor valve 50 is placed is at a right angle with respect to the longitudinal axis of the overthe septum and directpressure is applied to pierce distal valve 10. This ring 99 is used to attach the seal 36b to upper spike 72 through the septum and into the container. A conduit 20. Preferably, an upper conduit annular plug 20' is syringe the like can then be applied. as depicted in FIG. or inserted within upper conduit 20 to create a tight fit between 4, in assoc.ation with the first preferred embodiment, to withdraw fluid from the container. The pressure of the nose 35 pe~endicular ring 99, a ledge 101 in the upper conduit 2048 over the spike 58 pushes spike tip 60 through seal 64. and the plug 20'. The ring 99 assists in the reformation of 26 up0n withdrawal of a seal 36b to the same time, seal 64 is pushed back and compresses. (not shown)Compression is accommodated by seal grooves 68. Fluid is As shown in FIG. 12. the cup-like annular flange 95 and withdrawn from the container and the syringe is removed 40 ring 99 may both be used in connection with the valve 10, from the spike 58. Release of the pressure applied to seal 64 to provide the seal 36c. This seal 36c, provides rapid pennits the seal to return to its oridnal configuration. The refonnation upon withdrawal of a syringe (not shown) and spike ridges 66 facilitate seal reversibility. realizes the advantages of both the seals 3 6 ~ 36b. and Often the ingredients housed in containers are those that Another alternative embodiment of the seal, a seal 36d. is can be lyophilized at purchase. Lyophilized ingredients 45 shown in FIG. 13. In this embodiment, the seal 36d is require reconstitution before use. If the medicament requires comprised of seal cap 92, seal lip 96, and a side wall 150 reconstitution before use. then sterile water. saline, or other comprised of circular tires 100 stacked in series one on top fluid can be introduced into the container before fluid is of an adjacent larger diameter lower tire. The circular tires extracted. The two-way nature of the valve permits this 100 are preferably solid throughout the diameter of the without any special adaptation. After the syringe is removed, =jO the adaptor valve 50 automatically seals. Subsequently. cross-section thereof. These circular tires 100 will deform aliquots can be removed fromthe container by syringe or the and reform upon, respectively, compression and decompreslike. Alcohol or other compatible surface sterilizing agent sion of the seal 36d, thereby exposing or covering a spike (not shown) as the case may be. can be used to wipe the lip 62 and seal 64 before each use. Similar to the first embodiment, it is additionally contem- 55 As mentioned above. preferably seal 36d has a precut slit plated that a cap can be provided to fit over upper chamber 11 in the cap 92 lying along the longitudinal axis of the valve lip 62 between use. 10. The seal cap 92 has a unique configuration that insures The adaptor valve 50 can be adapted to function as a that the slit 11 closes and is sealed upon withdrawal of a syringe (not shown) and reformation of the seal 36d. It medicament adaptor for an intravenous container. In this case, the adaptor valve 50 is placed on a medicament 60 includes an enlarged, internal, pressure responsive member 200 which is integral with the cap 92. Between the proximal container for intravenous delivery and attached via tubing to an intravenous feed. Thus. the adaptor valve 50 can be 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 placed in fluid communication with a connector valve of F [ .1 to facilitate the flow of medicament fromintravenous lC fluid is under pressure, for example at the blood pressure of drip bottles. 65 the patient to which the valve 10 is attached. Referring to FIG. 14, fluid, for example the patient's blood, flows An alternative embodiment of the seal, a seal 36a. is through the holes 34 in the spike 26,filling the cavity 102. shown in FIG. 9. Seal 36a comprises a seal cap 92 at the

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Other components of the present invention interact with This fluid presses against the exterior of the member 200, 1 the various embodiments of the seal in a similar fashion to closing the slit 1 when the seal is decompressed as shown in FIGS. 14 and 19. The pressure from this fluid creates a their interaction with seal 36 of FIG. 2. Prior to use of valve high Pressure seal which Prevents fluid from escaping valve 10, it is preferable that the seal caps 40 or 92 be pierced 10 through the slit 11.There is a semi-c~findricalanntar 5 centrally by a steel needle in the axial direction, precutting flange tear ring 104 on the end of the member 200 which the seal to provide the slit 1 in order to allow for more rapid 1 advantageously extends the useful life of seal 36d. decompression and reformation of the seal upon piercing by Preferably* there is a tear ring lo4 integral with the the spike 26. The seals are advantageously formed from a member m0 the perimeter of the internal surface the material which can repeatedly reseal and prevent fluid from member 200, and a slight saucer-like &pression 204 in the lo flowingaround the seal material. The seal 36 should also be external surface of the seal. The pressure responsive element capable of being forced down and then spring back into in the d e c o ~ e s s e d state any orifice in the seal 36d position to reseal the valve. Material that is too soft will to provide an essentially fluid-tight seal while in the decomreseal eEectively; however, will not be capable of springing pressed state. The pressure responsive member 200 enables back after opening of the valve. Material that is too hard will the valve to maintain a fluid-tight seal even at very high 15 provide sufEcient spring force; however, will not effectively pressures sometimes experienced in medical seal. Thus, in a prefaed embodiment, the seal is when the valve 10 is c o ~ e c t e d a patient's to from a silicone having a hardness in the range from 30-70 artery. The center of the member 200 and the annular space Shore durometer units, and more preferably in the range with the entryway I l a to the orifice 1 .The 1 102 are 40-50 Shore ciurometer units. A cure silicone polymer in the pressurized fluid fills the annular space 102to apply pressure that compresses the member 200 to tightly close the entry- 20 preferred hardness range is available from Wacker Silicone COT. of Adrian, Mich. In some embodiments of the way to the orifice. In a preferred embodiment the distance from the entryway l l a to the proximal end of seal cap 92 is invention, it is desirable to provide additional lubricity to the from 0.500 to 0.075 inches and more preferably approxiseal 36 to allow it to spring back and reseal more effectively. mately 0.100 inch. Dow Chemical Co. produces a silicone formulation with As best illustrated in FIG. 22, the tip 32 is designed to 25 silicone oil built in to provide this additional lubricity. avoid tearing the seal. Tip 32 has three facets 210,212. and I general, the closing of the valve 10 is provided not by , 214 which are joined with each other along parting lines a. the ,ide wall of the seal 36 which immediately covers the b, and c- This junction of the facets 210. 212, and 214 through-holes 34, but by the seal cap 40, or seal cap 92 frequently is ragged and will tear the seal 36d. This is the prom end of the cavity 98 and the opening 25a. prevented by the parting lines a- b- and c, orjunctions, 30 Thus, the sealcaps 40 and 92 are &iciently thick to reseal disposed within recesses 220,222, and 224. respectively, to aftervalve closure. However, the the opening 25a provide "buried parting lines." seal caps 40 and 92 should also be sufficiently thin to allow Another alternative embodiment of the present invention them to readily return to the closed position. Preferably the using the seal 36d is shown in HG. 8 and FIGS- though l9 thickness of the caps 40 and 92 ranges between 0.075 and 2 . In this embodiment*the inner wall 1 of the upper end 35 0.500 inch and more preferably may be approximately 0.100 of the conduit 20 is provided with at least one, and inch. preferably, a plurality of radial indentations 107. The indenThe valve disclosed in this invention can be provided in tations 107 are elongated disposed generally parallel to the a and disposable form such that afterits use in a given longitudinal axis if the valve 10 in a symmetrical, star-like installation is exhausted, the device is discarded. configuration. Each indentation has opposed lateral edges 40 as described above, in any given installation, the device can 162 which seal36d of the seal be reused multiple times. Since the device does not 36d.The indentations provide space into which the seal 36d needles, there is little chance that the device will inadvertexpands upon compression. ently cause skin puncture. Therefore, the extra precautions ASbest shown in FIG. 8, the wall 181of the proximal end required for handling and disposing of needles is obviated of the conduit 20 is tapered inward at the same angle as the 45 It wiU be apprnent the detailed &scsiPtion provided the syringe 46. In accordance with nose 48 herein that the present invention can provide for the elimistandards, the taper is 0.006 inch Per linear inch. The wall nation of nearly all needles usedin the medical environment. as the nose 48 bears against the lS2 the of With the use of the valve of the present invention, the need nose sfides into the opening 25a to push the seal 36d inward for all needles except those that are directly input into a compressing it and forcing the tip 32 of the spike 36 to enter 50 patient is, advantageously. the slit 1 .The seal 36d expands upon compression to fill 1 OPERAITON essentially completely the upper p o ~ o n of the indentations s 107. Some sections of the seal 36d are wedged between the The valve 10 is used to provide a closed, patient access edges 162 and other sections fill the indentations 107.As the system for transfenring a predetermined amount of medicaliquid flows k o u g h the nose 48 through holes 34, air in the 55 tion from a remote source to the patient. The valve 10 is connected by the distal end to the patient, for example, a nose 48 is forced out of the nose 48 and expelled from valve 10 between walls 181 and 182. Thus, essentially the entire vein or artery in fluid communication with the valve. Blood fills the valve, but the seal 364 for example, prevents any prescribed dosage is delivered through valve 10 to the blood from leaking from the valve. The delivery end or nose patient. Fluid flows through the through-holes 34, but does not leak between either the seal 36d and the wall 181 or 60 48 of the medical implement is inserted into the valve as between the abutting walls 181 and 182. depicted in FIG. 8, pushing the nose 48 against the seal to compress the seal suf6cientlyto allow the tip 32 of the spike FIGS. 15, 16, 17, and 18 depict embodiments of seals, 24 to pierce the seal and enter said delivery end The namely, seal 36e, seal365 and seal36g, which are substantially the same as the seals 36a (FIG. lo), seal 36b (FIG. 1 ) 1 , predetermined amount of medication in its entirety may now and seal 36c (FIG. 12), except the side wall 150 employing 65 be transferred through the nose 48 into the valve 10 and into the circular tires 100 is used in place of the accordion wall the patient. Since the nose 48 and seal 36d engage in a manner so that the tip 32 of the spike element 24, upon poxtion 94.

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piercing the seal, meets the seal to avoid formation of any 5. The medical valve of claim 1, wherein said seal is precut to fonn a tiny orifice therein, allowing the tip of said dead space at the interface between nose 48 and the seal spike to pass through said seal easily upon compression of surface 40b. Transfer directly through the valve 10 of said seal in the distal &..ection. essentially the entire predetermined amount of medication 6. The medical valve of claim 1, wherein said seal from the syringe 46 to the patient, so that essentially none of 5 c~m@sesa silicone polymer. saidpredetennined amount is collected in any dead space in 7. The medical valve of claim 1, wherein said medical the valve, is accomplished with this invention. Upon withvalve further comprises a support number enabling said drawing the nose 48 from the valve 10 the seal 36d returns valve to be removably attached to a fluid dispenserto the decompressed state to close the valve and maintain while in said decompressed state a fluid tight seal even at 10 8- The n~edicalvalve of claim 1, whuein said body contains at least one radical indentation. high pressures and after repeated uses. 9. A medical valve comprising: O a bodv including wall structure defining an internal cavitv SCOPE OF THE - N ha$ng a end and a distal end, said proximz The above presents a description of the best mode conend having an opening sufliciently large to receive a 15 templated of carrying out the present invention, and of the delivery end of a medical implement which transfers manner and process of making and using it, in such full, fluid through said delivery end, said body having a clear. concise, and exact terms as to enable any person plurality of radial indentations in an interior wall skilled in the art to which it pertains to make and use this thereof; invention. This invention is, however, susceptible to modi20 a spike having a tip, at least one hole located at or near fications and alternate constructions from that discussed said tip, and a passageway in communication with the above which are fully equivalent. Consequently, it is not the hole that allows fluid to flow through said hole, said intention to limit this invention to the particular embodi. spike being seated within the cavity such that said tip ments disclosed. On the contrary, the intention is to cover all is enclosed within the cavity; and modifications and alternate constructions coming within the 25 a resilient seal which is adapted to be moved distally in spirit and scope of the invention as generally expressed by the cavity into a compressed state upon insertion of the the following claims, which particularly point out and disdelivery end of the medical implement into said tinctly claim the subject matter of the invention. opening, said seal moving proximally in the cavity and I claim: returning to a decompressed state upon removal of said 1 A medical valve comprising: . 30 delivery end from said opening, said seal in the decoma body including wall structure defining an internal cavity pressed state having a section which fills essentially having a proximal end and a distal end, said proximal completely a portion of the cavity adjacent said end having an opening sufficiently large to receive a opening. said seal section bearing against said wall delivery end of a medical implement which transfers structure near said opening to seal said opening, and in fluid through said delivery end; 35 the compressed state said seal section being located in a spike having a tip, at least one hole located at or near the cavity distal of said opening. said tip, and a passageway in communication with the 10. The medical valve of claim 9, wherein said seal hole that allows fluid to flow through said hole, said expands into said radial indentations upon distal compresspike being seated within the cavity such that said tip sion of said seal. is enclosed within the cavity; and 40 11. The medical valve of claim 9, wherein said seal a resilient seal which is adapted to be moved distally in comprises a series of O-ring elements stacked together and connected to form a unitary structure. the cavity into a compressed state upon insertion of the delivery end of the medical implement into said 12.The medical valve of claim 9, wherein said seal has a wall defined by a number of ringed wall sections which opening. said seal moving proximally in the cavity and returning to a decompressed state upon removal of said 45 collapse and expand in accordion-like fashion. delivery end from said opening, said seal in the decom13. The medical valve of claim 9, wherein said seal is pressed state having a section which fiUs essentially precut to form a tiny orifice therein, allowing the tip of said completely a portion of the cavity adjacent said spike to pass through said seal easily upon compression of said seal in the distal direction. opening. said seal section bearing against said wall structure near said opening to seal said opening. and in 50 14. The medical valve of claim 9, wherein said seal the compressed state said seal section being located in comprises a silicone polymer. the cavity distal of said opening. said seal comprising 15. The medical valve of claim 9, wherein said medical a series of O-ring elements stacked together and convalve further comprises a support member enabling said nected to fonn a unitary structure. valve to be removably attached to a fluid dispenser. 2. The medical valve of claim 1. wherein said O-ring 55 16.The medical valve of claim 9, wherein said seal in the decompressed state has a proximal end substantially flush elements have increasing diameters in the distal direction. 3. The medical valve of claim.1, wherein said seal in the with the proximal end of said cavity of said body. 17.The medical valve of claim 16,wherein said proximal decompressed state has a proximal end substantially flush end of said seal is substantially flat. with the proximal end of said cavity of said body. 4. The medical valve of claim 3,wherein sa