U.S. patent application number 10/640098 was filed with the patent office on 2004-02-19 for medical valve with fluid escape space.
Invention is credited to Lopez, George A..
Application Number | 20040034325 10/640098 |
Document ID | / |
Family ID | 24289976 |
Filed Date | 2004-02-19 |
United States Patent
Application |
20040034325 |
Kind Code |
A1 |
Lopez, George A. |
February 19, 2004 |
Medical valve with fluid escape space
Abstract
A medical valve has a body and a flexible element. The body
includes a wall structure defining an internal cavity having an
inside and an outside. The body also has a proximal end and a
distal end. The proximal end has an opening sufficiently large to
receive a tip of a delivery end of a medical implement which
transfers fluid through the delivery end. The body has a fluid
escape space in its wall structure. The flexible element is adapted
to be moved into a compressed state upon insertion of the tip of
the medical implement into the opening. The flexible element is
sufficiently resilient to return to a decompressed state upon
removal of the tip of the medical implement from the opening. The
fluid escape space is in fluid communication with the outside of
the cavity when the seal is in its compressed state.
Inventors: |
Lopez, George A.; (Laguna
Beach, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
24289976 |
Appl. No.: |
10/640098 |
Filed: |
August 13, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10640098 |
Aug 13, 2003 |
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10004561 |
Dec 4, 2001 |
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6635044 |
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10004561 |
Dec 4, 2001 |
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09495559 |
Feb 1, 2000 |
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6325782 |
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09495559 |
Feb 1, 2000 |
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09055646 |
Apr 6, 1998 |
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6019748 |
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09055646 |
Apr 6, 1998 |
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08572934 |
Dec 15, 1995 |
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5738663 |
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Current U.S.
Class: |
604/249 ;
604/256 |
Current CPC
Class: |
A61M 2039/262 20130101;
A61M 2039/266 20130101; A61M 2039/1027 20130101; A61M 2039/267
20130101; A61M 39/10 20130101; A61M 39/26 20130101; A61J 2200/10
20130101; A61M 2039/1072 20130101 |
Class at
Publication: |
604/249 ;
604/256 |
International
Class: |
A61M 005/00 |
Claims
The following is claimed:
1. A medical valve for controlling the flow of fluid between a
first medical implement and a second medical implement, said valve
comprising: a body comprising an opening adapted to receive the
first medical implement, and a wall structure defining an internal
cavity adapted for fluid communication with the second medical
implement, said cavity comprising a neck portion in fluid
communication with said opening and a main portion with a larger
internal diameter than the neck portion; a flexible element
positioned in said cavity movable between an uncompressed position
in which a portion of the flexible element bears against the wall
structure near said opening and obstructs fluid flow through said
valve and a compressed position in which fluid flow is permitted
through said valve, said flexible element comprising a wall with an
inner surface and an outer surface, the wall flexing to accommodate
axial compression of said flexible element, said flexible element
comprising an end fitting against a ring-shaped support to assist
in securing said flexible element in said cavity, said flexible
element in said uncompressed position comprising a first external
diameter near said opening, a second external diameter in said neck
portion and a third external diameter in said main portion, said
second diameter being smaller than said first diameter and said
third diameter, and at least a portion of the outer surface of the
wall of the flexible element between the second diameter and the
third diameter being tapered; and a fluid escape space in the wall
structure of the body for relieving fluid from a space between the
flexible element and the body in the cavity.
2. The valve of claim 1, wherein the fluid escape space comprises
at least one groove.
3. The valve of claim 2, wherein the fluid escape space terminates
at an end of the body adapted to receive the first medical
implement.
4. The valve of claim 2, wherein the fluid escape space terminates
at a location on the outer surface of the body between an end
adapted to receive the first medical implement and an opposite end
adapted to receive the second medical implement.
5. The valve of claim 1, wherein an end of the flexible element
near the opening of the body in its uncompressed position is
substantially flat.
6. The valve of claim 1, wherein said flexible element in the
uncompressed position has an end substantially flush with the
opening of said cavity of said body.
7. The valve of claim 1, further comprising: a rigid member
positioned within the flexible element to assist in supporting the
flexible element and to assist in maintaining the flexible element
along an axial centerline of the cavity when the flexible element
moves between the uncompressed position and the compressed
position.
8. The valve of claim 1, wherein the flexible element substantially
completely fills the opening in its uncompressed position.
9. A medical valve for controlling the flow of fluid between a
first medical implement and a second medical implement, the valve
comprising: a body comprising an opening adapted to receive the
first medical implement, and a wall structure defining an internal
cavity adapted for fluid communication with the second medical
implement, the cavity comprising a neck portion in fluid
communication with the opening and a main portion with a larger
internal diameter than the neck portion; a flexible element
positioned in the cavity movable between an uncompressed position
in which a portion of the flexible element bears against the wall
structure near the opening and obstructs fluid flow through the
valve and a compressed position in which fluid flow is permitted
through the valve, the flexible element comprising a wall with an
inner surface and an outer surface, the wall flexing to accommodate
axial compression of the flexible element, the flexible element in
the uncompressed position comprising a first external diameter near
the opening, a second external diameter in the neck portion and a
third external diameter in the main portion, the second diameter
being smaller than the first diameter and the third diameter, and
at least a portion of the outer surface of the wall of the flexible
element between the second diameter and the third diameter being
tapered; and a fluid escape space in the wall structure of the body
for relieving fluid from a space between the flexible element and
the body in the cavity.
10. The valve of claim 9, wherein the fluid escape space comprises
at least one groove.
11. The valve of claim 9, wherein the fluid escape space terminates
at an end of the body adapted to receive the first medical
implement.
12. The valve of claim 9, wherein the fluid escape space terminates
at a location on the outer surface of the body between an end
adapted to receive the first medical implement and an opposite end
adapted to receive the second medical implement.
13. The valve of claim 9, wherein an end of the flexible element
near the opening of the body in its uncompressed position is
substantially flat.
14. The valve of claim 9, wherein the flexible element in the
uncompressed position has an end substantially flush with the
opening of the cavity of the body.
15. The valve of claim 9, further comprising: a rigid member
positioned within the flexible element to assist in supporting the
flexible element and to assist in maintaining the flexible element
along an axial centerline of the cavity when the flexible element
moves between the uncompressed position and the compressed
position.
16. The valve of claim 9, wherein the flexible element
substantially completely fills the opening in its uncompressed
position.
17. A medical valve for controlling the flow of fluid between a
first medical implement and a second medical implement, the valve
comprising: a body comprising an opening adapted to receive the
first medical implement, and a wall structure defining an internal
cavity adapted for fluid communication with the second medical
implement, the cavity comprising a neck portion in fluid
communication with the opening and a main portion with a larger
internal diameter than the neck portion; a flexible element
positioned in the cavity movable between an uncompressed position
in which a portion of the flexible element bears against the wall
structure near the opening and obstructs fluid flow through the
valve and a compressed position in which fluid flow is permitted
through the valve, the flexible element comprising a wall with an
inner surface and an outer surface, the wall flexing to accommodate
axial compression of the flexible element, the flexible element in
the uncompressed position comprising a first cross-section near the
opening having a first internal diameter and a first external
diameter, a second cross-section in the neck portion having a
second internal diameter and a second external diameter and a third
cross-section in the main portion having a third internal diameter
and a third external diameter, the second external diameter being
smaller than the first external diameter and the third external
diameter, and the third internal diameter being greater than the
second internal diameter and the second internal diameter being
greater than the first internal diameter; and a fluid escape space
in the wall structure of the body for relieving fluid from a space
between the flexible element and the body in the cavity.
18. The valve of claim 17, wherein the fluid escape space comprises
at least one groove.
19. The valve of claim 17, wherein the fluid escape space
terminates at an end of the body adapted to receive the first
medical implement. The valve of claim 17, wherein the fluid escape
space terminates at a location on the outer surface of the body
between an end adapted to receive the first medical implement and
an opposite end adapted to receive the second medical
implement.
20. The valve of claim 17, wherein the inner surface in the
uncompressed position has a taper between the first cross-section
and the second cross-section that is different than a taper between
the second cross-section and the third cross-section.
21. The valve of claim 17, wherein an end of the flexible element
near the opening of the body in its uncompressed position is
substantially flat.
22. The valve of claim 17, wherein the flexible element in the
uncompressed position has an end substantially flush with the
opening of the cavity of the body.
23. The valve of claim 17, wherein the flexible element
substantially completely fills the opening in its uncompressed
position.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 10/004,561, filed on Dec. 4, 2001, which was a continuation of
U.S. application Ser. No. 09/495,559, filed on Feb. 1, 2000, now
U.S. Pat. No. 6,325,782, which was a continuation of U.S.
application Ser. No. 09/055,646, filed on Apr. 6, 1998, now U.S.
Pat. No. 6,019,748, which was a continuation of U.S. application
Ser. No. 08/572,934, filed on Dec. 15, 1995, now U.S. Pat. No.
5,738,663.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a closed, patient access system
which automatically reseals after administering medication using a
standard medical implement that directly connects with the system
without the need of any intermediary needles, caps or adaptors. A
two-way valve eliminating dead space is used which includes a seal
which, upon being compressed by the medical implement, is pierced
to open the valve and reseals upon being decompressed, maintaining
a fluid tight seal even at high pressures and after repeated
uses.
[0004] 2. Backgound Discussion
[0005] 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.
[0006] Many connectors or valves, especially those employing
several mechanical components, have a relatively high volume of
fluid space within them. This "dead space" within the device
prevents the accurate introduction of precise fluid volumes and
provides an opportunity for contamination upon disconnection of the
device. Connectors and adaptors often include valves that permit or
interrupt the flow of fluid along the course of fluid travel.
Several of those commonly in use employ metal needles to puncture
sterile seals. Such connectors are generally designed to
accommodate fluid flow in one direction. This means that the fluid
line must have connectors and tube aligned in complementary
directions. These connectors often require further manipulation if,
for example, the valve is inadvertently assembled in a direction
that will not facilitate fluid flow. These manipulations increase
handling, thereby increasing both the risk of contamination and the
amount of time required to establish the fluid connection.
[0007] Metal needles employed as part of connector devices often
have through-holes placed at the tip of the needle. Connection of
the valve with a flow line involves piercing the needle through a
sealed septum. Through-holes placed at the needle tip can core the
septum and release free particulates into the flow line. Such an
event can prove fatal to a patient. Such through-holes may also
become clogged easily with material from the septum. Moreover, the
use of a needle with a sharp point may also cause deterioration of
the septum.
[0008] 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.
[0009] A closed, patient access system that is easy to use and
employs only a valve device in communication with the patient that
need not be capped or interconnected with the medical implement
through a needle or adaptor, is swabbable, is sufficiently durable
to maintain its function after several manipulations, and maintains
a fluid-tight seal at high pressures, would be of great benefit to
the medical community.
SUMMARY OF THE INVENTION
[0010] The valve of this invention has several features, no single
one of which is solely responsible for its desirable attributes.
Without limiting the scope of this invention as expressed by the
claims which follow, its more prominent features will now be
discussed briefly. After considering this discussion, and
particularly after reading the section entitled, "Detailed
Description of the Preferred Embodiments," one will understand how
the features of this invention provide its advantages, which
include safety, reliable and repeatable performance, simplicity of
manufacture and use, and provides long life without
malfunction.
[0011] A preferred embodiment of a seal used in the present
invention comprises a series of O-ring elements stacked together
and connected to form a unitary structure. The O-ring elements have
increasing diameters, with the smallest diameter element being
adjacent the proximal end of the cavity. The O-ring element closest
to the proximal end of the seal contacts the wall of the spike
proximal the through-holes when the seal is in a decompressed
state, thereby preventing fluid from leaking from the interior of
the spike through the proximal opening in the housing. It is
desirable that at least the next immediate O-ring element also be
in contact with the spike proximate the through-holes. Such a
design prevents fluid from applying enough pressure on the slit to
force the slit open while the seal is in the decompressed state.
With the preferred embodiment fluid may reside in the spike and
between the spike and the seal distal the through-holes without
opening the slit in the seal cap. The seal is designed so that if
this fluid pushes the seal upwards slightly, lifting the first and
second O-ring elements upwards and off the spike, the O-ring
elements immediately distal the first and second elements move up
and contact the spike so as to ensure that fluid does not flow
through the seal cap and out of the valve. Maintaining this contact
around the spike avoids having fluid pressure on the slit force the
slit open, permitting the valve to leak.
[0012] In another feature of the present invention, the housing is
provided with fluid escape space, such as a groove or channel, to
permit fluid contained between the exterior of the seal and the
housing to escape during compression of the seal. In one
embodiment, the proximal end of the housing is provided with at
least one groove extending from the proximal end of the housing to
indentations contained within the housing. During the compression
of the seal, fluid between the exterior of the seal and the housing
travels in a proximal direction through the grooves and out of the
valve through the proximal end of the housing. In another
embodiment, a channel is provided as the fluid escape space through
the side wall of the housing. As the seal is compressed, fluid
between the exterior of the seal and the housing travels through
the channel to the exterior of the valve. As discussed in greater
detail below, providing a groove or channel to permit fluid between
the exterior of the seal and the housing side wall to escape from
the valve during compression of the seal, provides several
advantages.
BRIEF DESCRIPTION OF THE DRAWING
[0013] The preferred embodiments of this invention, illustrating
all its features, will now be discussed in detail. These
embodiments depict the novel and non-obvious methods and valves of
this invention as well as the medical implement indicators and
methods of use thereof, as shown in the accompanying drawing, which
is for illustrative purposes only. This drawing includes the
following Figures, with like numerals indicating like parts:
[0014] FIG. 1 is a perspective view of the first embodiment of a
valve useful in connection with this invention.
[0015] FIG. 2 is an exploded perspective view of the valve shown in
FIG. 1 illustrating spike, seal, and body or housing components of
the invention.
[0016] FIG. 3 is a longitudinal cross-sectional view of the
assembled valve of FIG. 1.
[0017] FIG. 4 is a schematic, longitudinal, cross-sectional view of
the assembled valve of FIG. 1 before compressing the seal.
[0018] FIG. 5 is a schematic, longitudinal, cross-sectional view
similar to FIG. 4 showing the valve during compression of the
seal.
[0019] FIG. 6 is a perspective view of a second embodiment of a
valve useful in connection with the present invention.
[0020] FIG. 7 is a longitudinal cross-sectional view of the valve
of FIG. 6.
[0021] FIG. 8 is a schematic illustration of an ANSI delivery end
of a medical implement compressing the seal of a valve.
[0022] FIG. 9 is a side elevation view, partially in cross-section,
of an embodiment of the seal.
[0023] FIG. 10 is a longitudinal cross-sectional view of the
assembled valve of FIG. 1 using the seal of FIG. 9.
[0024] FIG. 11 is a longitudinal cross-sectional view of the
assembled valve of FIG. 1 using another embodiment of the seal.
[0025] FIG. 12 is a longitudinal cross-sectional view of the
assembled valve of FIG. 1 using yet another embodiment of the
seal.
[0026] FIG. 13 is a longitudinal cross-sectional view of an
additional embodiment of the seal.
[0027] FIG. 14 is a longitudinal section of the seal shown in FIG.
13 used in connection with the spike device shown in FIG. 2.
[0028] FIG. 15 is a longitudinal partial cross-sectional view of a
still further embodiment of the seal of this invention.
[0029] FIG. 16 is a longitudinal cross-sectional view, after
assembly, of the valve shown utilizing the seal of FIG. 15.
[0030] FIG. 17 is a longitudinal cross-sectional view, after
assembly, of the valve shown utilizing still another embodiment of
the seal.
[0031] FIG. 18 is a longitudinal cross-sectional view, after
assembly, of the valve utilizing yet one more embodiment of the
seal.
[0032] FIG. 19 is a side elevation view, after assembly, of the
seal and spike shown in FIG. 14 connected to the body or housing
shown in FIGS. 20 and 21.
[0033] FIG. 20 is a cross-sectional view taken along line 20-20 of
FIG. 19.
[0034] FIG. 21 is a perspective view of the housing shown in FIG.
19, with sections broken away to show the wall structure of the
cavity containing the seal shown in FIGS. 13 and 14.
[0035] FIG. 22 is a greatly enlarged, cross-sectional view taken
along line 22-22 of FIG. 14.
[0036] FIG. 23 is a longitudinal cross-sectional view of another
preferred embodiment of the seal.
[0037] FIG. 24 is a partial cross-sectional view, after assembly,
of the valve shown utilizing the seal of FIG. 23 and another
preferred embodiment of the spike.
[0038] FIG. 25 is a partial cross-sectional view of the valve of
FIG. 24, illustrating grooves in the housing.
[0039] FIG. 26a is a top view of the valve of FIG. 25, illustrating
the grooves in the housing.
[0040] FIG. 26b is a top view of another preferred embodiment of
the valve with a channel shown in phantom through the side wall of
the valve.
[0041] FIG. 27 is a partial cross-sectional view of the valve of
FIG. 26b illustrating the channel.
[0042] FIG. 28 is a perspective view of the housing, with sections
broken away to show the wall structure of the cavity containing the
seal, including the groove in the housing.
[0043] FIG. 29 is an elevational view of a preferred embodiment of
the housing with a channel through the housing wall shown in
phantom.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0044] The term "proximal" is used to denote the end of the valve
and other components at or near the spike tip 32 in FIGS. 2 through
5, 10 through 12, 14, 16, 24, 25 and 27, and at or near the spike
tip 60 in FIG. 6, and at or near the seal cap 92 in FIGS. 8, 9, 13
through 19, 23, 24, 25 and 27. The term "distal" is used to denote
the opposite end of the valve, or spike tip, or seal. The term
"medical implement" is used to denote any medical tool known to
those of skill in the art that can facilitate the passage of
fluids, particularly liquids, therethrough. Examples of medical
implements that are contemplated include, but are not limited to,
tubing, conduit, syringes, IV sets (both peripheral and central
lines), piggyback lines, medical valves, and other components.
Medical implements are commercially available in standard sizes.
Thus, either or both ends of the valve can be provided with
fittings to accommodate such standard size medical implements.
[0045] The valve is a closed, patient access system which
automatically reseals after administering medication using a
medical implement that directly connects with the system without
the need of any intermediate needles, caps or adaptors. A two-way
valve is employed utilizing a reusable seal that may be repeatedly
pierced by an enclosed, protected spike rather than an exposed
metal needle. The valve facilitates fluid, particularly liquid,
transfer while maintaining sterility. The valve is easy to use and
is capable of locking in place. After use, the valve is swabbed in
the conventional manner with a suitable substance to maintain
sterility. The design of the valve avoids accidental needle sticks.
As will be discussed in detail below, the valve is useful as a
medical connector or adaptor to enable liquid flow from a sealed
container.
[0046] The first feature of the invention is that the valve has a
body including a wall structure defining an internal cavity having
a proximal end and a distal end. The cavity has an open space into
which the seal is pushed, and preferably has a plurality of radial
indentations in the wall structure that are adjacent the seal to
accommodate the expansion of the seal upon compression. The
proximal end has an opening sufficiently large to receive a
delivery end of a medical implement which transfers fluid through
the delivery end. In most applications, the delivery end of the
implement is tapered inward so that the wall structure and the
tapered delivery end fit snug against each other upon insertion of
the delivery end into the opening. The proximal end of the cavity
preferably is adapted to fit snug with an ANSI (American National
Standards Institute, Washington, D.C.) standard end of the medical
implement. Typically, the implement is a syringe, a connector or
inlet/outlet of an IV set, or any one of a wide variety of conduits
used in medical applications.
[0047] The second feature is that the spike has a tip with at least
one hole located at or near the tip, and a passageway in
communication with the hole that allows fluid to flow through this
hole. Preferably, the hole is in a side of the spike adjacent the
tip and is elongated, having a size of 18 gauge or greater. More
than one hole is desirable for many applications, and three,
symmetrically located holes inward of the proximal end are
preferred. The spike is seated inside the cavity and the tip is
embedded in the seal cap located at the proximal end of the seal.
The tip of the spike is blunt and rounded so as to avoid
deterioration of the seal from repeated penetration by the spike.
The spike may include at least one rib which allows air to enter a
space between the seal and the spike, thereby facilitating the
sealing of the opening when the implement is removed. The spike may
have a substantially conical shape, and the seal has a
complementarily, substantially conical shaped cavity within it
conforming to the shape of the spike.
[0048] The third feature is that the resilient seal is adapted to
be moved into a compressed state upon insertion of the tip of the
medical implement into the opening and returns to a decompressed
state upon removal of the tip. The seal in the decompressed state
has a section which fills essentially completely a portion of the
cavity adjacent the opening. In the compressed state, the seal
section is pushed by the delivery end of the medical implement away
from the opening and into the cavity. This seal section, known as
the seal cap, may have a precut slit in which the proximal end of
the spike is embedded. The delivery end of the implement and the
seal are adapted to engage so that when the tip of the spike
pierces the seal there is essentially no dead space between said
delivery end and the seal. Consequently, a predetermined dosage
amount of medication is transferred in its entirety to the patient
using this invention, with none of the prescribed amount being
collected in dead space in the valve. The delivery of an exact
amount of medication may be critical in some situations when
chemotherapeutic agents are being administered or small children
are being treated.
[0049] As best shown in FIGS. 1 and 2, the first embodiment of
valve 10, includes a valve body or housing 12, a spike element 24,
and a seal 36. The seal 36 is prepared from a resilient material
that is flexible, inert, impermeable to fluid, and readily
pierceable by the spike 26. In the valve embodiment shown in FIG.
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 FIG.
3, with the spike element 24 enclosed to prevent accidental sticks.
FIG. 2 illustrates how the housing 12, seal 36, and spike element
24 are attached without the need to use any adhesive or other
bonding agent or process. Mechanical connection which provides a
fluid tight closure is attained as is discussed subsequently. As
shown in FIGS. 4 and 5, the seal 36 moves within the housing 12,
being pierced by the spike element 24 to expose the tip 32 of the
spike element 24 to allow fluid to flow through the valve 10.
[0050] Referring to FIG. 1, one preferred embodiment of the housing
12 has a bell-shaped skirt 16 and an upper, preferably cylindrical,
conduit 20. The skirt 16 is integral with, and connected by an
annular ring 14, to the upper conduit 20. The skirt 16 creates a
shield for an inner conduit 18 of the spike element 24. This inner
conduit 18 is preferably cylindrical in shape, and slightly
tapered. Inner conduit 18 and upper conduit 20 comprise aligned
hollow tubes so that inner conduit 18 and upper conduit 20 are in
fluid communication with one another when the spike element 24
pierces the seal 36. There is an annular lip 25 surrounding a
circular opening 25a in the top of the conduit 20 (see FIG. 2).
[0051] In the first embodiment of the valve, the upper conduit 20
is adapted to receive the tip or nose 48 of an ANSI standard
syringe 46 (see FIGS. 4 and 5). It is, however, contemplated that
the outer diameter of the upper conduit 20 can be of any size to
accommodate the attachment of other connector devices thereto.
Advantageously, the proximal end of the upper conduit 20 can be
equipped with a locking mechanism to facilitate locking of the
valve 10 to a variety of medical implements. For example, referring
to FIG. 1, locking ears 22 near the proximal lip 25 of housing 12
are preferably provided such that the housing 12 can be locked into
any compatible Luer-Lock device known to those with skill in the
art. For example, referring to FIG. 19, conventional Luer-Lock
threads 180 can be provided on the outer diameter of upper conduit
20.
[0052] Referring to FIG. 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 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.
[0053] The hollow spike 26 has a tapered conical shape, ending in a
sharp, pointed tip 32. Preferably, along the length of the spike
are raised, protruding ridges 30. These raised ridges 30 extend
from the surface of the spike preferably between 0.2-2.0 mm. The
ridges 30 are preferably aligned along the length of the spike as
illustrated in FIG. 2. These ridges 30 serve to break any vacuum
created when the spike 26 is sealed as described hereinbelow.
Modifications to the alignment and orientation of the ridges are
discussed hereinbelow in association with their function. 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 10 mm and more preferably within
about 5 mm from the spike tip 32. These through-holes 34 may be of
any size, however, the larger the size of the through-holes the
greater the fluid flow rate through the valve 10. In a preferred
valve embodiment, the size of the through-holes 34 are 18-gauge to
provide a flow rate three times that of a standard 18-gauge
needle.
[0054] The seal 36 preferably has a seal cap 40 with a generally
flat top surface 40b, an outwardly tapered side wall 38, and a
lower lip 42. Its interior is hollow to provide the conically
shaped cavity 37 (FIG. 3). Thus, the seal 36 slips easily over the
spike element 24 to fit snugly within the cavity 37. The seal lip
42 is seated within the annular cuff 28 and wedged between the cuff
and the underside of the ring 14. There are longitudinal grooves 43
(FIG. 2) along the length of the seal 36 which provide air pockets
that facilitate compression of the seal 36 during use. The grooves
43 may be of variable shape or size to facilitate seal compression.
In the first valve embodiment, there is a single groove 43 which
completely surrounds the seal 36 between the seal cap 40 and the
lip 42.
[0055] The base of the seal 36 has a width such that the seal lip
42 fits snugly into the annular cuff 28. The hollow interior or
cavity 37 (FIG. 3) of the seal 36 is preferably tapered to conform
internally to the shape of the spike 24, having a wall portion 44
which contacts the spike 24 distal seal cap 40. The exterior of the
seal 36 is sized and shaped to fit inside the upper conduit 20 of
the housing 12. The cap 40 reseals the valve 10 when the top
surface 40b is proximal the through-holes 34. Preferably, the cap
40 substantially fills the 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
40 can be swabbed with alcohol or other disinfectant without
leakage of disinfectant into the valve 10. It is important that the
surface 40b be exposed so that it may be swabbed with a
disinfectant.
[0056] As best shown in FIG. 3, the spike 24, with contiguous inner
conduit 18, is affixed to the housing 12 through the association of
the external potion of annular cuff 28 and the internal portion of
annular ring 14. Although not necessarily required, these two
pieces may be affixed by any one of a variety of methods known to
those of skill in the art including, but not limited to, heat
sealing, glue, pressure lock, bonding or the like. The seal 36 fits
into the annular cuff 28 and is held in place by an internal lip 27
along the internal portion of the annular ring 14 of the housing
12. The length of the spike 24 is such that, after assembly, the
tip of the spike rests below the plane defined by the lip 25 of the
housing 12. Preferably, the spike tip 32 is approximately from
0.525" to 0.1" below the lip 25 of the housing 12. The seal 36 fits
snugly against the spike 24 and is essentially flush with the lip
25 of the housing 12. The spike tip 32 is thus embedded within the
seal cap 40 prior to use or may be approximately 0.025" distal the
seal cap 40 when the valve 10 is in the closed position. The inner
conduit 18 is partially shielded by the bell shaped skirt 16 of the
housing 12 (see FIGS. 1-3). The inner surface of the bell shaped
skirt 16 preferably has protruding threads 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.
[0057] During use, the valve is designed to be adapted as a two-way
valve. The orientation of the valve is independent to fluid flow
and dependent on the preferred orientation of the preexisting
connections. Thus, the valve can be used as a valve connector for
an intravenous central or peripheral piggyback connector in either
orientation. Parenteral fluid is delivered to patients through
tubing such that the liquid flows from a container through a
piercing element into the patient. The containers are frequently
changed or additional fluid bottles are added. The valve disclosed
herein is designed to interconnect medical implements along the
route of fluid delivery to the patient. However, the valve is also
useful in any environment in which a resealable fluid valve is
desired. During use, a connector of the appropriate size is fitted
over the 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.
[0058] FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the
medical implement connecting to the proximal end of the valve 10 is
a syringe 46. However, this connecting implement could be any
number of 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 FIG. 4
creates pressure on seal cap 40. The resulting downward pressure
compresses the seal 36. This pushes the tip 32 of the spike 26
through the seal cap 40 to expose the through-holes 34. Compression
is facilitated by the grooves 38. Fluid is now able to flow into
the syringe 46, or vice versa, depending on whether fluid is to be
withdrawn from the patient or medication injected into the patient.
FIG. 5 shows valve 10 opened by insertion of the nose 48 of the
syringe 46 into the opening 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
diagramed in FIGS. 4 and 5, or it can be rotated 1800 such that
fluid flows in the opposite direction.
[0059] Upon removal of the syringe from the spike 26, as shown in
FIG. 4, the seal 36 is free to return to its original shape and
cover the 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 30 permit air to pass
along the spike/seal interface to prevent vacuum formation and
allow free return of the seal 36. The ability of the seal 36 to
deform reversibly and return to its original position is
particularly useful because (1) it immediately stops fluid flow
through the valve 10, (2) it covers the recessed spike 26 to
maintain its sterility, and (3) it reduces the risk that the spike
could inadvertently pierce another object or person. In addition,
since the valve 10 lacks movable parts, except for the seal, it is
unlikely that when the seal 36 is pushed down, the valve 10 would
fail to function.
[0060] 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 when the valve 10 is closed. In one
preferred embodiment of the valve, the through-holes 34 are located
0.075" below the spike tip 32 (see FIG. 2). Additionally, the
through-holes 34 are sealed even if the seal 36 does not fully
return to its original configuration depicted in FIG. 4. Further,
the ability of the seal 36 to return reversibly to its original
position permits the reuse of the valve 10. Following
disconnection, and before reuse, the surface of pierced seal cap 40
is essentially flush with the housing 12. Thus, this flush surface
can advantageously be sterilized with alcohol or other surface
decontaminating substances. The skirt 16 and upper conduit 20
advantageously shield both connections from the surrounding
environment to protect the sterility of the connection. Further,
both the skirt 16 and upper conduit 20 function as collection
reservoirs to prevent fluid from dripping from the valve 10 during
manipulation.
[0061] 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
successively added, for example, to a fluid line in direct
communication with a patient's vein. Since the valve is easily
sterilizable and sealable, fluid lines can be added and removed
without disconnecting venous contact.
[0062] The valve 10 is preferably prepared from a hard plastic,
such as ABS plastic, but it is additionally contemplated that the
valve could be prepared from other medically inert materials known
to those in the art. The spike element 24 is preferably prepared
from the same material as the housing 12. However, a stronger
material, such as a poly-carbonate material, may be desirous for
the spike element 24 to enable it to pierce a variety of connecting
septums and seals. One particular advantage of this valve is that
it does not rely on the use of metal needles. This dramatically
reduces the risk of skin puncture during use and manufacture.
Further, the upper conduit 20 serves as a shield to the spike 26
such that skin contact with the spike 26 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.
[0063] In the embodiment of the valve illustrated in FIGS. 2-4, the
through-holes 34 are placed distal spike tip 32. This placement
provides two important advantages. First, the placement of the
through-holes 34 facilitates resealing of the valve 10 after use.
Second, if the through-holes were placed at the spike tip 32, the
holes 34 may core the seal cap 40 thereby introducing seal
particulate into the fluid flow and possibly plug the holes 34.
Thus, the longitudinal placement of the through-holes distal the
spike tip 32 prevents the introduction of particulates into the
fluid path and/or plugging of the through-holes 34. It is
additionally contemplated that the number and diameter of the
through-holes 34 can be adjusted to accommodate different fluid
velocities. In a preferred embodiment of the valve, 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 flow rates.
[0064] An important advantage of the valve 10 is that it has very
little dead space, thus the volume of liquid entering into the
valve 10 is substantially equivalent to the volume of fluid leaving
the valve 10. 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 10 in fluid communication
with a medical implement such as a syringe 46 is substantially
zero.
[0065] In another preferred embodiment of the valve, illustrated by
FIGS. 6 and 7, a disposable sterile adaptor valve 50 is provided to
function as a resealable lid for a container (not shown) of fluid.
The fluid can thus be removed from the fluid container or permitted
to flow from the container into a medical implement adapted to
house fluid in a sterile manner. As is the conventional practice,
an open mouth of the container will ordinarily be sealed with a
cover member (not shown).
[0066] FIG. 6 shows an adaptor valve 50 having a body including an
adaptor skirt 52. The adaptor skirt 52 will preferably fit snugly
over the open mouth of the container. The skirt 52 may be of any
size to accommodate a range of container sizes. A lengthwise slit
54 is preferably provided in at least one location along the length
of the skirt to ensure a snug fit between the skirt 52 and the
container. A chamber 56, preferably tubular in configuration,
extends upward from the skirt 52 and is similar in construction and
design to the upper conduit 20 of the first preferred valve
embodiment. Similar to the first valve embodiment, the proximal
portion of the valve may contain a locking mechanism 59 that
preferably comprises a Luer-Lock device or other locking device
known to those of skill in the art.
[0067] As depicted in FIG. 7, a spike 58 extends upward through a
tubular chamber 56. A spike tip 60 is preferably recessed from a
proximal lip 62 of the tubular chamber 56. In a closed position,
this tip 60 is covered by a seal 64, which is essentially the same
as seal 36. Protruding ridges 66 and seal grooves 68 facilitate
seal compression and promote closure following use. Thus, in the
closed position as illustrated in FIG. 7, the seal 64 covers the
through-holes 70 to prevent fluid out-flow from the container. The
adaptor valve 50 contains a second spike 72 which points in the
opposite direction as the spike 58. These spikes 52 and 72 are in
fluid communication with each other. The spike 72 extends downward
inside the adapter skirt 52. The two spikes preferably form one
component of the valve 50 while the skirt 52 and upper chamber form
a second component. These two components can be assembled in a
manner like that of the valve 10. The spike 72, like the spike 58,
has longitudinal through-holes 74 and a tip 76. The through-holes
74 are located inward of the tip 76. The adaptor valve 50 is thus
useable with containers holding sterile medicament having a cover
or septum seal at the open mouth of the container. Examples of
containers with such seals contemplated for use with this valve
include dosage bottles for intramuscular injector antibiotic
containers or the like. However, it is also contemplated that the
valve 50 can be adapted with its own seal and locking mechanism to
permit the valve to be employed on a variety of containers for
medicaments or other fluids. Medicaments in these types of
containers are preferably maintained under sterile conditions and
the volume and nature of the medicament is such that multiple
aliquots are intermittently removed over time. If the medicament is
reconstituted, then, during use, any covering over the opening on
the container is removed to reveal the rubber septum. The adaptor
valve 50 is placed over the septum and direct pressure is applied
to pierce distal spike 72 through the septum and into the
container. A syringe or the like can then be applied, as depicted
in FIG. 4, in association with the first preferred valve
embodiment, to withdraw fluid from the container. The pressure of
the nose 48 over the spike 58 pushes the spike tip 60 through the
seal 64. At the same time, the seal 64 is compressed. Compression
is accommodated by the seal grooves 68. Fluid is withdrawn from the
container and the syringe is removed from the spike 58. Release of
the pressure applied to the seal 64 permits the seal 64 to return
to its original configuration. The spike ridges 66 facilitate
movement of the seal 64.
[0068] 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
50 automatically seals. Subsequently, aliquots can be removed from
the container by syringe or the like. Alcohol or other compatible
surface sterilizing agents can be used to wipe the lip 62 and seal
64 before each use. Similar to the first valve embodiment, it is
additionally contemplated that a cap can be provided to fit over
the upper chamber lip 62 between uses.
[0069] The adaptor valve 50 can be adapted to function as a
medicament adaptor for an intravenous container. In this case, the
adaptor valve 50 is placed on a medicament container for
intravenous delivery and attached via tubing to an intravenous
feed. Thus, the adaptor valve 50 can be placed in fluid
communication with a connector valve of FIG. 1 to facilitate the
flow of medicament from intravenous drip bottles.
[0070] An alternative embodiment of the seal, a seal 36a, is shown
in FIG. 9. The seal 36a comprises a seal cap 92 at the proximal end
thereof and a seal lip 96 at the distal end thereof. A cup-like
annular flange 95 is provided proximal the 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 (FIG. 10) between ring
portions 94 and the housing and air pockets 13b between the spike
24 and seal 36a. The seal 36a contains a cavity 98 distal the seal
cap 92 and adjacent the ringed wall portions 94. The seal 36a
interacts with the spike 26 (FIG. 2) and other components of the
valve in a similar fashion to the seal 36 of FIG. 2.
[0071] Referring to FIG. 10, the cup-like annular flange 95 can 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 embodiment has two advantages. First,
the proximal end of the valve 10 can be swabbed with alcohol or
other disinfectant without leakage of disinfectant into the valve
10. Second, by affixing the cup-like annular flange 95 to the upper
conduit 20 at the proximal end thereof with the annular ring 97,
the repeated deformation and reformation of the seal 36a is
assisted.
[0072] In an alternative embodiment of the seal, the seal 36b is
shown in connection with the valve 10 in FIG. 11. The seal 36b is
similar to the seal 36a shown in FIGS. 9 and 10, as the seal 36a is
comprised of a seal cap 92, a side wall consisting of ringed wall
portions 94 and a seal lip 96. The seal 36a also has an outwardly
extending ring 99 which is at a right angle with respect to the
longitudinal axis of the valve 10. This ring 99 is used to attach
the seal 36b to the upper conduit 20. Preferably, an upper conduit
annular plug 20' is inserted within the upper conduit 20 to create
a tight fit between the perpendicular ring 99, a ledge 101 in the
upper conduit 20, and the plug 20'. The ring 99 assists in the
reformation of the seal 36b to enclose the spike 26 upon withdrawal
of a syringe (not shown).
[0073] As shown in FIG. 12, the cup-like annular flange 95 and ring
99 may both be used in connection with the valve 10, to provide the
seal 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.
[0074] Another alternative embodiment of the seal, a seal 36d, is
shown in FIG. 13. In this embodiment, the seal 36d is comprised of
a seal cap 92, a 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.
[0075] As mentioned above, preferably the 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 seal cap 92. Between the proximal end of the side
wall 150 and the member 200 is an annular space 102 which is filled
with the fluid in the cavity 98. This fluid is under pressure, for
example at the blood pressure of the patient to which the valve 10
is attached. Referring to FIG. 14, fluid, for example the patient's
blood, flows through the holes 34 in the spike 26, filling the
cavity 102. This fluid presses against the exterior of the member
200, closing the slit 11 when the seal is decompressed as shown in
FIGS. 14 and 19. The pressure from this fluid creates a high
pressure seal which prevents fluid from escaping valve 10 through
the slit 11. There is a semi-cylindrical annular flange tear ring
104 on the end of the member 200 which advantageously extends the
useful life of the seal 36d.
[0076] Preferably, there is a tear ring 104 integral with the
member 200 along the perimeter of the internal surface the member
200, and a slight saucer-like depression 204 in the external
surface of the seal. The pressure responsive element in the
decompressed state closes any orifice in the seal 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 11a 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 11a to the orifice 11. In a preferred valve embodiment the
distance from the entryway 11a to the proximal end of the seal cap
92 is from 0.500 to 0.075 inches and more preferably approximately
0.100 inch.
[0077] As best illustrated in FIG. 22, the tip 32 is designed to
avoid tearing the seal. The 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 is prevented by the parting
lines a, b, and c, or junctions, being disposed within recesses
220, 222, and 224, respectively, to provide "buried parting
lines."
[0078] Another alternative embodiment of the valve 10 using the
seal 36d is shown in FIG. 8 and FIGS. 19 through 21. In this
embodiment, the inner wall 160 of the upper end of the conduit 20
is provided with at least one, and preferably, a plurality of
radial indentations 107. The indentations 107 are elongated and
disposed generally parallel to the longitudinal axis of the valve
10 in a symmetrical, star-like configuration. 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.
[0079] Another preferred embodiment of the seal 36h is shown in
FIGS. 23 through 25 and 27. In this embodiment, the seal 36h
comprises a seal cap 92 having a saucer-like depression 204 (FIG.
23). The seal 36h contains a slit 11 having a proximal end adjacent
depression 204 and a distal end 11a at the distal end of seal cap
92. Referring to FIG. 23, circular tires 100 similar to those in
FIG. 13 are provided. The seal 36h has an internal cavity 98.
Further, the seal 36h preferably has a seal lip 96 as discussed in
more detail above.
[0080] As best shown in FIG. 8, the wall 181 of the proximal end of
the upper 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 the valve 10 between the walls 181 and 182. Thus,
essentially the entire prescribed dosage is delivered through the
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.
[0081] FIGS. 15, 16, 17, and 18 depict embodiments of seals,
namely, seal 36e, seal 36f, and seal 36g, which are substantially
the same as the seals 36a (FIG. 10), seal 36b (FIG. 11), and seal
36c (FIG. 12), except the side wall 150 employing the circular
tires 100 is used in place of the accordion wall portion 94.
[0082] Other components of the valve interact with the various
embodiments of the seal in a similar fashion to their interaction
with seal 36 of FIG. 2. Prior to use of the 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 not reseal effectively; however, will not be capable of
springing back after opening of the valve. Material that is too
hard will provide sufficient spring force; however, will not
effectively seal. Thus, in a preferred embodiment, the seal is
formed from a silicone having a hardness in the range from 30-70
Shore durometer units, and more preferably in the range 40-50 Shore
durometer units. A cure silicone polymer in the preferred hardness
range is available from Wacker Silicone Corp. of Adrian, Mich. In
some valve embodiments, it is desirable to provide additional
lubricity to the seal 36 to allow it to spring back and reseal more
effectively. Dow Chemical Co. produces a silicone formulation with
silicone oil built in to provide this additional lubricity.
[0083] 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 0.100 inch.
[0084] The valve can be provided in a sterile and disposable form
such that after its use in a given installation is exhausted, the
device is discarded. However, as described above, in any given
installation, the valve can be reused multiple times. Since the
valve does not employ needles, there is little chance that the
device will inadvertently cause skin puncture. Therefore, the extra
precautions required for handling and disposing of needles is
obviated. It will be apparent from the detailed description
provided herein that the valve can provide for the elimination of
nearly all needles used in the medical environment. With the use of
the valve described above, the need for all needles except those
that are directly input into a patient is, advantageously,
eliminated.
[0085] The valve 10 is used to provide a closed, patient access
system for transferring a predetermined amount of medication from a
remote source to the patient. The valve 10 is connected by the
distal end to the patient, for example, a vein or artery in fluid
communication with the valve. Blood fills the valve, but the seal
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 FIG. 8, pushing the nose 48 against
the seal to compress the seal sufficiently to allow the tip 32 of
the spike 24 to pierce the seal and enter said delivery end. The
predetermined amount of medication in its entirety may now be
transferred through the nose 48 into the valve 10 and into the
patient. Since the nose 48 and seal 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 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.
[0086] Another alternative embodiment of the seal, a seal 36h, is
shown in FIG. 23. In this embodiment, the seal 36h is similar to
seal 36d and is comprised of a 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. Side wall 150
defines cavity 98. The circular tires are preferably solid
throughout the diameter of the cross-section thereof. These
circular tires will deform and reform upon, respectively,
compression and decompression of the seal 36h, thereby exposing or
covering a spike (not shown) as the case may be.
[0087] Seal 36h also has a precut slit 11 in seal cap 92 lying
along the longitudinal axis of the seal 36h. Slit 11 remains sealed
when seal 36h is in a decompressed state. As explained earlier,
precutting the seal to provide slit 11 allows for more rapid
decompression and reformation of the seal upon piercing by the
spike. Unlike seal 36d, however, seal cap 92 of seal 36h is
substantially solid without having any pressure responsive member
as is employed in seal cap 92 for seal 36d.
[0088] An alternative embodiment of the present invention using
seal 36h is shown in FIG. 24. Spike 26a, residing within cavity 98
and having a proximal end with a tip 32 embedded in seal cap 92, is
shown to be more tubular, and less frustoconical than the spike 26
illustrated in other embodiments. Furthermore, the tip 32 of spike
26a is a blunt, rounded end, unlike the pointed tip of spike 26.
Because the end is rounded, the seal cap is not subjected to
deterioration through tearing by spike tip 32. Thus a tear ring for
the seal, as shown in FIG. 14 for example, is not necessary for
this embodiment.
[0089] Another feature of this embodiment is the arrangement of the
spike 26a with the seal 36h when the seal 36h is in a decompressed
state. In this state, rounded tip 32 of spike 36h is positioned to
be embedded in slit entryway 11a, while slit 11 remains closed to
any fluid flow. FIG. 24 shows the entire rounded tip 32 in contact
with the distal end of seal cap 92. Additionally, the side wall
circular tire closest to the proximal end of the seal, tire 100a,
contacts the side wall of spike 26a. It is desirable that at least
the next immediate distal circular tire, tire 100b, also be in
contact with the spike 26a proximate the through-hole 34. Having a
plurality of tires in contact with spike 26a proximal through-hole
34 prevents fluid from passing from cavity 98 through the proximal
end of the valve 10. Without such a design, fluid would leak
through through-hole 34, thereby applying enough fluid pressure on
slit 11 to force slit 11 open while the seal is still in a
decompressed state. Through-hole 34 should be distal the tires
100a, 100b, which contact spike 26a, so that fluid passing through
through-hole 34 will not apply pressure to slit 11, and instead
will be blocked by circular tires 100a and 100b creating a seal
between the spike 26a and seal 36h.
[0090] During medical applications, for example when the valve 10
is connected to a patient's artery, the patient's blood flows
through the holes 34 in spike 26a, filling the area in cavity 98
distal the second tire 100b. Since the fluid residing between the
first two tires, 100a and 100b, and between seal cap 92 and tire
100a constitutes a very small volume, the fluid cannot exert enough
pressure against the seal cap to open slit 11. Pre-cut seal cap 92
is designed to remain closed up to fluid pressure of 20 psi.
Therefore, blood pressure will not open the valve 10.
[0091] Upon connection of the distal end of valve 10 with a
patient's artery, however, as the blood pushes up against seal 36h,
the fluid may force seal cap 92 to move proximally, thereby also
pushing the sidewall tires 100 in the proximal direction. This
pressure may permit blood to flow past tires 100a and 100b to place
pressure on the slit 11. However, due to increased fluid pressure,
the tires immediately distal first and second tires 100a and 100b
move proximally and contact the spike 26a to take the original
positions of tires 100a and 100b so as to ensure that a plurality
of tires are always in contact with spike 26a. Because the sidewall
tires 100 of seal 36h are designed to bow outward from the proximal
to the distal end, the tires immediately distal tires 100a and 100b
may not be in contact with spike 26a when in their original
position. However, as will be understood by those of skill in the
art, if fluid flows through the spike 26a, through-hole 34 and into
cavity 98 of seal 36h, forcing the seal 36h to move in a proximal
direction, tires distal the first tire 100a and second tire 100b
will also move in a proximal direction and contact the spike 26a
proximally through-hole 34 strengthening the seal between the spike
26a and the seal 36h. That is, when fluid is not contained within
the cavity 98 of the valve 10, only the first tire 100a and second
tire 100b contact the spike 26a. However, once fluid is introduced
into the cavity 98 of the valve 10, the seal 36h may travel in a
proximal direction. If this occurs, tires directly distal second
tire 100b contact seal 26a in addition to the first tire 100a and
second tire 100b strengthening the seal between the seal 36h and
spike 26a and preventing fluid from traveling through spike 26a,
through the through-hole 34 into the cavity 98 and past the tires
100 to exert pressure on the slit 11 in the seal cap 92 of seal
36h.
[0092] An alternative embodiment of the housing, housing 12a, is
shown in FIG. 25. In this partial cross-sectional view, housing 12a
is similar to housing 12, except for grooves 303, 304 that are
provided along the longitudinal axis of the interior wall of the
upper conduit 20. The grooves 303, 304 are provided as fluid escape
spaces to ensure that a perfect seal between the seal cap 92 and
the inner wall 305 of the upper conduit 20 is not provided. The
grooves 303, 304 preferably run from the proximal end of the upper
conduit 20 distally past the portion of the upper conduit 20 in
contact with the seal cap 92. As best seen in FIG. 28, the groove
303 preferably extends from the proximal end of the upper conduit
20 of the housing 12a distally to the proximal end of the radial
indentations 107.
[0093] Provision of the fluid escape spaces provides the advantage
of allowing any fluid residing in the space between the seal 36h
and the upper conduit 20 to exit the housing upon compression of
the seal 36h. Referring to FIG. 25, during routine use of the valve
10 in transferring fluid, fluid may seep into the section of the
housing 12a between the seal 36h and the walls 305 of the upper
conduit 20. When this area is filled with fluid and the seal cap 92
is compressed distally by a medical implement (not shown), the user
may experience difficulty in forcing the seal cap 92 distally past
the through-hole 34 of the spike 26a, because the sidewall tires
100 no longer have any room within the upper conduit 20 to be
compressed due to the presence of the fluid. It is undesirable to
require the user to apply extra force to compress the seal because
oftentimes the user may twist the medical implement down onto the
seal, leading to deterioration of the seal and eventual tearing. In
addition, fluid between the seal 36h and the inner wall 305 of the
upper conduit 20 of the housing 12a may prevent the seal 36h from
compressing distal the through-hole 34 of the spike 26a. As a
result, the valve 10 would not function properly.
[0094] By providing grooves 303, 304 as fluid escape spaces, fluid
present between the seal 36h and the inner wall 305 of the upper
conduit 20 of the housing 12a may travel proximally through the
grooves 303, 304 upon compression of the seal 36h by a medical
implement (not shown). As the fluid is expelled from the valve 10
through the grooves 303, 304 at the proximal end of the housing
12a, the seal 36h may compress normally without use of excessive
force by a user of the valve 10.
[0095] FIG. 26a is a top plan view of the valve shown in FIG. 25.
Grooves 303, 304 are shown in the upper conduit 20 of the housing
12a of the valve 10. Importantly, when the seal 36h is compressed
distally by a medical implement (not shown), the seal 36h does not
expand into the grooves 303, 304 thereby preventing fluid flow
therethrough.
[0096] Another alternative embodiment for the housing, housing 12b,
is shown in FIG. 29. The housing 12b employs a channel 307 as a
fluid escape space which is substantially perpendicular to the
longitudinal axis of the valve 10. A channel 307 is a bore that
runs transversely through the side of the wall of the upper conduit
20, and is positioned distal to any Luer Lock threads 309 or other
locking mechanism that may surround the upper conduit 20 near its
proximal end. Similar to the grooves 303, 304, the channel 307
provides a passageway for fluid within the area between the seal 36
and the inner wall 305 of the upper conduit 20 to exit when the
sidewall tires 100 are compressed and expand into the radial
indentations 107. Since an avenue exists for the fluid to exit this
area, a user does not have to apply excessive force in pushing a
medical implement (not shown) distally into the valve 10.
[0097] FIG. 26b is a top plan view of the valve 10 shown in FIG.
29. The channel 305 is shown in phantom and is preferably located
in the upper conduit 20 of the housing 12b of the valve 10. Upon
compression of the seal 36h by a medical implement (not shown),
fluid between the upper conduit 20 and the seal 36h is expelled
from the valve 10 through the channel 307 and out the side wall of
the upper conduit 20. Thus, a channel 307 can be distinguished from
a groove by its expulsion of fluid through a side wall, rather than
the proximal end of the housing 12a, as for a groove 303.
[0098] As will be easily understood by those of skill in the art, a
channel and groove may be incorporated in combination to assist in
expelling fluid from the valve upon compression of the seal by a
medical implement. For example, upon compression of the seal, fluid
could travel through a groove proximally and thereafter through a
channel in communication with the groove. The channel could be
located distally the proximal end of the valve. Moreover, a single
groove or channel may be utilized or multiple grooves or channels
may be incorporated into the valve of the present invention as will
be easily understood by those of skill in the art.
[0099] Lack of a channel or groove as discussed above, may result
in deterioration of the seal 36 and prevent the seal cap 92 from
being pushed completely below through-hole 34. If the through-hole
is not completely open, the patient will not be able to receive a
constant flow rate of medication. In some situations, the delivery
of an exact amount of medication at a predetermined rate may be
critical for treatment, and, therefore, through-hole 34 must be
completely open for passage of medication from the medical
implement. The groove and/or channel ensures that the seal cap may
be pushed distally the through-hole and that the seal may be
compressed without any excessive force which may cause damage to
the seal.
* * * * *