U.S. patent application number 12/218057 was filed with the patent office on 2008-11-20 for medical valve.
Invention is credited to Kazuyoshi Harada, Katsuhiro Hiejima, Takuya Masuda, Ken Suzuki.
Application Number | 20080287905 12/218057 |
Document ID | / |
Family ID | 32821273 |
Filed Date | 2008-11-20 |
United States Patent
Application |
20080287905 |
Kind Code |
A1 |
Hiejima; Katsuhiro ; et
al. |
November 20, 2008 |
Medical valve
Abstract
A medical valve includes: (a) a housing having a hollow body
opened at the top end, wherein the tip of a male luer is to be
removably inserted in the housing; (b) a spike disposed to extend
longitudinally in the housing, the spike except at least the top
end portion being formed in an approximately tapered shape in which
its outside diameter becomes progressively smaller toward the top
end portion, wherein a fluid transferring passage, which is opened
radially outwardly, is formed to extend longitudinally in the
spike; and (c) an elastic seal having an elastically deformable
tubular shape fitted on the spike to seal the spike, the elastic
seal including a top end portion having an openable/closable
portion to be openably closed over the spike, wherein the elastic
seal is elastically deformed to be downwardly shrunk by downward
pressure due to the tip of the male luer.
Inventors: |
Hiejima; Katsuhiro;
(Osaka-shi, JP) ; Suzuki; Ken; (Osaka-shi, JP)
; Harada; Kazuyoshi; (Osaka-shi, JP) ; Masuda;
Takuya; (Osaka-shi, JP) |
Correspondence
Address: |
KUBOVCIK & KUBOVCIK
SUITE 1105, 1215 SOUTH CLARK STREET
ARLINGTON
VA
22202
US
|
Family ID: |
32821273 |
Appl. No.: |
12/218057 |
Filed: |
July 11, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10800913 |
Mar 16, 2004 |
|
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12218057 |
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Current U.S.
Class: |
604/411 |
Current CPC
Class: |
A61M 39/26 20130101;
A61M 2039/267 20130101; A61M 39/045 20130101 |
Class at
Publication: |
604/411 |
International
Class: |
A61J 1/22 20060101
A61J001/22 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 17, 2003 |
JP |
2003-71260 |
Claims
1. A medical valve, to which a male luer is to be separably
connected, comprising: (a) a housing having a hollow body opened at
the top end, wherein the tip of the male luer is to be removably
inserted in the housing; (b) a longitudinal spike disposed to
extend longitudinally in the housing, the spike except at least the
top end portion being formed in a shape approximately tapered
upwardly, wherein a fluid transferring passage is formed to extend
longitudinally in the spike, the bottom portion of the fluid
transferring passage being connected to a fluid circuit; and (c) an
elastic seal having an elastically deformable tubular shape fitted
on the spike to seal the spike, the elastic seal comprising a top
end portion having an openable/closable portion to be openably
closed over the spike, wherein the elastic seal is elastically
deformed to be downwardly compressed by downward pressure due to
the tip of the male luer, thereby the openable/closable portion is
brought into abutment with the spike, and is elastically deformed
to be opened radially outwardly to be fitted onto the spike, so
that the inside of the male luer communicates with the fluid
transferring passage of the spike, wherein the spike comprises: (i)
a joining portion constituting the top end portion of the spike;
and (ii) a plurality of longitudinal branch portions, which
constitutes the remaining portion of the spike, formed integrally
with the joining portion branching off from the joining portion,
each longitudinal branch portion extending downwardly from the
joining portion to the fluid circuit, and wherein the fluid
transferring passage is defined between the branch portions and an
inner surface of the elastic seal.
2. A medical valve, to which a male luer is to be separably
connected, comprising: (a) a housing having a hollow body opened at
the top end, wherein the tip of the male luer is to be removably
inserted in the housing; (b) a longitudinal spike disposed to
extend longitudinally in the housing, the spike except at least the
top end portion being formed in a shape approximately tapered
upwardly, wherein a fluid transferring passage is formed to extend
longitudinally in the spike, the bottom portion of the fluid
transferring passage being connected to a fluid circuit; and (c) an
elastic seal having an elastically deformable tubular shape fitted
on the spike to seal the spike, the elastic seal comprising a top
end portion having an openable/closable portion to be openably
closed over the spike, wherein the elastic seal is elastically
deformed to be downwardly compressed by downward pressure due to
the tip of the male luer, thereby the openable/closable portion is
brought into abutment with the spike, and is elastically deformed
to be opened radially outwardly to be fitted onto the spike, so
that the inside of the male luer communicates with the fluid
transferring passage of the spike, wherein the longitudinal spike
comprises a plurality of longitudinal divided bodies which are
formed into one pair in axial symmetry and extend longitudinally
along the entire length of the spike, and wherein the fluid
transferring passage is defined between the divided portions and an
inner surface of the elastic seal.
3. A medical valve, to which a male luer is to be separably
connected, comprising: (a) a housing having a hollow body opened at
the top end, wherein the tip of the male luer is to be removably
inserted in the housing; (b) a longitudinal spike disposed to
extend longitudinally in the housing, the spike except at least the
top end portion being formed in a shape approximately tapered
upwardly, wherein a fluid transferring passage is formed to extend
longitudinally in the spike, the bottom portion of the fluid
transferring passage being connected to a fluid circuit; (c) an
elastic seal having an elastically deformable tubular shape fitted
on the spike to seal the spike, the elastic seal comprising a top
end portion having an openable/closable portion to be openably
closed over the spike, wherein the elastic seal is elastically
deformed to be downwardly compressed by downward pressure due to
the tip of the male luer, thereby the openable/closable portion is
brought into abutment with the spike, and is elastically deformed
to be opened radially outwardly to be fitted onto the spike, so
that the inside of the male luer communicates with the fluid
transferring passage of the spike, wherein the spike comprises: (i)
two main longitudinal portions extending along the entire
longitudinal length of the spike; and (ii) a bridge portion formed
integrally with the main portions and disposed between a segment of
the main portions to join the main portions together, wherein the
fluid transferring passage is defined between the main portions and
an inner surface of the elastic seal.
4. A medical valve, to which a male luer is to be separably
connected, comprising: (a) a housing having a hollow body opened at
the top end, wherein the tip of the male luer is to be removably
inserted in the housing; (b) a longitudinal spike disposed to
extend longitudinally in the housing, the top end portion of the
spike having an approximately cylindrical shape and solid
structure, the top end surface of the spike being an approximately
hemispherical surface which is upwardly convex, the spike, except
the top end portion, being formed in an approximately tapered shape
in which the outside diameter becomes progressively smaller toward
the top end, wherein a fluid transferring passage extends
longitudinally in the outer peripheral surface of the spike, the
bottom portion of the fluid transferring passage being connected to
a fluid circuit; (c) an elastic seal having an elastically
deformable tubular shape fitted on the spike to seal the spike, the
elastic seal comprising a top end portion having an
openable/closable portion to be openably closed over the spike,
wherein the elastic seal is elastically deformed to be downwardly
compressed by downward pressure due to the tip of the male luer,
thereby the openable/closable portion is brought into abutment with
the spike, and is elastically deformed to be opened radially
outwardly to be fitted onto the spike, so that the inside of the
male luer communicates with the fluid transferring passage of the
spike; and wherein the fluid transferring passage is formed between
the outer peripheral surface of the spike and an inner surface of
the elastic seal.
Description
[0001] This application is a division of U.S. patent application
Ser. No. 10/800,913 filed Mar. 16, 2004, which claims priority of
Japanese Patent Application No. 2003-071260, filed Mar. 17, 2003,
which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a medical valve which makes
it possible to perform supply of a fluid and the like through the
connection of a male luer without using a metal needle because of
the problem of erroneous needle sticking and the like by an
operator, in a mixing plug which is provided in a fluid circuit,
for example, a fluid infusion bag, an intermediate portion of a
fluid infusion line (route) or an external fluid circuit, for the
purposes of effecting supply, mixing, additional administration of
medicament solutions such as trace elements, vitamins and
antibiotics.
DESCRIPTION OF THE RELATED ART
[0003] As a medical valve in which a male luer such as a syringe or
other fluid circuit is connected to a fluid infusion route without
using a metal needle, there is a medical valve in which a spike
contained in a housing is covered with an elastic seal (refer to,
for example, JP-T-7-505064, EP 0681493B1, U.S. Pat. No.
6,029,946).
[0004] In this construction, by the application of pressure by a
tip of a male luer, the elastic seal is compressed downwardly and
the spike is inserted through the elastic seal and is exposed
upwardly to enter the tip of the male luer. In this manner, the
inside of the male luer and a fluid transferring passage inside the
spike communicate with each other via an opening of a side surface
of the spike, whereby a fluid can be transferred. In addition, when
the application of pressure to the elastic seal by the tip of the
male luer is cancelled, the elastic seal is expanded from its
compressed state by its resilient force and is restored to the
original size, whereby the spike is sealed in the elastic seal.
[0005] The spike is generally made of a resin in terms of cost.
However, in the above-mentioned related art, the fluid transferring
passage is formed in the inside of the spike and is completely
covered with the peripheral wall portion of the spike, so that if
the outside diameter of the spike is made small, there is a need
for making the peripheral wall portion of the spike extremely thin,
and in this case, it is extremely difficult to form the spike from
a resin.
[0006] For this reason, it is more preferable that the inside
diameter of the tip of the male luer which the spike enters becomes
larger (for example, the inside diameter is 1.5 mm or more).
However, if the male luer is a syringe made of glass and the tip is
made of glass, it is difficult to enlarge the inside diameter of
the tip in terms of the problem of molding, and in this case, there
is the problem that the spike cannot be made to enter the tip and
that the male luer and the medical valve cannot be connected to
each other.
BRIEF SUMMARY OF THE INVENTION
[0007] As a result of earnest investigations made by the inventors
to solve the problems associated with the conventional techniques,
the invention has been completed.
[0008] An object of the invention is to provide a medical valve to
which a male luer can be easily connected even if the inside
diameter of the tip of the male luer is small.
[0009] The above-mentioned object and other objects of the present
invention will be clarified further more in the following
description, and these objects are attained by the present
invention comprising the constitution mentioned below.
[0010] The invention relates to a medical valve to which a male
luer is to be separably connected comprising:
[0011] (a) a housing having a hollow body opened at the top end,
wherein the tip of the male luer is to be removably inserted in the
housing;
[0012] (b) a spike disposed to extend longitudinally in the
housing, the spike except at least the top end portion being formed
in an approximately tapered shape in which its outside diameter
becomes progressively smaller toward the top end portion, wherein a
fluid transferring passage, which is opened radially outwardly, is
formed to extend longitudinally in the spike, the bottom portion of
the fluid transferring passage being connected to a fluid circuit;
and
[0013] (c) an elastic seal having an elastically deformable tubular
shape fitted on the spike to seal the spike, the elastic seal
comprising a top end portion having an openable/closable portion to
be openably closed over the spike, wherein the elastic seal is
elastically deformed to be downwardly shrunk by downward pressure
due to the tip of the male luer, thereby the openable/closable
portion is brought into abutment with the spike, and is elastically
deformed to be opened radially outwardly to be fitted onto the
spike, so that the inside of the male luer communicates with the
fluid transferring passage of the spike.
[0014] The medical valve to which a male luer is to be separably
connected may comprise:
[0015] (a) a housing having a hollow body opened at the top end,
wherein the tip of the male luer is to be removably inserted in the
housing;
[0016] (b) a solid spike disposed to extend longitudinally in the
housing, the spike except at least the top end portion being formed
in an shape approximately tapered upwardly, wherein a groove-shaped
fluid transferring passage, which is opened radially outwardly, is
formed to extend longitudinally in the peripheral surface of the
spike, the bottom portion of the fluid transferring passage being
connected to a fluid circuit; and
[0017] (c) an elastic seal having an elastically deformable tubular
shape fitted on the spike to seal the spike, the elastic seal
comprising a top end portion having an openable/closable portion to
be openably closed over the spike, wherein the elastic seal is
elastically deformed to be downwardly shrunk by downward pressure
due to the tip of the male luer, thereby the openable/closable
portion is brought into abutment with the spike, and is elastically
deformed to be opened radially outwardly to be fitted onto the
spike, so that the inside of the male luer communicates with the
fluid transferring passage of the spike.
[0018] The spike described below may be used instead of the spike
described above.
[0019] For example, the spike may comprise:
[0020] (i) a joining portion constituting the top end portion of
the spike; and
[0021] (ii) a plurality of branch portions, which constitutes the
remaining portion of the spike, formed integrally with the joining
portion to branch off downwardly from the joining portion,
[0022] and wherein the fluid transferring passage is defined
between the branch portions.
[0023] The spike may comprise a plurality of divided bodies
extending along the entire longitudinal length thereof,
[0024] and wherein the fluid transferring passage is defined
between the divided portions.
[0025] The spike may comprise:
[0026] (i) a plurality of main portions extending along the entire
longitudinal length of the spike; and
[0027] (ii) a bridge portion formed integrally with the main
portions and disposed between the main portions to join the main
portions together,
[0028] wherein the fluid transferring passage is defined between
the main portions.
[0029] The medical valve, to which a male luer is to be separably
connected, may comprise:
[0030] (a) a housing having a hollow body opened at the top end,
wherein the tip of the male luer is to be removably inserted in the
housing;
[0031] (b) a spike disposed to extend longitudinally in the
housing, the top end portion of the spike having an approximately
cylindrical shape, the top end surface of the spike being an
approximately hemispherical surface which is upwardly convex, the
spike except the top end portion being formed in an approximately
tapered shape in which the outside diameter becomes progressively
smaller toward the top end, wherein a fluid transferring passage,
which is opened radially outwardly, is formed to extend
longitudinally in the peripheral surface of the spike, the bottom
portion of the fluid transferring passage being connected to a
fluid circuit;
[0032] (c) an elastic seal having an elastically deformable tubular
shape fitted on the spike to seal the spike, the elastic seal
comprising a top end portion having an openable/closable portion to
be openably closed over the spike, wherein the elastic seal is
elastically deformed to be downwardly shrunk by downward pressure
due to the tip of the male luer, thereby the openable/closable
portion is brought into abutment with the spike, and is elastically
deformed to be opened radially outwardly to be fitted onto the
spike, so that the inside of the male luer communicates with the
fluid transferring passage of the spike.
[0033] The spike may comprise at least three fins projecting
radially outwardly from the axial portion, and wherein the fluid
transferring passages are defined between adjacent ones of the
fins.
[0034] The fins may be circumferentially spaced from one another at
equal intervals, the edge of each of the fins being placed in
abutment with the inside surface of the elastic seal.
[0035] A portion of the elastic seal, which is brought in abutment
with the fins, may have a cross section of an approximately
polygonal shape.
[0036] The bottom portion of the spike may be inserted in and fixed
to the housing.
[0037] The central portion of the bottom surface of the
openable/closable portion may be made approximately flat and be
opposed to the top end of the spike across a gap.
[0038] A ring-shaped projection, which projects radially inwardly
and is placed in abutment with the top end portion of the spike,
may be formed to extend around approximately the entire
circumference of the inside surface of the top portion of the
elastic seal.
[0039] The elastic seal except the openable/closable portion and
the bottom end portion may have a bellows-shaped shrinkable
portion.
[0040] The top end surface of the housing and the top end surface
of the elastic seal may be made substantially flush with each
other.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] FIGS. 1 to 5 show a first embodiment of the invention, and
FIG. 1 is a cross-sectional view.
[0042] FIG. 2 is a cross-sectional view taken along line A-A of
FIG. 1.
[0043] FIG. 3 is a perspective view of the spike of FIG. 1.
[0044] FIG. 4 is a view of the operating state of FIG. 1.
[0045] FIG. 5 is a view of the operating state of FIG. 4.
[0046] FIG. 6 is a perspective view showing a second embodiment of
the invention.
[0047] FIG. 7 is a perspective view showing a third embodiment of
the invention.
[0048] FIG. 8 is a perspective view showing a fourth embodiment of
the invention.
[0049] FIGS. 9 to 11 show a fifth embodiment of the invention, and
FIG. 9 is a perspective view.
[0050] FIG. 10 is a cross-sectional view taken along line B-B of
FIG. 9.
[0051] FIG. 11 is a cross-sectional view taken along line C-C of
FIG. 10.
[0052] FIGS. 12 to 17 show a sixth embodiment of the invention, and
FIG. 12 is a cross-sectional view.
[0053] FIG. 13 is a partly enlarged view of FIG. 12.
[0054] FIG. 14 is a cross-sectional view taken along line D-D of
FIG. 12.
[0055] FIG. 15 is a perspective view of the spike of FIG. 12.
[0056] FIG. 16 is a view of the operating state of FIG. 12.
[0057] FIG. 17 is a view of a modification of the invention shown
in FIG. 14.
DETAILED DESCRIPTION OF THE INVENTION
[0058] A first embodiment in which the invention is applied to a
mixing plug will be described below with reference to FIGS. 1 to 5.
FIGS. 1, 4 and 5 show a mixing plug, and the mixing plug has a
housing 1, a spike (slit rod) 2, and an elastic seal (member)
3.
[0059] As also shown in FIG. 2, the housing 1 has a hollow shape
opened at both top and bottom ends so that a male luer is removably
inserted into the housing 1, and has a body 7 and a connector 8.
Polycarbonate resins, acrylic resins, hard vinyl chloride resins,
high-density polyethylene resins, polypropylene resins,
acrylonitrile-butadiene-styrene block copolymer resins, polyamide
resins, polyethylene telephthalate resins, polybuthylene
telephthalate resins, polyacetal resins, fluororesins,
polyphenylene sulfide resins, polyethersulfone resins, polyether
ether ketone resins, liquid crystal polymeric resins and the like
can be enumerated as the constituent materials of the body 7 and
the connector 8. It is also possible to use reinforced materials
prepared by compounding the above-noted resins with glass fibers,
graphites, inorganic fillers, carbon nanotubes or the like.
Furthermore, to improve the sterility of an upstream-side
connecting portion 10 which will be described later, an
antimicrobial agent (such as silver- or zinc-substituted zeorite or
silver-supported calcium phosphate) may also be kneaded with the
constituent material of the body 7 and the like.
[0060] The body 7 is made hollow at both top and bottom ends, and a
top portion of the body 7 is made an upstream-side (male)
connecting portion ((male) coupling means or (male) coupling
portion) 10 to which a male luer is to be separably connected, and
a male screw portion 11 is formed on the peripheral surface of the
top portion. On the inside of the body 7, a small-diameter hole 12
which is made the inside surface of the upstream-side connecting
portion 10, a large-diameter hole 13 which is made larger in
diameter than the small-diameter hole 12, an engagement hole 17
which is made larger in diameter than the large-diameter hole 13,
and a female screw portion 14 which is made equal in diameter to
the engagement hole 17 and in which a female screw is formed are
integrally formed to be arranged in named order in the downward
direction. An abutment surface 16 which is formed in a stepped
shape and has a surface formed to face down is formed at the
boundary portion between the large-diameter hole 13 and the
engagement hole 17.
[0061] The connector 8 has a hollow shape opened at both top and
bottom ends, and is inserted and fixed in the bottom portion of the
body 7. The connector 8 has a mating portion 19 and a
downstream-side (male) connecting portion ((male) coupling means or
(male) coupling portion) 20 which are integrally formed to be
arranged in named order in the downward direction. The mating
portion 19 has a male screw formed around its peripheral surface,
and the downstream-side connecting portion 20 is made smaller in
diameter than the mating portion 19. A communication hole 22 is
formed to extend through the inside central portion of the
connector 8 in the longitudinal direction.
[0062] The mating portion 19 is inserted and screwed into the
female screw portion 14 of the body 7 and is fixed thereto. The
downstream-side connecting portion 20 projects downwardly from the
bottom end of the female screw portion 14 of the body 7 and is
tapered in the downward direction, and a fluid transferring tube 26
shown by way of an example of a fluid circuit is separably
connected to the downstream-side connecting portion 20.
Incidentally, the fluid circuit includes not only the tubes of
fluid infusion lines and external fluid circuits but also various
solution bags such as blood transfusion bags, and various devices.
Incidentally, the connector 8 may be bonded to the body 7 instead
of being provided with the mating portion 19.
[0063] The spike 2 is disposed to extend in the inside of the body
7 in the longitudinal direction from the bottom portion of the
small-diameter hole 12 through the large-diameter hole 13 to the
top end portion of the female screw portion 14, and is uprightly
set on and adhesively fixed to the mating portion 19 of the
connector 8. As also shown in FIG. 3, the top end portion of the
spike 2 is made a straight portion 2A having an approximately
constant outside diameter, and the remaining portion is made a
tapered portion 2B which is formed in an (approximately) tapered
shape so that its outside diameter becomes progressively smaller
toward the top end portion. Incidentally, the whole of the spike 2
may also be formed in an (approximately) tapered shape so that its
outside diameter becomes progressively smaller toward its top end.
The maximum outside diameter of the straight portion 2A is
preferably approximately 0.5-2.0 mm because, for example, the
inside diameter of a tip of a glass syringe used as a male luer is
1.0-2.5 mm. As the constituent material of the spike 2, not only
the same resins as the body 7 but also metal materials such as
stainless steel can be enumerated.
[0064] The spike 2 has at least three (in this embodiment, four)
fins 27 which project radially outwardly from its axial portion.
The fins 27 are circumferentially spaced from one another at equal
intervals and extend through the entire longitudinal length of the
spike 2, and longitudinal fluid transferring passages 28 are
defined between adjacent ones of the fins 27. Each of the fluid
transferring passages 28 is formed to extend through the entire
longitudinal length of the spike 2, and is opened radially
outwardly and is also opened at both top and bottom ends. The
bottom end opening of each of the fluid transferring passages 28
communicates with the communication hole 22 of the connector 8.
Incidentally, the fins 27 may also be disposed to extend over the
entire longitudinal length of the spike 2 except the straight
portion 2A.
[0065] The elastic seal 3 has an elastically deformable tubular
(approximately cylindrical) shape, and is fitted onto the spike 2
from above to seal the spike 2. The elastic seal 3 includes an
openable/closable portion 29, a shrinkable portion 30 and a flange
portion 31 which are integrally formed to be arranged in named
order in the downward direction. By downward pressure due to the
tip of the male luer, the elastic seal 3 is elastically deformed to
be downwardly shrunk, thereby the openable/closable portion 29 is
brought into abutment with the spike 2, and is elastically deformed
and opened radially outwardly to be fitted onto the spike 2, so
that the tip of the male luer is allowed to communicate with the
fluid transferring passages 28 of the spike 2. Natural rubber,
synthetic polyisoprene rubber, butyl rubber, chloroprene rubber,
silicone rubber, urethane rubber, styrene-butadiene rubber,
ethylene propylene rubber, acrylic rubber, fluororubber,
thermoplastic elastomers and the like can be enumerated as the
constituent material of the elastic seal 3.
[0066] The openable/closable portion 29 constitutes the top end
portion of the elastic seal 3 and has an approximately disk-like
shape, and is disposed in the top portion of the small-diameter
hole 12 of the body 7 and is located over the spike 2 and has a top
end surface (approximately) flush with the top end surface of the
body 7. The central portion of the bottom surface of the
openable/closable portion 29 is made a concave surface 32 which is
made hemispherical in an upwardly concave shape, and the concave
surface 32 opposes the top end of the spike 2 across a gap.
Incidentally, the concave surface 32 may also be placed in abutment
with the top end of the spike 2. The concave surface 32 may also be
placed in abutment with the peripheral surface of the straight
portion 2A of the spike 2. The outside diameter of the
openable/closable portion 29 is made (approximately) equal to or
slightly smaller than the inside diameter of the small-diameter
hole 11 of the body 7. A single (or two orthogonal) radial slit 33
is formed to extend longitudinally through the openable/closable
portion 29 except the peripheral portion thereof, and the slit 33
can be opened by radially outward elastic deformation of the
openable/closable portion 29.
[0067] The shrinkable portion 30 constitutes the greater part of
the elastic seal 3 and has a bellows-like form, and is extended
downwardly from the bottom surface of the openable/closable portion
29 and contains the spike 2. It is to be noted that when the
elastic seal 3 is pressed downwardly by the tip of the male luer,
the elastic seal 3 shrinks downwardly, and the greater part (or the
whole) of this shrinkage is performed by the shrinkable portion
30.
[0068] The flange portion 31 constitutes the bottom end portion of
the elastic seal 3 and has a ring-like shape, and is formed to
project radially outwardly from the bottom end portion of the
shrinkable portion 30. The flange portion 31 is fitted in the
engagement hole 17 of the body 7, and is clamped and fixed between
the abutment surface 16 of the body 7 and the mating portion 19 of
the connector 8.
[0069] In the above-described embodiment, when fluid infusion,
blood collection or the like is to be performed by means of the
mixing plug, after the top end surface of the mixing plug has been
sterilized, for example, a tip 38 of a syringe 37 which is shown as
one example of a male luer is inserted into the small-diameter hole
12 of the body 7 of the housing 1 from the top end opening, as
shown in FIGS. 4 and 5.
[0070] In this case, as shown by imaginary lines in FIG. 5, a
syringe with a lock member 40 having a female screw portion formed
around its inside surface is used as the syringe 37, and the
syringe 37 can be positively maintained in the above-mentioned
inserted state by screwing the female screw portion of the lock
member 40 onto the male screw portion 11 of the body 7.
[0071] The elastic seal 3 is pressed by the above-mentioned
insertion of the tip 38 of the syringe 37, and the shrinkable
portion 30 and the like of the elastic seal 3 shrink against their
resilient forces. During this time, since the spike 2 except at
least the top end portion is made the tapered portion 2B which is
formed in an (approximately) tapered shape so that the outside
diameter becomes progressively smaller toward the top end and the
outside diameter increases not stepwise but continuously in the
downward direction, the shrinkable portion 30 and the like of the
elastic seal 3 smoothly shrink during the shrinkage of the elastic
seal 3 without being caught by a peripheral surface of the spike 2.
In addition, since the elastic seal 3 except the openable/closable
portion 29 and the flange portion 31 is made the bellows-shaped
shrinkable portion 30, the elastic seal 3 smoothly shrinks for this
reason as well.
[0072] By the above-mentioned shrinkage and the abutment between
the slit 33 of the openable/closable portion 29 of the elastic seal
3 and the top end of the spike 2, as shown in FIG. 5, the
openable/closable portion 29 is elastically deformed radially
outwardly to open the slit 33 of the openable/closable portion 29,
whereby the openable/closable portion 29 is fitted onto the top end
portion of the tapered portion 2B of the spike 2 to expose the
straight portion 2A of the spike 2 and the top end portion of the
fluid transferring passages 28. Accordingly, since the inside of
the syringe 37 communicates with the tube 26 via the fluid
transferring passages 28 of the spike and the communication hole 22
of the connector 8, fluid infusion, blood collection or the like
can be performed similarly to the case of the related art.
[0073] When fluid infusion, blood collection or the like are
completed, the tip 38 of the syringe 37 is extracted from the body
7 of the housing 1. Accordingly, the shrinkable portion 30 and the
like are expanded and restored to the original size by the
resilient forces of the shrinkable portion 30 and the like of the
elastic seal 3. During this time, since the spike 2 except at least
the top end portion is made the tapered portion 2B which is formed
in an (approximately) tapered shape so that the outside diameter
becomes progressively smaller toward the top end, the shrinkable
portion 30 and the like of the elastic seal 3 smoothly expand
without being caught by a peripheral surface of the spike 2 in a
manner similar to the above-mentioned one. In addition, since the
elastic seal 3 except the openable/closable portion 29 and the
flange portion 31 is made the bellows-shaped shrinkable portion 30,
the elastic seal 3 smoothly expands for this reason as well.
Furthermore, at the same time as this expansion, the
openable/closable portion 29 also rises, and is restored to the
original position. Accordingly, the slit 33 of the
openable/closable portion 29 is closed, and the spike 2 is sealed
by the elastic seal 3.
[0074] According to the above-mentioned embodiment, the fluid
transferring passages 28 which are opened radially outwardly are
formed on the spike 2, and even if, as in the case of the related
art, the outside diameter of the spike 2 is made small in such a
way that the fluid transferring passages 28 are not completely
covered with the peripheral wall portion of the spike 2, there is
no need for making the peripheral wall portion of the spike 2
extremely thin, whereby even the spike 2 having a small outside
diameter can be easily formed from a resin or the like.
[0075] Accordingly, even in the case where the male luer is the
syringe 37 made of glass and, the tip 38 is made of glass and is
small in its inside diameter in the above-mentioned manner, the
spike 2 can be easily inserted into the tip 38, whereby the syringe
37 and the mixing plug can be easily connected to each other.
[0076] FIG. 6 shows a second embodiment of the invention, and the
fluid transferring passage 28 which is made a groove having a
V-like cross-sectional shape is formed to extend in the peripheral
surface of the solid spike 2 along the entire longitudinal length
thereof. The fluid transferring passage 28 may be formed to extend
along the entire longitudinal length of the spike 2 except the
straight portion 2A. In addition, in this embodiment as well as
third to fifth embodiments to be described later, as in the first
embodiment as described above, the outside diameter of the tapered
portion 2B is made progressively smaller toward the top end in a
manner similar to the above-mentioned one, but the outside diameter
may be made smaller not continuously but stepwise. In addition, the
whole of the spike 2 may be made as described above.
[0077] In the above-mentioned embodiment, since the spike 2 is made
solid and a groove having a V-like cross-sectional shape is simply
formed in the peripheral surface of the spike 2 to constitute the
fluid transferring passage 28, the strength of the spike 2 can be
made large, and there is no risk that the spike 2 is deformed
during the expansion, shrink and the like of the elastic seal
3.
[0078] FIG. 7 shows a third embodiment of the invention, and the
spike 2 has a joining portion 40 and a plurality of (in the shown
example, two) branch portions 41. The joining portion 40
constitutes the top end portion of the spike 2, and the remaining
portion of the spike 2 is made of the branch portions 41. The
branch portions 41 are formed integrally with the joining portion
40 and branch off in downward directions. The fluid transferring
passage 28 is defined between the branch portions 41.
[0079] FIG. 8 shows a fourth embodiment of the invention, and the
spike 2 is made of a plurality of divided bodies 43 which extend
along the entire longitudinal length of the spike 2. In this
embodiment, the divided bodies 43 are formed into one pair in axial
symmetry, and the fluid transferring passage 28 is defined between
the divided bodies 43.
[0080] In the above-mentioned embodiment, since the construction of
the spike 2 is simple, manufacturing can be easily performed.
[0081] FIGS. 9 to 11 show a fifth embodiment of the invention, and
the spike 2 has a plurality of (in the shown example, two) main
portions 45 and a bridge portion 46. The main portions 45 are
formed to extend along the entire longitudinal length of the spike,
while the bridge portion 46 is formed integrally with the main
portions 45 and is disposed between the main portions 45 to join
these main portions 45 together. The fluid transferring passage 28
is defined between the main portions 45.
[0082] In the above-mentioned embodiment, as the bridge portion 46
is made larger, the strength of the spike 2 can be made higher and
a dead space can be made smaller, whereas as the bridge portion 46
is made smaller, the spike 2 can be made smaller in diameter.
Namely, it is possible to easily modify the performance of the
spike 2, i.e., the mixing plug, by modifying the length and the
thickness of the bridge portion 46 within a range which does not
allow the bridge portion 46 to project outwardly from the spike
2.
[0083] FIGS. 12 to 17 show a sixth embodiment of the invention, and
as shown in FIGS. 12 and 16, the body 7 generally constitutes the
top-portion side of the housing 1, and the bottom surface of the
body 7 is made the abutment surface 16. A plurality of mating
projections 48 which project radially outwardly are
circumferentially spaced from one another at equal intervals around
the peripheral portion of the bottom portion of the body 7. The
inside surface of the body 7 except the small-diameter hole 12 in
the top portion is made a tapered hole 49 which is tapered
upwardly.
[0084] The connector 8 generally constitutes the bottom-portion
side of the housing 1. The connector 8 is constructed by integrally
forming an external tube portion 51 having a tubular shape disposed
to extend in the longitudinal direction, the downstream-side
connecting portion 20, and a ring portion 52. The downstream-side
connecting portion 20 has a tubular shape opened in the
longitudinal direction and is disposed to extend through the inside
of the external tube portion 51 concentrically in the longitudinal
direction, and the bottom-end portion of the downstream-side
connecting portion 20 projects downwardly from the external tube
portion 51. A longitudinally middle portion of the external tube
portion 51 and the top end portion of the downstream-side
connecting portion 20 are connected together by the ring portion 52
having a ring-like shape.
[0085] A plurality of mating holes 54 which are formed to extend
radially through the external tube portion 51 are circumferentially
spaced from one another at equal intervals around a peripheral
portion of the external tube portion 51 above the ring portion 52,
and the mating projections 48 of the body 7 are disengageably
engaged with the mating holes 54 by elastic deformation, whereby
the body 7 and the connector 8 are integrated. A portion of the
inside surface of the external tube portion 51 which is adjacent to
the ring portion 52 is made the engagement hole 17 in which the
flange portion 31 of the spike 2 is fitted. A portion of the inside
surface of the external tube portion 51 below the ring portion 52
is made the female screw portion 14 in which a female screw is
formed.
[0086] The inside of the downstream-side connecting portion 20 is
made the communication hole 22. In addition, the top surface of the
downstream-side connecting portion 20 and the ring portion 52 is
made an abutment surface 47, and this abutment surface 47 and the
abutment surface 16 of the body 7 are brought into abutment with
the flange portion 31 of the spike 2 to clamp this flange portion
31. Furthermore, a ring projection 56 which projects upwardly is
integrally formed on the abutment surface 47, and this ring
projection 56 bites the flange portion 31 of the spike 2 so that
the flange portion 31 is more firmly fixed to the housing 1.
[0087] The spike 2 has the straight portion 2A, the tapered portion
2B and an inserting portion 2C which are integrally formed to be
arranged in named order in the downward direction, as shown in
FIGS. 13 to 15 as well.
[0088] The straight portion 2A constitutes the top end portion of
the spike 2 and has an approximately cylindrical solid structure
having an approximately constant outside diameter, and the top end
surface of the straight portion 2A is made an hemispherical surface
58 which is upwardly convex. Accordingly, since the top end surface
of the straight portion 2A is made the hemispherical surface 58
which is upwardly convex, when the spike 2 comes into abutment with
the openable/closable portion 29 of the elastic seal 3 to open the
openable/closable portion 29, the openable/closable portion 29 is
smoothly opened. Since the straight portion 2A which is the top end
portion of the spike is made approximately cylindrical, the opening
of the openable/closable portion 29 smoothly moves downwardly along
the straight portion 2A of the spike 2 so that the
openable/closable portion 29 can be smoothly opened and closed.
[0089] The tapered portion 2B constitutes the spike 2 except the
top and bottom end portions and is formed in an (approximately)
tapered shape so that its outside diameter becomes progressively
smaller toward the top end.
[0090] The inserting portion 2C constitutes the bottom end portion
of the spike 2, and is made smaller in diameter than the outside
diameter of the bottom end of the tapered portion 2B and is made
constant in outside diameter. The inserting portion 2C is inserted
into the communication hole 22 of the connector 8 and is fixed to
the inside surface of the communication hole 22 by an adhesive or
by being fitted thereinto. Since the inserting portion 2C of the
spike 2 is inserted into and fixed to the communication hole 22 of
the connector 8, the spike 2 can be easily and firmly fixed to the
housing 1.
[0091] The tapered portion 2B and the inserting portion 2C are made
of at least three (in this embodiment, four) fins 27 which project
radially outwardly from its axial portion. The fins 27 are
circumferentially spaced from one another at equal intervals and
the longitudinal fluid transferring passages 28 are defined between
adjacent ones of the fins 27. Each of the fluid transferring
passages 28 is opened radially outwardly and is also opened at both
top and bottom ends. The bottom end opening of each of the fluid
transferring passages 28 communicates with the communication hole
22 of the connector 8.
[0092] The elastic seal 3 is a modification of the elastic seal of
the first embodiment, and has the openable/closable portion 29, the
shrinkable portion 30 and the flange portion 31 which are
integrally formed to be arranged in named order in the downward
direction.
[0093] The shrinkable portion 30 does not have a bellows-like form,
unlike the shrinkable portion 30 of the first embodiment. The
inside surface of the shrinkable portion 30 is preferably made a
smooth surface so that the shrinkable portion 30 can be smoothly
fitted onto the spike 2. The top portion of the shrinkable portion
30 is made approximately constant in both inside and outside
diameters, and an inside surface 3A of this top portion has one or
a plurality of ring-shaped projections 60 formed to be arranged in
the longitudinal direction as shown in FIG. 13. The ring-shaped
projections 60 are formed to project radially inwardly from the
inside surface of the shrinkable portion 30 and to extend around
(approximately) the entire circumference of the inside surface 3A
of the shrinkable portion 30. At least one of these ring-shaped
projections 60 is placed in abutment with the straight portion 2A
of the spike 2, whereby the pressure resistance (strength) of the
openable/closable portion 29 of the elastic seal 3 can be enhanced
to prevent accidental opening of the openable/closable portion
29.
[0094] The shrinkable portion 30 except the top portion is formed
in an (approximately) tapered shape so that its inside and outside
diameters become progressively smaller toward the top end. The
outside contours of the longitudinal cross-section of the
bottom-portion side of the shrinkable portion 30 is made wavy so
that the shrinkable portion 30 easily expands and shrinks.
[0095] Incidentally, it is preferable that an edge which is located
on the outermost side of each of the fins 27 of the tapered portion
2B of the spike 2 be placed in abutment with the inside surface 3A
of the elastic seal 3, because it is possible to decrease the
volume (or medical-valve volume or dead space) of the mixing plug
in the inside of the elastic seal 3 and it is possible to decrease
the amount of backflow of a medicament solution which occurs when
the tip 38 of the syringe 37 which is shown as one example of a
male luer is separated from the mixing plug. For this reason, in
this embodiment, for example, the inside diameter of the elastic
seal 3 is made smaller than the minimum outside diameter of the
fins 27, and the elastic seal 3 is fitted onto the spike 2 while it
is being elastically deformed, whereby the outside surface of the
fins 27 of the tapered portion 2B of the spike 2 is brought into
abutment with the inside surface 3A of the elastic seal 3. At this
time, a portion of the elastic seal 3, which is brought in abutment
with the fins 27, has a cross section of an approximately polygonal
shape. As shown in FIG. 14 by way of example, if the number of the
fins 27 of the spike 2 is four, the portion of the elastic seal 3,
which is brought in abutment with the fins 27, has a cross section
of an approximately quadrilateral shape, while as shown in FIG. 17
by way of example, if the number of the fins 27 of the spike 2 is
three, the portion of the elastic seal 3, which is brought in
abutment with the fins 27, has a cross section of an approximately
triangular shape. The outside diameter of each portion of the spike
2 is defined as follows. Namely, the smallest circuit that passes
part of the outermost edge of each portion of each of the fins 27
is assumed, and the diameter of the circle is made the outside
diameter of each portion of the spike 2. Incidentally, the portion
of the elastic seal 3, which comes into abutment with the fins 27,
may be previously made an approximately polygonal shape
corresponding to the number of the fins 27.
[0096] It is to be noted that the housing of the first embodiment
and the spike and the elastic seal of the sixth embodiment may also
be combined, or the spike and the elastic seal of the first
embodiment and the housing of the sixth embodiment may also be
combined.
[0097] In each of the embodiments, when the syringe is extracted
from the housing, the elastic seal expands by the resilient force
of the elastic seal, and a metal spring, a resin spring or the like
may also be used in combination for the purpose of assisting with
this expansion. In addition, although in each of the embodiments
the invention is applied to the mixing plug, the invention can be
applied to various other kinds of medical valves.
* * * * *