Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
I~l`MOVABT.E III/MOSriASIS VAIVE
The invention relates to a hemostasis valve corn-
prising a body haviny a central passage, and a diaphragm
having a wall member with a slit therein, the diaphragm
being rnounted in the central passage. In accordance
wi-th the invention the valve has fast release connector
means preferably in the form oE screw threads.
In the drawings which show a preferred eMbodiment,
Fig. l is a cross--sectlonal view of a hemos-tasis
valve in accordance with the present invention,
Fig. 2 is a cross-sectionai view of a preferred
embodiment of the invention with and without a catheter
inserted.
Fig. 3 is a perspective view of one embodiment of
the self-closing isolation diaphragm of the present inven-
tion.
Fig. 4 is a bottom view of the diaphragm of Fig.
3.
Fig. 5 is a side view of the diaphragm of Fig.
T}-e hemostasis valve i.s shown generally a-t 1. The valve
housing 2 has a re-taini.ng cap 3 thereover. The retaining cap
3 is preferably made of plastic. A cathe-ter seal 4 is held
in place by the retai.ning cap 3. A self-closina isolation
diaphra~m 5 has diaphragm upper flange surface 27 which
is in con-tac-t with catheter seaL lower surface 28. The
self-closing isolati.on diaphragm 5 has diaphragm wa]l member
37. The diaphragm wall member 37 has diaphragm i.nner side
surface 33, diaphragm outer bottom surface 21 and dia-
phragrn inner bottom surface 34. The self-closing isolation
diaphragm chamber 11 is bounded by diaphragm inner side
su:rface 33 and diaphragm inner bottom surface 34. The self-
closing isolation diaph:ragrn flallge 32 has diaphragm
lower flange surface 25 which is in contact with valve
housing top surface 26. The retaining cap provides fluid-
tight sealing by its tight retention with retaining cap
rib 20 which fi.ts into valve housing groove 19. The fit
hetween the retaininq cap 3, catheter seal 4 and the self-
closing isolation diaphragm flange 32 is such that
the catheter seal and the diaphragm flange 32 are compres-
sed by the retaining cap 3. The catheter seal 4 and the
diaphragm flange 32 are held in compression by the retain-
ing cap rib 20. The retaining cap 3 is provided with re-
~L~91~
-tain:ing {'ap bevelecl surfclce 15 which sl.opes into
retainirlg cap aperture 13 through which a catheter tube
may be inserted. The cathe-ter seal 4 is provided with
catheter seal aper-ture 14. Thu.s, when a catheter is
inserted throuc3h the valve it would extend through the re-
taining cap aperture 13, the catheter seal aperture 14 and
-the self-closing isolation diaphra~3m chamber ]1 whereupon
it would meet the diaphragm inner bot-tom surface 34 at the
diaphragm slit 12. The slit 1~ opens to al.low passage of
the catheter being inserted and the cat.heter passes
into and throuc3h the lower central passage 10. The lower
central passaye inner surface 9 provides support for the
catheter. The self-closing isolation diaphragm 5 is provided
with a diaphragm outer side surface 35. The surface 35 is
i.ntegrally connected with diaphragm rib 38. The diaphragm
rib 38 has a diaphragm rib side surface 36 and diaphragm
rib bot-tom surface 22.
~ Upon forcing the catheter through the diaphragm
slit 12 the diaphragm rib 38 compresses against the
upper central passage wall 24. Upon withdrawing the
catheter from the hemostasis valve 1 the compressed dia-
phragm rib 38 expands to its original position, causing
the diaphragm slit 12 to close.
The hemostasis valve 1 is provided with a fast
release connector 6 having connector threads 7 which are
available to connect the valve to the flange 52 of fast
connec-~ fas-tener 39 as shown in ~igure 2. The connec-tor
chamber wall 30 surrounds a connec-tor chamber 29.
The hemostasis valve is further provided with
a side passage 18. The side passage 18 has side passage
inner surface 16. Side passage outer surface 17 extends
outwardly from -the valve housing 2. Fast connect
fastener passage 49 has East connect passage inner sur-
face 48 through which the catheter C passes. The tubing
41 has tubing flange 43 which holds the tubing 41 to the
fast connect fastener 39. The fastener cap 40 has
fastener cap threads 44 which are threaded onto fast
connect fastener threads 45. As the fastener cap 40 is
threaded onto the fast connect fastener 39 the fastener
cap flange 42 compresses the tubing flange 43 against the
lower fast connect fastener surface 57. The tubing
41 has a tubing passage inner wall 46 which surrounds
the tubing passage 47. The tubing 41 has a tubing pass-
age outer surface 51 which is supported at its upper
end by fastener cap inner surface 50~
Figure 2 shows a modified version of -the cath-
eter seal in the form of cushion seal 104 having a
cushion lip outer curved surface 56 and a cushion lip
inner curved surface 55. The cushion lip inner
cllrved t~ r~l(e 55 has cus}~~ion lip l-)eveled surftlce 54
which is in contact with lipped diaphragm 132. T.iF~ped
cl:iclphragm 132 has a diar~hragm lip 53 and slit l12. The
lower central passaye of -the fas-t rel~ase connect~r has
a central axis A-A as shown ln Fiqure 1. The fast release
connector 6 is concentric with the ]ower cen-tral passage
10. The fast connect fastener 39 is coaxial with the lower
central passage 10.
As shown in Figure 2 when a ca-theter C is inserted
into the cushion seal the cushion lip outer curved surface
flexibly suppor-ts the catheter. As the catheter passes
through the slit 112 of -the li.pped diaphragm 132 the
diaphragm lip 53 is carried downwardly into the lower
central passage 10. ~pon further insertion the catheter
passes through the fast connect fastener passage 49 and
into the tublng passage 47.
In use fluids may be transferred through the
catheter C i.nto the blood vessel of the patient.
The hemostasis valve is operable for easy entry of the
catheter C and ye-t provides for positive closing as
the cathe-ter C is removed. The diaphra~m prevents any
leakage either inward or outward with applied pressures
to as high as 500 mm Hg. The hemostasis valve is operable
so that the tubing 41 may be separated from the valve
housing 2, leaving the tubing in place. This
al~ows for repl~cing the valve housing 2 in
case it is darnaged or contaminated. T}lis makes
it unnecessary to prepare a new entry site
in the patient. Figure 2 shows a preferred
embodiment of the invention with a cushioned
seal which prevents leakage even when the
catheter C is displaced to one side.
To the left of the center line in
Figure 2 an embodiment is shown with a
catheter inserted. To the right of the center
line in Figure 2 an embodiment is shown
without a catheter inserted.
In use the fluid is fed through side
passage ~8 from a bag of fluid which may be
suspended on a pole next to the patient. The
~ fluids may contain antibiotics,nutrients, or
any suitable liquid useful for intravenous
passage into the patient From the side
passage 18, the fluid travels into and ~ownwardly
in the central passage 58 by first passing through
the lower central passage 10. The fluid continues
downwardly through the fast connect fastener pas-
sage 49 and into the tubing passage 47~ the
tubiny 41 having previously been inserted into
the patient's vessel. The insertion of the tubing
41 into the patient's vessel may be done as is known
in the art. For example, the patient's vessel may
be opened by cutting followed by insertion of a
3~ string dilator. Into the string dilator is inserted
--7--
the tubing 41.
In using the h~nostasis valve 1 in conjur)ction
with the tubing 41 after it has been i~serted into a
vessel of the patient with fast connect fastener ~9
attached to the end of tubing 41, the hcmostasis
valve 1 may be connected to the fast connect fastener
39.
When the valve 1 is connected, as just mentione~
a catheter may be inserted as partially shown in
Figure 2 to the left side of the center line. The
path followed by the catheter provides for vers tility
of access to the patient's vessel by catheters of
various sizes and lengths and curvatures. Additionally,
this pa~h may be used for high volume of fluid deliv-
ery to the patient's vessel by using a large diametertubular catheter tv conve~ fluids therethrough~
When several different catheters have been
inserted in the patient's vessel, they may be passed
through the self-closing isolationdiaphragm ; and the
catheter seal 4 into the lower central passage 10 and
on downwardly as previously discussed. In place, the
self-closing isolation~iaphragm 5, provides fluid
tight sealing around the catheter so that leakage
does not occur. Upon removing the catheter, the
sel~ closing isolationdiaphragm 5 seals the upper
central passage 59 so that blood or other fluids from
the lower central passage 10 are not lost or contamin-
ated. The diaphragm wall membex 37 preferably has a
dome shape as shown in Figure 1 and Figure 2~ Inherent
in this shape, is the support needed to seal the slit
12 w}~ile rcsisting fl~ e.sure in l~,~er ccntral
passage 10 and upper centra] passage 59. The diaphr~m
rib 38 assists in maintaining fluid-tight sealing
axound the catheter C wl-ile it is inserted through
the self-closing diaphram 5. The diapllragm rib 38
also hclps to return the self-closing diaphragm to
its closed ~osition with the slit 12 closed after the
catheter C is withdrawn from the valve 1.
The self-closing isolation diaphragrn 5 is prefer-
ably made of a f lexible material such as natural or
synthetic rubber. S.unilarly, the catheter seal 4 is
preferably n~ade of natural or synthetic rubber
