U.S. patent number 3,817,240 [Application Number 05/266,996] was granted by the patent office on 1974-06-18 for multiple sample needle assembly with one-way valve and blood flow indicator.
This patent grant is currently assigned to Becton Dickinson and Company. Invention is credited to Waldemar A. Ayres.
United States Patent |
3,817,240 |
Ayres |
June 18, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
MULTIPLE SAMPLE NEEDLE ASSEMBLY WITH ONE-WAY VALVE AND BLOOD FLOW
INDICATOR
Abstract
A needle assembly for facilitating the collection of a blood
sample from a patient into an evacuated collection container and
indicating when a venipuncture has been accomplished and preventing
flow of fluid from the collection container into the patient during
and after collection of the blood sample. The assembly includes a
housing having a chamber therein, a forward penetrating end
including a cannula extending from the housing for penetration into
the blood vessel of a patient, and a rearward end including a
cannula extending from the housing and adapted to be coupled in
fluid communication with the interior of an evacuated collection
container. Surfaces of the assembly form a passageway for directing
blood from the blood vessel through the housing to the collection
container when the forward end is in the blood vessel and the
rearward end is in the container. A valve assembly is mounted in
the chamber in the housing and normally is in the unarmed position
with passages therein to permit blood to flow from the vein into
the chamber upon venipuncture. The assembly is shiftable to an
armed position to close the passageway from the vein into the
chamber by means of a resilient elastomeric valve member in the
chamber. The valve member is adapted to be responsive to a
reduction in fluid pressure at the rearward end to deform and
automatically open the passageway and permit blood to flow from the
blood vessel to the rearward end. Thereafter, the valve member is
responsive to a predetermined increase in fluid pressure at the
rearward end to automatically return to the closed position to
thereby prevent flow of fluid from the rear end of the assembly to
the blood vessel.
Inventors: |
Ayres; Waldemar A. (Rutherford,
NJ) |
Assignee: |
Becton Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
23016877 |
Appl.
No.: |
05/266,996 |
Filed: |
June 28, 1972 |
Current U.S.
Class: |
600/577; 604/205;
600/579; 600/584 |
Current CPC
Class: |
A61B
5/1545 (20130101); A61B 5/150389 (20130101); A61B
5/150519 (20130101); A61B 5/150732 (20130101); A61B
5/150221 (20130101); A61B 5/15003 (20130101); A61B
5/150351 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61b 005/14 () |
Field of
Search: |
;128/2F,2R,DIG.5,218NV,276 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan
& Kurucz
Claims
I claim:
1. A needle assembly for facilitating the collection of a blood
sample from a patient by first indicating when a venipuncture has
been accomplished, then transferring blood from the patient into an
evacuated container, while preventing any back flow from the
container into the patient, and automatically blocking the blood
flow due to venous pressure while shifting to successive sample
tubes to be filled with the same venipuncture, said needle assembly
comprising:
a housing having a chamber therein;
a forward penetrating end including a cannula extending from the
housing for penetration into the blood vessel of a patient;
a rearward end including a cannula extending from the housing and
adapted to be coupled in fluid communication with the interior of
an evacuated collection container;
surfaces of said assembly to form a passageway for directing blood
the blood vessel through the housing to the collection container
when the forward end is in the blood vessel and the rearward end is
in the container;
a valve assembly mounted in the chamber in the housing and normally
in the unarmed position with passages therein to permit blood to
flow from the vein into the chamber upon venipuncture and being
shiftable to an armed position to close the passageway from the
vein into the chamber by means of a resilient elastomeric valve
member in the chamber;
said valve member adapted to be responsive to a reduction in a
fluid pressure at the rearward end to deform and automatically open
the passageway and permit blood to flow from the blood vessel to
the rearward end and into a container, thereafter to be responsive
to a predetermined increase in fluid pressure at the rearward end
to automatically return to the closed position to thereby prevent
flow of fluid from the rear end of the assembly to the blood
vessel; and
the rear end of the penetration cannula being mounted in the
forward penetrating end of the housing extends rearwardly into the
chamber of the housing; an elastomeric sleeve slidably mounted on
the rear end of the penetration cannula in sealing engagement
therewith, the sleeve being shiftable between an unarmed position
and an armed position on said penetration cannula, the sleeve
having a closed rear end and a forward open end with the
penetration cannula mounted in the open end of the sleeve, at least
one transverse hole in the wall of the sleeve permitting
communication between the rear end of the penetration cannula and
the exterior of the sleeve when the sleeve is in the unarmed
position and said at least one transverse hole being closed when
the sleeve is shifted to the armed position, a slit in the wall of
the sleeve normally in closed position when the sleeve is in the
armed and unarmed position and adapted to automatically open when
there is a reduction in fluid pressure at the rearward end and
thereafter to automatically close when there is a predetermined
increase in fluid pressure at the rearward end, and an annular
flange extending from the forward open end portion of the sleeve to
facilitate engagement of the sleeve and shifting of the sleeve from
the unarmed to the armed position.
2. The invention in accordance with claim 1 wherein the cannula
extending from said rearward end is slidably mounted and has been
inserted after a tubular hollow cage is mounted on the slidable
cannula in the chamber of the housing in surrounding relationship
to the elastomeric sleeve, the cage being in engagement with the
flange on the sleeve so that shifting of the slidable cannula will
shift the cage and the engaged sleeve from the unarmed to the armed
position when moved in one direction and will disengage from the
sleeve when the slidable cannula is moved in the opposite
direction.
3. The invention in accordance with claim 1 wherein the housing is
made of a transparent material.
4. The invention in accordance with claim 2 wherein there is at
least one transverse opening in the side walls of the cage to
permit communication with the at least one transverse hole in the
sleeve so that when the sleeve is in the unarmed position and a
venipuncture is accomplished, blood will flow through the
penetration cannula, through the at least one transverse opening in
the sleeve and through the at least one transverse opening in the
cage into the chamber of the housing to provide an indication that
the venipuncture has been accomplished.
5. The invention in accordance with claim 2 wherein the cage is
mounted on the inner end of the slidable cannula so as to seal the
end thereof and the slidable cannula has a side opening therein
adjacent the rear end thereof so as to be positioned within the
chamber of the housing when the sleeve is in the unarmed position
and when the sleeve is in the armed position and a collection
container is coupled in fluid communication with the slidable
cannula, and the side opening being shiftable out of the chamber of
the housing and being sealed therefrom by the elastomeric sealing
disc when a collection container has been removed from the slidable
cannula and the slidable cannula has been withdrawn until surfaces
on the cage engage with surfaces in the housing to provide a stop
to further withdrawal of the slidable cannula.
6. Apparatus for collecting multiple blood samples from a patient
including the combination of:
A. a housing;
B. a first hollow, pointed needle extending forwardly from the
housing adapted for piercing the tissues of a patient and
conducting blood therefrom;
C. blood flow indicating means coupled with said first needle and
adapted to provide a visual signal when the needle has penetrated a
blood vessel;
D. a check valve means coupled with said first needle and adapted
to assume a first position to enable blood to flow out of the
patient and a second position to prevent any fluid from flowing
back into the patient;
E. a chamber in the housing in fluid connection with said check
valve;
F. a normally closed second valve means, and adapted when closed to
prevent any blood from flowing out of said chamber; and
G. a second hollow pointed needle means extending rearwardly from
the housing and having surfaces forming part of said second valve
means; said second needle means adapted to be moved from a first
position to a second position, and adapted to actuate said second
valve means, whereby when the second needle means is in its first
position said second valve means is closed, and when said second
needle means is in its second position said second valve means is
open to permit flow of blood from the patient to a blood container,
and as many other prescribed containers with one penetration of the
tissues of a patient with the first needle without blood spillage
when changing containers.
7. The invention in accordance with claim 6 including a blood
container with a resilient closure containing a partial vacuum, so
positioned and arranged that when said container is pushed forward
the resilient closure pushes the second needle means forward, which
causes the second valve to open and causes the second pointed
needle means to penetrate through the resilient closure, thereby
enabling the patient's blood to substantially fill the container,
and when the container and resilient closure are pulled backward
off the second needle means, this needle means moves causing the
second valve means to close, thereby preventing any further flow of
blood until another of said blood containers is used.
8. The invention in accordance with claim 6, wherein said blood
flow indicating means includes a passageway enabling air and blood
to flow into said chamber while bypassing said check valve
means.
9. The invention in accordance with claim 8, including means for
automatically closing said bypass passageway when the blood
container is coupled with the second hollow pointed needle
means.
10. The invention in accordance with claim 6, including means for
automatically moving said check valve means from an inoperative
position to an operative position when the second needle means is
coupled with the blood container and moved in the forward
direction.
11. The invention in accordance with claim 6, including means for
automatically changing said second valve means from a closed
condition to an open condition when the second needle means is
coupled with the blood container and moved in the forward
direction.
12. The invention in accordance with claim 6, including means for
automatically closing said second valve means when the second
needle means is coupled with and the blood container withdrawn in
the backward direction.
13. The invention in accordance with claim 6, where said check
valve means is made of a deformable resilient material having a
cylindrical shape closed at one end and having at least one slit
opening, normally closed, said slit opening adapted to open
automatically when the interior of said check valve means is
subjected to a greater fluid pressure than the exterior fluid
pressure, and the slit also is adapted to close automatically when
this pressure differential is absent or is reversed.
14. The invention in accordance with claim 6, including pusher
means cooperating with said check valve means, said check valve
means including at least one bypass passageway initially open,
whereby said bypass passageway is automatically closed when said
pusher means slides the check valve means axially along the inner
end of said first hollow needle so that the bypass passageway is
occluded by said first needle when second needle means is coupled
with the blood container closure and pushed in the forward
direction.
15. The invention in accordance with claim 14, wherein the check
valve means includes a flange portion and said pusher means
includes a hollow cylinder of rigid material mounted on the inner
end of the second hollow pointed needle means and is adapted to
engage the flange portion of said check valve means, whereby when
the second needle means is coupled with the blood container and
pushed in the forward direction the rigid hollow cylinder attached
to it pushes the check valve means in the forward direction until
the bypass passageway is closed.
16. The invention in accordance with claim 6, wherein the second
valve means includes an elastomeric seal adapted to maintain a
fluid-tight seal between said second needle means and said
chamber.
17. The invention in accordance with claim 16, wherein the second
valve means includes an annular projecting ring portion in the seat
of said elastomeric seal.
18. The invention in accordance with claim 16, wherein the second
valve means includes a retainer disc having an interference fit
with a portion of said chamber to retain said disc and said
elastomeric seal in place and having a clearance hole through which
said sliding second needle means extends.
19. The invention in accordance with claim 6, where said chamber is
defined by a forward housing portion and an attached rearward
housing portion including a transparent portion adapted to transmit
a visual indication of blood flow.
20. The invention in accordance with claim 19, wherein the forward
housing portion supports the first needle and check valve
means.
21. The invention in accordance with claim 19, wherein the rearward
housing portion supports the second hollow needle means and second
valve means.
22. The invention in accordance with claim 16, wherein said second
needle means has a side opening cooperating with said elastomeric
seal to act as said second valve means.
23. The method of transferring blood from a patient into a blood
sample assembly and container which includes the steps of:
A. inserting a first sharp pointed hollow needle into a patient's
blood vessel;
B. conducting the patient's blood through said first needle and
into a blood flow indicator;
C. pushing in the forward direction a partially evacuated blood
collecting container with a resilient closure after the blood flow
indicator has shown that the first needle has been successfully
inserted in the patient's blood vessel, causing a second hollow
pointed needle to penetrate through the resilient closure; and so
that the blood container is operatively connected with the blood
sample assembly;
D. actuating a check valve incident to said forward pushing of the
blood container insuring that blood can flow from the patient into
the blood container but that no fluid can flow back from the
container into the patient;
E. opening an exit valve between a chamber of said blood sample
assembly and the second hollow pointed needle incident to said
forward pushing of the blood container;
F. transferring blood from the patient's blood vessel under the
influence of the partial vacuum, through the first needle, through
the check valve, through the chamber of the assembly, through the
exit valve, and through the second needle until the blood container
is substantially filled;
G. removing the filled blood container in the backward direction
and thereby closing the exit valve;
H. repeating the foregoing steps C to G; and
I. in the same manner filling as many blood containers as desired
with a single puncture of the patient's blood vessel.
Description
BACKGROUND OF THE INVENTION
In the blood sampling field, there are several well known systems.
One of the more commonly used systems is the collection of blood
from a vein through a needle assembly into an evacuated container.
The evacuated container provides the pressure differential
necessary to facilitate flow and collection of the blood through
the needle assembly into the container. The basic system and
apparatus for collecting blood in this manner is disclosed in U.S.
Pat. No. 2,689,564 to Kleiner.
Improvements have been made in recent years to the basic evacuated
container system for blood sampling such as by the provision of a
valve on the assembly to automatically open and close the flow path
through the assembly as evacuated containers are coupled in
succession with the assembly. In this manner, a multiplicity of
samples can be collected in a multiplicity of containers with only
one venipuncture required. Needle assemblies with automatic valves
are shown and described in U.S. Pat. No. 3,469,572 to Nehring and
U.S. Pat. No. 3,494,352 to Russo et al. Frequently the evacuated
containers contain chemical materials, useful in the clinical
laboratory test to be conducted after mixing with the patient's
blood. However, these chemical materials may be harmful to a
patient if any were to flow from the evacuated container into the
patient's blood system. This problem has been successfully
eliminated by use of a one-way valve as shown and described in my
co-pending application Ser. No. 267,559 filed on June 29, 1972
In systems such as those referred to above, it has often been found
that it is desirable to provide an indication means on the needle
assembly to inform the operator when he has successfully
accomplished a venipuncture. Once a venipuncture has been
accomplished and indicated the indication means would no longer be
necessary and could be dispensed with during further operation of
the needle assembly in collection of one or more samples of blood
without danger of back flow. Consequently, it would be extremely
advantageous to provide a single device which includes a one-way
valve for use in collecting multiple samples of blood from a single
venipuncture into a multiplicity of collection containers while
eliminating the danger of back flow of fluid into the patient and
which includes a blood flow indication means which indicates that a
venipuncture has successfully been accomplished to the operator so
that the evacuated collection container can be fully coupled into
fluid communication with the needle assembly.
SUMMARY OF THE INVENTION
With the above background in mind, it is among the primary
objectives of the present invention to provide a multiple sample
collection needle assembly whereby a multiplicity of samples can be
obtained from a single venipuncture into a multiplicity of
collection containers with the needle assembly including a one-way
automatic valve which is responsive to a pressure differential to
permit blood to flow into the collection container and which is
automatically responsive to a predetermined pressure change to
automatically prevent back flow of fluid into the patient. A needle
assembly is also designed to include a blood flow indicator to
inform the operator when a venipuncture has been successful so that
a collection container can be fully coupled with the needle
assembly to provide fluid communication between the patient and the
collection container. The assembly is designed so that the
venipuncture indicator is deactivated upon accomplishment of a
successful venipuncture and thereafter leakage is prohibited from
the assembly between collections of separate samples in successive
collection containers.
To accomplish the above objectives, a needle assembly is provided
which includes a housing having a chamber therein, a forward
penetrating end including a cannula extending from the housing for
penetration into the blood vessel of a patient, and a rearward end
including a cannula extending from the housing and adapted to be
coupled in fluid communication with the interior of an evacuated
collection container. There are surfaces of the assembly which form
a passageway for directing blood from the blood vessel through the
housing to the collection container when the forward end is in the
blood vessel and the rearward end is in the container. A valve
assembly is mounted in the chamber in the housing and normally is
in the unarmed position with passages therein to permit blood to
flow from the vein into the chamber upon venipuncture. The assembly
is shiftable to an armed position to close the passageway from the
vein into the chamber by means of a resilient elastomeric valve
member in the chamber. The valve member is adapted to be responsive
to a reduction in fluid pressure at the rearward end to deform and
automatically open the passageway and permit blood to flow from the
blood vessel to the rearward end. Thereafter, the valve member is
responsive to a predetermined increase in fluid pressure at the
rearward end to automatically return to the closed position to
thereby prevent flow of fluid from the rear end of the assembly to
the blood vessel.
With the above objectives, among others, in mind, reference is had
to the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a side elevation view of the needle assembly of the
invention shown in engagement with a holder and with an evacuated
container in position for coupling therewith;
FIG. 2 is an enlarged fragmentary section view thereof subsequent
to an indicated venipuncture and prior to initial closure of the
valve member;
FIG. 3 is an enlarged sectional view of the needle assembly of FIG.
2 shown in the same operable position;
FIG. 4 is a sectional elevation view thereof subsequent to shifting
of the valve member to the closed position after indication of a
venipuncture and prior to completion of coupling in fluid
communication with an evacuated collection container;
FIG. 5 is an enlarged sectional view of the needle assembly of FIG.
4;
FIG. 6 is a fragmentary sectional elevation view thereof with an
evacuated collection container in full coupled fluid communication
with the needle assembly and the valve member in the opened
position to permit blood to flow between the vein and the
collection container;
FIG. 7 is an enlarged sectional elevation view of the needle
assembly as shown in FIG. 6;
FIG. 8 is a fragmentary sectional elevation view thereof with the
collection container having been removed and the valve member in
the closed position preventing flow between the ends of the needle
assembly;
FIG. 9 is a fragmentary enlarged elevation view of the needle
assembly as shown in FIG. 8; and
FIG. 10 is an exploded fragmentary perspective view of the needle
assembly of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The separated components of the needle assembly 20 are shown in
FIG. 10. The assembly includes a housing 21 which is in two parts,
a forward part 22 and a rear part 23. Mounted in the forward part
22 is a cannula 24 and mounted in the rear part 23 is a second
cannula 25. When forward end 22 is engaged with rear end portion 23
an interior chamber 26 is formed as shown in FIGS. 1-9. Housed in
chamber 26 is an elastomeric sleeve 27, a rigid cage 28, a
retaining disc 29, and an elastomeric sealing disc 30.
Forward end portion 22 has a tapered cylindrical outer rear surface
31 which frictionally engages with an inner cylindrical surface 32
on rear end 23. The frictional interengagement is rigid enough to
prevent disassembly of the parts of housing 21 during operation of
the assembly. If desired, to insure the interengagement of the
parts of housing 21, epoxy may be employed between surfaces 31 and
32 to achieve a positive blocking engagement.
A passageway 33 in forward end portion 22 permits communication
between the forward edge of end portion 22 and chamber 26. Cannula
24 is mounted in passageway 33 with a rear blunt end portion 34
extending into chamber 26 and a forward end portion terminating in
tip 35 extending forward of portion 22. Tip 35 is pointed to
provide a penetration end for venipuncture purposes.
Rear end portion 23 of the housing has a cylindrical principal
portion 36 for engagement with forward portion 22 and to provide
the majority of the boundary for chamber 26. The remainder of rear
end portion 23 has a reduced outer diameter which includes a
threaded surface 37 for threaded interengagement with a holder 38.
Holder 38 is utilized as a guide for an evacuated collection
container 39. A tube 40 containing at least a partial vacuum is
closed at its open end by a self-sealing punctureable stopper 41 to
form evacuated container 39.
Rear end portion 23 contains an axial passageway 42 providing
communication from the rear end of housing 21 into chamber 26.
Cannula 25 is slidably mounted in passageway 42.
The rear end of cannula 25 extends outwardly from housing 21 and
has a pointed tip 43 for penetration through stopper 41 of
evacuated container 39. Cannula 25 is slidably mounted in
passageway 42 of housing portion 36 and has its inner end 44
extending into chamber 26. Adjacent the inner tip of cannula 25 is
a side opening 45 which is shiftable into and out of chamber 26 as
cannula 25 slides during operation of the needle assembly. Sealing
disc 30 rests against the rear wall of chamber 26 and has a central
opening therein smaller in diameter than the outer surface of
cannula 25 so that the elastomeric sealing disc 30 retains sealing
engagement with cannula 25 as it slides with respect thereto. In
this manner, the integrity of chamber 26 is retained and leakage is
prevented at the rear end of housing 21. To assist in the sealing
function of disc 30, rigid sealing disc 29 is positioned in the
rear end of housing 21 in frictional engagement with the side walls
of the housing and retaining elastomeric disc 30 between its
undersurface and the rear wall of the housing. An annular ring 46
projecting from the housing engages with the surface of disc 30
opposite the retaining disc 29 in order to assure a clamping
engagement with disc 30 and preventing leakage from chamber 26
through passageway 42 of housing 21.
Mounted on the inner blunt end portion 44 of cannula 25 is cage 28.
The mounting can be achieved in any convenient manner such as by an
epoxy resin 47. Cage 28 may be constructed of a plastic material
and closes the end of end portion 44 of cannula 25. This leaves the
only access from chamber 26 into the bore of cannula 25 through
side opening 45. Cage 28 has a closed end mounted on cannula 25 and
an opposite open end and adjacent to the closed end are a number of
transverse side ports 48, for example, four, as shown. The side
ports are spaced about the circumference of cage 28. The outer
diameter of cage 28 is less than the inner diameter of housing 21
so that cage 28 is free to slide axially as sliding needle 25
slides. The cage 28 is cylindrically shaped and hollow so as to
receive the major portion of sleeve 27 therein with clearance for
the cage 28 to slide reciprocally with respect to sleeve 27. The
cylindrical rim at the open end of cage 28 engages with flange 50
on the circumference of the open end of sleeve 27. The open end
portion of sleeve 27 is mounted on the rear end 34 of cannula 24.
Cannula 24 is fixed in passageway 33 of housing 21 by any
convenient means such as epoxy 51. Sleeve 27 has its open end
expanded so that it frictionally engages with the rear end portion
34 of cannula 24 in sealing relationship. Sleeve 27 is shiftable to
an armed position as shown, for example in FIGS. 4-9 in contrast to
its initial unarmed position as shown in FIGS. 2 and 3. The
operational sequence of use of the needle assembly will be
discussed in detail below. In the unarmed position as shown in
FIGS. 2 and 3, sleeve 27 has a central passageway 52 to receive
rear portion 34 of cannula 24. Initially, only the forward open
portion of sleeve 27 is mounted on cannula 24 and to the rear of
blunt tip 53 of cannula 24, the sleeve 27 has one or more
transverse holes 54 to provide communication between the interior
of sleeve 27 and the exterior thereof. Additionally, adjacent the
rear end of sleeve 27 is a slit 55 which is normally in the closed
position due to the self-sealing elastomeric properties of sleeve
27. Any well known elastomeric self-sealing material such as
natural or synthetic rubber can be utilized for sleeve 27.
The components of housing 21 and cage 28 may be made of transparent
plastic parts so that the presence of blood can be readily visible
through them for indication purposes. Additionally, sleeve 27 could
be constructed of a transparent elastomeric material, however, this
is not generally utilized, since the blood will flow into
surrounding spaces provided and will be visible through the
transparent portions of the housings during indication procedures
as will be discussed in detail below. All of the components of the
assembly with the exception of the cannulas and the sleeve may be
constructed of a standard low cost plastic material or any readily
available substitute therefor.
As discussed above, cannula 25 is slidable into and out of the
housing a predetermined distance until limited by stops. The force
for moving cannula 25 is provided by the friction between cannula
25 and stopper 41 as the evacuated tube 39 is reciprocated within
holder 38 during the blood collection procedure. Although slidable,
cannula 25 is continuously hermetically sealed relative to its port
by elastomeric sealing disc 30 which has been penetrated by cannula
25.
FIG. 1 shows the needle assembly in position for use having been
threadedly engaged with a holder 38 and with an evacuated container
39 in position for engagement with the assembly. Fixed needle 24 is
supported by cylindrical portion 22 of housing 21 and is
hermetically sealed by epoxy 51 or any other convenient manner. The
rear end portion 34 of cannula 24 supports the elastomeric sleeve
27. An interference fit exists between bore 52 of sleeve 27 and the
outer surface of cannula 24. Transverse holes 54 are located to the
rear of cannula 24 in the initial position of the needle assembly
20 as shown in FIGS. 1 to 3. In this manner, an open air passageway
is provided from the open tip 35 of cannula 24 through the assembly
until it passes through side opening 45 in sliding cannula 25.
When sleeve 27 is pushed forward to encompass all of the rear
portion 34 of cannula 24 so that the forward edge of flange 50 of
the sleeve rests against inner wall of the housing, the cannula
will be positioned so as to occlude transverse openings 54 and
cannula 24 will be sealed by cap or sleeve 27.
Sliding cannula 25 supports valve cage 28. The tip of forward end
44 of cannula 25 is inserted into a recess in the rear end of valve
cage 28 and is sealed therein by epoxy 47 or any other common
sealing means. The inner diameter of cylindrical cage 28 is
substantially greater than the outer diameter of sleeve 27 so that
blood or air can readily flow out of the valve sleeve 27 around the
spaces between sleeve 27 and cage 28, and out through one or more
of the ports 48 of cage 28.
As shown in FIG. 10, portion 22 of housing 21 has a tapered
exterior surface 31 which mechanically fits and supports and seals
portion 32 of the cylindrical rear portion 23 of housing 21. Rear
portion 23 supports sliding needle 25 which is mounted in a close
sliding fit within passageway 42 through rear end portion 23. Rear
end portion 23 also supports elastomeric sealing disc 30 and the
retaining disc 29. Retaining disc 29 is a plastic molded part. It
may be constructed of any other common material for the purpose
required. It has an outside diameter which is an interference fit
relative to the narrowed region of the inside of rear housing
portion 23. In assembly of this seal, rear portion 23 is positioned
vertically. Then the elastomeric sealing disc 30 is dropped inside.
It is positioned to lie flat across the end of passageway 42. Then
the sealing disc 29 is dropped in and stops at the narrowed portion
56 of rear end 23. Then a small press or similar device is used to
push disc 29 down as far as it will go. The annular ring 46
projecting from the inner surface of portion 23 bites into the
elastomeric disc 30 under this pressure thereby assuring a
continuous seal.
Then, the cage 28 is joined to the tip of needle 25 by epoxy or any
other common affixing means. Thereafter, the pointed end 43 of
needle 25 is passed through the central hole of retainer disc 29
and pierces the elastomeric disc 30 and is then pushed into its
final position as shown in FIGS. 1-3. The cylindrical member
forming end portion 22 including cannula 24 is inserted into rear
end portion 23 until the tapered portions meet and seal. This
action also inserts a partial amount of end portion 34 of cannula
24 into the open end of sleeve 27. The assembly is then positioned
for use as depicted in FIG. 3.
In operation, threaded outer surface 37 of rear end 23 is screwed
into the threaded receiving surface of holder 38 in a conventional
manner. An evacuated container 39 is then positioned in the rear
part of holder 38 in position for use. This arrangement is depicted
in FIG. 1 of the drawings. The operator should not couple any
portion of the stopper 41 with the rear end of cannula 25 before
inserting cannula 24 into the vein of a patient. In this manner,
effectiveness of the blood flow indication portion of the needle
assembly will be assured.
Then, as shown in FIGS. 2 and 3, tip 35 of cannula 24 is inserted
into the patient's vein. At this point, a continuous open
passageway exists through the device in the following manner. Blood
will pass through cannula 24 and out through transverse holes 54 in
sleeve 27. It will then flow through the space between the outside
of sleeve 27 and the inside of cage 28 until it passes out through
ports 48 of cage 28. At this point, the blood will begin to fill
the substantial cylindrical space outside of cage 28 within chamber
26. If the blood is permitted to continue to flow, it will pass
through the side opening 45 in sliding cannula 25 and out through
tip 43 of cannula 25. The venous pressure of the patient's blood
causes the blood to flow unopposed through this series of open
passageways. When it substantially fills the chamber 26, it will
obviously be visible and the operator, who will be watching for
this blood flow indication, will then push the evacuated container
39 all the way into holder 38 so that cannula 25 penetrates through
stopper 41. This action of pushing the tube 39 all the way into
holder 38 will force needle 25, first, to slide forward so that
sleeve 27 is forced all the way onto rear portion 34 of cannula 24
and sleeve flange 50 abuts against the interior surface 57 of
housing 21 which provides a positive stop. The transfer will be
accomplished by the interconnection between cannula 25, cage 28,
and sleeve 27. The only restriction to the sliding of needle 25 is
the friction between sealing disc 30 and the outside surface of
cannula 25. This amount of friction is made substantially less than
the friction encountered when cannula 25 penetrates stopper 41. In
this way, sleeve 27 will be moved to its position for operation as
a valve member before cannula 25 pierces into the evacuated tube 40
of container 29. Sleeve 27 stays in operating position as a valve
member thereafter. FIGS. 4 and 5 show the assembly after sleeve 27
has been transferred to its forward position where it will act as a
valve member and just prior to penetration of stopper 41 by cannula
25.
In FIGS. 6 and 7 the forward movement of the evacuated container
has been completed and communication is provided between cannula 25
and the interior of tube 39. As shown, this causes slit 55 to open
in view of the pressure differential provided by the vacuum within
container 39 and blood to flow into tube 40 along the path as shown
by the arrows in FIG. 7. After the tube 40 is filled with blood,
and it is desired to fill one or more additional tubes, the
operator pulls container 39 out of the holder. In doing this, the
friction between stopper 41 and cannula 25 is substantially greater
than the friction between cannula 25 and sealing disc 30, so that
cannula 25 is moved rearwardly until the rear end of cage 28 abuts
against retaining disc 29 which provides a positive stop. This
action is completed before cannula 25 is pulled out of stopper 41.
In this position, side opening 45 of cannula 25 is to the rear of
sealing disc 30 and, therefore, no more blood can flow out of
cannula 25 until the next container 39 is inserted all the way into
the holder. Insertion of the following container 39 will once again
force cannula 25 and cage 28 forward exposing opening 45 to the
interior of chamber 26 and permitting blood to flow into the
container when cannula 25 is fully subjected to the interior of
evacuated tube 40. The closed position at the end of collection of
a first sample and prior to insertion of a second collection
container 39 is depicted in FIGS. 8 and 9 of the drawings. It
should be noted that tip 35 remains in the vein thereby enabling
multiple samples to be taken in a succession of collection
containers with only a single venipuncture. After the desired
number of samples have been taken, the assembly is disposable and
can be discarded.
In summary, needle assembly 20 performs a combination of functions.
It provides a one-way valve which is normally closed and alleviates
the danger of back flow during blood sampling procedures while at
the same time providing a blood flow indication means to notify the
operator when a proper venipuncture has been accomplished as well
as providing a multiple sampling device.
Thus, the above objectives of the present invention, among others,
have been effectively attained.
* * * * *