U.S. patent number 3,734,095 [Application Number 05/145,657] was granted by the patent office on 1973-05-22 for fluid infusion.
Invention is credited to Louis S. Santomieri.
United States Patent |
3,734,095 |
Santomieri |
May 22, 1973 |
FLUID INFUSION
Abstract
A novel fluid infusion assembly and method, the assembly
comprising a stylet catheter and associated novel guide core which
carries a surmounting self-sealing penetrable jacket accommodating
placement of a stylet needle within the catheter prior to
venipuncture and removal of the stylet needle subsequent to
venipuncture while a fluid delivery tube is continuously
communicating fluid to the catheter. An improved fluid coupling is
adapted to penetrate the jacket and guide core at selected
locations to provide an alternate site for delivering fluid to the
catheter or for delivering a plurality of fluids to the catheter
simultaneously. The stylet needle has, at the curved terminal end
thereof, an upstanding tab which novelly accommodates (1)
aspiration of blood from the vein to a transparent portion of the
tab, or (2) outflow of blood from the vein to a transparent portion
of the tab by normal blood pressure and capillary action to evince
a successful venipuncture. The method includes squeezing the tab
prior to and during venipuncture and thereafter aspirating blood
into the tab and also removing the stylet needle and penetrating
the self-sealing jacket with a fluid connector.
Inventors: |
Santomieri; Louis S.
(Vacaville, CA) |
Family
ID: |
22514021 |
Appl.
No.: |
05/145,657 |
Filed: |
May 21, 1971 |
Current U.S.
Class: |
604/168.01;
604/900 |
Current CPC
Class: |
A61M
39/02 (20130101); A61M 25/0693 (20130101); Y10S
604/90 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 39/02 (20060101); A61m
005/00 () |
Field of
Search: |
;128/214R,214.2,214.4,215,216,218M,218D,221,2F,DIG.5,278 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,024,410 |
|
Mar 1966 |
|
GB |
|
1,064,445 |
|
Dec 1953 |
|
FR |
|
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed and desired to be secured by United States Letters
Patent is:
1. A stylet catheter assembly comprising:
an essentially linear catheter tube of pliable material defining
the major axis of the assembly and having a forward tip to be
introduced into the vein of a patient;
an exterior female fitting in the nature of a substantially rigid
sleeve attached to the trailing end of the catheter tube, said
fitting comprising a hollow bore which opens at the trailing end
thereof and an exposed side wall having an elongated opening in the
side wall;
an elastomeric hollow self-sealing jacket generally axially
situated within and essentially contiguous to the hollow bore of
the fitting, the jacket being laterally exposed to the exterior at
said elongated opening;
a circuitously shaped elongated piercing means axially
coextensively disposed within the catheter tube and comprising a
forward sharpened end extending beyond the forward tip of the
catheter tube and a handle at the trailing end of the piercing
means, an intermediate portion of the piercing means angularly
extending through the jacket and through the side wall of the
fitting at the elongated opening and;
separate hollow guide means situated within the female fitting
adjacent the trailing end of the catheter tube through which the
piercing means extends, which guide means restricts to and fro
displacement of the piercing means within the catheter tube to
movement along said major axis.
2. In an assembly as defined in claim 1 wherein said jacket
comprises an outwardly projecting thickened portion which
essentially fills the elongated opening in the fitting and through
which the piercing means passes.
3. In an assembly as defined in claim 1 wherein said angularly
extending portion of the piercing means comprises a curvilinear
configuration.
4. In an assembly as defined in claim 1 wherein the angularly
extending portion of the piercing means comprises a laterally
offset portion defining a heel in the piercing means to gently
resist movement of the piercing means into or out of the
jacket.
5. In an apparatus as defined in claim 1 wherein the piercing means
comprises a needle and wherein the handle comprises a resiliently
flexible tab and forms an enclosure around the terminal end of the
needle, the tab being essentially transparent at least adjacent the
location of the enclosed terminal end of the needle so that the tab
may be finger-compressed prior to venipuncture to expel air from
the enclosure and released after venipuncture to aspirate blood
through the needle to evince completion of a proper
venipuncture.
6. In an apparatus as defined in claim 1 wherein the piercing means
comprises a needle and wherein the handle comprises a tab which is
provided with a visually observable fluid reservoir communicating
with the proximal end of the needle and also with the exterior of
the tab through a small opening whereby blood will flow into the
reservoir and become visually observable upon the completion of a
successful venipuncture.
7. The catheter assembly of claim 1 wherein the piercing means
comprise a hollow needle and the handle comprises an interior
hollow pocket for causing flashback.
8. The catheter assembly of claim 1 wherein the jacket is
interposed between the sleeve and the guide.
9. The catheter assembly of claim 1 wherein the jacket and the
guide are serially disposed within the sleeve along said axis.
10. The catheter assembly of claim 1 wherein the handle is
partially hollow for accommodating aspiration and flashback and
partially solid for accommodating venipuncture.
11. The catheter assembly of claim 1 wherein the jacket comprises a
thick radially projecting portion disposed within the side wall
opening of the female fitting.
12. The catheter assembly of claim 1 wherein said side wall opening
of the female fitting comprises a ramp surface for directing
displacement of the piercing means.
13. A stylet catheter assembly comprising a hollow catheter tube,
an outer sleeve integral with the catheter tube, an internal guide
core disposed within the sleeve, a penetrable self-sealing inner
jacket interposed between the outer sleeve and the guide core, and
a stylet comprising a hollow needle which comprises an elongated
linear leading portion extending through and beyond the catheter
tube and a curvilinear terminal portion which projects through the
jacket and out the side of the sleeve, a handle secured behind the
curvilinear terminal portion, the stylet being adapted to (1)
selectively penetrate the inner jacket through openings in the
outer sleeve to a position telescopically within the catheter for
insertion of the catheter into the lumen of a vein and (2) be
completely removed from the catheter after venipuncture with
negligible loss of blood the curvilinear portion of the needle
further comprising an aperture disposed adjacent the linear portion
and the inner guide core further comprising an inwardly-projecting
protuberance which, when the needle is in a predetermined position,
obstructs the aperture therein and, when the needle is moved from
the predetermined position, maintains the aperture in an
unobstructed location thereby providing fluid communication through
the aperture and the needle.
14. A stylet catheter assembly comprising a concentric arrangement
of parts comprising:
a pliable substantially linear catheter tube which defines an
axis;
a substantially rigid female sleeve fitting attached to the
proximal end of the catheter tube;
a generally hollow guide core disposed concentrically within the
female fitting and having an annular wall with a forward distal
central bore the axis of which is common with the axis of the
catheter tube, the guide core having a side slot and a side
aperture adjacent but spaced one from the other, each being
essentially transverse to said axes;
a resilient elastomeric sleeve disposed concentrically within the
female sleeve fitting between the fitting and the guide core so as
to seal the slot, aperture and hollow of the guide core.
15. In an assembly as defined in claim 14 further comprising a
hollow fluid coupling comprising a forwardly-tapered
outwardly-projecting leading end removably inserted through an
aperture in the female fitting the aperture in the guide core and
the elastomeric sleeve in fluid-sealed relation the hollow fluid
coupling also comprising a female connection adapted to receive
conventional male infusion connectors whereby infusion of the fluid
through the coupling into the catheter is accommodated.
16. In a stylet catheter assembly comprising an internally hollow
guide core which has a peripherally disposed elongated side wall
opening communicating with the hollow of the guide core to the
exterior thereof and an aperture offset from the elongated opening;
a fluid impervious resiliently flexible sleeve superimposed upon
the guide core in fluid-sealing relation; an elongated hollow
catheter tube in coaxial relation with the hollow core; and an
outer housing superimposed over the flexible sleeve and guide core,
the outer housing having an axially elongated slot which, in the
assembled position, is aligned with the side wall opening in the
guide core and an aperture aligned with the aperture in the core;
and tortuously shaped elongated piercing means extending through
the slot, the sleeve, the side wall opening, both apertures and the
catheter tube.
17. An intravascular catheter assembly comprising a linearly
directed hollow plastic catheter to be placed in the cardiovascular
system via venipuncture, the improvement comprising hollow
venipuncture structure for intravascular therapy comprising an
elongated tortuously configurated shaft comprising a linearly
extending portion disposed within the hollow of the plastic
catheter, and terminating in an exposed sharp leading tip, an
intermediate portion integral with and extending at least partially
transverse of the linearly extending portion through a hole in the
side of the linear catheter and a handle integral with the
intermediate transverse portion, the handle comprising a blood
flashback chamber in fluid communication with the interior of the
intermediate portion.
18. The improvement of claim 17 wherein the shaft is hollow and the
handle comprises a hollow aspirating tab, the hollow of the tab
being connected to the hollow of the shaft for at least partial
manual evacuation of air from the shaft prior to venipuncture and
vacuum driven flashback after venipuncture.
19. The improvement of claim 17 wherein the shaft is hollow and the
handle comprises an infusion fitting for placing fluids into a
patient through the hollow of the shaft upon venipuncture.
20. The improvement of claim 17 wherein the transverse intermediate
portion of the shaft is interposed between two short curved
portions.
Description
The present invention comprises a novel fluid infusion assembly and
method and more particularly an improved guide core and peripheral
sealing jacket for selective attachment of an improved fluid
coupling and selective insertion and withdrawal of a unique stylet
needle in a catheter.
Known stylet catheters principally comprise a linearly shaped
needle or stylet disposed within a catheter and connected at the
trailing end thereof to a plug which seals the trailing end of the
catheter during venipuncture. Subsequent to venipuncture, when it
is desired to pass fluid through the catheter into the vein, the
plug and attached needle must be removed to accommodate connection
of the fluid delivery tube to the catheter. During the time
increment after the needle has been removed and before the delivery
tube has been attached to the catheter, it is likely that blood
will flow through the catheter to the exterior thereof undesirably
causing blood staining of clothing or other adjacent material and
occasionally requiring a substantial cleanup process such as
complete change of bedding. Moreover, during the connection of the
delivery tube to the catheter, there is a substantial chance that
air may be introduced into the catheter tube which increases the
likelihood that a dangerous embolism will be developed within the
punctured vein. Moreover, prior to the invention of the novel fluid
assembly by the Applicant, it was difficult if not impossible to
accommodate infusion of more than one fluid through the same
catheter simultaneously.
It is, therefore, a primary object of the present invention to
overcome or alleviate problems of the mentioned type.
The presently preferred embodiment of the invention comprises a
stylet catheter associated with a novel guide core having a
penetrable self-sealing sleeve or jacket disposed thereon. When the
guide core is disposed directly adjacent the catheter, an axial
slot is disposed therein so that the linear end of a unique needle
may penetrate the self-sealing jacket and be inserted through the
interior of the catheter. The trailing end of the needle is curved
so as to be disposed exterior of the guide core when the stylet
needle is carried within the catheter. The trailing end of the
needle is integrally attached to an upstanding tab which provides
for "flash-back" of blood when a successful venipuncture is
performed. If desired, the guide core may be disposed intermediate
of a fluid delivery tube as well as adjacent the intravenous
catheter and, in either event, may be provided with a transverse
aperture accommodating penetration by an improved fluid coupling to
accommodate simultaneous infusion of more than one fluid at a
time.
It is, therefore, another primary object of the present invention
to provide a novel infusion assembly and methods which provide for
removal of the stylet needle and fluid delivery through a catheter
without interchange of coupling parts.
Another important object of the present invention is to provide an
improved method and assembly accommodating simultaneous infusion of
a plurality of fluids.
Another and no less important object of the present invention is
the provision for a unique stylet needle accommodating aspiration
of blood into a transparent reservoir which is unobstructed from
view when the stylet needle is disposed within the catheter to
demonstrate completion of a successful venipuncture.
One still further object of the present invention includes a novel
guide core and jacket combination including a novel method
providing for safe, efficient penetration and removal of needles or
couplings with negligible loss of blood.
Another and no less important object of the present invention is
the provision of an improved needle-guide core combination
accommodating selective infusion of fluid through the stylet
needle.
One further object is to provide a unique finger tab comprising
part of the stylet needle.
These and other objects and features of the present invention will
become more fully apparent from the following description and
appended claims taken in conjunction with the following drawings
wherein:
FIG. 1 illustrates in perspective one presently preferred infusion
assembly embodiment of the invention;
FIG. 2 is an exploded perspective view of the infusion assembly
illustrating the several component parts thereof;
FIG. 3 is a longitudinal cross section taken along lines 3--3 of
FIG. 1;
FIG. 4 is a longitudinal cross-sectional view taken along lines
4--4 of FIG. 1;
FIG. 5 is an enlarged cross-sectional elevation illustrating the
internal relationship of the catheter attachment and adjacent parts
of the embodiment of FIGS. 1 and 2;
FIG. 6 is a cross-sectional enlarged elevation of one presently
preferred tab embodiment;
FIG. 7 is a fragmentary cross section illustrating one embodiment
of the improved needle as it is disposed within the guide core;
FIG. 8 is a fragmentary cross section of another improved needle
disposed within the guide core;
FIG. 9 illustrates in perspective another presently preferred
embodiment of the outer self-sealing jacket;
FIG. 10 is a longitudinal cross section taken along lines 10--10 of
FIG. 9;
FIG. 11 is a transverse cross section taken along lines 11--11 of
FIG. 9;
FIG. 12 is a fragmentary perspective illustrating another presently
preferred infusion assembly embodiment;
FIG. 13 is an exploded perspective view of the infusion assembly of
FIG. 12 illustrating the respective component parts thereof;
FIG. 14 illustrates in fragmentary perspective the embodiment of
FIG. 12 with the needle removed and with a fluid coupling connected
therein;
FIG. 15 is a longitudinal cross section taken along lines 15--15 of
FIG. 14; 25, and is provided with a planar surface 262 at the
proximal end thereof for abutment by the distal end of the
self-sealing
FIG. 16 is a transverse cross section taken along lines 16--16 of
FIG. 14;
FIG. 17 illustrates in perspective one presently preferred
embodiment of a fluid coupling which may be used with the infusion
assembly of FIG. 12;
FIG. 18 is a side elevational view of another preferred embodiment
of the infusion assembly with parts broken away to reveal internal
parts thereof;
FIG. 19 is a schematic fragmentary perspective illustrating an
intermediate guide core and surmounting jacket used with the
infusion assembly of FIG. 12;
FIG. 20 is a transverse cross-sectional view taken along lines
20--20 of FIG. 19;
FIG. 21 is a longitudinal cross section taken along lines 21--21 of
FIG. 19;
FIG. 22 is a top plan view of an auxiliary tube accommodating the
coupling of FIG. 17, parts being broken away to reveal the internal
structure thereof;
FIG. 23 is a fragmentary perspective illustrating a further
presently preferred infusion assembly embodiment;
FIG. 24 is an exploded perspective view of the infusion assembly of
FIG. 23 illustrating the respective component parts thereof;
and
FIG. 25 is a longitudinal cross section of the embodiment of FIG.
23 taken on the line 25--25 thereof.
Reference is now made in detail to FIGS. 1 and 2 which depict one
embodiment of the infusion assembly generally designated 30, which
broadly comprises a needle sheath 32, a catheter 42, an outer
sleeve 48, an inner jacket 58, an inner guide core 60, and a stylet
needle 86.
The catheter tube 42 is preferably formed of a suitable transparent
or translucent radiopaque synthetic resin, such as polyvinyl,
polypropylene, polyethylene, polytetrafluoroethylene, etc. The
catheter 42 is centrally hollow and integrally attached at the
proximal end 43 thereof to the forwardly tapered projection 44
comprising the distal end of an outer sleeve 48. The tapered
projection 44 is adapted to be press-fit into the central bore 37
of a conventional needle sheath 32. The needle sheath 32 is
provided with an annular collar 34 having a planar face 38 at the
proximal end thereof, the collar 34 having axial ribs 36 providing
a non-slip finger-gripping surface for removing the needle sheath
from the outer sleeve when desired. The distal end 40 of the sheath
32 may be either opened to the air or obstructed with a cotton plug
or the like as is conventional. The needle sheath 32 is
sufficinetly long to entirely enclose the catheter 42 when in the
assembled position as illustrated in FIG. 1.
The outer sleeve 48 comprises a central bore 56 which terminates in
a bore 57 having a reduced diametral dimension (FIG. 5). The bore
57 is provided with a series of annular steps 46 which gradually
decrease in diametral dimension from the proximal end adjacent the
bore 56 to the distal end adjacent the bore 57. The steps 46 are
contiguous with the mating end 47 of the catheter 42 and are
preferably secured thereto with a suitable bonding agent such as
epoxy (not shown). Thus, the catheter 42 is immovably secured to
the outer sleeve 48.
The outer sleeve 48 is further provided with an axially disposed
slot 50 which opens outwardly at the proximal end 54 thereof and
terminates at 52 adjacent the axial midpoint of the outer sleeve
48. The purpose for the slot 50 will be subsequently more fully
described.
An inner guide core generally designated 60 is provided with a
forwardly tapering male fitting 62 at the distal end thereof and an
integrally connected peripherally enlarged forward flange 64. The
flange 64 and a rearwardly located flange 72 cooperate to define an
intermediate portion 74 having a reduced diametral dimension. The
flange 72 is an integral part of a diametrally enlarged coupling
socket 76. An axial bore 78 is disposed throughout the entire
length of the inner core 60 and is adapted to be disposed coaxially
with the hollow of catheter 42 in the assembled position. In the
assembled position, as illustrated in FIG. 5, the forwardly tapered
male fittng 62 is press-fit into the enlarged portion 47 of the
catheter 42 in the vicinity of the projection 44.
As shown in FIG. 2, the inner guide core 60 is provided with an
axial slot 66 having a distal end 68 terminating immediately
rearward of the peripheral flange 64 and a proximal end 70
terminating immediately forward of the flange 72. In the assembled
relation, slot 66 is preferably in alignment with slot 50 in the
outer sleeve 44.
The resilient, penetrable, self-sealing jacket 58 is carried by the
reduced diametral portion 74 of the core 60 between the flanges 72
and 64. The jacket 58 is preferably formed of latex rubber or
similar self-sealing material and, when suitably superimposed upon
the intermediate portion 74 of the guide core 60, forms a
substantial fluid seal therewith particularly around the periphery
of slot 66. The jacket 58 is telescopically disposed within the
outer sleeve 48 subsequent to its placement upon the inner core 60
as best illustrated in FIGS. 3-5.
If desired, a plug 82 having a forwardly tapered male fitting 80
may be press-fit within the coupling socket 76 to prevent
inadvertent flow of blood out of the coupling socket subsequent to
venipuncture. The male fitting 80 is provided with axially disposed
raised portions (not shown) as is conventional with standard luer
fittings and the coupling socket 76 preferably comprises luer dogs
(not shown) so that the fitting 80 and the coupling socket 76
cooperate to form a standard LUER-lok assembly. Also, the plug 82
is provided with axially disposed ribs 84 which facilitate
manipulation and removal of the plug 82 from the socket 76 when
desired. Clearly, a fluid delivery tube, such as tube 210 (FIG. 19)
may be coupled into the guide core 60 in place of the plug 82 as
will be subsequently more fully described.
A stylet needle generally designated 86 comprises, at the forward
end 90 thereof, a relatively short, hollow or cannulated tubular
steel needle having a central bore 89 (best shown in FIG. 3) and a
sharpened bevel point 88 which is capable of penetrating the skin,
the subcutaneous tissue and a body cavity such as a blood vessel of
a patient. In the assembled relation illustrated in FIG. 3, it can
be observed that the needle 86 projects a short distance beyond the
tip 41 of the catheter 44 for purposes of insertion of the catheter
42 into the blood vessel. The proximal end 91 of the needle 86 is
curved through essentially 90.degree. and terminates in a looped
end or tail 92. Thus, a tortuous passageway 98 is formed rearward
adjacent the proximal end 91 of the needle 86.
A resilient flexible tab, generally designated 94, surrounds the
looped end or tail 92 of the needle 86 immediately above the
proximal end 91 thereof. The tab 94 is preferably substantially
transparent and is fluid-sealed around a substantial portion of the
tail 92. The terminal end 93 is disposed within an interior cavity
96. Thus, when the tab 94 is squeezed between the fingers, air will
be forced out of the cavity 96 through the tortuous passageway 98
and out through the end 88 of the needle 86. Subsequent to
venipuncture, the pressure on the tab 94 may be released and the
resiliency or memory of the material comprising the tab will cause
the cavity 96 to expand to its original, non-collapsed position
thereby aspirating blood from the vein of the patient to the cavity
96 interior of the tab 94 and thus visually demonstrating a
successful venipuncture.
If desired, the tab embodiment generally designated 104 illustrated
in FIG. 6 may be substituted for the tab 94. In the embodiment of
FIG. 6, the tab material is bonded to the needle 86 at 106 which
needle terminates at 108, a short distance into the tab. A
substantially transparent chamber 110 is disposed in the tab 104
above the end 108 of the needle 86. The chamber 110 communicates
with the exterior of the tab 104 through a bleeder opening 112
which provides an air passageway into and out of the chamber 110.
Thus, when a successful venipuncture is performed, blood will flow
through the needle 86 by reason of the normal blood pressure and
capillary action to the chamber 110 where it can be readily
observed. Air which exists in chamber 110 will be exhausted through
the bleeder opening 112. However, the opening 112 is sufficiently
constricted so as to substantially inhibit any outflow of
blood.
The needle 86 may be modified (as shown in FIG. 7), if desired, to
provide a peripheral aperture 120 adjacent the curved proximal end
91 thereof. The aperture 120 is disposed in the surface of the
needle 86 which is essentially parallel to the bore 78 adjacent the
outside angle created by the curved end 91. When an aperture 120 is
provided in the needle 86, the guide core 60 is provided with an
internal protuberance or seal 122 which, in the assembled position,
substantially occludes the aperture 120 in the needle 86. When
desired, the needle 86 may be retracted slightly rearwardly so that
the shank 90 thereof will rest upon the nub 122, accommodating,
thereby, free flow of fluid through the bore 78 of the core 60 and
the hollow 89 of the needle 86 through the aperture 120.
FIG. 8 illustrates another presently preferred needle embodiment
generally designated 126 which may be used with the infusion
assembly of FIGS. 1 and 2. Needle 126 may be essentially identical
to the needle 86 except needle 126 is provided with a heel 128
adjacent the curved portion 130 thereof which is rearwardly offset
along the axis of the core 60. The heel portion 128 restrains the
needle 126 within the jacket 58 to inhibit inadvertent protraction
and retraction of the needle 126 relative to the guide core 60.
If desired, the self-sealing jacket 134 illustrated in FIGS. 9-11
may be substituted for the jacket 58. The jacket 134 is
substantially the same as jacket 58 except jacket 134 comprises a
raised puncture site 136 the proximal end 138 of which is disposed
flush with the end 54 of the outer sleeve 48 (FIG. 2) and the
distal end 139 of which seats contiguous adjacent the end 52 of the
slot 50 in the outer sleeve 48. Thus, the raised puncture site 136
is disposed within and substantially fills the slot 50 in the outer
sleeve 48. The increased thickness of the jacket 134 at the
puncture site 136 maximizes the self-sealing capacity of the jacket
134 when the needle 86 or 126 is removed therefrom.
FIGS. 12 and 13 illustrate another presently preferred infusion
assembly embodiment generally designated 150. The infusion assembly
150 is substantially the same as the infusion assembly 30 and like
parts are given corresponding numbers throughout.
Referring primarily to the differences in the embodiment comprising
FIGS. 12 and 13 your attention is directed to the outer sleeve
generally designated 153 which differs from the outer sleeve 48 in
that a transverse aperture 152 communicates the hollow 56 of the
outer sleeve with the exterior thereof. As is illustrated
particularly in FIG. 16, the aperture 152 preferably extends
through diametrically opposed sides of the outer sleeve 153 and is
located adjacent the axial midpoint of the sleeve. Clearly, any
suitable number of apertures could be provided in the outer sleeve
153 at essentially any desired location.
It should also be observed that the catheter 42 is in no way
secured to the tapered projection 44 or elsewhere on the outer
sleeve 153. On the contrary, the catheter 42 has an enlarged
conical shape at the proximal end 157 which is bonded or otherwise
secured to the male fitting 62 at the leading end of the inner core
generally designated 155 (see FIGS. 13 and 15).
The inner guide core 155 differs from the guide core 60 in that a
transverse aperture 154 is disposed laterally therethrough as best
illustrated in FIGS. 15 and 16. It is essential that apertures 152
and 154 are coaxially disposed when the infusion assembly 150 is in
the assembled position. With apertures 152 and 154 aligned, it is
possible to connect an adapter or coupling generally designated 156
(FIGS. 16 and 17) into the assembly as shown in FIG. 14. The
coupling 156 preferably comprises a cylindrical fitting 158
terminating in a forward, essentially planar front face 162 which
is continuous with a forwardly projecting shank 170. The shank 170
tapers forwardly at 172 to define a diametrally reduced throat 174.
The throat 174 defines the base of an annularly enlarged crown 176
which tapers forwardly to the terminal end 168 thereof. The
cylindrical fitting 158 has a central bore 160 (FIG. 16) which is
reduced in dimension to define an internal abutment surface 166 and
is continuous with diametrically reduced axial bore 164
communicating the bore 160 with the exterior at the end 168 of the
coupling 156. The bore 160 selectively receives in press-fit or
luer lock relation a mating coupling (not shown) from conventional
fluid delivery apparatus (not shown) or the leading end of a
conventional syringe, e.g., syringe 222 in FIG. 19.
The coupling 156 is selectively capable of penetrating the
self-sealing jacket 58 through apertures 152 and 154 in the outer
sleeve 153 and the inner core 155 respectively. Thus, if desired,
fluid may be communicated to the catheter 42 through either the
hollow 78 of the core 155 or through the bore 164 of the coupling
156 or both simultaneously.
If desired, the embodiment of FIG. 18 may be used in place of the
embodiments of FIGS. 1 and 12. The embodiment of FIG. 18 comprises
a novel guide core generally designated 186 which comprises a
forwardly tapered projection 188 which is diametrically reduced at
190 and integrally secured thereat to the catheter 42. The
cylindrical body 192 of the guide core 186 is provided with spaced
annular flanges 194 which define a seat for the self-sealing jacket
58. The guide core 186 is provided with a central bore 200
comprising a fluid passageway from the proximal end 198 of the
guide core 186 to the catheter 42. The central bore 200 may be
provided with conventional luer dogs (not shown) and may
accommodate conventional fittings adjacent the proximal end 198
thereof so that delivery tubes and/or syringes or the like may be
connected thereto. The guide core 186 is provided with an axial
slot (not shown) disposed in the cylindrical body 192 accommodating
passage of the needle 86 through the jacket 58 to the interior of
the guide core 186 and the catheter 42. If desired, transverse
apertures for receiving coupling 156 (FIG. 17) may also be located
at predetermined locations in the periphery of the guide core
186.
FIGS. 19-22 illustrate still another presently preferred embodiment
of the invention. In FIG. 19, the infusion assembly 30 is
illustrated in the assembled condition with the stylet needle 86
and finger tab 94 removed. The catheter 42 has been previously
located in a vein (not shown) in the arm 199 of a patient. A piece
of adhesive tape 201 has been placed across a portion of the arm
199 adjacent the puncture site as is conventional. The infusion
assembly is connected to a leading end 210 of a fluid delivery
tube, generally designated 209 by a coupling generally designated
202. The coupling 202 comprises a forwardly tapered male fitting
204 which is adapted to fit within the central bore 78 of the guide
core 60 (see FIG. 2). The fitting 204 is integral with an annular
collar 206 and laterally opposed wings 208 which accommodate easy
manipulation of the fitting 204 for attachment purposes. The
connection 202 is centrally hollow (not shown) to communicate fluid
from the delivery tube 209 to the interior of the catheter 42.
An intermediate portion of the tube 209 is provided with a novel
guide core 218, shown in FIG. 21. The inner guide core 218 has a
forward projection 212 adapted to be press-fit into the leading end
210. The inner core 218 is provided with a central bore 215 which
extends through the entire length thereof and which is adapted to
receive the leading end 220 of a coupling (not shown) connecting
the core 218 to a trailing end 240 of the delivery tube 209.
The inner core 218 may be provided with a transverse aperture 216,
best shown in FIG. 20, and telescopically carries thereupon the
self-sealing jacket 58. Thus, an adapter or coupling 156 (FIG. 17)
may be selectively inserted into the inner core 218 through the
jacket 58 to accommodate connection of the leading end 224 of a
conventional syringe 222 or the like. Clearly, if desired, another
fluid delivery tube could be connected to the guide core 218
through the coupling 156 instead of the syringe.
The trailing end 240 of the delivery tube 209 is connected in a
conventional manner to the neck 246 disposed in the tapered surface
244 of a conventional fluid dispensing bottle 242 or the like.
Although a fluid dispensing bottle 242 is illustrated in FIG. 19,
it should be appreciated that any fluid dispensing apparatus such
as plastic bottles, and other dispensing containers may be
used.
Referring now to FIG. 22, a Y-shaped adapter 226 is illustrated
which may be used to connect the trailing end 240 of the delivery
tube 209 to the leading end 210 thereof. The adapter 226 comprises
a main branch 228 which is interiorly connected at one end in
press-fit relation to a coupling (not shown) having a peripherally
enlarged flange 230. The flange 230 is integrally connected to the
trailing end 240 of the delivery tube 209. The other end of the
main branch 228 (not shown) is similarly coupled to the leading end
210 of the delivery tube 209. A secondary branch 232 opens
exteriorly at the end 235 and is provided thereat with a resilient
self-sealing cup 234 formed of latex rubber or the like. The latex
cup 234 is sealed to the branch 232 at the interface between the
edges 236 of the cup 234 and the periphery of the branch 232. The
cup 234 is adapted to be penetrated at 238 by the coupling 156 (see
FIG. 17). Thus, a plurality of fluids may be communicated at once
through the delivery tube 209.
In the method of using the presently preferred embodiments of the
invention reference is made particularly to the embodiments of
FIGS. 12-17 and 19, it being understood that the remaining
disclosed embodiments are used in a like manner.
With the apparatus in the assembled condition of FIG. 12, the plug
82 is removed and a fluid delivery tube is connected to the core
155. If desired, fluid may be then communicated into the core
adjacent the needle 86.
The technician or other user of the apparatus initially grasps the
tab 94 between the fingers and squeezes the sides together to expel
air within the tab 94. The needle cover 32 is removed and the
needle is placed within the lumen of a vein according to
conventional venipuncture techniques. The success of the
venipuncture can be visually demonstrated by releasing pressure on
the tab 94 and aspirating blood from the vein into the tab 94.
Thereafter, the needle 86 may be removed by withdrawing the needle
86 from the catheter 42 through the self-sealing jacket 58. Fluid
will then immediately pass into the vein through the catheter 42.
When desired, after the needle 86 has been removed, the fluid
coupling 156 may be forced to the interior of the guide core 155 by
penetrating the jacket 58 as illustrated in FIGS. 14 and 16. Either
before or after penetration of the jacket 58 by the coupling 156,
another fluid delivery tube (not shown) may be suitably connected
to the coupling 156 so that when penetration is complete, the fluid
passing through the coupling 156 will be communicated through the
catheter 42 to the vein simultaneously with the fluid passing
directly through the bore 78 of the core 155.
Similarly, if a core 218 (FIG. 21) is disposed intermediate of a
fluid delivery tube, the fluid coupling 156 may be disposed therein
to accommodate injection of medication or other fluids into the
fluid delivery tube. It should be appreciated that the needle 86
may be properly placed directly within the patient's vein to
withdraw a small blood sample or the like. The needle 86 may also
be caused to penetrate the wall of a catheter tube to obtain a
sample when the catheter tube is already indwelling. When a
properly sized catheter tube is not initially indwelling, the
needle can be used to cause a venipuncture and to place the
catheter tube within a vein. When the catheter tube is formed of
self-sealing material, the needle may be removed while the catheter
tube remains indwelling.
From the foregoing it is apparent that the novel invention
described accommodates removal of the stylet needle and subsequent
fluid delivery through a catheter without the interchange of
coupling parts and, significantly, provision is made for the
simultaneous administration of a plurality of fluids through the
same catheter. The unique stylet needle and integral tab make it
possible to visually observe the completion of a successful
venipuncture through aspiration of blood into a transparent
reservoir.
FIGS. 23, 24, and 25 illustrate another presently preferred
infusion assembly embodiment, indicated generally at 242 in FIG.
23. The infusion assembly 240 is substantially the same as the
infusion assembly 30 of FIG. 1 and similar parts have been given
similar reference numbers.
Referring primarily to the differences in the embodiment of FIGS.
23 through 25, the outer sleeve 244 comprises a central bore 246
having an inwardly and forwardly tapering throat 248 at the distal
and therefore terminating in a bore 250 of reduced diametral
dimensions, as best seen in FIG. 25. Moreover, the axially disposed
slot 252 is terminated short of the proximal end 254 of the outer
sleeve 244 and is provided with an outwardly and rearwardly
inclined surface 256 and has a portion 258 of enlarged transverse
dimension adjacent the distal end of slot 252.
The catheter 42 is similar to that of FIGS. 13 and 15 having an
enlarged conical shape at the proximal end 157 which is fixedly
secured, by bonding or the like, to male guide core fitting 260.
The male guide core fitting 260 is externally dimensioned to fit
snugly within the bore 246 and throat 248 of outer sleeve 244, as
seen in FIG. @%, AND IS PROVIDED WITH A PLANAR SURFACE @"@ AT THE
PROXIMAL END THEREOF FOR ABUTMENT BY THE DISTAL END OF THE
SELF-sealing jacket 58. As shown in FIG. 25, the proximal end 254
of the outer sleeve 244 extends beyond the proximal end of the
self-sealing sleeve 58 so that bore 246 of outer sleeve 244 forms a
socket 264 for receiving the male fitting 80 of plug 82 or a fluid
delivery tube, such as tube 210 of FIG. 19. A gap exists at 265
between the forward end of the sleeve 58 and the male fitting 260
so that, after removal of the needle, the sleeve 58 may be
displaced in a forward direction within outer sleeve 244 by
applying force on the trailing end thereof to position the needle
perforation in the sleeve 58 next to the inside wall of outer
sleeve 244 and thereby positively insure that no leakage will occur
through the perforation.
The stylet needle 86 is formed with a pair of opposing, right-angle
bends 266 and 268 adjacent the proximal end 270 thereof and the end
270 is press-fit into the bore 272 of a needle jacket 274. The bore
272 of needle jacket 274 extends axially completely through the
jacket 274 and a slot 276 adjacent the distal end of the jacket 274
communicates the slot 276 with the exterior of jacket 274 to
receive the portion 278 of needle 86 between bends 266 and 268.
Adjacent the proximal end of jacket 274, the bore 272 has a socket
280 of enlarged diametral dimensions to receive the male fitting
282 of a plug 284 which is preferably transparent. The plug 284 is
formed with a bore 286 extending axially there through which has a
portion 288 of reduced diametral dimension communicating with the
proximal end of the plug 284.
To assemble the infusion unit 242, as shown in FIGS. 23 and 25, the
stylet needle 86 is inserted through the self-sealing sleeve 58 and
catheter 42. When a venipuncture is performed, blood will flow
through needle 86 and into bore 286 of plug 284 due to natural
blood pressure to indicate a successful venipuncture. Thereafter,
the needle 86 may be removed. Either before or after the
venipuncture has been performed, plug 82 may be removed from the
proximal end of outer jacket 244 and replaced by a fluid delivery
tube, such as tube 210 of FIG. 19. In addition, if desired, plug
284 may be replaced by a fluid delivery tube, such as tube 210,
prior to the venipuncture to provide fluid at the tip of the stylet
needle 86 at the instant of venipuncture.
The invention may be embodied in other specific forms without
departing from the spirit or essential characteristics thereof. The
present embodiments are, therefore, to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description, and all changes which come within the
meaning and range of equivalency of the claims are therefore to be
embraced therein.
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