U.S. patent number 3,561,445 [Application Number 04/742,333] was granted by the patent office on 1971-02-09 for catheter placement unit.
This patent grant is currently assigned to Abbott Laboratories. Invention is credited to Richard M. Chittenden, Robert P. Earl, Gary D. Evans, Dean R. Katerndahl.
United States Patent |
3,561,445 |
Katerndahl , et al. |
February 9, 1971 |
CATHETER PLACEMENT UNIT
Abstract
A catheter placement unit adapted to advance a catheter in a
sterile state comprising a catheter having a hub, a concentric
needle and hub, a sheath, and a catheter container adapted to
enclose a relatively long catheter and being adapted to advance the
catheter from the container through the needle and sheath without
exposing the catheter. The container in its preferred form is
constructed of two halves which snap together to enclose the
catheter, and snap apart to expose the catheter. The halves are
relatively rotatable, and one half has two concentric walls, the
outer wall providing frictional force on the catheter coiled
therein, and causing the catheter to advance from the container
when the said half is rotated relative to the remaining half.
Inventors: |
Katerndahl; Dean R. (Wheaton,
IL), Earl; Robert P. (La Grange, IL), Evans; Gary D.
(Waukegan, IL), Chittenden; Richard M. (Grayslake, IL) |
Assignee: |
Abbott Laboratories (Chicago,
IL)
|
Family
ID: |
24984410 |
Appl.
No.: |
04/742,333 |
Filed: |
July 3, 1968 |
Current U.S.
Class: |
604/159 |
Current CPC
Class: |
A61M
25/0113 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214.4,348--350 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. In the combination including a needle having a hub with a
passage extending entirely through the needle hub; a catheter
within the passageway, a portion of the catheter extending from
said passage at said hub, said portion of the catheter housed
within a container, said container constructed of at least two
separable parts, one part constructed as a drum with a cylindrical
segment and one closed end, another part constructed as a cover for
the end of said cylindrical segment opposed said closed end, said
other part having an outlet, said catheter wound on said one part
and in frictional engagement with the inner surface of said
cylindrical segment whereby rotation of said one part relative to
said other part causes said catheter to move through said outlet in
response to the frictional engagement between said catheter and the
inner surface of said cylindrical segment.
2. The container of claim 1 wherein rotation of said one part
relative to said other part results in greater relative movement
between said catheter and said other part than between said
catheter and said one part.
3. The container of claim 2 wherein there is substantially no
relative movement between said catheter and said one part upon
relative movement between said one and said other parts comprises a
drum which also serves as said first half and which is rotatably
connected to said second half.
4. The container of claim 1 wherein said outlet is in direct
communication with a needle hub.
5. The container of claim 1 wherein the catheter is provided with a
wire stylet enclosed concentrically therein to render the catheter
manipulatable.
6. The container of claim 1 wherein said outlet has means to free
the catheter upon separation of said one part from said other
part.
7. The container of claim 6 wherein said outlet is a tubular member
connected tangentially to said other part.
8. The container of claim 6 wherein the means to free the catheter
comprises an outlet having a diameter sufficient to pass the
catheter.
9. The container of claim 6 wherein the means to free the catheter
comprises an outlet having two halves adapted to be longitudinally
separated to expose an axial slot of sufficient size to pass the
catheter radially out said slot.
Description
This invention broadly relates to devices used to implant catheters
in a recipient. More specifically, the invention relates to
implanting relative long catheters. Even more specifically, the
invention relates to units adapted to store and after incision to
advance a long catheter while maintaining the initial sterile
condition of the catheter.
Before explaining the exact nature of this invention by reference
to specific embodiments thereof, it is desirable to review the
factors which prompted the invention. The improvements of the
invention may best be appreciated by noting deficiencies in
previously used catheter placement units.
Generally, catheters now in use for intravenous applications may be
classified as "needle inside" or "needle outside." These
classifications result from the provision of a needle
concentrically arranged with respect to a catheter which catheter
is to be placed in a vein or body cavity. This concentric
arrangement has been found quite satisfactory but certain problems
of a practical nature are inherent in the arrangement. When a
catheter is to be implanted for such operations as transfusions of
fluids to the body, it is necessary to provide access to the body--
by using an incising element-- and then to provide a conduit for
fluid passage-- by using a hollow tube or catheter. Using a single
element as the incising element and conduit is not recommended due
to the danger of internal damage when the incising element is left
in place and the lack of sterility involved. Accordingly, the
concentric arrangement of incising element and conduit resulted.
However, in using these devices problems were encountered since the
needle used as an incising element is generally required to be long
and thin resulting in flexible needles that are hard to control and
breakable unless supported intermediate its ends. Additionally, a
catheter arranged outside the needle was likely to be contaminated
during the incision and a catheter arranged inside the needle was
likely to be lost by passing completely through the needle into the
vein.
In addition to the above-noted problems common to all catheters,
"long" catheters present further problems. Naturally, the longer a
catheter is the more susceptible it is to contamination, especially
during implanting. Additionally, long catheters were frequently
found to become entangled during implanting. This not only requires
destroying the sterility by manually untangling it, but also may
cause the fluid flow to cease. Special situations such as
intravenous pressures measurements, slow transfusions requiring
several days, and patients having weak vein structure require the
use of long catheters, e.g. 36 inches which are advanced through
the patient's veins.
To solve the problems encountered in using needle-inside long
catheters the present invention utilizes a container for a coiled
length of catheter which container has means to advance the desired
length of catheter from the container through the needle and into
the recipient without ever exposing that portion of the catheter to
be implanted and without danger of entangling the catheter.
It is a primary object of this invention to provide a catheter
placement unit adapted to maintain a catheter in a sterile state
during implanting operations.
Another object is to provide the described catheter container
having means to readily and easily advance a catheter into a
patient without manually engaging the catheter.
Still another object is to provide a catheter container which may
be discarded after the catheter is implanted to facilitate the
connection of extrinsic equipment.
These and other objects and advantages of this invention will
become apparent from a consideration of specific embodiments
illustrated in the drawings wherein like reference numerals
designate like elements and wherein:
FIG. 1 is a side view showing one embodiment of the assembled
catheter placement and advancement unit including a catheter
container with actuator unit according to this invention;
FIG. 2 is an exploded view in perspective showing the catheter
container of FIG. 1;
FIG. 3 is a side view of the sheathed needle with appurtenant
needle hub and sheath according to the embodiment of FIG. 1;
FIG. 4 is a side view of the partially unsheathed needle of FIG.
3;
FIG. 5 is a side view of the catheter with appurtenant catheter hub
and stylet of FIG. 1;
FIG. 6 is a side view, partly in section, of the catheter implanted
in a recipient wherein the catheter hub is engaged with the needle
hub and the catheter container has been discarded;
FIG. 7 is a side view, partly in section, of the catheter container
of FIG. 1;
FIG. 8 is a side view, partly in section, showing a second
embodiment of a catheter container with actuator according to this
invention;
FIG. 9 is a side view of a third embodiment of catheter container
with actuator according to this invention;
FIG. 10 is an end view of the embodiment of FIG. 9;
FIG. 11 is a side view, partly in section, of the actuator provided
in the embodiment of FIG. 9.
Referring to the FIGS. generally and particularly to FIGS. 1--7, a
preferred embodiment of a catheter placement unit is illustrated.
In these FIGS., the following major components are designated:
2-- catheter
4-- catheter hub
6-- catheter container
8-- needle
10-- needle hub
12-- external sheath
14-- internal sheath
16-- stylet
18-- stylet hub
Now referring specifically to FIG. 1, the assembled components may
be seen. In this FIG., a catheter 2 is coiled in a cylindrical
container 6 having an outlet 20. The catheter 2 is threaded through
outlet 20 and through a needle hub 10 and needle 8 which are
interconnected with outlet 20. Thus, the catheter unit is of the
needle-inside type. A protective external sheath 12 is integral
with needle hub 10 as is best seen with reference to FIGS. 3 and 4,
which are more fully explained hereinbelow. An internal sheath 14
initially covers needle 8. In operation, the internal sheath 14 is
removed and the catheter may be advanced through hollow needle 8 by
twisting the drum portion 22 of container 6.
Referring now to FIG. 2, the preferred embodiment of the catheter
container is seen to comprise three parts. Reference numeral 22
designates a first half which is a hollow drum portion with a
peripheral flange 24 for enclosing a coiled length of cather 2. The
drum portion 22 comprises a peripheral wall 26, a rear wall 28, a
hub 30, a lug 31 and the arcuate inner peripheral flange 24. The
second half of the container is designated 32 and it contains a
peripheral rim 34 having an inner diameter approximately the same
as the outer diameter of peripheral wall 26 of drum portion 22.
This size relationship allows drum portion 22 to fit within second
half 32 in the assembled state. Second half 32 has a front wall 36
which contains aperture 38 adapted to frictionally engage hub 30.
Outlet 20 is integrally molded as part of second half 32. The
outlet 20 defines a cylindrical passage which has an axial slot 40
enabling a catheter to be forced into or out of the outlet without
requiring that the entire catheter be threaded through said outlet
20. To maintain catheter sterility, axial slot 40 is normally
closed by cover 42 which snaps onto outlet 20. Cover 42 has an
extending rib which serves as a handle 44 and can be grasped to
remove cover 42 from outlet 20 thereby exposing axial slot 40 and
allowing a catheter to be separated from the catheter container
6.
Referring now to FIGS. 3 and 4, the combined needle 8, needle hub
10, and needle external sheath 12 is shown. This structure
corresponds to that disclosed in U.S. Pat. No. 3,323,523 and the
entire disclosure thereof in expressly incorporated herein by
reference. For purposes of understanding this invention, the unit
of FIGS. 3 and 4 is described herein in its relation to the present
novel catheter placement unit. A rigid cannula or needle 8 is
provided with a pointed end 46 and a connecting end 48. The
connecting end 48 is embedded in the needle hub 10 which is a
plastic tubular member. Connecting end 48 has a connecting flange
49 to insure that needle 8 is securely held in place. Needle hub 10
is provided with an enlarged cavity 50 in one end which is
initially fitted over adapter 52 on catheter container outlet 20
when the entire device is assembled (FIG. 1) and which cavity 50
also is adapted to receive the catheter hub after implanting (FIG.
6). The external sheath 12 comprises at least two parts swingably
attached to needle hub 10. A narrow annular sleeve 54 is slidably
mounted on the external sheath 12, so that when in position over
the external sheath 12 as in FIG. 3, the two halves of the sheath
are clamped together. When it is desired to use the device, the
sleeve 54 is slid back from the external sheath 12 into a position
on needle hub 10 (FIG. 4). The two halves of the external sheath
12, being swingably mounted on the hub 10, are extended laterally
as in FIG. 1, thereby exposing the needle 8 and internal sheath 14.
In the FIGS., the two halves of the external sheath 12 are hinged
to the hub 10 by a narrow strip 56, which is part of the wall
structure of external sheath 12 as shown in FIG. 4. After the
catheter 2 is inserted into the recipient and the needle 8 is
removed, the two halves of the sheath 12 are closed over the needle
8 and the annular sleeve 54 is slid over the external sheath 12 to
clamp the two halves together. The catheter 2 now extends through
the needle 8 and through an end slot 58 (see FIG. 4) which is
formed when the two halves of the external sheath 12 are clamped
together. The walls of end slot 58 gently grip the catheter without
restricting it to any meaningful degree and thereby prevent the
needle and needle hub assembly from slipping along the catheter 2,
in the final state as seen in FIG. 6. The protective external
sheath 12 maintains the catheter 2 in generally axial alignment
with the tubular needle 8 so that accidental piercing of the
catheter 2 by the pointed end 46 of the needle 8 cannot occur.
Without such a protective sheath, the catheter oftentimes bends
back against the pointed end of the needle and is punctured,
necessitating its withdrawal and the reinsertion of another
catheter with resultant discomfort and possible danger to the
patient.
The catheter 2 is initially supplied with a stiffening member
comprising an inner stylet 16 attached to a stylet hub 18. After
the catheter 2 is in place and the external sheath 12 is closed as
described above, the stylet 16 is removed by pulling stylet hub 18
until the entire stylet 16 is removed and discarded. Removal of the
stylet hub 18 from catheter hub 4 leaves the catheter hub 4
available to be connected to administration equipment, not shown.
The initial purpose of the stylet 16 is to provide rigidity in the
flexible catheter 2. In order to allow the catheter 2 to be reeled
from container 6 and to enable the catheter 2 to smoothly move
through the veins, a certain degree of rigidity is required.
Considering the reeling action, the catheter 2 with stylet 16
resists the coiled state due to the stress placed upon the wire
stylet 16 so that the coiled assembly tends to fly free of the coil
unless restrained. In the preferred embodiment the restraining
force is provided by placing the coil in the space defined by
peripheral wall 26 and inner peripheral flange 24 of container drum
portion 22. The tendency of the coil to fly apart forces the coil
against the peripheral wall 26 so that movement of said wall 26 by
manually rotating drum portion 22 results in the coil moving also.
When the coil is threaded through opening 60 in inner peripheral
flange 24 and then through outlet 20 in second half 32, it is seen
that revolving drum portion 22 with respect to second half 32 will
force the coiled catheter 2 out of the container 6 and into the
connected needle hub 10 in a smooth manner. This reeling motion is
utilized after venipuncture to advance the catheter through the
recipient's veins. Accordingly, it is seen that in the preferred
embodiment the catheter container comprises a hollow cylinder
having a drum portion and a second half wherein the actuator is
said drum portion which serves to reel the catheter out of the
hollow space within the container.
After the catheter 2 has been advanced to the desired extent the
container 6 may be removed from engagement with the catheter 2 and
needle hub 10 by pulling the needle hub out of engagement with
adapter 52. The pulling action causes the entire needle hub
assembly to slide along catheter 2. Next the cover 42 is removed by
pulling on handle 44 thereby exposing axial slot 40 of container
outlet 20. Now the container is separated by slight manual pressure
applied with the thumb on the projecting portion 62 of hub 30 which
extends through aperture 38. When the two halves are thus separated
the catheter hub 4 may be removed from drum portion 22 and the
catheter 2 may be disengaged from second half 32 by pulling it out
of axial slot 40 in outlet 20. When the stylet 16 is removed
extrinsic equipment may be connected to the catheter hub 4 and the
needle hub 10 may be slid back to engage catheter hub 4 in cavity
50. This sequence of steps results in a catheter which has been
advanced to the desired extent without even being exposed to
unsterile conditions or to manual handling.
The materials of construction may be any of those conventionally
used in catheter assemblies. The entire assembly with the possible
exceptions of stylet 16 and needle 8 may be formed of molded
plastic. By way of specific example polyethylene, polypropylene or
acrylic resins may be used. In choosing a suitable plastic the
catheter 2 and the catheter container 6 should preferably be of
translucent plastic allowing observation of fluid flow and of the
length of catheter remaining in the container.
Numbers may be printed on the enable designating increments of
length e.g. inches or centimeters to enable a user to readily
determine by looking at the container and the remaining coils how
much catheter has been advanced into a recipient. The needle 8 and
stylet 16 may be formed of any suitable materials such as stainless
steel, nylon, high density polyethylene or the like.
While particular emphasis has been placed on the preferred "reel"
embodiment, other suitable embodiments are at once evident from the
basic teaching. For example, FIG. 8 illustrates another container
for a coiled catheter wherein a bottlelike container 70 is
employed. In this embodiment the structure used to advance the
catheter 2 from the container 70 while maintaining a sterile
condition comprises a length of flexible plastic tubing 72. The
operation of this embodiment is similar with respect to the initial
preparation in that the same needle 8, needle hub 10 and external
sheath 12 are used. After sliding sleeve 54 onto needle hub 10, the
halves of external sheath 12 may separate by the hinge action of
narrow strips 56 to expose needle 8 and internal sheath 14.
Internal sheath 14 may be removed by sliding it off needle 8. The
container 70 comprises a conical container formed of translucent
plastic and having each end open. A first end 74 serves as an
outlet and receives flexible tubing 72 by frictionally engaging
same to provide a removable but hermetically sealed junction. A
second end 76 comprises a depending skirt which receives in
overlapping relationship a rigid plastic closure 78. Rigid plastic
closure 78 serves to house a coiled length of catheter 2 and
attached catheter hub 4. Again, the catheter contains a wire stylet
16 and stylet hub 18 which stylet makes the catheter 2 rigid and
therefore manipulatable. To restrain the stressed catheter coils,
flanges 80 are provided on rigid closure 78. The catheter hub 4 may
be allowed to lie on the face of closure 78 or it may be restrained
by suitable upstanding lugs (not shown) attached to closure 78 at
its face which supports said hub. Catheter 2 is threaded through a
space provided in restraining flanges 80 which space is analogous
to opening 60 of FIG. 2 and then up through outlet 74 into plastic
tubing 72 and thence through needle hub 10 and needle 8.
With external sheath 12 open, venipuncture is made and the catheter
2 is fed into the recipient by reciprocating flexible tubing 72.
The tubing 72 may be flexed downwardly and pressed inwardly so the
fingers indirectly grasp catheter 2 within said tubing, then the
tubing is flexed upwardly while still grasping catheter 2 and the
catheter is thus pulled out of the container and fed through needle
8 into the recipient. Repeated reciprocal movements are used until
the desired length of catheter has been implanted. The length
implanted can be readily determined since the conical bottle
container 70 is translucent and the catheter may be marked in
serial numbers designating increments of length (e.g. inches or
centimeters). When the desired length has been implanted, the
catheter may be freed of the container by pressing inwardly on the
flexible conical container 70. This pressure expands depending
skirt portion 76 of second end so that rigid closure 78 falls free.
Now catheter hub 4 may be grasped and separated along with any
remaining coils of catheter 2 from rigid closure 78.
Catheter 2 and catheter hub 4 may be separated from conical
container 70 and flexible tubing 72 by pulling tubing 72 away from
first end 74 thereby allowing the catheter and catheter hub 4 to
pass through outlet 74. Easy passage is achieved since first end 74
is larger in diameter than catheter hub 4. The flexible tubing 72
need not be separated but can remain a part of the final assembly
if desired. By forcing catheter hub 4 into the tubing 72, catheter
adapter 82 of catheter hub 4 will engage the cavity 50 of needle
hub 10 within tubing 72 and a rigid enclosed junction exists. Now
external sheath 12 may be closed and secured by sleeve 54 and wire
stylet 16 may be removed to clear catheter hub 4 for connection to
administration equipment, now shown.
Alternatively, tubing 72 may be removed by pulling needle hub 10
out of said tubing and then forcing catheter hub 4 through said
tubing 72. Now the needle hub 10 and catheter hub 4 may be
connected as before described with reference to FIG. 6. This
results in a final assembly identical to the final assembly
achieved with the first embodiment as shown in FIG. 6.
A third embodiment is illustrated in FIGS. 9--11. The assembled
structure is shown in FIG. 9 and comprises a container 90 for a
coiled catheter 2 which container comprises two interfitted halves
92 and 94. First half 92 contains an outlet 96 having an actuator
98. The outlet 96 serves also to support a needle 8 having a
protective sheath 100 slidably engaged thereon and the conventional
inner sheath 14. The opposite end of first half 92 contains an
inlet 102 having plug 104 therein. The plug 104 serves to prevent
contaminating foreign matter from reaching the catheter prior to
use and when removed aids in freeing the catheter from the
container 90 as is described hereinbelow. The catheter 2 and
catheter hub 4 are enclosed between first half 92 and second half
94 and contain a stylet with stylet hub (not shown) to render the
catheter manipulatable. To operate this embodiment, protective
sheath 100 is removed exposing needle 8 and internal sheath 14 is
removed. Then, venipuncture is made. Next, the catheter 2 is
advanced into the recipient by reciprocating actuator 98 within
slot 99. If desired, slot 99 may be fitted with a slotted flexible
plastic sleeve, not shown, which will engage actuator 98 and seal
the space but still will allow reciprocation of actuator 98. As
seen in FIG. 11, actuator 98 comprises a depending lug 106 which
engages a length of catheter (not shown) within the outlet 96 to
carry it forward as actuator 98 is moved forward. At the extreme
limit of the forward stroke of actuator 98 it may be disengaged
from the catheter 2 by pressing it into the position of FIG. 11.
Then actuator 98 is moved backward and allowed to engage the
catheter for another forward stroke. This action forces catheter
out of container 90 through needle 8 into the recipient without
manual engagement of the catheter. The container 90 is translucent
and the catheter is marked in increments of length so the length
advanced is readily discernable. To remove the container 90 flange
108 carried by first half 92 may be engaged and pulled up and away
from second half 94, thus opening the two halves of container 90
and exposing needle hub 10 for attachment to catheter hub 4 by
sliding catheter adapter 82 of catheter hub 4 into cavity 50 of
needle hub 10 as was done with the prior embodiments. Now the
container 90 may be discarded and the stylet within catheter 2 may
be removed to allow connection of the catheter to suitable
administration equipment.
While the embodiments herein described are structurally different
in certain specific details they all provide novel containers with
actuators to encase and implant a long catheter. The materials of
construction of the parts may be the same in each embodiment;
however, the specific materials are in no way limiting and are
given only by way of specific examples. From the inventive concepts
herein above-disclosed many modifications will become apparent to
those skilled in the art and mere substitutions of equivalent parts
and obvious modifications of the disclosed embodiments are
encompassed within the inventive concept. Having described this
invention in clear and concise and full terms;
* * * * *