U.S. patent number 3,856,009 [Application Number 05/364,798] was granted by the patent office on 1974-12-24 for catheter placement unit.
This patent grant is currently assigned to Johnson & Johnson. Invention is credited to Alon P. Winnie.
United States Patent |
3,856,009 |
Winnie |
December 24, 1974 |
CATHETER PLACEMENT UNIT
Abstract
A catheter for the administration of fluids into the body which
includes a length of precurved, flexible tubing permanently
attached to a gripping member having a winglike structure
projecting therefrom. A catheter assembly comprising a catheter
having a precurved distal portion and a gripping member permanently
attached thereto, an introducer needle disposed partially in the
catheter and a sleeve slidably disposed over the catheter tubing,
said sleeve being operable to prevent internal skiving of the
tubing when the introducer needle is moved forwardly within the
catheter tubing. A detachable, rigid grip is provided which may be
used to operatively connect the introducer needle with a syringe or
other pressure indicating accessory.
Inventors: |
Winnie; Alon P. (Wilmette,
IL) |
Assignee: |
Johnson & Johnson (New
Brunswick, NJ)
|
Family
ID: |
26897505 |
Appl.
No.: |
05/364,798 |
Filed: |
May 29, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
202256 |
Nov 26, 1971 |
3782381 |
Jan 1, 1971 |
|
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Current U.S.
Class: |
604/170.03;
604/530 |
Current CPC
Class: |
A61M
25/0606 (20130101); A61B 17/3401 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61M 25/06 (20060101); A61m
025/00 () |
Field of
Search: |
;128/347-350,214.4,221,DIG.9,DIG.16,DIG.26,214R,214.2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Parent Case Text
This is a division of application Ser. No. 202,256, filed Nov. 26,
1971, now U.S. Pat. No. 3,782,381, issued Jan. 1, 1974.
Claims
What is claimed is:
1. A catheter assembly comprising: a length of flexible tubing
precurved at its distal end; an introducer needle having a point at
its distal end removably disposed within said tubing; and
anti-skiving means mounted over said tubing and movable from a
position overlying a portion of said tubing that is not precurved
to a position overlying said precurved distal end so that said
distal end may be temporarily straightened to prevent internal
skiving of said tubing when said introducer needle is fully
positioned within said tubing.
2. The catheter assembly of claim 1 wherein said anti-skiving means
is a sleeve having a length sufficient to substantially straighten
the precurved end of said tubing.
Description
FIELD OF THE INVENTION
This invention relates to surgical instruments and, in particular,
to improvements in catheter placement units. The catheter of the
present invention is especially suited to the continuous or
intermittent administration of caudal or epidural anesthesia,
although it may likewise serve to introduce various desired fluids
into, for example, the lumen of a blood vessel or a body cavity
such as the abdomen. The present invention provides an improved
catheter which is particularly adapted to follow the general
conformation of the body at the site of administration of caudal or
epidural anesthesia and which is free of structural parts which
would, when the device is in use, endanger the patient's safety
and/or interfere with his comfort.
DESCRIPTION OF THE PRIOR ART
Many devices have been made to aid in the administration or
withdrawal of fluids from the body.
For example, U.S. Pat. No. 2,922,420 is directed to an epidural
needle device which can be inserted into the epidural space without
fear of puncturing the dura. The needle terminates in a blunt point
whose inner face is sloped in a particular fashion. Adjacent the
blunt point, and in the wall of the shaft, there is an elipsoidal
opening facing in the lateral direction. As the catheter is fed
through the lumen of the needle, the sloping internal face of the
blunt point directs the distal end of the catheter through the
elipsoidal opening into the epidural space. Since, however, the
diameter of the puncture made in the tissue (corresponding to the
outside diameter of the needle) is larger than the outside diameter
of the catheter inserted therein, the surgeon must stitch the
tissue around the catheter to prevent leakage from the puncture
site. Additionally, once the needle is removed and the catheter is
in place in the epidural space, there is a marked tendency for the
catheter to revert from the curved configuration temporarily
imparted thereto by the slope of the internal face of the needle to
the straight line configuration characterizing the catheter before
it was fed through the needle. This tendency of the catheter to
revert to its former configuration may cause tissue irritation
and/or discomfort to the patient.
U.S. Pat. No. 3,459,188 discloses a paracentesis stylet catheter
comprising a precurved catheter and an elongated piercing element
(stylet). The precurved portion of the catheter is straightened
when the elongated piercing element is within the catheter and
snaps back to its precurved configuration after removal of the
piercing element. Unfortunately, the longer the piercing element is
disposed within the curved portion of the catheter, the less likely
is the catheter to take on its precurved configuration after
removal of the piercing element. Additionally, when the piercing
element is inserted within the precuved catheter, there is a
tendency of the sharp point of the piercing element to skive (that
is, cut into thin layers) the inner surface of the catheter within
the curved portion. Subsequently, when the catheter is in place and
is being used for the introduction of fluids, small pieces of
catheter material may be inadvertently introduced into the
patient's body. Such an occurrence is particularly dangerous to the
patient's welfare where caudal or epidural anesthesia is being
administered.
U.S. Pat. No. 3,463,152 discloses a catheter placement unit having
a catheter within a needle which is slidably disposed in a sheath.
The sheath has attached thereto a holding member which grasps the
needle to facilitate the insertion thereof. Following
veni-puncture, the needle is retracted into the sheath, leaving the
catheter in place. The sheath then surrounds the point of the
needle to prevent inadvertent damage or discomfort to the patient.
Such a unit is bulky in use and in addition suffers from the usual
disadvantages of "needle over the catheter" devices.
U.S. Pat. No. 3,539,034 discloses a paracervical block anesthesia
assembly comprising a catheter having a precurved, hook-shaped
portion, a catheter stylet, a needle assembly, and an assembly
guide. The catheter stylet is removably received within the
catheter in order to straighten the curved portion thereof. When
the catheter stylet is inserted, the internal walls of the
precurved, distal portion of the catheter may be skived; and, if
the stylet is left within the catheter for any substantial length
of time, the curved portion of the catheter will begin to lose its
"preset" character.
SUMMARY OF THE INVENTION
In order to overcome the problems encountered in the use of prior
art devices, the present invention provides a precurved, over the
needle catheter wherein a wing assembly is permanently attached to
the proximal end of a length of flexible tubing. This wing assembly
functions initially to provide a gripping means by which the
anesthesiologist can exercise improved control during the actual
placement of the catheter in the patient's body; thereafter, the
wing assembly aids in the proper securement of the catheter at the
site of the tissue puncture.
The present invention also provides an anti-skive device which can
be operated to temporarily straighten the precurved portion of the
catheter. When its presence is no longer required, the anti-skive
device can be easily and quickly discarded. As its name suggests,
this anti-skive device prevents the inadvertent cutting away of
thin layers of the inner wall of the curved portion of the catheter
during the insertion therein of the introducer needle. Thus the
chance of small pieces of catheter material entering the patient's
body, and endangering his welfare, is eliminated.
Due to the presence of rigid, projecting elements and/or to their
relative bulkiness, some of the catheter placement units of the
prior art cause a significant amount of discomfort to the patient
under treatment. More importantly, other devices, for example those
wherein the introducer needle cannot be completely removed and
discarded after placement of the catheter, present sources of
potential danger to the patient. In order to eliminate patient
discomfort and insure his physical safety, the present invention
provides a catheter and extension tubing for use therewith which is
completely free from any rigid projections such as hubs, ribs
flanges, or handles, and which is relatively nonbulky. Once the
catheter is secured in place, there are no needles which may
accidentally puncture the catheter or injure the patient. Thus the
catheter of the present invention permits a considerable degree of
freedom in moving about, and the patient, if necessary or
desirable, may actually lie on the catheter without any
discomfort.
In order to further facilitate the catheter placement procedure,
the present invention provides a detachable, rigid, grip, adapted
at one end to fit into the introducer needle hub and at the other
end to receive a pressure indicating device, as for example, a
syringe. This rigid grip may be used in conjunction with the wing
assembly during the catheter insertion step. The pressure
indicating device is used to indicate when entry has been made into
the epidural space.
Accordingly, one object of this invention is to provide a catheter
placement unit useful in the continuous or intermittent
administration of caudal or epidural anesthesia.
Another object of my invention is to provude a means for the
prevention of internal skiving of a precurved catheter during the
insertion therein of an introducer needle or a stylet.
Still another object of my invention is to provide an "over the
needle" catheter having attached thereto means which initially
facilitate the placement of a catheter within the desired part of
the body and would subsequently assist in holding the catheter in
its desired position.
Another object of this invention is to provide a special rigid grip
which affords controlled insertion of an introducer needle and
catheter and which is adapted to be used in conjunction with a
syringe or other pressure indicating device to show entrance into
the epidural space.
Another object of this invention is to provide a catheter and
auxiliary tubing and fittings in such form as to insure the safety
and comfort of a patient during use thereof. Other objects and
advantages of my invention will become apparent to those skilled in
the art from a consideration of the following disclosure, claims
and drawings.
In the appended drawings,
FIG. 1 is an exploded perspective view of the components of one
embodiment of the epidural catheter placement unit of this
invention.
FIG. 2 is a side view, with some portions in section, of a needle
assembly partially inserted in a catheter over which an anti-skive
device is shown in a first, nonoperative position.
FIG. 3 is a view, similar to that of FIG. 2, wherein the anti-skive
device is shown in a second, operative position.
FIG. 4 is an enlarged detail section of the forward portion of FIG.
3 with the anti-skive device removed.
FIG. 5 is a detailed section of the needle hub, special grip, and
pressure-indicating device in operative position.
FIG. 6 is a detailed view of the extension tubing attached to the
gripping means at the distal end of the catheter.
FIG. 7 shows the needle assembly, with the catheter thereover,
inserted into the tissue to the epidural space.
FIG. 8 shows the introducer needle with the grip and pressure
indicating device attached thereto.
FIG. 9 shows the distal end of the catheter positioned in the
epidural space and the extension tubing attached to the gripping
means.
FIG. 10 is a perspective view of the catheter placed in the
epidural space and secured to the patient's back.
PREFERRED EMBODIMENT
FIG. 1 shows, for the purpose of illustrating the present
invention, a catheter placement unit which is particularly useful
in the administration of epidural anesthesia. The placement unit
includes a catheter 10, an introducer needle 30, an obturator 40, a
length of extension tubing 50, an anti-skive device 60, a rigid
grip 65, and a penetration needle 70.
Catheter 10 includes a length of flexible tubing 14, the proximal
end of which is permanently attached, as by epoxy or other suitable
material, to a gripping member 18. The distal portion 15 of
flexible tubing 14 is preset in a generally curved configuration
and has a beveled tip 16. Gripping member 18 has flexible wings 20
and 21 extending laterally from a housing 19 which defines a bore
22 (see FIG. 6). Bore 22 communicates and cooperates with the lumen
of flexible tubing 14 to provide a continuous hollow portion in
which the introducer needle may be removably received.
Introducer needle 30, consisting of a metal cannula 32 having a
point 34 at its distal end and a luer hub 36 permanently attached
to its proximal end, is adapted to removably receive an obturator
40. Obturator 40 has a solid shank portion 42, with a point 44 at
its distal end and a hub 46 permanently attached at its proximal
end; it is provided as part of the catheter placement unit for use
when it is desired to temporarily close off the lumen of the
introducer needle. The outside diameter of obturator shank 42 is
sized so that it may be easily inserted into and removed from
introducer needle 30. Point 44 of obturator 40 and point 34 of
introducer needle 30 are simultaneously ground to insure that point
44 will substantially completely close the opening defined in
introducer needle 30 by point 34 thereof. Cooperating indexing
means may be advantageously provided in the hubs of the introducer
needle and obturator, respectively, to insure proper alignment when
the obturator is disposed within the lumen of the introducer
needle. For example, as can be seen in FIG. 1, when the projection
48 on obturator hub 46 is seated in the notch 38 of introducer
needle hub 36, obturator 40 is properly aligned within the lumen of
introducer needle 30. In accordance with the present invention,
there is provided a rigid grip 65 which may be advantageously
constructed from any suitable plastic, for example polystyrene,
polyvinyl chloride or polypropylene.
As can be seen in FIGS. 1 and 5, rigid grip 65 has a central
portion 66 defining a bore 68 running axially therethrough and
projecting side portions 67. The distal end of the central portion
66 is tapered so that it may frictionally engage the female portion
of luer hub 36 of introducer needle 30, while the proximal end of
central portion 66 is adapted to receive a syringe or other
pressure indicating device.
Referring now to FIG. 2, where some parts are in section, there is
shown a side view of catheter 10, anti-skive device 60, introducer
needle 30 and obturator 40 as they would be assembled in a sealed,
sterilized package.
Obturator 40 is placed entirely within the lumen of introducer
needle 30. Projection 48 on the obturator engages the cooperating
slot 38 in the introducer needle to secure proper alignment of
introducer needle point 34 and obturator point 44, as previously
explained. Introducer needle 30, with obturator 40 properly aligned
therein, is inserted through the bore defined by housing 19 and
into the lumen of catheter tubing 14 to a point just short of the
beginning of the precurved portion of tubing 14, so that there is
no danger of the introducer needle point accidentally piercing or
skiving the internal wall of the tubing. Anti-skive device 60 is
placed over flexible tubing 14 of the catheter so that its one end
rests just adjacent the distal end of housing 19 and its other end
terminates at a point short of the beginning of the precurved
portion of the flexible tubing. Preferably, as shown in FIG. 2,
point 34 of introducer needle 30 and the distal end of anti-skive
device 60 are substantially co-terminating. Where this arrangement
of the parts is used, there is no force exerted on the precurved
distal portion of tubing 14 which would tend to straighten the
precurved configuration.
As stated above, catheter 10 comprises a length of flexible tubing
14 permanently attached to a gripping member 18 (FIG. 1). Flexible
tubing 14 may be constructed, in whatever guage desired, from any
of the plastics known to be useful and safe for placement in the
human body. Teflon polytetrafluoroethylene is particularly suited
for the purposes at hand because of its inherent lubricity and
chemical inertness.
Distal portion 15 of tubing 14 is preset, according to known
methods, in a generally curved configuration; this is especially
advantageous in the administration of epidural or caudal
anesthesia. Referring to FIGS. 7-10 wherein placement of the
flexible tubing for the purposes of administering epidural
anesthesia is illustrated, it is seen that in such a procedure,
distal portion 15 of tubing 14 is positioned within the epidural
space at an angle of about 90.degree. to the direction of entry
into the patient's back. The tubing, because of its preset
configuration, easily and permanently conforms to the path that it
must follow through the patient's body. Thus, the stress and
irritation that can result when an ordinary, straight length of
flexible tubing is made to conform to two substantially different
paths through the body is eliminated by use of the preset, curved
flexible tubing of the present invention.
Gripping member 18, to which flexible tubing 14 is permanently
attached, for example, by the use of an epoxy adhesive, includes a
housing 19 having wings, or lateral projections 20 and 21. Housing
19 may be best described as being semi-rigid, that is to say, it
has more rigidity in its axial direction than flexible tubing 14,
but is nevertheless sufficiently flexible in its radial direction
to yield upon the insertion, described later, of the distal portion
of extension tubing 50. Although the outside diameter of housing 19
is not critical, it is preferably kept small enough, consistent
with its semi-rigid nature, to insure patient comfort.
Wings 20 and 21 are made from flexible plastic or elastomeric
material and they are attached to housing 19 so that they may be
resiliently flexed through a variety of positions without breaking
away from the housing. The wings may define openings, and their
upper and/or lower surfaces may be appropriately scored to insure
more positive gripping.
Referring now to FIG. 3, which is similar to FIG. 2 and where again
some parts are in section, there is shown a side view of the parts
of FIG. 2, with anti-skive device 60 in an operative position.
Anti-skive device 60 has been slid forward over the precurved,
distal portion 15 of flexible tubing 14, thus temporarily
straightening it out, and introducer needle 30, with its indwelling
obturator 40 has been completely advanced by the anesthesiologist.
The distal portion of luer hub 36 of introducer needle 30 now abuts
the proximal end of housing 19.
As seen in FIG. 4, the beveled tip 16 of flexible tubing 14 is
preferably co-terminating with point 34 of the introducer needle.
Where the introducer needle is not needed to effect the primary
tissue puncture, point 34 thereof may be of the Crawford type, that
is, point 34 may be specially prepared to reduce the sharpness
thereof.
Referring to FIG. 5, there is shown a detailed section of the rigid
plastic grip 65 engaging luer hub 36 of introducer needle 30. The
distal end of the central portion 66 of grip 65 frictionally
engages the female socket defined by luer hub 36. At the opposite
end thereof, central portion 66 is adapted to receive a syringe or
other pressure indicating device.
The right-hand portion of FIG. 6 indicates how extension tubing 50
is detachably connected to the catheter. The end of the extension
tubing having tubular blunt 52 therein is inserted into bore 22
defined by housing 19. The extension tubing is held in place by
frictional engagement of its outer surface with the inner wall of
housing 19. When the catheter and extension tubing are thus
connected, it will be seen that there is an uninterrupted
passageway extending from luer hub 54 attached to the extension
tubing, through bore 22 defined by housing 19 of gripping member 18
to the distal end of flexible tubing 14.
One of the unique features of the present invention is the
provision of an anti-skive device 60 which serves to temporarily
straighten the precurved portion of catheter tubing 14 prior to
fully advancing introducer needle 30 therethrough. The use of this
device eliminates any possibility of the introducer needle
"skiving," or cutting away thin layers of, the internal wall of the
precurved portion of the catheter tubing. Anti-skive device 60,
seen in perspective in FIG. 1, comprises a length of plastic
material having a bore axially therethrough and sufficient rigidity
to hold the precurved portion of the catheter tubing in a
straightened position when the anti-skive device is moved from a
first, non-operative position (FIG. 2) to a second, operative
position (FIG. 3). The length of anti-skive device 60 is not
considered to be critical so long as it can effectively straighten
precurved portion 15 of flexible tubing 14. In order to do this, it
is preferred that the length of anti-skive device 60 be
substantially as long as the length of precurved portion 15. The
internal diameter of anti-skive device 60 must be sufficiently
larger than the outside diameter of flexible tubing 14 over which
it is placed to facilitate axial movement along the flexible
tubing; at the same time the internal diameter must be small enough
so as to insure temporary straightening of the precurved portion of
the flexible tubing.
In order to facilitate the introduction of fluids into the body,
there is provided, as part of the catheter placement unit of the
present invention, a length of extension tubing 50, constructed in
appropriate guage from a suitable flexible plastic or elastomeric
material. In one end of extension tubing 50, and partially
extending therefrom, is a rigid tubular blunt 52, which may be of
plastic or metallic construction. As can be seen in FIG. 6, the end
of tubing 50 carrying blunt 52 can be inserted into the proximal
portion of bore 22 of housing 19. The opposite end of the extension
tubing is attached to a plastic luer hub 54 which is adapted to
removably receive a puncturable, resealable diaphragm (not shown)
or other accessory, for example, a syringe fitted with a male luer
hub. Both the blunt 52 and the luer hub 54 are permanently attached
by suitable means to the extension tubing to insure positive seal
integrity.
Finally, there is provided a puncturing needle 70 having a point
adapted for piercing the tissue of the patient's body; this is used
by the anesthesiologist to make the initial puncture at the site
where the catheter is to be placed.
The procedure to be followed in using the catheter placement unit
of the present invention for the administration of epidural
anesthesia will now be described.
The site selected for insertion of the catheter is prepared
according to standard procedures.
Puncturing needle 70 is then used to make the initial penetration
of the body tissue to a point approaching the epidural space 76.
When the initial puncture is completed, puncturing needle 70 is
removed from the site.
Taking the catheter assembly as illustrated in FIG. 2 from the
package, the anesthesiologist slides anti-skive device 60 forwardly
over the precurved, distal portion 15 of flexible tubing 14,
thereby temporarily straightening the precurved portion. Introducer
needle 30, with its indwelling obturator 40, is then pushed forward
until cannula 32 is completely inserted within flexible tubing 14.
The relationship of the various components at this stage is
illustrated by FIG. 3, that is to say, the distal portion of the
luer hub 36 of introducer needle 30 abuts the proximal end of
housing 19, anti-skive device 60 is temporarily holding the
precurved, distal portion 15 in a straightened alignment and point
34 of introducer needle 30 and beveled tip 16 of flexible tubing 14
are substantially co-terminating.
Anti-skive device 60 is completely removed and discarded. The
anesthesiologist then folds the flexible wings 20 and 21 upwardly
from their position as illustrated in FIG. 1 to the position
illustrated in FIG. 7. Using the wings as thus folded in
conjunction with obturator hub 40, the anesthesiologist then
carefully inserts introducer needle 30 with catheter 10 thereover,
into the puncture previously made with the aid of needle 70. At
this stage, introducer needle 30 is adjacent, but has not
penetrated, epidural space 76 (FIG. 7). The anesthesiologist then
removes obturator 40 from within the introducer needle and, if
desired, inserts the distal end of central portion 66 of rigid grip
65 into the socket of luer hub 36. A syringe 72, or other
pressure-indicating device, is then inserted into the proximal end
of the central portion 66 of the rigid grip. The anesthesiologist
then uses wings 20 and 21, again folded upwardly as illustrated in
FIG. 7, and rigid grip 65, to carefully insert introducer needle 30
into epidural space 76. Entrance into the epidural space will be
shown by syringe 72 or other pressure indicating device attached to
the proximal end of central portion 66. After epidural space 76 has
been penetrated, the anesthesiologist removes introducer needle 30,
rigid grip 65, and syringe 72 by holding the gripping member 18
with one hand and pulling rigid grip 65 backwardly. Alternatively,
in the case where the anesthesiologist chooses not to employ rigid
grip 65, syringe 72 or the other pressure indicating device is
connected directly to the proximal end of luer hub 36 of introducer
needle 30, the upwardly folded wings are then used in conjunction
with syringe 72 (or the other pressure indicating device) to effect
entrance into epidural space 76. When that is done, syringe 72 (or
the other pressure indicating device) is removed from within luer
hub 36, and the procedure is completed as indicated below.
The end of the extension tubing 50 carrying rigid, tubular blunt 52
is then hooked up to housing 19; the other end is connected, via
the hub 54, to a syringe or other accessory containing the liquid
to be infused.
As best seen in FIG. 9, the anesthesiologist then grasps the
upwardly folded wings and moves flexible tubing 14 forwardly into
position within epidural space 76. As this is done, the preset
curve is restored to distal portion 15 of flexible tubing 14 so
that, as seen in FIGS. 9 and 10, flexible tubing 14 is properly and
comfortably positioned in epidural space 76.
Wings 20 and 21 are then folded downwardly and fastened to the
patient's back 78 by strips of adhesive tape 80.
* * * * *