U.S. patent number 3,585,996 [Application Number 04/744,089] was granted by the patent office on 1971-06-22 for arterial catheter placement unit and method of use.
This patent grant is currently assigned to Levoy's Corporation. Invention is credited to Karl A. Pannier, Jr., Gordon S. Reynolds.
United States Patent |
3,585,996 |
Reynolds , et al. |
June 22, 1971 |
ARTERIAL CATHETER PLACEMENT UNIT AND METHOD OF USE
Abstract
A catheter placement unit for positioning a catheter in a body
lumen, such as an artery or vein, for purposes of parenteral
infusion, or pressure monitoring, oximetery, or other diagnostic
purposes, and a method of utilizing such catheter placement unit.
The unit or assembly includes a hollow needle, a hub on the needle
and a self-sealing valve in the needle hub; a sheath, a catheter in
the sheath, and a hub carrying a hollow pilot projection, removably
connected to the sheath. The needle may, if desired, be initially
used separately and then the sheath and catheter connected to the
needle by joining the hubs with the pilot projection extending
through the valve to permit advancing the catheter through the
needle into a body lumen.
Inventors: |
Reynolds; Gordon S. (Salt Lake
City, UT), Pannier, Jr.; Karl A. (Salt Lake City, UT) |
Assignee: |
Levoy's Corporation (Salt Lake
City, UT)
|
Family
ID: |
24991385 |
Appl.
No.: |
04/744,089 |
Filed: |
July 11, 1968 |
Current U.S.
Class: |
604/158 |
Current CPC
Class: |
A61M
25/0111 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214.4,221,215,347,218NV,DIG 16/ |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
328,570 |
|
May 1903 |
|
FR |
|
430,890 |
|
Oct 1911 |
|
FR |
|
1,534,119 |
|
Jun 1968 |
|
FR |
|
689,131 |
|
Mar 1953 |
|
GB |
|
Other References
Morris et al., "Pressure-Perfusion Cannula," J. OF THORACIC SURG.
June 62, vol. 43, No. 6 pps. 822--24, 128--214.4.
|
Primary Examiner: Truluck; Dalton L.
Claims
We claim as our invention:
1. A catheter placement assembly, comprising
a hollow needle pointed at one end,
a hollow hub on the other end of said needle,
a self-sealing valve in said hub to prevent an outward flow and
loss of blood through the needle when the same is inserted in a
body lumen,
a sheath having a slit lengthwise thereof,
a hollow hub connected to the proximal end of said sheath,
a nose on said sheath hub removably frictionally engaged with said
needle hub,
means on said nose extending through and holding said valve open
when the hubs are engaged,
a catheter in said sheath, and
means for advancing the catheter and removing said sheath when the
catheter is advanced.
2. The assembly of claim 1 wherein said catheter is made of
material throughout its entire length having the strength and
lubricating property of polytetrafluorethylene.
3. The assembly of claim 1, including
a catheter advancer connected to one end of the catheter and
partially extending into said sheath,
a stop member on said sheath outward of said advancer, and
a dead end portion of said sheath outward of said stop member to
function as a handle to be held in one hand while manipulating said
advancer with the other hand.
4. The method of positioning a catheter contained in a sterile
sheath and removably connected at its proximal end to a hub having
a hollow pilot projection thereof, with the aid of a hollow needle
carrying a hub having a slit self-sealing valve therein, both said
hubs being removably and telescopically engageable, including the
steps of
inserting the hollow needle into a body lumen,
blocking the flow of blood through the needle by way of said
valve,
connecting the sheath to said needle by way of said hubs and
simultaneously penetrating said valve with said pilot projection,
and
advancing the catheter through said sheath and needle into the body
lumen.
5. The method of claim 4 wherein the body lumen is percutaneously
accessible and including the steps of
measuring the distance the catheter has been advanced through said
sheath,
applying such measurement to the body of the patient to denote when
the catheter is in an intrathoracic lumen, and
then withdrawing the needle and sheath relatively to the catheter
while holding the latter stationary.
Description
BRIEF DESCRIPTION OF THE PRIOR ART
Heretofore, when a patient's condition so indicated, a catheter has
been advanced through an artery into an intrathoracic artery, but
this could not be accomplished without having a sterile field of
operation, the use of sterile gloves, and the like, and without a
loss of blood over the operating field because the arterial blood
would spurt through the hollow needle with which the arterial
puncture was made. Consequently an objectionable mess resulted and
the attending surgeon's hands or gloves would be contaminated so
that someone else would have to actually advance the exposed
catheter through the needle. For these reasons the use of the
catheter in an intrathoracic artery was done when necessary, but
perhaps not always when it would be desirable.
BRIEF SUMMARY OF THE INVENTION
It is accordingly an object of the instant invention to provide a
catheter placement unit for positioning a catheter in an artery and
advancing it through the artery to an intrathoracic artery without
any exposure or loss of blood from the artery.
Also an object of this invention is the provision of a catheter
placement unit from which the hollow needle may be removed, before
insertion of the catheter, and used for sampling arterial blood to
determine cardiac output, chemistries, partial pressures, oxygen
saturations, etc., also without loss or exposure of blood from the
artery.
Other and further advantages of the instant invention include the
fact that the catheter is placed sterilely without any sterile
field of operation; fluoroscopy is not necessary for proper
placement of the catheter; the hollow needle embodied in the
placement unit is detachable for dye dilution curves and
chemistries; the catheter can be filled with solution, prior to
advancement, for high fidelity pressure recordings; the catheter
can be positioned the day before surgical procedure, used for
measurement at the time of surgery, and then later for measurements
in the postoperative recovery area; and the catheter can be placed
during surgery if such procedure is indicated. Still other
advantages will become apparent from the disclosures
hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS:
FIG. 1 is a fragmentary view of the catheter placement unit, with
parts broken away, and with the usual needle cover removed;
FIG. 2 is an enlarged vertical sectional view through the needle
and needle hub;
FIG. 3 is an enlarged vertical sectional view through the hub on
the end of the catheter sheath;
FIG. 4 is a fragmentary vertical sectional view of the needle hub
and sheath hub joined together after advancement of the catheter;
and
FIG. 5 is an elevational view of the self-closing valve in the
needle hub.
DESCRIPTION OF THE PREFERRED EMBODIMENT
While the instant invention may be utilized to position a catheter
in an artery or a vein, it will be herein described in connection
with its use in an artery, since for economical reasons it may be
preferable to utilize a placement unit having a less expensive
catheter and one in which the needle may not be removable from the
unit. For arterial use a catheter of vinyl or polyethylene such as
is commonly used for intravenous infusion is not satisfactory to a
desired extent, a catheter having a stronger wall that will not
expand or contract with the blood pulsations in an artery, and so
eliminate damping, as well as a catheter that is capable of
minimizing clotting to a great extent being necessary. To this end,
for arterial use a strong walled catheter of material such, for
example, as polytetrafluoroethylene which has extreme strength and
lubricating qualities is satisfactory for arterial work.
The instant placement unit includes a catheter that is made of
material such as polytetrafluoroethylene throughout the entire
length of the catheter. The catheter is long in order to insure it
reaching an intrathoracic artery of all patients regardless of
their size. For this purpose a catheter 100 centimeters in length
is satisfactory, and the catheter is preferably relatively small, a
19 gauge catheter being satisfactory.
Sterility of the catheter until it is fully advanced into a body
lumen is effectively maintained by enclosing the catheter in a
plastic sheath 2 having a slit 3 extending lengthwise thereof, such
a sheath being more fully described and disclosed in W. H. Ring et
al. U.S. Letters Pat. No. 3,262,448 issued July 26, 1966. In this
instance near its distal or outer end the sheath is provided with a
stop flange 4 outward of which is a short dead end section of
sheath 5 also flanged as at 6 and which functions as a handle to be
gripped when the catheter is advanced. The distal end of the
catheter extends into a hollow catheter advancer 7 embracing the
sheath and terminates within a hollow nipple 8 projecting at an
angle from the advancer 7, either or both of which may be grasped
between the thumb and finger of an operator for advancing the
catheter while holding the dead end section 5 in the other hand.
Also connected to the nipple 8 is a tube 9 terminating in a fitting
10 for connection to various diagnostic or infusion apparatus,
which fitting is maintained sterile and closed by a temporary cap
11 frictionally seated thereon. The advancer 7 is of the same
general type as that shown in FIGS. 1, 2 and 3 of a copending Karl
A. Pannier, Jr. application entitled "Catheter Placement Unit With
Unidirectional Locking Means to Prevent Catheter Retraction" filed
Mar. 21, 1966, Ser. No. 536,155, now Letters Pat. No. 3,438,373,
issued Apr. 15, 1969. The advancer has a portion thereof extending
through the slit in the sheath 2 to spread the sheath as the
catheter advances. The advancer is also provided with a nose 12 of
reduced size, terminating in a tapering flange 13 behind which is
an abrupt shoulder 14.
At the proximal end thereof, the sheath is provided with a hollow
hub or fitting 15, best seen in FIG. 3. The hub is provided with a
nose 16 from which a hollow pilot tube 17 of materially reduced
diameter extends. The sheath is restrained from separation from the
hub 15 until the catheter is fully advanced by means of a washer 18
having a plurality of teeth 19 struck therefrom and extending at an
angle to the sheath so that the teeth will bite into the sheath and
prevent it from being withdrawn from the hub. The washer 18 is held
in place between the end of the hub and a cap 20 provided with a
central aperture 21 of a size to receive the nose 13 on the
aforesaid advancer 7.
A hollow needle 22, pointed as indicated at 23, is removably
associated with the rest of the placement unit by means of a hollow
hub 24, best illustrated in FIG. 2. The needle shank is secured
within one end portion of the hub, and the hub is interiorly formed
to provide an annular shoulder 25 therein adjacent the other end.
Seated against that shoulder 25 is a self-sealing disc valve 26
made of a relatively thick piece of rubber or equivalent material
provided with several fine slits 27 which may satisfactorily be
arranged in the form of a "Y" as seen best in FIG. 5. This valve is
held in place against the shoulder 25 by means of a hollow cap 28
pressing against the opposite side of the valve and secured within
the body of the hub 24. The hollow cap 28 is shaped to receive
therein the nose 16 on the sheath hub 15 in an intimate frictional
fit, and when the parts are so joined the pilot tube 17 on the nose
16 extends through the valve 26 as seen in FIG. 4 to hold the valve
open. When the needle is removed from the sheath hub 15, the valve
automatically closes and prevents a flow of blood from the artery
through the needle. With a 19 gauge catheter, an 18 gauge needle is
satisfactory.
When the catheter placement unit is put to use, arterial puncture
may be performed in an accessible artery such as the radial,
brachial, ulnar or femoral artery and the catheter advanced to the
intrathoracic arteries for pressure measurements.
When the instant placement unit is put to use, for example in an
artery of the arm of the patient, the patient is preferably in the
supine position with the arm and hand positioned with the wrist
hyperextended using a special arm board such as the Romney
Cardiovascular Arm Station. The skin over the artery is prepared
for puncture by cleansing and injecting a local anesthetic. If the
catheter is to be immediately advanced to the intrathoracic
arteries when arterial puncture is made, the temporary protective
cap 11 on the tube 9 is removed and the fitting 10 attached to a
pressure transducer flushing system. In this way the catheter can
be flushed to remove any air bubbles and be completely filled with
fluid for high fidelity pressure recording. Next, the protective
sheath covering the needle (not shown in the drawings) is removed
and the artery punctured using oscilloscope monitoring to assure
proper entry into the lumen of the artery, the needle remaining
connected to the sheath hub 15. When the operator is certain that
the lumen of the artery has been properly entered the catheter may
be carefully advanced into the artery and on to the subclavian
artery. To accomplish this an assisting technician grasps the dead
end section 5 on the distal end of the sheath with one hand and
with the other hand moves the catheter advancer 7 toward the
needle, thus feeding the catheter through the needle into the
artery without exposing the catheter. To assure free passage of the
catheter through the artery it is preferable to observe the pulse
contour on the oscilloscope to determine any damping due to
obstruction of the catheter tip against the arterial wall. If
damping occurs, an is not due to clot in the catheter tip, careful
manipulation must be observed to bypass the point of contact if
such is possible. Caution must be exercised if the catheter is
retracted at all while the needle is in the artery because of the
risk of shearing the catheter on the end of the needle. No gloves
or a sterile field of operation are required, thus greatly reducing
the time and cost of catheter placement.
The position of the tip of the catheter can be determined by
measuring the distance the protective sheath has been withdrawn
from the advancer 7, and applying this distance to measure from the
needle hub up the arm of the patient. Fluoroscopy is not necessary
for catheter placement. When the catheter has been advanced to the
desired position, the needle is withdrawn from the artery and
finger pressure applied firmly over the artery holding the catheter
in position, and then the sheath may be withdrawn relatively to the
catheter advancer which is held stationary until the nose 13 of the
advancer can enter the opening 21 in the hub 20 on the catheter
sheath, spread the retaining fingers 19, and lock behind them at
the shoulder 14. The spreading of the fingers 19 permits the sheath
to be withdrawn and discarded. Finger pressure over the artery
should be maintained sufficiently for the artery to seal around the
catheter and thereafter a small pressure dressing using stretch
tape may be advisable. As soon as possible, after the needle has
been withdrawn from the artery, a needle protector such as one of
those set forth in V. P. Czorny et al. U.S. Letters Pat. No.
3,324,853 issued June 13, 1967, should be applied to the shaft of
the needle and the emerging catheter to prevent any kinking or
shearing of the catheter at that junction point. As an additional
precaution, one or two small strips of tape may be wound around
this protector to secure it against possible slipping. Pressure
measurements can then be recorded.
If desired, the catheter may be positioned the day before a
surgical procedure, used again for measurement at the time of
surgery, and then later for measurements in the postoperative
recovery area. During intervals when the catheter is not being used
for measurement it is filled with heparin or the equivalent through
a two-way stop cock, coiled on the wrist, and kept in place when a
light dressing, since preoperatively the patient may be
ambulatory.
When the catheter is to be removed from the artery, finger pressure
is again maintained over the artery for about fifteen minutes and a
pressure dressing applied for 2 or 3 hours after removal of the
catheter. The catheter may be used as described above in various
arteries such as the radial, brachial, ulnar, femoral and others.
If the percutaneous route is not feasible for some reason, the
catheter can be placed in position during surgery by the surgeon in
the operating room either directly into the thoracic vessels or
advanced after arterial cutdown.
In some cases, before the catheter is inserted, the needle may be
used for sampling arterial blood to determine cardiac output,
chemistries, partial pressures, or oxygen saturations, etc. In such
a case, the needle is removed from the placement unit, the needle
cap then being placed on the hub 15 of the catheter sheath to
protect the catheter until time for usage. The needle may then be
inserted in an artery and no arterial blood will be lost by virtue
of the valve 26 in the needle hub. Whatever apparatus the needle is
then connected to is provided with a fitting corresponding in
general to the nose portion of the sheath hub 15 and with a
projecting pilot tube 17 to open the valve in the needle upon
insertion of the fitting the needle hub. For dye dilution curves
the needle can be attached directly to the cuvette oximeter or
densitometer which is in turn connected to a pressure transducer
for monitoring the arterial puncture. Immediately following the dye
dilution determination the needle cap is removed from the sheath
hub 15, the unit connected to the pressure transducer and flushed
out as described above. The sheath hub may then be held in one hand
and the needle still in the artery is stabilized by holding the
needle hub with the other hand and an assistant removes the
oximeter or densitometer connection from the needle hub, and the
sheath hub is then immediately inserted into the needle hub. Should
some blood escape during the making of this connection, one or two
sponges placed under the needle just before the connection is made
will be sufficient to absorb that blood. The catheter may then be
advanced as above described.
It will be understood that modifications and variations may be
effected without departing from the scope of the novel concepts of
the present invention.
* * * * *