U.S. patent number 3,565,074 [Application Number 04/818,979] was granted by the patent office on 1971-02-23 for indwelling arterial cannula assembly.
This patent grant is currently assigned to Becton. Invention is credited to Philip R. Foti.
United States Patent |
3,565,074 |
|
February 23, 1971 |
INDWELLING ARTERIAL CANNULA ASSEMBLY
Abstract
An indwelling arterial cannula assembly includes a plastic
catheter coaxially removably mounted on a blunt tipped cannula
having a pointed stylet removably located in the bore thereof and
extended beyond the blunt tip of the cannula; and a method is
provided for positioning a portion of the plastic catheter of the
assembly into an artery. The method includes the steps of
projecting the assembly into the artery by piercing both the inner
and outer walls of the artery with the point of the stylet and
extending a portion of the assembly through the openings in both of
the walls. Then the stylet is removed from the assembly and the
remainder of the assembly is retracted until its forward tip
reenters the artery and fluid from the artery flows through the
cannula. The remainder of the assembly is then advanced into the
lumen of the vessel to the desired position with the blunt tip of
the cannula alleviating the danger of repuncture of the inner wall
of the artery. Finally, the plastic catheter is slid forward while
the cannula is removed therefrom which thereby locates a portion of
the catheter in the desired position in the artery.
Inventors: |
Philip R. Foti (Kailua,
HI) |
Assignee: |
Becton (Dickinson and Company,
East Rutherford)
|
Family
ID: |
25226925 |
Appl.
No.: |
04/818,979 |
Filed: |
April 24, 1969 |
Current U.S.
Class: |
604/164.11 |
Current CPC
Class: |
A61M
25/0606 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214.4,221,(I.C.Digest),348 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
|
|
|
|
1092011 |
|
Nov 1, 1954 |
|
FR |
|
646559 |
|
Jun 1, 1937 |
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DE (Pre-1945) |
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Primary Examiner: Dalton L. Truluck
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurvcz
Claims
I claim:
1. An indwelling arterial cannula assembly comprising: a rigid
cannula having a blunted forward tip, a hub connected to its rear
end and a passage therethrough; a plastic catheter having a passage
therethrough, a hub connected to its rear end and being coaxially
removably mounted on said cannula said catheter being shorter in
length than said cannula; and a stylet having a pointed forward
end, a hub attached to its rear end and being removably positioned
within the passage of said cannula with its forward end portion
extending beyond the blunted tip of said cannula thereby
facilitating the positioning of a portion of said assembly into an
artery and the subsequent removal of said cannula and stylet from
said catheter to leave a portion of said plastic catheter in the
desired position within said artery.
2. The invention in accordance with claim 1 wherein the forward
portion of said catheter tapers inwardly toward the forward end
thereof and terminates to the rear of the blunt tip of said cannula
to facilitate entrance of said assembly into said artery.
3. The invention in accordance with claim 1 wherein said cannula is
composed of a metallic material.
4. The invention in accordance with claim 1 wherein said pointed
stylet is composed of a metallic material.
5. The invention in accordance with claim 1 wherein said catheter
is composed of polytetrafluoroethylene.
6. The invention in accordance with claim 1 wherein said cannula is
rounded at its blunted tip end.
7. The invention is accordance with claim 1 wherein said printed
stylet extends 4 mm. beyond the blunted tip of said cannula.
8. A method of positioning into an artery a portion of a plastic
catheter of an indwelling arterial cannula assembly including a
plastic catheter coaxially removably mounted on a blunt tipped,
rigid cannula having a pointed stylet removably located in the bore
thereof and extending beyond the blunt tip of the cannula said
catheter being shorter in length than said cannula comprising;
projecting said assembly into the artery by piercing both the outer
and inner walls of the artery with the point of said stylet and
extending a portion of said assembly through the openings in the
walls of said artery; removing the stylet from said assembly;
retracting the remainder of said assembly until the forward tip
thereof reenters the artery and fluid from said artery flows
through said cannula; advancing the remainder of said assembly into
the lumen of the artery to the desired position with the blunt tip
of said cannula alleviating the danger of repuncture of the inner
wall of the artery; and sliding the plastic catheter forward while
removing the cannula therefrom thereby locating a portion of the
catheter in the desired position in the artery.
9. The invention in accordance with claim 8 wherein after said
cannula is removed from said catheter a plastic obturator is placed
into the lumen of the catheter to alleviate the danger of clotting
between the taking of samples of fluid from the artery.
10. The invention in accordance with claim 8 after said cannula is
removed from said catheter a syringe containing an anticoagulant
substance may be attached to the rear end of the catheter to
alleviate the danger of clotting between the taking of samples of
fluid from the artery.
Description
There are several different types of arterial indwelling needles in
use today. However, these needles produce various shortcomings when
is use which demand the development of an improved indwelling
arterial cannula assembly for application to a patient.
For example, one type of needle in use is a well-known Cournand
needle. This type of needle is generally considered as the original
arterial indwelling needle and it is constructed of all steel
materials. Therefore, when it is placed within the lumen of a
vessel which is located in a portion of the body where considerable
movement occurs which is often the case, extensive damage to the
vessel could occur. This happens quite often since this type of
needle is generally placed in an area where considerable flexing by
the patient would normally occur such as adjacent the elbow.
Consequently, this type of needle is difficult to leave in place
for many hours or days as is often necessary.
Several other attempts have been made to produce a needle which
will satisfy the requirements for providing an indwelling catheter
for an artery located in a difficult position such as discussed
above. For example, one combination employs a plastic catheter
positioned on a pointed needle which contains a pointed stylet
within its opening with the solid pointed end of the stylet being
aligned with the pointed end of the needle. The difficulty with
this type of arrangement is that it is very difficult to get into
an artery because of the pointed cannula or needle that remains
when the stylet is removed. Trying to slide the plastic catheter
and needle combination along the interior walls of the vessel
particularly if the vessel is located in a difficult position such
as an elbow joint will often cause repeated punctures of the vessel
and considerable damage.
Another problem with this type of needle is that the stylet and the
pointed cannula are generally beveled and have a common type of
needle tapered point. This presents a problem in the instance of
small and thin artery walls where it is preferable to have a
cleaner puncture to alleviate the danger of tearing the artery wall
which of course causes unwanted damage and also discomfort to the
patient. Of course the one feature that this type of needle
assembly has that the Cournand assembly does not have is the fact
that it leaves a flexible catheter in the artery instead of a stiff
steel needle as in the instance of the Cournand.
A further problem which often appears with existing needle
assemblies is that often the assembly does not slip easily into
place within the artery once the initial puncture is made.
Furthermore, there is often difficulty in sliding an obturator in
and out of the plastic catheter when it is in position within the
artery each time it is desired to pass fluid the through the
catheter. A catheter material which will facilitate this particular
step would also be advantageous in construction of the needle
assembly. Once again this also provides a catheter arrangement
which is less traumatic and discomforting to patients.
Other features which would be advantageous in an assembly of this
type would be to have the outer catheter arranged so that it has a
smooth taper from its forward point to its extreme diameter to
facilitate entrance within the artery. Furthermore, an assembly of
smaller gauges than previously utilized would facilitate use in
smaller more difficult arteries within the patient. Furthermore, a
tip on the assembly which is hard as well as having the above
advantages would be helpful in that it will not hang up on the
artery wall when entering. This is often the problem with
previously discussed assemblies of this type. Finally, a catheter
should be constructed of a material, if possible, which will lend
itself to disposability after single use. Therefore, it should be
of relatively low cost and relatively easy to manufacture.
Principally it is an objective of this invention to alleviate the
above discussed problems existent with presently used needles and
to provide a needle assembly which will achieve the above mentioned
advantageous features as well as satisfying the above discussed
requirements. The present indwelling arterial cannula assembly is
capable of easier placement thereby providing a higher success
rates in any user's hands. The resultant catheter is designed so as
to be more comfortable in place because of flexibility thereby
avoiding patient immobilization. This allows one to leave such a
catheter in place for comparatively long periods of time, for
example, in an intensive care unit. The introduction of the
assembly and catheter in its proper location is significantly less
traumatic to the patient and the assembly is readily adaptable for
use in routine pulmonary physiological studies, cardiac output
determinations and monitoring, indwelling arterial electrode use
for monitoring partial pressure of oxygen, and any procedure
requiring easy access to intermittent arterial blood samples over
an extended period of time. The technique and method of use of the
assembly is easily taught and the assembly is applicable to
children as well as adults.
A brief description of the structural features of the indwelling
arterial cannula assembly disclosed herein and its method of
application is now in order to generally point out how the above
mentioned features and objectives are obtained. An indwelling
arterial cannula assembly is provided for the positioning of a
portion of a plastic catheter into an artery wherein the assembly
includes a plastic catheter coaxially removably mounted on a blunt
tipped cannula having a pointed stylet removably located in the
bore thereof and extending beyond the blunt tip of the cannula. The
method of use of this assembly includes projecting the assembly
into the artery by piercing both the outer and inner walls of the
artery with the point of the stylet and extending a portion of the
assembly through the openings in both walls of the artery. The
stylet is then removed from the assembly and the remainder of the
assembly is retracted until the forward tip thereof reenters the
artery and fluid from the artery flows through the cannula. The
remainder of the assembly is then advanced into the lumen of the
artery to the desired position with the blunt tip of the cannula
alleviating the danger of repuncture of the inner wall of the
artery. Finally, the plastic catheter is slid forward while
removing the cannula therefrom which thereby locates a portion of
the catheter in the desired position within the artery.
With the above objectives in mind, reference is had to the attached
drawing for a more detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawing:
FIG. 1 is an exploded view of an indwelling arterial cannula
assembly of the invention;
FIG. 2 is a sectional elevational view of an indwelling arterial
cannula assembly of the invention;
FIGS. 3-7 illustrate in perspective a sequential series of steps
utilized in positioning the indwelling arterial catheter of the
assembly in proper position within an artery with arrows showing
the direction of flow of fluid within the artery and the direction
of the assembly and its elements during the sequential series of
steps.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Initially, discussion will be directed toward the cannula assembly
20 itself as attention is directed to FIGS. 1 and 2 of the
drawings. Assembly 20 is composed of three basic elements, a stylet
21, a cannula 22 and a catheter 23.
Stylet 21 may be constructed of any well-known material to give it
its solid properties such as a rigid metallic wire material. The
forward end of the stylet 21 has a sharp pointed tip 24 to
facilitate the assurance that only tiny pin holes are made in the
vessel or artery of the patient during the puncture procedure. The
rear end of stylet 21 has affixed thereto a hub 25 generally
constructed of any common rigid material.
Cannula 22 is also a rigid member and may be constructed of any
common type of rigid material, for example a metallic material such
as stainless steel. The forward tip 26 of the cannula 22 is blunted
and has a somewhat rounded configuration so that cannula 22 will
follow stylet 21 through a puncture hole in an artery but which is
not sharp enough to readily create a new puncture by itself.
Mounted on the rear end of the cannula 22 by any common means or
integral therewith is a hub 27. An axial bore 28 extends from the
forward tip 26 of the cannula 22 to the rear end thereof and
communicates with an opening 29 within hub 27 to provide a
continuous passage through cannula 22. Bore 28 is designed to
accommodate in close fitting relationship stylet 21 with the
forward portion of hub 25 positioned within opening 29 in hub 27.
When stylet 21 is thus positioned within cannula 22 the forward tip
24 thereof will extend beyond tip 26 of cannula 22 a predetermined
distance. Satisfactory results have been obtained with such as
assembly when stylet 21 extends approximately 4 mm. beyond the
blunt tip 26 of the cannula 22. However, this is not necessarily
required and this distance may be varied depending upon the
individual circumstances of use for the assembly 20.
The third principal element of assembly 20 is catheter 23 which
generally has a taper from its rear end to its forward tip 30. This
taper is to facilitate entrance of the catheter 23 through the
puncture created in an artery when assembly 20 in introduced
therein as will be readily apparent below. At the rear end of
catheter 23 either attached thereto by common means or integral
therewith is a hub 31. An axial bore 32 extends from the tip 30 of
catheter 23 rearwardly into communication with an opening 33 in hub
31 to combine therewith to form a continuous passage from one end
of catheter 23 to the other. Bore 32 and catheter 23 is of a
sufficient size to snugly accommodate cannula 22 when assembly 20
is formed and opening 33 in hub 31 is designed to accommodate the
forward portion of hub 27 of cannula 22. In this manner, stylet 21,
cannula 22 and catheter 23 may be assembled in coaxial relationship
to form indwelling arterial cannula assembly 20. The configuration
of each hub and bore of each element contribute to an interlocking
relationship between the elements in assembled form as is readily
apparent from FIG. 2.
Cannula 23 is generally constructed of a plastic material,
preferably flexible, which will be inert with the portions of the
body with which it comes in contact and which will readily
accommodate itself to the arterial configuration into which it must
extend. It also must be of a material which will readily permit it
to be introduced through the opening provided by tip 24 and tip 26
in the arterial walls with the minimum amount of resistance. A
material which has been found to be particularly effective for use
as catheter 23 is polytetrafluoroethylene which is commonly known
as Teflon. As is well known in the art, Teflon is inert to the
portions of the body with which it will come in contact as well as
the fluids with which it will come in contact. Furthermore, Teflon
being a natural lubricating material will easily follow its
predecessor needle portions of the assembly into the arterial
opening. Other plastic materials have been found to operate
successfully, but not as successful as Teflon when formed as
catheter 23 such as polyvinyl chloride with a silicone lubricated
inner bore and which is welded to hub 31. Several important
features of the catheter 23 which contribute to the ease with which
the assembly may be operated, is the fact that the catheter should
contain a smooth taper from its rear end to its forward tip, should
fit tightly on cannula 22 yet still be easily removable therefrom
and the plastic employed should be such that the tip may be
electromatically buffed, if desired, to increase hardness and to
alleviate the danger of "hang up" of the artery wall when it enters
the artery. Previously known cannula assemblies of this type have
produced this problem.
The term "hang up" refers to a catching of the forward edge of the
catheter on some portion of the artery as it is moved with respect
thereto which could cause tearing of the artery structure itself in
resultant damage and discomfort to the patient. Furthermore, the
material used for catheter 23 should be a disposable type of
material so that the assembly may be economically and easily
manufactured at low cost. The above discussed materials satisfy
these requirements as well as other materials which are known in
the art.
It should be noted as can be readily seen from FIG. 2 that the
smooth rather continuous engagement formed by tip 24 of stylet 21,
tip 26 of cannula 22 and tip 30 of catheter 23 facilitates the
entrance and movement of the assembly within the arterial area
during operation. In this regard it should be pointed out that tip
30 does not extend into coincidence with tip 26 of cannula 22 but
terminates a somewhat short distance therefrom. This contributes to
lessening the danger of "hang up" as well as limiting the extent of
tolerances required during manufacture and thereby facilitating the
production of an economic cannula assembly.
Turning to the operation and use of the assembly itself, reference
should be made to FIGS. 3--7 which shows the sequence of steps
employed in positioning catheter 23 properly within an artery 34. A
recommended technique for insertion would be as follows: Initially,
the vessel to be entered should be locally anesthetized. Then if
desired, scapel blade puncture of the skin is useful to avoid
resistance to easy manipulation while transfixing the underlying
vessel or artery.
If palpitating fingers are placed above and below the site of
arterial puncture, the following procedure aids in accurate,
atraumatic cannulation of the vessel, that is, to advance the long
needle stylet 21 through both walls somewhat tangentially. If it is
placed nearly square through the center of the lumen, slight
pressure will cause the blunt metallic cannula 22 to compress the
arterial wall, compromise the lumen and the distal pulse will
disappear or become markedly attenuated. A release of slight
pressure will bring back the pulse. This is a sure sign of proper
placement and the assembly 20 may then be advanced through both the
outer wall 35 and the inner wall 36 of vessel 34. If the described
sign is not obtained, it is best to withdraw completely, to begin
again, and only pin holes are left in vessel 34 principally due to
the sharp point 24 on stylet 21.
Once vessel 34 is transfixed and the entire assembly 20 has
extended through both walls of vessel 34, then stylet 21 may be
removed from the assembly. The remainder of assembly 20 should then
be retracted until the tip 26 of cannula 22 has reentered the
vessel which will be indicated by flow of fluid being established
so that it issues from hub 27 of cannula 22. This position is
indicated by FIG. 5 of the drawing. It should be noted at this
point that inner wall 36 of artery 34 will tend to close and seal
once again at the original point of puncture 37.
The next step is to advance the remainder of assembly 20 into the
lumen of artery 34 to the desired degree. As illustrated in FIG. 6,
the blunt tip 26 on cannula 22 will facilitate this movement in the
sense that it will allow the assembly to move through the vessel
without danger of tearing or repuncturing the inner wall of vessel
34.
The final step as illustrated in FIG. 7 is to simply slide the
plastic catheter 23 forward and remove blunt cannula 22 rearwardly
at the same time to properly locate catheter 23 within the lumen of
the artery 34 where it will assume the natural configuration of the
artery and may be kept in that position for a considerable length
of time. A plastic stylet or obturator may be placed into the lumen
of the needle to keep it from clotting between blood samples or if
the catheter's course is too tortuous, a syringe with anticoagulant
may be attached thereto. A common type of Teflon or obturator may
be sued used to occlude the Teflon catheter lumen since it will not
clot and flow will be maintained well. It is further recommended
that a sterile glove be used for intermittent sampling, especially
with smaller needles, to avoid contamination of the obturator
shaft. Obturators of this type are common as well as the use of a
syringe with an anticoagulant which may be attached to the hub of
the catheter. Therefore, since these items are not part of the
assembly itself they are not shown in the drawings for simplicity
purposes. Assemblies of this type may remain in place for a
considerable length of time without thromboembolic or other
problems and with a minimum of patient discomfort.
The advantages of such an assembly as disclosed herein are readily
apparent and include easier placement of an indwelling arterial
catheter and higher success rates in any hands. Furthermore, they
are more comfortable when placed in a difficult position because of
the flexible features possible thereby avoiding patient
immobilization. This allows one to leave such a catheter in place
for comparatively long periods of time, for example, in an
intensive care unit. It is readily apparent that from the ease of
and simplicity of construction, the utilization of the assembly is
significantly less traumatic for the patient and the assembly is
readily adaptable for use in routine pulmonary physiological
studies, cardiac output determinations and monitoring, indwelling
arterial electrode use for monitoring partial pressure of oxygen,
on-line arterial pressure monitoring, and any procedure requiring
easy access to intermittent arterial blood samples over an extended
period of time. As discussed above, the technique of use is easily
taught and the assembly is equally applicable to children as well
as adults.
Thus, the above mentioned objects of the invention, among others,
are achieved.
* * * * *