U.S. patent number RE34,086 [Application Number 07/565,987] was granted by the patent office on 1992-10-06 for medical placement device.
Invention is credited to Gordon P. George.
United States Patent |
RE34,086 |
George |
October 6, 1992 |
Medical placement device
Abstract
An apparatus for establishment of an airway in transtracheal
intubation via the cricothyroid membrane is disclosed in which the
design integrates within a single unit a curvilinear needle with
cutting blade, stylet, syringe and non-metal airway cannula in an
over-the-needle position. The integrated design enhances quick and
accurate placement of the airway in both emergency and
non-emergency applications.
Inventors: |
George; Gordon P. (Orem,
UT) |
Family
ID: |
26979958 |
Appl.
No.: |
07/565,987 |
Filed: |
August 10, 1990 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
315538 |
Feb 27, 1989 |
04898163 |
Feb 6, 1990 |
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Current U.S.
Class: |
128/200.26;
606/185; 606/51 |
Current CPC
Class: |
A61M
16/0472 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61M 016/00 () |
Field of
Search: |
;128/200.26,207.15,207.14,DIG.26,305,305.3,768,772,348.1
;604/104,107,280-283,49,51,52,53 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Eickholt; Eugene H.
Attorney, Agent or Firm: Polster, Polster and Lucchesi
Claims
I claim:
1. An apparatus for performing transtracheal intubation via the
cricothyroid membrane comprising, in combination:
a syringe means comprising at least one hollow barrel with a distal
end adapted for attachment of integral apparatus means;
a plunger means slideably disposed within said hollow barrel of
said syringe means;
a flexible stylet means slideably disposed within said barrel of
said syringe means;
a hollow curvilinear needle means integrally attached to said
distal end of said syringe means, said needle means having at its
distal end a sharpened edge to serve as a cutting blade; and
a non-metal hollow tube airway means which is slideably disposed
over said needle means.
2. An apparatus as set forth in claim 1 in which said syringe means
is comprised of a double-barrel means in which said plunger means
is slideably disposed within one barrel, and said stylet means is
slideably disposed within the other barrel.
3. An apparatus as set forth in claim 1 in which said stylet means
is integrally attached to said plunger means.
4. An apparatus as set forth in claim 1 which further comprises a
hollow tube means for dilation of the trachea which is slideably
disposed over said hollow tube airway means.
5. An apparatus as set forth in claim 1 in which said stylet means
is hollow.
6. An apparatus as set forth in claim 1 in which said needle means
further comprises a hollowed conduit along the entire length of
said needle means.
7. An apparatus as set forth in claim 1 in which said needle means
is straight.
8. An apparatus as set forth in claim 1 in which said hollow tube
airway means may be manufactured of a material which retains a
preformed shape original to its manufacture once placed within the
body cavity.
9. An apparatus as set forth in claim 1 in which said hollow tube
airway means is curvilinear and of a semi-rigid material.
.Iadd.
10. A tube introduction apparatus for intratracheal, intravenous,
intraplural, intraabdominal or urological use, comprising:
a hollow barrel having a proximal end and a distal end;
an elongated member partially disposed within said barrel and
moveable with respect to said barrel between a proximally retracted
position and a distally inserted position;
said elongated member having the proximal end thereof protruding
proximally outwardly of said proximal end of said barrel;
a hollow needle attached to the distal end of said barrel, said
needle having at its distal end a sharpened edge to serve as a
cutting blade;
a flexible stylet telescopically and slideably disposed within said
needle, said stylet having the proximal end thereof protruding into
said barrel and being at least distally moveable by said member
such that when said member is in the retracted position the distal
end of said stylet is located proximally of said sharpened edge of
said needle, and when said member is in the inserted position the
distal end of said stylet is located distally of said sharpened
edge;
a hollow conduit telescopically and slideably disposed on said
needle wherein the distal end of said conduit is initially proximal
of said sharpened edge of said needle, such that when said member
is in the inserted position, said stylet forms a guide for said
hollow conduit as said conduit is distally slideably removed from
said needle. .Iaddend. .Iadd.11. The apparatus as set forth in
claim 10 wherein said barrel is a syringe barrel and said elongated
member is a syringe plunger. .Iaddend. .Iadd.12. The apparatus as
set forth in claim 10 wherein said needle is straight. .Iaddend.
.Iadd.13. The apparatus as set forth in claim 10 wherein said
needle is curved. .Iaddend. .Iadd.14. The apparatus as set forth in
claim 10 wherein said member is permanently affixed to said stylet
and said stylet is moveable both proximally and distally with said
member. .Iaddend. .Iadd.15. The apparatus as set forth in claim 10
and further comprising means for permitting fluid flow from said
needle to said barrel. .Iaddend. .Iadd.16. The apparatus as set
forth in claim 15 wherein said means for permitting fluid flow
comprises said stylet being hollow to define a fluid passageway
therethrough. .Iaddend. .Iadd.17. The apparatus as set forth in
claim 10 wherein:
said barrel is a syringe barrel and said member is a syringe
plunger;
said plunger being retractably moveable with respect to said
stylet;
means for providing a fluid communication between the distal end of
said needle and the distal end of said plunger,
whereby when said plunger is retracted in said syringe barrel,
fluid will
be drawn into said barrel. .Iaddend. .Iadd.18. The apparatus as set
forth in claim 17 wherein:
said means for permitting fluid flow comprises said stylet being
hollow to define a fluid passageway therethrough. .Iaddend.
.Iadd.19. An apparatus for introducing a conduit into a mammalian
body, comprising:
a hollow syringe barrel with a proximal end and a distal end, said
barrel being open at its ends only;
a plunger slideably disposed within said hollow syringe barrel,
said plunger being manually movable back and forth in said syringe
barrel and having the proximal end thereof protruding from the
proximal end opening of said hollow barrel;
a hollow needle attached to the distal end of said syringe barrel,
said needle having at its distal end a sharpened edge to serve as a
cutting blade;
a flexible stylet slideably disposed within said needle, said
stylet being moveable at least distally with the distal end of said
plunger such that when said plunger is moved to its distal position
said stylet extends distally beyond said sharpened edge of said
needle;
a hollow conduit slideably disposed over said needle, said stylet
extending through said hollow conduit and out the distal end
thereof when the plunger is moved to its distal position in the
syringe barrel, such that said stylet forms a guide for said hollow
conduit as said conduit is slideably moved distally over the
needle. .Iaddend. .Iadd.20. The apparatus as set forth in claim 19
in which said stylet is integrally attached to said plunger.
.Iaddend. .Iadd.21. The apparatus as set forth in claim 19 in which
said needle, said stylet and said hollow conduit are co-axial.
Description
BACKGROUND OF THE INVENTION
This invention relates to .Iadd.a device for the medical placement
of a tube, for example, .Iaddend.the medical treatment of patients
who have an obstructed airway by means of tracheostomy or
cricothyrotomy. Under emergency circumstances, all physicians and
other medical personnel, no matter what their specialty, are
expected to know how to protect and maintain a patient's airway.
Even under non-emergency circumstances, an anesthesiologist, for
example, must maintain the airway, ventilation and oxygenation of a
patient who has been rendered unconscious by the doctor or another
health care professional by use of sedatives, hypnotics, or other
agents. These responsibilities have extended even to such health
care professionals as dentists, podiatrists, and emergency medical
technicians- persons who may witness an allergic reaction in a
patient brought on by use of drugs or remedies which have been
administered.
The typical methods of maintaining a patient's airway are by
anatomical positioning, clearing the passageway of foreign
materials, positive pressure mask ventilation, oral/nasal airways,
or oral/nasal approach to tracheal intubation. Following failure of
all of the typical methods of ventilation, the last method of
resort is transtracheal intubation via formal tracheostomy or
cricothyrotomy. These procedures, though infrequently required, are
recommended for use as a last means method. See, Clinics of
Anesthesiology, Tunstall and Sheikh, 1986.
In many patients, establishment of the airway may be formidable due
to morphological anomalies, such as a large tongue, excessive soft
tissue or tracheal displacement. Inabilities of the patient to
extend the head and neck or to open the mouth wide enough
contribute to the difficulty of maintaining the airway, as do other
morphological anomalies or physiological events such as floppy
epiglottis or laryngospasm.
Even the use of formal tracheostomy presents inherent problems.
Tracheostomy requires instrumentation which may not be available in
emergency situations. Additionally, given the time constraints
involved in an emergency, a tracheostomy may yield to the more
expedient procedure of cricothyrotomy. Circothyrotomy, considered
by many to be the preferred method of establishing an airway after
other methods have failed, is achieved by transtracheal intubation
via a percutaneous puncture through the cricothyroid membrane into
the trachea.
Methods for performing transtracheal intubation have been disclosed
in the prior art. U.S. Pat. No. 4,677,978 to Melker describes a
method for establishing a transtracheal airway. However, by its
design, the method is inherently ineffective in that once the
percutaneous placement of the needle is made, the needle and
syringe are removed so that a guide wire can be placed through the
catheter; this feature of the method significantly increases the
risk that the tube has not been properly placed in the trachea, and
subsequent placement of the wire through the catheter may result in
the wire being threaded into the subcutaneous tissues, or be unable
to be threaded at all. The system is also of a design which
requires the user to look away momentarily to grasp other pieces of
the instrument, movement which greatly impedes the quick and
accurate placement of the device.
Other devices exist on the market which have drawbacks similar to
those described above. In particular, these devices are complex,
difficult to use and manipulate and often requiring instructions.
It requires the practitioner to look away during placement of the
device which greatly increases the chance of improper establishment
of the airway. Even devices on the market which are composed of a
simple curved metal needle with attached blade and syringe present
problems in placement. In use, the hollow needle of the device may
be properly placed, but the tip of the blade may be improperly
positioned in the back wall of the trachea. Also, if the patient
moves, coughs, or begins to choke in a gagging response, the blade
may act as a scalpel causing severe damage.
The invention herein presents a new and more easily utilized
apparatus for achieving cricothyrotomy which overcomes many of the
problems encountered with the other methods enumerated above.
Ideally, a transtracheal device should be designed for rapid and
easy placement, with a high rate of success in establishing and
maintaining the patient's airway, while being safe to use, easily
utilized by all practitioners regardless of level of expertise, and
should be concentrically and concisely designed. The invention
herein fulfills these objectives, and therefore presents a new and
useful device in relation to the prior art. .Iadd.The device
according to the present invention can also be utilized for
insertion of a tube for such as intravenous use, intraplural use,
intraabdominal use or urological use. The following summary of the
invention, drawings and detailed description of the preferred
embodiments will be described in conjunction with transtracheal
use; however, the scope of the invention should be determined
solely by the language and limitations of the claims. .Iaddend.
SUMMARY OF THE INVENTION
The present invention is designed to facilitate transtracheal
intubation via percutaneous puncture through the cricothyroid
membrane. It comprises a curvilinear hollow metal needle with a
sharp blade-like surface at the distal end for penetration of the
cricothyroid membrane, a hollow-barreled syringe means, and a
plunger, slideably disposed within the syringe, to the distal end
of which is attached a flexible stylet. The curved needle is
inserted through the membrane. The placement of the blade in this
design allows the practitioner to hold the device in close
proximity to the patient, enabling the user to exercise fine
control of the needle. The curvature of the needle allows the
syringe component to be free of possible disturbance by movement of
the patient's chin. Once placed, the plunger of the syringe is
retracted to aspirate a small amount of air. Assured that the
needle placement is correct, the plunger is then advanced through
the syringe simultaneously advancing the stylet out of the needle
into the trachea. Thereafter, a final airway catheter which is in
an over-the-needle position is threaded down the needle and
subsequently over the stylet into the trachea. The needle and
stylet are then removed leaving the airway in place. The airway has
a threaded means at the proximal end to which airway modification
devices or tubes may be attached, and is tapered at its distal end
to facilitate unencumbered insertion. The final airway catheter may
be composed of rigid, semi-rigid or flexible plastic or other
synthetic material which has a sufficient quality of rigidity to
prevent kinking. The airway may also be composed of a "memory"
material which will cause it to assume a predetermined shape when
not being manipulated in relation to the stylet or needle.
In a modification to the preferred embodiment, the stylet is not
attached to the distal end of the plunger. In this embodiment, the
stylet is comprised of a hollow tube through which air may be
aspirated both before and after the stylet has been advanced into
the trachea. All other aspects of airway placement and withdrawal
of the integrated device are as described for the preferred
embodiment.
In another embodiment of this device, the styringe is a
"double-barrelled" design tapering at the distal end to form one
common chamber to which the metal needle attaches. Slideably
disposed within one barrel is the plunger, and the other barrel
maintains the stylet. When retracted, the plunger causes air to be
aspirated through the metal needle via the common chamber. A gasket
at the proximal end of the stylet barrel prohibits air from being
spirated from the outside. The stylet is actuated by a lever,
attached to the proximal end of the stylet, which passes through
and is slideable disposed along the length of the barrel of the
syringe housing the stylet. When the lever is manually pulled
toward the proximal end of the device, the stylet moves through the
metal needle; when the lever is advanced down the stylet barrel of
the syringe, the stylet simultaneously advances through the needle
and protrudes out the distal end of the needle.
With any of these embodiments, a dilator may be placed over the
needle followed by the non-metal airway over the dilator. The
dilator apparatus allows the use of a smaller needle and stylet,
and allows for the use of a larger final airway. The dilator has a
tapered distal end which reduces resistance to advancement of the
apparatus into the trachea. Further, with any of the embodiments
described, a metal needle may be used which has a hollow conduit
integrally manufactured into the inside wall of the needle. The
conduit runs the length of the needle and allows for the use of a
stylet which is of substantially the same diameter as the inner
diameter of the needle. The conduit in the needle thus provides a
means for aspirating air from the trachea when the plunger is
retracted. Alternatively, a stylet may be used which is hollow and
which allows aspirated air to pass through into the syringe.
This new apparatus may be used in either emergency situations or as
an elective means of establishing an airway. Though the embodiment
disclosed is optimally used in high flow (jet) oxygenation and/or
anesthesia, the airway established by the apparatus has the ability
to be used in low flow oxygenation and/or anesthesia either by
continuous or discontinuous positive pressure changes. Indeed, many
experts in the field have shown that transtracheal oxygenation at
greater than four liters per minute flow, via an 18 gauge needle or
catheter, can sustain acceptably normal oxygenation in anesthetized
patients who have otherwise obstructed airways. Further, it has
been shown that constant low pressure flow, constant "machine"
pressure limit flow, or high flow "jet" ventilation through a
percutaneous 14 gauge needle catheter can satisfactorily accomplish
oxygenation of the patient.
The present invention meets the optimal requirements desired in a
transtracheal intubation device because the integral design allows
accurate and quick placement of the device without having to reach
for other parts. The combination of the IV needle and the
syringe-type design, familiar to all health care practitioners,
makes the device easy to understand and use. These and other
advantages of the present invention will become apparent in the
following discussion.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partially cross-sectioned view of the embodiment where
the plunger and stylet are attached;
FIG. 2 is a partially cross-sectioned view of the embodiment where
the plunger and stylet are separate from one another;
FIG. 3 is a partially cross-sectioned view of the double-barrelled
syringe embodiment;
FIG. 4 is a display of the separate components of all the
embodiments;
FIG. 5 is an enlarged cross-section of the modified metal needle
illustrating the internal conduit;
FIG. 6 is a further embodiment of the device in which the needle,
stylet, and airway are without attachment to a syringe;
FIG. 7 is a partially cross-sectioned view of the device
illustrating placement through the cricothyroid membrane;
FIG. 8 is a partially cross-sectioned view of the device
illustrating advanced placement of the device in the trachea;
FIG. 9 is a partially cross-sectioned view of the device
illustrating advancement of the stylet through the needle;
FIG. 10 is a partially cross-sectioned view of the device
illustrating placement of the airway; and
FIG. 11 is a partially cross-sectioned view of the device
illustrating removal of the needle, stylet, and syringe, leaving
the airway in place.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The single-barrel embodiment of the device is illustrated in FIG. 1
in which the stylet 10 is attached to the bottom surface 11 of the
plunger 12, which is slideably disposed within the syringe 13. When
the plunger is being pulled to the fully retracted position so as
to cause aspiration of air from the trachea, the stylet is
completely retracted within the needle and air is allowed to pass
around the stylet and into the barrel of the syringe. When the
plunger is at a position half way through the syringe, the device
is said to be loaded. As illustrated by the "load position" in the
center of FIG. 1, the final airway 14 is in the over-the-needle
position (the curvilinear needle being disposed inside the airway),
and the tip of the needle 15 with the blade 16 is extended beyond
the end of the airway. As shown, the needle is preferably curved,
but the needle may be of varying curvature, or it may be straight.
As the plunger is advanced forward, the stylet is propelled through
the needle 15, and the distal end of the stylet 17 extends out from
the end of the needle, into the trachea.
In FIG. 2 an alternative embodiment is illustrated in which the
stylet 20 is not attached to the plunger 21, and the stylet,
therefore, does not move when the plunger is retracted for
aspiration of air. It should be noted that the stylet is withdrawn
into the needle. In this position air is allowed through the stylet
and into the syringe by withdrawal of the plunger. As the plunger
is advanced past the "loaded position", the stylet is propelled
through the needle 22 and the distal end of the stylet 23 extends
past the needle into the trachea.
FIG. 3 illustrates the double-barrel embodiment of the syringe,
generally at 30. The plunger 31 is slideably disposed within one
barrel of the syringe, and the stylet 32 is slideably disposed
within the other barrel of the syringe. The distal end of the
syringe narrows to become a single opening 33 to which is attached
the needle (disposed within the airway) and airway 34. As the
plunger is retracted aspirated air passes up through the metal
needle and in through the opening of the syringe 33. A gasket 35 at
the distal end of the stylet barrel slideably disposed about the
stylet disallows any aspiration of air from the stylet barrel. The
stylet is actuated by a lever 37 attached to the proximal end of
the stylet and extends through the wall of the stylet barrel,
moving up and down the length of the barrel through a slit therein.
Again, as the stylet is advanced forward by movement of the lever
37 in a downward fashion, the stylet advances through the needle
and out into the trachea.
FIG. 4 illustrates the component parts of the various embodiments.
The plunger with attached stylet 40 is shown separated from the
single barrel syringe 41. The separated plunger 42 and hollow
stylet 43 are also illustrated. The double-barrel syringe with
plunger 44 is illustrated beside the stylet 45 with actuating lever
46. The metal curvilinear needle 47 with blade at the distal end
illustrated, as are the final airway 48 and dilator 49. The
integrated configuration of each of these component parts is
illustrated at 50 in which the airway 51 is slideably disposed upon
the dilator 52 which is slideably disposed upon the needle 53
through which the stylet 54 extends. It should be noted that the
ultimate size of the invention, in any embodiment, may vary to
accommodate use in any size patient, from child to adult.
FIG. 5 is a cross-section view of the modified metal needle 60 into
one wall of which has been manufactured a hollow conduit 61. When
the stylet 62 is in the retracted position, aspirated air enters
the end-of the needle and is carried through the conduit into the
syringe (not shown). When the stylet 63 is propelled forward
through the metal needle and into the trachea, the conduit is
blocked.
A further embodiment of the device is illustrated in FIG. 6 in
which the needle 70 and overlying airway 71 are not attached to a
syringe. The stylet 72 is manually advanced through the needle and
into the trachea. In this embodiment, aspiration of air is
impossible, but the other principles relating to the placement of
the device without a syringe are as stated above for other
embodiments.
Placement of the device during a transtracheal intubation episode
is illustrated in FIGS. 7 through 11 using the double-barrel
embodiment of the invention. In FIG. 7 the needle has been inserted
into the neck of the patient and the blade of the needle is poised
over the cricothyroid membrane ready for insertion into the
trachea. In FIG. 8 the needle is advanced into the trachea, and the
plunger of the device is retracted for aspiration of air to assure
correct placement. In FIG. 9, the stylet is advanced, as indicated
by the arrow direction, and the stylet 80 is shown extended past
the needle into the trachea. The airway 81 is advanced into the
trachea guided by the stylet as illustrated in FIG. 10. Finally,
the integral device, including stylet, needle and syringe means, is
removed from the patient leaving the airway in place within the
trachea.
It is understood that the particular process of the invention
described herein is preferred. Obviously, numerous additional
modifications and variations of the present process are possible in
light of the above teachings such as intravenous use, intraplural
or intraabdominal or urological use. It is therefore to be
understood that within the scope of the appended claims, the
process may be practiced otherwise than as specifically described
herein.
* * * * *