U.S. patent number 3,817,250 [Application Number 05/299,941] was granted by the patent office on 1974-06-18 for instrument for performing a tracheostomy and other surgical procedures.
This patent grant is currently assigned to International Medical Devices, Inc.. Invention is credited to David T. Kline, Sol Weiss.
United States Patent |
3,817,250 |
Weiss , et al. |
June 18, 1974 |
INSTRUMENT FOR PERFORMING A TRACHEOSTOMY AND OTHER SURGICAL
PROCEDURES
Abstract
The surgical device herein set forth is adapted for use in
emergency tracheostomy procedures, as well as other procedures
wherein rapid penetration for aspiration, ventilation and
visualization is desired. The device carries an improved split
needle, which needle expands under the influence of an airway tube
in a more reliable and reproducible fashion than before. The device
carries a positive means for limiting penetration into the skin, as
well as having means for clearing obstructions in the airway
tube.
Inventors: |
Weiss; Sol (Encino, CA),
Kline; David T. (Sherman Oaks, CA) |
Assignee: |
International Medical Devices,
Inc. (Beverly Hills, CA)
|
Family
ID: |
23156977 |
Appl.
No.: |
05/299,941 |
Filed: |
October 24, 1972 |
Current U.S.
Class: |
128/207.29;
604/161 |
Current CPC
Class: |
A61M
16/0472 (20130101); A61M 16/0429 (20140204) |
Current International
Class: |
A61M
16/04 (20060101); A61b 017/32 (); A61b
017/34 () |
Field of
Search: |
;128/305,329,351 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: Drucker; I. Morley
Claims
We claim:
1. A surgical device adapted to puncture human skin which
comprises:
a hollow needle having a proximal end portion and a distal end of a
normal internal diameter, said distal end of said needle comprising
at least two sections which, taken together, terminate in a cutting
edge so as to form a means for puncturing skin;
means for holding said sections of said distal end of said needle
together and to enable said sections of said distal end of said
needle to be separable from each other and expand radially from the
said normal internal diameter of said distal end;
an airway tube movable through said needle from the proximal end
portion thereof to the distal end thereof, said airway tube being
of larger outer diameter than the said normal internal diameter of
said distal end of said needle whereby to expand radially said
distal end of said needle from its normal internal diameter as said
airway tube is moved through the distal end of said needle;
a collar member secured to said needle at an area remote from said
distal end of said needle, the distal end of said collar member
terminating short of said cutting edge of said needle when viewed
in side elevation, the distal end of said collar member limiting
the length of penetration of said needle into said human skin;
and
a cavity means formed in said collar member, said cavity means
enabling expansion of said needle to take place therewithin as said
airway tube is moved through said needle.
2. The surgical device of claim 1 wherein said collar member is
partly tubular and said distal end of said collar member is spaced
radially from said needle.
3. The surgical device of claim 1 wherein a line drawn parallel to
said leading edge of said collar forms both an acute and obtuse
angle with a line drawn through the longitudinal axis of said
needle, when viewed in side elevation.
4. The surgical device of claim 1 wherein said distal end of said
collar member has openings therein, second openings are provided in
the walls of said airway tube intermediate the ends of said airway
tube, said openings in said collar member increasing air
communication with said second openings in said airway tube.
5. The surgical device of claim 1 wherein said proximal end portion
of said needle is split into two sections, each section of which is
provided with pivotal means for pivotal movement within said collar
member.
6. The surgical device of claim 1 wherein said needle is formed in
two cooperating halves each half of said needle having a hollow
concavity formed therein near the cutting edge thereof, an
alignment member affixed within the concavity of one of said halves
of said needle near the cutting edge thereof and projecting
slightly beyond the side edges of said half of said needle, so that
the concavity of the other half of the said needle will
substantially enclose said alignment member when said needle is in
its non-expanded position.
7. The surgical device of claim 1 having a tubular member of
smaller diameter than the inside diameter of said airway tube
adapted to move through said airway tube and clear obstructions
therefrom.
8. The surgical device of claim 1 having a pair of radial
projection means projecting from said collar member of a size such
that the ends of the fingers of a user of said device can grasp
each of said radial projection means.
9. The surgical device of claim 5 wherein said pivotal means
comprises laterally projecting ears having facing surfaces that
diverge.
10. The surgical device of claim 1 wherein said airway tube has a
stop means limiting movement of said airway tube from the proximal
end portion of said needle to the distal end of said needle.
11. The surgical device of claim 10 wherein said stop means
comprises a flared end of enlarged diameter with respect to the
diameter of said airway tube.
12. The surgical device of claim 1 wherein said collar member has
means formed on the exterior surface thereof onto which tying
threads can be affixed.
13. The surgical device of claim 1 wherein said airway tube has an
internal diameter of from about 3-6 mm.
14. The surgical device of claim 1 wherein said collar member
limits the radial expansion of said needle.
15. The surgical device of claim 9 wherein the facing surfaces of
said projecting ears, when in abutment, limit the radial expansion
of said needle.
16. The surgical device of claim 1 wherein said needle has an
intermediate section connecting said proximal end portion and said
distal end of said needle, and the external cross-section of said
needle is substantially V-shaped commencing in the distal end of
said needle and terminating in said intermediate section of said
needle.
Description
BACKGROUND OF THE INVENTION
This invention relates to improvements of a device shown in U.S.
Pat. No. 3,688,773, pertaining to a Device for Performing
Tracheostomy and Other Surgical Procedures. One of the inventors
herein, Sol Weiss, was the sole inventor of said U.S. Pat. No.
3,688,773.
Tracheostomy is an operation for the purpose of relieving an
obstruction of the respiratory passage. The background and origin
of the operation is set forth in some detail in U.S. Pat. No.
3,688,773 incorporated herein by reference.
The device set forth in said U.S. Pat. No. 3,688,773 is believed to
be a major advance in the art of performing tracheostomies under
emergency conditions and is well suited for its purpose. The device
described in said patent comprises an expandable needle, enlarged
in a rear section and tapering to an end cutting portion so as to
form a means for puncturing skin and tissue, etc. The needle is
preferably formed in two halves which are held together in a
resilient manner. The needle is then inserted into the affected
area, e.g., the trachea. The internal dimensions of the needle are
such that when an air tube of from 3-6 mm. is thereafter inserted
therethrough, the needle halves are spread by the air tube passing
therethrough and in this way, the air tube contacts the tracheal
area and immediately allows the patient to breathe.
This invention relates to certain further improvements in the
device described in U.S. Pat. No. 3,688,773.
SUMMARY OF THE INVENTION
The major improvements in the device described and claimed in U.S.
Pat. No. 3,688,773 may be set forth as follows:
A. The needle halves are pivoted away from each other, under the
influence of the airway tube, in a more reliable and reproducible
fashion, than was hitherto possible.
B. The end of the needle is formed with indexing means for
alignment of the needle halves so as to insure that the needle ends
will mate into a smooth arcuate cutting edge even after repeated
use.
C. An effective limiting means preventing overinsertion or
underinsertion of the needle is provided by means of a collar
attached to the expandable needle. This collar also functions with
the needle to allow reliable and reproducible expansion of the
needle halves under the influence of the airway tube which is
inserted after the needle has made its penetration into the
affected area. The collar is also provided with appropriate
openings so as to enable increased air communication from the
exterior of the device into intermediate portions of the air
tube.
D. A means of clearing the entrance of the airway tube is provided
together with means to minimize any fragmentation as the entrance
is cleared. This means is referred to hereinafter as the
"obturator."
e. The device is provided with integrally formed tiedown rings
whereby the device, after insertion into the affected area of the
patient, can be firmly attached to the patient, if desired.
In addition to the foregoing, the present device has other
advantages which will become clear from the description and
drawings. This surgical device may not only be used in tracheostomy
procedures but may be used in a number of medical procedures
wherein aspiration, ventilation, and visualization are desired as
in the device set forth in U.S. Pat. No. 3,688,773. Furthermore,
this device enables a variety of sizes of airway tubes to be
inserted through a single needle because of the expandable nature
of the needle. It has been found that a standard airway tube of 5
to 6 mm is sufficient in most cases; however, the inner diameter of
the airway tube may be varied from 3 to 7 mm. if desired in any
particular case and the device may be provided with a set of airway
tubes of varying diameter together with the needle, collar and
several obturators.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows the surgical device of the invention in use and
inserted into the trachea;
FIG. 2 is a longitudinal, axial, cross-sectional view of the
surgical device of the invention, showing the needle inserted into
a patient and showing the air tube and obturator positioned for
insertion through the needle;
FIG. 3 is a cross-sectional view, of the surgical device, taken
along its longitudinal axis showing the needle, air tube and
obturator in fully inserted position in the patient;
FIG. 4 is a perspective view of the surgical device of my invention
showing the needle and attached collar, and showing the lower
portions only of the air tube and obturator;
FIG. 5 is a cross-sectional view of the surgical device, taken
along the longitudinal axis, showing the needle and air tube in
fully inserted position with the obturator removed;
FIG. 6 is a fragmentary cross-sectional view taken along the line
6--6 of FIG. 2;
FIG. 7 is an enlarged cross-sectional view taken along the line
7--7 of FIG. 2;
FIG. 8 is an enlarged fragmentary cross-sectional view taken along
the line 8--8 of FIG. 2;
FIG. 9 is a cross-sectional view taken along the line 9--9 of FIG.
5;
FIG. 10 is a top plan view of the obturator, as seen in the
assembly view taken along the line 10--10 of FIG. 2;
FIGS. 11, 12 and 13 are cross-sectional views taken along the line
11--11, 12--12 and 13--13, respectively, of FIG. 2; and
FIG. 14 is an enlarged fragmentary view, taken along the line
14--14 of FIG. 4.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The surgical device of this invention, designated generally by the
numeral 20 in the drawings comprises four major parts, the needle
22, the collar 24, which houses the needle and performs other
important functions, the airway tube 26, and the obturator 28.
As shown in FIGS. 2-5, the needle 22 is preferably made in two
similar halves 22a, 22b, each half carrying projecting ears or
hinge pins 30, 32, at the rear (or proximal end thereof) thereof
for positioning into collar 24 as will be described.
The needle 22 is provided with an oversized diameter at the
proximal portions thereof 37a, 37b, with respect to the airway tube
26 to be moved therethrough, as clearly seen in FIGS. 3 and 5 of
the drawings. The needle 22 is of undersized normal diameter, with
respect to the airway tube 26 to be passed therethrough, at its
forward (or distal) portions 36a, 36b again as clearly seen in
FIGS. 3 and 5. The proximal needle portions 37a, 37b fare smoothly
into the distal portions 36a, 36b by means of intermediate conical
portions 38a, 38b.
The airway tube 26 used is always cylindrical, but different sized
tubes may be required. The internal diameter of the airway tube 26
will vary from about 3-6 mm. depending on the use to which the
device is to be put, and other factors such as the size of the
patient. Therefore, the internal diameter of the proximal portion
of the needle 22 is usually greater than 6 mm. whereas the normal
(unexpanded) diameter of the distal portion of the needle 22 is
less than 3 mm. in diameter.
The cutting edges 34a, 34b of the distal needle portions 36a, 36b
are honed to a fine sharpness for cutting the skin 15 and tissue of
the affected area, e.g., the trachea. These cutting edges 34a, 36b
together form an arcuate, smooth, cutting edge 34 biased with
respect to the longitudinal axis of the needle 22. (See FIGS. 2 and
4). The needle halves 22a, 22b are resiliently held together by
means of an elastic band or O-ring 40 placed around the rear
portions 37a, 37b of the needle 22. The needle 22 and airway tube
26 are preferably made of a metal such as stainless steel.
The cutting edges 34a, 36b of the needle 22 are provided with
alignment means or indexing means 42, as most clearly seen in FIGS.
5, 7 and 8. The alignment means 42 preferably takes the form of a
small, truncated metal tube which is silver-soldered into the
concavity of the leading cutting edge 34a of needle half 22a. The
diameter of the tubular alignment means 42 is such that, while it
nests snugly into the concavity of edge 34a, it projects below the
cutting edge 34a, as seen in FIG. 7 and into the concavity of the
trailing cutting edge 34b, when the needle halves 22a, 22b are
adjacent each other. If the needle halves 22a, 22b are slightly
misaligned, after repeated use of the device 20, the alignment
means 42 cures any such misalignment by shifting leading cutting
edge 34b into alignment with trailing cutting edge 34a.
Referring now specifically to FIGS. 2, 12 and 13, another feature
of the surgical device 20 is shown.
In cross-section, the internal diameter of the needle 22 is
smoothly rounded throughout. The external portions of the needle
22, however, are provided with a fairly sharp V-shaped
configuration (see FIGS. 12 and 13) commencing from about the
middle of the distal portions 36a, 36b of the needle 22 and
terminating at a circumferential line within the intermediate
conical portions 38a, 38b of the needle 22 -- preferably at about
the sectional line where FIG. 13 is taken. The V-shaped exterior of
the needle 22, as described, permits much easier penetration
thereof into the hard fibrous cartilage of the tracheal area, than
does a smooth, rounded exterior.
The needle 22 is held within a collar 24, the collar 24 being
preferably made of a tough plastic material, e.g., a polycarbonate.
The collar has many other functions as will be described.
The collar 24 is formed with a generally tubular housing 50, the
diameter of the housing being larger than the external diameter of
the proximal portions 37a, 37b of the needle 22. The collar housing
50 is open at both ends and is provided, at its proximal end, with
a pair of diametrically opposed rectangular recesses 69 within
which the outwardly projecting hinge pins 30, 32 of the needle 22
fit, as best shown in FIGS. 2, 4, 6 and 14. This arrangement of
parts allows easy assembly of the needle 22 within the collar 24.
Thus, one need merely place the needle halves 22a, 22b, together so
that the hinge pins 30, 32 are in abutment and move the needle 22
through the collar housing 50 until the hinge pins 30, 32 are
nested snugly into hinge recesses 69. Then, a plastic cap 54 having
an internal bearing surface 57 is preferably adhesively affixed to
the collar housing so that the bearing surface 57 abuts the hinge
pins 30, 32 and prevents any movement thereof in the direction of
the longitudinal axis of the needle 22.
The cap 54 has a bore 55 passing therethrough, which bore is in
communication with the internal bore 33 of the needle 22. (See
FIGS. 3 and 5). The bore 55 is of a large enough diameter to enable
an airway tube 26 of 3-6 mm. in diameter or greater to be passed
therethrough and into bore 33 of the needle 22.
The hinge pins 30, 32 on needle halves 22a, 22b, respectively, have
facing or internal surfaces 44, 45. When the device 20 is not in
use, these facing surfaces 44, 45 assume the position shown in
FIGS. 2 and 14, wherein they are partially bearing on each other
and partially non-bearing due to the fact that the facing surfaces
44, 45 have portions that angle away from each other. If an airway
tube 26 of small internal diameter is thrust downwardly through the
needle 22, as shown in FIGS. 3 and 5, the needle halves 22a, 22b
expand, and rotate or pivot about hinge pins 30, 32 until the
angular portion of the facing surfaces 44, 45 abut each other. No
further needle expansion can take place because of this abutment of
the angular portion of the facing surfaces 44, 45 of the hinge pins
30, 32. The hinge pins 30, 32 having a diverging angle formed
between their facing surfaces will be termed herein and in the
claims as rocking hinge pins, and the recesses 69 will be termed
hinge recesses.
In some instances, the collar housing 50 will limit the expansion
of the needle 22. Thus, if an airway tube of large diameter, e.g.,
8-9 mm. overall is employed, the interior surface of the collar
housing 50 may be in abutment with the outer surface of the needle
before the facing surfaces 44, 45 of the rocking hinge pins are in
full abutment.
The outward needle expansion is thus limited in one of two ways --
thereby minimizing fragmentation of tissue adjacent the penetrated
area. Also, the collar-needle assembly and hinged rocking pin
assembly enables the device 20 to give reliable and reproducible
results.
The distal end 53 of the tubular collar housing 50 terminates at an
angle of substantially less than 90.degree. with respect to the
longitudinal axis of the needle 22; the angle preferably formed
therebetween is about 30.degree.. The surgical device 20, when used
as a tracheostomy device, is inserted into the skin and underlying
crico-thyroid membrane, along the angle shown in FIG. 2, and the
distal end 53 of the collar housing 50 effectively limits the
extent to which the needle 22 may be inserted into the affected
area. The aforedescribed limiting means is more effective than that
shown in U.S. Pat. No. 3,688,773 because the distal end 53 is
spaced from the needle 22, and this discontinuity is a more
positive limiting means. Furthermore, part of the distal end 53
makes an acute angle with the skin rather than an obtuse angle, and
this acute angulation is a more effective limiting means than that
shown in U.S. Pat. No. 3,688,773.
The collar 50 carries a pair of projections 52, which will be
referred to herein as stabilizer tips. The stabilizer tips 52 are
best seen in FIG. 4, and enable the user of the device 20 to firmly
grasp the collar 50, and attached needle 22, by placing the index
finger and middle finger of one hand behind each of the tips 52
while placing the thumb of the same hand on the outer end 56 of the
cap 54. (See FIG. 2, especially). In this positioning, the device
20 can readily be used surgically with one hand operation.
After the surgical device 20 is positioned in the affected area, a
hollow, tubular, airway tube 26 and obturator 28 are inserted into
and through bore 55 of cap 54, and thence through bore 33 of needle
22 until the flared end 66 of the airway tube 26 contacts the outer
end 56 of the cap 54. In this position (as shown in FIG. 3) the
distal end 67 of the air tube 26 extends just beyond the tip of the
needle edges 34a, 34b.
The obturator 28 has a tubular body 70 and is provided with a small
bore 71. It also has a blunted distal end 74 which, upon full
insertion through the airway tube 26, projects just beyond the
distal end 67 of airway tube 26. The blunted end 74 enables the
obturator to clear the entrance to the bore 60 of the airway tube
26 quickly and efficiently. The obturator 28 is provided with a
handle means 72, which, in this embodiment, takes the form of an
enlarged button 72 affixed to the obturator body 70. The button 72
is provided with a bore 72a, and the end of the tubular body 70 of
the obturator fits snugly into bore 72a. The bore 72a is in
communication with bore 71 and with the outside air by means of
opening 76. See FIGS. 2, 3 and 10.
The obturator 26 is removed from the airway tube 28 after the
entrance thereto is clear. The bore 60 of the airway tube 26 is now
in direct communication with the atmosphere, and oxygen may be
passed into the airway tube 26, through a universal or other type
of adaptor 80, if desired. The external configuration of cap 54 may
be further varied so as to provide for ready attachment to specific
oxygen input means or other respiratory aids.
It should be noted that the external surfaces of cap 54 merges
smoothly with the external surfaces of collar housing 50, and the
mutual external surfaces thereof are so formed as to readily
receive thereon universal adaptor means.
To increase air communication of the affected area with the outside
openings 62 are provided, in the walls of the airway tube 26 near
the front end thereof, as well as intermediate or rearward openings
or slots 64. The collar 24 is also provided with cutouts or
openings 68 in the distal end 53 of the collar housing 50 as best
seen in FIG. 4. These openings 68 are in proximity to the slots 64,
as seen in FIG. 5, and are provided so that an additional effective
air communication path to the airway tube can be utilized via
intermediate areas in the airway tube 26.
To perform a surgical procedure, e.g., a tracheostomy, the surgical
device 20 is held as shown in FIG. 2 (without the airway tube 26
and obturator 28). The arcuate cutting edge 34 is then pushed into
the trachea as shown in FIG. 2 and manipulated until a rush of air
is heard. The airway tube 26 and obturator 28 (therewithin) are
then inserted through the needle 22, as shown in FIG. 3. The
obturator 28 removes obstructions from the entrance of the airway
tube 26, and is removed immediately. The cleared airway tube 26 may
then be connected to oxygen inlet or other respiratory aid if
desired.
The surgical device 20 may be stably positioned around the neck of
the patient by means of thread 61 or the like being passed through
the openings 59a of tiedown rings 59 integrally formed on collar
housing 50. The thread 61 is affixed to the tiedown rings 59 and
thence tied around the neck of the patient, as shown in FIG. 1.
While a preferred embodiment of our invention has been shown and
described, modifications thereof will appear, and we therefore do
not wish to be restricted to the precise description set forth
herein, but to the claims which follow.
* * * * *