U.S. patent number 3,897,786 [Application Number 05/283,738] was granted by the patent office on 1975-08-05 for disposable myringotomy apparatus.
This patent grant is currently assigned to Richards Manufacturing Company. Invention is credited to Robert E. Garnett, Dwain C. Ray.
United States Patent |
3,897,786 |
Garnett , et al. |
August 5, 1975 |
Disposable myringotomy apparatus
Abstract
Disposable apparatus for use in performing a single operation of
the type in which a myringotomy tube is placed in an incision in
the tympanic membrane of the ear. The apparatus includes a
disposable inserter for inserting the myringotomy tube and various
other disposable devices needed in the operation, which are
sterilized and held as a unit in a package means for conveying the
apparatus and maintaining it sterile until the performance of the
operation.
Inventors: |
Garnett; Robert E. (Memphis,
TN), Ray; Dwain C. (Cordova, TN) |
Assignee: |
Richards Manufacturing Company
(Memphis, TN)
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Family
ID: |
26810529 |
Appl.
No.: |
05/283,738 |
Filed: |
August 25, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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112933 |
Feb 5, 1971 |
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Current U.S.
Class: |
606/109; 206/439;
604/61; 206/370; 606/108 |
Current CPC
Class: |
A61F
11/002 (20130101); A61F 2/0095 (20130101) |
Current International
Class: |
A61F
11/00 (20060101); A61F 2/00 (20060101); A61b
017/34 () |
Field of
Search: |
;128/305,314,33R,33B,350,127,130,264,329
;206/63.2R,72,46ST,46SG |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Recla; Henry J.
Attorney, Agent or Firm: Walker, III; John R.
Parent Case Text
This is a division of application Ser. No. 112,933 filed Feb. 5,
1971 now abandoned.
Claims
I claim:
1. Disposable myringotomy apparatus for performing an operation
which includes placing a myringotomy tube in the tympanic membrane
of the ear, said apparatus comprising a disposable inserter
including an elongated sleeve having a proximal end and a distal
end, a plunger slidably extending through said sleeve and being
positionable in a forward position in which said plunger extends
beyond the distal end of said sleeve to establish a protruding
portion for receiving a myringotomy tube thereon for placement into
a myringotomy opening in the tympanic membrane of the ear, a handle
attached to said sleeve adjacent the proximal end thereof, a
trigger having an upper portion and a lower portion, a flexible
connecting portion integrally formed with said trigger intermediate
the upper and lower portions thereof and integrally formed with
said handle, said trigger at said upper portion thereof being
pivotally attached to said plunger at the distal end thereof, said
trigger being initially in a first position to hold said plunger in
said forward position and being movable by pressure on said lower
portion to move said plunger and retract said protruding portion
into said sleeve to push the myringotomy tube off the end of said
plunger for retention in the myringotomy opening.
2. Disposable myringotomy apparatus for performing an operation
which includes placing a myringotomy tube in the tympanic membrane
of the ear, said apparatus comprising a disposable inserter
including an elongated sleeve having a proximal end and a distal
end, a plunger slidably extending through said sleeve and being
positionable in a forward position in which said plunger extends
beyond the distal end of said sleeve to establish a protruding
portion for receiving a myringotomy tube thereon for placement into
a myringotomy opening in the tympanic membrane of the ear, a
plastic handle attached to said sleeve adjacent the proximal end
thereof and being provided with a pair of finger holes therethrough
and terminating at the end remote from said sleeve in an arcuate
portion for fitting a finger, a plastic trigger having an upper
portion and a lower portion, a narrow flexible plastic connecting
portion integrally formed with said trigger intermediate the upper
and lower portions thereof and integrally formed with said handle,
said trigger at said upper portion thereof being pivotally attached
to said plunger at the distal end thereof, said trigger being
initially in a first position to hold said plunger in said forward
position and being movable by pressure on said lower portion to
move said plunger and retract said protruding portion into said
sleeve to push the myringotomy tube off the end of said plunger for
retention in the myringotomy opening.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention:
This invention relates to disposable apparatus for use in
performing an operation of the type in which a myringotomy tube is
placed in an incidion in the tympanic membrane of the ear.
2. Description of the Prior Art:
The type of operation in which the apparatus of the present
invention is adapted to be used is a well known one wherein an
incision is made in the tympanic membrane of the ear and a
myringotomy drain tube is inserted through the incision for
drainage purposes. One means of performing the above mentioned
insertion of the myringotomy tube is by a so-called Morgan
Myringotomy Tube Inserter which is an instrument fabricated by
Richards Manufacturing Co., the assignee of the present invention.
This instrument and the use thereof is described in the publication
ARCHIVES OF OTOLARYNGOLOGY, Vol 84, No. 3, Sept. 1966, page 131.
The above described instrument has a barrel or sleeve with a
protruding retractable pin. The diameter of the pin is slightly
greater than the internal diameter of the lumen of the myringotomy
tube. Due to this size difference, the plastic tube will hold a
tight compressing fit when mounted on the pin. There are
scissor-like handles for actuating the pin. Generally, a speculum
and an operating microscope are used. The barrel of the myringotomy
tube inserter with the myringotomy tube on the end thereof is
inserted through the speculum and into the incision made in the
tympanic membrane. Pressure on the rear scissors handle will
retract the pin, completely freeing the myringotomy tube from the
instrument as the pin retracts into the barrel. An alternate means
of inserting the myringotomy tube is by means of grasping the tube
with small alligator forceps.
The above described inserter instruments and other instruments used
in the operation are of a semi-permanent nature intended for long
use. For example, The Morgan Myringotomy Tube Inserter is a
stainless steel instrument which is used over and over in numerous
operations. The cost of this instrument is approximately $60, and
it must be sterilized before each operation by the operating
personnel.
THE PRESENT INVENTION
It is a purpose and object of the present invention to provide a
relatively inexpensive sterilized and disposable apparatus which is
self-contained and has the necessary implements and devices for
performing a single operation of the type in which a myringotomy
tube is placed in an incision in the tympanic membrane of the ear.
It is a further object to provide a convenient and time-saving
means for performing such an operation. Thus, it is not necessary
to take up the time of the operating personnel in sterilizing the
instruments, but rather the instruments and devices are available
in a compact package form already sterilized and which may be
thrown away after the single operation has been performed.
The means by which the foregoing objects and concepts of the
present invention are accomplished is by the structure of the
apparatus of the present invention which includes, among other
things, a disposable inserter for inserting the myringotomy tube in
the incision in the tympanic membrane of the ear.
The disposable inserter of the present invention includes an
elongated sleeve, a plunger slidably extending through the sleeve
and being positionable in a forward position in which the plunger
extends beyond the distal end of the sleeve to establish a
protruding portion for receiving a myringotomy tube thereon, a
plastic handle attached to the sleeve adjacent the proximal end of
the sleeve and which handle is provided with a pair of finger holes
therethrough and terminating in an arcuate portion for fitting the
finger of the user, a plastic trigger, a narrow flexible plastic
connecting portion integrally formed with the trigger and the
handle, and the trigger is pivotally attached to the plunger at the
distal end thereof with the trigger being initially in a first
position to hold the plunger in the forward position and being
movable by pressure on the lower portion to move the plunger and
retract the protruding portion into the sleeve and push the
myringotomy tube off the end of the plunger. In addition, the
apparatus of the present invention includes a sterilized disposable
liner for the speculum and a sheetlike drape having a hole
therethrough adapted to receive the speculum. Also, there is
provided a sterilized disposable knife for making the incision in
the tympanic membrane and at least one myringotomy tube is
provided. Additionally, if desired, a sterilized disposable ear
suction needle may be provided.
It is a further object to provide package means holding the
heretofore-mentioned instruments and devices as a unit preparatory
to performing the operation and for maintaining the instruments and
devices in a sterile condition.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a plan view of the apparatus of the present
invention.
FIG. 2 is a sectional view taken as on the line II--II of FIG.
1.
FIG. 3 is a side elevational view of the inserter of the present
invention.
FIG. 4 is a front view thereof.
FIG. 5 is a perspective view of the disposable speculum liner of
the present invention.
FIG. 6 is a perspective view of the disposable drape of the present
invention.
FIG. 7 is a view showing certain instruments of the present
invention in use ready to insert a myringotomy tube into the ear of
the person.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The disposable myringotomy apparatus 11 of the present invention
comprises in general a disposable myringotomy tube inserter 13, a
disposable knife 15, a disposable speculum liner 17, a disposable
drape 19, at least one myringotomy tube 21, a disposable suction
needle 23, and a disposable package or container 24 for holding the
inserter 13, knife 15, liner 17, drape 19, tube 21, and suction
needle 23 ready for use for the surgeon to perform a single
operation, and to maintain the above mentioned devices in a
sterilized condition until used by the surgeon.
Inserter 13 includes an elongated sleeve 25 preferably formed of
metal and having a proximal end 27 and a distal end 29. A pin or
plunger 31, also preferably formed of metal, slidably extends
through sleeve 25 and is positionable in a forward position, shown
in FIG. 3, in which the plunger extends beyond the distal end of
sleeve 25 to establish a protruding portion 33 for receiving the
myringotomy tube 21 thereon. A handle 35 which is preferably formed
of plastic or the like, as for example, polypropylene, has a barrel
portion 37 formed along the upper edge of handle 35. The barrel
portion 37 is preferably slit as at 39 along the length thereof and
is of a size so as to closely and grippingly receive sleve 25
adjacent the proximal end 27 thereof. Thus, the proximal end 27 of
sleeve 25 is forced into barrel portion 37 through slit 39
whereupon the resiliency of the plastic tightly holds the sleeve in
place, and, if desired, cement or the like may be utilized to
further fix the sleeve 25 to the barrel portion 37. Handle 35 has a
pair of holes 41 therethrough adapted to receive the surgeon's
first and second fingers. The lower end of handle 35 is provided
with an arcuate portion 43 so as to provide a resting place for the
third finger of the surgeon's hand. A trigger 45 which is
preferably formed of plastic and integrally formed with handle 35
has an upper portion 47 and a lower portion 49. A narrow flexible
connecting portion 51, preferably formed of the same plastic as
handle 35 and trigger 45 is integrally formed with trigger 45
intermediate the upper and lower portions 47, 49 thereof and
integrally formed with handle 35 on the upper rearward edge
thereof, as best seen in FIG. 3. Upper portion 47 is pivotally
attached to plunger 31 at the rearward end thereof by suitable
means as by bending the end of plunger 31 at right angles to the
main portion thereof and extending the bent end 53 through an
aperture in upper portion 47. Trigger 45 is molded or formed in a
first position as shown in FIG. 3 with lower portion 49 being
spaced from handle 35 and with the trigger holding the plunger 31
in the heretofore-mentioned forward position so that tube 21 may be
placed onto protruding portion 33, as seen in FIG. 4, when the
surgeon is preparing to put the tube 21 in the opening in the
tympanic membrane of the ear.
The knife 15 is preferably formed of an elongated malleable rod 55
of steel sharpened at one end as at 57 and having the other end
embedded in a handle 59, preferably formed of a plastic, such as
polypropylene.
Liner 17 is preferably formed of a thin piece of plastic, such as
polyethylene, which is sleevelike and conical in form as shown in
FIG. 5 so as to fit into the interior of a speculum, as speculum
61, shown in FIG. 7. In other words, the liner 17 being sterilized,
when fitted into the interior of the speculum 61, prevents the
relatively unsterile speculum from coming into contact with the
other devices and instruments used in the operation so as not to
contaminate them.
DRape 19 is preferably formed from a square sheet of flexible
plastic, as polyethylene, and has a hole 63 therethrough of a size
for receiving the speculum 61, as shown in FIG. 7. The drape 19 is
placed over the ear 65 and the speculum 61 is extended therethrough
so that the liner 17 protects the sterilized devices and parts from
the unsterile ear 65 during the operation.
It will be understood that liner 17 and drape 19 may be omitted
without departing from the spirit and scope of the present
invention.
The suction needle 23 is of conventional construction and is used
in a conventional manner, and therefore will not be described since
it is well known to those skilled in the art.
Container 24 preferably includes a plastic base portion 67, formed,
for example, from a polystyrene, having a shelf portion 69 which is
formed with depressions to receive the inserter 13, knife 15, liner
17, drape 19, suction needle 23, and myringotomy tube 21 so that
these devices and instruments will be depressed below the upper
surface 71 of shelf portion 69. Container 24 also includes a
covering 73 of rigid plastic or the like to cover shelf portion 69
and retain the instruments and devices in place and maintain them
in the sterile condition. Covering 73 is preferably of clear rigid
plastic and hinged along one edge as at 75 to bottom 69 and is
preferably provided with a suitable snaplock, not shown, on the
opposite edge 77 from the hinged edge. Alternately, if desired,
covering 73 may be formed from a thin flexible sheet of
polyethylene plastic which covers the entire surface 71 and base
portion 67, in which case the instruments and devices are
preferably sterilized by ethylene oxide gas which penetrates
through the plastic.
Preferably the myringotomy tube 21, or tubes, are placed in an
inner package 79 and then the inner package placed in a depression
in the base portion 67, as best seen in FIGS. 1 and 2. Inner
package 79 is preferably of a conventional type formed of plastic,
having a cavity 81 therein for receiving the myringotomy tube 21,
and having a removable top 83 tightly fitted over the rim 85 of the
cavity 81 and flexibly attached to the main body of the inner
package 79 by the flexible strap 87. Top 83 preferably has holes 89
therethrough so that the myringotomy tube 21 in the cavity 81 can
be sterilized while therein, either by autoclaving or by ethylene
oxide gas.
When it is desired to perform the operation, the covering 73 is
removed, and the myringotomy tube 21 is removed from the package 79
and placed on the protruding portion 33 of inserter 13, as
heretofore described. Also, as heretofore described, the liner 17
is placed in the speculum 61 and the two are then inserted through
the hole 63 of drape 19, which drape is placed over the ear 65, as
shown in FIG. 7. Then, the surgeon, with the use of the knife 15,
makes the incision, not shown, in the tympanic membrane 91 of the
ear. The surgeon then places the myringotomy tube 21 in the
above-mentioned incision and pushes trigger portion 49 towards
handle 35 to cause retraction of protruding portion 33 to withdraw
it from the myringotomy tube 21 and leave it in the incision in the
tympanic membrane. Also, if desired, the suction needle 23 may be
utilized in the conventional manner. Then, after the operation, the
surgeon disposes of the apparatus 11 and all the parts thereof.
Although the invention has been described and illustrated with
respect to a preferred embodiment, it will be understood that it is
not to be so limited since changes and modifications may be made
therein which are within the full intended scope of this
invention.
* * * * *