U.S. patent number 3,888,258 [Application Number 05/410,688] was granted by the patent office on 1975-06-10 for drain for the eardrum and apparatus for introducing the same.
Invention is credited to Taichiro Akiyama.
United States Patent |
3,888,258 |
Akiyama |
June 10, 1975 |
Drain for the eardrum and apparatus for introducing the same
Abstract
A drain for the eardrum is formed of a high polymer with the
properties of absorbency and swelling. An apparatus for inserting
the drain for the eardrum includes a needle with a sharp tip, a
tube sheathing the needle and a trigger to project the sharp end of
the needle from the end of the tube. When the trigger is drawn, the
sharp tip of the needle is extended from the end of the tube and is
then inserted into the drain, and used to bore a hole through the
eardrum and to insert the drain into the hole.
Inventors: |
Akiyama; Taichiro (Tokyo,
JA) |
Family
ID: |
26450783 |
Appl.
No.: |
05/410,688 |
Filed: |
October 29, 1973 |
Foreign Application Priority Data
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Nov 7, 1972 [JA] |
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47-111376 |
Nov 7, 1972 [JA] |
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47-128293 |
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Current U.S.
Class: |
606/109; 606/108;
128/DIG.8 |
Current CPC
Class: |
A61F
11/002 (20130101); A61F 2210/0004 (20130101); Y10S
128/08 (20130101) |
Current International
Class: |
A61F
11/00 (20060101); A61F 2/02 (20060101); A61b
017/32 (); A61b 017/43 () |
Field of
Search: |
;128/305,347,350,DIG.8,334UT |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Ballinger, Walter F. et al., "Operations Upon Coronary Arteries: .
. . ," IN Jour. Thoracic and Cardiovascular Surg. 485: 790-797.
1964. .
Salen, B. et al., "Exogenous Collagen In The Closure of Tympanic
Membrane Perforations." IN J. Laryn. Otol. 79:159-165. 1965.
Extract published in "Collagen Currents" 62; 54. August,
1965..
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Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: McDougall, Hersh & Scott
Claims
What is claimed is:
1. Apparatus for inserting a hollow drain in the eardrum
comprising:
a body;
a tube extending axially of said body from one end thereof;
a needle received within said tube and movable between a retracted
position and an extended position in which its tip projects from
the end of said tube remote from said body;
a contact element positioned within said body and mounted on the
rear end of said needle opposite said tip;
a spring within said body urging said needle into said retracted
position; and,
a pressing means mounted in said body for pressing on said contact
element for moving said needle from said retracted position to said
extended position, the outside diameter of said needle being
substantially equal to the inside diameter of said drain whereby
said needle is adapted to be received within the drain for
positioning of the drain adjacent said tip, and the outside
diameter of said tube being larger than the inside diameter of said
drain whereby said remote end of said tube is adapted to bear
against one end of said drain, said apparatus being thereby adapted
to be moved into position adjacent the eardrum, said needle being
adapted to be extended for forming a hole in the eardrum, and said
tube being adapted to be thereafter forced against said drain for
forcing the drain into said hole to thereby position the drain
relative to the eardrum.
2. Apparatus according to claim 1 wherein said pressing means is a
trigger pivotally mounted in said body.
3. Apparatus according to claim 2 further comprising: a drain
holder removably retained in a annularly grooved recess in said
body, said drain holder comprising a holder body, a handle at one
end of said holder body, a drain holding portion at the other end
of said holder body formed with holes to accommodate drains, and an
annular bulge around said holder body for engaging said groove to
retain said drain holder in said body.
4. Apparatus according to claim 1 wherein said pressing means is a
push button mounted on a leaf spring at the end of said body,
remote from said one end, the adjacent parts of said body being
formed as shoulders for engagement by the fingers of the operator
when pressing said button, said leaf spring being fixed to said
shoulders.
5. Apparatus according to claim 1 further comprising a detachable
guard tube enclosing said tube and mounted on said one end of said
body.
6. Apparatus according to claim 1 in combination with a drain for
the eardrum, said drain comprising a hollow element of polymeric
material having properties of absorbency and swelling.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a drain for the eardrum and an apparatus
for inserting the same into the eardrum, and more particularly to
an apparatus for inserting a drain into the eardrum by which a hole
is bored through the eardrum of a patient suffering from otitis
media and the drain inserted into the hole in the eardrum.
2. Description of the Prior Art
As is generally known, a drain for the eardrum is inserted into a
hole bored through the eardrum of an otitis media patient by a
scalpel to ensure that the hole does not close and that pus
generated in the middle ear will be discharged therethrough.
Conventional eardrum drains are formed of silicone rubber or
polyethylene, and no satisfactory method has been proposed by which
the drain can be surely held in the eardrum or which will prevent
the drain inserted into the hole in the eardrum from readily
falling from the eardrum. Therefore, conventional drains inserted
into the hole in the eardrum have often fallen from the eardrum
during medical treatment for otitis media and consequently the
trouble of inserting the drain into the hole in the eardrum has to
be taken again.
Moreover, no special apparatus for inserting the drain into the
eardrum has been satisfactorily developed. Consequently, when a
medical man wishes to insert the drain into the eardrum of the
patient, he incises the eardrum to a suitable length with a
scalpel, picks up the drain with a pincette and inserts the drain
into the incised eardrum. In the above-mentioned conventional
method, it is very troublesome to insert the drain into the incised
eardrum, and much operating time and a high level of skill are
required.
If the medical man incises the eardrum too much, the drain inserted
into the eardrum will be in an unstable state and there is the
possibility that the inserted drain may fall from the eardrum.
SUMMARY OF THE INVENTION
An object of this invention is to provide a drain for the eardrum
which does not easily fall from the eardrum when inserted.
Another object of this invention is to provide a novel apparatus
for inserting a drain in the eardrum by which the drain can be
easily and surely inserted.
A further object of this invention is to provide an apparatus for
inserting a drain for the eardrum by which a hole is properly bored
through the ear drum.
A still further object is to provide an apparatus for inserting a
drain for the eardrum which includes a drain-holder holding many
drains.
According to the invention, a drain for the eardrum is formed of a
polymeric material having the properties of absorbency and
swelling. Examples of suitable polymers include collagen, polyvinyl
alcohol, and a copolymer of the meta-acrylic acid glycol type.
Moreover, an apparatus for inserting the drain includes a needle
with a sharp tip and a tube sheathing the needle. The needle
projecting from the tube is inserted into the drain to hold it and
then a hole is bored through the eardrum by the sharp tip. Thus,
the needle is inserted together with the drain into the hole in the
eardrum and only the drain is left held in the eardrum.
The above and other objects, features and advantages of this
invention will become apparent from the following detailed
description of illustrative embodiments shown in the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of one embodiment of a drain for the
eardrum according to the invention;
FIG. 2 is a side view of one embodiment of a drain-inserting
apparatus according to the invention;
FIG. 3 is a greatly enlarged detailed vertical sectional view of an
important part of the embodiment shown in FIG. 2;
FIG. 4 is a perspective view of the drain-holder shown in FIG.
2;
FIGS. 5A to 5H are partly enlarged vertical sectional views showing
one manner of inserting a drain into the eardrum according to the
invention and removal of the inserted drain;
FIG. 6 is a partly sectional side view of another embodiment of
drain-inserting apparatus according to the invention; and
FIG. 7 is a front view of another embodiment shown in FIG. 6.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIG. 1, one embodiment of a drain for the eardrum
according to the invention will be described.
A drain 11 consists of a cylindrical main part 12 and a cylindircal
ancillary part 13, formed integrally with the rear end 12b of the
cylindrical main part 12 and having a larger diameter than the main
part 12. The outer surface 12 c of the free end 12a of the
cylindircal main part 12 is tapered or rounded. The length 1.sub.1
of the main part 12 is preferably about 2 mm., the length 1.sub.2
of the ancillary part 13 about 0.6 mm., the inside diameter d.sub.1
of the cylindircal main part 12 about 0.8 mm., the inside diameter
d.sub.2 of the cylindrical ancillary part 13 about 1.5 mm., the
wall thickness t.sub.1 of the main part 12 about 0.05 mm., and the
wall thickness t.sub.2 of the ancillary part 13 about 0.1 mm.
The drain 11 is formed of a high polymer having the properties of
absorbing and swelling, for example, collagen.
Collagen is particularly preferable for the formation of the drain
11 because it dissolves over a long period, or about 1 week after
the drain 11 has been inserted into the eardrum. The advantages
arising from the properties of absorbency and swelling, and of
dissolubility, will be described below. When only properties of
absorbency and swelling are required, polyvinyl alcohol, a
copolymer of the meta-acrylic acid glycol type (sold under the
trade name "Hydron"), mannitol, or certain of fluorine-containing
resins, or the combination of these, may be used for the formation
of the drain 11. However, the above-mentioned materials have to a
greater or lesser extent also the property of dissolubility.
Next, one embodiment of an apparatus 21 for inserting the drain 11
will be described with reference to FIGS. 2 to 4.
A boss 23 is formed on the upper end of a handle 22 made of metal
or synthetic resin. A cylindrical metallic body 25 is attached to
the handle 22 by a screw 24 at the boss 23. A metallic tube 27 is
attached by a screw thread to the leading end 25a of the
cylindrical metallic body 25 through a connecting element 26. A
metallic needle 28 with a sharp tip 28a is movably received in the
tube 27 and, in the interior 29 of the cylindircal metallic body
25, the rear end 28b of the needle is fixed to a contact element 30
which is in contact with an upper end 31a of a trigger 31 supported
rotatably on an axis 32. A compression spring 33 is disposed
between the connecting element 26 and the contact element 30 to
return the needle 28 to its original position.
A suitable length of needle 28 can be extended from the tip end 27a
of the tube 27 by grasping the handle 22 and drawing the trigger 31
(to rotate it anticlockwise around the axis 32 as shown in FIG. 3),
so that the upper end 31a of the trigger pushes the contact element
30 and the needle 28 moves forward in the tube 27 against the
compression spring 33.
When the trigger 31 is released, the trigger and the needle 28 are
resiliently returned to their original positions by the compression
spring 33, so that the tip 28a of the needle 28 is again withdrawn
within the tip end 27a of the tube 27. The outside diameter of the
needle 28 is equal to or a little smaller than the inside diameter
of the main part 12 of the drain 11 so that the needle 28 can be
inserted into the main part of the drain. The inside diameter of
the tube 27 is equal to or a little larger than the inside diameter
of the main part 12 of the drain 11 so that the tip end 27a of the
tube 27 can contact the bottom of the ancillary part 13 of the
drain 11. The outside diameter of the tube 27 is about 1 mm.
An opening 34 is formed in the rear end 25b of the cylindrical
metallic body 25, where a drain-holder 35 as shown in FIG. 4 is
removably mounted. The drain-holder 35, made of synthetic resin,
comprises a knob 36, an axially extending portion 37 for mounting,
an axially extending drain-holding portion 39 having numerous holes
38 for drains 11, and an annular bulge 40 formed on the surface of
the mounting portion 37. The main part 12 of each drain 11 is
inserted into a respective hole 38. The drain-holder 35 is mounted
at the rear end 25b of the cylindrical metallic body 25 by the
elastic-fitting of the bulge 40 in an annular groove 41 formed on
the cylindrical inner surface 34a of the opening 34.
Next, a method of using the drain-inserting apparatus 21 will be
described.
The drain-holder 35 is drawn out from the rear end 25b of the
cylindrical metallic body 25, and the tip end 28a of the needle 28
is inserted into one of the drains 11 held in the drain-holder 35.
For this purpose, the trigger 31 of the drain-inserting apparatus
21 is drawn by the forefinger so that the tip 28a of the needle 28
projects by about 2 mm. from the tip end 27a of the tube 27. The
drain 11 is taken out from the drain-holder 35, being held by the
tip 28a of the needle 28, as shown in FIG. 5A, since the diameter
of the hole 38 is only a little larger than the outside diameter of
the main part 12 of the drain 11 and the friction between the
surface of the hole 38 and the outer surface of the main part 12 is
smaller than the friction between the surface of the tip 28a of the
needle 28 and the inner surface of the main part 12. After the tip
28a of the needle 28 has been inserted into the drain 11, the
trigger 31 of the drain-inserting apparatus 21 is further drawn to
extend the tip 28a by a further 2 mm. from the tip end 27a of the
tube 27, as shown in FIG. 5B.
Next, a hole 45 for drain-insertion is bored through the eardrum 44
by the sharp tip 28a of the needle 28 projecting from the end 12a
of the drain 11, as shown in FIG. 5C. Furthermore, the tip 28a and
the drain 11 are inserted into the hole 45 by pressing on the
bottom of the ancillary part 13 of the drain 11 with the tip end
27a of the tube 27, as shown in FIG. 5D. As shown in FIG. 5E, the
tip 28a of the needle 28 is then withdrawn into the tube 27 by
releasing the trigger 31 of the apparatus 21 while the bottom of
the ancillary part 13 of the drain 11 is still being pressed by the
tip end 27a of the tube 27, as shown by FIG. 5D. Thus, only the
drain 11 is left inserted in the hole 45, as shown in FIG. 5F.
Pus formed in the middle ear is drained out to the outside of the
eardrum or into the outer ear, through the drain 11 inserted into
the eardrum, as above-described. Because the drain 11 is made of
high polymer with the property of absorbing and swelling, it
absorbs water to swell in a short time after insertion into the
eardrum, as shown in FIG. 5G. It is mainly the end portion 12a of
the main part 12 of the drain 11 that swells. The swelling-rate of
the drain 11 is preferably over 10 percent, and more preferably
over 20 percent, for example 20-30 percent. By such absorption and
swelling, the drain 11 is prevented from readily falling from the
eardrum 44, the eardrum 44 being located between the swollen end
12a of the main part 12 of the drain 11 and the ancillary part 13
of the drain, so that the drain 11 unexpectedly does not fall from
the eardrum 44 during medical treatment, but is securely held in
the eardrum 44 till the otitis media is perfectly healed. After
perfect healing of the otitis media, or as occasion demands, the
drain 11 can be easily taken out from the eardrum 44 by gripping
the ancillary part 13 of the drain 11 with a pincette 47 or the
like, as shown in FIG. 5H.
When the drain 11 is formed of collagen, it is not necessary to
take the drain 11 out from the eardrum 44, but rather the drain 11
may be left inserted into the eardrum 44, because it naturally
dissolves and at length disappears. In other words, when the drain
11 is formed of a high polymer having the property of dissolving
over a long period, it is not necessary to take out the drain 11
from the eardrum 44 after healing of the otitis media.
When the drain-inserting apparatus 21 is not in use, the
drain-holder 35 is fitted into the opening 34 and the tube 27 is
covered with a guard tube 46 as shown by the chain dotted line in
FIG. 2 so that the tube 27 and the needle 28 are prevented from
being accidentally bent. The end of the guard tube 46 is screw
threaded to the end of the connecting element 26.
FIG. 6 and FIG. 7 show another embodiment of a drain-inserting
apparatus 21 according to the invention. The parts of this
embodiment corresponding to the parts of the embodiment shown in
FIG. 2 and FIG. 3, carry the same reference numerals.
In this embodiment, a tube 27 is screw threaded to a
drain-inserting apparatus body 53 having a pair of shoulders 51, 52
through a connecting element 26. A push button 55 is supported by a
leaf spring 54 at the rear end of the body 53. One end 55a of the
push button 55 is in contact with a contact element 30 fixed to the
rear end 28b of a needle 28. In the operation, as in an injection
syringe, the body 53 is held in such a manner that the forefinger
and the middle finger are put on the pair of shoulders 51, 52 and
the thumb is put on the push button 55, as shown in FIG. 6. When
the push button 55 is pushed by the thumb against the leaf spring
54 it causes the needle 28 to move forward in the tube 27 against
the compression spring 33, as in the first embodiment of the
drain-inserting apparatus. Thus the tip 28a of the needle 28 is
extended from the tip end 27a of the tube 27, and when the push
button 55 is released by the thumb, the needle 28 is moved back to
the original position by the compression spring 33.
By the use of the invention as above-described, the drain is
prevented from falling unexpectedly from the eardrum during medical
treatment and the pus formed in the middle ear is reliably
discharged through the drain. Since the properties of absorbing and
swelling are realized only after the drain has been inserted into
the eardrum, the formed drain as it is, can be handled before being
deformed by the absorption and swelling. Moreover, the drain can be
very easily and rapidly inserted into the eardrum in comparison
with the conventional method, in which the eardrum is incised with
a scalpel and the drain is picked up with a pincette. Since with
the invention the hole is bored through the eardrum by the sharp
end of the needle, there is no possibility that the eardrum may be
erroneously incised too much, as it may be by the scalpel in the
conventional method, and the hole can be correctly bored through
the eardrum.
While there have been described preferred embodiments of the
invention, obviously modifications and variations are possible in
light of the above teachings. It is therefore to be understood that
within the scope of the appended claims, the invention may be
practised otherwise than as specifically described.
* * * * *