U.S. patent number 3,916,873 [Application Number 05/420,412] was granted by the patent office on 1975-11-04 for valve for tympanic membrane ear surgery.
Invention is credited to Eric I. Wasserman.
United States Patent |
3,916,873 |
Wasserman |
November 4, 1975 |
Valve for tympanic membrane ear surgery
Abstract
An air-permeable, chemically inert valve used to provide an air
passage through the tympanic membrane of the ear. A thin layer of
porous teflon covers the outer end of a tube lining a passageway
created in the tympanic membrane. The porous teflon is impermeable
to solids and liquids, but permeable to gases, thereby equalizing
the air pressure between the outer and middle ear. An
anti-coagulate coating may be applied to the teflon to prevent the
tympanic membrane from growing over it.
Inventors: |
Wasserman; Eric I. (Ventura,
CA) |
Family
ID: |
23666363 |
Appl.
No.: |
05/420,412 |
Filed: |
November 30, 1973 |
Current U.S.
Class: |
128/868; 128/867;
623/10; 181/135 |
Current CPC
Class: |
A61F
11/002 (20130101) |
Current International
Class: |
A61F
11/00 (20060101); A61B 019/00 (); A61F
001/18 () |
Field of
Search: |
;128/1R,350,151,152 ;3/1
;181/23 ;55/417,523 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Sciascia; Richard S. St.Amand;
Joseph M. Hollis; Darrell E.
Government Interests
STATEMENT OF GOVERNMENT INTEREST
The invention described herein may be manufactured and used by or
for the Government of the United States of America for governmental
purposes without the payment of any royalties thereon or therefor.
Claims
I claim:
1. A gas-permeable, chemically inert valve adapted for insertion in
the tympanic membrane of the ear comprising:
a. a chemically inert tubular member adapted for lining a
passageway through a tympanic membrane having an external surface
thereon, said external surface having a portion thereof
intermediate the ends of said tubular member about which said
tympanic membrane grows, said tubular member having a first opening
located at one end thereof and a second opening located at the
other end thereof; and
b. chemically inert means covering an entire cross-sectional area
of the passageway through said tubular member, said means being
impermeable to liquid and solids while being permeable to gases
whereby pressure between the middle ear and the outer ear is
equalized, while simultaneously preventing any passage of liquids
or solids therethrough.
2. The valve of claim 1 wherein said covering is affixed to said
first opening.
3. The valve of claim 1 wherein said covering means is affixed to
said second opening.
4. The valve of claim 1 wherein said tubular member has means about
the circumference thereof into which said tympanic membrane grows
for retaining said tubular member in said tympanic membrane.
5. The valve of claim 4 wherein said tubular member has a notch
around its circumference into which the tympanic membrane
grows.
6. The valve of claim 1 wherein said tubular member is fabricated
from a gas-permeable, solid-and-liquid impermeable, chemically
inert material.
7. The valve of claim 1 wherein said covering means is a thin-layer
of material made of teflon.
8. The valve of claim 1 wherein said covering means is a thin-layer
of material made of sintered stainless steel.
9. The valve of claim 1 wherein said covering means is a thin-layer
of material made of sintered metal.
10. The valve of claim 1 wherein said covering means is a
thin-layer of material .001 inch thick, having a water entry
pressure of 2 pounds per square inch and a density of 0.1 gram per
cubic centimeter.
11. The valve of claim 1 further comprising an anti-coagulating
coating covering said chemically inert covering means whereby said
tympanic membrane is prevented from growing over said covering
means.
12. A method of equalizing the gas pressure between the middle ear
and the outer ear utilizing a valve assembly which simulates the
eustachian tube function of the ear while preventing the
inadvertent passage of both solids and liquids including water, but
allowing the passage of gases through the tympanic membrane
comprising:
a. surgically creating a passageway in the tympanic membrane;
b. inserting said valve assembly which incorporates a solid and
liquid impermeable but gas permeable, chemically inert membrane
into said passageway; and
c. allowing the tympanic membrane to grow around said valve
assembly.
13. The method of claim 12, wherein immediately following the step
of inserting and immediately preceding the step of allowing, a
further step is inserted comprising coating said gas-permeable,
chemically inert membrane with an anti-coagulating material whereby
said tympanic membrane is prevented from growing over said
gas-permeable, chemically inert membrane.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to devices used to provide
an air passage through the tympanic membrane of the ear and, more
particularly, to air-permeable, chemically inert valves used to
provide an air passage through the tympanic membrane of the
ear.
2. Description of the Prior Art
Children born with a cleft palate condition exhibit a high
likelihood of repeated ear infection as a result of deficiencies
involved with the muscles associated with control of the eustachian
tube. While medication eliminates the infections, the basic
difficulty still remains. Consequently, an alternate method, based
on surgical techniques, is utilized to insert a plastic tube
between the middle and outer ear. The surgical procedure, described
as a "Tympanotomy with Insertion of Tube," is designed to prevent
the production of fluid in the inner ear by providing an auxiliary
path for air pressure equalization between the middle and outer
ear. Normally, the eustachian tube provides an airpath to equalize
the air pressure between the middle and outer ear and is controlled
by a muscle. When the muscle structure that controls the eustachian
tube is deficient, and when infection results in closure of the
eustachian tube, an air pressure differential develops between the
middle and outer ear. The air pressure differential results in the
production of fluid, which, if not removed, becomes increasingly
viscous, and ultimately leads to deafness. Surgical procedures are
utilized to remove the fluid through an incision in the tympanic
membrane, and a plastic collar assembly is subsequently
inserted.
The Donaldson Silastic Collar, as well as several other similar
devices, provide a method of simulating the function of the
eustachian tube to equalize the air pressure between the middle and
outer ear by means of an air passage. However, this, as well as
other existing devices also provide a passage for water and solid
particles into the inner ear. Precautions must be taken,
particularly in the case of small children, to prevent the entry of
water into the ear when bathing or engaging in other activities in
and around water.
SUMMARY OF THE INVENTION
The general purpose of the present invention is to provide a valve
for providing an air passage through the tympanic membrane of the
ear which will prevent the passage of solids and liquids, but will
allow passage of gases. To obtain this, a specific embodiment of
the present invention provides a thin-layer of porous teflon
covering the outer end of a tube lining a passageway created in the
tympanic membrane of the ear. The porous teflon prevents the
passage of liquids or solids, but allows the passage of gases
through the tube, thereby equalizing the air pressure between the
outer and middle ear. An anti-coagulate coating may be applied to
the teflon to prevent the tympanic membrane from growing over
it.
Accordingly, one object of the present invention is to equalize the
air pressure between the middle and outer ear.
Another object of the present invention is to provide a valve that
passes gases but does not pass liquids or solids.
Another object of the present invention is to allow persons having
valves in their ears to lead normal lives.
Another object of the present invention is to keep water out of the
middle ear.
Another object of the present invention is to keep airborne
particles out of the middle ear.
Another object of the present invention is to provide a chemically
inert valve.
Another object of the present invention is to prevent the tympanic
membrane from growing over the valve thereby rendering it
useless.
Another object of the present invention is to provide an
air-permeable valve.
Another object of the present invention is to equalize gaseous
pressure on both sides of a membrane.
Other objects and a more complete appreciation of the present
invention and its many attendant advantages will develop as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings in which like reference numerals designate
like parts throughout the figures thereof and wherein.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross sectional view of the ear.
FIG. 2 is a side view of a specific embodiment of the present
invention.
FIG. 3 is a rear view of the specific embodiment of FIG. 2.
FIG. 4a through e are graphs of the physical properties of a
thin-layer of teflon.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 illustrates the ear. Outer ear 100 is terminated by tympanic
membrane 16. Eustachian tube 104 serves to equalize the air
pressure between outer ear 100 and middle ear 102.
Turning now to FIG. 2, valve 10 comprises a tube 12 having a notch
14 midway between the two ends of tube 12. Notch 14 extends around
the entire circumference of tube 12. Tympanic membrane 16 grows
into notch 14. A passageway 18 extends through tube 12 along its
longitudinal axis. A thin-layer of material 20 is affixed to and
covers one end of tube 12. Valve 10 is a silastic collar with
thin-layer 20 attached thereto. It is noted that valve 10 of FIG. 2
is not drawn to scale. Tube 12 is a chemically inert means for
lining a passageway through tympanic membrane 16. Tube 12 serves as
a conduit. Tube 12 may be made of silicon rubber or any other
suitable chemically inert material that the body will not reject.
It is noted that there are many different devices of varying shapes
and sizes similar to tube 12 currently in medical use designed for
stability in the ear. A common characteristic of all such devices
is a passageway through them.
Thin-layer 20 is impermeable to solids and liquids, but permeable
to gases. Thin-layer 20 is, also, chemically inert thereby
restricting rejection by the body. There are a number of materials
currently available with such properties including a number of
metals and plastic foams which are chemically inert, air-permeable,
and liquid and solid impermeable. Sintered stainless steel and
sintered brass are two such metals. In addition, porous teflon
plastic may be utilized. Thin-layer 20 is bonded to tube 12 using a
chemically inert glue or other means. Thin-layer 20 may be made of
a porous teflon material being 2.54 .times. 10.sup.-.sup.3 cm thick
(0.001 inch), having a density of 0.1 gram per cubic centimeter,
and water entry pressure of nominally 2 pounds per square inch. It
is noted that thin-layer 20 may be attached to either end of tube
12 or anywhere in passageway 18 the only requirement being that
thin-layer 20 completely cover a cross sectional area of passageway
18.
FIG. 4a through 4e graphically illustrates the physical properties
of a porous teflon material. FIG. 4a graphically illustrates
porosity vs. density. FIG. 4b graphically illustrates porosity vs.
air permeability. FIG. 4c graphically illustrates porosity vs.
thermal conductivity. FIG. 4d graphically illustrates porosity vs.
size of largest pores. FIG. 4e graphically illustrates porosity vs.
water enter pressure. Line 30 illustrates the specific properties
of a teflon material satisfactory for use as thin-layer 20. It is
noted that the material of thin-layer 20 is selectable for a wide
variety of conditions that allow the optimization of pressure
differential, air-flow rate and pore size requirements.
The valve 10 is inserted in a passageway or opening surgically
created in tympanic membrane 16. Tympanic membrane 16 then grows
aroudn valve 10 fitting into notch 14. An anti-coagulate coating
may be placed in thin-layer 20 to prevent tympanic membrane 16 from
growing over thin-layer 20 thereby rendering valve 10 useless.
It is noted that all of valve 10 including tube 12 and thin-layer
20 may be made of an air-permeable, solid-and-liquid-impermeable,
chemically-inert material such as teflon. That is, tube 12 and
thin-layer 20 may be one piece thereby eliminating the need for
bonding discussed supra.
Obviously, numerous modifications and variations of the present
invention are possible in the light of the above teachings. It is
therefore to be understood that within the scope of the appended
claims the invention may be practiced otherwise than as
specifically described herein.
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