U.S. patent number 3,788,327 [Application Number 05/129,384] was granted by the patent office on 1974-01-29 for surgical implant device.
Invention is credited to Howard Donowitz, William J. O'Hara.
United States Patent |
3,788,327 |
Donowitz , et al. |
January 29, 1974 |
SURGICAL IMPLANT DEVICE
Abstract
Disclosed implant device includes a valve and conduit means for
controlling the intra-occular pressure build up in a diseased
eye.
Inventors: |
Donowitz; Howard (Freehold,
NJ), O'Hara; William J. (Freehold, NJ) |
Family
ID: |
22439695 |
Appl.
No.: |
05/129,384 |
Filed: |
March 30, 1971 |
Current U.S.
Class: |
604/247; 604/9;
604/175 |
Current CPC
Class: |
A61B
5/076 (20130101); A61B 3/16 (20130101); A61F
9/00781 (20130101) |
Current International
Class: |
A61B
3/16 (20060101); A61B 5/07 (20060101); A61F
9/007 (20060101); A61m 027/00 (); A61m
025/00 () |
Field of
Search: |
;128/348,35R,35V |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Ore, Svein et al., "Preparation of Surgical Implants From Silicone
Rubber by Means of a Postforming Technique." Surgery, pp. 385-390,
Aug. 1962. .
Ellis, R. A. "Reduction of Intraocular Pressure Using Plastics in
Surgery", in Amer. Jour. Ophthal., 50: 733 - 742, 1960. .
Teflon Armstrong Beveled Drain Tube, Advertisement of Richards Mfg.
Co., Memphis, Tenn. Copyright 1966..
|
Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: Fellen; Leonard R.
Claims
What is claimed is:
1. A surgical implant device for implantation in an eye
comprising:
an elongated shank member generally tubular in shape and having a
flange surrounding one end thereof, said shank member being
provided with a passageway opening in said one end through said
flange and axially extending through said shank and out the other
end thereof;
valve means seated within said passageway and normally positioned
to provide for closure thereof, said valve means opening in
response to a predetermined pressure differential within said
passageway and on opposing sides of the valve; and
means integrally formed on and disposed along said shank member
axially spaced from said flange for the retention of said device in
an eye;
said flange being in an inclined position relative to the axis of
said shank member and the side of said flange from which the shank
extends being arcuately contoured to conform generally to the
surface of a human eye.
2. A device as defined in claim 1 wherein said retention means
includes a plurality of spaced projections formed on the outside
surface of said shank member and angled upwardly toward said flange
portion.
3. A device as defined in claim 1 wherein a first portion of said
shank member depends from said flange portion and is necked down to
form a step with the remaining portion thereof, the remaining
portion of said shank member thereafter tapering toward said botton
end.
4. A device as defined in claim 1 wherein said flange includes a
ridge member integrally formed on the surface thereof opposite said
shank and concentric with the opening therein,
5. A device as defined in claim 1 wherein said valve means includes
a pair of opposing reed members integrally formed within said
passageway and extending thereacross so as to normally close off
said passageway.
6. A device as defined in claim 5 wherein said flange includes a
plurality of openings spaced around the periphery thereof.
7. A surgical device for implantation in an eye comprising:
a flange portion having top and bottom surfaces and a central
aperture therein;
an elongated body portion integral with said flange portion and
depending from the bottom surface thereof, said body portion having
an internal passageway continuous with said flange opening and
extending lengthwise through said body portion to an axially
in-line opening at the other end thereof;
pressure sensitive valve means seated within said passageway and
normally positioned to provide for closure of said passageway, said
valve means opening in response to a predetermined pressure
differential within said passageway and on opposing sides of the
valve;
said flange portion being generally circular in shape and overlying
said body portion in an inclined position relative to the
longitudinal axis of said body portion, said flange including a
plurality of apertures spaced along the periphery thereof; and
means integrally formed on and displaced along said body portion
beneath said flange portion for the retention of said device in an
eye, said retention means including a plurality of spaced
projections formed along the outside surface of said body portion
and angled upwardly toward said flange portion.
Description
This invention relates generally to surgical devices and more
particularly to a surgical device to be implanted in an eye for
controlling intra-occular pressure, as, for example, in a glaucoma
diseased eye wherein there is an increased pressure built up within
the eye from the accumulation of fluid.
Normally, fluid called aqueous humor, which constantly forms and
enters portions of the eye globe known as the anterior and
posterior chambers, are balanced by those fluids which leave the
eye by drainage through the canal of Schlemm. In glaucoma, for
example, more fluid is secreted than is discharged, which results
in an increase in intra-occular pressure, causing pain,
interference with vision, and eventual blindness. In acute and
chronic cases of glaucoma, this fluid imbalance is usually due to a
blockage of the canal of Schlemm from a change in the character of
the filtering or drainage tissues or a collapse of the angle of the
anterior chamber.
Many surgical procedures for treating acute and chronic glaucoma
and involving incisions and device implants have been proposed or
tried, all of which has met with rather varied and inconsistent
results. One such device includes, for example, an elongated
tubular section curved to the same radius as an eye and an attached
right angled section including a bore and adapted for insertion
into a hole surgically drilled in an eye so as to provide for the
drainage of fluid through the device into the retrobulbar space
behind the eye.
Particular problems and disadvantages apparent in this and other
prior art devices are the general lack of any provisions in the
devices to safeguard against excessive drainage of fluid which
could bring about a collapse of the anterior chamber causing a
possible loss of sight or the eye itself. The drilling of a hole,
for example, for receiving the right angled section for the
above-described device may in itself cause an excessive loss of
fluid. Also, devices of the type including an extended bore or
continuous open channel for fluid drainage also provide a means for
the outside entry of harmful bacteria into the anterior chamber,
with a possible resulting infection of the eye.
It is an object of the present invention to provide an implant
device which is simple in construction, free of the aforementioned
disadvantages and effective in controlling excessive intra-occular
pressure.
It is another object of the present invention to provide a device
which when surgically implanted in a glaucomatic eye operates in a
manner to relieve an excessive intra-occular pressure.
It is another object of the present invention to provide a device
which when implanted in a glaucoma diseased eye serves as a drain
for excess fluid built up in the anterior and posterior
chambers.
Briefly described, the implant device of the present invention
includes an elongated shank member have a passageway axially
extending therethrough and mounting a valve therein to normally
provide for closure of the passageway, the valve opening in
response to a predetermined pressure differential within the
passageway. A flange is provided on one end of the shank member to
anchor the implant device. Means are also provided on the shank
member for insuring retention of the device in the eye.
The novel features which are considered to be characteristic of the
invention are set forth with particularity in the appended claims.
The invention itself, however, both as to its organization and
method of operation as well as additional objects and advantages
thereof, will best be understood from the following description
when read in connection with the accompanying drawing in which:
FIG. 1 is a vertical section of a human eye showing the device of
the present invention implanted therein;
FIG. 2 is a perspective view of the implant device of the
invention;
FIG. 3 is a top view of the device of FIG. 2;
FIG. 4 is an enlarged front sectional view taken along the lines
4--4 of FIG. 3;
FIG. 5 is an enlarged section of the valve area shown in FIG. 4;
and
FIG. 6 is a modified front sectional view of the flange and upper
shank portion of the device.
Referring now to the drawing, and to FIG. 1 thereof, there is
illustrated a human eyeball which includes the lens 10, posterior
chamber 12, anterior chamber 14, iris 16, sclera 18, canal of
Schlemm 20, cornea 22, and the conjunctiva 24 of the eye. As shown
in the Figure, the device 26 of the present invention when
implanted in the eye preferably extends through the cornea 22 and
into the anterior chamber 14 of the eye.
With reference particularly now to FIGS. 2, 3, 4 and 5 in the
drawing, a preferred embodiment of an implant device in accordance
with the present invention comprises an elongated body or shank
portion 28 generally cylindrical in shape, slightly tapered, and
having a bore or passageway 30 extending axially therethrough. One
end 32 of the shank portion 28 is capped by an integrally formed
circular flange 34 with the passageway opening therethrough. The
other end of the passageway opens through the bottom portion 36 of
the shank 28 which has an obliquely slanted end face 38 to
facilitate implantation of the device 26 into an eye as will
hereinafter be described.
As shown particularly in FIG. 4, the flange portion 34 is
preferably slanted or obliquely positioned relative to the
longitudinal axis of the shank portion and has its top and bottom
surfaces 40 and 42 arcuately contoured so as to conform generally
to the cornea or other portion of the eyeball surface into which
the device is to be implanted. The flange portion 34 being seated
thereon thus serves to prevent the implant device from being
submerged into the eye after insertion.
In spaced array along the periphery of the flange portion 34 are a
plurality of apertures 44. Spaced downwardly from the flange
portion 34 and extending up and outwardly from the outside surface
of the shank portion 28 are a pair of integrally formed projections
or barbs 46 which may serve as a means for retaining the device in
the eye after implantation. It is important that the barbs 46 be
spaced sufficiently beneath the underside of the flange so as to
accommodate therebetween the wall thickness of the cornea or other
portion of the eyeball receiving the implant device, or alternately
be spaced so as to lock within the stroma or mid point of the
cornea.
In accordance with the invention, a valve means 48 is provided and
seated within the shank passageway 30 so as to normally provide for
a closure of the passageway, and for opening in response to a
predetermined pressure differential within the passageway and on
opposing portions of the valve means.
More particularly, and as shown in FIG. 5, a preferred valve means
includes a pair of opposing flexible web or reed-like members 50
and 52 formed integral with and extending out from the inside wall
surfaces bounding the passageway 30 and normally abutting one
another so as to close off the passageway and inhibit any flow
therethrough. Preferably the valve is formed in the shank portion
at a point intermediate the ends thereof. The abutting engagement
of the reed members 50 and 52 is such that the valve functions in a
one-way manner by allowing for the upward deflection of the reed
members 50 and 52 in response to the presence of a predetermined
increase in pressure exerted on the bottom surfaces 54 and 56 (as
viewed in the Figures) of the reed members relative to the pressure
exerted on the top surfaces 58 and 60 of the reed members.
It will be appreciated that in fabricating the device of the
invention, the material chosen must be inert and nontoxic. Also it
is desirable that the material be somewhat resilient so as to allow
for an integral formation within the internal passageway of a
one-way valve. One material that has proved satisfactory for this
purpose is manufactured by the DuPont Company, under the trade name
"Teflon". The double reed valve may be fabricated, for example, by
machining the shank portion bore from both ends to provide a
diaphragm like membrane between the bored end portions. The
membrane is then pierced to create a double reed type valve.
Piercing of the membrane is from the bottom end of the bore such
that the reed valve operates to open only toward the top or flange
end of the shank, thereby functioning as a one-way type valve. The
valve is thus dependent on the memory retention or resiliency of
the material of which it is formed, in addition to the back
pressure exerted on the flange side of the valve, to return to its
seat or closed position.
It should be noted that the pressure differential or program
setting to which the valve openly responds is determined by the
thickness of the membrane forming the reed members, the general
characteristics and resiliency of the material used in fabricating
the device as well as the size of the bore opening or
passageway.
Advantages in the use of a double reed type valve are the relative
ease with which the response threshold point of the valve can be
controlled, i.e., the point at which the valve responds to a
pressure difference. Also the greater the pressure difference, the
more the valve flaps or reed members will deflect to open the
passageway and allow for fluid discharge, the valve opening being
directly proportional to the applied pressure differential.
It will be also be apparent that other types of valve means, as,
for example, a ball valve, single reed valve or a spring valve may
be used in the construction of the device of the present
invention.
Insertion and operation of the implant device into an eye will now
be described.
As shown in FIG. 1, the device of the present invention may be
implanted into and through the cornea 22 and into communication
with the anterior chamber 14, the implantation preferably being
made in the upper portion of the cornea just beneath the canal of
Schlemm 20.
As was heretofore noted, the shank portion of the implant device is
preferably provided with a tapered outside contour as shown in the
Figures so as to facilitate easy insertion, either directly or
through a prepared tract into the eye. When insertion of the
implant device is to be in the cornea, for example, a hyperdermic
needle-like instrument is preferably used to first pierce the
cornea to provide a tract for receiving the device. The cornea is a
desirable area of the eye for receiving the device since the
inherent pliable nature of the cornea will permit the easy
implantation of the device and also enhance a sealing around the
shank portion of the device after it is received in the eye. Also,
in piercing the cornea to provide the receiving tract for the
implant device, there is substantially no tissue or fluid loss.
It will be understood that the device can be inserted directly into
the cornea without the aid of a tract. Also, other areas of the
eyeball may be used for implantation of the device of the present
invention.
Upon implantation, the device flange portion 34 will seat on the
cornea or other area of the eye receiving the device, while the
barb projections 46 lock against the underside of the receiving
tissue for retaining the device in the eye. Alternately, the barb
projections may be spaced so as to lock within the stroma of the
cornea, or mid area of the receiving tissue.
As was heretofore noted, the flange portion 34 of the implant
device may be provided with a plurality of apertures 44 spaced
around the periphery thereof. These flange apertures 44 may serve
two functions. When the device is implanted in the cornea portion
of the eye, the apertures allow the eye tears to wash and provide
for the normal irrigation of the cornea area under the flange.
Where the implant is in another area of the eye, as, for example,
through the sclera, the flange apertures may be used to anchor the
device in the eye with the aid of sutures.
Initially the pressure of the top surfaces 58 and 60 of the valve,
i.e., the discharge end of the valve, which is exposed to the
outside of the eye after implantation of the device, is at or about
the atmospheric pressure. Normally, the pressure inside the eye
globe, and more particularly in the anterior and posterior chambers
thereof is understood to be between 15 and 25 millimeters (mm.) of
mercury above the atmospheric pressure. With the occurrence of an
abnormal intra-occular build up of pressure inside the eye and
again particularly in the anterior chamber which after insertion of
the device is effectively in communication with the bottom surfaces
54 and 56 of the reed members, i.e., the intake end of the valve, a
point is reached, i.e., the threshold or program setting of the
valve, wherein the valve will open to allow the passage of fluid
from the anterior chamber through the shank bore of passageway to
the outside of the eye wherein it mingles with existing eye tears
and is disposed of in the normal manner. The increased
intra-occular pressure built up is in this way controlled. The
pressure point at which the valve may be programmed to open may,
for example, be between 20 and 25 mm. of mercury.
When the pressure difference on both sides of the valve membrane,
i.e., the top and bottom surfaces of the reed members, decreases to
a preset level substantially equal to the aforementioned program
setting, the valve closes. The rate and degree of valve opening is
a function of the amount of the intra-occular pressure and
consequently the pressures exerted on the bottom surfaces of the
valve reed members. The valve serves to regulate the flow of fluid
through the shank passageway in direct proportion to the degree of
excessive intra-occular pressure built up in the eye. Since the
intra-occular pressure will be changing as the valve allows for the
discharge of fluid, the valve reeds will tend to substantially open
and close or flutter in operation. Since the cornea does not have
blood vessels or a blood supply, by this fluttering action of the
valve, the circulation of the aqueous is enhanced against the
posterior part of the cornea. This is desirable since the aqueous
normally provides a means of carrying nourishment to the cornea and
also for the disposal of waste matter.
It should be noted that another advantage inherent in the implant
device of the present invention is its minute size. A device in
accordance with the invention has been constructed with an
operating valve as above-described and with a shank length of
approxiamtely 2.5 mm., a bore diameter of approximately 0.5 mm.,
and a flange portion 2 mm. in diameter.
It will be appreciated that the relatively small size of the device
will minimize friction between an eyelid and the device when
implanted. Also, during implantation of the device and because of
its size, there will be substantially no tissue of fluid loss.
Turning now to FIG. 6, there is illustrated a fragmentary sectional
view showing a modified embodiment of the flange and retaining
means portons of the implant device of the present invention.
More particularly, the upper end of the shank portion 28 is necked
down as shown so as to provide a step or shelf 62 which functions
to help retain the implant device in an eye in a manner similar to
that of the heretofore described barb projections shown in FIG. 4.
The top surface 40 of the flange portion 34 is provided with an
integrally formed annular rib or ridge member 64. With the device
implanted in an area of the eye other than the cornea, and more
particularly the sclera, the ridge 64 will serve to discourage the
formation of cicatrix or scar tissue over the flange opening of the
passageway.
It will thus be seen that the device herein described may be easily
implanted in a human eye, provides a minimum of discomfort to the
recipient, and functions in a simple, eyt effective manner to
control an intra-occular pressure build up. It will also be clear
that variations in the details of consruction which are
specifically illustrated and described may be resorted to without
departing from the scope of the invention.
* * * * *