U.S. patent number 3,732,858 [Application Number 04/799,476] was granted by the patent office on 1973-05-15 for apparatus for removing blood clots, cataracts and other objects from the eye.
This patent grant is currently assigned to Surgical Design Corp.. Invention is credited to Anton Banko.
United States Patent |
3,732,858 |
Banko |
May 15, 1973 |
APPARATUS FOR REMOVING BLOOD CLOTS, CATARACTS AND OTHER OBJECTS
FROM THE EYE
Abstract
The invention deals with surgical instrumentation for the
removal of generally foreign objects from the eye, including blood
clots and the lens of the eye, by inserting a pair of jaws for
engaging the object and removing portions thereof as required by
movement of the jaws relative to each other.
Inventors: |
Banko; Anton (Brooklyn,
NY) |
Assignee: |
Surgical Design Corp. (Long
Island City, NY)
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Family
ID: |
27117100 |
Appl.
No.: |
04/799,476 |
Filed: |
February 14, 1969 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
762286 |
Sep 16, 1968 |
3528425 |
Sep 15, 1970 |
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Current U.S.
Class: |
600/566; 604/267;
606/170; 604/22; 606/107 |
Current CPC
Class: |
A61B
17/32002 (20130101); A61B 17/34 (20130101); A61B
10/0266 (20130101); A61F 9/00745 (20130101); A61B
2017/00685 (20130101); A61B 2217/007 (20130101); A61B
2017/3492 (20130101); A61B 2017/306 (20130101); A61M
39/0247 (20130101); A61B 2017/320084 (20130101); A61B
10/0275 (20130101); A61M 3/0279 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61B 17/32 (20060101); A61F
9/007 (20060101); A61B 10/00 (20060101); A61B
17/30 (20060101); A61B 17/00 (20060101); A61M
3/02 (20060101); A61M 3/00 (20060101); A61M
1/00 (20060101); A61b 010/00 (); A61b 017/32 ();
A61m 001/00 () |
Field of
Search: |
;128/2,276,305,310,328,303,303.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Pace; Channing L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This is a continuation in part of applicant's co-pending
application Ser. No. 762,286 filed on Sept. 16, 1968, and now U.S.
Patent 3,528,425 which issued on Sept. 15, 1970, and which entire
subject matter of the co-pending application is incorporated herein
by reference as if fully set forth herein and in which applicant
discloses the method and apparatus for forming an opening in the
eye for the insertion of surgical instrumentation therein for
performing surgical procedures.
Claims
I claim:
1. Apparatus for cutting and then removing material from a portion
of the body of a human being or other animal in vivo comprising
elongated removal means adapted to be inserted within said body
portion, said elongated removal means formed with at least one
passage through a portion thereof and having a pair of jaws located
in proximity to and in communication with one end of said passage
at the operative end of the removal means with the other end of
said passage exiting from the removal means, at least one of said
jaws having cutting means thereon,
means for mounting said jaws such that one is rotatable relative to
the other to cut the material from the body while said removal
means is located therein,
and means connected to said removal means for providing a suction
force in said passage, said jaws being formed to present an opening
at the operative end of the instrument during a portion of arc of
rotation of one jaw relative to the other to bring by the action of
the suction force the material being removed in proximity to said
pair of jaws for cutting thereby, the material cut by said jaws
being conveyed by the suction force through the exiting end of the
passage while said removal means is still located in the body.
2. Apparatus as defined in claim 1, and further including drive
means operatively associated with said removal means for rotating
said jaws relative to each other.
3. Apparatus as in claim 1 wherein said removal means comprises two
elongated members located one within the other, a jaw being formed
at the free end of each said member, one of said members having an
opening for communicating with said passage, and means for
angularly rotating one of said members relative to the other.
4. Apparatus as in claim 1 wherein said members are rotatable by
said rotating means for 360.degree. relative to each other.
5. Apparatus as in claim 1 further comprising mean for supplying
fluid through a said passage proximate to said jaws.
6. Apparatus as in claim 4 wherein one of said elongated members is
formed to define the passage for the suction force.
7. Apparatus as in claim 4 further comprising means for moving one
of said members axially relative to the other to control the
cutting action of said jaws.
8. Apparatus as defined in claim 1 wherein at least one of said
jaws has an opening therein and said jaws are adapted to be moved
from an open to a closed position, permitting material to enter
said opening in said open position and substantially preventing
material from entering said opening in said closed position.
9. Apparatus as defined in claim 1 wherein said removal means
includes:
a. an elongate inner member with a central longitudinal opening
forming said passage, a conduit member communicating with the flow
passage,
b. an inner jaw adjacent one end of said inner member communicating
with the flow passage,
c. an elongate outer member rotatably mounted about the inner
member, and
d. an outer jaw adjacent one end of said outer member and shiftable
into and out of register with said inner jaw in the inner assembly
upon relative rotation of said inner and outer members.
10. Apparatus as defined in claim 9, wherein both jaws are formed
with openings, the relative cross-sectional areas of the openings
of said jaws being such that when in their open position with their
openings in register with each other, material may enter said
passage means, and when in their closed position with their
openings out of register with each other they substantially seal
off said passage means and prevent material from entering
therein.
11. Apparatus as defined in claim 9, wherein the forward end of
said outer member defines a tapered configuration to facilitate
penetration within the body by said removal means.
12. Apparatus as defined in claim 9,
a. wherein said jaw of said outer member defines an opening having
an elongated shaped surface with an outer edge and spaced apart
inner edge, said surface inclined upwardly from said inner edge to
said outer edge, and the forward extremity of said outer edge
extending above the axis of said outer member by a distance at
least equal to the wall thickness of said outer member jaw so as to
prevent rotation of said object by the rotation of the inner member
jaw relative to the outer member jaw, and
b. wherein said inner member jaw defines an opening having an
elongated shaped surface with an outer edge and a spaced apart
inner edge, said surface inclined upwardly from said inner edge to
said outer edge, and
c. at least one edge on each of said jaws defining a cutting edge
for severing the object extending therebetween.
13. Apparatus as defined in claim 1, wherein said removal means
includes:
a. an elongate outer member with a central, longitudinal opening
forming said passage, means on said outer member to connect with a
conducting member, said conducting member communicating with the
flow passage,
b. an outer jaw adjacent one end of said outer member communicating
with the flow passage,
c. an elongate inner member extending within said outer member for
angular displacement relative thereto, and
d. an inner jaw at substantially one end of said inner member and
shiftable into and out of register with the outer jaw upon relative
rotation of said inner and outer members.
14. Apparatus as defined in claim 13, wherein said outer member jaw
defines an opening having an elongated shaped surface with an outer
edge and spaced apart inner edge, said surface inclined upwardly
from said outer edge to said inner edge, with at least one of said
edges defining a cutting edge, and the forward extremity of said
inner edge extending above the axis of said outer member by a
distance at least equal to the wall thickness of said outer member
jaw so as to prevent rotation of the object by rotation of the
inner jaw.
15. Apparatus as defined in claim 13, wherein said inner member jaw
defines a head portion having substantially parallel spaced apart
faces with a transversely extending opening therebetween defining
one or more spaced apart cutting edges at said faces.
16. Apparatus as in claim 1 further comprising means as part of
said elongated removal means for supplying a second fluid to exit
from the operative end of said removal means to the portion of the
body from which the material is being removed.
17. Apparatus as in claim 16 wherein said fluid supply means
includes a passage formed in said elongated removal means which is
separate from the passage through which said suction force is
provided.
18. Apparatus as in claim 16 wherein said fluid supply means
includes the same passage through which said suction force is
provided.
19. Apparatus as in claim 1 wherein said removal means comprises
two elongated tubular members located one within the other, means
for mounting said members for relative angular rotation with
respect to each other, each of said members having an opening at
the free end thereof at least a portion of which can be brought
into registration with the opening of the other member, at least
one of said members being formed with a cutting means surrounding
at least a portion of its opening so that upon angular rotation of
the members relative to each other material which is located in the
path between said cutting means and the surface surrounding the
other opening will be cut.
20. Apparatus as in claim 19 wherein one of said elongated tubular
members defines the passage which is in communication with said
means for applying said suction force.
21. Apparatus as in claim 1 wherein said removal means comprises a
first elongated tubular member forming a fluid flow passage and
having an opening in proximity to one end thereof, jaw means formed
at said one end of said first member, a second elongated member
having jaw means at one end thereof, one of said jaw means being
formed with cutting means and defining with the jaw means of said
other member a cutting surface, and means for mounting said first
and second members for relative rotation with respect to each
other.
22. Apparatus as in claim 21 further comprising a second tubular
elongated member forming a second fluid flow passage, said second
tubular member having an opening adjacent the end thereof at the
operative end of the elongated removal means which communicates
with said fluid flow passage defined by said member.
23. Apparatus as in claim 21 wherein said second elongated member
has a knife blade at the end thereof which defines its jaw and
coacts with the jaw means of said first elongated member.
24. Apparatus as in claim 23 wherein said second elongated member
has a double faced knife blade.
25. Apparatus as in claim 22 wherein said second elongated member
includes a helical cutting surface, the end of said surface
defining the jaw means of said second member, which jaw means
coacts with the jaw means of said first member to cut the material,
said cut material being removed by said helical surface.
26. Apparatus as in claim 21 further comprising motor means for
rotating said first member relative to said second member.
27. Apparatus for removing an object from within the eye of a human
being or other animal in vivo, comprising:
A. removal means adapted to be inserted within said eye and
including:
a. an elongate outer assembly with a central flow passage forming
passage means, with an outer jaw substantially at one end of said
outer assembly connected to the flow passage, and
b. an elongate inner assembly extending within said outer assembly
for angular displacement relative thereto, with an inner jaw at
substantially one end of said outer assembly and shiftable relative
to said outer jaw upon relative rotation of said inner and outer
assembly,
c. said outer jaw defines opening having an elongated shaped
surface with an outer edge and spaced apart inner edge, said
surface inclined upwardly from said outer edge to said inner edge,
with at least one of said edges defining a cutting edge, and the
forward extremity of said inner edge extending above the axis of
said outer assembly by a distance at least equal to the wall
thickness of said outer jaw so as to prevent rotation of the object
by rotation of the inner jaw, and
d. said inner jaw defines a head portion having substantially
parallel spaced apart faces with a transversely extending opening
therebetween defining spaced apart cutting edges at said faces,
B. mounting means within said removal means for supporting said
inner and outer assembly for relative angular displacement relative
to each other so as to sever any material of said object extending
between said jaws as they are moved relative to each other, said
removed material of said object being contained within said passage
means,
C. means for maintaining a suction force in said passage means to
maintain said object in a substantially fixed position relative to
said jaws, said suction force being applied through said passage
means to said object,
D. means for forming a fluidized suspension of said removed
material by supplying a treatment fluid proximate to said jaws,
and
E. means for removing said fluidized suspension from said passage
means, said means including suction means connected to said passage
means for removal of said fluidized suspension therefrom.
28. Apparatus for performing eye surgery in a human being or other
animal in vivo, comprising:
A. means for progressively removing the lens of the eye from within
its capsule, said removal means including passage means and a pair
of jaws connected thereto at proximately one end thereof, said jaws
adapted to be moved relative to each other, and
B. means for maintaining a suction force in said passage means to
retain said lens in substantially fixed position relative to said
jaws,
C. means for effecting relative movement of said jaws so as to
sever the material of the lens extending therebetween as they are
moved relative to each other, said removed lens material being
contained within said passage means, and
D. means for supplying a fluid internally to said capsule to
prevent collapse thereof during removal of said lens.
Description
BACKGROUND OF THE INVENTION
The present invention relates generally to improvements in surgical
procedures related to the eye, and more particularly to methods and
apparatus for the removal of blood clots and other impurities,
including the lens from the eye.
The outstanding and unexpected results obtained by the practice of
the method and apparatus of the present invention, are attained by
a series of features, steps and elements, working together in
inter-related combination, and may be applied to biological
organisms in general and particularly the eyes of humans, and hence
will be so illustrated and described. The present invention may be
used to perform a biopsy at any portion of the anatomy as well.
Applicant has found that in order to perform various exploratory,
diagnostic, or other surgical procedures with respect to the eye,
that it is necessary for an incision or opening to be formed
through the wall thereof such that the instrumentation necessary
might be inserted therethrough. When the procedure intended is
completed it then becomes necessary to close the opening and permit
the incision in the wall of the eye to properly heal such that the
eye might function in a proper manner. In applicant's co-pending
patent application referred to above, the process of forming and
closing the opening is disclosed, and which incision might be
formed for use in accordance with the present invention. To
facilitate the discussion of applicant's present invention dealing
with the removal of blood clots or the lens of the eye, reference
is made to the co-pending application to merely illustrate one form
of initial surgical procedure that might be conducted to gain
access to the interior of the eye for practising the present
invention.
By way of illustration and not limitation, once an incision has
been made and a passageway formed from the exterior to the interior
of the eye then a variety of instruments may be inserted within the
passageway to accomplish physical tasks. In accordance with the
present invention the instrumentation is designed to be inserted
through the passageway for removing any object or deposit, such as
blood clots, tissue and impurities from vitreous material contained
within the eye as well as the removal of part or all of the
vitreous or the lens from the eye and its replacement with another
material.
The term "object" or "deposit" as used herein is intended to
include any portion of the body that is to be removed partially or
entirely therefrom for whatever purpose it is so desired. By way of
example and not limitation, this may include a blood clot, a
growth, such as a tumor, or other impurity in the eye, or any other
portion of the body however formed, the the of he eye, healthy,
diseased or dead tissue for a biopsy or other reason.
REMOVAL OF BLOOD CLOTS
Before proceeding to the details of the invention, let us first
review briefly generally known facts of the eye and the formation
of deposits or objects of which removal thereof is desired. The
retina of the eye is attached to the underlying choroid at the
optic nerve border posteriorly and at the ora serrata anteriorly.
Between these two points it is in contact with but not attached to
the choroid. The retina covers the entire inner aspect of the
eyeball posterior to the ora serrata. The ora serrata is the
junction of the retina and the ciliary body, in the average eye it
is about 8mm posterior to the limbus. The retina is composed of
inelastic nerve tissue, consisting of 10 distinct different layers,
normally it is transparent, when detached it appears gray.
Contained within the eye in front of the retina is the vitreous
material in which deposits are formed which may include blood
clots, other impurities, as well as tissue both healthy or
diseased.
Blood clots due to traumatic ruptures of retinal vessels or other
causes like diabetes, mellitus, hypertension, peri vasculitis or
retinal detachment are often disturbing to the vision. Hemorrhage
into the vitreous is an uncommon but serious disorder. There may be
sudden and complete loss of vision in the affected eye. The blood
often remains in the vitreous for months or forever.
The retina is usually damaged by prolonged intimate contact with
blood elements. If the vitreous clears it is possible that the
retina is detached and vision may be restored by surgical
reattachment. Beside blood clots there may be other impurities in
the vitreous or aqueous humor. The humor as a whole can also be
spoiled.
At the present time there is no effective, reliable or safe means
for removal of such blood clot deposit known to the applicant. In
certain parts of the eye a single small blood clot can not be
practically removed from the eye. The exchange of the vitreous as a
whole, to applicant's knowledge was never performed routinely. The
vitreous is a thick transparent gelatinous body which encompasses
two-thirds of the volume and weight of the eye. Because of the high
viscosity the vitreous cannot be aspirated through a hypodermic
needle with a syringe.
REMOVAL OF LENSES
A cataract is an opacity of the lens of the eye requiring
cryosurical techniques to obtain removal of the lens. The
cryoextraction usually requires lens extraction. At the present
time, only a congenital, up to the age of 20, cataract can be
aspirated through a relatively small incision. Aspiration is
possible because of the semi-fluidic consistency of the lens.
However when the lens material (cortex and nucleus) is hard and
cannot be aspirated routinely, a 20mm incision is made at about 3mm
from the limbus, the incision runs for 180.degree. from 9 o'clock
to 3 o'clock. There are two principal types of lens extractions
intracapsular and extracapsular (just removing lens leaving
capsule).
The intracapsular extraction consists in removing the lens within
its capsule, lens and capsule is grasped and pulled gently from the
eye. This operation has become the standard cataract procedure.
The extracapsular operation requires a rupture of the anterior
portion of the capsule first, the lens cortex and nucleus are
removed from the eye leaving the posterior capsule behind, this
kind of operation is indicated in some congenital and traumatic
cataract. Up to the age of twenty the lens is attached to the
vitreous and intracapsular extraction will surely lead to
considerable loss of vitreous and possible destruction of the
eye.
Prior to the extraction of the lens an enzyme is used, which has a
proteinoceous substance that accelerates reaction at body
temperature. It has a specifically tie effect on the zonules
(tougher at ages 20-50) and so making the removal of the lens much
easier. The lens is usually grabbed by a special lens capsule
forcep or cyro probe and pulled from the eye. Sutures are now tied
and the anterior chamber is reformed if necessary by injection of
saline. Occasionally, the cataract operation is combined with
corneal transplant, the lens and capsule is removed through the
front trephine opening of about 8mm diameter. In each instance the
pupil has to be widely dialated.
OBJECTS OF THE INVENTION
An object of the present invention is to provide an improved method
and apparatus for performing surgical procedures with respect to
the eye and other portions of the anatomy.
Another object of the present invention is to provide an improved
method and apparatus for removing objects from within the eye.
Another object of the present invention is to provide an improved
method and apparatus for the removal of blood clots from the eye in
a safe manner.
Another object of the present invention is to provide an improved
method and apparatus for opening the eye and introducing
instrumentation therein and removing the lens of the eye.
Another object of the present invention is to perform a cataract
operation in which the lens is removed and replaced with a
fluid.
Other objects and advantages of this invention will become apparent
as the disclosure proceeds.
SUMMARY OF THE INVENTION
The present invention is directed to the removal of objects from
humans and animals in vivo by surgical procedures s and
particularly those in the eye, as by first forming an opening to
gain access to the interior thereof and inserting therein removal
means having a pair of jaws movable relative to each other at
substantially one end of the removal means. Passage means are
provided in the removal means in communicating relationship to the
jaws and vented to the atmosphere to provide an exit of the removed
material therefrom. The jaws are positioned proximate to the object
for engagement therewith, which engagement is maintained by
providing a differential pressure at the removal site, either by a
venting of the passage means to the atmosphere, since the pressure
within the eye is generally greater than the atmosphere it will
force the object against the jaws and if a viscous material, will
effectuate a flow thereof into the passage means. On the other hand
if the object is of a hardened substance then a suction force may
be applied through the passage means to obtain the intimate contact
therebetween. Accordingly, the suction force may be used even on
viscous objects to increase the movement thereof.
Once the object is in place and pressural contact is maintained,
relative movement of the jaws is obtained by drive means so as to
sever any material of the object extending therebetween as the jaws
are moved relative to each other, with the removed material then
contained in the passage means. A suction force may be applied to
the passage means to remove the material therefrom.
In accordance with one aspect of the invention the jaws are adapted
to be moved from an open position permitting material to enter the
passage means, to a closed position substantially preventing
material from entering the passage means.
In accordance with another aspect of the invention the jaws may
define cutting edges such as for use in the extraction of the lens
and/or the capsule through a small (2mm) incision at the limbus
after the pupil is dilated. The incision may be made with a
specially designed two edged cutter, which produces the same
approximate incision every time. Part of the anterior capsule may
be removed so that the cutting edge can start chopping the softer
cortex and later the nucleus and the remainder of the capsule or
the cutting tip of the instrumentation may be pressed against the
anterior capsule to cut off part of it first. The instrumentation
then continues to cut away the lens and the material is removed,
which lens may be replenished with a fluid as a substitute thereof,
all in accordance with the invention
BRIEF DESCRIPTION OF THE DRAWINGS
Although the characteristic features of this invention will be
particularly pointed out in the claims, the invention itself, and
the manner in which it may be made and used, may be better
understood by referring to the following description taken in
connection with the accompanying drawings forming a part hereof,
wherein like reference numerals refer to like parts throughout the
several views and in which:
FIG. 1, is a somewhat schematic view of a human eye having the
instrumentation inserted therein for removal of a foreign object
therefrom, in accordance with the present invention;
FIG. 2, is a side view in section of the instrumentation of the
present invention;
FIG. 3, is an enlarged fragmentary side view in section of the jaws
in their open position;
FIG. 4, is an enlarged fragmentary side view in section of the jaws
in their closed position;
FIG. 5, is a sectional view along the line 5--5 of FIG. 3;
FIGS. 5A, 5B and 5C, are sectional views similar to FIG. 5,
illustrating the progressive movement of the jaws from their open
to closed position;
FIG. 5D, is a section view along the line 5D-- 5D of FIG. 4 and
illustrating the jaws in their closed position;
FIG. 6, is a side view substantially in section illustrating
another form of instrumentation in accordance with the present
invention;
FIG. 7, is an enlarged fragmentary side view in section of the jaws
illustrated in FIG. 6;
FIG. 8, is an enlarged fragmentary side view in section of the jaws
illustrated in FIG. 6 in another position;
FIG. 9, is a sectional view along the line 9--9 of FIG. 7;
FIG. 9A, is a sectional view similar to FIG. 9, showing the jaws in
a different angular position with respect to each other;
FIG. 9B, is a sectional view along the line 9B--9B of FIG. 8,
showing the jaws in another angular position relative to each
other;
FIG. 10, is an enlarged fragmentary side view in section of another
form of jaws in accordance with the present invention;
FIG. 11, is a sectional view along the line 11--11 of FIG. 10;
FIG. 12, is an enlarged fragmentary side view in section of another
form of jaws in accordance with the present invention;
FIG. 13, is a somewhat schematic view of a human eye having the
instrumentation inserted therein for removal of the lens
thereof;
FIG. 14, is an enlarged sectional view illustrating the removal
procedure for the eye lens;
FIG. 15, is a further enlarged and fragmentary side view in section
illustrating the removal process of the lens from the eye;
FIG. 16, is a view similar to FIG. 15, showing the jaws in a
different position relative to each other; and
FIG. 17, is a view similar to FIG. 15, showing the jaws in a
different position relative to each other.
PREFERRED EMBODIMENTS OF THE INVENTION
Referring now to the drawings and particularly to FIG. 1 thereof,
we see the schematic representation of an eye 10 having the various
portions thereof including a retina 12, choroid 20 and sclera 22.
The vitreous body or material 16 is contained within the retina 12
and vitreous membrane and is seen to include foreign objects 18
which may be in the form of blood clots or other impurities that
are desired to be removed from within the eye 10. The wall 25 is
intended to define any portion of the eye which when pierced will
connect the interior of the eye to the exterior and will generally
include all, or portions, of the retina 12, choroid 20 and sclera
22, or the sclera 22 and ciliary body 24.
Once the blood clot 18 is detected then the surgical procedure is
initiated, which first includes, in accordance with the teaching of
applicant's copending patent application, the forming of an
incision or opening 27 in the eye 10, to permit the insertion of
instrumentation 30 in the form of a probe therethrough to reach the
specific area to be treated. The removal process of the foreign
object as hereinafter described in greater detail, is capable of
being used not only for the eye but for various other operative
procedures and uses hereinabove disclosed, both with the eye and
other portions of the anatomy and is accordingly so described and
intended.
Once the opening 27 is formed the instrumentation 30 is inserted
therein such that the removal means 31 has its tip or distal end 32
thereof, positioned within the vitreous material 16 contained in
the eye 10 to obtain a continuous severing and removal of the blood
clot 18 therefrom.
The supporting means 35, which may be of a metallic or
thermoplastic material, as seen with respect to FIG. 1, extends
through the wall 25 and is positioned in and tightened in the
incision or opening 27 by a double mattress suture not shown. The
supporting means 35 should have the ability to rotate within the
opening 27. To provide a seal with the removal means 31 and
facilitate its sliding, the supporting means 35 should have a
minimum outside diameter to be inserted into the incision 27, and
possibly supported and rotated by a micromanipulator. Finally the
supporting means 35 should eventually provide for an increase in
volume of the vitreous cavity in order to reduce the pressure in
the eye 10, during the operation. The supporting means 25 comprises
a tubular body portion 37 which may be of circular cross-sectional
area so that it may be rotatable after it is seated through the
wall 25 of the eye 10 and includes an opening connecting the
interior of the eye to the exterior, and extending from the front
end to the rear end thereof. Sealing means 39 is provided in the
opening to prevent any of the internal fluids of the eye from
flowing out when the instrument 30 extends therethrough. The
sealing means 39 may include a sealing member 68, which may be in
the form of an O-ring to provide the sealing engagement with any
element inserted within the opening. Due to the viscosity of the
vitreous material a close tolerance at one point in the opening
between the removal means and supporting means may be sufficient to
provide the sealing engagement.
FIGS. 1 through 5D illustrate one embodiment of the present
invention in which the instrumentation 30 is illustrated in one
form thereof, in which the removal means 31 is inserted within the
eye 10 and is retained in position by the supporting means 35
extending through the opening 27 in the wall 25, in accordance with
applicant's copending invention. Once the supporting means 35 is
placed in position the removal means 31 is inserted through an
opening extending therethrough and the exact position is obtained
by the surgeon such that the distal end 32 thereof is placed
proximate to the object 18 for engagement with the jaws 36 and 38,
sometimes referred to as the inner jaw and outer jaw respectively
for convenience, of the removal means 31. the removal means 31 is
seen to include passage means 40 such that when the material is
removed from the object 18 by the pair of jaws 36 and 38, which are
in communicating relationship to the passage means 40 at
proximately one end thereof, the material may be conveniently
removed from the removal means 31 which is adapted to be inserted
in the body of a human being or other animal in vivo.
The removal means 31 includes an elongate inner assembly 42 with a
central longitudinal flow passage 44, which in this embodiment
forms the passage means 40, and extends through an elongated
tubular inner jaw member 45 having the jaw or port 36 at its
terminal end, and at its opposite end we have the inner assembly 42
adapted to be releasably connected with the lower end of a fluid
conducting tube member 46 which is in communicating relationship
with the flow passage 44 by means of supply member 48 which is
tubular and is interfitted within the conducting member 46 at one
end thereof and having a tubular extension member 50 between the
jaw member 45 and supply member 48, all of which are in
interfitting relationship to each other such that the material
removed from the object 18 may be moved by various means through
the passage means 40 and eventually removed from the removal means
31.
The removal means 31 further includes an elongate, outer assembly
52 rotatably engaged about and extending below the inner assembly
42 and includes an inner tubular jaw member 54 with a passageway 55
extending therethrough and having the jaw or port 38 at its
terminal end and at its opposite end connected to a support member
56 which in turn is connected to a tubular coupling member 58
having a gripping member 60 secured thereto as by threads 61 with
an annular wall portion 62 having an opening 63 through which the
supply member 48 extends. To facilitate the angular movement
between the jaws a gripping surface 64 which may be in the form of
knurling is provided on the exterior of the gripping member 60.
The gripping member 60 as seen in FIG. 1, may be in part engaged by
a finger of the user such that one assembly may be controlled and
moved angularly relative to the other since the inner assembly 42
and outer assembly 52 includes mounting means 65 for supporting the
respective inner and outer assemblies for relative angular
displacement relative to each other. The mounting means 65 may
include axially spaced apart support members or bushings for higher
rotatably mounted members, or as in the present embodiment it has
been found that a minimal spacing between the respective outer
diameter of the inner jaw member 45 and the passageway 55 of the
outer jaw member 54 is sufficient to permit hand movement
therebetween. The drawings are shown with a slight spacing
therebetween for convenience in illustration.
To effectuate relative movement drive means 68 is provided such as
by a collar 69 secured as by a mounting screw 70 to the supply
member 48 and which collar 69 may have an outer textured surface 71
such as by knurling such that it may be manually controlled to
facilitate its movement. As seen in FIG. 1, the fingers of the user
grasp the gripping member 60 and collar 69 and move same relative
to each other in an angular plane to obtain revolvment of the jaws
36 and 38 relative to each other.
As seen particularly in FIG. 2, the respective inner and outer
assemblies 42 and 52 are in coaxial alignment with each other and
mounting means 65 is provided to keep them relatively spaced for
the respective angular rotation or displacement of the jaws 36 and
38 relative to each other for material removal as hereafter
described. The outer assembly 52 and inner assembly 48 are
shiftable into and out of register with the respective jaws 36 and
38 upon relative rotation of the inner and outer assemblies
relative to each other such that the amount of material that is
removed may be controlled. The mounting means 65 due to the
relative slow rotation or angular displacement of the configuration
shown in FIG. 2, which if manually operated might be anywhere from
a fraction of a revolution to several thousand revolutions per
minute, although the respective jaw configuration may be used with
a power driven device as hereafter described, such that the
dimensional relationships of the inner jaw member 36 to the outer
jaw member 38 is sufficient to act as the mounting means 65 such
that a sliding fit is obtained to permit the angular rotation
therebetween.
The related angular movement between the respective inner jaw
member 45 and outer jaw member 54 is illustrated in FIGS. 3- 5D,
and as hereafter discussed this embodiment of the invention
utilizes the principle that the respective jaws 36 and 38 are
formed such that they may be moved relative to each other from an
open position as seen in FIGS. 3 and 5 to a closed position as seen
in FIGS. 4 and 5D, with the angular changing from the open to
closed position illustrated in FIGS. 5A, 5B and 5C.
It is appreciated that the actual pressure within the vitreous
material 16 is greater than that of the atmosphere and accordingly
we have a differential pressure established between the atmosphere
and the inner portion of the eye 10. This differential pressure in
accordance with the present invention may also be established by
applying an exterior force to any portion of the wall 25 of the eye
or by applying a suction force through the removal means 31 and
through the passage means 40 such as to facilitate the flow of the
removed material within the passage means 40 and thereafter from
within the removal means 31. The jaws 36 and 38 are shiftable into
and out of register with each other such that in practicing the
invention we initially insert the instrumentation 30 through an
opening formed in the supporting means 35 while the jaws are in
their closed position as seen in FIGS. 1 and 2, and maneuver same
until the distal end 32 thereof is as seen in FIG. 1 in proximity
to the object 18 which is to be partially or entirely removed
therefrom. The particular consistency of the object 18 will
generally indicate whether the respective jaws 36 and 38 define
cutting edges, and this will be dependent upon the viscosity of the
object which is being encountered.
The jaws 36 and 38, may be formed to define cutting edges for
severing or cutting of portions of the object 18 extending
therebetween, and as illustrated the outer jaw member 54 has a
front end portion 73 having a contoured exterior surface 74 to
facilitate its movement through the viscous material 16 and an
inner seat 75, shown as a conical depression for receiving the
complimentary shaped front end portion 77 of the inner jaw member
45 with its conical exterior surface 78 which mates with the seat
75 for coaxial alignment therewith.
The outer jaw member 54 has therein the outer jaw defining opening
or port 38 which is in communicating relationship to the flow
passageway 55 and defines an elongated or oval shaped surface 80
having an outer edge 81, and inner edge 82 preferably sharp to
define a cutting edge with the surface 80 inclined upwardly towards
the cutting edge 82 from the outer edge 81. The forward extremity
of the outer edge 81 or surface 80 should be above the axis of the
outer jaw member 54, and preferably a distance represented by the
dimension X which is at least equal to the wall thickness of the
outer jaw member 54, so as to prevent rotation of tissue or other
substances pulled by the penetrating point or cutting edges.
The inner jaw member 45 is similarly formed with the inner jaw
defining an opening or port 36 which is in communicating
relationship to the flow passage 44 and defines an elongated or
oval shaped surface 85 having an inner edge 86 with a spaced apart
outer edge 87 preferably sharp to define a cutting edge with the
surface 85 tapering upwardly from inner edge 86 to the outer edge
87.
To obtain the removal of the object 18 as contained in the passage
means 40 control means 90 is utilized and is connected to the
removal means 31 by the conducting member 46. To obtain a
differential pressure at the removal site or passage means a
suction force may be applied through the conducting member 46 which
is in communicating relationship to the passage means 40 and the
amount of force may be controlled by knob 91 such that the removed
material is sucked into the control or other means and disposed of.
A fluid supply control knob 92 is illustrated for use with the
embodiment of the invention in which a fluid supply is provided to
form a suspension with the removed material to facilitate its
removal. If fluid is desired in accordance with the embodiment
illustrated in FIGS. 1-5D it may intermittently be supplied through
the passage means 40 when the suction is not being applied.
OPERATION OF APPARATUS IN FIGS. 1-5D
The instrumentation 30 is adaptable to be used for removing objects
18 having various hardness characteristics, which if viscous, by
flowing between the jaws 36 and 38 and then separating the mass of
the object 18 from itself or the environ it is in, or by actually
cutting slices thereof for hardened substances.
In accordance with one aspect as illustrated in FIG. 1, the object
18 may be of a viscous material, or having a viscosity which is
capable due to the differential pressure either existing or to be
established to obtain a flow thereof into the passage means 40.
Assuming this to be the case for viscous materials, the removal
means 31 is positioned proximately to the object 18 and the jaws 36
and 38 are then moved initially to their open position as seen in
FIGS. 3 and 5 by angular rotation of the drive means 68 as
illustrated in FIG. 1, from their closed to open position, this
occurring after positioning the removal means 31 proximate to the
object for engagement with the jaws 36 and 38. Either before or
upon the jaws reaching their open position we have due either to
the greater pressure within the eye 10, than in the passage means
40 which is in communicating relationship with the atmosphere, a
differential pressure on the object 18 which is sufficient to
obtain a flow thereof within the passage means 40 when the jaws are
in their open position such that there is a partial if not entire
movement of the object into the passage means 40. Once all the
material of the object 18 is in the passage means 40 or the
movement of the material has stopped (due to insufficient
differential pressure or increased resistance to motion) then we
are affecting relative movement of the jaws 36 and 38 from their
open moved relative to each other resulting in all or a portion of
the object remaining within the passage means 40 when the jaws are
in their closed position as seen in FIGS. 4 and 5D. At this
instance the entire instrumentation might be removed if the amount
of material contained in the passage means 40 is adequate, or the
cycle of revolving the jaws from the open to closed position may be
repeated as often as required, the entrapped material by adjusting
the suction knob 91 may remove the material from the passage means
40.
The maintaining of a differential pressure between the passage
means 40 and essentially the environs of the object 18 is done to
retain them in substantially fixed position to each other during
the relative movement of the jaws 36 and 38. The force may be
transmitted to the site of removal in the direction of arrow 93 by
proper coupling of the conducting member 46 to the control means 90
which is shown to include the knob 91 for controlling suction and
another knob 92 for controlling fluid. The fluid control knob 92 is
illustrated as being a part of the control means 90 although it is
not contemplated for use necessarily with the embodiment
illustrated in FIGS. 1-5D but as hereafter explained is used with
other embodiments of the invention.
The suction means which gives us the suction force is selected
depending upon the viscosity and type of material from which the
object is made so that we are assured of the positioning of the
object 18 in abuting relationship to the distal end 32 of the
removal means 31. The suction force may be used with a viscous
object in that by applying same the removed material continues to
be removed out from within the passage means 40 into the control
means 90 so that the object contained within the passage means 40
is continuously moved therealong and does not clog or block the
jaws in their open position.
When the object 18 is of a hardened material or substance such that
a flow thereof is not anticipated, or the rate of flow is not
sufficient, then it is desired that sharp edges which act as
cutting edges 82 and 87 of the outer jaw 38 and inner jaw 36
respectively be provided so as to obtain by continued rotation of
the inner and outer assemblies 42 and 52 respectively by the drive
means 68, a progressively contacting, cutting and removal of
material of the object 18 as the jaws are repetitively closed. In
this instance the inherent differential pressure may be such as to
obtain a positionment of the object 18 abutting one or both of the
jaws 36 and 38 but as the cutting continues it is preferable that a
suction force be relied on to retain the object 18 and removal
means 31 in fixed position to each other. Thus, if the object
illustrated in FIG. 1, is of a hard material and essentially the
removal means 31 is positioned in its closed position adjacent the
object 18 and as discussed before the cutting edges 82 and 87 are
in communicating relationship with the passage means 40 at
proximately one end thereof, are then moved from their initially
closed position to an open position to begin the removal process.
By applying an ample suction force through the passage means 40 to
the object 18 it is retained in continuous contact with one of the
jaws 36 and 38 and by affecting relative movement of the cutting
edges 82 and 87 from their open to closed position they can
progressively contact, cut and thereby remove a layer of material
from the object 18. The configuration of the jaws as well as the
cutting edges as to both size and configuration will vary with
respect to the size of object to be removed and its hardness
characteristics.
The suction force from the control means 90 may be on continuously
to both remove collected material from within the passage means 40
and always assure a force in the direction of arrow 93 to pull it
into and retain it against the jaws when they are in their open
position. The thickness of each successive layer removed may be
controlled by the spaced apart dimensional relationship of the
cutting edges.
EMBODIMENT AS ILLUSTRATED IN FIGS. 6-9B
FIGS. 6-9B illustrate another embodiment of the present invention
in which the instrumentation 30a has drive means 68a that may be
operated by an electric motor 95a having power leads 96a connected
thereto, which instrumentation is utilized when sufficient amounts
of the object are to be removed and where the slower manual type of
operation is not preferred. This embodiment of the invention
contains jaws 36a and 38a which are of a different form than those
previously illustrated and as will be illustrated with respect to
FIGS. 10-12, but it should be pointed out that same are
interchangeable with the jaws in the embodiment illustrated in
FIGS. 1-5D and likewise the jaws of those illustrated figures may
be used with the instrumentation 30a illustrated in FIG. 6.
It has been found desirable for certain removal procedures to
provide a treatment fluid to the proximate location of the object
and which treatment fluid is utilized for forming a suspension of
the removed material which is then capable of being removed by a
suction or other force from the removal means 31a leaving the
worksite continually free of the removed material and likewise
removing same from the removal means. Accordingly, the removal
means 31a includes an inner assembly 42a and an elongate outer
assembly 52a with a central longitudinal flow passage 55a which
essentially forms the passage means 40a. The outer assembly 52a
includes a longitudinally extending jaw member 54a defining a jaw
38a or port at the distal end 32a thereof, which jaw member 54a is
supported at its substantially opposite end by a support member 56a
having a radial flange 98a for engagement with the support member
of the outer assembly 52a. The support member 56a is removably
secured at the front thereof to a threaded portion 99a of housing
member 100a which has a radial flange 101a which abuts up against
the front face 102a of the support member 56a and having a tubular
wall portion 104a defining a passageway 107a which has a downwardly
extending tip 104a for sealingly engaging the outer diameter of the
outer jaw member 54a after the lateral port holes 106a, which may
be provided to extend through the wall of the outer jaw member 54a.
At the opposite end of the housing member 100a we have a neck
portion 108a extending therefrom with a plurality circumferentially
spaced apart lateral ports 110a which communicate with the
passageway 107a extending between the enclosed outer portion of the
outer jaw member 54a and tubular wall portion 104a for providing a
fluid flow channel to the front lateral ports 106a to obtain a flow
in the initial direction of arrow 111a and in the subsequent
direction of arrow 112a, such that a fluid is supplied into the
passage means 40a between the inner assembly 42a and outer assembly
52a.
The inner assembly 42a has an inner jaw member 45a which may be of
a rod like shape with an enlarged jaw head 115a at one end thereof
for defining the jaw 36a with a port extending therethrough between
the parallel spaced apart faces 116a thereof, with cutting edges
87a extending along four edges as seen in FIGS. 7 and 8, and
hereafter explained in greater detail. The inner jaw member 45a
extends from a fastener 118a and may be integrally formed therewith
such that the extension member 50a to which the fastener is secured
is directly coupled to the power drive means 68a, having power
cables 96a extending therefrom, as by threaded stud 120a. The
casing of the drive means 68a has extending therefrom mounting
means 65a in the form of a support arm 122a with a threaded portion
adapted to receive the connecting member 124a which is connected to
the tubular coupling member 58a which in turn is secured to the
support member 56a.
To provide the requisite amount of treatment fluid from the control
means a fluid conduit 125a is provided and may be coupled to a
fluid supply hose not shown, and at one end thereof extends
exteriorally of the removal means 31a from the connecting member
124a such that fluid in the direction of arrow 111a may flow
therein and which forward portion of fluid conduit 125a extends
within support member 56a in communicating relationship at its
other end with a fluid supply port 126a within the support member
56a which opens into the spacing between the housing member 100a
and the support member 56a so as to permit the flow into the inlet
ports 110a. In like manner the removal means 31a for introducing
the suction force in the direction of arrow 105a to remove the
suspension that will be formed in the passage means 40a includes a
suction conduit 128a extending exteriorally of and partially
through the connecting member 124a at one end thereof and at its
opposite end coupled to the support member 56a and in communicating
relationship by the suction port 129a to the passage means 40a.
In this manner once the instrumentation 30a is positioned in place,
in a similar manner as illustrated with respect to FIG. 1, the
respective jaws 36a and 38a are then adapted to be moved angularly
relative to each other as seen particularly in FIGS. 9, 9A and 9B,
so that the removal of all or part of the object can be properly
accomplished. The inner jaw member 36a is seen to include an
enlarged head portion 115a having substantially parallel faces 116a
with a transversely extending opening between the faces 116a
forming the jaw or port therein and having spaced apart
substantially parallel surfaces 85a terminating in cutting edges
87a on each side thereof so that it is possible to slice away or
cut particles of the object as they are moved relative to each
other. The end of the outer jaw 38a has a conical pointed seat 75a
which is adapted to snugly receive the similarly contoured shape in
the jaw 36a with the outer assembly 52a having a rounded front end
74a to assist its movement through the viscous, or other cellular
material, until being positioned proximate to the object from which
the material is to be removed.
The jaws 36a and 38a, may be formed to define sharp edges which act
as cutting edges for severing or cutting of portions of the object
extending therebetween, and as illustrated the outer jaw member 54a
has a front end portion 73a having a contoured exterior surface 74a
to facilitate its movement through the viscous material and an
inner seat 75a, shown as a conical depression for receiving the
complimentary shaped front end portion 77a of the inner jaw member
45a with its conical exterior surface 78a which mates with the seat
75a for coaxial alignment therewith.
The outer jaw member 54a has therein the outer jaw defining opening
or port 38a which is in communicating relationship to the
passageway 55a and an oblong, elongated or oval shaped surface 80a
having an outer edge 81a, and inner edge 82a preferably sharp to
define a cutting edge, with the surface 80a inclined upwardly
towards the cutting edge 82a from the outer edge 81a. The inner
extremity of the outer member 82a or surface 80a should be above
the axis of the outer jaw member 54a, and preferably a distance
represented by the dimension X which is at least equal to the wall
thickness of the outer jaw member 54a, so as to prevent rotation of
tissue or other substances pulled by the penetrating point or
cutting edges.
The inner jaw member 45a is similarly formed with the inner jaw
defining an opening or port 36a which is in communicating
relationship to the flow passage 55a and defines an oblong or
elongated shaped surface 85a having parallel spaced apart inner
edges 86a with spaced apart outer edges 87a preferably sharp to
define a cutting edge with the surface 85a tapering upwardly from
inner edge 86a to the outer edge 87a.
In order to form the suspension of removed material and fluid,
which may be saline, the fluid may be supplied directly to the
chamber means 40a as illustrated in FIGS. 6 and 7, or directly to
the exterior of the removal means proximate to the jaws 36a and
38a, or directly to the passage means 40a and the removal site
simultaneously. If it is desired that the fluid be supplied
exteriorally of the removal means 31a then the lateral port holes
106a are adapted to extend through the tubular wall portion 104a as
seen in FIG. 8, and if simultaneous supply of fluid is desired
exteriorly and interiorly of the passage means 40a then the port
holes 106a may be provided as in FIGS. 7 and 8.
OPERATION OF APPARATUS IN FIGS. 6-9B
In using the instrumentation 30a illustrated in FIGS. 6-9B it will
be appreciated that first the removal means 31a is inserted such
that the jaws 36a and 38a are positioned adjacent the object such
that a portion thereof extends between the jaws, and by affecting
relative movement of the jaws it is possible to sever any portion
of the object extending therebetween as they are moved relative to
each other. The removed material of the object is contained within
the removal means 31a by entering the passage means 40a. By
maintaining a differential pressure it is possible to maintain the
object in fixed relationship to the jaws 36a and 38a such that as
the cutting is obtained, the object, since it might be situated in
a viscous material, is not forced away but is continuously engaged
by at least one of the cutting edges 82a and 87a to progressively
remove portions thereof.
The apparatus illustrated in FIGS. 6-9B is preferably used with a
hardened object so that cutting may be facilitated by a static
force being applied against the object towards the jaws to retain
same in contact therewith. In this embodiment the differential
pressure is obtained by using a suction force provided through the
suction conduit 128a, suction port 129a which is in communicating
relationship to the passage means 40a and in turn the jaws 36a and
38a, so that the object is continuously pulled between the jaws.
Since the device illustrated, as seen in FIGS. 9-9B the inner jaw
member 36a will continuously move through respective relative
positions in a given cycle, and in the position shown in FIG. 9B
has the cutting edge 87a in a parallel plane and adjacent the
cutting edge 82a of the outer assembly 52a such that the material
extending therebetween would be separated and removed as the
angular rotation illustrated in FIGS. 9 and 9A occurs. It is also
possible by regulating the relative rate of movement between the
jaws 36a and 38a per a given cycle, as well as the differential
pressure by regulating the control means illustrated in FIG. 1,
that the amount of material removed from the object and into the
passage means 40a per given cycle may be properly controlled. The
cycle, which is one complete revolution of the jaws relative to
each other, is then repeated as many times as required until the
amount of the object, which may be in its entirety, is removed from
the body. In this manner by controlling the differential pressure
it is possible to obtain a positionment of the object abutting the
jaws 36a and 38a so as to progressively contact, cut and remove the
material from the object as the jaws are moved relative to each
other.
By properly controlling the dimensional relationship between the
edge 82a of the outer jaw 38a to the cutting edge 87a of the inner
jaw 36a it is possible to control the amount of removal of the
material during the relative movement of the jaw members. One way
of specifically doing same is that by coaxially supporting the jaws
36a and 38a to provide a selected configuration of a given internal
cross-sectional area for one of the cutting edges 82a and providing
the other cutting edge 87a with a similar configuration but of an
enlarged cross-sectional area such that the thickness of the layer
of material removed is equal to the difference between the
respective cross-sectional areas if both are circular or the
lateral spacing between the cutting edges.
The control means is adapted to continuously supply a fluid to the
removal means 31a to assist in the removal operation of the object.
The fluid which may be in the form of a liquid collapse be provided
for various reasons, one of which is to replenish the removed
material from the object as well as any vitreous material lost in
the procedure in order to maintain the internal pressure of the eye
to prevent co-lapse of the retina and related portions. The eye has
an internal pressure and unless the removed material is replenished
there is a tendency for the wall of the eye to collapse which could
severely complicate the surgical procedure. Another important
reason for supplying the treatment fluid is to form a suspension
with the removed particles so that they are easily removed by
suction from the removal means 31a.
Particularly noting FIG. 8, I illustrate an aspect of the invention
in which if desired the liquid may be supplied exteriorally of the
removal means 31a and proximate to the object by having the lateral
ports 106a extending through the housing member wall 104a such that
the treatment liquid and the suction is applied proximate to the
object at spaced apart locations between which at least a section
of the removal means 31a is interposed so that the suction induces
the treatment liquid to mix with the removed material for ensuring
the continuous mixing and the removal of the material. In addition
the motion of the fluid will carry the material between the
jaws.
In operation the operator after positioning the instrumentation 30a
in position will adjust the fluid control knob on the control means
and the fluid from a supply will enter the fluid conduit 125a in
the direction of arrow 111a and then by means of fluid supply port
126a and lateral port holes 106a will reach the interior of passage
means 40a, the exterior of the removal means 31a adjacent the jaws
36a and 38a, or as explained above both the interior and exterior.
Since the jaws 36a and 38a in FIGS. 6-9B are essentially always
open the suction force is simultaneously maintained such that a
flow pattern is established into the passage means 40a in the
direction of arrow 111a and thereafter out in the direction of
arrow 112a through the suction conduit 128a. Simultaneously with
the fluid being supplied and suction force applied the drive means
68a is operational effecting rotation of the inner jaw 36a with the
resulting cutting of the object. The motor 95a of drive means 68a
may be of a variable speed type which is adjusted by the user
depending on the quantity and type of object being removed. After
removing the desired amount the drive means 95a is stopped with the
fluid supply and suction being discontinued by adjusting the
control means. The removal means 31a is then retracted from within
the body and the opening closed.
OTHER JAW CONSTRUCTIONS
FIGS. 10, 11 and 12 illustrate other alternate jaw construction
forms of jaw members that may be used for removal of the material
as desired. FIGS. 10 and 11, illustrate an inner jaw member 36b and
outer jaw member 38b with the latter having its outer assembly 52b
of similar construction to that illustrated in FIGS. 6-9B with the
outer jaw member 54b having a front end portion 73b with an inner
seat 75b, shown as a conical depression for receiving the
complimentary shaped front end portion 77b of the inner jaw member
45b with its conical frontal exterior surface 78b which mates with
seat 75b for coaxial alignment therewith. The inner jaw 36b has its
inner jaw member 45b formed having an outwardly radially extending
helical groove 130b running essentially the length thereof and
having a conical tip 78b at one end thereof such that the cutting
edge surface 87b thereof which forms the jaw 36b is seated within
the outer assembly 52b which has the jaw 38b defining an opening so
as to communicate with the passage means 40b, and as they are moved
relative to each other the helical groove 130b continues to remove
the object which moves along the passage means 40b permitting the
continuous removal of both the material and the liquid. The liquid
is supplied by the flow passage 107b which extends between the
housing member 100b and outer assembly 52b with the lateral ports
106b in communicating relationship with the passage means 40b as
indicated by the arrow 112b such that the flow of liquid and
removed material mixes therein and due to the angular rotation of
the inner assembly 42b the removal thereafter occurs. The
mechanical structure of the drive means for the tools illustrated
in FIGS. 10 and 11 may be of the design illustrated in FIG. 2 and
or FIG. 6.
FIG. 12, illustrates another form of the jaws 36c and 38c in which
the inner assembly 42c includes a jaw member 45c having a
longitudinally extending shaft 132c with a chisel point 133c at one
end thereof and having circumferentially wound about the exterior
surface of the shaft 132c the helical defining groove 130c such
that it acts as a pumping means for removal of the material. The
outer jaw 38c defining a lateral opening therein with the outer
assembly 52c having front end portion 73c with at least a flat
interior surface or seat 75c such that the chisel edge portion 87c
abuts it and as the angular movement is obtained removal of the
object occurs. In like manner fluid may be pumped in through the
passage means 40c and by the mixture forming and the pumping action
obtained by the helical grooves, the material is continuously
removed from the removal means 31c. This helical mechanism may
provide a controlled method of pumping materials with low viscosity
(natural or synthetic vitreous) into the body. To prevent the
collapse of the eye this mechanism may be used in that it can
supply and remove vitreous at a controlled rate.
CATARACT REMOVAL PROCEDURE
Before discussing in detail the use of the present invention for
lens removal it might be best to first review in greater detail
certain known facts to date. A cataract is a lens opacity and to
better understand its implications we have to learn more about the
lens.
Anatomy of the Lens: The lens is a biconvex almost completely
transparent structure, about 5mm thick and 9mm in diameter. It is
suspended behind the iris by the zonular fibers, which connect it
with the ciliary body. The lens is incapsulated in the lens
capsule, which is a thin transparent membrane, of which the front
part is called the anterior capsule, and the back part is called
the posterior capsule. Behind the posterior capsule is the vitreous
membrane. The posterior capsule and the vitreous membrane are not
easily separable in a young person. The lens is composed of a
central region or nucleus and the peripheral portion is called the
cortex, the nucleus is harder than the cortex.
Function of the Lens: The function of the lens is to focus light
rays upon the retina. In order to focus light from a distant
object, the ciliary muscle relaxes, tightening the zonular fibers
and reducing the thickness of the lens to its minimal dimension, in
this position parallel rays are focused on the retina. In order to
focus light rays from a near object the ciliary muscle releases the
tension on the zonules fibers, the lens shapes in a more spherical
body increasing its refractive power so that the focusing on the
retina is again obtained.
Composition of the Lens: The lens consists of about 65 percent
water and about 35 percent protein (with some trace of
minerals).
Cataract: A cataract is a lens opacity. Cataracts vary markedly in
degree of opacity, size and location. Cataracts may be due to a
variety of causes but are usually associated with ageing. Most
cataracts are not visible to the casual observer until they become
dense enough (mature) to cause blindness.
We have several types of cataracts:
1. A senile cataract is the most common type associated with
ageing. After surgery the visual (acuity) improves in ever 90
percent of the cases, the remainder either have pre-existing
retinal damage or develop post-surgical complications.
2. Congenital Cataract: They occasionally occur as a consequence of
maternal rubella during the first 3 months of pregnancy. These
cataracts may cause significant loss of vision, in such event lens
extraction by aspiration is done on one eye at the age of 6 months.
Surgery on the other eye is performed after the age of two (retina
detachment may occur after several months or years).
3. Traumatic Cataract: Most commonly due to a foreign body striking
the lens after passing through the outer structure of the eye, such
a cataract may also be caused by over-exposure to heat, X-ray,
radioactive material and ultraviolet exposure.
4. Cataract may also occur as a secondary effect of intraocular or
systemic diseases, as well as a result of some drugs.
Cataract Surgery: In a cataract operation the lens is removed from
the eye. At the present time there are two principal types of lens
extraction, they are:
1. Intracapsular when the lens is removed together with the
capsule, this is a standardized procedure. When the posterior
capsule is not attached to the vitreous membrane.
2. Extracapsular extraction is used in congenital and some
traumatic cataracts. As we know the posterior capsule may be
attached to the membrane and cannot be extracted without rupturing
the vitreous membrane, with serious consequences (vitreous loss,
vitreous hemorrhage, retina detachment, etc). For this operation,
the anterior capsule is first ruptured and removed then the cortex
and nucleus, leaving the posterior capsule behind.
At the present time a solution of chymotrypsin is injected under
the iris. This substance has a lytic (loosening) action on the
zonules making easier the removal of the lens. To perform the
actual operation of extracting the cataractous lens a conjunctival
incision is made 3mm from the limbus on an arc about 20mm long,
extending from 9 to 3 o'clock, at 12 o'clock a peripheral or full
iredectomy is then performed and the lens and capsule is grasped
and gently removed from the eye. The conjunctival flap is
reapproximated with the sutures. The anterior chamber is then
reformed by injection of soline. If the procedure is complicated by
vitreous loss, the chances of post operative retinal detachment,
glaucoma, and uveitis are increased.
Post operative care consists in having the eye bandaged for about 2
weeks, the patient has to move slowly and avoid any strain for
about 4 weeks. The material removed from the eye at the present
time by the conventional intracapsular cataract operation can now
be extracted through a 1 to 2mm incision.
CATARACT PROCEDURE OF PRESENT INVENTION
By using the new and novel method of the present invention, in
accordance with one aspect thereof an intracapsular procedure can
be performed, the incision can be made at any convenient place, no
iredectomy is necessary for this operation. The instrument of the
present invention is now inserted into the eye through the small
incision with the opening at its front, gently pressing against the
capsule. By rotating the internal cutter jaws, material from the
capsule and later from the lens is being chopped away from the mass
to be removed, by carefully orienting the front of the tip it is
possible to reach any remaining portion of the capsule or lens.
When only suction is needed the internal cutter jaw is stopped in
such a position not to block the front opening. It is important to
emphasize that only one piece (becoming smaller and smaller) of
capsule and one piece of lens is left in the eye during the
operation. The operation continues until the whole lens is
extracted. Extraction of the posterior capsule is optional.
Irrigation of the anterior parts of the eye is necessary to
maintain the pressure in the eye above the atmospheric pressure to
prevent its collapsing and to facilitate movement of the chopped
material in liquid suspension from the eye. After the lens and the
desired amount of capsule is removed, the instrument is extracted
and the incision closed with a single suture as with an ultrasonic
or other weld. Post operative care by use of the present invention
is greatly reduced due to the single stitch in place of many and
the relatively short incision (about 1/10 to 1/15 of the regular
one). The possibility of infection and retina detachment is also
reduced due to the small incision and maintained pressure in the
eye at all times. The instrument used to perform such a transfusion
of relatively dense, high viscosity liquid, may be shown in FIG.
12.
In accordance with another aspect of the invention an extracapsular
can be performed in which a different procedure is used so that the
capsule should remain in the eye. For such a case a 20mm incision
on the outer wall of the eye is needed to be able to reach the
anterior capsule with the instrument. A 1-2mm incision is now made
on the anterior capsule through which the instrument is now
inserted. The material to be removed is now the lens alone which is
being chopped by the instrument, parts of the lens are now removed
as previously described until the entire lens is extracted. By
keeping the liquid pressure in the capsule the lens will
practically float in it and will be kept adjacent to the cutting
instrument by the force of the moving liquid as well as by the
differential pressure which generates this flow. As described
previously the remainder of the lens in the capsule is always
confined in one piece which is getting smaller and smaller during
the operation until the last piece is being removed. After the
operation the instrument is extracted, or while in position the
capsule may be refilled with a specific natural or artificial
liquid to replace the lens, the instrument shown on FIG. 12, can be
used to inject or drive into the capsule liquid of high viscosity,
the capsule now has to be closed by a suture or by an ultrasonic or
other weld. The outer incision is also closed by sutures or weld,
the anterior chamber reformed and if everything went as expected no
glasses or contact lenses will be needed.
FIGS. 13-17, illustrate the use of the apparatus generally seen in
FIGS. 6-9B for cataract surgery, within the eye 10d, and in which
we have the removal of an object of high viscosity or hardened
material requiring a continuous cutting and removal as described.
The use of the invention takes into consideration the desirability
of maintaining the pressure constantly above the atmosphere within
the eye chamber or capsule such that it does not collapse as the
lens is gradually removed during the operation. It is possible to
maintain the pressure by retaining the volume of material within
the eye chamber or capsule constant such that we have an equal
volume of liquid therein. The incoming liquid has to replace the
liquid being lost through the incision and the material being
removed in subsequent removal steps. The operation includes forming
an incision, if desired using the supporting means illustrated in
FIG. 1 in conjunction with a double mattress suture which is used
to tighten the eye wall around the tip to maintain the pressure in
the eye and prevent appreciable amounts of liquid looses through
the incision with consequent increase in flow into and through the
eye in which case the streaming of the liquid may cause damage to
the single layer of cells of the inner surface of the cornea
forming the endothelium. By this surgical procedure it is possible
to maintain the lens material to be removed by suction and force of
moving liquid in contact with the removal means 31d between each
successive cut. Once the instrumentation 30d is embedded within the
lens material 18d, and as seen in FIGS. 15, 16 and 17 by
utilization of the suction force we have a portion of the lens 18d
extending between the jaws 36d and 38d and within the opening of
the inner jaw 36d. Once the object 18d is positioned as seen in
FIG. 15 and the angular movement between the respective jaw members
36d and 38d is obtained we have a continued slicing of particles
and removal thereof. As indicated above a fluid is used and
accordingly we may have the exterior port holes 106d as indicated
by arrow 112d providing a liquid medium within the eye chamber or
capsule such that it assists in the formation of a liquid
suspension which is easily removable by suction means transmitted
to the removal means 31d as hereinabove described.
For the extracapsular procedure, once the opening is formed in the
anterior capsule and the instrument is inserted, a differential
pressure is applied as by combined suction and pressure of incoming
liquid, the instrumentation 30d is moved forwardly into the lens
such that the distal end 32d thereof and particularly the jaws 36d
and 38d come in contact with the material and when the static
pressure in the capsule is such to force liquid in between the lens
and the capsule this facilitates limited motion of the lens in the
capsule even at the beginning of the operation such that the lens
almost somewhat floats and is separated from the capsule. The
vacuum in the passage means 40d causes the lens material 18d to
remain adjacent to the cutting edges 82d and 87d to shear the lens
mass when exposing it to the rotating cutting edges such that
consequentially the edges cut a slice of the mass of the lens 18d
and continues to remove same into the passage means 40d. As this
operation continues it can easily be appreciated that the entire
mass can be removed.
An important aspect of the present invention is the fact that it is
possible to remove the lens alone without actually engaging or
damaging, except for a small minimal opening formed of perhaps 2
millimeters, the anterior capsule. By being able to remove the
inner core without physically damaging the exterior capsule it
becomes possible to replace the lens material with a liquid
material that would permit the same transparency such that it would
not be necessary to remove the actual capsule itself. This is most
important in that if the remaining portions are kept in tact and
the zonules has remained in functioning condition then by replacing
the lens material with another type of material a person can
continue to use same as he had before without having to resort to
contact lenses and this is substantially important Accordingly,
supply means 135d, which may be represented by FIG. 12, may be
inserted into the anterior capsule and by conventional control
means associated therewith (not shown) replenish the removed lens
at a speed equal to the removal rate to thereby obtain a complete
transfusion of the lens with a liquid.
CONCLUSION
The above discussion clearly indicates that the present invention
may be used for the removal of a variety of objects from humans or
animals in vivo as desired, and particularly is related to the
areas associated with the eye in view of the unique characteristics
and problems associated such as that the pressure should be
accounted for and retained. This differential of pressure between
the exterior and interior of the eye also lends itself to assist in
the actual process as well as create the unique problems associated
therewith. Accordingly, the instrumentation is adaptable to be used
herein by those skilled in the field for removal of select objects
as desired and at rates that are appropriate for the portion
involved. This permits the insertion of the instrumentation, its
positioning and remaining in a given region until removed from the
opening, which opening is then closed in a conventional manner.
In particular with respect to cataract removal we have the unique
ability if desired to permit the lens capsule to remain in tact
while removing the lens therefrom. It should be pointed out that
this ability substantially lessens the dangers associated therewith
and particularly increases the comforts to the individual who is
operated on in this procedure.
Although illustrative embodiments of the invention have been
described in detail herein with reference to the accompanying
drawing, it is to be understood that the invention is not limited
to those precise embodiments, and that various changes and
modifications may be effected therein without departing from the
scope or spirit of the invention, except as defined in the appended
claims.
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