U.S. patent number 3,818,913 [Application Number 05/285,002] was granted by the patent office on 1974-06-25 for surgical apparatus for removal of tissue.
Invention is credited to Mark Wallach.
United States Patent |
3,818,913 |
Wallach |
June 25, 1974 |
SURGICAL APPARATUS FOR REMOVAL OF TISSUE
Abstract
Defective or unwanted tissue is removed such as from the lens of
an eye directing a pulsating high velocity liquid jet onto the
defecting tissue to disintegrate the tissue and sucking the liquid
entraining the disintegrated tissue from the area adjacent the
tissue by a suction conduit. Upon clogging of the suction conduit
and a corresponding change in pressure, the suction action is
momentarily reversed to eject the clogging tissue, which avoids
excessive suction build-up. The liquid is advantageously isotonic
and slightly alkaline and one or more jets converging to a
restricted area may be employed, the jets being ejected from a hand
manipulated nozzle.
Inventors: |
Wallach; Mark (New York,
NY) |
Family
ID: |
23092330 |
Appl.
No.: |
05/285,002 |
Filed: |
August 30, 1972 |
Current U.S.
Class: |
606/169; 606/166;
604/28; 606/170 |
Current CPC
Class: |
A61F
9/00736 (20130101) |
Current International
Class: |
A61F
9/007 (20060101); A61b 017/32 (); A61m
001/00 () |
Field of
Search: |
;128/276,278,297,303,305 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: Miskin; Howard C.
Claims
I claim:
1. An apparatus for disintegrating and removing animal tissue from
a preselected enclosed area comprising a hand manipulatable first
tube having a distally disposed outlet port, a liquid pulsating
pump having an inlet and an outlet, a source of liquid connected to
said pump inlet, means including a flexible conduit connecting said
first tube to said pump outlet, a suction conduit including an
outlet port disposed proximate said first tube outlet port, a
source of suction, and means including a flexible conduit
connecting said suction conduit to said source of suction, said
pump providing a stream of pulsating liquid through said first tube
outlet port at a frequency between 1 to 333 cycles per second, at a
pressure above atmospheric pressure of about 15 to about 200 p s i
and having a velocity of between 50 and 500 feet per second.
2. The apparatus of claim 1 including means for varying said pulse
frequency of said pulsating pump.
3. The apparatus of claim 1 including means for varying the outlet
pressure of said pulsating pump.
4. The apparatus of claim 1 wherein said first tube and said
suction conduit are parallel and joined side by side, said suction
conduit having an inlet port adjacent the distal end of said first
tube, the axis of said outlet port lying in a plane generally
perpendicular to the longitudinal axis of said first tube and
between the distal end of said first tube and said inlet port of
said suction conduit.
5. The apparatus of claim 1 wherein said first tube is
longitudinally extending and of annular transverse cross section
and having its leading annular end closed and provided with a
plurality of outlet passages whose longitudinal axes converge to a
common point, the axial portion of said tube defining said suction
conduit.
6. The apparatus of claim 1 wherein said first tube and suction
conduit are defined by coaxial inner and outer tubes
respectively.
7. The apparatus claim 1 wherein said first tube and suction
conduit are arranged side by side, said suction conduit is provided
with a longitudinally extending side port, and said first tube
includes an outlet port disposed proximally of said suction side
port.
8. The apparatus of claim 1 including means responsive to a drop in
pressure in said suction conduit below a predetermined level for
reversing the direction of flow in said suction conduit.
9. Apparatus of claim 8 wherein said reversing means returns to
normal suction in said suction conduit in response to the suction
pressure returning to said predetermined level.
10. Apparatus of claim 1 wherein said nozzle has an outlet port of
from about 0.001 inch to about 0.010 inch.
11. A nozzle for use with apparatus for disintegrating and removing
animal tissue by liquid jets comprising a tubular member having
inner and outer coaxial passageways, the outer passageway having a
leading annular end closed and provided with a plurality of outlet
ports whose longitudinal axes converge to a common point, first
means on said nozzle adapted to be coupled to a source of
pressurized fluid which interconnects to said outer passageway so
that said fluid exits said nozzle through said ports, second means
mounted on said nozzle interconnected to said inner passageway and
adapted to be coupled to a suction source, whereby a plurality of
fluid jets from said ports converge on said point located on the
tissue to disintegrate it, and disintegrated portions of tissue and
liquid are sucked into and withdrawn through the inner
passageway.
12. The method of disintegrating and removing animal tissue from a
preselected enclosed area with a nozzle having a working tip
comprising the steps of:
a. generating a stream of liquid;
b. forming the stream into pulses within a frequency of about 1/4
to about 333 cycles per second;
c. adjusting the rate of velocity of said stream of liquid from
about 50 to about 500 feet per second;
d. simultaneously directing the pulsating liquid jet onto a
confined area of said tissue to disintegrate said tissue into small
particles to form a suspension of particles in said liquid and
sucking the suspension of particles of said tissue from said
preselected area.
13. The method claim 12 further including providing the liquid
stream leaving said nozzle tip to have a cross sectional area at
the point of impingement on said tissue to not exceeding 0.0000785
square inch.
14. The method of claim 12 including the step of reversing said
suction responsive to the clogging of the flow of said sucked
liquid by relatively large tissue fragments.
15. The method of claim 12 including the step of providing said
liquid to be isotonic.
16. The method of claim 12 including the step of providing said
liquid to be alkaline.
Description
BACKGROUND OF THE INVENTION
The present invention relates generally to improvements in surgical
procedures and apparatus and it relates more particularly to an
improved method and apparatus for the disintegration and removal of
selected sections of animal tissue.
There are numerous surgical procedures which require the removal of
selected portions of tissue of an extremely delicate nature with a
minimum or no interference with or damage to the surrounding or
otherwise healthy tissue. Such procedures are frequently required
in surgical operations connected with the eye, such as in the
removal of cataracts and similar surgical procedures. The methods
and equipment heretofore employed and proposed are awkward and
highly time consuming in their use, require an extremely high
degree of skill, are often accompanied by damage to adjoining
healthy tissue and frequent failure and otherwise leave much to be
desired.
Instruments having a vibrating element or emitting pulses have been
used for cutting of material for some time for various uses. For
example, a vibrating element using a slurry for cutting has been
used for dental work and industrial applications with limited
success in limited work areas. U.S. Pat. Nos. 3,075,288, 3,076,904
and 3,213,537 illustrate such use in the dental field, and U.S.
Pat. No. 3,589,363 illustrates a vibrating knife or chisel to
remove tissue in small areas. As is apparent, when used in
inaccessible areas, a small inadvertent movement of the chisel can
damage tissue adjoining the tissue desired to be removed.
SUMMARY OF THE INVENTION
It is a principal object of the present invention to provide an
improved surgical method and apparatus.
Another object of the present invention is to provide an improved
method and apparatus for disintegrating or fragmenting animal
tissue in a preselected area and removing such disintegrated tissue
from said area.
Still another object of the present invention is to provide an
improved method and apparatus for disintegrating and removing
animal tissue from a predetermined area without adversely effecting
the surrounding tissue and which prevents excessive suction
build-up.
A further object of the present invention is to provide an improved
method and apparatus for disintegrating and removing tissue from
inaccessible areas with a minimum of adverse effect of the
surrounding and masking tissue.
Still a further object of the present invention is to provide a
method and apparatus of the above nature characterized by their
reliability, simplicity, fine areas of operation, great versatility
and adaptability and ease of application even in delicate an highly
hazardous environments.
The above and other objects of the present invention will become
apparent from a reading of the following description taken in
conjunction with the accompanying drawings which illustrate
preferred forms of the improved apparatus.
In a sense the present invention is predicated on the discovery
that hardened animal tissue in a closely confined and restricted
area can be disintegrated or finely fragmented by directing a fine
pulsating high velocity jet onto the desired area and sucking the
liquid of the impinging jet which has entrained or emulsified
therein the disintegrating tissue. The area of treatment can be
very precisely delineated and obviates the need for any alteration,
severance and significant penetration of any adjacent or overlying
tissue. Also, the incision can be kept very small as contrasted to
standard surgical techniques. The jet is produced by a very fine
nozzle and the tissue entraining liquid is likewise withdrawn by a
very fine conduit. Advantageously, any clogging of the suction
conduit by the tissue is eliminated by reversing the liquid flow in
the suction conduit in response to a sharp pressure drop therein.
Excessive suction build-up can damage an organ of the body, such as
an eyeball by collapsing the cornea. Also, the jet quickly
dissipates its energy when it impinges onto a yielding surface.
This is critical especially when the present suction is used in
connection with eye surgery such as removing a hardened lens of the
eye, with the tissue surrounding the lens being resilient.
The liquid jet contains no abrasive material and is advantageously
an isotonic solution of slight alkalinity, for example, of a pH of
about 7.4. The pulse frequency of the jet is advantageously widely
variable, depending on the specific organ with which it is used,
and can vary from 1 pulse every 15 seconds (4 pulses per minute,
i.e., 4 ppm) up to 333 pulses per second (20,000 ppm.). Further,
for some applications a continuous fine steam can be used. The
pressure is variable between about 15 and about 200 pounds per
square inch, preferably between 85 to 125 p.s.i., and its velocity
at the point of impingement between about 50 and about 500 feet per
second. The liquid jet diameter at the point of impingement is
advantageously of a diameter between about 0.001 and about 0.010 of
an inch and may be formed of a single jet stream or a plurality of
converging jet streams.
The inlet port to the suction conduit may be annular and surround
the liquid jet or it may be at the center of converging jets or
adjacent to a jet either parallel or perpendicular to the jet.
The improved method and apparatus may be employed in very delicate
and confined areas of little accessibility with a minimum of
secondary surgery and is very versatile, adaptable and easy and
convenient to operate with a minimum of side effects and
hazards.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an apparatus embodying the present
invention;
FIG. 2 is a fragmentary sectional view illustrating the application
of the apparatus of FIG. 1 to the treatment of eye lens tissue;
FIG. 3 is an enlarged fragmentary view partially in section of one
form of nozzle and suction tip of the apparatus of FIG. 1;
FIG. 4 is a view similar to FIG. 3 of another tip structure;
FIG. 5 is a sectional view taken along line 5 -- 5 in FIG. 4;
FIG. 6 is a view similar to FIG. 3 of still another form of tip;
and
FIG. 7 is a view similar to FIG. 3 showing a further tip
structure.
DESCRIPTION OF THE PRFERRED EMBODIMENTS
Referring now to the drawings, and particularly FIGS. 1 and 3
thereof which illustrate a preferred embodiment of the present
invention, the reference numeral 10 generally designates the
improved apparatus which is employed to great advantage in
practicing the present improved process in the removal of unwanted
tissue from the lens of a human eye, such as a cataract or the
like. The apparatus comprises a fine hand implement 11 which is
manipulated by the surgeon and includes three fine tubes joined
along their lengths as an integral unit, a nozzle tube 12, a
suction tube 13 and a drainage or bathing tube 14. The maximum
transverse dimension of the assembled tubes advantageously does not
exceed one hundred fifty thousandths of an inch (0.150"), each tube
having an inside diameter of between about 10 and 65 thousandths of
an inch (0.010" to 0.065") and an outside diameter of between about
20 and seventy-seven thousandths of an inch (0.020" to 0.077"), the
length of the working tip of the assembly advantageously being
about three-quarters of an inch (3/4") for optical applications.
Tube length can vary for other surgical applications.
The distal end of tube 12 is curved and closed and it is arranged
side by side with suction tube 13 whose distal end is open and
shortly rearwardly of the distal end of tube 12. A nozzle defining
circular port 16 is formed in the joined adjacent walls of tubes 12
and 13 and is directed parallel to the suction or inlet port 17 of
suction tube 13. The drainage liquid tube 14 extends somewhat less
than the full lengths of tubes 12 and 13 and is provided along its
distal length with small outlet ports 18. It should be noted that
the diameter of the nozzle port 16 is advantageously between 0.001
and 0.010 of an inch.
The proximate end of the nozzle tube 12 is connected by a high
pressure highly flexible tube 19 to the outlet of an adjustable
pulsing liquid feed device 20 whose inlet is connected to an
elevated tank 21 containing an isotonic solution of the composition
previously described. The pulsing device 20 may be of any
conventional construction in which the pulse frequency, pulse
duration, pressure and liquid volume velocity output are
continuously adjustable by knobs or by corresponding foot operated
controls. For example, the device 20 may include a positively
displacement pressure pump, such as a piston pump whose stroke is
adjustable and which is driven by a variable speed electric motor
and is provided with an adjustable pressure relief or by-pass valve
so that the above variable and adjustable parameters are easily and
conveniently achievable. Of course other systems serving the same
functions may be employed.
The proximate end of the suction tube 13 is connected by a flexible
tube 23 to a vacuum or suction pump 26 to withdraw any liquid and
entrained tissue from the area of the suction port 17.
Advantageously, a vacuum of between 110 and 130 mm. of mercury has
been found satisfactory for eye surgery applications for the
suction. However, it can vary according to the surgical
application. A pressure sensing element 24 communicates with the
tube 23 and is so adjusted that when the suction in tube 23 rise
above or conversely when the pressure falls below a predetermined
level consequent to the clogging of tube 13 or 23 by tissue sucked
up by the tube, it reverses the vacuum pump 26 to reverse the flow
in tubes 13 and 23 to eject the clogging tissue. Following the
ejection of the clogging material the vacuum pump 36 returns to its
normal functioning. The reverse flow in pipes 13 and 23 may be for
successive predetermined intervals until they are unclogged as
evidenced by the proper pressure sensed by element 24.
The irrigating pipe 14 is connected by a flexible tube 27 to an
elevated tank 28 by way of a valve 29 the tank 28 containing any
suitable washing solution, for example of the composition position
of the liquid contained in tank 21. This irrigating fluid helps
maintain the pressure in the eye and prevents the cornea from
collapsing. It should be noted that the flexible tubes 19, 23 and
27 are joined side by side as a highly flexible assembly thereby
greatly facilitating the convenient handling and manipulation of
the instrument 11.
In employing the apparatus 10 in operating on the eye, for example
in the removal of a cataract, the usual precautions are observed
and a small incision i.e., about one hundred seventy-five
thousandths of an inch (0.175") is made in the masking tissue, for
example in the cornea, to provide access for entry of the
instrument 11 into optimum engagement with the unwanted tissue. The
lens L to be treated may be in its normal position, but
advantageously is prolapsed into the anterior chamber.
The instrument 11 is inserted through the preformed incision into
confronting engagement with the unwanted tissue and the pulser 20,
the vacuum unit 26 is actuated and the valve 29 is opened, the
various parameters being adjusted to optimum conditions are
dictated by experience and as specified above.
A pulsating high velocity fine liquid jet is directed through the
nozzle port 16 onto the area of unwanted tissue of lens L to
fragment, disintegrate and emulsify the jet-subjected tissue, and
the jet liquid containing the entrained and emulsified tissue is
sucked up by suction unit 26. The liquid from the tube 14 keeps the
eye bathed in the desired manner. The instrument 11 is then
manipulated until all the unwanted tissue is fragmented and removed
and the instrument 11 is then retracted and the usual post
operative procedures followed. It should be noted that in the event
that a large tissue fragment is detached and lodges in tube 13 to
clog the tube 13 the action of the vacuum unit 26 is reversed in
response to the pressure sensing device 24 to eject the clogging
tissue, which is further fragmented by the jet so that it may be
properly withdrawn by the suction tube 13. Also, since the tissue
surrounding the lens is soft and yielding, the jet energy is
absorbed by the wall if the jet stream happens to miss the target
tissue.
The apparatus illustrated in FIGS. 4 and 5 differs from the
apparatus 10 primarily in the construction of the instrument 32
which corresponds to the instrument 11. Specifically the instrument
32 includes a pair of coaxial inner and outer tubes 33 and 34
respectively which delineate an annular outer conduit 36 and an
inner axial conduit 37. The distal end of outer conduit is closed
by an annular end wall 38 provided with circumferentially spaced
nozzle defining ports 39 which are directed toward a common central
point coaxial with the conduits 36 and 37 and forwardly
thereof.
The outer conduit 36 is connected by a flexible tube to a liquid
pulsing device corresponding to the pulsing device 20 and the
central conduit 37 is connected to a suction pump corresponding to
vacuum unit 26, likewise by of flexible hose.
The operation of the apparatus employing the instrument 32 is
similar to that using the instrument 10. A plurality of pulsating
high velocity jets 40 from nozzles 39 converge on a point located
on the unwanted tissue in lens L to disintegrate the jet subjected
tissue which is entrained in the jet liquid and sucked into and
withdrawn through the central suction tube 37.
The instrument 41 illustrated in FIG. 6 differs from that last
described primarily in that the pulsating jet emanates from the
axial tube and the tissue entraining liquid withdrawn by the
surrounding outer annular tube. The instrument 41 includes an outer
suction tube 42 open at its distal end and connected by a flexible
hose to a suction device corresponding to device 26 and a coaxial
tube 43 closed at its distal end and provided with a nozzle
defining port 44. The tube 43 is connected by a flexible hose to a
liquid pulsing device corresponding to device 20 and the apparatus
is employed in the manner earlier described.
In FIG. 7 of the drawings there is shown another form of tissue
removing instrument differing from those first described primarily
in that the pulsating liquid jet is directed at an angle to the
tissue approaching tangency and the liquid suction port extends
beyond the nozzle for an extended distance. Specifically the
improved instruments 46 include three interconnected rigid side by
side longitudinal tubes 47, 48 and 49 respectively. The tube 47 is
closed at its distal end and has a nozzle defining centrally
located port 50 formed in the front thereof and is connected by a
flexible tube to a pulsating liquid source corresponding to the
device 20. The second tube 48 is disposed alongside the tube 47 and
projects beyond the front end of tube 47 and is closed at its front
end. An elongated suction opening 51 is formed in the side wall of
tube 48 on the side of tube 47 and extends from a point forward of
the distal end of tube 47 to substantially the distal end of tube
48. The tube 49 is a bathing liquid tube and is secured to the
outer face of tube 48 and is provided with a plurality of
longitudinally spaced outlet ports. The tubes 48 and 49 are
connected by corresponding flexible tubes to a vacuum unit
corresponding to unit 26 and to a bathing liquid tank corresponding
to tank 28 respectively.
The instrument is employed in the manner similar to those earlier
described except that the pulsating jet emerging from the nozzle 50
is at an obtuse angle to the treated tissue and directs the tissue
entraining liquid toward the large suction opening 51.
While separate liquid sources are shown, a single source may be
used. Also, instead of a pump to produce the pressure for the jet,
the source of liquid can be pressurized, such as by a pressurized
tank, and a pulser only used. Also, while the jet stream from the
tip is shown generally cylindrical, it may expand slightly to a
conical shape; however, the area of contact should be kept as small
as possible. Further, while the jet openings were illustrated as
circular, other shapes can be used.
While there have been described and illustrated preferred
embodiments of the present invention it is apparent that numerous
alterations, omissions and additions may be made without departing
from the spirit thereof.
* * * * *