U.S. patent application number 12/633363 was filed with the patent office on 2011-06-09 for phacoemulsification hand piece with integrated aspiration pump.
This patent application is currently assigned to Alcon Research, LTD.. Invention is credited to Gary Sorensen, Glenn Sussman.
Application Number | 20110137231 12/633363 |
Document ID | / |
Family ID | 44082714 |
Filed Date | 2011-06-09 |
United States Patent
Application |
20110137231 |
Kind Code |
A1 |
Sorensen; Gary ; et
al. |
June 9, 2011 |
Phacoemulsification Hand Piece With Integrated Aspiration Pump
Abstract
An ophthalmic surgical hand piece comprises a driver coupled to
a horn. The horn is coupled to a needle. An aspiration pump is
integral with the hand piece and is located close to the needle. A
rigid length of aspiration line is located between the aspiration
pump and the needle. An optional pressure sensor is located between
the aspiration pump and the needle as well.
Inventors: |
Sorensen; Gary; (Laguna
Niguel, CA) ; Sussman; Glenn; (Laguna Niguel,
CA) |
Assignee: |
Alcon Research, LTD.
Fort Worth
TX
|
Family ID: |
44082714 |
Appl. No.: |
12/633363 |
Filed: |
December 8, 2009 |
Current U.S.
Class: |
604/22 |
Current CPC
Class: |
A61M 5/14228 20130101;
A61F 9/00745 20130101 |
Class at
Publication: |
604/22 |
International
Class: |
A61F 9/007 20060101
A61F009/007 |
Claims
1. An ophthalmic surgical hand piece comprising: a driver coupled
to a horn, the horn coupled to a needle; an aspiration pump
integral with the hand piece, the aspiration pump located close to
the needle; and a rigid length of aspiration line located between
the aspiration pump and the needle.
2. The hand piece of claim 1 further comprising: an aspiration
pressure sensor located between the aspiration pump and the
needle.
3. The hand piece of claim 1 further comprising: a vent valve
located in parallel with the aspiration pump, the vent valve being
variably controlled to variably control a vacuum produced by the
aspiration pump.
4. The hand piece of claim 1 further comprising: a moveable member
that engages a flexible length of aspiration line, a position of
the moveable member with respect to the flexible length of
aspiration line determining a leakage that decreases vacuum
pressure in the rigid length of aspiration line.
5. An ophthalmic surgical hand piece comprising: a driver coupled
to a horn, the horn coupled to a needle; an aspiration pump
integral with the hand piece, the aspiration pump located close to
the needle; a disposable segment coupled to the aspiration pump;
and a rigid length of aspiration line located between the
aspiration pump and the needle.
6. The hand piece of claim 5 further comprising: an aspiration
pressure sensor located between the aspiration pump and the
needle.
7. The hand piece of claim 5 further comprising: a vent valve
located in parallel with the aspiration pump, the vent valve being
variably controlled to variably control a vacuum produced by the
aspiration pump.
8. The hand piece of claim 5 further comprising: a moveable member
that engages disposable segment, a position of the moveable member
with respect to the disposable segment determining a leakage that
decreases vacuum pressure in the rigid length of aspiration line.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to phacoemulsification surgery
and more particularly to a device that better regulates pressure
experienced in the eye during cataract surgery.
[0002] The human eye functions to provide vision by transmitting
light through a clear outer portion called the cornea, and focusing
the image by way of a crystalline lens onto a retina. The quality
of the focused image depends on many factors including the size and
shape of the eye, and the transparency of the cornea and the lens.
When age or disease causes the lens to become less transparent,
vision deteriorates because of the diminished light which can be
transmitted to the retina. This deficiency in the lens of the eye
is medically known as a cataract. An accepted treatment for this
condition is surgical removal of the lens and replacement of the
lens function by an artificial intraocular lens (IOL).
[0003] In the United States, the majority of cataractous lenses are
removed by a surgical technique called phacoemulsification. A
typical surgical hand piece suitable for phacoemulsification
procedures consists of an ultrasonically driven phacoemulsification
hand piece, an attached hollow cutting needle surrounded by an
irrigating sleeve, and an electronic control console. The hand
piece assembly is attached to the control console by an electric
cable and flexible tubing. Through the electric cable, the console
varies the power level transmitted by the hand piece to the
attached cutting needle. The flexible tubing supplies irrigation
fluid to the surgical site and draws aspiration fluid from the eye
through the hand piece assembly.
[0004] The operative part in a typical hand piece is a centrally
located, hollow resonating bar or horn directly attached to a set
of piezoelectric crystals. The crystals supply the required
ultrasonic vibration needed to drive both the horn and the attached
cutting needle during phacoemulsification, and are controlled by
the console. The crystal/horn assembly is suspended within the
hollow body or shell of the hand piece by flexible mountings. The
hand piece body terminates in a reduced diameter portion or
nosecone at the body's distal end. Typically, the nosecone is
externally threaded to accept the hollow irrigation sleeve, which
surrounds most of the length of the cutting needle. Likewise, the
horn bore is internally threaded at its distal end to receive the
external threads of the cutting tip. The irrigation sleeve also has
an internally threaded bore that is screwed onto the external
threads of the nosecone. The cutting needle is adjusted so that its
tip projects only a predetermined amount past the open end of the
irrigating sleeve.
[0005] During the phacoemulsification procedure, the tip of the
cutting needle and the end of the irrigation sleeve are inserted
into the anterior segment of the eye through a small incision in
the outer tissue of the eye. The surgeon brings the tip of the
cutting needle into contact with the lens of the eye, so that the
vibrating tip fragments the lens. The resulting fragments are
aspirated out of the eye through the interior bore of the cutting
needle, along with irrigation solution provided to the eye during
the procedure, and into a waste reservoir.
[0006] Throughout the procedure, irrigating fluid is pumped into
the eye, passing between the irrigation sleeve and the cutting
needle and exiting into the eye at the tip of the irrigation sleeve
and/or from one or more ports, or openings, cut into the irrigation
sleeve near its end. This irrigating fluid is critical, as it
prevents the collapse of the eye during the removal of the
emulsified lens. The irrigating fluid also protects the eye tissues
from the heat generated by the vibrating of the ultrasonic cutting
needle. Furthermore, the irrigating fluid suspends the fragments of
the emulsified lens for aspiration from the eye.
[0007] A common phenomenon during a phacoemulsification procedure
arises from the varying flow rates that occur throughout the
surgical procedure. Varying flow rates result in varying pressure
losses in the irrigation fluid path from the irrigation fluid
supply to the eye, thus causing changes in pressure in the anterior
chamber (also referred to as Intra-Ocular Pressure or IOP.) Higher
flow rates result in greater pressure losses and lower IOP. As IOP
lowers, the operating space within the eye diminishes.
[0008] Another common complication during the phacoemulsification
process arises from a blockage, or occlusion, of the aspirating
needle. As the irrigation fluid and emulsified tissue is aspirated
away from the interior of the eye through the hollow cutting
needle, pieces of tissue that are larger than the diameter of the
needle's bore may become clogged in the needle's tip. While the tip
is clogged, vacuum pressure builds up within the tip. The resulting
drop in pressure in the anterior chamber in the eye when the clog
is removed is known as post-occlusion surge. This post-occlusion
surge can, in some cases, cause a relatively large quantity of
fluid and tissue to be aspirated out of the eye too quickly,
potentially causing the eye to collapse and/or causing the lens
capsule to be torn.
[0009] Various techniques, such as venting the aspiration line,
have been designed to reduce this surge. However, there remains a
need for improved phacoemulsification devices that reduce
post-occlusion surge as well as maintain a stable IOP throughout
varying flow conditions.
SUMMARY OF THE INVENTION
[0010] In one embodiment consistent with the principles of the
present invention, the present invention is an ophthalmic surgical
hand piece comprising a driver coupled to a horn, the horn coupled
to a needle an aspiration pump integral with the hand piece, the
aspiration pump located close to the needle; and a rigid length of
aspiration line located between the aspiration pump and the
needle.
[0011] In another embodiment consistent with the principles of the
present invention, the present invention is an ophthalmic surgical
hand piece comprising a driver coupled to a horn, the horn coupled
to a needle an aspiration pump integral with the hand piece, the
aspiration pump located close to the needle; a disposable segment
coupled to the aspiration pump; and a rigid length of aspiration
line located between the aspiration pump and the needle.
[0012] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are intended to provide further
explanation of the invention as claimed. The following description,
as well as the practice of the invention, set forth and suggest
additional advantages and purposes of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate several
embodiments of the invention and together with the description,
serve to explain the principles of the invention.
[0014] FIG. 1 is a diagram of the components in the fluid path of a
phacoemulsification system including a hand piece with an
integrated aspiration pump according to the principles of the
present invention.
[0015] FIG. 2 is a block diagram of a phacoemulsification hand
piece with an integrated aspiration pump according to the
principles of the present invention.
[0016] FIG. 3 is a block diagram of a phacoemulsification hand
piece with an integrated aspiration pump according to the
principles of the present invention.
[0017] FIG. 4 is a side view of a portion of a phacoemulsification
hand piece with an integrated aspiration pump according to the
principles of the present invention.
[0018] FIG. 5 is a cross section view of a portion of a
phacoemulsification hand piece with an integrated aspiration pump
according to the principles of the present invention.
[0019] FIG. 6 is a side view of a removable cartridge for use with
a phacoemulsification hand piece with an integrated aspiration pump
according to the principles of the present invention.
[0020] FIG. 7 is a perspective view of a removable cartridge for
use with a phacoemulsification hand piece with an integrated
aspiration pump according to the principles of the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] Reference is now made in detail to the exemplary embodiments
of the invention, examples of which are illustrated in the
accompanying drawings. Wherever possible, the same reference
numbers are used throughout the drawings to refer to the same or
like parts.
[0022] FIG. 1 is a diagram of the components in the fluid path of a
phacoemulsification system including a hand piece with an
integrated aspiration pump according to the principles of the
present invention. FIG. 1 depicts the fluid path through the eye
145 during cataract surgery. The components include an irrigation
source 120, an optional irrigation pressure sensor 130, an optional
irrigation valve 135, an irrigation line 140, a hand piece 150, an
aspiration line 155, an optional aspiration pressure sensor 160, an
optional vent valve 165, a pump 170, a reservoir 175 and a drain
bag 180. The irrigation line 140 provides irrigation fluid to the
eye 145 during cataract surgery. The aspiration line 155 removes
fluid and emulsified lens particles from the eye during cataract
surgery.
[0023] When irrigation fluid exits irrigation source 120, it
travels through irrigation line 140 and into the eye 145. An
irrigation pressure sensor 130 measures the pressure of the
irrigation fluid in irrigation line 140. An optional irrigation
valve 135 is also provided for on/off control of irrigation.
Irrigation pressure sensor 130 is implemented by any of a number of
commercially available fluid pressure sensors.
[0024] A hand piece 150 is placed in relation to the eye 145 during
a phacoemulsification procedure. The hand piece 150 has a hollow
needle (270 in FIGS. 2 & 3) that is ultrasonically vibrated in
the eye to break up the diseased lens. A sleeve located around the
needle provides irrigation fluid from irrigation line 140. The
irrigation fluid passes through the space between the outside of
the needle and the inside of the sleeve. Fluid and lens particles
are aspirated through the hollow needle. In this manner, the
interior passage of the hollow needle is fluidly coupled to
aspiration line 155. Pump 170 draws the aspirated fluid from the
eye 145. An optional aspiration pressure sensor 160 measures the
pressure in the aspiration line. An optional vent valve can be used
to vent the vacuum created by pump 170. The aspirated fluid passes
through reservoir 175 and into drain bag 180.
[0025] FIG. 2 is a block diagram of a phacoemulsification hand
piece with an integrated aspiration pump according to the
principles of the present invention. In FIG. 2, hand piece 150
comprises motor 210, shaft 220, removable cartridge 230, optional
aspiration pressure sensor 160, driver 250, horn 260, needle 270,
and aspiration line 280. Motor 210 rotates shaft 220. When the pump
is in operation, removable cartridge 230 is held against shaft 220.
Aspiration pressure sensor 160 is located between removable
cartridge 230 and the eye 145.
[0026] In FIG. 2, the pump 170 comprises motor 210, shaft 220, and
flexible tubing in removable cartridge 230. In one embodiment of
the present invention, shaft 220 has a spiral structure that
presses against the flexible tubing in removable cartridge 230. In
this manner, a screw-type or scroll-type aspiration pump is
implemented with motor 210, shaft 220, and flexible tubing in
removable cartridge 230. This is more clearly shown and described
in FIGS. 4 and 5. While pump 170 is described as a screw-type pump,
other types of pumps may also be used.
[0027] Aspiration line 280 is fluidly coupled to removable
cartridge 230. Aspiration line also extends through or around drive
250, horn 260, and needle 270. A lumen in needle 270 is fluidly
coupled to aspiration line 280. As described above, fluid and lens
particles are aspirated through the lumen of needle 270. Aspiration
pump 170 draws fluid and lens particles through the lumen of needle
270.
[0028] Driver 250 is typically an ultrasonic driver that produces
ultrasonic vibrations in horn 260. Horn 260 is typically a mass of
metal that is coupled to driver 250 and needle 270. In this manner,
vibrations produced by driver 250 are transferred to horn 260 and
to needle 270. Needle 270 is placed in the eye and vibrated to
fragment a cataractous lens.
[0029] Aspiration pressure sensor 160 measures the aspiration
pressure in aspiration line 280. While shown as located between
removable cartridge 230 and driver 250, aspiration pressure sensor
may be located at any location between pump 170 and the eye 145.
Aspiration pressure sensor 160 may be implemented by any of a
number of known pressure sensor devices.
[0030] FIG. 3 is a block diagram of a phacoemulsification hand
piece with an integrated aspiration pump according to the
principles of the present invention. The example of FIG. 3 has the
elements of FIG. 2 plus an optional vent valve 165. When optional
vent valve 165 is present, it acts to provide a venting path for
the aspiration pump 170. In this manner, pump 170 can be vented,
for example, to atmosphere when vent valve 165 is opened. As shown
in FIG. 3, aspiration line 280 has two paths--one path that goes
through removable cartridge 230, and another path that goes around
removable cartridge 230. This second path (that goes around
removable cartridge 230) and associated vent valve 165 may also be
incorporated into removable cartridge 230. When vent valve 165 is
opened, the aspiration or vacuum produced by pump 170 is decreased
as a result of it being vented to atmosphere.
[0031] FIGS. 4 and 5 are side and cross section views,
respectively, of a portion of a phacoemulsification hand piece with
an integrated aspiration pump according to the principles of the
present invention. FIGS. 4 and 5 more clearly show the details of
one example of a removable cartridge 230 and pump 170. In the
example shown, removable cartridge 230 comprises aspiration line
coupling 405, first tubing coupling 420, tubing holder 440, and
lever 430. These components are integrated into a frame as shown.
Removable cartridge 230 can be removed from the remainder of the
hand piece.
[0032] In the example of the removable cartridge shown in FIGS. 4
and 5, aspiration line coupling 405 can be attached to aspiration
tubing that is coupled to the surgical console. In this manner,
aspiration line coupling 405 is near the end of the hand piece that
is connected to the surgical console. A tube extends from
aspiration line coupling 405 to first tubing coupling 420. This
tube is a part of the aspiration line 280 shown in FIGS. 2 and
3.
[0033] Tubing holder 440 holds a flexible tube (not shown) that is
located between shaft 220 and tubing holder 440. Shaft 220 presses
the flexible tubing against tubing holder 440. As shaft 220
rotates, the spiral protrusion on shaft 220 pumps fluid through the
flexible tubing (thus implementing a screw-type or scroll-type
pump). Tubing holder 440 is made of a rigid material that is
suitable for holding flexible tubing. One end of the flexible
tubing is fluidly coupled to first tubing coupling 420, and the
other end of the flexible tubing is fluidly coupled to second
tubing coupling 425. In this manner, the flexible tubing is a part
of the aspiration line 280.
[0034] Lever 430 operates to secure removable cartridge 230 to the
remainder of the hand piece. While shown as a lever, other
mechanisms can be employed to secure removable cartridge to the
remainder of the hand piece.
[0035] Motor 210 is coupled to shaft 220 and serves to rotate shaft
220. Motor 210 can be controlled to control the movement of shaft
220 as more clearly described below. Motor 210 is typically a DC
motor but can be any type of motor or driver suitable for rotating
shaft 220.
[0036] In the example of FIGS. 4 and 5, a connector 450 connects
the flexible tubing held by tubing holder 440 to the hand piece
coupling 415. Connector coupling 410 interfaces with hand piece
coupling 415--either directly or via another part. In this manner,
the aspiration path passes through hand piece coupling 415,
connector coupling 410, connector 450, second tubing coupling 425,
the flexible tubing held by tubing holder 440, first tubing
coupling 420 and aspiration line coupling 405. Connector 450 is
connected to an end of shaft 220. In this manner, connector 450,
shaft 220, and motor 210 (along with the frame that holds these
parts) is attached to the driver 250 (which is coupled to the horn
260 and the needle 270).
[0037] The length of aspiration line between the pump and the eye
(i.e. between second tubing coupling 425 and needle 270) is minimal
(on the order of inches). In addition, this length of aspiration
line between the pump and the eye may be non-compliant (i.e. it can
be rigid). Having a small length of non-compliant tubing between
the pump 170 and the eye eliminates the surge associated with prior
art systems.
[0038] In operation, motor 210 rotates shaft 220. A controller (not
shown) controls the operation of motor 210. In this manner, shaft
220 may be rotated at any desired speed to produce any desired
vacuum. Further, shaft 220 may be stopped or rotated in an opposite
direction if desired. In this manner, motor 210 may be controlled
to rotate shaft 220 in either direction. When rotated, shaft 220
draws fluid through the flexible tube and acts to pump the fluid
through the aspiration line.
[0039] In another example, shaft 220 can be moved toward and away
from tubing holder 440. In this manner, the space between tubing
holder 440 and shaft 220 can be varied so that the flexible tubing
can be pinched to different degrees between shaft 220 and tubing
holder 440. In other words, shaft 220 can pinch the flexible tubing
held by tubing holder 440 very tightly to produce pumping action
that does not allow for leakage. Alternatively, as shaft 220 is
moved away from tubing holder 440, the flexible tubing is pinched
less tightly thus leading to a leakage and less of a vacuum or
pumping force. The position of shaft 220 with respect to tubing
holder 440 can be variably controlled to adjust the leakage through
the flexible tubing, and in turn adjust the vacuum produced by the
pump.
[0040] In another example (shown in FIG. 3), the position of shaft
220 with respect to tubing holder 440 can be fixed, and a vent
valve 165 can be used to produce leakage that adjusts the vacuum
produced by the pump. In this manner, vent valve 165 can be
variably controlled to control the amount of vacuum that is present
in the aspiration line (by controlling the amount of leakage
through vent valve 165).
[0041] The control of aspiration vacuum can be based on a reading
from aspiration pressure sensor 160. Aspiration pressure sensor 160
is located between the pump and the eye. In this manner, aspiration
pressure sensor 160 accurately reads the pressure conditions in the
aspiration line very close to the eye. Such a reading can be used
to precisely control the aspiration vacuum that is applied to the
eye.
[0042] FIGS. 6 and 7 are side and perspective views, respectively,
of a removable cartridge for use with a phacoemulsification hand
piece with an integrated aspiration pump according to the
principles of the present invention. In the example of FIGS. 6 and
7, the removable cartridge comprises aspiration line coupling, 405,
first tubing coupling 420, tubing holder 440, lever 430, and
opening 605. Opening 605 interfaces with second tubing coupling 425
as shown in FIG. 5. A piece of flexible tubing is located between
first tubing coupling 420 and opening 605. The removable cartridge
230 of FIGS. 6 and 7 can be reusable or disposable. In one example,
the removable cartridge is reusable and the flexible tubing in
disposable. In another example, the removable cartridge is
disposable along with the flexible tubing.
[0043] The design of the present invention allows for the
aspiration pump 170 to be very close to the eye 145. The distance
between the aspiration pump 170 and the eye 145 can be made to be
very small--on the order of inches. Placing the aspiration pump 170
close to the eye 145 allows for a very short length of aspiration
line to be located between the pump 170 and the eye 145. Moreover,
the length of aspiration line located between the pump 170 and the
eye 145 can be rigid (for example, it can be made of stainless
steel). This short length of non-compliant material that makes up
the aspiration line between the pump 170 and the eye 145 eliminates
any surge effect associated with conventional phacoemulsification
systems.
[0044] In conventional phacoemulsification systems, the aspiration
pump is located in a console. A relatively long length of flexible
tubing (six feet or more) is located between the aspiration pump
and the eye. This relatively long length of flexible tubing has a
lot of compliance--it can stretch in response to changes in vacuum
pressure. This compliance results in surges as previously
described. By incorporating the aspiration pump in the hand piece
(and placing it very close to the eye) and having a very short
length of non-compliant tubing between the aspiration pump and the
eye, these surges can be eliminated, thus resulting in a safer and
more efficient surgery.
[0045] From the above, it may be appreciated that the present
invention provides a pressurized infusion system for
phacoemulsification surgery. The present invention provides an
irrigation squeeze band device that more precisely controls fluid
pressure. The present invention is illustrated herein by example,
and various modifications may be made by a person of ordinary skill
in the art.
[0046] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *