U.S. patent application number 15/348471 was filed with the patent office on 2017-03-02 for laser surgery device and method.
The applicant listed for this patent is Brian Cisel. Invention is credited to Brian Cisel, Robert Alan Hasty, Arnold Ochoa, Arash Tom Salamat, Mike Wilkinson, Harley Michael Willey.
Application Number | 20170056111 15/348471 |
Document ID | / |
Family ID | 43449710 |
Filed Date | 2017-03-02 |
United States Patent
Application |
20170056111 |
Kind Code |
A1 |
Cisel; Brian ; et
al. |
March 2, 2017 |
LASER SURGERY DEVICE AND METHOD
Abstract
Laser surgery devices and methods of performing laser surgery
using laser surgery devices are described. The laser surgery device
may rotate a laser fiber along a longitudinal axis of the laser
fiber in a repeating pattern through a user-specified rotational
pattern. The laser surgery device may be optionally attached to a
surgical device to implement hands-free operation of the laser
surgery device.
Inventors: |
Cisel; Brian; (St Charles,
MO) ; Willey; Harley Michael; (Garland, TX) ;
Salamat; Arash Tom; (Plano, TX) ; Ochoa; Arnold;
(Garland, TX) ; Hasty; Robert Alan; (Carrollton,
TX) ; Wilkinson; Mike; (Richardson, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cisel; Brian |
St. Charles |
MO |
US |
|
|
Family ID: |
43449710 |
Appl. No.: |
15/348471 |
Filed: |
November 10, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13384133 |
Feb 10, 2012 |
9492231 |
|
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PCT/US10/41506 |
Jul 9, 2010 |
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15348471 |
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61225339 |
Jul 14, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 5/0601 20130101;
A61B 2018/00452 20130101; A61N 2005/0652 20130101; A61B 2018/1861
20130101; A61B 2018/00273 20130101; A61B 2018/2255 20130101; A61N
5/062 20130101; A61B 2018/00208 20130101; A61B 18/20 20130101; A61B
2018/00517 20130101; A61B 18/22 20130101; A61B 18/203 20130101 |
International
Class: |
A61B 18/22 20060101
A61B018/22 |
Claims
1. A laser surgery device to rotate a laser fiber along a
longitudinal axis of the laser fiber, the device comprising: an
inner cylinder nested within an outer case, wherein: the inner
cylinder is rotatably connected to the outer case; a rotational
axis of the interior cylinder is aligned with a central axis of the
outer case; and, the inner cylinder comprises an inner surface
defining a laser fiber lumen, wherein: the laser fiber lumen forms
a channel in which the laser fiber is detachably held; and, a laser
fiber tip protrudes from the laser fiber lumen at a device exit; a
motor and a power source operatively connected to the inner
cylinder such that the inner cylinder rotates in a first direction
and in a second direction when the motor is in operation; a
rotation speed control operatively connected to the motor; and, a
rotation sweep control operatively connected to the motor.
2. The device of claim 1, wherein the device rotates the laser
fiber along the longitudinal axis of the laser fiber in a
user-specified repeating pattern.
3. The device of claim 1, wherein the device rotates the laser
fiber at an essentially constant rotational speed ranging from
about 5.degree./second to about 360.degree./second.
4. The device of claim 3, wherein the rotational speed may be
increased or decreased during rotation of the laser fiber.
5. The device of claim 2, wherein the user-specified repeating
pattern comprises a clockwise rotation followed by a
counterclockwise rotation through a sweep angle ranging from about
90.degree. clockwise to about 90.degree. counterclockwise relative
to a downward vertical reference plane.
6. The device of claim 5, wherein the sweep angle ranges from about
30.degree. clockwise to about 30.degree. counterclockwise relative
to a downward vertical reference plane.
7. The device of claim 5, wherein the range of the sweep angle may
be increased or decreased during rotation of the laser fiber.
8. The device of claim 1, wherein the inner surface further defines
a control knob lumen, wherein: the control knob lumen opens to a
device entry at one end of the control knob lumen and to the laser
fiber lumen at the opposite end of the control knob lumen; the
laser fiber lumen opens to a device exit at one end of the laser
fiber lumen and to the control knob lumen at the opposite end of
the laser fiber lumen; and, the control knob lumen is contoured to
detachably hold a control knob.
9. The device of claim 1, wherein the motor is integrated into the
inner cylinder and the outer case.
10. The device of claim 1, wherein the device releasably holds the
laser fiber.
11. The device of claim 1, wherein the inner cylinder rotates
within the outer case.
12. The device of claim 1, wherein the laser fiber is part of an
endoscopic surgical laser comprising the laser fiber, a control
knob, and a shielded laser fiber connecting the laser fiber to a
laser source.
13. The device of claim 1, wherein the device is a part of a
cystoscope.
14. The device of claim 1, wherein the inner cylinder comprises the
inner surface defining a control knob lumen and the laser fiber
lumen.
15. The device of claim 1, wherein the device holds the laser fiber
and a control knob of the laser fiber in a fixed position in the
inner cylinder, and the inner cylinder rotates with respect to the
outer case.
16. The device of claim 1, wherein the motor is integrated into the
inner cylinder and the outer case to drive the inner cylinder in a
repeating pattern.
17. The device of claim 16, wherein the inner cylinder rotates in
the first direction and then in the second direction in a repeating
pattern when the motor is in operation.
18. The device of claim 1, wherein the inner cylinder clamps onto
the laser fiber.
19. A laser surgery device to rotate a laser fiber along a
longitudinal axis of the laser fiber, the device comprising: an
inner cylinder within an outer case, wherein: the inner cylinder is
rotatably connected to the outer case; a rotational axis of the
interior cylinder is aligned with a central axis of the outer case;
and, the inner cylinder comprises an inner surface defining a laser
fiber lumen, wherein: the laser fiber lumen forms a channel in
which the laser fiber is detachably held; and, a laser fiber tip
protrudes from the laser fiber lumen at a device exit; a motor and
a power source operatively connected to the inner cylinder such
that the inner cylinder rotates in a first direction and in a
second direction when the motor is in operation; a rotation speed
control operatively connected to the motor; a rotation sweep
control operatively connected to the motor; and, wherein the device
rotates the laser fiber in opposing directions along the
longitudinal axis of the laser fiber in a user-specified repeating
pattern.
20. A laser surgery device to rotate a laser fiber along a
longitudinal axis of the laser fiber, the device comprising: an
inner cylinder within an outer case, wherein: the inner cylinder is
rotatably connected to the outer case; a rotational axis of the
interior cylinder is aligned with a central axis of the outer case;
and, the inner cylinder comprises an inner surface defining a laser
fiber lumen, wherein: the laser fiber lumen forms a channel in
which the laser fiber is detachably held; and, a laser fiber tip
protrudes from the laser fiber lumen at a device exit; a motor and
a power source operatively connected to the inner cylinder such
that the inner cylinder rotates in a first direction and in a
second direction when the motor is in operation; a rotation speed
control operatively connected to the motor; a rotation sweep
control operatively connected to the motor; and, the inner surface
further defines a control knob lumen, wherein: the control knob
lumen opens to a device entry at one end of the control knob lumen
and to the laser fiber lumen at the opposite end of the control
knob lumen; the laser fiber lumen opens to a device exit at one end
of the laser fiber lumen and to the control knob lumen at the
opposite end of the laser fiber lumen; and, the control knob lumen
is contoured to detachably hold a control knob.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. National patent
application Ser. No. 13/384,133, filed Feb. 10, 2012, which is a
371 of PCT/US10/41506, filed Jul. 9, 2010, which claims the benefit
of U.S. Provisional Patent Application 61/225,339, filed Jul. 14,
2009, which are hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to laser surgery devices and
methods of performing laser surgery using laser surgery devices. In
particular, the present invention relates to laser surgery devices
to rotate surgical laser fibers about the longitudinal axis of the
laser fibers.
BACKGROUND OF THE INVENTION
[0003] Surgical lasers are used with increasing frequency for the
treatment of benign prostatic hypertrophy (BPH). In recent years,
surgical procedures utilizing lasers are gaining status as a
preferred surgical procedure for the long-term relief of BPH from
the perspective of both urologists and patients. Laser prostate
procedures have been touted as the first procedure ever to achieve
comparable durability to transurethral resection of the prostate
(TURP), the accepted standard of care in this field, and with a
lower incidence of complications compared with TURP. However, a
significant percentage of physicians prefer more traditional
surgical procedures over laser procedure treatments due to negative
patient outcomes, prolonged procedure times, and general
dissatisfaction with the procedure.
[0004] Much of the dissatisfaction with the laser procedure stems
from the complexity of the surgical techniques used, as well as the
multitude of tasks that must be performed simultaneously by the
physician while performing the laser procedure. During this
procedure, the physician must execute numerous movements
simultaneously, including depressing a foot-pedal to activate the
laser with one foot, manipulating the cystoscope with one hand to
position a distal tip of the laser fiber to within a few
millimeters of target tissue, and rotating a control knob with the
other hand to sweep the laser fiber back and forth at a constant
speed as well as to insert or retract the distal tip of the laser
fiber and/or cystoscope assembly within the surgical site. In
addition, the urologist must also monitor numerous other factors
such as the patient's vital signs, the video display of the distal
tip of the laser fiber in the surgical site, the adjustment of the
inflow and the outflow of the irrigation fluid to/from the surgical
site, and the laser power commanded from the laser source. As a
result, laser procedures are accompanied by a steep learning curve
for some urologists in which the initial procedures conducted by
the urologists adopting this technique may potentially incur a
higher risk of negative outcomes or complications.
[0005] A need exists in the art for a laser surgical device
designed to reduce the multi-tasking of a physician performing a
laser surgical procedure, as well as to introduce reliable and
repeatable movements of the laser fiber which will optimize patient
outcomes and increase urologist satisfaction.
SUMMARY OF THE INVENTION
[0006] In one aspect, the present invention provides a laser
surgery device to rotate a laser fiber along a longitudinal axis of
the laser fiber. In this aspect, the device includes a hollow inner
cylinder nested within a hollow outer case. The inner cylinder is
rotatably connected to the outer case, the rotational axis of the
interior cylinder is aligned with the central axis of the outer
case, and the hollow inner cylinder includes an inner surface that
defines a laser fiber lumen. The laser fiber lumen forms a channel
in which the laser fiber is detachably held, and the laser fiber
protrudes from laser fiber lumen at a device exit. The device also
includes a motor and power source operatively connected to the
inner cylinder such that the inner cylinder rotates in a first
direction and a second direction when the motor is in operation.
The device additionally includes a rotation speed control
operatively connected to the motor, and a rotation sweep control
operatively connected to the motor.
[0007] In another aspect, a laser surgery device is provided to
releasably hold a surgical laser apparatus that includes a laser
fiber and a control knob in a fixed position and to rotate the
laser fiber in a predefined repeating pattern. The device includes
a hollow inner cylinder nested within a hollow outer case. The
inner cylinder is rotatably connected to the outer case, the
rotational axis of the interior cylinder is aligned with the
central axis of the outer case, and the hollow inner cylinder
includes an inner surface that defines a control knob lumen and a
laser fiber lumen. The control knob lumen opens to a device entry
at one end and to the laser fiber lumen at the opposite end. The
laser fiber lumen opens to a device exit at one end and to the
control knob lumen at the opposite end. The control knob lumen is
contoured to detachably hold the control knob. The laser fiber
lumen forms a channel through which the laser fiber may be threaded
from the control knob lumen to the device exit. The device also
includes a motor operatively connected to a power source. The motor
is operatively connected to the inner cylinder such that the inner
cylinder rotates in a first direction and in a second direction
when the motor is in operation. The device further includes a
rotation sweep control and a rotation speed control that are both
operatively connected to the motor. The device additionally
includes a support assembly that includes an elongated support arm,
a clamp attached to one end of the support arm, and an attachment
assembly on the opposite end of the support arm. The clamp is
attached to a working channel of a laser cystoscope and the
attachment assembly also includes an attachment fitting and a
releasable latch. Alternatively, the clamp may attach to other
parts of the cystoscope.
[0008] Another aspect provides a laser surgery device to detachably
receive a surgical laser that includes a laser fiber, a control
knob, and a shielded laser fiber connecting the laser fiber to a
laser source. The device includes a hollow outer case that includes
an exterior surface, an interior surface, an upper casing, and a
lower casing. The upper casing and the lower casing are hingeably
connected along one line of intersection by two or more hinges
attached to the exterior surface. The upper casing and lower casing
are reversibly secured diametrically opposite to the two or more
hinges by at least one latch attached to the exterior surface. The
interior surface defines a main lumen extending along the
longitudinal axis of the outer cylinder. The device further
includes a hollow inner cylinder situated within the main lumen and
rotatably connected to the interior surface of the outer case such
that the axis of rotation of the inner cylinder coincides with the
longitudinal axis of the outer case. The inner cylinder includes an
inner surface, an outer surface, an upper member, and a lower
member. The upper member is attached to the upper casing and the
lower member is attached to the lower casing when the outer
cylinder is in an open position. The inner surface defines the
walls of a laser lumen fitted to the external shape of the laser
fiber, control knob, and shielded laser fiber. The shielded laser
fiber, control knob, and laser fiber may be placed within the inner
cylinder such that the laser fiber emerges from one end of the
surgical laser lumen and the shielded laser fiber emerges from the
opposite end of the surgical laser lumen. The upper member and
lower member reversibly clamp the surgical laser within the inner
cylinder when the outer case is latched in a closed position.
[0009] In this same aspect the device additionally includes an
electrical motor that includes a driveshaft protruding from a motor
unit. The motor unit is attached to the interior surface of the
outer case. The device also includes a power source electrically
connected to the motor, a drive gear attached to the end of the
driveshaft opposite to the motor unit, and a transmission gear
attached to the outer surface of the inner cylinder. The
transmission gear meshes with the drive gear. In addition, the
device includes a motor sweep control circuit electrically
connected to the electrical motor and a motor speed control circuit
electrically connected to the electrical motor.
[0010] In yet another aspect, a laser surgery device is provided
that includes an entry and an exit. In this aspect, the device may
detachably receive and hold a laser fiber and control knob. The
device also includes a hollow outer case that includes an exterior
surface and an interior surface. The interior surface forms the
walls of a cylindrical main lumen, which opens to the entry at one
end and to the exit at the opposite end. The interior surface
includes at least two circumferential outer depressions forming the
sides of at least two circumferential outer bearing channels spaced
along the longitudinal axis of the outer case. A plurality of
bearings is situated within each of the at least two outer bearing
channels such that the bearings are free to roll in a
circumferential direction along the outer bearing channels.
[0011] In this same aspect, the device additionally includes a
hollow inner cylinder centered within the main lumen. The main
lumen includes an inner surface and an outer surface. The outer
surface includes at least two circumferential inner indentations
forming the sides of at least two inner bearing channels. Each
inner bearing channel is aligned with one of the outer bearing
channels such that the plurality of bearings are enclosed by one of
the inner bearing channels from below and one of the outer bearing
channels from above. The inner cylinder rotates freely within the
outer case on the plurality of bearings.
[0012] Also in this same aspect, the device includes a transmission
gear that includes a plurality of transmission gear teeth. The
transmission gear is attached to the outer surface of the inner
cylinder such that the inner cylinder passes through the center of
the transmission gear along the rotational axis of the transmission
gear. The device additionally includes an electrical motor that
includes a driveshaft protruding from a power unit. The power unit
is attached to the interior surface of the outer case.
[0013] The device provided in this same aspect additionally
includes a drive gear that includes a plurality of drive gear teeth
operatively engaged with the cylinder gear teeth. The drive gear is
attached to the free end of the driveshaft through the center of
the drive gear, and the rotational axis of the drive gear is
parallel to the longitudinal axis of the inner cylinder. The device
also includes a motor sweep control operatively connected to the
motor, a motor speed control operatively connected to the motor and
to the motor sweep control, a power source connected to the motor
via the motor sweep control unit and the motor speed control unit,
and a laser fiber securing plug that includes a cylindrical plug
body, a ratchet catch, and an insertion arm.
[0014] In this same aspect, the plug body inserts into a control
knob lumen defined by the inner surface of the inner cylinder. The
control knob lumen opens to the device entry. The cylindrical plug
body includes an insertion end, a removal end opposite the
insertion end, an upper plug surface that includes a longitudinal
sector of the plug body, a lower plug surface situated
diametrically opposite to the upper plug surface that includes a
longitudinal sector of the plug body, and a narrow radial notch
extending longitudinally along the entire plug body and extending
radially from the central longitudinal axis of the plug body
through the lower plug surface. The ratchet catch includes at least
one retractable tooth attached in a longitudinal pattern along the
upper plug surface. The retractable tooth may engage a plurality of
ratchet teeth formed in a longitudinal pattern by the inner surface
of the inner cylinder at the upper region of the inner cylinder.
The insertion arm includes an elongated member attached at one end
to the removal end of the plug body. The insertion arm is
mechanically engaged to the ratchet catch such that the ratchet
catch may be reversibly retracted by applying a lateral inward
force to the insertion arm.
[0015] In this aspect, the device also includes an amount of
compressible material situated within a cylindrical laser fiber
lumen defined by the inner surface of the inner cylinder. One end
of laser fiber lumen opens to the control knob lumen at the end of
the control knob lumen opposite to the device entry, and the
opposing end of the laser fiber lumen opens to the device exit. The
device also includes a reference nub that includes a narrow
fin-shaped projection attached to the exterior surface along the
longitudinal axis and projecting radially outward. The device
additionally includes a motor sweep control switch mounted on the
external surface of the outer case which is electrically connected
to the motor sweep control circuit, and a motor speed control
switch mounted on the external surface of the outer case which is
electrically connected to the motor speed control circuit.
[0016] Yet another aspect provides a method of performing a laser
surgical procedure that includes providing a laser surgery system
that includes a laser source operatively connected to a surgical
laser fiber which protrudes from an outer case. The outer case
includes an exterior surface, a rotation speed control situated on
the exterior surface, and a rotation sweep control situated on the
exterior surface. The method also includes threading the surgical
laser fiber through a working channel of an endoscopic surgical
device into a surgical site, activating the rotation speed control
and the rotation sweep control to initiate a rotational movement of
the surgical laser fiber about the longitudinal axis of the laser
fiber, and activating the laser source to initiate the release of
laser energy from the laser fiber into the surgical site.
[0017] Still another aspect provides a method of performing a laser
surgical procedure that includes providing a surgical laser fiber
protruding from a control knob and providing a laser surgery device
that includes an outer case having an exterior surface, an
entrance, an exit, and an inner cylinder defining a control knob
lumen opening to the entrance at one end and to a laser fiber lumen
at the opposite end. The laser fiber lumen opens to the exit at one
end and to the control knob lumen at the opposite end. The laser
surgery device further includes a securing plug, and a rotation
speed control and a rotation sweep control situated on the exterior
surface.
[0018] In this same aspect, the method also includes threading the
surgical laser fiber through the laser fiber lumen from the
entrance, such that the control knob is situated within the control
knob lumen and the laser fiber passes through the laser fiber lumen
and protrudes from the exit. The method further includes inserting
the securing plug into the control knob lumen from the entrance
such that the securing plug is situated in the control knob lumen
between the control knob and the entrance, and threading the
surgical laser fiber protruding from the exit through a working
channel of an endoscopic surgical device into a surgical site. The
method additionally includes activating the rotation speed control
and the rotation sweep control to initiate a rotational movement of
the surgical laser fiber about the longitudinal axis of the laser
fiber, and activating the laser source to initiate the release of
laser energy from the laser fiber into the surgical site.
[0019] Still another aspect provides a method of performing a laser
surgical procedure that includes providing a surgical laser fiber
protruding from a control knob and providing a laser surgery
device. The laser surgery device includes an outer case with an
exterior surface, an entrance, an exit, an upper casing hinged to a
lower casing, and a latch diametrically opposite to the hinge line
between the upper casing and the lower casing. In addition, the
laser surgery device includes an inner cylinder rotatably attached
to the outer case. The inner cylinder includes an upper member, a
lower member, and an internal surface. The upper member is attached
to the upper casing and the lower member is attached to the lower
casing, such that the internal cylinder opens when the outer case
is opened. The internal surface defines a control knob lumen
opening to the entrance at one end and to a laser fiber lumen at
the opposite end. The laser fiber lumen opens to the exit at one
end and to the control knob lumen at the opposite end. When the
laser surgery device is in a closed position, the internal cylinder
rotates about the longitudinal axis of the laser fiber. The laser
surgery device additionally includes a rotation speed control and a
rotation sweep control installed on the exterior surface.
[0020] In this same aspect, the method further includes opening the
latch and separating the upper casing and lower casing, placing the
control knob into the control knob lumen in the lower member and
placing the surgical laser fiber into the laser fiber lumen in the
lower member such that the laser fiber protrudes from the exit, as
well as closing the upper casing and lower casing and securing the
outer case with the latch. The method additionally includes
threading the surgical laser fiber protruding from the exit through
a working channel of an endoscopic surgical device to a surgical
site, activating the rotation speed control and the rotation sweep
control to initiate a rotational movement of the surgical laser
fiber about the longitudinal axis of the laser fiber, and
activating a laser source operatively connected to the surgical
laser fiber to initiate the release of laser energy from the
surgical laser fiber into the surgical site.
[0021] Other aspects of the invention are described in detail
below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a side view of a laser surgery device attached to
a cystoscope.
[0023] FIG. 1A is a cross-sectional view of an outer sheath of a
cystoscope.
[0024] FIG. 2 is a perspective view of the insertion of a laser
fiber into a laser surgery device.
[0025] FIG. 3A is a perspective view of the insertion of a securing
plug into a laser surgery device.
[0026] FIG. 3B is a perspective view of an assembled laser surgery
device.
[0027] FIG. 4 is a longitudinal cross-sectional view of a control
knob and a retaining plug inserted in an inner cylinder of a laser
surgery device.
[0028] FIG. 5 is a perspective view of the entry of a laser surgery
device.
[0029] FIG. 6 is a perspective view of the exit of a laser surgery
device.
[0030] FIG. 7 is a longitudinal cross-sectional view of a laser
surgery device.
[0031] FIG. 8 is a cross-sectional view of a laser surgery device
through a bearing channel.
[0032] FIG. 9 is a cross-sectional view of a laser surgery device
through a drive gear and transmission gear.
[0033] FIG. 10 is a perspective view of the entry of a laser
surgery device with a clamshell outer casing.
[0034] FIG. 11 is a perspective view of the exit of a laser surgery
device with a clamshell outer casing.
[0035] FIG. 12 is a longitudinal cross-sectional view of a laser
surgery device with a clamshell outer casing.
[0036] FIG. 13 is a cross-sectional view of a laser surgery device
with a clamshell outer casing through a drive gear and transmission
gear.
[0037] FIG. 14 is a cross-sectional view of a laser surgery device
with a clamshell outer casing through a hinge and a latch.
[0038] FIG. 15 is a detailed side view of a laser surgery device
attached to a cystoscope.
[0039] FIG. 16 is a cross-sectional view of a support arm with a
hinge and a clamp fitting.
[0040] FIG. 17 is a cross-sectional view of the attachment of a
support arm to a laser surgery device.
[0041] FIG. 18 is a cross-sectional view of a support arm
attachment fitting mounted in a support arm attachment
receptacle.
[0042] FIG. 19 is a side view of a laser surgery device attached to
a cystoscope and mounted on a flexible support arm.
[0043] FIG. 20 is a cross-sectional view of a series of support arm
links of a flexible attachment arm.
[0044] FIG. 21 is a longitudinal cross-sectional view of a laser
surgery device with an integrated stepper motor.
[0045] FIG. 22 is a cross-sectional view of the laser surgery
device with the integrated stepper motor showing an integrated gear
and four integrated electromagnets.
DETAILED DESCRIPTION OF THE INVENTION
[0046] The present invention relates to laser surgery devices and
methods of performing laser surgery using a laser surgery device.
More specifically, the present invention provides a laser surgery
device to rotate a surgical laser fiber about the longitudinal axis
of the laser fiber. The laser surgery device may rotate the laser
fiber in a first direction and in a second direction. The rotation
may be in a repeating pattern in which the laser fiber rotates
clockwise and then counterclockwise through a user-specified sweep
angle and an essentially constant rotation rate.
[0047] The device is designed for use with an endoscopic device
including but not limited to cystoscope, colonoscope, gastroscope,
proctoscope, rhinoscope, bronchoscope, otoscope, gynoscope,
laparoscope, arthroscope, thoracoscope, mediastinoscope,
amnioscope, and panendoscope. In an exemplary embodiment, the
endoscopic device is a cystoscope. For purposes of illustration,
the laser surgery device used with a cystoscope is described
herein.
[0048] In general, the device is typically constructed from
materials capable of undergoing sterilization procedures without
diminishing in function. Non-limiting examples of suitable
construction materials for the device include heat resistant
plastics including polyetheretherketones, polyetherimides, phenol
formaldehydes, and polytetrafluoroethylenes, and metals including
stainless steel, aluminum, titanium, and alloys thereof.
[0049] Detailed descriptions of various aspects of the device, as
well as methods of using the device to perform laser surgeries are
provided below.
I. Overview
[0050] Referring to FIG. 1, a device 100 is shown along with a
cystoscope 106. To conduct laser surgery, a distal end 114 and an
outer sheath 118 of the cystoscope 106 are inserted through the
urethra of a patient to situate a laser fiber tip 124 in the
vicinity of a surgical site, for example the prostate gland. The
cystoscope 106 includes optics 110 to view a surgical area in which
the laser surgery is performed. The surgical site is illuminated by
a fiber optic cable (not shown) through a light guide 112 and an
optics channel 120 located within the outer sheath 118.
[0051] Irrigation fluid may be provided to fill the bladder prior
to performing surgery and to irrigate the surgical site during the
surgical procedure by way of an irrigation water inlet (not shown)
that introduces fluid through the outer sheath 118 of the
cystoscope 106. The irrigation fluid is drained via an irrigation
fluid outlet 116.
[0052] A laser fiber 104 is inserted through a working channel 108
and a laser fiber channel 122 so that a laser fiber tip 124
protrudes from the distal end 114 of the cystoscope 106. In use,
the laser fiber tip 124 directs laser energy downward and away from
the distal end 114, causing the vaporization, ablation, and/or
cauterization of tissues in the surgical site.
[0053] The device 100 fits over the laser fiber 104 and may
optionally connect to the outside of the working channel 108. The
laser fiber 104 protrudes from one end of the device 100. The laser
fiber 104 is connected to a laser source (not shown) via a shielded
laser fiber 102, which protrudes from the opposite end of the
device 100. The device 100 may optionally fasten to cystoscope 106,
for example on the outside of the working channel 108 as shown in
FIG. 1.
[0054] In use, the device 100 is activated, causing the laser fiber
tip 124 to rotate about its longitudinal axis. In one aspect, the
laser fiber tip 124 rotates clockwise and then counterclockwise
through a user-specified sweep angle at an essentially constant and
user-specified speed. The surgeon may adjust the speed and/or sweep
angle of the laser fiber tip 124 during rotation of the laser fiber
104.
[0055] The device 100 may be held in the hand of the surgeon during
rotation of the laser fiber 104. Alternatively, as shown in FIG. 1,
the device 100 may be fastened in place for hands-free operation of
the device 100 during surgery.
[0056] The device 100 may slide over the laser fiber 104, as shown
in FIGS. 1-4 in order to mechanically connect the device 100 to the
laser fiber 104. Alternatively, the device 100 may open in a
clamshell fashion to fit over the laser fiber 104, as shown in
FIGS. 10-14.
II. Description of Laser Fiber
[0057] The insertion of the laser fiber 104 into the device 100 is
shown in FIG. 2. The laser fiber 104 is a continuous fiber optic
cable that ends at the laser fiber tip 124. The laser fiber tip 124
includes a lens (not shown) that directs laser energy in a narrow
beam or cone to the tissue on the surgical site. The laser fiber
tip 124 may also include markings to indicate the orientation of
the laser fiber 104, for example to indicate the direction in which
the laser energy is directed.
[0058] A control knob 202 may be attached to the laser fiber 104
such that the laser fiber 104 threads through the center of the
control knob 202. Typically the control knob 202 is approximately
cylindrical in shape, with the laser fiber 104 running through the
central axis of the control knob 202. At the end of the control
knob 202 opposite to the laser fiber 104, a shielded laser fiber
102 attaches to the laser fiber 104. The shielding typically ends
at the control knob 202 at the point of insertion of the laser
fiber 104 into the control knob 202.
[0059] The control knob 202 may also include a thumb knob 212 that
indicates the orientation of the laser fiber 104. When used without
the device 100, the control knob 202 is rotated about its
longitudinal axis in order to rotate the laser fiber 104 during
surgery. The thumb knob 212 helps to assess the extent of the sweep
angle applied to the laser fiber 104 by the surgeon.
[0060] The control knob 202 may also include textural features to
facilitate gripping the control knob 202 while rotating the control
knob 202 during a surgical procedure. For example, the control knob
202 may include a plurality of raised knurls 220 separated by
depressions 218 on the surface of the control knob 202. The knurls
220 and depressions 218 may run longitudinally along the entire
length of the control knob, as illustrated in FIG. 2.
III. Description of Device
[0061] Referring to FIG. 5, the device 100 includes a hollow inner
cylinder 314 rotatably connected to a hollow outer case 208 such
that the inner cylinder 314 rotates about its longitudinal axis
within the outer case 208. The inner cylinder 314 surrounds a
control knob lumen 204 that is contoured to receive the control
knob 202 (not shown). The control knob lumen 204 includes a notch
210 at its upper portion, shaped to accommodate the thumb knob 212
of the control knob 202. The device 100 also includes an entrance
214 in which the laser fiber 104 is inserted, and a device exit 216
from which the laser fiber 104 protrudes when mounted in the device
100.
[0062] The outer case 208 forms an exterior surface 502 that may be
smooth or textured to facilitate gripping the device 100 during
rotation of the laser fiber 104. A reference nub 504 is attached to
the upper part of the exterior surface 502 to indicate the
orientation of the device 100. The reference nub 504 is typically a
fin-shaped projection that extends radially outward from the
exterior surface 502 of the device 100. The reference nub 504 is
typically centered along the length of the outer case 208, although
the reference nub 504 may be located anywhere on the outer case.
The reference nub 504 may range in length between about 5% and 100%
of the total length of the outer case 208.
[0063] The device 100 may further include an optional recharging
outlet 506 mounted on the outer case 208. The recharging outlet 506
is electrically connected to a power source 728 (not shown) inside
of the device 100. A connector plug of a power cord connected to an
electrical power outlet of an electrical utility grid (not shown)
may be inserted into the recharging outlet 506 to recharge the
power source 728 (not shown). After charging the power source 728,
the connector plug of the power cord may be disconnected from the
recharging outlet 506 for wireless use of the device 100.
[0064] Referring to FIG. 6, the outer case 208 further defines a
main lumen 508 within which the inner cylinder 314, and other
components of the device 100 such as the motor 725 (not shown) are
contained. The device 100 may further include a power control 610,
a rotation speed control 602 and a rotation sweep control 604
installed on the exterior surface 502. The power control 610 is an
electrical switch that opens and closes the electrical connection
between the power source 728 (not shown) and the motor 725 (not
shown). The rotation speed control 602 is an electrical switch that
is electrically connected to the motor speed control circuit 732
(not shown), and the rotation sweep control 604 is an electrical
switch that is electrically connected to the motor sweep control
circuit 734 (not shown). The rotation speed control 602 and the
rotation sweep control 604 may include any type of electrical
switch known in the art. The rotation speed control 602 and the
rotation sweep control 604 may be implemented as two separate
switches, or the function of both controls may be implemented as a
single switch. Non-limiting examples of suitable electrical
switches include pushbuttons, toggles, membrane switches, variable
resistance switches, DIP switches, and knife switches.
[0065] The electrical switches may be selected to provide feedback
to the user to indicate the current switch settings using any
feedback mechanism known in the art. For example, the switch may be
a dial or slider switch that moves past a series of markings
printed on the outer case 208 to visually indicate the control
setting of the switch. The switch may optionally incorporate a
visual display such as a series of one or more LEDs in a line that
illuminate in a pattern such as a bar of increasing length, or by
changing color or brightness, to indicate the setting of the
switch. The device 100 may encode the switch settings as an
electrical or electromagnetic signal that may be received and
superimposed onto the image of the surgical area viewed by the
optics 110.
[0066] The switch may be a toggle switch that indicates a switch
setting by one or more discrete tactile clicks and optionally a
change in the position of an end of the switch. The switch may
signal its position by vibrating in one or more pulses that change
in the vibration frequency of each pulse, the frequency of pulses
per second, the magnitude of the vibration, and any combination
thereof. The switch may signal its position by variation in the
force required to change the switch setting to a different
position. For example, a switch may require a higher force to move
to its most extreme setting. The switch may change the physical
size or shape of the device 100 to indicate the switch setting.
[0067] Alternatively, an auditory feedback mechanism may be used to
indicate the setting of a control switch. The switch may emit one
or more auditory tones that change in pitch, loudness, frequency of
tones per second, and any combination thereof to indicate the
position of the switch.
[0068] The rotation speed control 602 may command at least one or
more discrete rotation speeds for the laser fiber 104, or the
rotation speed control 602 may command a continuous range of
rotation speeds. The rotation speed control 602 may command a range
of rotation speeds ranging from about 5.degree./second to about
360.degree./second.
[0069] The rotation sweep control 604 may command at least one or
more discrete sweep angles for the laser fiber 104 or the rotation
sweep control 604 may command a continuous range of sweep angles.
Sweep angles, as defined herein, are specified as a maximum angle
of rotation of the laser fiber 104 clockwise or counterclockwise
relative to a vertical reference plane. The rotation sweep control
604 may command a range of sweep angles ranging from about
5.degree. to about 180.degree. clockwise and counterclockwise
relative to a vertical reference plane. The rotation sweep control
604 may command a range of sweep angles ranging from about
30.degree. to about 90.degree. clockwise and counterclockwise
relative to a vertical reference plane.
[0070] Optionally mechanical stops may be included that limit the
sweep range to a within a desired angular range of travel. The
mechanical stops may prevent the laser fiber 104 from moving to a
position in which the laser fiber tip 124 or any part of the
cystoscope 106 may be damaged while the laser is operational. The
function of the mechanical stops may also be implemented by using
the motor control circuits to cut power to the motor 725 to prevent
movement of the laser fiber 104 to undesired positions.
[0071] The device 100 may optionally include a compressible
material 606 situated within the laser fiber lumen 605 (not shown)
to hold the laser fiber 104 (not shown) in place during rotation of
the laser fiber 104. The compressible material 606 is selected to
maintain the laser fiber 104 near the center of the cross-section
of the working channel 108 without imparting a significant amount
of friction to the laser fiber 104. The compressible material
typically contains a small passageway through which the laser fiber
104 may pass or forms a passageway for the laser fiber 104 as the
laser fiber 104 is threaded through the working channel 108 (not
shown). Any suitable material may be used as the compressible
material including but not limited to natural rubber, synthetic
polyisoprene, butyl rubber, polybutadiene, styrene-butadiene
rubber, nitrile rubber, chloroprene rubber, polychloroprene,
ethylene propylene rubber, ethylene propylene diene rubber,
epichlorohydrin rubber, polyacrylic rubber, silicone rubber,
fluorosilicone rubber, polyether block amides, chlorosulfonated
polyethylene, ethylene-vinyl acetate, and combinations thereof.
[0072] FIG. 7 shows a cross-sectional view of the device 100. The
outer case 208 includes an exterior surface 502 and an interior
surface 710. The interior surface 710 defines a main lumen 508
containing the inner cylinder 314 and other device components. The
inner cylinder 314 includes an inner surface 702 and an outer
surface 706. The inner cylinder 314 typically has a larger outer
diameter near the entrance 214 to accommodate the control knob
lumen 204, and contracts to a smaller outer diameter in the region
716 containing the laser fiber lumen 605. An inner compartment 718
is defined between the interior surface 710 of the outer case 208
and the outer surface 706 of the inner cylinder 314.
[0073] The interior surface 710 of the outer case 208 further
includes two or more circumferential outer depressions forming the
walls of two or more outer bearing channels 712. A plurality of
bearings 714 are situated within each of the at least two outer
bearing channels 712. Similarly, the outer surface 706 of the inner
cylinder 314 includes two or more circumferential depressions
forming the walls of two or more inner bearing channels 708. Each
of the at least two inner bearing channels 708 is aligned with each
of the corresponding outer bearing channels 712. The plurality of
bearings 714 are free to roll along the circumferential enclosures
formed between each inner bearing channel 708 and each outer
bearing channel 712, thereby rotatably connecting the inner
cylinder 314 to the outer case 208.
[0074] The inner surface 702 of the inner cylinder 314 forms a
control knob lumen 204. The upper region of the inner surface 702
may optionally form two or more ratchet teeth 704 that are shaped
to interlock with the ratchet catch 306 of the securing plug 300
(not shown). The inner surface 702 also forms the laser fiber lumen
608 optionally filled with an amount of compressible material 606;
the laser fiber lumen 608 opens into the control knob lumen 204 and
to the device exit 216 at opposing ends.
[0075] The device 100 further includes a motor 725 that includes a
driveshaft 724 protruding from a power unit 726. The rotational
axis of the driveshaft 724 is in parallel alignment with the
longitudinal axis of the inner cylinder 314. The power unit 726 is
attached to the interior surface 710 of the outer case 208.
[0076] Any suitable power unit 726 known in the art may be utilized
in the device 100 so long as the power unit 726 is capable of
producing sufficient power within the space of the inner
compartment 718 using power sources commonly available in an
operating room, including but not limited to electrical power or
compressed air. Further, the power unit 726, like the other
components of the device 100, must be capable of withstanding the
conditions of sterilization without losing operational capability.
The power unit 726 may be reversible to simplify the design and
operation of the device 100. Non-limiting examples of suitable
power units 726 include stepper motors, DC electric motors, AC
electric motors, pneumatic motors, and hydraulic motors. In an
exemplary embodiment, the power unit 726 is a stepper motor.
[0077] A drive gear 722 is connected the free end of the driveshaft
724 opposite to the power unit 726 through the center of the drive
gear 722 such that the rotational axis of the drive gear 722 is
coincident with the rotational axis of the driveshaft 724. The
drive gear 722 includes at least two or more drive gear teeth 723
that mesh with at least two or more transmission gear teeth 721 of
a transmission gear 720. The transmission gear 720 is attached to
the outer surface 706 of the inner cylinder 314 such that the axis
of rotation of the transmission gear 720 is coincident with the
longitudinal axis of the inner cylinder 314. The laser fiber lumen
605 passes through the center of the drive gear 722. The drive gear
teeth 723 and transmission gear teeth 721 mesh to form an operative
connection between the motor 725 and the inner cylinder 314.
[0078] The inner compartment 718 further contains a power source
728 that is operatively connected to the motor 725. Any suitable
power source 728 known in the art may be used in the device 100 so
long as the power source 728 is compatible with the requirements of
the motor 725. Non-limiting examples of suitable power sources 728
include a compressed air source, a hydraulic pressure source, an AC
power supply, a DC power supply, a battery, and a rechargeable
battery. In an exemplary embodiment, the power source 728 is a
rechargeable electric battery. The use of batteries and
rechargeable batteries provides for wireless operation of the
device 100.
[0079] Motor control circuitry 730 is situated within the inner
compartment 718. The motor control circuitry 730 includes a motor
speed control circuit 732 operatively connected to the rotation
speed control 602 (not shown), and a motor sweep control circuit
734 operatively connected to the rotation sweep control 604 (not
shown). Optionally, the motor control circuitry 730 may also
include a laser fiber extension/retraction control circuit (not
shown) operatively connected to a longitudinal control (not
shown).
[0080] Any suitable control circuit components known in the art may
be used in the device 100, so long as the control circuit
components are appropriate for the type of power unit 726 selected
for the device 100. Non-limiting examples of suitable motor speed
control circuits 732 include variable resistors, torque converters,
valves, transistors in an H-bridge configuration, SCR controls, PWM
controls, MOSFETs, diodes, and switches. Non-limiting examples of
suitable motor sweep control circuits 734 include transistors in an
H-bridge configuration, position sensors with switches, servos with
switches connected to position feedback sensors, diodes, and
relays. Alternatively, the motor control circuitry 730 may be
implemented as an integrated circuit or as a microprocessor.
[0081] FIG. 8 shows a cross-section of the device 100 through one
of the outer bearing channels 712 and associated inner bearing
channel 708. The bearings 714 are free to roll circumferentially,
allowing the inner cylinder 314 to rotate relative to the outer
case 208.
[0082] FIG. 9 shows a cross-section of the device 100 through the
drive gear 722 and the transmission gear 720, in which the drive
gear teeth 723 are meshed with the transmission gear teeth 721
within the inner compartment 718. When the driveshaft 724 of the
motor 725 turns the drive gear 722, the drive gear 722 turns the
transmission gear 720, thereby causing the inner cylinder 314 to
rotate within the outer case 208.
[0083] Referring to FIG. 10, the device 100A may include at least
two hinges 1002 rotatably joining the upper casing 1004 and the
lower casing 1006 along a hinge line. The inner cylinder 314 may be
divided into an upper member 1008 that is operably attached to the
upper casing 1004 and a lower casing 1006 that is operably attached
to the lower casing 1006. The control knob lumen 204 may have a
diameter sized to accommodate the shielded laser fiber 102 (not
shown) near the entrance 214. The laser fiber 104 (not shown) and
the control knob 202 (not shown) are placed within the laser fiber
lumen 605 (not shown) and the control knob lumen 204 (not shown),
respectively, when the upper casing 1004 and the lower casing 1006
are separated, placing the device 100A in an open position.
[0084] Referring to FIG. 11, once the laser fiber 104 (not shown)
and the control knob 202 (not shown) are placed within the device
100A, the upper casing 1004 and the lower casing 1006 are rotated
together and secured with a latch 1102 that is mounted on the
exterior surface 502 of the outer case 208, situated diametrically
opposite to the hinge line.
[0085] FIG. 12 is a cross section of the device 100A, showing the
lower half of the device 100A including the lower casing 1006. In
order to align the upper casing 1004 (not shown) with the lower
casing 1006, the lower casing 1006 includes at least two or more
alignment peg receptacles 1202 to receive the corresponding
alignment pegs 1402 (not shown) included in the upper casing 1004
(not shown). To properly align the upper member 1008 (not shown)
with the lower member 1010, the lower member 1010 also contains at
least two or more alignment peg receptacles 1202 that receive the
corresponding alignment pegs 1402 included in the upper member
1008.
[0086] FIG. 13 is a cross-section through the latch 1102 of the
device 100A, showing the upper casing 1004 and lower casing 1006
secured together by the latch 1102. The latch 1102 may be any
releasable fastener mechanism known in the art that draws the upper
casing 1004 toward the lower casing 1006 as the latch is fastened
in order to firmly clamp the laser fiber 104 (not shown) and
control knob 202 (not shown) inside the device 100A in its closed
position. Non-limiting examples of suitable latches 1102 include
knuckle catches, rotary catches, tension catches, magnetic catches,
and draw latches. In an exemplary embodiment, the latch 1102 is a
draw latch.
[0087] The latch 1102 may be surface-mounted on the exterior
surface 502, or parts of the latch 1102 may be formed from the
material of the outer case 208 in the region where the edges of the
upper casing 1004 and lower casing 1006 meet diametrically opposite
to the two or more hinges 1002, as shown in FIG. 13.
[0088] FIG. 14 is a cross-section through the device 100A through
one of the hinges 1002. One of at least two alignment pegs 1402 are
situated diametrically opposite to a hinge 1002 in FIG. 14. The
alignment peg 1402 protrudes downward from the edge of the upper
casing 1004 and fits into an alignment peg receptacle 1202 that is
inset into the edge of the lower casing 1006. Fitting the alignment
pegs 1402 into the corresponding alignment peg receptacles 1202
aligns the upper casing 1004 with the lower casing 1006 and aligns
the upper member 1008 with the lower member 1010 when the device
100A is in the closed position.
[0089] The alignment peg 1402 may protrude upwards from the edge of
the lower casing 1006 and fit into an alignment peg receptacle 1202
that is inset into the edge of the upper casing 1004.
Alternatively, a ridge protruding from the edge of the upper casing
1004 may fit into a groove cut into the edge of the lower casing
1006. The edge of the upper casing 1004 may optionally include
notches or scallops that fit into corresponding shapes cut into the
edge of the lower casing 1006.
[0090] Referring to FIG. 15, a support arm 1502 may be used to
attach the device 100 to the working channel 108, allowing the
hands-off operation of the device 100 during surgery. The support
arm 1502 is typically an elongated structure that includes a clamp
fitting 1504 on one end, and a support arm receptacle 1508 on the
opposite end.
[0091] The clamp fitting 1504 attaches the support arm 1502 to some
part of the cystoscope 106, for example the exterior of the working
channel 108 as shown in FIG. 15. The clamp fitting 1504 may be
firmly attached by twisting a tightening screw 1506. Any clamping
mechanism known in the art may be used to secure the support arm
1502 to the working channel 108, including but not limited to band
clamps, bar clamps, Cardellini clamps, C-clamps, magnetic clamps,
handscrew clamps, vise-grip clamps, and toggle clamps.
[0092] The support arm receptacle 1508 removably attaches the
support arm 1502 to the device 100. Any removable attachment device
known in the art may be used including but not limited to clamping
mechanisms, latching mechanisms, screw fitting mechanisms, magnetic
coupling mechanisms, and Velcro mechanisms. As shown in FIG. 15,
the support arm receptacle 1508 may be a socket contoured to
accommodate a support arm attachment fitting 1510. The support arm
1502 is attached to the exterior surface 502 of the outer case 208
(not shown). The support arm 1502 may further include a quick
release lever 1512 that locks the support arm attachment fitting
1510 into the support arm receptacle 1508. Any attachment mechanism
may be used so long as the device 100 may be quickly and easily
removed during rotation of the laser fiber 104 with minimal
mechanical disruption to the device 100 or the laser fiber 104 (not
shown). By actuating the quick release lever 1512, the support arm
1502 may be disengaged from the device 100 such that the physician
may manually hold the device 100 while the device 100 provides the
rotation to the laser fiber 104.
[0093] The support arm 1502 may optionally include a support arm
hinge 1514 designed and located to swing the support arm receptacle
1508 away from the device 100 and the cystoscope 106 when the
support arm 1502 is detached from the device 100.
[0094] FIG. 16 is a cross section of the support arm 1502 taken
through the clamp fitting 1504 and support arm hinge 1514. The
clamp fitting 1504 may include a stationary arm 1602 as well as an
adjustable arm 1604 that pivots on a hinge 1606. The clamp fitting
1504 is placed around the working channel 108 and the adjustable
arm 1604 is tightened toward the stationary arm 1602 by rotating
the tightening screw 1506. The tightening screw passes through a
flange 1610 containing an unthreaded opening 1620 sized to receive
the tightening screw 1506 and into a screw fitting 1618 that is
threaded to receive the threads of the tightening screw 1506. The
screw fitting 1618, contained within a moveable arm flange 1608,
moves the adjustable arm 1604 toward the stationary arm 1602 as the
tightening screw 1506 is tightened.
[0095] The support arm hinge 1514 includes a hinge attachment
fitting 1614 that fits between the blades of a fork fitting 1612.
The hinge attachment fitting 1614 is joined to the fork fitting
1612 by a hinge pin 1616 inserted through a series of aligned holes
through the fork fitting 1612 and the hinge attachment fitting
1614. Any hinge mechanism known in the art may be used at any
location along the support arm, so long as the support arm is
capable of swinging away from the device 100 and cystoscope 106
when the support arm 1502 is detached from the device 100.
[0096] FIG. 17 is a cross-section of the support arm receptacle
1508 and support arm attachment fitting 1510. The support arm
attachment fitting 1510 slides into the support arm receptacle 1508
and is held in the support arm receptacle 1508 by the fastening of
the quick-release lever 1512.
[0097] Referring to FIG. 18, the support arm receptacle 1508 may
have a square-shaped cross-sectional shape that fits into the
square-shaped depression in the support arm attachment fitting
1510. Any cross-sectional shape may be used, so long as the
rotation or other movement of the support arm attachment fitting
1510 relative to the support arm receptacle 1508 is minimized when
the support arm 1502 is attached to the device 100.
[0098] The support arm 1502 may be constructed from any suitable
rigid material possessing sufficient strength to support the device
100 during rotation of the laser fiber 104. In addition, the
support arm material should be capable of withstanding the
conditions of sterilization without distorting in shape or
weakening in strength. Non-limiting suitable materials to be used
for the support arm 1502 include high-temperature polymers, and
metals such as stainless steel, aluminum, and titanium.
[0099] Referring to FIG. 19, a flexible support arm 1902 may be
used to attach the device 100 to the cystoscope 106. The flexible
support arm 1902 is designed to flex when pushed or twisted by the
surgeon in order to adjust the position of the device 100 relative
to the cystoscope 106 during the operation of the device 100.
However, the flexible support arm 1902 should be suitably rigid in
the absence of adjustments by the surgeon to allow hands-off
operation of the device 100. In addition, the flexible support arm
1902 is designed to bend to away from the device 100 and cystoscope
106 when the device 100 is detached from the flexible support arm
1902.
[0100] The flexible support arm 1902, as shown in cross-section in
FIG. 20, may include a series of support arm links 2002A-D that are
mechanically linked together in a sequential series. Each link 2002
includes a neck 2006 that connects to a spherical ball 2008 at one
end of the link 2002. Within each link 2002, the neck 2006 and
spherical ball 2008 are attached to a link body 2004. The opposite
end of the link 2002 is formed into a cup-shaped socket fitting
2010 that is contoured to receive a ball 2008 from another link
2002. For example, the ball 2008 of link 2002a fits into the socket
fitting 2010 of link 2002b, and the ball 2008 of link 2002b fits
into the socket fitting 2010 of link 2002c, and so on. The ball
2008 and adjacent socket fitting 2010 form a ball-and-socket joint
capable of rotating in any arbitrary direction in response to
forces applied by the surgeon. However, the interface between each
ball 2008 and its adjacent socket fitting 2010 should possess
static friction forces that are sufficiently strong to hold the
device 100 in place during rotation of the laser fiber 104.
[0101] Any material possessing sufficient material strength and
static friction characteristics may be used in the construction of
the flexible support arm. In addition, the material of the support
arm should be capable of withstanding the conditions of
sterilization without degrading. Non-limiting examples of suitable
materials for the flexible support arm include high-temperature
polymers, and metals such as stainless steel, aluminum, and
titanium.
[0102] Referring to FIGS. 21 and 22, the motor used to rotate the
interior cylinder 314 may be integrated into the structures of the
device 100B. As shown previously, the device 100B may include an
inner cylinder 314 that rotates within the interior surface 710 of
the outer case 208 on a plurality of bearings 714 situated between
two or more inner bearing channels 708 and corresponding outer
bearing channels 712. The inner cylinder 314 typically has a larger
outer diameter near the entrance 214 to accommodate the control
knob lumen 204, and contracts to a smaller outer diameter in the
region containing the laser fiber lumen 605. An inner compartment
718 is defined between the interior surface 710 of the outer case
208 and the outer surface 706 of the inner cylinder 314.
[0103] The device 100B also includes a nonferrous gear body 2102
attached to the outer surface 706 of the inner cylinder 314 such
that the axis of rotation of the nonferrous gear body 2102 is
coincident with the longitudinal axis of the inner cylinder 314. A
plurality of ferrous gear teeth 2104 are attached to the outer
surface of the nonferrous gear body 2102 in a circumferential
pattern. Two or more electromagnets 2106A-D are attached to the
interior surface 710 of the outer case 208 in alignment with the
plurality of ferrous gear teeth 2104 and distributed around the
circumference of the interior surface 710.
[0104] The plurality of ferrous gear teeth 2104 and the two or more
electromagnets 2106A-D together function as a stepper motor. When
one of the electromagnets 2106A is activated, the ferrous gear
teeth 2104 in the vicinity of the activated electromagnet 2106A are
attracted by the magnetic force generated by the activated
electromagnet 2106A, causing a rotation of the inner cylinder 314.
As each successive electromagnet 2106B-D is activated, all other
electromagnets 2106 are inactivated, and the inner cylinder 314 is
further rotated by the magnetic attraction between the ferrous gear
teeth 2104 and the activated electromagnet 2106B-D.
[0105] The rotation speed, rotation direction, and sweep angle may
all be determined by the activation sequence and timing of the
electromagnets 2106A-D. The activation sequence and timing of the
electromagnets 2106A-D may be controlled by the motor speed control
circuit 732 and the motor sweep control circuit 734 (not shown).
The period of time that each electromagnet 2106A-D is activated,
and the total time taken to activate all electromagnets 2106A-D in
the activation cycle may be used to control the rotation speed of
the inner cylinder 314. The simultaneous activation or inactivation
of all electromagnets 2106A-D may be used to stop the rotation of
the inner cylinder 314. The sequential order in which each of the
electromagnets 2106A-D is individually activated may be used to
specify the direction of rotation of the inner cylinder 314.
[0106] For example, in order to achieve a clockwise rotation of the
inner cylinder 314, the electromagnets may be activated in a
repeating clockwise pattern such as electromagnetic 2106A, followed
by electromagnetic 2106C, electromagnet 2106B, electromagnet 2106D,
and then electromagnet 2106A to repeat the activation cycle.
Similarly, the electromagnets may be activated in a
counterclockwise pattern in order to reverse the direction of
rotation of the inner cylinder 314.
IV. Installation of Laser Fiber into Device
[0107] In various configurations, the laser fiber 104 may be
installed in the device 100 by sliding the laser fiber 104 through
the entrance 214, as shown in FIG. 2. As shown in FIGS. 10-12, the
device 100A may optionally open in a clamshell manner such that the
laser fiber 104 (not shown) may be placed directly inside the laser
fiber lumen 605 (not shown); the laser fiber 104 may then be
secured by closing the device 100A using a latch 1102.
[0108] A. Slide Laser Fiber into Device
[0109] Referring to FIG. 2, the laser fiber 104 is inserted into
the control knob lumen 204 at the entrance 214 of the device 100.
As the laser fiber 104 is inserted, it passes through a laser fiber
lumen 605 (not shown) that connects to the control knob lumen 204
and opens to the device exit 216. As the laser fiber 104 is pushed
further through the device 100, the insertion face 228 of the
control knob 202 is inserted into the control knob lumen 204.
[0110] The device 100 may include a contoured inner cylinder 206
that includes a plurality of ridges 222 separated by furrows 224.
Each ridge 222 of the contoured inner cylinder 206 is contoured to
be opposite in shape to each depression 218 of the control knob
202. Each furrow 224 of the contoured inner cylinder 206 is
contoured to be opposite in shape to each knurl 220 of the control
knob 202. As a result, the inner surface 702 (not shown) of the
contoured inner cylinder 206 engages cooperatively with the control
knob 202 as the control knob 202 is inserted into the contoured
inner cylinder 206. The control knob 202 may be force-fit into the
device 100 and held in place by frictional forces.
[0111] Alternatively, the control knob 202 may be held in place by
a securing plug 300, as shown in FIG. 3A. The securing plug 300 may
include a cylindrical plug body 302 contoured to fit within the
control knob lumen 204 behind the control knob 202. The securing
plug 300 may further include a plug notch 304 extending from the
central axis radially downward through the lower edge of the plug
body 302 for the entire length of the plug body 302. The securing
plug 300 may also include an elongated insertion arm 308 attached
to the removal end 312 of the securing plug 300. The insertion arm
308 may be mechanically engaged to the ratchet catch 306 such that
the ratchet catch 306 is reversibly retracted by applying a lateral
inward force to the insertion arm 308.
[0112] The plug notch 304 of the securing plug 300 may be slipped
over the shielded laser fiber 102, as shown in FIG. 3A. The
securing plug 300 may be slipped along the shielded laser fiber 102
toward the control knob lumen 204. The insertion arm 308 may then
be used to push the securing plug 300 further into the control knob
lumen 204 until the insertion end 310 of the securing plug 300
butts up against the removal face 226 of the control knob 202,
thereby holding the laser fiber 104 and control knob 202 in place.
The securing plug 300 is shown fully inserted into the control knob
lumen 204 in FIG. 3B.
[0113] The securing plug 300 may further include a ratchet catch
306 designed to mesh with at least one ratchet tooth 704 on the
upper part of the notch 210 in the inner cylinder 314, as shown in
FIG. 4. After the control knob 202 is inserted into the control
knob lumen 204, the securing plug 300 is inserted into the control
knob lumen 204 such that the ratchet catch 306 engages with at
least one ratchet tooth 704. As the securing plug 300 advances into
the control knob lumen 204, the ratchet catch 306 deflects downward
as it passes each ratchet tooth 704 and returns to an undeflected
position between adjacent ratchet teeth 704. The securing plug 300
is advanced into the control knob lumen 204 until the insertion end
310 is pressed against the removal face 226 of the control knob
202. The control knob 202 is immovably held in place by the
pressure of the insertion end 310 of the securing plug 300 against
the removal face 226 of the control knob 202.
[0114] Once installed, the securing plug 300 is held in place by
the ratchet catch 306, which is mechanically engaged with one of
the ratchet teeth 704. To remove the securing plug 300, a lateral
force may be applied to the insertion arm 308, causing the
retraction of the ratchet catch 306 into the plug body 302. The
securing plug 300 may then be pulled out of the control knob lumen
204.
[0115] Alternatively, the plug body 302 may be contoured such that
the securing plug 300 may be inserted and force-fit into the
control knob lumen 204 and held in place by frictional forces. The
securing plug 300 may optionally be threaded on its outer surface
in order to twist into the control knob lumen 204 and the inner
surface of the control knob lumen 204 may be similarly threaded to
receive the plug body 302. The securing plug 300 may be held in
place using magnets incorporated into the plug body 302 and the
inner cylinder 314, using a clip mounted on the shielded laser
fiber 102 between the plug body 302 and the entrance 214, a clip
attached to the outer case 208, by retaining pins extending from
the plug body 302 into the inner cylinder 314, or by retaining pins
extending from the inner cylinder 314 into the plug body 302.
[0116] B. Place Laser Fiber into Device with Clamshell Outer
Casing
[0117] The device 100A may optionally open in a clam-shell fashion,
as previously described and illustrated in FIG. 10 and FIG. 11. The
device 100A may be opened to expose the lower member 1010, as
illustrated in FIG. 12. After the device 100A is opened, the laser
fiber 104 is placed into the laser fiber lumen 608 and the control
knob 202 is placed in the control knob lumen 204. The control knob
lumen 204 may be contoured to closely fit the external shape of the
control knob 202. The upper casing 1004 (not shown) is then closed
over the lower casing 1006 and secured by fastening the latch 1102
(not shown). The tension of the fastened latch 1102 clamps the
control knob 202 and laser fiber 104 securely inside the control
knob lumen 204 and the laser fiber lumen 608 respectively.
[0118] Alternatively, the control knob lumen 204 may be lined with
a compressible material (not shown) to enhance the fit of the
control knob 202 within the control knob lumen 204. This
compressible material may be attached to the inner surface 702
within the control knob lumen 204. Any suitable compressible
material may be used including but not limited to natural rubber,
synthetic polyisoprene, butyl rubber, polybutadiene,
styrene-butadiene rubber, nitrile rubber, chloroprene rubber,
polychloroprene, ethylene propylene rubber, ethylene propylene
diene rubber, epichlorohydrin rubber, polyacrylic rubber, silicone
rubber, fluorosilicone rubber, polyether block amides,
chlorosulfonated polyethylene, ethylene-vinyl acetate, and
combinations thereof.
V. Method of Using Device
[0119] The device 100 may be used to perform a laser surgical
procedure. The method of performing a surgical laser procedure
includes providing a surgical laser fiber 104 protruding from a
control knob 202, sliding the laser fiber 104 through the laser
fiber lumen 605 as described above, and inserting the securing plug
300 behind the control knob 202 to securely fasten the laser fiber
104 and control knob 202 inside the device 100. This method further
includes threading the laser fiber 104 through the working channel
108 of the cystoscope 106 until the laser fiber 104 is in the
proximity of the surgical site. Once the laser fiber 104 is in
place in the surgical site, the rotation speed control 602 and
rotation sweep control 604 are activated, resulting in the
activation of the motor speed control circuit 732 and motor sweep
control circuit 734, respectively. The motor control circuitry 730
activates the power unit 726, which in turn rotates the driveshaft
724. The rotation of the driveshaft 724 is transmitted to the inner
cylinder 314 via the transmission gear 720. The rotation of the
inner cylinder 314 imparts a corresponding rotation to the laser
fiber 104, which is secured within the inner cylinder 314. The
rotational motion of the laser fiber 104 may include a repeated
pattern described above. This method further includes activating
the laser source that is connected to the laser fiber 104,
resulting in the release of laser energy into the surgical
site.
[0120] The rotation speed and/or the sweep angle associated with
the rotational motion of the laser fiber 104 may be held at
essentially constant values for the duration of the surgical
procedure. Alternatively, the rotation speed and/or sweep angle may
be increased or decreased independently during the duration of the
surgical procedure by manipulating the rotation speed control 602
and rotation sweep control 604, respectively.
[0121] In an alternative method of performing a surgical laser
procedure, the laser fiber 104 and control knob 202 may be placed
inside of the device 100 by opening the device 100 in a
clamshell-like manner and placing the laser fiber 104 and control
knob 202 into the laser fiber lumen 605 and control knob lumen 204
and closing the device 100, as described above. This method
performing a surgical laser procedure then proceeds by activating
the rotation speed control 602, rotation sweep control 604, and
laser source as described above.
VI. Alternative Aspects of the Device
[0122] A. Alternative Motions of Laser Fiber
[0123] The device 100 may impart alternative motions to the laser
fiber 104 in addition to the rotational movements described above
during operation of the device 100. The device 100 may impart a
displacement along the longitudinal axis of the laser fiber 104
corresponding to an insertion or withdrawal motion of the laser
fiber 104 from the surgical site. The displacement along the
longitudinal axis may occur in a forward direction and then a
reverse direction in a repeating cycle, corresponding to a cyclic
insertion and withdrawal motion. Alternatively, the displacement
along the longitudinal axis may occur in a the insertion direction
only, or in the withdrawal direction only, with no cyclic
longitudinal direction change. The speed of the longitudinal
motion, and the displacement distance relative to a reference
displacement may be independently varied during the rotation of the
laser fiber 104 by the device 100.
[0124] The longitudinal and rotational movements of the laser fiber
104 may be accomplished simultaneously, or the longitudinal
movements may be accomplished independently of the rotational
movements. The longitudinal movements may further be implemented as
a direct function of the rotational movements. The functional
dependence of the longitudinal movements upon the rotational
movements may be determined by the motor speed control circuit 732,
motor sweep control circuit 734, or any combination thereof. A
separate switch may be included in the device 100 to control the
longitudinal motion of the laser fiber 104, or the longitudinal
control function may be integrated into one or more switches that
also control the rotational movement of the laser fiber 104.
[0125] B. Alternative Control Schemes of Laser Fiber Movement
[0126] The device 100 may implement any one or more of at least
several control schemes to control the movement of the laser fiber
104 by the device 100. The rotation speed, sweep angle,
longitudinal displacement distance and longitudinal displacement
speed may be controlled independently using the corresponding
controls. Alternatively, the rotation speed, sweep angle,
longitudinal displacement speed, and longitudinal displacement
distance may be controlled in a coordinated manner using a feedback
control scheme in which any one or more of the states of the laser
fiber motion including but not limited to rotation speed, sweep
angle, longitudinal displacement speed, and longitudinal
displacement distance are measured and communicated to a control
system that may automatically adjust any one or more of the states
of the laser fiber motion using one or more previously stored
functions of any one or more of the states of the laser fiber
motion. Any one or more of the states of the laser fiber motion may
be adjusted as a function of other measured feedback quantities
including but not limited to the cavitation of the fluid in the
surgical site, the temperature of the fluid in the surgical site,
the location of the laser fiber tip 124 within the surgical site,
the temperature of the laser tip 124, the color of tissues in the
surgical site, and the laser power setting of the laser source.
[0127] In one illustrative example, the device 100 may include a
control system scheme in which the rotation speed is adjusted as a
function of the sweep angle, in order to maintain a constant
rotation period, defined herein as the time taken by the laser
fiber 104 to rotate from its most clockwise position to its most
counterclockwise position and back to its starting position. In
this example, the control system would slow down the rotation speed
of the laser fiber 104 if the surgeon commanded a narrower sweep
angle, so that the time taken by the laser fiber 104 to sweep
through one cycle at the narrower sweep angle was the same as the
time taken to sweep through one cycle at the previous wider sweep
angle.
[0128] C. Recording and Storage of Laser Fiber Movements
[0129] The device 100 may optionally include computer readable
media to store the laser fiber movements accomplished by the device
100 for review after completion of the surgical procedure. The
computer readable media may include volatile media, nonvolatile
media, removable media, non-removable media, and/or other media
that can be accessed by a general purpose or special purpose
computing device. For example, computer readable media may include
computer storage media and communication media. Computer storage
media further may include volatile, nonvolatile, removable, and/or
non-removable media implemented in a method or technology for
storage of information, such as computer readable instructions,
data structures, program modules, and/or other data. Communication
media may, for example, embody computer readable instructions, data
structures, program modules, algorithms, and/or other data,
including as or in a modulated data signal. The communication media
may include an information delivery system. The communication media
may include wired and/or wireless connections and technologies and
may be used to transmit and/or receive wired or wireless
communications. Combinations and/or sub-combinations of the
systems, components, modules, and methods and processes described
herein may be made.
[0130] The computer readable media may record any data signal
generated by the device 100 that may be used to reconstruct the
laser fiber movements accomplished by the device 100 during a
surgical procedure. Non-limiting data signals that may be recorded
on the computer readable media include electrical signals such as
voltages and currents generated by any of the electrical components
of the device 100 including but not limited to the motor control
system, power supply, and motor.
[0131] Alternatively, the computer readable media may record
signals generated by sensors included in the device 100 to monitor
the laser fiber movements. Non-limiting examples of sensors
suitable for incorporation into the device 100 include
potentiometers, accelerometers, linear variable differential
transformers (LVDTs), capacitive transducers, proximity sensors,
rotary encoders, piezo-electric transducers, and photodiode
arrays.
[0132] Those skilled in the art will appreciate that variations
from the specific embodiments disclosed above are contemplated by
the invention. The invention should not be restricted to the above
embodiments, but should be measured by the following claims.
* * * * *